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Omni III User's Manual Va.1.0-20140124

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OMNI III

Patient Monitor

USER’S MANUAL

Ver A.1.0 © 2014 Infinium Medical, Inc. All rights reserved.

Issued Date: Jan 24th, 2014


User’s Manual of OMNI III Patient Monitor

Infinium Medical Inc.

Website: www.infiniummedical.com

Address: 12151 62nd St North #5 Largo Fl, 33773 USA

Toll Free (US call only): 866-918-8434

International: 1-727-531-8434

Fax: 1-727-531-8436

To obtain information about a warranty, if any, for this product, contact Infinium Medical Inc,

Technical Services or your local Infinium Medical, Inc. representative.

PHASEIN is a trademark of PHASEIN AB

RESPIRONICS is a trademark of PHILIPS RESPIRONICS

Masimo is a trademark of Masimo SET

Nellcor is a trademark of NELLCOR OXIMAX

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User’s Manual of OMNI III Patient Monitor

CONTENTS
SAFETY INFORMATION ...............................................................................................................1
INTRODUCTION ............................................................................................................................4
INTENDED USE......................................................................................................................4
ABOUT THIS MANUAL.........................................................................................................4
CONTROLS, INDICATORS, AND SYMBOLS..............................................................................5
FRONT PANEL ........................................................................................................................5
LEFT SIDE PANEL..................................................................................................................6
RIGHT SIDE PANEL ...............................................................................................................7
REAR PANEL ..........................................................................................................................7
SYMBOLS................................................................................................................................8
DISPLAY SCREEN PARTITION...................................................................................................10
WAVEFORM AREA...............................................................................................................11
PARAMETER AREA .............................................................................................................11
MESSAGE AREA ..................................................................................................................11
SYSTEM SETUP............................................................................................................................12
FACTORY SEVICING SETUP ..............................................................................................12
OPTIONAL MODULE...........................................................................................................13
WAVEFORM SELECT...........................................................................................................13
PRINTER................................................................................................................................13
CONFIG MANAGER.............................................................................................................14
DRUG CALCULATION ........................................................................................................14
HEMODYNAMIC CAL.........................................................................................................14
LANGUAGE SETUP .............................................................................................................14
DEMO DISPLAY ...................................................................................................................15
OTHER SETUP ......................................................................................................................15
HOW TO MONITOR .....................................................................................................................16
DISPLAY MODE ...........................................................................................................................17
OXYCRG SCREEN ...............................................................................................................17
LARGE FONT SCREEN........................................................................................................17
ALARM & SOUND .......................................................................................................................19
ALARM ..........................................................................................................................................19
ALARM SETUP .....................................................................................................................19
VISUAL ALARM INDICATORS ..........................................................................................20
ALARM SUSPEND ...............................................................................................................20
ALARM SWITCH..................................................................................................................20
SOUND...........................................................................................................................................21
ALARM SOUND ...................................................................................................................21
HEART-BEAT (PULSE-TONE) .............................................................................................21
KEY BEEPS............................................................................................................................21
SILENCE ................................................................................................................................21

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User’s Manual of OMNI III Patient Monitor

ECG MONITORING ......................................................................................................................22


ELECTRODE INSTALLATION ............................................................................................22
CABLE AND LEADWIRE INSTALLATION .......................................................................25
ECG SETUP ...........................................................................................................................25
ST-SEGMENT ANALYSES ...................................................................................................27
ARRHYTHMIA ANALYSIS..................................................................................................29
12-LEAD ECG MONITORING .............................................................................................30
ERROR MESSAGES OF ECG MONITORING....................................................................31
MAINTENANCE AND CLEANING.....................................................................................31
RESP MONITORING.....................................................................................................................33
RESP ELECTRODE INSTALLATION..................................................................................33
RESP SETUP ..........................................................................................................................33
MAINTENANCE AND CLEANING.....................................................................................34
SPO2 MONITORING.....................................................................................................................35
SPO2 MONITORING PRINCIPLE........................................................................................35
SPO2 SENSOR INSTALLLATION .......................................................................................35
SPO2 SETUP ..........................................................................................................................35
MEASUREMENT LIMITATIONS ........................................................................................36
SPO2 ERROR MESSAGES ...................................................................................................37
MASIMO INFORMATION....................................................................................................37
NELLCOR INFORMATION..................................................................................................38
NIBP MONITORING .....................................................................................................................39
NIBP MONITORING PRINCIPLE ........................................................................................39
NIBP CUFF FITTING ............................................................................................................39
NIBP MONITORING INITIALIZATION..............................................................................40
NIBP SETUP ..........................................................................................................................40
NIBP LIST OBSERVATION...................................................................................................42
MEASUREMENT LIMITATIONS ........................................................................................43
NIBP ERROR MESSAGES....................................................................................................44
MAINTAINENCE AND CLEANING....................................................................................44
TEMP MONITORING ...................................................................................................................45
THEORY OF OPERATION....................................................................................................45
TEMP SENSOR INSTALLATION.........................................................................................45
TEMP SETUP.........................................................................................................................45
TEMP ERROR MESSAGES ..................................................................................................46
MAINTAINENCE AND CLEANING....................................................................................46
ETCO2 MONITORING (OPTION) ...............................................................................................47
THEORY OF OPERATION....................................................................................................47
WARNINGS............................................................................................................................47
ABBREVIATIONS AND TERMINOLOGY .........................................................................48

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User’s Manual of OMNI III Patient Monitor

ZEROING THE CO2 MODULE............................................................................................48


PATIENT AND TUBING PREPARATION............................................................................48
ETCO2 SETUP .......................................................................................................................50
ADVANCED SETUP..............................................................................................................52
CALIBRATION ......................................................................................................................53
STATUS/ERROR MESSAGES ..............................................................................................53
MAINTENANCE AND CLEANING.....................................................................................54
IBP MONITORING (OPTION)......................................................................................................55
THEORY OF OPERATION....................................................................................................55
INTRODUCTION ..................................................................................................................55
WARNING..............................................................................................................................55
PREPARATION FOR MONITORING...................................................................................56
INSTRUCTIONS FOR USE OF TRANSDUCER MONITORING KIT...............................56
IBP SETUP .............................................................................................................................57
SET TRANSDUCER ZERO...................................................................................................60
PROMPT MESSAGE .............................................................................................................61
MAINTAINENCE AND CLEANING....................................................................................61
ANESTHETIC AGENT MONITORING(OPTION, PHASEIN)..............................................62
PHASEIN IRMA™ MAINSTREAM PROBE...............................................................................62
INTRODUCTION ..................................................................................................................62
SAFETY .................................................................................................................................63
SYSTEM ASSEMBLY INSTRUCTION................................................................................63
ZEROING PROCEDURE ......................................................................................................65
ALARMS................................................................................................................................66
CLEANING ............................................................................................................................67
MAINTENANCE ...................................................................................................................67
PHASEIN ISA™ SIDESTREAM ANALYZER.............................................................................68
INTRODUCTION ..................................................................................................................68
SAFETY .................................................................................................................................69
ANALYZER SYSTEM SET-UP.............................................................................................70
PRE-USE CHECK..................................................................................................................70
CONSUMABLE .....................................................................................................................71
ALARMS................................................................................................................................73
AUTOMATIC ZEROING.......................................................................................................74
CLEANING ............................................................................................................................74
MAINTENANCE ...................................................................................................................74
MAC (Minimum Alveolar Concentration) CACULATION ...................................................75
ADVERSE EFFECTS ON PERFORMANCE .......................................................................77
ANESTHETIC AGENT DISPLAY ........................................................................................77

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User’s Manual of OMNI III Patient Monitor

ANESTHETIC AGENT SETUP.............................................................................................78


ANESTHETIC AGENT MONITORING(OPTION, DRÄGER) ..............................................80
THEORY OF OPERATION AND DESCRIPTION ...............................................................80
PATIENT CONNECTIONS....................................................................................................81
ANESTHETIC AGENT DISPLAY ........................................................................................82
ANESTHETIC AGENT SETUP.............................................................................................83
MAC (Minimum Alveolar Concentration) Calculation ..........................................................85
CALIBRATION ......................................................................................................................85
CARDIAC OUTPUT MONITORING (OPTION) .........................................................................87
THEORY OF OPERATION....................................................................................................87
SENSOR INSTALLATION ....................................................................................................87
C.O. DISPLAY........................................................................................................................88
C.O. SETUP............................................................................................................................88
INFLUENCING FACTORS ...................................................................................................89
BLOOD TEMPERATURE MEASUREMENT ......................................................................89
PATIENT INFORMATION ADMINISTRATION..........................................................................91
PATIENT BASIC INFORMATION SETUP...........................................................................91
ADD NEW PATIENT .............................................................................................................92
DELETE PATIENT.................................................................................................................92
TREND ...........................................................................................................................................93
TREND OBSERVATION .......................................................................................................93
TIME SETUP..........................................................................................................................93
MARK EVENT SETUP .........................................................................................................94
TREND TIME.........................................................................................................................95
TREND GRAPH ANALYSIS.................................................................................................95
TABULAR TREND ANALYSIS............................................................................................96
ALARM EVENT ....................................................................................................................97
LAST WAVEFORM ...............................................................................................................97
CALCULATION.............................................................................................................................99
INTRODUCTION ..................................................................................................................99
DRUG CALCULATION ........................................................................................................99
HEMODYNAMIC CALCULATION ...................................................................................100
RECALL DATA............................................................................................................................102
RECALL DATA STORAGE.................................................................................................102
RECALL DATA DISPLAY...................................................................................................102
RECALL OPERATION DESCRIPTION .............................................................................102
RS-232 INTERFACE....................................................................................................................104
OVERVIEW..........................................................................................................................104
CABLE CONNECTION.......................................................................................................104
EXPORTING TREND DATA...............................................................................................104

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User’s Manual of OMNI III Patient Monitor

PRINTER (OPTION) .................................................................................................................105


PRINTER SETUP.................................................................................................................105
PRINT REAL-TIME WAVEFORM......................................................................................105
PRINT TABULAR TREND..................................................................................................105
GRID OUTPUT ....................................................................................................................106
PRINT ALARM EVENT......................................................................................................106
PRINT EVENT LIST............................................................................................................106
PRINT EXPLANTION.........................................................................................................106
WAVEFORM PRINT EXPLANATION ...............................................................................107
BATTERY OPERATION..............................................................................................................108
INTRODUCTION ................................................................................................................108
BATTERY RECYCLE..........................................................................................................108
DISPOSAL OF DEVICE COMPONENTS ..................................................................................109
PERIODIC SAFETY CHECKS....................................................................................................110
CLEANING ..................................................................................................................................110
SPECIFICATIONS ....................................................................................................................... 111
EMC..............................................................................................................................................120
ELECTROMAGNETIC IMMUNITY..................................................................................120

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User’s Manual of OMNI III Patient Monitor

FIGURES
Figure 1: Front Panel.................................................................................................................5
Figure 2: Left Side Panel...........................................................................................................6
Figure 3: Right Side Panel ........................................................................................................7
Figure 4: Rear View for Main Unit ...........................................................................................7
Figure 5: Display Screen.........................................................................................................10
Figure 6: Tree Diagram for System Setup Menu ....................................................................12
Figure 7: Keypad to input ASCIIS ..........................................................................................14
Figure 8: Window for oxyCRG...............................................................................................17
Figure 9: Window for Large Font ...........................................................................................18
Figure 10: 5-lead Electrode Placement ...................................................................................22
Figure 11: C-electrode Placement ...........................................................................................23
Figure 12: 12-Lead Electrode Placement ................................................................................24
Figure 13: Tree Diagram for ECG Setup ................................................................................25
Figure 14: Window for ARR Review......................................................................................29
Figure 15: Window for ARR Retail Information.....................................................................30
Figure 16: Window for Full 12-Lead ECG .............................................................................31
Figure 17: Tree Diagram for Resp Menu ................................................................................34
Figure 18: Tree Diagram for SpO2 Setup Menu......................................................................36
Figure 19: Tree Diagram for NIBP Setup Menu .....................................................................40
Figure 20: Window for NIBP List Observation ......................................................................43
Figure 21: Tree Diagram for Temp Setup Menu .....................................................................45
Figure 22: Tree Diagram for EtCO2 Setup Menu....................................................................50
Figure 23: Tree Diagram for EtCO2 Advanced Setup .............................................................52
Figure 24: Tree Diagram for IBP1 or IBP2 Setup Menu ........................................................58
Figure 25: Window for IBP1 or IBP2 Wave Scale..................................................................59
Figure 26: Window for IBP1 or IBP2 Alarm Setup ................................................................59
Figure 27: Tree Diagram for Multi-Gas Setup Menu..............................................................78
Figure 28: Tree Diagram for Multi-Gas Waveform Setup Menu ............................................84
Figure 29: The Diagram for C.O. Sensor Installation .............................................................87
Figure 30: Window for C.O. Display ......................................................................................88
Figure 31: The Diagram for Blood Temperature Measurement ..............................................90
Figure 32: Tree Diagram for Patient Setup .............................................................................91
Figure 33: Tree Diagram for Time Setup ................................................................................94
Figure 34: Window for Mark Event Setup ..............................................................................94
Figure 35: Window for Event List...........................................................................................94
Figure 36: Window for Trend Graph.......................................................................................95
Figure 37: Window for Basic Parameters Tabular Trend ........................................................96
Figure 38: Window for IBP Tabular Trend..............................................................................96
Figure 39: Window for C.O. Tabular Trend ............................................................................97
Figure 40: Window for Alarm Event Review..........................................................................97
Figure 41: Window for Last Waveform Review .....................................................................98
Figure 42: Window for Drug Calculation ...............................................................................99
Figure 43: Window for Hemodynamic Calculation ..............................................................100
Figure 44: Window for Indication Information.....................................................................102
Figure 45: Window for Recall Patient...................................................................................103
Figure 46: Window for Trend Management with ID.............................................................103
Figure 47: Real-time Waveform Print ...................................................................................105
Figure 48: Basic Tabular Trend Print ....................................................................................105
Figure 49: Alarm Event Print ................................................................................................106
Figure 50: Event List Print....................................................................................................106

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User’s Manual of OMNI III Patient Monitor

SAFETY INFORMATION
This section contains important safety information related to general use of the OMNI III
Patient Monitor. Other important safety information appears throughout the manual in
sections that relate specifically to the precautionary information. Read all text surrounding
all precautionary information.

The OMNI III can be powered by one or two internal battery that provides 2 hours of
monitoring from fully charged batteries. The batteries are continuously recharged when
AC power is connected to the monitor.
A warning message appears on the screen and an audible alarm sounds when the
remaining battery power is only enough for 15 minutes of operation. The user should
connect the monitor to an external power source to avoid loss of patient monitoring action.
External power sources may be connected, disconnected, and reconnected without
interrupting the monitoring action.

[NOTE]: Before use, please read this manual carefully.

[WARNING]: The OMNI III is defibrillator proof. It may remain attached to the patient
during defibrillation or while an electrosurgical unit is in use, but the readings may be
inaccurate during use and shortly thereafter.

[WARNING]: The OMNI III Patient Monitor is a prescription device and is to be


operated by qualified personnel only.

[WARNING]: Occasionally, electrical signals at the heart do not produce a peripheral


pulse. If a patient’s beat-to-beat pulse amplitude varies significantly (for example,
pulsus alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and
pulse rate readings can be erratic and an alternate measuring method should be used
for confirmation.

[WARNING]: Explosion hazard. DO NOT use the OMNI III in the presence of
flammable anesthetics or gases.

[WARNING]: DO NOT lift the monitor by the sensor cable, blood pressure hose, or
power cord because the cable, lead, or cord could disconnect from the monitor,
causing the monitor to drop on the patient.

[WARNING]: The OMNI III may not operate effectively on patients who are
experiencing convulsions or tremors.

[WARNING]: Disconnect the OMNI III and sensors during magnetic resonance
imaging (MRI) scanning. Use during MRI could cause burns or adversely affect the
MRI image or the monitor’s accuracy. Also, to avoid burns, remove the sensors from
the patient before conducting MRI.

[WARNING]: The user must check the equipment prior to use and ensure its safe and
proper use.

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User’s Manual of OMNI III Patient Monitor

[WARNING]: To ensure that the leakage current protection remains within the
specifications, use only the patient cables supplied with, or specifically intended for
use with the OMNI III Monitors.

[WARNING]: To ensure patient safety, DO NOT place the monitor in any position that
might cause it to fall on the patient.

[WARNING]: For pacemaker patients, the OMNI III may continue to count pacemaker
rate during occurrences of cardiac arrest or some arrhythmias. To reduce the likelihood
of this, ensure that the Pacer Detect setting is ON in the ECG menu when monitoring
such patients. DO NOT rely entirely upon the OMNI III alarms. Keep pacemaker
patients under close surveillance.

[WARNING]: Connection of non-isolated devices to the RS-232 connector may cause


chassis leakage to exceed the specification standards.

[WARNING]: Enclosure leakage current is less than 100 microamperes (µA);


however, always consider additional leakage current that can be caused by other
equipment used on the patient at the same time as these monitors.

[WARNING]: DO NOT autoclave, ethylene oxide sterilize, or immerse these monitors


in liquid. Unplug the monitors before cleaning or disinfecting.

[WARNING]: DO NOT use the OMNI III to monitor patients who are linked to
heart/lung machines.

[WARNING]: To prevent electrical hazards to all personnel, these monitors must be


properly grounded. The chassis grounding assembly, Universal Switching Power
Supply, and the power cord supplied with the equipment provides for this protection.
DO NOT attempt to defeat this protection by modifying the cords or using ungrounded
adapters.

[WARNING]: It is possible for the patient to receive a burn due to an improperly


connected electrosurgical unit. Additionally, the monitor could be damaged or
measurement errors could occur. Certain steps can be taken to mitigate against this
problem, such as not using small ECG electrodes, selecting ECG electrode sites
remote from the expected RF paths, using large electrosurgical return electrodes, and
verifying that the electrosurgical return electrode is properly attached to the patient.

[WARNING]: ECG cables 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 using again.

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User’s Manual of OMNI III Patient Monitor

[WARNING]: Line isolation monitor transients 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 and electrode directions for
use.

[WARNING]:
Defibrillation and Electrosurgery: DO NOT touch the patient, or table, or
instruments, during defibrillation.
After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied in accordance with the manufacturer’s instructions.
ECG cables can be damaged when connected to a patient during defibrillation. Check
cables for functionality before using them again.
According to AAMI specifications the peak of the synchronized defibrillator discharge
should be delivered within 60 ms of the peak of the R wave. The signal at the ECG
output on the OMNI III patient monitors is delayed by a maximum of 30 ms. Your
biomedical engineer should verify that your ECG/Defibrillator combination does not
exceed the recommended maximum delay of 60 ms.
When using electrosurgical (ES) equipment, never place ECG electrodes near to the
grounding plate of the ES device, as this can cause a lot of interference on the ECG
signal.

[Caution]: When connecting the OMNI III to any instrument, verify proper operation
before clinical use. Both the OMNI III and the instrument connected to it must be
connected to a grounded outlet. Accessory equipments connected to this Patient Monitor
must be certified according to the respective IEC standards (e.g. IEC 60950 for
information technology equipment and IEC 60601-1 for medical electrical equipment).
Furthermore all configurations shall comply with the valid version of the system standard
IEC 60601-1-1.

Any person who connects additional equipment to the signal input or signal output is
responsible to ensure the system complies with the requirements of the valid version of
the system standard IEC 60601-1-1. If you have any questions, please be free to contact
our company or customer service. in doubt, contact our company or customer service.

To ensure accurate readings, consider the environmental conditions that are present and
the condition of the patient. See the appropriate sections of the manual for specific safety
information related to these conditions.

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User’s Manual of OMNI III Patient Monitor

INTRODUCTION
INTENDED USE
ABOUT THIS MANUAL
INTENDED USE
The OMNI III Patient Monitor is a comprehensive monitoring system with eight traces
compiling, processing, analyzing and displaying data from up to nine different patient
parameters. It integrates parameter measuring modules, display and printer in one device,
featuring in compactness, lightweight and portability. Built-in battery facilitates
transportation of patient.
The purpose and function of the OMNI III Patient Monitor is to monitor ECG, heart rate,
NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, dual
temperature, EtCO2, dual IBP, anesthetic gas (AG), C.O. (Cardiac Output) for adult,
neonate and pediatric patients in all hospital areas and hospital-type facilities. It may be
used during hospital transport and in mobile, land-based environments, such as
ambulances.

WARNING: The OMNI III Patient Monitor is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and symptoms.

ABOUT THIS MANUAL


This manual explains how to set up and use the OMNI III Patient Monitor. Important safety
information relating to general use of the OMNI III appears before this introduction. Other
important safety information is located throughout the text where applicable. Read the
entire manual including the Safety Information section before you operate the
monitor.

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User’s Manual of OMNI III Patient Monitor

CONTROLS, INDICATORS, AND SYMBOLS


FRONT PANEL
LEFT SIDE PANEL
RIGHT SIDE PANEL
REAR PANEL
SYMBOLS
FRONT PANEL

Figure 1: Front Panel

No FUNCTION
Icon
.
1 ALARM INDICATOR
In normal mode, no indicator lights.
In alarm mode, the alarm indicator lights or flashes.
2 POWER SWITCH
This toggle switch turns the secondary power from on to off from the monitor.
The monitor will continue to charge the battery as long as the AC cable is plugged
in, even if the power switch is in the off station.
3 DC ON
This LED indicates that the monitor is powered by battery.
4 AC ON
This LED indicates that the monitor is plugged in to AC.
5 START/STOP
Toggles between starting and stopping NIBP measurement
6 SILENCE
Press this button once to restrain the system sound and alarm sound, press it
again to restore the system sound and alarm sound.
7 SETUP
Press to call up system configuration setup menu

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User’s Manual of OMNI III Patient Monitor

8 FREEZE
Press this button once to freeze current display waveforms, press it again will
release them.
9 TREND
To indicate a reference to trend information.
10 PRINT
Real-time print current waveform curve and parameters
11 ROTARY KNOB
Use it to set up parameters. Rotate the KNOB clockwise or counterclockwise to
choose the item, press the rotary knob, then rotate it to change the item.

LEFT SIDE PANEL

Figure 2: Left Side Panel

No FUNCTION
.
1 Oxygen Saturation Sensor Socket
2 C.O. Cable Socket (Option)
3 Channel 1 IBP Port (Option)
4 Channel 2 IBP Port (Option)
5 NIBP Socket
6 AG/EtCO2 Sensor Socket (Option)
7 Channel 1 Temperature Probe Socket
8 Channel 2 Temperature Probe Socket
9 AAMI ECG Cable Connector
10 Battery access

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User’s Manual of OMNI III Patient Monitor

RIGHT SIDE PANEL

Figure 3: Right Side Panel

No FUNCTION
.
1 1WATER TRAP (Option)
This plastic container collects condensation from the multi-gas sample line.
2 2Printer (Option)

REAR PANEL

Figure 4: Rear View for Main Unit

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User’s Manual of OMNI III Patient Monitor

No FUNCTION Icon
.
1 1AC Input 100-240V
The AC power connection is where facility line power is 50/60Hz,
connected to this monitor, the AC power fuses must be 150VA
replaced with the same type and rating fuse.
2 2Equipotentiality Ground
Solve the ground loop and mains problem by designing
several alternate courses for electrical energy to finds its way
back to ground.
3 Peripheral VGA display connector
VGA
4 Ethernet Interface
RJ45 interface, used for connection between Central Station
and Patient Monitor. It also can be used for upgrade system.
5 3RS-232 I/O
This digital interface connector provides serial data to most RS232
RS-232 devices.
Used for communication interface and upgrade system

SYMBOLS
The following symbols may appear on the packaging, monitor or in user’s manual:
Type BF Applied Part

Defibrillation-Proof Type CF Applied Part


To identify a defibrillation-proof type CF applied part complying with
IEC 60601-1.
Note 1 - C = Cardial.
Note 2 - F = Floating Applied Part.
Rechargeable Battery
To indicates the positioning of the cells.
Manufacture’s Serial Number

Fuse Information

Date Of Manufacture

Manufacturer

Fragile
Contents of the transport package are fragile therefore it shall be
handled with care.

This Way Up
Indicates correct up right position of the transport package.

Keep Away From Rain


Transport package shall be kept away from rain.

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User’s Manual of OMNI III Patient Monitor

Stacking Limit By Number


Maximum number of identical packages which may be stacked on
one another is eight.

General Warning, Caution, Risk Of Danger


Please read the instructions carefully before operating the product.

Stand-by
To identify the switch or switch position by means of which part of the
equipment is switched on in order to bring it into the stand-by
condition.

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User’s Manual of OMNI III Patient Monitor

DISPLAY SCREEN PARTITION

Figure 5: Display Screen

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User’s Manual of OMNI III Patient Monitor

All TFT display screen is divided into three areas:


WAVEFORM AREA
This area will display the waveforms: ECG, PLETH, RESP, ART, PA, EtCO2, Gas and so
on. The waveform channel number is decided by the choice of Display Mode. Displaying
waveforms are depended on the choice of Waveform Select. And also, the user can use
menu to distribute the combination of window waveforms and oxyCRG or C.O. (Cardiac
Output).
PARAMETER AREA
This area consists of HR, RESP, SpO2, TEMP, NIBP(SYS、DIA、MAP), EtCO2, Gas and so
on. Of course, the user can use menu to distribute the combination of window Parameters
and NIBP data list.
MESSAGE AREA
Time, Patient Information, Power State and some prompt information are list here.

On the condition of main screen displaying, press the ROTARY KNOB to pop the menu
correspond with the white box on the screen, press the function buttons of
SILENCE,TREND and SETUP etc. button also can pop the correlated menu. Turning the
ROTARY KNOB can move among the menu items; and to press the ROTARY KNOB can
access the choosing item (enter submenu if available), then turn the ROTARY KNOB to
change the value of it and then press the ROTARY KNOB can exit from the menu item.
So the new setup value becomes effective. If you want to exit from menu, just choose the
menu item of EXIT or OK (or CANCEL) and press the ROTARY KNOB.

NOTE: The function of soft-key is equal to hard-key in the panel. In this


manual, we only describe the operation for soft-key. Of course, the user can
finish relevant operation for Start/stop NIBP, Silence, System setup, Trend,
Print by hard-key.

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User’s Manual of OMNI III Patient Monitor

SYSTEM SETUP
System Setup includes: Factory Setup, Optional Module, Waveform Select, Printer,
Config Manager, Drug Calculation, Hemodynamic, Language, Display Mode, Alarm
Suspend, Sweep Direction and etc.

Press the button of SETUP to pop the menu below:


IBP Module

Factory Setup EtCO2 Module


Gas Module

ECG 12-lead
Optional Module
C.O. Module
HL7 Function

Channel 1
Waveform Select ……
Channel 8

Status
Grid Output
Alarm Print
Printer Auto Print
Parameters Only
Waveform 1
Waveform 2
Waveform 3
System Setup Hospital Name

Load User Config


Config Manager Save Current Config
Delete User Config
Drug Calculation
Export User Config
Hemodynamic Cal

Language

Demo

Display Mode

Alarm Suspend

Sweep Direction

Sound Level

Heart Sound

HL7

About

Screen Cal

Figure 6: Tree Diagram for System Setup Menu


FACTORY SEVICING SETUP
Servicing engineer use only.

1. If inputting “IP SETUP” for the password, the window for Ethernet IP address setup of

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User’s Manual of OMNI III Patient Monitor

the Patient Monitor will pop out. It is used for connecting between Patient Monitor and
Central Station. This IP address is available only when the patient monitor is
re-powered on.
2. If inputting “NUIPSET.” for the password, you can set the remote address, which
should be as same as server IP, when you upgrade the program using Ethernet.
OPTIONAL MODULE
You can input different passwords to open the relevant modules such as IBP, EtCO2, Gas,
12-Lead ECG, C.O. and HL7 interface.
WAVEFORM SELECT
Select WAVEFORM SETUP item to pop the menu of system Setup.

The waveforms from top to bottom can be selected from ECG I, ECG II, ECG III, ECG
avR, ECG avL, ECG avF, ECG V, Pleth, Resp, IBP1, IBP2, EtCO2, and AG.

The IBP1, IBP2, EtCO2, AG could be chosen only when the related module be opened.
If the ECG Lead Type is 12-lead, screen can display full 12-lead ECG waveforms.
PRINTER
Pick PRINTER item in the SYSTEM SETUP menu to finish the settings below.
STATUS
Use to display the connecting state of printer. Connected or Disconnected.
GRID OUTPUT
ON to make waveform print out has a net background, just like record paper. Contrary
when closed.
ALARM PRINT
If this item is set to ON, It can print a slip of waveform of 10 seconds (the preceding 4
seconds before the recording till the current 4 seconds) when an alarm is happened.
AUTO PRINT
5 minutes, 10 minutes, 20minutes, 30 minutes and 60 minutes are for choice, if the
“Parameters Only” menu is set to on, after related interval, it will only print parameters’
value automatically. If it is set to off, it will print Waveform and Parameters’ value
automatically. Also, you can choice “OFF”, and then the print should be executed by
manual.
PARAMETERS ONLY
If this item is set to ON, It could print the parameters’ value only. For example HR, NIBP,
RR, SpO2, IBP1, IBP2, ST, T1, T2, EtCO2, nN2O, inENF and expENF and so on.
WAVEFORM 1 or 2 or 3
This item is to choose what waveform is to print out.
HOSPITAL NAME
Click this item to input or change the hospital name. When click the input name location, a
keypad will display, you can select any word on it as following picture:

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User’s Manual of OMNI III Patient Monitor

Figure 7: Keypad to input ASCIIS


CONFIG MANAGER
LOAD USER CONFIG
If the parameter settings are confused on irrational, you can call the Default Config to
recover original state. Also you can choose the setting which is saved by yourself. The
screen will display a menu to let you confirm the setup.

After return to the above confirmation menu, a message of “Load Configuration Data
Success!” will display in the message highlight area, showing that the system has begun
to work with the new settings.
SAVE CURRENT CONFIG
You can change monitor settings as required and then save the changed settings into a
user configuration so that system can call up these settings at the next time of open. You
will be asked to input the user’s name in order to distinguish different settings. The Patient
Monitor can save multiple user configurations. The screen will display a menu to let you
confirm the setup:

After return to the above confirmation menu, a message of “Config Data Saved!” will
display in the message highlight area, showing that the system and all monitoring
parameter settings have been saved (see each chapter).

[NOTE]
Make sure that the changes are suitable for your patient.

DELETE USER CONFIG


Delete the user config saved before.
DRUG CALCULATION
Refer to the CALCULATION section for details.
HEMODYNAMIC CAL
Refer to the CALCULATION section for details.
LANGUAGE SETUP
Use to select language for the monitor system. The language can be switched only after
inputting the correct password of “language”.

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DEMO DISPLAY
The Demo mode is for demonstration purpose only. To avoid that the simulated data are
mistaken for the monitored patient’s data, you must not change into demo mode during
monitoring, otherwise, improper patient monitoring and delayed treatment could result.

This function is for servicing engineer only.


OTHER SETUP
SOUND LEVEL
I, II, III, IV and OFF for choice. IV means the loudest sound.
HEART SOUND
QRS, Pulse, IBP1, IBP2 or OFF for choice, the factory-set is QRS.

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HOW TO MONITOR
1. According to the parameter needed, connect the correlated sensors to the sockets on
the left panel;
2. Connect with the power supply, press the power switch in the front panel;
3. Power indicator is bright, the display screen enter the main screen after 25 seconds;
4. Connect the detector with the patient;
5. Set monitoring parameters (see chapters below) ;
6. Enter the monitoring state.

CAUTION: If the OMNI III is to be stored for a period of 2 months or longer, notify
service personnel to remove the battery from the monitor prior to storage. Recharge
the battery when the battery has not been recharged for 2 or more months.

CAUTION: Follow local government ordinances and recycle instructions regarding


disposal or recycling of device components, including batteries.

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User’s Manual of OMNI III Patient Monitor

DISPLAY MODE
OXYCRG SCREEN
LARGE FONT SCREEN

OMNI Patient Monitor has six modes for display such as 10 Waveforms, 8 Waveforms, 6
Waveforms, 3 Waveforms, Large Font and OxyCRG.

In addition, when the module function for C.O. or 12-Lead is opened, you can also choose
the display mode for C.O. or Full 12-Lead ECG.

Especially, 3 Waveforms mode is usually used when the ECG Lead Type is 3 Leads.
When the Lead Type is 5 Leads, the default display mode is 8 Waveforms; when the Lead
Type is 12 Leads, the default display mode is Full 12-Lead. Also you can set the display
mode as required.
OXYCRG SCREEN
To have a split screen view of oxyCRG, you could select Display Mode for oxyCRG. The
interface is as below:

Figure 8: Window for oxyCRG

The split screen view covers the lower part of the waveform area and shows HR Trend,
SpO2 Trend and RR Trend (or Resp Waveform). At the bottom, there are controls as
below:
OXYGEN SETUP
TIME
In the time menu, you can select 1 minute, 2 minutes, 4 minutes and 8 minutes
RR/RESP
You can select either RR Trend or Resp Waveform for display.
PRINT
Through this soft-key, you can print out the currently displayed oxyCRG trends by the
printer.
LARGE FONT SCREEN
To enter the big numeric screen: select the Display Mode for Large Font. The interface is
as below:

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User’s Manual of OMNI III Patient Monitor

Figure 9: Window for Large Font

You can select your desired parameters to display in this screen.

In the Waveform Select menu, you can select the waveform related to the parameter you
want. For example: if you want display the big numeric of SpO2 value and PR value in the
screen, you could select the Pleth in the channel1 or other channel. For parameters
having a waveform, the waveform will also be displayed.

[NOTE]: The first ECG Waveform is corresponding to HR Value. The second ECG
Waveform is to NIBP Value. The third ECG Waveform is to Temp Value. The other
ECG Waveform is to nothing.

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ALARM & SOUND

ALARM
When the monitor detects certain conditions that require user attention, the OMNI III
Patient Monitor enters an alarm state. The monitor response is indicated by:
• Visual alarm indicators
• Audible alarm indicators
• Print-on-alarm (if printer installed)
• Identification of out-of-limit vital signs in trend data
ALARM SETUP
ALARM PRIORITY
The monitor’s visual and audible responses to a detected alarm depend on the priority
of the alarm; High, Medium, or Low.
A higher priority alarm will supersede a lower priority alarm.
The three categories of alarms are summarized in the following paragraphs. The text
indicates the message shown on the screen.

In this menu, you can set the alarm priority, which functioned when the parameters’
numeric value limits violated, for HR, ARR, ST, SpO2, PR, Resp, NIBP, Temp, IBP and
EtCO2, each priority has two items for choice, High and Medium. The default is all
medium.

HIGH PRIORITY
Indicating that immediate OPERATOR response is required:
Asystole (4 seconds have passed with no heart beats from ECG, preceded by
detecting valid ECG-derived heart rate data.)
Loss of Pulse from SpO2 (and no valid ECG)

MEDIUM PRIORITY
Indicating that prompt OPERATOR response is required:
High/Low numeric value limits violated (such as High/Low SpO2 limits violated,
High/Low Sys./Dia. blood pressure limits violated, High/Low Respiration Rate limits
violated, High/Low Temperature limits violated, etc.)

LOW PRIORITY
Indicating that OPERATOR awareness is required:
Senor or leads off (such as ECG Leads Off, SpO2 Cable/Sensor Disconnect,
Temperature Probe Disconnect, etc.) , Low Battery (alarm commences when the
OMNI III has at least 10 minutes of operating time remaining) and communications
errors for modules.

ALARM LIMITS

In the menu, you can set all the Parameters’ Alarm Limits as you need. The setting here is
equivalent to set in relevant Parameter Setup Menu. The same menu item will change at
the same time.

WARNING: Before using the monitor each time, check alarm limits to ensure
that they are appropriate for the patient being monitored.

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User’s Manual of OMNI III Patient Monitor

VISUAL ALARM INDICATORS


When an alarm occurs, the OMNI III responds with visual alarm indications. The
flashing rates for the three categories of alarms are shown. The OMNI III uses
flashing colors to indicate high and medium priority alarm as following Flashing Rates.

Alarm Category Flashing Rate


High Priority Two flashes in 1 second
Medium priority One flash in 2 seconds
Low priority Constant (on) (non-flashing)

When a low priority alarm occurs, a non-flashing alarm message appears in the
message area. If more than one low priority alarm is present, the alarm messages
“rotate”. On the OMNI III numeric frame background color will change to a solid yellow
for a low priority alarm

A medium priority alarm is activated when a parameter is outside its alarm limits, the
out-of-limit numeric value and the bell icon in the corresponding Numeric Frame flash
at the medium priority rate. Only the numeric frame background color will flash yellow
for a medium priority alarm in the OMNI III.

When the high-priority Asystole alarm occurs, the heart rate numeric value and the
corresponding bell icon flash at the high priority rate. Only the numeric frame
background color will flash red for a high priority alarm in the OMNI III. A non-flashing
Asystole message appears in the message area and will override any other
messages which may be present (there is no message “rotation” in this instance).

ALARM SUSPEND
if you want to temporarily prevent alarms from sounding, you can pause alarms by
pressing the softkey or hardkey “Silence”. When alarms are suspended:
No alarm lamps flash and no alarms are sounded.
No alarm messages are shown.
The remaining pause time is displayed in the alarm prompt area.
During Alarm Suspend, monitoring continues for all parameters; the numeric values
and waveforms continue to operate normally. Trend memory operates normally. The
single-function buttons continue to operate normally.

The Patient Monitor enters into the alarm paused status as soon as it is turned on.
The user can set the suspend time in the Alarm Suspend Menu. There are four items
for choice. 1 minute, 2 minute, 3 minute, Permanent.

When the alarm pause time expires, the alarm suspended status is automatically
cancelled. Also you can press the “Silence” key to terminate the alarm suspended
condition. If you choose “Permanent”, it means that the alarms suspend permanently.

WARNING: DO NOT switch off or pause or decrease its volume to the alarm if
patient safety could be compromised.

ALARM SWITCH
When any alarm switch is set to be OFF, the alarm indicator will not light, the relative

alarm parameter will not flash and relative parameter area will appear an icon of .

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User’s Manual of OMNI III Patient Monitor

SOUND
ALARM SOUND
Like the mild sound of BEEP. There are four items of Ⅰ, Ⅱ, III and Ⅳ for alarm levels
in turn from low to high.

The following encoded auditory alarm signals categorized by alarm condition and
priority:

Alarm Category Encoded Auditory


High Priority c c c-c c
Medium priority ccc
Low priority eC
[NOTE 1]: The characters c,e refer to relative musical pitches and C is one octave c.
[NOTE 2]: A high priority alarm signal is generated with the five pulses, repeat
once, for total of 10 pulses.

HEART-BEAT (PULSE-TONE)
The heart-beat or pulse-tone is a sound of RUB-A-DUB. In the Setup menu, there are
QRS, PULSE, IBP1, IBP2 and OFF for choice, when the choice is QRS, the system will
sound by heart-beat sound. When the choice is PULSE, the system will sound by
pulse-tone sound and the sound frequency is changed with the SpO2 Value. When the
choice is IBP1 or IBP2, the system will sound by IBP sound. When the choice is OFF, the
system will close the heart-beat sound or pulse-tone or IBP.

KEY BEEPS
The key beep sounds come along with clicking function items.

SILENCE

Click this function button to disable all sounds except for the key beeps. A symbol of
displays in the message area, click this button again to restore all sounds except for the
key beeps.

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ECG MONITORING
ELECTRODE INSTALLATION
CABLE AND LEADWIRE INSTALLATION
ECG SETUP
12-LEAD ECG MONITORING
ERROR MESSAGES OF ECG MONITORING
MAINTENANCE AND CLEANING
ELECTRODE INSTALLATION
Some points should be paid attention to in ECG monitoring:
1. Check the lead and cable. The damaged or ruptured one cannot be used.
2. Link up the lead set and cable, and connect the electrode to the lead.
3. Choose the suitable skin at which the electrode should be pasted. Use alcohol to
clean the skin and remove the skin grease. Paste the electrode on the patient and
check that whether they are contact well.
4. The electrodes must be moved away to check the skin every 24 hours, if the skin is
found inflamed of damaged evidently, substituted a new electrode to another
position.
5. Make sure no conductive part of electrodes is in contact with the ground and other
conductive.

5-Leadwire Electrode Placement

Follow the methods below to place the 5–lead electrode.

Figure 10: 5-lead Electrode Placement


□ WHITE (RIGHT ARM) ELECTRODE (RA)—is placed near the right shoulder, directly
below the clavicle.
□ BLACK (LEFT ARM) ELECTRODE (LA)—is placed near the left shoulder, directly
below the clavicle.
□ GREEN (REFERENCE) ELELCTEODE (RL)—is placed on the right hypogastria.
□ RED (LEFT LEG) ELELCTEODE (LL)—is placed on the left hypogastria.
□ BROWN(CHEST)ELECTRODE(V or C)-is placed on the chest as illustrated below:
[NOTE]
Only the ECG cable presented by our factory can be used.
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:

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User’s Manual of OMNI III Patient Monitor

Figure 11: C-electrode Placement


□ V1 is on the 4th intercostal space at the right sterna margin.
□ V2 is on the 4th intercostal space at the left sterna margin.
□ V3 is at the midway between V2 and V4 electrodes.
□ V4 is on the 5th intercostal space at the left clavicular line.
□ V5 is on the left anterior axillary line, horizontal with V4 electrode.
□ V6 is on the left middle axillary line, horizontal with V4 electrode.
□ V3R-V7R is on the right side of the chest in positions corresponding to those on the left.
□ VE is over the xyphoid. As for the V-lead position on the back, it should be placed at
one of the positions below.
□ V7 is on the 5th intercostals space at the left posterior axillary line of back.
□ V7R is on the 5th intercostals space at the right posterior axillary line of back.

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User’s Manual of OMNI III Patient Monitor

12-Leadwire Electrode Placement

12-lead ECG uses 10 electrodes, which


are placed on the patient’s four limbs and
chest. The limb electrodes should be
placed on the soft skin and the chest
electrodes placed according to the
physician’s preference.

Lead Placement for Surgical Patients

The surgical site should be taken into


consideration when placing electrodes on
a surgical patient. e.g. for open-chest
surgery, the chest electrodes can be
placed on the lateral chest or back. To
reduce artifacts and interference from
electrosurgical units, you can place the
limb electrodes close to the shoulders and
lower abdomen and the chest electrodes
on the left side of the mid-chest. Do not
place the electrodes on the upper arm.
Otherwise, the ECG waveform will be very
small. Figure 12: 12-Lead Electrode Placement

WARNING:
When using electrosurgical units (ESU), patient leads should be placed in a
position that is equal distance from the Electrosurgery electrotome and the
grounding plate to avoid burns to the patient. Never entangle the ESU cable
and the ECG cable together.
When using electrosurgical units (ESU), never place ECG electrodes near
to the grounding plate of the ESU, as this can cause a lot of interference on
the ECG signal.

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User’s Manual of OMNI III Patient Monitor

CABLE AND LEADWIRE INSTALLATION


1. Insert the plug of ECG into socket on the left panel of monitor, make sure that the
salient of plug is direct to the notch of socket when inserting.
2. Connect the electrode lead to the patient’s cable.
ECG SETUP
Turn the ROTARY KNOB and move the white box to the Waveform or Parameter area of
ECG, this menu can finish settings below:
Alarm Switch
HR Alarm High
HR Alarm Low
ECG Lead
ECG Setup ECG Gain
ECG Filter
ECG Notch
Lead Type
ECG Cascade
Sweep Speed
Sweep Color
Pacemaker
Detection
ECG Test
ST Alarm
ECG Verify
ST Analysis
ST Analysis ST Alarm High
ST Alarm Low
ST Adjust

ARR Analysis
ARR Source
PVC Monitor
ARR Analysis PVC Alarm
Count
ARR Relearn
ARR Alarm
Setup
ARR Review
Figure 13: Tree Diagram for ECG Setup

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User’s Manual of OMNI III Patient Monitor

ALARM SWITCH
ON and OFF for choice, the factory–set is ON.
If the HR value is above or below the HR alarm limit, when the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .
HR ALARM HIGH
The range is:80~400 bpm,the factory-set is 130 bmp,the single-step adjustable step-
length is 5 bpm.
HR ALARM LOW
The range is:20~150 bpm,the factory-set is 50 bmp,the single-step adjustable step-
length is 5 bpm.
ECG LEAD
When the Lead Type is 5 Leads or 12 Leads, the item is not selectable. When the Lead is
3 Leads, you can choose it for Lead I or Lead II or Lead III.
ECG GAIN
The user can freely choose one from items of X0.25, X 0.5, X1.0 and X2.0. The bigger the
gain is, the larger the waveform amplitude is. The factory-set is X1.0. When the display
mode is 10 Waveforms, it could not choose the item for X2.0.
ECG FILTER
The ECG Filter setting defines how ECG waveforms are smoothed. Freely select three
different modes which are Surgery, Monitor or Diagnose. The factory-set is Monitor.
Monitor: Use under normal measurement conditions
Diagnose : Use when diagnostic quality is required. The unfiltered ECG
waveform is displayed so that changes such as R-wave notching or discrete
elevation or depression of the ST segment are visible.
Surgery: Use when the signal is distorted by high frequency or low frequency
interference. High frequency interference usually results in large amplitude
spikes making the ECG signal look irregular. Low frequency interference usually
leads to wandering or rough baseline. In the operating room, the surgery filter
reduced artifacts and interference from electrosurgical units. Under normal
measurement conditions, selecting ‘Surgery’ may suppress the QRS complexes
too much and then interfere with ECG analysis.
ECG NOTCH
The notch filter removes the line frequency interference. When ECG filter is Monitor or
Surgery mode, the notch filter always stays on. Only when the filter is Diagnose mode,
you can switch the notch filter on or off as required. ECG notch can be set 50Hz or 60Hz
according to power line frequency. The factory-set is 50Hz.
LEAD TYPE
3 leads and 5 leads for choice, the factory-set is 5 leads. 12-lead can be chosen only
when the ECG 12-Lead is ON in Optional Module.
ECG CASCADE
ON or OFF, if choose ON, an ECG waveform will take up two channels. After filled up with
the first channel, the waveform will follow the second channel. In the cascade mode, the
waveform could only sweep from left to right. The default-set is OFF.
SWEEP SPEED
Select from 12.5 mm/s, 25 mm/s, 50 mm/s and 100 mm/s. The factory-set is 25 mm/s.
SWEEP COLOR

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User’s Manual of OMNI III Patient Monitor

Select from White, Gray, Red, Yellow, Green, Cyan, Blue, and Magenta. The default-set is
Green.
PACEMAKER DETECTION
It is important to set the paced status correctly when you start monitoring ECG. When the
Pacemaker Detection is set to ON, the pace pulse markers “|”are shown on the ECG
waveforms when the patient has a paced signal.

[WARNING]
1. For paced patients, you must set Pacemaker Detection to ON. If it is incorrectly
set to OFF, the patient monitor could mistake a pace pulse for a QRS and fail to
alarm when the ECG signal is too weak. DO NOT rely entirely on alarms when
monitoring patients with pacemakers. Always keep these patients under close
surveillance.
2. For non-paced patients, you must set Pacemaker Detection to OFF. If it is
incorrectly set to ON, the patient monitor may be unable to detect premature
ventricular beats (including PVCs) and perform ST segment analysis.

ECG TEST
Used by engineer only.

ECG VERIFY
Used by engineer only.

ST-SEGMENT ANALYSES
ST-segment analysis calculates ST-segment elevations and depressions for individual
leads and then displays it as numeric in the ECG Parameter area. A positive value
indicates ST-segment elevation; a negative value indicates ST segment depression. It is
not intended for neonatal patients.

As shown in the figure below, the ST measured for each beat complex is the vertical
difference between two measurement points with the R-wave peak as the baseline for the
measurement.

ST ALARM SWITCH
The default value is OFF. The alarm is triggered when the ST measurement value
exceeds the alarm limits. If the ST Alarm is ON, the ST value blinks, the alarm sounds and
the alarm indicator flashes, and the information column will give the note that ST HIGHER
or ST LOWER.
ST ALARM LIMIT

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User’s Manual of OMNI III Patient Monitor

Set the ST alarm upper limit and lower limit separately. The range is:-2~2 mV. The
default upper limit is +0.30 mV, the default lower limit is -0.30 mV. The single-step
adjustable step- length is 0.02 mV.
ST ANALYSIS SWITCH
The default value is OFF, only the choice of ON can operate the ST Segment Monitoring.
Meanwhile, the TREND GRAPH or TREND TABLE can be opened by the button of
TREND to see the tendency displaying on the graph or table.
ST ADJUST
ISO (Base Point)
Set the baseline point, its adjustable range is –508 ms~–4 ms, the default value is –80ms,
it shows that the reference point is the position 80ms before the peak of R- wave locates.
ST (Measurement Point)
Set the measuring point, its adjustable range is +8 ms~+508 ms, the default value is
+108ms, it shows that the reference point is the position 108 ms after the peak of R- wave
locates.

These two points can be adjusted by clicking the button of << or >>. The value and the
indicating line will change simultaneously.

NOTE: The ST measurement point should be adjusted if the patient’s HR or ECG


morphology changes significantly.

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ARRHYTHMIA ANALYSIS
The monitoring system supports the self relearn function to accommodate itself to new
conditions such as different patients. The user can edit the arrhythmia type. For each type
system saves 8 items arrhythmia and totally saves 104 items.

WARNING:
Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not
designed to detect atrial or supraventricular arrhythmias. It may incorrectly identify the
presence or absence of an arrhythmia. Therefore, a physician must analyze the
arrhythmia information with other clinical findings.

ARR ANALYSIS
Set arrhythmia analysis to be ON or OFF. The factory-set is OFF.
ARR SOURCE
Select between lead I, lead II and Lead III, and the factory-set is lead II. The user can
switch the ECG lead if the current lead’s signal is weak.
PVC MONITOR
Set PVC monitor to be ON or OFF. The factory-set is ON, if the premature ventricular
contraction times exceed the PVC ALARM COUNT, the system will alarm.
PVC ALARM COUNT
Its set range is from 1 to 10. The factory-set is 10.
ARR RELEARN
Self relearn to accommodate itself to new conditions. Such as different patients,
cardiograph changes a lot.
ARR ALARM SETUP
Set all kinds of arrhythmia alarm to be ON or OFF. The all factory-sets are ON.
ARR REVIEW

Figure 14: Window for ARR Review


1. Select: To choose an arrhythmia item.
2. Wave: To review the selected arrhythmia item includes items of HR,ST,PR, SpO2,
NIBP, Temp, Resp, PVC and so on,

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User’s Manual of OMNI III Patient Monitor

Figure 15: Window for ARR Retail Information


3. Rename: To rename a selected ARR item.
4. Delete: To delete a selected ARR item.
5. Sort: to sort the arrhythmia items by Time or Type. The factory-set is by Time.
Arrhythmia analysis can monitor 13 kinds of arrhythmias. Refer to below.
ASY --- Asystole
FIB --- Fibrillation
VTA --- Ventricular tachycardia
ROT --- R ON T
RUN --- Ventricular Run
TPT --- Ventricular Triplet
CPT --- Ventricular Couplet
VPB --- Ventricular prematare beat
BGM --- Bigeminy
TGM --- Trigeminy
TAC --- Tachycardia
BRD --- Bradycardia
MIS --- Miss beat

12-LEAD ECG MONITORING


Entering the 12-lead ECG Monitoring Screen

1. Enable the 12-Lead ECG function in the Optional Module.


2. Refer to the section ECG Monitoring---->Electrode Installation for placing the
electrodes.

3. In the ECG Setup menu, select Lead Type. Then choose 12-Lead.

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User’s Manual of OMNI III Patient Monitor

Figure 16: Window for Full 12-Lead ECG

ERROR MESSAGES OF ECG MONITORING


Sometimes messages will display above the ECG waveform:

Prompts Explanation
Lead off ECG leads fall off the skin or the monitor
ECG Signal Weak Monitor system can not calculate HR value
when the ECG Signal is too weak.

MAINTENANCE AND CLEANING


PATIENT CABLE AND LEAD
After every times of using, the cable must be cleaned and following the methods below:
Clear the paste on body and the remainder of electrolyte on the electrode. The
paste-eradicator can be used when removing the adhesive tape remainder, but
acetone, alcohol, ammonia, chloroform and other strong solvent are not suggested,
because they would finally damage the vinyl cable.
Use a sponge moistened in mild soap liquid or other suitable detergent solution to
clean the cable and then dry them. Do not submerge the cable into the water.
Check each cable to see whether they are corroded, damaged or degenerated. Do
not use pressure cooker to disinfect the cable and electrode or heat them to
75℃(167F) and higher temperature. If there is dirt on the material surface, you can
use the abluent which will not left remainder to clean and any metal grinding medium
like floss is forbidden. The storing temperature should be -20℃ till 75℃(-68F till
167F). Hang or place them flat so as not to be damaged.
ADDING POINTS
HR calculating stability has a process, ECG lead switching sometimes affect HR
which will become stable after a while. The change of gain and filter may influent the

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User’s Manual of OMNI III Patient Monitor

HR calculating stability too. Another factor which affecting HR calculation is the QRS
waveform, if T wave is too high, HR will be make mistake too. Arrhythmia sometimes
influent HR calculation too.
Choosing suitable ECG waveform range and complete QRS waveform has important
effect in the accuracy of HR calculation.

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RESP MONITORING
RESP ELECTRODE INSTALLATION
RESP SETUP
MAINTENANCE AND CLEANING
RESP ELECTRODE INSTALLATION
The monitor measures respiration from the amount of thoracic impedance between two
ECG electrodes. The change of impedance between the two electrodes, (due to the
thoracic movement), produces a respiratory waveform on the screen.
For RESP monitoring, it is not necessary for additional electrodes, however, the placing 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.
The sensor of RESP Electrode’s installation is same as ECG’s.

[NOTE]
The RESP monitoring is not recommended to be used on patients who are very active,
as this can cause false alarms.

The scheme picture for placing the 5 Electrodes for Respiratory Monitoring is seen as
followings:

[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 so
as to avoid cardiac overlay or artifacts from pulsating blood flow. This is particularly
important for neonates.
RESP SETUP
Turn the ROTARY KNOB in the SYSTEM SETUP menu, choose the WAVEFORM
SELECT item to enter the WAVEFORM SELECT SETUP menu, open the RESP
monitoring function. Then move the white box to the RESP Waveform or Parameter area,
press the ROTARY KNOB to pop the menu of RESP Setup.

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User’s Manual of OMNI III Patient Monitor

Figure 17: Tree Diagram for Resp Menu


The menu can finish settings as below:
ALARM SWITCH
ON and OFF for choice, the factory–set is ON.
If the RESP value is above or below the RESP alarm limit, when the choice is ON, the
alarm is activated; when the choice is OFF, the alarm indicator will not light, the relative
alarm parameter will not flash and relative parameter area will appear an icon of .
RESP ALARM HIGH
The RESP alarm upper-limit, the range is 8~120 bpm,and the factory-set is 30 bpm,the
single-step adjustable step- length is 1 bpm.
RESP ALARM LOW
The RESP alarm lower-limit, the range is 6~100 bpm,and the factory-set is 8 bpm,the
single-step adjustable step- length is 1 bpm.
RESP GAIN
The user can freely choose one from items of X0.25, X 0.5, X1.0 and X2.0. The bigger the
gain is, the larger the waveform amplitude is. The factory-set is X1.0.
SWEEP SPEED
Choose from 6.25 mm/s, 12.5 mm/s and 25.0 mm/s, and the factory-set is 6.25mm/s.
SWEEP COLOR
From White, Gray, Red, Yellow, Green, Cyan, Blue, and Magenta for choice, the
default-set is Cyan.
DISPLAY
The ON and OFF for choice. Pick ON can display RESP, pick OFF would not display the
RESP, but this do not influent the actual data of trend.
Applications: when the patient’s thorax or abdomen is subjected too much interference,
the RESP monitoring is not accurate, so it is suggested to close the RESP display.

MAINTENANCE AND CLEANING


It is the same as the ECG monitoring.

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User’s Manual of OMNI III Patient Monitor

SPO2 MONITORING
SPO2 MONITORING PRINCIPLE
SPO2 SENSOR INSTALLLATION
SPO2 SETUP
MEASUREMENT LIMITATIONS
SPO2 ERROR MESSAGES
SPO2 MONITORING PRINCIPLE
Arterial oxygen saturation is measured by a method called pulse oximetry. 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 amount of light transmitted depends on many factors, most of which are constant.
However, one of these factors, the blood flow in the arteries, varies with time, because it is
pulsating. By measuring the light absorption during a pulsation, it is possible to derive the
oxygen saturation of the arterial blood. Detecting the pulsation gives a PLETH waveform
and pulse rate signal.

About SpO2、SaO2、SjvO2
□SpO2:It is the arterial blood oxygen saturation lever measuring by oximeter.
□SaO2:It is the oxygen saturation of arterial blood
□SjvO2:It is the oxygen saturation of the jugular blood.

[WARNING]
Pulse oximeter can overestimate the SpO2 value in the presence of HB-CO, Met-HB or
dye dilution chemicals.

SPO2 SENSOR INSTALLLATION


1. Insert the plug of SpO2 sensor into the SpO2 socket on the left panel of monitor. Make
sure that the salient of plug must direct to the notch of socket when inserting of
unplugging, otherwise the measurement will not be reliable and the sensor connector will
be damaged.
2. Wear the finger-probe on the finger; make sure that the finger tip is the same
direction as the finger direction indicated on the probe.
SPO2 SETUP
Turn the ROTARY KNOB to move the white box on the screen to the SpO2 Waveform or
Parameter area, as graph below:

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User’s Manual of OMNI III Patient Monitor

Alarm Switch

SpO2 Alarm High

SpO2 Alarm Low


SpO2 Setup
Sweep Speed

Sweep Color

Factory Setup
Figure 18: Tree Diagram for SpO2 Setup Menu
The menu can finish settings as below:

ALARM SWITCH
ON and OFF for choice, the factory–set is ON.
If the SpO2 value is above or below the SpO2 alarm limit, when the choice is ON, the
alarm is activated; when the choice is OFF, the alarm indicator will not light, the relative
alarm parameter will not flash and relative parameter area will appear an icon of .
SPO2 ALARM HIGH
The SpO2 alarm upper-limit, the range is 50~99 %,and the factory-set is 99%,the
single-step adjustable step- length is 1 %.
SPO2 ALARM LOW
The SpO2 alarm lower-limit, the range is 50~99 %,and the factory-set is 85%,the
single-step adjustable step- length is 1%.
SWEEP SPEED
Choose from 12.5 mm/s to 25.0 mm/s, and the factory-set is 12.5 mm/s.
SWEEP COLOR
From White, Gray, Red, Yellow, Green, Cyan, Blue, and Magenta for choice, the
default-set is Blue.
SPO2 FACTORY SETUP
Click “Factory Setup” and input “SPO2….”password, then come into “SpO2 Setup”
Menu to SpO2 Factory Setup.

There are three SpO2 modules for choice: BCI, Nellcor and Masimo.
More detail please contact with local distributor or service engineer

This item is for servicing engineer use only.


MEASUREMENT LIMITATIONS
1. The measurement is decided by the pulsating characteristic of blood stream in
artery or arterial blood vessel. The arterial blood stream may decreased to the level
which cannot be measured in conditions below:
Shock
Hypothermia
Vasoactive medicines are applied
Anemia
2. The measurement are also decided by the condition how the oxyhemoglobin and
reduced-hemoglobin absorb the light of special wave-length. If there are other

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User’s Manual of OMNI III Patient Monitor

material can absorb the same wave-length light, they can cause the measurement
false or lower than the actual value of SpO2, for example:
Carboxyhemoglobin
Methemoglobin
Methylene blue
Carmine indigo
3. The strong light in the environment also can influent measurement. Some suitable
light-tight material to cover the sensor which can improve the measure quality.

[WARNING]
Prolonged and continuous monitoring may increase jeopardy of unexpected
change of dermal condition such as abnormal sensitivity, rubescence, vesicle,
repressive putrescence, and so on. It is especially important for neonate and
patient of poor perfusion or immature dermogram to check the sensor placement
by light collimation and proper attaching strictly according to changes of the skin.
Check regularly the sensor placement and move it when the skin deteriorates.
More frequent examinations may be required for different patients.
DO NOT use SpO2 sensors during magnetic resonance imaging (MRI). Induced
current could potentially cause burns. The sensor may affect the MRI image, and
the MRI unit may affect the accuracy of the oximetry measurements.

SPO2 ERROR MESSAGES


PLETH Waveform may display messages as below:

PROMPTS EXPLAINATION

Search Too Long Search-time of SpO2 is too long

Searching For Pulse. . . On searching for pulse signal

Sensor Off Sensor falls off or the finger fails to insert


into the finger-probe
SpO2 Com Error SpO2 board has communication error with
the mainboard

MASIMO INFORMATION
TRADEMARK AND LICENSING LABELS

MASIMO PATENTS
This device is covered under one or more the following U.S.A. patents: 5,758,644;
5,823,950; 6,011,986; 6,157,850; 6,263,222; 6,501,975; 7,469,157 and other applicable
patents listed at http:// www.masimo.com/patents.htm.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to
use the device with unauthorized sensors cables which would, alone, or in combination

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User’s Manual of OMNI III Patient Monitor

with this device, fall within the scope of one or more of the patents relating to this device.
NELLCOR INFORMATION
TRADEMARK AND LICENSING LABELS

NELLCOR PATENS
This device is covered under one or more the following U.S. Patents: 4,802,486;
4,869,254;4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500;
5,803,910;5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,591,123; 6,708,049; Re.35,122
and international equivalents U.S.A international patents pending.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to
use the device with unauthorized replacement parts which would, alone, or in combination
with this device, fall within the scope of one or more of the patents relating to this device.

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User’s Manual of OMNI III Patient Monitor

NIBP MONITORING
NIBP MONITORING PRINCIPLE
NIBP CUFF FITTING
NIBP MONITORING INITIALIZATION
NIBP SETUP
NIBP LIST OBSERVATION
MEASUREMENT LIMITATIONS
NIBP ERROR MESSAGES
MAINTAINENCE AND CLEANING
NIBP MONITORING PRINCIPLE
The Non-invasive Blood Pressure (NIBP) module measures the blood pressure using the
oscillometric method.
It is applicable for adult, pediatric and neonatal usage.
There are three modes of measurement available: Manual, Automatic and Stat. Each
mode displays the diastolic, systolic and mean blood pressure.

[WARNING]
You must not perform NIBP measurements on patients with sickle-cell disease or
under any condition which the skin is damaged or expected to be damaged.
For a thrombasthenia patient, it is important to determine whether measurement of
the blood pressure shall be done automatically. The determination should be based
on the clinical evaluation.
Before starting a measurement, verify that you have selected a setting appropriate for
your patient(adult、pediatric or neonate.) Ensure that the correct setting is selected
when performing measurements on neonate, because the higher adult BP level is not
suitable for neonate, it may be dangerous for the neonate to use an over pressure
level.
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.

NIBP CUFF FITTING


1. Whether choosing the suitable cuff which match the arm of patient influent much on
the accuracy of NIBP measurement. The cuff width recommend by AMERICA HEART
SOCIETY is the 40% of upper arm circumference or the 2/3 of the upper arm length.
2. Apply the blood pressure cuff to the patient’s arm:
Make sure that the cuff is completely deflated.
Apply the appropriate size cuff to the patient, and make sure that the symbol “φ” is
over the appropriate artery. Ensure that the cuff is not wrapped too tightly around the
limb. Excessive tightness may cause discoloration and eventual isocheimal of the
extremities.
3. Make sure that the cuff has not been twisted.。
4. Insert the air pipe into the NIBP socket on the left panel of monitor. Ensure that the
spring block on the left side of socket has been pressed
When inserting or unplugging the pipe, otherwise measurement process will be irregular
and the sensor connector will be damaged.

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User’s Manual of OMNI III Patient Monitor

[WARNING]
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
erroneous readings. If the cuff size is in question, then use a larger cuff.
Make sure that the cuff edge falls within the range of 〈-〉. If does not, change a
more suitable cuff.
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. If this is not possible you
should apply the following corrections to the measured values:
If the cuff is placed higher than the heart level, add 0.9mmHg (0.12kPa) for each
inch of difference.
If it is placed lower than the heart level, deduct 0.9mmHg (0.12kPa) for each inch of
difference.

NIBP MONITORING INITIALIZATION


After opening the host machine, check the information indicating area before NIBP
monitoring, if there is a note of NIBP MODULE SELF-CHECK OK, it shows that the NIBP
module operate well, then begin NIBP monitoring, and the NIBP monitoring before this
information is invalid; if there is NIBP MODULE SELF-CHECK ERROR, it shows that the
NIBP module cannot be proceeded, press the button of START/STOP to give another
time of self-checking or machine-opening, if it is also this information, contact with
servicing engineer.
NIBP SETUP
Turn ROTARY KNOB and move the white box on screen to the NIBP Parameter Area.
Press the ROTARY KNOB to pop the NIBP Setup menu.

Figure 19: Tree Diagram for NIBP Setup Menu


This menu can finish settings below:
ALARM SWITCH
ON and OFF for choice, the factory–set is ON.
If the NIBP value is above or below the NIBP alarm limit, when the choice is ON, the alarm
is activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .

PRESSURE UNIT
mmHg or kPa,the factory–set is mmHg.

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User’s Manual of OMNI III Patient Monitor

PATIENT TYPE
ADULT TYPE
It can apply to the adult mode. In the initiated measurement, inflate the cuff to 180mmHg
(24kPa), if the NIBP value cannot be measured, then inflate the cuff to higher than the
form value by 50mmHg (6.7kPa), the maximum value cannot exceed 280mmHg
(37.3kPa), and the enduring pressure range is 50-280mmHg. The factory–set is ADULT
TYPE.
PEDIATRIC/NEONATAL TYPE
It can apply to the PEDDIATRIC or NEONATAL mode. In the initiated measurement,
inflate the cuff to 60mmHg (8kPa), if the NIBP value cannot be measured, then inflate the
cuff to higher than the form value by 30mmHg (4kPa), the maximum value cannot exceed
150mmHg (20kPa), and the enduring pressure range is 50-150 mmHg.

If this setup is before the NIBP module initiation, the set is not effective.

Inflating range showing above has been realized on NIBP, NIBP use this inflation range to
make sure the safety of patient.

INFLATION TYPE
There are three items for choice. Manual, Auto and STAT.

MANUAL MODE: :
Press the button of START/STOP to begin inflation, the information indicating area
display “Manual measuring… “which shows that it is on measurement just the moment.
If the NIBP measurement is finished, NIBP parameter area will display values and the
information indicating area will give a note of “Manual measuring end!”, then the
measurement process finished.
If the NIBP value cannot be measured, NIBP parameter area will display error messages
and automatically begin three times of measurement again, if the value cannot be
measured also, the information indicating area will give a note of “RETRY OVER!” and
never measure again.
During the measurement, press the button of START/STOP again will stop the NIBP
measurement process and the information indicating area will give a note of STOP
MANUAL MEASURING.

AUTOMATICAL MODE
NIBP parameter area will display the countdown of "Auto measuring..." (TIME INTERVAL),
so long as reaching the zero point, machine will automatically precede inflating
measurement again and again until the mode be changed.

Start a measurement manually. The monitor will then automatically repeat NIBP
measurements at the set time interval.

If the NIBP measurement is finished, NIBP parameter area will display values and the
information indicating area will give a note of "Auto measuring end!". And then begin
another measurement until the mode is changed.
If the NIBP value cannot be measured, NIBP parameter area will display error messages
and the first measurement automatically begin three times of measurement again, if the
value cannot be measured. Also, the information indicating area will give a note of
“RETRY OVER!” and automatically go on the next measurement until the mode is
changed.
If the button of START/STOP be pressed during any period of countdown, it is
immediately begin inflation measurement.
During the measurement, press the button of START/STOP again will stop this period of

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User’s Manual of OMNI III Patient Monitor

NIBP measurement process and the information indicating area will give a note of "Stop
auto measuring", but the automatic measurement period is continuous.
[WARNING]
Prolonged non-invasive blood pressure measurements in Auto mode may be
associated with purport, isocheimal and neuropathy in the limb wearing the cuff.
When monitoring a patient, examine the extremities of the limb frequently for normal
color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure
measurements.

STAT MODE
In the stat mode, it will measure NIBP continually for three times. And then it will end
automatically. Of course, you can press the button of START/STOP to end the
measurement manually.
Press the button of START/STOP to begin inflation, the information indicating area
display "STAT measuring..." which shows that it is on measurement just the moment; If
the NIBP measurement is finished, NIBP parameter area will display values and the
information indicating area well give a note of "STAT measuring end".

If the NIBP value cannot be measured, NIBP parameter area will display error messages
and automatically begin three times of measurement again, if the value cannot be
measured also, the information indicating area will give a note of “RETRY OVER!”, and
then continue another time of measurement which lasts 5 minutes and then stop.
During the measurement, if press the button of START/STOP again, the information
indicating area will give a note of "STOP STAT TEST" to stop the NIBP measurement and
exit from this mode。

[NOTE]
The value having been measured will display on the NIBP parameter area for 240
minutes unless a new measurement begin during this period. On the appropriate
trend graph and trend table, the parameter will exist for correlated time length.
TIME INTERVAL
This setting is used supported by automatic inflation mode. You can input the time
interval as you want. The range is 1 min to 4 hours.
ALARM LIMIT SETUP
SYS UPPER SYS LOWER DIA UPPER DIA LOWER
Limits LIMIT(mmHg) LIMIT(mmHg) LIMIT(mmHg) LIMIT(mmHg)
Patient
Type
Adult 30~240 30~240 15~180 15~180
Factory-set:150 Factory-set:100 Factory-set:90 Factory-set:50
Neonatal 30~240 30~240 15~180 15~180
Factory-set:90 Factory-set:40 Factory-set:60 Factory-set:20
Pediatric 30~240 30~240 15~180 15~180
Factory-set:120 Factory-set:70 Factory-set:70 Factory-set:40

The single-step adjustable length of alarm limit above is 5 mmHg.


FACTORY SETUP
Servicing engineer uses this function only.
NIBP LIST OBSERVATION
Turn ROTARY KNOB and move the white box on screen to the NIBP List Area. Press the
ROTARY KNOB to pop the NIBP List Tabular.

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User’s Manual of OMNI III Patient Monitor

Figure 20: Window for NIBP List Observation

The NIBP list can save 256 groups of data.

[NOTE]
Only after the NIBP value has been measured can it be added to the NIBP Data List.
NIBP list can save 256 groups of data at all, if exceed, the new data will kick the most
former data out of the list and be added to the list automatically.

MEASUREMENT LIMITATIONS
To different patient conditions, the oscillometric measurement has certain limitations. The
measurement is in search of regular arterial pressure. 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 with the measurement, making the measurement unreliable or longer to derive.
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 with 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 has caused an irregular heartbeat. The measuring time thus 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 is
changing 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 since
reduced blood flow to the peripheries will cause reduced pulsation of the arteries.
HEART RATE EXTREMES
Measurements cannot be made at a heart rate of less than 40 bpm and greater than 240
bpm.

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User’s Manual of OMNI III Patient Monitor

NIBP ERROR MESSAGES


Message indicating area may display messages like below:

Patient moving! Serial error


Pressure < 10 mmHg! NIBP renew self-check...
Pressure < 1.3 kPa! NIBP self-check...
Pressure > 325 mmHg! NIBP self-check error!
Pressure > 43.3 kPa! NIBP inter error!
Serial overtime! Patient type error!
Reset error! Setup patient...
Zero reset error! NIBP self-check ok!

MAINTAINENCE AND CLEANING


[NOTE]
DO NOT squeeze the rubber tube on the cuff.

REUSABLE BLOOD PRESSURE CUFF


The cuff can be sterilized by means of conventional autoclaving, gas or radiation
sterilization in hot air ovens or disinfected by immersion in decontamination solutions, but
remember to remove the rubber bag if you use this method. The cuff should not be
dry-cleaned. The cuff can also be machine-washed or hand-washed; the latter method
may prolong the service life of the cuff. Before washing, remove the latex rubber bag, and
for machine-washing, close the Velcro fastening. Allow the cuff to dry thoroughly after
washing, and then reinsert the rubber bag.

To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the
rubber tubes line up with the large opening on the long side of the cuff. Now roll the bag
lengthwise and insert it into the opening on the long side of the cuff. Hold the tubes and
the cuff and shake the complete cuff until the bag is in position. Thread the rubber tubes
from inside the cuff, and out through the small hole under the internal flap.

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User’s Manual of OMNI III Patient Monitor

TEMP MONITORING
THEORY OF OPERATION
TEMP SENSOR INSTALLATION
TEMP SETUP
TEMP ERROR MESSAGES
MAINTAINENCE AND CLEANING
THEORY OF OPERATION
The monitor provides one or two isolated temperature measurement channels (T1 and
T2). If the second temperature channel is installed, the temperature difference between
the two channels is an available option. Temperature difference is displayed as “∆T” or
delta temperature.
The monitor utilizes a temperature probe with a thermistor to give continuous electronic
temperature readings of either core body temperature via rectal/esophageal probe or skin
temperature via an external sensor.

TEMP SENSOR INSTALLATION

1.Insert the plug of T1 or/and T2 sensor into the sensor socket on the left panel of
monitor.
2.Put the probe on the patient according to the explanation of probe usage (lacuna and
body).

[WARNING]
Inspect the probe for wear or splitting after every disinfection/sterilization process is
complete. If wearing or splitting of the probe is found upon visual inspection, a new
probe should be used.

TEMP SETUP
Turn the ROTARY KNOB to move the white box on the screen to the TEMP
Parameter Area, presses the ROTARY KNOB to pop the menu of TEMP Setup, see
below:

Figure 21: Tree Diagram for Temp Setup Menu


The menu can finish settings as below:

ALARM SWITCH
ON and OFF for choice, the factory–set is ON.

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User’s Manual of OMNI III Patient Monitor

If the TEMP value is above or below the TEMP alarm limit, when the choice is ON, the
alarm is activated; when the choice is OFF, the alarm indicator will not light, the relative
alarm parameter will not flash and relative parameter area will appear an icon of .
TEMP UNIT
Fahrenheit or Celsius for choice, the factory-set is Celsius.
TEMP ALARM UPPER-LIMIT
The T1 or T2 alarm upper-limit, the range is 10~50℃℃ (50~122℉ ℉),and the factory-set is
38.0℃
℃(100.4℉℉), the single-step adjustable step- length is 0.1℃
℃(0.2℉
℉).
TEMP ALARM LOWER-LIMIT
The T1 or T2 alarm lower-limit, the range is 10~
~50℃
℃(50~122 ℉),and the factory-set is
36℃
℃(96.8℉℉),the single-step adjustable step- length is 0.1℃
℃(0.2℉
℉).
TEMP ADJUST
This item is for servicing engineer use only.
TEMP ERROR MESSAGES
TEMP SENSSOR OFF: the TEMP probe falls off the monitor.
MAINTAINENCE AND CLEANING
REUSABLE TEMP PROBES
1. The TEMP probe should not be heated above 100℃ (212oF). It should only be
subjected briefly t temperatures between 80℃ (176oF) and 100℃ (212oF).
2. The probe must not be sterilized in steam.
3. To clean the probe with alcohol detergent solution.
4. To clean the probe, hold the tip with one hand and with the other hand rubbing the
probe down in the direction of the connector using a moist lint-free cloth.

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ETCO2 MONITORING (OPTION)


THEORY OF OPERATION
WARNINGS
ABBREVIATIONS AND TERMINOLOGY
ZEROING THE CO2 MODULE
PATIENT AND TUBING PREPARATION
ETCO2 SETUP
ADVANCED SETUP
CALIBRATION
STATUS/ERROR MESSAGES
MAINTENANCE AND CLEANING
THEORY OF OPERATION
Carbon dioxide monitoring is used to monitor continuous carbon dioxide and report the
End Tidal carbon dioxide (EtCO2), inspired CO2 and respiratory rate values of the
intubated and non-intubated adult, pediatric, infant and neonatal patient.

In carbon dioxide monitoring system, infrared light is generated by the sensor and
beamed through the sample cell to a detector on the opposite side. CO2 from the patient
that is aspirated into the sample cell absorbs some of this infrared energy. The monitor
determines CO2 concentration in the breathing gases by measuring the amount of light
absorbed by these gases. EtCO2 is displayed as a numerical value in millimeters of
mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform
(capnogram) may be displayed which is a valuable clinical tool that can be used to assess
patient airway integrity and proper endotracheal tube (ETT) placement. Respiration rate is
calculated by measuring the time interval between detected breaths.

There are two methods for measuring CO2 in the patient’s airway:
1. Mainstream measurement uses a CO2 sensor attached to an airway adapter directly
inserted into the patient’s breathing system.
2. Sidestream/Microstream measurement samples expired patient gas at a constant
sample flow from the patient’s airway and analyzes it with a CO2 sensor built into the
CO2 module.
WARNINGS
DO NOT position the sensor cables or tubing in any manner that may cause
entanglement or strangulation. Support the carbon dioxide monitoring system airway
adapter to prevent stress on the ET tube.
Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use
cannula kits and on-airway adapters may compromise functionality and system
performance leading to a user or patient hazard. Performance is not guaranteed if an
item labeled as single patient use is reused.
Inspect the sidestream on-airway adapters and sidestream sampling kits for damage
prior to use. DO NOT use the sidestream on- airway adapters and sidestream
sampling kits if they appear to be damaged or broken.
Replace the sidestream on-airway adapters and sidestream sampling kits if
excessive secretions are observed.
Monitor the CO2 check waveform (Capnogram). If you see changes or abnormal
appearance the patient and the sampling line. Replace line if needed.
DO NOT apply excessive tension to any cable.
DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min +/-
10 ml/min from the airway or patients that can not tolerate the added dead space to
the airway.
DO NOT connect the exhaust tube to the ventilator circuit.
DO NOT stick appendage into sample receptacle.
Always insert sample cell before inserting the on-airway adapter into the ventilated

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User’s Manual of OMNI III Patient Monitor

circuit.
Always remove the on-airway adapter from the ventilated circuit before removing the
sample cell.
Nitrous oxide, elevated levels of oxygen, helium, Xenon, halogenated hydrocarbons,
and barometric pressure can influence the CO2 measurement.
ABBREVIATIONS AND TERMINOLOGY
EtCO2 End tidal carbon dioxide
INSP CO2 Inspired minimum CO2
AWRR Air-way respiration rate
BARO Barometric Pressure
ZEROING THE CO2 MODULE
The sample cell zero allows the CO2 Module to adjust to the optical characteristics of the
sample cell only when requested.

For optimal accuracy, a CO2 Module zero should be performed whenever the CO2 Module
is connected to the Patient Monitor.

Before performing a CO2 Module zero, the CO2 Module should be removed from the
Patient Monitor and the airway adapter type to be used in the circuit should be inserted
into the CO2 Module. Care should be taken ensure that the airway adapter is clear of any
residual CO2 gas. The maximum elapsed time for a CO2 Module zero is 30 seconds.
The typical time for a zero is 15 – 20 seconds.

Several CO2 Module conditions may also request that a zero be performed. These
requests stem from changes in the airway adapter that may indicate that the sensor is not
in optimal measuring condition. When this occurs, the airway adapter should be
checked to ensure optical occlusions such as mucus have not obscured the adapter
window. If occlusions are found, the airway adapter should be cleaned or replaced.

NOTE:
System does not allow adapter zero for 20 seconds after the last breath is
detected.
System does not allow adapter zero if temperature is not stable.
An adapter zero cannot be performed if a sample cell is not connected to the
module.

PATIENT AND TUBING PREPARATION


1. MODULE MOUNTING
a. Put the CO2 module into the bracket of the rear panel of the monitor.
b. Check that monitor is switched off,Insert the plug of CO2 sensor into the corresponding
sensor socket marked with EtCO2 icon on the left panel of monitor.

WARNING: Don’t hot plug EtCO2 module, that is make sure that the OMNI III is
powered off before Insert the connector of CO2 sensor into EtCO2 socket. Otherwise
the CO2 module may be damaged by power supply from EtCO2 socket of OMNI III.

2. CONNECTING THE SAMPLE KIT


a. The sample cell of the sampling kit must be inserted into the sample cell receptacle of
the CO2 Module as shown in following figure. A “click” will be heard when the sample cell
is properly inserted.

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User’s Manual of OMNI III Patient Monitor

b. Connect the CO2 tubing to Nasal and Nasal/Oral Sidestream Kits.


c. Inserting the sample cell into the receptacle automatically starts the sampling pump.
Removal of the sample cell turns the sample pump off.
d. To remove the sampling kit sample cell from the sample cell receptacle, press down on
the locking tab and pull the sample cell from the sample cell receptacle.

DIRECTIONS
For use of single patient use nasal and nasal/oral sidestream kits

CAUTION: The Nasal and Nasal/Oral Cannula kits are intended for single patient use. Do
NOT reuse or sterilize the cannula kit as system performance will be compromised.
1. Verify that the cannula kit is clean, dry and undamaged. Replace the cannula kit if
necessary.
2. Insert the sample cell into the sample cell receptacle as shown in above figure on
connecting the Sample Kit section. A “click” will be heard when properly inserted.
3. Perform a sample cell zero if prompted by the host system.
4. Place the nasal cannula kits onto the patient as shown in following figure.

5. Some patients are prone to mouth breathing. The Oral/Nasal sampling cannula
should be used on these patients, as most, if not all of the CO2 is exhaled through the
mouth. If a standard nasal CO2 sampling cannula is used with these patients, the
EtCO2 number and capnogram will be substantially lower than actual.
6. When using the Nasal or Oral/Nasal CO2 sampling kits with oxygen delivery, place
the cannula on the patient and then attach the oxygen supply tubing to the oxygen
delivery system and set the prescribed oxygen flow.
7. If the oral/nasal cannula is used, the oral sampling tip may need to be trimmed to
adequately fit the patient (see following figure). Place the cannula onto the patient as
shown in above figure. Observe the length of the oral cannula tip. It should extend
down past the teeth and be positioned in the mouth opening. Remove the cannula
from the patient if the tip needs to be trimmed.

CAUTION: DO NOT cut the oral cannula tip when the cannula is on the patient.
CAUTION: Remove the sampling kit sample cell from the CO2 Module Inlet Port when not
been use.

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ETCO2 SETUP
Turn the ROTARY KNOB to move the white box on the screen to the EtCO2 Area, presses
the ROTARY KNOB to pop the menu of EtCO2 Setup, see graph below:
Alarm Switch

EtCO2 Alarm High


EtCO2 Alarm Low
AWRR Alarm High
AWRR Alarm Low
Apnea Delay
EtCO2 Setup
EtCO2 Unit

Wave Scale

Fill In Waveform

Sweep Speed

Sweep Color

EtCO2 Period
Start Zeroing
Zero Setup
Zero Gas Type

Oxygen
Balance Gas
Advanced Setup
Anesthetic
BARO.
Gas Temp
Figure 22: Tree Diagram for EtCO2 Setup Menu

ALARM SWITCH
ON and OFF for choice, the factory–set is ON. When the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .
ETCO2 ALARM HIGH
The range is 20~100 mmHg,and the factory-set is 60 mmHg.
ETCO2 ALARM LOW
The range is 10~95 mmHg,and the factory-set is 15 mmHg.
AWRR ALARM HIGH

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User’s Manual of OMNI III Patient Monitor

The range is 10~150 mmHg,and the factory-set is 30 mmHg.


AWRR ALARM LOW
The range is 5~100 mmHg,and the factory-set is 5 mmHg.
The single-step adjustable length of alarm limit above is 5 mmHg.
ASPHYXIA DELAY
This setting is used to set the no breaths detected time-out. This time-out is the time
period in seconds following the last detected breath at which the CO2 module will signal
no breaths detected. The monitor will alarm if the patient has stopped breathing for longer
than the preset apnea time.
The setting range is 10~60 seconds,and the factory-set is 10 seconds.
ETCO2 UNIT
mmHg, kPa or percent (%), the factory –set is mmHg.
WAVEFORM SCALE
Use this setting to adjust the amplitude measurement (size) of the displayed EtCO2
waveform scale manually.
There are two items for choice: 0~75 mmHg, 0~150 mmHg.
FILL IN WAVEFORM
Use this setting to fill in the bottom portion of the waveform on any channel of the
display; the “fill in” can be canceled by choosing NO item.
SWEEP SPEED
From 12.5mm/s and 25mm/s for choice, the factory-set is 12.5mm/s.
SWEEP COLOR
From White, Gray, Red, Yellow, Green, Cyan, Blue, and Magenta for choice, the
default-set is Cyan.
ETCO2 PERIOD
This setting is used to set the calculation period of the EtCO2 value. The end-tidal CO2
value is the highest peak CO2 value of all end of expirations (end of breaths) over the
selected time period. If less than two breaths exist in the selected time period, the value
will be the maximum EtCO2 value for the last two breathes.
This setting has 1 breath, 10 seconds and 20 seconds for choice, the factory–set is 1
breath.
ZERO SETUP
Zero steps refer to “Zeroing the CO2 Module” section detailed.
Complete the zero procedure by press “Start Zeroing” item. During zeroing, a message
of “EtCO2 Zero Started” will be display on the message area.

ZERO GAS TYPE

NOTE: During the CO2 module warmup period after the monitor is powered on, the
monitor will perform an automatic zero calibration. The maximum elapsed time for a
CO2 Module zero is 30 seconds. The typical time for a zero is 15 – 20 seconds.

When performing a zero on room air, this setting should be set to room air (the default).
Only change to nitrogen (N2) when performing a zero on 100% N2 gas. This is provided
for use in a laboratory environment.

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User’s Manual of OMNI III Patient Monitor

ADVANCED SETUP
Pick “ADVANCED SETUP” item to call up the related menu:

Figure 23: Tree Diagram for EtCO2 Advanced Setup


SET GAS COMPENSATIONS
The measurement of CO2 is affected by temperature, pressure, and gas compensations.
The barometric pressure as well as the presence of O2, N2O, helium, and anesthetic
agents in the gas mixture needs to be compensated for by the CO2 module in order to
achieve its stated accuracy. The instrument settings for these parameters should be set
when initially connecting to the CO2 module and whenever there is a change in the
conditions at the patient airway.
In the CO2 module, the temperature of the gas in the airway also effects the CO2
measurement. It is necessary to adjust the instrument setting for the gas temperature to
achieve the maximum accuracy for the CO2 module.

OXYGEN COMPENSATION
The setting range is 0~100 %. The factory–set is 16 %.
BALANCE GAS
There are room air, N2O and Helium items to choose.
ANESTHETIC AGENT
Use this setting to correct for the compensation of the gas mixture administered to the
patient. Anesthetic agent is ignored when the balance gas is set to helium.
The setting range is 0.0~20.0 %. The factory –set is 0.0 %.

[NOTE]
At 700mmHg of pressure, the correct CO2 value is 35.0 mmHg.

BAROMETRIC PRESSURE
This setting is used to set current Barometric Pressure.
The setting range is 400~850 mmHg. The factory –set is 760 mmHg.
GAS TEMPERATURE
This setting is used to set temperature of the gas mixture. This setting is useful when
bench testing using static gasses where the temperature is often room temperature or
below.
The setting range is 0~50℃. The factory –set is 35℃.

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CALIBRATION
No routine user calibration required.
Safety lock-outs:
System does not allow sample cell zero for 20 seconds after the last breath is
detected.
System does not allow sample cell zero if temperature is not stable.
An adapter zero cannot be performed if a sample cell is not connected to the
module.

STATUS/ERROR MESSAGES
Messages Descriptions
Sensor Off The CO2 sensor is not connected
Sensor Warm Up One of the following conditions exist:
Sensor under temperature
Temperature not stable
Source Current unstable
Sensor Over Temp Make sure sensor is not exposed to extreme heat (heat lamp,
etc.). If error persists, return sensor to factory for servicing.
Sensor error Check that the sensor is properly plugged in. Reinsert or reset
the sensor if necessary. If error persists, return sensor to factory
for servicing.
Sensor Zeroing. . A zero is currently in progress.
Zero Required To clear, check airway adapter and clean if necessary. If this
does not correct the error, perform an adapter zero. If you must
adapter zero more than once, a possible hardware error may
exist.
Check Sampling Line To clear, clean if sampling line mucus or moisture is seen. If
the sampling line is clean, perform a zero.
CO2 Out of Range The value being calculated is greater than the upper CO2 limit
(150 mmHg, 20.0 kPa, or 19.7 %). The maximum value output
is the upper CO2.
Check Airway To clear, clean airway adapter if mucus or moisture is seen. If
Adapter the adapter is clean, perform a zero.
Pump Life Exceed The manufacturer stated pump life has been exceeded. Service
may be required if Pneumatic System Error is present and can
no longer be cleared.
Sensor Setup. . . The CO2 sensor is setting process.
EtCO2 Zero Error: The CO2 sensor is not ready for a EtCO2 Zero
Sensor Not Ready.
EtCO2 Zero Error: Breaths have been detected by the CO2 module within the last
Breath Detected. 20 seconds while a CO2 module zero was attempted.

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MAINTENANCE AND CLEANING


SCHEDULE
The CO2 Module flow rate accuracy should be verified by direct measurement using a
calibrated flow meter every 12 months.

CLEACING
Cleaning the CO2 Module case, Cable and connector:
1. Use a cloth dampened with isopropyl alcohol 70%, a 10% aqueous solution of sodium
hypochlorite (bleach), a 2% gluteraldehyde solution, ammonia, mild soap or disinfectant
spray cleaner such as Steris Coverage® Spray HB.
2. Wipe down with a clean water-dampened cloth to rinse and dry before use. Make
certain that the sensor windows are clean and dry before reuse.

[NOTE]
DO NOT immerse or sterilize the CO2 Module.

Cleaning the Sidestream On-Airway Adapters and Sidestream Sampling Kits:


Sidestream on-airway adapters and sidestream sampling kits are single patient use. Treat
in accordance with hospital protocols for handling single patient use devices.

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User’s Manual of OMNI III Patient Monitor

IBP MONITORING (OPTION)


THEORY OF OPERATION
INTRODUCTION
WARNING
PREPARATION FOR MONITORING
INSTRUCTIONS FOR USE OF TRANSDUCER MONITORING KIT
IBP SETUP
SET TRANSDUCER ZERO
PROMPT MESSAGE
MAINTAINENCE AND CLEANING
THEORY OF OPERATION
There are two ways of measuring blood pressure: Direct (Invasive Pressure or IP) and
Indirect (Non-invasive Blood Pressure or NIBP) method. The indirect method uses
simple equipment but provides limited physiological information. The direct or invasive
method (IP) provides accurate pressure measurements in regions of the cardiovascular
system that are inaccessible to the indirect method.

To measure blood pressure by the invasive method, a catheter is inserted in a blood


vessel and taken to the point of interest. The catheter has a transducer that provides
electrical signals, which are then processed and analyzed by the monitor. Measurement
of blood pressure by the invasive method gives the systolic (maximum), diastolic
(minimum) and means pressure.

The invasive pressure range is from -30 to 300 mmHg, allowing the operator to use the
monitor for measuring arterial pressure, pulmonary artery pressure and central venous
pressure.

INTRODUCTION
When an invasive pressure is selected to be displayed on a waveform channel, the
monitor will default to the label IBP1 or IBP2, which indicates a general “Invasive
Pressure”. In addition, the monitor allows the selection of a pressure channel label that
more clearly identifies a measurement. The choices for invasive arterial pressures are:

ART Arterial Blood Pressure


PA Pulmonary Artery Pressure
CVP Central Venous Pressure
RAP Right Arterial Pressure
LAP Left Arterial Pressure
ICP Intracranial Pressure

WARNING
For invasive pressure monitoring, routinely inspect the catheter and/or pressure line
for leaks after zeroing. Always follow the pressure transducer/catheter
manufacturer’s use recommendations.
Always zero the pressure transducer(s) prior to patient use.
Non-physiological pulsatile invasive pressure waveforms (e.g., such as found during
intra-aortic balloon pump use) can lead to inaccurate blood pressure readings. If
questionable value is observed, re-check patient’s pressures by alternate means
before administering medication or therapy.
The operator should avoid contact with the conductive parts of the appurtenance
when being connected or applied.
Disposable IBP transducer or domes should not be reused.

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User’s Manual of OMNI III Patient Monitor

Use only the pressure transducer designated by our company.


Verify transducer cables fault detection before beginning of monitoring phase. Unplug
the transducer of the channels from the socket, the screen will display the error
message and audible alarm is activated, the other channel is the same.
If any kind of liquid, other than solution to be infused in pressure line or transducer, is
splashed on the equipment or its accessories, or may enter the transducer or inside
the monitor, contact the hospital service center immediately.
If there are air bubbles in the pressure line or the transducer, you should flush the
system with solution to be infused.
Calibrate the instrument either whenever a new transducer is used, or as frequently
as indicated by your hospital procedures policy.

PREPARATION FOR MONITORING


Preparing for invasive pressure monitoring requires the following steps:

- Installation of Transducer Cable


- Kit Set Up
- Purging Air from the Lines
- Zeroing, Leveling and Calibration
- Connecting monitoring system to patient
- Set IP channel and label
- Rescale the IP waveform
- Set the alarm limits
- Select printer option

INSTRUCTIONS FOR USE OF TRANSDUCER MONITORING KIT

INSTALLATION OF TRANSDUCER CABLE


1. Insert the plug of IBP transducer cable into the corresponding sensor socket on
the left panel of monitor and check that monitor is switched on.
2. Prepare the pressure tubing and transducer by flushing through the system with
normal saline solution. Ensure the system is free of air bubbles.
3. Connect that patient catheter to the pressure line; making sure that there is no air
present in the catheter of pressure line.
4. Position the transducer so that it is the level with the patient’s heart,
approximately midaxillary line.
5. Check if you have selected the correct lable.
6. Zero the transducer.
KIT SET UP

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User’s Manual of OMNI III Patient Monitor

This section detail refers to relate to content detailed of instructions for use for disposable
transducer monitoring kit.

PATIENT MOUNT

This section detail refers to relate to content detailed of instructions for use for disposable
transducer monitoring kit.

IBP SETUP
Turn the ROTARY KNOB to move the white box on the screen to the IBP1 or IBP2
Waveform or Parameter Area, presses the ROTARY KNOB to pop the menu of IBP Setup,
see below:

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User’s Manual of OMNI III Patient Monitor

Alarm Switch

Pressure Unit

Set Label
P1 Setup Sweep Speed
Sweep Color
Zero IBP1
Zero IBP2
Zero Both
Wave Scale
Alarm Setup
Figure 24: Tree Diagram for IBP1 or IBP2 Setup Menu
ALARM SWITCH
ON and OFF for choice, the factory–set is ON. When the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .
PRESSURE UNIT
mmHg and KPa for choice, the factory-set is mmHg.

NOTE: The pressure unit is displayed in accord with setup of NIBP menu.

SET LABEL
ART, PA, CVP, RAP, LAP and ICP are selectable.
SWEEP SPEED
From 12.5mm/s, 25mm/s or choice, the factory-set is 25mm/s.
SWEEP COLOR
From White, Gray, Red, Yellow, Green, Cyan, Blue, and Magenta for choice, the
default-set is Red.
WAVEFORM SCALE
Pick “waveform scale” to call up the following menu:

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Figure 25: Window for IBP1 or IBP2 Wave Scale

The waveform and corresponding scale values will be displayed in the IBP waveform area.
These scales can be set according to the table given below:
HI: IBP value of High Limit scale;
LO: IBP value of Low Limit scale.

Labels High Low


ART 50-300 0-100
PA 20-150 -10-50
CVP 0-150 -10-150
RAP 0-150 -10-150
LAP 0-150 -10-150
ICP 0-150 -10-150

ALARM SETUP
Press the alarm setup item to popup the IBP1 or IBP2 alarm setup menu as below:

Figure 26: Window for IBP1 or IBP2 Alarm Setup


The alarm setup range for high or low is from 0 to 300mmHg for ART label. The
factory-set for high limit is 150 mmHg. The factory-set for low limit is 75 mmHg.

The alarm setup range for high or low is from -10 to 120mmHg for PA label. The
factory-set for SYS high limit is 90 mmHg. The factory-set for SYS low limit is 60

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mmHg. The factory-set for DIA high limit is 75 mmHg. The factory-set for DIA low limit
is 45 mmHg.

The alarm setup range for high or low is from -10 to 40mmHg for CVP, RAP, LAP and
ICP label. The factory-set for MAP high limit is 30 mmHg. The factory-set for MAP low
limit is 10 mmHg.

SET TRANSDUCER ZERO


After the system has been primed and mounted , zero the transducer. The
following procedure should be completed periodically.
1. Turn zero reference stopcock “off” to the patient and remove yellow
nonvented cap from the side port that opens the zero reference stopcock to
air.
[NOTE]
The air-fluid interface of the zero reference stopcock should be at or near the right
atrial (mid-axillary) level.

2. Open the IBP Setup menu and then choose the “Zero IBP”. You can Zero
IBP1 and IBP2 at the meantime.

Upon connection of an invasive pressure transducer, the monitor will seek a steady
pressure for zeroing. A sequence of on-screen status messages will be displayed.

a. As soon as the power switch is turned on, “SENSOR OFF!” will be displayed on the
screen in the message highlight area.

b. When an invasive pressure transducer is inserted into the IP receptacle on the left
side panel of the monitor, the initial waveform may be visible immediately based
upon the most recently selected scale. The waveform scale numbers are not
shown until transducer is zeroed. If the pressure transducer or interconnect cable
is defective, the on-screen message “SENSOR OFF, UNABLE TO ZERO!” will
remain on the screen. In this case, try another transducer or another cable.

3. Turn zero reference stopcock “off” to the side port. Replace nonvented yellow
cap.

[NOTE]
It is the responsibility for the user to ensure that a zero procedure has recently
been done on the transducer, otherwise there will be on recent, valid zero value
for the instrument to use, which may result in inaccurate measurement results.
Turn off patient 3-way stopcock before you start the zero procedure.
The transducer must be vented to atmospheric pressure before the zero
procedure.

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PROMPT MESSAGE
Messages Descriptions
OVERANGE, ZERO FAIL! Make sure that the stopcock is vented to
atmosphere. If the problem persists, contact
service representative if necessary.
TIMED OUT, ZERO FAIL! Make sure that monitor is not in DEMO mode.
Contact service representative if necessary.
SENSOR OFF, UNABLE TO Make sure that channel 1 or channel 2’s
ZERO! transducer is not off, and then proceeds zeroing.
ZERO IN PROCESS! A zero is currently in progress.
ZERO OK! The zero procedure is completed.

MAINTAINENCE AND CLEANING


Make sure that the device is switched off and disconnected from the power cable before
cleaning the monitor or the transducer.

The disposable transducers or caps is a single use kit, must not be re-sterilized or
re-used.

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ANESTHETIC AGENT MONITORING(


(OPTION, PHASEIN)

PHASEIN IRMA™ MAINSTREAM PROBE


INTRODUCTION
SAFETY
SYSTEM ASSEMBLY INSTRUCTION
ZEROING PROCEDURE
ALARMS
CLEANING
MAINTENANCE

PHASEIN ISA™ SIDESTREAM ANALYZER


INTRODUCTION
SAFETY
ANALYZER SYSTEM SET-UP
PRE-USE CHECK
CONSUMABLE
ALARMS
AUTOMATIC ZEROING
CLEANING
MAINTENANCE
MAC CALCULATION
ADVERSE EFFECTS ON PERFORMANCE
ANESTHETIC AGENT DISPLAY
ANESTHETIC AGENT WAVEFORM SETUP
ANESTHETIC AGENT PARAMETER SETUP

PHASEIN IRMA™ MAINSTREAM PROBE


INTRODUCTION
PHASEIN IRMA™ mainstream multi-gas probe is intended for gas monitoring of adults,
pediatric and infant patients in anesthesia, intensive care and emergency care.

The IRMA probe comprises a state-of-the-art, single path, nine-channel non-dispersive


infrared (NDIR) gas bench, a barometric pressure sensor, a power regulator, a CPU and a
RS-232 digital interface. The unit weighs less than 25 g.

The probe is available in various configurations for different clinical applications.


Concentrations of carbon dioxide, nitrous oxide, Halothane, Enflurane, Isoflurane,
Sevoflurane and Desflurane in different combinations are determined together with
derived parameters such as respiration rate, waveform data and inspired/expired
concentrations of all gases.

The IRMA probe snaps in place on the IRMA airway adapter that includes PHASEIN’s
XTP™ windows. The airway adapter is inserted between the endotracheal tube and the
breathing circuit, and the gas measurements are obtained through the XTP windows in the
sides of the adapter.

Running on a standard low voltage DC, the IRMA probe is designed with portability in
mind and has low power consumption, typically less than one watt. It has been specially
designed to be extremely easy to integrate in any host device for display of real time and
derived breathing gas data.

The IRMA main stream multi-gas probe is intended to be connected to other medical
devices for display of real time and derived monitoring data of CO2, N2O, and the

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User’s Manual of OMNI III Patient Monitor

anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. It is


intended to be connected to a patient breathing circuit for monitoring of inspired/expired
gases during anesthesia, recovery and respiratory care. It may be used in the operating
suite, intensive care unit, patient room and emergency medicine settings for adult,
pediatric and infant patients.

It is not intended to be used as the only means of monitoring a patient. It shall always be
used in combination with other vital signs monitoring devices and/or professional human
judgments of patient condition. The IRMA probe is intended to be used by trained and
authorized health care professionals only.
SAFETY
WARNINGS
DO NOT use the IRMA Adult/Pediatric airway adapter with infants as the adapter
adds 6 ml dead space to the patient circuit.
Replace the adapter if rainout/condensation occurs inside the airway adapter.
Use only PHASEIN manufactured IRMA airway adapters.
DO NOT use the IRMA Infant airway adapter with adults as this may cause excessive
flow resistance.
The IRMA probe is not intended to be in patient contact.
Incorrect probe zeroing will result in false gas readings.
The IRMA probe is intended for use by authorized and trained medical personnel
only.
The IRMA probe must not be used with flammable anesthetic agents.
Disposable IRMA airway adapters shall not be reused. Reuse of the single use
adapter can cause cross infection.
Used airway adapters shall be disposed of in accordance with local regulations for
medical waste.
The IRMA probe is intended only as an adjunct in patient assessment. It must be
used in conjunction with other assessments of clinical signs and symptoms.
DO NOT place the IRMA airway adapter between the endotracheal tube and an
elbow as this may allow patient secretions to block the adapter windows and result in
incorrect operation.
To keep secretions and moisture from pooling on the windows, always position the
IRMA probe in a vertical position with the LED pointing upwards.
DO NOT use the IRMA airway adapter with metered dose inhalers or nebulized
medications as this may affect the light transmission of the airway adapter windows.

CAUTIONS
Never sterilize or immerse the IRMA probe in liquid.
DO NOT autoclave the devices as this will damage them.
DO NOT apply tension to the sensor cable.
DO NOT operate the device outside the temperature environment
(U.S.): Federal law restricts this device to sale by or on the order of a physician.

SYSTEM ASSEMBLY INSTRUCTION


SET-UP
1. Plug the IRMA connector into the Patient Monitor EtCO2/Gas socket and switch the
power on.
2. Snap the IRMA probe on top of the IRMA airway adapter. It will click into place when
properly seated.

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User’s Manual of OMNI III Patient Monitor

3. A green LED indicates that the IRMA probe is ready for use.

4. Connect the 15 mm male connector of IRMA/airway adapter to the breathing circuit


Y-piece.

5. Connect the 15mm female connector of IRMA/airway adapter to the patient’s


endotracheal tube.

Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s


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 vapor and eliminates the
need of changing the adapter. It allows free positioning of the IRMA probe as well.

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User’s Manual of OMNI III Patient Monitor

6. Always position the IRMA probe with the status LED pointing upwards unless the IRMA
probe is protected with an HME

PLACEMENT OF IRMA PROBE


When connecting IRMA probe to an infant patient circuit, it is important to avoid a direct
contact between the IRMA probe and the infant's body.
If, for whatever the reason, the IRMA probe is in direct contact with any parts of the
infant's body, an insulation material shall be placed between the IRMA probe and the
body.

WARNING: The IRMA probe is not intended to be in patient contact

PRE-USE CHECK
Prior to connecting the IRMA airway adapter to the breathing circuit, verify gas readings
and waveforms on the monitor before connecting the airway adapter to the patient circuit.
Perform the tightness check of the patient circuit with the IRMA probe snapped on the
IRMA airway adapter.

ZEROING PROCEDURE

WARNING: Incorrect probe Zeroing will result in false gas readings.

In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.

Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe,
without connecting the airway adapter to the patient circuit, and then using OMNI III to
transmit a Zero reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during
the Zeroing procedure. The presence of ambient air (21% O2 and 0% CO2) in the IRMA
airway adapter is of crucial importance for a successful Zeroing. Always perform a pre-use

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User’s Manual of OMNI III Patient Monitor

check after zeroing the probe.

IRMA CO2 probes:


Zeroing needs to be performed ONLY when an offset in gas values is observed, or when
an unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probe after power on and after changing
the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED
on the probe will be blinking for approximately 5 seconds while zeroing is in progress.

IRMA AX+ probes:


Zeroing should be performed every time the IRMA airway adapter is replaced, or
whenever an offset in gas values or an unspecified gas accuracy message is displayed.
Allow 30 seconds for warm up of the IRMA AX+ probes after power on and after changing
the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED
on the probe will be blinking for approximately 5 seconds while zeroing is in progress.

ZERO BY MONITOR
After install the PHASEIN gas module, and Click the Anesthetic Agent Waveform and
Parameter Area to pop up the menu of Multi-Gas Setup Advanced setup manual zero,
Monitor will conduct a zero procedure and “zero in progress” message will be displayed.

ALARMS
GAS ALARM LIMIT

Gas type HIGH (%) LOW(%)


FIAGT 5 0
ETAGT 5 0
FICO2 0.5 0
ETCO2 8 2
FIN2O 100 0
FIO2 100 18
ETO2 100 5

STATUS LED ON IRMA PROBE

Status Meaning
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light 1) Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adapter

[NOTE]: 1) Valid for IRMA AX++ probes only

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CLEANING
The IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or
maximum 70% isopropyl alcohol.
Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe.

Caution: Never sterilize or immerse the IRMA probe in liquid.

MAINTENANCE

Gas readings should be verified at regular intervals with a reference instrument or with
calibration gas. The recommended interval is once every year.

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PHASEIN ISA™ SIDESTREAM ANALYZER


INTRODUCTION
The ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA
AX+ and ISA OR+), which are intended to be connected to OMNI III Patient Monitor for
measuring breath rate and the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit
for the monitoring of inspired/expired gases during anesthesia, recovery and respiratory
care. The intended environment is the operating suite, intensive care unit and patient
room. ISA CO2 is also intended to be used in road ambulances. The intended patient
population is adult, pediatric and infant patients.

[NOTE 1]: An ISA sidestream gas analyzer should never be used as the only means
of monitoring a patient.
[NOTE 2]: An ISA sidestream gas analyzer shall only be connected to medical
devices approved by PHASEIN.

Patents
PHASEIN AB holds the following patents regarding products described in this manual:
SE519766; SE519779; SE523461; SE524086. Other patents are pending.
Trademarks
PHASEIN IRMA™, PHASEIN ISA™, PHASEIN XTP™, Sigma Multigas Technology™,
LEGI™, Nomoline™, IRMA EZ Integrator™, PHASEIN Gas Master™ and PHASEIN Gas
Master™ are trademarks of PHASEIN AB.

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User’s Manual of OMNI III Patient Monitor

SAFETY
CLASSIFICATION
According to the degree of safety of application in the presence of FLAMMABLE
ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE:
The ISA is not suitable for use in the presence of FLAMMABLE ANAESTHETIC
MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE.
According to the degree of protection against harmful ingress of water:IPX4
According to sterility: The ISA system contains no sterile parts.
According to the model of operation: CONTINUOUS OPERATION
According to the degree of protection against electric shock:
Nomoline Family sample lines are classified as DEFIBRILLATION PROOF TYPE BF
APPLIED PART
The combination of OMNI III and ISA shall be considered a ME SYSTEM.

WARNINGS
The ISA sidestream gas analyzer is intended for use by authorized and trained
medical personnel only.
Use only Nomoline sampling lines manufactured by PHASEIN.
The ISA sidestream gas analyzer must not be used with flammable anesthetic
agents.
Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
DO NOT re-use disposable sampling lines.
DO NOT lift the ISA/OMNI III by the sampling line as it could disconnect from the ISA/
OMNI III >, causing the ISA/ OMNI III to fall on the patient.
Used disposable sampling lines shall be disposed of in accordance with local
regulations for medical waste.
DO NOT use adult/pediatric type sampling line configurations with infants, as this
may add dead space to the patient circuit.
DO NOT use infant type sampling line configurations with adults, as this may cause
excessive flow resistance.
DO NOT use the ISA sidestream gas analyzer with metered-dose inhalers or
nebulized medications as this may clog the bacteria filter.
Check that the gas sample flow is not too high for the present patient category.
Since a successful zeroing requires the presence of ambient air (21% O2 and 0%
CO2) in the gas analyzer, ensure that the ISA is placed in a well ventilated place.
Avoid breathing near the ISA sidestream gas analyzer before or during the zeroing
procedure.
The Nomoline sampling line and its interfaces are non-sterile devices. To avoid
damage, do not autoclave any part of the sampling line.
Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
Measurements can be affected by mobile and RF communications equipment. Make
sure that the ISA sidestream gas analyzer is used in the electromagnetic environment
specified in this manual.
ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It
must be used in conjunction with other assessments of clinical signs and symptoms.
Replace the sampling line if the sampling line input connector starts flashing red, or a
Nomoline occlusion message is displayed on the OMNI III
No modification of this equipment is allowed without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
ISA sidestream gas analyzers are not designed for MRI environments.
During MRI scanning, the OMNI III must be placed outside the MRI suite.
Use of high frequency electrosurgical equipment in the vicinity of the ISA/OMNI III
may produce interference and cause incorrect measurements.

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DO NOT use external ambient cooling of the ISA device.


DO NOT apply negative pressure to the Nomoline (i.e. by a syringe) to remove
condensed water.
Too strong positive or negative pressure in the patient circuit might affect the sample
flow.
Strong scavenging suction pressure might affect the sample flow.
Exhaust gases should be returned to the patient circuit or a scavenging system.
Always use a bacteria filter on the evac side if sampled gas is intended to be
re-breathed.
DO NOT place the ISA gas analyzer in any position that might cause it to fall on the
patient.

CAUTIONS
The ISA “plug-in and measure” analyzers should be securely mounted in order to
avoid the risk of damage to the ISA.
DO NOT apply tension to the ISA sidestream gas analyzer cable.
DO NOT operate the ISA sidestream gas analyzer outside the specified operating
temperature environment.
(US Only) Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.

ANALYZER SYSTEM SET-UP


1. Securely mount the ISA analyzer.

2. Connect the ISA analyzer interface cable to the OMNI III Patient Monitor.

3. Connect a Nomoline Family sampling line to the ISA analyzer input connector.

4. Connect the gas sample exhaust port to a scavenging system or return the gas to the
patient circuit to prevent pollution of the operation room when N2O and/or anesthetic
agents are being used.
5. Power up the OMNI III Patient Monitor.
6. A green LED indicates that the ISA analyzer is ready for use.
7. Perform a pre-use check as described in section “Pre Check”.
PRE-USE CHECK
Before connecting the Nomoline sampling line to the breathing circuit, do the following:
1. Connect the sampling line to the ISA gas inlet connector (LEGI)
2. Check that the LEGI shows a steady green light (indicating that the system is OK)
3. For ISA AX+ module with O2 option fitted:

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User’s Manual of OMNI III Patient Monitor

Check that the O2 reading on the monitor is correct (21%).


4. Breathe into the sampling line and check that valid CO2 waveforms and values are
displayed on the OMNI III Patient Monitor.
5. Occlude the sampling line with a fingertip and wait for 10 seconds.
6. Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light.
7. If applicable:
Perform a tightness check of the patient circuit with the sampling line attached.
CONSUMABLE
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.
THE NOMOLINE FAMILY
To overcome the shortfalls of current gas sampling solutions, the Nomoline Family
sampling lines have been developed for the ISA sidestream gas analyzers.

Unlike traditional solutions that remove water vapor and collect water in a container, the
Nomoline Family sampling lines incorporates a unique water separation (NO Moisture)
section, which removes condensed water. The NOMO section also has a bacteria filter
which protects the gas analyzer form water intrusion and cross contamination.

The Nomoline Family sampling lines are specially designed for 50 ml/min low sample flow
applications. The Nomoline Family sample lines have 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 Family sampling lines are available in the following versions:

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(The Nomoline Family sampling lines; Nomoline with male Luer Lock connector, Nomoline
Airway Adapter Set with integrated airway adapter and the Nomoline Adapter with female
Luer Lock connector.)

The Nomoline Airway Adapter Set with integrated airway adapter can be used with
intubated patients.
The Nomoline with a male Luer Lock type connector is compatible with any normal
configuration that uses a female Luer Lock connector. When connecting to a T-adapter,
be sure to use a PHASEIN T-adapter that samples the gas from the center of the
T-adapter (see below).

(For optimal water handling, always use T-adapters with the sampling point in the center
of the adapter, as shown to the left in the figure above.)

The Nomoline Adapter with female Luer Lock connector connects to a standard male Luer
to Luer sample line (Nomo Extension) as well as to different kinds of third-party cannulas
for oral and nasal sampling. Combining the Nomoline Adapter with the Nomo Extension
and T-adapter results in a similar product as the Nomoline Airway Adapter Set (see
below).

(Combining Nomoline Adapter with the Nomo Extension and T-adapter results in a similar
product as the Nomoline Airway Adapter Set.)

(If using third-party sample tubes or cannula, make sure that the inner diameter does not
exceed 1 mm since this will increase the ISA’s total system response time.)

[NOTE]: Using sample tubes or cannula with larger inner diameter than 1 mm will
increase the response time of ISA’s total system.

[WARNING]: DO NOT apply negative pressure to remove condensed water from the
Nomoline Family sampling line.

[WARNING]: DO NOT use the ISA gas analyzer with metered-dose inhalers or
nebulized medications as this may clog the bacteria filter.

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[WARNING]: DO NOT apply negative pressure to remove condensed water from the
Nomoline Family sampling line.

[WARNING]: Dispose nomoline family sampling lines in accordance with local


regulations for biohazardous waste.

[WARNING]: Use only airway T-adapters with the sampling point in the center of the
adapter.

[WARNING]: DO NOT re-use disposable single-patient use Nomoline Family


sampling lines due to the risk of cross contamination.

[WARNING]: DO NOT sterilize or immerse Nomoline Family sampling lines in liquid.

[WARNING]: DO NOT use T-adapter with infants, as this adds 7 ml dead space to the
patient circuit.

[WARNING]: Do only use sample lines intended for anesthetic agents if N2O and/or
anesthetic agents are being used.
REPLACEMENT OF NOMOLINE AND NOMOLINE AIRWAY ADAPTER SET
The Nomoline and Nomoline Airway Adapter Set are single-patient use products.
They should be replaced according to good clinical practice or when an occlusion
message appears. Occlusion occurs when the sample flow is too low. This is indicated by
a flashing red LEGI together with a message on OMNI III.
REPLACEMENT OF NOMOLINE ADAPTER
The Nomoline Adapter is a multiple-patient use product.
The Nomoline Adapter should be replaced according to good clinical practice or when an
occlusion message appears. Occlusion occurs when the sample flow is too low. This is
indicated by a flashing red LEGI together with a message on OMNI III.
REPLACEMENT OF T-ADAPTER AND NOMO EXTENSION
The T-adapter and Nomo Extension are single-patient use products.
They should be replaced according to good clinical practice or when an occlusion
message appears. Occlusion occurs when the sample flow is too low. This is indicated by
a flashing red LEGI together with a message on OMNI III.
ALARMS
Gas Alarm limit
Gas type HIGH (%) LOW (%)
FIAGT 5 0
ETAGT 5 0
FICO2 0.5 0
ETCO2 8 2
FIN2O 100 0
FIO2 100 18
ETO2 100 5

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Status indicated by ISA LED

Indication Status
Steady green light System OK
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line
AUTOMATIC ZEROING
The infrared gas analyzer needs to establish a zero reference level for the CO2, N2O and
anesthetic agent gas measurement. This zero calibration is here referred to as "zeroing".
ISA sidestream gas analyzers perform zeroing automatically by switching the gas
sampling from the respiratory circuit to ambient air. The automatic zeroing is performed
every 24 hours, and takes less than 3 seconds for ISA CO2 gas analyzers and less than
10 seconds for ISA multigas analyzers.
If the ISA sidestream gas analyzer is fitted with an oxygen sensor, the automatic zeroing
will also include room air calibration of the oxygen sensor.

[WARNING]: Since a successful zeroing requires the presence of ambient air (21% O2
and 0%CO2) in the gas analyzer, ensure that the ISA is placed in a well ventilated
place. Avoid breathing near the ISA sidestream gas analyzer before or during the
zeroing procedure.

CLEANING
The “plug-in and measure” ISA sidestream gas analyzers should be cleaned on a regular
basis.
Use a cloth moistened with max 70% ethanol or isopropyl alcohol to clean the analyzer.
To prevent cleaning liquids and dust from entering the ISA gas analyzer through its LEGI
connector, keep the Nomoline sampling line connected while cleaning the analyzer.

[WARNING]:
The Nomoline sampling lines are non-sterile devices. To avoid damage, DO NOT
autoclave any part of the sampling line.
Never sterilize or immerse the ISA sidestream gas analyzer in liquid.Since a
\\ successful zeroing requires the presence of ambient air (21% O2 and 0%CO2) in
the gas analyzer, ensure that the ISA is placed in a well ventilated place. Avoid
breathing near the ISA sidestream gas analyzer before or during the zeroing
procedure.

MAINTENANCE
Once every year, or whenever gas readings are questionable, perform a leakage check as
below and verify gas readings with a reference instrument or with calibration gas.
Calibration gas can be ordered from PHASEIN AB (www.phasein.com).

LEAKAGE CHECK
1. Connect a new Nomoline sampling line with male luer lock to the ISA LEGI and check
that the LEGI shows a steady green light.
2. Connect a short of silicon tubing with an inner diameter of 3/32” (2.4 mm) to the
Nomoline male luer.
3. Exhale a long breath into the silicon tubing until the CO2 concentration is greater than
4.5 vol % or 34 mmHg.

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4. Quickly connect the silicon tubing tightly to the exhaust port.


5. Wait 1 minute until the CO2 concentration has stabilized. Note the value.
6. Wait 1 minute and check that the CO2 concentration has not decreased more than 0.4
vol% or 3 mmHg. If it has decreased more there is a major leakage in the ISA unit or in the
Nomoline. DO NOT operate the ISA if there is a major leakage in the unit.
MAC (Minimum Alveolar Concentration) CACULATION
Minimum alveolar concentration (MAC) is a standard for comparing the potency of
inhalation anesthetics. 1 MAC represents the end-tidal concentration of an agent (at sea
level) that, in 50 percent of a tested population, prevents gross muscular movement in
response to a painful, standardized stimulus.
The MAC value may be calculated and displayed by using end-tidal (Et) gas
concentrations according to the following formula:

% Et ( AA1) % Et ( AA2) % Et ( N 2O )
MAC = + +
X ( AA1) X ( AA2) 100
X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%

[NOTE]: Altitude, patient age and other individual factors are not considered in the
formula above.

SYMBOLS

Symbol Title Explanation


Instructions for use Consult instructions for use

Catalog number

Serial number

Batch code

Year of manufacture

Use by date [YYYY-MM-DD] The device should not be taken into


operation after the date accompanying the
symbol.
Temperature limitation

Pressure limitation

Humidity limitation

DO NOT re-use Nomoline and Nomoline Airway Adapter Set


are intended for single patient use
Biohazardous waste Nomoline Family sampling lines shall be
disposed as biohazardous waste

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Symbol Title Explanation


For EU only: For EU only:
Waste Electrical and Electronic Electrical and electric equipment shall be
Equipment (WEEE) collected and recycled in accordance with
(Directive 2002/96/EC)
ETL Listing Mark Conforms to ANSI/AAMI 60601-1:2005 Cert.
to CAN/CSA-C22.2 No.60601.1:2008.

Conformité Européenne Complies with 93/42/EEC Medical Device


Directive when connected to medical
0413 devices approved by PHASEIN AB.
IP classification indicating level of “Splash-proof”
water protection
Rx only (US Only) Caution: Federal law restricts this
device to sale by or on the order of a
licensed healthcare practitioner.
CO2 ISA equipped to measure CO2 only

Multigas (AX+ or OR+) ISA equipped to measure multiple gases

Sigma Multigas Technology The product is fitted with PHASEIN Sigma


Multigas Technology
Gas Inlet See sections 7.1 (build-in module) or 7.2
(“plug-in and measure” analyzer)
Gas Outlet See sections 7.1 (build-in module) or 7.2
(“plug-in and measure” analyzer)
Defibrillation-proof type BF The applied part of ISA is the Nomoline
applied part Family sampling line

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ADVERSE EFFECTS ON PERFORMANCE


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 25°C
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 flows through the sampling line, the gas temperature will adapt to
ambient before reaching the gas analyzer. As the NOMO section removes 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:
  3.8  
EtCO 2 (BTPS ) = EtCO2 * 1 −   
  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.
ANESTHETIC AGENT DISPLAY
DISPLAY
Open the PHASEIN Gas module and then choose to display AG waveform in the
“Waveform Select” menu. See graph below.

SENSOR STATUS
Sensor Off
Check Sample Line
Sensor error
Zero in Progress
Unspecified accuracy

PHYSIOLOGIC AGENT STATUS


ID: The gas module has identified an agent. In this state, the corresponding ID indicates
one of the 5 anesthetic agents.

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ANESTHETIC AGENT TYPE


HAL:Halothane
ENF:Enflurane
ISO:Isoflurane
SEV:Sevoflurane
DES:Desflurane
ANESTHETIC AGENT SETUP
Turn the ROTARY KNOB to move the white box on the screen to the AG Waveform or
Parameter Area, press the ROTARY KNOB to pop the menu of Multi-Gas Setup, see
below:

Figure 27: Tree Diagram for Multi-Gas Setup Menu


ALARM SWITCH
ON and OFF for choice, the factory-set is ON. When the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .
APNEA DELAY
This setting is used to set the no breaths detected time-out. This time-out is the time
period in seconds following the last detected breath at which the CO2 module will signal
no breaths detected.

The setting range is 10~60 seconds, and the factory-set is 10 seconds.


AGENT TYPE
“Auto ID”, “Halothane”, “Enflurane”, “Isoflurane”, “Sevoflurane” and “Desflurane” for
choice.
If the AAM has no “Auto ID” function, the anesthetic agent type needs to be selected
manually.
WAVEFORM SCALE
“0-10%” and “0-20%” for choice, the factory-set is “0-10%”. Use this setting to
adjust the amplitude measurement (size) of the displayed EtCO2 waveform scale
manually.

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WAVE FILL
Use this setting to fill in the bottom portion of the waveform on any channel of the
display.
SWEEP SPEED
12.5mm/s and 25mm/s for choice, the factory-set is 12.5mm/s.
SWEEO COLOR
It provides white, red, green, cyan, blue, yellow, gray and magenta which can be
chosen.
GAS UNIT SETUP
“mmHg”, “kPa” and “%” for choice, the factory-set is %
ALARM SETUP

High Low
FI Agt 0.0-20.0 factory-set:5.0(%) 0.0-20.0 factory-set:0.0(%)
ET Agt 0.0-20.0 factory-set:5.0(%) 0.0-20.0 factory-set:0.0(%)
FI CO2 0.0-10.0 factory-set:0.5(%) 0.0-10.0 factory-set:0.0(%)
ET CO2 0.0-10.0 factory-set:8.0(%) 0.0-10.0 factory-set:2.0(%)
RR 0-100 factory-set:30(rpm) 0-100 factory-set:5 (rpm)
FI N2O 0-100 factory-set:100(%) 0-100 factory-set: 0(%)
ET N2O 0-100 factory-set:100(%) 0-100 factory-set: 0(%)
FI O2 18-100 factory-set:100(%) 18-100 factory-set:18(%)
ET O2 0-100 factory-set:100(%) 0-100 factory-set:5(%)

ADVANCED SETUP
ZERO GAS TYPE
“Scrubbed Air/N2/O2”, “Room Air” and “100% O2” for choice, the factory-set is “Room Air”.

O2 COMPENSATIONS
The anesthetic agents in the gas mixture need to be compensated in order to achieve its
stated accuracy. The instrument settings for this parameter should be set when the O2
sensor is unconnected. But when install the O2 sensor, this function isn’t available.

STANDBY MODE

When measurements are temporarily not needed, the monitor can switch the AAM from
‘Operation Mode’into ‘Standby Mode’. During standby, some internal components of
the module are switched off, which increases the lifetime of the module. When
measurements are needed again, the device must be switched back into ‘Operation
Mode’. The latter transition will usually take less than 30 seconds.

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ANESTHETIC AGENT MONITORING(


(OPTION, DRÄGER)

THEORY OF OPERATION AND DESCRIPTIONS
PATIENT CONNECTIONS
ANESTHETIC AGENT DISPLAY
ANESTHETIC AGENT SETUP
MAC CALCULATION
CALIBRATION
THEORY OF OPERATION AND DESCRIPTION
The Anesthetic Agent Module (AAM) incorporates the latest design techniques and
solid-state technology to redefine compactness and reliability. Miniaturization and
performance advancements lead to an extremely cost-effective measuring of all five
relevant anesthetic agents, as well as carbon dioxide and nitrous oxide. Ingenious
solid-state design means that there are no moving parts to wear out.

The result is a solution that is highly shock-proof, while featuring low power consumption
and an exceptional degree of integration flexibility into the finished product.

The infrared technology consists of a multi-spectral detector that operates according to


the principles of absorption measuring and ray mixture. During each use, the infrared light
is reflected in four directions after which it passes through a filter. The filters are laid out so
that they are only permeable for a small wave length bandwidth in which the analyzed gas
shows a particular absorption characteristic. Consequently, it is possible to determine the
concentration of the gas, based on the light intensity measured by a sensor. And unlike
other sensors, the AAM is not susceptible to cross-sensitivities due to gases like water
vapour, ethanol or acetone.

A rapid response time of less than 350 ms for CO2 and less than 500 ms for other gases
enables the AAM to differentiate between inhaled and exhaled gas concentrations. Plus,
the functional range of the AAM provides automatic identification of the agent, including
identifying and quantifying a mixture of two different anesthetic gases. Yet both sensors
are lifetime calibrated and require only minimal maintenance.

WaterLock - the advanced water trap from Dräger Medical protects your gas measuring
equipment against infiltration water, bacteria and viruses. This user friendly product
improves the longevity and accuracy of your devices. The WaterLock has a guaranteed
operating life of four weeks and can be reused as often as needed during this time.

For hygienic draining, all you need to do is remove the water trap from its mounting, insert
a commercial syringe and extract the water. The WaterLock owes its high efficiency to two
hydrophobic Goretex-membranes made of PTFE. These micro-porous filters have a pore
size of only 0.2µm, which is impermeable to condensed water and contaminants. Yet it
allows the measured gas to pass through without a noteworthy decrease in pressure. The
design of the filter housing creates a self-purification effect that helps prevent clogging.

Furthermore, the system has been constructed to optimize top-level accuracy for real-time
curves and render impossible overflows of the water trap tank.

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Warning:
Always test sampling line adapter for a tight connection and proper operation before
attaching to a patient.
Sevoflurane is an investigative drug and can only be used on humans where
authorized by governing agencies within the individual countries.
The outputs of the two oscillators are mixed and filtered to produce a signal that is
the difference in frequency of the two. The difference frequency is used to calculate
the concentration of the selected gas.
The response for agent detection depends on the response time of the detector and
the sample flow rate. At a flow rate of 140 ml/min., the response time is adequate for
breath rates up to eighteen (18) breaths per minute. For breath rates over this,
performance may be affected.
Since the sensitivity of the gas detector is different for each gas, it is necessary to
select which gas is being administered.

Note:
Patient Waste Gas Removal:
Continuous exposure of Health Care workers to waste anesthetic gases (including
halogenated agents and nitrous oxide) is not recommended. Always attach both waste
gas connections on the rear of the monitor to the room’s gas evacuation system. Avoid
venting any waste anesthetic gas directly into the room air as exposure to waste
anesthetic gases above the recommended OHSA limits could result.

PATIENT CONNECTIONS
Use only original Infinium Medical Inc. sampling lines and accessories; other sampling
lines may cause inaccurate readings and malfunctions. Change sampling line and airway
adapter for each patient.

Complete the patient connections following the below steps:


1. Select the suitable Water Trap Cartridge/Adapter and install the fixed seat on the side
of the Patient Monitor.
2. Connect the sample line with the water trap adapter.
3. Connect the sample’s other end with the patient via airway adapter.
4. Connect Endotracheal Tube with an anesthesia or ventilator circuit with a side stream
outlet.

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ANESTHETIC AGENT DISPLAY


DISPLAY
Open the DRAGER Gas module and then choose to display Gas waveform in the
“Waveform Select” menu. See graph below.

SENSOR STATUS
Sensor Off
Check Watertrap/Sample Line
Hardware Failure
Occlusion
Zero in Progress
Sensor Standby(See the menu setup below)
Sensor Warm Up

The Zero Procedure has the purpose to maintain proper accuracy of the measurements.

Zero requests typically occur after the warm-up phase (a couple of minutes or so after
start-up) of a sensor component and then again in regular time intervals (every two hours).
Under certain circumstances the module will indicate extraordinary zero requests (e.g.
after returning from Standby Mode or Switched Off mode). Most AAM have an internal
zero management that schedules the regular zero requests in an intelligent way, such that
zero requests for several individual parameters are synchronized with each other. By this,
zero requests will occur less frequent, and also the zeroing process can be conducted for
several gas parameters at the same time. As a consequence, zeroing will consume less of
the operation time and the availability of measured data is improved.

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The time needed for conducting a Zero Procedure varies between different sensor heads.
Typically, it will require between ca. 20 seconds and 1 minute. In the course of the Zero
Procedure, the setting of the valve and the pump change temporarily. When the Zero
Procedure is finished, the module will automatically restore the valve and pump settings
prior to the procedure.

PHYSIOLOGIC AGENT STATUS


ID: The AAM has identified an agent. In this state, the corresponding ID indicates one of
the 5 anesthetic agents.

CALC: Calculate…, The Patient Gas Module is currently busy with identifying the present
agent(s). This status typically lasts for a couple of seconds.
“Calculate” is a condition in which the agent mixture algorithm is not sure about the
detected agents. Usually it comes up if no single agent history is available and a mixture
situation occurs. Then it may stay for a few seconds.

OVER: Overflow
The gas concentration has increased above the maximum threshold.

MIX: Mixture
The Patient Gas Module can not identify the present agent(s). The reason is the presence
of
- Either a mixture of too many anesthetic agents
- or other unidentifiable gases

FORCE:
Forced mode is used for the non-automatic Identification.

These sensors are not able to identify which of the volatile anesthetic agents Halothane,
Enflurane, Isoflurane, Sevoflurane or Desflurane is contained within the patient gas. This
type of sensor is always operated in “Forced Mode”.

In this mode the monitor will specify the type of anesthetic agent for the AAM with the
command “Select Anesthetic Agent”. The ID of the Physiologic Agent then reflects the
forced agent.

EST: Estimated
The AAM can not identify the present agent(s) but only give an estimation of one of the
present agents. The reason is the presence of
- Either a mixture of too many anesthetic agents
- Or other unidentifiable gases
ANESTHETIC AGENT TYPE
HAL Halothane
ENF Enflurane
ISO Isoflurane
SEV Sevoflurane
DES Desflurane
ANESTHETIC AGENT SETUP
Turn the ROTARY KNOB to move the white box on the screen to the AG Waveform or
Parameter Area, press the ROTARY KNOB to pop the menu of Multi-Gas Setup, see
below:

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Figure 28: Tree Diagram for Multi-Gas Waveform Setup Menu

ALARM SWITCH
ON and OFF for choice, the factory-set is ON. When the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash and relative parameter area will appear an icon of .
APNEA DELAY
This setting is used to set the no breaths detected time-out. This time-out is the time
period in seconds following the last detected breath at which the CO2 module will signal
no breaths detected.

The setting range is 10~60 seconds, and the factory-set is 10 seconds.


AGENT TYPE
“Auto ID”, “Halothane”, “Enflurane”, “Isoflurane”, “Sevoflurane” and “Desflurane” for
choice.
If the AAM has no “Auto ID” function, the anesthetic agent type needs to be selected
manually.
WAVEFORM SCALE
“0-10%” and “0-20%” for choice, the factory-set is “0-10%”. Use this setting to
adjust the amplitude measurement (size) of the displayed EtCO2 waveform scale
manually.
WAVE FILL
Use this setting to fill in the bottom portion of the waveform on any channel of the
display.
SWEEP SPEED
12.5mm/s and 25mm/s for choice, the factory-set is 12.5mm/s.
SWEEO COLOR
It provides white, red, green, cyan, blue, yellow, gray and magenta which can be
chosen.

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GAS UNIT SETUP


“mmHg”, “kPa” and “%” for choice, the factory-set is %
ALARM SETUP

High Low
FI Agt 0.0-20.0 factory-set:5.0(%) 0.0-20.0 factory-set:0.0(%)
ET Agt 0.0-20.0 factory-set:5.0(%) 0.0-20.0 factory-set:0.0(%)
FI CO2 0.0-10.0 factory-set:0.5(%) 0.0-10.0 factory-set:0.0(%)
ET CO2 0.0-10.0 factory-set:8.0(%) 0.0-10.0 factory-set:2.0(%)
RR 0-100 factory-set:30(rpm) 0-100 factory-set:5 (rpm)
FI N2O 0-100 factory-set:100(%) 0-100 factory-set: 0(%)
ET N2O 0-100 factory-set:100(%) 0-100 factory-set: 0(%)
FI O2 18-100 factory-set:100(%) 18-100 factory-set:18(%)
ET O2 0-100 factory-set:100(%) 0-100 factory-set:5(%)

ADVANCED SETUP

ZERO GAS TYPE


“Scrubbed Air/N2/O2”, “Room Air” and “100% O2” for choice, the factory-set is “Room Air”.

O2 COMPENSATIONS
The anesthetic agents in the gas mixture need to be compensated in order to achieve its
stated accuracy. The instrument settings for this parameter should be set when the O2
sensor is unconnected. But when install the O2 sensor, this function isn’t available.

STANDBY MODE

When measurements are temporarily not needed, the monitor can switch the AAM from
‘Operation Mode’into ‘Standby Mode’. During standby, some internal components of
the module are switched off, which increases the lifetime of the module. When
measurements are needed again, the device must be switched back into ‘Operation
Mode’. The latter transition will usually take less than 30 seconds.

MAC (Minimum Alveolar Concentration) Calculation

The MAC value may be calculated and displayed by using end-tidal (ET) gas
concentrations according to the following formula:
%ET ( AA1) % ET ( AA2) % ET ( N 2O )
MAC = + +
X ( AA1) X ( AA2) 100
X (AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=0.25%, DES=6.0%

[NOTE]: The altitude and the patient age as well as other individual factors are not
taken into account in the above described formula. ET gas concentrations for
secondary agent (AA2) is only available for IRMA AX+/OR+ probes.

CALIBRATION
The gas module doesn’t require calibration.

The gas module is calibrated once in the factory during production and this calibration is

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valid for the complete lifetime of the module. During operation, to compensate for drifts,
the module will request a Zeroing Procedure in regular intervals. After a zeroing command
from the host the module conducts the Zero Procedure automatically.

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CARDIAC OUTPUT MONITORING (OPTION)


THEORY OF OPERATION
SENSOR INSTALLATION
C.O. DISPLAY
C.O. SETUP
INFLUENCING FACTORS
BLOOD TEMPERATURE MEASUREMENT
THEORY OF OPERATION
The cardiac output (C.O.) measurement invasively measures cardiac output and other
hemodynamic parameters using the right heart (atria) thermodilution method. A cold
solution of known volume and temperature is injected into the right atrium through the
proximal port of a pulmonary artery (PA) catheter. The cold solution mixes with the blood
in the right ventricle and the change in blood temperature is measured with a thermistor at
the distal end of the catheter in the pulmonary artery. The temperature change is
displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value
from this curve. The C.O. value is inversely proportional to the area under the curve. As
cardiac output varies continuously, a series of measurements must be carried out to
achieve a reliable C.O. average value.
Always use the average of multiple thermodilution measurements for therapy decisions.
The monitor is capable of storing 6 measurements.

[NOTE]:
:C.O. monitoring is restricted to adult patients only.

SENSOR INSTALLATION
[WARNING]
Make sure that the accessories never come into contact with conductive parts.

1. Connect the C.O. cable to the C.O. socket on the left panel of monitor.
2. Interconnect the C.O. module, catheter and syringe as shown below. Make sure that:
The module is securely inserted.
The PA catheter is in place in the patient.
The C.O. cable is properly connected to the module.

Figure 29: The Diagram for C.O. Sensor Installation

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C.O. DISPLAY
The C.O. Monitor window is displayed on the monitor as shown below. To enter the
[System Setup] menu, select the [Display Mode] and choose the C.O item. C.O. item can
be chosen only when the C.O. Module is opened in the Optional Module.

Figure 30: Window for C.O. Display


1. Currently measured numeric
2. Currently measured C.O. curve
3. Measurement result views
4. Averaged values
5. Buttons
C.O. START
When the “Start” Button is enable, press it and then inject the solution quickly and
smoothly. As shown in the figure 25, during the measurement, the currently measured
thermodilution curve is displayed in monitor view.
At the end of the measurement, the thermodilution curve is transferred to one of the 6
result views and the monitor prompts you to wait for a certain period of time before starting
a new measurement.

[NOTE]
A maximum of 6 measurement results can be stored. If you perform more than six
measurements without rejecting any, the oldest will be automatically deleted when
a seventh curve is stored. Select from the 6 measurement curves and the system
will automatically calculate and display the averaged C.O. and C.I. values.
When injecting, the stopcock to the PA catheter is open and the stopcock to the
injectate solution is closed. After the measurement is completed, turn off the
stopcock to the PA catheter and turn on the stopcock to the injectate solution, and
then draw the injectate solution into the injectate syringe.
The system can automatically adjust the X-axis scale range to 30 s or 60 s and
Y-axis scale range to 0.5℃, 1.0℃, or 2.0℃.
C.O. SETUP
PATIENT HEIGHT
Input the height of monitoring patient.
PATIENT WEIGHT
Input the weight of monitoring patient. Check if the height and weight are appropriate for
your patient. Change if necessary

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IT SOURCE
You can set it to Auto or Manual.
If choose Auto, the injectate temperature is automatically obtained. When “IT Source” item
is switched to ‘Manual’, you can enter the injectate temperature in the “IT Temp” menu.
IT TEMP
The temp range is 0.0~27.0℃ (32.0~80.6℉). The temp unit is set in Temp Setup.
CALC COFFICIENT
The calculation coefficient which influences the C.O. value, input by user, is associated
with catheter physical properties. The range is 0.001~0.999.The default value is 0.542.
BT ALARM SWITCH
ON and OFF for choice, the factory–set is ON. When the choice is ON, the alarm is
activated; when the choice is OFF, the alarm indicator will not light, the relative alarm
parameter will not flash.
BT ALARM HIGH
The BT alarm upper-limit, the range is 37.1~43.0℃(98.8~109.4℉),and the factory-set is
39.0℃(102.2℉).
BT ALARM LOW
The BT alarm lower-limit, the range is 23.1~37.0℃(73.4~98.6℉),and the factory-set is
36.0℃(96.8℉).
INFLUENCING FACTORS
The factors that affect cardiac output are:
Temperature of injectate solution
Volume of injectate solution
Patient’s baseline of blood temperature
Patient’s inspiratory/expiratory cycle
Placement of catheter with relation to proximity of lung field, the catheter itself
The patient cardiac rhythm and hemodynamic status, and any other rapid IV solutions
which are infused while the C.O. measurement is being performed

Some technique suggestions to obtain accurate C.O.:


Injectate solution must be cooler than the patient’s blood
Inject solution rapidly and smoothly
Inject at end-expiration
BLOOD TEMPERATURE MEASUREMENT
As shown below, the blood temperature is measured with a temperature sensor at the
distal end of the catheter in the pulmonary artery.

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Figure 31: The Diagram for Blood Temperature Measurement

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PATIENT INFORMATION ADMINISTRATION


PATIENT BASIC INFORMATION SETUP
ADD NEW PATIENT
DELETE PATIENT
PATIENT BASIC INFORMATION SETUP
When you start the monitor, it will pop up a countdown window to remind you to set
the patient information. If you choose YES, you can set patient information directly.

Also you can set by turning the ROTARY KNOB and move the white box to the patient
information area at the top left corner to pop up patient setup menu. You can have
settings as below:

Figure 32: Tree Diagram for Patient Setup


ID
Set the ID number of patient. The ID number for each patient is different and unique.

[NOTE]: If you set the same ID with previous patient, the measurement data record
will be saved following after the previous data with same ID.

NAME
The input character range is: uppercase, A-Z, point (.) and blank character.
Patient name support the display method of English, and do not support the Chinese
character input. The user can input 9 characters at most.

SEX
Set the patient gender, the default setting is MALE.

BLOOD
Set the blood type of patient. It can be:N/A(unknown type) , A , B , O , AB , RH+ , RH-
and so on, the default setting is N/A.

AGE
Set the age of patient. The range is 0 ~120, the default setting is 20.

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[NOTE]
The Patient Monitor displays physiological data and stores them in the trends as
soon as a patient is connected. This allows you to monitor a patient that is not
saved information yet. However, it is recommended that you fully admit a patient so
that you can clearly identify your patient, on recordings, reports and networking
devices.

[NOTE]
Once the user chooses the method of YES to exit from the Patient Information
Setup, all information of patient will be refreshed and the trend data will be
renovated.

ADD NEW PATIENT


If you want to change other patient, you should input new patient information first.
You have two ways to achieve it.
1. Turn the ROTARY KNOB and move the white box to the patient information area and
then press it. You can add a new patient directly.
2. Popup the “Pause” Menu and then choose “Start new case”.

DELETE PATIENT
The monitor can save eight groups patient information for recall. You can delete the
previous patient in order to add new.

Popup the “Recall” Menu, enter into “Delete the patient” menu and choose one as you
required.

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TREND
TREND OBSERVATION
TIME SETUP
MARK EVENT SETUP
TREND TIME
TREND GRAPH ANALYSIS
TABULAR TREND ANALYSIS
ALARM EVENT
LAST WAVEFORM
TREND OBSERVATION
Monitoring system will save and trace the trend of parameters below:
Heart Rate (HR), Oxygen Saturation (SpO2)
Noninvasive Blood Pressure (SYS, DIA, Mean Blood Pressure)
Temperature(Temp)
Pulse Rate (PR)
Respiration Rate (RR)
End-tidal Carbon Dioxide (EtCO2)
Invasive Blood Pressure (IBP1, IBP2)
C.O.(Cardiac Output)
EVENT

Press the function button of TREND button to pop the graph below:

Data-recording Status Bar:


It is used to show the current data-recording length. For example, the user set a
trend of 15 minutes, if the color of bar right moment is red, it means that the
data-recording time is shorter than 15 minutes, i.e. the data-recording length is
smaller than the time-length choosing by user; if the color is light-blue, it means that
the data-recording is equal to the choosing time-length; if the bar presents the
light-blue and green alternately, it means that the data-recording length is larger than
the setup time length, and the light-blue part is the proportion of data-recording
length covered by the time-length, and the green part is the proportion of
data-recording length covered by time-length which has not been chosen.

TIME SETUP
In order to review data easily and intuitively, you should have set a right time.
Turn the ROTARY KNOB to move the white box on the screen to the Time Area,
press the ROTARY KNOB to pop the menu of Time Setup. You can have settings as
below:

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Figure 33: Tree Diagram for Time Setup


The value of year, month, day, hour and minute can be set, also you can set the Time
Mode to 12h or 24h. system will amend the internal clock according to the new settings.

Once the system time realigned, the trend data will renew correspondingly.
On entering the master screen, please checks whether the monitor time and the current
time are consistent, if not, please correct them.

MARK EVENT SETUP


During the patient monitoring, some event occurred will influence the patient and lead to
the waveforms or parameters change. In order to analysis the effect, you can mark the
event for recall.
There are four types of events that you can define. You can freely define the implication of
each type.

The menu is like the chart below:

Figure 34: Window for Mark Event Setup


MARK EVENT
Choose the related event item as you want from A, B, C and D. There is a V mark signal
for the ones selected
Choose the method of YES to exit, and the event marked is become effective immediately
upon the exit, or else it will not become effective.
When an event occurs, all the measurement numeric at the event trigger time is stored.

The Event can be recall from Event list in the Trend. See chart below:

Figure 35: Window for Event List

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IMPORTANCE OF EVENT MARKING:


It can classify the circumstances which influence the parameter monitoring on patient,
for example, medicine taking, injection and other treatment, These events, displaying
on trend graph and table, are very important to the parameter analysis.

TREND TIME
Trend time is the time length before current time.

There are twelve items for trend time choosing: 30 minutes, 60 minutes, 90 minutes, 3
hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours. For
instance, if 30 minutes is chose as the reference trend time, then we can recall the trend
change of 30 minutes before current time.

TREND TIME INTERVAL


Trend Time Interval means how often the system stores a trend data. Different trend
reference time has its correlated trend time interval, the relation between them are show
below:

Time Time Interval


30 minutes 6 seconds
60 minutes 12 seconds
90 minutes 18 seconds
3 hours 36 seconds
6 hours 72 seconds
12 hours 144 seconds
18 hours 216 seconds
24 hours 288 seconds
36 hours 432 seconds
48 hours 576 seconds
60 hours 720 seconds
72 hours 864 seconds

TREND GRAPH ANALYSIS


TREND GRAPH ADMITTANCE
Press the “Trend Graph” button to pop up the Graphical Trend window.

Figure 36: Window for Trend Graph


Each page display the trend chart of one parameter, the user can change them by
choosing PARAMETER, and the order is as below:
HR, SpO2, RESP, NIBP, ST, PR, TEMP, inAgt, expAgt, inN2O, EtCO2, IBP1, IBP2.

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The newest data is on the right side of the graph, time is displaying on the bottom of the
graph at the scale-of-24 hours, the upper and lower limit of parameter is displaying on the
left side of graph.

CURSOR BAR
It is the red vertical line on the trend graph for indication. The parameters’ values in
the graph are gotten at the time the red vertical line indicates.

Press the “Shift Left” or “Shift Right” button. You will move the red cursor bar left or right
until it is at the position as required.
TABULAR TREND ANALYSIS
TREND TABLE ADMITTANCE
Press the “Tabular Trend” button to pop up the Tabular Trend window. The trend Table
menu will display in the waveform area on the screen.
Sixteen groups of parameters are listed every one page and three hundred groups in total.
These data will be listed follow the order of from new to former and the time is displaying
at the scale-of-24 hours. The parameter name is display on the top of chart and the invalid
data will not display.
BASIC TABULAR TREND

Figure 37: Window for Basic Parameters Tabular Trend


IBP TABULAR TREND

Figure 38: Window for IBP Tabular Trend


C.O. TABULAR TREND

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Figure 39: Window for C.O. Tabular Trend


TREND TABLE MOVING
Press the “PageUp”, “PageDown”, “Print”, “Clear” button to complete relevant operation.
If the “Clear” be choosing, the data all saved in the trend will be deleted.
TRANSFERRING TRENDS VIA RS-232
The entire trend memory can be transferred to an external computer via the RS-232
interface. Refer to the RS-232 INTERFACE section for details.
ALARM EVENT
In this window, you can recall the alarm information. It includes the parameter’s waveform
and value exceeds the limits.

In this window you can select the alarm parameter (10 parameters), alarm waveform (12
waveforms) and alarm times (8 times).

Figure 40: Window for Alarm Event Review


LAST WAVEFORM
Press “Last Waveform” button to pop up the last waveform review window like the graph
below:

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Figure 41: Window for Last Waveform Review


When there are waveforms display for demonstration or real-time measurement, the
system only save data for the last 16 seconds and display two selectable waveforms, the
happened time for the late waveforms will display on the title bar in the window.

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CALCULATION
INTRODUCTION
DRUG CALCULATION
HEMODYNAMIC CALCULATION
INTRODUCTION
The calculation feature is available with your Patient Monitor. The calculated values, which
are not directly measured, are computed based on the values you input.

OMNI III Patient Monitor can mainly perform calculations: Drug calculation, Hemodynamic
calculation.

[NOTE]: The calculation feature is independent of other monitoring functions and can
be therefore used for patients being monitored by other monitors. Any operation in a
calculation window does not affect the monitoring for patients.

DRUG CALCULATION
HOW TO OPERATE
1. Select “System Setup” --- ”Drug Calculation” menu. The interface is as Figure 45:
2. Select the appropriate settings. The drug calculation program has a library of
commonly used drugs, of which drug A through drug E are for those not specified in
this library.
The drugs are as follows: Aminophylline, Dobutamine, Dopamine, Epinephrine,
Heparin, Isuprel, Lidocaine, Nipride, Nitroglycerin, Pitocin, drug A, B, C, D, E.
The user must enter values following the doctor’s instructions, and then the
calculated value can only be used.

Figure 42: Window for Drug Calculation


DRAG UNIT
Each drug has its fixed unit or unit series. Among a unit series, one unit may change to
another automatically depending on the entered value.
The units for each drug are as follows:
Drug A, B, C, Aminophylline, Dobutamin, Dopamine, Epinephrine, Isuprel, Lidocaine,
Nipride and Nitroglycerin use the unit series: g, mg and mcg.
Drug D, Heparin and Pitocin use the unit series: unit, KU (kilo units) and MU (million
units).
Drug E uses the unit: mEg (milli-equivalents).
You must select the proper drug name (A, B, C, D or E) according to the units when you
define a drug not listed this library.
TITRATION TABLE

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Select “Titration Table” in the “Drug Calculation” window after the drug calculation is
finished.
In the titration table, when you change “Reference”, “Interval”, “Dose Type”, the titrated
value will change accordingly.

Select “Print” item to print out the currently displayed titrated values by the printer.
HEMODYNAMIC CALCULATION
Hemodynamic, meaning literally “Blood flow, motion and equilibrium under the action of
external forces”, is the study of blood flow or the circulation. It explains the physical laws
that govern the flow of blood in the blood vessels.

Hemodynamic calculation has an important meaning for clinical guidance.

HOW TO OPERATE
1. Select “System Setup” --- ”Hemodynamic Cal” menu. The interface is as Figure 46:
2. Confirm you have input correct values.
3. Select the “Calculation” button. The system performs a calculation per the current
settings and displays the calculated values.
If a calculated value is outside the range, its background will highlight in yellow.
You can press the “Reference Range” button to view its normal range in the unit
field.
Invalid values are displayed as “---”.
4. Press the “Print” button; the currently displayed calculations are printed out by the
printer.
5. Review the previously performed calculations by selecting “Calculation Review”.
Review the input data by selecting “Check Input”.

Figure 43: Window for Hemodynamic Calculation

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INPUT PARAMETERS
Abbreviation Unit Full Spelling
C.O. l/min Cardiac Output
HR bpm Heart Rate
PAWP mmHg Pulmonary Artery Wedge Pressure
ART Mean mmHg Artery Mean Pressure
PA Mean mmHg Pulmonary Artery Mean Pressure
CVP mmHg Central Venous Pressure
EDV ml End-Diastolic Volume
Height cm Height
Weight kg Weight

OUTPUT PARAMETERS
Abbreviation Unit Full Spelling
C.I. l/min/m2 Cardiac Index
BSA m2 Body Surface Area
SV ml Stroke Volume
SVI ml/m2 Stroke Index
SVR DS/cm5 Systemic Vascular Resistance
SVRI DS﹒m2/cm5 Systemic Vascular Resistance Index
PVR DS/cm5 Pulmonary Vascular Resistance
PVRI DS﹒m2/cm5 Pulmonary Vascular Resistance Index
LCW Kg﹒m Left Cardiac Work
LCWI Kg﹒m/m2 Left Cardiac Work Index
LVSW g﹒m Left Ventricular Stroke Work
LVSWI g﹒m/m2 Left Ventricular Stroke Work Index
RCW Kg﹒m Right Cardiac Work
RCWI Kg﹒m/m2 Right Cardiac Work Index
RVSW g﹒m Right Ventricular Stroke Work
RVSWI g﹒m/m2 Right Ventricular Stroke Work Index
EF % Ejection Fraction

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RECALL DATA
RECALL DATA STORAGE
RECALL DATA DISPLAYS
RECALL OPERATION DESCRIPTIONS
RECALL DATA STORAGE
Recall Data in graphical or tabular format can be displayed on the screen or transferred to
on the computer for analysis via RS232 interface, and printed if a printer is installed.

The recall data for all parameters is the average of a 6-second sample of the data.
Seventy two (72) hours of recall data is stored in a nonvolatile memory, and remain in
storage when the monitor is in Standby.

A new print of recall data is started each time the monitor is turned on. A recall data record
is defined as the data from one power on event to the Standby power event. A date/time
annotation is included at the start of each new print (up to eight patients’) and the print can
be correlated with the patient. Once the recall memory has stored 72 hours of data, the
oldest recall data will be overwritten by new data.
RECALL DATA DISPLAY
The Recall data are displayed in graphical or tabular format. The recall information in
graphical format for a selected parameter is shown as a line connecting each of the points
representing the stored 6-second average.

The information stored for each recall episode can include:


• Numeric vital signs for all the measurements monitored
• Waveforms for up to 12 measurements of alarm events for your choice

You can navigate through the recall database to view events retrospectively, and you can
document recalls on a recording or report marked with the patient name, patient ID, the
data and time.
RECALL OPERATION DESCRIPTION
1. You should input ID and name of a patient first for recall
After you power on the monitor, there is a window pop out on the screen to remind you
input the patient’s ID as following:

Figure 44: Window for Indication Information

The above window will be automatically closed in count down 10 seconds.

2. Press the “Recall” soft-key to open the recall function for up to 8 patients
3. Select the patient’s ID for recall

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Figure 45: Window for Recall Patient


Select one ID for a patient, and then enter the Trend Management window with Patient ID
as following:

Figure 46: Window for Trend Management with ID

[NOTE]
This trend management-default window is for a patient which has no ID number.
The introduction of trend data recall refers to chapter TREND.

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RS-232 INTERFACE
OVERVIEW
CABLE CONNECTION
EXPORTING TREND DATA
OVERVIEW
Patient data can be obtained through the RS-232 I/O connector on the rear panel of the
monitor by connecting it to an attached PC.

CAUTION: DO NOT download patient data when the monitor is monitoring a patient.
This may cause the monitor to lock up.
CABLE CONNECTION
The 9-pin connector mounted on the rear panel provides an access port for a serial
(RS-232) interface to a suitably configured personal computer. Its pins layout is seen as
following picture:

RS-232 Serial Interface Connections:


Pin # Signal Definition
1 not used
2 TXD Transmit Data
3 RXD Received Data
4 not used
5 GND Signal Ground
6 not used
7 not used
8 not used
9 +5V Power Supply

EXPORTING TREND DATA


In order to download trend data from the OMNI III, communication software should be
installed in the external computer. The transfer protocol should be set as follows:
Baud Rate: 19,200
Data Bits: 8
Start Bit: 1
Stop Bits: 1
Odd Parity: 1

Connect the OMNI III to the serial port of the computer using a cable. Start the
communication program on the computer and export trend data from the OMNI III.

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PRINTER (OPTION)

PRINTET SETUP
PRINT REAL-TIME WAVEFORM
PRINT TABULAR TREND
GRID OUTPUT
PRINT ALARM EVENT
PRINT EVENT LIST
PRINT EXPLATION
WAVEFORM PRINT EXPLARION
PRINTER SETUP
Please refer to chapter SYSTEM SETUP for details.

[NOTE]: This is thermal printer which must use the thermal printer paper (the
specification is 48 mm on width).

PRINT REAL-TIME WAVEFORM


Press the “Print” soft-key, the statement of “Printing Started” appears on the bottom of
screen, which shows that the print process is going on. If you want to terminate print
during the printing process, just press the “Print” soft-key again. The printer stop
immediately as the statement of “Printing Stopped” will appears on the bottom of screen.

Form the preceding 8 seconds before the printing. It can print a burst of two or three
waveforms.

The print contents also include Patient Name, Hospital name, Print Time, HR, ST, RESP,
SpO2, NIBP (SYS, DIA,) T1, T2, EtCO2, IBP1, IBP2 and so on. See graph below:

Figure 47: Real-time Waveform Print


PRINT TABULAR TREND
Not only can you print the basic parameter trend table, but also other special table as IBP
Tabular, EtCO2 Tabular and so on.

[NOTE]: The special tabular is enabled when the relevant module is opened.

Figure 48: Basic Tabular Trend Print

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GRID OUTPUT
Some printer paper without grid, in order to observe the waveform easily, you can set the
grid form. The set method refers to Chapter SYSTEM SETUP.
When the Grid Output is set to ON (default value is OFF), then the parameters being
printed are in the grid form.
PRINT ALARM EVENT
When a parameter value violates the range limits, you can recheck the alarm trend
through press “Trend” soft-key and then choose “Alarm Event”. In the Alarm trend menu,
you can choose the “Print” item to record the alarm information.

One paper of alarm report, includes Patient Name, Alarm Message, Alarm Happened
Time, waveform if the parameter has and parameter’s numeric.

Figure 49: Alarm Event Print

If the alarm print is set to ON, It can print a slip of waveform of 10 seconds (the preceding
4 seconds before the printing till the current 4 seconds) when an alarm is happened.

[NOTE]: “-------” means invalid parameter.

PRINT EVENT LIST


Print out the event list for review.

Figure 50: Event List Print


PRINT EXPLANTION
INSERTING PAPER
Press the button of the catch on the printer, open the catch and take the old paper roll out
and insert a new one into the paper cassette. Pay attention that the paper is turning swiftly.
Pull a small length of paper out of the catch from the lower end of the roll (If it is the upper
end, the paper reel installed conversely), close the catch, and make sure that the paper is
just in the groove, or else paper advance will not be orderly.
ATTENTIONS
The time of continuous print cannot exceed 2 minutes.
DO NOT press the button of print when there is no paper, or the printer head will
be damaged.
Only thermal printer paper can be used.
If there is too much dust, use a sponge lightly moistened with alcohol to clean the
correlated parts.

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INDICATING MESSAGES

Message Meaning
Start printing. . . Printing process is going on.
Break printing! The button of print been pressed again
during the process of printing, so it can
press the button once again to re-start it
Printer Door Open Printer’s door has been opened
Printer Door Close Printer’s door has been closed
Printer Paper Ok Showing that printer paper has been
installed well
Printer No Paper Printer paper has been used up
Printer UnLink! Printer has not been connected to monitor.
Print Not Ready Printer hasn’t been connected well

WAVEFORM PRINT EXPLANATION


Paper Advance Speed: 25mm/s
Scale Specification: ×0.5 expresses 1mV/3.25mm
×1 expresses 1mV/6.5mm
×2 expresses 1mV/13mm

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BATTERY OPERATION
INTRODUCTION
OMNI III Patient Monitor is designed to operate on one or two XHP5Ah rechargeable
Lithium ion battery whenever AC power supply is interrupted. The battery is charged
whenever the patient monitor is connected to an AC power source regardless of whether
or not the patient monitor is currently on.

A new, fully charged battery will provide about 2 hour of monitoring time under the
following conditions: no audible alarms, no analog or serial output devices attached, and
no backlight. The charge and discharge cycles life of the battery is about 300 times.

When the battery is being charged, the DC Led is ON; a symbol dynamic will be displayed
in the upper right quarter of the screen to indicate the status of recharging. Until it is full,
the symbol changes to static. When the monitor is powered by the battery, the DC Led will
flicker and a symbol which represents the electric energy of the battery will be displayed in
the upper right quarter of the screen.

When operating on battery, the monitor will prompt alarm and shut off automatically when
the electric energy is low. When the electric energy is lower than 25 % of total power
capacity, the alarm will be active, at the same time the message of “Battery Power Low”
will display in the message area in the top of screen. The battery symbol will change to
empty.

Connect the monitor to AC power at this moment can recharge the battery while operating.
If keep operating on the battery, the monitor will shut off automatically upon exhaustion of
the battery.

[NOTE]: Whenever the monitor is connected to AC power, the battery is being


charged. Therefore, it is recommended that the monitor remain connected to AC
power when not in use. This will make available a fully charged battery for use at any
time.

[NOTE]: As the battery is used and recharged over a period of time, the amount of
time between the onset of the low battery alarm and the instrument shut-off may
become shorter.
If the backlight is turned off during a low battery condition, it cannot be turned back on.
It is recommended that the internal battery is replaced by qualified service personnel
every 24 months.

[CAUTION]: If the OMNI III is to be stored for a period of 2 months or longer, notify
service personnel to remove the battery from the monitor prior to storage. Recharge
the battery when it has not been charged for 2 or more months.

BATTERY RECYCLE
When a battery has visual signs of damage, or no longer holds a charge, it should be
replaced. Remove the old battery from the Patient Monitor and recycle it properly. To
dispose of a battery, follow local laws for proper disposal.

[WARNING]: DO NOT disassemble batteries, or put them into fire, or cause them to
short circuit. They may ignite, explode, or leak, causing personal injury.

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DISPOSAL OF DEVICE COMPONENTS

Follow local governing ordinances and recycling instructions regarding disposal or


recycling of device components, including batteries.

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PERIODIC SAFETY CHECKS


It is recommended that the following checks be performed every 24 months.
• Inspect the equipment for mechanical and functional damage.
• Inspect the safety relevant labels for legibility.

WARNING: DO NOT spray, pour, or spill liquid on OMNI III, its accessories,
connectors, switches, or openings in the chassis. DO NOT immerse the OMNI III
or its accessories in liquid or clean with caustic or abrasive cleaners.

CLEANING
To clean the OMNI III, dampen a cloth with a commercial, nonabrasive cleaner and wipe
the exterior surfaces lightly. Do not allow any liquids to come in contact with the power
connector or switches. Do not allow any liquids to penetrate connectors or openings in the
instrument. For cables, sensors, and cuffs, follow the cleaning instructions in the
directions for use that accompany these accessories.

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SPECIFICATIONS
SAFETY
Meet the requirement of EN60601 series, CE marking according to MDD93/42/EEC
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air
or with oxygen or nitrous oxide
Type of Protection: Class I (on AC power)
Internally powered (on battery power)
Degree of Protection: Type BF, defibrillation-proof CF - Applied part
Sterilization or Disinfection methods: 70% isopropyl alcohol solution or a nonstaining
disinfectant.
Operation Mode: Continuous Operation
Protection Against Ingress of Liquid’s: IPX0
APPLICATION
Neonatal, pediatric and adult patients
Physical Dimensions & Weight
Base Unit: 309mm H×365mm W×159mm D
Weight: 6 kgs
PEFORMANCE SPECIFICATIONS
Display: 15〞color TFT
Resolution: 1024 x R.G.B. x 768
Trace: 6,8 ,10 or 12 waveforms
Waveforms: ECG(I, II, III, aVR, aVL, aVF, V1-V6), PLETH,
RESP, IBP1, IBP2, ETCO2, AG
Indicator: Alarm indicator
Power indicator
QRS beep and alarm sound
Trend time: From 30 minutes to 72 hours
ECG
Input: 5/3/12-lead ECG cable and standard AAMI line
for connection
Standards: ANSI/AAMI EC13
EN60601-2-27 / IEC60601-2-27
Lead Choice: 3-Lead: I, II, III
5-Lead: I, II, III, aVR, aVL, aVF, V
12- Lead: I, II, III, aVR, aVL, aVF, V1~V6
Gain Choice: ×0.25,×0.5,×1.0,×2.0
ECG Waveforms: 12 channels
CMRR (Common Mode Rejection >100 dB at 50 Hz or 60 Hz
Ratio):
Frequency Characteristic: 0.67~40 Hz (+3dB attenuation)
Differential Input Impedance: >5 MΩ
Sweep Speed: 12.5, 25, 50 and 100 mm/s
HR Display Range: 30~300 bpm
Accuracy: ±1bpm or ±1%, whichever is greater
Alarm Limit: Upper Limit: 80~400 bpm
Lower Limit: 20~150 bpm
Electrode Offset Potential Tolerance: ± 300 mV
Input Signal Range: ±5 mV ( peak-to-peak value)
Defibrillator Discharge: <5 sec
Bandwidth(-3dB): Diagnostic Mode: 0.05 Hz~130 Hz
Monitor Mode : 0.5 Hz~40 Hz
Surgical Mode : 1 Hz~20 Hz
Recovery: <8 s

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Pace Pulse Markers: Pace pulses meeting the following conditions are
labelled with a PACE marker:
Signal Amplitude:±10 mV~±700 mV
Pulse Width:0.1 ms~2 ms
Signal Rising and Falling Time:10μs~100 μs
Pace Pulse Rejection: When tested in accordance with the ANSI/AAMI
EC13-2002: Sections 4.1.4.1 and 4.1.4.3, the
heart rate meter rejects all pulses meeting the
following conditions.
Signal Amplitude: ±2 mV~±700 mV
Pulse Width:0.1ms~2 ms
Signal Rising and Falling Time:10 μs~100 μs
RESP
Measure Method: RA-LL Impedance
Lead: Lead II
Respiration Excitation Waveform: <300 μA, sinusoid, 62.5 kHz (±10%)
Range: 0~120 rpm
Accuracy: ±3 rpm
Alarm Limit: Upper Limit: 8~120 rpm
Lower Limit: 6~100 rpm
Sweep Speed: 6.25, 12.5 and 25 mm/s
Gain Choice: ×0.25,×0.5,×1.0,×2.0
Respiration Impedance Range: 0.3 Ω~5 Ω
Baseline Impedance Range: 200Ω~2500Ω (using an ECG cable with
1kΩ resistance)
NIBP
Measuring Technology: Automatic Oscillating Measurement
Cuff Inflating: <30 s(0~300 mmHg,Standard Adult Cuff)
Measuring Period : AVE < 40 s
Mode: Manual, Auto, STAT
Measuring Interval In AUTO Mode: 2 minutes~4 hours
Pulse Rate Range: 30 bpm~250 bpm
Measuring Range: Adult/Pediatric Mode
SYS 40~250 (mmHg)
DIA 15~200 (mmHg)
Neonatal Mode
SYS 40~135 (mmHg)
DIA 15~100 (mmHg)
Resolution: 1mmHg
Pressure Accuracy: Maximum Mean Error: ±5mmHg
Maximum Standard Deviation: 8mmHg
Overpressure Protection: Adult Mode : 280(mmHg)
Neonatal Mode : 150 (mmHg)
Alarm Limit: SYS(Upper/Lower): 30~240 mmHg
DIA (Upper/Lower) : 15~180 mmHg
SpO2
Standard: ISO 9919
ASpO2: Anti-motion SpO2
Measuring Technology: Light absorption method
SpO2 Measurement Range: 0~100 %
SpO2 Accuracy: 70~100 %: ±2 %
0~69 % : Undefined

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PR Measurement Range: 30~250 bpm


PR Accuracy: ±2 bpm(non-motion)
±3 bpm (motion)
SpO2 Alarm Limit: Upper Limit : 50~99 %,
Lower Limit : 50~99 %
SpO2 Probe: Red Light LED Wavelength: 660±5 nm
Infrared Light LED Wavelength: 940±10 nm
Option Type: Masimo, Nellcor
(See their modules’ relative technical
specifications)
Refreshing Rate: 1s
TEMP
Standards: EN 12470-4
Measuring Technology: Thermal Resistance
Scale: Selectable ℃ or oF
Channel: 2 Channels
Range: T1 and T2 : 25℃~50℃/77 oF~122 oF
Delta T: 0℃~5.5℃/ 0oF~9.9 oF
Accuracy: ±0.2℃(25.0℃~34.9℃) / (77℉~94.8℉)
±0.1℃(35.0℃~39.9℃) / (95℉~103.8℉)
±0.2℃(40.0℃~44.9℃) / (104℉~112.8℉)
±0.3℃(45.0℃~50.0℃) / (113℉~122℉)
Display Resolution: 0.1℃(0.2 oF)
Alarm Limit: Upper Limit: 10℃~50℃/50℉~122 ℉
Lower Limit: 10℃~50℃/50 ℉~122℉
IBP
Standards: EN 60601-2-34/IEC 60601-2-34
Measuring Technology: Direct Invasive Measurement
Measurement Range: -10~300 mmHg
Resolution: 1 mmHg
Accuracy: ±1 mmHg or ±2 %, whichever is greater
Refreshing Rate: 1s
Channel: 2 channels
Alarm Limit: LABEL HI(mmHg) LO(mmHg)
ART(SYS,DIA) 0~300 0~300
PA(SYS,DIA) -10~120 -10~120
CVP,LAP,RAP, -10~140 -10~40
ICP(MAP)
Zero Range: ±120 mmHg
Excitation: 5V DC ±2%
Pressure Transducer: Sensitivity, 5µV/V/mmHg
Impedance Range: 300~3000 Ω
Transducer Sites: ART, PA,CVP, RAP, LAP, ICP
C.O.
Measurement Method: Thermodilution Method
Measurement Range: C.O. 0.1~20 L/min
BT 23~43℃
IT 0~27℃
Resolution: C.O. 0.1 L/min
BT, IT 0.1℃
Accuracy: C.O. ±5% or ±0.1 L/min, whichever
is greater, as measured using
electronically generated flow

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curves.
BT, IT ±0.1℃(without sensor)
Alarm Range: BT 23~43℃
Repeatability: C.O. ±2% or ±0.1 L/min, whichever
is greater, as measured using
electronically generated flow
curves.
Alarm Limit: Range Step
BT High: (low limit + 1)~43℃ 0.1 ℃
(low limit + 1.8)~109.4 °F 0.1 °F
BT Low: 23~(high limit - 1) ℃ 0.1 ℃
CO2
Mode of Sampling: Sidestream or Mainstream
Measurement technology: Infrared Absorption
ETCO2 Alarm Limit: Upper Limit : 20~100 mmHg
Lower Limit : 10~95 mmHg
awRR Alarm Limit: Upper Limit : 10~150 rpm
Lower Limit : 5~100 rpm
Apnea Time: 10~60 s
Sidestream CO2 Module
Standards: ISO 21647
Principle of Operation: Non-dispersive Infrared (NDIR) single beam
optics, dual wavelength, no moving parts.
Initialization Time: Capnogram displayed in less than 20 s, at an
ambient temperature 25 ℃ ,full specifications
within 2 minutes.
CO2 Measurement Range: 0~150 mmHg (0~19.7 %, 0~20 kPa)
CO2 Calculation Method: BTPS (Body Temperature Pressure Saturated)
CO2 Resolution: 0~69 mmHg: 0.1 mmHg
70~150 mmHg: 0.25 mmHg
CO2 Accuracy: 0~40 mmHg: ± 2 mmHg
41~70 mmHg : ± 5 % of reading
71~100 mmHg: ± 8 % of reading
101~150 mmHg: ±10 % of reading
Above 80 breath per minute ± 12 % of reading
[NOTE]:Gas temperature at 25℃ ℃.
CO2 Stability: Short Term Drift: Drift over four hours shall not
exceed 0.8 mmHg maximum.
Long Term Drift: Accuracy specifications will be
maintained over a 120 hours period.
CO2 Noise: RMS noise of the sensor shall be less than or
equal to 0.25 mmHg at 5 % CO2
Sampling Rate: 100 Hz
ETCO2 Calculation: Method: Peak of the expired CO2 waveform
Selections: 1 breath, 10 s, 20 s
Inspired CO2 Measurement: Range: 3~50 mmHg
Method: Lowest reading of the CO2 waveform in
the previous 20 s
Selection: 20 s (not user-selectable)
awRR Measurement Range: 2~150 rpm
awRR Accuracy: ±1 breath
Response Time: <3 s ( includes transport time and rise time)
Mainstream CO2 Module

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Standards: ISO 21647


Principle of Operation: Non-dispersive Infrared (NDIR) single beam
optics, dual wavelength, no moving parts.
Initialization Time: Capnogram displayed in less than 20 s, at an
ambient temperature 25 ℃ ,full specifications
within 2 minutes.
CO2 Measurement Range: 0~150 mmHg (0~19.7 %, 0~20 kPa)
(Barometric Pressure supplied by Host)
CO2 Calculation Method: BTPS (Body Temperature Pressure Saturated)
CO2 Resolution: 0~69 mmHg: 0.1 mmHg
70~150 mmHg: 0.25 mmHg
CO2 Accuracy: 0~40 mmHg: ± 2 mmHg
41~70 mmHg : ± 5 % of reading
71~100 mmHg: ± 8 % of reading
101~150 mmHg: ±10 % of reading
Above 80 breath per minute ± 12 % of reading
[NOTE]:Gas temperature at 35℃ ℃.
CO2 Stability: Short Term Drift: Drift over four hours shall not
exceed 0.8 mmHg maximum.
Long Term Drift: Accuracy specifications will be
maintained over a 120 hours period.
CO2 Noise: RMS noise of the sensor shall be less than or
equal to 0.25 mmHg at 7.5 % CO2
Sampling Rate: 100 Hz
ETCO2 Calculation: Method: Peak of the expired CO2 waveform
Selections: 1 breath, 10 s, 20 s
[NOTE]: the minimum reported differential
value between the baseline and CO2 value
shall be 5 mmHg
Inspired CO2 Measurement: Range: 3~50 mmHg
Method: Lowest reading of the CO2 waveform in
the previous 20 s
Selection: 20 s (not user-selectable)
awRR Measurement Range: 0~150 rpm
awRR Accuracy: ±1 rpm
Response Time: Less than 60 ms – Adult reusable or single
patient use
Less than 60 ms – Infant reusable or single
patient use
ANESTHETIC AGENTS(OPTION, PHASEIN)
InfraRed Mainstream Analyzer (IRMA)
Standards: ISO 21647
Operating Temperature: IRMA CO2 : 0~40°C / 32 ~104°F
IRMA OR/OR+: 10~35°C / 50 ~95°F
IRMA AX+ : 10~40°C / 50 ~104°F
Operating Humidity: 10~95 % RH, non-condensing
Storage and Transportation Humidity: 5~100 % RH, condensing
IRMA CO2/AX+: 525~1200 hPa
(525 hPa corresponding to an altitude of 4 572 m
/ 15 000 feet)
Operating Atmospheric Pressure:
IRMA OR/OR+: 700~1200 hPa
(700 hPa corresponding to an altitude of 3 048 m
/ 10 000 feet)
Breath Detection: Adaptive threshold, mimimum 1 vol% change in

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CO2 concentration
Respiration Rate: 0~150 rpm. The respiration rate is displayed
after three breaths and the average value is
updated every breath.
Calibration: Zeroing recommended when changing Airway
adapter. No span calibration required for the IR
bench. Room air calibration of oxygen sensor
performed automatically when charging airway
adapter (<5 s)
Warm-up Time: Concentration are reported and the automatic
agent identification is running within 10 s.
Primary Agent Threshold: 0.15 vol%. When an agent is identified,
concentrations will be reported even below 0.15
vol% as long as apnea is not detected.
Secondary Agent Threshold: 0.2 vol% + 10% of total agent concentration
Agent Identification Time: < 20 s (Typically <10 s)
Total System Response Time: <1s
[NOTE]: Primary agent threshold is 0.3 vol% for IRMA OR. When the concentration
has passed the threshold, the concentration will be reported even below 0.3 vol%.
Accuracy Specifications—During Standard Conditions
Range1)
Gas CO2 OR AX+/OR+ Accuracy
CO2 0~15 0~10 0~10 ±(0.2 vol% + 2 % of reading)
15~25 10~20 10~15 ±(0.3 vol% + 2 % of reading)
15~25 Unspecified
N2O --- 0~100 0~100 ±(0.2 vol% + 2 % of reading)
HAL, ISO, ENF --- 0~5 0~8 ±(0.15 vol% + 5 % of reading)
5~12 8~25 Unspecified
SEV --- 0~8 0~10 ±(0.15 vol% + 5 % of reading)
8~15 10~25 Unspecified
DES --- 0~18 0~22 ±(0.15 vol% + 5 % of reading)
18~25 22~25 Unspecified
2) 2)
O2 --- 0~100 0~100 ±(1 vol% + 2 % of reading)
[NOTE 1]: Gas concentration reported in units of volume percent.
[NOTE 2]: IRMA OR/OR+ only.
Accuracy Specifications-During All Conditions 1)
Gas Accuracy
CO2 ±(0.3 vol% + 4% of reading)
N2O ±(2 vol% + 5% of reading)
Agents 2) ±(0.2 vol% + 10% of reading)
O2 ±(2 vol% + 2% of reading)
[NOTE 1]: The accuracy specification is valid for the operating temperature and humidity
conditions specified.
[NOTE 2]: The accuracy specification is not valid if more than two agents are present in the
gas mixture.
ANESTHETIC AGENTS(OPTION, PHASEIN)
Infrared Sidestream Analyzer (ISA)
Standards: ISO 21647
Mechanical Robustness: ISA CO2:
Meets the shock and vibration requirements
for transport of SS-EN ISO 21647:2004
clause 21.102 and SS-EN 1789:2007 clause
6.3.4.2.
ISA OR+/AX+:

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Meets the shock and vibration requirements


of SS-EN ISO 21647:2004 clause 21.101
Operating Temperature: ISA CO2: 0~50 °C (32 ~122 °F)
ISA OR+/AX+: 5~50 °C (41 ~122 °F)
Storage Temperature: −40~70 °C (−40 ~158 °F)
Operation Humidity: < 4 kPa H2O (non-condensing)
(95 %RH at 30 °C)
Storage Humidity: 5~100 %RH (condensing)
(100 %RH at 40 °C)
Operating Atmospheric Pressure: 52.5~120 KPa
(corresponding to a max altitude of 4 572 m /
15 000 feet)
Storage Atmospheric Pressure: 20~120 kPa
(corresponding to a max altitude of 11 760 m /
38 600 feet)
Water Handing: Sampling line with proprietary water removal
tubing
Sampling Lines: 2 ± 0.1 m and 3 ± 0.1 m versions
Breath Detection: Adaptive threshold, minimum 1 vol% change
in CO2 concentration.
Respiration Rate: 0~150 ± 1 breaths/minute
Sampling Flow Rate: 50 ± 10 ml/min
Compensations: ISA CO2: Automatic compensation for
pressure and temperature. Manual
compensation for broadening effects on CO2.
ISA OR+/AX+: Automatic compensation for
pressure, temperature and broadening effects
on CO2.
Calibration: No span calibration is required for the IR
bench. An automatic zero reference
calibration is performed at startup and then
every 24 hours1).
Warm-up Time: ISA CO2: < 10 s (Concentrations reported and
full accuracy)
ISA OR+/AX+: < 20 s (Concentrations
reported, automatic agent identification
enabled and full accuracy)
Typical Rise Time at 50 ml/min sample CO2: <=200 ms (<=250 ms for ISA OR+/AX+)
flow: N2O: <=350 ms
Agents:<=350 ms
O2: <=450 ms
Primary Agent Threshold: 0.15 vol%. When an agent is identified,
(ISA OR+/AX+) concentrations will be reported even below
0.15 vol%
Secondary Agent Threshold: 0.2 vol%+10 % of total agent concentration
(ISA OR+/AX+)
Agent Identification Time: < 20 s (typically < 10 s)
(ISA OR+/AX+)
Total System Response Time: < 3 s (with 2 m sampling line)
Accuracy--Standard Conditions
The following accuracy specifications are valid for dry single gases at 22 ± 5 °C and 1013 ±
40 hPa.
Gas Range2) Accuracy
CO2 0~15 vol% ±(0.2 vol% + 2 % of
15~25 vol% reading)

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Unspecified
N2O 0~100 vol% ±(2 vol% + 2 % of reading)
HAL, ENF, ISO 0~8 vol% ±(0.15 vol% + 5 % of
8~25 vol% reading)
Unspecified
SEV 0~10 vol% ±(0.15 vol% + 5 % of
10~25 vol% reading)
Unspecified
DES 0~22 vol% ±(0.15 vol% + 5 % of
22~25 vol% reading)
Unspecified
O2 0~100 vol% ±(1 vol% + 2 % of reading)
[NOTE 1]: Every 8 hours for ISA OR+/AX+.
[NOTE 2]: All gas concentrations are reported in units of volume percent and may be
translated into mmHg or kPa by using the reported atmospheric pressure.
Accuracy--All Conditions
The following accuracy specifications are valid for all specified environmental conditions.
Gas Accuracy
CO2 ±(0.3 kPa + 4% of reading)
N2O ±(2 kPa + 5% of reading)
Agents 1) ±(0.2 kPa + 10% of reading
O2 ±(2 kPa + 2% of reading)
[NOTE 1]: The accuracy specification is not valid if more than two agents are present in the
gas mixture. If more than two agents are present, an alarm will be set.
Anesthetic Agents(OPTION, DRÄGER)
Standards: ISO 21647
Method: Infrared Absorption
Gas Sorts: Halothane, Isoflurane, Enflurane, Sevoflurane,
Desflurane, CO2, N2O, O2(option)
Zeroing Interval: Once per day (first zeroing 35 minutes after
power on, then once every 24 hours)
Zerong Duration: < 15 s
Operation Temperature (temperature +10℃~+50℃
around module)
Start Up Time (from power on to < 4 minutes
transmission of measurements with
non-ISO accuracy)
Accuracy: CO2: ± (0.43 vol% + 8 % rel.)
N2O: ± (2 vol% + 8 % rel.)
Agents: ± (0.15 vol% + 15 % rel.)
O2: ± (2.5 vol% + 2.5 % rel.)
Sample Gas Flow Rate: 200 mL/min
Rise Time: CO2 <= 350 ms
N2O <= 350 ms
Agents <= 350 ms
O2 <= 500 ms
Respiration Rate: 0~80 bpm
Voltage Input Range: 10.5~62 V
Measurement Range: Halothane, Isoflurane: 0~8.5%
Enflurane, Sevoflurane: 0~10%
Desflurane: 0~20%
CO2: 0~10%
N2O: 0~100%
O2: 0~100%
NETWORKING

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Wired Networking: Industry Standard: IEEE 802.3 wired network


Connected Bedside Number: Up to 32
bedside monitors
RJ45 Interface or RS232 Serial Port
Wireless Networking: Industry Standard: 802.11b/g wireless network
Transmission Distance : ≥ 50m (Visual
Distance)
Frequency Range: 2.400~2.4835 GHz
Supports TCP/IP and Wi-Fi Protocols
POWER
Source: External AC Power and Internal Battery
AC Power: 100~240VAC, 50/60Hz, 150VA
Rechargeable Lithium ion battery
Type XHP5Ah
Nominal Voltage 11.1V
Rated Capacity 5000mAh/55.5Wh
Operating time under 2 hours
Battery: the normal condition
(one battery)
Operating time after 15 minutes
the first alarm of low
battery
Number of Batteries 2
Charge Time: When the monitor is powered off:
3 hours from depletion to 90 percent charge, 4
hours to full charge.
When the monitor is powered on:
6 hours from depletion to 90 percent charge, 8
hours to full charge
ENVIRONMENTAL SPECIFICATIONS
Temperature: Operating : 5~40 °C
Storage: -10~45 °C
Humidity Range: Operating : ≤80 %
Storage : ≤80 %
RECORDER (OPTION)
Record Width: 48 (mm)
Paper Speed: 25 (mm/s)
Trace: 1, 2 or 3
VGA OUTPUT
Video Signals: RGB: 0.7Vp-p/75Ω;
Horizontal/Vertical Synchronization: TTL Level

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EMC
The product is in radio-interference protection class A in accordance with EN55011. The
product complies with the requirement of standard EN60601-1-2:2007 “Electromagnetic
Compatibility - Medical Electrical Equipment”.

ELECTROMAGNETIC IMMUNITY
This section constitutes the guidance and OMNI III Patient Monitor’s declaration regarding
electromagnetic immunity. The OMNI III Patient Monitor is intended for use in the
electromagnetic environment specified below. The customer or the user of the OMNI III
Patient Monitor should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic environment
level level – guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or
discharge (ESD) 8 kV air 8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30%.
Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital
IEC 61000-4-4 1 kV for input / 1 kV for input / environment.
output lines output lines
Surge 1 kV 1 kV Mains power quality should be that of a
IEC 61000-4-5 differential differential typical commercial or hospital
Mode Mode environment.
2 kV 2 kV
differential differential
Mode Mode

Voltage dips, <5 % UT1 <5 % UT2 Mains power quality should be that of a
short interruptions (>95 % dip in (>95 % dip in typical commercial or hospital
and voltage UT) for 0.5 UT) for 0.5 cycle environment. If the user of the
variations on cycle OMNI III Patient Monitor requires
power supply 40 % UT continued operation during power mains
input lines 40 % UT (60 % dip in UT) interruptions. it is recommended that the
IEC 61000-4-11 (60 % dip in for 5 cycles OMNI III Patient Monitor be powered from
UT) for 5 an uninterruptible power supply or a
cycles 70 % UT battery.
(30 % dip in UT)
70 % UT for 25 cycles
(30 % dip in
UT) for 25 <5 % UT
cycles (>95 % dip in
UT) for 5 sec
<5 % UT
(>95 % dip in
UT) for 5 sec

Power frequency Power frequency magnetic fields should


3 A/m
(50/60 Hz) be at levels characteristic of a typical

Note: UT is the a. c. mains voltage prior to application of the test level.

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Immunity test IEC 60601 test Compliance Electromagnetic environment


level level – guidance
magnetic field 3 A/m location in a typical commercial or hospital
IEC 61000-4-8 environment.
Portable and mobile RF communications
equipment should be used no closer to
any part of the OMNI III Patient Monitor,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.

Recommended separation distance:

 3.5 
Conducted RF 3 Vrms 3 Vrms d =  P
IEC 61000-4-6 150 kHz to 80  V1 
MHz
 3.5 
d =  P
Radiated RF 3 V/m 3 V/m  V1 
IEC 61000-4-3 80%AM@2Hz 80 MHz to 800 MHz
80 MHz to 2.5
GHz
7
d =  P
Only ISA CO2 is 20 V/m 20 V/m  E1 
tested at 20 V/m 80%AM@1kH
800 MHz to 2.5 GHz
z
Where P is the maximum output power
80 MHz to 2.5
rating of the transmitter in watts (W)
GHz
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:

121
User’s Manual for OMNI Portable Patient Monitor

Immunity test IEC 60601 test Compliance Electromagnetic environment


level level – guidance
[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 OMNI III Patient Monitor is used exceeds the applicable RF
compliance level above, The OMNI III Patient Monitor should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the OMNI III Patient Monitor.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RF communications


equipment and the OMNI III Patient Monitor

The OMNI III Patient Monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled.
The customer or the user of the OMNI III Patient Monitor can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the OMNI III Patient Monitor as recommended below, according to
the maximum output power of the communications equipment

Rated maximum Separation distance according to frequency of transmitter [m]


output power of
transmitter [W]

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
 3.5   3.5  7
d =  P d =  P d =  P
 V1   V1   E1 

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters 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.

122

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