Omni III User's Manual Va.1.0-20140124
Omni III User's Manual Va.1.0-20140124
Omni III User's Manual Va.1.0-20140124
Patient Monitor
USER’S MANUAL
Website: www.infiniummedical.com
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,
-I
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
- II
User’s Manual of OMNI III Patient Monitor
- III
User’s Manual of OMNI III Patient Monitor
- IV
User’s Manual of OMNI III Patient Monitor
-V
User’s Manual of OMNI III Patient Monitor
- VI
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
- VII
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.
[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]: 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.
-1
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]: DO NOT use the OMNI III to monitor patients who are linked to
heart/lung machines.
[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.
-2
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.
-3
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.
-4
User’s Manual of OMNI III Patient Monitor
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
-5
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.
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
-6
User’s Manual of OMNI III Patient Monitor
No FUNCTION
.
1 1WATER TRAP (Option)
This plastic container collects condensation from the multi-gas sample line.
2 2Printer (Option)
REAR PANEL
-7
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
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.
-8
User’s Manual of OMNI III Patient Monitor
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.
-9
User’s Manual of OMNI III Patient Monitor
- 10
User’s Manual of OMNI III Patient Monitor
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.
- 11
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.
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
Language
Demo
Display Mode
Alarm Suspend
Sweep Direction
Sound Level
Heart Sound
HL7
About
Screen Cal
1. If inputting “IP SETUP” for the password, the window for Ethernet IP address setup of
- 12
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:
- 13
User’s Manual of OMNI III Patient Monitor
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.
- 14
User’s Manual of OMNI III Patient Monitor
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.
- 15
User’s Manual of OMNI III Patient Monitor
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.
- 16
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:
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:
- 17
User’s Manual of OMNI III Patient Monitor
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.
- 18
User’s Manual of OMNI III Patient Monitor
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.
- 19
User’s Manual of OMNI III Patient Monitor
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 .
- 20
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:
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.
- 21
User’s Manual of OMNI III Patient Monitor
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.
For 5-lead set, attach the C-electrode to one of the indicated positions as below:
- 22
User’s Manual of OMNI III Patient Monitor
- 23
User’s Manual of OMNI III Patient Monitor
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.
- 24
User’s Manual of OMNI III Patient Monitor
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
- 25
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
- 26
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
- 27
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.
- 28
User’s Manual of OMNI III Patient Monitor
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
- 29
User’s Manual of OMNI III Patient Monitor
3. In the ECG Setup menu, select Lead Type. Then choose 12-Lead.
- 30
User’s Manual of OMNI III Patient Monitor
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.
- 31
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.
- 32
User’s Manual of OMNI III Patient Monitor
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.
- 33
User’s Manual of OMNI III Patient Monitor
- 34
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.
- 35
User’s Manual of OMNI III Patient Monitor
Alarm Switch
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
- 36
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.
PROMPTS EXPLAINATION
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
- 37
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.
- 38
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.
- 39
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.
PRESSURE UNIT
mmHg or kPa,the factory–set is mmHg.
- 40
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
- 41
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
- 42
User’s Manual of OMNI III Patient Monitor
[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.
- 43
User’s Manual of OMNI III Patient Monitor
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.
- 44
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.
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:
ALARM SWITCH
ON and OFF for choice, the factory–set is ON.
- 45
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.
- 46
User’s Manual of OMNI III Patient Monitor
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
- 47
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.
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.
- 48
User’s Manual of OMNI III Patient Monitor
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.
- 49
User’s Manual of OMNI III Patient Monitor
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
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
- 50
User’s Manual of OMNI III Patient Monitor
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.
- 51
User’s Manual of OMNI III Patient Monitor
ADVANCED SETUP
Pick “ADVANCED SETUP” item to call up the related menu:
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℃.
- 52
User’s Manual of OMNI III Patient Monitor
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.
- 53
User’s Manual of OMNI III Patient Monitor
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.
- 54
User’s Manual of OMNI III Patient Monitor
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:
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.
55
User’s Manual of OMNI III Patient Monitor
56
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:
57
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:
58
User’s Manual of OMNI III Patient Monitor
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.
ALARM SETUP
Press the alarm setup item to popup the IBP1 or IBP2 alarm setup menu as below:
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
59
User’s Manual of OMNI III Patient Monitor
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.
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.
60
User’s Manual of OMNI III Patient Monitor
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.
The disposable transducers or caps is a single use kit, must not be re-sterilized or
re-used.
61
User’s Manual of OMNI III Patient Monitor
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
62
User’s Manual of OMNI III Patient Monitor
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.
63
User’s Manual of OMNI III Patient Monitor
3. A green LED indicates that the IRMA probe is ready for use.
64
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
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
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
65
User’s Manual of OMNI III Patient Monitor
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
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
66
User’s Manual of OMNI III Patient Monitor
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.
MAINTENANCE
Gas readings should be verified at regular intervals with a reference instrument or with
calibration gas. The recommended interval is once every year.
67
User’s Manual of OMNI III Patient Monitor
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.
68
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.
69
User’s Manual of OMNI III Patient Monitor
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.
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:
70
User’s Manual of OMNI III Patient Monitor
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:
71
User’s Manual of OMNI III Patient Monitor
(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.
72
User’s Manual of OMNI III Patient Monitor
[WARNING]: DO NOT apply negative pressure to remove condensed water from the
Nomoline Family sampling line.
[WARNING]: Use only airway T-adapters with the sampling point in the center of the
adapter.
[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
73
User’s Manual of OMNI III Patient Monitor
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.
74
User’s Manual of OMNI III Patient Monitor
% 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
Catalog number
Serial number
Batch code
Year of manufacture
Pressure limitation
Humidity limitation
75
User’s Manual of OMNI III Patient Monitor
76
User’s Manual of OMNI III Patient Monitor
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
77
User’s Manual of OMNI III Patient Monitor
78
User’s Manual of OMNI III Patient Monitor
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.
79
User’s Manual of OMNI III Patient Monitor
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.
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.
80
User’s Manual of OMNI III Patient Monitor
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.
81
User’s Manual of OMNI III Patient Monitor
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.
82
User’s Manual of OMNI III Patient Monitor
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.
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:
83
User’s Manual of OMNI III Patient Monitor
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.
84
User’s Manual of OMNI III Patient Monitor
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
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.
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
85
User’s Manual of OMNI III Patient Monitor
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.
86
User’s Manual of OMNI III Patient Monitor
[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.
87
User’s Manual of OMNI III Patient Monitor
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.
[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
88
User’s Manual of OMNI III Patient Monitor
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
89
User’s Manual of OMNI III Patient Monitor
90
User’s Manual of OMNI III Patient Monitor
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:
[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.
91
User’s Manual of OMNI III Patient Monitor
[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.
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.
92
User’s Manual of OMNI III Patient Monitor
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:
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:
93
User’s Manual of OMNI III Patient Monitor
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.
The Event can be recall from Event list in the Trend. See chart below:
94
User’s Manual of OMNI III Patient Monitor
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.
95
User’s Manual of OMNI III Patient Monitor
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
96
User’s Manual of OMNI III Patient Monitor
In this window you can select the alarm parameter (10 parameters), alarm waveform (12
waveforms) and alarm times (8 times).
97
User’s Manual of OMNI III Patient Monitor
98
User’s Manual of OMNI III Patient Monitor
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.
99
User’s Manual of OMNI III Patient Monitor
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.
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”.
100
User’s Manual of OMNI III Patient Monitor
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
101
User’s Manual of OMNI III Patient Monitor
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.
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:
2. Press the “Recall” soft-key to open the recall function for up to 8 patients
3. Select the patient’s ID for recall
102
User’s Manual of OMNI III Patient Monitor
[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.
103
User’s Manual of OMNI III Patient Monitor
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:
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.
104
User’s Manual of OMNI III Patient Monitor
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).
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:
[NOTE]: The special tabular is enabled when the relevant module is opened.
105
User’s Manual of OMNI III Patient Monitor
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.
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.
106
User’s Manual of OMNI III Patient Monitor
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
107
User’s Manual of OMNI III Patient Monitor
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]: 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.
108
User’s Manual of OMNI III Patient Monitor
109
User’s Manual of OMNI III Patient Monitor
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.
110
User’s Manual for OMNI Portable Patient Monitor
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
111
User’s Manual for OMNI Portable Patient Monitor
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
112
User’s Manual for OMNI Portable Patient Monitor
113
User’s Manual for OMNI Portable Patient Monitor
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
114
User’s Manual for OMNI Portable Patient Monitor
115
User’s Manual for OMNI Portable Patient Monitor
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+:
116
User’s Manual for OMNI Portable Patient Monitor
117
User’s Manual for OMNI Portable Patient Monitor
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
118
User’s Manual for OMNI Portable Patient Monitor
119
User’s Manual for OMNI Portable Patient Monitor
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
120
User’s Manual for OMNI Portable Patient Monitor
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).
121
User’s Manual for OMNI Portable 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
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
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