POOYANDEGAN RAH SAADAT

OPERATORS MANUAL

ALBORZ B7

PD-W-18/3

OPERATION MANUAL

POOYANDEGAN RAH SAADAT CO.

No. 48, Elm-o-Sanat university st., Hengam st., Resalat highway, TEHRAN IRAN Tel: +98 21 77180630-4 Fax: +98 21 77180629 Web site: Email: Customer Services: Tel: +98 21 77180645 Cell: +98 912 1977157 www.saadatco.com info@saadatco.com

Legal responsible:
HEYER Medical AG Mrs. Gertrud Werner Carl-Heyer - Str. 1-3 56130 Bad Ems, Germany Tel: +49 2603 791-145 Fax: +49 2603 791-209 E-Mail: Info@heyermedical.de

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Contents
CHAPTER 1 INTRODUCTION........ 1.1 GENERAL WARNING........... 1.2 GENERAL INFORMATION ......... 1.3 SCREEN DISPLAY................ 1.4 BUTTON FUNCTIONS...... 1.5 INTERFACES. 1.6 BUILT-IN BATTERY. CHAPTER 2 SYSTEM CONFIGURATION 2.1 SIGMA. 2.2 TREND 2.3 ALARM... 2.4 SETUP. 2.5 PATIENT INFORMATION 2.6 RECORDER 2.7 ABOUT CHAPTER 3 ALARM. 3.1 ALARM CATEGORIES. 3.2 ALARM MODES 3.3 ALARM CAUSE. 3.4 ALARM SILENCE BUTTON FUNCTION... 3.5 PARAMETER ALARM.. 3.6 WHEN AN ALARM OCCURS.. CHAPTER 4 ECG MONITORING... 4.1 GENERAL................................................................................................... 4.2 ECG WINDOW........................................................................................... 4.3 ECG ALARM MESSAGES........................................................................ 4.4 ECG CABLE CLEANING.. CHAPTER 5 RESP MONITORING . 5.1 GENERAL................................................................................................... 5.2 RESP WINDOW.. 5.3 RESP ALARM MESSAGES...................................................................... CHAPTER 6 SPO2 MONITORING. 6.1 GENERAL.................................................................................................. 6.2 SPO2 WINDOW. 6.3 SPO2 ALARM MESSAGES...................................................................... 6.4 SPO2 PROBE CLEANING. CHAPTER 7 NIBP MONITORING.. 7.1 GENERAL................................................................................................... 7.2 NIBP WINDOW.. 7.3 NIBP ALARM MESSAGES....................................................................... 7.4 NIBP CUFF CLEANING... CHAPTER 8 TEMP MONITORING 8.1 GENERAL................................................................................................... 8.2 TEMP WINDOW 8.3 TEMP ALARM MESSAGES...................................................................... 8.4 TEMP SENSOR CLEANING AND STORAGE... 1-1 1-1 1-4 1-6 1-7 1-9 1-12 2-1 2-2 2-2 2-4 2-5 2-7 2-8 2-9 3-1 3-1 3-1 3-3 3-3 3-3 3-4 4-1 4-1 4-6 4-10 4-12 5-1 5-1 5-1 5-3 6-1 6-1 6-5 6-7 6-8 7-1 7-1 7-4 7-7 7-9 8-1 8-1 8-2 8-3 8-3

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CHAPTER 9 IBP MONITORING. 9.1 GENERAL................................................................................................... 9.2 IBP WINDOW. 9.3 IBP ALARM MESSAGES......................................................................... 9.4 IBP TRANSDUCER CLEANING............................................................. CHAPTER 10 GAS MONITORING (mainstream).................................................... 10.1 GENERAL.............................................................................................. 10.2 GAS WINDOW... 10.3 GAS ALARM MESSAGES................................................................... 10.4 IRMA SENSOR CLEANING...... CHAPTER 11 GAS MONITORING (sidestream).. 11.1 GENERAL. 11.2 GAS WINDOW. 11.3 ISA SENSOR ALARM MESSAGES... 11.4 ISA SENSOR CLEANING... CHAPTER 12 CSM MONITORING 12.1 GENERAL. 12-2 CSM SYSTEM..... 12-2-1 CSM MODULE.. 12-2-2 CSM ON PATIENT MONITOR........ 12.3 CSM ALARM MESSAGE AND TROUBLESHOOTING................. 12.4 CSM MODULE CLEANING AND MAINTENANCE CHAPTER 13 ST MONITORING 13.1 GENERAL. 13.2 ST ANALYSIS WINDOW 13.3 ST ALARM MESSAGE CHAPTER 14 ARRHYTHMIA MONITORING. 14.1 GENERAL. 14.2 ARR ANALYSIS WINDOW CHAPTER 15 RECORDING..... 15.1 GENERAL................................................................................................ 15.2 RECORDING TYPE........ 15.3 RECORDER OPERATIONS AND STATUS MESSAGES........ 15.4 RECORDER PAPER. 15.5 RECORDER STATUS MESSAGE...... 15.6 RECORER CLEANING CHAPTER 16 PATIENT SAFETY... CHAPTER 17 CARE AND CLEANING.. 17.1 SYSTEM CHECK........ 17.2 CLEANING... 17.3 STERILIZATION.. 17.4 DISINFECTION.... CHAPTER 18GETTING STARTED.. 18.1 OPEN THE PACKAGE AND CHECK................................................... 18.2 PLACE THE BATTERY FUSE............................................................... 18.3 CONNECT THE POWER CABLES........ 18.4 POWER ON THE MONITOR..... 18.5 CONNECT PATIENT SENSORS

9-1 9-1 9-2 9-8 9-9 10-1 10-1 10-10 10-17 10-20 11-1 11-1 11-7 11-13 11-16 12-1 12-1 12-7 12-7 12-15 12-18 12-20 13-1 13-1 13-3 13-6 14-1 14-1 14-3 15-1 15-1 15-1 15-2 15-2 15-4 15-4 16-1 17-1 17-1 17-1 17-2 17-2 18-1 18-1 18-1 18-1 18-1 18-2

OPERATION MANUAL CHAPTER 19 TECHNICAL SPECIFICATION..... 19-1 CHAPTER 20 ACCESSORIES AND ORDERING INFORMATION.... 20-1 20.1 ECG ACCESSORIES 20-1 20.2 SPO2 ACCESSORIES....... 20-1 20.3 NIBP ACCESSORIES........ 20-1 20.4 TEMP ACCESSORIES.. 20-2 20.5 IBP ACCESSORIES... 20-2 20.6 GAS ACCESSORIES (mainstream)... 20-2 20.7 GAS ACCESSORIES (sidestream)..... 20-2 20.8 CSM ACCESSORIES..... 20-2 CHAPTER 21 TROBULE SHOOTING........................................................................ 21-1 APPENDIX I LIST OF MONITOR,S PARAMETERS (SELECTIONS AND DEFAULTS) APPENDIX II MONITOR ERROR MESSAGES APPENDIX III MASIMO MODULE APPENDIX IV EMC APPENDIX V IRMA Design and theory APPENDIX VI ISA Design and theory

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Chapter 1 Introduction
for an overall safety instruction, please refer to 1.1 General Warning. for an overall introduction to the monitor, please refer to 1.2 General Information. for various messages displayed on the screen, please refer to 1.3 Display Screen. for basic operating instructions, please refer to 1.4 Button Function and Basic Operation. for allocation of interface sockets, please refer to 1.5 Peripheral Interfaces. for important facts to be noted during the battery recharging procedure, please refer to 1.6 Built-in Rechargeable Battery.

1.1 General Warning

Warning Patient Care Monitor is intended for clinical monitoring application with operation only granted to appropriate medical staff. Warning Before use, carefully read this manual, directions for use of any accessories, all precautions, and all specifications. Warning The vital sign monitor is intended for use only as an adjunct in patient assessment .It must be used in conjunction with clinical signs and symptoms. Warning If the accuracy of any measurement does not seem reasonable, first check the patient's vital signs by alternate means and then check the monitor for proper functioning. Warning Do not use the patient monitor during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The monitor may affect the MRI image, and the MRI unit may affect the accuracy of monitor measurements. Warning Do not place the monitor in any position that might cause it to fall on the patient. Warning There could be hazard of electrical shock by opening the monitor casing. All servicing and future upgrading to this equipment must be carried out by personnel trained and authorized by manufacturer.

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Warning Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide. Warning To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. Warning The user must check that equipment and accessories function safely and see that it is in proper working condition before being used. Warning Alarm must be set up according to different situation of individual patient. Make sure that audio sounds can be activated when alarm occurs. Warning Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation emitted from such devices may result in strong interference with the monitor performance. Warning Do not touch the patient, table nearby, or the equipment during defibrillation. Warning The equipment and devices connected to it should form an equipotential body to ensure effective grounding. Warning The doctor shall consider all well-known side-effects when using the patient monitor. Warning There will be some risks of polluting the environment associated with the disposal of the device and cables at the end of their useful lives. The device and accessories shall be disposed in accordance with national laws after their useful lives. Contact your municipality to check where you can safely dispose of old batteries. Warning Do not expose the system near any local heating item such as the direct radiation.

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Warning Do not use one monitor for two or more patient at the same time. Warning It is possible to increase leakage current when several systems are connected to the patient simultaneously. Warning Monitor software is designed in a way that hazards arising from errors in the software programmed are minimized. Warning Do not connect items not specified as parts of the monitor. Warning Vital sign monitor needs to be installed and put into service according to the EMC information provided in the APPENDIX III Warning If water sprayed into the device or accessories, turn the device off and dry it with a soft cloth. Then turn it on again.

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1.2 General Information

Environment: Temperature Working Transport and Storage Humidity Altitude Power Supply 5 to 40C -20 to 60C 20-90 %( None condensing) -200 to 3000m 90-260VAC, 50/60Hz PMAX= 75W

General instruction: The ALBORZ B7 Patient Monitor (Figure 1-1) is adaptable to adult and neonatal usage. It can monitor vital signals as ECG, Respiratory Rate, SPO2, NIBP, Dual IBP, CO2, O2, N2O, Anesthesia Agent, Dual-TEMP and Cerebral State Index. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. Large high-resolution display provides clear view of waveforms. The POWER switch is on the front panel ( in Figure 1-1). Three indicators for power, alarm and battery are on the front panel of system. The green indicator lights, when the device is powered on ( in Figure 1-1). The ALARM indicator, flashes or lights when alarm occurs ( in Figure 1-1) and the battery indicator is green, when the battery is charged otherwise it is orange. ( in Figure 1-1). The sockets of the sensors are at the left side of system. Other sockets and power plug-in are at the side. Warning During the system is powered on, the indicators light. If all indicators light, it will show proper functioning of indicators.

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Figure 1-1 bed side Monitor's picture Patient Care Monitor performs monitoring of: ECG Heart Rate (HR), ST segment, PVCs/min, Arrhythmias ECG waveforms RESP Respiratory Rate (RR) Respiration Waveform SPO2 Saturation pulse oximetery (SPO2), Pulse Rate (PR) SPO2 Plethysmogram NIBP Systolic pressure, Diastolic pressure , Mean arterial pressure (MAP) TEMP Channel-1 Temperature (T1), Channel-2 Temperature (T2), Differential temperature between two channels (DT) IBP Channel-1 IBP (IBP1), Channel-2 IBP (IBP2), CO2 EtCo2, FiCo2, AWRR Multi-gas EtN2O, FiN2O, EtO2, FiO2, EtAA, FiAA AA is included 5 anesthesia agent (DES, ISO, SEV, HAL and ENF) CSM CSI%, BS%, SQI%, EMG% Vital sign monitor provides extensive functions as visible & audible alarm, storage and report printout, trend data, NIBP measurements and 80 arrhythmias event recall. Depending on customer's order, MASIMO or SAADAT modules can be installed on vital sign monitor optionally. Depending on customer's order, mainstream or sidestream CO2 module can be installed on system optionally. Vital sign monitor is a user-friendly device with operations conducted by a few buttons on the front panel and a rotary knob. Refer to 1.4 Button Functions for details.
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1.3 Screen Display

Vital sign monitor has a color TFT display. The patient Parameters, waveforms, alarm messages, bed number, date, system status and error messages is displayed on the screen. The screen is divided into three areas: Header Area; Waveform Area; Parameter Area. (Figure 1-2)

Figure1-2 Monitor Main Display Header Area: The Header Area is at top of the screen displaying operating state of the monitor and status of the patient. The parameters in Header Area are bed number, type of patient (adult or neonate), current date and time The above messages appear on the screen throughout the monitoring process. Other information of the Header Area comes up only with respective monitoring status. They are: indicates the remaining battery charge "ALARM SILENCE" appears when the alarm silence button is pressed. "NETWORK" appears when the system is connected to central system. Waveform/Menu Area: All waveforms can be displayed at the same time. The waveforms from top to bottom are: ECG, SpO2, IBP1, IBP2, EEG (for 12 or larger) and RESP/CO2/Multi-gas (coming from ECG module or CO2 module or Multi-gas module) Gain, filter, lead and sweep of the ECG are displayed as well .The three dotted lines from top to bottom show the highest scale, reference scale and lowest scale of IBP waveform. These values can be manually set. All menus in monitor always appear at fixed areas on the screen. When the menu is displayed, some waveforms become invisible. The size of the menu is also fixed, covering the lowest 2, 3, 4 or 5 waveforms.
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OPERATION MANUAL Parameter Area Parameters are displayed at a fixed position .The monitoring results are displayed in the Parameter Area. The parameters refresh every second, except that the NIBP values refresh each time the measurement is over. Alarm indicator: In normal mode, the alarm indicator is not lit. In alarm mode, the alarm indicator lights or flashes. Warning Always verify the audible and visible (LED) alarms when monitor powers on. Please refer to Chapter 3 for details.

1.4 Button Functions

All the operations to monitor are executed through buttons and knob at the right of the front panel. The names of the buttons are above them. They are (Figure 1-3):

Figure 1-3 bedside monitor's Buttons and Knob Rotary Knob This knob can be used to select and change the settings. Operations can be performed by turning it clockwise, counter clockwise or pressing it down. The square frame that moves with the knob turning, is referred to as "cursor". When no menu is displayed, turning the knob clockwise can locate the cursor at: ECG, NIBP, SPO2, IBP, EEG, and RESP/CO2/Multi gas parameter Area of screen. When the cursor is placed at any area, the user can change the current setting. When at any of the last items, related parameters menu can be called up for setting changes. Operation is as follows: When you move the cursor to a certain item: 1. A menu pops up, by pressing the knob. 2. Move the cursor frame to related parameter in opened menu by turning the knob. 3. Change the content by pressing the knob on the special parameters and choose your setting and confirm your selection by pressing it.
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OPERATION MANUAL Power Press to power on or off the system HOME/MENU Press to call up the HOME WINDOW. Refer to Chapter 2 HOME WINDOW START/STOP Press to inflate the cuff to start a blood pressure measurement. When measuring, press again to stop the measurement and deflate the cuff. REC/STOP Press to start a real time recording from ECG signal and all monitoring parameters. Press during recording to stop it Freeze When in normal mode, press to freeze all the waveforms on the screen. When in freeze mode, press to restore the waveform refreshing.

Alarm Silence Press to suspend alarm and disable all sound signals for 120 seconds. ("ALARM SILENCE" appears in the Header Area). Press again to restore all sound signals and remove the message. NOTE: If new alarm occurs under Alarm Suspension/Silence state, Suspension/Silence state will remove.

Warning Before using the system on the patient, user must check the buttons function and be sure that it is in proper working functionality as described above.

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1.5 Interfaces
For the verity of operation, different kinds of interfaces are in different parts of the monitor. At the right side is the recorder's paper inlet cover. (If the system has a recorder) At the left side are the connectors for patient cables and the sensors, as shown in Figure 1-4. Connector for TEMP1 probe Connector for TEMP2 probe Connector for IBP1 transducer Connector for IBP2 transducer Connector for SAADAT Spo2 Sensor Connector for MASIMO Spo2 Sensor Connector for ECG cable Connector for CO2/Multi-gas sensor Connector for NIBP cuff

a) SAADAT Spo2

b) MASIMO Spo2

Figure 1-4 Warning For SAADAT SPO2, the shape of ECG and SPO2 connectors are the same. The user should be note to place the ECG and SPO2 cables in corresponding connectors. Warning White sign of ECG connector on the side panel should be in front of the white sign of the ECG cable connector. Warning For proper connection between SAADAT SPO2 and ECG cable, white sign of spo2 connector on the side panel should be in front of the white sign of the spo2 probe connector.

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This symbol means "BE CAREFUL". Refer to the manual.

Indicates that the instrument is IEC-601-1 Type CF (Defibrillation proof applied part) equipment. The module with this symbol contains an F- Type isolated (floating) patient applied part which provides a high degree of protection against shock, and is usable during defibrillation.

Indicates that the instrument is IEC-601-1 Type BF(Defibrillation proof applied part) equipment which is defibrillator proof. The module with this symbol contains an F- Type isolated (floating) patient applied part which contains an adequate degree of protection against shock, and is suitable for use during defibrillation Other symbols in the monitor are explained in chapter 16.

Figure 1-5 Rear Panel Following sockets are on the rear panel as illustrate in Figure 1-5. Equipotentiality Jack Equipotential grounding terminal for connection with the hospital's grounding system. Power Supply: 90-260 (VAC), 50/60 (Hz). DC INPUT External power supply (e.g. in ambulances) VGA SLAVE MONITOR: Monitor interface for external standard VGA color monitor. Working mode: 800600,256 colors Interface: D-sub 15 pins Pin 1. Red Video Pin 9. NC
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OPERATION MANUAL Pin 2. Green Video Pin 3. Blue Video Pin 4. Ground Pin 5. NC Pin 6. Red Ground Pin 7. Green Ground Pin 8. Blue Ground Pin 10. Ground Pin 11. NC Pin 12. NC Pin 13 Horizontal Sync Pin 14. Vertical Sync. Pin 15. NC

How to use: 1) Install the VGA slave monitor in the same room with the patient but keep it away from the patient more than 1.5m. The monitor is intended to be used as an assistant monitoring device. 2) Plug the connection cable while the VGA slave monitor is off. 3) Power on the monitor, same time or after power on the VGA slave monitor. 4) Adjust brightness and contrast properly. Warning If DC-INPUT power supply in cars like ambulances is used (ambulances with body that is connected to the negative pole of the battery), for safety requirements, DC to DC or DC to AC converter with the isolation of 1500VAC (at least), must be used. Using 220V of power supply in ambulances is recommended. Preparing mentioned DC to DC or DC to AC converter, please contact technical department of manufacturer. External alarm The output external alarm for warning devices drive at nurse station. FUSE F 3A Warning If you are going to store the patient monitor or you don't want to use it for along time (more than 10 days), remove the fuse or battery. Network Interfaces The data transmission technique is full duplex and the interfacing standard is RS 422. Warning Patient monitor must be connected to SC1201 or SAHAND series central system only. Warning Use only the recommended central cable for connecting monitor to central system. Wired Remote Control The friendly user short keys for remote control access.

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1.6 Built-in Battery

Patient Care Monitor is equipped with a rechargeable battery. The battery will be automatically recharged when the monitor connects to the AC INPUT .When the battery is completely discharged, it takes about 16 hours to charge it again. When the AC INPUT is plugged in, turning the system on or off doesnt have any effect on the process of charging the battery. If the battery is completely charged, the system can work about 80 minutes without connecting to the AC INPUT. " is displayed on the Header Area of the screen to indicate the status of recharging, Symbol " in which the yellow part represents the remaining battery charge.This symbol is only displayed when the AC INPUT is not plugged in. If the AC INPUT is plugged in, the status of charging battery will be shown by battery indicator at the right side of screen. When the battery indicator is completely green, the battery if full charged and when it is orange, means that the battery is being charged. The battery doesnt charge when the system connects to the DC INPUT (ambulance electricity). The fuse on the rear panel protects the battery while charging the battery or when the system is not connected to AC INPUT. When the fuse is damaged, the system can not work with battery and if the AC INPUT is plugged in, the battery indicator will be always green. Warning When you store the system for a long time or the system is used for the first time, you should first place the fuse on the rear panel of monitor and then connect it to the AC INPUT for about 24 hours. During this time you must not use the patient monitor without AC INPUT. Warning The monitor will shut down automatically if the battery power is low. When the electric energy is going out, the monitor will sound beeping and display "BATTERY LOW" in the Header Area. Connecting the monitor to the AC power at this moment can recharge the battery while operating. If you keep on using the battery, the monitor will shut down automatically.

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Chapter 2 System Configuration

for last saved ECG signal, please refer to 2.1 SIGMA for previous value of measured parameters, please refer to 2.2 TREND. for alarm setting and a alarm volume adjustment, please refer to 2.3 ALARM for date and time setting please refer to 2.4 SETUP Patient Care Monitor features flexible configurations. The configuration is done through operations on the HOME WINDOW (figure 2-1), by pressing the HOME/MENU button on the front panel of monitor

Figure 2-1 HOME WINDOW

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2.1 SIGMA
Patient monitor is able to save last 300 seconds ECG signal and it is visible in 15 traces in SIGMA WINDOW. Pick "SIGMA" in HOME WINDOW to call up the following menu:

Figure2-2 HOME/SIGMA WINDOW In this window there are ECG current settings, ECG LEAD, ECG GAIN and SIGMA SWEEP. Refer to Chapter 4 ECG MONITORING for details.

2.2 TREND
The latest 72 hour trend value of parameters is recorded every 20 seconds. Pick "TREND" in the HOME WINDOW to call up the following menu:

Figure 2-3 HOME/TREND WINDOW Y-axis stands for related value and X-axis for time.
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OPERATION MANUAL To select trend graph of a specific parameter: Pick parameter name (the most left item) and select a requested parameter name by turning the knob. Available options are HR, SPO2, RESP, T1, T2, IBP1, IBP2, CO2, N2O, O2, AA, PVCs and ST. To change the display scale: Pick "SCALE" (the second left item) to adjust the Y-axis scale and thus change the trend curve in proportion.
PARAMETER HR SPO2 RESP T1 T2 IBP1 IBP2 CO2 O2 N2O AA PVCs ST SCALE1 MIN 0 80 0 30 30 -20 -20 0 0 0 0 0 -0.2 MAX 60 100 60 42 42 50 50 50 50 50 1.0 20 0.2 SCALE2 MIN 0 60 0 24 24 -20 -20 0 0 0 0 0 -0.5 MIN 120 100 120 48 48 100 100 100 100 100 2.0 50 0.5 SCALE3 MIN 0 0 0 0 0 -20 -20 0 0 -1 MAX 240 100 240 48 48 200 200 3.0 100 +1 SCALE4 MIN -50 -50 0 -2 MAX 300 300 5.0 2 SCALE5 MIN 50 50 0 MAX 250 250 10.0 SCALE6 MIN 0 MAX 20.0 -

To select how long the trend graph is displayed: Pick the third left item, available options are 15 and 30 min, 1, 2, 4, 8, 12, 24, 36, 48 , 60 and 72 hours To obtain trend data of a specific time: Cursor line in trend graph shows specific time. You can move the cursor line to change the time by pressing the fourth left item and turning the knob, when the time interval (the third left item) is set at 15 and 30 min, and 1 or 2 hours. Parameters at mentioned time are displayed on the right side of the TREND WINDOW menu. To select time interval of trend in x-axis Pick "SHIFT"(the fifth left item) to adjust the start and stop time. By every clicking on the SHIFT, the x scale will be changed in the extent of the specified time of the third left item.

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2-3 ALARM
Pick "ALARM" in HOME WINDOW to call up, the following menu:

Figure 2-4-a HOME/ALARM WINDOW

Figure 2-4-b HOME/ALARM WINDOW Note: (2-4-a HOME/ALARM WINDOW) appears when you choose Resp or GAS module is off and (2-4-b HOME/ALARM WINDOW) appears when you choose GAS.

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OPERATION MANUAL Alarm settings are all together in this menu. ALARMS ON/OFF Pick "ON" to enable the alarm functions. Pick "OFF" to disable the alarm functions such as audio alarm, parameters blinking and alarm light indicator. In "OFF" mode there will be a beside all parameters. This function changes alarm parameters ON or OFF all together, but you are able to change every specified alarm parameters separately in its own window. ALARM FREEZE Pick "ON" to freeze all the related signals when parameter's value violates adjusted alarm limits are activated. In freeze mode, press "Freeze" button on the front panel to release the waveform refreshing Pick "OFF" to disable signal freezing when alarm is activated. ALARM VOLUME Pick "ALARM VOLUME" to set the volume of alarm sound. The selection ranges from 1 to 7. 1 represents minimum volume, while 7 represents maximum volume. Rotating the knob increases or decreases the volume. NOTE: All other settings in this menu are about alarm on or off and high or low limit of monitor measurable parameters alarm ranges. You are able to set these items in related parameters menu. Refer to modules chapters for details.

2.4 SETUP
After choosing "SETUP" in HOME WINDOW menu, the following menu will be called up:

2.5 HOME / SETUP WINDOW CALENDAR DATE TIME BED NUMBER ADULT/NEONATE available options are "SOLAR" and "CHRISTIAN". set the current date of monitoring set the current time of monitoring patient bed number (1...99) available options are "ADULT" and "NEONATE".

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OPERATION MANUAL LANGUAGE LARGE DISPLAY DISPLAY OFF LOAD DEFAULT available options are ENGLISH, SPANISH ,ITALIAN ,FRENCH, RUSSIAN,TORKISH and POLISH. available options are "PAGE1" and "PAGE2" and "OFF" display off, until a button is pressed or an alarm occurs. picks it to call up the following menus:

2.6.a SETUP / DEFAULT WINDOW

2.6.b SETUP / DEFAULT WINDOW Note: (2.6.a SETUP / DEFAULT WINDOW) appears when you choose Resp or GAS module is off and (2.6.b SETUP / DEFAULT WINDOW) appears when you choose GAS. If you choose any options in this window, the system will load the factory settings of related parameters. (Refer to appendix I for factory settings of parameters (default)). Because of changing all your previous settings, the system asks if you are sure to change all by this message: ECG SETTING WILL BE DEFAULT, ARE YOU SURE? YES NO CLEAR MEMORY You can clear stored parameters in system such as parameters saved in TREND window, NIBP LIST window, CSM TREND window and ARR EVENT LIST window. For each separate window, a message will appear on the screen which asks you whether to clear that item or not. These messages are as a follow:

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OPERATION MANUAL TREND WILL BE CLEARED, ARE YOU SURE? YES NO NIBP LIST WILL BE CLEARED, ARE YOU SURE? YES NO CSM TREND WILL BE CLEARED, ARE YOU SURE? YES NO ARR LIST WILL BE CLEARED, ARE YOU SURE? YES NO

2.5 PATIENT INFORMATION

After choosing "PATIENT INFORMATION" in HOME WINDOW menu, the following menu will be called up:

2-7 HOME/PATIENT INFORMATION WINDOW Press "NEW" to enter new patient information, All patient information will be cleared by some confirmation questions. Press "EDIT" to edit current patient information. The information menu is as a follow:

2-8 HOME/PATIENT INFORMATION WINDOW NAME PATIENT ID BIRTH DATE GENDER WEIGHT HEIGHT DR. NAME HOSPITAL WARD Patient name (length: 15 characters) Hospital ID for patient (length: 15 characters) Date of the birth Available options are MALE and FEMALE Available between 0.5 to 300 Kg Available between 10 to 300 cm Doctor name (length: 10 characters) Hospital name (length: 15 characters) Hospital ward name (length: 10 characters)
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2.6 RECORDER
After choosing "RECORDER" in HOME WINDOW menu, the following menu will be called up:

2-9 HOME/RECORDER WINDOW INTERNAL RECORDER Pick "ON" to enable internal recorder and record via it. Pick "OFF" to disable the internal recorder and record via central system TRACE1 Choose the first trace of print out record while manual recording. Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF TRACE2 Choose the second trace of print out record while manual recording. Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF. RECORDER SWEEP Available options for RECORDER SWEEP are 12.5, 25 and 50 mm/s. MANUAL RECORD TIME Available options for MANUAL RECORD TIME are "MANUAL" and "CONTINUOUS". PERIODIC TRACE1 Choose the first trace of print out record while automatic recording. Available options are ECG, SPO2, IBP1, IBP2 , RESP and OFF PERIODIC TRACE2 Choose the second trace channel of print out record while automatic recording. Available options are ECG, SPO2, IBP1, IBP2, RESP and OFF. PERIODIC INTERVAL For choosing interval time in periodic recording mode . Available selections are 15min, 30min,1h,2h,4h,8h,12h,24h and OFF. ALARM RECORD While alarm recording for each parameter is set ON, it automatically starts recording when alarms happened.
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2.7 ABOUT
After choosing "ABOUT" in HOME WINDOW menu, the following menu will be called up:

2-10 HOME/ABOUT WINDOW

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Chapter 3 Alarm
This chapter gives general information about alarm and corresponding functions. Warning Always verify the audible and visible alarms when monitor is powered on.

3.1 Alarm Categories

The patient monitors alarms can be classified into three categories: physiological alarms, technical alarms and prompt messages.

3.1.1 Physiological alarms

Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition.

3.1.2 Technical alarms

Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion due to proper operation or mechanical problems.

3.1.3 Prompt messages

As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarm messages, the patient monitor will show some messages telling the system status. Messages of this kind are included into the prompt message category and usually displayed in the prompt information area. But for some measurements, their related prompt messages are displayed in their respective parameter windows.

3.2 Alarm Modes

3.2.1 Alarm Level and Setup
Patient Care Monitor offers three levels of alarm. Level I alarm indicates the patient's life is in danger or the monitor under use has serious problems. It is the most serious alarm. Level II alarm means serious warning. Level III alarm is a general warning. Patient monitor has preset the alarm level for the parameters. You can also modify the classification using the method described in module's chapters.

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3.2.2 Alarm Modes

Alarm messages will be prompted through screen, indicator, and sound according to different levels. Screen Display When an alarm occurs, the parameter which triggers the alarm, blinks. Alarm Indicator Alarm indicator flashes red for Level I alarm, yellow for Level II alarm and lights yellow for Level III alarm. Alarm Sound Corresponding alarm, sound will be activated, if the alarm is not silent (i.e., the SILENCE button has not been pressed to make SILENCE state). The sounds of the alarm for the three levels are different: Level I alarm sounds "DO-DO-DO--DO-DO" twice every 10 seconds; Level II alarm sounds "DO- DO-DO" every 25 seconds; Level III alarm sounds "DO-" every 50 seconds. Alarm volume value increases in six incremental steps from lowest value of 45 dB in Step 1 to a maximum of 82 dB in step 7. NOTE: When alarms of different levels occur at the same time, the monitor prompts the alarm of the highest level. And, when multiple alarms of same levels occur simultaneously, the patient monitor will detect them and give visual and audible alarm indications accordingly.

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OPERATION MANUAL

3.2.3 Alarm verification during power on

During the monitor is being powered on, audible and visible (yellow and red indicator) alarms will be self tested. Every time that monitor is powered on, the system beeps, and yellow and red indicator light about 2.5 seconds separately. If no beeps heard or no alarm indicator is lighted, do not use this device to monitor any patient, and notify Customer Service.

3.3 Alarm Cause

Alarm occurs when alarm for parameter is evoked; Conditions that activate the parameter alarms: When the measurement value exceeds the adjusted alarm limits and the alarm is in "ON" mode. If the monitor detects situations like ASYSTOLE or APNEA, alarm occurs. Alarm will not activate if the alarm is in "OFF" mode.

3.4 Alarm Silence Button Function

Pressing the "Alarm Silence" button once can suspend all alarm sounds for 2 minutes. Message "ALARM SILENCE" prompts in the Header Area for 120 seconds. During the 2 minutes if new alarm occurs, the Silence status will be terminated and both audible and visible alarms are triggered. If within the 2 minutes of alarm suspension the operator presses "Alarm Silence" button, the alarm suspension status will be ended and the normal alarm status resumed immediately.

3.5 Parameter Alarm

The setup of the alarm parameters can be found in related menus separately. In the menu for a specific parameter, you can check and set the alarm limit and the alarm status. When a parameter alarm is 'OFF', this symbol " " is displayed near the parameter. For the parameters of which alarm is set to 'ON', the alarm will be triggered when at least one of them exceeds the alarm limits. The following actions take place: 1. 2. 3. Alarm message is displayed on the screen. The monitor beeps in its corresponding alarm level and volume. Alarm indicator flashes.

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OPERATION MANUAL

3.6 When an Alarm Occurs

When an alarm occurs, the patient monitor will indicate it to the user through visual or audible alarm indications without delay. It is needed to identify the alarm and act appropriately according to the cause of the alarm. 1. 2. 3. 4. 5. Check the patient's condition. Identify the module in alarm. Identify the cause of alarm. Silence the alarm, if necessary. When cause of alarm has been over, check that the alarm is working properly.

You will find the alarm messages for the individual parameters in each module's chapter. NOTE: The maximum remote alarm signal generation delay (e.g. indicating alarm signal in central system.) is less than 3 seconds.

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OPERATION MANUAL

Chapter 4 ECG Monitoring

4.1 GENERAL
Monitoring the ECG produces a continuous waveform of the patient's cardiac electric activity for an accurate assessment of his current physiological state. The process of depolarization and repolarization of the myocardium generates electric potential that are sensed by ECG electrodes on the skin. These electrodes are typically attached to the patient's right arm, left arm and left leg for 3 leads monitoring. The monitor processes and amplifies these signals and presents the ECG waveform on the screen. Only proper connection of the ECG cables can ensure satisfactory measurement. - It takes about 6 seconds to change heart rate from 80 to 120 bpm. (Test method is according to AAMI standard EC13:1993) - It takes about 8 seconds to change heart rate from 80 to 40 bpm. (Test method is according to AAMI standard EC13:1993) - When Tachycardia (200 bpm HR) happens, it takes 6 seconds to alarm. In this case the low alarm limit should be set in 60 bpm and high alarm limit on 100 bpm. - It takes 10 seconds to alarm after cardiac arrest (from 80 bpm to 0 bpm). NOTE: The above results are according to HR average of 4 seconds. - The ECG monitoring is able to reject 1.2 mV TALL-T. - The current that is applied to the patient for lead-sensing is 90nA. - Active noise suppression specification: The common noise signal with maximum inverse current amplitude of 10A is delivered to the reference lead. - The ECG patient cable consists of 2 parts: The cable that is connected to the monitor and the lead set that is connected to the patient. Warning Do not touch the patient, bed, table nearby or the monitor during defibrillation. Warning Use only the recommended manufacturer ECG cable for monitoring. Other ECG cables and leads may cause improper performance and/or provide inadequate protection during defibrillation
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OPERATION MANUAL Warning Line Isolation Monitor (LIM) transient may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual. Warning When you connect the cables and electrodes, make sure that no metal part is in contact with the safety ground. Verify that all ECG electrodes are correctly attached to the patient. NOTE: Interference from a non-grounded instrument near the patient and/or ESU (Electro Surgical Unit) interference can cause inaccuracy of the waveform. 1. Prepare the patient's skin prior to place the electrodes. The skin is a poor conductor of electricity, therefore preparation of the patient's skin is important to facilitate good electrode contact to skin. Shave hair from sites, if necessary. Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because increases skin impedance). Rub the skin briskly to increase capillary blood flow in the tissues and remove skin grease. 2. Put the electrodes on the patient. (Figure 4-1, 4-2) Before attaching, apply some conductive jelly on the electrodes if the electrodes are not self-supplied electrolyte. 3. Attach clip or snap to electrodes prior to placement. Warning Use only one type of electrode on the same patient to avoid variations in electrical resistance. For ECG monitoring, it is recommended to use silver/silver chloride electrode. When dissimilar metal are used for different electrodes, the electrodes may cause large offset potentials due to polarization, which may be severe enough to prevent obtaining an ECG trace. Using dissimilar metals may also increase recovery time after defibrillation.

ECG electrodes placement for monitoring

Figure 4-1 ECG 3-lead placement

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OPERATION MANUAL Electrode placement for 3 lead set (figure 4-1) Right Arm (RA): red electrode, be placed near the right shoulder, directly below the clavicle. Left Arm (LA): yellow electrode, be placed near the left shoulder, directly below the clavicle. Left Arm (LL): green electrode, be placed on the left hypogastrium.

Figure 4-2 ECG 5-lead placement Electrode placement for 5 lead set (figure 4-2) Right Arm (RA): red electrode, be placed near the right shoulder, directly below the clavicle. Left Arm (LA) : yellow electrode, be placed near the left shoulder, directly below the clavicle. Chest (C) : white electrode, be placed on the chest as illustrated in figure 4-2 Right Leg (RL) : black electrode, be placed on the right hypogastrium. Left Leg (LL) : green electrode, be placed on the left hypogastrium. NOTE: To ensure patient safety, all leads must be attached to the patient. For 5-lead set, attach the C-electrode to one of the indicated positions as below (Figure 4-3) V1 on 4th intercostal space at the right sterna margin. V2 on 4th intercostal space at the left sterna margin. V3 midway between V2 and V4 electrodes. V4 on the 5th intercostal space at the left clavicular line. V5 on the left anterior axillary line, horizontal with V4 electrode. V6 on the left middle axillary line, horizontal with V4 electrode. V3R-V6R on the right side of the chest in positions corresponding to those on the left. VE over the xiphoid position. For posterior C lead placement, place the C electrode at one of the following locations. V7 on the 5th intercostal space at the left posterior axillary line of back. V7R on the 5th intercostal space at the right posterior axillary line of back
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OPERATION MANUAL

Figure 4-3 C-electrode placement for 5-lead set Depending on lead type (3 leads or 5 leads), you can choose different lead I, II, III, aVR, aVL, aVF, V.

Figure 4-4 ECG lead Warning Check everyday whether there is skin irritation resulted from the ECG electrodes. If so, replace electrodes every 24 hours or change their sites. Warning Verify lead fault detection prior to the start of monitoring phase. Unplug the ECG cable from the socket, the screen will display the error message "ECG NO CABLE"

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OPERATION MANUAL

Warning When using Electrosurgery equipment, leads should be placed in a position in equal distance from Electrosurgery electrotome and the grounding plate to avoid cautery. Electrosurgery equipment wire and ECG cable must not be tangled up. The placing of the ECG leads will depend on the type of surgery that is being performed. For example, with open chest surgery the electrodes may be placed laterally on the chest or on the back. In the operating room, artifacts can sometimes affect the ECG waveform due to the use of ESU (Electro Surgical Unit). To reduce this effect, you can place the electrodes on the right and left shoulders and on the left side of hypogastrium. Avoid placing the electrodes on the upper arms; otherwise the ECG waveform will be too weak. Warning When using ESU, never place an electrode near the grounding plate of the Electrosurgery device, otherwise there will be a great deal of interference with the ECG signal. Warning It is possible for the patient to be burnt due to an improper connection of the natural electrode of ESU. Warning ECG cable may be damaged if they are connected to a patient during defibrillation. Cables that have been connected to a patient during defibrillation should be checked for functionality before being used again. NOTE: If an ECG waveform is not accurate while the electrodes are tightly attached, try to change the lead. NOTE: Interference from a non-grounded instrument near the patient and/or ESU interference can cause inaccuracy of the waveform.

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OPERATION MANUAL Normal QRS complex is: Tall and narrow with no notches. With tall R-wave completely above or below the baseline With T -wave less than one-third of the R-wave height. With P-wave much smaller than the T -wave.

Figure 4-5 standard ECG Waveform Warning Do not touch the patient, table nearby, bed or the equipment during defibrillation. Warning Do not immerse ECG leads completely in water, solvents or cleaning solutions because the connectors are not waterproof. Do not sterilize ECG cable by irradiation, steam, or ethylene oxide. Warning For the patients with pacemaker, the monitor may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon monitor alarms. Keep the patients with pacemaker under close surveillance.

4.2 ECG WINDOW

Pick ECG, the following menu will pop up:

Figure 4-6 ECG WINDOW

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OPERATION MANUAL ECG LEAD: by pressing ECG LEAD, the following menu will pop up:

Figure 4-7 ECG / LEAD WINDOW "" "" "" ECG TRACE: You can choose following lead for trace 1 to 4: to count the heart rate and show RA-LA waveform to count the heart rate and show RA-LL waveform

to count the heart rate and show LA-LL waveform LA LL "aVR" to count the heart rate and show RAwaveform 2 RA LL waveform "aVL" to count the heart rate and show LA2 RA LA "aVF" to count the heart rate and show LLwaveform 2 RA LA LL "V" to count the heart rate and show Cwaveform 3 (You can choose aVR, aVL, aVF, V just when ECG is in 5 lead mode). CABLE TYPE To adjust ECG measurement mode to "3 WIRES" or "5 WIRES ". DISPLAY FORMAT When monitoring with "5 LEAD", in the ECG / LEAD window set the display format to: Cascade: the ECG waveform area shows 1 waveform. 2 trace: the ECG waveform area shows 2 waveform. 4 trace: the ECG waveform area shows 4 waveform. When monitoring with "3 LEAD", only cascade is applicable. ECG GAIN To adjust the size of ECG waveforms, select gain value for each lead from 0.25,0.5,1,2, 4 and AUTO. In "AUTO" mode, the monitor chooses an appropriate level automatically. ECG SWEEP Available options for ECG SWEEP are 12.5, 25, and 50 mm/s.
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OPERATION MANUAL ECG FILTER For clearer and more detailed waveform
FILTER TYPE NORMAL EXTENDED FREQUENCY RANGES APPLICATION

0.5-40HZ 0.05-100HZ

MONITOR

0.5-24HZ

In normal use In diagnostic application. but the ECG waveform might have some noises This mode may reduce perturbance and Interference from Electrosurgery equipment or when the system has high noises or doesn't have equipotential earth

HR AVERAGE Available options for HR AVERAGE are 4, 8 and 16 sec. HR SOURCE Heart rate may be drived by ECG, SPO2,IBP1 or IBP2. In AUTO mode Patient monitor automatically derives heart rate from ECG whenever a valid ECG signal is present. If ECG is not present, depending on priority of SPO2 , IBP1 and IBP2 , the heart rate value is derived from every signal that is being monitored. NOTE: Driving HR from IBP signal is possible just in ART, PAP, RVP, LVP and IBP labels. NOTE: If HR SOURCE is ON and IBP cable is not connected to the system, HR value will not displayed. NOTE: Driving HR value from IBP signal is not possible in the following condition and the HR value will be ---: - IBP1/IBP2 STATIC PRESSURE message on the display - IBP1/IBP2 SEARCH message on the display - HR value less than 25 NOTE: HR value measurement range is 25 ~250bpm, when the HR is derived from IBP signal. BEAT VOLUME Range: 1-7;"OFF" indicates silence, while 7 indicates maximum volume.

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OPERATION MANUAL PACE DETECT "ON" for patient with pacemaker," OFF" for patient without pacemaker. When it is "ON","PACE: ON" will be displayed on the screen. When PACE DETECT is "ON", the system ECG monitoring detects and rejects pacemakergenerated signals from ECG signal so that they will be ignored in determining heart rate. Detected pacemaker signals will be marked on the ECG waveform as 1 centimeter spike. Monitoring of patients with pacemaker is not generally affected when PACE DETECT is enable. However, in some instances if the patient does not have a pacemaker, it may be desirable to turn the detection function OFF so that artifacts in the waveform will not be mistaken for a pacemaker signal. Warning For patient with pacemaker, the PACE DETECT function must be switched "ON", otherwise, the pacing impulse may be counted as normal QRS complex. ECG CALIB "ON", 1mV calibrated ECG wave will be displayed. When it is "ON", the calibration waveform will display until closing the ECG WINDOW or turning the rotary switch..

ALARM Pick "ALARM" in ECG WINDOW to call up the following menu:

Figure 4-8 ECG/ALARM WINDOW ALARM LEVEL Selectable between 1,2. Level 1 represents the most serious case. HR ALARM Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol instead of alarm limits in Parameters Area. HR LIMIT ECG alarm is activated when the heart rate exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:30 and max:250)
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OPERATION MANUAL ARR ANALYSIS Pick "ARR ANALYSIS" in ECG WINDOW to call up the window for arrhythmia analysis setting. This monitor is able to detect up to 12 types of arrhythmia. Refer to chapter 14 ARR MONITORING for complete description of arrhythmia analysis in the system. ST ANALYSIS Pick "ST ANALYSIS" in ECG WINDOW to call up the window for ST analysis setting. The system is able to monitor ST segment deviation. Refer to chapter 13 ST MONITORING for complete description of ST analysis in the system.

4.3 ECG Alarm Messages

Alarm sounds when: 1. The heart rate exceeds adjusted alarm limits, and/or, 2. The ECG ASYSTOLE Alarm Heart rate alarm ECG ASYSTOLE Situation Heart rate violates adjusted alarm limits Heart beat is not detected in last 10 seconds. Visual prompts HR value blinks. Alarm indicator flashes. HR is "00" and blinks "ECG ASYSTOLE" is displayed. Alarm indicator flashes. Audio sound Activated

Activated

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ECG messages include: Message cause

ECG NO CABLE ECG cable is not connected to the system

solution
Connect ECG cable

explanation
Alarm level 3, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

Check for any possible sources of ECG NOISE ECG signal is noisy or saturated. signal noise form the area around the cable and electrode, and check the patient for great motion and also check the lead wires. ECG CHECK LEADS Reference lead or more than one chest lead is not properly connected. Mentioned leads are not properly connected. ECG amplitude is lower than standard limit Power off and then on the system .If ECG DEFECT ECG module failure this message is displayed again the user should contact local Customer Service. RL or other leads are CHECK RL OR ALL not properly connected when ECG lead is V, aVR, aVF or aVR. CHECK LL OR ALL CHECK LA OR ALL CHECK RA OR ALL LL or other leads are not properly connected when ECG lead is I LA or other leads are not properly connected when ECG lead is II RA or other leads are not properly connected when ECG lead is III Make sure that all electrodes and patient cable are properly connected Make sure that all electrodes and patient cable are properly connected Make sure that all electrodes and patient cable are properly connected Make sure that all electrodes and patient cable are properly connected Check the situation of the chest leads

Alarm level 3, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

Alarm level 2, Pressing ALARM Make sure that all electrodes and patient cable are properly connected SILENCE, alarm will be disable and ignore this fault.

ECG CHECK LA,RA,LL ECG SIGNAL WEAK

Make sure that mentioned electrode is properly connected

Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

Last 4 messages in the table are just for 5 lead mode. After checking the mentioned solution, if above mentioned messages are displayed again, the ECG cable may be damaged and you should contact with local Customer Services.
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OPERATION MANUAL

4.4 ECG CABLE CLEANING

If there is any sign indicating that the ECG cable may be damaged or deteriorated, replace it with a new one instead of continuing its application on the patient. Cleaning Use soft cloth moistened in mild soap liquid or cleaning agent containing 70% ethanol to clean the ECG cable. Sterilization To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first. It is recommended to use 70% alcohol or isopropanol 70% as sterilization material. Disinfection To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first.

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5 RESP Monitoring
5.1 GENERAL
The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes (RA-LL, RA-LA). The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. The signal with frequency greater than 62.5KHZ is applied to the patient for respiration measurement. For RESP monitoring, it is not necessary for additional electrodes, however, place of electrodes is important. Some patients, due to their clinical condition, expand their chest laterally, causing a negative intrathoracic pressure. In these cases it is better to place the two RESP electrodes laterally in the right axillary and left lateral chest areas at the maximum point of breathing movement to optimize the respiratory waveform. NOTE: The RESP monitoring is not recommended to be used on patients, who are very active, as this can cause false alarms. Checklist for RESP Monitoring 1. Prepare the patient's skin prior to placing the electrodes. 2. Attach the electrodes to the patient and attach snap or clip to the electrodes. 3. Switch on the monitor. NOTE: Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes to prevent cardiac overlay or artifacts from pulsating blood flow. This is particularly important for neonates.

5.2 RESP WINDOW

Pick RESP to call up the following menu:

Figure 5-1 RESP WINDOW

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OPERATION MANUAL RESP LEAD Available options for RESP LEAD are "RA-LA" and "RA-LL" RESP GAIN To adjust the size of ECG waveforms, Select gain value for each channel from 0.25,0.5,1, 2 and 4 . RESP SWEEP Available options for RESP SWEEP are 3,6,12,5, and 25 mm/s. ALARM LEVEL Selectable between 1 and 2. Level 1 represents the most serious case. RR ALARM Pick "ON" to enable RESP alarm functions such as parameters blinking, audio alarm and light indicator.Pick "OFF" to disable the alarm functions, and there will be a" "symbol instead of alarm limits in Parameters Area. RR LIMIT RESP alarm is activated when the respiration rate exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (min:5 and max:150) APNEA LIMIT To set the standard of judging an apnea case. It ranges from 10 to 40 seconds, increases/ decreases by 5s. CAPNO/RESP To select RESP or CAPNO module for measuring respiratory rates. Available options are RESP and CAPNO. In RESP mode, CAPNO module is set to Standby mode and RESP parameters and waveform are displayed.

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OPERATION MANUAL

5.3 RESP Alarm Message

Alarm is activated when the respiration rate exceeds adjusted alarm limits. Alarm RR Alarm APNEA Situation Respiration rate violates adjusted alarm limits Non-respiration condition overruns adjusted time Visual prompt RESP value blinks Alarm indicator flashes. Alarm indicator flashes "RESP APNEA" blinks Audio sound Activated Activated

RESP messages include: message

RESP CHECK LEADS

Cause
The RESP leads are not properly connected.

solution
Make sure that all electrodes, lead are properly connected

explanation
alarm level 3,The message is blinking Alarm is activated when RR ALARM is "ON". Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

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OPERATION MANUAL

6 SPO2 Monitoring
6.1 GENERAL
What does it measure? SPO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SPO2 oxygen saturation of 97%. The SPO2 value on the monitor will be 97%. The SPO2 value shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The SPO2 module can also provide a pulse rate signal. Operating Principals Arterial oxygen saturation is measured by a method called pulseoximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin. It measures how much light sent from light sources on one side of the sensor, is transmitted through patient tissue (such as a finger or an ear), to a receiver on the other side. The sensor measurement wavelengths are nominally 660nm for the Red LED and 880nm for Infrared LED. Maximum optical power output for LED is 5mW. The amount of light transmitted depends on many factors, most of which are constant. However, one of these factors, the blood volume in the arteries, varies with time, because it is pulsating. Measuring the light absorption during a pulsation, derive to calculation of the oxygen saturation of the arterial blood. Detecting the pulsation gives pulse rate signal. The SPO2 value, pleth waveform and pulse rate are displayed on the main screen. Pleth waveform is displayed normalised and its amplitude is not proportional to blood volume changes. Improper SPO2 signal or value are indicated by different messages or alarms if necessary.

The system SPO2 monitoring is calibrated to display functional saturation. This saturation given by the oxyhaemoglobin divided by the sum of the oxyhemoglobin and the deoxyhemoglobin (HHb), represented mathematically as:

SPO2

O2 Hb 100 O2 Hb HHb

NOTE: A pulseoximetry is an early warning device .Use lab co-oximeter to understand the patient's condition completely.

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OPERATION MANUAL NOTE: The precision of pulse-oximeter and probes can not be evaluated by simulators and pulse-oximeter testers.

Warning Use only the recommended manufacturer SPO2 sensor for monitoring .Other SPO2 sensors may cause improper monitor performance. Warning Regarding the selected module, use accessories specified for each spo2 module (refer to chapter 20) Warning While choosing sensor, consider sensor direction for use, written on the package such as patient's age and weight or if the sensor is reusable or disposable. Warning Pulseoximetry can overestimate the SPO2 value in the presence of Hb-CO, Met-Hb or dye dilution chemicals. Warning ESU wire and SPO2 cable must not be tangled up. Warning Do not use the sensor on extremities with arterial catheter or venous syringe. Warning High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps and direct sunlight can interfere with the performance of an SPO2 sensor .to prevent interference from ambient light, ensure that the sensor is properly applied .and cover the sensor site with opaque material. Failure to take this action in high ambient light conditions may result in inaccurate measurements. NOTE: SPO2 module updates SPO2 parameter every 1 sec. NOTE: Do not perform SPO2 and NIBP measuring in same arm at simultaneously; because obstruction of blood flow during NIBP measuring may adversely affect the SPO2 value.

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OPERATION MANUAL SPO2 Measuring Range SPO2 Alarm Rang SPO2 Accuracy Pulse Rate Measuring Range Materials used in our SPO2 sensors are innoxious. SPO2 measurement: 1. Turn on the monitor. 2. Attach the sensor to the appropriate site of the patient finger. Refer to Figure 6-2 for the proper method. 3. Plug the connector of the sensor extension cable into the SPO2 socket on the left side of the device. 0 - 100 % 20 - 100 % 70% - 100% 50% - 70% 25-240 bpm

2% 3%

Figure 6-2 placing the SPO2 sensor NOTE: Make sure the nail covers the light window. The wire should be on the backside of the hand. NOTE: SPO2 value always displays at the same position. Pulse Rate will display only when "HR SOURCE" is set at "SPO2" in the ECG WINDOW menu.

Warning Verify sensor cable fault detection before beginning of monitoring phase. Unplug the SPO2 sensor cable from the socket, the screen will display the error message "SPO2 NO PROBE" Warning Do not use the sterile supplied SPO2 sensors if the packaging or the sensor is damaged and return them to the vendor.

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OPERATION MANUAL Warning Measurement limitations In operation, the accuracy of oximetry measurement can be affected by: High-frequency electrosurgical interference and defibrillation. Excessive patient movement. Injection of intravascular dye such as indocyanine green or methylen blue. Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and methemoglobin Sensor temperature (maintain between 28 C and 42 C for best operation) External illumination more than 5,000 lumens/square meter (typical office lighting) Improper sensor application. Venous pulsations Cabling entanglement or strangulation Placement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or intravascular line Do not use oximeters and oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. Warning Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition such as abnormal sensitivity, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. Check per 2-3 hours the sensor placement and move it when the skin deteriorates. More frequent examinations may be required for different patients. Warning Tissue damage or inaccurate measurement can be caused by incorrect application or use of an SPO2 sensor, for example by wrapping the sensor too tightly or by applying supplemental tape. Warning Loss of pulse signal can occur when The patient is in cardiac arrest or in shock. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. There is arterial occlusion proximal to the sensor. Warning Do not immerse sensor and patient cable completely in water, solvents, or cleaning solutions because the sensor and patient cable are not waterproof.

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6.2 SPO2 WINDOW

The SPO2 WINDOW menu is as follows:

Figure 6-3 SPO2 WINDOW SPO2 RESPONSE Available options for SPO2 RESPONSE are "SLOW","NORMAL" and "FAST" SLOW : least affected by patient motion. User must be aware that changes in SPO2 are reported more slowly comparing to other modes. Normal : recommended for most clinical situations Fast : useful for special application such as sleep studies in which the user desired fast response mostly affected by patient motion. SPO2 PLETH SWEEP Available options for SPO2 PLETH SWEEP are 12.5 and 25 mm/s. ALARM LEVEL Selectable between 1 and 2. Level 1 represents the most serious case. SPO2 ALARM Pick "ON" to enable SPO2 alarm functions such as parameters blinking, audio alarm, and light indicator.Pick "OFF" to disable the alarm functions and there will be a" "symbol instead of alarm limits in Parameters Area. SPO2 LIMIT SPO2 alarm is activated when the SPO2 exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (min: 20 and max:100)

SPO2 SENSITIVITY (MASIMO MODULE) Available options for SPO2 SENSITIVITY are NORMAL, MAX and APOD. NORMAL: The perfusion threshold has different limits as the perfusion calculation is data dependent .Specially; there is an intelligent algorithm which adjusts the low perfusion limit in accordance with the quality of the incoming plethysmography waveform between 0.50% and 0.02%. This mode provides the best combination of sensitivity and probe-off detection performance. This mode is recommended for the majority of patients

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OPERATION MANUAL MAX: Recognizing that some clinicians may want the absolute low perfusion performance (0.02%) all of the time and may be willing to sacrifice sensor off detection, Masimo provides a maximized sensitivity mode. This mode should be used for the sickest patients, where obtaining a reading is most difficult. Maximum Sensitivity is designed to interpret and display data for even the weakest of signals. This mode is recommended during procedures and when clinician and patient contact is continuous. In MAX mode, the message "SPO2 MAX SENS." displays on the screen with yellow colour. APOD (Adaptive Probe Off Detection): This mode is not advisable for patients with low perfusion because the system has the least sensitivity to signal changes in this mode. It is used in situations having risk of probe detachment (e.g. children or uneasy patients). By selecting this mode, SPO2 APOD MODE appears on the screen. SPO2 PULSE RATE Pick ON to display HR and SPO2 values simultaneously. If there is high quality ECG signal and HR SOURCE is in AUTO mode, PR value is displayed next to SPO2 value, Otherwise, (no suitable ECG signal) HR is measured from SPO2 signal and PR value is displayed instead of HR value.

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6.3 SPO2 Alarm Message

Alarm occurs when SPO2 exceeds the alarm limit. Alarm
SPO2 Alarm SPO2 ASYSTOLE

Situation
SPO2 violates adjusted alarm limits Pulse beat is not detected in last 10 seconds.

Visual prompts
SPO2 value blinks. Alarm indicator flashes. HR is "0" and blinks Message "SPO2 ASYSTOLE" is displayed Alarm indicator flashes.

Audio Sound
Activated

Activated

SPO2 message includes: message

SPO2 NO PROBE

Cause
SPO2 probe is disconnected from the monitor. correctly monitor.

solution
Make sure that the probe is connected to the

explanation
Alarm level 3,The message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2,The message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2,The message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2,The message is blinking. Alarm is activated when SPO2 ALARM is "ON". Pressing ALARM SILENCE, alarm is suspended for at least 120s. Alarm level 2,The message is blinking. Alarm is activated when SPO2 ALARM is "ON". Pressing ALARM SILENCE, alarm is suspended for at least 120s.

SPO2 PROBE DEFECT

The SPO2 probe is damaged

Change the SPO2 probe.

SPO2 PROBE OFF

SPO2 probe may be detached from the patient.

Make sure that SPO2 probe is properly attached to the patient Make sure that SPO2 probe is properly connected to the patient (refer to page 6-2). Make sure that SPO2 probe is properly connected to the patient (refer to page 6-2). Move the sensor to another place, provoke blood recycle, and calm the patient. Change the place of the probe. Power off and then on the system

SPO2 CHECK PROBE

SPO2 probe is not properly positioned to the patient

SPO2 HIGH AMBIENT LIGHT

This may be caused by entering environmental light into the probe SPO2 is not calculable due to

SPO2 SEARCH SPO2 SIGNAL WEAK

some reasons such as long time motions. The SPO2 signal amplitude is too weak or undetectable.

Alarm level 2,The message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

SPO2 DEFECT

SPO2 module failure

.If this message is displayed again, the user should contact local After Sale Service.

After checking the mentioned solution if above mentioned messages are displayed again, the SPO2 probe may be damaged and you should contact with local Customer Services.

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OPERATION MANUAL

6.4 SPO2 PROBE CLEANING

To clean the sensor, first remove it from the patient and disconnect it from the monitor. You may then clean the probe by wiping it with a 70% isopropyl alcohol pad. Allow the probe to dry prior to placement on a patient. Warning Do not sterilize the patient cable and probes by autoclave, irradiation, steam or ethylene oxide. Warning To prevent damage, do not immerse the probe in any liquid solution. Warning Do not use any probe or cable that may be damaged or deteriorated.

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OPERATION MANUAL

7 NIBP Monitoring
7.1 GENERAL
NIBP (Non-invasive Blood Pressure) processing by the monitor uses the oscillometric measuring technique. A motorized pump inflates the cuff initially, until the pressure effectively occludes flow of blood in the extremity. Then, under monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects air pressure and transmits a signal to the NIBP circuit. As the cuff pressure is reduced, blood flows in the previously occluded artery and changes the measured pressure values sensed by the transducer. The point at which oscillation increases sharply is defined as systolic pressure. As the cuff continues to deflate, oscillation amplitude increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the mean arterial pressure. The point at which the system detects a loss of oscillation is defined as the diastolic pressure. This method of blood pressure measurement equals cuff-stethoscope method. According to the European standard EN 1060-1: Specification for Non-invasive sphygmomanometers Part 1, General requirements. It is applicable for adults and neonates. There are three modes of measurement available: manual, automatic and stat. Each mode displays the systolic, diastolic and mean blood pressure. In the MANUAL mode, only one measurement is performed. In the AUTO mode, the measurement is cycled. You can set the interval time to 1,2,3,5,10,15, 20, 30, 45, 60 and 90 minutes and 2, 4, 6, 8, 12, 16, 20, 24 hours. In STAT mode, measurement is performed up to ten times in 5 minutes and with 30s interval between measurements. If an error occurs, NIBP measurement is suspended.

Warning 1. You must not perform NIBP measurements on patients under any condition which the skin is damaged or expected to be damaged. 2. Ensure that the correct setting is selected when performing measurements on children. It may be dangerous for the children to use an over pressure level. NIBP Measuring Warning Before starting a measurement, verify that you have selected a setting appropriate for your patient (adult or neonate.) Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation.

7-1

OPERATION MANUAL Warning Use only recommended manufacturer Blood Pressure Cuffs and Hose. Using other cuffs or hoses may result in inaccuracies. Warning Blood pressure measurement can be affected by the position of the cuff and patient's physiological condition. Warning According to general requirement for safety, Luer lock connectors are not used .Don't use NIBP cuff with Luer lock connector because if Luer lock connector is used, there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped in to blood vessel. Warning Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled. Warning In this module, the max cuff pressure is 288 mmHg for adults and 146 mmHg for neonates. There is also an independent pressure controller inside the device. Also, the max time that the cuff can be under pressure is limited to 2 min. It is important not to perform continuous measurement that can lead to nerves, muscle and skin damages. 1. Plug in the air hose and switch on the system. 2. Apply the blood pressure cuff to the patient's arm or leg following the instructions below (Figure 7-1). Ensure that the cuff is completely deflated. Apply the appropriate size cuff to the patient. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia.

Figure 7-1 Applying Cuff NOTE: The width of the cuff should be either 40% of the limb circumference (50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff can cause
7-2

OPERATION MANUAL erroneous measurement. If the cuff size is in question, then use a larger cuff. (refer to chapter 20 for more detail about size of cuff.) 3. Connect the cuff to the air hose. The limb chosen for taking the measurement should be placed at the same level as the patient's heart. 4. Check whether the patient mode is appropriately selected. To change the patient mode, choose SETUP from the HOME WINDOW, the HOME/SETUP WINDOW menu will pop up. Pick ADULT/NEONATE to make necessary changes.

5. Select a measurement mode in the NIBP WINDOW menu.Refer to the following instructions," Operation Hints ", for details. 6. Press the START/STOP button on the front panel to start a NIBP measurement. Operation Hints 1. To start a MANUAL measuring: Press the START/STOP button on the front panel 2. To stop a MANUAL measuring Repress the START/STOP button on the front panel 3. To start AUTO measuring: Select NIBP WINDOW menu and pick AUTO for measuring interval setting, then Press START/STOP button on the front panel. Warning Prolonged non-invasive blood pressure measurements in Auto mode may be associated with ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements. 4. To start a MANUAL measuring during the AUTO mode: Press START/STOP button on the front panel.

5.

To stop AUTO measuring: Select the NIBP menu and set AUTO /MANUAL to MANUAL mode. NOTE: If you are in doubt about the accuracy of any measurement(s), check the patient's vital signs by an alternative method before checking the functionality of the monitor. Warning If liquid is inadvertently splashed on the equipment or its accessories, turn off the system and dry it with soft cloth and then use it again.
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OPERATION MANUAL Measurement Limitations In different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure pulse. In those circumstances, when the patient's condition makes it difficult to detect, the measurement becomes unreliable and measuring time increases. The user should be aware that the following conditions could interfere the measurement and make the measurement unreliable or longer. In some cases, the patient's condition will make a measurement impossible. Patient Movement Measurements will be unreliable or may not be possible if the patient is moving, shivering or having convulsions. These motions may interfere the detection of the arterial pressure pulses. In addition, the measurement time will be prolonged. Cardiac Arrhythmia's Measurements will be unreliable and may not be possible if the patient's cardiac arrhythmia causes an irregular heart beat. Thus the measuring time will be prolonged. Heart-lung Machine Measurements will not be possible if the patient is connected to a heart-lung machine. Pressure Changes Measurements will be unreliable and may not be possible if the patient's blood pressure changes rapidly over the period of time during which the arterial pressure pulses are being analyzed to obtain the measurement. Severe Shock If the patient is in severe shock or hypothermia, measurements will be unreliable because of reduced pulsation of the arteries. Heart Rate limits Measurements can not perform at a heart rate of less than 40 bpm and greater than 240 bpm.

7.2 NIBP WINDOW

NIBP measurement result is displayed as follows:

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OPERATION MANUAL
NIBP WINDOW menu

Figure 7-2 NIBP WINDOW NIBP UNIT Pick this item to adjust measurement unit. (Options: mmHg or KPa) ALARM LEVEL Selectable between 1 and 2. Level 1 represents the most serious case. NIBP ALARM Pick "ON" to enable NIBP alarm functions such as parameters blinking, audio alarm and light indicator. Pick "OFF" to disable the alarm functions and there will be a " "symbol instead of alarm limits in Parameters Area. NBP SYS LIMIT SYS alarm is activated when the systolic pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Min:30 and max:240) NBP DIA LIMIT DIA alarm is activated when the diastolic pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:20 and max:180) NBP MAP LIMIT MAP alarm is activated when the mean arterial pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:25 and max:200) AUTO/MANUAL/STAT There are three modes of measurement available: MANUAL, AUTO and STAT. In the MANUAL mode, only one measurement is performed. In the AUTO mode, measurement is repeated over a specified period of time ; available intervals are 1,2,3,5,10,15,20,30 ,45,60,90 minutes and 2, 4,6,8,12,16,20,24 hours. In STAT mode, measurement is performed up to ten times in 5 minutes and with 30s interval between measurements. If an error occurs, NIBP measurement is suspended. <MODULE START> To start measurement

7-5

OPERATION MANUAL <MODULE STOP> To stop measurement <MODULE RESET> To adjust max pressure at 150 mmHg for adults and 70 mmHg for neonates.

NIBP LIST Patient monitor can review the latest 100 NIBP measurement data. Pick "NIBP LIST" in the NIBP WINDOW to invoke the result and time of the latest NIBP measurements, as shown in Figure 7-3

Figure 7-3 NIBP/NIBP LIST WINDOW By pressing the first left item you can select a line of NIBP recorded data and you will be able to delete a line of data in NIBP LIST by pressing the "DELETE".(second left item) MODULE CHECK Available options are "NIBP MANOMETER","NIBP LEAKAGE","MODULE SELF TEST","MODULE STOP". NIBP MANOMETER Wrap the cuff around a rigid cylinder. Connect a calibrated reference manometer and a ball pump by means of a T-piece connector and hoses to the monitor. Set the monitor in" NIBP MANOMETER" mode. Inflate the pneumatic system to 0, 50 and 200 mmHg by ball pump separately. The difference between the indicated pressure of the reference manometer and the indicated pressure of the monitor should not exceed 3 mmHg. NIBP LEAKAGE Wrap the cuff around a cylinder of an appropriate size, and the circumference of the applied cuff does not exceed that of the cylinder more than 7%.Set the monitor in "NIBP LEAKAGE" mode.

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OPERATION MANUAL The monitor inflates the cuff up to 170mmHg and keeps it constant for 15 sec .If air leakage result is satisfactory, "NIBP LEAK OK" message is displayed; otherwise you will receive "PNUMATIC LEAK" message. NOTE: These test must only done by personnel trained and authorized by manufacturer.

7.3 NIBP Alarm Message

Alarm occurs when the pressure (SYS. DIA or MAP) exceeds the alarm limit Alarm SYS ALARM DIA ALARM MAP ALARM Situation SYS violates adjusted alarm limits or violates lower than 50mmHg DIA violates adjusted alarm limits MAP violates adjusted alarm limits or violates lower than 30mmHg Visual prompt SYS value blinks alarm indicator flashes. DIA value blinks alarm indicator flashes. MAP value blinks alarm indicator flashes. Audio sound Activated Activated Activated

7-7

OPERATION MANUAL NIBP messages include: Message SELF-TEST FAILED LOOSE CUFF MODE ERROR AIR LEAK AIR PRESSURE ERROR SIGNAL WEAK RANGE EXCEED EXCESSIVE MOTION OVER PRESSURE SENSED SIGNAL SATURATED PNEUMATIC LEAK TIME OUT SYSTEM FAILURE NIBP DEFECT LOW BATTERY NIBP NO MODULE STOP PRESSED Cause NIBP hard ware module failure Cuff is completely unwrapped, no cuff attached Use adult cuff instead of neonate cuff or occlusion happened in air way Air leak in cuff, hose or connector Unstable pressure value(e.g. kinked hoses)because valve cannot open normally Very weak patient signal due to a loosely wrapped cuff or extremely weak pulse from patient. Measuring pressure is more than upper limit (255mmHg)for adult or (135mmHg) for neonate Arm movement, noisy signal or irregular pulse(e.g. arrhythmia) Measuring pressure exceeded safe software limit, 290 mmHg for adult and 145mmHg for neonate. Large motion artifact that saturates the amplifier's amplitude handling capability Leakage during leak test Measuring time exceeds 120 seconds (adult) or 90 seconds .(neonate) Error occurs in pump, A/D sampling, pressure transducer or software. NIBP module failure The Charge of battery is low so NIBP measurement is not possible (while the monitor is working with battery). No NIBP module is installed. NIBP stop key has been pressed during measurement.

NIBP STOP Measurement is stopped by NIBP module because of special reason. NIBP LEAKAGE O.K Successful leakage test. All alarm level for these messages (except the last third message) is set in NIBP WINDOW. Pressing ALARM SILENCE, alarm will be disable and ignore this fault until reoccurrence.

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OPERATION MANUAL

7.4 NIBP CUFF CLEANING

Warning Do not press the cuff and tubing with a hot iron. Cleaning Durable one-piece cuffs may be safely cleaned with a damp cloth (70% alcohol or 0.5% bleach solution may be used) or washed in water (140F, 60C maximum) with soap or detergent. Sterilization Do not use steam or heat to sterilize the cuff. Gas sterilization may be used if necessary. Disinfection Glutaraldehyde type liquid disinfectants may be used on durable cuffs. Prolonged used of these disinfectants at full strength may cause discoloration of the white cuff marking.

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OPERATION MANUAL

CHAPTER 8 TEMP Monitoring

8.1 GENERAL
Measurement of patient temperature is accomplished by processing the signal from a probe containing temperature dependent resistor called thermistor .Value of this resistor is measured by the monitor continuously and displayed on screen. Patient monitor has two different kind of temperature probe, a probe for esophageal /rectal temperature measurement and other for skin temperature measurement. Specification: Measuring and Alarm Range Accuracy Delay time For rectal/esophageal probe For skin probe

0~50 C 0.2 C 50sec 20sec

Two TEMP probes can be used together to obtain 2 temperature data and compare them to determine the temperature difference. TEMP monitoring setup: Plug TEMP probe directly into the monitor. Attach the TEMP probe(s) properly to the patient. Switch on the system. Inspection and recalibration Visually inspect the probe for cracks, holes, crazing etc, prior to each use. If any such degradation in the cable jacket is discovered, discard probe according to your hospital's procedure for medical waste. When using temperature probe, the user must determine that a probe style is suitable and sufficiently flexible for esophageal or rectal use. Probe cannot be "recalibrated" per se, but should be inspected monthly by the hospital Biomedical Equipment group to ensure they are working properly. Probes can be tested by plugging into a patient monitor and looking for an electrical open or shortcircuit, Intermittent reading or extremely inaccurate readings which would indicate probe wire damage. The sensor stability is well-documented; Probe accuracy should not drift out of tolerance over the normal life of probe. NOTE: Please be note that the metal side should be used for making measurements. WARNING Handle the TEMP probes with due care. The probe and cable should be rolled up to a loose loop when not in use. Over straining will result in mechanical damage of the probes. WARNING The temperature probes carry a one-year warranty on workmanship, components and accuracy tolerances. Probe life with normal use should exceed one year.
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OPERATION MANUAL

WARNING Using ESU with temperature measurement simultaneously, may cause patient burn. If possible, remove the probe from patient contact before activating the surgical unit or other RF source. If probe must be used simultaneously with electrosurgical apparatus, hazards can be reduced by selecting a temperature monitoring point which is remote from the expected RF current path to the ground return pad. WARNING The calibration of the temperature measurement is necessary every two years (or as frequently as dictated by your Hospital Procedures Policy). When you need to calibrate the temperature measurement, contact the local After Sale Service.

8.2 TEMP WINDOW

The TEMP WINDOW menu is as follows:

Figure 8-1 TEMP WINDOW UNIT Pick this item to set measurement unit. (Options: C or F) ALARM LEVEL Selectable between 1 and 2. Level 1 represents the most serious case. TEMP ALARM Pick "ON" to enable TEMP alarm functions such as parameters blinking, audio alarm, and light indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol instead of alarm limits in Parameters Area. T1 LIMIT T1 alarm is activated when the channel-1 temperature exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:0 and max:50) T2 LIMIT T2 alarm is activated when the channel-2 temperature exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:0 and max:50) DT LIMIT DT alarm is activated when the different between channel-1 and channel-2 exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(min:0 and max:50)
8-2

OPERATION MANUAL T1 is Channel-1 of temperature. T2 is Channel-2 of temperature DT is the temperature difference between the above two.

8.3 TEMP ALARM MESSAGES

Alarm occurs when: The Alarm function is "ON" and temperature exceeds adjusted alarm limits.

8.4 TEMP SENSOR CLEANING AND STORAGE

To clean the temp sensor, first remove it from the patient and disconnect it from the monitor. NOTE: Reusable temperature probes are sold non- sterile. Cleaning Probe should be cleaned of bioburden prior to disinfection or sterilization to improve the effectiveness (as recommended in ANSI/AAMI ST35: Good Hospital Practice: Handling and Biological Decontamination of Reusable Medical Device,1991) When wiping clean, hold the probe in one hand at the sensing tip and wipe the probe and lead wire toward the plug. Excessive pressure could stretch the cable jacket and break the internal wires, destroying the probe .Continued flexing of lead wires in use and cleaning can also break the internal wire . Avoid contact with strong, aromatic, chlorinate, ketone, ether or ester solvents. Prolonged immersion in alcohols or mild organic solvents, detergent solutions or highly alkaline solutions will cause the vinyl to lose flexibility. The probe plugs should not be immersed. Sterilization Ethylene oxide is the preferred sterilization method. After sterilization, probes must be safely and thoroughly ventilated before handling or use. Using a generic EtO sterilizing procedure, YSI recommends an aeration time of 12 hours minimum to dissipate residual EtO in probe below 250ppm. Disinfection Probes may be disinfected by washing with 70% isopropanol, activated dialdehyde (Cidex) or sodium hypochlorite (bleach diluted 1:10 minimum in water.) After washing probes should be rinsed thoroughly with water. Brief immersion of the probe in detergent solutions is not harmful. Manufacturer does not make any claim as to the efficacy of these chemicals for infection control. Please consult your hospital's Infection Control Officer for the applicable disinfection policies. Warning Never boil the standard YSI400 or YSI700 series temperature probe. Storage and Handling When not in use, probes and leads should be loosely coiled and stored at room temperature .Do not wrap probes around equipment cases to avoid damaging internal wires.
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OPERATION MANUAL

CHAPTER 9 IBP Monitoring

9.1 GENERAL
Specification: Displaying and measuring ranges (for all labels) -50~300(mmHg) Alarm ranges IBP -50~300(mmHg) ART -50~300(mmHg) LVP -50~300(mmHg) PAP -50~120(mmHg) RVP -50~100(mmHg) CVP -50~100(mmHg) LAP -50~100(mmHg) RAP -50~100(mmHg) Resolution 1 (mmHg) Accuracy 2 % or 2mmHg each one is greater Patient Monitor measures direct blood pressure (SYS, DIA and MEAN) of the selected blood vessel through two channels, and displays two BP waveforms Warning The operator should avoid contacting with to the conductive parts of the system when being applied. Warning When using ESU (Electrosurgery equipment), the transducer and the cables should not be contacted with the conductive part of ESU to protect patient against burns. Warning Disposable IBP transducer or domes should not be reused. Warning Be careful that all packages are safe before using domes, and make sure that they are sterilized and pay attention to the expiry date. Warning Use only the pressure transducer listed in the Chapter 20.5 IBP Accessories. The specified transducer are designed to have the special ability to protect patient against the electrical shock (especially for the leak current allowed), and it is protected against the effects of a discharge of a cardiac defibrillator. It can be used in the surgical operation. During defibrillation, the IBP waveform may be distorted temporarily. Warning Verify transducer cables fault detection prior to the start of monitoring phase. Unplug the transducer of the channel 1 from the socket, the screen will display the error message "IBP1 NO SENSOR" and the audible alarm is activated with level 3. Next channel is the same.
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OPERATION MANUAL Preparatory steps for IBP measurement (Figure 8-2): 1 Plug the pressure cable into corresponding socket. 2 Prepare the pressure tube and transducer by flushing through the tubing system with normal saline solution. Ensure that the tubing system is free of air bubbles. 3 Connect the patient catheter to the pressure line, making sure that there is no air present in the catheter or pressure line. Warning If there are air bubbles in the pressure line or the transducer, you should flush the solution to the system. 4 5 6 7 Place the transducer at the same level with the patient's heart. Check if you have selected the correct label name. See the next chapter for details. Zero the transducer. See the next section for details. Calibrate the IBP monitor with a reference pressure if you have changed the transducer or if you are not sure about the accuracy. See the next section for details.

Figure 9-1 IBP Monitoring

9.2 IBP WINDOW

The IBP WINDOW menu is as follows:

Figure 9-2 IBP WINDOW IBP1/IBP2 UNIT Pick this item to adjust measurement unit. (Options: mmHg, Kpa, cmH2O)
9-2

OPERATION MANUAL IBP1/IBP2 LABLE Suitable label should be selected, regarding the place of measurement. The available pressure labels are:
Label ART LVP PAP RVP CVP LAP RAP Definition Arterial Blood Pressure Left Ventricle Pressure Pulmonary Artery Pressure Right Ventricle Pressure Central Venous Pressure Left Atrium Pressure Right Atrium Pressure

Warning IBP algorithm will vary according to the selected label. Therefore in the case of improper label selecting, the accuracy of the measurement may be decreased. IBP SWEEP Available options for IBP SWEEP are 3,6,12.5 and 25mm/s. IBP GRID Select "ON" to divide each IBP signal to 5 parts with white dot lines. IBP FILTER In order to have a more clear and detailed waveform, 3 filter types can be selected: Available options are 22Hz, 16Hz, and 8Hz. 22Hz : Recommended in normal use and the most clinical situation. It has the most measuring accuracy among the called filters. 16Hz : When the signal is a bit noisy. 8Hz : This mode is recommended to reduce noise and interface resulted from ESU and also when the system has a high noise level or doesnt have equipotential earth. While using this filter the measuring accuracy might be decreased. ALARM Pick "IBP ALARM" in IBP WINDOW to call up the following menu:

Figure 9-3 IBP/ALARM WINDOW IBP1/IBP2 ALARM Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light Indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol instead of alarm limits in Parameters Area.
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OPERATION MANUAL IBP1/IBP2 ALARM LEVEL Selectable between 1,2. Level 1 represents the most serious case. SYS ALM SYS alarm is activated when the systolic pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. DIA ALM DIA alarm is activated when the diastolic pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. MEAN ALM MEAN alarm is activated when the mean pressure exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. NOTE: The alarm High/Low limits for SYS, DIA and MEAN of ART, LVP, PAP, RVP, CVP, LAP, and RAP are listed as follow. Note that the CVP, LAP and RAP only have MEAN pressure, therefore the alarm limit are only for MEAN. The alarm occurs when the value exceeds the set limits.
Lable IBP ART LVP PAP RVP CVP LAP RAP Min Alarm High (mmHg) -50 -50 -50 -50 -50 -50 -50 -50 Min Alarm High (mmHg) 300 300 300 120 100 100 100 100 Step (mmHg) 5 5 5 1 1 1 1 1

IBP SCALE Pick "IBP SCALE" in IBP WINDOW to call up the following menu:

Figure 9-4 IBP/SCALE WINDOW The waveform and corresponding scale appears in the IBP waveform area with 3 dotted lines representing HIGH limit scale, SIGN cursor, and LOW limit scale from the top to the bottom values of the three scales can be manually set or automatically by Auto scale. You can change the scales for IBP, ART and LVP labels by step of 10 and for PAP, RVP, CVP, LAP and RAP labels by step of 5.

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OPERATION MANUAL AUTO SCALE Pick <AUTO SCALE>in IBP WINDOW to adjust the scale automatically .Scales are adjusted in a way that signal occupied approximately 80% of IBP waveform area. IBP ZERO Pick < ZERO> in IBP WINDOW to call up the following menu:

Figure 9-5 IBP/ZERO WINDOW NOTE: Since transducers need to be warmed to achieve the best accuracy it is recommended to zero the system at least 15 minutes after connecting the IBP transducer to the system. NOTE: Zero procedure should be performed before starting the monitoring and at least once a day after each disconnection and connection of the cable. Zero the transducer: 1-The transducer should be placed at mid-heart level. 2-Turn off patient stopcock. 3-The transducer must be vented to atmospheric pressure. 4-Select < IBP1/IBP2 ZERO > to start zeroing procedure for each channel. The message "PLEASE WAIT" will display during the procedure. When the procedure finished successfully the message "IBP1/IBP2 OK" appears. The last zeroing time will be saved and displayed in its corresponding place. 5-turn stopcock to patient on and the other stopcock to atmospheric pressure off. The following messages may prompt up in ZERO WINDOW: "IBP1/IBP2 NO SENSOR, UNABLE TO ZERO" Make sure that the transducer is connected or not, then start zeroing. "IBP1/IBP2 OVERANGE, FAILED ZEROING" Make sure that the stopcock is vented to atmosphere. If the problem persists, contact after sale service. "IBP1/IBP2 UNSTABLE PRESSURE, UNABLE TO ZERO" Make sure that the transducer is not attached to the patient and that the stopcock is vented to atmosphere or perhaps the tubing system is hited accidentally .If the problem persists, contact customer service.
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OPERATION MANUAL IBP CALIB

Pick < CALIB> in IBP WINDOW to call up the following menu:

Figure 9-6 IBP/CALIB WINDOW

Figure 9-7 IBP CALIBRATION

Mercury calibration should be performed by the biomedical engineering department either whenever a new transducer is used, or as frequently as dictated by your Hospital Procedures policy. The purpose of the calibration is to ensure that the system gives you accurate measurements. Before starting a mercury calibration, a zero procedure must be performed.

Warning You must never perform this procedure while patient is being monitored.

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OPERATION MANUAL

1. 2. 3. 4. 5. 6. 7.

Attach the tubing to the sphygmomanometer. Ensure that connection that would lead to patient is off. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient catheter. Open the port of the 3-way stopcock to the sphygmomanometer. Raise the sphygmomanometer to set value that you adjusted in CALIB WINDOW menu. Choose a CAL-> in the CALIB WINDOW menu. Press the rotary knob to start the calibration.

The message "PLEASE WAIT" will display during the procedure. "IBP1/IBP2 CALIBRATION OK" indicates that the calibration procedure is completed successfully.The last calibration time will be saved and displayed in its corresponding place. The following messages may prompt up in CALIB WINDOW: "IBP1/IBP2 NO SENSOR, UNABLE TO CALIBRATE" Make sure that the transducer is connected or not, then start calibration procedure. "IBP1/IBP2 OVERANGE, UNABLE TO CALIBRATE" Verify that adjusted pressure in menu and sphygmomanometer pressure are equal.If the problem persists, contact after sale service. "IBP1/IBP2 UNSTABLE PRESSURE, UNABLE TO CALIBRATE" Make sure that the transducer is not attached to the patient or perhaps the tubing system is hited accidentally .If the problem persists, contact customer service.

8. Remove the sphygmomanometer tubing and extra connector.

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OPERATION MANUAL

9-3 IBP Alarm Messages

Alarm occurs when the pressure (SYS, DIA or MEAN) exceeds the alarm limit Alarm SYS ALARM DIA ALARM MEAN ALARM Situation SYS violates adjusted alarm limits DIA violates adjusted alarm limits. MEAN violates adjusted alarm limits. Visual prompt SYS value blinks alarm indicator flashes. DIA value blinks alarm indicator flashes. MEAN value blinks alarm indicator flashes. Audio sound Activated Activated Activated

IBP message include: Message

IBP1/IBP2 NO SENSOR IBP1/IBP2 ADJUST SCALE

cause

solution
Check the transducer connection.

explanation
Alarm level 3, The message is blinking. SILENCE, Pressing alarm ALARM will be

Channel 1 or 2 transducer is not connected.

disabled and ignore this fault. IBP1 or IBP2 signal is in out of display range for about 5 seconds. This condition occurs when the maximum and minimum values of a pulsatile pressure signal (Just for IBP, ART, PAP, RVP and LVP labels) differ by less than 3mmHg.In this case, only Mean pressure is displayed IBP1/IBP2 STATIC PRESSURE in this state. This message can be caused by the following reason: A physiological condition e.g. asystole Transducer turned off to the patient. A catheter tip lodged against a vessel wall. A clot on the catheter tip. IBP signal cant be processed by the IBP1/IBP2 SEARCH software because the signal is weak or less pulsatile. Check all IBP measurement setup is suitable or not. Check necessary. patient and treat if Check patient and do necessary treatment Turn on the stopcock to patient and turn it off to the atmospheric pressure. Follow hospital procedure for dislodging catheter. Follow hospital procedures for clotted catheters. Alarm level 3, The message is blinking. SILENCE, Pressing alarm ALARM will be Press <AUTO SCALE> in IBP WINDOW menu.

disabled and ignore this fault.

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OPERATION MANUAL

9.4 IBP TRANSDUCER CLEANING

Clean all blood and other outer materials from the external surface of the transducer and cable using a slightly damp cloth and a mild detergent solution. Do not immerse. do not use alcohol or solvents on the clamps. Rinse thoroughly. NOTE: The disposable transducers or domes must not be re-sterilized or re-used. NOTE: For protecting environment, the disposable transducers or domes must be recycled or disposed properly. Warning Does not autoclave or ETO sterilize the transducer?

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OPERATION MANUAL

CHAPTER 10 GAS Monitoring (mainstream)

10.1 GENERAL
Patient Monitor provides mainstream method for Gas measurement. The mainstream multi-gas probe is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases of adults, pediatrics and infant patient during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room and emergency medicine settings. The sensor head is available in various configurations for ICU and OR applications. Concentrations of carbon dioxide (CO2), nitrous oxide(N2O), halothane(HAL), enflurane(ENF), isoflurane(ISO), sevoflurane(SEV) and desflurane(DES) in different combinations are determined together with derived parameters such as respiratory rate, waveform and inspired/expired concentrations of all gases. It is available in various parameter configurations as follow: CO2 only sensor: CO2 ICU sensor: CO2, O2 OR sensor: CO2, N2O, O2, two anaesthesia agent (HAL, ISO, ENF, SEV, DES) OR+ sensor: CO2, N2O, O2, two anaesthesia agent (HAL, ISO, ENF, SEV, DES), automatic gas detection AX sensor: CO2, N2O, two anaesthesia agent (HAL, ISO, ENF, SEV, DES) AX+ sensor: CO2, N2O, two anaesthesia agent (HAL, ISO, ENF, SEV, DES), automatic gas detection

Measuring principle
The IRMA sensor head snaps in place on the top of the airway adapter that includes the optical components for measuring all gases. The airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit. The respiratory gas measurements are obtained by continuously measuring the infrared gas absorption through the XTP windows in the gas flow through the adapter. To measure the concentrations and identify the gases, absorption of up to nine different wavelengths of infrared light is measured. The measurement of CO2, N2O and anaesthetic agents in the breathing gas mixture is based on the fact that the different gas components absorb infrared light at specific wavelengths. A microprocessor continuously calculates the CO2, N2O and anaesthetic agent concentrations from the infrared light absorption measurements. Using matrix calculations to identify which anaesthetic agents are present in the gas mixture. The oxygen measurements are obtained through an oxygen port at the top of the airway adapter. Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore measured using an ultra rapid response time oxygen sensor. (For more detail refer to APPENDIX IV) The measured parameters are EtCo2, EtN2O, EtO2, EtAA (End Tidal CO2/N2O/O2,Anesthesia Agent), FiCo2, FiN2O, FiO2, FiAA (Fraction Inspiratory CO2/N2O/O2/Anesthesia Agent) and AWRR (Air Way Respiratory Rate) and MAC.

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OPERATION MANUAL

MAC (Minimum Alveolar Concentration)

This is a concept to compare efficiency of different anesthesia gases. In other words, the concentration of anesthesia in a persons longs that prevents reaction to surgery stimulus (pain) during surgery in almost 50% persons. MAC value is calculated using current volume of gases as follows: MAC = %ET(AA1)/X(AA1) + %ET(AA2)/X(AA2) + %ET(N2O)/100 X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0% Note: Patient age is not included at the above formula same as other personal elements. The current volume of gases for collateral anesthesia (AA2) is available only for IRMA AX+/OR+. Warning The IRMA probe is intended for use only as an adjunct in patient assessment .It must be used in conjunction with clinical signs and symptoms.

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OPERATION MANUAL

Oxygen sensor:
IRMA mainstream multi-gas probe consists of an O2 sensor cell as an option. IRMA oxygen sensor is specially designed to provide an ultra fast response time, thus allowing a breath-by-breath analysis of the oxygen waveform at a proximal location (i.e. between the patient's endotracheal tube and the Y-piece of the breathing circuit). The vast majority of oxygen sensors available on the market are normally too slow for a breath-to-breath gas analysis. For anaesthesia machines and ventilators already equipped with oxygen measuring devices, the IRMA sensor is available with an O2 sensor dummy instead of the normal oxygen sensor. Figure 10-1 shows both the normal O2 sensor and the oxygen sensor dummy. The ultra fast response time oxygen sensor is normally integrated in the IRMA sensor head allowing proximal measurement of INSP/EXP oxygen concentrations.

Figure10-1 Oxygen sensor dummy and oxygen sensor. The oxygen sensor dummy can be replaced at any time by a normal sensor to allow oxygen measurements with the IRMA sensor. To replace the oxygen sensor, remove the depleted oxygen sensor by using a screwdriver or other suitable tool and turn in a counterclockwise direction. Remove the depleted sensor and carefully screw the new oxygen sensor into position. Warning Oxygen sensor for replacement should be stored in a cold environment (+2C~+8C) and should be taken into operation before the expired date printed on the package. Replace the oxygen sensor every four months, when the system warns to change the sensor with "REPLACE O2 SENSOR" message or when the oxygen readings are questionable. Warning Use only the recommended oxygen sensor for O2 monitoring .Other oxygen sensors may cause improper performance. (Refer to chapter 19 for detail) Warning Depleted oxygen sensors shall be disposed of in accordance with local regulations for biologically hazardous materials. Warning Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is not in use. Warning Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable product and contains a caustic electrolyte and lead.
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OPERATION MANUAL

Airway adapter:
The airway adapter is designed as a disposable for both adult/pediatric and infant applications. The adult/pediatric adapter is available with or without an oxygen port. The airway adapter with an oxygen port is equipped with a hydrophobic bacteria filter to protect the oxygen sensor from contamination. For anaesthesia machines and ventilators already equipped with oxygen measuring device, the airway adapter is available without an oxygen port.

Figure 10-2 IRMA airway adapters: Adult/pediatric with and without an oxygen port and infant adapter. Warning Disposable airway adapters shall not be reused. Used disposable airway adapters shall be disposed of in accordance with local regulations for contaminated and biologically hazardous fluids. Warning Do not use the IRMA adapter if adapter or its package is damaged and return it to the vendor. Warning Use only the recommended IRMA airway adapters for monitoring .Other airway adapters may cause improper performance. (Refer to chapter 19 for detail) Warning Do not use the adult/pediatric airway adapter with infants as the adapter adds 6ml dead space to the patient circuit. Warning Do not use the infant airway adapter with adults as this may cause excessive flow resistance. The infant airway adapter has specially designed connectors for minimizing the dead space and can be used even for very small patients. The infant adapter is available without an oxygen port only.

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OPERATION MANUAL

Preparatory steps for gas measurement (Figure 10-3):

1. Plug the IRMA connector into the bedside monitor side panel. 2. Snap the IRMA sensor head on top of the IRMA airway adapter. It will click into place when properly seated.

Figure 10-3 a Preparatory Step2 3. A green indicator indicates that the IRMA sensor is ready for use.

Figure 10-3 b. Preparatory Step3 4. Connect IRMA airway adapter 15 mm male connector to the breathing circuit Y-piece.

Figure 10-3 c. Preparatory Step4

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OPERATION MANUAL 5. Connect the IRMA airway adapter 15 mm female connector to the patients endotracheal tube.

Figure 10-3 d. Preparatory Step5 NOTE: Alternatively, connect an HME (Heat Moisture Exchanger) between the patients endotracheal tube and the IRMA probe. Placing an HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapour and eliminates the need of changing the adapter. It allows free positioning of the IRMA probe as well.

Figure 10-3 e. HME option 6. Unless the IRMA probe is protected with an HME always position the IRMA sensor with the indicator pointing upwards.

Figure 10-3 f. Preparatory Step6

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OPERATION MANUAL

Pre-use check:
Before connecting the IRMA airway adapter to the breathing circuit, verify the O2 calibration by checking that the O2 reading on the monitor is correct (21%).See Room air calibration section for instructions on how to perform room air calibration. Perform the tightness check of the patient circuit with the IRMA sensor head snapped on the IRMA airway adapter. Verify that there has not been any accumulation of gas between the IRMA sensor head and the XTP windows by checking that the CO2 readings on the monitor are correct before connecting a patient to the breathing circuit. Check that the connections have been made correctly by verifying an actual CO2 waveform on the monitor display. NOTE: There is no drift of measurement accuracy. NOTE: Variations in barometric pressure do not have any effects due to internal barometric pressure compensation. NOTE: There is no adverse effects on stated performance due to cycling pressure of up to 10 KPa.

Room air calibration of oxygen sensor

Room air calibration of oxygen sensor will be performed automatically at regular intervals whenever the IRMA sensor head is disconnected from the IRMA airway adapter. If IRMA sensor is kept in operation for a long time period without being disconnected from the airway adapter, or if the operating temperature for oxygen sensor changes significantly, the IRMA sensor will indicate that a new room air calibration is required and the message will appear on the screen. Use the following procedure to perform a room air calibration of the sensor: 1. Disconnect the IRMA sensor from the airway adapter. 2. Wait until the indicator starts blinking with red light. 3. Snap the IRMA sensor back on the airway adapter. 4. Check that the indicator turns green. 5. While not connected to the breathing circuit, check that the O2 reading on the monitor is 21%.

Gas span check:

Gas reading should be verified at regular intervals with a reference instrument. (It should be done just by trained and authorized personnel of manufacturer.) Warning The device can only be operated by personnel who have passed professional training and are familiar with this manual.
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Warning Dont use the device in the environment which contains flammable anesthetic gas. Warning Before any interpretations are made of parameters readings and waveforms one, assure that the multi-gas probe is functioning correctly. Partial obstruction of airway with water can result in distorted waveforms. A leak in the airway may result in low parameters measurements. Check the monitor to see if it is functioning properly. Warning Measurements can be affected by mobile and RF communications equipment. It should be assured that the IRMA sensor is used in the electromagnetic environment specified. Warning Do not place the IRMA airway adapter between the ET tube and an elbow, as this may allow patient secretions to block the adapter windows.

Figure 10-4 airway adapter connection Warning To keep secretions from pooling on the windows, position the IRMA airway adapter with its windows in a vertical position and not in a horizontal position.

Figure 10-5. IRMA airway adapter position

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OPERATION MANUAL

NOTE: Do not use the IRMA airway adapter with MTERED DOSE INHALERS or nebulized medications because this may affect the light transmission of the airway adapter windows. NOTE: Do not apply tension to the sensor cable. NOTE: Do not operate the device at temperature outside operating range as a below: IRMA ICU/OR/OR+: 10~35C IRMA AX/AX+: 10~40C IRMA CO2: 0~40C Warning Verify sensor detection before starting GAS monitoring. Unplug the sensor from IRMA connector to verify that the error message "NO SENSOR "is displayed. For more information of IRMA module refer to APPENDIX IV.

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OPERATION MANUAL

10.2 GAS WINDOW

NOTE: After PHASEIN capnography probe is connected to the monitor, at first sensor type (ISA or IRMA) is detected by the system and then displayed in front of the CO2 signal. NOTE: System displays Gas window for IRMA sensor as default. If when Gas window is open ISA probe is connected to the system, by exiting this window and entering it again you can change this window for ISA sensor. This change also can be made in GAS ALARM window. The GAS WINDOW menu is as follows:

Figure 10-6 GAS WINDOW Co2 UNIT Pick this item to adjust measurement unit for EtCo2. (Options: mmHg, KPa, %V) Co2 in %V is the Co2 value (in mmHg) divided by ambient barometric pressure (in mmHg) which is a percentage of the barometric pressure.

!!

PEtCo 2 ( mmHg ) pBrometric ( mmHg )

EtCo2(%V) =

!!

133.322 PEtCo 2 ( mmHg ) 1000

EtCo2(KPa) =

SIGNAL SWEEP Available options for SIGNAL. SWEEP are 3, 6, 12,5 and 25mm/s.

SIGNAL SCALE Depending on selected signal chooses by user different scale options is available as following table:

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CO2 Waveform Scale 0-50 mmHg, 0-6% 0-100 mmHg, 0-10% <AUTOSCALE>

O2 Waveform Scale 0-50% 0-100% <AUTOSCALE>

N2O Waveform Scale 0-50% 0-100% <AUTOSCALE>

AA Waveform Scale 1,2,3,5,10,20% <AUTOSCALE>

AUTOSCALE is an option to adjust the scale automatically to display waveform in the best way.

WAVEFORM Pick this item to select which gas waveform displays on the screen. Available Options are CO2, N2O, O2, and AA.

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OPERATION MANUAL COMPENSATE The presence of oxygen and nitrous oxide can cause some interference in CO2 measurement. This is known as spectral broadening, and must be compensated. N2O is measured and automatically compensated for in all IRMA sensors. Only when IRMA2 (CO2) probe is connected to the monitor, N2O concentrates can be transmitted to the sensor. Available options for COMPENSATE are 0-100%N2O. The O2 compensation is performed automatically for all IRMA sensors with the oxygen sensor available on it. When using an IRMA without an oxygen sensor, i.e. when oxygen measurement is performed by the other device like anesthesia machines and ventilators already equipped with O2 measuring devices, the current oxygen concentration should be transmitted to the sensor Available options for COMPENSATE are OFF and 1-100%O2 when O2 sensor is available, it is "AUTO" and it doesn't change when O2 sensor is available. GAS UNIT Pick this item to adjust measurement unit for O2, N2O, AA (DES, HAL, ISO, ENF, SEV) (Options: KPa, %V) AGENT In IRMA OR, Pick this item to select which anaesthesia agent values display on the screen. Available Options are DES, HAL, ISO, SEV and ENF. In IRMA OR+, there is automatic identification of anesthesia agent and it is "AUTO" in menu and couldn't change. NOTE: In IRMA OR system will be able to monitor the anesthesia agent value when it exceeds 0.2%. NOTE: In IRMA OR+, if the concentration of anesthesia agent doesnt exceed agent detection threshold, "AA?" will be displayed instead of the name of anesthesia agent in Multi-gas parameters window. NOTE: In IRMA OR+, if there is two anesthesia agent mixtures in patient airway and their concentration exceed agent detection thresholds, the message "AA1, AA2 AGENT MIXTURE" is displayed on the screen and "MIX" is displayed instead of the name of anesthesia agent in Multi-gas parameters window.

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OPERATION MANUAL WORK MODE Available options for WORK MODE are "standby" and "measure". The default is "measure" mode .When gas monitoring is required, select "measure" mode." standby" mode disables monitoring to decrease the power consumption and extend the life cycles of IR source and IRMA sensor. NOTE: When not using gas monitoring functions, it is suggested to disconnect the sensor. NOTE: If the monitor doesnt detect any CO2 signal for 30 minutes, after connecting IRMA sensor, the monitor automatically disables gas monitoring to decrease the power consumption and extend the life cycles of IR source and sensor. The monitor will be set in "standby" mode. NOTE: If the monitor doesnt detect adapter of IRMA sensor for 10 minute, after connecting IRMA sensor, the monitor automatically disables monitoring to decrease the power consumption and extend the life cycles of IR source and sensor. The monitor will be set in "standby" mode. NOTE: When the system is in standby mode, you can enable GAS monitoring in GAS window by setting work mode in measure. GAS/RESP Available options are "GAS" and "RESP" to select GAS or RESP as mode to monitor RESP parameters .When selecting "GAS", the system will keep the current status. When selecting "RESP", the system switches GAS module to standby mode, and toggle to display RESP waveform and parameters. FILL SIGNAL Pick "ON" to show the waveform in a filled form.

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OPERATION MANUAL ALARM Pick "ALARM" in GAS WINDOW to call up the following menu:

Figure 10-7 GAS/ALARM WINDOW GAS ALARM Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol instead of alarm limits in Parameters Area. ALARM LEVEL Selectable between 1, 2. Level 1 represents the most serious case. EtCO2 LIMIT Alarm is activated when the EtCo2 exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: 0.4~13%V step0.1%V) Default for upper limit is 6.5%V and for lower limit is 2.6%V. FiCO2 HIGH Alarm is activated when the FiCo2 exceeds adjusted ALARM HIGH value (Range: 0.4~13 %V step 0.1%V), Default for upper limit is 1.3%V. AWRR LIMIT Alarm is activated when the AWRR exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value.(Range :1-120BrPM step1BrPM) Default for upper limit: Adult: 30BrPM Neonate: 60BrPM Default for lower limit: Adult: 5BrPM Neonate: 15BrPM APNEA LIMIT Pick it to set the standard of judging an apnea case. It ranges from 10 to 40 seconds, increases/decreases by 5s. When we choose "OFF", in apnea case alarm will be deactivated. EtN2O LIMIT Alarm is activated when the EtN2O exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: 1~100%V step1%V) Default for upper limit is 75%V and for lower limit is 35%V.
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OPERATION MANUAL FiN2O LIMIT Alarm is activated when the FiN2O exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: 1~100%V step1%V) Default for upper limit is 75%V and for lower limit is 35%V. EtAA LIMIT Alarm is activated when the EtAA exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value FiAA LIMIT Alarm is activated when the FiAA exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. NOTE: FiAA and EtAA have different alarm ranges for every anesthesia agent as a follow: Anesthesia agent HAL DES ISO SEV ENF Alarm range 0.1~5% 0.1~18% 0.1~5% 0.1~8% 0.1~5% Step Alarm limit default 0.1% 0.5~1.5% 0.1% 5~10% 0.1% 0.8~2% 0.1% 1~3% 0.1% 0.5~1.5%

EtO2 LIMIT Alarm is activated when the EtO2 exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: 18~105%V step1%V) Default for upper limit is 50%V and for lower limit is 100%V. FiO2 LIMIT Alarm is activated when the FiO2 exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: 18~105%V step1%V) Default for upper limit is 50%V and for lower limit is 100%V. ZERO Pick "ZERO" in GAS WINDOW to call up the following menu:

Figure 10-8 GAS/ZERO WINDOW

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OPERATION MANUAL A zero reference calibration of the IR measurement should be performed whenever an offset in gas reading is discovered or if "CO2 INVALID, PLEASE ZERO" alarms appear. NOTE: Zero reference calibration should only be performed by qualified service technicians, and should NOT be a part of normal operating procedures. The probe must work at least 15 minutes in measurement mode for warming up. Pressing zero before passing this time, the message UNABLE TO ZERO, SENSOR WARMING UP will be shown and zeroing procedure wont be done. Warning For accurate measurements, IRMA sensor should be set zero to room air. Warning Incorrect probe zero calibration will result in false gas readings. 1. 2. Select well ventilated room to perform the calibration. Make sure the sensor is connected to system and no error message is displayed (except APNEA) 3. Choose a < ZERO> in the ZERO WINDOW menu. 4. Press the rotary knob to start zeroing. The message "PLEASE WAIT" will be displayed during the procedure. "ZERO IS OK." indicates that the zeroing procedure is completed successfully.The last zeroing time will be saved and displayed in its corresponding place.If an error happened during zeroing the error message will be displayed in ZERO WINDOW. Special care should be taken to avoid breathing into the adapter during the zero reference calibration procedure. The presence of ambient air (21% O2 and 0%CO2) in the IRMA airway adapter is of crucial importance for a successful zero reference calibration. Always perform a pre-use check after performing zero reference calibration.

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10.3 GAS Alarm Messages

Alarm is activated when parameters exceed adjusted alarm limits: Alarm AWRR Alarm EtCo2 Alarm FiCo2 High Alarm RESP APNEA EtN2O Alarm FiN2O Alarm EtAA Alarm FiAA Alarm EtO2 Alarm FiO2 Alarm Situation Respiration rate violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits FiCo2 violates adjusted high alarm limits Non-respiration condition overruns adjusted time End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits Visual prompt AWRR value blinks. Alarm indicator flashes. EtCo2 value blinks. Alarm indicator flashes. FiCo2 value blinks. Alarm indicator flashes Alarm indicator flashes. "RESP APNEA" blinks. EtN2O value blinks. Alarm indicator flashes. FiN2O value blinks. Alarm indicator flashes. EtAA value blinks. Alarm indicator flashes. FiAA value blinks. Alarm indicator flashes. EtO2 value blinks. Alarm indicator flashes. FiO2 value blinks. Alarm indicator flashes. Audio sound Activated Activated Activated Activated Activated Activated Activated Activated Activated Activated

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OPERATION MANUAL GAS messages include:

Message SYSTEM FAULT Cause Sensor error Solution Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Change adapter Connect adapter Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem exists again turn off and on the system and if again this message appears contact after sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Change the adapter. Explanation Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing Alarm silence, alarm is suspended for at least 120S Alarm level 3. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

REPLACE ADAPTOR NO ADAPTOR

IR signal low There is no adaptor connect to the sensor.

CO2 INVALID.

CO2 outside specified accuracy range.

O2 INVALID.

O2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

N2O INVALID.

N2O outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

AGENT INVALID

Agent outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

ACCUTACY INVALID, PLEASE ZERO.

Two or more agent are out of accuracy range except O2

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

INVALID AMBIENT PRESSURE

Ambient pressure outside operating range.

Alarm level 2 . Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing Alarm silence, alarm is suspended for at least 120S

INVALID AMBIENT TEMPERATURE

Internal temperature outside operation range. Adapter O2 port Clogged or plugged.

O2 PORT FAILURE

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OPERATION MANUAL
Alarm level 2 . Pressing alarm Silence, Alarm will be disabled and will ignore this fault. Alarm level 2. Pressing Alarm silence, alarm is suspended for at least 120S. Alarm level 3 Pressing alarm Silence, Alarm will be disabled and ignore this fault.

REPLACE O2 SENSOR

O2 sensor lifetime is passed.. If the sensor operate for a long time period without being disconnected from the adapter or the operating temperature for oxygen sensor changes significantly Sensor is disconnected from system Manual setting and if no breath is detected for 30 min and ETCO2 is less than 4 mmHg for more than 30 min or when the monitor does not detect adapter of IRMA sensor for 10 min. - The accuracy of the agent identification and measurement could not be guaranteed. - More than 2 aesthetic agents are present in the breathing circuit - High concentrations of solvents, cleaning agents or other interfering gases are present in the breathing circuit

Place new O2 sensor

ROOM AIR O2 CALIB REQUIRED

Perform room air calibration. Connect sensor if problem exist again, Contact after sales service of manufacturer.

NO SENSOR

SENSOR STANDBY MODE

AGENT ID UNRELIABLE*

* Only available for IRMA AX+/OR+

Indicator status on the IRMA sensor head: Steady green light Blinking green light (IRMA AX+/OR+ only) Steady red light Blinking red light Blinking green light System OK Zero Reference check in progress Sensor error Check adapter Standby mode

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10.4 IRMA SENSOR CLEANING

1. The IRMA sensor can be cleaned using a cloth moistened with ethanol or isopropyl alcohol. 2. Do not reuse, sterilize, or clean airway adapter on another patient as they are designed for single use. Warning The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will damage them. Warning Never sterilize or immerse the IRMA sensor in liquids.

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CHAPTER 11 GAS Monitoring (Sidestream)

11-1 GENERAL
GAS monitoring provides a continuous waveform of airway gas concentration as a function of time. The waveform enables physician to evaluate adequacy of gas exchange in the lungs, integrity of the patients airway, cardiopulmonary function and ventilator function.

Vital sign monitor uses sidestream method for gases measurement. A Nomoline sampling line is connected to patient respiratory circuit in ISA analyzers for monitoring of inhaled and exhaled gases during anesthesia, recovery or respiratory cares. ISA sensors may be used in operation room, ICU or patient room for emergency medical services or transportation emergency and they are applicable for neonates and adults. Different configurations of this sensor are available in the market. These sensors have ability to identify different gases as CO2, N2O and five anesthetic gases (Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane) by parameters as respiratory rate, waveform and concentration of inhaled/exhaled gases. Different types of the sensor are as follows: ISA CO2: ISA AX +: CO2 CO2, N2O, two anesthetic agent (DES, SEV, ENF, ISO and HAL), MAC and Automatic agent identification ISA OR +: CO2, O2, N2O, two anesthetic agent (DES, SEV, ENF, ISO and HAL), MAC and Automatic agent identification

Measuring principle Gas monitoring uses infrared (IR) spectroscopy method to measure and identify different gases. Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light. Since the absorption is proportional to the concentration of gas molecule, the concentration can be determined by comparing its absorption. For ISA AX+ or ISA OR+ sensor, absorption of nine different wavelengths of infrared light is measured in order to identify the gases and measure their concentrations.

The measurement of CO2, N2O and anaesthetic agents in the breathing gas mixture is based on the fact that the different gases absorb infrared light at specific wavelengths.
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OPERATION MANUAL

A microprocessor continuously calculates the CO2, N2O and anesthetic agent concentrations from the infrared light absorption measurements using matrix calculations to identify which anesthetic agents are present in the gas mixture. Measurable parameters by ISA sensor are: EtCO2, EtN2O, EtAA (End tidal of these gases), FiCO2, FiN2O and FiAA (Fraction inspiratory of these gases) and Air Way Respiratory Rate and MAC. NOTE: It takes less than 10 seconds to display gas waveform data and 1 minute that the accuracy and other operating specification of the system comply with technical specification in chapter 19.

Warning ISA probe is intended for use only as an adjunct in patient assessment .It must be used in conjunction with clinical signs and symptoms. Warning ISA probe should be connected only to approved devices of PHASEIN Company.

MAC (Minimum alveolar concentration)

Minimum alveolar concentration or MAC is a concept used to compare the strengths of anesthetic vapors; in simple terms, it is defined as the concentration of the vapor in the lungs that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus. The MAC value may be calculated and displayed by using end-tidal (ET) gas concentrations according to the following formula: MAC = %ET (AA1)/X (AA1) + %ET (AA2)/X (AA2) + %ET (N2O)/100 X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0% NOTE: The patient age as well as other individual factors is not taken into account in the above described formula. ET gas concentrations for secondary agent (AA2) are only available for ISA (Multi-gas) probe.

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OPERATION MANUAL

Sampling Line
ISA sidestream analyzer continuously removes sampled gas from respiratory circuit (Nasal cannula, respiration mask or Y-piece connected to breathing tube). Sampled gas enters the analyzer through the sampling line; it is usually warm and humid and cools down in contact with the walls of a sampling line and condenses in form of water droplets. These droplets could occlude the sampling line and interfere with gas measurements. Nomoline sampling line protects ISA sidestream analyzer from these problems. Unlike traditional methods that remove water vapor and collect it in a container, Nomoline removes water and water vapor by a water separation section in a unique method. This section made of a special polymer and bacterial filter that removes water vapor and condenses it and passes through a membrane surface while has no effect on CO2 and anesthetic agents. Nomoline sampling line has a lock connector through which can be connected to Nasal cannula. ISA sensor goes to Standby mode when sampling line is not connected to it, as soon as the sampling line is connected to ISA sensor; it turns on and starts measurement. Nomoline has rapid response time that it makes CO2, N2O, and anesthetic agents measurement possible even at high respiratory rates. ISA analyzer is applicable for adults, pediatrics and neonates.

Warnings related to sampling line

Warning Do not use sampling line if it or its package is damaged and return it to the vendor.

Warning Use only the recommended ISA sampling line by the manufacturer. Other sampling lines may cause sensor improper performance. (Refer to chapter 20 for more detail) Warning Disposable sampling lines shall not be reused .Used sampling lines shall be disposed of in accordance with local regulations for biologically hazardous materials. Warning If sampling line is connected to the patient for a long time period, you should replace it every two weeks or when Sampling line clogged message is displayed. (Each one happens earlier)

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OPERATION MANUAL

Warning Do not place sampling line in a way that it is tangled around the patient neck and cause suffocation. Warning Do not use the adult/pediatric sampling line with infants as the sampling line adds dead space to the patient circuit.

Warning Do not use the infant sampling line with adults as this may add excessive flow resistance to patient breathing circuit.

The infant sampling line has designed in a way that minimizes the dead space and can be used even for very small patients.

Warning Don not use ISA probe with artificial breathing devices or Nebulizer as this may cause bacterial filter occlusion. Warning Never use a syringe to extract settled water in Nomoline.

Preparatory steps for Multi-gas monitoring (Figure 11-3)

1. 2. 3. 4. 5. 6. Plug the ISA sensor into corresponding connector on the side panel of patient monitor. Snap the sampling line head on the ISA sensor. It will click into place when properly seated. About ISA AX+ or ISA OR+, connect exhaust of sampled gases to a collection system or restore them again to patient breathing flow. Power on the monitor. A green indicator indicates that the ISA sensor is ready for use. Connect the ISA sampling line to the patients endotracheal tube.

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OPERATION MANUAL

Pre-use check
Before connecting the sampling line to the breathing circuit, perform following steps to ensure accuracy of patient circuit connections. 1. Snap the sampling line head on the ISA sensor. 2. A green indicator on ISA sensor indicates that it is ready for use. 3. For ISA OR+ sensor, check that O2 reading on the monitor is 21%. 4. Breathe into the sampling line to check that displayed CO2 value and waveform on the monitor are correct. 5. Occlude the sampling line by your finger and wait for 10 sec. 6. Check if occlusion message is displayed on the monitor and ISA sensor indicator flashes in red. 7. Verify that sampling line is connected to patients breathing tubes securely. NOTE: There is no drift of measurement accuracy. NOTE: Variations in barometric pressure do not have any effects due to internal barometric pressure compensation. NOTE: There are no adverse effects on stated performance due to cycling pressure of up to 10 KPa.

Warning The device can only be operated by personnel who have passed professional training and are familiar with this manual.

Warning Dont use the device in the environment which contains flammable anesthetic gas.

Warning Before any interpretations are made of EtCo2 reading and waveform, assure that the capnography system is functioning correctly. Monitor contamination by secretions and Partial obstruction of sampling line with water can result in distorted CO2 waveforms. A leak in the sampling line may result in low EtCo2 measurements. Check the monitor to see if it is functioning properly. Warning Don not expose the monitor with sidestream capnography module to vibration and impact.

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OPERATION MANUAL

Warning Measurements can be affected by mobile and RF communications equipment. It should be assured that the ISA sensor is used in an environment without electromagnetic radiations. Warning Do not use ISA probe during magnetic resonance imaging (MRI) scanning. Therefore transfer it outside the MIR room. Warning Using electro surgery devices (High frequency equipments) adjacent to ISA probe may cause measurement interference.

NOTE: Do not apply tension to the ISA sensor cable. NOTE: Do not operate the ISA sensor at temperature outside operating range as a below: ISA CO2: 0~50C ISA OR+/ AX+: 5~50C Warning Verify ISA sensor detection before starting GAS or CO2 monitoring. Unplug the ISA sensor from its connector to verify that the error message "NO SENSOR "is displayed. NOTE: Refer to APPENDIX VI for more information about ISA module.

Warning Positioning the monitor lower than the patient may facilitate condensed water and secretions move towards the system thereby resulting in blockage of filters. Keep the system preferably above the patient level. This prevents secretions and water dribbling down the tube towards the monitor end and extends the lifetime of the filters.

Zeroing procedure
ISA gas analyzer should have a reference zero level for CO2, N2O and anesthetic agent measurement that this calibration process is called zeroing. ISA probe automatically perform zeroing procedure by switching the sampling line from respiratory tubes.

11-6

OPERATION MANUAL Automatic zeroing procedure is performed one to three times every 24 hours. It takes up to 3 sec to perform zeroing for ISA (CO2) probe and up to 10 sec for ISA (Multi gas). After zeroing procedure is completed, a flat line signal and message ZEROING IN PROGRESS will be displayed. If ISA probe is used accompanied by oxygen sensor, in automatic zeroing room air will be used for O2 sensor calibration.

Warning Special care should be taken to avoid breathing into the adapter during the zero reference calibration procedure. The presence of ambient air (21% O2 and 0%CO2) in the ISA probe is of crucial importance for a successful zero reference calibration. NOTE: Use manufacturer especial fasteners to connect ISA sensor to the infusion stand.

11-2 GAS WINDOW

NOTE: After PHASEIN capnography probe is connected to the monitor, at first sensor type (ISA or IRMA) is detected by the system and then displayed in front of the CO2 signal. NOTE: System displays Gas window for IRMA sensor as default. If when Gas window is open ISA probe is connected to the system, by exiting this window and entering it again you can change this window for ISA sensor. This change also can be made in GAS ALARM window. The GAS WINDOW is as follows:

Figure 11-1 GAS WINDOW

11-7

OPERATION MANUAL Co2 UNIT Pick this item to adjust CO2 measurement unit. (Options: mmHg, KPa, %V) EtCo2 in %V is the EtCo2 value (in mmHg) divided by ambient barometric pressure (in mmHg) which is a percentage of the barometric pressure.

!!

PEtCo 2 ( mmHg ) pBrometric ( mmHg )

EtCo2(%V) =

!!

133.322 PEtCo 2 ( mmHg ) 1000

EtCo2(KPa) =

SIGNAL SWEEP Select it to adjust Multi-gas signals sweep. Available options for SIGNAL SWEEP are 3, 6, 12/5 and 25mm/s. SIGNAL SCALE Depending on selected signal chosen by user different scale options is available as following table: CO2 Waveform Scale 0-50 mmHg, 0-6% 0-100 mmHg, 0-10% <AUTOSCALE> O2 Waveform Scale 0-50% 0-100% <AUTOSCALE> N2O Waveform Scale 0-50% 0-100% <AUTOSCALE> AA Waveform Scale 1,2,3,5,10,20% <AUTOSCALE>

AUTOSCALE is an option to adjust the scale automatically to display waveform in the best way.

WAVEFORM Pick this item to select which gas waveform displays on the screen. Available Options are CO2, N2O, O2, and AA.

O2 COMPENSATE The presence of oxygen can cause some interference in CO2 measurement. This is known as spectral broadening, and must be compensated. The O2 compensation is performed automatically for all ISA sensors with the oxygen sensor available on it. When using an ISA without an oxygen sensor, i.e. when oxygen measurement is performed by the other device like anesthesia machines and ventilators, the current oxygen concentration should be transmitted to the sensor Available options for COMPENSATE are OFF and 1-100%O2 when O2 sensor is available, it is "AUTO" and it doesn't change when O2 sensor is available.

11-8

OPERATION MANUAL N2O COMPENSATE The presence of N2O can cause some interference in CO2 measurement. This is known as spectral broadening, and must be compensated. N2O is measured and automatically compensated for in ISA sensors (AX+/OR+). Therefore N2O concentration should be transmitted to ISA sensor (CO2). Available options are 0-100%. NOTE: You can see this item only when ISA (CO2) sensor is connected to the system. In other modes (ISA AX+/OR+), this item is removed from the respective menu. In other words CO2 menu for ISA (CO2) and IRMA (CO2) is similar except for N2O COMPENSATE option. GAS UNIT Pick this item to adjust measurement unit for O2, N2O, AA (DES, HAL, ISO, ENF, SEV) (Options: KPa, %V) AGENT In ISA AX+/OR+, there is automatic identification of anesthesia agent and "AUTO" is displayed in menu and couldn't change. NOTE: In IRMA OR+, if the concentration of anesthesia agent doesnt exceed agent detection threshold, "AA?" will be displayed instead of the name of anesthesia agent in Multi-gas parameters window.

NOTE: In ISA OR+, if there is two anesthesia agent mixtures in patient airway and their concentration exceed agent detection thresholds, the message "AA1, AA2 AGENT MIXTURE" is displayed on the screen and "MIX" is displayed instead of the name of anesthesia agent in Multi-gas parameters window.

WORK MODE Available options for WORK MODE are "standby" and "measure". The default is "measure" mode .When gas monitoring is required, select "measure" mode." standby" mode disables monitoring to decrease the power consumption and extend the life cycles of IR source and ISA module. NOTE: When not using gas monitoring functions, it is suggested to disconnect the sensor.

11-9

OPERATION MANUAL NOTE: If the monitor doesnt detect any CO2 signal for 30 minutes, after connecting ISA sensor, the monitor automatically disables gas monitoring to decrease the power consumption and extend the life cycles of IR source and sensor. The monitor will be set in "standby" mode. NOTE: Sensor remains in standby mode until the sampling line is connected to ISA sensor. After sample line connection the sensor switches on and starts measurement. NOTE: For enabling ISA sensor, you can enter Gas window and set the monitor on measure mode. GAS/RESP Select this item to determine that respiration evaluation is performed by "Multi-gas" or"RESP" module. Available options are "GAS" and "RESP". When selecting "RESP", the system switches Multi-gas module to standby mode, and displays RESP waveform and parameters. FILL SIGNAL Pick "ON" to show the waveform in a filled form.

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OPERATION MANUAL

ALARM Pick "ALARM" in GAS WINDOW to call up the following menu:

Figure 11-2 GAS/ALARM WINDOW GAS ALARM Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light indicator. Pick "OFF" to disable the alarm functions and there will be a " " symbol in Multi-gas Parameters Area. ALARM LEVEL Selectable between 1, 2. Level 1 represents the most serious case. EtCO2 LIMIT Alarm is activated when the EtCo2 exceeds adjusted ALARM HIGH or LOW limit (Range: 0.4~13%V step0.1%V) Default for upper limit is 6.5%V and for lower limit is 2.6%V. FiCO2 HIGH Alarm is activated when the FiCo2 exceeds adjusted ALARM HIGH limit (Range: 0.4~13 %V step 0.1%V), Default for upper limit is 1.3%V. AWRR LIMIT Alarm is activated when the AWRR exceeds adjusted ALARM HIGH or LOW limit. (Range: 1-120BrPM) Default for upper limit: Adult: 30BrPM Neonate: 60BrPM Default for lower limit: Adult: 5BrPM Neonate: 15BrPM APNEA LIMIT Pick it to set the standard of judging an apnea case. It sets to 10 - 40 seconds and "OFF" andincreases/decreases by 5s.

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OPERATION MANUAL

EtN2O LIMIT Alarm is activated when the EtN2O exceeds adjusted ALARM HIGH or LOW limit. (Range: 1~100%V step1%V) Default for upper limit is 75%V and for lower limit is 35%V. FiN2O LIMIT Alarm is activated when the FiN2O exceeds adjusted ALARM HIGH or LOW limit. (Range: 1~100%V step1%V) Default for upper limit is 75%V and for lower limit is 35%V. EtAA LIMIT Alarm is activated when the EtAA exceeds adjusted ALARM HIGH or LOW limit. FiAA LIMIT Alarm is activated when the FiAA exceeds adjusted ALARM HIGH or LOW limit. NOTE: FiAA and EtAA have different alarm ranges for every anesthesia agent as a follow:
Anesthesia agent HAL DES ISO SEV ENF Alarm range 0.1~5% 0.1~18% 0.1~5% 0.1~8% 0.1~5% Step 0.1% 0.1% 0.1% 0.1% 0.1% Alarm limit default 0.5~1.5% 5~10% 0.8~2% 1~3% 0.5~1.5%

EtO2 LIMIT Alarm is activated when the EtO2 exceeds adjusted ALARM HIGH or LOW limit. (Range: 18~105%V step1%V) Default for upper limit is 100% and for lower limit is 50%. FiO2 LIMIT Alarm is activated when the FiO2 exceeds adjusted ALARM HIGH or LOW limit. (Range: 18~105%V step1%V) Default for upper limit is 100%V and for lower limit is 50%V.

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OPERATION MANUAL

11.3 ISA Sensor Alarm Messages

Alarm is activated when Gas parameters exceed adjusted alarm limits: Alarm AWRR Alarm EtCo2 Alarm FiCo2 High Alarm APNEA EtN2O Alarm FiN2O Alarm EtAA Alarm FiAA Alarm EtO2 Alarm FiO2 Alarm Situation Respiration rate violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits FiCo2 violates adjusted high alarm limits Non-respiration condition overruns adjusted time End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits End Tidal Co2 violates adjusted alarm limits Visual prompt AWRR value blinks. Alarm indicator flashes. EtCo2 value blinks. Alarm indicator flashes. FiCo2 value blinks. Alarm indicator flashes Alarm indicator flashes. "RESP APNEA" blinks. EtN2O value blinks. Alarm indicator flashes. FiN2O value blinks. Alarm indicator flashes. EtAA value blinks. Alarm indicator flashes. FiAA value blinks. Alarm indicator flashes. EtO2 value blinks. Alarm indicator flashes. FiO2 value blinks. Alarm indicator flashes. Audio sound Activated Activated Activated Activated Activated Activated Activated Activated Activated Activated

11-13

OPERATION MANUAL GAS messages include:

Message SYSTEM FAULT CHECK SAMPLING LINE SAMPLING LINE CLOGGED Cause Sensor error Solution Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Change sampling line Remove obstruction otherwise change the sampling line by a correct one. Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Replace O2 sensor by a new one. Replace O2 sensor by a new one. Explanation Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 3. Pressing Alarm silence, alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120sec.

IR signal low

Sampling line occlusion

CO2 INVALID

CO2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

O2 INVALID

O2 outside specified accuracy range. N2O outside specified accuracy range. Agent outside specified accuracy range. Anesthesia agents are out of accuracy range except O2 Ambient pressure outside operating range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2 . Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and will ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing Alarm silence, alarm is suspended for 120S.

N2O INVALID

AGENT INVALID ACCUTACY INVALID, PLEASE ZERO. INVALID AMBIENT PRESSURE

INVALID AMBIENT TEMPERATURE

Internal temperature outside operation range.

REPLACE O2 SENSOR O2 SENSOR ERROR

O2 sensor lifetime is passed.

Sensor failure If the sensor operate for a long time period without being disconnected from the sampling line or the operating temperature for oxygen sensor changes significantly

O2 SPAN CALIB REQUIRED

Perform room air calibration.

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OPERATION MANUAL
CO2 value is more than 800 PPM (0.80%V) and measurement accuracy is low. Sensor is disconnected from system Manual setting and if no breath is detected for 30 min and ETCO2 is less than 4 mmHg for more than 30 min or when the monitor does not detect the sampling line. - The accuracy of the agent identification and measurement could not be guaranteed. - More than 2 aesthetic agents are present in the breathing circuit - High concentrations of solvents, cleaning agents or other interfering gases are present in the breathing circuit Perform automatic zeroing procedure in an environment with CO2 less than 0.80%V. Connect sensor if problem exist again, Contact after sales service of manufacturer. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 3 Pressing alarm Silence, Alarm will be disabled and ignore this fault.

ZERO REFERENCE CALIB REQUIRED

NO SENSOR

SENSOR STANDBY MODE

AGENT ID UNRELIABLE2

Only available for ISA AX+/OR+

Indicator status on the ISA sensor:

Steady green light Blinking green light Blinking blue light Steady red light Blinking red light System OK Zero Reference check in progress There are anesthesia agents Sensor error Check sampling line

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OPERATION MANUAL

11.4 ISA SENSOR CLEANING

1. The ISA sensor should be cleaned regularly by using a cloth moistened with ethanol or 70% isopropyl alcohol. 2. Connect the sampling line to the corresponding connector on the ISA sensor when you clean the sensor to prevent dust and liquid entering. Warning The ISA sampling line is non-sterile device. Do not autoclave the devices as this will damage them. Warning Never sterilize or immerse the ISA sensor in liquids.

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OPERATION MANUAL

CHAPTER 12 Cerebral State Monitoring

12.1 GENERAL
For many years, anesthesia technicians have been using homodynamic parameters of patients such as heart rate, blood pressure and other vital signs, and devices such as capnographs and pulse-oximeters to evaluate patient consciousness. Non of these parameters are directly connected to the consciousness, and physicians are required to perform indirect measurements to determine appropriate dose for each patient to prevent pain during surgery. Although there are some standards for dose prescription, These doses are not necessarily appropriate for all patients such as women and patients with different ages or having unknown diseases. There has been several overdosing that extended patient anesthesia period, recovery period and resulted in puke in addition to economic cost. Another dangerous condition happens when there is insufficient dose for the patient and he/she is not completely unconscious and can not react during surgery. In this condition, the patient has an ambiguous sense of the environment and can result in long term psychological disorders. There has been many efforts to use patient vital signs for consciousness measurement and doses prescription based on vital signs, not based on patient age, gender and physiological conditions. The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained professionals to measure the level of consciousness (LOC) in all area of the hospital .Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM module displays the CSI but does not perform any data interpretation. All data interpretation is performed by a physician. The monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anesthetized or sedated patient in all areas of the hospital. Measuring principle An instrumentation amplifier collects ongoing EEG with a high Common Mode Rejection Ratio ensuring a high-quality EEG acquisition. Special algorithms that eliminate their effects on subsequent CSI calculations detect artefacts. The performance of the CSI is based on the analysis of the frequency content of the EEG signal. The energy of the EEG is evaluated in specific frequency bands. These are used to define two energy ratios called alpha () and beta (). Both of these show a shift in energy content from the higher to the lower frequencies during anaesthesia. The relationship between these quantities is also analysed as a separate parameter (-).

ratio ln

E3042.5 Hz E612 Hz

ratio ln

E30 42.5 Hz E11 21Hz

The monitor also on-line evaluates the amount of instantaneous burst suppression (BS) in each thirty-second period of the EEG. This measurement quantifies the amount of "silent" or "flat" EEG periods characteristic of the deepest levels of hypnosis. These four parameters are used as input to a fuzzy logic classifier system that calculates the Cerebral State Index.

12-1

OPERATION MANUAL

Figure 12-1 measurement principle The measured parameters in csm monitor are CSI, BS, EMG and SQI as follow: CSI Scale The CSI is a unit-less scale from 0 to 100, where 0 indicates a flat EEG and 100 indicate EEG activity corresponding to the awake state. The range of adequate anaesthesia is designed to be between 40 and 60. All values in the table are approximate values based on the mean values of the patient behaviour. The relationship among the CSI, the clinical state and the OASS (Observers Assessment of Alertness and Sedation) score is shown in the table below: CSI Clinical State OAAS 90-100 Awake 5 80-90 Drowsy 4 60-80 Light anesthesia or sedation 3 40-60 Range considered as adequate for surgical 2-1 anesthesia 10-40 Deep anesthesia, in most cases accompanied 1 by burst suppression. 0-10 Close to coma, BS larger than 75 .When CSI <1 is below 3, the EEG is practically iso-electric. The prediction probability (Pk) between the CSI and the OAAS was 0.92. The OASS score correspond to: OASS Clinical State 5 Respond readily to name spoken in normal tone. 4 Lethargic response to name spoken in normal tone. 3 Responds only after name called loudly and /or repeatedly. 2 Does not respond to mild prodding or shaking. 1 Does not respond to noxious stimulus. EMG High levels facial muscular or electromyographic (EMG) activity can interface with the CSI under certain circumstance .The monitor incorporates an EMG filter that removes most of the potential interfering EMG activity. The EMG bar shows the energy of the EMG level in the 75-85 Hz frequency band (0-100 logarithmic). EMG activity is expected to be present when the patient is awake. When the patient is asleep, EMG activity can increase due to: Reflex reactions to painful stimuli during surgery. Lack of muscular relaxation. Muscular rigidity caused by some opioids (analgesics). Presence of large external electrical fields, e.g. elector surgical unit.
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OPERATION MANUAL

The EMG bar should be checked frequently, especially in case of a sudden increase in the CSI. If the increase in CSI is accompanied by an increase in muscular activity, there is a risk that EMG is causing interference. When this happens, attention must be paid to the stimuli received by the patient during surgery. In the presence of hypnotically unrelated EMG, administration of a neuromuscular blocking agent will cause the CSI to decrease. Since patients receiving neuromuscular blocking agents cannot exhibit movement as a sign of arousal, the CSI is a valuable tool in their anaesthetic management. Burst Suppression Indicator The monitor include a Burst Suppression indicator to show periods when the EEG is iso-electric or flat .The indication appears in the csm window and shows the percentage of burst suppression over the last 30 seconds of EEG signal. A BS% =20 readouts means that the EEG has been iso-electric during 20% of the last 30 seconds. SQI Value (artifact and noise control) The artefact rejection algorithm ensures that the incoming EEG is not contaminated with noise. When excessive noise is detected, the signal quality is reduced reflecting the disturbance. The artifact rejection algorithm will be active especially when electro surgical unit and equipment creating external interference is used. When the SQI is 100, show that the EEG signal is in the best quality. Warning The device can only be operated by personnel who have passed professional training and are familiar with this manual. Warning The monitor will not render accurate readings when used on patients with severe neurological disorders and patients under 2 years of age. Warning The monitor will not render accurate readings when used on patients weight less than 70% or more than 130% of ideal body weight and recent use of psycho-active medication, including alcohol Warning The use of pacemakers might cause either long periods of artifacts or elevated CSI values. Warning Do not use the monitor when cardiac defibrillator is used. Patient cables are not protected against defibrillation. NOTE: Operating the monitor close to equipment radiating high-energy radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause signal disturbance. If this happens, reposition the monitor away from the source of interference.

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OPERATION MANUAL Warning When used with elector surgical unit please note the positioning of the neuro sensors. In order to reduce the hazard of burns, the neuro sensors should not be located between the surgical site and the electro surgical unit return electrode. Warning Not to be used in the presence of flammable gases; explosion risk. Warning Pay attention if the CSM monitor is connected to a patient connected to other equipment. The total of leakage current may exceed the allowable limit and cause a possible hazard to the patient. Warning The conductive parts of neuro sensor should not contact other conductive parts including earth. Warning The monitor should be used in conjunction with other patient monitoring parameters and clinical signs. This will ensure the optimum balance of the anesthesia/sedation administration. Warning Do not open the CSM case. There are no user-serviceable parts inside. The case should only be opened by qualified service personnel using proper grounding techniques. When the case is opened, an electrical shock hazard exists which can result in serious injury to persons and instrument component damage.

Skin Preparation and Sensor Positioning

To ensure low sensor impedance, clean skin with mild soap and water is recommended as a skin cleanser. NOTE: Alcohol is not recommended as a skin cleanser; it leaves a film layer that may cause high sensor impedance. If alcohol is used, ensure 30 second dry time. The CSM Procedure Pack contains a skin preparation product and 3 neuro sensors. NOTE: The performance of the csm module is only guaranteed by the manufacture when the CSM Procedure Pack is used. Dry-abrading the skin gently using the skin prep product or with a dry wash cloth or gauze, to remove the non conductive skin layer. Positioning of the three neuro sensors is shown in figure11-2. The advanced signal processing of the monitor ensures that a deviation in the positioning of the sensors up to 2 cm (0.78 in) has no significant influence on the index. However, it is recommended to place the sensors on an area of the skull where only a few muscle fibres are present in order to achieve the best quality signal.

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OPERATION MANUAL

Figure 12-2 Neuro Sensor Placement White electrode (1) : middle of forehead Green electrode (2) : left side of forehead Black electrode (3) : mastoid of forehead NOTE: Make sure no part of the neuro sensors is in contact with any other conductive parts including earth/ground If skin rash or other unusual symptoms develop, remove sensors from patient. Change neuro sensors every 24 hours to check skin integrity. Warning Neuro sensors are disposable and should not be reused and before use attention to the expiry date. NOTE: Once the neuro sensors have been secured on the skin, attach the colour-coded wires on the patient cable to appropriate sensor. NOTE: Shown in figure 12-2 is a left sided setup; rights sided is also acceptable. NOTE: Place neuro sensors at the side farthest from the surgical area. Picture below shows how to use neuro sensor.

Figure 12-3 Correct use of neuro Sensors After opening he csm neuro sensors package, close the package like figure below. If you dont perform as figure below, the neuro sensors loose their quality.

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OPERATION MANUAL

Figure 12-4 Correct maintenance of neuro sensors in its package Warning The patient cable is very sensitive. Do not stretch it. Warning Use only the recommended CSM cable and neuro sensor for CSM monitoring. Other accessory may cause improper performance. (Refer to chapter 20 for detail) Warning Do not repair defective CSM cables and send it for after sale service. Manufacturer does not take responsibility for measurement accuracy of repaired cable.

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OPERATION MANUAL

12-2 CSM system

The monitor can show and record online csm data on the patient monitor for this reason it needs CSM module. This part connects to patient monitor by wireless technology.

12-2-1 CSM module

Figure 12-5 CSM module

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OPERATION MANUAL CSM module Key and control

Figure 12-6 CSM module Key and control

12-8

OPERATION MANUAL 1.Power On Press once 1.Power Off Press and hold it for 5 seconds. 1. Wireless Link connection, disconnection or reconnection. Press twice within 1 second 2.Red error light Lights up when neuro sensor error situation are detected. 3. Green adapter. Light when power adapter is connected. 4.Display area of csm module 5.Mute key mutes alarms 6.Set Event key /Set connection to patient monitor with CSM wireless card. 7.Display key change between graphical and information screen 7a.For immediate impedance update. Press down firmly for one second. 8.Event key Select event type /Select patient monitor with CSM wireless card among all. 9.Control key Used for menu selection of parameter setting. 9a.Use the Control key to scroll in the menus or set values. 9b.Select a submenu or function 9c.Go back one menu level CSM Module Setup Menu

Figure 12-7 CSM setup menu How to select menu settings from Display Mode 1. Remove battery lid. 2. From any Display Mode, press any arrow on the Control key (9). 3. The upper menu appears.

12-9

OPERATION MANUAL How to set parameter values 1. Press the Control key (9a) to select menu. 2. Press the Control key (9b) to enter submenu. 3. Press the Control key (9a) to select parameter. 4. Press the Control key (9b) to highlight parameter value. 5. Press the Control key (9a) to select parameter value. 6. Press the Control key (9b) to store setting or (9c) to cancel the selection and return without any change. 7. Press the Control key (9c) to go back in one menu level steps. If the Control key has not been activated in 20 sec, the CSM module returns to Operation Display Mode and stores the settings. CSM Module Settings Parameters Menu Description High Alarm Low Alarm High Limit Low Limit Language Contrast RF interface Set clock Backlight Alarm Alarm Alarm Alarm Selects the CSI Alarm High Option Selects the CSI Alarm Low Option Selects the CSI High Alarm Level Selects the CSI Low Alarm .Level Value(Default) ON/OFF(OFF) ON/OFF(OFF) 2-99(60) 1-98(25) English 15-35(22) ON/OFF(ON)

Config Selects device language Config Selects display contrast Select radio link active. If turned OFF the link is Config completely inactive. Sets clock :Date format, Year, Month, Date, Config Hours, Minutes, Seconds Config Set display light and light brightness Automatically established a wireless link to any monitor with CSM wireless card within approx. Config 10 meters or to specified monitor with CSM wireless card.

AutoLNK

0=Off (1=Normal) 2=Bright Inactive/Active/SN (Inactive)SN is only displayed if link is established.

Device Information Menu

Figure 12-8 Device Information Menu This menu shows some extra information about the csm module.

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OPERATION MANUAL Events Menu Pressing the Event Type key brings up the following selection menu:

Figure 12-9 Event Menu The following options can be selected: Induction, Intubation, Maintenance, Surgery, Injection, Note, End Maintenance, and Movement. When the desired option has been selected, press the Set Event key (6) to confirm. If no selection is made within 5 seconds the system returns to the current Display Mode. Only the event numbers are visible on Display Mode C. When you set event this event will be shown in csm trend of patient monitor. Event can be set with interval of 3 seconds. CSM module display modes The CSM module always starts with display A Switch between display A, B, C, D and E by pressing the Display key (7).

Figure 12-10 CSM module display mode A Main information window with CSI, BS%, EMG%, SQI%, clock, operation time and battery operation

Figure 12-11 CSM module display mode B Displays 3 seconds of EEG waveform. Use Event key (8) to scale up and down. EEG scales are 200V, 100V (default), 50V, 20V and 10V.

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OPERATION MANUAL

Figure 12-12 CSM module display mode C CSI trend curve with event markers. EMG% is displayed as a bar in the right panel. Operation time and numeric value of the actual CSI and BS%. The time scale for the trend curve is 5.27 minutes and each tag is 60 seconds

Figure 12-13 CSM module display mode D CSI trend histogram with 5-minute interval showing average, lowest and highest CSI values within the interval. EMG% is displayed as a bar in the right panel.

Figure 12-14 CSM module display mode E Sensor impedance, CSI, BS%, clock and operation time. When display E is active, the sensor impedance is updated every 60 seconds. Press Display key (7a) firmly for immediate impedance update. The EEG waveform derives from the signal recorded between the frontal and mastoid electrodes. The frequency content is 2-35 Hz. An icon labelled LNK in display mode E indicates the state of the data transfer connection via the csm link. An icon labelled BAT in display mode A indicates the remaining battery capacity. Battery 50 % charged Battery charging when icon animated Battery fully charged (if not animated)

12-12

OPERATION MANUAL The CSM module can be operated in two different modes, Batteries operated and CSM power operated. Warning Only standard csm rechargeable battery CSMX04 or alkaline batteries must be used. NOTE: Always use new Alkaline batteries to ensure best results Insert battery correctly

Warning Only use recommended adapter in this manual for charging the battery. NOTE: There is no alarm if battery is not connected. If no battery is inserted, the csm module is switched off when the external csm power is removed. There is no internal backup battery in the monitor. NOTE: The clock is powered by an internal battery with a limited life (minimum 6 years from date of manufacture).When the battery is used up, the clock will be reset, and the click will blink on start up. The csm module should then be sending for service. Rechargeable batterys useable time (fully charged CSMX04 only) Wireless link OFF OFF OFF ON ON ON Backlight level OFF 1 2 OFF 1 2 useable time (hours) 10.5 9.0 7.0 10.0 8.5 6.5

NOTE: Using 9V alkaline disposable batteries, the batteries use time indicates in table above can be multiplied by 2 to 3.

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OPERATION MANUAL

Figure 12-15 CSM module battery charging 1. Insert the CSM rechargeable battery as indicated. 2. Connect power cable to outlet and turn on power. 3. Green indicator (3 at figure 11-6) lights up. 4. Turn on csm module 5. When the CSM module is connected to an electrical outlet, and turned on, the CSM module can be operated while the battery is charged. If power is disconnected the CSM will continue running on the CSM battery. NOTE: The CSM module can be operated on mains with the CSM Power, with or without any type of approved battery inserted. NOTE: When csm rechargeable battery (CSMX04) is used, it will charge automatically while the electrical power is connected. Only csm battery (CSMX04) will be charged in the CSM module.

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12-2-2 CSM on patient monitor

1-Turn on the csm module. 2-The CSM module shows a list of monitor with CSM wireless card found. Select the ID of desired monitor with the Event key on the CSM module and the CSM LINK status indicator at right side of panel flashes. 3-Accept the desired monitor by pressing the Set key. When link has been established the CSM LINK status indicator will show a constant light. 4-The communication is performed and you can see csm parameters like CSI%, BS%, SQI%, EMG% and also EEG signal on the patient monitor display. CSM patient monitor display When highlight is place at CSM area, press the knob, the following window (csm large page) will pop up:

Figure 12-16 CSM large page This window is a special page for CSM display to show detail information of csm parameters in lager area and also you can change the different settings of csm on it. To enable or disable trend graph of BS parameter: Pick the most left item to enable or disable the BS trend. To enable or disable trend graph of SQI parameter: Pick the second left item to enable or disable the SQI trend. To enable or disable trend graph of EMG parameter: Pick the third left item to enable or disable the EMG trend. NOTE: The CSI parameter trend always shows on this page and the user is not able to disable displaying of it.
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OPERATION MANUAL To select how long the trend graph is displayed: Pick the forth left item, available options are 15min, 30min and 1-24H by the step of 1H. While the cursor line has not moved in csm large page, every click on forth left item, the x scale will be displayed based on the chosen trend interval till current time. Moving the cursor to chose a specific time and pressing trend time interval item (the forth left item), x scale will be zoomed in and zoomed out equal to the trend interval according to the specific time the cursor line shows. To obtain trend data of specific time: Cursor line in trend graph shows specific time. You can move the cursor line to change the time by pressing the fifth left item, when trend time interval (the forth left item) is set at 15 min, 30 min, 1H and 2H and turning the knob. Parameters at mentioned time are displayed on the right side of the csm large page with its specific color. To select time interval of trend in x-axis: Pick (the sixth left item) to adjust the start time and stop time of x-axis. By every clicking on the , the x scale will be changed in extend of the specified time of forth left item To change EEG gain: Pick EEG GAIN (the seventh item left) to adjust the Y scale of EEG signal and thus change the EEG signal in proportion. Available options are 25V and 50-250V by step of 50V. To review the event: Patient monitor can review the 255 csm event data. Pick EVENT LIST to invoke the result and time of latest event data, CSM/EVENT LIST WINDOW will pops up as shown in figure below:

Figure 12-17 CSM/EVENT LIST WINDOW By pressing the first left item of EVENT LIST WINOW, you can select a line of event recorded data and you will be able to delete a line of data in EVENT LIST WINDOW by pressing DELET. And all event list for new patient bye pressing DELETE ALL

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OPERATION MANUAL NOTE: For every event there is an event mark at specific time of trend when trend time interval is set at 15 min, 30 min, 1H and 2H To enable or disable the csm alarm limit: Pick CSM ALM ON/OFF to enable CSI alarm function such as parameters blinking, audio alarm and light indicator. PickOFF to disable the alarm functions and there will be a will be a " " symbol instead of alarm limits in Parameters Area. To set the CSI alarm limit: Press the 10th left item to set the CSI limit. Alarm is activated when the CSI parameter exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (default:min=35,max=60) NOTE: CSI alarm level is always in level II. NOTE: Every change in csm large page setting is seen in csm window in normal state.

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12.3 CSM Alarm Messages and Troubleshooting

Alarm limit is activated as a follow: Alarm CSI Alarm Situation Cerebral state index violates adjusted alarm limits Visual prompt CSI value blinks. Alarm indicator flashes. Audio sound Activated

CSM messages on patient monitor include:

Message Cause

CSM ELECTROD ALARM

Placement of neuro sensors and their connections might be in problem. This alarm can also be caused by high frequency instrument. If the impedance of the white or black sensors exceeds 1k, the SQI will fall gradually. Poor impedance conditions may cause the SQI to fall to 50%. Artefacts can have many causes: high frequency instrument, EMG, etc. are typical causes. If SQI falls because of extensive use of high frequency instrument, it will rise as soon as the high frequency instrument is stopped If sensor impedance is > 5k the CSI, BS and EMG will be blanked

CSM SQI LOW

CSM IMPEDANCE HIGH

Solution Check all neuro sensors and their connections. Check the patient cable. If not connected, then connect it. If faulty, replace patient cable. Check if either of the neuro sensors are disconnected or badly connected. Replace faulty sensor. Check that all neuro sensors and cable connections are correctly connected. Has the use of any mechanical device that could generate high frequency activity (e.g. patient warmer) been initiated or is any such device in close proximity to the CSM neuro sensors? If possible move disturbing device away from the neuro sensors. Check grounding of disturbing device. Reduce the influence from disturbing device by disconnecting CSM Power to let the CSM module run from the battery. Check that neuro sensors are not dry. Check that the skin has been cleaned properly. Clean and prepare skin as described in this manual and attach new neuro sensors.

CSM LINK OFF

CSM module is off or it is on but Try to establish wireless communication. wireless communication is not Refer to section 11-2-2 established. All alarm level for these messages is always in level 3. Pressing ALARM SILENCE, alarm will be disabled and ignored this fault.

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OPERATION MANUAL There is some error message that displayed just in csm module as follow:
Message Cause Hardware error If patient cable or the electrodes are connected while the csm module is performing the start up check. Solution Turn the csm module off and then on, if the problem exist contact after sale service of manufacturer. 1. Turn off the csm module 2. Disconnect patient cable. 3. Turn on the csm module. 4. When the start up check has finished connect the patient cable for normal operation.

Error codes (1-10 and 14) Error codes (11,12 and 13)

Troubleshooting CSM module does not turn on when power key is pressed? - Change to a new battery or a fully recharged battery. - If changing the battery does not help, contact after sale service of manufacturer. CSI is higher than expected - Check anesthetic delivery systems: IV lines and status of vaporizers. - Some patients require a higher dose of drugs due to interpatient variability. - Adequate dosing for maintenance may not be sufficient for increased stimulation.

CSI rises along with EMG High levels of facial muscular or electromyographic (EMG) activity can elevate the CSI under certain circumstances. When this happens, attention must be paid to the stimuli received by the patient during surgery. When the patient is asleep, EMG activity can increase due to reflex reactions to painful stimuli during surgery, lack of muscular relaxation or muscular rigidity caused by some opioids (analgesics). In the presence of hypnotically unrelated EMG, administration of a neuromuscular blocking agent may cause the CSI to decrease. NOTE: Facial muscles recover sooner than skeletal muscles. When these artifacts are present, the CSI should be interpreted with caution. LINK indicator on CSM link does not turn on - Check that this correct CSM link is chosen on the CSM module. - If CSM module cannot find the monitor with wireless CSM card. Relocate the monitor to obtain better signal quality, Turn on RF communication in the CSM module.

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12.4 CSM module cleaning and maintenance

Cleaning Clean csm module, csm patient cable and other csm accessory periodically by wiping the outer case with a lint-free cloth lightly moistened with warm water and a mild, non-abrasive cleaning solution or 70% isopropyl alcohol. NOTE: The csm module is resistant to the following cleaning solutions Warm water Isopropyl alcohol 99% Acetone 10% Hydrogen peroxide 3% Warning Do not allow fluids to spill or drip on the csm module. Storage If the monitor is to be stored for a longer period, it should first be cleaned and the battery removed. Store in a clean, dry atmosphere at room temperature and, if available, use the original packaging for protection. Warning No user- replaceable fuses in the monitor or csm power. Warning The csm module should be disposed of taking into consideration environmental factors, local laws and regulations. All components can be safely disposed of in the approved manner as per hospital or locally regulated guidelines. Remove battery, If any, before disposal. Maintenance To ensure the monitor remains in good operating condition, it is important to keep it clean and carry out the routine maintenance procedures. There are no serviceable parts in this instrument and all service is to be carried out by the manufacturer. NOTE: If the monitor is dropped, damaged or subjected to excessive moisture or high temperature, immediately be taken out of service for examination by qualified service personnel. NOTE: As required Clean the external surfaces of the monitor thoroughly before and after a prolonged period of storage NOTE: Every 12 months, inspect power adapter plug and cable for damage and also perform electrical safety check. (Including leakage current measurement) NOTE: Disconnect from battery power when performing maintenance. NOTE: Should an instrument be dropped or severely shaken, it should immediately be taken out of service and inspected by qualified service personnel to ensure its proper function prior to use.
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CHAPTER 13 ST Monitoring
13.1 GENERAL
ST segment deviation is defined as the displacement above or below the isoelectric level. The measurement of deviation compares the isoelectric point to the ST measurement point. The isoelectric point defines the point of zero voltage (no electrical activity) with a default position of 80ms from R wave as 0msec in the horizontal (time) axis. The ST point occurs in the ST segment between J-point and the T wave, at a default position of 110 ms after R wave. The following figure illustrates a typical QRS complex.

Figure 13-1 ST Measurement Algorithm The ST measurement for each beat complex is vertical difference between the two measurement points, ST and ISO. The ST analysis examines QRS complexes classified as normal beats (beat detection and classification information provided by the arrhythmia algorithm are used to eliminate beat that are ventricular in origin). The monitor combines the measurements and features of normal beats into a composite (or average) QRS complex. It derives the ST segment deviation from this average. The ST segment algorithm documents changes in ST segment in adult patients that can be indicative of the severity and duration of myocardial ischemia. Since many ischemic episodes are silent or painless, countinuous monitoring of ST segment changes can provide the earliest warning of ischemic events. NOTE: ST monitoring is available for adult and pediatric patient and it is not recommended for neonates.

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OPERATION MANUAL NOTE: If there are not at least 5 normal complexes in the last 50 beats of ECG signal, the ST value will not be displayed. ST monitoring function is OFF as a default. You can switch it ON, when this monitoring is necessary. When ST monitoring is enabled, current ST values are trended and can be reviewed on the TREND window. NOTE: Measurement unit of ST segment is mV.

Figure 13-2 ST value in ECG parameters area Measurement range of ST segment is between -2.0mV to +2.0mV. Measurement symbol of ST segment + means elevating and -means depressing.

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OPERATION MANUAL

13.2 ST ANALYSIS WINDOW

Pick "ST ANALYSIS in the ECG WINDOW to call up the following menu:

Figure 13-3 ST ANALYSIS WINDOW ST ANALYSIS Pick this item to enable or disable ST monitoring. The default is OFF. When the ST monitoring is disabled ST OFF is displayed in ECG parameter area. ST ALARM Pick "ON" to enable alarm functions such as parameters blinking, audio alarm and light Indicator.Pick "OFF" to disable the alarm functions and there will be a " " symbol instead of alarm limits in Parameters Area. ALARM LEVEL Selectable between 1,2. Level 1 represents the most serious case. ST LIMIT ST alarm is activated when the ST segment value exceeds adjusted ALARM HIGH value or falls below adjusted ALARM LOW value. (Range: -2 ~ +2 step 0.1) Default for upper limit is +0.2 and for lower limit is -0.2. EVENT DURATION Pick this item to determine the time that a potential ST alarm condition must persist on ECG waveform before the monitor classifies it as a valid alarm condition. Available options for EVENT DURATION are OFF, 15s, 30s, 45s and 60s.The default is OFF and alarm will be activated immediately if alarm condition happens.

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OPERATION MANUAL ST REALERN Pick to start a learning procedure. The RELEARN message is displayed in the ECG waveform area of the screen. It takes usually about 20 seconds During relearn procedure the following action will be done: - Blanks average stored dominant QRS complex currently displayed on the DEFAULT POINT Window. - Learns and identifies the new dominant QRS complex template. - New complex is displayed on DEFAULT POINT Window. NOTE: You can do relearn procedure by selecting <ARR RELEARN> in ECG/ARR ANALYSIS window. NOTE: The monitor automatically begins to learn a reference template whenever you execute any of the following tasks (If ST ANALYSIS is ON and there is no technical ECG alarm active, like CHECK LEAD): - Turning on the monitor - Connecting ECG cable. - Changing an ECG lead configuration. - Choosing NEW in HOME / PATIENT INFORMATION NOTE: A yellow vertical marker with LRN label On ST in TREND window shows the time in which the learning procedure has been done. DEFAULT POINT Pick "DEFAULT POINT" in the ST ANALYSIS WINDOW to adjust the position of both ISO and ST measurement points. When you change the ST and ISO measuring point on the DEFAULT POINT Window, the monitor recomputes the ST deviation value accordingly.

Figure 13-4 ECG/ST ANALYSIS/DEFAULT WINDOW

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OPERATION MANUAL As shown above, the DEFAULT WINDOW shows the dominant QRS complex template. Two vertical lines indicate the positions of the ISO and ST points. ISO: It is the base point, used to indicate the baseline point of the ST analysis. The default is 80ms. ST: It is the ST measurement point. The default is 110ms. (Selectable between 5 to 400 ms by step of 5ms) The reference point is the position where the peak of R-wave locates. NOTE: It is good clinical practice to check the position of ISO and ST measuring points before starting ST monitoring and finishing learning procedure. NOTE: In practice, the accurate determination of ISO and ST measuring points requires careful clinical evaluation. NOTE: The ST measurement point should be adjusted if patients HR or ECG morphology changes significantly. If the template is not established, a horizontal line will display. And if the ST ANALYSIS is OFF, the message ST ANALYSIS KEY IS OFF appears in this window. You may select ISO or ST, and then switch the knob left or right to move the cursor line. When the cursor is at the required position, you may select the base point or the measurement point. NOTE: Abnormal QRS complex is not considered in ST segment analysis. NOTE: If pace is on (for patient with pacemaker) or while learning procedure, there is no waveform in DEFAULT POINT Window and you can see just ISO and ST line, In this condition, ST value will not be measured. NOTE: A red vertical marker with CHG label On ST in TREND window shows the time in which the measuring point has been changed.

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13.3 ST Alarm Messages

Alarm limit is activated as a follow: Alarm Situation ST segment value violates ST Alarm adjusted alarm limits ST messages on patient monitor include:
Message ST OUT OF RANGE HIGH Cause The ST algorithm has calculated value +1mV outside the high end of the ST measurement range.

Visual prompt ST value blinks. Alarm indicator flashes.

Audio sound Activated

Solution
Check the isoelectric and ST measuring points. Observe the patient and treat if clinically indicated.

ST OUT OF RANGE LOW

The ST algorithm has calculated value -1mV outside the low end of the ST measurement range.

Check the isoelectric and ST measuring points. Observe the patient and treat if clinically indicated.

All alarm level for these messages is set in ST WINDOW. Pressing alarm silence, alarm is suspended for at least 120S.

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CHAPTER 14 Arrhythmia Monitoring

14.1 GENERAL
Arrhythmia means any disturbance or irregularity of cardiac rhythm. Stability of the cardiac rhythm is essential for sufficient pumping function of the heart and adequate cardiac output. Maintaining adequate cardiac output is vital for organ perfusion and survival. Arrhythmia can cause a decrease in cardiac output. Therefore fast and accurate detection of arrhythmia is critical. The medical professionals can use the arrhythmia analysis to evaluate patients condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and give proper treatment. NOTE: If arrhythmia monitoring is ON, the heart rate is calculated by the arrhythmia software. NOTE: This monitor can detect up to 12 types of arrhythmia. NOTE: Arrhythmia monitoring is available for adult and pediatric patient and it is not recommended for neonates. Warning The ARR monitor can only be operated by personnel who have passed professional training and are familiar with this manual. Warning The ARR monitor is intended for use only as an adjunct in patient assessment .It must be used in conjunction with clinical signs and symptoms. NOTE: It is recommended to use ECG lead I or II to have the best accuracy of ARR software.

Arrhythmia detection algorithm principle

The arrhythmia algorithm is based on template matching. (A template is a group of beats matching the same morphology.)The algorithm detects QRS complexes, generates QRS templates and performs beat labelling. This algorithm is divided into three parts: detector, classifier and labelling. The detector algorithm detects waves in ECG signal that could be QRS complexes. The classifier algorithm forms templates of similar QRS complexes. During the learning phase an initial set of QRS template is built. Then the monitor creates a reference template based on its identification of the patients dominant QRS pattern. When a new true QRS complex is detected, it is compared with the existing templates. If no match is found, a new QRS template is added to the template set. The labelling algorithm analyses all templates. Each template and the beats belonging to it are labelled with one of the following names: normal beats, ventricular beats and questionable beats. Through this process, the monitor can verify an arrhythmia events occurrence. Parallel to this process there is an algorithm for detection of ventricular fibrillation. Detection of ventricular fibrillation is based on waveform analysis.
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Beat and rhythm classification

Beat classification refers to the analysis of individual beats. If the new beats features do not match those of the normal template, the new beat is classified as premature or questionable. The monitor uses all detected beats to calculate the heart rate, eliminating questionable beats from arrhythmia classification. Rhythm classification refers to analysis of sequences of beats. The monitor compares the sequence of the last twelve beats with the sequences stored in the monitors memory. If it detects two or more events simultaneously, the monitor alarms in order of event priority. The following table describes available beat classifications: Arrhythmia ECG ASYSTOLE Event and Beat Classification 5 seconds pass without the detection of valid QRS complex. Ventricular Fibrillation: The monitor identifies a sinusoidal waveform with fibrillation characteristics. (Certain ventricular tachycardias have sinusoidal waveforms closely resembling those of ventricular fibrillation. Because of the similarity of these waveforms, the monitor may classify such types of ventricular tachycardia as ventricular fibrillation.) Ventricular Tachycardia: N or more PVCs are detected in a time interval T= (60*(N-1))/R, where N is defined as the VTAC count and R is defined as the VTAC rate. Ventricular Run: Series of 3 to N-1 consecutive PVCs with a beat to beat rate the VTAC rate. Accelerated Idioventricular Rhythm: Series of 3 or more PVCs with a beat to beat rate less than the VTAC rate. Ventricular Bigeminy: Sequence of beats with the pattern : normal, PVC, normal, PVC, normal, PVC Ventricular Trigeminy: Sequence of beats with the pattern : normal, normal, PVC, normal, normal, PVC Ventricular Couplet: Sequence of beats with the pattern : normal, PVC, PVC, normal, PVC, PVC Sinus Tachycardia: HR TACHY rate setting. A PVC or other abnormal beat breaks the analysis sequence and restarts analysis. Sinus Bradycardia: HR BRADY rate setting. A PVC or other abnormal beat breaks the analysis sequence and restarts analysis. Actual R-R interval more than 2.1 times of the average R-R interval. More than N (event count set in the ARR SETUP WINDOW) PVC per minute.

VFIB ARRHYTHMIA

VTAC ARRHYTHMIA RUN ARRHYTHMIA AIVR ARRHYTHMIA BIGEMINY ARRHYTHMIA TRIGEMINYARRHYTHMIA COUPLET ARRHYTHMIA TACHY ARRHYTHMIA BRADY ARRHYTHMIA PAUS ARRHYTHMIA FREQUENT PVCs

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OPERATION MANUAL Premature Ventricular Contraction (PVC) is ectopic impulse originating from ventricles, before the normal electrical activation sequence of the heart has occurred. The PVC value is shown in ECG parameter window and updated every 5 seconds. When ARR analysis is enabled, current PVC values are trended every 20 second and can be reviewed on the TREND window.

Figure 14-1 PVC value in ECG parameters area NOTE: When PACE is turned ON, for patient with pacemaker, the system will not detect the arrhythmia relating to premature ventricular beats. (Including PVCs counting)

14.2 ARR ANALYSIS WINDOW

Pick "ARR ANALYSISin the ECG WINDOW to call up the following menu:

Figure 14-2 ECG/ARR ANALYSIS WINDOW ARR MONITOR Pick this item to enable or disable arrhythmia monitoring. The default is OFF. When the Arrhythmia monitoring is disabled PVCs OFF is displayed in ECG parameters area.

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OPERATION MANUAL ARR SETUP Pick ARR SETUP in ARR ANALYSIS Window to call up the following menu:

Figure 14-3 ECG/ARR ANALYSIS /ARR SETUP WINDOW The ARR SETUP table allows you to configure arrhythmia monitoring accordingly to your patients needs. All detectable arrhythmia events listed in the first column of the table .Using the remaining columns, you can modify the attributes of each event. Fields that are not applicable for certain event category are shown with dash symbol, while those that cannot be modified are ghosted. Modifying arrhythmia settings: 1. Scroll the cursor frame to parameters whose arrhythmia functions you wish to configure and click. 2. Scroll to the function you wish to modify. (The first column, ALARM LEVEL , is highlighted when you first click on a parameter.) 3. Click to access settings of the selected arrhythmia function. 4. Dial through settings and click to confirm your selection. 5. Repeat step 1-4 to configure additional arrhythmia functions or parameters. ALARM LEVEL Available options are 1,2 and OFF to set the grade of alarm for every arrhythmia event. (For more detail about alarm levels refer to chapter 3.) Pick "OFF" to disable the alarm functions of selected arrhythmia. ALARM LEVEL for ASYSTOLE cannot be modified and always is in level 1.

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OPERATION MANUAL RATE With count, you can determine the point at which an event call is triggered. You cant modify the rate for ASYSTOLE, VFIB, COUPLET, BIGEMINY, TRIGEMINY, PAUS and FREQUENT PVCs . RUN and AIVR derive their settings from VTAC and cannot be modified .They are included to quantify their derivation, based on current VTAC values. VTAC: Selectable between 100 and 200 by step of 10. RUN: Same as VTAC rate AIVR: VTAC rate-1 TACHY: Selectable between 100 and 200 by step of 10. BRADY: Selectable between 30 and 105 by step of 5. COUNT With rate, you can determine the point at which an event call is triggered. You cant modify the count for ASYSTOLE, VFIB, COUPLET, BIGEMINY, TRIGEMINY,TACHY,BRADY and PAUS. VTAC: Selectable between 5 and 12 by step of 1. RUN: Selectable between 3 and VTACcount -1 by step of 1. AIVR: Count3 FREQUENT PVCs: Selectable between 1 and 15 by step of 1. ARCHIVE You can determine whether the selected event is stored, recorded automatically or both. You can view stored events on ARR EVENT RECALL Window. STR: Stores selected arrhythmia event. REC: Automatically generates a recording of selected event. STR/REC: Event stored and recorded.(even when event alarm is turned off) OFF: No action if arrhythmia event activates. ALL ALARM LEVEL Press to set the level of all arrhythmia alarms to the same value. ALL ARCHIVE Press to set all arrhythmia ARCHIVE condition to the same state.

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OPERATION MANUAL ARR EVENT RECALL Pick " ARR EVENT RECALL in ARR ANALYSIS WINDOW to call up the following menu:

Figure 14-4 ECG/ARR ANALYSIS /ARR EVENT RECALL You can review any stored arrhythmia event (maximum 80 events) in this menu. To review different event pages: Maximum of 8 arrhythmia events can be displayed in the window simultaneously. When there is more than 8 events, different pages are available. Pick the most left item to review different pages. To select an arrhythmia event: Pick the second left item to select an arrhythmia event displayed in the window. To delete an arrhythmia event: Pick the forth left item to choose an arrhythmia event for removing from list. When you use this item the selected event will be highlighted, and removed if you exit the window. NOTE: To ignore deleting a selected item, click on the DEL/UNDEL key one more time before exiting from this window.

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OPERATION MANUAL To see detail information of arrhythmia event: Pick the third left item to call up the following window:

Figure 14-5 ECG/ARR ANALYSIS /ARR EVENT RECALL/WAVE WINDOW In this window, waveform and time of selected arrhythmia event are displayed as well as the parameter values at the event time. UP-DOWN This option allows you to page up and down to review the waveform and the parameters of other arrhythmia events.

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OPERATION MANUAL ARR RELEARN Pick to start a learning procedure. The RELEARN message is displayed in the ECG waveform area of the screen. NOTE: You can do relearn procedure by selecting <ST RELEARN> in ECG/ST ANALYSIS window. NOTE: In most situations the learning phase takes about 20 second. NOTE: If the monitor couldnt find 6 matching beats after 20 seconds, the relearn procedure is continuing and the RELEARN message is remaining on display, till acceptable condition is happened. NOTE: While the monitor is in learning phase, all arrhythmia alarms and trend collection are suspended. NOTE: Before starting learning procedure, verify the quality of the ECG signal and ensure that the patients ECG displays a normal reference pattern. NOTE: The monitor automatically begins to learn a reference template whenever you execute any of the following tasks (If ARR ANALYSIS is ON and there is no technical ECG alarm active, like CHECK LEAD): - Turning on the monitor - Connecting ECG cable. - Changing an ECG lead configuration. - Choosing NEW in HOME / PATIENT INFORMATION NOTE: It is recommended to perform relearn procedure under the following conditions: - A lead is reconnected or electrodes are repositioned. - Eight hours have passed since last reference complex learned. - Other significant changes appear on the morphology of the patients ECG.

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Chapter 15 RECORDING
15.1 General
The bedside monitor has an option of thermal dot matrix recorder. Depending on customer's order, GSI or SAADAT modules can be installed on vital sign monitor optionally. Performance of the Recorder Recorder sweep is selectable between 12.5, 25 and 50 mm/s. Up to 2 selectable waveforms recording. The real time and freeze recording. The selectable automatic time interval recording. The selectable automatic alarm recording.

15.2 Recording type

Monitor provides several recording types: Continuous real-time recording 10, 20 and 30 seconds real-time recording. 10 seconds automatic recording. Parameters alarm recording. Arrhythmia alarm recording. Frozen waveform recording. TREND recording. NIBP LIST recording. ARR EVENT LIST recording. ARR WAVE recording. Manual recording Continuous real-time recording starts from last 5 seconds when you press the Rec/Stop key and stops when you press it again. 10, 20 and 30 s Recording Real time recording starts from last 5 seconds when you press Rec/Stop and it will automatically stop after 10, 20 or 30 seconds depending on your setting. Automatic Recording The monitor starts the recording for 10 seconds according to interval time set in the "PERIODIC INTERVAL" of the "RECORDER WINDOW" menu. Refer to 2.6 Recorder for details. Alarm Recording If ALARM REC is set ON in each parameters window, the system automatically starts recording when an alarm occurs. Alarm recording is activated when the numeric parameters violate adjusted alarm limits or when an arrhythmia event occurs. When an alarm of parameters has occurred only numeric parameters will be recorded and parameters value that triggered the alarm record, marked with an arrow. During HR alarm recording, the monitor also records 20 seconds ECG waveform. You can ON or OFF alarm recording in HOME /RECORDERWINDOW and also it can be set in each parameters menu.( When the system has internal recorder option and it is enabled) Freeze Waveform Recording The monitor prints out 20 seconds of the selected waveforms and numeric parameters in
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OPERATION MANUAL FROZEN mode. So you can freeze the abnormal waveforms on the screen and record it. TREND Recording The monitor can print out the trend graph and numeric parameters in the current TREND WINDOW. Pick "RECORD" in TREND WINDOW to start recording. NIBP LIST Recording The monitor can print out entire of the list in NIBP LIST WINDOW. Pick "RECORD" in NIBP LIST WINDOW to start recording. ARR EVENT LIST Recording The monitor can print out entire of the list in ARR EVENT LIST WINDOW. Pick "RECORD" in ARR EVENT LIST WINDOW to start recording. ARR WAVEFORM Recording The monitor can print out stored arrhythmia waveforms in ARR EVENT RECALL/WAVE WINDOW. Pick "RECORD" in this window to start recording.

15.3 Recorder operations and status messages

Notes on Recording Recording Type: MANUAL RECORD PERIODIC RECORD ALARM RECORD (name of the alarm parameter) FREEZE RECORD (Parameter) TREND RECORD NIBP LIST RECORD ARR EVENT LIST RECORD ARR WAVEFORM RECORD Recording Date and Time Bed number Patient name, Patient ID, Gender, Height, Weight, Date of birth Parameter name and value Sweep Speed ECG lead and gain or RESP lead on the waveform Hospital and ward name Dr Name

15.4 Recorder paper

You should use 50mm paper for GSI recorder and 58mm paper for SAADAT recorder. NOTE: Use only manufacturer recommended white thermosensitive record paper, otherwise the recording quality may be poor and the thermosensitive printhead may be damaged. NOTE: Do not use grid paper. NOTE: Do not use paper with edges that are pasted or have turnups at the start of the roll. If they need to be used unavoidably, replace with new paper roll as soon as possible
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OPERATION MANUAL before entire roll is used up. Warning Do not touch the recorder head while recording and immediately after recording because it is so hot and may lead to personal injury including burns. Warning While the recorder is working, the record paper goes out steadily. By pulling the paper, the recorder will be damaged. Loading the paper: Pull down the switch on the recorder case. Insert a new roll of paper into the paper cassette. Printing side of the paper should face the thermo sensitive printhead. Close the recorder door. NOTE: Thermo sensitive surface of paper should be placed facing the head. Be sure to place the paper correctly.

a. incorrect placement b. correct placement Figure 15-1 recorder paper placement NOTE: The paper detector may not operate properly if covered with foreign matter. Therefore, if you find foreign matter on the sensor, remove it and clean the sensor. NOTE: If the paper is jammed, open the recorder door and remove the paper. Do not pull the paper by force. NOTE: Be careful when inserting paper. Avoid damaging the thermosensitive printhead. Do not touch thermosensitive print head. NOTE: It is recommended to use the paper with coloured marks intended to aware that the paper is near to finish. Otherwise, the operator should be sure about sufficient paper for recording.

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15.5 Recorder status messages

Message
Rec. Software Error Recorder Fault Door Open Out of Paper Print head High Temp Print head High Vol. Print head Low Vol. Time out Error

Cause
Software error Hardware error The recorder door is open Record paper finished. The thermal head is too hot. Print head voltage is high. Print head voltage is low. The recorder could not record.

Solution
Turning the system off and then on if problem exist again contact to customer service of manufacturer. Turning the system off and then on if problem exist again contact to customer service of manufacturer. Close the recorder door. Insert recorder paper. Stop operation for some minutes. Turning the system off and then on if problem exist again contact to customer service of manufacturer. Turning the system off and then on if problem exist again contact to customer service of manufacturer. Turning the system off and then on if problem exist again contact to customer service of manufacturer.

15.6 Recorder cleaning

When foreign matter adheres between the thermal head and platen roller, it may cause print failure. If accumulation of paper powder or foreign matter is seen, or print quality seems to have deteriorated, clean the thermal head and platen roller. Clean the head elements and platen roller surface using alcohol and a cotton swab. Wait until the alcohol dries then close the recorder door. Warning Do not clean the printer immediately after printing because thermal head and its periphery are hot during and after printing. NOTE: Do not use sandpaper, cutter knifes etc. when cleaning. They will damage the heat element.

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CHAPTER 16 PATIENT SAFETY

The Patient Monitor is designed to comply with the international safety standard requirements for medical electrical equipment. This device has floating inputs and is protected against the effects of defibrillation and ESU. If the correct electrodes are used and applied in accordance with the manufacturer instructions, the screen display will recover within 10 seconds after defibrillation.

This symbol indicates that the monitor is CF type and Defibrillation proof applied part according to IEC-601-1. The module with this symbol contains an F- Type isolated (floating) patient applied part providing a high degree of protection against shock, and is usable during defibrillation.

This symbol indicates that the monitor is BF type and Defibrillation proof applied part according to IEC-601-1. The module with this symbol contains an F- Type isolated (floating) patient applied part which contains an adequate degree of protection against shock, and is usable during defibrillation Note: Type BF applied parts are not suitable for direct cardiac application. Warning Do not touch the patient, bed or instrument during defibrillation. Follow the instructions below to ensure a completely safe electrical installation. The environment where the Patient Care Monitor will be used should be reasonably free from vibration, dust, corrosive or explosive gases, extremes of temperature, humidity and so on. The Patient Monitor operates within specifications at ambient temperatures between 0C and 40C. Ambient temperatures that exceed these limits could affect the accuracy of the monitor and cause damage to the modules and circuits. Grounding the patient monitor To protect the patient and hospital personnel, the case of patient monitor must be grounded. The patient monitor is equipped with a detachable 3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-wire receptacle .If a 3wire receptacle is not available, consult the hospital electricians. If there is any doubt regarding the completeness of the protective grounding wire, the equipment must be operated with internal battery or DC input.

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OPERATION MANUAL Equipotential Grounding Protection class I instruments are already included in the protective grounding (protective earth) system of the room by way of grounding contacts in the power plug. For internal examinations on the heart or the brain, the Patient Care Monitor must have a separate connection to the equipotential grounding system. One end of the equipotential grounding cable (potential equalization conductor) is connected to the equipotential grounding terminal on the rear panel of the monitor and the other end to one point of the equipotential grounding system. The equipotential grounding system is for the safety function of the protective grounding conductor if ever there is a break in the protective grounding system. Examinations in or on the heart (or brain) should only be carried out in medically used rooms incorporating an equipotential grounding system. Check each time before use that the instrument is in perfect working order. Warning Possible explosion hazard if used in the presence of flammable anesthetics. Explanation of Symbols in the Monitor

This symbol means "BE CAREFUL". Refer to the manual

Equipotential grounding system.

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CHAPTER 17 CARE AND CLEANING

17.1 System Check
Before using the monitor, do the following: Check if there is any mechanical damage on the system and accessories. Check if all the power cable and accessories are firmly connected. Check if all the functions of keyboard and modules to make sure that the monitor is in proper condition. If you find any damage on the monitor, stop using the monitor on patient, and contact the biomedical engineer of the hospital or local After Sale Service. The overall check of the monitor, including the safety check, should be performed only by qualified personnel. All the checks that need to open the monitor and the safety check and maintenance should be performed by Customer Service. Note: It is recommended to calibrate the system by manufacturer every 2 years. The IBP and capnography modules should be calibrated every 6 month. Warning If users do not follow a satisfactory maintenance schedule, the monitor may become invalid, and human health may be endangered. Note: To ensure maximum battery life, it is recommended that, at least once a month, the monitor be run on battery until it turns itself off and then recharged. (For details about battery care see 1.5)

17.2 Cleaning
Warning Before cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line. The Patient Monitor must be kept dust-free. Regular cleaning of the monitor shell and the screen is strongly recommended. Use detergents such as soap and water to clean the monitor shell. Note Please pay special attention to the following items: 1. Most cleaning agents must be diluted before use. Follow the manufacturer's direction carefully to avoid damaging the monitor. 2. Don't use rough material, such as steel wool etc. 3. Don't let the cleaning agent enter into the chassis of the system. 4. Don't leave the cleaning agents on any part of the equipment.
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OPERATION MANUAL The monitor and sensor surface can be cleaned with hospital-grade ethanol and dried in air or with a clean cloth.

17.3 Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Recommended sterilization material: Activated dialdehyde (Cidex) Caution Do not let liquid enter the monitor. No part of the monitor can be subjected to immersion in liquid. Do not pour liquid onto the monitor during sterilization. Use a moistened cloth to wipe up any agent remaining on the monitor.

17.4 Disinfection
Examples of disinfectants that can be used for the case of monitor are listed below: Hydrogen Peroxide 3% Alcohol 70% Isopropanol Enpropanol To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Caution Do not use EtO gas to disinfect the monitor. NOTE: Manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents. Please contact infectious disease experts in your hospital for details. NOTE: Do cleaning, sterilization and disinfection of slave monitor same as the bed side monitor. Appropriate cleaning, sterilization and disinfection materials for accessories are introduced in each module's chapters.

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CHAPTER 18 GETTING STARTED

18.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully. Keep the package for possible future transportation or storage. Check for any mechanical damage. Check for the existence of the power cable and accessories. If there is any problem, contact the distributor immediately.

18.2 Place the battery fuse

When you use the system for the fist time, you should place the fuse on the rear panel.

18.3 Connect the Power Cables

Connection procedure of the AC power line: Make sure the AC power supply complies with following specification: 200-240 VAC, 50 /60Hz Apply the power cable provided with the monitor. Plug the power cable to power supply socket of the monitor. Connect the other end of the power cable to a grounded 3-wire power receptacle. NOTE: Make sure that the battery indicator lights. If it does not light, check your local power supply and power cable connection. If the problem still exists, contact the local After Sale Service. NOTE: The battery needs to be charged after transportation or storage. If the power supply is not properly connected before turning on the monitor, it may not work properly because of insufficient power. Connect the power supply to charge the battery for about 24 hours.

18.4 Power on the Monitor

Press POWER to power on the monitor. At the same time a beep will be heard and yellow and red indicator light about 2.5 seconds separately. After 30 seconds or so, the system will display the monitoring screen after self-test, and you can perform normal monitoring now. NOTE: Check all the functions of modules that may be used and make sure that the monitor is in good connection.
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OPERATION MANUAL NOTE: The battery must be recharged after each use to ensure adequate electricity reserve. To do so, you only connect the system to AC INPUT. Warning If any sign of damage is detected, or the monitor displays any error messages, do not use it on any patient. Contact biomedical engineer in the hospital or local After Sale Service immediately.

18.5 Connect Patient Sensors

Connect all the necessary accessories between the monitor and the patient. NOTE: For information on correct connection, refer to each module's chapters

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CHAPTER 19 TECHNICAL SPECIFICATIONS

CLASSIFICATION
Protection against electroshock Mode of operation Harmful Liquid Proof Degree Method of sterilization and disinfection Safety of anesthetic mixture Class I, Type CF for all modules (except Multi-gas module that is BF) (based on IEC 60601-1) Continues operation equipment Ordinary equipment, (without Liquid Proof) Refer to each module's chapters and chapter 17 for detail. Not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.

DISPLAY
Displaying Waveforms Numeric Parameters COLOR TFT 1280 1024, 17 ECG, PLETH, IBP, RESP/GAS,EEG (All Freezable) HR,PVCs,ST,SPO2, NIBP (SYS, DIA, MAP), IBP1(SYS,DIA,MAP), IBP2(SYS,DIA,MAP), RR, T1, T2, DT, EtCo2, FiCo2, AWRR, EtN2O, FiN2O, EtO2, FiO2, EtAA, FiAA, CSI%, BS%, EMG%, SQI%, Alarm limits Keys and rotary knob

Operation Method

ECG
Leads Dynamic Range Leakage Current Lead Off Current Gain Calibration Filters CMRR Internal Noise Input Impedance QRS Detection Heart Rate Range Accuracy Tall T-Wave Pacer Detection/Rejection Selectable 3 or 5 Wires For 3 wire: I, II, III For 5 wire :I,II,III,V,aVR,aVF,aVL 5 mV < 10 A < 90 nA 4, 2, 1, 1/2, 1/4, Auto 1mV, 0.5 sec MONITOR (0.5 - 24 Hz) NORMAL (0.5 - 40 Hz) EXTENDED (0.05-100 Hz) > 98 dB < 30 V RTI > 5 Mohm Duration : 40 to 120 msec Amplitude : 0.5 to 5 mV for Adult 0.2 to 5 mV for Neonate 15 - 300 bpm for adult 15 - 350 bpm for neonate 1% or 2 bpm Reject up to 1.2 mV Amp. Duration : 0.1 - 2 msec Amp: 2 to 700 mV (Without over/undershoot) Reject From Heart Rate Counter Re-insert into ECG to display on screen 1 V/S Defibrillator and Electrosurgery ANSI/AAMI EC-13

Minimum Slew Rate Protection Standards

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ARRHYTHMIA ANALYSIS
Type Learning Method Memory ASYS, VFIB, VTAC, RUN, AIVR, COUPLET, BIGEMINY, TRIGEMINY, TACHY, BRADY, PAUS, FREQUENT PVCs Rapid Learning: only 20 Seconds Required for Recognition of Dominant Rhythm. Real Time Arrhythmia Detection with Innovative Feature. Capability of storing the latest 80 ARR event. (waveform and Parameters)

ST ANALYSIS
Display resolution: Measurement Range Alarm Range: Features: Update period: 0.01 mV -2mv to +2mv -2mv to +2mv User Adjustable Isoelectric and ST Point Trending of ST Values 5 Sec.

NIBP
Measurement method Measurement mode Measurement time Measurement Range Oscillometric Manual/Automatic(intervals between 5min-24hour) /Stat 18-26 sec (excluding cuff pressurization time) Adult: SYS 25 ~ 250 mmHg DIA 10 ~ 220 mmHg MAP 15 ~ 250 mmHg Neonate: SYS 25 ~ 135 mmHg DIA 10 ~ 110 mmHg MAP 15 ~ 125 mmHg 3 mmHg full range Adult 150 mmHg, Neonate 70 mmHg Meet ANSI/AAMI SP-10/1992 Up to 100 Records

Pressure Transducer accuracy Initial Inflation Target Overall System Efficacy Memory

SPO2 (Pulse Oximetry)

Method Range Accuracy Pulse Rate Range
Masimo Option

2 Wave Length Pulse Wave Type 50 to 100 % 2% (SPO2 71 ~ 100%) 3% (SPO2 50 ~ 70%) 25 - 250 BPM
Yes

TEMPERATURE
Probe Type Range Accuracy YSI-700/ YSI 400 Compatible 0 - 50 C 0.2 C

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RESPIRATION
Method Base Resistance Dynamic Range Breath Rate Range
Accuracy

Impedance 250 -1250 Ohm 0.2 - 2 Ohm 6 - 150 BrPM

2% or 2 BrPM

IBP (Optional)
Channel Measurement Range Pressure Filter Press Sensor Sensitivity Press Sensor Impedance Resolution Accuracy 2 Channels SYS -50 ~ 300 mmHg DIA -50 ~ 300 mmHg MAP -50 ~ 300 mmHg 8Hz, 16Hz,22Hz selectable 5 V / V / mmHg 300 ~ 2500 Ohm 1 mmHg 1 % or 1mmHg (each one is greater)Without Transducer

Multi-gas (Mainstream)
Power supply 4.5-5.5 VDC, max 1.4W Method Infrared absorption Measuring mode Mainstream IRMA Harmful Liquid Proof Degree IPX1 Et and Fi Parameters Fi and ET are displayed after one breath and have a continually updated breath average. IRMA CO2 :CO2, CO2 waveform IRMA ICU:CO2,O2, 2 selectable waveform IRMA OR:CO2,O2,N2O, Anaesthesia Agent(HAL,ISO,ENF,SEV,DES) 5 selectable waveform, MAC IRMA OR+: CO2,O2,N2O, Anaesthesia Agent(HAL,ISO,ENF,SEV,DES) 5 selectable waveform, Automatic identification, MAC Sensor head 3-10 channel NDIR type gas analyzer measuring at 4-10m. pressure, temperature and full spectral interference correction. Sensor Dimension (WDH) 372725mm Sensor weight <30g(cable exclude) Oxygen sensor integrated ultra-fast response time galvanic oxygen sensor. >62500 oxygen hours Calibration No routine calibration required Room air calibration of O2 sensor performed automatically when changing airway adapter (<5sec) Warm-up time concentrations reported in less than 10s, full accuracy with in 1 minute Surface temperature max 55C / 133F Rise time (@10 l/min) CO2 90ms O2300ms N2O300ms HAL,ISO,SEV,ENF,DES300ms Delay time 140ms Primary agent threshold 0.2% V/V Secondary agent threshold 0.2% +10% of total agent concentration Agent identification time <20 seconds Total system response time < 1 second AWRR measuring range 3~100BrPM

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Accuracy specifications-during standard conditions: Gas measuring range accuracy CO2 0~10% (0.2% ABS+2% REL) 10~20% Unspecified N2O 0-100% (0.2% ABS+2% REL) HAL,ISO,ENF 0-5% (0.15%ABS+5%REL) 5-12% Unspecified SEV 0-8% (0.15%ABS+5%REL) 8-15% Unspecified DES 0-18% (0.15%ABS+7%REL) 18-22% Unspecified O2 0-10% Unspecified 10-100% (1% ABS+2%REL) Accuracy specification-during all condition CO2 (0.3% ABS or 4% REL) N2O (2% ABS or 5%REL) Single agent (0.2% ABS or 10%REL) Dual agent (0.2% ABS or 10% of total agent concentration) O2 (2% ABS+2%REL) Note1 : The accuracy specification is valid for all specified environment conditions, and includes effects from the following interfering gases : N2O, O2, HAL, ISO, ENF, SEV, DES, Ethanol, Isopropyl alcohol, Acetone, Methane, He. See Appendix IV for effects from water vapour partial pressure on gas reading. Note2: The accuracy specification is not valid if more than one gas for IRMA OR and more than two gas for IRMA OR+/AX+ are in the gas mixture.

Multi-gas (Sidestream)
Power supply 4.5-5.5 VDC ISA CO2: <1.4 W (normal op.), <1.8 W (peak @ 5 VDC) ISA AX+: <1.6 W (normal op.), <2.0 W (peak @ 5 VDC) ISA OR+: <2.0 W (normal op.), <2.4 W (peak @ 5 VDC) Infrared absorption Sidestream Fi and ET are displayed after one breath and have a continually updated breath average. ISA CO2 :CO2, CO2 waveform ISA OR+/AX+:CO2,O2, N2O, primary and secondary Agent(HAL,ISO,ENF,SEV,DES) ISA OR+/AX+: primary and secondary agent. 2-9 channel NDIR type gas analyzer measuring at 4-10m. ISA CO2/AX+: 784933mm ISA OR+: 478899mm ISA CO2/AX+: 130g (including cable) ISA OR+: 400g (including cable) No span calibration is required for the IR bench. An automatic zero reference calibration is performed at startup and then every 24 hours. ISA CO2: Automatic compensation for pressure and Temperature. Manual compensation for broadening effects on CO2. ISA CO2/AX+: Automatic compensation for pressure, temperature and broadening effects on CO2. ISA CO2: <10 seconds (concentrations reported and full accuracy) 19-4

Method Measuring mode Et and Fi Parameters

Automatic agent identification Sensor head Sensor Dimension (WDH) Sensor weight Calibration Compensation

Warm-up time

OPERATION MANUAL
ISA OR+/AX+: <20 seconds (concentrations reported, automatic agent identification enabled and full accuracy) ISA CO2: 0 to 50C ISAOR+ /AX+: 5 to 50C -40 to 70C <4 kPa H2O (non-condensing) (95 %RH at 40C) 5 to 100 %RH (condensing) (100 %RH at 40C) 52.5 to 120 kPa (Corresponding to a max altitude of 4572 m/15000 feet) 20 to 120 kPa CO2 200 ms ( 250 ms for ISA OR+/AX+) N2O 350ms Agents 350ms 450ms O2 0.15 V%. When an agent is identified, concentrations will be reported even below 0.15 V% 0.2 V% +10% of total agent concentration <20 seconds (Typically <10 seconds) < 3 second (with 2m sampling line) 50 10 ml/min 0~150BrPM

Operating temperature

Storage temperature Operating humidity Storage humidity Operating atmospheric pressure Storage atmospheric Typical rise time at 50 l/min sample flow

Primary agent threshold (ISA OR+/AX+) Secondary agent threshold (ISA OR+/AX+) Agent identification time (ISA OR+/AX+) Total system response time Sampling flow rate Respiration rate

Accuracy specifications-during standard conditions: Gas measuring range accuracy CO2 0~15% (0.2 V% +2% of reading) 15~25% Unspecified N2O 0-100% (0.2 V% +2% of reading) HAL,ISO,ENF 0-8% (0.15 V%+5% of reading) 8-25% Unspecified SEV 0-10% (0.15 V% +5% of reading) 10-25% Unspecified DES 0-22% (0.15 V% +7% of reading) 22-25% Unspecified O2 0-100% (1 V% +2% of reading) Accuracy specification-during all condition CO2 (0.3 kPa + 4% of reading) N2O (2 kPa + 5% of reading) Agents (0.2 kPa + 10% of reading) O2 (2 kPa + 2% of reading) Note1: The accuracy specification is valid for all specified environment conditions. Note2: The accuracy specification is not valid if more than tow agents are present in the gas mixture. If more than tow agents are present, an alarm will be set.

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CSM (Optional)
EEG sensitivity Noise CMRR Input impedance Sample rate CSI and update EMG BS% Digital output Wireless range Display size Alarms Artifact rejection Sensor impedance range Battery 400V <2Vp-p <0.4V RMS, 1-250 Hz >140dB >50Mohm 2000 samples/sec(14 bits equivalent) 0-100. Filter 6-42Hz, 1sec. update 0-100 logarithmic. Filter 75-85 Hz,1 sec. update 0-100%. Filter 2-42 Hz, 1 sec. update Wireless to CSM card in monitor (ISM 2.4GHz) Up to 10 meters 1.3" x 0.7" High/low with user selectable limit Automatic 0-10kOhm I measurement current 0.01A Rechargeable NiMH or 9V Alkaline (6AM6/IEC: 6LR61/ANSI: 1604A) Supply current 30mA(typical) Max. battery lifetime-Alkaline 30h(stand alone) 18h(transmitting wireless) Battery recharge time 4 Hours (CSMX04 Only) Weight 4.6 ounces (130 g) with battery Dimensions 4.62.71.2 Classification Internal power supply Class II, type BF, continuous use Sensors Danmeter Neuro Sensors Cable length 77 with 14 split Mounting options Velcro strip l.7x0.9" Memory Data recording 18 hours CSM module Environment - Operation Temperature 10~40C Rel humidity 30~75% Air pressure 700~1060 hPa CSM module Environment-Transport and storage Temperature 10~40C * Rel. humidity 30~95% Air pressure 700~1060hPa *If transport without sensors:-20~70C

RECORDER (Optional)
Model Printing Speed Paper General Scanning / SAADAT Thermal Printer 12.5, 25, 50 mm/sec 50mm (for GSI) / 58mm (for SAADAT) by 100 foot roll

ALARM
Sources Alarm On/Off Alert Error messages, all other Parameter Limits Selectable for All Parameters Blinking on Display, Volume Selectable Audio Alarms, Light indicator

TREND
Sources HR, PVCs, ST, SPO2, NIBP, RR, T1, T2, IBP1(SYS,DIA,MAP), IBP2(SYS,DIA,MAP), EtCo2, FiCo2, AWRR, EtN20, FiN2O, EtO2, FiO2, EtAA, FiAA (ISO, DES, ENF, HAL, SEV) 15 and 30 min, 1, 2, 4, 8, 12, 24, 36, 48 , 60 and 72 20 sec

Trend Time Resolution

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INPUT/OUTPUT
Network
Connection Digital, Serial, RS422, Full Duplex 8/16 BED to One CENTRAL system

GENERAL
Safety Protection AC Power Internal Battery Dimension (cm) Weight Based on IEC 60601-1 Against Electro surgery and Defibrillator 90 - 260 VAC, 50/60 Hz Sealed Lead Acid, Rechargeable, 12 V, 3.3 AH Charge Time: 16 Hours Usage: More than 1 Hours (Full Charge) 42 (W) 36 (H) 17 (D) 8 Kg (approximately)

ENVIRONMENTAL
Temperature For gas module Humidity Altitude Operating: 5 to 40 C Storage: -20 to 60 C Operating: 10 to 35 C Storage: -20 to 50C) 20 to 90 % (Non condensing) -200 to 3000 m

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CHAPTER 20 ACCESSORIES and ORDERING

Information
This chapter lists the recommended accessories used for patient monitor. Warning The accessories listed below are specified to be used for bedside monitor. Manufacturer does not take responsibility for any possible hazard to the patient or monitor if other accessories are used

20.1 ECG Accessories

ECG PATIENT CABLE 3 LEAD ECG PATIENT CABLE 5 LEAD PART.#:10-003 PART.#:10-038

20.2 SPO2 Accessories

For SAADAT Module:
SPO2 Finger Probe Adult - FS01 SPO2 Extension Cable SPO2 Finger Rubber Probe -Adult - SR-3212-9 PART.#:12-018 PART.#:12-019 PART #:12-034

For MASIMO Module:

SPO2 Extension Cable-PC SERIES SPO2 Finger Probe Single use - neonate < 10Kg-LNOP Neo SPO2 Finger Probe - Adults & pediatrics > 30Kg - LNOP DCI SPO2 Finger Probe - Single use - Adults >30Kg - LNOP Adt SPO2 Finger Probe - Single use - pediatrics & slender adults >10Kg &<50Kg - NOP Pdt SPO2 Finger Probe - Single use - neonate <1Kg or with poor skin integrity -LNOP Neo Pt SPO2 Finger Probe - Pediatrics>10Kg &<50Kg - LNOP DCIP SPO2 Finger Probe - Adults & Pediatrics>30Kg, spot check application - LNOP DCSC SPO2 Ear Probe - LNOP EAR SPO2 Yi Probe - Adults & Pediatrics - LNOP YI SPO2 Finger Probe - Adults & Pediatrics>30Kg, spot check application -LNOP DCSC PART.#:18-008 PART.#:18-013 PART.#:18-009 PART.#:18-012 PART.#:18-011 PART.#:18-016 PART.#:18-017 PART.#:18-018 PART.#:18-025 PART.#:18-026 PART.#:18-027

20.3 NIBP Accessories

NIBP Cuff Adult thigh - 1836cm - MINDRAY NIBP Cuff Large Adult - 1533cm - MINDRAY NIBP Cuff Adult - 1223cm - MINDRAY NIBP Cuff Child - 918cm - MINDRAY NIBP Cuff Infant - 612cm - MINDRAY CUFF HOSE - MINDRAY NIBP Cuff Infant - 618cm CAS - CR5206 NIBP Cuff - Small Child - 721cm CAS - CR5207 NIBP Cuff - Child - 927cm CAS - CR5209 NIBP Cuff - Small Adult - 1230cm CAS - CR5212 NIBP Cuff Adult - 1437.5cm CAS -CR5214 NIBP Cuff - Large Adult - 1642cm CAS - CR5216 CUFF HOSE CAS PART.#:13-026 PART.#:13-027 PART.#:13-028 PART.#:13-029 PART.#:13-030 PART.#:13-031 PART.#:13-019 PART.#:13-020 PART.#:13-021 PART.#:13-022 PART.#:13-023 PART.#:13-024 PART.#:13-025

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20.4 TEMP Accessories

TEMP Probe Skin Adult - FMT400AS TEMP Probe Esophaguel / Rectal Adult - FMT PART.#:10-045 PART.#:10-046

20.5 IBP Accessories

IBP Transducer, MEDEX - .MX860/866 Novatrans IBP Disposable Dome MEDEX - MX860/866 Novatrans Dome IBP Extension Cable MEDEX - MX860/866 Novatrans Extension IBP Transducer MEDEX - MX960 Logical IBP Disposable Dome MEDEX - MX960 Logical Dome IBP Extension Cable MEDEX - MX960 Logical Extension IBP Transducer - Capto SP844 IBP Disposable Dome - Capto SP844 Dome IBP CAPTO Cover Holder - Capto SP844 Cover Holder IBP CAPTO Holder - Capto SP844 Holder PART.#:16-001 PART.#:16-031 PART.#:16-032 PART.#:16-002 PART.#:16-033 PART.#:16-034 PART.#:16-028 PART.#:16-029 PART.#:16-035 PART.#:16-030

20.6 GAS Accessories (Mainstream)

IRMA CO2 only probe IRMA ICU probe IRMA OR probe IRMA OR+ probe IRMA AX probe IRMA AX+ probe IRMA Disposable Airway Adapter without O2 port IRMA Disposable Airway Adapter with O2 port IRMA Disposable Airway Adapter for infant IRMA Adapter Cable IRMA O2 sensor PART. # 20-020 PART. # 20-021 PART. # 20-022 PART. # 20-023 PART. # 20-038 PART. # 20-039 PART. # 20-025 PART. # 20-026 PART. # 20-035 PART. # 20-027 PART. # 20-024

20.7 GAS Accessories (Sidestream)

ISA CO2 only probe . ISA AX+ probe ISA OR+ probe Nmoline with luer lock connector. 2 m. Box of 25 PART. # 20-046 PART. # 20-049 PART .# 20-052 PART. # 20-045

20.8 CSM Accessories

CSM2 Complete Module SET CSM rechargeable battery-CMX04 CSM power/charger-CSMX05 CSM patient cable-CSMX06 CSM carrying case-CSMX09 CSM procedure pack-CSMX005 CSM Neuro Sensors (25pc/bag) -DMX001 CSM clip for patient cable-CSMX007 CSM2 module-CSM004 PART. # 22-002 PART. # 22-003 PART. # 22-004 PART. # 22-005 PART. # 22-006 PART. # 22-009 PART. # 22-010 PART. # 22-011 PART. # 22-012

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CHAPTER 21 TROUBLE SHOOTING

Repairing the internal parts of the monitor must be only done by trained and authorized personnel of After Sale Service; otherwise manufacturer. will not take any responsibility for any possible hazard to the patient and the monitor. Troubleshooting guide is intended to help users to solve minor problems caused by incorrect use of the monitor or failure of accessories. When you face any problem, please be sure that you have followed all procedure mentioned in Correct Action column before you contact with After Sale Service.
Fault Symptoms
Not to be turned on Unable to work with Battery Battery is discharged Fuse of Battery is faulty Others ECG cable is not connected correctly Bad placement of leads and electrodes Others Loose connection of electrodes Earth connection failure Wrong ECG filter Others If "PACE ON"for patient without Pace marker , ECG noise will be received as PACE. Others ECG signal is noisy or isnt suitable Others Electrodes are not connected correctly Patient move during measurement Others Location of sensor isnt suitable Faulty sensor Others SPO2 probe in an unsuitable place. Faulty sensor Others Patient movement during measurement Probe is in an unsuitable place. Others Incorrect air hose connection. Air hose occluded or tangled. Air hose or cuff leakage Others No cuff or Air hose is connected Wrong cuff placement Patient movement during measurement Others No zeroing before use noisy source exists near by system or accessories faulty sensor Others

Possible Cause

Correct Action
Check POWER AC path Call for service Charge the battery for 10 hours Check fuse existence Call for service Connect ECG cable correctly Check leads and electrodes. Dont use old and faulty electrodes Call for service Check electrodes and leads Check earth Set filter mode correctly Call for service Turn Paced detect OFF in ECG menu Check leads and electrodes. Change lead to display the best ECG signal Call for service Check leads and electrodes. change RESP lead Calm patient Call for service Put the sensor in suitable place Change sensor Call for service Change the place of probe on patient Change probe Call for service Calm patient Change the place of probe Call for service Check connection Check Air hose Change faulty accessory Call for service Check cuff and air hose Change cuff placement Calm patient Call for service zeroing keep system and cable away from noise source change sensor Call for service

NO ECG waveform

Noisy ECG waveform

Spike on ECG waveform

Unstable HR No RESP signal No good waveform Unstable RR Strange T1,T2 No SPO2 waveform Noisy waveform Strange SPO2 value

NIBP can not inflate

NIBP measurement is not successful strange NIBP value.

Strange IBP value Noisy IBP signal

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APPENDIX I
, LIST OF MONITOR S PARAMETERS (SELECTIONS AND DEFAULTS)
Menu item ECG LEAD ECG GAIN ECG SWEEP ALARM LEVEL HR ALARM HR HIGH ALARM HR LOW ALARM ECG FILTER HR SOURCE BEAT VOLUME PACE DETECT ECG CALIB ECG AVERAGE LEAD TYPE RESP LEAD. RESP GAIN RESP SWEEP ALARM LEVEL RR ALARM RR HIGH ALARM RR LOW ALARM APNEA LIMIT SPO2 RESPONSE SPO2 PLETH SWEEP ALARM LEVEL SPO2 ALARM SPO2 HIGH ALARM SPO2 LOW ALARM SPO2 SENSITVITY SPO2 PULSE RATE NIBP UNIT ALARM LEVEL NIBP ALARM SYS HIGH ALARM SYS LOW ALARM DIA HIGH ALARM DIA LOW ALARM MAP HIGH ALARM MAP LOW ALARM Selection The parameters in ECG menu I,II,III,V,aVR,aVF,aVL 0.25,0.5,1,2,4,AUTO 12.5,25,50mm/s 1,2 ON,OFF HR LOW ALARM +5 to 250 30 to HR HIGH ALARM -5 MONITOR,NORMAL,EXTENDED ECG,SPO2,AUTO 1,2,3,4,5,6,7,OFF ON,OFF ON,OFF 4,8,16SEC 3LEAD,5 LEAD The parameters in RESP menu RA-LA,RA-LL 0.25,0.5,1,2,4 3,6,12.5,25mm/s 1,2 ON, OFF RR LOW ALARM +1 to 150 5 to RR HIGH ALARM -1 10 to 40S, OFF The parameters in SPO2 menu SLOW, NORMAL,FAST 12.5,25mm/s 1,2 ON,OFF SPO2 LOW ALARM +1 to 100 20 to SPO2 HIGH ALARM -1 NORMAL, MAX, APOD ON,OFF The parameters in NIBP menu mmHg, KPa 1,2 ON,OFF SYS LOW ALARM +5 to 240 30 to SYS HIGH ALARM -5 DIA LOW ALARM +5 to 180 20 to DIA HIGH ALARM -5 MAP LOW ALARM +5 to 200 25 to MAP HIGH ALARM -5 Default II AUTO 25 1 OFF 150Bpm 50Bpm NORMAL AUTO 2 OFF OFF 8SEC 3LEAD RA-LA 1 12.5mm/s 1 OFF 25Brpm 5Brpm 10S NORMAL 25mm/s 1 OFF 100 85 NORMAL OFF mmHg 1 OFF 150 mmHg 80 mmHg 120 mmHg 60 mmHg 150 mmHg 80 mmHg

OPERATION MANUAL
1 min, 2 min,3min,5min,10min,15min,20min 30min,45 min, 60 min, 90 min 2hr,4hr,6 hr, 8 hr,12 hr, 16 hr 20 hr, 24 hr, MANUAL,STAT The parameters in TEMP menu TEMP UNIT ALARM LEVEL TEMP ALARM T1 HIGH ALARM T1 LOW ALARM T2 HIGH ALARM T2 LOW ALARM DT HIGH ALARM DT LOW ALARM IBP UNIT ALARM LEVEL IBP ALARM IBP HIGH ALARM C,F 1,2 ON, OFF T1 LOW ALARM +1 to 50 0 to T1 HIGH ALARM -1 T2 LOW ALARM +1 to 50 0 to T2 HIGH ALARM -1 DT LOW ALARM +1 to 50 0 to DT HIGH ALARM -1 The parameters in IBP menu mmHg, KPa,cmH2O 1,2 ON,OFF IBP LOW ALARM +5 to 300 mmHg 1 OFF SYS: 150 mmHg DIA: 100 mmHg MEAN: 115 mmHg SYS: 80 mmHg DIA: 50 mmHg MEAN: 60 mmHg SYS: 150 mmHg DIA: 100 mmHg MEAN: 115 mmHg SYS: 80 mmHg DIA: 50 mmHg MEAN: 60 mmHg SYS: 150 mmHg DIA: 20 mmHg MEAN: 80 mmHg SYS: 80 mmHg DIA: -5 mmHg MEAN: 20 mmHg SYS: 40 mmHg DIA: 20 mmHg MEAN: 30 mmHg SYS: 5 mmHg DIA: -5 mmHg MEAN: 0 mmHg SYS: 40 mmHg DIA: 15 mmHg MEAN: 30 mmHg SYS: 5 mmHg DIA: -5 mmHg MEAN: 0 mmHg 15 mmHg -5 mmHg 20 mmHg -5 mmHg 15 mmHg -5 mmHg C 1 OFF 39 35 40 36 50 0

AUTO/MANUAL

MANUAL

IBP LOW ALARM

-50 to IBP HIGH ALARM -5

ART HIGH ALARM

ART LOW ALARM + 5 to 300

ART LOW ALARM

-50 to ART HIGH ALARM -5

LVP HIGH ALARM

LVP LOW ALARM +5 to 300

LVP LOW ALARM

-50 to LVP HIGH ALARM -5

PAP HIGH ALARM

PAP LOW ALARM +1 to 120

PAP LOW ALARM

-50 to PAP HIGH ALARM -1

RVP HIGH ALARM

RVP LOW ALARM +1 to 100

RVP LOW ALARM CVP HIGH ALARM CVP LOW ALARM LAP HIGH ALARM LAP LOW ALARM RAP HIGH ALARM RAP LOW ALARM

-50 to RVP HIGH ALARM -1 CVP LOW ALARM +1 to 100 -50 to CVP HIGH ALARM -1 LAP LOW ALARM +1 to 100 -50 to LAP HIGH ALARM -1 RAP LOW ALARM +1 to 100 -50 to RAP HIGH ALARM -1 2

OPERATION MANUAL
The Parameters in GAS WINDOW(Mainstream & Sidestream) CO2 UNIT GAS UNIT ALARM LEVEL GAS/RESP O2 COMPENSATE N2O OMPENSATE CO2 SCALE O2/N2O SCALE AA SCALE SIGNAL SWEEP WORK MODE GAS ALARM APNEA ALARM AWRR LOW AWRR HIGH EtCo2 LOW EtCo2 HIGH FiCo2 HIGH EtO2,FiO2 LOW EtO2,FiO2 HIGH EtN2O, FiN2O LOW EtN2O, FiN2O HIGH EtDES, FiDES LOW EtDES, FiDES HIGH EtISO, FiISO LOW EtISO, FiISO HIGH EtENF, FiENF LOW EtENF, FiENF HIGH EtSEV, FiSEV LOW EtSEV, FiSEV HIGH EtHAL, FiHAL LOW EtHAL, FiHAL HIGH WAVEFOEM AGENT FILLED SIGNAL ZERO EEG Gain CSM ALARM CSI LOW CSI HIGH ALARM VOLUME CALENDAR ADUL\NEONATE BED NUMBER KPa, %V, mmHg KPa, %V 1,2 GAS, RESP 1-100 vol%, OFF 0-100 vol% ( ONLY FOR ISA CO2, IRMA2 CO2 ) 6%,10%,Auto scale 0-50%,0-100%, Auto scale 1,2,3,5,10,20%, Auto scale 3mm/s, 6mm/s, 12mm/s, 25mm/s MEASURE, STANDBY ON,OFF 10s,15s,20s,25s,30s,35s,40s,OFF 1~(HIGH-1) (LOW+1) ~120 0.4~(HIGH-0.1) (%V) (LOW+0.1)~13(%V) 0.4~ 13(%V) 18~(HIGH-1) (%V) (LOW+1)~105(%V) 1~(HIGH-1) (%V) (LOW+1)~100(%V) 0.1~(HIGH-0.1) (%V) (LOW+0.1)~18(%V) 0.1~(HIGH-0.1) (%V) (LOW+0.1)~5(%V) 0.1~(HIGH-0.1) (%V) (LOW+0.1)~5(%V) 0.1~(HIGH-0.1) (%V) (LOW+0.1)~8(%V) 0.1~(HIGH-0.1) (%V) (LOW+0.1)~5(%V) CO2,N2O,O2,AA ISO,ENF,HAL,DES,SEV For IRMA(OR+) & IRMA(AX+) & ISA(OR+) & ISA(AX+): AUTO ON,OFF Only for Mainstream The Parameters in CSM WINDOW 25uV,50-250uV ON,OFF 1~(HIGH-1) (LOW+1)~100 SYSTEM DEFUALT 1,2,3,4,5,6,7 SOLAR, CHRISTIAN ADUL,NEONATE 1..99 3 100uV OFF 35% 60% 1 CHRISTIAN ADULT 01 mmHg %V 2 GAS 21% 0% 10% 100% 20% 12.5mm/s MEASURE OFF ADULT NEONATE 30S 15S 5 BrPM 15 BrPM 30 BrPM 60 BrPM 2.6%V 6.5%V 1.3%V 50%- ( For IRMA ICU: 25 ) 100% 35% 75% 5% 10% 0.8% 2% 0.5% 1.5% 1% 3% 0.5% 1.5% CO2 HAL,AUTO OFF

OPERATION MANUAL

APPENDIX II
MONITOR ERROR MESSAGES
Message cause Alarm indication ECG ERROR MESSAGES
ECG NO CABLE ECG cable is not connected to the system Alarm level 3, Pressing ALARM Connect ECG cable Check for any possible sources of signal noise form the area around the ECG NOISE ECG signal is noisy or saturated. cable and electrode, and check the patient for great motion and also check the lead wires. Make sure that all ECG CHECK LEADS Reference lead or more than one chest lead is not properly connected. electrodes and patient cable are properly connected ECG CHECK LA,RA,LL ECG SIGNAL WEAK Mentioned leads are not properly connected. ECG amplitude is lower than standard limit Make sure that mentioned electrode is properly connected Check the situation of the chest leads Power off and then on the system .If this message is ECG DEFECT ECG module failure displayed again the user should contact local After Sale Service. CHECK RL OR ALL RL or other leads are not properly connected when ECG lead is V, aVR, aVF or aVR. Make sure that all electrodes and patient cable are properly connected Make sure that all CHECK LL OR ALL LL or other leads are not properly connected when ECG lead is I electrodes and patient cable are properly connected Make sure that all CHECK LA OR ALL LA or other leads are not properly connected when ECG lead is II electrodes and patient cable are properly connected Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault. SILENCE, alarm will be disabled and ignore this fault. Alarm level 3, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

explanation

OPERATION MANUAL
Make sure that all CHECK RA OR ALL RA or other leads are not properly connected when ECG lead is III electrodes and patient cable are properly connected Alarm level 2, Pressing ALARM SILENCE, alarm will be disable and ignore this fault.

RESP ERROR MESSAGES

Alarm is activated when RR ALARM RESP CHECK LEADS The RESP leads are not properly connected. Non-respiration condition overruns adjusted time alarm level 3 The message is blinking alarm level 1 The message is blinking is "ON". Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. APNEA Pressing ALARM SILENCE, alarm is suspended for at least 120s.

RESP ERROR MESSAGES

Alarm level 3, the message is blinking RESP CHECK LEADS The RESP leads are not properly connected. Make sure that all electrodes, lead are properly connected Alarm is activated when RR ALARM is "ON". Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

SPO2 ERROR MESSAGES

SPO2 NO PROBE SPO2 probe is not connected to the monitor. Make sure that the probe is correctly connected to the monitor. Change the SPO2 probe. Alarm level 3, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. The SPO2 probe is damaged Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. SPO2 probe may be detached from the patient. Make sure that SPO2 probe is properly attached to the patient Make sure that SPO2 SPO2 CHECK PROBE SPO2 probe is not properly positioned to the patient probe is properly connected to the patient (refer to page 6-2). Make sure that SPO2 This may be caused by entering environmental light into the probe probe is properly connected to the patient (refer to page 6-2). Move the sensor to SPO2 SEARCH SPO2 is not calculable due to some reasons such as long time motions. The SPO2 signal amplitude is too weak or undetectable. another place, provoke blood recycle, and calm the patient. SPO2 SIGNAL WEAK Change the place of the probe. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Alarm is activated when SPO2 ALARM is "ON". Pressing ALARM SILENCE, alarm is suspended for at least 120s. Alarm level 2, the message is blinking. Alarm is activated when SPO2 ALARM is "ON". Pressing ALARM SILENCE, alarm is suspended for at least 120s.

SPO2 PROBE DEFECT

SPO2 PROBE OFF

SPO2 HIGH AMBIENT LIGHT

OPERATION MANUAL
Power off and then on the system .If this message is SPO2 DEFECT SPO2 module failure displayed again, the user should contact local After Sale Service. SPO2 ASYSTOLE SPO2 probe is disconnected from the monitor. Make sure that the probe is correctly connected to the monitor. Change the SPO2 probe. Alarm level 3,the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. The SPO2 probe is damaged Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2,the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

SPO2 PROBE DEFECT

NIBP ERROR MESSAGES

SELF-TEST FAILED Alarm level 2, the message is blinking. NIBP hard ware module failure Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Cuff is completely unwrapped, no cuff attached. Use adult cuff instead of neonate MODE ERROR cuff or occlusion happened in air way AIR LEAK Air leak in cuff, tube or connector Unstable pressure value (e.g. kinked hoses) because valve cannot open normally. Very weak patient signal due to a SIGNAL WEAK loosely wrapped cuff or extremely weak pulse from patient. RENG EXCEEDED EXCESSIVE MOTION OVER PRESSURE SENSED SIGNAL SATURATE PNEUMATIC LEAK Measuring pressure is more than upper limit (255mmHg)for adult or (135mmHg) for neonate Arm movement, noisy signal or irregular pulse(e.g. arrhythmia) Measuring pressure exceeded safe software limit, 290 mmHg for adult and 145mmHg for neonate. Large motion artifact that saturates the amplifier's amplitude handling capability Leakage during leak test Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. AIR PRESSURE ERROR Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

LOOSE CUFF

OPERATION MANUAL
Measuring time exceeds 120 TIME OUT seconds for adult or 90 seconds for neonate SYSTEM FAILURE Error occurs in pump, A/D sampling, pressure transducer or software. NIBP module failure The Charge of battery is low so LOW BATTERY NIBP measurement is not possible (while the monitor is working with battery NIBP NO MODULE STOP PRESSED NIBP STOP NIBP LEAKAGE O.K No NIBP module is installed. NIBP stop key has been pressed during measurement. Measurement is stopped by NIBP module because of special reason. Successful leakage test Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. NIBP DEFECT Pressing ALARM SILENCE, alarm will be disabled and ignore this fault. Alarm level 2, the message is blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

IBP ERROR MESSAGES

Alarm level 3, The message is IBP1/IBP2 NO SENSOR Channel 1 or 2 transducer is not connected. Check the transducer connection. blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

IBP1/IBP2 ADJUST SCALE

IBP1 or IBP2 signal is in out of display range for about 5 seconds.

Press <AUTO SCALE> in IBP WINDOW menu.

OPERATION MANUAL
This condition occurs when the maximum and minimum values of a pulsatile pressure signal (Just for IBP, ART, PAP, RVP and LVP labels) differ by less than 3mmHg.In this case, only Mean pressure is IBP1/IBP2 STATIC PRESSURE displayed in this state. This message can be caused by the following reason: A physiological condition e.g. asystole Transducer turned off to the patient. A catheter tip lodged against a vessel wall. A clot on the catheter tip. Check all IBP IBP1/IBP2 SEARCH IBP signal cant be processed by the software because the signal is weak or less pulsatile. connections and measurement setup are proper or not. Check patient status and treat if necessary. Check patient and do necessary treatment Turn on the stopcock to patient and turn it off to the atmospheric pressure. Follow hospital procedure for dislodging catheter. Follow hospital procedures for clotted catheters. Alarm level 3, The message is

blinking. Pressing ALARM SILENCE, alarm will be disabled and ignore this fault.

OPERATION MANUAL
GAS (SIDESTREAM) ERROR MESSAGES

SYSTEM FAULT Sensor error

Turn the system off and on and if problem still exists, contact after sales service of manufacturer Change sampling line Remove obstruction otherwise change the sampling line by a correct one. Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Replace O2 sensor by a new one. Replace O2 sensor by a new one.

Alarm level 2. Pressing Alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 3. Pressing Alarm silence, alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120sec.

CHECK SAMPLING LINE SAMPLING LINE CLOGGED Sampling line occlusion IR signal low

CO2 INVALID

CO2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

O2 INVALID

O2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

N2O INVALID

N2O outside specified accuracy range.

AGENT INVALID ACCUTACY INVALID, PLEASE ZERO. INVALID AMBIENT PRESSURE INVALID AMBIENT TEMPERATURE REPLACE O2 SENSOR O2 SENSOR ERROR

Agent outside specified accuracy range.

Anesthesia agents are out of accuracy range except O2

Ambient pressure outside operating range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec.

Internal temperature outside operation range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing Alarm silence, Alarm will be disabled and will ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec.

O2 sensor lifetime is passed. Sensor failure

If the sensor operate for a long time period without being disconnected from the O2 SPAN CALIB sampling line or the REQUIRED operating temperature for oxygen sensor changes significantly.

Perform room air calibration.

Alarm level 2. Pressing Alarm silence, alarm is suspended for 120S.

OPERATION MANUAL
ZERO REFERENCE CALIB REQUIRED CO2 value is more than 800 PPM (0.80%V) and measurement accuracy is low. Perform automatic zeroing procedure in an environment with CO2 less than 0.80%V. Connect sensor if problem exist again, Contact after sales service of manufacturer.
Enter GAS window and set WORK MODE on MEASURE.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec.

NO SENSOR

Sensor is disconnected from system. If it is set manually or no breath is detected for 30 min and ETCO2 is less than 4 mmHg for more than 30 min or when the monitor does not detect the sampling line. - The accuracy of the agent identification and measurement could not be guaranteed. - More than 2 aesthetic agents are present in the breathing circuit - High concentrations of solvents, cleaning agents or other interfering gases are present in the breathing circuit

Alarm level 3 Pressing alarm Silence, Alarm will be disabled and ignore this fault.

SENSOR STANDBY MODE

AGENT ID UNRELIABLE3

it is only available for ISA AX+/OR+.

OPERATION MANUAL

GAS (Mainstream) ERROR MESSAGES

SYSTEM FAULT Sensor error

Turn the system off and on and if problem still exists, contact after sales service of manufacturer Change the adaptor

Alarm level 2. Pressing Alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec Alarm level 3. Pressing Alarm silence, alarm will be disabled and ignore this fault.

REPLACE ADAPTOR NO ADAPTOR

IR signal low There is no adaptor connected to the sensor.

Connect the adaptor Zero the sensor, if the problem still exists, turn off and on the system and if again this message appears contact after sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Zero the sensor, if the problem still exists, contact After sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Turn the system off and on and if problem still exists, contact after sales service of manufacturer. Connect the adaptor Replace O2 sensor by a new one.

CO2 INVALID

CO2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

O2 INVALID

O2 outside specified accuracy range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault. Alarm level 2. Pressing alarm Silence, Alarm will be disabled and ignore this fault.

N2O INVALID

N2O outside specified accuracy range.

AGENT INVALID ACCUTACY INVALID, PLEASE ZERO. INVALID AMBIENT PRESSURE INVALID AMBIENT TEMPERATURE O2 PORT FAILURE REPLACE O2 SENSOR

Agent outside specified accuracy range.

Anesthesia agents are out of accuracy range except O2

Ambient pressure outside operating range.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec.

Internal temperature outside operation range. Adapter O2 port Clogged or plugged. O2 sensor lifetime is passed. If the sensor operate for a long time period without being disconnected from the sampling line or the operating temperature for oxygen sensor changes significantly.

Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing alarm Silence, Alarm will be disabled for 120 sec. Alarm level 2. Pressing Alarm silence, Alarm will be disabled and will ignore this fault.

ROOM AIR O2 CALIB CALIB REQUIRED

Perform room air calibration.

Alarm level 2. Pressing Alarm silence, alarm is suspended for 120S.

OPERATION MANUAL
Sensor is disconnected from system. If it is set manually or no breath is detected for 30 min and ETCO2 is less than 4 mmHg for more than 30 min or when the monitor does not detect the sampling line. - The accuracy of the agent identification and measurement could not be guaranteed. - More than 2 aesthetic agents are present in the breathing circuit - High concentrations of solvents, cleaning agents or other interfering gases are present in the breathing circuit Connect sensor if problem exist again, Contact after sales service of manufacturer.
Enter GAS window and set WORK MODE on MEASURE.

NO SENSOR

Alarm level 3 Pressing alarm Silence, Alarm will be disabled and ignore this fault.

SENSOR STANDBY MODE

AGENT ID UNRELIABLE4

it is only available for IRMA AX+/OR+.

OPERATION MANUAL
CSM ERROR MESSAGES

CSM ELECTROD ALARM

CSM SQI LOW

Check all neuro sensors and their connections. Check the patient cable. If not Placement of neuro connected, then sensors and their connect it. If faulty, connections might be in replace patient problem. This alarm can cable. also be caused by high Check if either of frequency instrument. the neuro sensors are disconnected or badly connected. Replace faulty sensor. Check that all neuro sensors and cable connections are correctly connected. Has the use of any mechanical device If the impedance of the that could generate white or black sensors high frequency exceeds 1k, the SQI activity (e.g. patient will fall gradually. Poor warmer) been impedance conditions initiated or is any may cause the SQI to such device in close fall to 50%. Artefacts proximity to the can have many causes: CSM neuro high frequency sensors? instrument, EMG, etc. If possible move are typical causes. If disturbing device SQI falls because of away from the extensive use of high neuro sensors. frequency instrument, it Check grounding will rise as soon as the of disturbing high frequency device. instrument is stopped Reduce the influence from disturbing device by disconnecting CSM Power to let the CSM module run from the battery.

OPERATION MANUAL Check that neuro sensors are not dry. Check that the skin has been If sensor impedance is > cleaned properly. 5k the CSI, BS and Clean and prepare EMG will be blanked skin as described in this manual and attach new neuro sensors. Try to establish CSM module is off or it wireless is on but wireless communication. communication is not Refer to section 12established. 2-2
ST ERROR MESSAGES

CSM IMPEDANCE HIGH

CSM LINK OFF

ST OUT OF HIGH RANGE

The ST algorithm has calculated value +1mV outside the high end of the ST measurement range. The ST algorithm has calculated value -1mV outside the low end of the ST measurement range.

ST OUT OF LOW RANGE

Check the ISO and ST measuring points. Observe the patient and treat if clinically indicated. Check the ISO and ST measuring points. Observe the patient and treat if clinically indicated. Turn the system off and then on if problem still exists, contact After sales service of the manufacturer. Turn the system off and then on if problem still exist, contact to After sales service of the manufacturer. Close the recorder door. Insert a new paper roll into the recorder. Stop operation for some minutes.

RECORDER ERROR MESSAGES

REC. SOFTWARE ERROR

Software error

RECORDER FAULT

Hardware error

DOOR OPEN

The recorder door is open Record paper finished. The thermal head is too hot.

OUT OF PAPER PRINTED HIGH TEMP

OPERATION MANUAL Turn the system off and then on if problem still exists, contact to After sales service of the manufacturer. Turn the system off and then on if problem still exists, contact to After sales service of the manufacturer. Turn the system off and then on if problem still exists, contact to After sales service of the manufacturer.

PRINTED HIGH VOL

Print head voltage is high.

PRINTED LOW VOL

Print head voltage is low.

TIME OUT ERROR

The recorder could not record.

OPERATION MANUAL

ALARM MESSAGES
ALARM SITUATION VISUAL PROMPTS AUDIO SOUND

ECG ALARMS HEART RATE ALARM

Heart rate violates adjusted alarm limits Heart beat is not HR value blinks. Alarm indicator flashes. HR is "00" and blinks "ECG ASYSTOLE" is displayed. Alarm indicator flashes. Activated Activated

ECG ASYSTOLE

detected in last 10 seconds.

RESP ALARMS
Respiration rate

RR ALARM

violates adjusted alarm limits Non-respiration

RESP value blinks Alarm indicator flashes. Alarm indicator flashes "RESP APNEA" blinks

Activated

APNEA

condition overruns adjusted time

Activated

SPO2 ALARMS SPO2 ALARM SPO2 violates adjusted alarm limits Pulse beat is not detected in last 10 seconds. SPO2 value blinks. Alarm indicator flashes.
Activated

SPO2 ASYSTOLE

HR is "0" and blinks Message "SPO2 ASYSTOLE" is displayed Alarm indicator flashes. NIBP ALARMS
SYS value blinks alarm indicator flashes. DIA value blinks alarm indicator flashes. MAP value blinks alarm indicator flashes.

Activated

SYS violates

SYS ALARM

adjusted alarm limits or violates lower than 50mmHg DIA violates adjusted alarm limits MAP violates adjusted alarm limits or violates lower than 30mmHg

Activated

DIA ALARM

Activated

MAP ALARM

Activated

IBP ALARMS SYS ALARM

SYS violates adjusted alarm limits DIA violates adjusted alarm limits. MEAN violates adjusted alarm limits. SYS value blinks alarm indicator flashes. DIA value blinks alarm indicator flashes. MEAN value blinks alarm indicator flashes. Activated

DIA ALARM MEAN ALARM

Activated Activated

OPERATION MANUAL
CO2 ( sidestream & Mainstream ) ALARMS
Respiration rate

AWRR ALARM

violates adjusted alarm limits End Tidal CO2

AWRR value blinks Alarm indicator flashes. EtCo2 value blinks Alarm indicator flashes. FiCo2 value blinks Alarm indicator flashes Alarm indicator flashes "RESP APNEA" blinks. EtN2O value blinks. Alarm indicator flashes. FiN2O value blinks. Alarm indicator flashes. EtAA value blinks. Alarm indicator flashes. FiAA value blinks. Alarm indicator flashes. EtO2 value blinks. Alarm indicator flashes. FiO2 value blinks. Alarm indicator flashes.

Activated

EtCo2 ALARM

violates adjusted alarm limits FiCo2 violates

Activated

FiCo2 ALARM

adjusted high alarm limits Non-respiration

Activated

APNEA

condition overruns in adjusted time End Tidal Co2

Activated

EtN2O ALARM

violates adjusted alarm limits End Tidal Co2

Activated

FiN2O ALARM

violates adjusted alarm limits End Tidal Co2

Activated

EtAA ALARM

violates adjusted alarm limits End Tidal Co2

Activated

FiAA ALARM

violates adjusted alarm limits End Tidal Co2

Activated

EtO2 ALARM

violates adjusted alarm limits End Tidal Co2

Activated

FiO2 ALARM

violates adjusted alarm limits Cerebral state index violates adjusted alarm limits

Activated

CSM ALARMS CSI ALARM

CSI value blinks. Alarm indicator flashes. Activated

ST ALARMS ST segment value

ST ALARM

violates adjusted alarm limits

ST value blinks. Alarm indicator flashes.

Activated

OPERATION MANUAL

APPENDIX III
MASIMO MODULE
Masimo module The Masimo SET MS-7 pulse oximeter is based on three principles: 1 Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry). 2. The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography). 3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. The Masimo SET MS-7 pulse oximeter as well as traditional pulse oximetry determines SpO2 by passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode serves as the photodetector. Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume. This assumes that the blood flow in the region of the sensor passes entirely through the capillary bed rather than through any arterio-venous shunts. The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean absorbance (DC) at each of two wavelengths, 660 nm and" 905 nm: S (660) = AC (660)/DC (660) S (905) = AC (905)/DC (905) The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals: R= S (660)/S (905) This value of R is used to find the saturation SpO2 in a look-up table built into the oximeter's software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. The Masimo SET MS-7 pulse oximeter assumes that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of noise during the pulse. MS-7 decomposes S (660) and S (905) into an arterial signal plus a noise component and calculates the ratio of the arterial signals without the noise: S (660) = S1 + N1 S (905) = S2 + N2 R= S1/S2

OPERATION MANUAL
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the saturation SpO2 in an empirically derived equation into the oximeter's software. The values in the empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. The above equations are combined and a noise reference (N') is determined: N' =S (660) - S (905) R If there is no noise N' = 0: then S (660) = S (905) R which is the same relationship for the traditional pulse oximeter. The equation for the noise reference is based on the value of R, the value being seeked to determine the SpO2. The MS-7 software sweeps through possible values of R that correspond to SpO2 values between 1% and. 100% and generates an N' value for each of these R values. The S (660) and S (905) signals are processed with each possible N' noise reference through an adaptive correlation canceller (ACC) which yields an output power for each possible value of R (i.e., each possible SpO2 from 1% to 100%). The result TM is a Discrete Saturation Transform (DST ) plot of relative output power versus possible SpO2 value as shown in the following figure where R corresponds to SpO2 = 97%:

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO2 value. This entire sequence is repeated once every two seconds on the most recent four seconds of raw data. The MS'-7 SpO2 therefore corresponds to a running average of arterial hemoglobin saturation that is updated every two seconds.

OPERATION MANUAL

APPENDIX IV
EMC
Warning Use only the recommended bedside monitor accessory .Using the accessory other than in relevant chapter may cause to increase the EMISSION or decrease the IMMUNITY of system. Warning Measurements can be affected by mobile and RF communications equipment. It should be assured that the bedside monitor is used in the electromagnetic environment specified. Warning To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. Warning Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation emitted from such devices may result in strong interference with the monitor performance.

Guidance and manufacturer's declaration electromagnetic emissions

The ALBORZ B7 Patient Care Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the ALBORZ B7 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The ALBORZ B7 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Group 1

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class B Class A The ALBORZ B7 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

OPERATION MANUAL

Guidance and manufacturer's declaration electromagnetic immunity

The ALBORZ B7 Patient Care Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the ALBORZ B7 should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 IEC 60601 test level 6 kV contact 8 kV air Compliance level Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst IEC 61000-4-4

2 kV for power supply lines 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

1 kV differential mode 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT) for 0.5 cycle Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 40% UT (>60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the ALBORZ B7 requires continued operation, it is recommended that the ALBORZ B7 be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic 3 A/m field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of test level.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

OPERATION MANUAL

Guidance and manufacturer's declaration electromagnetic immunity

The ALBORZ B7 Patient Care Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the ALBORZ B7 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the ALBORZ B7, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.17 d = 1.17 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3V d = 2.33 3 V/m

P P 80 MHz to 800 MHz

P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ALBORZ B7 is used exceeds the applicable RF compliance level above, the ALBORZ B7 should be observed to verify normal operation. If abnormal performance is observed, additional measures may necessary, such as reorienting or relocating the ALBORZ B7 . b Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

OPERATION MANUAL
Recommended separation distances between Portable and mobile RF communications equipment and the ALBORZ B7 The ALBORZ B7 Patient Care Monitor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ALBORZ B7 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ALBORZ B7 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.17 P d = 1.17 P d = 2.33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.70 3.70 7.37 100 11.7 11.7 23.3 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

OPERATION MANUAL

APPENDIX V
IRMA Design and theory
This section describes the basic concepts used in PHASEIN IRMA in terms of design, technical solutions and gas measurement. 1. Basic design features PHASEIN IRMA mainstream multi-gas probe consists of an IRMA sensor head, an oxygen sensor cell (optional) and an airway adapter. As all necessary calibration constants are stored within each IRMA sensor head, the probes can be replaced without the need for recalibration.

Figure 1. PHASEIN IRMA sensor head with airway adapter. The IRMA sensor head includes a multi-channel IR bench, a barometric pressure sensor, a signal processor, a power regulator, and a RS-232 digital interface.

Figure2. PHASEIN IRMA sensor head. The ultra compact multi-channel IR micro bench comprises a high reliability infrared source, an infrared chopper wheel with an integrated brush less DC micro motor, an infrared detector and all necessary components for processing the infrared measurement signal.

OPERATION MANUAL

Chopper wheel with brushless DC micro motor

Figure 3. IRMA multi-channel IR micro bench. The airway adapter, with or without an oxygen port (optional), includes the optical components for TM measuring gases - the XTP windows that are transparent to light in the wavelength ranges of interest.

Figure 4. IRMA airway adapter with oxygen port.

Figure 5. IRMA airway adapter without an oxygen port. The ultra fast response time oxygen sensor is normally integrated in the IRMA sensor head allowing proximal measurement of INSP/EXP oxygen concentrations.

OPERATION MANUAL

Figure 6. IRMA ultra fast response time oxygen sensor. 2 Gas measurement and identification The IRMA sensor head snaps in place on the top of the airway adapter that includes the optical components for measuring all gases. The airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit. The respiratory gas measurements are obtained by continuously measuring the infrared gas absorption through the XTP windows in the gas flow through the adapter. To measure the concentrations and identify the gases, absorption of up to nine different wavelengths of infrared light is measured.

Figure 7. PHASEIN IRMA IR light path through XTP airway adapter.

The measurement of CO2, N2O and anesthetic agents in the breathing gas mixture is based on the fact that the different gas components absorb infrared light at specific wavelengths. A microprocessor continuously calculates the CO2, N2O and anesthetic agent concentrations from the infrared light absorption measurements using matrix calculations to identify which anesthetic agents are present in the gas mixture.. Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore measured using an ultra rapid response time oxygen sensor (see Section 2.2 Oxygen measurement).

OPERATION MANUAL 2.1 Infrared measurement technology The absorption spectra for CO2, N2O and the five anesthetic agents halothane, enflurane, isoflurane, sevoflurane and desflurane are shown in the figure below.

Figure 8. Absorption spectra. PHASEIN IRMA uses the absorption peaks at 4.2 and 3.9 m for the measurement of CO2 and N2O respectively, and five different wavelengths in the 8-12 m range for anesthetic agent measurements. Two additional wavelengths beside the absorption peaks are used as references. To measure the absorption of light at these wavelengths, a broadband infrared radiation source is used. The light transmitted from the infrared source passes through the XTP windows and is then filtered using a set of narrow optical band pass filters. The individual filters are mounted in a rapidly rotating filter wheel that intersects the light path before the light reaches the infrared detector.

Figure 9. Optical path. No radiation will be absorbed if the airway adapter is empty. The output signal from the detector will thus have its maximum amplitude at a concentration of zero, with lower amplitudes at higher concentrations.
4

OPERATION MANUAL 2.2 Oxygen measurement A fuel cell oxygen sensor uses a membrane that allows diffusion of O2 into the sensor. Inside the sensor, there is a sensing electrode (cathode) made of a noble metal such as gold or platinum, and a working electrode made of a base metal such as lead or zinc. The electrodes are immersed in an electrolyte. Fuel cell oxygen sensors are current generators and do not require any external power supply. By connecting a resistor between the anode and the cathode, a voltage proportional to the 02 concentration is generated. Since the measurement involves a chemical reaction, the fuel cell is gradually consumed during the process (also when the equipment is not in use), and requires replacement at regular intervals. PHASEIN's oxygen sensor is specially designed to provide an ultra fast response time, thus allowing a breath-by-breath analysis of the oxygen waveform at a proximal location (i.e. between the patient's endotracheal tube and the Y-piece of the breathing circuit). The vast majority of oxygen sensors available on the market are normally too slow for a breath-to-breath gas analysis.

Figure 10. IRMA ultra fast response time For monitors, anesthesia machines and ventilators already equipped with oxygen measuring devices, the IRMA sensor is available with an O2 sensor dummy instead of the normal oxygen sensor. Figure 11 shows both the normal O2 sensor and the oxygen sensor dummy.

Figure11. Oxygen sensor dummy and oxygen sensor. The oxygen sensor dummy can be replaced at any time by a normal sensor to allow oxygen measurements with the IRMA sensor.

OPERATION MANUAL 3 PHASEIN XTPTM airway adapter The disposable airway adapter is inserted between the endotracheal tube and the Y-piece of the breathing circuit. The respiratory gas measurements are obtained through the XTP windows in the sides of the adapter. As the airway adapter is positioned directly in the airway, its performance can be affected by water vapor, patient secretions or nebulized medications that can accumulate on the adapter's windows. The water vapor can condense on the surface of the adapter windows in the format of small discrete water droplets. This condensation can affect the light absorption through the windows thus affecting the precision of the measurement. The design and material technology of the XTP windows have special features that prevent a decrease in performance when water vapor is present. The root cause of water droplet formation is the difference in surface tension between the plastic and water. This mismatch means that the water condenses into discrete droplets with a high contact angle. Figure 12 illustrates a water droplet with various contact angles showing the effects of condensed water on light transmission.

Figure 12. Effect of condensed water on light transmission. The XTP windows are specially designed using the latest advances in material technology to provide a window minimizing the impact of water vapor on light transmission. Figure 13 illustrates the light transmission in a XTP window.

Figure13. Light transmission through a XTP window For optimal results, the airway adapter shall not be placed between an ET tube and an elbow, as this may allow patient secretions to block the adapter windows. The XTP airway adapter shall be positioned with its windows in a vertical position to help keep patient secretions from pooling on the windows.

OPERATION MANUAL The airway adapter is designed as a disposable for both adult/pediatric and infant applications. The adult/pediatric adapter is available with or without an oxygen port.

Figure 14. IRMA airway adapters: Adult/pediatric with and without an oxygen port and infant adapter. The airway adapter with an oxygen port is equipped with a hydrophobic bacteria filter to protect the oxygen sensor from contamination. Figure.15 illustrates the flow of gases in the adapter and the location of the hydrophobic bacteria filter.

Figure15. Flow of gases through an IRMA airway adapter with an oxygen port. For monitors, anesthesia machines and ventilators already equipped with oxygen measuring devices, the airway adapter is available without an oxygen sensor port (see Fig.15). Warning Do not use the IRMA adult/pediatric airway adapter with infants as the adapter add 6 ml dead space to the patient circuit. The IRMA airway adapter has specially designed connectors for minimizing the dead space and can be used even for very small patients. The infant adapter is available without an oxygen port only.

OPERATION MANUAL Effect of water vapor The total pressure of the gas mixture is estimated by measuring the actual barometric pressure in the IRMA sensor .The partial pressure and the volume percentage of CO2, N2O, O2 and anaesthetic
agents depend on the amount of water vapor in the breathing gas. The O2 measurement will be calibrated to show 20.8% at actual ambient temperature and humidity level, instead of showing actual partial pressure.

20.8% O2 corresponds to the actual O2 concentration in room air with 0.7%H2O concentration (for example at 25C and 23% RH). The measurement of CO2, N2O and anaesthetic agents (e.g. all gases measured by the IR-bench) will always show the actual partial pressure at the current humidity level. The effects of water vapor are illustrated by the examples in the following table.O2 is assumed to be room air calibrated at 25C and 23%RH. The two columns to the right show the relative error in displayed concentrations when adding or removing water vapor from the gas mixture, and referencing the measurement to dry gas conditions at actual temperature and pressure (ATPD) or saturated conditions at body temperature (BTPS). Temp RH [C] [%] 10 20 25 25 25 30 37 37 20 20 0 23 50 80 100 100 P [mbar] 1013 1013 1013 1013 1013 1013 1013 700 H2O part. pres. [mbar] 2 5 0(ATPD) 7.3 16 42 63(BTPS) 63 Err(rel) [%]
0 0

err(rel)[%] err(rel) ATPD[%] BTPS -0.2 -0.5 0 -0.7 -1.6 -4.1 -6.2 -9.0 +6.0 +5.7 +6.2 +5.5 +4.6 +2.0
0 -2.8

0 0 0
0 0 0

The table above illustrates that the gas concentrations in the alveoli, where the breathing gas is saturated with water vapor at body temperature (BTPS), are 6.2% lower than the corresponding concentrations in the same gas mixture after removal of all water vapor (ATPD). If calibration of O2 is not performed with room air humidity equal to 0.7% H2O, the difference between the O2 concentration delivered by IRMA and the actual partial pressure of O2 will be equal to the concentration of ambient water vapor -0.7%(O2 diff [%] = Conc H2O[%]-0.7%. For example, if a room air calibration of O2 is performed at a humidity of 1.6% H2O (corresponding to 50% RH at 25C) the standard calibration value of 20.8% O2 will be 1.6%0.7%=0.9% too large. The correct O2 concentration (actual partial pressure of O2) at theses conditions is (1-0.009)*20.8=20.6%O2.

OPERATION MANUAL

APPENDIX VI
ISA Theory and design
1. Gas measurements
The measurement of CO2, N2O and anesthetic agents is based on the fact that different gases absorb infrared light at specific wavelengths. The analysis of respiratory gases by the ISA gas analyzers are therefore performed by continuously measuring the infrared light absorption in the gas flow through an infrared spectrometer. Oxygen, on the other hand, does not absorb infrared light to the same extent as other breathing gases and is therefore measured using alternative methods. The gas analysis At the heart of an ISA gas analyzer, the SIGMA spectrometer is seated. The SIGMA spectrometer uses a proprietary broadband infrared radiation source to transmit light through the gas sample. Before reaching the gas sample, the light path is intersected by narrowband optical filters that only let through light corresponding to selected wavelength peaks of the measured gases. At the other end of the light path, a sensor detects the portion of the light that is not absorbed by the gas. The amplitude of the detector output is an inverse function of the gas concentration. Thus, at a concentration of zero, the amplitude is at its maximum. If the gas sample is a mixture of several components that absorb light at the same wavelength, such as a mixture of two anesthetic agents, the absorbed radiation will be the sum of the absorption of the agents. To determine the concentration of each of the individual gases, several filters have to be used. The ISA gas analyzers therefore uses the SIGMA spectrometer, which contains up to nine different narrowband filters to facilitate simultaneous measurement of CO2, N2O and a mixture of any two of the five anesthetic agents.

Figure 1. Gas absorption spectra

OPERATION MANUAL The selection of the optical filters within the spectrometer is crucial to the characteristics and performance of the gas analyzers. The SIGMA spectrometer uses the strong absorption peaks at 4.2 and 4.5 m for CO2 and N2O measurements and five wavelengths in the 8 to 10 m long wave infrared range (LWIR) for the anesthetic agent calculations. The LWIR contains strong absorption peaks for the anesthetic agents and negligible interference from other common respiratory gases, such as alcohol and acetone, that could degrade measurement accuracy. In addition to the measurement filters, two optical filters appropriately located within the 4 to 10 m range are used as references.

2. Oxygen measurement
Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore measured using alternative methods. The ISA OR+ analyzer is fitted with a paramagnetic oxygen sensor, and the ISA AX+ module is designed be fitted with either a paramagnetic or a galvanic (fuel-cell) oxygen sensor. Paramagnetic oxygen analysis Paramagnetic oxygen analyses are based on measurements of the attractive force exerted by a strong magnetic field applied to the oxygen molecules in a gas mixture. The paramagnetic analyzer distinguishes oxygen from other gases as a function of their magnetic susceptibility. Due to its paramagnetic nature, oxygen is attracted into the magnetic field, while most other gases are not. On a scale, where oxygen is assigned the value 100, most other gases have a magnetic susceptibility of close to zero. The Servomex sensor An oxygen sensor well suited for the ISA gas analyzer is the PM1116 paramagnetic oxygen sensor from Servomex. In this sensor, a symmetrical non-uniform magnetic field is created. If oxygen is present, it will be attracted into the strongest part of this field. Two nitrogen-filled glass spheres are mounted on a rotating suspension within the magnetic field. Centrally on this suspension, a mirror is mounted. A light beam projected on the mirror is reflected onto a pair of photocells. Oxygen attracted into the magnetic field will push the glass spheres from the strongest part of the magnetic field, causing the suspension to rotate. When this rotation is detected by the photocells, a signal is generated and passed to a feedback system. The feedback system will pass a current around a wire mounted on the suspension, causing a restoring torque that keeps the suspension in its original position. The current flowing around the wire is measured. This current is directly proportional to the oxygen concentration.

10

OPERATION MANUAL

Figure 2. Oxygem measurement with Servomex PM1116 paramagnetic oxygen sensor.

The most important benefits of the paramagnetic oxygen sensor are: Fast rise time High stability and accuracy No chemicals to replace or renew Low maintenance requirements Galvanic oxygen analysis As an alternative to the paramagnetic sensor, the ISA gas analyzer is designed be fitted with a galvanic oxygen sensor. A galvanic fuel-cell oxygen sensor uses a membrane that allows diffusion of O2 into the sensor. Inside the sensor, there is a sensing electrode (cathode) made of a noble metal such as gold or platinum, and a working electrode made of a base metal such as lead or zinc. The electrodes are immersed in an electrolyte. Fuel-cell oxygen sensors are current generators and do not require any external power supply. By connecting a resistor between the anode and the cathode, a voltage proportional to the O2 concentration is generated. Since the measurement involves a chemical reaction, the fuel cell is gradually consumed during the process (also when the equipment is not in use), and requires replacement at regular intervals.

3. Sampling
A sidestream gas analyzer continuously removes a gas sample flow from the respiratory circuit, for example a nasal cannula, a respiratory mask or the Y-piece of an intubated patient. The gas sample is fed through a sampling line to the gas analyzer. The sampled gas is usually warm and humid, and cools down in contact with the wall of the sampling line. Water therefore condenses in form of droplets on the inner wall of the sampling line. These droplets could potentially occlude the sampling line and interfere with the gas measurement.

11

OPERATION MANUAL

The Nomoline To overcome the shortfalls of current gas sampling solutions, the Nomoline sampling line has been developed for the ISA sidestream gas analyzers. Warning: Use only Nomoline sampling lines manufactured by PHASEIN. Unlike traditional solutions that remove water vapor and collect water in a container, the Nomoline sampling line incorporates a unique water separation section, the NOMO section. This section is made of a special polymer and a hydrophobic bacteria filter that removes water vapor and aspired or condensed water. Water and water vapor passes through the membrane-like surface of the sampling line and evaporates into the surrounding air, while leaving O2, CO2 and anesthetic gases unaffected.

Figure 3. The Nomoline (no moisture) sampling line. To protect the ISA analyzer, the Nomoline includes a filter with the bacterial filter efficiency of 99.9980 %. It is important to be aware that secretions and nebulized medications may attach to the surface of the bacteria filter, and may cause clogging. Warning: Do not use the ISA gas analyzer with metered-dose inhalers or nebulized medications as this may clog the bacteria filter. The Nomoline sampling lines are specially designed for 50 ml/min low sample flow applications. The Nomoline has a very low dead space that results in an ultra-fast rise time, making measurements of CO2, N2O and anesthetic agents possible even at high respiratory rates. ISA sidestream gas analyzers are therefore suitable for adult, pediatric and infant patients. The Nomoline sampling line is available in 2 and 3 meter versions and comes with a male Luer Lock type connector to work with different kinds of third-party sampling equipment, including patient interfaces for intubated, nasal and oral sampling. Although the selection of optimal patient interfaces is crucial, the Nomoline sampling line fits in any normal configuration.

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OPERATION MANUAL Flow control During normal operation, a sidestream gas analyzer is continuously fed with a small sample gas flow. To pull the gas through the sampling line and maintain a steady flow, a high-precision flow control system is required. In ISA sidestream gas analyzers, the flow control system consists of an integrated micro pump, a zero valve and a flow controller. The pump is fitted with a low-power brushless motor having three miniature ball bearings to ensure trouble free operation without regular maintenance. Its balanced shaft design and integrated pneumatic filter virtually eliminate pressure and flow variations. System response In any sidestream gas monitoring system, there are three major time parameters involved: Total system response time Delay time Rise time When designing a sidestream gas monitoring system, the physical characteristics of several components have to be considered. Parameters such as sampling volume, tubing material, tubing diameter and the physical design of the sampling interfaces play decisive roles in determining the responsiveness of the system. Generally, the total system response time equals the delay time plus the rise time. The delay time is defined as the time required for a step function change at the sampling site to result in 10% of the final value. Parameters affecting the delay time are the sample flow rate, tubing length and tubing inner diameter. In mainstream gas monitoring, where no tubing exist, the delay time is virtually zero, whereas a sidestream system has a sample delay time of a few seconds. The rise time is defined as the time required for a step function change at the sampling site to bring about a rise from 10% to 90% of the final gas concentration value.

4. Gas data concentration

Gas measurement units Gas concentration is reported in units of volume percent. The concentration is defined as: % gas =
Partial pressure of gas component Total pressure of gas mixture

* 100

The total pressure of the gas mixture is measured by a cuvette pressure sensor in the ISA gas analyzer. For conversion to other units, the actual atmospheric pressure sent from the ISA sidestream analyzer may be used, e.g.

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OPERATION MANUAL

CO2 in mmHg = (CO2 concentration) x (atm. pressure value in kPa from ISA) x (750 / 100). Example: 5.0 vol% CO2 @ 101.3 kPa 0.05 x 101.3 x 750 / 100 = 38 mmHg Effects of humidity The partial pressure and the volume percentage of CO2, N2O, O2 and anesthetic agents depend on the amount of water vapor in the measured gas. The O2 measurement will be calibrated to show 20.8 vol% at actual ambient temperature and humidity level, instead of showing actual partial pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in room air with 0.7 vol % H2O concentration (at 1013 hPa this equals for example 25C and 23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g. all gases measured by the IR-bench) will always show the actual partial pressure at the current humidity level. In the alveoli of the patient, the breathing gas is saturated with water vapor at body temperature (BTPS). When the breathing gas is sampled, and passing the sampling line, the gas temperature will get close to the ambient temperature before reaching the ISA sidestream gas analyzer. As the Nomoline removed all condensed water, no water will reach the ISA gas analyzer. The relative humidity of the sampled gas will be about 95%. If CO2 values at BTPS are required, the following equation can be used: EtCO2 (BTPS) = EtCO2 * ( 1 ( 3.8 / Pamb) ) where: EtCO2 = EtCO2 value sent from ISA [vol %] Pamb = Ambient pressure sent from ISA [kPa] 3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa] EtCO2(BTPS) = EtCO2 gas concentration at BTPS [vol%] O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O. Spectral broadening The presence of oxygen and nitrous oxide can cause some interference in the CO2 measurement. This is known as spectral broadening. Nitrous oxide, N2O: ISA sidestream analyzers capable of N2O measurements automatically compensates for spectral broadening caused by nitrous oxide. When using an ISA sidestream gas analyzer without this capability, the current nitrous oxide concentration should be transmitted to the ISA Gas analyzer using the SetN2O command. For most applications, sufficient accuracy in CO2 measurement will be achieved by setting N2O to one standard concentration used always with N2O in use, as recommendation 50 vol%, SetN2O 50
14

OPERATION MANUAL for actual concentrations in the span 30 70 vol% N2O. When N2O is not in use send SetN2O 0. The default value is 0. By using this range, see table below, the maximum CO2 error with N2O compensation on (30-70%) will be limited to 3.2 % relative. N2O range 0-30 vol% 30-70 vol% Oxygen, O2: ISA sidestream analyzers capable of O2 measurements automatically compensates for spectral broadening caused by nitrous oxide. When using an ISA sidestream gas analyzer without this capability, the current nitrous oxide concentration should be transmitted to the ISA Gas analyzer using the SetO2 command. For most applications, sufficient accuracy in CO2 measurement will be achieved by dividing the oxygen concentration into three ranges: high, medium and low. By using these ranges, along with the SetO2 values in the table below, the maximal relative CO2 error will be limited to 1.2%. O2 range 0-30 vol% 30-70 vol% 70-100 vol% O2 parameter 0 50 85 N2O parameter 0 50

5. Interfering gas and vapor effects Gas or vapor N2O HAL 4) ENF , ISO , SEV 4) DES 4) Xe (Xenon) 4) He (Helium) 4) Metered dose inhaler propellants 4) C2H5OH (Ethanol) 4) C3H7OH (Isopropanol) 4) CH3COCH3 (Acetone) 4) CH4 (Methane) 4) CO (Carbon monoxide) 5) NO (Nitrogen monoxide) 5) O2 5)
4)

Gas level 60 V% 4 V% 5 V% 15 V% 80 V% 50 V% 0.3 V% 0.5 V% 1 V% 3 V% 1 V% 0.02 V% 100 V%

2)

CO2 ISA CO2 ISA AX+ - 1) +8 % of reading 3) +12 % of reading 3) -10 % of reading 3) -6 % of reading 3) - 1) - 1) - 1) - 1) - 1) - 1) - 2) - 1) - 1) - 1) - 1) - 1) - 1) - 2)

Agents - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1)

N2O - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1) - 1)

Not for use with metered dose inhaler propellants

Note 1: Negligible interference, effect included in the specification Accuracy, all conditions above.
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OPERATION MANUAL

Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect included in the specification Accuracy, all conditions above. Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2. Note 4: According to the EN ISO 21647:2004 standard. Note 5: In addition to the EN ISO 21647:2004 standard.

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