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Classification: Class II b,
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
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:
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.
Any UTAS product from which UTAS 's original serial number tag or product
identification markings have been altered or removed;
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.
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.
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
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:
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
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)
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
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.
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 %
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.
Figure 2
Each screen individually configurable, data layout customization is possible in
basic configuration.
Figure 3
On the front panel of the monitor there is a company logo and a name of the
model of monitor
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.
* 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".
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;
Figure 6
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
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! Connecting cables and accessories which are not included in the
delivery may cause a negative effect on the monitor's EMC characteristics.
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
Figure 10
Figure 11
Figure 12
Figure 13
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".
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.
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.
3 4 7 8
1 2 5 6
12 11 10
9
Figure 17
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
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.
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.
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
– «Pediatric»
– «Neonatal»
Figure 21
10
Figure 22
Figure 23
Figure 24
Figure 25
Figure 26
Figure 27
Figure 28
Figure 29
Figure 30
When the BIS module is working, the status of the channel is displayed in the status
bar.
Figure 31
The window displays:
Figure 32
Figure 33
Figure 34
Figure 35
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):
Figure 36
Warning! Detected arrhythmia type will have red color below the
indication “Arrhythmia Analysis” during 10 seconds since
registration.
Figure 37
Note! This ECG wave display mode only shows ECG waves.
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.
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);
Sweep speed Change a sweep speed of ECG waveforms (3.12, 6.25, 12.5,
25 and 50 mm/s)
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”);
Date and Time Activates the menu item “Date and Time”;
LED QRS Enabling / disabling the QRS light cycle indicator lamp
indicator (optional).
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:
Figure 42
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)
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;
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
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.
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)
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.
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
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);
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%)
Pulse Volume Is used for changing sound of pulse volume (10-100% with
a step of 10%)
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);
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);
Year Setting the current date, the category "Year" (numerical value);
Hour Setting the current time, the category "Hour" (numerical value);
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;
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”);
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")
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");
Figure 53
In this menu you can select and change the following parameters displayed on
the screen:
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
Figure 55
In this menu you can select and change the following parameters displayed on
the screen:
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;
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”)
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
Figure 56
In this menu you can select and change the following parameters displayed on
the screen:
Figure 57
In this menu you can select and change the following parameters displayed on
the screen:
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.
Figure 58
This submenu sets parameters of the "Venous Puncture" mode, which is used to
block peripheral blood circulation during venipuncture:
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.
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.
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 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”);
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.
Figure 61
Figure 62
In this submenu, you can view additional calculation parameters when measuring
the parameters of central hemodynamics using the ICG method.
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
Figure 63
This submenu sets parameters for the respiration rate measurement channel (RR):
Figure 64
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”);
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”)
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").
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”);
Figure 67
Figure 68
This menu is used to set the priority level parameters for each of the monitored
parameters or to turn off the alarm system:
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”);
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”).
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”).
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”).
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% )
Nurse call Alarm Switching on/off or selecting priority level of nurse call alarm
(“Off”; “Info”; “Advisory”; “Warning”; “Crisis”);
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.
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”;
Keyboard Help Informational window about main keys on the front panel of
the monitor;
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
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
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).
Figure 76
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)
In the right upper part of the window there are buttons for managing trends:
The keys for selecting the mode for displaying table or graphic
/ trends.
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.
Figure 77
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.
Entered Parameters
Figure 78
Calculated parameters
– VO2=1.34×CO×Hg×(SaO2-SvO2);
– VO2=CO × (CaO2 - CvO2).
Figure 79
Figure 80
Figure 81
Figure 82
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.
Figure 83
Figure 85
Measured parameters:
Figure 86
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.
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"
Default settings
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.
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.
Figure 88
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.
The device simultaneously registers the following leads: I, II, III, aVR, aVL, aVF, V.
Figure 89
Figure 90
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;
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 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:
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.
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
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
To review trends of ST segment offset in all ECG leads, use the key “TRENDS” on
the front panel of the monitor.
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".
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.
Setting of alarm delay limits for APNEA is set in the submenu "RR",
item "APNEA Delay".
Do not start or operate the monitoring device unless the setup was
verified to be correct.
Severe anemia
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.
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.
Figure 94
Figure 95
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.
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
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.
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
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.
Figure 100
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.
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:
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
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.
2. Attachment Wraps
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.
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).
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).
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).
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
NOTE: Clip the clothing clip to the patient gown to reduce cable pulling on the
measuring site.
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.
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.
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
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.
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.
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.
Figure 114
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
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).
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.
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).
Verify correct positioning and reposition if necessary (the black lines should
align).
Figure 120
4. Reattachment
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.
Figure 122
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
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.
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
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
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.
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”.
SpO2 sensor and its cable should be as far from the cables
of electrosurgical tool as possible.
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
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.
The device forms NIBP trend and stores it into the memory (refer to TRENDS).
Caution! The cuff (or air hose) can be connected after switching on the
monitor.
Figure 129
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 ".
Figure 130
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 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.
Figure 132
Remove the sensor and the connecting catheter from the sterile package,
observing the rules of asepsis.
Figure 134
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
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
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.
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
Figure 137
Figure 140
Activate capnography channel in the menu "CO2" of the monitor (setting "ON").
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."
Operating procedure
Figure 141
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.
1. Capnography sensor;
2. The airway adaptor.
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".
Figure 121
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.
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.
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.
Do not use the IRMA Infant adaptor with adults as this may
cause excessive flow resistance.
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
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.
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.
Check that the gas sample flow is not too high for the
present patient category.
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 open BISx for any reason. The seal to prevent liquids
from entering the BISx may be damaged if opened.
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
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.
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.
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
10
Figure 156
Figure 157
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.
Figure 158
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.
Figure 159
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.
Figure 161
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.
Figure 163
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
Figure 164
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.
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.
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.
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.
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;
Also additional screen can be used for Central Monitoring, duplicate all
information from patient monitor. Support UniScreen visualization technology.
Figure 168
Figure 169
M1 M2 M3 M32
M1 M2 M3 M32
Figure 170
Figure 171
Power cord included in the set of equipment can only be used for
AC line power operation.
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.
When the power LED on the front panel of the monitor is green, the monitor is
connected to mains 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”.
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):
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.
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.
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.
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.
Caution! Any repairs and servicing of the equipment are performed only
by the manufacturer, or authorized representative.
visual and audible alarms are switched off (a grey triangle is crossed by
red lines)
According to the priority level (danger degree) alarms have different audible and
visual indication.
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:
Alarms”. In the top of the window crossed-out grey bell “ ” indicates that
audible alarm is switched off.
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.
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).
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
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
- 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.
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.
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
Grey inscription on
Preparing to measuring. Checking the module’s
Thermodilution a white
Wait measurement availability
background
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
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
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.
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.