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PATIENT MONITOR UM 300

MODELS: UM 300-10, UM 300-15, UM 300-20


Device: UМ 300 Patient Monitor

Classification: Class II b,

Regulation 10 of Annex IX of the Medical Device Directive 93/42/EEC

CE Marking:

Version #: 7.04
Date: July 2018
Software Ver.: 7R4X

This device is covered under one or more of patents as set forth at:
http://www.masimo.com/patents.htm

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Manufacturer's Responsibility

All information contained in this manual is believed to be correct. UTAS shall not
be liable for errors contained herein nor for incidental or consequential damages
in connection with the furnishing, performance, or use of this manual.

UTAS is responsible for safety, reliability and performance of this product only in
the condition that:

All installation operations, expansions, changes, modifications and repairs


of this product are conducted by UTAS authorized personnel;

This product is operated under strict observance of this manual.

Warranty

This warranty is exclusive and is in lieu of all other warranties, expressed or implied,
including warranties of merchantability or fitness for any particular purpose.

Exemptions

UTAS’s obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product
or the use of parts or accessories not approved by UTAS or repairs by people
other than UTAS authorized personnel.

This warranty shall not extend to

Any UTAS product which has been subjected to misuse, negligence or


accident;

Any UTAS product from which UTAS 's original serial number tag or product
identification markings have been altered or removed;

Any product of any other manufacturer.

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Contact Information

Manufacturer: UTAS Technologies s.r.o.

Address: Stavitelska, 1, 831 04 Bratislava,


Slovakia

Tel: (+421) 220 620 001


Fax: (+421) 220 620 002

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Preface

Manual Purpose

This manual contains the instructions necessary to operate the Patient Monitor
safely and in accordance with its function and intended use. Observance of this
manual is a prerequisite for proper product performance and correct operation
and ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents
may not apply to your monitor. If you have any question, please contact us.

This manual is an integral part of the product. It should always be kept close to
the equipment so that it can be obtained conveniently when needed.

Intended Audience

This manual is geared for clinical professionals who are expected to have a
working knowledge of medical procedures, practices and terminology as
required for monitoring of critically ill patients.

This operating Instruction provides the necessary information for proper operation
of the UM300 series Patient Monitor.

General knowledge of multiparametric vital signs monitoring and an


understanding of the features and functions of the UM300 Patient Monitor are
prerequisite for its proper use. Do not operate the Monitor without completely
reading and understanding the instructions in this manual

Illustrations

All illustrations in this manual serve as examples only. They may not necessarily
reflect your monitoring setup or data displayed on your patient monitor.

Note! Purchase or possession of this device does not carry any express or
implied license to use this device with replacement parts which
would, alone or in combination with this device, fall within the
scope of one of the patents relating to this device.

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TABLE OF CONTENTS
Equipment Symbols ........................................................................................................ 11
1 Introducing Patient Monitors UM-300 series ........................................................... 12
2 General specification............................................................................................... 14
2.1 GENERAL INFORMATION ...............................................................................................14
3 Specifications ............................................................................................................ 16
3.1 ECG..........................................................................................................................16
3.2 QTC-VIEW...................................................................................................................18
3.3 ST-SEGMENT ................................................................................................................18
3.4 ARRHYTHMIA ANALYSIS .................................................................................................18
3.5 ARRHYTHMIA EVENTS AND ST SEGMENTS RECORD ............................................................19
3.6 RESPIRATION RATE ........................................................................................................19
3.7 HEART RATE VARIABILITY ...............................................................................................19
3.8 HR .............................................................................................................................20
3.9 SPO2..........................................................................................................................20
Masimo SET SpO2 specifications 1234567 .................................................................. 20
Nellcor Oximax SpO2 specifications ...................................................................... 22
3.10 NIBP .......................................................................................................................22
3.11 IBP..........................................................................................................................24
3.12 TEMPERATURE ...........................................................................................................24
3.13 SIDESTREAM AND MAINSTREAM CO2 MONITORING ......................................................25
3.14 ANESTHETIC AGENTS (AAG) MONITORING ..................................................................25
3.15 CENTRAL HEMODYNAMIC PARAMETERS ......................................................................25
3.16 BIS INDEX.................................................................................................................26
3.17 IMPEDANCE CARDIOGRAPHY (ICG)..........................................................................26
3.18 DISPLAY ...................................................................................................................27
3.19 PRINTER (OPTION) .....................................................................................................27
3.20 POWER SUPPLY .........................................................................................................27
3.21 ALARMS...................................................................................................................28
3.22 PATIENT CARD .........................................................................................................28
3.23 TRENDS ....................................................................................................................28
3.24 RECORDS.................................................................................................................28
3.25 UNISCREEN TECHNOLOGY .........................................................................................29
3.26 OPERATION WITH THE CENTRAL MONITORING STATION ...................................................30
3.27 NAVIGATION ............................................................................................................30
3.28 NETWORK CONNECTIONS ..........................................................................................30
3.29 MONITOR MOUNTING................................................................................................30
3.30 ADDITIONAL .............................................................................................................30
4 Main parts and keys ................................................................................................. 31
4.1 FRONT PANEL ..............................................................................................................31
4.2 RIGHT SIDE PANEL.........................................................................................................32
4.3 LEFT SIDE PANEL ...........................................................................................................33
Universal connector UniPort .................................................................................. 34
4.4 REAR SIDE ...................................................................................................................38

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5 Information windows and display graphic symbols ............................................. 40
5.1 DISPLAY INFORMATION MODES .....................................................................................40
5.2 STANDARD DISPLAY MODE ...........................................................................................40
5.3 LARGE NUMBER DISPLAY MODE....................................................................................43
5.4 MINI TREND DISPLAY MODE........................................................................................44
5.5 «QTC-VIEW» WINDOW .................................................................................................45
5.6 TOUCH SCREEN LOCK MODE ........................................................................................46
5.7 BED-TO-BED VIEWER MODE ...........................................................................................47
5.8 “HR” WINDOW ...........................................................................................................49
5.9 “SPO2” WINDOW ........................................................................................................50
Masimo SET SpO2 technology................................................................................. 50
Nellcor Oximax SpO2 technology .......................................................................... 51
5.10 “NIBP” WINDOW .....................................................................................................51
5.11 “IBP” WINDOW ........................................................................................................52
5.12 “RR” WINDOW.........................................................................................................53
5.13 “TEMP” WINDOW .....................................................................................................53
5.14 “ETCO2” WINDOW ..................................................................................................54
5.15 THE GAS MODULE WINDOW “AAG”..........................................................................54
5.16 «BIS» WINDOW .........................................................................................................55
5.17 WINDOW “CENTRAL HEMODYNAMICS PARAMETERS” ...................................................56
5.18 IMPEDANCE CARDIOGRAPHY (ICG) ..........................................................................56
5.19 PICCO...................................................................................................................57
5.20 “AVERAGE QRS-COMPLEXES OF MONITORED ECG LEADS” WINDOW...........................58
5.21 “WAVE OF GAS CONCENTRATION/IMPEDANCE WAVE” WINDOW ..................................58
5.22 WINDOWS OF MEASUREMENT MODULES THAT HAVE DIFFERENT VIEW AND POSITION. .........59
5.23 WINDOW OF THE MAIN WAVEFORMS...........................................................................60
5.24 WINDOW OF 12 STANDARD ECG LEADS ....................................................................61
6 Menu Operation........................................................................................................ 62
6.1 GENERAL INSTRUCTIONS HOW TO WORK WITH MENU .......................................62
6.2 MENU “SETTINGS”........................................................................................................63
6.3 SUBMENU “SYSTEM SETTINGS” .......................................................................................65
6.4 SUBMENU “PROFILE” ....................................................................................................67
6.5 SUBMENU “HOT KEYS” .................................................................................................68
6.6 SUBMENU “PRINTER” (OPTIONAL) ..................................................................................69
6.7 SUBMENU “RECORDS” .................................................................................................71
6.8 SUBMENU “TRENDS” .....................................................................................................72
6.9 SUBMENU “MINI TREND”...............................................................................................73
6.10 SUBMENU “SOUND” ..................................................................................................74
6.11 SUBMENU “NETWORK SETUP” .....................................................................................75
6.12 SUBMENU “DATE AND TIME” ......................................................................................76
6.13 MENU “CHANNELS SETTINGS” ....................................................................................77
6.14 SUBMENU “ECG” ....................................................................................................78
6.15 SUBMENU “ST” .........................................................................................................79
6.16 SUBMENU “ARRHYTHMIA” ..........................................................................................80
6.17 SUBMENU “HR” ........................................................................................................81
6.18 SPO2 SETTINGS .........................................................................................................82
Masimo SET SpO2 settings ........................................................................................ 82

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Nellcor Oximax SpO2 settings ................................................................................. 84
6.19 SUBMENU “NIBP”.....................................................................................................85
6.20 SUBMENU “VENOUS PUNCTURE” (OPTIONAL) ..............................................................86
6.21 SUBMENU “TEMPERATURE” .........................................................................................87
6.22 SUBMENU “IBP” .......................................................................................................88
6.23 SUBMENU “THERMODILUTION”....................................................................................90
6.24 SUBMENU “ICG” .....................................................................................................91
6.25 SUBMENU “RESPIRATION” ..........................................................................................92
6.26 SUBMENU “CO2” .....................................................................................................93
6.27 SUBMENU “GAS MODULE”(AAG MODULE) ................................................................94
6.28 SUBMENU “BIS”........................................................................................................96
6.29 MENU “ALARMS” .....................................................................................................97
6.30 SUBMENU “ADVANCED” .........................................................................................101
6.31 MENU “PATIENT” ....................................................................................................102
6.32 MENU “APPLICATIONS” ..........................................................................................104
6.33 MENU “RECORDS LIST” ...........................................................................................105
6.34 SUBMENU “SHOW TRENDS” ......................................................................................108
6.35 SUBMENU “DRUG CALCULATOR” .............................................................................110
6.36 SUBMENU “OXYGENATION CALCULATIONS” .............................................................111
6.37 SUBMENU “VENTILATION CALCULATIONS” .................................................................113
6.38 SUBMENU “HEMODYNAMIC CALCULATIONS” ............................................................115
6.39 SUBMENU “AP 24H VARIABILITY” .............................................................................118
6.40 SUBMENU “HEART RATE VARIABILITY” (HRV) .............................................................118
6.41 MENU “OXYCARDIORESPIROGRAM” ........................................................................120
6.42 SUBMENU “COMMANDS .........................................................................................121
7 Printing (optional) ................................................................................................... 121
7.1 DIRECT PRINTING........................................................................................................121
7.2 PRINTING IN THE OPERATION MODES OF THE MONITOR ....................................................122
Printing in the “Freeze” mode .............................................................................. 122
Printing in the “RECORDS” mode ......................................................................... 122
Printing in the “TREND” mode ............................................................................... 122
7.3 RELOADING PAPER.....................................................................................................122
8 Monitoring ............................................................................................................... 123
8.1 ECG MONITORING ...................................................................................................123
ECG Monitoring for Adults .................................................................................... 123
ECG monitoring for neonates............................................................................... 124
Scheme of placement of a 3-Lead Wire ECG Cable (Einthoven's Triangle)... 125
Scheme of placement of the 5-Lead Wire ECG Cable .................................... 127
Scheme of placement of the 10- Lead Wire ECG Cable ................................. 128
Connecting the ECG cable to the monitor ........................................................ 129
ECG analysis for 12 leads ...................................................................................... 131
8.2 MONITORING ARRHYTHMIA ........................................................................................131
8.3 QTC INTERVAL MONITORING .......................................................................................132
8.4 MONITORING OF THE ST SEGMENT OFFSET .....................................................................133
8.5 MONITORING OF RESPIRATION RATE ............................................................................134
8.6 MONITORING OF SPO2 ..............................................................................................135
8.6.1 MASIMO SET SPO2 MONITORING .............................................................................135

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8.6.2 NELLCOR OXIMAX SPO2 MONITORING .....................................................................168
8.7 MONITORING OF NIBP...............................................................................................172
8.8 “VENOUS PUNCTURE” MODE.......................................................................................175
8.9 MONITORING OF TEMPERATURE ...................................................................................176
8.10 MONITORING OF IBP ..............................................................................................178
8.11 MONITORING OF CO2 ...........................................................................................183
8.12 SIDESTREAM CO2 MONITORING...............................................................................183
8.13 MONITORING OF СО2 CONTENT IN THE MAIN STREAM ...............................................185
8.14 MONITORING OF ANESTHETIC AGENTS (MAINSTREAM MODE) .......................................188
Alarms ..................................................................................................................... 189
Status of the IRMA multi-gas probe ..................................................................... 189
System assembly instruction ................................................................................. 189
Cleaning ................................................................................................................. 190
Preventive maintenance ...................................................................................... 190
Zeroing Procedure: ................................................................................................ 192
8.15 MONITORING OF ANESTHETIC AGENTS (SIDESTREAM MODE) .........................................195
Alarms ..................................................................................................................... 196
Status of the ISA multi-gas probe ......................................................................... 196
System assembly instruction ................................................................................. 197
Cleaning ................................................................................................................. 197
Replacement of sample line ................................................................................ 197
Pre-use check ........................................................................................................ 198
Preventive maintenance ...................................................................................... 198
8.16 MONITORING OF BISPECTRAL INDEX (BIS) .................................................................201
Technical Specifications ....................................................................................... 201
Safety precautions ................................................................................................ 201
Care and Cleaning ............................................................................................... 202
Operation procedure............................................................................................ 202
BISx monitoring ....................................................................................................... 205
BISx trends ............................................................................................................... 206
BISx Trend Data Screen ......................................................................................... 206
How the BISx Monitoring System Works ................................................................ 207
BISx and Patient Interface Cable ......................................................................... 207
BIS Sensors ............................................................................................................... 207
8.17 MEASUREMENT OF HEMODYNAMIC PARAMETERS USING THERMODILUTION .....................209
Thermodilution mode windows ............................................................................ 209
Setting up measurement: ..................................................................................... 212
Performing Measurements .................................................................................... 213
The Principle of PAWP measuring ..............Ошибка! Закладка не определена.
8.18 IMPEDANCE CARDIOGRAPHY MODULE (ICG) ...........................................................215
Precautions and limitations................................................................................... 216
Description of the module .................................................................................... 217
Performing a measurement.................................................................................. 218
Cleaning and disinfection .................................................................................... 221
9 Additional display MCM22 .................................................................................... 222
9.1 SPECIFICATION ..........................................................................................................222
9.2 FRONT AND LEFT SIDE PANELS .......................................................................................222
9.3 GENERAL DESCRIPTION ...............................................................................................222

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9.4 CONNECTION ...........................................................................................................223
9.5 CONFIGURATION .......................................................................................................223
10 Work in Central Station UNET............................................................................... 224
10.1 CENTRAL STATION STRUCTURE DIAGRAM....................................................................225
10.2 WEB VIEWER ..........................................................................................................225
11 Safety considerations and general instructions................................................ 227
11.1 TRANSPORTATION AND STORAGE ..............................................................................227
11.2 GENERAL INSTRUCTIONS ..........................................................................................227
11.3 INSTALLATION .........................................................................................................229
11.4 OPERATION............................................................................................................229
11.5 BATTERY OPERATION................................................................................................230
12 Cleaning and disinfection................................................................................... 231
12.1 GENERAL POINTS ....................................................................................................231
12.2 CLEANING .............................................................................................................231
12.3 DISINFECTION .........................................................................................................232
13 Maintenance and troubleshooting .................................................................... 232
14 Alarm and output messages .............................................................................. 235
14.1 VISUAL AND AUDIBLE ALARM INDICATION ..................................................................235
14.2 SWITCHING OFF ALARM ...........................................................................................237
15 Warranty ............................................................................................................... 239
Appendix A. List of displayed messages ................................................................... 240
Appendix B. Configurations of the monitor ................................................................ 249
Appendix C. Manufacturer's manual and declaration - electromagnetic emission250
Appendix D. Manufacturer's manual and declaration – noise immunity ............... 250
END-USER LICENSE AGREEMENT ................................................................................... 253
NOTES ............................................................................................................................. 254

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EQUIPMENT SYMBOLS

Wired
Serial Number
connection
Manufacture
SD card
date
Manufacture’s Wireless
address connection
Ukrainian Sound
approval mark Volume
System
CE marking
silenced

Settings Alarms

Mode of Patient
Monitoring – Bed-to-bed
Adult
Mode of Patient
Drug
Monitoring –
Calculator
Pediatric
Mode of Patient
Monitoring – Waveforms
Neonatal
Battery
Records list
indicator
Venous
Cardiac
Puncture
pacemaker
(option)
Application Print
Check BIS
Channels
sensor
Type CF applied part. Defibrillator-proof protection
against electric shock

II Protection class from electric shock

Attention! Check out the user's manual

Temperature conditions of transportation and usage

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1 INTRODUCING PATIENT MONITORS UM-300 SERIES
This manual contains the instructions necessary to operate the UM 300 patient
monitors

Caution! Familiarize yourself with all instructions including warnings and


cautions before starting to apply it on patients. Read and keep
the instructions about maintenance and cleaning of the
equipment.

The manual is applicable to the following UM 300 series Patient Monitors:


Patient Monitor UM 300 -10
Patient Monitor UM 300 -15
Patient Monitor UM 300 -20

The range of options depends on the configuration of the patient monitor.


UM300 is used (depending on configuration) for continuous monitoring of
patient’s vital signs of adult, pediatric and neonatal age categories, graphical
and digital data visualization and storage in non-volatile memory, getting
diagnostic data, printing out and exporting necessary information.

The device can operate with all age groups of patients in intensive and critical
care units, surgical rooms and emergency cars.
The patient monitor can operate from 100-250 V, 50/60Hz, built-in battery as well
as from a vehicle power supply with optional DC/AC inverter.

Main features:

Registration and monitoring of ECG using a 3, 5, 10-leads ECG cable;


Continuous automatic measurement of heart rate (HR) and pulse rate (PR)
of a patient with selectable source (ECG, SpO2, IBP, ICG, Auto);
Arrhythmia registration and automatic recording;
ST-segment monitoring;
Determination of heart rate variability (HRV);
Oxycardiorespirogramm (OxiCRG) recording and visualization;
Continuous automatic measurement of respiration rate (RR) by chest
impedance method with Reprogram (RG) visualization;
Oxygen saturation of arterial blood (SpO2) monitoring and
photoplethysmogram (PLE) visualization. Measurement technology - digital
circuit signal processing: Masimo SET or Nellcor Oximax;
Automatic monitoring of systolic, diastolic, mean arterial blood pressure
and pulse by oscillometric method (NIBP);
Continuous automatic monitoring of temperature (T);
Continuous automatic monitoring of invasive blood pressure (IBP);
Sidestream or mainstream СО2 monitoring in inspired/expired breathing
mixture;
Depth of anesthesia monitoring with BIS-index (BIS-module);

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Anesthetic Agent (AAg) module with sidestream or mainstream monitoring
of N2O, СО2, О2, Hal, Iso, Enf, Sev, Des concentration;
Central hemodynamic monitoring using invasive thermodilution
technology: Cardiac Output (C.O.), Stroke Volume (SV), Cardiac Index (CI),
Stroke Volume Index (SVI);
Continuous central hemodynamic monitoring using noninvasive technology
– impedance cardiography (ICG);
Neuromuscular transmission monitoring (NMT);
UniPort – universal connector modular technology for optional modules
connection;
Patient information management system;
Visualization of patient’s status on display and monitoring data export
and/or print;
Automatic or manual record of the data in graphic and digital form in the
non-volatile memory;
Storage of acquired data as trends (full disclose and mini trends) into
memory;
Alarm system of patient’s status and status of the monitoring system;
Control of the monitor via the context menu with a touch screen or a wheel
knob;
"Hot" access and programmable buttons for frequently used manipulation;
HDMI interface for connection of an external display for enhanced
visualization of patient data (UniScreen);
Simultaneous display of up to 13 real-time waveforms (for UM300-15 and
UM300-20);
Individual user profiles for screen customization;
Ability to connect to the hospital information network through a wired
(Ethernet) and wireless (Wi-Fi) LAN interface;
Manual and automatic adjustable display brightness;
SD-card, USB interfaces for service and data export purposes;
Availability of synchronization signal output for external devices;
Connectivity to nurse call system;
Bed-to-Bed viewer for checking status of other patients from the monitor;
Drug Calculator, Ventilation, Oxygenation and Hemodynamic Calculation
software tools;
Bed-to-Bed Viewer;
Web Viewer for remote access to patient vital data from mobile devices;
Defibrillator and electrosurgical instrument protection;

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2 GENERAL SPECIFICATION
2.1 General information
The device operates on AC line power 100-250V with a frequency 50/60 Hz or
internal battery.
Power consumption – 50 W

The monitors comply with requirements of the Medical Device Directive


93/42/EEC.
In addition, the product complies with:
IEC EN 60601-1:2015,
IEC EN 60601-1-2:2007,
IEC EN 60601-1-6:2010,
IEC EN 60601-1-8:2007,
IEC EN 60601-2-27:2014,
IEC EN 80601-2-30:2013,
IEC EN 60601-2-34:2011,
IEC EN 60601-2-49:2011;
IEC 62304:2006;
IEC 62366:2007
IEC 60068-2-64

Classification (according to IEC 60601-1) – Class I, Type CF, Continuous Operation

Dimensions and weight parameters


Dimensions, mm Weight, kg
UМ300-10 280 х 220 х 50 2.5
UМ300-15 390 х 320 х 50 5
UМ300-20 520 х 330 х 50 7.5

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Limits of monitored parameters:
HR 0-350 bpm
SpO2 0-100%;
RR 0-150 1/min
Temperature 0°С to +50°С
NIBP:
“Adult”, “Pediatric”:
Systolic 35 to 260 mmHg;
Diastolic 15 to 215 mmHg;
MAP 20 to 235 mmHg;
Pulse 30 to 240 bpm
“Neonatal”:
Systolic 35 to 135 mmHg;
Diastolic 15 to 105 mmHg;
MAP 20 to 115 mmHg;
Pulse 40 to 240 bpm
IBP -50 to +450 mmHg
СО2 from 0 to 20% or 0-150 mmHg
(СО2)
from 0 to 15% (AAg module)
N2O from 0 to 100%
O2 from 0 to 100%
Hal from 0 to 8%
Iso from 0 to 8%
Des from 0 to 22%
Enf from 0 to 8%
Sev from 0 to 10%
Cardiac Output (C.O.) 0,1-20 l/min
BIS- index 0-100
ST segment -2,5 - +2,5 mV

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3 SPECIFICATIONS
3.1 ECG
The device registers the following ECG leads:
I, II, III (3-leads cable);
I, II, III, aVR, aVL, aVF, V (5-leads cable);
dI, dII, dIII, daVL, daVR, daVF, dV1, dV2, dV3, dV4, dV5, dV6 (5-leads cable
– for optional derived 12 ECG - EASY ECG);
I, II, III, aVL, aVR, aVF, V1, V2, V3, V4, V5, V6 (10-leads cable – for standard
12 ECG leads).
Input signal range: 0.01 - 20 mV
Input signal offset: ± 500 mV
Internal voltage noise not more than 20 µV
Input impedance: >20 MOhm
ECG signal bandwidth: from 0.05 to 75 Hz
Sampling rate – 2000 Hz
CMRR – 100 dB
Anti-drift system
Adaptive digital filters 50/60 Hz
Visualization of chosen ECG-waveforms
Sensitivity 2,5; 5; 10; 20; 40 mm / mV, or AUTO (0,25; 0,5; 1; 2; 4 or Auto)
The relative sensitivity setting error: ± 5%
Sweep speed: 3.12; 6,25, 12,5; 25; and 50 mm/s
Heart rate Measurement range: from 0 to 350 bpm
Start of HR indication ~10 seconds
HR accuracy: ± 1 bmp
Full electrical isolation, defibrillation and coagulator protected
Response time of heart rate after defibrillation ~10 seconds
Protection against artifacts and electromagnetic interference
ECG modes: Surgical (0,4-20 Hz), Monitor (0,1-40 Hz), Diagnostic (0,05-75 Hz).
Output to synchronization with a defibrillator
The pacemaker signals detection with the following parameters:
amplitude of ± 2 to ± 700 mV;
duration of 0.1 to 2 ms
Electrode skin contact quality detection
Visualization: 7 ECG waveforms, 1 mV calibration, average QRS complexes
QRS-complex amplitude: from 0.25 to 5 mV
QRS-complex duration: from 25 to 200ms
UniPort 12-lead ECG Module for 10-wire ECG cable
During heart rate and respiration monitoring the system is automatically
changeover to an alternative ECG lead when current lead is not available for
registration.
Heart rate calculation algorithm is based on moving average method with
adaptive user-specified averaging time.
The maximum amplitude of the T wave, for heart rate measurement accuracy is
less than 1 mV, if aQRS <= aT <= 2 * aQRS, where aQRS - the amplitude of the
QRS-complex, aT - T-wave amplitude
The HR is updating on the display every 5 seconds, the heart rate averaging time
settings available in the HR menu.

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Figure 1 Alternating QRS complexes and ventricular tachycardia waveforms for
testing pattern recognition capability

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Caution! When 50/60Hz filter is activated, recovery time after an
overload may exceed 3 seconds.

3.2 Qtc-view
QTc is the ECG interval that begins at the QRS complex and ends at the end of
the T wave. It reflects the time required for the depolarization and repolarization
of the ventricular myocardium.
Method for calculating the QT interval correction: Bazett.
Ability to select lead: I, II, III, AVR, AVL, AVF, V.
Setting the ∆QTc alarm limits: 30 ms to 100 ms.
Setting the alarm limits Qtc: from 300 ms to 600 ms.
Manual record of the reference QTc segment
3.3 ST-segment
Integrated system of ST-segment analysis (simultaneously for all monitored leads)
Automatic detection and measurement after J point.
Manual adjustment of measurement point: from 20 to 80 ms and “Auto” after J
point.
Measurement units selection: millivolts (mV) or millimeter (mm)
Alarm range setting: from – 2.5 mV to +2.5 mV (from -25 mm to +25 mm)
ST-segment visualization on average QRS complexes in red color
3.4 Arrhythmia analysis
Integrated system of arrhythmia analysis, indication and automatic storage:
Fibrillation/flutter;
Sinus tachycardia;
Sinus bradycardia;
Tachycardia;
Bradycardia;
Extreme tachycardia;
Extreme bradycardia;
Sinus arrhythmia;
PAC (premature atrial (supraventricular) complexes);
PVC (premature ventricular complexes);
PAC trigeminy;
PVC trigeminy;
VF Ventricular fibrillation
frequent PAC;
frequent PVC;
PAC bigeminy;
PVC bigeminy;
Ventricular rhythm;
Twin PACs;
Twin PVCs;
Supraventricular tachycardia;
VT Ventricular tachycardia;
PVT Polymorphic ventricular tachycardia

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R-on-T PVC
Supraventricular paroxysmal tachycardia;
Ventricular paroxysmal tachycardia;
Asystole;
Pause.
3.5 Arrhythmia events and ST segments record
All events for ST segment alarms, and all events for of arrhythmias are
automatically recorded in the nonvolatile memory. The number of slots for record
is 16, record length is 8 seconds.

3.6 Respiration rate


Method: impedance measurements using ECG leads I or II (RL or RF electrodes)
Sweep speed: 3.12, 6.25; 12.5; 25; 50 mm/s
Gain: 1/4, 1/2, x1, x2, x4, x8, x16, and AUTO
Graphic and numeric visualization of RR
Sensitivity range: from 0.2 to 5 Ohm
Range: 0-150 1/min
Accuracy: ±1 1/min
The impedance range at 100 kHz from 50 Ohm to 50 kOhm
Amplifier bandwidth: from 0.05 to 4.0 Hz
The method of respiration rate averaging: moving average from 30 to 60 seconds
(depending on the breath rate)
Survey current value 500 µA at the frequency of 100 kHz
The relative error of the sweep rate: ± 10%
Apnea limits: 5-60 sec

3.7 Heart Rate Variability


Number of cardio cycles (NN) – quantity of RR intervals
Mean cardio cycle – length of mean cardio cycle
Mode – most frequently occurring value of cardio interval
Mode amplitude – number of cardio intervals corresponding to the mode value
SDNN – standard deviation of NN intervals
PNN 50% - NN50 count divided by the total number of all NN intervals
RMSSD – The square root of the mean squared differences of successive NN
intervals
VLF – power in the very low frequency range
LF – power in the low frequency range
HF – power in the high frequency range
LF/HF – ratio LF/HF
LFn – normalized capacity in the low frequency range
HFn - normalized capacity in the high frequency range
Total power – variance of all NN intervals
Spectrum (VLF – green, LF – red, HF – blue)
Variational range – Coefficient of variation of the full array of RR interval
IVE --index of vegetative balance
RVF – rhythm vegetative index

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IARP – indicator of the adequacy of regulatory processes
SI – index of tension of regulatory systems (by the R. Baevsky method)

3.8 HR
Calculation by method of moving average with user defined averaging time,
and instant beat to beat calculation.
HR visualization with indicating the source of the signal.
HR signal source: ECG, PLE, IBP, ICG, Auto
Range: from 0 to 350 bpm
Accuracy: ± 1 bpm
Averaging time from 5 to 60 seconds
Visualization refresh rate – 5 seconds
Displaying of high and low values of HR alarm
Visualization of HR alarm priority status
HR sound with silence option

3.9 SpO2
Method: non-invasive
Monitoring technology - digital circuit signal processing:
Masimo SET
Nellcor Oximax (optional)

Masimo SET SpO2 specifications 1234567


Range: 0-100%
Resolution: 1%
Accuracy during no motion condition:
± 2 digits (70-100% adults, pediatrics);
± 3 digits (70-100% neonates);
In range of 0% to 69% not specified.
Accuracy during motion condition:
± 3 digits (70-100% adults, pediatrics);
± 3 digits (70-100% neonates);
In range of 0% to 69% not specified.
Pulse rate range: 25-240 bpm
Pulse rate accuracy during no motion condition (adult, pediatric, neonates): ±3
digits
Pulse rate accuracy during motion condition (adult, pediatric, neonates): ±5 digits
PR resolution: 1 bpm
Average mode: 2, 4, 8, 10, 12, 14, 16 seconds
PLE scale mode /4, /2, ×1, ×2, ×4, ×8 or Auto
FastSAT mode ON/OFF
Smart Tone mode ON/OFF
SIQ curve ON/OFF
Automatic self-test when powered on
Automatic setting of default parameters
Adjustable volume audible pulse: OFF, 10% to 100%

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Alarm silence: 1, 2, 3, 5, 10, 15, all mute
Pulse rate out of limits alarm
SpO2 rate out of limits alarm
Perfusion index out of limits alarm
Audible Alarm Delay settings range 0, 5, 10, 15 seconds
SpO2 visualization selectable color (16 types)
Sensor condition alarm
Sensitivity: Normal, APOD, MAX
The sensitivity mode setting allows the clinician to adapt the SpO2 measurement
sensitivity to the patient’s level of SpO2 signal strength and quality at the
measurement site.
Normal Sensitivity is the recommended for patients who are experiencing
some compromise in blood flow or perfusion. It is advisable for care areas
where patients are observed frequently, such as the intensive care unit
(ICU).
Adaptive Probe Off Detection (APOD) Sensitivity is the recommended
sensitivity mode where there is a high probability of the sensor becoming
detached. It is also the suggested mode for care areas where patients are
not visually monitored continuously. This mode delivers enhanced
protection against erroneous pulse rate and arterial oxygen saturation
readings when a sensor becomes inadvertently detached from a patient
due to excessive movement.
Maximum Sensitivity (MAX) is recommended for use on patients with weak
signals (e.g. high ambient noise and/or patients with very low perfusion)
and for use during procedures or when clinician and patient contact is
continuous such as in higher acuity settings.
(1) The Masimo SET technology with Masimo sensors has been validated for no motion accuracy in human blood studies on healthy adult male
and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-
Oximeter and ECG monitor. This variation equals ±1standard deviation. Plus or minus one standard deviation encompasses 68% of the
population.
(2) The Masimo SET technology with Masimo sensors has been validated for motion accuracy in human blood studies on healthy adult male and
female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at
an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of
70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1 standard deviation, which encompasses 68% of
the population.
(3) The Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2™ simulator and
Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%.
This variation equals ±1 standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
(4) The Masimo SET Technology with Masimo Neo sensors has been validated for neonatal motion accuracy in human blood studies on healthy
adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions,
at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies
in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals ±1 standard deviation. Plus or minus
one standard deviation encompasses 68% of the population. 1% has been added to the results to account for the effects of fetal hemoglobin
present in neonates.
(5) The Masimo SET technology with Masimo sensors has been validated for pulse rate accuracy for the range of 25 -240 bpm in bench top testing
against a Biotek Index 2™ simulator. This variation equals ±1 standard deviation. Plus or minus one standard deviation encompasses 68% of
the population.
(6) Sensor accuracy specified when used with Masimo technology using a Masimo patient cable for LNOP sensors, RD SET sensors, the LNCS
sensors, or the M-LNCS sensors. Numbers represent Arms (RMS error compared to the reference). Because pulse oximeter measurements are
statistically distributed, only about two-thirds of the measurements can be expected to fall within a range of ± Arms compared to the reference
value. Unless otherwise noted, SpO2 accuracy is specified from 70% to 100%. Pulse Rate accuracy is specified from 25 to 240 bpm.
(7) Masimo M-LNCS, LNOP, RD SET, and LNCS sensors types have the same optical and electrical properties and may differ only in application
type (adhesive/non-adhesive/hook & loop), cable lengths, optical component locations (top or bottom of sensor as aligned with cable), adhesive
material type/size, and connector type (LNOP 8 pin modular plug, RD 15 pin modular plug, LNCS 9 pin, cable based, and M-LNCS 15 pin, cable
based). All sensor accuracy information and sensor application instructions are provided with the associated sensor directions for use.

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Nellcor Oximax SpO2 specifications
Range: 0-100%
Resolution: 1%
Accuracy:
± 2% (70-100%);
± 3% (40-70%);
In range of 1% to 40% not rated.
Pulse rate range: 0-350 bpm
PR resolution: 1 bpm
PR accuracy: ± 1 bpm
SpO2 values averaging periods for 10, 15, 20, 30 sec, respectively to HR averaging
settings
Beat to beat data refresh
Pulse sound tone modulation according to SpO2 level
Gain photoplethysmogram: /4, /2, x1, x2, x4, x8 or AUTO
Photoplethysmogram waveform and pulse amplitude visualization
Perfusion index from 0.02 to 20%
Sweep speed: 3.12, 6,25, 12.5, 25 and 50 mm/s
SpO2 response time ~ 10 seconds
The relative error of the sweep speed: ± 10%
SpO2 alarm limits visualization;
SpO2 alarm priority status visualization;
Oxycardiorespirogram (OxyCRG) visualization;
Full electrical isolation, defibrillation protected
Protection against artifacts and electromagnetic interference
Intelligent movement, tremor, electromagnetic and other artifacts elimination
system.
Neonatal, pediatric and adult, disposable or reusable sensors
SatSeconds intelligent alarm system (Nellcor Oximax only)

3.10 NIBP
Method: oscillometric with dual specification
The measurement is performed during cuff pressurization stage, until systolic blood
pressure level is reached, and the subsequent refinement of measurements with
gradual cuff depressurization with effective analysis of movement and other
artifacts.
Parameters: systolic, diastolic, mean pressure and pulse rate
Resolution: 1 mm Hg
Value: mmHg, kPa
Blood Pressure Measurement Range:
Adult:
Systolic 20 - 300 mmHg
Diastolic 10 - 240 mmHg
MAP 10 - 270 mmHg
Pulse 30 - 240 1/min
Pediatric:
Systolic 15 - 230 mmHg

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Diastolic 10 - 220 mmHg
MAP 10 - 220 mmHg
Pulse 30 - 240 1/min
Neonatal / Infant:
Systolic 10 - 150 mmHg
Diastolic 10 - 120 mmHg
MAP 10 - 120 mmHg
Pulse 40 - 240 1/min
Maximum cuff pressure range:
Neonatal from 0 to 150 mm Hg. (0-20 kPa)
Pediatric from 0 to 300 mm Hg. (0-40 kPa)
Adult from 0 to 300 mm Hg. (0-40 kPa)
The initial cuff inflation pressure is set automatically.
Absolute cuff pressure measuring error: ± 2 mm Hg.
Protection of the maximum pressure in the cuff:
Adult / Pediatric - 300 mmHg in native mode and the availability of backup
protection, according to IEC 60601-2-30-95;
Neonatal / Infant - 150 mmHg in native mode and the availability of
backup protection, according to IEC 60601-2-30-95.
Protecting - measurement time limit:
Adult / Pediatric - 180 seconds
Neonatal / Infant - 90 seconds
Alarm limits settings for Systolic, Diastolic and MAP
Visualization of:
systolic, diastolic, mean pressure and pulse rate;
measurement units;
operation mode;
time of the last measurement;
timer to next automatic measurement
current cuff pressure;
alarm priority status
messages about measurement errors.
Modes:
“Manual”;
“Auto” (with intervals from 1 to 480 min);
“STAT”;
“Venous puncture” (option).

Venous puncture mode settings


– Adult – pressure range 20-280 mmHg, time limit up to 90
seconds;
– Pediatric - pressure range 20-200 mmHg, time limit up to 90
seconds;
– Neonatal / Infant - pressure range 20-130 mmHg, time limit
up to 90 seconds;

Selectable visualization of measurement results from 1 to 3 groups indicating the


measurement time.

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Protection against artifacts and electromagnetic interference.
Automatic leakage test in the system.
Neonatal, pediatric and adult cuffs, one tube cuffs or double tube (option).
3.11 IBP
Method: invasive
Channels: 1, 2, 3, 4
Range: from -50 to +450 mmHg.
Resolution: 1 mmHg.
Accuracy: ± 1 mmHg (in range -50 to 99 mmHg), ± 1% (in range 100 to 450
mmHg)
Sensitivity: 5.0 μV/V/mmHg.
HR range: from 0 to 350 1/min.
HR accuracy: ± 2 1/min
Measurement modes are set by the user
Measurement of systolic, diastolic and mean pressure or mean pressure only.
Averaging time period and update the values of pressure on the screen:
an average from 5 to 60 seconds, depending on the HR.
Update: beat to beat.
Amplifier bandwidth: from 0 to 20 Hz
The relative error of the sweep rate: ± 10%
Zero balancing range: from -150 to +200 mmHg
The absolute error of zero balancing: less than ± 1 mm Hg
Ability to work with reusable sensors IAD MH960 firm Medex (Germany)
Compatible with disposable IBP transducers TruWave (Edwards Lifesciences), IAD
Combitrans (BBraun), and Becton Dickinson (BD) transducers.
The possibility of measuring low pressures, including negative pressures (CVP, etc.)
(up to negative 50 mmHg.)
IBP modes:
ART – arterial blood pressure;
FEM– femoral artery pressure;
PA – pulmonary artery pressure;
CVP – central venous pressure;
LA – left atrial pressure;
RA – right atrial pressure;
RV – right ventricular pressure;
LV – left ventricular pressure;
UAC – umbilical artery catheter*;
UVC – umbilical venous catheter*;
ICP – Intracranial pressure;

3.12 Temperature
Channels: 1 or 2.
Sensor type: YSI 400.
Range: from 0 to +50°С.
Accuracy: ± 0.1°C (34-44°С);
Sensors: skin, cavity.
Protection against artifacts and electromagnetic interference.

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The average period: 1 second
Calculating and displaying the temperature difference (2-channel).
Alarm for each channel temperature.
Temperature difference Alarm.
3.13 Sidestream and mainstream CO2 monitoring
Method: infrared absorption mainstream or sidestream
Measurement FiСО2 and EtСО2
Range: 0-20% or 0-150 mmHg.
Accuracy: ± 2 mmHg (0-40 mmHg).
Sweep speed: 3.12, 6.25; 12.5; 25; 50 mm/s.
The relative error of the sweep speed: ± 10%
Gas compensation: N2O, O2 and Des
Respiration rate: 0-150 1/min.
Units: % or mmHg.
Initialization Time:
capnogram displayed in less than 20 seconds, at an ambient temperature of 25°C;
full specifications within 2 minutes.
Water Resistance: IPX4 – Splash-proof (for mainstream – sensor head only; for
sidestream – when Sample Cell is inserted in Sample Cell receptacle)
Apnea Mode.
CO2 waveform visualization.
3.14 Anesthetic agents (AAg) monitoring
Method: infrared spectrometry mainstream or sidestream
Gases: СО2, N2O, Hal, Iso, Des, Enf, Sev.
Optional measurement of oxygen (O2) by using galvanic or paramagnetic
oxygen sensor.
Range:
O2: 0-100%;
СО2: 0-15%;
N2O: 0-100%;
Hal: 0-8%;
Iso: 0-8%;
Des: 0-22%;
Enf: 0-8%;
Sev: 0-10%.
3.15 Central Hemodynamic Parameters
Method: thermodilution.
Parameters:
“CO” (Cardiac Output);
“SV” (Stroke Volume);
“CI” (Cardiac Index);
“SVI” (Stroke Volume Index)
Bolus temperature
Blood temperature
∆T
Measurement modes of injection temperature:

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“Manual”;
“Automatic”.
Injection temperature: from 0.0 °С to +30.0 °С.
Injection volume: from 3 ml to 20 ml.
“CO” – from 0.1 to 20.0 l/min.
Accuracy ± 0.1 l/min or ±5%.
Visualization: “CO”, “SV”, “CI”, “SVI”, hemodynamic profile.
3.16 BIS Index
Depth estimate of anesthesia: combined treatment of EEG with the Bispectral
Index (BIS-index) measurement.
Bispectral Index (BIS): 0 to 100
Visualization of the BIS-index trends over time.
Bandwidth: 0.25 to 100 Hz (- 3dB)
Noise (EEG Waveform): < 0.3 μV RMS (2.0μV peak-to-peak)
Impedance Measurement Range: 0 to 999 kOhm
Signal quality index (SIQ): 0-100%
Electromyographic Strength (EMG): 25 to 100 dB (where 1μV = 40dB)
Burst Count (BC): 0 to 30
Suppression Ratio (SR): 0 to 100%
3.17 Impedance Cardiography (ICG)
Method: Impedance Cardiography, Bio-impedance, noninvasive, continuous
Signals: ICG

Parameters:
Heart Rate
Thoracic Fluid Content
Stroke Volume / Index
Cardiac Output
Systemic Vascular Resistance / Index
Oxygen Delivery Index

Range:
HR 40-250 1/ min
SV 0-250 ml
SVRI 0-8000 dyn・s・
cm-5・m2
SI 0-125 ml/m2
CO 0-30 l/min
TFC 5-150 1/kOhm
SVR 0-3500 dyn・s・
cm-5
DO2I 0-1500
ml/min/m2
Accuracy:
HR ±10 %
SV ±15 %
SVRI ±15 %

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SI ±15 %
CO ±15 %
TFC ±10 %
SVR ±15 %
DO2I ±15 %

3.18 Display
Size:
UМ-300 -10 - 25.4 cm (10'')
UМ-300 -15 - 38.1 cm (15'')
UМ-300 -20 - 50.8 cm (20'')
Type: color, TFT, bright, viewing angle 160°, touch screen.
Resolution:
UМ-300 -10 - 1280x800
UМ-300 -15 - 1366x768
UМ-300 -20 - 1920x1080
Number of displayed waveforms: up to 13 waveforms (ECG, plethysmogram,
Respiration waveform, IBP waves, EEG waves).
Simultaneous viewing all numeric parameters from 6 to 14.
Manual/automatic adjustable .
Freezing waveforms on the display screen for detailed analysis of waveforms
segments.
Waveforms speed: 3.12, 6.25, 12.5; 25; and 50 mm/s.
Parameters size, color, position customization are available.
3.19 Printer (option)
Paper width: 58 mm.
Speed: 12,5 mm/s; 25 mm/s; 50 mm/s.
Format: waves, diagrams, tables, digital.
Number of waveforms: from 1 to 3 waves.
Printing waveform segments (3 waves in a user-selected combination)
simultaneously with digital parameters.
Patient card printout on/off.
Millimeter grid printout on/off.
Trends printing: 4-720 hours.
Automatic printout on alarm event on/off
Automatic printout on arrhythmia event on/off
3.20 Power supply
AC line power 110-230 V, 50/60 Hz.
Battery line power: up to 2 hours of battery backup
External 12V DC power source with optional DC/AC converter 12V (10-16V).
When connected to AC line power, the battery is charged automatically.
Unlimited time of continuous operation on external power supply.

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3.21 Alarms
The monitor has multilevel audible and visual alarms of all monitored parameters,
condition of sensors and internal battery.
Adjustable alarm volume: user defined from 0% to 100% in increments of 10%.
Having the opportunity to modulation SpO2 pulse rate tones sound, regardless of
the volume audible alarm.
Ability to pause the audio alarm for 1, 2, 3, 5, 10, 15 minutes or for Next Event.
Alarms are divided:
according to categories: patient status alarm, system status alarm;
according to the type: visual (color difference, flashing status) and audible
(sound signal);
according to priorities: “Information”, “Advisory”, “Warning”, “Crisis”.

Automatic record of monitored data on alarm event.


Automatic report printout on alarm event.

3.22 Patient Card


Patient card for data input:
ID;
Name;
Hospital;
Department
Date of birth;
Sex;
Height;
Weight;
Age category
3.23 Trends
The monitor generates trends of all monitored parameters with a timestamp.
The trend can be viewed on the display and printed out;
The trend can be visualized in the Mini Trend additional window.
Trend length/resolution: 18h/15s, 36h/30s, 72h/60s, 144h/2min, 360h/5min,
720h/10min.
MiniTrend length: 30, 60,120 minutes with resolution of 1s.
Trends sampling rate: graphical and tabular trends with sampling of 15 s, 30 s, 1, 2,
5 min, 10 min.
3.24 Records
Nonvolatile memory allows storing segments of ECG, PLE, IBP and respiration
waveform in order to view them and print out.
The number of Records, no less than 100 events (external memory card MicroSD).
Modes: automatic and manual, by alarm.

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3.25 UniScreen Technology
This technology optimizes clinical visualization by sharing waveforms and digital
parameters on two independent displays in order to eliminate possible
compromises in visualization priority that usually linked with screen size. Each
screen can be individually adjusted according to clinical needs:

Arrange optimization of data layout for easy control and readout.


Control, monitored/calculated parameters grouping.
Make information more visually comprehensible using different methods of
graphic visualization on each screen.
Easy trends/history/records/data analysis and monitoring settings without
hiding important live monitoring data.

Connection interface – HDMI


Secondary screen resolution – 1920х1080
Secondary screen diagonal limit – not limited

Note! Additional screen is not main screen repeater (slave), the


visualization settings of the second screen is configured separately
from the main screen. Duplication is possible for training purpose by
activation REPEAT settings in the "Screen 2" menu.

Figure 2
Each screen individually configurable, data layout customization is possible in
basic configuration.

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3.26 Operation with the central monitoring station
Number of monitors: up to 32.
Interfaces: Ethernet (LAN), Wi-Fi (WLAN).
The monitor settings can be changed from the central station.
Required quantity of the UM 300 monitors to be displayed can be selected from
the list of all connected patient monitors.
Operation with 2 displays when 32 monitors are connected.
Simultaneous visualization of the data received from 16 bedside patient monitors
on one display.
Real-time displaying of all parameters (depends on the monitor configuration)
received from the monitors and waveforms – no less than 2 waves for one monitor
in case of combined monitoring and up to 9 waves for one selected monitor.
Saving selected information into the database – 20 sec ECG segments and 72
hours of trends.
Continuous recording (length up to 72 hours) of 9 waveforms for each monitor
into the database.
Automatic detection (along with automatic saving 20 sec ECG segments into the
database) of arrhythmia type and heart rate abnormality.
Automatic detection and displaying of ST-segment.
Automatic registration, displaying and storage of events and alarms (at least 1000
events for each monitor).
Input, editing and saving patient data.
Records, trends, settings data import from each monitor. Statistical processing of
trend records.
Data printout on laser or thermal printers.
3.27 Navigation
Touch screen
Encoder
Programmable buttons.
3.28 Network connections
Connection to PC by Ethernet.
Connecting to Central Station by Ethernet or Wi-Fi.
3.29 Monitor mounting
The device can be mounted on the wall, medical rail, vertical tube or pendant
using the VESA 75 compatible mounting adaptor.
3.30 Additional
UniScreen external monitor for data sharing/copy (HDMI).
ECG sync output for defibrillator (option).
Memory card slot (Micro SD).
The ambient light sensor (option).
Nurse call interface (option).
Drug calculator.
Ventilation, Oxygenation, Hemodynamic Calculation
Up to 12 user profiles.

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4 MAIN PARTS AND KEYS
4.1 Front panel

Figure 3

On the front panel of the monitor there is a company logo and a name of the
model of monitor

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4.2 Right side panel
On the right side of the monitor measuring channels connectors and wheel knob
are placed.

Figure 4

Above each connector there is the name of the measurement channel. Your
monitor may have not all the connectors shown in this figure, or may have
additional ones, depending on the ordered model.

On the right side of the panel (figure is above) are located:


1. Wheel knob;
2. Universal “UniPort” connectors for additional modules;
3. Connector for capnography (CO2) sensor;
4. Connector for pulse oximetry (SpO2) sensor;
5. Connectors for temperature channels*;
6. Connector for ECG cable;
7. Pneumatic connector of NIBP channel.

* In monitors with one temperature channel there is only one connector for the
temperature sensor, which is located on the place of the connector "TEMP1" and
called "TEMP".

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Note! The following measuring modules can be connected to the
universal UniPort connector: 12-channel ECG module, multi-gas
module, invasive pressure measurement module (up to 4
channels), FiO2 measurement module, module for measuring
central hemodynamics parameters by thermodilution method,
impedance cardiography module, anesthesia depth measurement
module according to BIS technology, the NMT neuromuscular
conduction module, thermal printer module.

4.3 Left side panel

Figure 5

On the left side of the monitor (figure is above) the following elements are
placed:
1. ON/OFF button;
2. External Wi-Fi antenna
3. Micro SD card slot;
4. Network connector Ethernet LAN;
5. HDMI Output for connecting an external monitor;
6. 2xUSB connectors;
7. AC power connector;

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Universal connector UniPort
The UniPort universal connector technology allows to configure the monitor
directly near the patient's bed by connecting additional modules that are
necessary in the current clinical situation.
All additional functions could be connected simply by attaching the appropriate
module-in-cable (module-in-cable) to any UniPort connector on the patient
monitor (see figure below).
All connected modules are recognized automatically and the monitor screen is
automatically reconfigured to visualize new parameters (plug-and-play).

Figure 6

An extended set of monitored parameters is provided by connecting the


following UniPort modules:

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Figure 7

IBP module (up to 4 channels)

12-Channel ECG module

Multi-gas module: (CO2 O2, CO2,


N2O Hal, Iso, Enf, Sev, Des);

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Module for monitoring the depth of
anesthesia using BIS technology;

Module for measuring cardiac output


by thermodilution method;

Module for monitoring the


parameters of central hemodynamics
using impedance cardiography
method;

Module of monitoring the degree of


suppression of neuromuscular
conduction (NMT)

Module of UniPort channels number


extension - UniPort Hub

External thermal printer module

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Characteristics of connecting cables

Length,
№ Name Designation not more Note
than m
1 General power cable 230V XINI A-D VW-1 80 oC 300V 20 AWG 5 Unshielded

2 Interface cable Tons international Ltd. 2 Unshielded

3 ECG Cable ECG.CAB.01 4 Unshielded

4 SpO2 Cable PLS.USPO2.16 2 Unshielded

5 Temperature probe ТЕМ.SEN.01 3 Unshielded

6 IBP Cable IBP.XCB.02 4 Unshielded

Note: The use of other cables is PROHIBITED and may cause mismatch of equipment with safety and
EMC requirements.

Attention! When using the monitor it is necessary to take into account special
EMC precautions. The monitor must be installed and put into operation in
accordance with the information on the EMC, which is specified in the
accompanying documentation.

Attention! When using the monitor, it is necessary to take into account the
influence of mobile radio-frequency devices on the safe and adequate
functioning of the monitor.

Attention! The monitor should not be used in close proximity to other


equipment. If it is necessary to use them in close proximity, the normal
operation of the monitor should be checked in the configuration that will be
used during operation.

Attention! Connecting cables and accessories which are not included in the
delivery may cause a negative effect on the monitor's EMC characteristics.

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4.4 Rear side

Figure 8

On the rear panel of the monitor there is a metal plate 120 × 120 mm, which is
intended for mounting the device (VESA 75 standard).
Together with monitor could be supplied such mounting devices:
1. Mounting on a vertical pipe:

Figure 9

2. Mounting on a mobile trolley:

Figure 10

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3. Mounting on the wall.

Figure 11

4. Mounting on a medical rail

Figure 12

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5 INFORMATION WINDOWS AND DISPLAY GRAPHIC SYMBOLS
5.1 Display Information Modes
All modifications of UM-300 monitors have two display modes "Standard" and
"Large numbers". To select the display mode, go to the "Screen Mode" submenu
of the "Settings" menu and select the desired mode.
5.2 Standard Display Mode

Figure 13

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Figure 14

1. System message line;


2. Visualization of determination of pacemaker pulses”;
3. Full name of the patient;
4. Patient mode;
5. "SD card" symbol;
6. Connection to the data exchange network;
7. Battery charge indication”;
8. General level of sound alarm”;
9. Time indication;
10. Window “HR”;
11. Window “SpO2”;
12. Window “NIBP”;
13. Window “IBP1/2”;
14. Window “IBP3/4”;
15. Window “Central hemodynamics parameters”
16. Window “T1/T2”;
17. Window “O2”;
18. Window “BR”;
19. Navigation menu line
20. Programmable buttons;
21. Arrhythmia analysis*;
22. Scale of curves sensitivity;
23. Window of main curves;
24. Window and trend “BIS”;
25. Window “Mini trend”;
26. Window “Gas Module”;
27. Window "Averaged QRS-complexes";

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28. Window "Gas concentration curve, impedance curve" (selected
between BR, CO2, O2, N2O and AAg);
29. Display element associated with the status of the ECG channel setting;
30. ECG signal quality indicator;
31. ECG filter mode;
32. Sweep speed of displaying curves;
33. Fast access buttons on the monitor screen.

Note! When ECG signal quality level is less than 40%, the arrhythmia
analysis is not carried out!
When the BIS module is on, only 4 curves are displayed on the UM-
300. You can choose from:(PLE,PLE-SIQ, I, II, III, aVL, aVR, aVF, V1,
V2, V3, V4, V5, V6, EEG1, EEG2, IBP1, IBP2 ).
The "Averaged QRS" window is displayed on the place of the BIS
module when it is turned off.
When the BIS module and the Averaged QRS are on, only 1 curve
is displayed on the UM-300 screen. You can choose from: (PLE, I, II,
III, aVL, aVR, aVF, V1, V2, V3, V4, V5, V6, EEG1, EEG2, IBP1, IBP2).
Only one "Additional Window" is available for displaying -
"Averaged QRS" or "Mini Trend".

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5.3 Large Number Display Mode

Figure 15

In the "Large numbers" mode, only 1 chosen curve is displayed on the screen (PLE,
PLE-SIQ, I, II, III, aVL, aVR, aVF, V1, V2, V3, V4, V5, V6, EEG1, EEG2, IBP1, IBP2).
A mini-trend window can be activated next to the curve.

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5.4 Mini TREND Display Mode

Figure 16

When the "Mini Trend" mode is enabled, user can select the mini-trends to be
displayed on the screen.

Duration of the Mini Trend can be configured in the menu "Settings" / "System
Settings" / "Mini Trend" menu and can be set: 30min, 1 hour or 2 hours. Resolution
of Mini Trends is - 1 sec.

User can select up to 6 parameters for simultaneous displaying in the Mini Trend
windows.

Mini Trend windows are located next to the monitor curves and do not overlap
them.

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5.5 «Qtc-view» window

3 4 7 8
1 2 5 6

12 11 10
9

Figure 17

The window displays:


1. Name of monitored parameter ("Qtc-view");
2. Graphical representation of the interval QT;
3. Status of alarm at the top and bottom level of QTc (see "Alarm indication
and sound");
4. Row of values of Qtc (current and reference);
5. Status of signaling of changing ΔQTc (see "Alarm indication and sound");
6. Row of values of ΔQtc (current and reference);
7. Column of current values;
8. Column of reference values;
9. Displaying the calculation method;
10. Row of QT values;
11. Row of time values QT;
12. Date and time of setting of the base segment

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5.6 Touch Screen Lock mode

Figure 18

Use the Encoder to lock Touch Screen. Press and hold the Encoder for 3 sec. After
that, a window with the proposed commands appears on the screen:
When Touch Screen is locked, you could select 4 command:
Screen - return to main screen;
Alarm - block the alarm for a set time;
NIBP – START/STOP NIBP in manual mode
Lock/Unlock – Lock/Unlock the Touch Screen

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5.7 Bed-to-bed Viewer mode
When several monitors work on the same local network, it is possible to view the
patient's graphic and digital data from one monitor to on another. In one
window, you can view data on the vital status of several patients at once (up to
32 patients).

Figure 19

The UM300 monitor has the ability to view each patient separately - graphical
curves and digital values (option).

Figure 20

All alarms from monitors which are located in the same local network using the
Bed-to-Bed function can be displayed on another monitor display.

In this window, such system messages of inter-bed monitoring can also be


displayed:

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1. "No network".

2. "No server".

3. "Connecting ...".

4. "Data downloading".

System message area 1. 1. In this area, the system messages of the device
are displayed. Such as:
2. 2. "Printer: no paper" - when trying to activate
printing without installed paper in the printer
compartment;
3. 3. "Recording" - at the moment when the curve
segments are stored in the device memory, when the
"Record" button is pressed;
4. 4. "Charge the battery" - when the battery is low;
5. 5. "IWR signal is detected" - when an artificial
pacemaker impulse is detected.

«Demo» Symbol Displays when demo mode is on


Symbol "Connected to the data Displays when the monitor is connected to the
exchange network" central station.

"Record" Symbol Displayed while recording the current curves


into the non-volatile memory of the monitor.

Symbol "General sound alarm is Displays when the sound alarm is disabled by
off" the user for 1 to 15 minutes or until the Next
event, while the countdown timer is displayed
under the icon (until the sound alarm turns on
automatically). When the sound alarm is
completely turned off via the "Alarm" submenu
(the "GENERAL SIGNAL ALARM" item is set to

"OFF"), there will be a symbol:

Battery charge indicator symbol Constantly displayed as a symbol of battery


At the same time, the battery charge level
is shown schematically by the "fullness" of the
battery symbol. At a critical decrease of the
battery charge, the symbol turns red.

"Patient mode" Indication


– «Adult»

– «Pediatric»
– «Neonatal»

When the "Neonatal" mode is activated, data

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for all measuring channels are processed by
specially developed programs for more
accurate and safe measurement of the
parameters of newborns.

Time indication Time is displayed, which is set through submenu


"Date and Time"
Symbol "Determination of It is displayed if patient has a pacemaker and
pacemaker pulses" the function "Determining the pacemaker" is
enabled

"SD card" Symbol Displayed when an SD card is activated in the


monitor
5.8 “HR” window

Figure 21

The following values are displayed in the “HR” window:

1. Name of monitored parameter (HR);


2. HR source (ECG, PLE, IBP any of 4 possible channels);
3. Visual pulse indication;
4. Status of HR sound alarm;
5. HR value (big green numbers);
6. Visualization of alarm limits of the HR with the indication of the upper and
lower limits (numerical values);
7. Name of monitored parameter (ST);
8. The name of the ECG lead that displays the ST segment displacement
("V"),;
9. The digital value of the ST segment displacement;
10. Status of sound alarm by ST-rise and ST-depression;
11. Name of the monitored parameter ("PVC");
12. Number of recorded violations of the rhythm of the heart per minute
(ventricular extrasystoles) (the value is displayed in red);
13. Status of the sound alarm according to the PVC.

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5.9 “SpO2” window
Masimo SET SpO2 technology
1 2 3 4 5 6

10

Figure 22

The following values are displayed in the “SpO2” window:

1. Name of monitored parameter (SpO2);


2. SpO2 value determined by plethysmogram;
3. Channel status message
4. Status of SpO2 sound alarm;
5. Monitored parameter (Pulse rate);
6. Pulse rate value;
7. SIQ status;
8. Sensitivity settings;
9. Perfusion index (PI) value;
10. Upper and lower limits of SpO2 alarm;

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Nellcor Oximax SpO2 technology

Figure 23

The window displays:

1. Name of monitored parameter (SpO2);


2. SpO2 value determined by plethysmogram;
3. Status of SpO2 sound alarm;
4. Graphical column indicating upper and lower limits of SpO2 alarm
(numeric form);
5. Name of monitored parameter (Pulse rate);
6. Pulse rate value (numeric form);
7. SatSecondsTM Limit indicator;

5.10 “NIBP” window

Figure 24

The window displays:

1. Monitored parameter (NIBP);


2. Units of measurement (mmHg);
3. Value of systolic arterial blood pressure;
4. Value of diastolic arterial blood pressure;
5. Value of mean arterial blood pressure;

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6. Status of NIBP sound alarm;
7. Time of last measurement;
8. Mode of NIBP measurement: "Manual", when the automatic NIBP
measurement mode "Automatic" is activated, the message "AUTO" is
displayed, in the continuous mode - message "STAT";
9. Timer (in AUTO mode - the countdown will be until next measurement, in
STAT mode - countdown will be 5 minutes);
10. Name of monitored parameter (pulse), value and units of measure
(bpm);
11. Current pressure in the cuff.

5.11 “IBP” window

Figure 25

The window displays:

1. Name of monitored parameter (“IBP1”);


2. Diastolic pressure;
3. Systolic pressure;
4. Mean pressure;
5. Monitored pressure mode (set by user):
“ART” – arterial blood pressure;
“FEM” – femoral arterial pressure;
“PA” – pulmonary artery pressure;
“CVP” – central venous pressure;
“LA” – left atrial pressure;
“RA” – right atrial pressure;
“RV” – right ventricular pressure;
“LV” – left ventricular pressure;
ICP - intracranial pressure
6. Status of sound alarm channel IBP1;
7. Status of sound alarm channel IBP2;
8. Name of monitored parameter (“IBP2”);
9. Chanel status.

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Note! When monitoring CVP, LA, RA, RV, LV, ICP the average blood
pressure value is displayed.

When measuring thermodilution using a Swan-Hans catheter, the pulmonary


artery wedge pressure or pulmonary capillary wedge pressure (PCVP) is
measured - the pressure recorded in the distal pulmonary artery branch with an
bloated balloon. This pressure is considered as an equal to the pressure in the left
atrium (LA).
5.12 “RR” window

Figure 26

The window displays:

1. Name of monitored parameter (RR);


2. Numerical value of RR ;
3. Source of RR values (ECG (lead I or II) or CO2 with turned on
capnometry channel );
4. Status of sound alarm.
5.13 “Temp” window

Figure 27

The window displays:


1. Name of monitored parameter (“TEMP”);
2. Numeric value of T1;
3. Numeric value of T2;
4. Short title of temperature difference and the value of temperature
difference (Δ);
5. Temp units (ºC or F);
6. Status of sound alarm.

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5.14 “ETCO2” window

Figure 28

The window displays:

1. Name of monitored parameter (EtCO2);


2. Numerical value of EtCO2 ;
3. Name of monitored parameter (FiCO2);
4. Numerical value of FiCO2;
5. Units of measurement (mmHg or %);
6. Status of sound alarm;
5.15 The Gas Module window “AAg”

Figure 29

The window displays:


1. Name of the window (AAg Module);
2. Symbol of nitrous oxide (N2O);
3. N2O concentration in Inhaled air;
4. N2O concentration in exhaled air;
5. N2O Status of sound alarm;
6. Indication of anesthetic agent (Halothane (Hal), Isoflurane (Iso),
Enflurane (Enf), Sevoflurane (Sev), Desflurane (Des));
7. Concentration of inhalation anesthetic vapor on expiration (In this
example, desflurane);
8. Concentration of inhalation anesthetic vapor on inspiration;
9. Status of sound alarm according to the values of inhalation anesthetic;
10. Symbol of Oxygen “O2”;
11. O2 concentration during inspiration;
12. O2 concentration during expiration (if the option is available);
13. Status of O2 sound alarm;

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14. Indication “MAC” ();
15. Numerical value of “MAC”.

Note! If the gas module detects a second anesthetic in the gas


mixture, then in a corresponding column of gas module
window there will be shown name and a concentration value
of the first and second anesthetic by turn.

5.16 «BIS» window

Figure 30

The window displays:


1. Name of monitored parameter (BIS)
2. Level of Signal Quality Indicator (SQI)
3. Numerical value of BIS
4. Name of monitored parameter (level of CNS depression) (SR)
5. Numerical value of SR
6. Units of measurement (%)
7. Name of monitored parameter (Number of EEG bursts) (BC)
8. Name of monitored parameter (EMG)
9. Level of Electromyograph activity (EMG)
10. Status of BIS sound alarm

When the BIS module is working, the status of the channel is displayed in the status
bar.

As the number of EEG bursts (BC) is an alternative method of


quantitative depression, in the case of poor signal quality or
Note!
depression level below 5% this parameter will not be
displayed on the monitor screen.

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5.17 Window “Central hemodynamics parameters”

Figure 31
The window displays:

1. Name of monitored parameter (CO) (minute blood volume or cardiac


output);
2. Numerical value of CO;
3. Name of monitored parameter (SV) (shock ejection);
4. Numerical value of SV;
5. Name of monitored parameter (CI) (cardiac index);
6. Numerical value of CI;
7. Name of monitored parameter (SVI) (shock index);
8. Numerical value of SVI;
9. Time of the last measurement.
5.18 Impedance cardiography (ICG)

Figure 32

The window displays:


1. Name of monitored parameter (CO) (cardiac output);
2. Index of signal quality;
3. Name of monitored parameter (SV) (stroke volume);
4. Numerical value of SV;
5. Name of monitored parameter (SVR) (Systemic vascular resistance);
6. Numerical value of SVR;
7. Name of monitored parameter (TFC) (Thoracic fluid content);
8. Numerical value of TFC;
9. Numerical value of CO;

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5.19 PiCCO

Figure 33

The window displays:

1. Name of monitored parameter (PCCI) (the index of cardiac output


pulse);
2. PCCI units (l/min/m2);
3. Numerical value of PCCI;
4. Name of monitored parameter (GEDI - global end diastolic volume
index);
5. GEDI units (ml/m2);
6. Numerical value of GEDI;
7. Name of Monitored parameter (SVV - stroke volume variation);
8. SVV units (%);
9. Numerical value of SVV;
10. Name of monitored parameter (ELWI - extravascular lung water
index);
11. ELWI units (ml/kg);
12. Numerical value of ELWI.

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5.20 “Average QRS-complexes of monitored ECG leads” window

Figure 34

The window displays:


1. Name of monitored parameter Average QRS;
2. Average values of ST-segments in the corresponding leads.;
3. ECG interval from J point to the point of ST-segment, marked by red
color;
4. The value of the ST segment offset relatively to the isoline (in mV or
mm);
5. ST-segment sound alarm status.

5.21 “Wave of gas concentration/impedance wave” window

Figure 35

The window displays:

1. Coefficient of gain (scale);


2. Waveform of breathing (the color depends on monitored parameter);
3. Sweep speed of the wave;
4. Monitored parameter (concentration/gas partial pressure/ vapor of anesthetic
inhalation or thoracic impedance).

Note! The breathing waveform (respirogram) is always visualized at the


bottom of the screen

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5.22 Windows of measurement modules that have different view and
position.

Windows are placed one after another, downwards and to the left (below NIBP
window) in the following sequence (if one of the measurement channels is
absent, there is no a corresponding window as well):

Window Window description


IBP When there is one IBP channel in the monitor - “IBP” window is
displayed, if there are two IBP channels - two windows are
IBP1+IBP2
displayed: “IBP1” and “IBP2”.
The "RR" window is displayed in all monitor models
RR
“EtCO2” window is displayed in monitors with СО2 and multi-gas
channel, when СО2 or multi-gas channel is switched on (СО2
EtCO2
channel automatically switches on, when multi-gas option is
activated)
Multi-Gas “Multi-Gas” window is displayed only in monitors with multi-gas
module option.
Temp When there is one temperature channel, “Temp” window is
Temp1+2 displayed. If there are two temperature channels, windows
Temp2 “Temp1” and “Temp2” are displayed, except for the monitor
Temp1 with multi-gas option, where the window “Temp1+2” is displayed.
In the "wave of the gas concentration / impedance wave"
The wave of window the impedance wave HR is displayed, when the CO2
the gas and gas module are off. Capnogram is displayed when the CO2
concentration channel is on. When the gas module is on, displayed wave can
/ impedance be selected from the sub-menu "CO2 and Gas module ", the
wave wave changes its color depending on the gas: CO2, O2, N2O,
and Controlled inhalation anesthetic.

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5.23 Window of the main waveforms

Figure 36

The window displays:

1. Indication of “Arrhythmia Analysis”;


2. Status of sound alarm;
3. ECG channel sensitivity scale;
4. Indication of displayed waves (I, II III, V, AVR, AVL);
5. Main curves (ECG, PLE, IBP (IBP1 and/or IBP2), EEG1, EEG2 );
6. ECG sensitivity scale;
7. Monitoring mode.

Warning! Detected arrhythmia type will have red color below the
indication “Arrhythmia Analysis” during 10 seconds since
registration.

Displayed IBP curve is possible to zoom: ("Off", "0-20" "0-50", "0-


100" "0-150" "0-200" "0-250" mmHg), as well as with the optimal
scale at which the scale is automatically determined

Note! Curves can be displayed in several modes: non-inertial and


fixed (stop on the screen).

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5.24 Window of 12 standard ECG leads

Figure 37

The window displays the following values:

1. Indication of “Arrhythmia Analysis” function activity;


2. Status of sound alarm;
3. ECG sensitivity scale;
4. Main ECG waves (I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6);
5. Indication of current ECG filter mode;
6. Sweep speed of the wave.

Note! This ECG wave display mode only shows ECG waves.

If derived 12 lead ECGs are displayed, waves are displayed with a


prefix «d»:
(dI, dII, dIII, dAVR, dAVL, dAVF, dV1, dV2, dV3, dV4, dV5, dV6)

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6 MENU OPERATION
The present chapter describes how to operate the menu (main menu and
submenu).
6.1 GENERAL INSTRUCTIONS HOW TO WORK WITH MENU
The structure of the main menu and submenus depends on the model of the
monitor, and there may be no menu items and submenus responsible for measuring
channels unavailable in your monitor model, but described in this chapter.
Pressing the wheel knob activates the navigation menu bar at the bottom of the
display, which contains main menu items. You can also activate the navigation bar
using the touch screen. You just need to touch the desired button on the screen.
With the help of the touch screen, it is also possible to activate channels, simply by
clicking on the required channel window on the display.

Figure 38

To activate the item in the main menu structure, using the buttons on the main unit,
you have to rotate the MANIPULATOR BUTTON to place the cursor (highlighted in
gray color ) on the desired item in the main menu ("Settings", "Patient", etc.) and to
push the MANIPULATOR BUTTON - the submenu of the selected item will be displayed
on the screen.
To Exit from the menu you have to press the "MAIN SCREEN" button on the monitor's
quick access panel or to press the button « » or « » to return to the previous menu.
Selecting a submenu item (after opening the main menu window) is performed by
rotating the MANIPULATOR BUTTON or by pressing the corresponding area of the
touch screen. To change the variable value of the submenu item you can rotate the
MANIPULATOR-BUTTON or use the touch screen (with activated the submenu item ).
The structure of submenu items is described below.

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6.2 Menu “Settings”

Figure 39

In this menu you can select and change the following parameters displayed on
the screen:
Display mode Is used to select the display mode (“Standard” or “Large
Numbers”)

Display ECG only Displaying only ECG in the main waveforms window:
("On" (Standard 12 ECG waves), "Off" (from 1 to 7 ECG
waves)).
Traces 1-7 Is used for selection of waveforms that are displayed on the
screen (ECG leads, photoplethysmography, curve of IBP,
measured by invasive method and EGG wave (name of the
option is changed against the corresponding signal);

Trace number Selection the quantity of waveforms displayed on the screen


(from 2 and up to 7) or 12 EGG waveforms optionally.

Line width Changing the width of lines of graphical information (1 or 2


dots)

Sweep speed Change a sweep speed of ECG waveforms (3.12, 6.25, 12.5,
25 and 50 mm/s)

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Scrolling Switching on / off the flexible information display mode ("On",
"Off")

Colors Is used for changing colors of channels (“brown”, “coral”,


“cyan”, “gold”, “green”, “indigo”, “magenta”, “maroon”,
“navy”, “olive”, “orange”, “pink”, “red”, “teal”, “violet”,
“yellow” or “colors by default”)

Bright Is used for changing the display brightness according to


ambient light in automatic or manual mode (AUTO, 0% to
100%)

Add. Window Is used for displaying one additional window (“Off”,


“Averaged QRS”, “Mini Trend”).

Language Setting the menu language and monitored parameters);

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6.3 Submenu “System Settings”

Figure 40

In this menu you can select and change the following parameters displayed on
the screen:
Demo Switching Demo mode of monitor (“On”, “Off”);

Profile Selection of user profile to save user settings, hospital


and factory settings of the measured parameters (12
profiles). To reset user settings for each profile, go to the
"System settings" submenu and then select "Default
settings". In this case, resetting settings for each profile
will be carried out individually.

Hot Keys This submenu is used to program 3 buttons on the


monitor screen for quick access (“Button1”, “Button2”,
“Button3”);

Printer Activates the menu item “Printer” (optional);

Records Activates the menu item “Records”;

Trends Activates the menu item “Trends”;

Mini Trend Activates the menu item “Mini TREND”;

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Sound Activates the menu item”Sound”;

Network Setup Allows to configure the connection parameters for


connecting to a central station or to a network of
monitors;

Date and Time Activates the menu item “Date and Time”;

Filter Inclusion of one selectable network filter ("50 Hz", "60


Hz");

Standby Allows to switch the monitor into a standby mode on a


user-defined time ( "Off", "1 min", "2 min", "5 min");

Encoder Is used for changing Encoder sensitivity (“Low”,


Sensitivity “Medium”, “High”);

LED QRS Enabling / disabling the QRS light cycle indicator lamp
indicator (optional).

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6.4 Submenu “Profile”

Figure 41

In this menu you can select and change the following parameters displayed on
the screen:
Profile Selection of user profile to save user settings, factory
settings, hospital settings of the measured parameters
(12 profiles).

Name Enter the profile name into the memory of the monitor:

Default Settings Setting parameters of monitor in Default (“Factory”,


“User”, “Hospital”)

Set default Setting the default settings at the user's choice


settings

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6.5 Submenu “Hot Keys”

Figure 42

This submenu is used for programming 3 buttons or 4 buttons (optional) on the


monitor screen:
Button 1, Setting the selection of any function from the provided
Button 2, list:
Button 3

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6.6 Submenu “Printer” (optional)

Figure 43

In this menu you can select and change the following parameters displayed on
the screen:
Auto print Setting “ON”, “Off” auto print when (when alarm is on);
(Alarm)
Auto print Setting “ON”, “Off” auto print (when arrhythmia is detected);
(Arrhythmia)

Line Width Setting printer line width (1, 2);

Print intensity Setting printer intensity level (Low, Medium, High);

Trace1, Selecting the first waveform printed on the thermal paper: ECG
Trace2, leads (“І”, “ІІ”, “ІІІ”, “AVR”, “AVL”, “AVF”, “V1-V6”),
Trace3 photoplethysmogram (“PLE”), IBP waveform (“IBP1”, “IBP2”),
EEG1, EEG2;

Trace Number Selecting number of traces (1-3);

Print Speed Setting print speed of information, that is printed on the thermal
paper (12.5, 25 or 50 mm/s);

Record Length , Setting the length of record printout on the thermal paper

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cm (from 10 to 50 cm);

Length of Trends, Setting length of trend printout on the thermal paper (from 4 to
h 360 hours).

Grid Enables “ON” or disables “OFF” the millimeter grid printing. Use
this function for paper without millimeter grid only.

Patient Card Print Setting patient card printing ("On", "Off").

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6.7 Submenu “Records”

Figure 44

In this menu you can select and change the following parameters displayed on
the screen:
Auto record Switching on/off Auto record (ALARM) (“On”, “Off”);
(ALARM)

Auto record Switching on/off Auto record (Arrhythmia) (“On”, “Off”);


(Arrhythmia)

Traces 1...7 Is used for selection waveforms that are displayed on


the screen (ECG leads, photoplethysmography, wave
of blood pressure, measured by invasive method and
EGG wave (name of the option is changed against the
corresponding signal);

Trace number Selection the quantity of recorded waveforms (from 2


and up to 5);

Sweep Speed Setting sweep speed of ECG waves (12.5, 25 or 50


mm/s);

If you need to save a fragment of the electrocardiogram, plethysmogram and


the invasive pressure curve in manual mode, you should press the "RECORD"

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button on the quick access panel. In this case, the 7 main curves obtained within
15 seconds before pressing the "RECORD" button will be saved in the monitor
memory with the time of recording.

Monitor saves wave curves in the automatic mode, when arrhythmias appear (if
there are no key presses on the display for 2 minutes).

To view saved records, use the "Records" submenu in the "Applications" menu.

In the internal nonvolatile memory of the monitor, you can save 24 records. 25th
record will be recorded instead of the first, and so on.

When using an external memory card (micro SD), you can save from 100 records
of the same duration, the maximum number of possible records on the SD card
depends on the capacity of SD card. If an external memory card is used, all
records and trends will be stored on the external memory card.

6.8 Submenu “Trends”

Figure 45

In this menu you can select and change the following parameters displayed on
the screen:

Trend interval Is used for choosing trend interval (18h /15 sec; 36h /30

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sec; 72h /1 min; 144h /2 min; 360h /5 min or 720h /10
min);

Trend Clearing Clears all the trends in all user profiles;

6.9 Submenu “Mini Trend”

Figure 46

In this menu you can select and change the following parameters displayed on
the screen:
Duration Is used for choosing duration for mini trend (30 min, 1,
2h);

Parameter 1-6 Is used for displaying chosen parameter on the screen


(HR, SpO2, Temp, NIBP, IBP, RR, ST I, ST II, ST III, ST AVR, ST
AVL, ST AVF, ST V, Arrhythmia, CO2, BIS )

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6.10 Submenu “Sound”

Figure 47

In this menu you can select and change the following parameters displayed on
the screen:
Crisis Alarm Is used for changing sound of crisis alarm volume (10-
Volume 100% with a step of 10%)

Warning Alarm Is used for changing sound of warning alarm volume (10-
Volume 100% with a step of 10%)

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Caution Alarm Is used for changing sound of caution alarm volume (10-
Volume 100% with a step of 10%)

Pulse Volume Is used for changing sound of pulse volume (10-100% with
a step of 10%)

Keyboard Is used for changing sound of keyboard volume (Off, 10-


Volume 100%)

6.11 Submenu “Network Setup”

Figure 48

In this menu you can select and change the following parameters displayed on
the screen:

Bed # Selection of the Bed Number (this settings must be unique for
each monitor in the ward);

Station Settings of the connection status to the central station ON/OFF;

Station URL Setting parameters of IP address of the Central Station;

Bed2Bed Settings of the connection status to the Bed2Bed Server ON/OFF

Bed2Bed URL Setting parameters of IP address of the Bed2Bed Server;

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6.12 Submenu “Date and Time”

Figure 49

In this menu you can select and change the following parameters displayed on
the screen:
Date Setting the current date, the category "Day" (numerical value);

Month Setting the current date, the category "Month" (numerical


value);

Year Setting the current date, the category "Year" (numerical value);

Hour Setting the current time, the category "Hour" (numerical value);

Minute Setting the current time, the category "Minute" (numerical


value);

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6.13 Menu “Channels Settings”

Figure 50

This submenu is used to set the operation parameters of all channels. The
availability of channels depends on the model of the UM-300 monitor and the
number of connected UniPort modules:

ECG;
ST;
Arrhythmia;
HR;
SpO2;
NIBP;
Venous Puncture
Temperature;
IBP1;
IBP2;
Thermodilution;
Respiration;
CO2;
Gas Module;
BIS;
ICG;
NMT;

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6.14 Submenu “ECG”

Figure 51

In this menu you can select and change the following parameters displayed on
the screen:
ECG Switching on/off ECG channel (“Off”, “1-7 leads”;
“Derived12”, “Standard 12”);
Sweep Speed Setting parameters of sweep speed: (3,12; 6,25; 12,5;
25; and 50 mm/s);
Sensitivity Setting sensitivity parameters of ECG signal (5, 10, 20
and 40 mm/mV, AUTO or × 0.125, × 0.25, × 0.5, × 1, × 2,
× 4, AUTO););
Filter Mode Setting operation mode of ECG channel: (“Surgery”,
“Monitor”, “Diagnostic”);

Mains Filter Switching on/off 50 Hz mains filter (“50 Hz”, “Off”,


“Adaptive 50 Hz”);
Pacemaker Detection Switching on/off pacemaker analysis (“On”, “Off”);
Contact Checking Switching on/off control of contact quality (“On”,
“Off”);
ECG color Is used for changing ECG channel color;
ECG Switching on/off ECG channel (“Off”, “1-7 leads”;
“Derived12”, “Standart 12”);

ECG electrodes Activates a window for checking actual contact

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check quality ( in %) of each ECG electrode with patient’s
skin;

QTc lead Serves to select the lead for interval QTc analysis
(I,II,III,AVR,AVL,AVF,V)

ΔQTc Alarm Is used to set the alarm limit for the parameter
"ΔQTc" (from 30 to 100 [ms]) and to enable / disable
the alarm detection and notification channel of
displacement detection channel ΔQTc ("Off", "Info",
"Warning", "Danger", "Crisis")
Is used to set the alarm limit for the QTc parameter (from
QTc Alarm 300 to 600 [ms]) and to enable / disable the alarm system
and to alert of upper and lower limits of the QTc ("Off",
"Info", "Warning", "Danger", "Crisis")

QTc: set baseline Manual setting of the reference QTc segment.

6.15 Submenu “ST”

Figure 52

In this menu you can select and change the following parameters displayed on
the screen:
Average QRS Enabling / disabling the option of determining the averaged QRS-
complexes ("On" or "Off");

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J+ Setting a point of ST offset: distance from J point (“Auto”, 20,
40, 60, 80 ms);
ST unit Is used to set the units of measurement for the ST offset ("mm" or
"mV");
ST rise Is used to set the alarm limit for the "ST rise" parameter (from 0.00
alarm, mV / mm to 2.50) and to turn on / off the alarm system and to notify the ST
» segment offset detection channel ("Off", "Informational", "Warning",
"Danger", "Crisis" ):
ST depression Is used to set the alarm limit for the "ST depression" parameter
alarm, mV / mm (from -2.50 to 0.00) and to turn on / off the alarm system and to
notify the ST segment offset detection channel ("Off",
"Informational", "Warning", "Danger", "Crisis" ):

6.16 Submenu “Arrhythmia”

Figure 53

In this menu you can select and change the following parameters displayed on
the screen:

Arrhythmia Switching on/off automatic Arrhythmia analysis (“On”, “Off”).


Arrhythmia Switching on/off Arrhythmia Alarm, setting the priority of the
Alarm "Arrhythmia" option (“Off”, “Info”, Advisory”, “Warning”,
“Crisis”).
Auto Record Setting on/off Auto Record of Arrhythmia analysis (“On”,
(Arrhythmia) “Off”).
Auto Print Setting on/off Auto Print of Arrhythmia analysis (“On”, “Off”).
(Arrhythmia)
PVC Alarm Setting upper limit of premature ventricular complex (PVC)
alarm per minute (from 1 to 100) and switching on/off PVC
alarm (“Off”, ”Info”, “Advisory”, “Warning”, “Crisis”).

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6.17 Submenu “HR”

Figure 54

In this menu you can select and change the following parameters displayed on
the screen:
HR Source Selection of Heart Rate source (“ECG”, “PLE”, “IBP1, “IBP2” or
“Auto”);
HR Averaged Is used to change time period of heart rate (HR) averaging
Time (10 sec, 15 sec, 20 sec, 30 sec);

HR Alarm Setting the upper and lower limits of the alarm system and the
measurement channel notification (Upper - from 5 to 350,
Lower - from 0 to 345). Enabling/disabling alarm system and
notification of the heart rate channel ("Off", "Info", "Warning",
"Danger", "Crisis").
HR color Is used to select the color of the values on the heart rate
channel

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6.18 SpO2 Settings
Masimo SET SpO2 settings

Figure 55

In this menu you can select and change the following parameters displayed on
the screen:

SpO2 Switching on/off SpO2 measurement channel (“On”, “Off”);

Scale Choosing the scale of gain for plethysmograph waveform


(“/4”, “/2“, ×1”, “×2”, “×4”, “×8” or “Auto”);

SpO2 Averaging The user-selectable averaging feature allows the clinician to


Time select the desired level of visibility to subtle variations in the
measured value. Selectable Settings (seconds) (“2-4”, “4-6”,
“8”, “10”, “12” “14”, “16”);

Alarm Delay This option allows the user to establish a user-selectable delay
in the audible alarm after an SpO2 alarm threshold has been
breached. Selectable Settings (seconds) (“0”, “5”, “10”, “15”).
The delay only affects audible alarms for SpO2 – and yet does
not delay the on-screen, visual indication of an SpO2 alarm
limit violation. The purpose of this setting is to allow clinicians
to minimize audible alarms in care settings where such
transitory, non-actionable desaturations exist;

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Sensitivity Mode The sensitivity mode setting allows the clinician to adapt the
SpO2 measurement sensitivity to the patient’s level of SpO2
signal strength and quality at the measurement site.
Selectable Settings (“Normal”, “APOD”, “MAX”)

FastSAT FastSat enables rapid response to, and display of, fast
changes in SpO2 by giving priority to the most recent data.
Selectable Settings (“ON”, “OFF”);

Smart Tone Smart Tone effects pulse beep and allows a pulse beep to
continue even when the pleth waveform is corrupt due to
motion. When Smart Tone is off, the pulse beep is suppressed
during signs of motion. Selectable Settings (“ON”, “OFF”)

SIQ Settings of SIQ waveform visualization under the PLE, which


shows the acquired measurement confidence and timing of
each detected pulse relative to the pleth. The height of
vertical lines indicate the relative confidence of the
measurement (higher vertical lines - higher confidence)
Selectable Settings (“ON”, “OFF”)

SpO2 alarm Setting of the upper and lower limits of the "SpO2"
measurement channel alarm (Upper - from 2% to 99% OFF,
Lower - from 1% to 98%). Enabling/disabling alarm system and
notification of the measuring channel "SpO2" ("Off", "Info",
"Warning", "Danger", "Crisis").

SpO2 PI alarm Setting of the upper and lower limits of the Perfusion Index (PI)
alarm (Upper - from 0.04% to 19%, Lower - from 0.03% to 18%).
Enabling/disabling alarm system and notification of the
Perfusion Index (PI) alarm ("Off", "Info", "Warning", "Danger",
"Crisis").

SpO2 color Is used to select the color of the values on the SpO2 channel

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Nellcor Oximax SpO2 settings

Figure 56

In this menu you can select and change the following parameters displayed on
the screen:

SpO2 Switching on/off SpO2 measurement channel (“On”, “Off”);


Scale Choosing the scale of gain for SpO2 channel (“/4”, “/2“, ×1”,
“×2”, “×4”, “×8” or “Auto”);
SatSeconds Limit Setting limits of SatSeconds (“Off”, “10”, “25”, “50”, “100”);
SpO2 Alarm Setting of the upper and lower limits of the "SpO2"
measurement channel alarm (Upper - from 1 to 100, Lower -
from 0 to 99). Enabling/disabling alarm system and
notification of the measuring channel "SpO2" ("Off", "Info",
"Warning", "Danger", "Crisis").

SpO2 color Is used to select the color of the values on the


plethysmographic waveform

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6.19 Submenu “NIBP”

Figure 57
In this menu you can select and change the following parameters displayed on
the screen:

NIBP Mode Setting measurement mode of arterial blood pressure


(Manual, Auto, STAT);
NIBP Cycle Setting the interval for automatic measurement mode of
arterial blood pressure (from 1 to 480 min);
NIBP units Selection of the NIBP dimension values(“mmHg”, “kPa”);

NIBP SYS Alarm, Setting upper (from 5 to 300) and lower (from 0 to 295) limits of
mmHg/kPa systolic NIBP pressure alarm and switching on/off NIBP SYS
alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);
NIBP DIA Alarm, Setting upper (from 5 to 300) and lower (from 0 to 295) limits of
mmHg/kPa diastolic pressure NIBP alarm (from 5 to 300) and switching
on/off NIBP DIA alarm (“Off”, “Info”, “Advisory”, “Warning”,
“Crisis”);
NIBP MAP Setting upper (from 5 to 300) and lower (from 0 to 295) limits of
Alarm, averaged pressure NIBP alarm (from 5 to 300) and switching
mmHg/kPa on/off NIBP MAP alarm (“Off”, “Info”, “Advisory”, “Warning”,
“Crisis”);

NIBP color Is used to select the color of the values on the NIBP channel.

NIBP Start/Stop Is used to initiate or to cancel NIBP measurement

Start Venous Is used to initiate or to cancel venous puncture procedure


puncture

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6.20 Submenu “Venous Puncture” (optional)

Figure 58

This submenu sets parameters of the "Venous Puncture" mode, which is used to
block peripheral blood circulation during venipuncture:

Venous Puncture Switching On/Off Venous Puncture Mode (“On”, “Off”).


Mode

Pressure Level Setting pressure level in the compression cuff which will be
enough for temporarily block of a peripheral blood circulation
during venous puncture measurement (from 20 to 280
mmHg).

When “Venous Puncture” mode on, Monitor displays window " Venous Puncture "
instead of NIBP window with countdown timer for the automatic venting of air in
the cuff (see “Venous Puncture” mode).

To start the procedure of venous puncture, you need to click on "NIBP start/stop"
button on the front panel of Monitor. In this case Monitor will set the present level
of pressure in the compression cuff.
Bleeding off an air from the cuff will start automatically, but no later than in 90,
120 and 180 seconds (for modes - "Neonatal", "Pediatric" and "Adult"), or before
the expiration of that time when you click on "NIBP start/stop" button.

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6.21 Submenu “Temperature”

Figure 59

In this menu you can select and change the following parameters displayed on
the screen:
Temperature1 Switching on/off Temperature1/2 channels (“On”, “Off”);
(TEMP1),
Temperature2
(TEMP2)
Temperature Units Setting temperature dimension (“ºС” or “F”);

Temperature, ºС/F Setting upper limit (from 0.1 to 45.0 ºС), lower limit (from 0.0
Alarm to 49.9 ºС) of Temperature measurement channel and
switching on/off Temperature Alarm (“Off”, “Info”,
“Advisory”, “Warning”, “Crisis”);

ΔT, ºС/F Alarm Setting ΔT limit (from 0.3 to 5.0) and switching on/off ΔT
Alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);

Temp color Is used to select the color of the values on the Temperature
channel.

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6.22 Submenu “IBP”

Figure 60

This submenu sets parameters for the blood pressure measurement channel by an
invasive method (IBP1)
IBP1 Mode Switching on and selection the area of measurement,
switching off IBP1 channel (“Off”, “ART”, “FEM”, “PA”, “CVP”,
“LA”, “RA”, “RV”, “LV”, “ICP”).

IBP1 Scale Switching On/Off IBP1 wave scaling (“0-20”, “0-50”, “0-100”,
“0-150”, “0-200”, “0-250”, “-50-250*”, “Off”);

IBP1 Set optimum Setting optimum IBP1 wave scale (“70-140*”);


scale

IBP1 SYS Alarm, Setting upper (from -45 to +450 mmHg) and lower limit (from -
mmHg/ kPa 50 to +445 mmHg) of systolic pressure IBP1 Alarm. Switching
on/off IBP1 SYS Alarm (“Off”, “Info”, “Advisory”, “Warning”,
“Crisis”);

IBP1 MAP Alarm Setting upper (from -45 to +450 mmHg) and lower limit of
averaged pressure IBP1 Alarm (from – 50 to +445 mmHg).
Switching on/off IBP1 MAP Alarm (“Off”, “Info”, “Advisory”,
“Warning”, “Crisis”);

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IBP1 DIA Alarm Setting upper (from -45 to +450 mmHg) and lower limit of
diastolic pressure IBP1 Alarm (from – 50 to +445 mmHg).
Switching on/off IBP1 DIA Alarm (“Off”, “Info”, “Advisory”,
“Warning”, “Crisis”);

IBP1 IBP2 When the mode is on, the display monitor displays IBP1 and
Overlapping IBP2 curves, overlapped on each other;

IBP color Is used to select the color of the values on the IBP channel.

IBP1 Zeroing IBP sensors will be calibrated, when this option is activated.

IBP1 Filter Mode Switching on and selection the filter mode (“Diagnostic”,
“Monitor”)

Note! If a monitor has only one IBP channel, than in the IBP submenu
there will be items only for a one IBP channel. You can have up
to 4 IBP channels.

Warning! Displaying the IBP curve is possible with a visualized scaling ("Off", "0-
20", "0-50", "0-100", "0-150", "0-200", "0-250"), and also by using the
optimal scale.
Changes in the scale of the IBP curve can be accompanied by a
shift of the curve upward to other curves. In this case, you must
select the optimal scale.

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6.23 Submenu “Thermodilution”

Figure 61

This submenu sets parameters of measuring the parameters of central


hemodynamics:

Volume, ml Setting the value of the volume of the injected bolus


(from 3 to 20 ml);

Temp, ºC Setting the value of bolus temperature;

BSA, m2 Setting the value of the patient body area, according


to the input data of height and weight based on the
Gehan and George formulas. You can also enter
manually calculated value. If you enter calculated
values of the area, in the windows, "Height" and
"Weight" Monitor will display asterisks instead of
numerical values;

Height, m Setting the value of patient height;

Weight, kg Setting the value of patient weight;

Comp. constant Setting the value of computing constant (indicated in


the accompanying documentation to the Swan-Ganz
catheter);

Apply Application of user-defined parameters.

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6.24 Submenu “ICG”

Figure 62

In this submenu, you can view additional calculation parameters when measuring
the parameters of central hemodynamics using the ICG method.

To increase the accuracy of calculations, you have to enter the following


parameters:
CVP -- Central venous pressure;
PAWP -- Pulmonary artery wedge pressure;
Hgb – hemoglobin;
weight and height of the patient in the patient's card;
to carry out NIBP measurements;
to check SpO2 indications

Calculated parameters:
HR – heart rate;
SV – stroke volume;
SVR -- Systemic vascular resistance;
SVRI -- Systemic Vascular Resistance Index
SI -- Stroke Volume Index;
CO -- cardiac output;
TFC -- Thoracic fluid content;
DO2I -- Oxygen Delivery Index

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6.25 Submenu “Respiration”

Figure 63

This submenu sets parameters for the respiration rate measurement channel (RR):

Respiration Switching on/off RR channel (“On”, “Off”);


Speed Selection of RR Speed value (3.12, 6.25, 12.5; 25; 50 mm/s.);
Scale Scaling value of impedance respiratory waveform — respirogram ("/
4", "/ 2", "× 0.5", "× 1", "× 2", "× 4", "× 8", "× 16", "× 32", "× 64 ","
AUTO ");
Lead Lead selection for RR measuring (“Auto” “I” “II”), (“Auto” –
selecting “II” (preferable) or “I” lead depending on
electrodes contact;
RR Alarm Setting Upper limit (from 1 to 150) and Lower limit (from 0 to 149) of
RR Alarm and switching on/off RR Alarm (“Off”, “Info” “Advisory”,
“Warning”, “Crisis”);
APNEA Delay Setting apnea time interval (from 5 to 60 sec with a step of 5
sec) of alarm at detection of apnea and switching on/off
Alarm
Apnea Alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);

RR color Is used to select the color of the values on the RR channel.

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6.26 Submenu “CO2”

Figure 64

This submenu sets parameters for measuring CO2 concentration:


CO2 Switching on/off “СО2” channel (“On”, “Off”);

Speed Selection of CO2 wave speed value (3.12, 6.25, 12.5, 25, 50
mm/s.);

CO2 Units Is used for choosing CO2 measurement units (mmHg or %);

CO2 Wave Selecting СО2 waveform scale range (25, 50, 100, 200 mmHg;
Scale 2.5, 5, 10, 20 %);

EtCO2 Alarm Setting upper (from 1 mmHg to 150 mmHg; from 0,1 % to 20 %)
and lower limits of EtСО2 alarm (from 0 mmHg to 149 mmHg;
from 0% to19.9 %). Switching on/off EtCO2 Alarm (“Off”, “Info”,
“Warning”, “Advisory”, “Crisis”);

O2 Setting oxygen concentration (0-100) for compensation the


compensation effect of O2 on CO2 value;

Balance gas Setting gas balance (air, N2O, He);

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AAg Setting AAg concentration (0.0-20.0) for compensation the
Compensation effect of AAg on CO2 value;

Atm.Pressure, Selecting the current atmospheric pressure (400-850 mmHg);


mmHg

APNEA Delay Choosing Apnea Delay parameters at APNEA detection (from 5


to 60 with a step of 5 sec.). Switching on/off APNEA Alarm (“Off”,
“Info”, “Warning”, “Advisory”, “Crisis”);

CO2 color Is used to select the color of the values on the CO2 channel.

CO2 Zeroing Calibration of СО2 module. Setting "0" of the CO2 channel
6.27 Submenu “Gas module”(AAg Module)

Figure 65

In this menu you can select and change the following parameters of Gas
Module:
GAS Module, CO2 Switching on/off “GAS Module” channel (“On”, “Off”)

CO2 Switching on/off “CO2” channel (“On”, “Off”)

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Speed Setting the sweep speed of Gas Module wave value (3.12,
6.25, 12.5, 25, 50 mm/s.).
AAg Waveform Scaling of the AAg waveform (2.5, 5, 10, 20%).
Scale

Select Curve Selection of the Curve from: (CO2, N2O, AAg, O2 ).

Multi AAg Alarm Switching on/off Alarms of the Gas Module (“Off”, “Info”
“Advisory”, “Warning”, “Crisis”).
AAg Alarm Setting Upper (from 2.1 to 15) and Lower (from 2.0 to 14.9)
AAg (Gas Module) Alarms. Switching on/off AAg Alarms
(“Off”, “Info”, “Advisory”, “Warning”, “Crisis”).

O2 Alarm Setting Upper (from 20 to 100) and the Lower (from 18 to 198)
limits of the O2 channel alarm. Switching on/off O2 channel
alarm("Off", "Info", "Advisory", "Warning", "Crisis").
N2O Alarm Setting Upper (from 18 to 100) and the Lower (from 16 to 98)
limits of the N2O channel alarm. Switching on/off N20 channel
alarm("Off", "Info", "Advisory", "Warning", "Crisis").

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6.28 Submenu “BIS”

Figure 66

In this menu you can select and change the following parameters displayed on
the screen:
BIS Switching on/off BIS module (“On”, “Off”);

BIS Alarm Setting Upper (from 4 to 100) and Lower limits of BIS
Alarm (from 3 to 99). Switching on/off BIS Alarm (“Off”,
“Info”, “Advisory”, “Warning”, “Crisis”);

Filters Switching on/off EEG filtration system (“On”, “Off”);

Smoothing Rate Settings of EEG Smoothing Rate mode (10s/15s/30s);

Scale EEG Scaling EEG wave (25uV/50uV);

Additional trend Choosing Additional trend for displaying («Off », «EMG»,


«SR», «SQI»);

Impedance Switching on/off Impedance checking (“On”, “Off”).

Checking BIS Switching on/off BIS Sensor checking (“Show”, “Hide”).


sensor

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6.29 Menu “Alarms”

Figure 67

Figure 68

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Figure 69

This menu is used to set the priority level parameters for each of the monitored
parameters or to turn off the alarm system:

Audible Alarm Switching on/off audible alarm (“On”, “Off”);

HR Setting Upper (from 1 to 350) and lower limits (from 0 to 345)


of HR Alarm. Switching on/off or selecting priority level of HR
Mode Alarm: “Off”; “Info”; “Advisory”; “Warning”; “Crisis”;

ST Elevation Setting limits (from 0.00 to 2.50) of ST Elevation, Alarm.


Switching on/off or selecting priority level of ST Elevation
Alarm: “Off”; “Info”; “Advisory”; “Warning”; “Crisis”;

ST Depression Setting limits (from -2.50 to 0.00) of ST Depression, Alarm.


Switching on/off or selecting priority level of ST Depression
Alarm: “Off”; “Info”; “Advisory”; “Warning”; “Crisis”;

SpO2 Setting Upper (from 1 to 100) and lower Limits (from 0 to 99) of
SpO2 Alarm. Switching on/off or selecting priority level of SpO2
Mode Alarm: “Off”; “Info”; “Advisory”; “Warning”; “Crisis”;
NIBP SYS Setting Upper (from 5 to 300) and Lower (from 0 to 295) limits
of systolic arterial pressure NIBP alarm and switching on/off
NIBP SYS alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);

NIBP DIA Setting Upper (from 5 to 300) and Lower (from 0 to 295) limits
of diastolic arterial pressure NIBP alarm and switching on/off
NIBP DIA alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);

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NIBP MAP Setting Upper (from 5 to 300) and Lower (from 0 to 295) limits
of mean pressure NIBP alarm and switching on/off NIBP MAP
alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”);

IBP SYS Setting Upper (from -45 to +450 mmHg) and Lower (from – 50
to +445 mmHg) limits of systolic pressure IBP Alarm. Switching
on/off IBP SYS Alarm (“Off”, “Info”; “Advisory”, “Warning”,
“Crisis”).

IBP MAP Setting Upper (from -45 to +450 mmHg) and Lower (from – 50
to +445 mmHg) limits of mean pressure IBP Alarm. Switching
on/off IBP mean Alarm (“Off”, “Info”; “Advisory”, “Warning”,
“Crisis”).

IBP DIA Setting Upper (from -45 to +450 mmHg) and Lower (from – 50
to +445 mmHg) limits of diastolic pressure IBP Alarm. Switching
on/off IBP SYS Alarm (“Off”, “Info”; “Advisory”, “Warning”,
“Crisis”).

RR Setting Upper (from 1 to 150) and Lower (from 0 to 149) limits


of RR Alarm. Switching on/off RR Alarm (“Off”, “Info”,
“Advisory”, “Warning”, “Crisis”).

EtCO2 Setting Upper (from 1 mm Hg to 99 mm Hg, 1% to 20%) and


Lower (from 0 mm Hg to 98 mm Hg, 0% to 19.9%) limits of the
alarm of CO2 parameter. Switching on/off CO2 parameter
Alarm (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”).
APNEA Delay Setting the time interval (from 5 to 60 sec, with the step of 5
sec) of the alarm for the time parameter between two
adjacent breaths. Switching on / off the alarm system
according to the APNEA parameter (“Off”, “Info”, “Advisory”,
“Warning”, “Crisis”).

AAg Setting Upper (from 2.1 till 15) and Lower (from 2.0 till 14.9)
limits of AAg Alarms. Switching on/off AAg Alarms (“Off”,
“Info”, “Advisory”, “Warning”, “Crisis”).

Multi AAg Switching on/off multi-Alarm system of the Gas module


channel (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”)

O2 Setting Upper (from 20 to 100) and Lower (from 18 to 198) limits


of alarm of the O2 parameter. Switching on/off Alarms of the
O2 channel (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”).
N2 O Setting Upper (from 18 to 100) and Lower (from 16 to 98) limits
of alarm of the N2O parameter. Switching on/off Alarms of
the N2O channel (“Off”, “Info”, “Advisory”, “Warning”,
“Crisis”).

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Temperature Setting Upper (from 0.1 ° C to 45 ° C) and the Lower (from 0.0 °
C to 44.9 ° C) limits of alarm for the "Temperature" parameter.
Switching on/off Alarms of the Temperature measurement
channel (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”).

ΔT Setting parameters of the alarm for the temperature


difference (from 0.3 ° C to 5.0 ° C). Switching on/off Alarms of
the ΔТ (“Off”, “Info”, “Advisory”, “Warning”, “Crisis”).

Arrhythmia Setting upper limit of the number of ventricular extrasystoles


(PVC) (from 1 to 100). Switching on / off or selecting the
priority of the alarm by ("Off", "Informational", "Warning",
"Danger", "Crisis"). Switching on/off or selecting the alarm
priority of the ARITHMY option (“Off”, “Info”, “Advisory”,
“Warning”, “Crisis”).
PVC Setting Upper limit of the premature ventricular complex
(heart rhythm disturbances) for the minute (PVC) alarm (from
1 to 100) and switching on/off PVC alarm (“Off”, “Info”,
“Advisory”, “Warning”, “Crisis”).

BIS Setting Upper (from 4 to 100) and lower (from 3 to 99) limits of
BIS Alarm. Switching on/off BIS Alarm (“Off”, “Info”,
“Advisory”, “Warning”, “Crisis”).

Advanced Is used for selection submenu "Advanced" and setting


additional alarm parameters.

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6.30 Submenu “Advanced”

Figure 70

This submenu is used to set additional alarm parameters for each of the
monitored parameters or to turn off the alarm:

Single press It is used to select for what time to turn off the alarm after a
“ALARM OFF” single press of the alarm deactivation button ("1 min", "2 min",
"3 min"),
Double press It is used to select for what time to turn off the alarm after
“ALARM OFF” double pressing the alarm deactivation button ("5 min", "10
min", "15 min", "Next event"),
Crisis Alarm Selecting the Crisis alarm volume (from 10% to 100% with the
Volume step of 10% )
Warning Alarm Selecting the Warning alarm volume (from 10% to 100% with
Volume the step of 10% )

Advisory Alarm Selecting the Advisory alarm volume (from 10% to 100% with
Volume the step of 10% )

Auto record Switching on/off auto record alarm (“On”, “Off”);


(ALARM)
Auto print Switching on/off auto print alarm (“On”, “Off”);
(ALARM)

Nurse call Alarm Switching on/off or selecting priority level of nurse call alarm
(“Off”; “Info”; “Advisory”; “Warning”; “Crisis”);

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6.31 Menu “Patient”

Figure 71

In this menu you can enter the patient’s data into to the memory of the monitor:
1. ID;
2. First Name
3. Middle Name;
4. Last Name;
5. Hospital;
6. Department.
7. Years of birth;
8. Sex;
9. Weight;
10. Height;
11. Age Mode;
12. Clear Card;
13. Trend Clearing.

To enter the data:


1. By short pressing the corresponding position of the touch screen, or by
using ENCODER BUTTON, activate the main menu window on the monitor
display;
2. Select the "Patient" menu;
3. A submenu with a list of graphs appears on the monitor screen. Select one

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of them and virtual keyboard will be activated automatically;
4. Using the ENCODER BUTTON or the touch screen, enter the required data
according to the following algorithm:
select the menu “Patient Card” and press the ENCODER or use touch-
screen display, after that the virtual keyboard will be activated;
enter the required information by pressing the ENCODER BUTTON or
using the touch screen when selecting the required symbol on the
virtual keyboard (to erase the symbol, press "BS");
after entering the required data, press the "Enter" key;
5. Rotate the ENCODER to select the next menu option (or just use the touch
screen to select needed option);
6. Similarly enter the required values in the other required submenu rows;
7. After entering patient data (first name, last name) will be visualized on the
monitor display.

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6.32 Menu “Applications”
In this menu you can select and change the following parameters displayed on
the screen:

Figure 72

In this menu you can select and change the following parameters displayed on
the screen:
Record list This submenu is used to view 15-second wave curves from
the memory of the monitor
Show Trends This submenu is used to display the trend window
Start Venous Switching on/off venous puncture mode (“On”, “Off”);
Puncture (option)

Drug Calculator This submenu displays the window “Drug calculator”, which
allows to enter data for further automatic calculation of
volume and rate of medication injection. For more detailed
information see chapter “Drug Calculator”;

Oxygenation Is used to activate and edit the Oxygen calculation


Calculations window.
Ventilation Is used to activate and edit the Ventilation calculation
Calculations window.
Hemodynamic Is used to activate and edit the Hemodynamic calculation
Calculations window.
HR Variability Selection of the source of HRV analysis ("ECG", "PLE"). For

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more detailed information see chapter "Heart Rate
Variability".
OxiCRG Displays the “Oxycardiorespirogram” window (OxyCRG).
For more detailed information see chapter
“Oxycardiorespirogram”;

Thermodilution Displays the “Thermodilution” window. For more detailed


information see chapter “Thermodilution”;

Keyboard Help Informational window about main keys on the front panel of
the monitor;

Bed-to-Bed Is used to activate the window to review the status of other


patients from the network from any monitor
Commands Activates the submenu item "Commands"

Note! For the safety of the patient, the patient's card can be filled and
applied only from the Central Station.
6.33 Menu “Records list”

Figure 73

This submenu is used for viewing 30-second fragments of wave curves recorded in
the non-volatile memory of the monitor

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To view a record from the monitor's memory, you need to:

rotate the ENCODER BUTTON or to use the touch screen to activate the
"Applications" menu;
select the "Record list" submenu;
Turn the ENCODER or use touch screen to activate "Records List" menu.
In the appeared window, by rotating the ENCODER BUTTON or by using the
touch screen, select the required record: the record number (the number
of the last record is displayed at the top of the window), the date and time
of saving, the abbreviated name of the detected arrhythmia during
recording, patient name

In the "Settings" menu, select those curves (from 2 to 7) that you want to see in the
record and to display on the screen.

Figure 74

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Figure 75

In the right top corner there are buttons:


Is used to return to the Record list

/ The keys for selecting the display mode of digital /


graphic data recordings

Setting the "Records" function

Return to the main mode of the monitor is carried out by a short press of the
button "BASIC SCREEN", located on the front panel of the monitor.

To save the segments of the monitored curves, you must click the "Record" button
on the keyboard shortcut. When arrhythmia, the curves are automatically
recorded in the monitor's memory (automatic recording of arrhythmia is enabled
by default).

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6.34 Submenu “Show Trends”

Figure 76

The UM300 monitor forms trends (permanent memorization of the values of


monitored parameters in non-volatile memory) of monitored parameters with a
help of real-time mark, and provides the ability to view the trend on the graphic
display. It is also possible to display the numerical values of the monitored
parameters in real time and the trends of these values simultaneously.

The length of the trend is adjustable and can be set up to 720 hours. The data is
recorded in the form of digital tables and graphic trends. Trend curves with full
displaying of data are recorded up to 720 hours.

To view TRENDS, click on the "TRENDS" button, then a window will be opened for
selecting parameters for which trend analysis is available (see the figure below)

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Saving of data obtained as a result of monitoring is performed in two forms:
graphical (graph) and digital (table with digital values).

In the right upper part of the window there are buttons for managing trends:

Is used to select the parameter to display from the list.

Is used to reduce the scale of displayed trends.

Is used to zoom up scale of the displayed trends.

The keys for selecting the mode for displaying table or graphic
/ trends.

Is used to display "Trends" menu

To view trend in the form of tabular data, it is necessary to press the "TREND"
button on the front panel and enter the trend display mode in the graphic view,
then press the ENCODER BUTTON - trend in the form of a table with digital values
will be displayed.
The process of printing of data from the "TREND" mode is described in the chapter
"Printing from the TREND mode".
When you turn off the monitor, it saves the previously stored information on the
monitored parameters. Up to 1000 groups of NIBP measurement trends are stored.
If it is necessary to clean the storage of device from the "old" trend - enter the
"Patient" menu on the navigation bar and select the "Trend Clearing" submenu
item.

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6.35 Submenu “Drug Calculator”

Figure 77

This menu is used to optimize the calculation of infusion therapy.

Using the pop-up window “Drug calculator”, enter the required data to
determine the infusion rate and volume:
The line “Dose”: enter the required injection of dose and dose units
The line “Speed”: enter the required injection of speed and speed units
The line “Concentration”: enter the concentration of substance and
concentration units
The line “Weight”: enter the patient’s weight, kg
The line “Height”: enter the patient’s height, m
The line “BSA”: enter the patient’s BSA, m2 or the monitor will calculate it
automatically after the patient's weight and height will be entered.
The calculation results are displayed at the top of the window.

To enter the data, perform the following operations:


1. By rotating the ENCODER BUTTON or by using the touch screen, select the
"Application" menu and then the "Dose Calculator" submenu in it ;
2. The "Drug Calculator" window will appear on the monitor screen.
3. Using the ENCODER BUTTON or touch screen, select a window for data
entry.
4. Turn the ENCODER BUTTON or use the touch screen to select the desired
item. The data should be entered in the parameters window, after that the
entered value has to be confirmed by pressing the "Enter" key.
5. After the necessary data is entered, the resulting values of the volume and
speed of infusion will be displayed.
6. Click the "Home screen" button, or the cross in the upper right corner of the
window to close the window

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6.36 Submenu “Oxygenation Calculations”

In the "Oxygenation Calculation" window, there are editable parameters and


calculated parameters. In order to calculate the required parameter, you need
to pay attention to the formulas below, which indicate which parameters you
have to enter into the window "Oxygenation Calculation – Editing".

In order to open the window "Oxygenation Calculation - Editing", it is necessary to


press the button " " in the window "Oxygenation Calculation - Editing" using the
touch screen.

Entered Parameters

Figure 78

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Abbreviation Unit Norm limit Full spelling
C.O. L/min 4÷7 Cardiac output
FiO2 % 40 ÷ 70 Oxygen concentration on inspiration
(21 ÷ 100)
PaO2 mmHg 80 ÷ 100 Arterial oxygen level
PaCO2 mmHg 35 ÷ 45 Arterial carbon dioxide level
SaO2 % 93 ÷ 100 Arterial oxygen saturation
PvO2 mmHg 40 Venous oxygen level
SvO2 % 60 ÷ 80 Venous oxygen saturation
Hb g/L 120 ÷180 Hemoglobin concentration
CaO2 ml/L 170 ÷ 240 Arterial oxygen saturation
CvO2 ml/L 120 ÷ 170 Venous oxygen content
VO2 ml/min 180 ÷ 280 Oxygen consumption
RQ None 0.8 Respiratory quotient
ATMP mmHg Atmospheric pressure
Height cm Height
Weight kg Weight

Calculated parameters

Abbreviation Unit Norm limit Full spelling


BSA m2 Body surface area
VO2 calc ml/min Oxygen consumption
C(a-v)O2 ml/L 30 ÷ 50 Arterial and venous oxygen content
difference
O2ER % 22 ÷ 30 Coefficient of oxygen extraction from the
blood
DO2 ml/min 640 ÷ 1200 Oxygen transportation
PAO2 mmHg 80 ÷ 100 Alveolar oxygen level
AaDO2 mmHg 5 ÷ 15 Alveolar-arterial oxygen difference
CcO2 ml/L Capillary oxygen content
Qs/Qt % 3÷5 Venous admixture
C.O. calc L/min Calculated cardiac output

1. Oxygen consumption VO2 calc (ml/min):

– VO2=1.34×CO×Hg×(SaO2-SvO2);
– VO2=CO × (CaO2 - CvO2).

2. Arterial and venous oxygen content difference:


C(a-v)O2 = CaO2-CvO2;
3. Coefficient of oxygen extraction from the blood:
O2ER=(CaO2 - CvO2)/CaO2 ;
4. Oxygen transportation:
DO2=CO ×CaO2 ;
5. Alveolar oxygen level:
– PAO2=(FiO2 × [Patm - PH2O]) - (PaCO2 ÷ R),
PH2O – partial pressure of water (47 mmHg at 37 degrees C);
– PAO2=((PB-PH2O)× FiO2) – (PaCO2/RQ),
PB – atmospheric pressure.

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6. Alveolar-arterial oxygen difference:
AaDO2 = (713 x FiO2) – (PaCO2 / RQ) – (PaO2)
7. Capillary oxygen content:
CcO2 = (Hgb ×1.34) + (0.0031 × PaO2)
8. Venous admixture:
Qs/Qt = (CcO2 - CaO2)/(CcO2 - CvO2),
9. Calculated cardiac output
C.O.calc=VO2/(CaO2-CvO2);

6.37 Submenu “Ventilation Calculations”


In the "Ventilation Calculation" window, there are editable parameters and
calculated parameters. In order to calculate the required parameter, you need
to pay attention to the formulas below, which indicate which parameters you
have to enter into the window "Ventilation Calculation – Editing".

In order to open the window "Ventilation Calculation - Editing", it is necessary to


press the button " " in the window "Ventilation Calculation - Editing" using the
touch screen.
Entered parameters

Figure 79

Abbreviation Unit Norm limit Full spelling


40 ÷ 70
FiO2 % Oxygen concentration on inspiration
(21 ÷ 100)
RR rpm 14 ÷ 18 Respiration Rate
PeCO2 mmHg 35 ÷ 45 CO2 pressure in the exhaled air
PaCO2 mmHg 35 ÷ 45 Arterial carbon dioxide level
PaO2 mmHg 80 ÷ 100 Arterial oxygen level
TV ml 500 Breath volume
RQ None 0,8 Respiratory coefficient
ATMP mmHg Atmospheric pressure

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Calculated parameters

Figure 80

Abbreviation Unit Norm limit Full spelling


PAO2 mmHg 80÷100 Partial pressure of oxygen in the blood
AaDO2 mmHg 5÷15 Alveolar-arterial oxygen difference
Pa/FiO2 mmHg Oxygenation ratio
a/AO2 % Arterial to alveolar oxygen ratio
MV L/min 5÷10 Minute ventilation
Vd ml 120÷200 Volume of physiological dead space
Physiological dead space in percent of tidal
Vd/Vt % 0,2÷0,35
volume
VA L 4÷10 Alveolar volume

1. Partial pressure of oxygen in the blood PAO2:


PAO2 = (FiO2 × (Patmos – PH2O)) – (PaCO2 / RQ)
2. Alveolar-arterial oxygen difference AaDO2:
AaDO2 = (713 × FiO2) – (PaCO2 / RQ) – (PaO2)
3. Arterial to alveolar oxygen ratio a/AO2:
a/AO2= PaO2/ PAO2
4. Minute ventilation:
MV=TV × RR/1000
5. Volume of physiological dead space:
Vd=TV × (PaCO2 -PeCO2 )/PaCO2
6. Physiological dead space in percent of tidal volume:
Vd/Vt=Vd/TV
7. Alveolar volume:
VA=(TV-Vd) × RR/1000

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6.38 Submenu “Hemodynamic Calculations”
In the "Hemodynamic Calculation" window, there are editable parameters and
calculated parameters. In order to calculate the required parameter, you need
to pay attention to the formulas below, which indicate which parameters you
have to enter into the window " Hemodynamic Calculation – Editing".

In order to open the window " Hemodynamic Calculation - Editing", it is necessary


to press the button " " in the window " Hemodynamic Calculation - Editing"
using the touch screen.
Entered parameters

Figure 81

Abbreviation Unit Norm limit Full spelling


C.O. L/min 4÷7 Cardiac Output
60÷90
HR bpm Heart rate
(20÷300)
PAWP mmHg 2-15 Pulmonary artery wedge pressure
mmHg 80÷100
Art Mean Artery mean pressure
(20÷300)
Art Sys mmHg Artery systolic pressure
Art Dia mmHg Artery diastolic pressure
PA Sys mmHg Pulmonary artery systolic pressure
PA Dia mmHg Pulmonary artery diastolic pressure
PA Mean mmHg 7-18 Pulmonary artery mean pressure
CVP mmHg 3÷8 Central venous pressure
LV_D mm Left ventricular diameter
ESV ml 50 (16-143) End-systolic volume
Height cm Height
Weight kg Weight

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Calculated parameters

Figure 82

Abbreviation Unit Norm limit Full spelling


C.I. L/min/m2 2,8÷4,2 Cardiac index
BSA m2 Body surface area
SV ml 55-100 Stroke volume
SVI ml / m2 Stroke volume index
SI ml / m2 33-47 Stroke index
SVR DS/cm5 90÷1400 Systemic vascular resistance
DS× m2 / 2130±450
SVRI Systemic vascular resistance index
cm 5
PVR DS/ cm 5 67±30 Pulmonary vascular resistance
DS× m2 / 123±54
PVRI Pulmonary vascular resistance index
cm 5
(3,4÷4,2) ×
LCW kg×m Left cardiac work
(1,0×3,0)
kg×m / 3,4÷4,2
LCWI Left cardiac work index
m2
(50÷60) ×
LVSW g×m Left ventricular stroke work
(1,0÷3,0)
50÷60 Left ventricular stroke work index during one
LVSWI g×m / m2
stroke
RCW kg×m 0,54÷0,66 Right cardiac work
kg×m / (0,54÷0,66) /
RCWI Right cardiac work index
m2 (1,0÷3,0)
(7,9÷9,7) ×
RVSW g×m Right ventricular stroke work
(1,0÷3,0)
RVSWI g×m / m2 7,9÷9,7 Right ventricular stroke work index
EDV ml 65-240 End-diastolic volume
EDVI ml / m2 End-diastolic volume index
ESVI ml / m2 End-systolic volume index
EF % 55-70% Ejection fraction
EFI %/ m2 Ejection fraction index

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1. Cardiac index
CI=CO/BSA
2. Stroke volume
SV=CO × 1000/HR
3. Stroke index
SI=SV/BSA
4. Systemic vascular resistance
SVR=((ArtMean - CVP) × 80)/CO
5. Systemic vascular resistance index
SVRI=((ArtMean - CVP) × 80)/CI
6. Pulmonary vascular resistance
PVR=((PAMean - PAWP) × 80)/CO
7. Pulmonary vascular resistance index
PVRI=((PAMean - PAWP) × 80)/CI
8. Left cardiac work
LCW= (ArtMean - PAWP) × CO × 0.014
9. Left cardiac work index
LCWI= (ArtMean - PAWP) × CI × 0.014
10. Left ventricular stroke work
LVSW=SV × (ArtMean - PAWP) × 0.0136
11. Left ventricular stroke work index
LVSWI=SI × (ArtMean - PAWP) × 0.0136
12. Right cardiac work
RCW=0.0144× C0× PAMean
13. Right cardiac work index
RCWI=0.0144× CI× PAMean
14. Right ventricular stroke work
RVSW=SV × (PAMean - CVP) × 0.0136
15. Right ventricular stroke work index
RVSWI=SI × (PAMean - CVP) × 0.0136
16. Ejection fraction
EF=(SV/EDV) × 100

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6.39 Submenu “AP 24h Variability”

In this submenu the daily variation of blood pressure is assessed, in which the
parameters are separately analyzed during sleep and wakefulness.

Calculations of the variability of blood pressure by channels NIBP, IBP1, IBP2, IBP3,
IBP4 are shown here.

Two indicators of daily BP variability are calculated:


Calculated with an adjustment for the actual duration of the day and night
periods (SD);
Average real VAD (ARV24).

ARV24 averages the absolute difference of blood pressure levels between


successive measurements and takes into account the sequence in which the
measurements were performed and is calculated by the formula:
,
where — is an interval between

6.40 Submenu “Heart Rate Variability” (HRV)


The monitor stores, calculates and displays the data required for the heart rate
variability analysis. You can adjust the parameters in the submenu “HRV” (heart
rate variability).
In the appeared window you can see: "Histogram", "Spectrum of power",
"Rhythmogram", and “Description”.

Figure 83

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Figure 84

Figure 85

Measured parameters:

Number of cardiocycles (NN) – quantity of RR intervals.


Average cardiocycle - the duration of the average cardiocycle;
Mode – most frequently occurring value of cardio interval.
Amplitude of mode - the value
SDNN – standard deviation of NN intervals.
PNN 50% - the percentage of intervals NN 50, from all intervals (NN 50 -
the number of NN pairs differing by more than 50 ms);
RMSSD – The square root of the mean squared differences of
successive NN intervals.
VLF – power in the very low frequency range.
LF – power in the low frequency range.
HF – power in the high frequency range.
LF/HF – ratio LF/HF.
LFn – normalized capacity in the low frequency range.
HFn - normalized capacity in the high frequency range
Total – total range of spectrum
Variational scale - the coefficient of variation of the full array of
cardiointervals;

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IVE is the index of vegetative balance;
RVF – rhythm vegetative index.
IARP – indicator of the adequacy of regulatory processes;
SI – index of tension of regulatory systems (by the method of R.
Baevsky);
The power spectrum in which green is VLF, red - LF, blue - HF.

6.41 Menu “Oxycardiorespirogram”

Figure 86

The menu "Oxycardiorespiogram" is used for simultaneous displaying of SpO2


graphs, instantaneous heart rate values (in case, when the heart rate source is
selected as ECG) or instantaneous pulse rate values (in case, when the source of
the heart rate is selected as SpO2), as well as the respiration curve.

The following diagrams are displayed in the window:


SpO2 waveform for the last 6 minutes (scrolling - up to 1 hour);
HR waveform for the last 6 minutes (scrolling - up to 1 hour);
Respiration waveform for the last 6 minutes (scrolling - up to 1 hour).

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6.42 Submenu “Commands

This submenu is used for quick access to the following commands:

IBP1 Calibration , When this menu is activated, the invasive blood


IBP2 Calibration , pressure sensors are calibrated. If there is only one IBP
channel in the monitor, the submenu of the IBP
contains the submenu items only for one channel,
called the IBP;
IBP1 optimal scale Is used to set the optimal scale of the IBP curve;
IBP2 optimal scale
СО2 zero setting Automatic calibration of the CO2 module;
BIS sensor check Is used for checking the quality of the superimposed
BIS sensor.
O2 compensation Automatic compensation of the O2.
Balance Gas Is used for selecting the Balance Gas («Air», «N2O»,
«He»)
AAg compensation Automatic compensation of the AAg (0.0-20.0)
O2 air test The start of an air test on the O2 sensor (in the case
of using a galvanic oxygen sensor)

O2 full calibration The start of full calibration of the O2 sensor (in the
case of using a galvanic oxygen sensor).

7 PRINTING (OPTIONAL)
The device can be equipped with a built-in or external thermal printer for
recording on thermal paper ECG signal, photoplethysmogram, invasive blood
pressure curves, electroencephalograms.

The device allows to print ECG segments, photoplethysmogram, invasive pressure


curves, electroencephalograms, digital results of monitored parameters in the
main mode, as well as printing from the "STOP", "RECORD" and "TREND" modes.
7.1 Direct printing
For direct printing of waveforms, press and hold the key “PRINT” on the front panel
of the monitor. A segment of ECG wave and (or) plethysmogram displayed on
the screen and numeric information of the monitored parameters will be printed
out on a thermal paper.

To select the curves that should be printed on thermal paper and printing speed,
use the submenu "Print", in the submenu items "Signal1", "Signal2" and "Signal3"

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and set the necessary values for printing. Using this menu, set the desired printing
speed.

Note! Direct printing on a thermal paper is possible only in the Main


Screen mode.

7.2 Printing in the operation modes of the monitor


Printing in the “Freeze” mode
Press the key “Freeze”, to print out in the “Freeze” mode. After that press the key
“PRINT” (without holding the key “Freeze”). A segment of waveforms displayed on
the screen of 10 to 50 cm length (depending on the print length preset in the
menu PRINT) and also numeric information of the monitored parameters will be
printed out.
Printing in the “RECORDS” mode
For printing in the “RECORDS” mode, enter the menu “RECORDS” and select the
required record from the “Record list” submenu. After that press (not hold) the key
“PRINT” on the front panel of the monitor. Segments of the waveforms registered
in the record of 10 to 50 cm length (depending on the print length preset in the
menu PRINT) will be printed out.
Printing in the “TREND” mode
For trends printing, press the key “TRENDS” to display the required information.
While viewing the trends, press the key “PRINT” and the displayed trend will be
printed out. Trend length is set in the menu “Print” in the option “Print Length Trend,
h”.
7.3 Reloading paper
To replace the paper in the thermal printer, perform the following steps:
1. Open the printer cover by lifting the lever up until it clicks.
2. Load the thermos-paper into the printer with a thermo-sensitive surface
upwards.
3. Close the printers cover (until it clicks).

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8 MONITORING
8.1 ECG Monitoring
This function allows you to monitor heart rate (determined by ECG) and
graphical displaying of ECG-curves. Diagnosis of ECG is carried out with a
3/5/10-electrode cable.
The device registers the following ECG leads:
I, II, III (3 Lead Wire cable);
I, II, III, aVR, aVL, aVF, V (5 Lead Wire cable);
dI, dII, dIII, daVL, daVR, daVF, dV1, dV2, dV3, dV4, dV5, dV6 (5 Lead Wire
cable – for measurement 12 computed ECG leads);
I, II, III, aVL, aVR, aVF, V1, V2, V3, V4, V5, V6 (10 Lead Wire cable – for
simultaneously measurement of 12 standard ECG leads).

ECG Monitoring for Adults


A good contact of the electrodes with the skin is an important condition for
obtaining a good ECG signal, since the skin is a poor conductor of
electricity. Prepare the patient's skin at the location of the electrodes:

1. Select skin areas without any damage


2. If necessary, the hair in the place of installation of the electrode must be
shaved;
3. Rinse skin thoroughly with soap and water and rinse off soap residues. It is
not recommended to use alcohol, as this results tanning of the skin and
increases the electrical resistance;
4. Dry the skin well;
5. Carefully remove the dead skin cells with skin preparation paper to the
ECG to improve conductivity in the areas where the electrodes will be
applied;
6. Before applying electrodes, connect clamps or latches to them. Before
applying electrodes, apply a special gel on them.
7. Place the electrodes on the patient's body according to the selected
scheme.
8. Insert the patient cable into the ECG connector. The ECG curve and
numerical values will appear on the monitor screen.

Default settings

Factory default ECG channel settings:


sensitivity - 10 mm / mV;
speed - 25 mm / s;
filter 50/60 Hz - off;
ECG filtration mode - monitoring;
The pacemaker detector is off.

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ECG monitoring for neonates

The registration of the electrocardiogram is an obligatory element of monitoring


the vital functions of the neonate's body, especially with severe perinatal
pathology.

The complexity of the ECG interpretation in neonates is related both to the


restructuring of the neonatal blood circulation system and to the technical
difficulties associated with the insufficient quality of fixation and
electroconductivity of the electrodes, which in turn depends on the design
features and quality of the materials from which the electrodes were made.
In this regard, the following recommendations should be considered:

Given the increased predisposition of the skin of the neonates to diaper


rashes, electrodes made only on the basis of microporous tissue should be
used in neonatology.
Given the minimum size of the neonatal electrodes and the relatively small
area of contact with the skin, a decrease of impedance could be
achieved only by the use of special gels.
Electrodes with wet gel can be used in neonatal practice only in case of
emergency transportation of a neonate, or in an operating room where the
ambient temperature is relatively low.
Electrodes used for the long-term recording of ECG in neonates under
intensive care and intensive care units should contain only a solid gel with a
special bactericidal agent that prevents the growth of bacteria at the
place of contact with the skin.
Given the high frequency of X-ray investigations in the setting of
resuscitation and neonatal intensive care , it is preferable to use X-ray
transparent versions of the electrodes.
Despite all of the above, the duration of the continuous use of neonatal
electrodes, which ensures good quality of the ECG signal and does not
irritate the skin of the neonate, is up to 48 hours. Use neonatal electrodes for
a longer period are undesirable.
The additional fixation of electrodes by a medical adhesive plaster is
categorically contraindicated.

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Scheme of placement of a 3-Lead Wire ECG Cable (Einthoven's Triangle)

Three colored ECG cable must be connected to the three electrodes of the
corresponding colors. 3 leads are formed, they form the triangle of Einthoven.

R - red lead, always negative


polarity
L - yellow lead, positive for lead
I, negative for lead II
F - green lead, always positive
polarity

Figure 87

For monitoring purposes with the three lead system, the red electrode is placed
just below the clavicle (collarbone) on the right shoulder. When registering leads I
and II, the red electrode has a negative polarity

The green electrode is an electrode with a positive polarity in leads II and III, and
has to be connected below the left pectoral muscle near the apex of the heart.

The yellow electrode is connected below the left clavicle near the shoulder. The
yellow electrode switches polarity dependent on the lead chosen. With lead I,
the yellow electrode becomes positive (red is always negative). The yellow
electrode assumes a negative polarity in lead III.

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If the three electrodes are colored as red, yellow and black, place the electrodes
on the patient according to this scheme:

Figure 88

R – the red electrode is located at the right mid-clavicular line;


L – the yellow electrode is located at the left mid-clavicular line ;
N – the black or ground electrode can be positioned at a convenient
location anywhere on the torso.

Caution! If the 3-lead wire is colored red, yellow and black, the monitor
register lead I.

If the 3-lead wire is colored red, green and black, the monitor
register lead II.

If the 3-lead wire is colored yellow, green and black, the


monitor register lead III.

If the 3-lead wire is colored red, yellow and green, the


monitor register leads I, II, III.

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Scheme of placement of the 5-Lead Wire ECG Cable
Place the electrodes on the patient according to the scheme of placement of 5-
lead ECG cable of 12 derived ECG leads. ECG electrodes can be placed either
on the patient’s limbs or on the body.

Caution! Use disposable ECG electrodes only according to the


patient category stated on the package: adult, pediatric,
neonatal.

The device simultaneously registers the following leads: I, II, III, aVR, aVL, aVF, V.

Figure 89

R – the red electrode is located at the right mid-clavicular line;


L – the yellow electrode is located at the left mid-clavicular line;
F – green electrode is located below the left pectoral muscle near the
apex of the heart at the 5th intercostal space;
C – white electrode is located along the sternum between the black and
green electrodes, on the xiphoid process;
N – the black or ground electrode can be positioned at a convenient
location anywhere on the torso or opposite to the green electrode.

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Scheme of placement of the 10- Lead Wire ECG Cable
Place the electrodes on the patient according to the standard scheme of
placement of 10-lead ECG cable.

Figure 90

(R) red electrode – to the right hand;


(L) yellow electrode – to the left hand;
(F) green electrode – to the left leg;
(N) black electrode – to the right leg.

Figure 91

(C1), white and red electrode – to the right of the sternum at the fourth
intercostal space;
(C2), white and yellow electrode – to the left of the sternum at the
fourth intercostal space;
(C3), white and green electrode – to the fifth rib, the geometric mean
between the C2 and C4;
(C4), white-brown electrode – to the fifth intercostal space on the left
mean clavicular line;

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(C5) white and black electrode – between C4 and C6 on the left
anterior axillary line;
(C6) purple and white electrode – to the left middle axillary line at the
level of C4.

Connecting the ECG cable to the monitor

Connect the lead cable to the ECG connector on the corresponding measuring
module (12 ECG) and connect the module to the universal UniPort connector on
the monitor housing.

In the MENU mode, set the ECG leads required for visualization on the display.

Using the "ECG" submenu, set the value "On", "1-7 leads", "Calculated 12",
"Standard 12" in the "ECG" item, depending on which ECG cable is used for
monitoring.

Use SENSITIVITY and SWEEP SPEED parameters to set the required values of ECG
signal amplification and sweep speed.

With the correct installation of the electrodes, after a few seconds, the device
automatically adapts to the bioelectrical characteristics of the patient, as
evidenced by the appearance of the ECG on the display.
From this moment the device starts ECG monitoring.

If there is no cable or contacts of all electrodes of the ECG cable with the
patient's body, the message "Cable is not connected" is displayed in the "Heart
rate" window and above each ECG curve on the screen, which are displayed in
gray color.

In case of poor-quality imposition or absence of contact (electrode detachment,


etc.) of some electrodes of the ECG cable with the patient's body, the curves
visualized on the screen, in which a poor-quality contact is fixed, are shown in
gray color in the graph and are accompanied by the message "No contact" with
the list of electrodes participating In the registration of this lead.

The selection (viewing) of ECG-curves displayed on the display can be carried


out while the device is operating. In this case, the number of ECG curves on the
display can be changed from 1 to 12. In the menu "Settings" in the "Number of
signals" is set the desired number of curves displayed on the ECG display.

Warning! It is forbidden to use disposable electrodes with expired shelf life.

Do not apply electrodes to damaged skin.

Do not use electrodes with dried gel.

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It is forbidden to use disposable electrodes for more than 24
hours.

Do not reuse disposable electrodes.


The conductive parts of the electrodes or of the sensor and
connectors must not touch other conductive parts, including the
ground.
If the defibrillator is used, the contact of the defibrillator
electrodes with the monitor electrodes is not allowed. Do not
touch the patient, the table, nearby table, equipment or the
system during defibrillation. The defibrillator discharge (shot) does
not affect the system settings.
The use of an electrosurgical devices and a defibrillator does not
affect the operation of the monitor.
It is allowed to use only those accessories and consumables that
are supplied by the manufacturer.
To reduce the risk of burns during the operation of high-frequency
electrosurgical equipment, ECG electrodes should be placed as
far as possible from the electrodes of high-frequency
electrosurgical equipment.
Pacemaker !!! The pulse rate can be calculated from the
frequency specified by the pacemaker during cardiac arrest or
some arrhythmias. Do not rely entirely on ALARMS. A patient with
a pacemaker needs increased attention. Examine these
instructions to take into account the pacemaker pulses when the
monitor measurement deviates
If the lead wires or electrodes are intentionally disconnected by
the medical operator, use the Alarm Reset function to turn off the
sound of technical alarm. The visual alarm will be active, and the
monitor will react to further alarm conditions

The displaying of ECG curves in gray color is an indication of the


state of impossibility of monitoring the corresponding ECG leads
due to the absence or unsatisfactory quality of ECG electrode
contact or channel overload. At the same time, ECG monitoring
is performed on the remaining leads, including such functions of
heart rate monitoring as determination of arrhythmias, etc.

Note! Use disposable ECG electrodes in strict accordance with


expiration limits and manufacturer's instructions.
Marking of electrodes is located on the plug-adaptor of the

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ECG-cable, use the notations located in the bottom row.
A patient with a pacemaker requires increased attention, since
the pacemaker's work makes it difficult to register the
occurrence of ASYSTOLIA.

ECG analysis for 12 leads

In UM-300 monitors, by using the 10-lead ECG cable, all 12 standard leads are
analyzed for pathological conditions in the following categories: pathological
ECG, pathological ECG rhythm, border ECG, normal ECG, atypical ECG.

The device analyzes more than 200 types of pathological conditions. A list of the
main ones is given below:

8.2 Monitoring Arrhythmia


The device allows you to automatically identify, record and analyze the main life-
threatening arrhythmia.

After detecting the arrhythmia, the message appears in red color with the name
of the detected arrhythmia under the "Arrhythmia analysis" line. The device
automatically records each episode of arrhythmia occurrence in its memory,
indicating the type of arrhythmia and time of occurrence, upon condition if there
are no presses on the monitor buttons for 2 minutes. The device forms and stores
the trend of arrhythmias in the non-volatile memory of the monitor. Wave curves
(15-second duration) can be viewed using the submenu LIST OF RECORDS in the
APPLICATIONS menu.
Setting alarm parameters by the number of detected ventricular extrasystoles is
carried out by using "ARITHMIA" the submenu.

Warning! Violation of the rules of positioning ECG electrodes entails


erroneous determination of arrhythmias.

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8.3 QTc interval monitoring

the QT interval is automatically measured by the Monitor beat by beat. The QT


interval represents electrical depolarization and repolarization phases of the
ventricular myocard. A lengthened QT interval is a marker for the potential of
ventricular tachyarrhythmias like torsades de pointes and a risk factor for sudden
death. The duration of QT interval varies greatly depending on gender, age,
heart rate and medication. Normally, the duration of the interval QT is 300-450
milliseconds.
Due to dependency of QT duration from heart rate, specific correction is applied
for more accurate QT estimation. Corrected value of QT is marked as QTc. QTc is
determined using special correction methods (Basett, Frederick, Sagi). The QTc
adjustment formula determines the QT interval at a heart rate of 60 beats per
minute. This will allow the comparison of QT values for a certain time interval at
different heart rate.
The QTc calculation by the Basett’s formula is done as such:

For this Basett’s formula QT interval and the RR interval (distance between two R-
points on the ECG) are given in millimeters, and ECG should be recorded at a
speed of 25mm/sec. Normal values are between 300 and 450ms. The device
allows monitoring the QTc interval in all 7 ECG leads: I, II, III, aVR, aVL, aVF and V,
with selectable lead for visualization.
QT is shortened with increasing heart rate (HR) and lengthens when heart rate
slows. Elongation of the QTc interval means that the heart muscle needs more
time than usual to recharge between myocardial contractions. Extended QTc
interval means increased risk of arrhythmia, in severe cases, can lead to fainting,
cardiac arrest or sudden death. Elongation of QTc may be associated with
congenital defects, electrolyte imbalance, or with the use of medication for the
treatment of MDR-TB, such as Bedakvilin (BDQ) and Delamanide (DLM), as well as
some altered agents such as moxifloxacin and clofazimine.

Figure 92

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QTc interval monitoring procedure:
To start monitoring of QTc interval, click the “Settings” button "Additional
windows" select the "QTc window"
QTc monitoring settings can be opened by direct push on QTc window, or it is
available in the EGC channel configuration menu.
QTc alarm settings and its priority is carried out in the ECG configuration window
in the items "ΔQTc Alarm" and "QTc Alarm".

Warning! Violation of the rules of positioning of ECG electrodes entails


erroneous determination of the displacement of QTc interval.

Note! QTc monitoring is available only in Adult and Pediatric age


category. Pay attention on proper settings of age category for
each patient.

8.4 Monitoring of the ST segment offset


The device can perform ST segment offset analysis in all 7 ECG leads: I, II, III, aVR,
aVL, aVF and in one of the chest leads.
Using the submenu “ST”, set the following parameters for analysis of ST segment
offset relative to the isoline:

Automatic or manual setting the time offset from the J point (from
0 to 80 milliseconds) to the point of ST segment
J+<>ms
elevation/depression relative to the isoline

Unit Setting units of ST segment (in mm or mV)

The device automatically forms trends of ST segment offset value.

To review trends of ST segment offset in all ECG leads, use the key “TRENDS” on
the front panel of the monitor.

The value of ST segment offset (numeric) in each displayed ECG lead is


simultaneously displayed in the window of average QRS complexes. ST segment
(J + set or automatically selected value) is marked red on each average QRS
complex.

Using the submenu “ST”, set the alarm parameters of ST segment in the options “ST
offset” and “ST alarm”.

Setting of alarm limits for ST channel and its priority is carried out by using the
submenu "ST".

Warning! Violation of the rules of positioning of ECG electrodes entails


erroneous determination of the displacement of the ST-segment.

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8.5 Monitoring of Respiration Rate
The device makes it possible to monitor the patient's respiration rate by the
method of impedance rheography - monitoring the change in the electrical
resistance of the patient's thorax during breathing.
To monitor the respiratory rate, I or II standard ECG leads are used. The user can
chose RR monitoring by I, II standard lead, or in AUTO mode.
By default, the RR is registered by the II lead.

Installation of electrodes and connection of the ECG cable are described in


detail in the chapter "ECG monitoring".

Figure 93

After connecting the ECG cable, activate the respiratory rate measurement
channel by using the "RR" submenu. If the electrodes are correctly installed after a
few seconds, the device will start monitoring the respiration rate, as evidenced by
the breathing curve on the LCD display and the numerical values of respiration
rate in the RR window on the display.

The device generates and stores the RR trend in the non-volatile memory of the
monitor.

Setting the alarm limits of the RR channel and its priority is carried out using the
"RR" submenu.

Warning! Violation of the rules of superpositioning of ECG electrodes entails


erroneous measurement of RR.

Setting of alarm delay limits for APNEA is set in the submenu "RR",
item "APNEA Delay".

For a stable RR measurement, it is necessary to ensure a


qualitative contact of the ECG electrodes.

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8.6 Monitoring of SpO2
8.6.1 Masimo SET SpO2 monitoring
Masimo SET is intended for use in systems incorporating Masimo compatible or
Masimo approved pulse oximetry technology which are intended for continuous
noninvasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2) and pulse rate (measured by a SpO2 sensor) for adult, pediatric and
neonatal patients. The sensor may be used in either a hospital or a mobile
environment.
The monitor is to be operated by, or under the supervision of, qualified personnel
only. The manual, accessories, directions for use, all precautionary information,
and specifications should be read before use. The sensors must be disposed
according to the facilities policy.
All Masimo sensors have CE mark in accordance with the requirements of Council
Directive 93/42/EEC (MDD), as amended by Directive 2007/47/EC (M5).
Additionally, all Masimo patient cables and sensors listed in this document are
RoHS compliant per EU Directive 2011/65/EU (RoHS 2).
Masimo products are designed and manufactured by Masimo Corporation in
accordance with applicable device standards and regulations. Refer to the
Declaration of Conformity for a complete listing of applicable standards and
regulations. The Declaration of Conformity for various sensor family groups is
available upon request. Sensor and cable availability is subject to change,
contact your Masimo representative for ordering information.

Warning! As with all medical equipment, carefully route patient cabling to


reduce the possibility of patient entanglement or strangulation.

Do not place the monitoring device or accessories in any position


that might cause it to fall on the patient.

Do not start or operate the monitoring device unless the setup was
verified to be correct.

Do not use the monitoring device during magnetic resonance


imaging (MRI) or in an MRI environment.

Do not use the monitoring device if it appears or is suspected to be


damaged.

Explosion hazard: Do not use the monitoring device in the presence of


flammable anesthetics or other flammable substance in combination
with air, oxygen-enriched environments, or nitrous oxide.

To ensure safety, avoid stacking multiple devices or placing anything


on the device during operation.

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Warning! To protect against injury, follow the directions below:

Avoid placing the device on surfaces with visible liquid spills.

Do not soak or immerse the device in liquids.

Do not attempt to sterilize the device.

Use cleaning solutions only as instructed in this operator's


manual.

Do not attempt to clean the device while monitoring a patient.

To protect from electric shock, always remove the sensor and


completely disconnect the monitoring device before bathing the
patient.

If any measurement seems questionable, first check the patient’s


vital signs by alternate means and then check the monitoring
device for proper functioning.

Inaccurate SpO2 readings may be caused by:

Improper sensor application and placement

Elevated levels of COHb or MetHb: High levels of COHb or MetHb


may occur with a seemingly normal SpO2. When elevated levels of
COHb or MetHb are suspected, laboratory analysis (CO-Oximetry)
of a blood sample should be performed.

Elevated levels of bilirubin

Elevated levels of dyshemoglobin

Vasospastic disease, such as Raynaud’s, and peripheral vascular


disease

Hemoglobinopathies and synthesis disorders such as


thalassemias, Hb s, Hb c, sickle cell, etc.

Hypocapnic or hypercapnic conditions

Severe anemia

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Warning! Very low arterial perfusion

Extreme motion artifact

Abnormal venous pulsation or venous constriction

Severe vasoconstriction or hypothermia

Arterial catheters and intra-aortic balloon

Intravascular dyes, such as indocyanine green or methylene blue

Externally applied coloring and texture, such as nail polish,


acrylic nails, glitter, etc.

Birthmark(s), tattoos, skin discolorations, moisture on skin,


deformed or abnormal fingers. etc.

Skin color disorders

Interfering Substances: Dyes or any substance containing dyes that


change usual blood pigmentation may cause erroneous readings.

The monitoring device should not be used as the sole basis for
medical decisions. It must be used in conjunction with clinical signs
and symptoms.

The pulse oximetry channel of the monitor cannot be used for


apnea monitoring purpose.

The monitoring device may be used during defibrillation, but this


may affect the accuracy or availability of the parameters and
measurements.

The monitoring device may be used during electrocautery, but this


may affect the accuracy or availability of the parameters and
measurements.

The pulse oximetry channel of the monitor cannot be used for


arrhythmia analysis purpose.

SpO2 is empirically calibrated in healthy adult volunteers with normal


levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb).

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Warning! Do not adjust, repair, open, disassemble, or modify the monitoring
device or accessories. Injury to personnel or equipment damage
could occur. Return the monitoring device for servicing if necessary.

Usage notes:
A functional tester cannot be used to assess the accuracy of the monitor.
High-intensity extreme lights (such as pulsating strobe lights) directed on the
sensor, may not allow the monitoring device to obtain vital sign readings.
When using the Maximum Sensitivity setting, performance of the "Sensor Off"
detection may be compromised. If the monitoring device is in this setting
and the sensor becomes dislodged from the patient, the potential for false
readings may occur due to environmental "noise" such as light, vibration,
and excessive air movement.
Do not loop the patient cabling into a tight coil or wrap around the
monitoring device, as this can damage the patient cabling.
Additional information specific to the Masimo sensors compatible with the
monitoring device, including information about parameter/measurement
performance during motion and low perfusion, may be found in the sensor's
directions for use (DFU).
Cables and sensors are provided with X-Cal™ technology to minimize the
risk of inaccurate readings and unanticipated loss of patient monitoring.
Refer to the Cable or Sensor DFU for the specified duration of the patient
monitoring time.

Caution! Do not place the monitoring device where the controls can
be changed by the patient.

Electrical shock and flammability hazard: Before cleaning,


always turn off the device and disconnect from any power
source.

When patients are undergoing photodynamic therapy they


may be sensitive to light sources. Pulse oximetry may be used
only under careful clinical supervision for short time periods to
minimize interference with photodynamic therapy.

Do not place the monitoring device on electrical equipment


that may affect the device, preventing it from working
properly.

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Caution! If SpO2 values indicate hypoxemia, a laboratory blood sample
should be taken to confirm the patient’s condition.

If the Low Perfusion message is frequently displayed, find a


better perfused monitoring site. In the interim, assess the
patient and, if indicated, verify oxygenation status through
other means.

Change the application site or replace the sensor and/or


patient cable when a “Replace sensor” and/or “Replace
patient cable”, or a persistent poor signal quality message
(such as “Low SIQ”) is displayed on the monitoring device.
These messages may indicate that patient monitoring time is
exhausted on the patient cable or sensor.

If using pulse oximetry during full body irradiation, keep the


sensor out of the radiation field. If the sensor is exposed to the
radiation, the reading might be inaccurate or the device
might read zero for the duration of the active irradiation
period.

To ensure that alarm limits are appropriate for the patient


being monitored, check the limits each time the monitor is
used.

Variation in measurements may be profound and may be


affected by sampling technique as well as the patient's
physiological conditions. Any results exhibiting inconsistency
with the patient’s clinical status should be repeated and/or
supplemented with additional test data. Blood samples should
be analyzed by laboratory instruments prior to clinical decision
making to completely understand the patient’s condition.

Do not submerge the monitor in any cleaning solution or


attempt to sterilize by autoclave, irradiation, steam, gas,
ethylene oxide or any other method. This will seriously damage
the monitoring device.

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Caution! Electrical Shock Hazard: Carry out periodic tests to verify that
leakage currents of patient-applied circuits and the system
are within acceptable limits as specified by the applicable
safety standards. The summation of leakage currents must be
checked and in compliance with IEC 60601-1 and UL60601-1.
The system leakage current must be checked when
connecting external equipment to the system. When an event
such as a component drop of approximately 1 meter or
greater or a spillage of blood or other liquids occurs, retest
before further use. Injury to personnel could occur.

Disposal of product - Comply with local laws in the disposal of


the device and/or its accessories.

To minimize radio interference, other electrical equipment that


emits radio frequency transmissions should not be in close
proximity to the monitor.

Replace the cable or sensor when a replace sensor or when a


low SIQ message is consistently displayed while monitoring
consecutive patients after completing troubleshooting steps
listed in this manual.

Next types of sensors are used according to the application way:


Adult or Pediatric Reusable Finger Sensor:

Figure 94

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Reusable Multi-site Sensor:

Figure 95

Disposable Adult, Pediatric, Infant, Neonatal and Preterm SpO2


adhesive sensors:

Figure 96

Adult & Pediatric Reusable Finger Sensor application and direction for use:

INDICATIONS:
The Adult and Pediatric reusable sensors are indicated for either “spot check” or
continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with
adult and pediatric patients during both no motion and motion conditions, and
for patients who are well or poorly perfused in hospitals, hospital-type facilities,
mobile, and home environments.

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Sensor type DCI DCI-P
Patient weight range > 30 kg 10 - 50 kg
Application site Finger or toe Finger or toe
Saturation Accuracy, ± 2% ± 2%
No Motion
Saturation Accuracy, ± 3% ± 3%
Motion
Pulse Rate Accuracy, ± 3 bpm ± 3 bpm
No Motion
Pulse Rate Accuracy, ± 5 bpm ± 5 bpm
Motion
Low Perfusion Accuracy SpO2 ± 2% SpO2 ± 2%
Pulse ± 3 bpm Pulse ± 3 bpm

The Adult and Pediatric reusable sensors are for use with UM300 Patient Monitors
containing Masimo SET oximetry and licensed to use LNCS sensors Consult UTAS
Representative for compatibility of particular Monitor and sensor models.
The LNCS DCI and DCI-P sensors have been validated with Masimo SET Oximetry
Technology.

Warning! Masimo sensors and cables are designed for use with
monitoring devices containing Masimo SET® oximetry or
licensed to use Masimo sensors.

CONTRAINDICATIONS

The Adult and Pediatric reusable sensors are contraindicated for use on active
patients or for prolonged periods of use. They are not intended for long-term
monitoring. They must be removed and repositioned to a different monitoring site
at least every four (4) hours. If extended monitoring is required, use of disposable
adult or pediatric adhesive sensors is recommended.

Warnings All sensors and cables are designed for use with specific
monitors. Verify the compatibility of the monitor, cable and
sensor before use, otherwise degraded performance
and/or patient injury can result.
The site must be checked frequently or per clinical
protocol to ensure adequate adhesion, circulation, skin
integrity and correct optical alignment.
Exercise extreme caution with poorly perfused patients; skin
erosion and pressure necrosis can be caused when the
sensor is not frequently moved. Assess site as frequently as
every (1) hour with poorly perfused patients and move the
sensor if there are signs of tissue ischemia.
Circulation distal to the sensor site should be checked
routinely.
During low perfusion, the sensor site needs to be assessed
frequently for signs of tissue ischemia, which can lead to

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pressure necrosis.
With very low perfusion at the monitored site, the reading
may read lower than core arterial oxygen saturation.
Do not use tape to secure the sensor to the site; this can
restrict blood flow and cause inaccurate readings. Use of
additional tape can cause skin damage, and/or pressure
necrosis or damage the sensor.
Sensors applied too tightly or that become tight due to
edema will cause inaccurate readings and can cause
pressure necrosis.
Misapplied sensors or sensors that become partially
dislodged may cause incorrect measurements.
Venous congestion may cause under reading of actual
arterial oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not be below
heart level (e.g. sensor on hand of a patient in a bed with
arm dangling to the floor, Trendelenburg position).
Venous pulsations may cause erroneous low SpO2 readings
(e.g. tricuspid value regurgitation, Trendelenburg position).
The pulsations from intra-aortic balloon support can be
additive to the pulse rate on the oximeter pulse rate
display. Verify patient’s pulse rate against the ECG heart
rate.
The sensor should be free of visible defects, discoloration
and damage. If the sensor is discolored or damaged,
discontinue use. Never use a damaged sensor or one with
exposed electrical circuitry.
Carefully route cable and patient cable to reduce the
possibility of patient entanglement or strangulation.
Avoid placing the sensor on any extremity with an arterial
catheter or blood pressure cuff.
If using pulse oximetry during full body irradiation, keep the
sensor out of the radiation field. If sensor is exposed to the
radiation, the reading might be inaccurate or the unit
might read zero for the duration of the active radiation
period.
Do not use the Monitor during MRI scanning or in a MRI
environment.
High ambient light sources such as surgical lights
(especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct
sunlight can interfere with the performance of the sensor.
To prevent interference from ambient light, ensure that the
sensor is properly applied, and cover the sensor site with
opaque material, if required. Failure to take this precaution
in high ambient light conditions may result in inaccurate
measurements.
High levels of COHb or MetHb may occur with a seemingly

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normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
Elevated levels of Carboxyhemoglobin (COHb) may lead
to inaccurate SpO2 measurements.
Elevated levels of Methemoglobin (MetHb) will lead to
inaccurate SpO2 measurements.
Elevated Total Bilirubin levels may lead to inaccurate SpO2
measurements.
Intravascular dyes such as indocyanine green or
methylene blue or externally applied coloring and texture
such as nail polish, acrylic nails, glitter, etc. may lead to
inaccurate SpO2 measurements.
Inaccurate SpO2 readings may be caused by severe
anemia, low arterial perfusion or motion artifact.
To prevent damage, do not soak or immerse the sensor in
any liquid solution. Do not attempt to sterilize the sensor.
Do not modify or alter the sensor in any way. Alteration or
modification may affect performance and/or accuracy.
Do not attempt to reprocess, recondition or recycle
Masimo sensors or patient cables as these processes may
damage the electrical components, potentially leading to
patient harm.

1. Site Selection
Choose a site that is well perfused and least restricts a conscious patient’s
movements. The ring finger of the non-dominant hand is preferred.
Alternatively, the other digits on the non-dominant hand may be used.
Always choose a site that will completely cover the sensor’s detector
window. The great toe or long toe (next to the great toe) may be used on
restrained patients or patients whose hands are unavailable.
Site should be cleaned of debris prior to sensor placement.

Caution! Before using the sensor, ensure that the sensor is physically
intact, with no broken or frayed wires or damaged parts.

2. Attaching the sensor to the patient.


Open the sensor by pressing on hinge tabs. Place the selected digit over the
sensor window of the Adult or Pediatric Sensor. The fleshiest part of the digit
should be covering the detector window in the lower half of the sensor. The
top half of the sensor is identified by the cable. On a finger site, the tip of the
finger should touch the raised digit stop inside the sensor. If the fingernail is
long, it may extend over and pass the finger stop (refer to the figure below).

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Figure 97

The hinged tabs of the sensor should open to evenly distribute the grip of the
sensor along the length of the finger. Check position of sensor to verify
correct positioning. Complete coverage of the detector window is needed
to ensure accurate data (refer to the figure below).

Figure 98

Orient the sensor so that the cable will be running towards the top of the
patient’s hand (as shown on the figure below). Connect the sensor
connector to a patient cable

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Figure 99

NOTE: With smaller digits, in order to completely cover the detector window, it
may be necessary to use a lower weight range sensor. The sensor is not intended
for use on the thumb or across a child’s hand or foot.

3. Attaching the Sensor to the Patient Cable


Properly orient the sensor connector (1) and insert the sensor connector
completely into the patient cable connector (2) (refer to the figure below).
Completely close the protective cover (3).

Figure 100

4. Disconnecting the Sensor from the Patient Cable


Lift the protective cover (1) to gain access to the sensor connector (2) (as
shown on the figure below).
Pull firmly on the sensor connector (2) to remove from the patient cable (3).
To avoid damage, pull on the sensor connector, not the cable.

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Figure 101

CLEANING

1. Remove the sensor from the patient and disconnect it from the patient
cable.
2. Clean the sensor and cable by wiping with a 70% isopropyl alcohol pad.
3. Allow the sensor and cable to dry thoroughly prior to placement on a
patient.
or
1. If low-level disinfection is required, use a 1:10 bleach / water solution.
2. Saturate a cloth or gauze pad with the cleaning solution and wipe all
surfaces of the sensor and cable.
3. Saturate another cloth or gauze pad with sterile or distilled water and
wipe all surfaces of the sensor and cable.
4. Dry the sensor and cable with a clean cloth or dry gauze pad.

Caution! Do not use undiluted bleach (5% - 5.25% sodium


hypochlorite) or any cleaning solution other than those
recommended here because permanent damage to the
sensor may occur.
Do not immerse the sensor or connector in any liquid
solution.
Do not sterilize by irradiation, steam autoclave or
ethylene oxide.

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Multisite Reusable Sensor application and direction for use:

The Multisite Reusable Sensor is indicated for either spot “check” or the
continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and
pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant,
and neonatal patients during both no motion and motion conditions and for
patients who are well or poorly perfused in hospitals, hospital-type facilities,
mobile, and home environments. The Multisite Reusable Sensor is indicated as
follows:

Application Site Multiple


Saturation Accuracy, No Motion ± 2% Adults/Pediatrics/Infants, ± 3% Neonates
Saturation Accuracy, Motion ± 3%
Pulse Rate Accuracy, No Motion ± 3 bpm
Pulse Rate Accuracy, Motion ± 5 bpm
Low Perfusion Accuracy SpO2 ± 2% Adult/Pediatrics/Infants, ± 3% Neonates
Low Perfusion Accuracy Pulse ± 3 bpm

The Multisite Reusable Sensor is applied to the sensor site using Masimo
attachment wraps. The attachment wraps are for single-patient use only.
The Multisite Reusable Sensor is for use only with instruments containing Masimo
SET® oximetry. The Masimo Attachment Wraps are for use only with Masimo YI
Reusable Multisite Sensors. Consult UTAS Representative for compatibility of
particular instrument and sensor models. The YI series has been validated with
Masimo SET Oximetry Technology.
The sensor must be removed and the site inspected at least every four (4) hours
or sooner, and, if indicated by circulatory condition or skin integrity, reapplied to
a different monitoring site.

Warning! Masimo sensors and cables are designed for use with
monitoring devices containing Masimo SET® oximetry or
licensed to use Masimo sensors.

CONTRAINDICATIONS

The Multisite Reusable Sensor is contraindicated for patients who exhibit allergic
reactions to foam urethane products and/or adhesive tape.

Warnings All sensors and cables are designed for use with specific
monitors. Verify the compatibility of the monitor, cable and
sensor before use, otherwise degraded performance
and/or patient injury can result.
The site must be checked frequently or per clinical
protocol to ensure adequate adhesion, circulation, skin
integrity and correct optical alignment.
Exercise extreme caution with poorly perfused patients; skin
erosion and pressure necrosis can be caused when the
sensor is not frequently moved. Assess site as frequently as
every (1) hour with poorly perfused patients and move the

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sensor if there are signs of tissue ischemia.
Circulation distal to the sensor site should be checked
routinely.
During low perfusion, the sensor site needs to be assessed
frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
With very low perfusion at the monitored site, the reading
may read lower than core arterial oxygen saturation.
Do not use tape to secure the sensor to the site; this can
restrict blood flow and cause inaccurate readings. Use of
additional tape can cause skin damage, and/or pressure
necrosis or damage the sensor.
Sensors applied too tightly or that become tight due to
edema will cause inaccurate readings and can cause
pressure necrosis.
Misapplied sensors or sensors that become partially
dislodged may cause incorrect measurements.
Venous congestion may cause under reading of actual
arterial oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not
be below heart level (e.g. sensor on hand of a patient in a
bed with arm dangling to the floor, Trendelenburg
position).
Venous pulsations may cause erroneous low SpO2 readings
(e.g. tricuspid valve regurgitation, Trendelenburg position).
The pulsations from intra-aortic balloon support can be
additive to the pulse rate on the oximeter pulse rate
display. Verify patient’s pulse rate against the ECG heart
rate.
The sensor should be free of visible defects, discoloration
and damage. If the sensor is discolored or damaged,
discontinue use. Never use a damaged sensor or
one with exposed electrical circuitry.
Carefully route cable and patient cable to reduce the
possibility of patient entanglement or strangulation.
Avoid placing the sensor on any extremity with an arterial
catheter or blood pressure cuff.
If using pulse oximetry during full body irradiation, keep the
sensor out of the radiation field. If sensor is exposed to the
radiation, the reading might be inaccurate or the unit
might read zero for the duration of the active radiation
period.
Do not use the sensor during MRI scanning or in a MRI
environment.
High ambient light sources such as surgical lights
(especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct
sunlight can interfere with the performance of the sensor.

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To prevent interference from ambient light, ensure that the
sensor is properly applied, and cover the sensor site with
opaque material, if required. Failure to take this precaution
in high ambient light conditions may result in inaccurate
measurements.
High levels of COHb or MetHb may occur with a seemingly
normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
Elevated levels of Carboxyhemoglobin (COHb) may lead
to inaccurate SpO2 measurements.
Elevated levels of Methemoglobin (MetHb) will lead to
inaccurate SpO2 measurements.
Elevated Total Bilirubin levels may lead to inaccurate SpO2
measurements.
Intravascular dyes such as indocyanine green or
methylene blue or externally applied coloring and texture
such as nail polish, acrylic nails, glitter, etc. may lead to
inaccurate SpO2 measurements.
Inaccurate SpO2 readings may be caused by severe
anemia, low arterial perfusion or motion artifact.
Do not attempt to sterilize by irradiation, steam, autoclave
or ethylene oxide.
Do not modify or alter the sensor in any way. Alteration or
modification may affect performance and/or accuracy.
Do not attempt to reprocess, recondition or recycle
Masimo sensors or patient cables as these processes may
damage the electrical components, potentially leading to
patient harm.
High oxygen concentrations may predispose a premature
infant to retinopathy. Therefore, the upper alarm limit for
the oxygen saturation must be carefully selected in
accordance with accepted clinical standards.

1. Site Selection
Always choose a site that will completely cover the sensor’s detector
window.
The site should be free of debris prior to sensor placement.
Choose a site that is well perfused and least restricts a conscious patient’s
movements.
The sensor is not intended for placement on the ear, if the ear is the desired
monitoring site, the Masimo TC-I reusable sensor is recommended.

NEONATES (1-3 kg), Standard Wrap / CleanShield Wrap / Foam Wrap:


The preferred sites are the outer aspect of the foot, under the fourth toe or the
outer aspect of the palm of the hand.
INFANTS (3-10 kg), Standard Petite Wrap / Foam Wrap:

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The preferred sites are the outer aspect of the foot, under the fifth toe or the
outer aspect of the palm of the hand, under the fifth finger. For infants with fat
or edematous feet, the great toe or thumb is recommended
ADULTS (> 30 kg) and PEDIATRICS (10-50 kg), Standard Wrap / CleanShield Wrap
/ Petite Wrap / Foam Wrap:
The preferred sites are the middle or ring finger of the non-dominant hand.
Alternatively, the great or second toe may be used.

2. Attachment Wraps

Body weight Clean Shield® Standard Standard Wrap Foam Wrap


range Multisite Wrap Petite Wrap
1 – 3 kg + + +
3 – 10 kg + + +
10 – 30 kg + +
10 – 50 kg + +
> 30 kg + + + +

3. Attaching the adhesive squares to the sensor (not required for CleanShield
Multisite Wrap)

For improved adherence of the adhesive squares to the sensor wipe the
sensor pads with 70% isopropyl alcohol and allow to dry prior to attaching the
adhesive squares.
Remove the adhesive squares from the backing and attach one square to
each window of the sensor pads (emitter and detector) (refer to the figure
below). Avoid touching the sticky side prior to applying to the sensor pads.

Figure 102

Do not remove the release liner until ready to apply the sensor to the site.

Caution! Do not use adhesive squares on fragile skin.

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4. Attaching the Sensor to the Patient

The foam wrap can be trimmed to the shorter length for smaller site applications
such as a child’s finger or toe or a pre-term infant’s foot or hand.

Remove the backing from the adhesive wrap, leaving the backing on the
tab end (Standard Wrap, CleanShield Wrap and Standard Petite Wrap only).
Push the “button” on the emitter sensor pad (cable is marked with a red
indicator) through the hole on the left and the remaining button on the
detector sensor pad through the hole on the (as shown on the figure below).

Figure 103

NOTE: Use the center hole of the Petite Wrap for patients 3 – 30 kg. Refer to the
picture below

Figure 104

Fold the upper portion of the attachment tape down over the sensor pads
(as shown on the figure below) and remove the release liner from the folded
over section of the adhesive wrap prior to applying the sensor to the site
(CleanShield Wrap only).

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Figure 105

NEONATES (1-3 kg) and INFANTS (3-10 kg), Standard Wrap / CleanShield Wrap /
Foam Wrap
Direct the sensor cable toward the patient. Orient the YI on the outer aspect
of the foot or hand with the center of the wrap under the 5th digit and the
detector window on the fleshy portion and the emitter window (cable is
marked with a red indicator) directly opposite (refer to the figure below).

Figure 106

Secure the small tape end and remove the remaining backing (Standard
Wrap, CleanShield Wrap and Standard Petite Wrap only).
Wrap the tape loosely enough to avoid restricting circulation around the site
and to maintain proper alignment of the detector and emitter windows
(refer to the figure below).

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Figure 107

If using the Foam Wrap, secure the Foam Wrap using the hook and loop tab
(as shown on the figure below).

Figure 108

NOTE: When placing the YI on the hand, it is recommended that the EMITTER
(cable is marked with a red indicator) pad be placed on the palm of the hand,
under the 4th or 5th finger

ADULTS (> 30 kg) and PEDIATRICS (10-50 kg), Standard Wrap / CleanShield Wrap /
Petite Wrap / Foam Wrap
Direct the sensor cable toward the patient. Orient the YI on the selected site
so the detector window is on the fleshy portion and the emitter window
(cable is marked with a red indicator) directly opposite on the nail bed (refer
to the figure below).

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Figure 109

Secure the small tape end (as shown on the figure below)and remove the
remaining backing (Standard Wrap, CleanShield Wrap and Standard Petite
Wrap only).

Figure 110

Wrap the adhesive or foam wrap around the finger loosely enough to avoid
restricting circulation around the site and to maintain proper alignment of
the detector and emitter windows (refer to the figure below).

Figure 111

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155
NOTE: When placing the YI on a finger or toe, the EMITTER (cable is marked with a
red indicator) pad must be placed on the NAIL side.

Caution! Replace the attachment wrap whenever the


adhesive does not adequately adhere the sensor to
the patient or when the attachment wrap becomes
soiled from excessive use

NOTE: Clip the clothing clip to the patient gown to reduce cable pulling on the
measuring site.

5. Attaching the Sensor to the Patient Cable

Properly orient the sensor connector (1) and insert the sensor connector
completely into the patient cable connector (2) (refer to the figure below).
Completely close the protective cover (3).

Figure 112

NOTE: The Masimo LNCS connector type is shown for reference only in the
image above. Always refer to directions for use supplied with the sensor or
cable prior to use for additional instructions and application information
specific to the Masimo cable or sensor type being used.

6. Disconnecting the Sensor from the Patient Cable

Lift the protective cover (1) to gain access to the sensor connector (2) (as
shown on the figure below).
Pull firmly on the sensor connector (2) to remove from the patient cable (3).
To avoid damage, pull on the sensor connector, not the cable.

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Figure 113

NOTE: The Masimo LNCS connector type is shown for reference only in the
image above. Always refer to directions for use supplied with the sensor or
cable prior to use for additional instructions and application information
specific to the Masimo cable or sensor type being used.

CLEANING

Caution! Do not use undiluted bleach (5%-5.25% sodium hypochlorite)


or any cleaning solution other than those recommended
here because permanent damage to the sensor could
occur.
Do not immerse the connector of the YI cable in any liquid
solution.
Do not sterilize by irradiation, steam, autoclave,
Gluteraldehyde (Cidex) or ethylene oxide.
Using excessive force when removing the attachment wrap
may damage the sensor.

To surface clean the sensor:


1. Remove the sensor from the patient and disconnect it from the patient
cable.
2. Clean the sensor and cable by wiping with a 70% isopropyl alcohol pad.
3. Allow the sensor and cable to dry thoroughly prior to placement on a
patient.
or
1. If low-level disinfection is required, use a 1:10 bleach / water solution.
2. Saturate a cloth or gauze pad with the cleaning solution and wipe all
surfaces of the sensor and cable.
3. Saturate another cloth or gauze pad with sterile or distilled water and
wipe all surfaces of the sensor and cable.
4. Dry the sensor and cable with a clean cloth or dry gauze pad.

To clean or disinfect the sensor using a soaking method:

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1. Place the sensor in the cleaning solution (1:10 bleach/water solution), so
that the sensor and desired length of cable are completely immersed.

Warning! Do not immerse the connector end of the sensor cable as


this may damage the sensor.

2. Dislodge air bubbles by gently shaking the sensor and cable.


3. Soak the sensor and the cable for at least 10 minutes and not greater than
24 hours. Do not immerse the connector.
4. Remove from cleaning solution.
5. Place the sensor and the cable in room temperature sterile or distilled
water for 10 minutes. Do not immerse the connector.
6. Remove from the water.
7. Dry the sensor and cable with a clean cloth or dry gauze pad.

NOTE: The cleaning and disinfection instructions mentioned above are desired for
Masimo reusable YI sensors only. Always refer to directions for use supplied with
the sensor or cable prior to use for additional instructions and application
information specific to the Masimo cable or sensor type being used.

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SpO2 adhesive sensors application and direction for use:

The Adult, Pediatric, Infant, Neonatal and Preterm adhesive sensors are indicated
for single patient use for continuous noninvasive monitoring of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2
sensor) for use with adult, pediatric, infant, and neonatal patients during both no
motion and motion conditions, and for patients who are well or poorly perfused in
hospitals, hospital-type facilities, mobile, and home environments.

Sensor Adtx-3 Pdtx-3 Inf-3 Neo-3 NeoPt-3 NeoPt-500


< 3 kg - > 40
Body weight > 30 kg 10 - 50 kg 3 - 20 kg < 1 kg < 1 kg
kg
Neonatal:
Thumb or hand or foot
Application site Finger or toe Finger or toe Hand or foot Hand or foot
great toe Adult: finger
or toe
Saturation Neonatal ±
Accuracy, ± 2% ± 2% ± 2% 3% ± 3% ± 3%
No Motion Adult ± 2%
Saturation
± 3% ± 3% ± 3% ± 3% ± 3% ± 3%
Accuracy, Motion
Pulse Rate
Accuracy, ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm
No Motion
Pulse Rate
± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm ± 5 bpm
Accuracy, Motion
Neonatal ±
Low Perfusion
± 2% ± 2% ± 2% 3% ± 3% ± 3%
Accuracy SpO2
Adult ± 2%
Low Perfusion
± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm ± 3 bpm
Accuracy Pulse

Warning! Masimo sensors and cables are designed for use with
monitoring devices containing Masimo SET® oximetry or
licensed to use Masimo sensors.

CONTRAINDICATIONS:
The LNCS adhesive sensors are contraindicated for patients who exhibit allergic
reactions to foam rubber products and/or adhesive tape.

Warnings All sensors and cables are designed for use with specific
monitors. Verify the compatibility of the monitor, cable and
sensor before use, otherwise degraded performance
and/or patient injury can result.
The site must be checked frequently or per clinical
protocol to ensure adequate adhesion, circulation, skin
integrity and correct optical alignment.
Exercise caution with poorly perfused patients; skin erosion
and pressure necrosis can be caused when the sensor is
not frequently moved. Assess site as frequently as every (1)
hour with poorly perfused patients and move the sensor if
there are signs of tissue ischemia.

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159
Circulation distal to the sensor site should be checked
routinely.
During low perfusion, the sensor site needs to be assessed
frequently for signs of tissue ischemia, which can lead to
pressure necrosis.
With very low perfusion at the monitored site, the reading
may read lower than core arterial oxygen saturation.
Do not use tape to secure the sensor to the site; this can
restrict blood flow and cause inaccurate readings. Use of
additional tape can cause skin damage, and/or pressure
necrosis or damage the sensor.
Sensors applied too tightly or that become tight due to
edema will cause inaccurate readings and can cause
pressure necrosis.
Misapplied sensors or sensors that become partially
dislodged may cause incorrect measurements.
Venous congestion may cause under reading of actual
arterial oxygen saturation. Therefore, assure proper venous
outflow from monitored site. Sensor should not be below
heart level (e.g. sensor on hand of a patient in a bed with
arm dangling to the floor).
Venous pulsations may cause erroneous low SpO2 readings
(e.g. tricuspid value regurgitation).
The pulsations from intra-aortic balloon support can be
additive to the pulse rate on the oximeter pulse rate
display. Verify patient’s pulse rate against the ECG heart
rate.
The sensor should be free of visible defects, discoloration
and damage. If the sensor is discolored or damaged,
discontinue use. Never use a damaged sensor or one with
exposed electrical circuitry.
Carefully route cable and patient cable to reduce the
possibility of patient entanglement or strangulation.
Avoid placing the sensor on any extremity with an arterial
catheter or blood pressure cuff.
If using pulse oximetry during full body irradiation, keep the
sensor out of the radiation field. If sensor is exposed to the
radiation, the reading might be inaccurate or the unit
might read zero for the duration of the active radiation
period.
Do not use the sensor during MRI scanning or in a MRI
environment.
High ambient light sources such as surgical lights
(especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct
sunlight can interfere with the performance of the sensor.
To prevent interference from ambient light, ensure that the
sensor is properly applied, and cover the sensor site with

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opaque material, if required. Failure to take this precaution
in high ambient light conditions may result in inaccurate
measurements.
High levels of COHb or MetHb may occur with a seemingly
normal SpO2. When elevated levels of COHb or MetHb are
suspected, laboratory analysis (CO-Oximetry) of a blood
sample should be performed.
Elevated levels of Carboxyhemoglobin (COHb) may lead
to inaccurate SpO2 measurements.
Elevated levels of Methemoglobin (MetHb) will lead to
inaccurate SpO2 measurements.
Elevated Total Bilirubin levels may lead to inaccurate SpO2
measurements.
Intravascular dyes such as indocyanine green or
methylene blue or externally applied coloring and texture
such as nail polish, acrylic nails, glitter, etc. may lead to
inaccurate SpO2 measurements.
Inaccurate SpO2 readings may be caused by severe
anemia, low arterial perfusion or motion artifact.
To prevent damage, do not soak or immerse the sensor in
any liquid solution.
Do not modify or alter the sensor in any way. Alteration or
modification may affect performance and/or accuracy.
Do not attempt to reuse on multiple patients, reprocess,
recondition or recycle Masimo sensors or patient cables as
these processes may damage the electrical components,
potentially leading to patient harm.
High oxygen concentrations may predispose a premature
infant to retinopathy. Therefore, the upper alarm limit for
the oxygen saturation must be carefully selected in
accordance with accepted clinical standards.

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1. Site Selection
Always choose a site that is well perfused and will completely cover the
sensor’s detector window.
Site should be cleaned of debris and dry prior to sensor placement.

LNCS, NeoPt-3 and NeoPt-500 Preterm Sensors


< 1 kg The preferred site is the foot. Alternatively, across the palm and back
of the hand can be used.

LNCS Neo, Neo-3 Neonatal/Adult Sensors


< 3 kg The preferred site is the foot. Alternatively, across the palm and back
of the hand can be used.
> 40 kg The preferred site is the middle or ring finger of non-dominant hand.

LNCS Inf, Inf-3 Infant Sensors


3-20 kg The preferred site is the great toe. Alternatively, the toe next to the
great toe, or the thumb can be used.

LNCS Pdtx and Pdtx-3 Pediatric Sensors


10-50 kg The preferred site is middle or ring finger of non-dominant hand.

LNCS Adtx and Adtx-3 Adult Sensors


> 30 kg The preferred site is the middle or ring finger of non-dominant hand.

2. Attaching the sensor to the patient:


Open the pouch and remove the sensor. Remove the backing from the
sensor, if present.

Figure 114

PRETERM (< 1kg) and NEONATES (< 3 kg)


For fragile skin, the stickiness of the medical grade adhesive can be
diminished or eliminated by daubing the adhesive areas with a cotton ball or
with gauze. This step does not apply to the NeoPt-500 (Refer to Figure
above).
Direct the sensor cable so that it either points away from the patient or runs
along the bottom of the foot. Apply the detector onto the fleshy part of the

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lateral aspect of the sole of the foot aligned with the fourth toe. Alternatively,
the detector may be applied to the top of the foot (not shown). Complete
coverage of the detector window is needed to ensure accurate data (Refer
to Figure below).

Figure 115

Wrap the adhesive/foam wrap around the foot and ensure that the emitter
window (red star) aligns directly opposite of the detector. Be careful to
maintain proper alignment of the detector and emitter windows while
attaching adhesive/foam wrap to secure the sensor (Refer to Figure below).

Figure 116

Verify correct positioning and reposition if necessary.

INFANTS (3 - 20 kg)
Direct the sensor cable so that it either points away from the patient or runs
along the bottom of the foot. Position the detector onto the fleshy part of the
great toe. Complete coverage of the detector window is needed to ensure
accurate data (Refer to Figure below).

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163
Figure 117

Wrap the adhesive wrap around the toe and ensure that the emitter window
(red star) aligns on the top of the toe directly opposite the detector (Refer to
Figure above).
Verify correct positioning and reposition if necessary.

PEDIATRIC (10 - 50 kg) and ADULT (> 30 kg)


Orient the sensor cable so that the detector can be placed first. Place the tip
of the finger on the dashed line with the fleshy part of the finger covering the
detector window. Press the adhesive wings one at a time onto the finger.
Complete coverage of the detector window is needed to ensure accurate
data (Refer to Figure below).

Figure 118

Fold the sensor over the finger with the emitter window (red star) positioned
over the fingernail. Secure the wings down one at a time around the finger.
When properly applied, the emitter and detector should be vertically aligned
(Refer to Figure below).

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Figure 119

Verify correct positioning and reposition if necessary (the black lines should
align).

3. Attaching the Sensor to the Patient Cable


Insert the sensor connector completely into the patient cable connector (1).
Completely close the protective cover (2) (Refer to Figure below).

Figure 120

4. Reattachment

ADULT AND PEDIATRIC


The sensor may be reapplied to the same patient if the emitter and detector
windows are clear and the adhesive still adheres to the skin.

INFANT AND NEONATAL


The adhesive tabs included with the LNCS Inf, Inf-L, Inf-3, Neo, Neo-L and
Neo-3 sensors are double sided adhesive tabs used when the stickiness of the
adhesive covering the optical components are no longer effective.
Place an adhesive tab over each window of the sensor with the white area
outside the adhesive area as shown, remove the protective paper that
covers each tab and reapply the sensor to the same patient (Refer to Figure
below).

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Figure 121

When the adhesive on the first set of tabs is no longer sticky, a second set
may be applied. Up to 3 sets of adhesive tabs may be applied to each
window, placing one on top of the other.
If the adhesive no longer adheres to the skin, use a new sensor.

NOTE: When changing application sites, or reattaching sensor, first


disconnect sensor from the patient cable.

5. Disconnecting the Sensor from the Patient Cable


Lift the protective cover to gain access to the sensor connector (1). Pull firmly
on the sensor connector to remove from the patient cable (2) (Refer to
Figure below).

Figure 122

Caution! To prevent damage, do not soak or immerse the sensor in any


liquid solution. Do not attempt to sterilize by irradiation, steam,
autoclave or any method other than ethylene oxide as indicated.

STERILIZATION
The LNCS Adtx, Adtx-3, Pdtx, Pdtx-3, Neo, Neo-L, Neo-3, NeoPt, NeoPt-L,
NeoPt-3, NeoPt-500, Inf, Inf-L and Inf-3 sensors have been validated for
sterilization by Ethylene Oxide (EO). The sensors may remain within their
pouch, or be wrapped in sterilization wrap, for the sterilization process. If a
sterilization wrap is used, only FDA-cleared sterilization wraps are to be used

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The following is the validated sterilization cycle:
Preconditioning Parameters
Temperature 54°C
Relative Humidity 40%
Vacuum Set Point 1.3 psia
Preconditioning Time 30 minutes
Sterilization Parameters
Temperature 54°C
Relative Humidity 40%
EO Concentration 600-750 mg/L
Gas Exposures Time (full cycle)
LNCS Adtx, Adtx-3, Pdtx or Pdtx-3 Wrapped or Pouched 120 Minutes
LNCS Inf, Inf-L, Inf-3, Neo, Neo-L,
Neo-3, NeoPt, NeoPt-L, NeoPt-3 or NeoP-500 Pouched 120 Minutes
LNCS Inf, Inf-L, Inf-3, Neo, Neo-L,
Neo-3, NeoPt, NeoPt-L, NeoPt-3 or NeoPt-500 Wrapped 180 Minutes
Aeration Time (full cycle) 12 Hours
Aeration Temperature 51-59°C

The Masimo logo sticker is located on the back part of the device.

On some monitors the label may look slightly different from that shown. If the label
is readable, there is no need to change it. The device is covered by one or more
of the U.S. Patents: 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785;
6,002,952; 6,036,642; 6,067,462; 6,206,830; 6,157,850 and other applicable patents.
If the label does not contain the Masimo patent information, visit the official web-
page http://masimo.com/patents.

Possession or purchase of this device does not convey any express or implied
license to use the device with replacement parts which would, alone, or in
combination with this device, fall within the scope of one or more of the patents
relating to this device.
The receiving party will obtain no right of any kind or license under any patent
application or patent by reason of this Manual. The license and right granted in
this Manual shall not be construed to confer any rights upon LICENSEE by
implication, estoppel, or otherwise as to any technology not specifically identified
in this Manual as Licensed Patents or Licensed Technology. All confidential
Information will remain the sole property of the party disclosing such information
or data.

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8.6.2 Nellcor Oximax SpO2 monitoring

1. Apply the sensor to the patient finger, avoiding excessive pressure. The
sensor cable should be set on the back of the finger and can be fixed on
the patient’s arm to reduce artifacts.
2. Remove colored nail polish from the application site.
3. Before monitoring ensure the pulse waveform is displayed on the monitor
screen.

Figure 123

Common sensor application and connection instructions

Attach SpO2 sensor to the SpO2 connector on the front panel of the monitor.
Apply the sensor so that the light emitter and the photo-detector are directly
opposite each other, avoiding excessive pressure. All light from the emitter must
pass through the patient’s tissue.
Application sites:
For adults and children (over 3 years): toe, fingers.
For neonates and infants (under 3 years): metatarsus, wrist, toe.
Sensor cable can be fixed to reduce artifacts.
Before monitoring ensure the pulse waveform is displayed on the monitor screen.
Otherwise any SpO2 values will be insufficient.

Figure 124

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Figure 125

Figure 126

It is important to ensure the sensor is fixed. You may use a strap or any other
appropriate materials to fix it. If required to avoid sensor contact with patient skin,
a finger cot, a thin white cloth or any other translucent materials can be used.

Activate the menu option “SpO2” and toggle to “On”. In the menu “DISPLAY”,
select “PLE” for one of the signals. The plethysmogram is displayed on the screen
in the field of selected signal and is yellow-colored. For the pulse rate monitoring
(not heart rate) enter the menu option “HR”, activate the menu option “HR
Source” and select the value “PLE”. HR will be calculated on the basis of the
plethysmogram.

Set the limits of SpO2 and HR alarms. You can change the limits either before or
during monitoring. As a signal is averaged it causes a delay in SpO 2 response
time. There is a delay of 10-20 seconds from the moment when the actual oxygen
saturation starts decreasing and to the moment when its value is changed on the
display.

In case of oxygen saturation is below 40% the validity of SpO2 readings is unsure.
Achieving data for calibration within this range is life-threatening for study volunteers.

Tone of audible signals of heart rate calculated on the basis of the


plethysmogram changes according to SpO2 value. A range of SpO2
measurement is divided into four intervals: from 100 to 95%, from 94 to 90%, from
89 to 85% and lower 85%. Each interval has its tone of audible signals: the lower

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SpO2 – the lower tone. To switch off the audible signal of heart rate indication,
press the key ALARM on the front panel of the monitor.

During SpO2 monitoring, observe perfusion indicator values (PI in SpO2 window)
and signal quality indicator values (SQI in SpO2 window). SpO2 and RR values are
reliable in case PI value is above 0.05%. In case PI value is under 0.05%, adjust
SpO2 sensor or change the application site (another finger, extremities). SQI value
can be displayed in three colors: green – conditions of pleth wave registration are
good enough, yellow - conditions of pleth wave registration are satisfactory, red -
conditions of pleth wave registration are bad. Usually bad registration conditions
are caused by improper SpO2 sensor application and also continuous motion
artifacts, exceeding amplitude of pulse waveform.

The device forms SpO2 trend and stores it into the memory (refer to TRENDS).

To set SpO2 alarm limits and priority, enter the menu option SpO2 (menu option
SpO2 and Alarm).

For cleaning and disinfecting sensors use substances and methods listed in the
chapter “Care and Cleaning”.

Warning! Do not use wet or damaged SpO2 sensors.

Do not use SpO2 sensors during MRT scanning. It may


influence the accuracy of SpO2 measurement and
scanning results.

Do not place SpO2 sensor on a damaged skin.

Do not apply SpO2 sensor and NIBP measuring on the same


limb.

Caution! Delay in SpO2 response time is caused by averaged signal.

Before monitoring ensure the pulse waveform is displayed


on the monitor screen. Otherwise any SpO2 values will be
insufficient.

Using any method of SpO2 sensor application you must


ensure that all light from the emitter passed through the
patient’s tissue reaches photodetector.

Avoid high level of ambient light (especially electric light


and/or light of changing intensity) where SpO2 sensor is
located.

Change SpO2 sensor application site every 3-4 hours to

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achieve reliable readings.

Too low arterial blood pressure, undercooling of limbs and


prolonged application of the sensor may result in too low
pulsatile flow that leads to incorrect measurements.

SpO2 sensor and its cable should be as far from the cables
of electrosurgical tool as possible.

Heart rhythm disorder may influence the accuracy of


taking pulse signal by pulse oximeter.

In case of oxygen saturation is below 40% the validity of


SpO2 readings is unsure.
Sat Seconds

Covidien (Nellcor) recommends developers to implement the use of SatSeconds


on the host system to reduce nuisance alarms.
SatSeconds monitors both degree and duration of desaturation as an index of
desaturation severity. Thus, the SatSeconds feature helps distinguish clinically
significant events from minor and brief desaturations that may result in nuisance
alarms.
SatSeconds technique
Set upper and lower % of SpO2 alarm limits by using traditional alarm
management. Then set the SatSeconds limit to activate the SatSeconds control
software. The SatSeconds algorithm calculates the SatSeconds integral every
second when the measured % of SpO2 exceeds alarm limit thresholds or after
returning to values within alarm limits.
The SatSeconds algorithm calculates the SatSeconds integral using the number of
percentage points that the % of SpO2 falls outside the alarm limit (depth) is
multiplied by the number of Seconds that the % of SpO2 remains outside that limit
(duration). This can be stated as an equation:
Points (depth) x Seconds (duration) = SatSeconds integral

Figure 127

Monitors alarm limit violations, waiting to alarm until an alarm limit violation of sufficient
depth and duration occurs, based on the cumulative depth and duration defined by

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SatSeconds limit settings. When three or more limit violations occur within 60 seconds,
an alarm sounds even if no violation of the SatSeconds limit setting occurs.

8.7 Monitoring of NIBP


In the monitor the oscillometric method is used for measuring NIBP: systolic (SYS),
diastolic (DIA), mean (MAP) (calculated automatically) and pulse.

Operation in the NIBP mode

Choose cuff for NIBP measurement in accordance with patient’s age (adult,
children, neonatal) with one or two tubes, as well as the following conditions: cuff
width must be not less than the diameter of limb in 20 - 50%.

Figure 128

Place the cuff on the patient’s shoulder so that the output of the connecting tube
was directed toward the elbow and was above the projection of the brachial
artery. The lower edge of the cuff should be at 2.5 cm above the elbow.

When the monitor is switched on, attach the cuff to NIBP connector on the front
panel of the monitor using air tubing.

Apply the cuff to a limb at the same level as the patient’s heart. The marking on
the cuff must match the artery location.

There are three methods of measuring NIBP:


Manual – the measurement is performed after the key “NIBP start/stop” is
pressed. The measurement is performed on demand. Results of
measurement are displayed in the window “NIBP”.
Auto – continually repeated measurements with intervals set in the menu
“NIBP”, option “Cycle NIBP”.
STAT - rapid series of measurements over a five minute period, then the
monitor returns to the previous mode (Auto or Manual).

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Using the submenu “NIBP” and option “NIBP mode”, set operation parameters of
NIBP.

The device forms NIBP trend and stores it into the memory (refer to TRENDS).

Warning! For measuring blood pressure of neonates use neonatal


mode and neonatal cuff only.

Avoid compression or restriction on the cuff and/or pressure


tubes during the measurement. It can lead to invalid data.

Do not place the cuff, intravascular catheter and/or the


intravenous drip of drugs on the same limb.

There are no contraindications for use.

Consider the risk of using the monitor when working with


pregnant patients.

It is forbidden to apply a cuff to the damaged skin.

It is forbidden to apply a cuff on the hand from the side of


the removed lacteal gland.

Inflating the cuff can cause loss of functioning of another


device on this limb (in case of such application).

Do not allow the inflation tube to be kinked that may allow


continuous cuff pressure and blood flow interference
resulting in injury.

Do not use NIBP module in the presence of flammable


anesthetics.

Do not operate the Monitor unless it has been properly


calibrated. Inaccurate blood pressure readings may result.
A calibration check is recommended once every year. A
pneumatic check is recommended once a year.

Do not alter the Monitor's air hose. Proper monitor


performance is not ensured if the tubing is altered.
Modification of the air hose will void the warranty. Avoid
compression or restriction of pressure tubes.

During the NIBP measurement, the patient should sit down,


remove the shoes, and the legs should be located on the
floor. Also, support should be provided for the arms and

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back, the cuff location should be on the right at the level of
the artery of the heart.
The patient should be relaxed and should not talk.
Before the start of the first measurement, a minimum of 5
minutes should elapse before the patient relaxes.
The operator must be not far from the monitor and patient.

Take into account that the measured values may depend


on the measurement site, the position and the
physiological condition of the patient. Upon receipt of
unexpected measured values, the operator must ensure
that they are correct.

Under normal climatic conditions of application,


environmental factors do not affect the measurement
results.

At higher temperatures, humidity, and height, the product


characteristics may be differ.

Incorrect setting of alarm limits may result in malfunctioning


of the alarm!

The operation of the electro-surgical device does not


affect the operation of the monitor. Protection from the
patient's fire is not provided.

The NIBP measuring channel was clinically examined in


accordance with ISO 81060: 2013.

Caution! The cuff (or air hose) can be connected after switching on the
monitor.

During the measurement, the limb on which the cuff is applied


should be monitored for the condition. In case of symptoms of
prolonged absence of blood supply (change in the color of the
skin), it is necessary to stop the process of measuring the pressure
and to loosen or remove the compression cuff from the limb.

With frequent use of the STAT regime, a sharp decrease in blood


supply to the limb is possible, which can lead to oxygen
starvation of the tissues of the corresponding limb.

Blood pressure and pulse can fluctuate greatly between


measurements; the Monitor cannot alert the user to changes in
blood pressure occurring between measurement cycles

A NIBP monitor does not operate effectively if a patient is having

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seizure activity, convulsions or tremors, or is connected to a
heart/lung machine

Error during NIBP measurement


If arterial blood pressure measurement failed, a cause is displayed under NIBP
indicators (see NIBP window).
8.8 “Venous puncture” mode
During operation in “Venous Puncture” mode the window Venous Puncture and
the remaining time till automatic deflation in the cuff are displayed instead of
NIBP window.

Figure 129

The following information is displayed in the window:


1. Name of monitored parameter (Venous Puncture);
2.Units (mmHg);
3. Countdown timer;
4. Message:
“Press <NIBP> to start” – displayed before starting Venous Puncture
mode
“Press <NIBP> to stop” – displayed after starting Venous Puncture mode
5. Current pressure in the cuff.

Venous puncture mode is used to block the peripheral blood circulation during
venous puncture.
Perform the following:
Place the cuff on the patient’s arm;
Set the required pressure value in the menu option “Venous Puncture
Level”;
Activate this mode in the menu “Venous puncture”;
Press the key “NIBP start/stop” on the front panel of the monitor.
Air deflating from the cuff will occur automatically no later than in 90, 120 and 180
seconds (respectively, in the modes - "Neonatal", "Children" and "Adult"), or
before the expiration of this time by pressing the NIBP start / stop button again ".

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“AIR LEAK” in case of air leakage in a cuff or a tube of NIBP system

“LOOSE in case of disconnected cuff or tube of NIBP system


CUFF”

“CRITICAL P” in case of excess of maximum-permissible pressure level, for


“Adult” mode – more than 280 mmHg, for “Neonatal” mode –
more than 150 mmHg.

Exit from the venous puncture mode is performed automatically in 2 minutes.

8.9 Monitoring of Temperature


Operation procedure
Apply a temperature probe to a patient:
It is recommended to fix a skin probe in axillary space using a strap;

Figure 130

It is recommended to fix a rectal probe in straight intestine: for adults 3-


5 cm, for neonates 1-1.5 cm.

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Figure 131

Attach the temperature sensor to the connector TEMP (TEMP1 or TEMP2


in case when two temperature channels are available).

Using the main menu, activate the temperature channel (or channels), setting
the value “ON” in the submenu “Temp” (“Temp1” and/or “Temp2” in case when
two temperature channels are available).
In case a temperature probe is applied correctly, the monitor will display stable
measurements of patient body temperature in 5 minutes.

The device forms TEMP trend and stores it into the memory (refer to TRENDS).

The required temperature alarm status and limits are set in the options TEMP and
TEMP low/TEMP high (submenu option TEMP and Alarm).

For cleaning and disinfecting temperature probes use substances and methods
listed in the chapter “Care and Cleaning”.

Warning! Do not place temperature probe on a damaged skin.

Caution! Metal part of the skin probe is its active part.

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8.10 Monitoring of IBP

TruWave Disposable Pressure Transducers manufactured by Edwards


Lifesciences are used for IBP monitoring.

Warning! Do not use other type of IBP transducers which differ from
type specified in this manual. Never reuse disposable
pressure transducers.

Make sure that the applied parts of IBP system never come
into contact with other electric parts or devices.

To avoid risk of harm to the patient health during high-


frequency surgical procedure, ensure that the monitor's
cables and transducers never come into contact with the
high-frequency surgical devices.
Operation procedure

Monitoring of IBP is carried out by disposable sensors.


Connect the IBP cable to the UniPort connector of the 2IBP module, and
the module, in turn, to the UniPort connector on the right side panel of the
patient monitor UM 300..

Figure 132

Remove the sensor and the connecting catheter from the sterile package,
observing the rules of asepsis.

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Figure 133

Disposable IBP transducer:


1. Line to patient
2. Stopcock
3. Transducer vent port
4. Snap-Tab device
5. Test port
6. To IV Set
7. IBP cable connector
8. Transducer case

Figure 134

Disposable connection catheter


1. To IV catheter,
2. Stopcock,
3. Connector for connecting to the IBP sensor.

Prepare the heparinized flush solution.


Using aseptic technique, remove the transducer and kit from the sterile
packaging.
Assemble the IBP monitoring system (transducer and connecting catheter)
and ensure all connections are secure.

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Connect the set to the bag with heparinized flush solution. Hang the bag
approximately 60 cm above the patient. This height will provide
approximately 45 mmHg of pressure that enough for initial setup.
Fill the drip chamber halfway with flush solution
Flush the system to exhaust all air from the tubing by turning the appropriate
stopcocks. Ensure that the transducer and stopcocks are free of air
bubbles.

Figure 135

1. IV pole
2. Pressurized bag with heparinized flush solution
3. Flushing set
4. Valve
5. IBP transducer
6. Stopcock
7. IBP catheter (pressure line)
8. IBP connection cable
9. Dual IBP connection module
10. Monitor

Caution! Significant distortion of the pressure waveform or air emboli


can result from air bubbles in the setup.

Filling the system

Transducer Vent Port must be closed.


Mount the transducer either on the patient’s body per hospital procedure
or on a pole using the appropriate clamp and holder.
Flush solution is passed to the set. Pressurize the flush solution bag
(recommended flow rate 3±1 ml/hr. with the bag pressurized to 300 mmHg)
or attach a syringe pump (infusion rate 3 ml/hr.).

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Pull the Snap-Tab device for fast-flush procedure
Connect pressure tubing to the catheter in accordantly to manufacturer’s
instructions.
Calibrate the transducer (see below).
Flush system per hospital policy.
Caution! After each fast-flush operation, observe the drip chamber
to verify that the continuous flush rate is as desired.

Zeroing and Calibration of IBP Sensor

Adjust the altitude level of the transducer vent port (the fluid-air
interface) to correspond height level of the vessel where pressure is
being measured. For example, in cardiac pressure monitoring, place the
transducer for zeroing procedure at level of the right atrium. This is at the
phlebostatic axis, determined by the intersection of the middle axillary
line and the fourth intercostal space.
Remove the non-vented cap and open the vent port to the
atmosphere.
Calibrate pressure transducer by activation of the IBP Calibration in the
proper menu of IBP channel, and ensure successful finalization of the
procedure.
Ensure that there are no air bubbles in the tubing system.
Turn back the vent port from the atmosphere and plug the non-vented
cap.
System is ready for pressure monitoring.

Routine maintenance

Follow hospital policies and procedures concerning frequency of transducer


zeroing, replacing and maintaining pressure monitoring lines. The TruWave
disposable pressure transducer (included in the kit) is precalibrated and has a
negligible drift with time.
Adjust zero pressure reference point every time when height level of the
patient is changed.

Caution! When rechecking zero or verifying accuracy, ensure that


non-vented cap is removed before opening the
transducer vent port to the atmosphere.

Periodically check fluid path for air bubbles. Make sure that connecting
lines and stopcocks remain tightly fitted.
Periodically observe the drip chamber to verify that the continuous flush
rate is as desired.
It is recommended to replace disposable transducers every 96-hours during
IBP monitoring. Replace other components of the system, including the
tubing, flushing set, and flush solution, at the time when the transducer is
replaced.

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In case you need to display IBP waveform, enter the submenu option and
set up IBP (IBP1 or IBP2) in one of enabled options Trace.

Example of mounting of the IBP transducer on a patient’s forearm:

Figure 136

The device forms IBP trend and stores it into the memory (refer to TRENDS
menu).
The setting of alarm limits for the IBP channel and its priority is carried out by
using the submenu "IBP".
For cleaning and disinfecting of the IBP cable use substances and methods
listed in the chapter “Care and Cleaning”.

Warning! Do not use IBP systems after the expired date of use. Expired date
use of IBP systems is mentioned on the package.
Do not use if package is opened or damaged.
Do not use flushing set during intracranial pressure monitoring.
Never reuse disposable pressure transducers.
Do not allow air bubbles to enter the system, especially during
atrial pressure monitoring.
Avoid contact with any cream or ointment that may destroy
polymeric materials.
Do not expose fluids to electrical connections.
Do not autoclave the reusable IBP cable
The operation of the electro-surgical device does not affect the
operation of the monitor. Protection from the patient's fire is not
provided.
If the defibrillator is used, the contact of the defibrillator
electrodes with the monitor electrodes is not allowed. Do not
touch the patient, the table or nearby table, equipment or the
system during defibrillation. The defibrillator discharge does not
affect the system settings.

Caution!
Use only recommended IBP monitoring sets mentioned in the list
of equipment.
The device can be equipped with two monitoring channels of
invasive blood pressure IBP1 and IBP2.
The volumetric displacement does not exceed 0.03 mm 3/100
mm Hg for a converter without a flow device.
Expiry date of IBP systems is mentioned on the package. Do not
use the systems after the expiry date is over.
For the accurate calibration, avoid excessive pressure in the
disposable system before the monitor is switched on. Connect

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the system to the patient after the monitor is switched on and
calibration procedure is completed successfully.
During CVP, LV, RV, RA, LA, ICP monitoring mode, a value of
mean pressure only available on the screen
Use syringe pump for accurate dosage of flush solution volume
to neonatal and infant patients.
The pressure above 300 mm Hg in the flushing system can lead to
excessive flow rates. As a result, a potentially dangerous increase
in blood pressure and an overdose of the liquid may occur.
IBP catheter can be obstructed by a blood clot if a pressure in
the flushing system is insufficient.
Pressure readings can change quickly and dramatically
because of loss of proper calibration, connection loose, or
air in the system

8.11 Monitoring of CO2


8.12 Sidestream CO2 monitoring
Operation procedure
Connect capnography module to connector (EtCO2) on the front panel of the
monitor.

Figure 137

Connect the receiving air tube to the appropriate connector on capnography


module.

Figure 138 Figure 139

Fixing the receiver air tube is attended by a click.

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Install the air adaptor in the breathing circuit.

Figure 140

Activate capnography channel in the menu "CO2" of the monitor (setting "ON").

In the window "Wave of gas concentration/impedance wave " - will be displayed


capnogram.

The receiving air tube should be changed in the operation process. Changed
tube when in the window “EtCO2” appears message "check sampling tube".

The device generates and stores EtCO2 trend in non-volatile memory of the
monitor (see "Trends").

Setting the operation limits and its priority of the EtCO2 channel alarm by using
the menu “EtCO2”.

For cleaning and disinfection of the adaptor and the receiver of the air tube,
materials and methods which are used - see the chapter "Care and
Maintenance."

Caution! If capnography module is not used for monitoring the


condition of the patient, keep the unit turned off. This will
prolong the life capnography module.

The optimal rate of pumping air - 50 ml/min set


automatically when you turn on the module.

The package includes a receiving room air tube for single


use.

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8.13 Monitoring of СО2 content in the main stream

Operating procedure

Capnography sensor connection rules:


Connect the capnography sensor connector to the CO2 connector on the
right side of the monitor.

Figure 141

Activate in the monitor the function of determining the content of carbon


dioxide in the inhaled and exhaled air, setting the submenu "CO2" in the
"CO2" option "On".
In the "Gas concentration / impedance curve" window, a capnogram will
be displayed in this case.
In the "EtCO2" window, "Capnograph warm up" will be displayed, and the
adaptor must be disconnected from the capnography sensor.
After preparing the capnography sensor, the inscription "Check the air
adaptor" is displayed on the monitor.

Figure 142

Put the capnography sensor on the air adaptor. To do this, insert the
capnography sensor into the air adaptor and squeeze until it clicks lightly. In
this case, the air adaptor must be disconnected from the breathing circuit.
Before connecting the sensor, make sure that the adaptor windows are
clean and dry. If necessary, clean the windows, or replace the adaptor.

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Figure 143

1. Capnography sensor;
2. The airway adaptor.

Calibrate the capnography sensor. To do this, activate the "Calibration"


item in the submenu "CO2" of the patient monitor. The "Calibration" window
will appear on the display, in the "EtCO2" window - the message
"Capnograph Calibration". Wait for the window to close.

During calibration, the adaptor with the sensor installed should be located
at a sufficient distance from any sources of CO2, including the patient,
physician, exhaust valves of the ventilator.

Install the air adaptor with capnography sensor into the breathing circuit,
between the triple adaptor of the breathing circuit and the angled
adaptor.

Figure 144

You can begin to monitor the carbon dioxide content in the inhaled and exhaled
air.

The device forms and stores the EtCO2 trend in the non-volatile memory of the
monitor.

Setting of alarm limits for EtCO2 channel and its priority is carried out with the help
of the submenu "EtCO2".

For the cleaning and disinfection of the capnography module, the substances
and methods which are used - see chapter "Care and maintenance".

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Warning! The disposable air adaptor is designed for single use. To avoid
inaccurate measurements, these adaptors are not allowed to
be reused or sterilized.

During the prolonged use of the air adaptor and its


contamination, the adaptor can be cleaned with running
water, the use of alcohols and alcohol-containing solutions is
strictly prohibited.

When installing and handling the air adaptor, avoid contact of


hands and objects with the optical windows of the adaptor.

DO NOT install the air adaptor immediately behind the


endotracheal tube to the corner adaptor!

Figure 121

Note! Place the capnography sensor only in an upright position.

When changing the air adaptor, a preliminary calibration of


the capnography sensor is necessary.

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8.14 Monitoring of anesthetic agents (mainstream mode)
For monitoring inspired and expired gases and anesthetic agents in mainstream
mode UM300 uses the IRMA multi-gas probe (produced by Masimo).

Figure 145

UM300 with connected the IRMA multi-gas probe is intended to display real time
and derived monitoring data of CO2, N2O, O2 and anesthetic agents (Halothane,
Isoflurane, Sevoflurane and Desflurane). It is intended to be connected into a
patient breathing circuit for monitoring of inspired/expired gases during
anesthesia, recovery and respiratory care. It may be used in the operating room,
intensive care unit, patient room and emergency medicine settings for adult,
pediatric and infant patients.

Ranges of gases concentration measuring


СО2 - from 0 to 15%
N2O - from 0 to 100%
O2 - from 0 to 100%
Hal - from 0 to 8%
Iso: - from 0 to 8%
Des: - from 0 to 22%
Enf: - from 0 to 8%
Sev: - from 0 to 10%

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Alarms
UM300 sets limits and controls alarms conditions (see also menu ”CO 2 &Gas
module”)
Alarm Alarm
Name of condition condition
Controlled parameters alarm limits priority for priority for
in menu low gas high gas
level level
Inspired halogenated anesthetic agent AAg Medium Medium
Exhaled CO2 EtCO2 Medium Medium
Inspired CO2 FiCO2 Medium
Inspired nitrous oxide N2O Medium Medium
Inspired O2 O2 Medium Medium
Inspired O2 < 18% High
Multiple halogenated anesthetic agent
Medium
present
APNEA detection High

Status of the IRMA multi-gas probe


Description of the status LED situated on the IRMA sensor head
Steady green light System is OK
Blinking green light
(IRMA AX+/OR+ Zero Reference check is in progress
only)
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adaptor

System assembly instruction


Plug the IRMA connector into the IRMA input of the monitor UM300 or to the
UniPort by special module and switch the power on
Snap the IRMA sensor head on top of the IRMA airway adaptor. It will click
into place when properly seated.

Figure 146

A green LED indicates that the IRMA sensor is ready for use.
Connect IRMA airway adaptor’s 15 mm male connector to the breathing
circuit Y-piece.

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Figure 147

Connect IRMA airway adaptor’s 15 mm female connector to the patient’s


endotracheal tube.

Figure 148

Always position the IRMA sensor with the O2 cell pointing upwards.

Figure 149

Cleaning
The IRMA sensor can be cleaned by using a cloth moistened (not wet) with max
70% ethanol or 70% isopropyl alcohol. Always remove the Airway Adaptor before
cleaning.
Preventive maintenance
Oxygen sensor replacement:
Replace the oxygen sensor every four months or whenever the oxygen
readings are questionable.
Oxygen sensors for replacement should be stored in a cold environment (+
2 ºC - +8 ºC) and should be taken into operation before USE-BY date
printed on the package.
To replace the oxygen sensor, remove the depleted oxygen sensor by using
a screwdriver and turn in a counter-clockwise direction. Remove the
depleted sensor and carefully screw the new oxygen sensor into position.

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The oxygen sensor contains chemical substances and shall be disposed
according to local regulations for batteries. Do not leave depleted oxygen
sensors mounted in the IRMA probe, even if the probe is not in use.
Be sure to perform a Room air calibration of the oxygen measurement after
replacing the oxygen sensor.
Gas span check
Gas measurements should be verified at regular intervals with a reference
instrument.

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Zeroing Procedure:
Zeroing of IRMA CO2/ICU probes:
Zeroing needs to be performed ONLY when an offset in gas values is
observed, or when an unspecified gas accuracy message is displayed.
Allow 15 minutes for warm up of the IRMA CO2/ICU probes after power on
before proceeding with the Zeroing Procedure.
Allow the IRMA probe to warm up for at least 1 minute after changing
airway adaptor before transmitting the Zero Reference calibration
command.
Zeroing is performed by snapping a new IRMA adaptor onto the IRMA
probe, without connecting the airway adaptor to the patient circuit, and
then using the patient monitor UM 300 to transmit a Zero Reference
command to the IRMA probe.
Avoid breathing into adaptor during the Zero Reference calibration.
Always perform a pre-use check after Zeroing the probe.

Zeroing of IRMA AX/OR probes:


Zeroing should be performed every time the IRMA airway adaptor is
replaced or whenever an offset in gas values is observed, or an unspecified
gas accuracy message is observed.
Allow 15 minutes for warm up of the IRMA AX/OR probes after power on
before proceeding with the Zeroing Procedure.
Allow the IRMA probe to warm up for at least 1 minute after changing
airway adaptor before transmitting the Zero Reference calibration
command.
Zeroing is performed by snapping a new IRMA adaptor onto the IRMA
probe, without connecting the airway adaptor to the patient circuit, and
then using the patient monitor UM 300 to transmit a Zero Reference
command to the IRMA probe.
Avoid breathing into adaptor during the Zero Reference calibration.
Always perform a pre-use check after Zeroing the probe.

Zeroing of IRMA AX+/OR+ probes:


Zeroing should be performed every time the IRMA airway adaptor is
replaced or whenever an offset in gas values is observed, or an unspecified
gas accuracy message is observed.
Allow 15 minutes for warm up of the IRMA AX+/OR+ probes after power on
before proceeding with the Zeroing Procedure. The green LED on the
probe will be blinking for approximately 5 seconds while Zeroing is in
progress.
Allow the IRMA probe to warm up for at least 1 minute after changing
airway adaptor before transmitting the Zero Reference calibration
command.
Zeroing is performed by snapping a new IRMA adaptor onto the IRMA
probe, without connecting the airway adaptor to the patient circuit, and

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then using the patient monitor UM 300 to transmit a Zero Reference
command to the IRMA probe.
Avoid breathing into adaptor during the Zero Reference calibration.
Always perform a pre-use check after Zeroing the probe.

Warning! The IRMA sensor is intended for use by authorized and


trained medical personnel only.

The IRMA sensor must not be used with flammable


anesthetic agents.

Disposable IRMA airway adaptors shall not be reused. Used


disposable airway adaptors shall be disposed of in
accordance with local regulations for medical waste.

Use only PHASEIN manufactured oxygen sensor cells.


Depleted oxygen sensors shall be disposed of in
accordance with local regulations for batteries.

Do not use the IRMA Adult/Pediatric airway adaptor with


infants as the adaptor adds 6 ml dead space to the patient
circuit.

Do not use the IRMA Infant adaptor with adults as this may
cause excessive flow resistance.

Measurements can be affected by mobile and RF


communications equipment.

It should be assured that the IRMA probe is used in the


electromagnetic environment specified in this manual.

Do not place the IRMA airway adaptor between the


endotracheal tube and an elbow, as this may allow patient
secretions to block the adaptor windows and result in
incorrect operation.

To keep secretions and moisture from pooling on the


windows or oxygen sensor port, always position the IRMA
airway adaptor with its windows in a vertical position and
the IRMA oxygen sensor pointing upwards.

Do not use the IRMA airway adaptor with metered dose


inhalers or nebulized medications as this may affect the
light transmission of the airway adaptor windows.

Do not try to open the oxygen sensor assembly. The oxygen


sensor is a disposable product and contains a caustic

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electrolyte and lead.

The IRMA probe is intended only as an adjunct in patient


assessment. It must be used in conjunction with other
assessments of clinical signs and symptoms.
Incorrect probe zero calibration will result in false gas
readings.

Incorrect agent selection by the user for IRMA AX/OR (no


automatic agent identification) will result in false agent
readings.

Using IRMA AX/OR (no automatic agent identification) with


gas mixtures containing more than one agent will result in
false agent readings.

Replace the adaptor if rainout/condensation occurs inside


the airway adaptor.

Note! Never sterilize or immerse the IRMA probe in liquid.

The IRMA oxygen sensor cell and IRMA airway adaptors


are non-sterile devices. Do not autoclave the devices as
this will damage them.

Do not apply tension to the probe cable.

Do not operate immerse the IRMA probe outside the


specified operating temperature environment.

Do not leave depleted oxygen sensors mounted in the


IRMA probe, even if the probe is not in use.

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8.15 Monitoring of anesthetic agents (sidestream mode)
For monitoring inspired and expired gases and anesthetic agents in sidestream
modeUM300 uses the ISA multi-gas probe.

UM300 with connected the ISA multi-gas probe is intended to be connected to a


patient breathing circuit for monitoring of inspired/expired gases during
anesthesia, recovery and respiratory care.

The ISA product family consists of different types of sidestream gas analyzers,
intended to be connected to other medical devices for display of real time and
derived monitoring data of a selection of CO2, N2O, O2 and the anesthetic
agents Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. It may be
used in the operating suite, intensive care unit, patient room and for applicable
versions emergency medicine/ emergency transport settings for adult, pediatric
and infant patients.

а) b) c)
Figure 150

а) ISA AX+ – CO2, N2O, 5AA, AA ID,


b)ISA CO2 – CO2,
c)ISA OR+ – CO2, O2, N2O, 5 AA, AA ID

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Alarms
UM300 sets limits and controls alarms conditions (see also menu ”CO 2&Gas
module”)
Alarm
Alarm
Name of condition
condition
Controlled parameters alarm limits priority for
priority for
in menu low gas
high gas level
level
Inspired halogenated anesthetic agent AAg Medium Medium
Exhaled CO2 EtCO2 Medium Medium
Inspired CO2 FiCO2 Medium
Inspired nitrous oxide N2O Medium Medium
Inspired O2 O2 Medium Medium
Inspired O2 < 18% High
Multiple halogenated anesthetic agent
Medium
present
APNEA detection High
Status of the ISA multi-gas probe
Indication Status
Steady green light System is 1OK
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line

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System assembly instruction
To set up the UM 300 for gas analysis, follow these steps:
Connect the ISA analyzer interface cable to the Patient monitor UM 300.
Connect a Nomoline sampling line to the ISA analyzer input connector.

Figure 151

Connect the gas sample exhaust port to a scavenging system or return the
gas to the patient circuit.
Power up the Patient monitor UM 300.
A green LED indicates that the ISA analyzer is ready for use.
Perform a pre-use check as described in section below.

Warning! Always check the ISA gas analyzer is mounted on the UM


300 in fixed position by means of the special holder.

Cleaning
ISA sidestream gas analyzers could be cleaned on a regular basis.
Use a cloth moistened (not wet) with max 70% ethanol or 70% isopropyl alcohol to
clean the analyzer.
To prevent cleaning liquids and dust from entering the ISA gas analyzer through its
LEGI connector, keep the Nomoline sampling line connected while cleaning the
analyzer.

Note! The Nomoline sampling lines are non-sterile devices. To


avoid damage, do not autoclave any part of the
sampling line.

Never sterilize or immerse the ISA sidestream gas analyzer


in liquid.

Replacement of sample line


The Nomoline sample line is non-reusable.
Every two weeks or whenever a “Sample line clogged” message appears on the
UM300, whichever comes first, the Nomoline sample line should be replaced.

Warning! Always use a bacteria filter on the exhaust side if sampled


gas is intended to be re-breathed.

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Pre-use check
Before connecting the Nomoline sampling line to the breathing circuit, do the
following:
1. Connect the sampling line to the ISA gas inlet connector (LEGI)
2. Check that the LEGI shows a steady green light (indicating that the system
is OK) for ISA OR+ and ISA AX+ module with O2 option fitted:
14. Check that the O2 reading on the monitor is correct (21%).
3. Breathe into the sampling line and check that valid CO2 waveforms and
values are displayed on the Patient monitor UM 300.
4. Occlude the sampling line with a fingertip and wait for 10 seconds.
5. Check that an occlusion alarm is displayed and that the LEGI shows a
flashing red light.
6. If applicable: Perform a tightness check of the patient circuit with the
sampling line attached.
Preventive maintenance
The ISA sidestream gas analyzers are permanently factory calibrated. The
analyzers stable design, results in no routine calibrations. However, to meet any
local or specific customer requirements, a basic maintenance plan is nevertheless
highly recommended. This section specifies a number of maintenance tasks that
can be performed on an annual basis.

Several of the recommended maintenance tasks require the use of a suitable


calibration gas mixture. A cylinder containing such mixture may be acquired from
the vendor of your choice, provided the following gas concentrations and
accuracy. Depending on your application, either a CO2 or a multigas calibration
gas mixture shall be used:

ISA CO2 gas analyzers ISA multigas analyzers


Gas Concentration Gas Concentration
CO2 4 to 11 % CO2 4 to 11 %
O2 45 to 100 % N2O 30 to 100 %
DES 2 to 10%
O2 45 to 100 %
Accuracy for all gases: ±0.03 vol% or ±(0.02 vol% + 0.1% of reading), whichever is
greatest.

Warning! Since a successful zeroing requires the presence of ambient


air (21% O2 and 0% CO2) in the gas analyzer, ensure that
the ISA is placed in a well ventilated place. Avoid
breathing near the ISA sidestream gas analyzer before or
during the zeroing procedure.

The ISA sidestream gas analyzer is intended for use by


authorized and trained medical personnel only.

Use only Nomoline sampling lines manufactured by

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PHASEIN.

The ISA sidestream gas analyzer must not be used with


flammable anesthetic agents.

Carefully route the sampling line to reduce the risk of


patient entanglement or strangulation.

Do not re-use disposable sampling lines.

Do not lift the Patient monitor UM 300 by the sampling line


as it could disconnect from the monitor, casing the monitor
to fall on the patient.

Used disposable sampling lines shall be disposed of in


accordance with local regulations for medical waste.

Do not use adult/pediatric type sampling line


configurations with infants, as this may add dead space to
the patient circuit.

Do not use infant type sampling line configurations with


adults, as this may cause excessive flow resistance.

Do not use the ISA sidestream gas analyzer with metered-


dose inhalers or nebulized medications as this may clog the
bacteria filter.

Check that the gas sample flow is not too high for the
present patient category.

Since a successful zeroing requires the presence of ambient


air (21% O2 and 0% CO2) in the gas analyzer, ensure that
the ISA is placed in a well ventilated place. Avoid
breathing near the ISA sidestream gas analyzer before or
during the zeroing procedure.

Measurements can be affected by mobile and RF


communications equipment.

Make sure that the ISA sidestream gas analyzer is used in


the electromagnetic environment specified in this manual.

ISA sidestream gas analyzer is intended only as an adjunct


in patient assessment. It must be used in conjunction with
other assessments of clinical signs and symptoms.

Replace the sampling line if the sampling line input

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connector starts flashing red, or a Nomoline occlusion
message is displayed on the host monitor.

No modification of this equipment is allowed without


authorization of the manufacturer. If this equipment is
modified, appropriate inspection and testing must be
conducted to ensure continued safe operation.

ISA sidestream gas analyzers are not designed for MRI


environments.

During MRI scanning, the Patient monitor UM 300 must be


placed outside the MRI suite.

Operating high frequency electrosurgical equipment in the


vicinity of the monitor may produce interference and
cause incorrect measurements.

Too strong positive or negative pressure in the patient


circuit might cause incorrect readings and internal
damage.

Strong scavenging suction pressure might cause incorrect


readings and internal damage.

Exhaust gases should be returned to the patient circuit or a


scavenging system.

Do not place the ISA gas analyzer in any position that might
cause it to fall on the patient.

Note! The Nomoline sampling line and its interfaces are non-
sterile devices. To avoid damage, do not autoclave any
part of the sampling line.

Do not apply tension to the ISA sidestream gas analyzer


cable.

Do not operate the ISA sidestream gas analyzer outside


the specified operating temperature environment.

Never sterilize or immerse the ISA sidestream gas analyzer


in liquid.

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8.16 Monitoring of Bispectral Index (BIS)
The Bispectral Index (BIS) is a measure of the effects of anesthesia and sedation
on the brain. The BIS sensor is placed on the forehead of the patient with a
specific orientation over either the left or right hemisphere after minimal skin
preparation. The BIS sensor detects EEG signals that are used to obtain numerical
values, including BIS values, which shows the level of patient consciousness.
Technical Specifications
BISx allows to receive EEG waveform and the following parameters:
1. Bispectral Index (BIS)
The Bispectral Index is a continuous processed EEG parameter that
correlates to the patient’s level of hypnosis, where 100=awake and 0=flat line
EEG.
2. Signal Quality Indicator (SQI)
The Signal Quality Indicator (SQI) is a measure of the signal quality for the
EEG channel source. SQL provides information about values of BIS, SR, BC
complexes. When signal quality is too low to accurately calculate a BIS value, the
BIS value and other trend variables that are adversely affected by artifact will not
be displayed on the screen.
3. Electromyograph (EMG)
The EMG bar graph displays the power (in decibels) in the frequency range
70 - 110 Hz. This frequency range contains power from muscle activity as well as
power from other high-frequency artifacts.
4. Suppression Ratio (SR)
The Suppression Ratio (SR) is the percentage of time over the last 63-second
period that the EEG signal is considered to be in the suppressed state.
5. Burst Count (BC)
Burst Count (BC) is an alternative method of quantifying suppression, reported as
the number of EEG bursts per minute. The system defines a “burst” as a short
period of EEG activity, preceded and followed by periods of inactivity.
Safety precautions

Warning! Due to elevated surface temperature, do not place BISx in


prolonged direct contact with patient’s skin, as it may
cause discomfort. The conductive parts of electrodes or
sensor and connectors should not contact other
conductive parts, including earth.

To reduce the hazard of burns during use of high frequency


surgical equipment, the sensor or electrodes should not be
located between the surgical site and the electro-surgical
unit return electrode.

The sensor must not be located between defibrillator pads


when a defibrillator is used on a patient connected to the
BISx system.

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To minimize the risk of patient strangulation, the patient
interface cable (PIC) must be carefully placed and
secured.

Do not open BISx for any reason. The seal to prevent liquids
from entering the BISx may be damaged if opened.

Service or repairs must be performed only by qualified


biomedical technicians.

Considerations when using Electro-Convulsive Therapy


(ECT) equipment during BIS monitoring: Place ECT
electrodes as far as possible from the BIS sensor to minimize
the effect of interference.

When connecting or disconnecting BISx, take care not to


touch the exposed contacts of either connector. Damage
due to electrostatic discharge may result.
Care and Cleaning
Clean any spillage of blood or solutions on either the monitor or BISx as soon as
possible. Dried blood is very difficult to remove. Use lint-free absorbent towels for
spill cleanups. Dampen the towel with detergent and lukewarm water to aid in
cleaning. After cleaning, wipe the PIC connector ends with alcohol and allow to
dry completely!

Warning! Medical equipment will be made in after-sales service only


after cleaning and disinfection of the main unit and
sensors. Repairs are not carried out, and the equipment is
returned to the customer in case of violation of this
requirement.

Operation procedure
After you have familiarized yourself with the safety information in the introductory
section of this manual, prepare a suitable environment, properly connect the BISx
and PIC cables to UM-300.

Follow these steps to prepare the BISx Monitoring System for operation.
1. Startup and System Check. Press the « » button on the monitor to start
the monitor.
2. Attach BIS Sensor to Patient.

Figure 152

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202
Prepare sensor site and place the BIS sensor on the patient in accordance with
the instructions included on the sensor packaging.

Caution! The BISx Monitoring System has been designed to operate


with a BIS sensor. The sensor is a silver/silver chloride
electrode array that utilizes Aspect's patented Zipprep
technology and uses a proprietary connector. Use of other
electrodes is not recommended.

Warning! The conductive parts of electrodes or sensor and


connectors should not contact other conductive parts,
including earth.

To reduce the hazard of burns during use of high-frequency


surgical equipment, the sensor or electrodes should not be
located between the surgical site and the electro-surgical
unit return electrode.

The sensor must not be located between defibrillator pads


when a defibrillator is used on a patient connected to the
BISx system.
To minimize the risk of patient strangulation, the patient
interface cable (PIC) must be carefully placed and
secured

3. Secure the BISx. Using the attachment clip, secure the BISx to a
convenient location near the patient's head.
4. Attach the BIS Sensor to the PIC

Figure 153

To insert the sensor into the PIC, line up as shown and insert the sensor tab into the
PIC sensor connector until an audible “click” is heard. The Sensor Integrity Check
is initiated each time that a sensor is connected to the PIC to make certain that a
valid, unexpired sensor is in use.

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5. Sensor Check

The Sensor Check tests the impedance of each electrode on the BIS sensor to
verify that it is within an acceptable range for monitoring. A Sensor Check is
initiated automatically when the sensor and PIC are connected to the BISx. It may
also be initiated by the user by selecting step «Check BIS Sensor» at the BIS
submenu.

The message, “Sensor Check in Progress” appears. When the sensor successfully
passes the test, the Main Screen displays and monitoring begins. If the sensor does
not immediately pass the test, or if the user has manually initiated the test, the
Sensor Check Graphic Screen displays. This screen shows the sensor with each
electrode numbered. Colors indicate the status of each electrode:

Figure 154

Hollow circle – No status is available. The electrode label will appear after a few
seconds.
Green circle– The electrode impedance is within the acceptable range. When all
circles are green, monitoring can begin.
Red circle – The electrode impedance is not within the acceptable range. Press
the edges of the sensor to ensure adhesion and then press each circle for 5
seconds to ensure proper contact. Check all connections. If the problem persists,
remove sensor, clean skin thoroughly, and reapply sensor or apply new sensor in
accordance with instructions on the sensor packaging.
Gray circle - The electrode impedance cannot be determined due to electrical
interference (noise) from another source. Monitoring will not commence until the
source of the noise has been removed and all electrodes have passed the sensor
check.

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If the user has requested the Sensor Check and all electrodes pass the test, the
circles return to their original display color (green) and the label, “PASS” displays
at the bottom of the screen.

Figure 155

In this display, the impedance value for each electrode, in kilo Ohms,
appears on the screen along with its status:
PASS - An electrode passes if the impedance for that electrode is less than 7.5 kilo
ohms. The ground electrode (electrode #2) must be less than 30 kilo ohms to pass.
HIGH - An electrode is labeled “HIGH” if its impedance value is above 7.5 kilo
ohms (30 kilo ohms for the ground electrode). As long as the combined
impedance of electrodes #1 and #3 and the combined impedance of
electrodes #1 and #4 is less than 30 kilo ohms, the sensor check will be
considered successful.
NOISE - If the signal from the electrode goes beyond the measurable range.
POOR CONTACT - The electrode is not in contact with the patient.
To return to the previous display, press the «MAIN SCREEN» key. IT ALLOWs you to
exit the test before the end of the sensor check, but the sensor check may be
completed successfully for normal monitoring.

BISx monitoring
Monitor UM300 displays EEG-waveforms, the window of BISx, time trend changes
in the basic design parameters for the BISx channel, the Bispectral Index – BIS, the
Signal Quality Indicator – SQI, the Electromyograph – EMG, the Suppression Ratio
– SR, the Burst Count – BC

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BISx trends
Trends allow us to observe the dynamics of changes in the basic parameters of
the BISx channel for the last hour. Trends can display the BIS, EMG, SR, SQI
waveforms (set menu).
BISx Trend Data Screen

10
Figure 156

The window displays:


1. EEG sensitivity scale
2. Indication of displayed waves
3. Main waves (EEG1, EEG2)
4. Sweep speed of the waves
5. Window of BIS trends
6. Monitored parameter (EMG)
7. Units (dB)
8. Monitored parameter (BIS)
9. Value of BIS
10. Time
11. Value of EMG
12. Status bar

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Note! In the EEG1 and/or EEG2 display mode, only 4 curves are
displayed in the curve window, with the possibility to select the
curve of the monitored parameter (ECG, PLE, IBP (IBP1, IBP2,
IBP3 and / or IBP4), EEG1 and EEG2)
How the BISx Monitoring System Works
A sensor placed on the patient’s head transmits EEG signals to the BISx. The BISx
filters the data, analyzes it for artifact and processes it using digital signal
processing techniques, then sends the data to the monitor for display. The
purpose of processing the EEG waveform data is to extract characteristic features
from the complex signal in order to provide easier pattern recognition of changes
over time during the recording. These data are displayed on the screen
according to the preferences set by the user in the menu system.

Figure 157

BISx and Patient Interface Cable


The BISx receives, filters, and processes patient EEG signals. It is located close to
the patient's head where the EEG signal is less subject to interference from other
medical equipment.
The BISx is shown in Figure 135. Its long flexible Monitor Interface Cable connects
to the front of the monitor. The Patient Interface Cable (PIC) connects the BIS
sensor to the BISx.
The attachment clip on the BISx is used to secure it in a convenient location near
the patient's head.

Caution! Do not open BISx for any reason. The seal to prevent liquids
from entering the BISx may be damaged if opened.
Service or repairs must be performed only by qualified
biomedical technicians.
BIS Sensors
The sensor is the single use component of the BIS Monitoring System and should
be replaced after each use. For details on how to apply the sensor to the patient
and how to connect to the BIS Monitoring System, refer to the BIS Sensor’s
instructions of use.

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BIS Patient's clinical condition
Awake
100
Responds to normal voice
Moderate sedation
80 Responds to loud commands or mild
prodding/shaking
General Anesthesia
60 Low probability of explicit recall
Unresponsive to verbal stimulus
40 Deep Hypnotic State
20 Burst Suppression
0 Flat Line EEG

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8.17 Measurement of hemodynamic parameters using thermodilution
Measured parameters:
C.O. (Cardiac Output);
SV (Stroke Volume);
CI (Cardiac Index);
SVI (Stroke Volume Index);
Values of several measurements are averaged if needed.
Working with the channel for measuring the parameters of central
hemodynamics using the thermodilution method begins with pressing the "CO"
field on the main screen of the device. After that the "Parameters" window
becomes available.

Thermodilution mode windows


Window “Parameters”
The window is used to enter bolus parameters, patient anthropometric data,
Swan-Ganz catheter constant, clear records of previous measurements.

Figure 158

You can perform the following operations in the window “Parameters”:


Enter the injection volume (from 3 to 20 ml) against the option “Volume,
ml”;
A mark is put against the option “Temperature, ºC” in case injection
temperature is entered manually (button “Auto” is not activate, the
window is grey with white circle in the left upper corner of the button). If the
option is not activate, injection temperature is automatically measured by
injectate temperature probe;
Injection temperature is displayed against the option “Auto”. When the
window of the option “Temperature, ºC” is blue, injection temperature

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window is active and data are entered manually. Otherwise the window is
blocked, data received by injectate temperature probe are displayed;
Computational constant (is given in accompanying documents of Swan-
Ganz Catheter) is entered against the option “Comp constant”;
Patient height (needed to calculate a body surface area) is entered
against the option “Height, cm”;
Patient weight (needed to calculate a body surface area) is entered
against the option “Weight, kg”;
Result of patient body surface calculation based on height and weight
data and formulas of Gehan and George is displayed against the option
“BSA” or entered, if calculated manually;
“Apply” – when activated, entered data are used for calculations after
confirmation.

The following messages are displayed in the window “Thermodilution”, when the
window “Parameters” is activated:
“Check injectate temperature probe is in solution” is displayed when “Set
temperature” is not marked;
“Set injection temperature manually” is displayed when “Set temperature”
is marked;
“Set injection temperature manually. Probe is not connected!” is displayed
when injectate temperature probe is disconnected.
Data input in the window “Parameters”
1. Use the “Encoder Button” or touch screen to operate throughout the
windows:
2. Rotating the Encoder Button, select a window for data input (a window is
grey, a value is white);
3. Press the Encoder Button to activate a selected window (a window is blue,
a value is white);
4. Or Press the on touch screen to activate a selected window.
5. When a window with numeric value is activated, an input line appears in
the window: numbers from 0 to 9, dot, symbols “BS” and “Enter”.
6. Rotating the Encoder Button or pressing the touch screen, select a required
option (blue background, white symbols). When numbers and the dot are
selected and activated (the Encoder Button is pressed), the data are
entered in the window of parameter, being changed. When “Del” option is
activated, a selected symbol (number or dot) is deleted in the window of
parameter, being changed. Activate “Enter” option to confirm the input
and close the input line.
Automatic registration of injection temperature
This option is activate (button “Auto” is grey with little blue circle in the left upper
corner of the button).
Use a bolus temperature catheter.
Place injectate temperature probe in a solution with the same temperature as
injection temperature. Place the probe in solution before you start the
measurement (before you press “Start” pop-up key) for at least 1 minute.

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When injection temperature is determined by temperature probe, the values of
the window “Parameters” and a message “Check injectate temperature probe is
in solution” are displayed in the window “Confirmation”.
Window “Thermodilution”
Measurement process and measurement results are displayed in the window.

Figure 159

The window includes:


Name of the window (on top: white letters, blue background);
Operation part (black background);
Status line (below: black letters, white background).

1. Operation part includes:


Scale of the dilution curve (in black frame with timestamp of
measurement). The scale is changed during measurement;
Input data of injection and a patient (white symbols in a frame on the left
below);
Results of measurement (in white frame on the right below: hemodynamic
parameters, units, parameters values (black symbols));
Pop-up keys (grey or blue background, white letters);
“Start/Stop” – to begin/stop the measurement;
“Parameters” – to open the window “Parameters”. When measurement is
started, parameters editing is blocked;

2. The following messages are displayed in status line:


“Press Start to begin measurement” is displayed after the window
“Thermodilution” is opened by the first measuring;
“Preparing to measuring. Wait” – checking module availability;

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“Faulty module” is displayed when measurement line of hemodynamic
parameters is damaged;
“Error: Injectate temperature probe not ready or not connected!” is
displayed when injectate temperature probe is not connected or not
ready (no reliable data of solution temperature – the probe is in solution less
than 1 minute);
“Error: Catheter not ready or not connected!” is displayed when Swan-
Ganz catheter is not connected or not ready (no reliable data of blood
temperature – catheter is in blood vessel less than 1 minute);
“Inject now!” is displayed when the system is ready to begin measuring.
Start injecting within 10 seconds;
“Error: Injection not registered!” is displayed when no change of blood
temperature in the pulmonary artery is observed within 10 seconds after
“Start” pop-up key is pressed;
“Warning: Not enough data for calculating parameters!” is displayed when
measuring is interrupted by pressing “Stop” pop-up key and acquired data
are insufficient for accurate calculation of hemodynamic parameters;
“Error: Measurement time over!” is displayed when blood temperature has
not reached the initial value after injection within 1 minute after “Start”
pop-up key is pressed;
“Measurement complete. Ready for new measurement!” is displayed after
measurement is complete and indicates that the system is ready to perform
the next measurement;

Results of the last measurement are displayed before the next one.
Setting up measurement:
1. Connect the Svan Ganz catheter connecting cable and the temperature
sensor cable to the corresponding connectors on the front panel of the
cardiac output module, and the module, in turn, to the universal UniPort
connector on the right side panel of the UM 300 monitor.

Figure 160

2. Prepare and connect IBP transducers to the monitor (see Monitoring IBP).
3. Activate IBP module.
4. Calibrate IBP transducers (see Monitoring IBP).
5. Using aseptic technique, remove thermodilution catheter (Swan-Ganz
catheter) from the sterile packaging and connect it C.O. cable.

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6. Attach IBP systems to the cannulas of Swan-Ganz catheter (IBP1 to the
cannula “DISTAL” – yellow tube, IBP2 to the cannula “PROXIMAL” – blue
tube). Fill Swan-Ganz catheter with heparinized flush solution through IBP
systems. Do not allow air bubbles to enter IBP systems and Swan-Ganz
catheter.

Figure 161

7. After preparing the transducers, place Swan-Ganz catheter per hospital


procedure.
Performing Measurements
1. After installing the Swan-Ganz catheter, activate the "Thermodilution" item
in the "Channels" menu on the monitor screen.
2. The "Thermodilution" window will open and the "Options" window will
appear automatically above it. Enter the required data.
3. Confirm the data by clicking on the "Apply" button, pay attention to the
parameters of the bolus temperature. If the bolus temperature is
automatically measured, make sure that the temperature sensor is in
solution..
4. In the "Thermodilution" window, activate the virtual "Start" button. After the
appearance of the inscription in the status line "Enter bolus!" Within 10
seconds, start the bolus injection using the method established in the
hospital.
5. If the bolus is not started within 10 seconds, an error message will appear in
the status bar of the Thermodilution window.
6. If the bolus is started on time, a measurement will automatically start, the
progress of which will be displayed in the Thermodilution window.
After the measurement process is over, the measured and calculated
parameters of the central hemodynamics are displayed in the "Thermodilution"
window and the channel is ready for the next measurement.

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Printing from the Thermodilution mode
The measurement data is output from the "Thermodilution" window by pressing
the "PRINT" button located on the front panel of the device.
When printing from the "Thermodilution" window on thermal paper, the
following data is printed:
Time and date of measurement;
Data on the bolus and patient;
Measurement results;
Current monitored indicators.

Pulmonary artery wedging pressure (PAWP)


PAWP is used to determine the pressure in the left atrium. The obtained
information allows estimating intravascular volume of blood and function of the
left ventricle.
The principle of PAWP measuring is shown on the figure. The measurements are
carried out by using the Swan-Gans catheter IBP channel.

Figure 162

The balloon at the distal end of the catheter inserted into the pulmonary artery is
inflated until blood flow becomes obstructed. This will cause the formation of a
blood column between the end of the catheter and the left atrium, and the
pressure at both ends of the column will be balanced. The pressure at the end of
the catheter becomes equal to the pressure in the left atrium. The pressure at the
end of the catheter at the moment of occlusion with a balloon of the pulmonary
artery is called PAWP, which, in the absence of an obstruction between the left
atrium and the left ventricle, is considered equal to the end diastolic pressure in
the left ventricle (EDPLV).
At the time of "wedging" of the pulmonary artery, the nature of the pressure curve
changes rapidly.
Further, by using this parameter (PAWP) in the calculation of hemodynamics, it is
possible to calculate a number of indicators.

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8.18 Impedance cardiography module (ICG)
Introduction
The ICG module is designed to provide hemodynamic parameters based on the
measurement of thoracic electrical bio-impedance. The system allows the
assessment of a patient´s hemodynamic status and ventricular function by
determining hemodynamic parameters as well as indexed versions of those
parameters.
Changes in the volume and speed of the blood in the aorta cause changes in
thoracic impedance. Monitors process these changes using the algorithm of
adapted analysis of physiological signals.

Figure 163

Q - the beginning of ventricular depolarization;


PEP - pre-expulsion period;
B - opening of the aortic valve;
C - maximum systolic flow;
X - closure of the aortic valve;
O - the opening of the mitral valve;
LVET - time of expulsion of the left ventricle;
PT is the propagation time of the pulse wave.

With the help of this module, a simultaneous assessment of the central and
peripheral circulation is provided.

Impedance plethysmography
The blood flow in the peripheral vessels is characterized by the time of the pulse
wave propagation and by the amplitude and duration of the IPG complexes. IPG
is used to detect pathological and pharmacological changes in peripheral blood
flow and can be used to assess cerebral blood flow.

Measured parameters:
Impedance cardiography measures the following hemodynamic parameters:
– TFC - Thoracic fluid content (inverse to thoracic basic impedance)
– PEP - Pre-Ejection Period

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– LVET - Left Ventricular Ejection Time
– Indexes of contractility VI, ACI: Velocity Index, Acceleration Index
– HR - Heart Rate
Following parameters can be calculated:
– SV, CO - Stroke Volume, Cardiac Output
– HI - Heather Index
– STR - Systolic Time Ratio
– SVRI - Systemic Vascular Resistance (requires blood pressure value)
– LCW - Left Cardiac Work (requires blood pressure value)
With reference to body surface area the following indexed parameters can be
calculated:
– SI, CI - Stroke Volume Index, Cardiac Index
– SVR - Systemic Vascular Resistance Index
– LCWI - Left Cardiac Work Index
Device can be used for following clinical applications:
– Non-invasive monitoring of the above hemodynamic parameters including
trend analysis
– Determination and checking of the hemodynamic state of a patient
including management of heart failure and hypertension therapy
– Cardiologic diagnosis using hemodynamic parameters and waveform
shape analysis
– Optimization of pacemaker settings.
Additional information and a detailed description of the measuring
method, the parameters, the application of impedance cardiography, and
its limitations are given in the Software Manual.

Precautions and limitations


The measuring instrument allows measurements for adult patients in a calm
position. The measured parameters can be used only under condition of
qualitative ECG and ICG signals.
The method of impedance cardiography (ICG) is based on a theoretical model
of the flow of blood in the chest (aorta).
The following conditions may adversely affect the accuracy of the ICG systems
and are relative contraindications to the use of ICG systems:
1. Septic shock
2. Aortic valve regurgitation and defect of septum
3. Severe aortic sclerosis, aortic prosthesis
4. Severe hypertension (MAP > 130 mmHg)
5. Cardiac arrhythmia

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6. Tachycardia with a heart rate higher than 200 bpm
7. Patient heights below 120 cm (48″) or above 230 cm (90″)
8. Patient weights less than 30 kg (67 lbs.) or greater than 155 kg (341 lbs.)
9. Patient movement
10. Aortic balloon or aortic balloon pump
11. Simultaneous use of electrical cautery systems during surgical procedures

The ICG module is intended for measurements on adults. When measuring on


infants and neonates, it is necessary to use the program module and patient
cable corresponding to this age category.
During operations on the opened thorax the current distribution can be distorted
and can lead to inaccuracies.

Description of the module


ICG patient cable
The patient's cable for impedance cardiography contains a small module that
includes a splitter cable with an integrated electronic unit.

Figure 164

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Figure 165

On the patient's cable there are indicators showing its status: orange and green.
The type plate is located on the back side and lists important information about
the device, including the serial number. This number is required to obtain
technical service assistance and warranty repairs.
Located on the front side there are green and orange LED indicators (2) which
gives information about the device. Depending on the current status the
following can be indicated:
green orange Description of function
The electronic part of the patient cable is not
○ ○ connected with the power supply; cable is
disconnected or the device is switched off
Patient cable is ready to use, but the measurement
☼ ○
has not been started
● ○ Measurement is running; sensor contact is good
Bad contact between sensors and patient: at least
one lead wire is disconnected or not properly fixed;
● ☼
sensors are too dry (eventually new sensors are
necessary)
Insufficient contact between sensors and patient: at
● ● least one lead wire is disconnected or not properly
fixed; sensors are too dry (new sensors are necessary)
Patient cable has power but the software cannot
○ ☼ access the cable; software has not been started or is
not ready for measurement
○ LED off ☼ LED flashing ● LED on

Performing a measurement
To start the measurement, you must connect the ICG cable to the ICG module.
Then connect the ICG module to the universal UniPort channel on the right panel
of the monitor and activate the ICG channel in the monitor's submenu.
Next, following the electrode placement scheme, install the electrodes on the
patient's body.

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Application of ICG sensors

Impedance cardiography requires four dual sensors to be placed to the patient.


The following picture shows the application of the sensors:

Figure 166

These sensors have been designed especially for ICG application and include
dual gel pads, whereby the current is passed through the circular gel pad and
the signal is measured though the rectangular gel pad (which has 60 % more
surface area than the circular pad, facilitating signal reception). Additionally,
these sensors have a fixed distance between injecting and measuring gel pads,
which is very important with this technique. Consequently, both the mechanical
dimensions as well as the electrolyte guaranties exact and reliable results of the
ICG sensors.
1. Apply one sensor to each side of the patient’s neck. The rectangular part
of the sensor should be positioned at the root of the neck, the circular part
should be positioned in direction of the ear lobe.
2. The rectangular sensor of the neck sensors is connected with the purple
sensor lead wire, the sensor with the circular gel pad is connected to the
blue lead wire.
3. Apply the two remaining sensors on each side of the thorax along the
midaxillary line. The rectangular part of the sensor of the sensor is positioned
closest to the heart at the level of the Xiphoid point. The circular part of the
sensor is placed in direction of the legs.
4. Connect the green lead wire to the rectangular sensors of the thorax
sensors and the orange lead wire to the lowest (circular) sensor gel pad.

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Safety requirements
Warning! According to the Medical Device Directive (MDD) the ICG
module belongs to class II a and, therefore, is not intended for
monitoring of vital physiological parameters, where the nature
of variations is such that it could result in immediate danger to
the patient.
The Federal law requires that the ICG module should be used
only by or on the order of a physician. Generally, all persons
using the ICG module must be qualified and understand the
measuring method and the operation.

The ICG module belongs to the application class BF (Body Floating). Therefore,
the sensors can be freely placed on the intact body surface. A direct contact
with the heart or vessels is not allowed.
Only connect one patient at the same time to the ICG module.
The sensors must not have a direct contact to other electrically conductive
materials.
Because of hygienic reasons only use disposable ICG sensors.
Before monitoring patients with pacemakers, ensure that the function of the
pacemaker cannot be influenced by the measuring current used for impedance
cardiography. In the case of minute ventilation pacemakers the use of the ICG
module is not allowed if the minute ventilation function of the pacemaker is
activated.
The ICG module is not intended to be used while exposing the patient to high
frequency current.
Handle the ICG patient cable and lead wires carefully and position them so that
they do not cross over each other or other cables or power cords to avoid signal
interference.
Do not expose the cables to mechanic or thermic impact. Avoid temperatures
above 40 °C (100 °F).
The measuring unit should neither be placed on a surface, which emits heat nor
exposed to direct sunlight.
The ICG module is not protected against splashing water. Therefore, do not
operate in bathrooms or other areas where water damage is possible.
The ICG module is not protected against explosive substance. Therefore, do not
use the measuring device in the presence of flammable anesthetics or gases.
The ICG patient cable of the ICG module is protected against accidentally
ingress of liquids. Nevertheless, in case that water or other liquids ingress into the
case, the device must be disconnected immediately.
To ensure that the ICG module functions safely, do not subject it to high levels of
humidity or to strong electrical or electromagnetic interference fields.
The ICG module must always be kept in safe and reliable working order and must
be checked regularly.
The ICG module is protected against cardiac defibrillations. No preparation is
needed before the application of the defibrillator. The ICG module will return to
the standard operation within 10s after discharge.

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Cleaning and disinfection
It is recommended to clean and to disinfect the ICG patient cable of the OEM
ICG module regularly.

Warning! Disconnect the ICG patient cable from the OEM ICG module
before cleaning or disinfection.

Clean the ICG patient cable with a soft cloth. Do not use any abrasive or
corrosive substances.
We recommend neutral cleaning agents or disinfecting substances, like ethanol
(70-80%), propanol (70-80%) or aldehyde (2-4%). Ensure that no disinfectant gets
onto the contact points of the plugs and sockets, and that no liquid seeps into
the device.
Caution! Never gas-sterilize the ICG patient cable. They are covered
with a PVC shroud that can react with the gas-sterilization
procedure to form a highly toxic ethyl nitrite. Sterilization in an
autoclave, with ultrasound or gamma rays is also not permitted.

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9 ADDITIONAL DISPLAY MCM22
9.1 Specification
Diagonal of the display: 22’’ (55,88 сm)
Display type: color LCD (touch screen optional)
Screen resolution: 1920х1080
Power supply: 100 - 250В, 50/60Hz
Interfaces: HDMI (wireless optional)
Class of protection: ІР32
9.2 Front and left side panels

Figure 167

On the left side of the monitor (figure is above) the following elements are
placed:
1. ON/OFF button;
2. AC power connector;

9.3 General description


The MCM 22 "allows to visualize additional information from monitors UM-300.

This information may be:


- Values of monitored parameters.
- Waveform curves of monitored parameters.
- Additional window: MiniTrends, Avarage Qrs, QTc analyses.
- Status information: Patient info, Network status, battery status, Alarm volume
status, time.

Also additional screen can be used for Central Monitoring, duplicate all
information from patient monitor. Support UniScreen visualization technology.

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9.4 Connection
Connect the MCM22 to patient monitor by HDMI cable to the HDMI connector on
the interface panel of the UM300 monitor. Turn on additional display and patient
monitor by pressing the On/Off button. After booting the system, make sure that
the additional screen displays data from the patient monitor.
9.5 Configuration
Push the «Screen 2» button on screen to activate screen2 configuration menu

Figure 168

Configure the screen2 visualization of digital graphical data using the


configuration menu "DISPLAY 2" (see Fig. below).

Figure 169

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10 WORK IN CENTRAL STATION UNET
The central station and bedside monitors, which are connected to it by wired or
wireless data transmission channels, are designed for the following operations:

Changing monitor settings from a central station;


Select the required number of UM 300 for visualization from the total list of
connected monitors;
Support 2 displays (with a resolution of 1280x1024) when 32 monitors are
working;
Synchronous visualization at one central station display information
received from 16 bedside monitors;
Real-time displaying of all parameters (depending on the configuration of
the screen) coming from UM 300 and wave curves - not less than 2 curves
for a single monitor at synchronous monitoring and up to 9 curves for single
monitor;
"Freezing" the displayed curves for the monitor;
Record of user-selected information into a database (DB) – from 30s ECG
intervals and up to 72 hours of trends;
Continuous recording (up to 72 hours) in a database of nine wave curves
for each monitor;
Automatic recognition (auto-saving 20-second segments of ECG into the
database) types of arrhythmias, and ;
Automatic detection and visualization of ST-segment;
Automatic recording and displaying of events and alarms into the
database (not less than 1,000 for each monitor);
Input, editing and storing identification data of the patient;
Reading from the monitors the database records, viewing documentation,
trends and parameters of HRV (HRV);
Trends statistical analysis;
Keeping current and archived (stored information about the patients after
their discharge) databases;
Documentation of patient monitoring on laser and thermal printer ;
The automatic printing with information up to 20 seconds 2 ECG waveforms
when a high priority alarm occurs.

The accumulated monitoring data and patient data can be transferred to


another monitor via a central station or directly from the monitor to the monitor.

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10.1 Central Station structure diagram

M1 M2 M3 M32

M1 M2 M3 M32
Figure 170

10.2 Web Viewer


Web Viewer is remote continuous patient monitoring software solution. It
provide remote access to patients’ clinical information in near real-time, enabling
you to closely monitor a patient’s condition while you are away from the
bedside. It allows clinicians to remotely view:
• Patient information (waveforms, alarms, pressure/volume loops)
• On any web-enabled devices (smartphones, tablets, desktops, Workstation
on Wheels, central nurse station monitoring)

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Web Viewer operates on a standard PC, Mac or tablet PC, providing easy
remote access to patient data. With the Web Viewer you can quickly check the
status of your patients directly from your PC without making a trip to the bedside
or even to the hospital.

Features and Benefits:

• View near real-time streaming waveforms for any patient


• Access patient data using Internet Explorer
• Secure password protected log-on
• Client devices are not limited to Mobile Viewers use only, allowing other
applications to be used as well

Figure 171

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11 SAFETY CONSIDERATIONS AND GENERAL INSTRUCTIONS
Safety considerations
Warning! Don’t operate the monitor before reading this manual.

The monitor must only be operated by persons who have studied


the present manual.

Power cord included in the set of equipment can only be used for
AC line power operation.

Strongly avoid any kind of incidental liquids, particles and other


subjects (metal dust, wires, water, etc.) that could get inside the
monitor and accessories.

In case of violation of this demand, STOP OPERATION OF THE


DEVICE IMMEDIATELY! The monitor must be checked on electrical
safety by a specialist in post-sales service.

It is PROHIBITED TO USE the monitor (the unit, accessories) if:

the housing is opened or damaged;


the cables or connectors are damaged;
the incidental things, particles or liquids got inside the device.

11.1 Transportation and storage


The monitor can be transported by all kinds of covered transport means in
accordance with freight requirements suitable for each vehicle.

Warning! The device contains lithium-ion batteries, keep the rules of


transportation of devices in accordance with established norms.

The monitor can be stored in the manufacturer’s package, except stores of


railroad terminals, at a temperature range from +10°С to +40°С.

11.2 General instructions


Examine the monitor after unpacking, check its configuration in accordance with
the list of equipment and ensure it has no damages.

Caution! In case of transportation of the monitor in conditions of high


humidity or low temperature keep it in a transport package for 8
hours in a warm, dry place.

The monitor must be operated in the following conditions:

Temperature range from +10°С to +40°С;


Relative humidity to 98% at 25°С without condensation

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Conductive parts of electrodes and their connectors, which are intended for
working parts including neutral electrode, should not touch other conductive
parts and the ground.

When the monitor is operated on AC power, it must be connected only to


earthed, non-defective, medical grade mains.

The monitor is used in Intensive Care Units/Critical Care Units, labor wards, during
patient transportation, including ambulance.
The monitor may be used in electro surgery.

Warning! It is forbidden to use several sets of ECG electrodes connected to


different monitors on one patient.

Caution! It is allowed to use electrosurgical instruments and defibrillator at


the same time with the monitor.

If a patient has an electro cardio-stimulator, cardiogram may


have waves that correspond to electro cardio stimulator and
distort QRS complexes.

While using defibrillator, contact between electrodes of


defibrillator and monitor is forbidden.

Calibration of modules (except IBP, CO2 and multi-gas modules) is performed by


manufacturer and there is no need in additional calibration by a user.

Simulators of biomedical signals are used to check the accuracy of monitor


functioning and its accessories in accordance with a description enclosed with a
simulator.
Switch on a Demo mode and set up such alarm limits for each option, which
would be lower and higher than corresponding limits in a Demo mode, to check
visual and audible alarm signals of each option. Then you need to check the
appearance of visual and audible alarms.
When monitoring process is finished, the monitor should be SWITCHED OFF. It will
prolong a service life of display backlight lamp.

Warning! During storage and operation:


Protect the monitor and accessories against falling and hitting,
direct sunlight, caustic substances and other environmental
hazards;
Do not place the monitor close to functioning heating devices or
in rooms with abnormally high humidity;
Do not open the monitors;
Do not store the monitor with extremely discharged battery.

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11.3 Installation
Place the Monitor in a convenient position for operation.
Connect the monitor to the mains with grounding.
Attach sensors to the corresponding connectors of the monitor.
Place necessary sensors and electrodes on a patient according to a scheme of
placement.
Sensors can be connected to the monitor and placed on the patient during the
operation, if necessary.
11.4 Operation
Attach a power cord to the connector on a left side of the monitor and then
connect it to AC power source 110/230 V, 50/60 Hz for mains-powered operation
or battery charging.

Caution! Switching between battery-powered and mains-powered (AC)


operation is performed without interrupting monitoring!

When the power LED on the front panel of the monitor is green, the monitor is
connected to mains power.

Caution! When the monitor is connected to mains power, check the


power LED – if it is yellow, the monitor is running on battery
power.

Ensure the connection is proper (power cord, mains, etc.) and power LED is
green.
Press the on/off key and hold it for 1-2 seconds before the monitor turns on
(the on/off key is on the left side of the monitor). After few seconds the monitor
will start to boot main application and auto-test program. The indicators of
patients’ vital signs, time and date will appear on the screen while boot is
successfully complete.

The memory is tested after the monitor is switched on. If the memory is damaged,
a message “Test RAM Failure” appears on the screen. In this case personnel
should apply to a company, which provides servicing of the monitor.

When time and date on the monitor do not coincide with an actual time and
date, correct the data in the item “Time”.

Select a mode of measurement in the item “Configuration”: “Neonatal” – for


neonates, “Adult” – for other age groups.

Adjustment of alarm volume and pulse sound is performed in the menu.


The battery recharges automatically whenever the monitor is connected to mains
power.

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11.5 Battery operation
There is a mains power input on the left side of the monitor. To operate the
monitor on battery power - unplug the AC cable from the monitor. The device
will be automatically switched to the battery.

Switching between battery-powered and mains-powered (AC) operation is


performed automatically without interrupting monitoring process.

The battery recharges automatically whenever the monitor is connected to mains


power. You can see the battery status information in the “Battery Status” window
in the upper information field of the screen.

The monitor is equipped Li-Ion battery cells with internal control system of battery
status and charging unit.
“Battery Status” window and power LED indicate battery status information and
charging process.

When the battery capacity is significantly decreased (less 10 min. before the
monitor switches off automatically):

yellow power LED on the front panel starts flashing;


When the battery is significantly discharged (less 5 min. before the monitor
switches off automatically):
an audible alarm is activated;
“Battery Status” window is red and starts flashing.

When these signals appear, immediately switch off the monitor and (or) connect
the monitor to the mains power to avoid a battery malfunction.

Caution! When the battery is critically discharged the monitor switches off
automatically.

Battery backup time depends on screen size, number of activated monitoring


channels and their monitoring modes. In case of a decrease in the operating
time of the device from a fully charged battery to less than 1 hour, you should
contact the manufacturer or the service center for service assistance.

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12 CLEANING AND DISINFECTION
Use substances and methods listed in this chapter to clean or disinfect your
equipment. Warranty does not cover damage caused by using unapproved
substances or methods.
UTAS makes no claims regarding the efficacy of the listed chemicals or methods
as a means for controlling infection. Consult your hospital’s Infection Control
Officer or Epidemiologist.
12.1 General points
Keep your monitor, sensors, extensions, cables and other accessories free of dust
and dirt. After cleaning and disinfection, check the equipment carefully. Do not
use if you see signs of deterioration or damage. If you need to return any
equipment to UTAS, decontaminate it first.
Observe the following general precautions:

Warning! Do not use alcohol solution.


Always use the lowest possible concentration of chemicals.
Do not allow liquid to enter the case.
Do not immerse any part of the equipment in liquid.
Never use abrasive material (such as steel wool or silver polish).
Never use bleach.

Caution! Do not use the product if the liquid accidentally enters the
monitor, battery or UniPort modules, contact your service
personnel or UTAS service engineer.

12.2 Cleaning
Clean the case with a lint-free cloth moistened with warm water (+40 °С
maximum) and soap.

Clean the sensors, extensions, cables and other accessories with a lint-free cloth
moistened with warm water (+40 °С maximum) and soap.

Warning! Do not use strong solvents such as acetone or trichloroethylene!

Take extra care when cleaning the screen of the monitor because it is more
sensitive to rough cleaning methods than the housing. Do not permit any liquid to
enter the monitor case and avoid pouring it on the monitor while cleaning. Do
not allow water or cleaning solution to enter the connectors of the monitor, the
extensions and measurement modules. Wipe around, not over, connector
sockets.

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12.3 Disinfection

Warning! Always use the lowest possible concentration of chemicals.

Do not mix disinfecting solutions as hazardous gases may result.

Disinfect the product as determined by your hospital’s policy.


Clean equipment before disinfecting.
It is recommended to use water solutions of disinfecting agents.

13 MAINTENANCE AND TROUBLESHOOTING


Maintenance is performed by persons operating the equipment.
Maintenance includes:
visual inspection;
cleaning;
charging battery;

The visual inspection of the monitors and accessories should be performed daily.
Inspection includes the following procedures:
examine exteriors and cables for general physical condition;
inspect the connectors sockets;
examine condition of controls and indicators;
examine the housings, accessories and sealing for damage.

Battery charging is performed before each long-term battery operation mode.


When the monitor is not operated for a long time, charge the battery once per 3
months.
The battery is replaced after its service life is over.

Caution! Any repairs and servicing of the equipment are performed only
by the manufacturer, or authorized representative.

Maintenance is carried out by persons operating the device in accordance with


the requirements of IEC standard 62353.

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232
Possible malfunctions and ways of their elimination
Troubleshooting table

Malfunction Reason The way of solving the problem


The AC power socket is
The monitor does not turn defective (when using AC Repair the AC power socket
on power)
Monitor is defective Contact service center
Battery discharge is equal to or
Monitor turned off Charge the battery
below the critical
Indication of the inscription:
Damage of the monitor memory Contact service center
"Damage of memory"
Verify proper sensor and sensor size
Inappropriate sensor size or
for the patient. Set the SpO2 sensor
sensor measurement location
correctly
Reposition sensor to site with strong
Incorrect SpO2
Low SIQ or Perfusion SIQ and PI. Submit blood sample for
measurement
Index (PI) values laboratory oximetry test for
comparison
Replace defective sensor, contact
Damage of the SpO2 sensor
the manufacturer
Cable is disconnected from the Disconnect and reconnect the
Module not connected monitor. cable. If the cable fails to operate,
replace the cable.
Faulty module, Module error
- Board Failure,
Hardware error Contact service center
Module error - Diagnostic
Failure
Sensor is disconnected from Check to see if the sensor LED is
patient cable. flashing. Disconnect and reconnect
No Sensor Connected
Sensor connected upside down the sensor. If the LED fails to operate,
into patient cable. replace the sensor.
Properly reconnect the sensor to the
unit or patient cable.
Replace Sensor Sensor is damaged
If the sensor is damaged, replace the
sensor
Wrong sensor type is Verify proper sensor connected.
Incompatible Sensor connected. If the sensor is damaged, replace the
Sensor is damaged sensor.
Properly reapply the sensor on the
Sensor not connected to patient patient and reconnect the sensor to
Sensor Off Patient properly. the unit or patient cable.
Sensor is damaged If the sensor is damaged, replace the
sensor
Cable is disconnected from the Disconnect and reconnect the
No Cable Connected monitor. cable. If the cable fails to operate,
replace the cable.
Properly reapply the sensor on the
Sensor not connected to patient and reconnect the sensor to
No Adhesive Sensor patient/cable properly. the unit or patient cable.
Sensor is damaged If the sensor is damaged, replace the
sensor

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Verify proper sensor and sensor size
Improper sensor type. for the patient.
Poorly perfused site. Check and see if blood flow to the
Sensor is too tight. site is restricted. Be sure that the
A disorder such as hypothermia, sensor is not on too tight.
Low Perfusion Index
vasoconstriction, hypovolemia, Set monitor to MAX sensitivity.
peripheral vascular disease or Warm the patient or sensor site.
anemia. Move sensor to better perfused site. If
Sensor is damaged. the sensor is damaged, replace the
sensor
Properly reapply the sensor on the
patient and reconnect the sensor to
Poor contact or additional
the unit or patient cable.
Interference Detected interference found. Faulty sensor
If the sensor is damaged, replace the
or cable. Monitor hardware error
sensor.
Contact service center.
Eliminate direct light to the sensor
Too intensive ambient
Too Much Light site. Shield the sensor from excessive
(environmental) light
or strobing light.
Improper sensor type or Check and see if blood flow to the
application. site is restricted.
Excessive motion relative to Check the placement of the sensor.
Low SpO2 Signal IQ
perfusion, or poor perfusion. Re-apply sensor or move to a
Sensor or cable is damaged or different site.
not functioning Replace sensor or cable.
If device fails to display within 30
seconds, disconnect and reconnect
Pulse Search Message Device is searching for pulse sensor to patient. If pulse search
continues, move
sensor to better perfused site
Incorrect installation of leads or Set the lead wire or electrodes
electrodes correctly
Incorrect ECG
Bad contact of ECG electrodes
measurement Use saline or ECG gel
with the patient's skin
Damage of the ECG cable Contact the manufacturer
Incorrect installation of leads or Set the lead wire or electrodes
Incorrect ECG
electrodes correctly
measurement
Damage of the ECG cable Contact service center
Incorrect Temperature Damage of the temperature
Contact service center
measurement sensor
Eliminate clamping of the silicone
Silicone tube clamping
tube
Incorrect NIBP measurement
Damage of tube or compression
Contact service center
cuff
Presence of air in the hydraulic Bleed the air out from the hydraulic
system system
Incorrect IBP measurement
The IBP sensor is not calibrated Calibrate the IBP sensor
The IBP system is defective Contact service center
Incorrect measurement of Contact service center
Damage of the gas module
gas concentrations
Printer does not work The printer is defective Contact service center

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14 ALARM AND OUTPUT MESSAGES
The monitor is equipped with multilevel audible and visual alarms in accordance
with ISO / IEC 9703-2 for all monitored parameters, condition of sensors, internal
battery and charging unit.
Alarms are divided into:
According to categories: patient status alarm, system status alarm.
According to the type: visual (color difference, flashing status) and audible
(sound signal).
According to priorities: info, advisory, warning, crisis.
System status alarm has a lower priority as compared with patient status alarm.

14.1 Visual and audible alarm indication


Alarms of patient status and system status have different sound (tone and
modulation) and also different fields on the screen for displaying messages:
Messages of patient status are displayed in parameter windows and on the
waveforms fields;
Messages of system status are displayed in the information field of the
screen and on the control panel.
Alarm status:

visual and audible alarms are switched off (a grey triangle is crossed by
red lines)

info (a grey bell is crossed by red lines )

advisory (a grey triangle) – low priority

warning (a yellow triangle) – medium priority

crisis (a red triangle) – high priority

According to the priority level (danger degree) alarms have different audible and
visual indication.

Characteristics of audible alarms in the standard ISO/IEC 9703-2:


PRIORITY LEVEL AUDIBLE INDICATION VISUAL INDICATION
Monotone signal: three
Flashing parameter, red
CRISIS + two signals in an
symbol or inscription
audio packet
Monotone signal with Flashing parameter,
WARNING three single signals in symbol or inscription.
an audio packet Color - yellow
Flashing parameter,
ADVISORY Low priority alarms symbol or inscription
(grey).
INFO Is not sounded A grey inscription

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By default settings an audible signal has a variable tonality and the sound power
level does not exceed 56 dBA
Characteristics of visual alarms:
PRIORITY LEVEL COLOR OF MESSAGE MESSAGE FREQUENCY WORKING CYCLE
High Red 2 Hz 40%
Medium Yellow 0,6 Hz 40%
Law Cyan constant 100%

Factory default alarm limits:

Parameter/Mode Adult Pediatric Neonatal


Heart rate 50 – 140 min-1 50 – 140 min-1 100 - 180 min-1
ST segment -0.2 - +0.2mV -0.2 - +0.2mV ---
PVC 10 min-1 5 min-1 ---
Pulse rate 50 – 140 min-1 50 – 140 min-1 100 - 180 min-1
SpO2 88 – 100 % 88 – 100 % 88 – 99 %
PI 0,3 - 19 0,3 - 19 0,3 - 19
TEMP 35.5 – 38.5 °C 35.5 – 38.5 °C 35.5 – 38.5 °C
RR 8 – 30 min-1 8 – 30 min-1 30 – 100 min-1
APNEA 20 s 20 s 10 s
EtCO2 30 – 50 mmHg 30 – 50 mmHg 30 – 50 mmHg
SYS 90 – 160 mmHg 70 – 120 mmHg 40 – 90 mmHg
NIBP DIA 50 – 90 mmHg 40 – 70 mmHg 20 – 60 mmHg
MAP 70 – 130 mmHg 50 – 100 mmHg 30 – 70 mmHg
IBP SYS 90 – 160 mmHg 70 – 120 mmHg 55 – 90 mmHg
ART, FEM, DIA 50 – 90 mmHg 40 – 70 mmHg 20 – 60 mmHg
LV, AUX* MAP 70 – 110 mmHg 50 – 90 mmHg 35 – 70 mmHg
SYS 10 – 35 mmHg 24 – 60 mmHg 24 – 60 mmHg
IBP DIA 0 – 16 mmHg -4 – +4 mmHg -4 – +4 mmHg
PA
MAP 0 – 20 mmHg 12 – 26 mmHg 12 – 26 mmHg
SYS --- --- 55 – 90 mmHg
IBP DIA --- --- 20 – 60 mmHg
UAC*
MAP --- --- 35 – 70 mmHg
IBP
CVP, LA,
MEAN 0 – 10 mmHg 0 – 4 mmHg 0 – 4 mmHg
RA, RV,
ICP
IBP MEAN --- --- 0 – 4 mmHg
UVC*
* Optional IBP modes

Caution! When creating a new patient profile, alarm limits will reset to
factory default.

Changing the default Alarm Levels is possible using the tools only in the Service
Centers or by the manufacturer.
A user can set alarm priority of monitored parameters, using menu option ALARM,
and of arrhythmias, using option ARRHYTHMIA.
The device gives appropriate audible and/or visual alarm signal (according to
the set priority) in the following cases:

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when the values of monitored parameters exceed set limits - delay 10
seconds;
when SpO2 sensor, temperature sensor, ECG electrodes and NIBP cuff are
absent or incorrectly applied, a message appears in the window of the
corresponding parameter;
when the pulse wave is absent or has a poor signal quality; message “PULSE
ABSENT”.
when cardio complexes are absent or disappear; message “ASYSTOLE”.

Caution! ASYSTOLE always has priority CRISIS and it cannot be


changed by user.

when non-invasive blood pressure is incorrectly measured;


when arrhythmia is detected;
when the battery is significantly discharged.
Alarm limits of monitored parameters are set in the menus of the corresponding
parameters.
Battery status alarm is described in the chapter “Battery operation”.
14.2 Switching off alarm
The alarm can be switched off for 1, 2, 3, 5, 10 and 15 minutes or to the Next Event
for more convenient operation. Press the key ALARM (one press or double press).

A crossed-out grey triangle and time indication will appear on the


information field.
If a new dangerous situation appears during this period, alarm is automatically
switched on.
If you press the key ALARM double times and choose in the menu “Alarms”
submenu “Advanced” / “Double Press” / “Next Event” -- alarm is automatically
switched on when a new dangerous situation appears.
If “ASYSTOLE” or Engineer Alarms appears, you can switch off this alarm only for
concrete period of time (1, 2, 3, 5, 10 and 15 minutes).

Caution! AUDIBLE and VISUAL ALARM INDICATION can be switched


off in the menu option “Alarm” of the corresponding
parameter by selecting the option “Info”. A crossed-out
grey triangle in the upper corner of the parameter
indicates that audible and visual alarm is switched off.
You can switch off all audible alarms if choose the menu “Alarms” / “Audible

Alarms”. In the top of the window crossed-out grey bell “ ” indicates that
audible alarm is switched off.

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Warning! Incorrect setting of alarm limits may result in improper operation!
If other patient monitors are used in the same room, there is a
possibility of danger arising from the alarm system from other monitors.
The delay time for triggering an alarm after the occurrence of a
situation leading to an alarm does not exceed 5 s (30 ms).
The delay between the occurrence of an alarm signal and the
moment of video or audio visualization does not exceed 5 s (30 ms).
The time for the generation of a technical alarm signal does not
exceed 5 s (30 ms).
After termination of event that generates the alarms stops, visual and
audible alarms will turn off.
Pay attention to the default system alarms for monitoring channels in
order to avoid the danger of incorrect installation of these signals.

When working with a central station, the monitor connected to it can send data
on the triggering of alarms. The central station and its parts can be placed not in
the patient's environment. Wired communications are used for signal transmission.

When monitors work with the Central Station, the alarm delay times from the
various moments of occurrence of the situations leading to the alarm to different
points according to I.6.4.2 of IEC 60601-1-8 standard, do not exceed 5 s.

In the event of a communication failure between the connected monitors and


the Central Station, the CS generates a technical alarm.

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15 WARRANTY
The manufacturer guarantees that devices meet the requirements of the
technical specification on condition that the consumer observes the rules of
operation, transportation and storing.

The warranty period for the monitor UM 300 is in the warranty certificate.
To obtain warranty service, the equipment must be provided in pure state and in
complete package, except that cases which are previously agreed with the
Head of Service Center.

Warranty is the case of equipment defects (loss of work capacity) or any of its
components, except for:
Mechanical damage (including accidental), obtained as a result of fire,
impact or accident;
Mechanical damage resulting from working equipment with overrunning
use and load characteristics declared by the manufacturer;
Use of equipment for other purposes;
Electrical damage units and components resulting from power line surges,
improper connections, improper choice of the supply voltage;
Electrical damage units and components associated with a hit on them
water, steam, acids and other liquids, as on the carcass and into inside;
Damage associated with the life of insects and small animals;
Defects resulting from the use of non-original spare parts, as well as
maintenance, repair or modification of equipment or supplies by private
individuals or organizations without the written permission of Service Center;
If additional equipment connected not properly;
In case of damage of manufacturer seals on the devices or equipment
units;
Defects that have arisen as a consequence of breach maintenance terms
and conditions, transportation or storage stated in the ER;
Faults resulting from the normal wear and tear or the end of the life of
equipment components (consumables) declared in the Data Sheet for the
equipment (cable leads, electrodes, batteries and similar components);
Defects arising as a consequence of using accessories, supplies, or other
parts which are not approved by the manufacturer and/or by the supplier.
In warranty repairs (replacement) may be refused when the tagging of
equipment is absent or when it is impossible to read and to identify it
(damage, shading).

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APPENDIX A. LIST OF DISPLAYED MESSAGES
Messages Channel Description Indication
ECG, SpO2, IBP,
HR, Temp, СО2, Displayed when the channel is
Channel off Grey inscription
AAg Module, BIS, off
CO
Lack of contact between the
Cable not Connected ECG, HR ECG cable and the patient’s Grey inscription
body (displayed instead of HR)
Red in flashing
mode, displayed
instead of the
The absence of QRS
heart rate signal;
ASYSTOLE ECG, HR complexes during the time
monotonous
more than asystole threshold
signal: 3+2 signal
in the audio
package
Warning about no SpO2
Gray in the
Module not connected SpO2 module connected to the
flashing mode
device
Displayed during initialization
Module init SpO2 Grey inscription
period after plug the module
Gray in the
Warning about module flashing mode, the
Faulty module, SpO2
communication failure sound of technical
alarm
Module error - Board Gray in the
Warning about module board
Failure, flashing mode, the
SpO2 failure or diagnostic test of the
Module error - sound of technical
module failed
Diagnostic Failure alarm
Gray in the
Warning about no sensor flashing mode,
No Sensor Connected SpO2
connected to the device signal according
to alarm priority
Gray in the
Warning - sensor replacement
flashing mode,
Replace Sensor SpO2 required due to defective
signal according
sensor
to alarm priority
Gray in the
Warning about incompatible flashing mode,
Incompatible Sensor SpO2
sensor connected signal according
to alarm priority
Gray in the
Warning about removing flashing mode,
Sensor Off Patient SpO2
(disconnection) of the sensor signal according
to alarm priority
Gray in the
Warning about no SpO2 cable flashing mode,
No Cable Connected SpO2
connected to the device signal according
to alarm priority
Gray in the
Warning about disconnection
flashing mode,
No Adhesive Sensor SpO2 or no adhesive sensor
signal according
connected
to alarm priority
Gray in the
Displayed during pulse signal
Pulse Search SpO2 flashing mode,
search period
signal according

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to alarm priority
Gray in the
Warning about low perfusion
flashing mode,
Low Perfusion Index SpO2 index, reading accuracy can
signal according
be affected
to alarm priority
Warning about interference Gray in the
detected during flashing mode,
Interference Detected SpO2
measurement, reading signal according
accuracy can be affected to alarm priority
Warning about high intensity
Gray in the
of ambient (environmental)
flashing mode,
Too Much Light SpO2 light detected during
signal according
measurement, reading
to alarm priority
accuracy can be affected
Gray in the
Warning about poor signal
flashing mode,
Low SpO2 Signal IQ SpO2 quality, reading accuracy can
signal according
be affected
to alarm priority
Gray in the
flashing mode,
Demo Mode SpO2 Displayed in demo mode
signal according
to alarm priority
Gray in the
SpO2*, IBP, Temp., Warning about removing flashing mode, the
Sensor Off
СО2 (disconnection) of the sensor sound of low
priority

Warning about the SpO2


PROBE BROKEN SpO2* Grey inscription
sensor faultiness

Red in flashing
Information about the mode; the audio
NO PULSE SpO2*,HR
absence of pulse signal according
to alarm priority
Chanel off, faulty
SpO2* With faulty SpO2 channel Grey inscription
module
Warning about the SpO2
Sensor error, Reconnect
SpO2* sensor faultiness or improper Grey inscription
or Replace sensor
connection
During blood pressure Gray in the
MEASURING NIBP
measurement flashing mode
Leakage of air from the cuff or Gray in the
AIR LEAK NIBP
tube of NIBP system flashing mode
Occlusion in the NIBP system Gray in the
OCCLUSION NIBP
(e.g. bending of a tube) flashing mode
When the cuff or tube of NIBP Gray in the
LOOSE CUFF NIBP
system is disconnected flashing mode
Exceeding the allowable level Gray in the
CRITICAL PRESSURE NIBP
of pressure flashing mode
With significant influence on Gray in the
ARTIFACTS NIBP
the cuff during measurement flashing mode
During excess of the limit of Gray in the
TIME OVER NIBP
the measurement time flashing mode
Any other measurement Gray in the
ERROR NIBP
hindrance flashing mode
It is difficult for the software
Gray in the
WEAK PULSE NIBP algorithm to identify patient’s
flashing mode
pulse because of poor pulse

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rate, dressed cuff or
incorrectly chosen the size of
the cuff
Warning about poor signal Gray in the
WEAK Signal NIBP
quality. No signal flashing mode

During the absence of Gray in the


contact between the flashing mode, the
Lead I ABSENT RR
electrodes of the first lead and sound of low
the patient's body priority

During the absence of


Gray in the
contact between the
flashing mode, the
Leads I & II ABSENT RR electrodes of the first and the
sound of low
second lead and the patient's
priority
body

During the absence of Gray in the


contact between the flashing mode, the
Lead II ABSENT RR
electrodes of the second lead sound of low
and the patient's body priority

During the absence of Red in the flashing


breathing (chest impedance mode;
RR, CO2, AAg changes, changes in the monotonous
APNEA
Module concentration of carbon signal: 3+2 signal
dioxide during inhalation and in the audio
exhalation) package

During the preparation of the


Sensor Warm up CO2 Grey inscription
capnograph module to work

During the absence of,


Check Adaptor CO2 damage or pollution of air Grey inscription
adaptor

During calibration
Zeroing CO2, AAg Module Grey inscription
capnograph or gas module

If the calibration of
capnograph module is
necessary (in monitors with
Zero Required CO2 Grey inscription
capnograph module
determining CO2 in the main
stream)
During the excess of the
threshold temperature of
Sensor over Temp CO2, AAg Module capnograph or AAg module, Grey inscription
caused by external or internal
factors.
During the exceeding of
Grey inscription in
CO2 out of Range CO2 threshold of maintenance of
the flashing mode
carbon dioxide in respiratory

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mixture
During the obstacle for air
intake (in monitors with Grey inscription in
Sampling Line clogged CO2
capnograph module in the the flashing mode
side stream)

A suction line of capnograph


Grey inscription in
No Sampling Line CO2 module in the side stream is
the flashing mode
not connected

- Sensor readings below 5% O2


O2 port failure AAg Module - Sensor not connected or Grey inscription
obstructed
- When you switch on (before
use);
- In the absence or improper
O2 calibration required AAg Module previous calibration; Grey inscription
- During fixing of deviation
from previous calibration in
the process of checking for air.

- At incorrect
calibration(rejection in
procedure of calibration, for
example serve of not 100% О2
O2 calibration error AAg Module Grey inscription
on the second step);
- At the attempt of calibration
of defective or worthless
sensor.

Internal error of sensor (in


monitors with the AAg module
O2 sensor error AAg Module Grey inscription
in a side stream). Appeal to
service department.
Warning about the need to
Replace O2 sensor AAg Module Grey inscription
replace the O2 sensor
Checking the O2 sensor in the
О2 Roomair Test AAg Module Grey inscription
air
Test is completed Checking the O2 sensor in the
AAg Module Grey inscription
successfully air completed successfully
Checking the O2 sensor in the
Unsuccessful Test AAg Module Grey inscription
air completed unsuccessfully
Checking the O2 sensor in the
Unsuccessful Test. air completed unsuccessfully.
Full Scale Calibration is AAg Module It is necessary to carry out a Grey inscription
required. full calibration of the sensor
O2.

A full calibration of the O2


O2 Fullscale Calibration AAg Module Grey inscription
sensor is taking place

Calibration
A full calibration of the O2
is completed AAg Module Grey inscription
sensor completed successfully.
successfully
A full calibration of the O2
Unsuccessful
AAg Module sensor completed Grey inscription
Calibration
unsuccessfully.

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The values of measured
Outside specified
AAg Module parameters are outside the Grey inscription
accuracy range
limits of accuracy

The AAg module overheat


happened. Disconnect the
Internal temperature
AAg Module module, until it got cold and Grey inscription
outside operating range
check, what can be reason of
overheat.

The AAg module overheat


happened. Disconnect the
Ambient pressure
AAg Module module, until it got cold and Grey inscription
outside operating range
check the level of
environment pressure.
The gas module is not ready to
AAg identification and
work(not warmed up) or
concentration are AAg Module Grey inscription
readings are outside of the
unreliable
accuracy
The error of identification of Grey inscription on
Key Validation Error BIS the module. Appeal to a yellow
service. background
Grey inscription on
The error of a hardware
Hardware Error BIS a yellow
module. Appeal to service.
background
Grey inscription on
BISx Module is BISx module loading, please
BIS a white
initializing... wait for its completion.
background
Attention! BIS module is not Grey inscription on
BISx not connected BIS
connected. a red background
Warning of error during Grey inscription on
Sensor not connected BIS
connection of sensor. a red background
Grey inscription on
Checking the sensor, wait for
Sensor Checking... BIS a white
its completion
background

Informational message that Grey inscription on


ARTIFACT BIS the EEG signal artifacts are a white
detected background

The information in the course Grey inscription on


GROUND CHECK BIS of the periodic inspection of a white
the sensor (ground electrode) background

Warning about poor signal


Grey inscription on
quality with poor electrode
Bad signal quality BIS a white
contact with the patient. No
background
signal

Remove error and press It is necessary to correct


Grey inscription on
<M.SCREEN> or reason of bad quality of signal
BIS a white
reconnect BISx to error and reconnect the
background
continue BIS monitoring module to continue the work

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Poor signal quality with poor
electrode contact with the Grey inscription on
Poor signal quality BIS patient. The signal is displayed a white
on the screen, but may not be background
entirely reliable

Grey inscription on
At exceeding of threshold of
BIS out of target range BIS a white
BIS
background
Sensor Error, Sensor is badly connected or Grey inscription on
BIS
Detach/Reattach did not pass verification a red background

The connected sensor is


Grey inscription on
Invalid Sensor BIS defective, badly connected
a red background
or did not pass verification

BIS sensor exceeded the time


Too Many Uses. Grey inscription on
BIS limit of use; the sensor must be
Replace Sensor a red background
replaced.

Warning of disrepair of cable,


Invalid Cable. Replace Grey inscription on
BIS it is necessary to replace a
Cable a red background
cable
BIS cable exceeded the limit
Too Many Uses. Grey inscription on
BIS of use; the cable must be
Replace Cable a red background
replaced soon.
Grey inscription on
Warning: Used > 24 hrs. BIS sensor is used by more than
BIS a white
Replace sensor 24 hours, replace the sensor
background
To exceeding the limit on the Grey inscription on
Uses Remaining = X BIS number of the BIS sensor uses a white
remaining X times background
BIS sensor is connected Grey inscription on
Re-prep Sensor BIS improperly. Connect the a white
sensor. background
Grey inscription on
A warning about
Sensor off BIS a white
disconnecting of the BIS sensor
background
Sensor expired Preventing the use of Grey inscription on
Performance may be BIS previously used BIS sensor and a white
compromised its probable error background
During the periodic inspection
High Combined of the sensor detected a Grey inscription on
Impedance. Check BIS general increase of a white
Sensor impedance. Recheck the background
sensor and reconnect it.
Grey inscription on
Last Sensor Check A warning about incorrect
BIS a white
Failed. Re-prep sensor sensor test.
background
System error. Grey inscription on
BISx Error - DSC Err 23 BIS Appeal to service a white
department. background
System error. Grey inscription on
BISx Error - DSC Err 24 BIS Appeal to service a white
department. background

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A system error occurred during Grey inscription on
EEG packet was lost BIS data transfer. Appeal to a white
service department. background
A system error occurred. Grey inscription on
Non-recoverable error
BIS Appeal to service a yellow
was occurred
department. background
A system error occurred. Grey inscription on
Unsolicited error was
BIS Appeal to service a yellow
occurred
department. background
Grey inscription on
Sensor doesn’t support 2
EEG2 channel is absent BIS a white
channels of EEG
background
Grey inscription on
In Progress... BIS Checking the BIS sensor a white
background

Displayed after opening a Grey inscription on


Press <Start> to begin
Thermodilution window «Thermodilution» a white
measurement
during the first measurement background

Grey inscription on
Preparing to measuring. Checking the module’s
Thermodilution a white
Wait measurement availability
background

Displayed when the measuring Grey inscription on


Faulty module Thermodilution central hemodynamics a white
channel is damaged background

Measurement of Grey inscription on


Measurement canceled Thermodilution thermodilution parameters has a white
been canceled background

Displayed if the temperature


sensor is not connected or
Error: Injectate temp. Grey inscription on
bolus is not ready (no reliable
probe not ready or not Thermodilution a yellow
data of solution temperature -
connected! background
the sensor is in the solution less
than 1 minute)

Displayed if the Swan-Ganz


catheter is not connected or is
Error: Catheter not Grey inscription on
not ready (no reliable data of
ready or not Thermodilution a yellow
the temperature of blood - a
connected! background
catheter in the bloodstream is
less than 1 minute)

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Displayed when the monitor is
Grey inscription on
ready to measure, it is
Inject now! Thermodilution a green
necessary to start the injection
background
of a bolus within 10 seconds

Displayed in the absence of


changes in temperature of Grey inscription on
Error: Injection not
Thermodilution blood in the pulmonary artery a yellow
registered!
within 10 seconds after background
pressing the "Start" button;

Displayed after stop of the


measurement process by
pressing a virtual button "Stop"
Warning: Not enough
when there is insufficient Grey inscription on
data to calculate Thermodilution
amount of recorded data to a red background
parameters!
accurately calculate the
parameters of central
hemodynamics.

Displayed if the temperature


of the blood after injection of
Grey inscription on
Error: Measurement a bolus over 1 minute from the
Thermodilution a yellow
time over! moment you press a virtual
background
button "Start" did not return to
its original value.

Displayed after the


Measurement Grey inscription on
measurement, indicates the
completed. Ready for Thermodilution a white
readiness of the device to a
new measurement! background
new measurement.

Temperature sensor is not


Set up injection Grey inscription on
connected, and there is a
temperature manually. Thermodilution a white
need to manually set the
Probe is not connected! background
temperature of the bolus.

At the beginning of
temperature measurements
Grey inscription on
fluctuations were registered,
Error: No stable baseline Thermodilution a yellow
the module can’t
background
unambiguously determine the
temperature of blood

Grey inscription on
Error: No valid Bolus was entered not in time
Thermodilution a yellow
thermodilution curves or forgot to enter
background

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247
Values of measured
Error: Calc parameters Grey inscription on
parameters are outside the
out of range. Check Thermodilution a yellow
limits, you should check the
parameters background
parameters

Information about the need to


Check injectate Grey inscription on
make sure that the
temperature probe is in Thermodilution a white
temperature of the bolus was
solution! background
in the solution

A need to manually set the


Grey inscription on
Set injection temperature of the bolus,
Thermodilution a white
temperature manually possibly the sensor is not
background
connected
Grey inscription in
Information about connecting
SD card is connected SD card* the message
the SD card
window
Grey inscription in
SD card is Information about
SD card* the message
disconnected disconnecting the SD card
window
Grey inscription in
SD card operating Information that the work with
SD card* the message
activated the SD card is activated
window
Information that the work with Grey inscription in
Internal memory
SD card* the internal memory is the message
operating activated
activated window

SD card is faulty, the card is Grey inscription in


Failed SD card SD card* not formatted or improperly the message
installed window
System Messages
on the left in the Warning of absence of the
NO BATTERY window of system battery, in case if a battery is Red inscription
reports not present or out of order
on the left in the Warning of discharge of the
LOW BATTERY window of system battery, it is necessary to Red inscription
reports charge a battery
on the left in the Information about the need to
CHARGE BATTERY window of system charge the battery, it is Red inscription
reports discharged
on the left in the
Information that artificial
Pacemaker detected window of system Grey inscription
pacemaker is found
reports
Warning appears in the
on the left in the
moment of printing with no
Printer: NO PAPER window of system Grey inscription
paper or its not properly
reports
putting
on the left in the
Warning that the monitor
DEMO window of system Grey inscription
works in demo mode
reports
on the left in the Warning that there is a record
Record window of system of information in the memory Grey inscription
reports of the monitor
Measuring module error on the left in the System error. Appeal to Red inscription

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248
window of system service department
reports
on the left in the
Warning that it is necessary to
NIBP Zero Required window of system Red inscription
calibrate the NIBP channel
reports
Inscription appears in the
on the left in the surgical and neonatal modes
Average QRS is not
window of system of the monitor. QRS is disabled Grey inscription
available
reports for the adequate monitor
working
* for optional configuration

APPENDIX B. CONFIGURATIONS OF THE MONITOR


Basic configuration
Number
Name of the
Monitored values. of Notes
option
channels
3/5 electrode cable (basic
equipment). Synthesis of
ECG, HR, ST – segment, 12 ECG leads by using 5
ECG 1
arrhythmias. electrode cables or 10
electrode cables is
optional
RR Respiration rate. 1
SpO2, pulse rate,
Pulse oximetry 1
plethysmogram.
Systolic, diastolic and mean
NIBP 1
arterial blood pressure.
The channel for
Monitor is equipped with a
measuring the
The content of carbon single capnography
content of carbon
dioxide in the inhaled and 1 channel (with the
dioxide in the
exhaled air. determination of CO2 in
inhaled and
the main or side stream).
exhaled air.
Temperature Body temperature. 1 or 2
Options
Systolic pressure, diastolic
pressure, mean arterial
IBP up to 4
pressure, measured by the
invasive method.
Impedance Measurement of the minute
cardiography volume of blood by a non- 1
module (ICG) invasive method
Measurement of the level of
BIS module sedation during general 1
anesthesia.
The channel for
measuring the
Concentration of СО2, N2O,
concentration of
О2, halothane, isoflurane,
gases and Function of СО2 module is
enflurane, sevoflurane, 1
inhalational provided by gas module
desflurane in inspired and
anesthetics vapors in
expired air.
the respiratory
mixture.

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249
Measurement of minute
volume of blood by
thermodilution method.
Cardiac Output C.O. (Cardiac Output); 1
SV (Stroke Volume);
CI (Cardiac Index);
SVI (Stroke Volume Index).
10 electrode cable.
12 lead ECG, HR, ST – Registration of 12 ECG
12 lead ECG 1
segment, arrhythmias. leads by using 10
electrode cable
Monitoring of transmission of TOFscan device is used
Neuro-muscular
electrostimulation signal to 1 with optical wire for data
transmission (NMT)
the muscles exchange interface

APPENDIX C. MANUFACTURER'S MANUAL AND DECLARATION -


ELECTROMAGNETIC EMISSION
UM-300 resuscitative-surgical Monitors intended for use in the electromagnetic
environment, which is showed below. The supplier or user of the resuscitative-surgical UM-
300 monitors should ensure their use in the specified environment.

Test for electromagnetic


Correspondence Electromagnetic environment - instructions
emission

UM-300 resuscitative-surgical Monitors use radio-


frequency energy only for the performance of
Radio-frequency emission internal functions. The level of radio-frequency
Group 1
according to CISPR 11: 2007 interference emissions is low, probably will not
lead to disruption of the functioning of the
electronic equipment located near it.

Radio-frequency emission
Class A
according to CISPR 11
UM-300 resuscitative-surgical Monitors are
Harmonic current component intended for use in all premises, except in those
Class A
according to IEC 61000-3-2 used for household purposes and those in which
low-voltage distribution electrical networks are
Voltage fluctuations and
applied and used for domestic purposes
flicker according to DSTU IEC Corresponds
61000-3-3

APPENDIX D. MANUFACTURER'S MANUAL AND DECLARATION – NOISE IMMUNITY


UM-300 resuscitative-surgical Monitors intended for use in the electromagnetic
environment, which is showed below. The supplier or user of the resuscitative-surgical UM-
300 monitors should ensure their use in the specified environment.
Level of compliance
Test level according to Electromagnetic environment -
Test for noise immunity with noise immunity
SSU IEC 60601-1-2 instructions
requirements
Electrostatic ± 6 kV contact ± 6 kV contact The floors of the room must be
discharge (ESD) discharge discharge made of wood, concrete or

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250
according to IEC ceramic tiles. If the floors are
61000-4-2 covered with synthetic material,
± 8 kV air discharge ± 8 kV air discharge
then the relative humidity should be
at least 30%
Nanosecond impulse ± 2 kV for power The quality of electrical energy in
± 2 kV for power lines
noise by lines the building electrical network must
IEC 61000-4-4 correspond to the typical conditions
± 1 kV for Input / ± 1 kV for Input /
for industrial or hospital
Output lines Output lines
environments.
Microsecond pulsed ± 1kV linear ± 1kV linear The quality of electrical energy in
high-power the building electrical network must
interference IEC correspond to the typical conditions
61000-4-5 ± 2kV of phase ± 2kV of phase for industrial or hospital
environments.
Conductive noise 3 V in the frequency 3V The distance between the used
induced by radio- zone from 150 KHz to monitor, including cables, should
frequency 80 MHz and outside not be less than the recommended
electromagnetic the frequencies separation distance, which is
fields according to allocated for ISM calculated in accordance with the
IEC 61000-4-6 devices above expression in relation to the
transmitter frequency
Recommended separation distance
is:
D = 1.16 √P
D = 1,164√P from 80 MHz to 800 MHz
D = 2.33√P from 800 MHz to 2.5 GHz
The radio frequency 3 V/m in the 3 V/m where P is the maximum rated
electromagnetic frequency zone from output of the transmitter (W), in
accordance with the value set by
field 80 MHz to 2.5 GHz
the transmitter manufacturer.
IEC 61000-4-3
D is the recommended spacing (m).
The field strength in the propagation
of radio waves from stationary radio
transmitters from the results of
observations of the electromagnetic
situation should be lower than the
level of compliance in each
frequency zone. Interference may
occur near equipment marked with
the following sign:
Tests for resistance 3 A/m 3 A/m Magnetic fields with the frequency
to the magnetic of the supplied network must
field of the industrial correspond to the level in ordinary
frequency by commercial and medical
IEC 61000-4-8 institutions.
Voltage dips, short <5% UH (voltage <5% UH (voltage The quality of electrical energy in
interruptions and drop> 95% UH) drop> 95% UH) the electrical network must meet
voltage variations at within 1 period within 1 period the conditions for industrial or
the input of power hospital environments. If the user of

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251
lines 70% UH (voltage drop 70% UH (voltage drop the product requires continuous
IEC 61000-4-11 30% UH) 30% UH) operation during the interruption of
during 25 periods during 25 periods the mains voltage, it is
recommended to provide power
from an uninterruptible power
source.
Note 1: At 80 MHz and 800 MHz levels, a higher frequency range applies.
Note 2: These provisions are not applicable in all situations. The propagation of electromagnetic radiation depends
on the level of absorption and reflection from structures, objects and people.
a The power fields of fixed transmitters, such as base stations for radiotelephones (cellular / wireless), as well as land

mobile and amateur radio stations, stations broadcasting at AM and FM frequencies and broadcasting cannot
theoretically be predicted with high accuracy. To evaluate the electromagnetic radiation of stationary radio
transmitters, one should consider conducting an electromagnetic investigation of the site. If the level of the
measured power fields of the place where the equipment is used exceeds the specified permissible level of radio
emission, the operation of the equipment should be monitored to ensure normal functioning. When detecting
malfunctions in the device, additional measures should be taken to improve its operation, for example, reorient or
relocate the device.
b With a frequency range from 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

Recommended distances between portable and mobile radio communication


facilities, equipment and systems which are not intended for life support.
Recommended distances between portable and mobile radio equipment and the device
This medical device is intended for use under conditions in which radio-frequency interference is
controlled. The purchaser or user of the device may prevent the occurrence of electromagnetic
interference while maintaining the minimum distance between portable and mobile radio transmitters
and the device in accordance with the following recommendations, taking into account the maximum
value of the transmitter output power.
Rated maximum Separation distance depending on the transmitter frequency (m)
output power of 50 kHz - 80 MHz 80 МHz - 800 МHz 800 МHz - 2.5 GHz
transmitter (W) d = 1.2 √P d = 1.2 √P d = 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters whose nominal and maximum values are not listed above, the recommended
separation distance (d) in meters (m) can be determined by the formula which is used to determine the
frequency of the transmitter in which P is the maximum transmitter output power in watts (W), according
to the manufacturer’s data.
Note 1: At 80 MHz and 800 MHz levels, the separation distance for the high frequency zone is applied.

Note 2: These provisions are not applicable in all situations. The propagation of electromagnetic
radiation depends on the level of absorption and reflection from structures, objects and people.

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END-USER LICENSE AGREEMENT
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU (“PURCHASER”) AND UTAS.
IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE
ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE,
WITH YOUR SALES RECEIPT TO UTAS FOR A FULL REFUND.
a. Grant of License. In consideration of payment of the license fee, which is part of the price paid for
this product, UTAS grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense,
to use the copy of the incorporated software/firmware, and documentation in connection with Purchaser's
use of Masimo products for their labeled purpose. UTAS reserves all rights not expressly granted to
Purchaser.
b. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any Masimo
software and/or firmware and the documentation, and all copies thereof, remain at all times vested in
Masimo Corporation, licensor to UTAS, and they do not pass to Purchaser.
c. Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of
law or otherwise, without UTAS's prior written consent; any attempt without such consent, to assign any
rights, duties or obligations arising hereunder shall be void.
d. Copy Restrictions. The software/firmware, mask works, circuit board layouts, and accompanying
written materials are copyrighted. Unauthorized copying of the software, including software that has been
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abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17
U.S.C. §117.
e. Use Restriction. As the Purchaser, you may physically transfer the products from one location to
another provided that the software/firmware is not copied. You may not electronically transfer the
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alone, or in combination with this device, fall within the scope of one or more of the patents relating to the
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f. Non-Authorized Accessories. Masimo technology is designed to operate together with Masimo
devices, cables, sensors, and accessories as an integrated system. When any component of the system is
compromised, erroneous measurements can occur. Accordingly, the use of unauthorized cables, sensors,
or accessories, such as third-party reprocessed or copycat sensors, can yield unreliable results when used
with a Masimo device. The performance of Masimo technology is not validated when used with any
unauthorized cable, sensor, or accessory.
g. Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be
transferred to anyone, except other end-users, without the prior written consent of UTAS. In no event may
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h. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its
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i. U.S. Government Rights: If you are acquiring software (including the related documentation) on
behalf of any part of the United States Government, the following provisions apply: the software is deemed
to be “commercial software” and “commercial computer software documentation,” respectively pursuant to
DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release,
performance, display or disclosure of the software (including the related documentation) by the U.S.
Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be
prohibited except to the extent expressly permitted by the terms of this agreement.

UM 300 Operation Manual Version 04-18/7.04.3


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NOTES

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