Passport V Operators Manual
Operating Instructions
Datascope
Passport®
Operating Instructions
Datascope
Passport®
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Copyright © Mindray DS USA, Inc., 2009-2014. All rights reserved. Contents of this publication may not be reproduced in
any form without permission of Mindray DS USA, Inc.
0070-00-0704-02
Passport V Operating Instructions
Table of Contents
Foreword ....................................................................................................................................................... vii
Warnings, Precautions, and Notes.................................................................................................................... vii
Warnings ...................................................................................................................................................... viii
Precautions .................................................................................................................................................... xii
Notes ............................................................................................................................................................ xvi
Intended Use
......................................................................................................................................... xvii
Unpacking .................................................................................................................................................... xvii
Symbols and Descriptions
............................................................................................................................. xviii
General Product Description.............................................................................................. 1 - 1
General Product Description
.........................................................................................................................1 - 2
Key Features ..................................................................................................................................................1 - 3
Keys and Front Panel ....................................................................................................................................1 - 4
Display ..........................................................................................................................................................1 - 8
Physical Views ..............................................................................................................................................1 - 11
Front View ..............................................................................................................................................1 - 11
Rear View...............................................................................................................................................1 - 12
Left Side Panel.........................................................................................................................................1 - 13
Right Side Panel ......................................................................................................................................1 - 14
Top View................................................................................................................................................1 - 15
System Configuration........................................................................................................ 2 - 1
Installation Menu ............................................................................................................................................2 - 1
Advanced Installation Setup Menu (Network) .....................................................................................................2 - 4
Monitor Setup Menu........................................................................................................................................2 - 6
Advanced Setup .............................................................................................................................................2 - 7
How to Set the Clock/Date and Time .........................................................................................................2 - 8
Transferring Monitor Default Settings..........................................................................................................2 - 8
Configuration Management .............................................................................................................................2 - 9
Patient Management ........................................................................................................ 3 - 1
Description.....................................................................................................................................................3 - 1
Setting-up Patients ...........................................................................................................................................3 - 2
Patient Menu ..........................................................................................................................................3 - 2
Discharging a Patient .....................................................................................................................................3 - 4
Data Transfer .................................................................................................................................................3 - 5
Transferring User Configuration ................................................................................................................3 - 5
Remote View ................................................................................................................................................3 - 6
Monitor/Display Troubleshooting ....................................................................................................................3 - 11
ECG Monitoring ................................................................................................................ 4 - 1
Description ....................................................................................................................................................4 - 1
ECG Screens..................................................................................................................................................4 - 2
Numeric Tile: ECG .................................................................................................................................4 - 2
Waveform: ECG .....................................................................................................................................4 - 3
Front Panel: ECG Keys ....................................................................................................................................4 - 5
Menus: ECG Main and Submenus ....................................................................................................................4 - 6
ECG Menu ............................................................................................................................................4 - 6
Arrhythmia Menu (optional) ......................................................................................................................4 - 8
ST Menu ................................................................................................................................................4 - 10
ECG Sizes Menu .....................................................................................................................................4 - 12
ECG Setup Menu ...................................................................................................................................4 - 12
Preparation and Lead Placement.......................................................................................................................4 - 15
Skin Preparation......................................................................................................................................4 - 15
Electrode Patch Location ...........................................................................................................................4 - 15
Lead Placement .....................................................................................................................................4 - 16
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Table of Contents
Description .....................................................................................................................................4 - 16
Setting Lead Naming Standard .........................................................................................................4 - 16
Lead Placement: Standard 3-wire Lead Sets ........................................................................................4 - 17
Lead Placement: Standard 5-wire Lead Sets ........................................................................................4 - 18
Lead Placement: Lead II Monitoring ...................................................................................................4 - 19
Lead Placement: Modified Chest Lead (MCL) Monitoring ......................................................................4 - 20
Lead Placement: Neonates ...............................................................................................................4 - 21
Lead Placement: Pacemaker Patients ..................................................................................................4 - 22
Arrhythmia Algorithm ......................................................................................................................................4 - 23
Noise and Artifact ...................................................................................................................................4 - 23
Heart Rate Average ................................................................................................................................4 - 23
Filtering Pacer Signals ..............................................................................................................................4 - 24
ECG Amplitude .......................................................................................................................................4 - 24
Learning .................................................................................................................................................4 - 24
Beat Detection and Typing ........................................................................................................................4 - 24
Arrhythmia Alarms (optional)............................................................................................................................4 - 25
Lethal Arrhythmia Alarms .........................................................................................................................4 - 25
Asystole Alarm ................................................................................................................................4 - 25
Ventricular-Fibrillation (V-FIB) Alarm ...................................................................................................4 - 25
Ventricular Tachycardia (V-TACH) Alarm ...........................................................................................4 - 26
Non-Lethal Arrhythmia Alarms ..................................................................................................................4 - 26
Bigeminy Alarm ..............................................................................................................................4 - 26
Brady (Bradycardia) Alarm ...............................................................................................................4 - 26
Couplet Alarm ................................................................................................................................4 - 26
Irregular Heart Rate Alarm ...............................................................................................................4 - 27
PVC/minute Alarm ..........................................................................................................................4 - 27
Run Alarm ......................................................................................................................................4 - 27
Trigeminy Alarm ..............................................................................................................................4 - 27
Ventricular Rhythm (V-Rhythm) Alarm .................................................................................................4 - 27
Arrhythmia Analysis (Optional) ........................................................................................................................4 - 28
Arrhythmia Analysis Setup .......................................................................................................................4 - 29
ST Analysis (Optional) ....................................................................................................................................4 - 30
Numeric Tile: ST .....................................................................................................................................4 - 31
ST Analysis Setup ....................................................................................................................................4 - 31
Adjusting the ISO and J/ST Point ......................................................................................................4 - 32
Adjusting ST Measurement Points .....................................................................................................4 - 32
Relearning ST or Arrhythmia Analysis ................................................................................................................4 - 33
ECG Troubleshooting .....................................................................................................................................4 - 34
Respiration Monitoring ..................................................................................................... 5 - 1
Description ....................................................................................................................................................5 - 1
Resp Screens ..................................................................................................................................................5 - 2
Numeric Tile: Resp...................................................................................................................................5 - 2
Waveform: Resp .....................................................................................................................................5 - 2
Resp Menu.....................................................................................................................................................5 - 3
Thoracic Impedance.................................................................................................................................5 - 4
Respiration and CO2 Troubleshooting ...............................................................................................................5 - 5
SpO2 Monitoring............................................................................................................... 6 - 1
Description ....................................................................................................................................................6 - 1
SpO2 Screens ................................................................................................................................................6 - 2
Numeric Tile: SpO2 .................................................................................................................................6 - 2
Waveform: SpO2 ....................................................................................................................................6 - 2
SpO2 Menu ..................................................................................................................................................6 - 3
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Table of Contents
SpO2 Pulse Oximetry ......................................................................................................................................6 - 5
Masimo SET® SpO2.................................................................................................................................6 - 6
Nellcor® SpO2........................................................................................................................................6 - 7
DPM SpO2 .............................................................................................................................................6 - 9
SpO2 Troubleshooting and SpO2 Menu Performance Considerations ...................................................................6 - 11
NIBP Monitoring ............................................................................................................... 7 - 1
NIBP Description ............................................................................................................................................7 - 1
Displaying Measured Pressure
...............................................................................................................7 - 1
Display Time-out for NIBP Measurement ....................................................................................................7 - 1
Measurement Modes .............................................................................................................................7 - 2
NIBP Screens .................................................................................................................................................7 - 3
NIBP Numeric Tile ...................................................................................................................................7 - 3
NIBP List Display ....................................................................................................................................7 - 4
NIBP Menu ...................................................................................................................................................7 - 5
NIBP Measurements ........................................................................................................................................7 - 7
Manual NIBP Measurements .....................................................................................................................7 - 7
Automatic Interval NIBP Measurements.......................................................................................................7 - 8
Suspension of NIBP Measurements ............................................................................................................7 - 9
Retry measurement ..................................................................................................................................7 - 9
Reset .....................................................................................................................................................7 - 9
NIBP Pressure Limit Fail Safe .....................................................................................................................7 - 9
Cuff Inflation Timeout ...............................................................................................................................7 - 10
Start and Stop Keys .................................................................................................................................7 - 10
NIBP Auto Time Out Functions...................................................................................................................7 - 10
Indirect BP Measurements and Associated Errors .........................................................................................7 - 10
Recommendations for Automatic Blood Pressure Measurements .....................................................................7 - 11
Cuff Size ................................................................................................................................................7 - 11
Other Factors ..........................................................................................................................................7 - 11
User Verification of Passport V Blood Pressure Measurements ...................................................................7 - 11
Newborn NIBP Technique ........................................................................................................................7 - 11
NIBP List Tile ...........................................................................................................................................7 - 12
Adaptive Inflation Pressure .......................................................................................................................7 - 12
NIBP Troubleshooting ......................................................................................................................................7 - 13
Temperature Monitoring ................................................................................................... 8 - 1
Description
.................................................................................................................................................8 - 1
Temperature Screens .......................................................................................................................................8 - 2
Numeric Tile: Temp..................................................................................................................................8 - 2
Temperature Probes ........................................................................................................................................8 - 3
Skin Temperature Sensor with 400 Series Thermistor....................................................................................8 - 3
Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor .......................................................8 - 4
Esophageal/Rectal Temperature Probe with 400 Series Thermistor ................................................................8 - 6
Reusable DPM Temperature Probes ............................................................................................................8 - 7
Temperature Troubleshooting ...........................................................................................................................8 - 8
IBP Monitoring (optional) .................................................................................................. 9 - 1
IBP Description ..............................................................................................................................................9 - 1
Pressure Labels ........................................................................................................................................9 - 1
IBP Screens ...................................................................................................................................................9 - 3
IBP Numeric Tile ......................................................................................................................................9 - 3
IBP Waveform .........................................................................................................................................9 - 4
IBP Menu ......................................................................................................................................................9 - 5
Measuring IBP ...............................................................................................................................................9 - 7
IBP Troubleshooting.........................................................................................................................................9 - 8
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Table of Contents
CO2 Monitoring (optional) ............................................................................................... 10 - 1
Description ..................................................................................................................................................10 - 1
CO2 Screens ...............................................................................................................................................10 - 2
Numeric Tile: CO2 ................................................................................................................................10 - 2
Waveform: CO2 ...................................................................................................................................10 - 2
CO2 Menu ..................................................................................................................................................10 - 3
CO2 Setup Menu (DPM Sidestream Only) ................................................................................................10 - 5
Microstream® CO2 Monitoring (Optional) ................................................................................................10 - 7
CO2 Troubleshooting ....................................................................................................................................10 - 8
Gas Monitoring (optional) ............................................................................................... 11 - 1
Description ..................................................................................................................................................11 - 1
Gas Screens.................................................................................................................................................11 - 3
CO2 Numeric Tile ................................................................................................................................11 - 3
Gas Numeric Tile .................................................................................................................................11 - 3
Gas Waveform .....................................................................................................................................11 - 4
Gas Menu ..................................................................................................................................................11 - 5
Measure Unit .......................................................................................................................................11 - 6
Automatic identification of Anesthetic Agents ...........................................................................................11 - 6
Gas Module 3 Pre-use Test .....................................................................................................................11 - 8
Gas Module Troubleshooting .........................................................................................................................11 - 8
Drug Calculations............................................................................................................ 12 - 1
Description...................................................................................................................................................12 - 1
Drug Calculations ..................................................................................................................................12 - 1
Alarms ........................................................................................................................... 13 - 1
Alarms.....................................................................................................................................................13 - 1
Adjusting Alarms ..................................................................................................................................13 - 1
Alarm Limits ........................................................................................................................................13 - 3
Auto Set Alarms ....................................................................................................................................13 - 5
Alarm Violations ...................................................................................................................................13 - 6
Verifying Alarm Functionality ................................................................................................................13 - 8
Alarm Troubleshooting ...........................................................................................................................13 - 9
Messages ....................................................................................................................... 14 - 1
Physiological Alarm Messages .......................................................................................................................14 - 1
HR .......................................................................................................................................................14 - 1
Arrhythmia............................................................................................................................................14 - 1
RESP ....................................................................................................................................................14 - 2
TEMP ...................................................................................................................................................14 - 2
SpO2 ...................................................................................................................................................14 - 2
NIBP ....................................................................................................................................................14 - 2
IBP.......................................................................................................................................................14 - 3
CO2 ....................................................................................................................................................14 - 3
GAS ....................................................................................................................................................14 - 3
Technical Alarm Messages.............................................................................................................................14 - 4
ECG Alert Message ...............................................................................................................................14 - 4
RESP Alert Message ...............................................................................................................................14 - 4
TEMP Alert Message ..............................................................................................................................14 - 5
SpO2 Alert Message..............................................................................................................................14 - 5
NIBP Alert Message ...............................................................................................................................14 - 5
IBP Alert Message..................................................................................................................................14 - 6
CO2 Alert Message ...............................................................................................................................14 - 6
GAS Alert Message ...............................................................................................................................14 - 6
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Passport V Operating Instructions
Table of Contents
System Level .........................................................................................................................................14 - 7
Prompt Messages..........................................................................................................................................14 - 8
ECG Prompt Message ............................................................................................................................14 - 8
Resp Prompt Message ............................................................................................................................14 - 8
SpO2 Prompt Message ..........................................................................................................................14 - 9
Temp Prompt Message ...........................................................................................................................14 - 10
NIBP Prompt Message............................................................................................................................14 - 11
IBP Prompt Message ..............................................................................................................................14 - 13
CO2 Prompt Message ............................................................................................................................14 - 13
GAS Prompt Message ............................................................................................................................14 - 16
Main Control System..............................................................................................................................14 - 18
Power Supply........................................................................................................................................14 - 19
Data Management.................................................................................................................................14 - 19
Configuration Management ....................................................................................................................14 - 20
Network ...............................................................................................................................................14 - 20
Print .....................................................................................................................................................14 - 21
Alarm Troubleshooting ...........................................................................................................................14 - 22
Trends ............................................................................................................................ 15 - 1
Description...................................................................................................................................................15 - 1
Quick Trends................................................................................................................................................15 - 2
List Trends ....................................................................................................................................................15 - 3
Graphic Trends.............................................................................................................................................15 - 5
OxyCRG......................................................................................................................................................15 - 7
Trends Troubleshooting ..................................................................................................................................15 - 10
Printing .......................................................................................................................... 16 - 1
Description...................................................................................................................................................16 - 1
Print Setup Menu .........................................................................................................................................16 - 1
Local Printer (Optional)...........................................................................................................................16 - 2
Remote/Local Printer Troubleshooting.......................................................................................................16 - 4
User Maintenance ........................................................................................................... 17 - 1
Description...................................................................................................................................................17 - 1
Care and Disinfection of the Passport V Monitor............................................................................................17 - 2
Care and Cleaning of SpO2 Sensors...............................................................................................................17 - 3
Care and Cleaning of Reusable Temperature Probes .........................................................................................17 - 3
Care and Cleaning of Reusable Cuffs..............................................................................................................17 - 4
Reusable Cuffs with Bladders ..................................................................................................................17 - 4
Reusable Bladderless Cuffs .....................................................................................................................17 - 5
Battery Replacement and Maintenance ............................................................................................................17 - 6
Local Printer Paper Replacement .....................................................................................................................17 - 7
Care and Storage of Thermal Chart Paper .......................................................................................................17 - 7
Care and Cleaning of 3- and 5-lead ECG Cables and Lead wires ......................................................................17 - 8
Accessories ..................................................................................................................... 18 - 1
ECG............................................................................................................................................................18 - 1
ECG Electrodes .....................................................................................................................................18 - 1
ECG Cables .........................................................................................................................................18 - 1
ECG Leadsets .......................................................................................................................................18 - 2
SpO2 .........................................................................................................................................................18 - 3
Masimo SpO2 Module ...........................................................................................................................18 - 3
Nellcor SpO2 Module ............................................................................................................................18 - 5
DPM SpO2 Module ...............................................................................................................................18 - 5
NIBP ...........................................................................................................................................................18 - 6
Temperature ................................................................................................................................................18 - 7
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Table of Contents
Disposable 400 Series Temperature Probes .............................................................................................. 18 - 7
Reusable DPM Temperature Probes ..........................................................................................................18 - 7
Disposable DPM Temperature Probes ....................................................................................................... 18 - 7
IBP .............................................................................................................................................................. 18 - 8
CO2............................................................................................................................................................ 18 - 9
Oridion Microstream CO2 Module ..........................................................................................................18 - 9
DPM Sidestream CO2 Module and Gas Module 3 .................................................................................... 18 - 9
Gas Module 3 Accessories ..................................................................................................................... 18 - 10
Mounting Kits, Rolling Stands, and Accessories ................................................................................................ 18 - 11
Cables and Networking.................................................................................................................................18 - 12
Battery and Miscellaneous ............................................................................................................................. 18 - 13
Appendix ...................................................................................................................... 19 - 1
Equipment Environment and Safety Specifications ............................................................................................. 19 - 1
Power Specifications
..................................................................................................................................19 - 3
Clock .......................................................................................................................................................... 19 - 4
Weight and Dimension.................................................................................................................................. 19 - 4
Display Specifications ...................................................................................................................................19 - 4
Sound ....................................................................................................................................................... 19 - 5
Marking ......................................................................................................................................................19 - 5
Performance Characteristics ........................................................................................................................... 19 - 6
ECG Specifications ................................................................................................................................ 19 - 6
RESP ....................................................................................................................................................19 - 12
IBP....................................................................................................................................................... 19 - 13
NIBP Performance and Functional Characteristics .....................................................................................19 - 14
Masimo SET SpO2 Performance Requirements .........................................................................................19 - 16
DPM SpO2 Performance Requirements ..................................................................................................... 19 - 19
Nellcor SpO2 ........................................................................................................................................ 19 - 20
CO2 Performance Characteristics ............................................................................................................19 - 21
Temperature Performance Characteristics ............................................................................................... 19 - 25
Gas Module Performance Characteristics ................................................................................................. 19 - 26
Input/Output Communications ...................................................................................................................... 19 - 28
Communication Protocols ...............................................................................................................................19 - 29
Data Storage................................................................................................................................................ 19 - 29
Printing ........................................................................................................................................................ 19 - 30
Agency Compliance...................................................................................................................................... 19 - 30
Safety Designations ...................................................................................................................................... 19 - 31
Safety Classification .............................................................................................................................. 19 - 31
Safety Performance Index ....................................................................................................................... 19 - 31
Electromagnetic Capability ............................................................................................................................ 19 - 34
EMC Safety ......................................................................................................................................... 19 - 34
Passport V......................................................................................................................................... 19 - 35
Radio Regulatory Compliance..................................................................................................................19 - 39
Gas Module 3 ...................................................................................................................................... 19 - 41
Warranty Statements .................................................................................................................................... 19 - 45
Customer Service .......................................................................................................................................... 19 - 47
Manufacturer's Responsibility ........................................................................................................................ 19 - 47
Glossary......................................................................................................................... 20 - 1
Glossary of Terms ....................................................................................................................................... 20 - 1
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Passport V Operating Instructions
Foreword
Introduction
Foreword
The Passport V Operating Instructions are intended to provide information for proper
operation.
General knowledge of monitoring and an understanding of the features and functions of the
Passport V monitor are prerequisites for its proper use.
NOTE:
Do not operate this monitor before reading these instructions.
Information for servicing this instrument is contained in the Passport V Service Manual,
part number 0070-00-0705. For additional information or assistance, please contact an
authorized service representative in your area.
CAUTION:
U.S. Federal Law restricts this device to sale by or on the order
of a physician or other practitioner licensed by state law to use
or order the use of this device.
NOTE:
Figures in this manual are provided for reference purposes
only. Screens will likely differ based on the monitoring device
configuration, licenses available, parameters selected and
patient configuration of the Passport V monitor.
Patents: This device is covered under one or more of the following U.S. Patents: 5,300,859;
5,485,847; 5,657,750; 5,676,141; 5,743,263; 5,758,644; 5,823,950; 5,857,461;
6,011,986; 6,035,223; 6,157,850; 6,226,539; 6,263,222; 6,411,833; 6,422,240;
6,437,316; 6,463,310; 6,501,975; 6,591,123; 6,708,049; 7,016,715; 7,039,538;
7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774;
7,212,847; 7,400,919; foreign equivalents; and Masimo patents (www.masimo.com/
patents.htm). Possession or purchase of this device does not convey any express or implied
license to use the device with replacement parts which would, alone, or in combination with
this device, fall within the scope of one or more of the patents relating to this device.
Warnings, Precautions, and Notes
Please read and adhere to all warnings, precautions and notes listed here and in the
appropriate areas throughout this manual.
A WARNING is provided to alert the user to potential serious outcomes (death, injury, or
serious adverse events) to the patient or the user.
A CAUTION is provided to alert the user to use special care necessary for the safe and
effective use of the device. They may include actions to be taken to avoid effects on patients
or users that may not be potentially life threatening or result in serious injury, but about which
the user should be aware. Cautions are also provided to alert the user to adverse effects on
this device of use or misuse and the care necessary to avoid such effects.
A NOTE is provided when additional general information is applicable.
Passport V Operating Instructions
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Introduction
Warnings
Warnings
WARNING: Use of the Passport V is restricted to one patient at a time.
WARNING: This device is not intended for direct cardiac application.
WARNING: Internal Electrical Shock Hazard - This unit does not contain any
user-serviceable parts. Do not remove instrument covers. Refer
Servicing to qualified personnel.
WARNING: Do not use this monitor during MRI (Magnetic Resonance
Imaging) scanning. Induced current could potentially cause
burns. Accuracy of measurements on this unit and the MRI unit
may also be affected.
WARNING: To reduce the hazard of burns in the high-frequency surgical
neutral electrode connection, the electrodes should not be
located between the surgical site and the electro-surgical unit
return electrode.
WARNING: Ensure that conductive parts of the ECG electrodes do not
contact other conductive parts including earth ground. Do not
connect any non-isolated accessories to the Passport V or to the
ECG or invasive pressure channel inputs when connected to a
patient. Ensure that the total chassis leakage currents of all
connected units does not exceed 300µA. Use an IEC 60601-1
approved isolation / separation transformer if required. Do not
simultaneously touch the patient and any piece of electrical
equipment if any cover has been removed from the equipment.
WARNING: Electrode polarization: some electrodes may be subject to large
offset potentials due to polarization. Use only electrodes as
recommended by Mindray. Recovery time after application of
defibrillator pulses may be especially compromised. Squeeze
bulb electrodes commonly used for diagnostic ECG recording
may be particularly vulnerable to this effect. Electrodes of
dissimilar metals should not be used unless the amplifier can
handle polarization potentials as high as 1 volt (V).
WARNING: The AC line cord and interface cables (i.e. non-patient cables)
may utilize the same ground. Therefore, removal of the AC line
cord does not necessarily isolate the Passport V if non-patient
interface cables are attached.
WARNING: Observe extreme caution when a defibrillator is used on a
patient. Do not touch any part of patient, table, or monitor
when a defibrillator is in use.
WARNING: Do not incinerate battery; possible explosion may occur.
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Passport V Operating Instructions
Warnings
Introduction
WARNING: To ensure that alarms can sound if the Gas Module/Passport V
loses power, at least one charged battery must be installed in
the Passport V at all times.
WARNING: Do not put MPSO (Multiple Portable Socket Outlets, i.e. Multiple
outlet extension cords) used with the Passport V or its
accessories on the floor. Connect only Passport V accessories to
the same MPSO as the Passport V. Do not overload the MPSO.
Do not connect other equipment to the same MPSO with the
Passport V, as it may increase system leakage current.
WARNING: Reliably attach Potential Equalization connector to the safety
ground when interconnecting Passport V with other medical or
non-medical electrical equipment to minimize the risk of
excessive leakage current and/or shock hazard.
WARNING: Do not reuse disposable accessories. Dispose of single use items
in accordance with hospital policy.
WARNING: Compressed gasses are considered Dangerous Goods/
Hazardous Materials per I.A.T.A. And D.O.T. regulations. It is a
violation of federal and international law to offer any package
or over pack of dangerous goods for transportation without the
package being appropriately identified, packed, marked,
classified, labeled and documented according to D.O.T. and
I.A.T.A. regulations. Please refer to the applicable I.A.T.A.
Dangerous Goods Regulations and/or the Code of Federal
Regulations 49 (Transportation, Parts 171-180) for further
information.
WARNING: Route cables neatly. Ensure cables, hoses and wires are kept
away from patient’s neck to avoid strangulation. Keep floors
and walkways free of cables to reduce risk to hospital
personnel, patients and visitors.
WARNING: Do not use a damaged or broken unit or accessory. Periodically,
check all cables (e.g., AC line cord and patient connection
cables) for damage that may occur through normal use.
Replace cable if damaged in any way.
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
WARNING: Pacemaker patients’ rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or some
arrhythmias. Do not rely entirely upon rate meter alarms. Keep
pacemaker patients under close surveillance. See the Appendix
section of this manual for disclosure of the pacemaker pulse
rejection capability of this instrument.
Passport V Operating Instructions
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Introduction
Warnings
WARNING: Due to physiologic differences in the patient population, the
Passport V may occasionally not alarm or may sound a false
alarm for some arrhythmia patterns. The arrhythmia analysis
feature is intended to detect ventricular rhythms only. High-risk
patients should be kept under close surveillance.
WARNING: Trace Gas Hazard - When using the optional Gas Module, a
health hazard exists when trace amounts of vaporized
anesthetic agents are chronically inspired by operating room
personnel. See Appendix A in NFPA 56A on Inhalation
Anesthetics. During any procedure where such agents are
employed, the Gas Module exhaust output should be connected
to a medical gas-scavenging system.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenging system is strongly recommended to
prevent exposure of hospital personnel to the patient’s
respiratory sample. Vacuum (negative pressure) should not
exceed 1 mmHg at the Gas Module Pump Exhaust fitting.
Excessive scavenge vacuum may result in damage to the Gas
Module’s internal pump.
WARNING: When monitoring CO2, the maximum sampling rate at the
nasal cannula is 150ml/min with the DPM CO2 module. This
device should not be used on patients whose breathing could
be impaired by these vacuum flow rates.
WARNING: When monitoring an anesthesized patient in an operating room
environment, connection from the exhaust port of the Passport
V to the hospital’s waste gas scavenging system is
recommended to prevent exposure of hospital personnel to the
patient’s respiratory sample.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas Module 3
with a neonatal water trap). This device should not be used on
patients whose breathing could be impaired by this vacuum
flow rate.
WARNING: Operation of the Passport V below the minimum amplitude or
value of PATIENT physiological signal may cause inaccurate
results.
WARNING: Use of ACCESSORIES, transducers and cables other than those
specified in the manual may result in increased Electromagnetic
Emissions or decreased Electromagnetic Immunity of the
Passport V. It can also cause delayed recovery of the monitor
after the discharge of a cardiac defibrillator.
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Passport V Operating Instructions
Warnings
Introduction
WARNING: Use of the Passport V in the vicinity of explosive anesthetics
and in the presence of electromagnetic interference or power
overloads caused by electrosurgical or diathermy instruments
could create a potential hazard or could damage the monitor.
WARNING: The use of gas sampling accessories in Gas Module 3 other than
those specified may cause significant measurement errors and
patient risk.
WARNING: Use of accessories, transducers and cables other than those
specified in the manual may result in increased Electromagnetic
Emissions or decreased Electromagnetic Immunity of the Gas
Module 3.
WARNING: With the exception of stacking on a Gas Module with the
appropriate mounting brackets, the Passport V should not be
used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the Passport V and Gas Module
should be observed to verify normal operation in the
configuration in which they will be used.
WARNING: If the water trap breaks or becomes damaged during
operation, there is a risk that bacteria and/or mucus may
contaminate the Gas Module.
WARNING: The Gas Module must not be used with flammable anesthetic
agents.
WARNING: SpO2 sensors, SpO2 accessories, and temperature probes
should be disposed of in accordance with local regulations.
WARNING: Shut down the monitor and disconnect all power cords from the
outlet before cleaning.
WARNING: Connect only DRYLINE™ gas sampling lines to the water trap.
Note that there may be other compatible tubes present that
must not be used (e.g. IV lines).
WARNING: Do not use DRYLINE™ Neonatal sampling lines (blue Luer lock
nuts) with DRYLINE™ Adult/Pediatric water traps. Do not use
DRYLINE™ Adult/Pediatric sampling lines (colorless Luer lock
nuts) with DRYLINE™ Neonatal water traps. These
configurations could result in incorrect measurement data.
WARNING: Do not use Adult/Pediatric type water traps and/or sampling
lines with neonates to avoid high sampling flow.
WARNING: The contents of the Gas Module water trap should be handled
as a potential infection hazard. The water trap, sampling line
and airway adapter should be disposed of in accordance with
local regulations for contaminated and biologically hazardous
items.
Passport V Operating Instructions
0070-00-0704-02
xi
Introduction
Precautions
WARNING: CO2 FilterLines® should be treated as biohazardous waste and
disposed of in accordance with local regulations for
contaminated and biologically hazardous items.
WARNING: Use the recommended cleaning methods for the DRYLINE™
water traps. Do not clean or wash the filter housing of the
water trap. Never allow alcohol to enter the filter housing.
Never force air through the water trap.
WARNING: A hazard can exist if different alarm presets are used for the
same or similar equipment in any single area.
WARNING: The user should check that the current alarm settings on the
Passport V monitor are appropriate prior to use on each
patient.
Precautions
CAUTION:
Always place the monitor on a rigid, flat surface or on
approved mounts. Do not block ventilation or speaker vents.
CAUTION:
Do not carry the Passport V using the integrated grip handle if
the unit is mounted to another item (e.g., a rolling stand or Gas
Module 3).
CAUTION:
Never place fluids on top of this monitor. In case of accidental
spillage, wipe clean immediately and have the monitor serviced
to ensure no hazard exists.
CAUTION:
To avoid possible damage to the Passport V, and to provide
protection against the effect of the discharge of a cardiac
defibrillator and against burns, use only approved ECG cables
and approved accessories listed in the Accessories chapter.
CAUTION:
To prevent condensation, allow the Passport V to warm up and
dry if it is moved from a cold to warm location.
CAUTION:
The Passport V may not meet its performance specifications if
stored or operated outside of specified temperature and
humidity ranges.
CAUTION:
Prior to use, be sure the rail supporting the bed rail mounting
hook can support the weight of the monitor. Consult the bed
manufacturer’s specifications if necessary. The Company is not
responsible for injury or damage resulting from improper or
inadequate support of the monitor.
CAUTION:
Use the power cord provided with the product. If a substitute is
necessary, use only hospital grade power cords.
xii
0070-00-0704-02
Passport V Operating Instructions
Precautions
Introduction
CAUTION:
Line Isolation Monitor transients may resemble actual cardiac
waveforms, thus inhibiting heart rate alarms. Check lead wires
for damage and ensure good skin contact prior to and during
use. Always use fresh electrodes and follow proper skin
preparation techniques.
CAUTION:
Blood pressure cuffs must be used with the manufacturer’s
correct and approved hoses.
CAUTION:
Please consult a physician for interpretation of blood pressure
measurements.
CAUTION:
A blood pressure measurement can be affected by the position
of the patient, and his / her physiological condition as well as
other factors, such as patient movement.
CAUTION:
Observe caution on all patients (Neonates, Pediatrics, and
Adults), when NIBP is set to STAT Mode or the 1-minute interval,
to minimize the possibility of nerve injury occurring during use
of automatically cycled blood pressure cuffs.
CAUTION:
Observe caution when NIBP measurement is performed on
patients suffering from sickle cell disease, or are expected to
have skin injuries.
CAUTION:
Observe caution when NIBP measurement is performed on a
patient’s limb with venous transfusion or catheters.
CAUTION:
Tissue damage or inaccurate measurements may be caused by
incorrect SpO2 sensor application or use, such as wrapping too
tightly, applying supplemental tape, failing to inspect the
sensor site periodically, or failing to position appropriately.
Carefully read the sensor directions for use, the Passport V
Operating Instructions, and all precautionary information
before use.
CAUTION:
Passport V Operating Instructions
Inaccurate SpO2 measurements may be caused by:
•
Incorrect sensor application or use
•
Significant levels of dysfunctional hemoglobins, (e.g.,
carboxyhemoglobin or methemoglobin)
•
Intra-vascular dyes such as indocyanine green or
methylene blue
•
Exposure to excessive illumination such as surgical
lamps (especially ones with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating
lamps, or excessive ambient light. In such cases, cover
the sensor site with opaque material
•
Excessive patient movement
•
Venous pulsations
•
Electro-surgical interference
0070-00-0704-02
xiii
Introduction
Precautions
CAUTION:
•
Placement of a sensor on an extremity that has a blood
pressure cuff, arterial catheter, or intra-vascular line
•
Nail polish or fungus
In certain situations in which perfusion and signal strength are
low, such as in patients with thick or pigmented skin,
inaccurately low SpO2 readings will result. Verification of
oxygenation should be made, especially in preterm infants and
patients with chronic lung disease, before instituting any
therapy or intervention.
CAUTION:
Many patients suffer from poor peripheral perfusion due to
hypothermia, hypovolemia, severe vasoconstriction, reduced
cardiac output, etc. These symptoms may cause a loss in vital
sign readings.
CAUTION:
Prolonged and continuous monitoring may increase the risk of
skin erosion and pressure necrosis at the site of the sensor.
Check the SpO2 sensor site frequently to ensure proper
positioning, alignment and skin integrity at least every eight (8)
hours; with the Adult and Pediatric re-usable finger sensor,
check every four (4) hours; for neonates and patients of poor
perfusion or with skin sensitive to light, check every 2 - 3
hours; more frequent examinations may be required for
different patients. Change the sensor site if signs of circulatory
compromise occur.
CAUTION:
When equipped with Masimo SET® SpO2, use only Masimo SET
Oxygen Transducers including Masimo SET LNOP® and LNCS®
Patient Dedicated Adhesive Sensors and Masimo SET PC Series
Patient Cables. Use of other oxygen transducers may cause
improper oximeter performance.
CAUTION:
When equipped with Nellcor® SpO2, use only Nellcor oxygen
transducers including Nellcor Oxisensor® and OxiMax® patient
dedicated adhesive sensors. Use of other oxygen transducers
may cause improper oximeter performance.
CAUTION:
When equipped with DPM SpO2, use only DPM oxygen sensors
and cables. Use of other oxygen sensors may cause improper
oximeter performance.
CAUTION:
Vacuum (negative pressure) should not exceed 1 mmHg at the
Passport V Pump Exhaust fitting. Excessive scavenge vacuum
may result in an Occlusion message or damage to the Passport
V’s internal pump. The scavenging system must be on during
calibration.
CAUTION:
When cleaning SpO2 sensors, do not use excessive amounts of
liquid. Wipe the sensor surface with a soft cloth, dampened
with cleaning solution. Do not attempt to sterilize.
xiv
0070-00-0704-02
Passport V Operating Instructions
Precautions
Introduction
CAUTION:
Some disinfectants may cause skin irritation. Please rinse cuff
thoroughly with water to remove any residual disinfectants.
CAUTION:
The internal sampling system of the Gas Module does not need
to be cleaned or sterilized. There is no reverse flow back to the
patient. If the internal sampling system is suspected to be
clogged or dirty, the module should be serviced by an
authorized service person only.
CAUTION:
To avoid permanent damage, do not expose metal components
(pins, sockets, snaps) to disinfectants, soaps or chemicals.
CAUTION:
Do not connect NIBP Luer fittings to Blood Pressure Cuff or
Monitor.
CAUTION:
Some pacemakers may contain a respiratory sensor that may
produce artifact on an ECG waveform.
CAUTION:
The monitor display provides data and waveform information
over its entire area. Do not cover any part of the monitor
display with tape or labels.
CAUTION:
A functional tester cannot be used to assess the accuracy of the
pulse oximeter probe or a pulse oximeter monitor.
CAUTION:
Replace lithium-ion batteries with part number
M05-010001-06 (Mindray) or 0146-00-0099 ONLY.
CAUTION:
Gas Module 3 must be moisture protected whenever
transported. This can be done with a protective plastic bag in
which water-absorbing materials (e.g. silica gel) have been
included.
CAUTION:
Contamination with CO2, N2O or Anesthetic Agent in the air
surrounding the Gas Module may cause significant
measurement errors. The Gas Module exhaust output should be
connected to a medical gas-scavenging system.
CAUTION:
The Passport V monitor is not compatible with 700 Series
temperature probes.
CAUTION:
Do not unplug the storage device from any of the SB ports on
the Passport V while transferring data, as indicated on the
menu or prompt areas of the monitor. Data may be lost or
corrupted and the storage device may become damaged.
Passport V Operating Instructions
0070-00-0704-02
xv
IntroductionAvoid simultaneous contact with the patient and the SP1 and SP2 ports on the Passport V to avoid excessive leakage current.
CAUTION:
Devices connected to the Passport V must meet the
requirements of the applicable IEC standards (e.g., IEC 60950
safety standards for information technology equipment and IEC
60601-1 safety standards for medical electrical equipment). The
system configuration must meet the requirements of the IEC
60601-1-1 medical electrical systems standard. Any personnel
who connects devices to the signal input/output port of the
Passport V is responsible for providing evidence that the safety
certification of the devices has been performed in accordance to
the IEC 60601-1-1. Please contact Technical Support if you have
any questions about connecting devices to the data port.
CAUTION:
The Gas Module must be power cycled if the Passport V monitor
is powered off.
Avoid simultaneous contact with the patient and the SP1 and SP2 ports on the
Passport V to avoid excessive leakage current.
Notes
NOTE:
This unit is not designed to be used with a peripheral pulse
sensor. SpO2 is a standard function in this monitor, and may be
used to obtain a plethysmograph waveform and heart rate.
NOTE:
The comparison testing conducted via the auscultatory method
used both Phase 4 and Phase 5 Korotkoff sounds. Reports of
study findings for both the auscultatory method as well as the
intra-arterial methods are available by contacting Technical
Support (800) 288-2121, ext. 8116 or (201) 995-8237.
NOTE:
Potential hazards due to errors in software or hardware have
been minimized by actions taken in accordance with IEC 606011-4.
xvi
0070-00-0704-02
Passport V Operating Instructions
Intended Use
Introduction
Intended Use
The Passport V monitor is intended for intra hospital use under the direct supervision of a
licensed healthcare practitioner. The indications for use for the Passport V monitor include
the monitoring of the following human physiological parameters:
• ECG waveform derived from 3- or 5-lead measurements
• Heart Rate derived from selected sources (ECG, IBP, SpO2)
• Pulse Oximetry (SpO2)
• ST Segment Analysis derived from 3 or 5 ECG lead measurements
• Arrhythmia Detection derived from 3 or 5 ECG lead measurements
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) - up to two (2) channels
• Respiration Rate/waveform derived from ECG or CO2
• CO2, inspired and end tidal waveform
• Anesthetic agents, O2 (inspired and expired)
• Temperature
• IV Drug Calculations
The target populations are adult, pediatric, and neonate; except Arrhythmia Detection and
ST Segment Analysis for which the target populations are adult and pediatric only; and IV
Drug Calculations for which the target population is adult only.
Unpacking
Remove the instrument from the shipping carton and examine it for signs of shipping
damage. Save all packing materials, invoice and bill of lading. These may be required to
process a claim with the carrier. Check all materials against the packing list. Contact the
Service Department at (800) 288-2121 or (201) 995-8237 (U.S.A and Canada), or (201)
265-8800 (outside U.S.A. and Canada) for prompt assistance in resolving shipping
problems.
Passport V Operating Instructions
0070-00-0704-02
xvii
Symbols and Descriptions
SYMBOL DESCRIPTION
SYMBOL
DESCRIPTION
Attention, Consult Accompanying
Documents / Refer to Manual
Type B Equipment
Electrical Hazard
Type BF Equipment
Shock Hazard
Defibrillator Proof Type BF Equipment
Equipotentiality
Defibrillator Proof Type CF Equipment
Alternating Current (AC)
Alarm Off Icon
Direct Current (DC)
Alarm Silence Icon
Power On/Off
Alarm Silence Permanently Icon
Data Input
Earth (Ground)
Data Output
Protective Earth (Ground)
Data Input/Output
Full Battery
Gas Port Input
Low Battery
Gas Port Output
No Battery Present
Chart Local Printer Output
Battery Charging
Video Output
xviii
NIBP Connection
Manufacturer
Separate treatment from general waste at
end of life
Interference may occur in the vicinity of
equipment marked with this symbol
0070-00-0704-02
Passport V Operating Instructions
For single-patient use only, do not reuse.
Manufacturer’s reference/catalogue
number
For Neonatal use
Manufacturer’s batch number
Not for Neonatal use
Serial number
Conformité Européenne (CE) Marking of
Conformity to European Medical Device
Directive. CEXXXX represents the Notified
Body number
Classified by Underwriters Laboratories
Inc. with respect to electric shock, fire
and mechanical hazards, only in
accordance with UL 60601-1, CAN/
CSA C22.2 NO.601-1, IEC 60601-1-1,
IEC 60601-2-25, IEC 60601-2-27, IEC
60601-2-30, IEC 60601-2-34, IEC
60601-2-49.
CS1 Port Connection
The wireless status icon indicates that the
2.4 GHz radio is activated.
Wireless Enabled and not communicating
SB Storage Device Connection
Passport V Operating Instructions
0070-00-0704-02
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0070-00-0704-02
Passport V Operating Instructions
1.0
General Product Description
FIGURE 1-1 The Passport V Patient Monitor
Passport V Operating Instructions
0070-00-0704-02
1-1
General Product Description
1.1
General Product Description
General Product Description
The Passport V is a vital signs monitor intended for intrahospital use on human patients.
The Passport V is a three (3) to eight (8) trace monitor. The unit has many features and
functions, yet is easy to use through an integrated keypad, Navigator Knob and an intuitive
menu system.
The Passport V has a 12.1 inch color display and comes standard with 3 or 5-lead ECG,
Masimo SET® SpO2, Non-invasive Blood Pressure, Respiration, Continuous Temperature and
IV Drug Calculations, and support for Gas Module 3 connectivity.
The Passport V may be configured to suit your department by adding software and
hardware optional features. Optional software features include ST and Arrhythmia analysis.
Optional hardware features include up to 2 Invasive Blood Pressure Channels, DPM CO2,
MicroStream® CO2, Anesthetic Gases, DPM SpO2, Nellcor® OxiMax® SpO2, three-trace
Local Printer, and 2.4 GHz wireless networking.
Digital displays are provided for Heart Rate, Non-invasive Blood Pressure (NIBP), Pulse
Oximetry (SpO2), Respiration Rate, and Temperature. Optional digital areas provided for
Invasive Blood Pressure (up to two), Anesthetic Agents, O2 and N2O, ST, CO2, and MAC.
The optional local printer provides hard copies of all digital data and waveforms as well as
trend information.
When powered on, the self-check feature of the Passport V provides verification of proper
operation.
The Passport V monitor can be mounted on a rolling stand, a wall mount bracket, gas
machine arm, bedrail, Gas Module or operated as a tabletop instrument.
The Passport V has the capability of interfacing with Gas Modules, Remote Displays,
Defibrillators, and Nurse Call Systems.
The Passport V monitor is powered by an AC connection or internal batteries.
The Passport V provides Remote View. This feature enables the user to view the numeric
and waveform data of another patient who is being monitored at a remote location.
1-2
0070-00-0704-02
Passport V Operating Instructions
General Product Description
1.2
Key Features
Key Features
FEATURES
STANDARD
OPTIONAL
Display
12.1 inch color liquid crystal
display
External Remote Color Display (SVGA)
Automatic Sensor Detection and
Waveform Display
8-trace erase bar refresh
ECG
3 or 5-lead
(I, II, III, aVR, aVL, aVF, V)
ST Analysis
ECG Cascade
Arrhythmia Analysis
ESIS Capability (3 or 5-lead)
Blood Pressure
Non-Invasive Blood Pressure
SET®
SpO2
Masimo
Temperature
One channel for 400 series
probes
Respirations
Lead-selectable Impedance
Trend
Tabular and Graphic trends with
6000 trend data entries
Power
Internal isolated power module
Up to 2 channels of Invasive Blood Pressure
DPM SpO2, Nellcor® OxiMax® SpO2
DPM CO2, Microstream® CO2
Gas Module with Automatic Agent ID
Second lithium-ion battery
Lithium-ion battery
Printing
Local Printer, Remote Printer
External
Interfaces
Gas Module, Nurse Call systems,
DIAP communications,
Defibrillator sync, Ethernet
network
Calculation
IV drug calculations
Other
Soft Grip Handle
Mounting kits
Navigator Knob
Patient and monitor data transfer
Wireless network
Dedicated keys
Multi-language
supported
interface
Passport V Operating Instructions
English, French, German, Italian,
Spanish, Brazilian-Portuguese,
Russian,Dutch
0070- 00-0704-02
1-3
Keys and Front Panel
1.3
General Product Description
Keys and Front Panel
The front panel keys are used to access many main functions quickly and easily. The figure
below shows the keys and a brief explanation follows.
1
5
4
7
9
8
11
12
14
15
17
18
19
2
3
6
10
13
16
20
21
FIGURE 1-2 Front panel keys and Navigator Knob
1. Lead
Press this key to select the next ECG lead to display in Waveform 1. Each time you press this
key, the next available ECG lead displays.
2. Size
Press this key to select the next available size of ECG for Waveform 1. Each time you press
this key, the next available ECG size displays. When the largest ECG size is displayed, the
next key press displays the smallest size.
3. View
Press this key to see multiple leads of ECG when using the 5-lead ECG cable. Press this key
repeatedly to toggle between multi-lead view, large numeric display, and normal screen.
4. Start
Press this key to begin an NIBP measurement or to begin or re-start automatic interval
measurements.
5. Interval
Press this key to modify the NIBP interval measurement time. The choices are: Off, STAT, 1
min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hr, or 4 hr.
If Off is selected, NIBP measurements can be performed manually only. If STAT is selected,
measurements will be continuous for a period of 5 minutes. Afterward, the monitor will switch
to 5-minute intervals.
6. Stop
Press this key to stop any NIBP measurement. If the interval mode is activated, pressing this
key disables the interval mode measurements. An NIBP: Idle message displays until the
interval mode is restarted.
1-4
0070-00-0704-02
Passport V Operating Instructions
General Product Description
Keys and Front Panel
7. Zero All (with IBP option)
Press this key to set the current pressure for all invasive pressure channels to zero. This key
does not affect any channels monitoring pressure. If the zero process is not successful, one of
the following messages is displayed: Pulsatile Pressure. Cannot Zero! or Pressure
Overrange. Cannot Zero!
8. Limits
Press this key to display the Alarm Settings Menu. The Alarm Settings Menu provides
access to view or change alarm values.
9. Silence All
Press this key to suspend audio alarms on all parameters. The alarms remain suspended for a
user selected amount of time. This amount of time is set in the Alarm Setup Menu. While
the alarms are suspended, an Alarm Silence icon and message All Alarms Silenced For
X:XX mins display in the upper area of the screen. X:XX is the time remaining in minutes
and seconds. Press this key again during the suspended alarm time to re-enable the audio
alarm. If the suspend time was set to Permanent in the Alarm Setup Menu, the message
All Alarms Silenced Permanently is displayed. Note that the Permanent selection
will be available only if Enable Silence All Permanent Selection is set to “Yes” in the
Installation Menu.
10. Silence
Press this key to suspend audio alarms on all currently alarming parameters. The alarms
remain suspended for a user selected amount of time as set in the Alarm Setup Menu or
until the alarm condition is no longer present. Any new alarms that occur while the alarm
tone is silenced will disable the silence and sound the alarm tone. While the alarms are
suspended, an Alarm Silence icon and message Alarm Silenced For X:XX mins display
in the upper area of the screen.
11. Strip
Press this key to initiate a printout to the selected device.
• If the print destination is the local printer, then pressing this key will produce a print strip
of up to three (3) waveforms. The print length (16 or 32-seconds) can be set in the Print
Setup menu. Pressing this key during a print job will abort the strip printout.
• If the print destination is a remote Central Station, then pressing this key will initiate a
printout at the Central Station.
• If the print destination is a remote printer, then pressing this key will initiate a printout at
the remote printer.
12. Cont ECG
Press this key to initiate a continuous ECG 1, 2, or 3 waveform printout from the internal
printer. Press this key again to abort printing. The first three ECG waveforms displayed on the
screen are printed continuously in real-time. If only one or two ECG waveforms are displayed
on the screen, they will be printed.
Passport V Operating Instructions
0070-00-0704-02
1-5
Keys and Front Panel
General Product Description
13. Print Trend
Press this key to initiate printing of the displayed trend. By default, the monitor’s stored trend
information will be printed by the internal printer. Pressing this key during a print job will
abort printing.
• If the print destination is a remote Central Station, then pressing this key will initiate a
trend report at the Central Station.
• If the print destination is a remote printer, then pressing this key will initiate a trend report
at the remote printer.
14. Standby
Press this key to place the Passport V into a STANDBY mode. While in STANDBY mode,
monitoring is discontinued and the alarms are in permanent suspension, interval NIBP
measurements are placed in idle mode, CO2 pump is shut off, and the display shuts down.
The monitor notifies the central station and other monitors. Except for the power on/off switch
and the STANDBY key, all the other hard keys on the front panel are disabled. When in the
STANDBY mode, the message To Begin Monitoring, press Standby. is displayed.
NOTE:
Trend data is not cleared in the STANDBY mode. When the
STANDBY mode is released, NIBP INTERVAL is in IDLE MODE
and requires reactivation via the START key. The CO2 pump
automatically reactivates if the DPM or Microstream® sensor
is in place.
Press the Standby key to exit the STANDBY mode and return to the normal screen. When
exiting from the standby mode to the monitoring mode, the monitor responds as follows:
• Restores parameter measurement: Start arrhythmia relearning. Gas modules recover the
working status before the standby mode. NIBP measurement will not start automatically.
• Restores normal data storage.
• All the alarms are activated.
• The screen becomes the one displayed before the standby mode.
• The function of auxiliary output is restored.
• The functions of input devices (such as the hard keys on the front panel) are activated.
• The monitor notifies the central station and other monitors.
15. Discharge
Press this key to discharge a patient.
16. Mark Event
Press this key to cause a time stamp event marker to be noted in the trend memory.
17. Trends
Press this key repeatedly to toggle through the following screens: Quick Trend, List Trend,
Graphic Trend, and normal screen (or OxyCRG, if the patient size is set to Neonate).
18. Normal Screen
Press this key at any time to return the screen to the normal monitoring mode. All menus are
closed.
1-6
0070-00-0704-02
Passport V Operating Instructions
General Product Description
Keys and Front Panel
19. Navigator Knob
Rotate this knob to highlight the various menus or functions on the display. Press the center of
the knob to select the highlighted item. Selecting the item may open a menu, perform a
function, or select an option.
20. Battery Charging LED
A green LED located above the battery icon indicates that the battery charger is active. The
charger will not always be active when AC power is present. It is dependent on the battery
charge condition. The LED is not an indication of the condition of the batteries or their charge
level. Charged batteries must be installed in the monitor to ensure uninterrupted operation
while switching from AC to battery power.
21. AC Power LED
A green LED located above the AC present icon is used to indicate that the unit is connected
to the AC power.
Passport V Operating Instructions
0070-00-0704-02
1-7
Display
1.4
General Product Description
Display
The display of the Passport V provides menus, waveforms, parameter information, and
messages. The Passport V includes a display setup function that allows customization of
the display. Preferred setup details can be programmed and saved.
The operator of the Passport V should be positioned in front of the monitor at a
comfortable distance to view all displayed waveforms and text.
Main Menus
Message
Area A
2
8
6
1
Waveform
Area
7
Message
Area B
3
4
Parameter
Menus
Numeric
Tiles
5
Status Icon
Area
FIGURE 1-3 Normal Screen Display
1. Waveform Area
The waveform area is used to display windows which contain parameter waveforms. Up to 8
waveforms may be displayed. The top waveform is always set to display the ECG waveform
and cannot be changed. By default, SpO2 (Pleth) waveform will appear as the second
waveform. Respiration will appear as the third waveform. If pressure transducers are
plugged into the P1 and P2 ports, the screen will reformat to display the additional
waveforms. CO2 will display as the fourth waveform; IBP will appear as the fifth and sixth
waveform. The setup can be changed to display any of the available parameters and
waveforms.
1-8
0070-00-0704-02
Passport V Operating Instructions
General Product Description
Display
2. Main Menus
The Main Menus of the Passport V are always displayed in the upper area of the screen
and are accessed using the Navigator Knob. The Main Menu headings are Patient,
Monitor Setup, Print Setup, Parameters, and Functions. These menus enable the
user to enter patient specific data, customize the monitor, setup printing or transfer patient
data.
The Functions Menu provides the following choices: Normal Screen, Remote View,
Drug Calculator, Copy Patient Data to Storage Device, Copy Patient Data
from Storage Device, and System Information.
The Normal Screen selection returns the view to the normal screen.
There are two options for data transfer. Copy patient data to Storage Device and
Copy patient data from Storage Device options allow for the transfer of patient
specific data from monitor to monitor.
3. Parameter Menus
The Parameter Menus enable the user to review and customize various parameter display
and alarm attributes. Use the Navigator Knob to access these menus. Parameters supported
include: ECG, ST, ART, CVP, SpO2, NIBP, Resp, CO2 (optional), and Gas (optional).
4. Numeric Tiles
The numeric tiles display digital data for each available parameter.
5. Status Icon Area
Battery Status Icon:
When batteries are installed and the monitor is functioning on battery power, the battery
indicator provides a visual reference for the approximate charge level of the batteries. See
the following examples.
Full Battery
Low Battery
No Battery Present
When the battery charge is low, but not below the cutoff voltage, a flashing low battery icon
is displayed and a special low battery sound is activated.
WARNING: To ensure that alarms can sound if the Gas Module/Passport
V loses power, at least one charged battery must be
installed in the Passport V at all times.
NOTE:
Passport V Operating Instructions
At least 15 minutes is available to turn off the monitor or
insert a new battery after the low battery alarm occurs.
0070-00-0704-02
1-9
Display
General Product Description
CS Status Icon:
If displayed, the CS status icon indicates that the CS1 port is connected to another device.
CS1 Port Connection
Wireless Status Icon:
If displayed, the wireless status icon indicates that the 2.4 GHz radio is activated.
2.4 GHz Radio Activated
If displayed, the wireless status icon indicates that wireless enabled and NOT
communicating.
Wireless Enabled
NOTE:
It applies to Version 01.04.00 and higher.
SB Status Icon:
If displayed, the SB status icon indicates that a storage device has been connected to the
SB port.
SB Storage Device Connection
6. Message Area A
This message area is located above the ECG waveform window. Messages regarding the
ECG/heart rate, alarm status, physiological alarms, and technical alarms are displayed
here.
• Physiological alarms are located on the left side.
• Technical alarms are located on the right side.
• ECG prompts are located at the top of waveform 1.
7. Message Area B
This message area is located below the last row of numeric tiles. Messages regarding NIBP,
IBP, printer status, system status, SpO2, CO2, and Gas Module are displayed here.
8. Alarm Status Icon Area
This area displays an Alarm Off icon if any alarm for a monitored parameter has been set to
Off. This area will display an Alarm Silence icon if an alarm has been silenced.
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0070-00-0704-02
Passport V Operating Instructions
General Product Description
Physical Views
1.5
Physical Views
1.5.1
Front View
4
2
3
1
FIGURE 1-4 Front Panel
1. Front Panel Hard Keys
Provides access to most main functions.
2. Navigator Knob
Rotates clockwise and counter-clockwise to navigate through menu selections.
It also can be pressed to select a highlighted item.
3. Display
Displays all waveforms and numeric data.
4. Alarm Light
Indicates that an alarm has been activated.Alarm Light (not shown). The WARNING (or
Priority 1) LED is red. The CAUTION (or Priority 2) LED is yellow.
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1 - 11
Physical Views
1.5.2
General Product Description
Rear View
1
MP1
SB1
SB2
RD1
CS1
SP1
SP2
4
2
3
FIGURE 1-5 Rear Panel
1. Soft Grip Handle
Provides a secure method to carry the monitor.
2. AC Receptacle (with an integrated cord retension clip)
Provides an inlet for an AC power cord.
3. Equipotential Lug
Provides equipotential grounding of hospital equipment.
4. Main I/O Connector Ports
Area dedicated for the use of an optional communication port.
• MP1: Allows connectivity to one of the following: Nurse Call or Defibrillator.
• SB1, SB2: Allows copying and transferring of patient data and user settings.
• RD1: Allows duplicate display of the main display on an SVGA-compatible monitor.
• CS1: Allows connectivity via an RJ45-based network.
• SP1, SP2: Allows connectivity to Gas Module 3 and DIAP.
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Passport V Operating Instructions
General Product Description
1.5.3
Physical Views
Left Side Panel
1
8
2
3
4
9
6
5
7
FIGURE 1-6 Left Side Panel
1. P1 Connector (optional)
2. P2 Connector (optional)
3. T1 Connector
4. ECG/EKG Connector
5. SpO2 Connector (Masimo or Nellcor shown in figure)
6. NIBP Rectus Connector
7. Battery Compartment
8. CO2 Input (Optional DPM CO2 shown in figure)
9. CO2 Exhaust Connector
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Physical Views
1.5.4
General Product Description
Right Side Panel
1
2
FIGURE 1-7 Right Side Panel
1. Power Switch
A momentary switch that turns power ON or OFF but does not prevent charging of the
batteries. Press the top of the switch once to turn the unit ON. Press the top of the switch
again to turn the unit OFF.
2. Local Printer (optional)
A thermal strip chart local printer with integral paper spool.
1 - 14
0070-00-0704-02
Passport V Operating Instructions
General Product Description
1.5.5
Physical Views
Top View
1
FIGURE 1-8 Top View
1. Soft Grip Module Handle
This integrated grip handle is used for carrying the Passport V.
WARNING: Do not carry the Passport V using the integrated grip handle
if the unit is mounted to another item (e.g., a rolling stand
or Gas Module 3).
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Physical Views
General Product Description
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Passport V Operating Instructions
2.0
System Configuration
2.1
Installation Menu
The Installation Menu allows the user to change and save default configuration settings for
the Passport V, such as date format, time format, and temperature units. All the hard keys
are disabled (except the Navigator Knob) in Installation Mode.
FIGURE 2-1 Installation Menu
Passport V Operating Instructions
0070-00-0704-02
2-1
Installation Menu
System Configuration
To access the Installation Menu:
1. Turn off the Passport V.
2. Press and hold the Discharge key on the front panel.
Simultaneously, power up the Passport V monitor.
3. Release the Discharge key when the Installation Menu is displayed.
4. Set each item as necessary using the Navigator Knob.
5. To save all of the chosen settings, choose “Save Current” before leaving this menu.
6. To return to normal operating mode, cycle power to the Passport V monitor.
The following table describes the Installation Menu structure:
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Save Current
2-2
COMMENTS
Select to save current
settings as defaults.
Select Language
ENGLISH
FRENCH
GERMAN
ITALIAN
SPANISH
PORTUGUESE
RUSSIAN
DUTCH
Set up at factory
Select to change language.
Date Format
Y/M/D
M/D/Y
D/M/Y
M/D/Y
Select to change date
format.
Time Format
12 hour
24 hour
12 hour
Select to change time
format.
NIBP Timeout
15
30
45
60
15 min
Select to change NIBP time
out.
Temperature Units
°F
°C
°F
Select to change
temperature units.
Changing temperature
units will cause temperature
alarm limits to be restored
to default values.
Weight Units
lbs
kg
lbs
Select to change weight
units.
Height Units
inches
cm
inches
Select to change height
units.
CO2 Units
mmHg
%
kPa
mmHg
Select to change CO2
units. Changing CO2 units
will cause CO2 alarm limits
to be restored to default
values.
ECG Standard
AHA
IEC
AHA
Select to change standard
for ECG.
min
min
min
min
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Passport V Operating Instructions
System Configuration
Installation Menu
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
COMMENTS
Notch Filter
50 Hz
60 Hz
Off
60 Hz
Select to change notch filter
for ECG.
ESU Filter
Auto
Disable
Auto
Select to change the ESU
filter.
SpO2 Sensor Off
Audio
Off
Once
Repeat
Off
Select to change the SpO2
Sensor Off Audio alert
type.
SpO2 Tones
Standard Tones
Alternate Tones
Standard Tones
Select to change the SpO2
tones.
Enable Arrhythmia All
Off Selection
Yes
No
No
Select to enable or disable
the Arrhythmia All Off
menu selection.
Apnea Latch
On
Off
On
Select to turn apnea alarm
latching on or off.
Enable Silence All
Permanent Selection
Yes
No
No
Select to enable or disable
the Permanent Audio Off
menu selection.
Auxiliary Output
Nurse call
Analog Output
Defib Sync
Nurse Call
Select to change the
function of the Auxiliary
Output interface.
Nurse Call Mode
Normally Open
Normally Close
Normally Open
Select to change the type
of Nurse Call system
Set up Serial Port 1
None
DIAP
Gas Module
None
Select to set up comm port.
Set up Serial Port 2
None
DIAP
Gas Module
None
Select to set up comm port.
Copy Monitor Defaults
to Storage Device
Select to copy monitor
defaults to Storage Device.
Copy Monitor Defaults
from Storage Device
Select to copy monitor
defaults from Storage
Device.
Re-boot in demo mode
No
Yes
No
Set to “YES” to start the
monitor in demonstration
mode on next power-up.
Normal monitoring will
resume after cycling power
in demonstration mode.
Restore factory
defaults
Select to restore factory
defaults
Advanced Installation
Setup
Select to access Advanced
Installation Setup Menu.
Change Password
Select to change
password.
Options
Select to add/view
options.
Passport V Operating Instructions
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2-3
Advanced Installation Setup Menu (Network)
2.2
System Configuration
Advanced Installation Setup Menu (Network)
Use the Advanced Installation Setup Menu for network configuration of the Passport V.
FIGURE 2-2 Advanced Installation Setup Menu
To access the Advanced Installation Setup Menu:
1. Turn off the Passport V.
2. Press and hold the Discharge key on the front panel.
Simultaneously, power up the Passport V monitor.
3. Release the Discharge key when the Installation Menu is displayed.
4. Rotate the Navigator Knob to navigate and select the Advanced Installation Setup
Menu.
5. Set each item as necessary using the Navigator Knob.
6. To save all of the chosen settings, select Previous Menu
〉 Save Current.
7. To return to normal operating mode, cycle power to the Passport V monitor.
The following table describes the Advanced Installation Setup Menu structure:
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Passport V Operating Instructions
System Configuration
Advanced Installation Setup Menu (Network)
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Previous Menu
COMMENTS
Select to return to previous
menu.
DIAP Baud Rate
9600
19200
9600
Select to change DIAP
protocol baud rate.
Enable Network
Wired
Wireless
Wired
Select to change the type
of communications with
Panorama.
Wireless is always
displayed as an option, but
will function only if the
wireless option is installed.
Connect To Central
Station
Yes
No
No
Select No to disable
communication with the
Central Station.
Select Yes to enable
communication with the
Central Station. If
communication has failed,
the message “No
Arrhythmia Detection at
Central” is displayed.
IP Address
7.6.6.50
Select to set up the IP
address.
Subnet Mask ID
255.255.255.0
Select to set up subnet
mask ID.
Configure Wireless AP
Press to enable or disable
the operation of
configuring wireless AP.
Search Printer
Select to search for printers
on the network.
Select Printer
Select to change the target
printer already found.
Paper Size
Select to change the printer
paper size.
Device ID
Set at the factory. Not userselectable.
Passport V Operating Instructions
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2-5
Monitor Setup Menu
2.3
System Configuration
Monitor Setup Menu
Select the Monitor Setup Menu to configure audio and display settings.
FIGURE 2-3 Monitor Setup Menu
To access the Monitor Setup Menu:
1. Power up the Passport V. The normal screen is displayed.
2. Rotate the Navigator Knob to Monitor Setup. Press the knob to select it.
3. Configure the settings as desired.
4. To exit, press the Normal Screen key on the front panel.
The following table describes the Monitor Setup Menu selections:
MENU TITLE
ON SCREEN
2-6
MENU CHOICES
DEFAULT
COMMENTS
Normal Screen
Select to return to Normal Screen (or
press the Normal Screen key on the
front panel).
Display Setup
Select to make changes to the display
format. Save as defaults if desired.
Alarm Volume
low to high volume
Mid-level
Select to change alarm volume.
Beep Volume
silence to high volume
Mid-level
Select to change systole beep volume.
Color
Select to access Color Setup Menu.
Advanced Setup
Select to access Advanced Setup
Menu.
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Passport V Operating Instructions
System Configuration
2.4
Advanced Setup
Advanced Setup
Select the Advanced Setup to configure date, time and other settings.
FIGURE 2-4 Advanced Setup
To access the Advanced Setup:
1. Power up the Passport V. The normal screen is displayed.
2. Rotate the Navigator Knob to Monitor Setup
select it.
〉 Advanced Setup. Press the knob to
3. Configure the settings as desired.
4. To exit, press the Normal Screen key on the front panel.
The following table describes the Advanced Setup selections:
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
COMMENTS
Previous Menu
Select to return to the
previous menu.
Set Date
Select to set date.
Set Time
Select to set time.
NIBP Start Mode
Passport V Operating Instructions
Interval Mode
Timer Mode
0070-00-0704-02
Interval Mode
Select Interval mode to
synchronize NIBP Start
with the integral clock.
Select Timer Mode fo
synchronize the NIBP start
with the interval selected in
relation to the real time
clock.
2-7
Advanced Setup
System Configuration
MENU TITLE
ON SCREEN
Nurse Call
2.4.1
MENU CHOICES
DEFAULT
COMMENTS
Off
1 second
Continuous
Off
Select to choose nurse call
activation time.
Arrhythmia Menu
Select to open the
Arrhythmia Menu.
Restore User Defaults
Select to load user defaults
as current settings.
Save Current
Select to save current
settings as defaults. Enter
password.
How to Set the Clock / Date and Time
The date and time are set in the Monitor Setup Menu
〉 Advanced Setup
1. Using the Navigator Knob, highlight Monitor Setup. Press the Navigator Knob to
open the menu.
2. Use the Navigator Knob to select Advanced Setup, then select either Set Date or
Set Time.
3. Turn the Navigator Knob to select a new setting. Once the desired choice is highlighted,
press the Navigator Knob.
4. This setting is saved when Yes is selected via the confirmation prompt.
2.4.2
Transferring Monitor Default Settings
When installing several Passport V monitors with identical display and alarm settings it is
not necessary to set each unit separately. A DPM storage device may be used to copy the
settings from monitor to monitor.
NOTE:
CAUTION:
Use only storage devices supplied by Mindray.
Do not unplug the storage device from any of the SB ports
on the Passport V while transferring data, as indicated on
the menu or prompt areas of the monitor. Data may be lost
or corrupted and the storage device may become damaged.
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Passport V Operating Instructions
System Configuration
2.5
Configuration Management
Configuration Management
If the monitor is inadvertently powered down (due to power failure or battery depletion),
monitor settings are recovered as follows:
• If the monitor is restarted within 60 seconds, the latest user-settings will be restored.
• If the monitor is restarted after 60 but before 120 seconds, the settings restored may be
either the latest user-settings or the user-saved settings.
• If the monitor is restarted after 120 seconds, the user-saved configurations will be
restored.
Passport V Operating Instructions
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2-9
Configuration Management
System Configuration
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Passport V Operating Instructions
3.0
Patient Management
3.1
Description
The Passport V comes with default factory settings which enable you to begin monitoring
without setting any of the waveforms, parameters, alarms, or functions. However, all of these
settings can be changed for specific patient or departmental needs.
Certain operating characteristics are based on the selected patient size (e.g. NIBP start
pressure). The patient size selection should be matched to the actual patient before
monitoring begins.
Passport V Operating Instructions
0070-00-0704-02
3-1
Setting-up Patients
3.2
Patient Management
Setting-up Patients
1. Turn the monitor on using the ON/OFF switch. Ensure the previous patient’s data has
been removed from the monitor by discharging previous patient.
2. Connect the patient to the monitor, apply appropriate accessories such as ECG
electrodes, blood pressure cuff, etc.
3. Enter patient information into the Passport V via the Patient Menu, check patient
size.
4. If desired, press the START key to initiate a non-invasive blood pressure measurement.
3.2.1
Patient Menu
To display the Patient Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Patient by rotating the Navigator Knob.
3. Use the Navigator Knob to enter patient information. Monitor settings are stored for
each patient size.
NOTE:
Verify monitoring settings when the patient size is changed.
FIGURE 3-1 Patient Menu
3-2
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Passport V Operating Instructions
Patient Management
Setting-up Patients
Patient Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to Normal Screen (or press the
Normal Screen key on the front panel).
Patient Size
Adult (default)
Pediatric
Neonate
Note: When changing Patient Size, some patient
info may need to be re-entered.
Gender
Unspecified (default)
Male
Female
Select to enter or change patient gender.
Date of Birth
Unspecified (default)
Select to enter or change date of birth.
First Name
Select to enter or change patient’s first name.
Last Name
Select to enter or change patient’s last name.
ID #
Select to enter or change Patient ID.
Bed #
Select to enter or change patient bed number.
Height
Unspecified (default)
Select to enter or change patient height.
Weight
Unspecified (default)
Select to enter or change patient weight.
Drug Calculator
Select to open Drug Calculation Menu.
Discharge
Select to discharge patient from monitor.
Entering a Patient’s First / Last Name, ID Number and Bed Number
To enter the patient’s First Name, Last Name, ID Number and Bed Number
complete the following steps:
1. Open the Patient Menu and scroll down through the menu using the Navigator
Knob.
2. Select the patient data you wish to enter or change.
3. Press the Navigator Knob and a keypad will appear on the screen.
4. To enter patient information highlight the appropriate characters.
5. When finished entering the data select Done and press the Navigator Knob to close
the keypad.
6. The patient information will appear in the upper right hand corner of the display. This
data will also appear on printouts.
NOTE:
Passport V Operating Instructions
Since Remote View requires selecting a “Bed #”, a unique
number for each bed should be used. The following
standard format for this demographic is recommended:
0070-00-0704-02
3-3
Discharging a Patient
Patient Management
• Start the Bed # with a room number that has a fixed number of digits. For example,
if the maximum number of digits that is used in numbering the rooms is 4, then for
room 102, a leading zero would be added to get the 4th digit - 0102.
• Follow the room number with a letter to identify the particular bed within the room.
For example, a room with 2 beds would have bed A and bed B.
• An example of a complete “Bed #”: Bed B in room 513 (in a facility where there
are up to 4 digits in a room number) would be identified as 0513B.
Entering a Patient’s Date of Birth
To enter the patient’s Date of Birth complete the following steps:
1. Open the Patient Menu and scroll down through the menu using the Navigator
Knob.
2. Select Date of Birth from the menu. Press the Navigator Knob and a pop-up
window will emerge with day, month and year choices for Date of Birth.
3. To enter the patient’s Date of Birth, turn the Navigator Knob and scroll until you
reach the desired dates.
4. When finished with the Date of Birth, press the Navigator Knob to return to the
Patient Menu.
3.3
Discharging a Patient
To discharge a patient from the Passport V:
1. On the front panel:
Press the Discharge key
or
On the normal screen:
Select Patient 〉 Discharge
Discharging a patient from the Passport V clears the following:
• Patient information (except Patient Size and Bed No.)
• Physiological alarms and technical alarms
• Prompt messages irrelevent with the patient management
• Corresponding history data (includes Trend data, Events, OxyCRG Trend data, Dose
calculations)
• Operations in process (includes local printing and NIBP measurement)
3-4
0070-00-0704-02
Passport V Operating Instructions
Patient Management
Data Transfer
3.4
Data Transfer
3.4.1
Transferring User Configuration
Patient configuration and data can be transferred to and from the Passport V via a DPM
storage device inserted into the SB1 or SB2 port, located in the back of the unit. The
maximum time of data download or upload is about 1 min.
The transferred patient data includes the following:
• Patient demographics (not including Bed No.)
• Trend & Event Data
NOTE:
Newly generated trend or event data, or on-going changed
patient demographics may not be transferred during the
downloading process.
CAUTION:
Do not unplug the storage device from any of the SB ports
on the Passport V while transferring data, as indicated on
the menu or prompt areas of the monitor. Data may be lost
or corrupted and the storage device may become damaged.
Passport V Operating Instructions
0070-00-0704-02
3-5
Remote View
3.5
Patient Management
Remote View
The Remote View selection enables the user to view the numeric and waveform data of
another patient monitored by a different Passport V at a remote location.
To display Remote View:
On the normal screen:
Select Functions
〉 Remote View.
The Remote View feature allows the simultaneous display of data from two patients on a
single monitor. The monitor at the user’s current location is defined as the host monitor. While
maintaining visibility of the primary patient at the host monitor, the Remote View Menu
enables the user to view the numeric data and two selectable waveforms of another patient
who is being monitored at a remote location. The monitor at the remote location is defined as
the remote monitor. Visual and audio alarms occurring at the remote monitor are also
received through the Remote View Menu at the host monitor
.
FIGURE 3-2 Remote View Menu on Main Display
The “Enable Network” option in Installation Menu
〉 Advanced Installation Setup
Menu must be set to “Wired” or “Wireless” for Remote View capability to be available.
Only Passport V monitors on an approved hardwired or wireless network can be viewed
remotely.
NOTE:
3-6
Unstable wireless signals may be caused by the monitor
operating beyond the network coverage, interference from
nearby equipment, or by exceeding network capacity limit.
0070-00-0704-02
Passport V Operating Instructions
Patient Management
Remote View
NOTE:
Remote View function is not available between wireless
monitors, nor for wireless monitors to view wired monitors.
Remote View function is available between wired monitors,
or for wired monitors to view wireless monitors.
All Remote View controls are contained within the Remote View Menu. Opening other
menus from the monitor’s keypad, or pressing the Normal Screen key, will close the
Remote View Menu.
The Remote View Menu displays data as follows:
• The waveforms that are displayed are user-selectable through the Remote View
Setup Menu, as described in the table on page 3-8. Corresponding numeric tiles
are displayed to the right of the waveforms. The numeric data for a maximum of fifteen
(15) parameters that are not related to the waveforms is displayed in the “Numeric
Data Area” located directly below the waveforms.
• The colors of the waveforms and all numeric data correspond to the settings of the host
monitor (not the remote monitor).
• When numeric data for a particular parameter is unavailable, dashes (– – –) are
displayed.
• If a high or low alarm limit has not been set, an Alarm Off icon is displayed.
• Remote View alarms follow the alarm settings at the remote monitor, displaying in a
priority-appropriate, reverse-video color.
• If the remote monitor is placed into Standby mode, the message “In Standby” is
displayed in the Remote View Window.
NOTE:
Respiration alarm text messages are also displayed in the
displayed in the message area (upper part) of the Remote
View Menu window as follows:
• If Apnea is detected, the message “APNEA” is displayed.
• If CVA is detected, the message “CVA” is displayed.
• If high impedance is detected from the ECG electrodes, the
message “CHK LEAD” is displayed.
The Remote View Menu also provides the following menu choices: Normal Screen,
Select Beds, Setup, Remote Silence, Remote Silence All, and Remote Print.
1. Normal Screen — this selection removes the Remote View Menu from the display.
2. Select Beds — this selection opens the Select Beds menu from which beds may be
selected to be included in the care group. All networked beds will be in que but only 8
can be selected.
Passport V Operating Instructions
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3-7
Remote View
Patient Management
3. Setup — this selection opens the Remote View Setup Menu shown in FIGURE 3-3.
This menu enables the user to configure the display and functionality of the Remote
View Menu.
FIGURE 3-3 Remote View Setup Menu
The following table provides a listing of the Remote View Setup Menu items:
Remote View Setup Menu
MENU ITEM
SELECTIONS
COMMENTS
Waveform 1
All waveforms available
on the remote monitor.
Only waveforms available on the remote monitor
will be listed as selections for this menu item. The
menu selections for Wave 1 will not include the
waveform that is currently selected as Wave 2.
Waveform 2
All waveforms available
on the remote monitor.
Only waveforms available on the remote monitor
will be listed as selections for this menu item. The
menu selections for Wave 2 will not include the
waveform that is currently selected as Wave 1.
Remote Silence For
1 min
2 min (default)
3 min*
5 min*
10 min*
Select to choose duration of Remote Silence.
Remote Silence
All For
Permanent*
1 min
2 min (default)
3 min*
5 min*
10 min*
Select to choose duration of Remote Silence All.
Previous Menu
*
3-8
Select to return to previous menu.
These selections will not be available if the language chosen in the Installation Menu is French.
0070-00-0704-02
Passport V Operating Instructions
Patient Management
Remote View
4. Remote Silence / Remote Silence All — this selection silences the audio portion of
a remote alarm for the duration that is selected from the Remote Silence For /
Remote Silence All For list in the Remote View Setup Menu. The factory default
is 2 minutes. While the audio alarm is silenced:
• The visual alarm indicators remain displayed.
• The message ALARMS SILENCED FOR X:XX mins is displayed in the message
area of the Remote View Menu. The X:XX in the message is a digital timer for the
silence time remaining.
• If a new remote alarm occurs during this time, the current alarm will remain silenced
while its digital timer continues to count down, and the new alarm tone will sound.
• An Alarm Silence icon is displayed in the top left of the Remote View window.
• If Remote Silence is selected again, the digital timer is reset.
NOTE:
The Remote Silence selection silences only the alarms
indicated in the Remote View Menu. It does not silence the
primary patient's alarms or alarm sounds at the remote
location.
5. Remote Print – Select to request a remote print.
6. Remote Silence All — this selection silences the audio alarm tones of all remote
alarms for the duration that is selected from the Remote Silence All For list in the
Remote View Setup Menu. The factory default is 2 minutes. While the audio alarms
are silenced:
• the visual alarm indicators remain displayed
• the message All Alarms Silenced For X:XX mins is displayed in the message
area of the Remote View Menu. The X:XX in the message is a digital timer for the
silence time remaining
NOTE:
If “Permanent” is selected from the Remote Silence All For
list, “All Alarms Silenced Permanently” is displayed in the
message area of the Remote View Menu.
• an Alarm Silence icon (a crossed bell) is displayed in the numeric tiles and in the
“Numeric Data Area”
If Remote Silence All is selected again, the audio alarm tones are re-enabled.
NOTE:
The Remote Silence All selection silences only the alarms
indicated in the Remote View Menu. It does not silence the
primary patient's alarms or alarm sounds at the remote
location.
7. Remote Print — this selection sends a print request to the remote monitor. The printout
will be as configured in the Print Setup menu of the remote monitor.
NOTE:
Passport V Operating Instructions
When a Remote Print is requested, there is no indication that
the printout was completed as requested. The user should
verify the successful print at the printer.
0070-00-0704-02
3-9
Remote View
Patient Management
Remote View Message Area
• If more than one message is being received, they are alternately displayed.
• All arrhythmia alarms, priority one alarms, and priority two alarms generate the
appropriate audio alerts at the host monitor, and the associated alarm text messages
are displayed in the Remote View Message Area. See section 4.7 (pg. 4-25)
"Arrhythmia Alarms (optional)" for the specific arrhythmia alarm text messages that
can be displayed.
NOTE:
The Lethal Arrhythmia alarms (V-Tach, V-Fib, and Asystole)
are latched alarms. They cannot be acknowledged by
selecting "Remote Silence "or "Remote Silence All" in the
"Remote View Menu". If an alarm is acknowledged while a
lethal condition still exists, the audio alert of the alarm will
be silenced for XX minutes, where XX is the number
minutes selected in “Remote View Menu” 〉 “Setup” 〉
“Remote Silence For” or “Remote Silence All For”. However,
the visual alert of the alarm and the alarm message will
continue to remain active in the Remote View Message
Area.
If a new lethal condition occurs while the initial lethal alarm
is silenced, the new lethal alarm will not break through but
not be silenced. If the lethal condition is resolved while the
alarm is silenced, the alarm will be terminated.
• All alarm messages for parameters are displayed in the Message Area of the Remote
View Menu window.
• If Apnea is detected, the message “Apnea” is displayed.
• If CVA is detected, the message “CVA” is displayed.
• Remote View displays Technological Alarm messages and Physiological Alarm
messages.
3 - 10
0070-00-0704-02
Passport V Operating Instructions
Patient Management
3.6
Monitor/Display Troubleshooting
Monitor/Display Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
No trace for a desired
parameter
Improper attachment of
transducer or cable to monitor.
Check transducer / cable
connection.
Faulty transducer or cable.
Try a new transducer or cable.
Mains power switch may not be
on.
Press mains power switch on
side panel.
Unit may not be plugged into an
AC outlet.
Check power cord (Is it plugged
in?)
If used as a portable, battery
pack may be drained.
If battery pack is drained, plug
into an AC outlet to recharge the
battery. A period of 5.5 hours
(monitor OFF) or 8.5 hours
(monitor ON) is required for a
full charge of lithium-ion
batteries.
Monitor or display is damaged.
Contact Customer Support.
Disabled Alarm Tone
Silence key pressed.
Check for alarm silence symbol
and message.
Beep volume low.
Increase beep volume.
Cooling Fan Failure
The unit running on AC power
and the cooling fan is not
operational.
Contact Customer Support.
Patient Information did not
appear on display
No data entered.
Enter proper patient data.
Done was not selected from
keypad after entering data.
Go to the proper keypad enter
data, select Done when
finished.
Incorrect Date or Time
Data not entered or entered
incorrectly.
Follow instructions from “How
to Set the Clock / Date and
Time”.
Display Appears to be Off
Passport V Operating Instructions
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Monitor/Display Troubleshooting
Patient Management
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0070-00-0704-02
Passport V Operating Instructions
4.0
ECG Monitoring
4.1
Description
ECG is a continuous waveform of a patient's cardiac electrical activity. An ECG waveform
will display in the first waveform area of the Passport V.
The quality of an ECG signal is directly affected by electrode site skin preparation, electrode
patch quality and ECG lead placement. If artifact is present on the ECG waveform, then the
arrhythmia processing, alarm processing, and quality of the monitoring function may be
affected. The presence of artifact can prevent the monitor from establishing an accurate ECG
reference waveform, increasing the difficulty experienced in assessing the ECG rhythm.
Optimizing the ECG signal is imperative for accurate monitoring. Use high quality
electrodes, designed to acquire the ECG with excellent base line stability, recovery from
defibrillation and minimum artifact from patient movement.
With the Passport V, ECG can be obtained by using a 3- or 5-lead ECG cable in
conjunction with a 3- or 5-lead set and skin electrodes. For best performance and safety,
inspect the ECG cables and electrodes daily.
Features:
• Provides the function of ECG1 cascade display on the normally monitored screen.
• The Passport V supports the Mortara algorithm (V3.2.8).
• Supports 3- and 5-lead configuration and automatic identification of lead configuration.
• The ECG algorithm includes up to three parts: HR calculation, ST analysis (if installed)
and ARR analysis (if installed).
• Displays HR, PVCs and ST segment parameters and ECG waveforms (if installed).
• The ECG waveforms can be displayed normally or in All ECG View (via View key)
when a 5-lead leadset is in use.
• When using a 5-lead cable, 3-lead configuration will be selected automatically if the RL
lead becomes detached from the patient.
Passport V Operating Instructions
0070-00-0704-02
4-1
ECG Screens
ECG Monitoring
4.2
ECG Screens
4.2.1
Numeric Tile: ECG
The ECG numeric tile displays the following:
• ECG label
• HR value, HR unit, HR alarm limits
• PVCs parameter name, PVCs value (not displayed when arrhythmia is OFF or not
installed)
• ST segment value (not displayed when ST segment analysis is OFF and Combine HR/ST
is set to Off or not installed)
• HR source
NOTE:
In Large Numeric Screen, ST values and PVC/min are not
displayed in the ECG numeric tile.
ECG Label
HR Measured Value
High Alarm Limit
Low Alarm Limit
HR Unit
PVCs Measured Value
HR Source
FIGURE 4-1 ECG numeric tile without ST displayed
ECG Label
HR Measured Value
High Alarm Limit
Low Alarm Limit
PVCs Measured Value
HR Unit
ST Unit
HR Source
ST Values
FIGURE 4-2 ECG numeric tile with ST displayed
4-2
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
4.2.2
ECG Screens
Waveform: ECG
The ECG waveform tile displays the following:
• Every ECG waveform area displays ECG lead name, ECG scale, and filter mode.
• A pacer marker is displayed when an external pace pulse is detected.
• ECG Prompt Messages are displayed in the top of ECG1 waveform area:
Message "Pacer Reject On" is displayed in the right top of waveform area.
Other ECG prompt messages are displayed in the middle top of ECG1 waveform area.
FIGURE 4-3 ECG waveform, 3-lead normal monitoring (cascade is turned on)
FIGURE 4-4 ECG waveform, 5-lead normal monitoring (2 channel)
Passport V Operating Instructions
0070-00-0704-02
4-3
ECG Screens
ECG Monitoring
FIGURE 4-5 ECG waveform, 1mV scale overrange
4-4
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
4.3
Front Panel: ECG Keys
Front Panel: ECG Keys
ECG Keys (Front Panel)
KEY
COMMENTS
LEAD
Press to change ECG1 lead selection.
The ECG1 menu selection in ECG Menu has the same function.
In All ECG View, this key is disabled.
SIZE
Press to change ECG1 waveform size.
The ECG1 Size menu option in the ECG Sizes Menu has the same function.
In All ECG View, this key is disabled.
VIEW
Press to display the All ECG View screen. In All ECG View, the order of the
waveforms displayed is I, II, III, aVR, aVL, aVF, V.
Press this key repeatedly to toggle between multi-lead view, large numeric display,
and normal screen.
When returning to Normal Screen from All ECG View, the order of the ECG
waveforms is displayed as configured in the ECG Menu.
Passport V Operating Instructions
0070-00-0704-02
4-5
Menus: ECG Main and Submenus
ECG Monitoring
4.4
Menus: ECG Main and Submenus
4.4.1
ECG Menu
FIGURE 4-6 ECG Menu
To display the ECG Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 ECG
or
Select the ECG tile.
3. To exit, press the Normal Screen key on the front panel.
4-6
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Menus: ECG Main and Submenus
ECG Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to Normal Screen (or press the
Normal Screen key on the front panel).
ECG
ECG
ECG
ECG
ECG
ECG
For 3-lead leadset:
I, II, III
Select to change ECG lead to be analyzed.
1
2
3
4
5
6
For 5-lead leadset:
I, II, III, aVR, aVL,
aVF, V
Defaults:
ECG 1 =
ECG 2 =
ECG 3 =
ECG 4 =
ECG 5 =
ECG 6 =
II
I
V
aVR
aVL
aVF
When a 3-lead configuration is detected, only ECG1
is displayed.
When a 5-lead configuration is detected, ECG1 to
ECG6 can be displayed.
In Normal screen, the ECG lead displayed can be
selected as required.
In All ECG View, the ECG1 to ECG6 options can
be selected as required.
The effect of 3-lead and 5-lead switchover:
5-lead to 3-lead: If ECG1 is I/II/III, then ECG1 is
unchanged. Otherwise, automatically change to II.
3-lead to 5-lead: ECG1to ECG6 are unchanged from
the previous 5-lead setting.
Speed
6.25 mm/s
12.5 mm/s
25 mm/s (default)
50 mm/s
Select to change the trace speed (mm/s) of the ECG
waveform. Applies to all ECG leads.
Arrhythmia Menu
Select to open the Arrhythmia Menu.
Available only if Arrhythmia option is installed.
Disabled if Patient Size = Neonate.
ST Menu
Select to open the ST Menu.
Available only if ST option is installed.
Disabled if Patient Size = Neonate.
Relearn
—
Select to manually initiate the relearning process for
ST Measurements or Arrhythmia Analysis.
Relearn is disabled if at least one of the following:
• Patient Size = Neonate.
• ST Analysis and Arrhythmia = Off.
• ST Analysis and Arrhythmia are not configured.
After relearning is started, arrhythmia relearning and
ST relearning are performed simultaneously. The
arrhythmia and ST analysis templates are recreated
and the message “Relearning...” is displayed. During
relearning, ST and PVCs are displayed as “– – –“.
Arrhythmia relearning should be automatically
started when:
• Lead type is changed.
• ECG lead wires are reconnected to the patient.
• Analysis lead is changed.
• Patient size is changed.
• Arrhythmia analysis is turned on.
• Module is turned on.
• Exiting Standby mode.
Passport V Operating Instructions
0070-00-0704-02
4-7
Menus: ECG Main and Submenus
ECG Monitoring
ECG Menu
MENU ITEM
SELECTIONS
COMMENTS
ECG Sizes Menu
0.125 cm/mV
0.25 cm/mV
0.5 cm/mV
1 cm/mV (default)
2 cm/mV
4 cm/mV
Select to open the ECG Sizes Menu.
Sets the ECG size (waveform gain) for:
• ECG1 only if using 3-lead
• ECG1 to ECG6 if using 5-lead
All ECG waveforms are displayed with 1cm/mV gain
in the All ECG View (via View key).
All ECG waveforms are displayed with the
user-selected gain after exiting the All ECG View.
All ECG waveform gains remain unchanged after
switchover between 3-lead and 5-lead modes.
NOTE: The SIZE key on the front panel is used to
change ECG1 waveform size. The “ECG1 Size”
menu option in the ECG Sizes Menu has the same
function. (In All ECG View, this key is disabled.)
4.4.2
ECG Setup
Select to open the ECG Setup Menu.
See section 4.4.4 (pg. 4-12) "ECG Sizes Menu".
Resp Menu
Select to open the Respiration Menu.
See section 4.4.5 (pg. 4-12) "ECG Setup Menu".
Arrhythmia Menu (optional)
FIGURE 4-7 Arrhythmia Menu
NOTE:
4-8
The Arrhythmia Menu is disabled if Patient Size = Neonate.
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Menus: ECG Main and Submenus
To display the Arrhythmia Menu:
1. On the front panel, press the Alarms: Limits key to display the Alarm Settings
Menu, and select Arrhythmia Menu
or
On the normal screen:
Select Monitor Setup 〉 Advanced Setup 〉 Arrhythmia Menu
or
Select Parameters 〉 ECG 〉 Arrhythmia Menu
or
Select the ECG tile 〉 Arrhythmia Menu.
2. To exit, press the Normal Screen key on the front panel.
Arrhythmia Menu
MENU ITEM
SELECTIONS
COMMENTS
Previous Menu
—
Select to return to previous menu.
Arrhythmia Setup
Asystole
V-Tach
V-Fib
PVC/min
V-Rhythm
Couplet
Run
Bigeminy
Trigeminy
Irregular HR
Brady
Select to set individual arrhythmia alarm
characteristics.
For each arrhythmia selection, choose:
Alarm: On or Off
Priority: 1 or 2
Print: On or Off
Lethal arrhythmias (Asystole, V-Tach, and V-Fib) are
Priority 1 and cannot be changed. The factory default
for all arrhythmia alarms is On.
All On
—
Select to set all arrhythmia alarms to On.
Non-lethals off
—
Select to set all non-lethal arrhythmia alarms to Off.
All Off
—
Select to set all arrhythmia alarms to Off.
“All Off” is displayed only if “Enable Arrhythmia All
Off Selection” = Yes in the Installation Menu.
Relearn
—
Select to manually initiate the relearning process for ST
Measurements or Arrhythmia Analysis.
Disabled if Arrhythmia = Off.
After relearning is started, arrhythmia relearning and
ST relearning are performed simultaneously. The
arrhythmia and ST analysis templates are recreated
and the message “Relearning...” is displayed. During
relearning, ST and PVCs are displayed as “– – –“.
Arrhythmia relearning should be started when:
• Lead type is changed.
• ECG lead wires are reconnected to the patient.
• Analysis lead is changed.
• Patient size is changed.
• Arrhythmia analysis is turned on.
• Module is turned on.
• Exiting Standby mode.
PVC/min
Passport V Operating Instructions
1 to 30
default = 10
Select to change the High PVC/min alarm rate limit.
The PVC/min parameter is displayed when PVC/min
arrhythmia alarm is set to On.
0070-00-0704-02
4-9
Menus: ECG Main and Submenus
ECG Monitoring
Arrhythmia Menu
4.4.3
MENU ITEM
SELECTIONS
COMMENTS
Asystole Delay
3 to 10 seconds
default = 5
Select to change the Asystole Delay Time.
V-Tach Rate
100 to 180 BPM
default = 130
Select to change the V-Tach alarm rate limit.
V-Tach PVC
3 to 15
default = 3
Select to change the required number of PVCs detected
in a continuous sequence before V-Tach is detected and
labeled.
ST Menu
FIGURE 4-8 ST Menu
NOTE:
4 - 10
The ST Menu is disabled if Patient Size = Neonate.
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Menus: ECG Main and Submenus
To display the ST Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 ST Menu
or
Select the ECG tile 〉 ST Menu.
3. To exit, press the Normal Screen key on the front panel.
ST Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to Normal Screen (or press the Normal
Screen key on the front panel).
ST Analysis
On
Off (default)
Select to turn ST analysis on or off.
On: ST analysis is active. ST values are displayed.
Off: ST analysis is inactive. ST values are not displayed.
Note: If Filter is set to Surgery or Monitor when ST
Analysis is set to On, the ST analysis automatically uses
the ST filter without changing the user-selected filter
setting. The user can select Diagnostic Filter setting. If
Filter is set to ST or Diagnostic when ST Analysis is set to
On, the ST analysis uses the Filter setting. The filter
displayed in ECG waveform areas is coincident with
actual filter mode.
Combine ST/HR
On (default)
Off
Select to determine location of ST values. Combine
moves ST to heart rate window.
On: ST values are displayed in the HR numeric tile.
Off: ST values are displayed in the ST numeric tile.
Relearn
—
Select to manually initiate the relearning process for ST
Measurements or Arrhythmia Analysis.
Disabled if ST Analysis = Off.
After relearning is started, arrhythmia relearning and ST
relearning are performed simultaneously. The arrhythmia
and ST analysis templates are recreated and the
message “Learning...” is displayed. During relearning,
ST and PVCs are displayed as “– – –“.
Arrhythmia relearning should be started when:
• Lead type is changed.
• ECG lead wires are reconnected to the patient.
• Analysis lead is changed.
• Patient size is changed.
• Arrhythmia analysis is turned on.
• Module is turned on.
• Exiting Standby mode.
ISO
Passport V Operating Instructions
-200 to -4 msec
Select to adjust isoelectric point.
Adjustable in 8 msec increments.
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4 - 11
Menus: ECG Main and Submenus
ECG Monitoring
ST Menu
4.4.4
MENU ITEM
SELECTIONS
COMMENTS
J/ST
4 to 200 msec
Select to adjust J and ST measurement points.
Adjustable in 8 msec increments.
ST -pt
40 msec
60 msec (default)
80 msec
60/80 msec
Select to adjust distance of ST point to the J point.
ECG Sizes Menu
f
FIGURE 4-9 ECG Sizes Menu
To display the ECG Sizes Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 ECG 〉 ECG Sizes Menu
or
Select the ECG tile 〉 ECG Sizes Menu.
3. To exit, press the Normal Screen key on the front panel.
4.4.5
ECG Setup Menu
FIGURE 4-10 ECG Setup Menu
4 - 12
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Menus: ECG Main and Submenus
To display the ECG Setup Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 ECG 〉 ECG Setup Menu
or
Select the ECG tile 〉 ECG Setup Menu.
3. To exit, press the Normal Screen key on the front panel.
ECG Setup Menu
MENU ITEM
SELECTIONS
COMMENTS
Previous Menu
—
Select to return to previous menu.
Filter
Surgery
Monitor (default)
ST
Diagnostic
Select to change filter mode for ECG. Diagnostic or ST
must be used for ST analysis.
Channel Bandwidth:
Surgery = 1 to 20 Hz
Monitor = 0.5 to 40 Hz
ST= 0.05 to 40 Hz
Diagnostic = 0.05 to 150 Hz
Note: If Filter is set to Surgery or Monitor when ST
Analysis is set to On, the ST analysis automatically uses
the ST filter without changing the user-selected filter
setting. If Filter is set to ST or Diagnostic when ST
Analysis is set to On, the ST analysis uses the Filter
setting. The filter displayed in ECG waveform areas is
coincident with the actual filter mode.
HR Source
Pacer Reject
Auto (default)
ECG
Art
UA
LV
PA
SpO2
Select to change heart rate source.
On
Off (default)
Select to turn pacer reject on (pacer artifact blanked
from display) or off (pacer artifact displayed).
The selections are available if the corresponding
parameters are configured. The selections are in order
of priority from high to low: Auto, ECG, ART, UA, LV,
PA, SpO2.
If Auto is selected, the monitor will switch to the current
highest-priority measuring module, and will display the
actual heart rate source in the numeric tile. If the
module for the selected HR source becomes
unavailable, the monitor will switch to the next
available source.
On: Rejects the pacing pulse, and filters the pacing
pulse from the ECG waveforms. The message "Pacer
Reject On" is displayed on the top right of the ECG1
waveform area.
Off: Pacing pulse is not rejected.
Pacer
Enhancement
On
Off (default)
Select to turn pacer enhancement on or off.
On: If there is pacing pulse, a short, straight vertical
line is used on all ECG waveforms to mark pacing
pulse.
Off: Pacing pulse is not rejected
Passport V Operating Instructions
0070-00-0704-02
4 - 13
Menus: ECG Main and Submenus
ECG Monitoring
ECG Setup Menu
MENU ITEM
SELECTIONS
COMMENTS
ECG Cable
Auto (Default)
3 Lead
5 Lead
Select to change the ECG cable type being used.
ECG Noise Audio
On (Default)
Off
Select to turn ECG Noise audio signal on or off.
On: An audio alarm tone is triggered when ECG
Noise is detected.
ECG Noise Delay
3 to 30 seconds
Default = 5 seconds
Select to change the number of seconds to delay the
ECG Noise Alarm.
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
CAUTION:
To avoid possible damage to the Passport V, and to provide
protection against the effect of the discharge of a cardiac
defibrillator and against burns, use only approved ECG
cables and approved accessories listed in the Accessories
chapter.
CAUTION:
Line Isolation Monitor transients may resemble actual
cardiac waveforms, thus inhibiting heart rate alarms. Check
lead wires for damage and ensure good skin contact prior
to and during use. Always use fresh electrodes and follow
proper skin preparation techniques.
WARNING: This device is not intended for direct cardiac application.
4 - 14
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Preparation and Lead Placement
4.5
Preparation and Lead Placement
4.5.1
Skin Preparation
Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites
should be clean and dry and should provide a smooth flat surface. Incidental electrical
activity and inaccurate readings may arise from incorrect skin preparation.
The following procedure is recommended for secure electrode patch application:
1. Shave the chest hair from the electrode sites in a circular area with a diameter of
2 – 4 inches.
2. Use a dry gauze pad to remove excess skin oils, skin cells and residue from the
electrode sites. Never rub the skin until it is raw or bleeding.
NOTE:
4.5.2
Prepare the electrode site with alcohol only if the skin is
extremely greasy. If alcohol is used as a drying agent,
always allow the skin to dry before placing the electrode
patch on the skin.
Electrode Patch Location
NOTE:
Store electrode patches at room temperature and open just
prior to use.
NOTE:
Avoid more than one type of electrode on a patient because
of variations in electrical resistance.
NOTE:
Avoid placing electrode patches directly over bone
prominences or over any high activity movement areas such
as shoulders or arms because muscle motion produces
electrical activity. If an electrode patch is placed over a large
muscle such as the pectorals, the monitor may detect this
additional muscle activity and could lead to false
arrhythmia calls.
NOTE:
Using a Transcutaneous Electrical Nerve Stimulator (TENS):
Since a TENS unit transmits electrical impulses, avoid placing
ECG electrode patches near the TENS electrodes. ECG
electrode patches may need to be repositioned and the ECG
lead viewed may need to be adjusted until the optimum ECG
tracing is obtained.
1. To prevent evaporation of the contact gel medium, peel the backing off of the electrode
patch only when it is ready for use. Visually inspect the contact gel medium for
moistness. If the gel medium is not moist, do not use the electrode patch. Dry electrode
patches are not conductive.
NOTE:
Passport V Operating Instructions
If using the snap type electrode wires, attach the electrode
patch to the lead wire before placing patch on the patient.
0070-00-0704-02
4 - 15
Preparation and Lead Placement
ECG Monitoring
2. Attach the electrode patch to the skin at the prepared site. Smooth the electrode patch
down in a circular motion to ensure proper skin contact. If using soft gel electrodes,
never push down directly over the contact gel medium as this may displace the gel and
cause monitoring artifact. If using hard gel electrodes, it is recommended that during
application, the center of the electrode should be slightly pressed onto the skin to ensure
direct contact. Consult the electrode patch manufacturer’s instructions for specific use.
3. Secure the lead wires to the patient according to hospital practice. For additional
information see section NOTE:, “It is recommended that electrode patches be changed
at least every 24 – 36 hours to maintain proper contact with the skin. Some patients
may require electrodes to be changed more often. Electrode patches are disposable and
should be applied only once. Try to avoid reusing the exact same electrode site during
reapplication. If an electrode becomes wet with fluid, change the electrode patch.”.
WARNING: Route cables neatly. Ensure cables, hoses and wires are
kept away from patient’s neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.
NOTE:
It is recommended that electrode patches be changed at least every
24 – 36 hours to maintain proper contact with the skin. Some
patients may require electrodes to be changed more often.
Electrode patches are disposable and should be applied only once.
Try to avoid reusing the exact same electrode site during
reapplication. If an electrode becomes wet with fluid, change the
electrode patch.
4.5.3
Lead Placement
4.5.3.1
Description
For lead placement, the computerized arrhythmia algorithm works best when the patient’s R
wave is significantly larger than the P wave or the T wave. If the R wave is not significantly
larger than other lower voltage waves on the ECG tracing, the computer may have some
difficulty in identifying the appropriate waves. On some patients, electrode patch placement
and/or the viewed ECG lead may need to be adjusted in order to obtain a significant R
wave.
4.5.3.2
Setting Lead Naming Standard
This manual presents lead placement according to the guidelines of the American Heart
Association (AHA) and the International Electro-Technical Commission (IEC).
LEAD NAMING STANDARDS
4 - 16
LEAD POSITION
AHA
IEC
CHEST
V
C
LEFT LEG
LL
F
RIGHT LEG
RL
N
LEFT ARM
LA
L
RIGHT ARM
RA
R
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
Preparation and Lead Placement
The Passport V provides two lead naming standards in the Installation Menu: IEC and
AHA.
To set the lead naming standard on the Passport V:
1. Press and hold the Discharge key on the front panel.
Simultaneously, power up the Passport V monitor.
2. Release the Discharge key when the Installation Menu is displayed.
3. Select ECG Standard.
4. Choose AHA or IEC.
5. Cycle power to the Passport V monitor.
4.5.3.3
Lead Placement: Standard 3-wire Lead Sets
A 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3-wire
lead placement is as follows.
White
Black
RA
Red
Yellow
R
LA
L
Green
Red
F
LL
FIGURE 4-11 3-wire Lead Placement
(AHA)
FIGURE 4-12 3-wire Lead Placement
(IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Passport V Operating Instructions
0070-00-0704-02
4 - 17
Preparation and Lead Placement
4.5.3.4
ECG Monitoring
Lead Placement: Standard 5-wire Lead Sets
A 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V)
simultaneously. The recommended 5-wire lead placement is as follows.
Black
White
Yellow
Red
Green
RA
LA
Brown
V Lead
(any V
position)
Black
R
L
V
White
C Lead
(any C
position)
C
Green
RL
LL
N
F
Red
4 - 18
FIGURE 4-13 5-wire Lead Placement
(AHA)
FIGURE 4-14 5-wire Lead Placement
(IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the RL (green) electrode on the
patient’s lower right abdomen within the
rib cage frame.
• Place the N (black) electrode on the
patient’s lower right abdomen within the
rib cage frame.
• Place the V (brown) electrode in one of
the V-lead positions (V1 – V6) depicted
in the following section.
• Place the C (white) electrode in one of
the C-lead (C1 – C6) positions depicted
in the following section.
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Passport V Operating Instructions
ECG Monitoring
4.5.3.5
Preparation and Lead Placement
Lead Placement: Lead II Monitoring
The recommended lead placement for Lead II monitoring is as follows.
White
Black
RA
LA
Red
Yellow
R
L
Red
Green
F
LL
FIGURE 4-15 Lead II Monitoring (AHA)
FIGURE 4-16 Lead II Monitoring (IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead II on the monitor. Lead II is
Select ECG Lead II on the monitor. Lead II is
the direct electrical line between the RA
the direct electrical line between the R (red)
(white) electrode and the LL (red) electrode.
electrode and the F (green) electrode.
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Preparation and Lead Placement
4.5.3.6
ECG Monitoring
Lead Placement: Modified Chest Lead (MCL) Monitoring
The recommended lead placement for MCL monitoring is as follows.
Red
White
Black
Yellow
RA
R
Red
LA
4 - 20
L
LL
Green
F
FIGURE 4-17 MCL Monitoring with a
3-wire Lead Set (AHA)
FIGURE 4-18 MCL Monitoring with a
3-wire Lead Set (IEC)
• Place the RA (white) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode on the
right sternal border, at the fourth
intercostal space within the rib cage
frame.
• Place the L (yellow) electrode on the
right sternal border, at the fourth
intercostal space within the rib cage
frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
Select ECG Lead I for MCL1 monitoring.
Select ECG Lead I for MCL1 monitoring.
Lead I is the direct electrical line between
Lead I is the direct electrical line between
the RA (white) electrode and the LA (black)
the R (red) electrode and the L (yellow)
electrode.
electrode.
Select ECG Lead II for MCL6 monitoring.
Select ECG Lead II for MCL6 monitoring.
Lead II is the direct electrical line between
Lead II is the direct electrical line between
the RA (white) electrode and the LL (red)
the L (red) electrode and the F (green)
electrode.
electrode.
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Passport V Operating Instructions
ECG Monitoring
4.5.3.7
Preparation and Lead Placement
Lead Placement: Neonates
Using a 3-wire lead set, ECG lead placement on a neonate is usually directed towards
obtaining the best possible respiration data through the ECG thoracic impedance technique.
Thoracic impedance is usually measured between the Right Arm and Left Arm electrode
patches. These patches should be placed on the chest directly across from each other to
optimize the measuring of the neonate’s chest movement. The recommended lead placement
for neonate monitoring is as follows.
Black
Yellow
Red
RA
LA
R
L
Green
Red
LL
F
White
FIGURE 4-19 Neonatal 3-wire Lead
Placement (AHA)
FIGURE 4-20 Neonatal 3-wire Lead
Placement (IEC)
• Place the RA (white) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the R (red) electrode under the
patient’s right clavicle, at the midclavicular line within the rib cage frame.
• Place the LA (black) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the L (yellow) electrode under the
patient’s left clavicle, at the midclavicular line within the rib cage frame.
• Place the LL (red) electrode on the
patient’s lower left abdomen within the
rib cage frame.
• Place the F (green) electrode on the
patient’s lower left abdomen within the
rib cage frame.
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Preparation and Lead Placement
4.5.3.8
ECG Monitoring
Lead Placement: Pacemaker Patients
The recommended lead placement for monitoring a pacemaker patient is as follows.
Pacer
White
Pacer
Red
Yellow
Black
Red
FIGURE 4-21 3-wire Lead Placement for a
Pacemaker Patient (AHA)
FIGURE 4-22 3-wire Lead Placement for a
Pacemaker Patient (IEC)
Pacer
White
V
Brown
Green
Green
Red
Pacer
Yellow
Black
V
White
Red
FIGURE 4-23 5-wire Lead Placement for a
Pacemaker Patient (AHA)
Black
Green
FIGURE 4-24 5-wire Lead Placement for a
Pacemaker Patient (IEC)
A pacemaker patient usually requires a different electrode patch placement configuration
than a non-pacemaker patient.
Do not place an ECG electrode directly over the pacemaker generator. Place the electrode
patches 3 – 5 inches away from the pacemaker generator area. For example, if the
pacemaker generator is located in the right subclavian area, relocate the Right Arm
electrode closer in towards the center of the chest.
WARNING: Pacemaker patients’ rate meters may continue to count the
pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter
alarms. Keep pacemaker patients under close surveillance.
See the Appendix section of this manual for disclosure of the
pacemaker pulse rejection capability of this instrument.
CAUTION:
4 - 22
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
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Passport V Operating Instructions
ECG Monitoring
4.6
Arrhythmia Algorithm
Arrhythmia Algorithm
The Passport V uses an arrhythmia algorithm to monitor ECG waveform data. The
algorithm creates ECG waveform templates based on a patient’s normal ECG data and uses
them to analyze newly received data. The algorithm verifies that data is free from noise and
artifact, and that it does not deviate from the patient’s normal ECG rhythms.
A normal ECG waveform typically includes consistent spacing between R waves, a sharp
and well defined QRS complex, and an ECG baseline that is free of noise and artifact.
R
ST Point
J Point
P
ISO Point
ST deviation
(Depression or Elevation)
T
Q
40 to 80 msec
S
ST Segment
FIGURE 4-25 Sample Waveform
4.6.1
Noise and Artifact
The presence of noise or artifact in an ECG waveform makes the accurate detection and
classification of heartbeats difficult. To best optimize performance, all leads should be free of
noise.
Some of the causes of ECG noise include poor skin preparation, improperly attached
electrodes, dried electrode gel, defective lead wires, and patient movement. The algorithm
uses several techniques to differentiate a patient’s QRS complexes from noise sources.
If noise levels are too high for a particular lead, a message is posted, and the data is
dropped from analysis until the signal quality is re-established.
If noise levels are too high, the following will occur until the signal quality is re-established:
• Beat detection is suspended
• All rhythm calls are suspended
• An ECG Noise message is displayed
4.6.2
Heart Rate Average
The heart rate average is computed using the 16 most recent R-R intervals for heart rates
above 48 beats per minute. If the heart rate calculated using the last 4 beats is less than 48
beats per minute, then this rate is used. All detected beats are used to compute the heart rate.
A separate ventricular rate is used in the algorithm to determine rhythms like ventricular
tachycardia and ventricular run.
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Arrhythmia Algorithm
4.6.3
ECG Monitoring
Filtering Pacer Signals
In order to prevent pacer pulses from being mistaken for QRS complexes, they are removed
from the ECG data that is sent to the arrhythmia algorithm for analysis.
4.6.4
ECG Amplitude
The QRS detection threshold algorithm setting is fixed between 0.15 and 0.45 mV to avoid
detecting noise spikes or P-waves as valid beats. Changing the display gain on the monitor does
not affect the signal that is used by the algorithm for beat detection. For optimal performance, the
leads selected for monitoring should have an amplitude of 0.5 to 1 mV or more.
4.6.5
Learning
The process of learning is used to establish a normal beat template for a patient. The learn
period is dependent on the heart rate and the dominant pattern. Learning should not be
initiated during a primarily ventricular rhythm because an ectopic beat may be established
as normal.
A learn should be initiated when beats are not being properly detected, or when they are
being erroneously classified. However, if a signal is not strong enough, or lead data is
extremely noisy, better signal quality must be established before a learn can be effective.
4.6.6
Beat Detection and Typing
The following table describes the leads that are used to measure beat detection and beat
typing.
DESCRIPTION
3-WIRE LEAD SET
5-WIRE LEAD SET
Leads used for Beat Detection
Determined by viewed lead
II and V
Leads used for Beat Typing
Determined by viewed lead
II, V, and I
Leads used for V-Fib Detection
Determined by viewed lead
II and V
The search for the next beat begins after a refractory period to avoid detecting T- waves as
valid QRS complexes. For all patient sizes, the minimum QRS amplitude that can be detected
is between 0.15 and 0.45 mV depending on the width of the QRS complexes.
Beat typing aligns and compares each new heartbeat to reference templates that were
previously stored in the system. A beat typing algorithm classifies the beats.
• If an incoming beat matches a template that has already been classified, it is given the
same label as the template. The template parameters are updated with the features from
this new beat.
The real time ECG analysis library incorporates ventricular ectopic beat detection as a part
of arrhythmia analysis.
• Beats are measured for compensatory pause, QRS width, QRS positive and negative
areas, and R wave positive and negative amplitudes. This process uses multiple leads
when available.
• A scoring algorithm is then applied to those measurements to determine whether or not a
beat is ectopic.
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Passport V Operating Instructions
ECG Monitoring
4.7
Arrhythmia Alarms (optional)
Arrhythmia Alarms (optional)
Arrhythmia alarms are activated based on the patterns in the patient ECG waveform rhythms.
Beat detection for a 5-lead wire set is determined by using a combination of leads II and V.
When using a 3-lead wire set, beat detection is determined by using the lead being viewed.
The lethal and non-lethal arrhythmia alarms in this section may be detected by the arrhythmia
algorithm.
NOTE:
4.7.1
Arrhythmia alarms are not available for the Neonate patient size.
Lethal Arrhythmia Alarms
A lethal arrhythmia is an arrhythmia that can be life threatening to a patient if left untreated.
Ventricular Tachycardia (V-Tach), Ventricular Fibrillation (V-Fib), and Asystole alarms are
classified as lethal arrhythmia alarms. These alarms automatically default to Alarm Priority 1
and cannot be changed.
NOTE:
4.7.1.1
Lethal arrhythmia alarms are latched alarms. Even after the
alarming condition is resolved, a latched alarm will continue
until it is acknowledged by pressing the “Silence” or “Silence
All” key on the front panel keypad. If the alarm is
acknowledged while the lethal condition still exists, the audio
portion of the alarm will be silenced for the duration that is
selected from the “Silence For” list in the “Alarm Setup”
menu, but the alarm message will remain in message area A.
If a new lethal condition occurs while the initial lethal alarm
is silenced, the new lethal alarm will not break through but
not be silenced. If the lethal condition is resolved while the
alarm is silenced, the alarm will be terminated.
Asystole Alarm
An Asystole alarm is activated when no QRS complexes are detected for the configured
time period in the absence of Ventricular Fibrillation.
The time period range for an Asystole alarm is user-selectable from 3 to 10 seconds.
The Asystole alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• An Asystole text message above the ECG1 waveform area.
4.7.1.2
Ventricular-Fibrillation (V-FIB) Alarm
A V-FIB alarm is activated when a fibrillated waveform (P, QRS or T waves can no longer be
identified) is detected. V-FIB is defined as “irregular, disorganized electrical activity of the
heart”. The V-FIB detection algorithm runs in parallel to the beat detection algorithm and
continuously examines the incoming data.
The V-FIB alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A V-FIB text message above the ECG1 waveform area.
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Arrhythmia Alarms (optional)
4.7.1.3
ECG Monitoring
Ventricular Tachycardia (V-TACH) Alarm
A V-TACH alarm is activated as follows:
• The range of the V-TACH rate is between 100 to 180 beats per minute.
AND
• The V-TACH lethal arrhythmia alarm is activated when the configured number of
consecutive PVCs is reached. The range for the V-TACH threshold is 3 – 15 beats per
minute.
A V-TACH alarm is a Priority 1 alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A V-TACH text message above the ECG1 waveform area.
4.7.2
Non-Lethal Arrhythmia Alarms
A Non-Lethal Arrhythmia is an arrhythmia that is most likely not life threatening to a patient.
Bigeminy, Bradycardia, Couplet, Irregular Heart Rate, PVC/min, Run, Trigeminy, and
Ventricular Rhythm (V-Rhythm) alarms are classified as non-lethal arrhythmia alarms. All other
Non-Lethal Arrhythmias default to Alarm Priority 2. The Alarm Priority for non-lethal
Arrhythmia is user-selectable between 1 and 2.
NOTE:
4.7.2.1
Non-lethal arrhythmia alarms are not latched alarms and
can be acknowledged at any time. To acknowledge a nonlethal arrhythmia alarm, press the “Silence” key on the
keypad.
Bigeminy Alarm
The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one
normal beat are detected.
The Bigeminy alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• A BIGEMINY text message above the ECG1 waveform area.
4.7.2.2
Brady (Bradycardia) Alarm
The Brady alarm is activated when the heart rate falls to a value 10% lower than the user
selected value for low heart rate alarm.
The Brady alarm is an alarm event that produces:
• Alarm visual alarm indicator. Since Bradycardia is always accompanied by a low
heart rate alarm, the Priority 1 audio alarm will sound.
• A Brady text message above the ECG1 waveform area.
4.7.2.3
Couplet Alarm
The Couplet alarm is activated when two consecutive PVCs are detected between normal
beats.
The Couplet alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• A COUPLET text message above the ECG1 waveform area.
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Passport V Operating Instructions
ECG Monitoring
4.7.2.4
Arrhythmia Alarms (optional)
Irregular Heart Rate Alarm
The Irregular Heart Rate alarm is activated when the measured variations in the R-R
interval over a period of time exceeds a preset limit established by the arrhythmia algorithm.
The Irregular Heart Rate alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• An IRREGULAR HR text message above the ECG1 waveform area.
4.7.2.5
PVC/minute Alarm
The High PVC alarm is activated when the number of PVCs detected per minute exceeds the
configured threshold. The PVC limit can be set to Off, or 1 to 30 PVCs per minute.
The High PVC alarm is an alarm event that produces :
• Alarm visual and audio alarm indicators.
• A High PVC text message above the ECG1 waveform area.
NOTE:
PVC/min will not be displayed during periods of Ventricular
Rhythms, V-TACH, V-FIB and Asystole.
4.7.2.6
Run Alarm
The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals
or exceeds the user defined V-Tach Rate. The number of consecutive PVCs that constitute a
Run is one beat less than the minimum used to identify V-Tach.
The Run alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• A RUN text message above the ECG1 waveform area.
4.7.2.7
Trigeminy Alarm
The Trigeminy alarm is activated when three or more cycles of one PVC coupled to two
normal beats are detected. This rhythm could also cause an Irregular HR alarm.
The Trigeminy alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• A TRIGEMINY text message above the ECG1 waveform area.
4.7.2.8
Ventricular Rhythm (V-Rhythm) Alarm
The V-Rhythm alarm is activated when more than 2 consecutive PVCs occur at a rate that is
less than the user defined V-Tach Rate.
The V-Rhythm alarm is an alarm event that produces:
• Alarm visual and audio alarm indicators.
• A VENTRICULAR RHYTHM text message above the ECG1 waveform area.
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Arrhythmia Analysis (Optional)
4.8
ECG Monitoring
Arrhythmia Analysis (Optional)
NOTE:
Arrhythmia analysis is available for Adult and Pediatric
patients only.
WARNING: Due to physiologic differences in the patient population, the
Passport V may occasionally not alarm or may sound a
false alarm for some arrhythmia patterns. The arrhythmia
analysis feature is intended to detect ventricular rhythms
only. High-risk patients should be kept under close
surveillance.
The Passport V is capable of identifying ventricular arrhythmia patterns in Adult and
Pediatric size patients. Arrhythmia analysis may be enabled or disabled via the
Arrhythmia Menu. By default, arrhythmia analysis is enabled if the option is installed.
FIGURE 4-26 Arrhythmia Menu
Arrhythmia alarm calls are classified as Priority 1 or Priority 2.
Asystole, Ventricular Tachycardia, and Ventricular Fibrillation are classified as Priority 1
and the priority level cannot be changed by the user. In addition, these alarms will
sound continuously until the user presses the Silence or Silence All key, regardless of
whether the patient’s condition has improved.
The other arrhythmia alarms (listed below) are classified as Priority 2 by default. The
characteristics and priority level of all non-lethal alarms can be changed at the user’s
discretion via the Arrhythmia Setup menu option.
The following alarm calls can be made when Arrhythmia Analysis is set to “All On” (default
setting):
• Asystole, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Run,
PVC/Min, Couplet, Bigeminy, Trigeminy, Irregular HR and Bradycardia.
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Passport V Operating Instructions
ECG Monitoring
Arrhythmia Analysis (Optional)
The following alarm calls will be made when Arrhythmia analysis is set to “Non-lethals Off”:
• Asystole, Ventricular Tachycardia, and Ventricular Fibrillation.
When Arrhythmia analysis is set to “All Off,” no arrhythmia alarm calls will be made.
NOTE:
4.8.1
The “All Off” selection in the “Arrhythmia Menu” is only
available if “Enable Arrhythmia All Off Selection” is set to
“Yes” in the Installation Menu.
Arrhythmia Analysis Setup
ARR TYPE
OPTION
DESCRIPTION
Asystole
Asystole Delay
No QRS complex is detected within the set "Asystole Delay",
which is judged as one Asystole event.
V-Tach
V-Tach Rate
V-Tach PVC
HR is greater than or equal to the set "V-Tach Rate" and the
number of continuous PVCs is greater than or equal to the set
"V-Tach PVC" threshold, which is judged as one V-Tach
event.
Brady
Brady Low
When HR is 10% less than the HR low alarm limit , it is
judged as one Bradycardia event.
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ST Analysis (Optional)
4.9
ECG Monitoring
ST Analysis (Optional)
NOTE:
ST analysis is available for Adult and Pediatric patients only.
R
ST Point
J Point
P
ISO Point
ST deviation
(Depression or Elevation)
T
Q
S
40 to 80 msec
FIGURE 4-27 ST Monitoring
The formula for calculating ST segment offset value is: ST segment offset value = VST-VISO. If
3-lead is detected, analysis provides one ST value from one ECG waveform (ECG1). If 5-lead
is detected, analysis provides all seven ST values.
The depression or elevation of the ST segment is measured as the vertical distance between
the isoelectric (ISO) point which provides the baseline, and the ST point (See figure above).
ST measurements are available on a maximum of three user selected ECG leads at a point
situated 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from
the algorithmically determined end point of the QRS (J Point). In addition, the user can also
select from three (3) different settings for the ST measurement point (80, 60, or 40 ms) from
the J-point and independent of heart rate. These measurements are valid only on normal
beats. Abnormal beats, like ventricular beats, are excluded from the analysis of the ST
segment. Ventricular paced beats are also rejected from the analysis of the ST segment,
because pacemaker tails distort the shape of the ST segment.
ST segment changes are continuously measured by the monitor, but update of the displayed
ST data is different depending on the ECG cable in use. When using a 3 or 5-lead ECG
cable, the displayed ST data is updated approximately every 10 seconds.
NOTE:
4 - 30
The ST algorithm has been tested for accuracy of the ST
segment data. The significance of the ST segment changes
must be determined by a clinician.
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Passport V Operating Instructions
ECG Monitoring
4.9.1
ST Analysis (Optional)
Numeric Tile: ST
The ST numeric tile displays the following:
• ST label
• ST unit
• Lead name and corresponding ST measured value
ST Label
Lead
Unit
Values
FIGURE 4-28 ST numeric tile. ECG1, ECG2, and ECG3 are displayed from top to bottom
with the corresponding ST values. ST values are rounded off to 1 decimal
place.
4.9.2
ST Analysis Setup
ST analysis begins when the feature is turned on from Parameters 〉 ST Menu. By default,
ST data will appear in the Heart Rate Tile, when using a 3-lead or 5-lead leadset.
When using a 3-lead leadset, ST Analysis is performed on the lead chosen as ECG1. With a
5-lead leadset, ST Analysis is performed on all seven leads.
To display ST data in a separate tile, set a waveform to display any ECG wave (i.e., ECG2,
ECG3, etc.), then set Combine ST/HR to OFF.
FIGURE 4-29 ST Menu
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ST Analysis (Optional)
4.9.2.1
ECG Monitoring
Adjusting the ISO and J/ST Point
1. Open the ST Menu by using the Navigator Knob to select the ST parameter heading.
ST Menu can also be accessed through the ECG Menu.
2. Ensure the ST Analysis selection in the ST Menu is On. The Passport V will learn
the patient's QRS complexes (one for a 3-lead leadset or 3 for a 5-lead leadset). These
learned complexes will appear in the ST Menu with the monitor-selected ISO and J/ST
points displayed.
3. Scroll to the ISO selection to adjust the isoelectric point on the learned QRS complex.
The isoelectric point is the area of the QRS complex following the P-wave and before the
start of the Q-wave.
4. Adjust the ISO point by pressing the Navigator Knob and turning to adjust the white
ISO reference line. Press the Navigator Knob when the ISO point is satisfactory.
5. Scroll to the J/ST point heading. Adjust the J/ST point by pressing the Navigator Knob
and turning to adjust the orange and green J/ST reference lines. Press the Navigator
Knob when the J/ST points are satisfactory.
6. To adjust the ST-pt, scroll to the ST-pt heading and press the Navigator Knob to display
a list of ST measurement point settings. Select the appropriate setting, then press the
Navigator Knob when the ST-pt choice is satisfactory.
4.9.2.2
Adjusting ST Measurement Points
ST measurement points refer to ISO point (isoelectric reference point) and ST point. The
Mortara algorithm uses the J+X method to position the ST point, which is located at X position
on the right of J point.
The following table describes the range of ST measurement points and their steps.
POINT
OPTION/RANGE
STEP
ISO
-200 to -4ms
8ms
J/ST
4 to 200ms
8ms
ST-pt
40ms, 60ms, 80ms,
60/80ms
/
ST-pt is set to 60 or 80ms from the J point. When HR is greater than 120 bpm, the distance
between ST point and J point is set at 60ms; when HR is lower or equal to 120 bpm, the
distance between ST point and J point is set at 80ms.
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Passport V Operating Instructions
ECG Monitoring
4.10
Relearning ST or Arrhythmia Analysis
Relearning ST or Arrhythmia Analysis
Automatic Relearning
The Passport V initiates the learning process for ST measurements or Arrhythmia analysis
after one of the following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling ST or Arrhythmia analysis
• The lead has been changed in ECG 1 waveform (3-lead only)
• Patient Size is changed
• Whenever the Relearn function is selected from the ST, ECG or Arrhythmia
Menus
• The monitor switches between 3-lead and 5-lead mode
Manual Relearning
To initiate a manual relearn, select Relearn from the ECG Menu, Arrhythmia Menu, or
ST Menu.
It is recommended to initiate a manual Relearn after one or more of the following:
• The ECG electrodes have been repositioned
• Sufficient time has passed since the last Relearn
• After significant changes to the patient QRS complex
• After significant changes to the patient ECG rhythm
• A clinician has observed clinically questionable arrhythmia calls
A Relearn must be initiated if “Learning” occurred during a “Leads Off” condition.
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ECG Troubleshooting
4.11
ECG Monitoring
ECG Troubleshooting
MESSAGE/PROBLEM
Noisy ECG traces
SOLUTION
Loose or dry electrodes.
Apply fresh, moist electrodes.
Defective electrode wires.
Replace wires as necessary.
Patient cable or leads are
routed too close to other
electrical devices.
Eliminate 50-60 Hz
interference.
Excessive Electro-surgical
Interference
Wrong ECG cable used.
Use ESIS ECG cable with
internal filter block.
NOTE: Respiration monitoring
via the ECG electrodes will not
be available when using the
cable.
Muscle Noise
Inadequate skin preparation
prior to application of
electrode, tremors, tense
subject, and/or poor electrode
placement.
Repeat skin preparation and
electrode location procedures.
Apply fresh, moist electrodes.
Avoid areas of the torso that are
very muscular.
Intermittent Signal
Connections not tight and/or
properly secured.
Ensure proper connection.
(Electrode to lead, lead to
cable, cable to monitor).
Electrodes dry or loose.
Re-prep skin and apply fresh,
moist electrodes.
Cable or lead wires damaged.
Check with continuity tester.
Electrodes dry.
Re-prep skin and apply fresh,
moist electrodes.
Alarm limits set too close to
patient's normal heart rate.
Readjust.
R-wave wrong size.
Must have a higher amplitude
than the other ECG waves, like
the P and T waves.
Excessive patient movement or
muscle tremor.
Reposition electrodes and
secure with tape, if necessary.
Gain set too low.
Readjust as required (Set via the SIZE key).
Electrodes dry / old.
Apply fresh, moist electrodes.
Excessive alarms: heart rate,
lead fault
Low Amplitude ECG Signal
No ECG Waveform
4 - 34
REASON
Skin improperly prepared.
Abrade skin.
This could be the patient’s
normal QRS complex.
Verify with a 12-lead electrocardiogram.
Electrode could be positioned
over a bone or muscle mass.
Move ECG patches closer
towards each other.
Gain set too low.
Readjust as required (Set via the SIZE key).
Lead wires and patient cable
not fully or properly inserted.
Check for proper insertion.
Cable or lead wires damaged.
Check with lead continuity
tester.
0070-00-0704-02
Passport V Operating Instructions
ECG Monitoring
ECG Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Base Line Wander
Patient moving excessively.
Secure lead wires and cable to
patient.
Patient's respiration.
Reposition electrodes.
Electrodes dry or loose.
Re-prep skin and apply fresh,
moist electrodes.
Static build up around patient.
Check with local biomedical
personnel.
ECG Filter set to “ST” or
“Diagnostic” mode.
Set ECG Filter to “Monitor”
mode.
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ECG Troubleshooting
ECG Monitoring
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Passport V Operating Instructions
5.0
Respiration Monitoring
5.1
Description
Intended patient types: Adult, Pediatric, Neonate.
Respirations, or the amount of breaths per minute, are measured by two methods in the
Passport V:
The first method is thoracic impedance through the ECG signal. The respiration signal is
measured between two ECG electrodes:
• RA and LA of ECG Lead I, or
• RA and LL of ECG Lead II
The second is by CO2 exchange via internal CO2 or via the external Gas Module. Section
5.3.1 discusses the monitoring of CO2 with thoracic impedance. Chapter 10.0 discusses the
monitoring of CO2 with Sidestream and Microstream capnography.
Passport V Operating Instructions
0070-00-0704-02
5-1
Resp Screens
Respiration Monitoring
5.2
Resp Screens
5.2.1
Numeric Tile: Resp
The Resp numeric tile displays the following:
• Parameter name: Resp
• Measured value (RR is ” – – –” for CVA or Apnea)
• Respiration Source: ECG
• Alarm limits
• RR unit: RPM
RR Value
Resp Label
Resp Unit
High Alarm Limit
Low Alarm Limit
FIGURE 5-1 Resp Numeric Tile
5.2.2
Waveform: Resp
• The Resp waveform tile displays the following: Resp waveform
• Waveform size
FIGURE 5-2 Resp Waveform Tile
5-2
0070-00-0704-02
Passport V Operating Instructions
Respiration Monitoring
5.3
Resp Menu
Resp Menu
To display the Resp Menu:
On the normal screen:
Select Parameters
〉 Resp
or
Select the ECG tile
〉 Resp Menu
or
Select the Resp tile
FIGURE 5-3 Respiration Menu
Resp Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to Normal Screen (or press the
Normal Screen key on the front panel).
Resp Lead
I
II (default)
Select to change respiration lead for ECG.
When the current Resp Lead drops, the Resp
waveform will be a straight line.
Resp
On (default)
Off
Select to turn respiration on or off.
On: Opens the Resp Module to start respiratory
measurement.
Off: Closes the Resp Module to stop respiratory
measurement. Displays "OFF" in Resp numeric tile.
Passport V Operating Instructions
0070-00-0704-02
5-3
Resp Menu
Respiration Monitoring
Resp Menu
MENU ITEM
SELECTIONS
COMMENTS
Size
1
2
3 (default)
4
5
Select to change respiration size.
3.125 mm/s
6.25 mm/s (default)
12.5 mm/s
25 mm/s
Select to change respiration trace speed.
On (default)
Off
Select to turn respiration apnea alarm on or off.
Speed
Apnea Alarm
After the wave Size is changed, the current wave is
displayed at the selected size.
After the wave speed is changed, the waveform area
is refreshed and the wave sweeps at the selected
speed.
Off: Apnea Alarm will not be activated.
On: Apnea Alarm will be activated when the delay
time is equal to or exceeded.
Note: This setting is only valid for the Resp module.
If Patient Size = Neonate, the Apnea Alarm is always
on and cannot be changed by the user.
5.3.1
Thoracic Impedance
The Passport V monitor presents a small electrical signal across the RA and LA ECG limb
leads. This signal changes as the patient’s chest wall rises and falls during the breath cycle.
The advantage of the thoracic impedance method is that respiration is obtained noninvasively. It is important to use cables with internal resistors for thoracic impedance.
ECG ESIS choke block cables have electrical filters that may be used in electro-cautery
environments where ECG interference can be substantial. These filters remove the electrocautery noise, but also block the signal used by the Passport V monitor to measure
respiration.
The filling and emptying of the heart chambers can interfere with the thoracic impedance
signal, so called cardiovascular artifact (CVA), such that the respiratory signal matches the
heart rate. The Passport V warns the operator when the respiration value equals the heart
rate by displaying “CVA”.
If the patient’s airway is obstructed and the patient attempts to breath, then the chest wall can
move and create a respiratory signal even though no gas flow is occurring in the patient.
CAUTION:
5-4
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
0070-00-0704-02
Passport V Operating Instructions
Respiration Monitoring
5.4
Respiration and CO2 Troubleshooting
Respiration and CO2 Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Resp. Waveform Too Large
Scales set inappropriately.
Change lead selection.
Change Respiration scale.
Resp. Waveform Too Small
Patient breathing is shallow
Change lead selection.
or patient is turned on side.
Scale set inappropriately.
Change respiration scale.
Apnea delay may be
Choose another apnea
improperly set.
delay
Patient may be having
Reposition electrodes to
frequent episodes of CVA.
better detect respirations.
Scale size may be too low.
Change Respiration scale
No Resp. Waveform or
Respiration turned Off.
Turn respiration On
Rate Displayed
(Off will be displayed in
False Apnea Alarm
Resp. tile).
Patient connected using
Check that proper patient
ESIS choke cable.
cable is used. Use approved
non-ESIS patient cable.
“CHK Lead” Message
Cable not connected.
Check cable.
CO2 not selected in
Set CO2 in Display Setup
Display Setup Menu.
Menu.
Increased impedance
caused by one of the
following:
Chest hair under
Prep chest.
electrodes.
Dried electrode gel.
Change electrodes.
Electrode off.
Replace electrode.
Lead off.
Replace lead.
Cracked lead wires.
Replace lead wires.
Poor skin prep.
Clean and abrade skin
before applying electrodes.
“CVA” Message
Can be caused by shallow
Check the patient.
breathing or an apnea
event.
Passport V Operating Instructions
Patient HR and respiratory
Adjust scales or leads if
rate identical.
necessary.
0070-00-0704-02
5-5
Respiration and CO2 Troubleshooting
5-6
Respiration Monitoring
MESSAGE/PROBLEM
REASON
SOLUTION
Resp Disturbed
Patient Movement
External Interference.
Check patient
For impedance - Check
Electrode Contacts / reposition
electrodes/cable
Check environment for source
of interference.
Resp Rate Overrange
Respiration Outside of
measureable range
Check patient.
Resp: Initialization Error
During the Resp module poweron,as the Resp module
communication stops,system
fails to communicate with
module.
Contact Technical Support.
Resp: Communication Error
System can't communicate
correctly with Resp module,and
receive the error data packets.
Restart the monitor.If the error
still appears,please contact
Technical Support.
Resp: Communication Stop
As the Resp module
communication stops, the data
packets sent by the module
can not be received.
Contact Technical Support.
Resp: High Impedance
Connections not tight and/or
properly secured.
Electrodes dry or loose.
Cable or lead wires damaged.
Ensure proper connection.
(Electrode to lead, lead to
cable, cable to monitor).
Re-prep skin and apply fresh,
moist electrodes.
Check with continuity tester
0070-00-0704-02
Passport V Operating Instructions
6.0
SpO2 Monitoring
6.1
Description
The Passport V supports the following SpO2 modules:
• Masimo SpO2 Module
• DPM SpO2 module
• Nellcor SpO2 module
SpO2 measurement provides two parameters (SpO2 and PR) and one waveform (Pleth).
Passport V Operating Instructions
0070-00-0704-02
6-1
SpO2 Screens
SpO2 Monitoring
6.2
SpO2 Screens
6.2.1
Numeric Tile: SpO2
The SpO2 numeric tile displays the following:
• SPO2 & PR label
• SPO2 & PR Value
• SPO2/PR unit
• SpO2 High and Low Alarm Limits
• Sat-seconds Icon (Nellcor)
• Desat alarm limit
SpO2 Measured Value
SpO2 Label
High Alarm Limit
Sat-Seconds Icon PR Label
Low Alarm Limit
Desaturation Limit
SpO2 Unit
PR Value
PR Unit
FIGURE 6-1 SpO2 Numeric Tile
The display rules of Sat-Seconds Icon:
• If Sat-Seconds is set to 10 seconds, 25 seconds, 50 seconds, or 100 seconds, the SatSeconds icon will be displayed.
• The Sat-Seconds icon displays and fills when the low SpO2 limit is violated. When the set
amount of time has been reached, the SpO2 alarm will sound.
• The Sat-Seconds icon displays and fills regardless of the “NIBP Simultaneous” setting.
6.2.2
Waveform: SpO2
• The SpO2 waveform tile displays the following: Pleth waveform
FIGURE 6-2 SpO2 Pleth Waveform
6-2
NOTE:
Wave speed: The Passport V does not provide a separate
Pleth speed setting. ECG speed setting is valid for both Pleth
and ECG waveforms. After ECG waveform speed is
changed, the Pleth shall be refreshed as the speed setting.
NOTE:
Scale: The amplitude of the Pleth wave is self-adjusted
according to the height of the waveform area.
0070-00-0704-02
Passport V Operating Instructions
SpO2 Monitoring
6.3
SpO2 Menu
SpO2 Menu
To display the SpO2 Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 SpO2
or
Select the SpO2 tile
The Passport V displays different SpO2 menus according to the SpO2 module type.
FIGURE 6-3 SpO2 Menu (Nellcor SpO2)
SpO2 Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to normal screen (or press the
Normal Screen key on the front panel).
NIBP Simultaneous
Off (default)
On
Select On when monitoring SpO2 and NIBP on the
same limb simultaneously.
On: During NIBP measurement, SpO2 and PR
alarm status is locked until the end of the NIBP
measurement.
Off: SpO2 and PR alarm status is not affected by
the NIBP measurement.
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0070-00-0704-02
6-3
SpO2 Menu
SpO2 Monitoring
SpO2 Menu
MENU ITEM
SELECTIONS
COMMENTS
SpO2 sensitivity
(DPM)
High
Medium (default)
Low
High = 7 sec
Medium = 9 sec
Low = 11 sec
SpO2 sensitivity
(Masimo)
Normal (default)
High
Normal: Intended for most clinical conditions,
when the patient needs normal examination.
High: Intended when patient is in recovery, low
perfusion conditions.
SpO2 average
time (Masimo)
2–4 seconds
4–6 seconds
8 seconds (default)
10 seconds
12 seconds
14 seconds
16 seconds
SpO2 average time refers to a specific time (X
seconds) within which the SpO2 data collected is
averaged for display.
Sat-Seconds
(Nellcor)1
0 second (default)
10 seconds
25 seconds
50 seconds
100 seconds
Sets the Sat-Seconds limit.
When Sat-Seconds reaches or exceeds the set limit,
the low SpO2 alarm is triggered.
If SpO2 measurement fluctuates outside the set limit
for three times within 1 minute, the low SpO2 alarm
will be triggered even though the set Sat-Seconds
limit is not reached.
The Sat-Seconds function does not affect the Desat
alarm. Once the SpO2 is below the Desat limit, the
Desat will be triggered.
1
Sat-Seconds (Nellcor only) is calculated as follows:
n
Sat-Seconds =
∑ [ SpO2 ( i ) – SpO2 ( lim )
× t( i )) ]
i=1
where,
n represents the number of SpO2 values that falls outside the alarm limit.
SpO2 (i) represents each SpO2 value that violates the alarm limit.
SpO2 (lim) represents the corresponding high or low alarm limit.
t (i) is the time that SpO2 (i) lasts, and the unit is s.
6-4
0070-00-0704-02
Passport V Operating Instructions
SpO2 Monitoring
6.4
SpO2 Pulse Oximetry
SpO2 Pulse Oximetry
Pulse oximetry is a continuous and non-invasive measurement of the amount of oxygen
attached to the hemoglobin in red blood cells. SpO2 is an estimation of arterial oxygen
saturation, SpO2 may be used interchangeably with SaO2. The Passport V comes
standard with Masimo SET® SpO2. Nellcor® OxiMax® SpO2 and DPM SpO2 are options.
SpO2 Measurements
1. Select the appropriate sensor for the patient.
2. Attach the SpO2 patient cable to the sensor and plug the other end of the patient cable
into the SpO2 connector located on the left side panel of the monitor.
NOTE:
Do not place the sensor on an extremity with an IV catheter
or blood pressure cuff in place.
3. The pleth waveform and digital SpO2 value will be displayed by default in the second
waveform and parameter area. If desired, enter the Display Setup Menu to position
Pleth waveform and data in an alternate location.
Calibration
The oximetry sub-system incorporates automatic calibration mechanisms. No other
calibration is required.
Auto Scaling
The pleth waveform is automatically scaled and is not proportional to the patient’s pulse
volume. There is no adjustment that can be made to the pleth waveform.
CAUTION:
Tissue damage or inaccurate measurements may be caused
by incorrect SpO2 sensor application or use, such as
wrapping too tightly, applying supplemental tape, failing to
inspect the sensor site periodically, or failing to position
appropriately. Carefully read the sensor directions for use,
the Passport V Operating Instructions, and all precautionary
information before use.
CAUTION:
Inaccurate SpO2 measurements may be caused by:
Passport V Operating Instructions
•
Incorrect sensor application or use
•
Significant levels of dysfunctional hemoglobins, (e.g.,
carboxyhemoglobin or methemoglobin)
•
Intra-vascular dyes such as indocyanine green or
methylene blue
•
Exposure to excessive illumination such as surgical
lamps (especially ones with a xenon light source),
bilirubin lamps, fluorescent lights, infrared heating
lamps, or excessive ambient light. In such cases, cover
the sensor site with opaque material
•
Excessive patient movement
•
Venous pulsations
•
Electro-surgical interference
0070-00-0704-02
6-5
SpO2 Pulse Oximetry
6.4.1
SpO2 Monitoring
•
Placement of a sensor on an extremity that has a blood
pressure cuff, arterial catheter, or intra-vascular line
•
Nail polish or fungus
CAUTION:
In certain situations in which perfusion and signal strength
are low, such as in patients with thick or pigmented skin,
inaccurately low SpO2 readings will result. Verification of
oxygenation should be made, especially in preterm infants
and patients with chronic lung disease, before instituting
any therapy or intervention.
CAUTION:
Many patients suffer from poor peripheral perfusion due to
hypothermia, hypovolemia, severe vasoconstriction,
reduced cardiac output, etc. These symptoms may cause a
loss in vital sign readings.
CAUTION:
Prolonged and continuous monitoring may increase the risk
of skin erosion and pressure necrosis at the site of the
sensor. Check the SpO2 sensor site frequently to ensure
proper positioning, alignment and skin integrity at least
every eight (8) hours; with the Adult and Pediatric re-usable
finger sensor, check every four (4) hours; for neonates and
patients of poor perfusion or with skin sensitive to light,
check every 2 - 3 hours; more frequent examinations may
be required for different patients. Change the sensor site if
signs of circulatory compromise occur.
CAUTION:
When cleaning SpO2 sensors, do not use excessive amounts
of liquid. Wipe the sensor surface with a soft cloth,
dampened with cleaning solution. Do not attempt to
sterilize.
Masimo SET® SpO2
Passport V monitors equipped with Masimo SET SpO2 allow the user to adjust
Sensitivity and SpO2 Average Time. The user should choose the sensitivity mode
depending upon signal quality and patient motion. In most cases, the normal setting is
appropriate. If patient motion is limited, high sensitivity can be used.
It is also possible to change the averaging time of the Saturation and Pulse Rate
measurements. The SpO2 Average Time can be changed to 2-4, 4-6, 8, 10, 12, 14,
or 16 seconds.
CAUTION:
When equipped with Masimo SET® SpO2, use only Masimo
SET Oxygen Transducers including Masimo SET LNOP® and
LNCS® Patient Dedicated Adhesive Sensors and Masimo SET
PC Series Patient Cables. Use of other oxygen transducers
may cause improper oximeter performance.
Masimo SET Sensors
Masimo SET provides a family of sensors suitable for a wide variety of clinical settings and
patients. Specific sensors have been developed for neonates, infants, children, and adults.
All sensors are indicated for continuous non-invasive monitoring of arterial oxygen saturation
(SpO2) and pulse rate, all sensors are non-sterile and usable during patient movement.
The Adult Reusable Finger Sensors can also be used for spot check applications if needed.
All sensors are intended for single-patient use only unless indicated as “reusable.”
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Passport V Operating Instructions
SpO2 Monitoring
6.4.2
SpO2 Pulse Oximetry
Nellcor® SpO2
CAUTION:
When equipped with Nellcor® SpO2, use only Nellcor
oxygen transducers including Nellcor Oxisensor® and
OxiMax® patient dedicated adhesive sensors. Use of other
oxygen transducers may cause improper oximeter
performance.
Nellcor Sensors
Nellcor provides a family of sensors suitable for a wide variety of clinical settings and
patients. Specific sensors have been developed for neonates, infants, children, and adults.
Oxisensor® and OxiMax® oxygen transducers are sterile adhesive sensors with optical
components mounted on adhesive tape. Oxiband® oxygen transducers and the Duraform®
oxygen transducer system are reusable sensors that are applied with disposable adhesive.
The Durasensor DS-100A Adult Digit Oxygen Transducer is a reusable sensor with its optical
components mounted in a plastic casing. The Nellcor RS-10 and Max-Fast® oxygen
transducers are adhesive sensors for application on the forehead or temples.
Packaging of sterile sensors shall ensure sterile conditions until opened or damaged or until
expiration date is reached.
NOTE:
Consideration should be given to the disposal of packaging
waste.
To order all Nellcor accessories and sensors call 1-888-744-1414.
Selecting a Nellcor Sensor
Sensors are designed for specific sites on patients with designated weight ranges. To select
the appropriate sensor, consider the patient’s weight, level of activity, adequacy of perfusion,
which sensor sites are available, whether sterility is required, and the anticipated duration of
monitoring.
NOTE:
Only Nellcor oxygen transducers should be used with the
Passport V monitors with Nellcor OxiMax® pulse oximetry.
Sat-Seconds Alarm Management
With traditional alarm management, high and low alarm limits are set for monitoring oxygen
saturation. During monitoring, as soon as an alarm limit is violated, an audible alarm
immediately sounds. When the patient % SpO2 fluctuates near an alarm limit, the alarm
sounds each time the limit is violated. Such frequent alarm can be distracting. Nellcor’s SatSeconds alarm management technique is used to reduce these nuisance alarms.
The Sat-Seconds feature is available with the Nellcor SpO2 module to decrease the
likelihood of false alarms caused by motion artifacts. To set the Sat-Seconds limit, select SatSeconds in the SpO2 Setup menu and then select the appropriate setting.
Passport V Operating Instructions
0070-00-0704-02
6-7
SpO2 Pulse Oximetry
SpO2 Monitoring
With Sat-Seconds alarm management, high and low alarm limits are set in the same way as
traditional alarm management. A Sat-Seconds limit is also set. The Sat-Seconds limit controls
the amount of time that SpO2 saturation may be outside the set limits before an alarm
sounds. The method of calculation is as follows: the number of percentage points that the
SpO2 saturation falls outside the alarm limit is multiplied by the number of seconds that it
remains outside the limit. This can be stated as the equation:
Sat-Seconds= Points × Seconds
Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. For
example, the figure below demonstrates the alarm response time with a Sat-Seconds limit set
at 50 and a low SpO2 limit set at 90%. In this example, the patient % SpO2 drops to 88% (2
points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and
then to 84% (6 points) for 6 seconds. The resulting Sat-Seconds are:
After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50
Sat-Seconds would have been exceeded.
Saturation levels may fluctuate rather than remaining steady for a period of several seconds.
Often, the patient % SpO2 may fluctuate above and below an alarm limit, re-entering the
non-alarm range several times. During such fluctuation, the monitor integrates the number of
%SpO2 points, both positive and negative, until either the Sat-Seconds limit is reached, or the
patient %SpO2 re-enters the non-alarm range and remains there.
6-8
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Passport V Operating Instructions
SpO2 Monitoring
6.4.3
SpO2 Pulse Oximetry
DPM SpO2
The digital SpO2 value displays on the SpO2 LED (7), and the SpO2 Pulse Rate displays on
the Pulse Rate LED (6).
CAUTION:
When equipped with DPM SpO2, use only DPM oxygen
sensors and cables. Use of other oxygen sensors may cause
improper oximeter performance.
NOTE:
Refer to instructions included with each SpO2 sensor and
cable for proper placement and use.
NOTE:
Consideration should be given to the disposal of packaging
waste.
1. Select an SpO2 sensor that is appropriate for the patient size.
2. Attach the connector of the SpO2 sensor to the SpO2 extension cable.
3. Attach the SpO2 sensor to the patient’s finger (or other appropriate site).
4. Align the key slot on the connector on the end of the SpO2 extension cable with the
SpO2 receptacle on the right side panel of the Passport V. Push the connector into the
SpO2 receptacle until a “click” is heard. The SpO2 measurement displays when the
Passport V detects that the sensor is connected to the patient. A plethysmogram
displays to the left of the SpO2 numeric tile (if SpO2 is selected in the TRACE SETUP
menu).
NOTE:
To disconnect the cable from the Passport V, pull straight out
on the collar of the connector marked with two arrows.
Monitoring with a Reusable Y Sensor (Adult and Pediatric)
The reusable Y SpO2 sensor consists of the sensor and its sheath. One side of the sensor has
an LED with an infrared detector and the other side has a pulse detector.
1. Insert the LED and pulse detector ends of the Y SpO2 sensor into the respective grooves
of the sheath (see FIGURE 6-4 and FIGURE 6-5).
FIGURE 6-4 Inserting the Y SpO2 sensor into the sheath
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6-9
SpO2 Pulse Oximetry
SpO2 Monitoring
FIGURE 6-5 The Y SpO2 sensor inserted in the sheath
2. Once inserted, place the sensor on the patient's finger, hand or foot. Check sensor
position before securing it to the patient.
3. To secure the sensor, place the side of the sensor belt with V edge into the V groove on
the corresponding side of the sheath. Repeat with the other side, ensuring the belt is
secure, but comfortably placed on the patient. If necessary, adjust the belt using the
second lock bar.
4. Ensure the sensor's LED and pulse detector sides are opposite each other.
5. Check sensor site frequently. If the sensor is too tight it may cause venous pulsation and
therefore result in inaccurate measurement. Perform frequent site checks to verify skin
integrity is not compromised.
6 - 10
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Passport V Operating Instructions
SpO2 Monitoring
6.5
SpO2 Troubleshooting and SpO2 Menu Performance Considerations
SpO2 Troubleshooting and SpO2 Menu
Performance Considerations
To ensure optimal performance, use an appropriate sensor, apply it as directed and observe
all warnings and cautions.
If excessive ambient light is present, cover the sensor site with opaque material. Failure to do
so may result in inaccurate measurements. Light sources that can affect performance include
surgical lights, especially those with a xenon light source, bilirubin lamps, fluorescent lights,
infrared heating lamps, and direct sunlight.
In the event that you are unable to get a reading, or the reading you get is inaccurate,
consider the following:
• If your patient is poorly perfused, try applying the sensor to another site - such as a
different finger or toe.
• Check that the sensor is properly aligned.
• In electrosurgery, make sure sensor is not too close to ESU devices or cables.
• Check to make sure the site area is clean/non-greasy. Clean site and sensor if needed.
CAUTION:
A functional tester cannot be used to assess the accuracy of
the pulse oximeter probe or a pulse oximeter monitor.
NOTE:
If the supply mains has been interrupted during SpO2
monitoring, the Passport V will switch power to battery
backup if at least one battery has been installed and
charged. If power has been completely interrupted, SpO2
monitoring will continue when the supply mains is restored
or a fully charged battery is installed, and power has been
recycled to the monitor.
PROBLEM
REASON
SOLUTION
Unable to obtain SpO2
Patient has poor perfusion.
Switch limbs / Notify
reading
physician.
Sensor not on Patient.
Reapply sensor.
Cables loose / not
Check connections, switch
connected.
cable.
Ambient light.
Switch limbs and cover
sensor with opaque material.
No SpO2 waveform
Waveform not selected to
Go to the Display Setup
Display.
Menu, choose to display
Pleth in the waveform area.
Cable or sensor not
Check cable and sensor.
plugged in.
Passport V Operating Instructions
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6 - 11
SpO2 Troubleshooting and SpO2 Menu Performance Considerations
SpO2 Monitoring
PROBLEM
REASON
SOLUTION
Low amplitude SpO2
SpO2 sensor on same limb as
Check sensor placement,
signal
cuff.
move as necessary.
Patient has poor perfusion.
Switch limb / Notify
physician.
“– – –” in Digital Data
Data is above maximum
Check sensor placement,
value.
move as necessary. Switch
Data is below maximum
limb/Notify physician.
value.
Parameter is not available.
Lead or sensor is off.
Refer to Chapter 14.0 Messages for Physiological Alarm Messages, Technical Alarm
Messages, and Prompt Messages.
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Passport V Operating Instructions
7.0
NIBP Monitoring
7.1
NIBP Description
Intended patient types: adult, pediatric, neonatal.
The Passport V calculates NIBP values using the oscillometric method of noninvasive blood
pressure measurement. The NIBP measurement includes Systolic (Sys), Diastolic (Dia) and
Mean Blood Pressure. These measurements correspond to comparisons with auscultatory
values, measured using the fifth Korotkoff sound within ANSI/AAMI SP10 standards for
accuracy.
Blood pressure measurements determined with the Passport V are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultation method, within the
limits prescribed by the American National Standard, Electronic or automated
sphygmomanometers.
7.1.1
Displaying Measured Pressure
A valid value is displayed as Sys/Dia(Mean). When a reset is performed or the patient size
is changed, the data is displayed as dashes. Upon measurement failure, "XXX" will be
displayed. During an NIBP measurement the real-time cuff pressure is displayed in the Mean
pressure area.
When a valid measurement is completed, the Elapsed Time display begins counting. Initial
display is "ET:– – – min".
7.1.2
Display Time-out for NIBP Measurement
Provides time-out for the NIBP readings display. Options are 15 min, 30 min, 45 min, 60
min. When Display Time-out occurs the NIBP values display invalid data "– – –". If the NIBP
values have trigged the physiological alarms,the alarms are stopped when the NIBP Display
time-out occurs.
Passport V Operating Instructions
0070-00-0704-02
7-1
NIBP Description
7.1.3
NIBP Monitoring
Measurement Modes
The Passport V Provides three measurement modes: Manual, Automatic, STAT modes.
Manual mode: When NIBP Interval is set to off, then the NIBP is in manual mode and
"Off" appears in the NIBP numeric tile, the message "NIBP: Manual Mode" is displayed in
message area B.
Press START key to start an NIBP measurement. The message "NIBP: Measuring" is
displayed. When the measurement is completed, the measured results are displayed and the
monitor enters the NIBP waiting status and prompt message "NIBP: Idle" is displayed.
During the manual measurement, pressing the STOP key on the front panel, stops the manual
measurement and prompt message "NIBP: Idle" is displayed until START is pressed again.
Automatic Mode: When NIBP Interval is set to anything other than Off, the NIBP is in
automatic mode. Once the Automatic mode interval is selected, the prompt message "NIBP:
Press the START key" is given in message area B.
Press START key to start the first NIBP measurement and prompt "NIBP: Measuring". When
this time measurement is completed, the measured results are displayed and the prompt
message "NIBP: Interval" is displayed. The next measurement will start after the selected
interval has expired.
If the automatic interval is set at 1 minute, then after 10 minutes of automatic measurements
the interval will change to a 10 minute interval.
During the automatic measurement, pressing the STOP key on the front panel, will stop the
automatic measurement. The message "NIBP: Idle" will be displayed until START is pressed
again.
NOTE:
If the interval is changed during the Automatic
measurement interval, the new interval starts from the time
when such change is made.
NOTE:
In Automatic Mode, a measurement can be started
manually during the interval between two timed
measurements. If STOP key is pressed, both the manual
mode measurement and automatic mode measurement are
stopped.
NOTE:
When the system time is changed during the automatic
measurement, it will enter idle mode after completing the
current measurement. Press the START key on the front
panel if it is necessary to start measurement.
STAT Mode: When NIBP Interval is set to STAT mode, "STAT" appears in the NIBP numeric
tile and the prompt message "NIBP: STAT" is displayed in message area B.
Press the START key to start the STAT measurement sequence and the message "NIBP:
Measuring" appears in message area B. When this measurement is completed, the results
are displayed. STAT measurements will continue for a period of 5 minutes. Afterward, the
monitor will switch to 5-minute intervals.
During the STAT measurement, press STOP key on the front panel, stop the STAT measurement
and the prompt message "NIBP: Idle" will be displayed until START is pressed again.
NOTE:
7-2
If the 5 minute STAT cycle expires and a measurement is in
progress, the STAT cycle will end at completion of the
measurement that is in progress.
0070-00-0704-02
Passport V Operating Instructions
NIBP Monitoring
NIBP Screens
7.2
NIBP Screens
7.2.1
NIBP Numeric Tile
The NIBP numeric tile displays the following:
• NIBP label
• The measured results (Sys, Dia and Mean)
• Unit of measurement
• Interval
• Elapsed time from the last successful measurement.
• The cuff pressure
• Alarm limits for Sys, Dia, and Mean BP
NIBP Label
Systolic Value
Diastolic Value
Unit of Pressure
Time Elapsed From Last
Valid Measurement
Mean Value
Measurement Interval
FIGURE 7-1 NIBP Numeric Tile
Passport V Operating Instructions
0070-00-0704-02
7-3
NIBP Screens
7.2.2
NIBP Monitoring
NIBP List Display
Displays the last 5 NIBP measurements. Contents to display:
• NIBP label
• Systolic pressure /Diastolic pressure (Mean pressure)
• Interval Time
• Unit of measure
• Time measurement was completed.
NIBP Label
Systolic Value
Time
Unit of Pressure
Diastolic Value
Mean Value
Measurement Interval
FIGURE 7-2 NIBP List Display
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Passport V Operating Instructions
NIBP Monitoring
7.3
NIBP Menu
NIBP Menu
To display the NIBP Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 NIBP
or
Select the NIBP tile
FIGURE 7-3 NIBP Menu
NIBP Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to normal screen (or press the
Normal Screen key on the front panel).
Set Start Pressure
Adult: 100 to 280
(default = 180)
Select to adjust initial NIBP pump up pressure in
increments of 5. The selection range varies
according to the Patient Size.
Pediatric: 60 to 180
(default = 140)
Neonate: 40 to 120
(default = 100)
Passport V Operating Instructions
0070-00-0704-02
The Set Start Pressure cannot be changed during
an NIBP measurement or the five minutes STAT
measurement.
7-5
NIBP Menu
NIBP Monitoring
NIBP Menu
MENU ITEM
SELECTIONS
COMMENTS
Interval
Off (default)
STAT, 1 min, 2 min,
3 min, 5 min, 10 min,
15 min, 20 min,
30 min, 1 hr, 2 hr, 4 hr
Select to change NIBP measurement interval.
Off: manual mode. The message "NIBP: Manual
Mode" is displayed at the bottom of the screen.
STAT: STAT measurement. The message "NIBP:
STAT" is displayed at the bottom of the screen.
Note: The Interval cannot be changed during an
NIBP measurement or the five minutes STAT
measurement.
NIBP End Tone
On (default)
Off
Select to turn NIBP End Tone On or Off.
On: A dual beep tone sounds on completion of a
successful NIBP measurement.
Off: Tone does not sound after the measurement.
Note: A single beep tone will always sound in the
event of an unsuccessful measurement, after all
retries have been attempted.
The NIBP End Tone does not sound if the user stops
the measurement by pressing the NIBP STOP key.
NIBP End Tone audio volume is controlled by the
alarm audio volume.
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Passport V Operating Instructions
NIBP Monitoring
NIBP Measurements
7.4
NIBP Measurements
7.4.1
Manual NIBP Measurements
1. Select a blood pressure cuff that is appropriate for the size of the patient. Measure limb
for the best results.
NOTE:
A cuff that is too narrow for the limb will result in
erroneously high readings. The correct size of the pressure
cuff for a given patient has, among other considerations, a
direct bearing on the accuracy of the obtained NIBP
measurements. Base selection of the cuff size on the limb
circumference of the patient. The design dimensions of the
cuffs and their intended uses are based on
recommendations of the American Heart Association.
NOTE:
Cuffs become brittle as they age and sometimes develop
permanent folds that can leave temporary marks on the
limb. Any cuffs that exhibit this effect should be replaced.
NOTE:
Ensure that the pressure tubes are not compressed or
restricted.
NOTE:
The pressure on the limb may not fall to zero between
measurements if the cuff is wrapped too tightly. Therefore,
ensure that the cuff is properly applied.
NOTE:
The skin is sometimes fragile (i.e., on pediatrics, geriatrics,
etc.). In these cases, a longer interval between
measurements should be considered to decrease the
number of cuff inflations over a period of time. In extreme
cases, a thin layer of soft roll or cotton padding may be
applied to the limb in order to cushion the skin when the
cuff is inflated. This measure may affect NIBP performance
and should be used with caution.
2. Attach cuff hose to NIBP Connector.
3. Apply the cuff to the patient. To reduce errors, the cuff should be adjusted for a snug fit.
Little or no air should be present within the cuff. Be sure the cuff lies directly against the
patient’s skin. No clothing should come between the patient and the cuff.
NOTE:
The NIBP cuff should not be placed on a limb that is being
utilized for any other medical procedure. For example, an IV
catheter or an SpO2 sensor.
4. If not already selected, select the Patient Size through the Patient Menu. Choices
are Adult, Pediatric or Neonate.
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7-7
NIBP Measurements
NIBP Monitoring
5. If necessary, change the initial cuff inflation pressure through the NIBP Menu. Initial
cuff inflation pressures depend on the patient size setting. The values for cuff inflation
are identified in the following table:
PATIENT SIZE
SETTING
INITIAL CUFF
INFLATION VALUES
DEFAULT
SETTING
MAXIMUM
INFLATION VALUES
Adult
100 - 280 mmHg
180 mmHg
295 mmHg
Pediatric
60 - 180 mmHg
140 mmHg
190 mmHg
Neonate
40 - 120 mmHg
100 mmHg
145 mmHg
6. Press START to begin an NIBP measurement.
CAUTION:
Blood pressure cuffs must be used with the manufacturer’s
correct and approved hoses.
CAUTION:
Please consult a physician for interpretation of blood
pressure measurements.
CAUTION:
A blood pressure measurement can be affected by the
position of the patient, and his / her physiological condition
as well as other factors, such as patient movement.
NOTE:
Inflate the cuff only after proper application to the patient’s
limb. Cuff damage can result if the cuff is left unwrapped
and then inflated.
NOTE:
Changing the patient size, during measurement will stop the
current measurement and the cuff shall be deflated.
7. The cuff begins to inflate to the selected cuff pressure. After reaching the selected value
the cuff begins to slowly deflate and the Passport V collects oscillometric pulsations.
8. If the initial cuff inflation is found to be inadequate, the unit retries with a higher inflation
pressure (+50 mmHg in adult or pediatric mode; +40 mmHg in neonate mode).
9. The patient should remain still to avoid the introduction of unnecessary motion artifact.
After the cuff pressure drops below the diastolic pressure, the results of the measurement
are displayed.
10. If NIBP End Tone is set to On in the NIBP Menu, a double tone will sound to
indicate a successful NIBP measurement.
The NIBP measurement will be automatically removed from the display after a predetermined
time interval. The NIBP timeout interval is 15 minutes by default and can be set to a different
value through the Installation Menu.
7.4.2
Automatic Interval NIBP Measurements
There are two modes available for automatic NIBP measurements. They are the Interval
Mode and the Timer Mode. The Interval Mode allows you to set the interval between
measurements. For example, if the interval is set to 10 minutes and the START key is pressed
at 10:12, the measurements will be taken at 10:12, 10:22, 10:32, etc. The Timer Mode
allows you to set an interval that is synchronized with the real time clock. For example, if the
timer is set to 30 and the START key is pressed at 10:12, the measurements will be taken at
10:12, 10:30, 11:00, 11:30, etc.
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0070-00-0704-02
Passport V Operating Instructions
NIBP Monitoring
NIBP Measurements
1. Select the Interval Mode or the Timer Mode in the Monitor Setup Menu
Advanced Setup.
〉
2. Select the NIBP tile (or Parameters) 〉 NIBP 〉 Interval. Rotate the Navigator Knob
to the desire selection. The selections are: OFF, STAT, 1, 2, 3, 5, 10, 15, 20, 30, 1
hr, 2 hr and 4 hours.
3. Press the Start key to begin taking interval measurements.
NOTE:
If the monitor is in the interval mode when it is turned ON,
no measurement will be taken until the Start key is pressed.
Automatic Adjustment in the Interval Mode
In the Interval Mode, the unit adjusts the inflation pressure according to the previous
reading of the systolic pressure. After the first measurement in the timer mode, the inflation
pressure is the previous systolic +50 mmHg in the Adult Mode or Pediatric Mode and
+40 mmHg in the Neonate Mode.
7.4.3
Suspension of NIBP Measurements
1. Press STOP to suspend an automatically timed measurement sequence or to end a
measurement cycle already in progress (deflate cuff).
2. Press START to take an immediate measurement and resume a suspended timed
measurement sequence.
7.4.4
NOTE:
You can press STOP at any time to postpone a scheduled
measurement or to terminate a measurement cycle already
in progress.
CAUTION:
Observe caution on all patients (Neonates, Pediatrics, and
Adults), when NIBP is set to STAT Mode or the 1-minute
interval, to minimize the possibility of nerve injury occurring
during use of automatically cycled blood pressure cuffs.
Retry measurement
If an NIBP measurement fails, the measurement is retried up to three times. The message
"NIBP: Retry" is displayed after the cuff deflates. If the measurement fails all three retries, the
Display shows the Sys, Dia, and Mean values as "XXX".
7.4.5
Reset
Reset can occur as NIBP module error(e.g. communication error). If the cuff is being inflated,
it will deflate as soon as it receives the reset signal.
When the module resets, the prompt message "NIBP: Resetting..." is displayed in the
message area B.
7.4.6
NIBP Pressure Limit Fail Safe
If the cuff is over-pressurized, the cuff will automatically vent to atmosphere.
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7-9
NIBP Measurements
7.4.7
NIBP Monitoring
Cuff Inflation Timeout
If the cuff pressure does not attain 15mmHg within 20 seconds for adult and pediatric, or
15mmHg within 10 seconds for neonate, then the cuff is vented and the message NIBP:
Retry or NIBP: Unable to Measure message is displayed in the lower left corner of the
screen.
The cuff will inflate to 15mmHg within 20 seconds for adult and pediatric, and 15mmHg
within 10 seconds for neonate.
7.4.8
Start and Stop Keys
The Start and Stop keys on the front panel have the following effects on the timed
measurement sequence (Interval or Timer Mode).
Interval Mode is set and you press the Start key:
• An unscheduled measurement is made. Taking this unscheduled measurement does not
affect the timing of the interval cycle, therefore, the scheduled measurements will be
taken as if there were no interruptions. Only one measurement is taken for each
measurement cycle - therefore, if the unscheduled measurement coincides with the
scheduled measurement, it counts as the scheduled measurement. If the interval is
changed without pressing the Stop key, interval measurements will continue at the
newly chosen interval.
Interval Mode is set and you press the Stop key during the measurement:
• The cuff deflates and interval measurements are suspended.
Interval Mode is set and you change the interval:
• The measurement cycle is reset with the new interval. A measurement will be taken
after you press the Start key.
7.4.9
NIBP Auto Time Out Functions
The NIBP data will time out on the display under the following conditions:
• When the elapsed time exceeds the pre-set time out in the installation mode
• If a measurement is unsuccessful, the display values are replaced with “XXX” and a
tone sounds.
7.4.10
Indirect BP Measurements and Associated Errors
Place the patient in a supine position to obtain true physiological pressure. If the cuff is not at
the patient’s heart level, the pressure values obtained will not reflect the true physiological
pressure. Instead, the readings will be decreased by 1.86 mmHg for every inch the cuff is
placed above the heart level and increased by 1.86 mmHg for every inch the cuff is placed
below the heart level. This effect is due to hydrostatic pressure.
Blood weight influences blood pressure readings. The value of the weight of blood depends
on where the measurement is taken with respect to the heart. When the patient is supine, on
a flat surface, the arm is near enough to the heart level that no adjustment of the NIBP
readings is necessary.
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Passport V Operating Instructions
NIBP Monitoring
7.4.11
NIBP Measurements
Recommendations for Automatic Blood Pressure Measurements
The following practices are recommended when making automatically cycled blood pressure
measurements:
• Position and support the limb in such a way as to minimize stretching of and weight
exertion on affected nerves
• Avoid cuff placement that applies pressure on the ulnar nerve. Cuff tubing should not
exit the cuff over the course of the ulnar nerve at the elbow
• Select a measurement interval that provides adequate venous drainage during cuff
deflation
• Periodically inspect the limb bearing the cuff in order to detect venostasis
• If necessary move cuff to another limb to relieve single-limb stress
7.4.12
Cuff Size
Using a narrow cuff gives erroneously high pressure readings. If a standard cuff is applied to
an obese patient or a patient with large biceps, the extra tissue and fat will dissipate the
applied pressure requiring an additional pressure increase to collapse the artery. On the
other hand, over-wrapping a slender arm gives erroneously low pressure readings because
too much force per unit area is exerted. This requires less pressure to collapse the artery.
7.4.13
Other Factors
An accurate determination of blood pressure by the Passport V can be difficult if cardiac
rhythm is irregular. Irregular cardiac rhythm changes the stroke volume from beat to beat.
This changing stroke volume may increase the time it takes the Passport V to take a
measurement. The Passport V makes up to four successive attempts to obtain a
measurement. If a measurement cannot be taken after four tries, the numeric displays are
zeroed.
7.4.14
User Verification of Passport V Blood Pressure Measurements
Regular service to blood pressure equipment will help ensure accurate measurements.
Consult your Service Manual for appropriate information. If you question the accuracy of the
Passport V, verify the blood pressure with a manometer.
Auscultatory verification can be made at the same time the Passport V is taking a
measurement. Apply a bell stethoscope over the brachial artery. Do not allow the
stethoscope to touch either the patient’s clothing or the pressure cuff.
7.4.15
Newborn NIBP Technique
Newborn patients present unique obstacles to NIBP measurement. Their vital signs can
change from moment to moment, and their tiny physiological signals are very prone to noise
interference. The following suggestions will help you to obtain the best possible NIBP
measurement:
1. Try to measure infants when they are calm. A kicking/crying baby may disturb or jiggle
the cuff, causing noise within the system and resulting in unstable blood pressure
readings. If necessary, hold the cuffed limb steady, without impeding circulation. Do not
hold onto the cuff and do not pat the cuffed limb to comfort the child.
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7 - 11
NIBP Measurements
NIBP Monitoring
2. Try the calf. Irritable newborns will react to the cuff pressure but may tolerate the calf
better than the arm. Place the cuff just above the ankle.
3. Use the correct Newborn and Infant size cuffs. When applying, verify the cuff’s
Index line falls between the Range lines.
4. Try disposable cuffs. Disposable cuffs are more pliant than reusable ones. They
generally fit smaller infants better.
5. Place the cuff lightly. If the cuff is too snug, it won’t work properly. On infants, you should
be able to easily move the cuff over the limb.
NOTE:
7.4.16
NIBP cannot be taken under all conditions. Even manual
methods, employing a sphygmomanometer and
stethoscope, will not work on unstable or active patients.
NIBP List Tile
The NIBP List tile can display up to five of the most recent NIBP measurements in row form.
These measurements are displayed from newest (in the top row) to oldest (in the bottom row).
As shown in the example of FIGURE 7-4, each row displays a time stamp, the three digit
systolic and diastolic pressures separated with a “/”, and the three digit mean pressure in
parentheses.
FIGURE 7-4 Example NIBP List Tile
The NIBP List tile can be configured from the Display Setup Menu to display in one of the
numeric tiles (1 - 5) and it has a menu target labeled “NIBP” that opens the NIBP Menu.
7.4.17
Adaptive Inflation Pressure
During Interval or STAT mode, the inflation pressure is adjusted according to the previous
reading of the systolic pressure. After the first successful measurement, the inflation pressure
is the previous systolic +50 mmHg in the adult mode, +50 mmHg in the pediatric mode, and
+40 mmHg in the neonate mode.
If a manual measurement is taken between interval readings, the manual measurement uses
Adaptive Inflation because the unit is in Interval Mode.
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Passport V Operating Instructions
NIBP Monitoring
7.5
NIBP Troubleshooting
NIBP Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Unable to obtain a BP
Patient movement
Wait until patient is calm or
gently hold limb.
Cuff or hose NOT attached /
leaking
Check all connections.
HR irregular / arrhythmia present
Check Patient and notify
Physician.
Blood pressure is out
of range.
Check Patient and verify BP
with manual method.
Improper cuff size / brand
Measure patient limb. Use
only properly sized approved
accessories.
Incorrect cuff size
Measure Patient limb, use
correct cuff.
Patient movement
Wait until patient is calm or
gently hold limb.
Reading too high or too low
Refer to Chapter 14.0 Messages for Physiological Alarm Messages, Technical Alarm
Messages, and Prompt Messages.
NOTE:
Always have an alternate method of BP verification
available.
NOTE:
On vasoconstricted patients, failure to evacuate air from the
cuff can distort BP measurement.
NOTE:
Cuff should be at heart level.
NOTE:
The presence of an arrhythmia may increase the time
required to complete a measurement and may cause
measurement cycle to extend beyond a point where a
measurement can be completed.
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NIBP Troubleshooting
NIBP Monitoring
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Passport V Operating Instructions
8.0
Temperature Monitoring
8.1
Description
Intended patient types: Adult, Pediatric, Neonate.
The temperature measurement function of the Passport V is designed to take a continuous
temperature reading from 400 series or compatible probes.
Temp units of " C" and " F" are available. The temperature units can be adjusted in the
Installation Menu.
Passport V Operating Instructions
0070-00-0704-02
8-1
Temperature Screens
Temperature Monitoring
8.2
Temperature Screens
8.2.1
Numeric Tile: Temp
The Temp numeric tile displays the following:
• Parameter label (Temp)
• Measurement results
• Temp unit
• Alarm limits
Temp Label
Temp Measured Value
Temp Unit
High Alarm Limit
Low Alarm Limit
FIGURE 8-1 Temperature Numeric Tile
If a temperature transducer cable is plugged into the T1 port, but no measurement is
performed or the measured value is invalid, dashes "- - -" are displayed in the Temp numeric
tile. If a cable is not plugged into the T1 port, the Temp numeric tile is not displayed at all.
8-2
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Passport V Operating Instructions
Temperature Monitoring
8.3
Temperature Probes
Temperature Probes
CAUTION:
8.3.1
The Passport V monitor is not compatible with 700 Series
temperature probes.
Skin Temperature Sensor with 400 Series Thermistor
Description (0206-03-0300-02)
Monitoring of skin surface temperature is a well accepted procedure for the detection of
hypothermic and hyper thermic conditions. The Skin Temperature Sensor is designed for
placement on the surface of the skin. The skin temperature sensor consists of a thermistor
embedded in an adhesive backed foam disk. One side of the foam disk is covered by a
metallic film. The opposite surface of the foam is coated with a medical grade hypoallergenic adhesive suitable for skin application. The hypo-allergenic adhesive holds the
sensor in situ. The foam thermally insulates the sensor and the metallic layer reflects external
infrared heat energy thus providing accurate measurement of body temperature.
The temperature transducer is in the form of an electrically insulated 400 series thermistor.
The accuracy of the thermistor is ± 0.2° Celsius in the range of 5° Celsius to 45° Celsius. The
assembly is disposable, single use only, and packaged sterile.
This device is intended for use with electronic temperature monitors accepting 400 series
thermistor sensors or equivalent that are equipped with alarms. To interconnect the probe
with the instrument, use cable part number 0012-00-0975.
Electrical leakage current of the device, when used with the monitor and cable, comply with
IEC 601-1/EN60601-1.
Indications
The Skin Temperature Sensor is indicated for use in the routine monitoring of skin
temperature.
Contraindications
The Skin Temperature Sensor may be contraindicated over traumatized areas.
Adverse Reactions
Adverse reactions reported during applications of Skin Temperature Sensors include: skin
abrasions and tissue burns due to aberrant electro-cautery current pathways.
Directions For Use And Precautions
1. Dry skin completely in the area intended for sensor placement.
2. Remove the protective backing and place the sensor onto the previously dried skin area.
3. Align the sensor’s connector with the monitor cable’s connector and push firmly to assure
full contact. Forced mating of the connectors without proper alignment may cause
damage to the connectors and interruption in electrical continuity.
Passport V Operating Instructions
0070-00-0704-02
8-3
Temperature Probes
Temperature Monitoring
WARNING: During procedures employing electro-cautery, use currently
acceptable procedures to minimize conditions of the
thermistor and lead wires functioning as an alternate path
for radio-frequency current to return to ground, causing
localized tissue burns. Procedures which may minimize risk
of electro-surgical burns are: keep both active and ground
electrodes of the electro-cautery system in close proximity
so that the temperature sensor is outside the radiofrequency current field. Keep temperature monitor with its
associated cables separated from electro-cautery systems.
Unusual, fast artificial variations in temperature readings
may occur with concomitant applications of the electrocautery system.
WARNING: Sterile unless unit container is opened or damaged.
CAUTION:
8.3.2
Single use.
Destroy after single use.
Do not resterilize.
Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Esophageal Stethoscope with 400 Series Thermistor Temperature
Sensor
Description (0206-03-0112-02, 0206-03-0118-02)
The esophageal stethoscope with temperature sensor is a disposable device which provides
for accurate measurement of core body temperature as well as transmission of heart and
lung sounds. Heart and lung sounds are transmitted across a thin cuff wall, through the side
and distal openings of the tube. Made of a special material which optimizes sound
transmission and remains both durable and flexible, the cuff maintains its integrity and
prevents secretion from entering the tube. For connection to any standard ear piece, a male
luer adaptor is attached to the proximal end of the esophageal stethoscope. The stethoscope
is 19 inches (48.3cm) long. The tube, the cuff and luer adaptor are made of lightweight, nontoxic, implant tested material.
The temperature transducer is in the form of an electrically insulated “400” series thermistor,
which is permanently secured within the lumen of the esophageal stethoscope. The thermistor
is placed at the distal end of the tube. The accuracy of the thermistor is ±0.2°C in the range
of 5 - 45°C.
The assembly is disposable, single use only, and packaged sterile. It is available in sizes 12
and 18 French.
This device is intended for use with electronic temperature monitors accepting 400 series
thermistor sensors or equivalent that are equipped with alarms. To interconnect the probe
with the instrument, use cable part number 0012-00-0975.
Electrical leakage current of the device (sensor and esophageal stethoscope) when used with
monitor and cable, comply with IEC 601-1/EN 60601-1.
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Passport V Operating Instructions
Temperature Monitoring
Temperature Probes
Indications
The esophageal stethoscope with temperature sensor is indicated where patient temperature
monitoring is desired along with accurate heart and lung sound monitoring. The sensor is
designed for insertion into the esophagus.
Contraindications
The use of the esophageal stethoscope may be contraindicated in neonates and small infants
undergoing tracheostomy or internal jugular artery catheterization or remote surgical
procedures.
Adverse Reactions
Adverse reactions reported during applications of esophageal stethoscopes with or without
temperature sensors include accidental tracheal or bronchial intubation accompanied with
airway obstruction, esophageal abrasion and or perforation, pharyngeal abrasion and
tissue burns due to aberrant electro-cautery radiofrequency current pathways.
Directions for Use and Precautions
1. If a patient has to be intubated with an endotracheal tube, perform the intubation prior
to the placement of the esophageal stethoscope.
2. Lubricate the stethoscope prior to the insertion and place the stethoscope in accordance
with currently acceptable medical procedures.
3. Verify position of the stethoscope by direct laryngoscopy or other acceptable medical
techniques.
4. Align the sensor’s connector with the monitor cable’s connector and push firmly to assure
full contact. Forced mating of the connectors without proper alignment may cause
damage to the connectors and interruption in electrical continuity.
WARNING: During the surgical procedures which employ electrocautery, use currently acceptable procedures to minimize
conditions of the thermistor and lead wires functioning as
an alternate path for radio-frequency current to return to
ground, causing localized tissue burns. Procedures which
may minimize risk of electro-surgical burns are: keep both
active and ground electrodes of the electro-cautery system
in close proximity so that the sensor is outside the radiofrequency current field; keep temperature monitor with its
associated cables separated from electro-cautery systems.
Unusual, fast artificial variations in temperature readings
may occur with concomitant applications of the electrocautery system.
WARNING: Sterile unless unit container is opened or damaged.
CAUTION:
Passport V Operating Instructions
Single use.
Destroy after single use.
Do not resterilize.
Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
0070-00-0704-02
8-5
Temperature Probes
8.3.3
Temperature Monitoring
Esophageal/Rectal Temperature Probe with 400 Series Thermistor
Description (0206-03-0209-02, 0206-03-0212-02)
Hypothermia and hyperthermia are well recognized clinical conditions necessitating
temperature monitoring. The economical and disposable Esophageal/Rectal Temperature
Probe is a sensitive and accurate temperature transducer, to be used clinically where
continuous temperature monitoring is required.
The temperature sensor is in the form of an electrically insulated “400” series thermistor,
which is permanently secured within a PVC tube. The bullet tipped PVC tube provides for
atraumatic insertion. The thermistor is placed at the distal end of the tube. The accuracy of
the thermistor is ± 0.2°C in the range of 5 - 45°C.
The assembly is disposable, single use only, and packaged sterile. It is available in sizes 9
and 12 French.
This device is intended for use with electronic temperature monitors accepting 400 series
thermistor sensors or equivalent that are equipped with alarms. To interconnect the probe
with the instrument, use cable part number 0012-00-0975.
Electrical leakage current of the device (sensor and PVC tube) when used with monitor and
cable, comply with IEC 601-1/EN 60601-1.
Indications
The Esophageal/Rectal Temperature Probe is indicated where continuous patient temperature
monitoring is desired. The sensor is designed for insertion into the esophagus, nasopharynx,
or rectum.
Contraindications
The use of the esophageal/rectal sensor may be contraindicated in neonates and small
infants undergoing tracheostomy or internal jugular artery catheterization and remote
surgical procedures.
Adverse Reactions
Adverse reactions reported during applications of these sensors include: accidental tracheal
or bronchial intubation accompanied with airway obstruction, esophageal or rectal abrasion
and/or perforation, pharyngeal abrasions and tissue burns due to aberrant electro-cautery
radio-frequency current pathways.
8-6
0070-00-0704-02
Passport V Operating Instructions
Temperature Monitoring
Temperature Probes
Directions For Use And Precautions
1. If a patient has to be intubated with an endotracheal tube, perform the intubation prior
to placing the temperature probe into esophagus.
2. Lubricate the temperature probe prior to insertion and place the probe in accordance
with currently acceptable medical procedures.
3. Verify position of the probe by acceptable medical procedures.
4. Align the sensor’s connector with the monitor cable’s connector and push firmly to assure
full contact. Forced mating of the connectors without proper alignment may cause
damage to the connectors and interruption in electrical continuity.
WARNING: During the surgical procedures which employ electrocautery, use currently acceptable procedures to minimize
conditions of the thermistor and lead wires functioning as
an alternate path for radio-frequency current to return to
ground, causing localized tissue burns. Procedures which
may minimize risk of electro-surgical burns are: keep both
active and ground electrodes of the electro-cautery system
in close proximity so that the temperature sensor is outside
the radio-frequency current field; keep the temperature
monitor with its associated cables separated from electrocautery systems. Unusual, fast artificial variations in
temperature readings may occur with concomitant
applications of the electro-cautery system.
WARNING: Sterile unless unit container is opened or damaged.
CAUTION:
8.3.4
Single use.
Destroy after single use.
Do not resterilize.
Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Reusable DPM Temperature Probes
WARNING: SpO2 sensors, SpO2 accessories, and temperature probes
should be disposed of in accordance with local regulations.
Passport V Operating Instructions
0070-00-0704-02
8-7
Temperature Troubleshooting
8.4
Temperature Monitoring
Temperature Troubleshooting
\
MESSAGE/PROBLEM
REASON
SOLUTION
Temperature Probes not
Working
Poor contact from probes to body
Check the body surface contact
at the probe tip.
Reposition or apply
thermoconductive gel.
Temperature not displayed
8-8
Improper display setup
Check Display Setup in
Monitor Setup Menu and
change as desired.
Cable not plugged in
Check the cable.
0070-00-0704-02
Passport V Operating Instructions
9.0
IBP Monitoring (optional)
9.1
IBP Description
Intended patient types: adult, pediatric, neonatal.
Invasive Blood Pressure (IBP) is a direct measurement of the patient's arterial or venous blood
pressure. IBP utilizes a catheter that is inserted directly into a vein, artery or other pressure
access areas, and is connected to a transducer for interpretation of Systolic (Sys), Diastolic
(Dia), and Mean blood pressures. Up to two Invasive Blood Pressure channels are available.
Invasive Blood Pressure measurement is an option for the Passport V.
The Passport V supports the measurements of two invasive blood pressures. It provides
systolic pressure, diastolic pressure and mean pressure values.
When measuring Art/UA/LV/PA pressure, the channel can serve as an HR source.
• When displaying a pulsatile pressure, the format shall be SYS/DIA (MEAN)
• When displaying non-pulsatile pressure, the format shall be MEAN (SYS/DIA)
• When displaying ICP, the format shall be MEAN CePP.
9.1.1
Pressure Labels
IBP1, IBP2 waveforms may be labeled according to the site of insertion. The labels are
identified in the following table:
LABEL
DEFINITION
Art
Arterial Blood Pressure
UA
Umbilical Artery Pressure
LV
Left Ventricular Pressure
PA
Pulmonary Artery Pressure
Passport V Operating Instructions
0070-00-0704-02
9-1
IBP Description
IBP Monitoring (optional)
LABEL
DEFINITION
CVP
Central Venous Pressure
ICP
Intracranial Pressure
LA
Left Atrial Pressure
RA
Right Atrial Pressure
P1, P2
Not specified pressure
labels
The Default labels: Art, CVP.
The pressure labels for each channel cannot be the same. That is, if a pressure label is
selected in one channel, it will not appear among the available label options for the other
channel.
P1 and P2 can be set to Pulsatile or Mean. The default setup is Pulsatile.
• When 'Pulsatile' is selected, the channel displays data in pulsatile pressure format
SYS/DIA (MEAN) and the waveform scale defaults to 0-160 mmHg. The measured
systolic value is displayed.
• When 'Mean' is selected, the channel displays data in non-pulsatile pressure format
MEAN (SYS/DIA) and the waveform scale defaults to 0-20 mmHg. The measured mean
pressure value is displayed.
• For all other pressure labels, the data will be displayed in a fixed format, depending on
the Measure Pressure selection in the IBP Menu. If “Pulsatile” is selected, the measured
systolic (SYS/DIA (MEAN)) is displayed. If “Mean” is selected, the measured mean
pressure value (MEAN (SYS/DIA)) is displayed.
9-2
0070-00-0704-02
Passport V Operating Instructions
IBP Monitoring (optional)
IBP Screens
9.2
IBP Screens
9.2.1
IBP Numeric Tile
The IBP numeric tile displays the following:
• IBP pressure label
• Measured values for systolic pressure, diastolic pressure, mean pressure (pulsatile: Sys/
Dia(Mean), non-pulsatile: Mean(Sys/Dia))
• Alarm limits
• Unit of measurement - mmHg
Display requirements:
• Resolution: 1 mmHg
Arterial Pressure Label
Unit of Pressure
Systolic Value
Systolic Alarm Limits
Diastolic Value
Mean Value
Mean Alarm Limits
Diastolic Alarm Limits
FIGURE 9-1 Arterial Pressure Numeric Tile (Art)
Central Venous Pressure Label
Mean Value
Mean Alarm Limits
Unit of Pressure
Systolic Value
Diastolic Value
Systolic Alarm Limits
Diastolic Alarm Limits
FIGURE 9-2 Central Venous Pressure Numeric Tile (CVP)
Passport V Operating Instructions
0070-00-0704-02
9-3
IBP Screens
IBP Monitoring (optional)
Intracranial Pressure Label
Unit of Pressure
ICP Value
Cerebral Perfusion Pressure
Alarm Limits
CePP Value
FIGURE 9-3 ICP Numeric tile (with Cepp parameter)
9.2.2
IBP Waveform
FIGURE 9-4 IBP waveform tile (Art)
9-4
0070-00-0704-02
Passport V Operating Instructions
IBP Monitoring (optional)
9.3
IBP Menu
IBP Menu
To display an IBP Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 [IBP Label] (for example, Art or CVP)
or
Select the [IBP Label] tile (for example, Art or CVP)
FIGURE 9-5 IBP Menu (Art)
IBP Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to normal screen (or press the
Normal Screen key on the front panel).
Label
Art, PA, UA, CVP, LV,
LA, RA, ICP, P1, P2
P1 default: Art
P2 default: CVP
Measure Pressure
Pulsatile
Mean
Select to change measure pressures for P1/P2.
Available when pressure channel is labeled P1 or
P2.
Speed
12.5 mm/s
25 mm/s (default)
Select to change invasive pressure trace speed.
Adjustments affect both IBP channels.
Passport V Operating Instructions
0070-00-0704-02
9-5
IBP Menu
IBP Monitoring (optional)
IBP Menu
MENU ITEM
SELECTIONS
COMMENTS
Scale
-10 to 10 mmHg
0 to 20 mmHg
0 to 40 mmHg
0 to 60 mmHg
0 to 80 mmHg
0 to 140 mmHg
60 to 140 mmHg
0 to 160 mmHg
0 to 225 mmHg
0 to 320 mmHg
Select to change IBP scale.
IBP Filter Setting
8 Hz
12 Hz (default)
20 Hz
Select to change IBP filter settings.
The filter setting is linked to both IBP channels.
Zero
—
Select to zero IBP channel.
Defaults:
Art: 0 to 160 mmHg
UA: 0 to 80 mmHg
LV: 0 to 160 mmHg
PA: 0 to 40 mmHg
CVP: 0 to 20 mmHg
ICP: 0 to 20 mmHg
LA: 0 to 20 mmHg
RA: 0 to 20 mmHg
P1, P2: If Measure Pressure is All, default is 0 to
160 mmHg. If Measure Pressure is Mean, default is
0 to 20 mmHg.
The IBP transducer must be zeroed before initial
measurements during setup to obtain correct
pressure value. If the transducer is not zeroed the
measured value will be displayed as "XXX".
Implement IBP zeroing when any of the following
occurs:
• Use of new sensor or sensor cables
• Reconnection of the sensor with the monitor
• After monitor restart
• Occurrence of incorrect pressure readings
"Zero ALL" key on the front panel is to zero all IBP
channels. The zero key for a single channel is
available in each IBP menu. The zero key is
disabled until zeroing is completed.
In some conditions, zeroing can not be completed,
and message shall be displayed.
• Pulsatile Pressure. Cannot Zero!
• Pressure Overrange. Cannot Zero!
9-6
0070-00-0704-02
Passport V Operating Instructions
IBP Monitoring (optional)
9.4
Measuring IBP
Measuring IBP
1. Plug the pressure transducer cable into the IBP port(s) on the left side panel.
2. The IBP1 and IBP2 waveforms will appear by default as the fifth and sixth waveforms on
the display with their associated data to the right of the waveforms. The waveforms may
be moved to another location or turned off by accessing the Display Setup Menu.
NOTE:
The arterial pressure catheter should not be used on a limb
that is being utilized for any other medical procedure. For
example, an IV Catheter, NIBP Cuff or an SpO2 sensor.
3. Connect catheter line with flushing device to a pressure transducer.
4. Zero pressure transducer as follows:
a. Open transducer vent to atmosphere.
b. Press the IPB: Zero All key on the front panel, or individually zero pressure lines
by opening individual IBP menus.
After the automatic zero process is complete, the pressure display should indicate zeros.
NOTE:
If an IBP channel zeroing failed, for Pulsatile Pressure or
Pressure Overrange, the message “Pulsatile Pressure.
Cannot Zero!” or “Pressure Overrange. Cannot Zero!” is
displayed.
5. Close the pressure transducer vent from atmosphere.
6. Select the desired pressure scale in the IBP Menu.
7. Zero and flush the pressure line at regular intervals per standard hospital procedure.
NOTE:
Passport V Operating Instructions
Pressure transducers are protected against the effects of
defibrillation and electrocautery.
0070-00-0704-02
9-7
IBP Troubleshooting
9.5
IBP Monitoring (optional)
IBP Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Damped Invasive
Waveform
Air bubbles in tubing.
Eliminate air from tubing.
Kinked catheter.
Change position of catheter,
check patient.
Catheter against wall of blood
vessel.
Check for leaks at connector, flush
catheter.
Blood in tubing.
Pump pressure bag up to 300
mmHg.
Catheter partially occluded with
clot.
Consult physician.
Improper Setup.
Check display setup in monitor
setup.
Cable not plugged in.
Check cable.
Transducer not connected.
Check transducer connection.
Stopcock turned improperly.
Check transducer.
Transducer not zeroed.
Check and zero the transducer.
IBP not Displayed / No
IBP Waveform
Dashes are displayed
The measured result is invalid or
out of range.
IBP might be set to non-pulsatile
labels like CVP, LA, RA, and ICP.
9-8
Abnormally High or Low
readings
Transducer too HIGH or to LOW.
Check patient adjust transducer
rezero.
Unable to Zero
Stopcock not open to
atmosphere.
Check transducer.
0070-00-0704-02
Passport V Operating Instructions
10.0
CO2 Monitoring (optional)
10.1
Description
Intended patient types: Adult, Pediatric, Neonatal. The Passport V supports the following
CO2 modules:
• Sidestream--DPM CO2 module (M02B)
• Microstream--Oridion Medical miniMediCO2 module
The Passport V provides three parameters (ET CO2, InspCO2, and awRR) and a CO2
waveform for CO2 measurement.
Passport V Operating Instructions
0070-00-0704-02
10 - 1
CO2 Screens
CO2 Monitoring (optional)
10.2
CO2 Screens
10.2.1
Numeric Tile: CO2
The CO2 numeric tile displays the following:
• Parameter name of CO2 module
• Units of measure
• Measured values of ET CO2, InspCO2 and awRR
• High and low alarm limits for ET CO2
• CO2 Source (Int. CO2 or GM)
FIGURE 10-1 CO2 Numeric Tile
10.2.2
Waveform: CO2
The CO2 waveform tile displays the following:
• Waveform
• Waveform scale values
• Unit of measurement
FIGURE 10-2 Resp Waveform Tile
10 - 2
0070- 0-0704-02
Passport V Operating Instructions
CO2 Monitoring (optional)
10.3
CO2 Menu
CO2 Menu
To display the CO2 Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 CO2
or
Select the CO2 tile.
FIGURE 10-3 CO2 Menu (DPM Sidestream CO2)
Passport V Operating Instructions
0070-00-0704-02
10 - 3
CO2 Menu
CO2 Monitoring (optional)
FIGURE 10-4 CO2 Menu (Oridion Microstream CO2)
CO2 Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to normal screen (or press
the Normal Screen key on the front
panel).
Speed
3.125 mm/s
6.25 mm/s (default)
12.5 mm/s
25 mm/s
Select to adjust waveform speed.
Scale
mmHg:
15 mmHg, 20 mmHg, 25 mmHg,
50 mmHg (default), 80 mmHg,
Select to change CO2 scale.
%:
2.0%, 2.5%, 3.5%,
7.0% (default), 10.0%
The unit of measure for CO2 can be
selected in the Installation Menu. The
choices are: mmHg, kPa and %.
kPa:
2.0kPa, 2.5kPa, 3.5kPa,
7.0kPa (default), 10.0kPa
Preferred CO2
Source
Gas Module (default)
Internal CO2 Module
If a CO2 source Module is OFF, that
Module option shall be disabled and
appear grey.
No matter if the source Module is ON or
OFF, the selection status of the preference
source shall not change.
10 - 4
0070-00-0704-02
Passport V Operating Instructions
CO2 Monitoring (optional)
CO2 Menu
CO2 Menu
MENU ITEM
SELECTIONS
Selection
COMMENTS
Gas Module 3
Status
Internal CO2
Module Status
Active CO2
Source
Gas Module
OFF
OFF
None
Gas Module
OFF
ON
Internal CO2 Module
Gas Module
ON
OFF
Gas Module
Gas Module
ON
ON
Gas Module
Internal CO2
Module
OFF
OFF
None
Internal CO2
Module
OFF
ON
Internal CO2 Module
Internal CO2
Module
ON
OFF
Gas Module
Internal CO2
Module
ON
ON
Internal CO2 Module
Note: ON/OFF Status of the Module:
If the Gas Module is connected to a serial port configured to ‘Gas Module’, and
the power is switched on, the module is considered to be ON. Otherwise it is
considered to be OFF.
If the Oridion CO2 Module is installed and a Filterline is connected, the module
is considered to be ON. Otherwise it is considered to be OFF.
If the DPM CO2 Module and water trap are installed, the module is considered
to be ON, Otherwise it is considered to be OFF.
Flow Rate
10.3.1
70 ml/min
100 ml/min (default)
120 ml/min
150 ml/min
Applicable to DPM Sidestream CO2
module only.
Note: For Oridion Microstream CO2, the
flow rate is 50ml/min. It is not user
adjustable.
CO2 Setup Menu (DPM Sidestream Only)
To display the CO2 Setup Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
On the normal screen:
Select Parameters
〉 CO2 〉 CO2 Setup
or
Select the CO2 tile
〉 CO2 Setup.
NOTE:
To extend the lifetime of the watertrap and module,
disconnect the watertrap and set the operating mode to
Standby mode when CO2 monitoring is not required.
NOTE:
The watertrap collects water drops condensed in the
sampling line and therefore prevents them from entering
the module. It is important to periodically drain the
watertrap to avoid water blocking the airway.
Passport V Operating Instructions
0070-00-0704-02
10 - 5
CO2 Menu
CO2 Monitoring (optional)
NOTE:
The watertrap has a filter to prevent bacterium, water, and
secretions from entering the module. After long-term use,
dust or other substances may compromise the performance
of the filter or even block the airway. In this case, replace
the watertrap. It is recommended to replace the watertrap
once every month, or when the watertrap is found leaky,
damaged, or contaminated.
FIGURE 10-5 CO2 Setup Menu (DPM Sidestream Only)
CO2 Setup Menu (DPM Sidestream Only)
MENU ITEM
SELECTIONS
COMMENTS
Previous Screen
—
Select to return to the previous menu.
Humidity
Compensation
On
Off (default)
Select On for Body Temperature Pressure
Saturation (BTPS).
Select Off for Ambient Temperature and Pressure
Dry (ATPD).
Note: If using the Oridion Medical
miniMediCO2 module, the humidity
compensation is always on.
O2
Compensation
0 (default) to 100%
Select the O2 level used for O2 compensation.
Note: The sum of compensation values input for
oxygen, nitrous oxide and desflurane must not
be greater than 100%.
10 - 6
0070-00-0704-02
Passport V Operating Instructions
CO2 Monitoring (optional)
CO2 Menu
CO2 Setup Menu (DPM Sidestream Only)
MENU ITEM
SELECTIONS
COMMENTS
N2 O
Compensation
0 (default) to 100%
Select the N2O level used for N2O
compensation.
Note: The sum of compensation values input for
oxygen, nitrous oxide and desflurane must not
be greater than 100%.
Desflurane
Compensation
0 (default) to 24%
Select the Des level used for Des compensation.
Note: The sum of compensation values input for
oxygen, nitrous oxide and desflurane must not
be greater than 100%.
10.3.2
Microstream® CO2 Monitoring (Optional)
Microstream CO2 modules provide Expired CO2, Inspired CO2 and Respiration Rate
monitoring utilizing a small lumen FilterLine®. Microstream capnography is accomplished via
a nasal cannula (non-intubated) or through an adapter set for use in a breathing circuit
(intubated). Microstream can be used on adult, pediatric and neonatal patients.
WARNING: When monitoring an anesthesized patient in an operating
room environment, connection from the exhaust port of the
Passport V to the hospital’s waste gas scavenging system is
recommended to prevent exposure of hospital personnel to
the patient’s respiratory sample.
To begin monitoring Microstream CO2:
1. Open CO2 input door and connect the proper FilterLine® to the Monitor. Connect the
opposite end to the patient.
NOTE:
Ensure all tubing connections are secure.
NOTE:
Consideration should be given to the disposal of packaging
waste.
CAUTION:
When connecting a sampling line to the monitor, screw the
sampling line connecter clockwise into the monitor CO2 port
until it can no longer be turned to ensure that it is connected
securely to the monitor. This will assure that there is no leak
of gases during measurement at the connection point and
that measurement accuracy is not compromised. Loose or
damaged connections may compromise ventilation or cause
an inaccurate measurement of respiratory gases. Securely
connect all components and check connections for leaks
according to standard clinical procedures.
CAUTION:
If too much moisture enters the sampling line (i.e., from
ambient humidity or breathing of unusually humid air), the
message “Clearing FilterLine” will appear in the message
area. If the sampling line cannot be cleared, the message
“FilterLine Blockage” will appear in the message area.
Replace the sampling line once the “FilterLine Blockage”
message appears.
Passport V Operating Instructions
0070-00-0704-02
10 - 7
CO2 Troubleshooting
10.4
CO2 Monitoring (optional)
CO2 Troubleshooting
Refer to Chapter 14.0 Messages for Physiological Alarm Messages, Technical Alarm
Messages, and Prompt Messages.
10 - 8
0070-00-0704-02
Passport V Operating Instructions
11.0
Gas Monitoring (optional)
11.1
Description
The Gas Module functionality is applicable to adult, pediatric and neonatal patients.
The indications for use for the Gas Module include monitoring of airway gases during
anesthesia and/or assisted respiration. The intended environment of use is the anesthesia
department, including the Operating Room (OR), post anesthesia care units (PACU), and
equivalent.
Refer to the Gas Module Operating Instructions (0070-00-0696-XX) for further operation and
performance specifications.
The Passport V supports the Artema Gas Module-3. Anesthetic gases are identified
automatically.
• Passport V
The following parameters are measured:
• Expired (Et) and inspired (Insp) values for CO2, N2O, O2, and Agent
• MAC value
• awRR
CO2, O2 and Agent waveforms are displayed.
The Gas Module measures the inspired and expired concentrations of anesthetic gases, O2,
N2O and CO2 for display in a numeric tile. The inspired and expired concentrations of CO2
are displayed in the CO2 tile. Measurements can be acquired via a nasal cannula (nonintubated) for oxygen and CO2 only or through a sampling line connected to a breathing
circuit (intubated).
Passport V Operating Instructions
0070-00-0704-02
11 - 1
Description
Gas Monitoring (optional)
The Minimum Alveolar Concentration (MAC) is also displayed in the Gas tile. MAC is a
calculated value defined in ISO 21647:2004(E) as follows:
MAC - alveolar concentration of an inhaled anesthetic agent that, in the
absence of other anesthetic agents and at equilibrium, prevents 50% of
subjects from moving in response to a standard surgical stimulus.
The MAC value is calculated using the following formula:
% (ET AA) % (ET N2O)
MAC (AA) = --------------------------------------------- + ----------------------------------------------------x(AA)
x(N2O)
where AA is the anesthetic agent in use, ET AA is the end-tidal agent concentration, x(AA) is
a clinically-derived coefficient based on anesthetic agent (known as 1MAC values), ET N2O
is the end-tidal N2O concentration and x(N2O) is a clinically-derived coefficient for N2O
(also known as the 1MAC value). From ISO 21647:2004(E), the 1MAC values used in the
calculation are:
HALOGENATED AGENT
1MAC
(IN OXYGEN)
% VOLUME FRACTION
Halothane
0.77
Enflurane
1.7
Isoflurane
1.15
Desflurane
7.3
Sevoflurane
2.1
N2O
105
With the exception of Desflurane, the 1MAC values shown in this
table apply to an age sample of 40-years-old. The Desflurane 1MAC
value applies to an age sample of 25-years-old.
11 - 2
NOTE:
The calculated MAC value is not corrected for ambient
pressure (altitude & barometric effects), patient age, patient
core temperature or any other individual factors influencing
the effect of volatile anesthetic agents.
NOTE:
If mixed agents are detected, the MAC value is invalidated
(displayed as dashes).
0070-00-0704-02
Passport V Operating Instructions
Gas Monitoring (optional)
11.2
Gas Screens
Gas Screens
To display the desired numeric and waveform tiles:
1. From the normal screen, select Monitor Setup
〉 Display Setup.
2. Rotate the Navigator Knob to the desired tile location and press the knob to open a
selection of parameters.
3. Rotate the Navigator Knob to the desired parameter and press the knob to select it.
11.2.1
CO2 Numeric Tile
The CO2 Numeric Tile displays the following:
• CO2 parameter name
• Inspired measurement of CO2
• Expiratory measurement of CO2
• CO2 unit of measurement
• Insp/ET labels
• Alarm limits
• Respiration Source
• Respiration Rate measurement
• Respiration Rate unit of measurement
FIGURE 11-1 CO2 Numeric Tile
11.2.2
Gas Numeric Tile
The Gas Numeric Tile displays the following:
• Gas parameter name;
• Insp and Exp labels for Agent, O2, and N2O
• Units of measurement for Agent, O2, and N2O
• Measured Values for Agent, O2, and N2O
• MAC Label
• Measured value of MAC
Passport V Operating Instructions
0070-00-0704-02
11 - 3
Gas Screens
Gas Monitoring (optional)
FIGURE 11-2 Gas Numeric Tile
11.2.3
Gas Waveform
The CO2, O2, or Anesthetic Agent waveform tile displays the following:
• Waveform
• Scale Values
• Unit of measurement
FIGURE 11-3 Gas waveform (CO2)
11 - 4
0070-00-0704-02
Passport V Operating Instructions
Gas Monitoring (optional)
11.3
Gas Menu
Gas Menu
To display the Gas Menu:
1. On the front panel:
Press the Normal Screen key to return to the normal screen.
2. On the normal screen:
Select Parameters 〉 Gas
or
Select the O2, N2O, or Gas tile
FIGURE 11-4 Gas Menu
Gas Menu
MENU ITEM
SELECTIONS
COMMENTS
Normal Screen
—
Select to return to Normal Screen (or press the
Normal Screen key on the front panel).
Speed
3.125mm/s
6.25mm/s (default)
12.5mm/s
25mm/s
Select to change respiration trace speed.
The CO2, Gas, and O2 waveform speed settings
change simultaneously.
Agent Scale
1%
2.5%
5%
10% (default)
15%
20%
Select to change agent scale.
The lower limit of all of the gas waveform scales is
fixed to "0". The upper limit of the gas waveform
scale is user adjustable.
O2 Scale
30%
60%
100% (default)
Select to change O2 scale.
The lower limit of all of the O2 waveform scales is
fixed to "0". The upper limit of the O2 waveform
scale is user adjustable.
Passport V Operating Instructions
0070-00-0704-02
11 - 5
Gas Menu
Gas Monitoring (optional)
Gas Menu
MENU ITEM
SELECTIONS
COMMENTS
Mixed Agent
Audio
On (default)
Off
Select to turn mixed agents audio alarm on or off.
On: If Mixed agents are detected, the “Mixed
Agent” alarm tone will sound.
Off: If Mixed agents are detected, the “Mixed
Agent” alarm tone will not sound.
Pump Restart
Select to restart the Gas Module pump.
This selection is not available while the pump is
functioning normally.
The system shuts off the pump and gives a pump off
alarm when a pneumatic error occurs.
The pump can be restarted manually after the pump
is shut off.
Zero Gases
Select to zero gas module.
Zeroing is performed to eliminate the effects of
baseline drift occurring during measurement.
Manual zeroing is supported.
A zeroing prompt should be provided during
zeroing. A zeroing error alarm should be given in
the case of zeroing failure.
11.3.1
Measure Unit
The unit of measurement for CO2 can be manually selected in the Installation Menu. The
choices are: mmHg, %, and kPa. The unit of measurement for O2, N2O and Anesthetic
Agent is %.
11.3.2
Automatic identification of Anesthetic Agents
If Mixed Agents are identified, then the MAC value are invalidated and dashes are
displayed. The actual value of primary agent concentration,N2O, CO2 and O2 data is
displayed as usual.
When the Anesthetic Agent is not identified the agent is labeled as "AGENT", no Anesthetic
Agent related physiological alarms are activated.
Menus and the corresponding display areas are refreshed once the Anesthetic Agent is
identified.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min (120 ml/min for Gas
Module 3 with a neonatal water trap). This device should
not be used on patients whose breathing could be impaired
by this vacuum flow rate.
NOTE:
11 - 6
The Gas Module 3 is equipped with automatic barometric
pressure compensation.
0070-00-0704-02
Passport V Operating Instructions
Gas Monitoring (optional)
Gas Menu
NOTE:
The Gas Module 3 uses a fixed correction of 11 hPa to
compensate for the influence of water vapor in the gas
sample, when converting the gas readings to ATPD. An
increase in the ambient H2O partial pressure to 30 hPa
(i.e. 28 °C, 80% RH or 33 °C, and 60% RH) will cause a
general error for all gases of only -2% REL.
Monitoring Anesthetic Gases, O2, N2O and/or CO2
NOTE:
To prevent moisture from entering the pneumatic system,
ensure that the Gas Module is always installed and
operated in the horizontal orientation shown in all graphical
depictions.
1. Power ON the Gas Module.
2. Power ON the patient monitor while holding down the Discharge key to enter into its
Installation Mode.
3. From the patient monitor Installation Menu, set the correct serial port to “Gas
Module” and then select “Save Current”.
4. Restart the patient monitor to enter normal monitoring mode.
5. Set alarms as desired.
NOTE:
DRYLINE™ Sample Lines are for use with Gas Module 3 only.
6. For non-intubated patients, apply the nasal cannula to the patient. For intubated patients
connect the sample line to the breathing circuit. Refer to instruction provided in the
sample line packets.
7. Connect the other end of the nasal cannula or sample line to the Gas Module at the
input port.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenging system is strongly recommended to
prevent exposure of hospital personnel to the patient’s
respiratory sample. Vacuum (negative pressure) should not
exceed 1 mmHg at the Gas Module Pump Exhaust fitting.
Excessive scavenge vacuum may result in damage to the
Gas Module’s internal pump.
CAUTION:
Contamination with CO2, N2O or Anesthetic Agent in the air
surrounding the Gas Module may cause significant
measurement errors. The Gas Module exhaust output
should be connected to a medical gas-scavenging system.
8. Check for a clean water trap.
9. Observe the capnogram on the monitor’s display. On Passport V powerup, O2, Agent
and N2O numbers will display. CO2 numbers will be displayed when a valid breath is
detected.
NOTE:
The Gas Module 3 must be warmed up a minimum of 45
seconds for ISO accurate CO2, O2, N2O, and agent readings.
NOTE:
Consideration should be given to the disposal of packaging
waste.
Passport V Operating Instructions
0070-00-0704-02
11 - 7
Gas Module Troubleshooting
Gas Monitoring (optional)
10. If not already set, use the Display Setup Menu to select the gas waveforms to be
displayed.
11. If desired, the gas waveform speed and scale can be changed in the Gas Menu.
11.3.3
Gas Module 3 Pre-use Test
Prior to each use, perform the following test with the Gas Module 3 to verify that the gas
analyzer and sample system are functioning properly:
1. Verify that the appropriate water trap is properly installed and that the appropriate
sampling line is connected.
• DRYLINE™ Adult/Pediatric water trap used with DRYLINE™ Adult/Pediatric sampling
line (colorless Luer lock nut)
• DRYLINE™ Neonatal water trap used with DRYLINE™ Neonatal sampling line (blue
Luer lock nut)
2. Verify that the water trap container is less than half full.
3. Occlude the sampling line and verify that the occlusion alarm functions properly.
4. Breathe into the sampling line and verify that a CO2 waveform is correctly displayed on
the monitor.
5. Sample room air for 30 seconds and verify that the monitor oxygen output is 21%
(± sensor inaccuracy).
11.4
Gas Module Troubleshooting
Refer to Chapter 14.0 Messages for Physiological Alarm Messages, Technical Alarm
Messages, and Prompt Messages.
11 - 8
0070-00-0704-02
Passport V Operating Instructions
12.0
Drug Calculations
12.1
Description
The Passport V supports drug calculations, accessible through the Functions Menu.
The Drug Calculator selection opens the (IV) Drug Calculation Menu. This menu
calculates both the infusion rate and the concentration rate of IV medications.
12.1.1
Drug Calculations
The Passport V has the ability to calculate and display IV drug infusion rate and
concentration based upon patient weight and/or drug dosage.
Drug calculations may also be accessed through the Patient Menu. Drug calculations are
only available if the Patient Size is set to Adult.
Drug Calculation Formulas
For Drug Concentration, the Passport V uses the following formula:
( Drug Amount)
------------------------------------------------------- = Concentration
( Solution Volume)
For a weight-based Drug Infusion Rate, the Passport V uses the following formula:
(Dose
---------------------Ordered)
------------------------------x-----(Weight
----------------------------in
--------kg)
-----------x------(Solution
-----------------------------Volume)
------------------------ = Infusion Rate ( ml/hr )
(Drug Amount)
For a non-weight-based Drug Infusion Rate, the Passport V uses the following formula:
( Dose Ordered) x (Solution Volume)
------------------------------------------------------------------------------------------------------------------ = Infusion Rate ( ml/hr )
( Drug Amount)
Passport V Operating Instructions
0070-00-0704-02
12 - 1
Description
Drug Calculations
Drug Calculator
When “Drug Calculator” is chosen from the Patient Menu or the Functions Menu, the
Drug Calculator is displayed. An example Drug Calculator that is set for a weightbased drug is shown in FIGURE 12-1.
FIGURE 12-1 Drug Calculator set for a weight-based drug
The following table describes the menu structure of the Drug Calculator:
Drug Calculator Menu Structure
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Normal Screen
Select to return to normal
screen (or press the
Normal Screen key on
the front panel).
Drug Name
See the “GENERIC
NAME” and “BRAND
NAME” columns of the
table in the Adult
Medication Choices
subsection. The Drug A –
D choices are for drugs
that are not listed in the
table.
Unspecified
Select to choose
medication.
Weight
1 to 1100 lbs or
1 to 500 kg
Unspecified
Select to enter or change
patient weight.
*
12 - 2
ACTIONS/
COMMENTS
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
0070-00-0704-02
Passport V Operating Instructions
Drug Calculations
Description
Drug Calculator Menu Structure (Continued)
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Drug Units
mcg, mg, g, units, mU
mcg for Drug A, B,
C or D. For drugs
listed in the table in
the Adult
Medication
Choices
subsection, see the
“DEFAULT UNITS”
column.
ACTIONS/
COMMENTS
Select to change drug
units.
This menu item is only
selectable if Drug A, B, C
or D is chosen.
Otherwise, the default
unit for the specified drug
is used. If Drug Units are
changed for Drug A, B,
C or D, Drug Amount,
Solution Volume, Dose/
min, Dose/hr, Dose/kg/
min and Dose/kg/hr will
be reset to blank fields
and Infusion Rate and
Concentration will be
invalidated.
Drug Amount
Based on current Drug
Units setting.
Select to enter amount of
drug in IV bag.
Solution Volume
10 to 1000 ml
Select to enter volume of
solution in IV bag.
Dose/min*
0.01 to 10000.00
If the chosen drug is
Vasopressin, the
Default is 0.200
Select to enter dosage of
drug to be infused per
minute.
For all other drugs,
the Default is 1.00
Dose/hr*
0.01 to 10000.00
If the chosen drug is
Vasopressin, the
Default is 12.00
Select to enter dosage of
drug to be infused per
hour.
For all other drugs,
the Default is 60.00
Dose/kg/min*
Dose/kg/hr*
If the chosen drug is
Milrinone, 0.005 to
2.000
If the chosen drug is
Milrinone, the
Default is 0.375
For all other drugs, 0.01
to 10000.00
For all other drugs,
the Default is 1.00
If the chosen drug is
Milrinone, 0.300 to
120.000
If the chosen drug is
Milrinone, the
Default is 22.500
For all other drugs, 0.01
to 10000.00
For all other drugs,
the Default is 60.00
Infusion Rate
*
Select to enter dosage of
drug to be infused per
minute based upon
patient weight. Please
verify patient weight.
Select to enter dosage of
drug to be infused per
hour based upon patient
weight. Please verify
patient weight.
This menu item is
automatically calculated
as previously described
in this section using the
values entered for other
menu items.
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
Passport V Operating Instructions
0070-00-0704-02
12 - 3
Description
Drug Calculations
Drug Calculator Menu Structure (Continued)
MENU TITLE
ON SCREEN
MENU CHOICES
DEFAULT
Concentration
Print Units
ACTIONS/
COMMENTS
This menu item is
automatically calculated
as previously described
in this section using the
values entered for other
menu items.
Dose/min, Dose/hr,
Dose/kg/min, Dose/kg/
hr
Dose/kg/min
(when the chosen
drug is weightbased)
Select to choose which
unit of measurement will
be printed when you
select Print Table.
Dose/min (when the
chosen drug is nonweight-based)
This menu item is
automatically populated
with the appropriate
default when: 1) a Drug
Name is chosen, 2) the
patient Weight is
specified (for a weightbased drug), and
3) Dose/min, Dose/hr,
Dose/kg/min or Dose/
kg/hr is specified.
If the dose is entered as
Dose/min, then the menu
choices will be Dose/min
or Dose/hr.
If the dose is entered as
Dose/kg/min, then the
menu choices will be
Dose/kg/min or Dose/
kg/hr.
If the dose is entered as
Dose/hr, then Dose/hr
will be the only menu
choice for the Print Units.
If the dose is entered as
Dose/kg/hr, then Dose/
kg/hr will be the only
menu choice for the Print
Units.
If the chosen drug is
Milrinone, then Dose/
kg/min will be the only
menu choice for the Print
Units.
Print Table
*
12 - 4
Select to print Drug
Calculation data.
When any one of the menu items marked with an asterisk (*) is changed, the others are
automatically updated.
0070-00-0704-02
Passport V Operating Instructions
Drug Calculations
Description
The following table details adult medication choices:
Adult Medication Choices
IS THE PATIENT’S
WEIGHT USED IN
THE
CALCULATION?
DEFAULT
UNITS
DEFAULT
SOLUTION
VOLUME
DEFAULT
DRUG
AMOUNT
GENERIC
NAME
BRAND NAME
Aminophylline1
Theophylline
Y
mg
500 ml
500 mg
Diltiazem1
Cardizem
N
mg
125 ml
125 mg
Dobutamine1
Dobutrex
Y
mcg
250 ml
500 mg
Dopamine1
Inotropin
Y
mcg
250 ml
400 mg
Epinephrine
HCL1
Adrenalin
N
mcg
250 ml
1mg
Esmolol HCL1,2
Brevibloc
Y
mcg
500 ml
5000 mg
Fentanyl Citrate1
Sublimaze
Y
mcg
100 ml
5 mg
1
Heparin
N
units
250 ml
12,500 units
Inamrinone
Lactate1
Inocor
Y
mcg
250 ml
500 mg
Insulin, Regular1
Humulin
N
units
100 ml
100 units
Isoproterenol
HCL1
Isuprel HCL
N
mcg
500 ml
2 mg
Labetalol HCL1,2
Normodyne
N
mg
200 ml
200 mg
Lidocaine HCL1,2
Xylocaine HCL
N
mg
500 ml
2000 mg
Lorazepam
Ativan
N
mg
500 ml
40 mg
Midazolam
HCL1,2
Versed
Y
mg
125 ml
125 mg
Milrinone
Lactate1,2
Primacor
Y
mcg
200 ml
20 mg
Nicardipine
HCL1
Cardene
N
mg
250 ml
25 mg
Nitroglycerin1
Tridil
N
mcg
250 ml
50 mg
Nitroprusside
Sodium1
Nipride
Y
mcg
250 ml
50 mg
Norepinephrine1
Levophed
N
mcg
250 ml
4 mg
Phenylephrine1
Neosynephrine
N
mcg
250 ml
10 mg
Procainamide
HCL1
Pronestyl
N
mg
500 ml
2000 mg
Propofol1
Diprivan
Y
mcg
50 ml
500 mg
Vasopressin2
Pitressin
N
units
250 ml
250 units
Heparin Sodium
1
2
Gahart B and Nazareno A. 2002 Intravenous Medications. St. Louis: Mosby, 2001.
Algozzine G, Algozzine R, and Lilly D. Critical Care Intravenous Infusion Drug Handbook.
St. Louis: Mosby, 2002.
Passport V Operating Instructions
0070-00-0704-02
12 - 5
Description
Drug Calculations
This page intentionally left blank.
12 - 6
0070-00-0704-02
Passport V Operating Instructions
13.0
13.1
Alarms
Alarms
The Passport V monitor provides a broad range of alarm settings.
FIGURE 13-1 Alarm Settings Menu
13.1.1
Adjusting Alarms
WARNING: The user should check that the current alarm settings on the
Passport V monitor are appropriate prior to use on each
patient.
Passport V Operating Instructions
0070-00-0704-02
13 - 1
Alarms
Alarms
Setting Parameter Alarm Limits
1. To access the Alarms Settings Menu press the ALARMS LIMITS key. The main
Alarm Settings Menu displays.
2. Use the Navigator Knob to set alarm limits as desired for currently monitored
parameters.
NOTE:
Alarm Limits are not saved when the monitor is turned off
for more than 2 minutes, unless you select Save Current
from the Advanced Setup Menu.
3. The Alarm Setup menu also provides options for setting alarm delay times and alarm
silence features.
FIGURE 13-2 Alarm Setup Menu
Alarm Setup Menu
MENU ITEM
SELECTIONS
COMMENTS
Show Limits
Off (default)
On
Select to display or remove alarm limits from
parameter files.
Silence For
1 min
2 min (default)
3 min*
5 min*
10 min*
Select to choose time period for an individual
alarm to be silenced.
Silence All For
Permanent*
1 min
2 min (default)
3 min*
5 min*
10 min*
Select to choose time period for all alarms to be
silenced.
Central Silence
Off (default)
On (default)
Select to control audio alarm at central activated
by Silence key.
Previous Menu
*
13 - 2
Select to return to previous menu.
These selections will not be available if the language chosen in the Installation Menu is French.
0070-00-0704-02
Passport V Operating Instructions
Alarms
Alarms
Alarm Setup Menu
MENU ITEM
SELECTIONS
COMMENTS
Alarm Delay
None (default)
1 second
2 seconds
3 seconds
4 seconds
5 seconds
6 seconds
7 seconds
8 seconds
Select to adjust audio alarm delay time.
Apnea Delay
10 seconds
15 seconds
20 seconds (default)
25 seconds
30 seconds
35 seconds
40 seconds
45 seconds
50 seconds
55 seconds
1 min
Select to adjust apnea delay time.
ST Alarm Delay
30 seconds (default)
45 seconds
1 min
90 seconds
2 min
3 min
Select to adjust ST alarm delay time.
*
13.1.2
These selections will not be available if the language chosen in the Installation Menu is French.
Alarm Limits
A separate table of alarm limit settings is maintained for each patient size. When the patient
size is changed, the corresponding selections are automatically used. See table below for
alarm ranges. Default settings appear in bold text
FIGURE 13-3 Alarm Settings Menu - Set Limits
Passport V Operating Instructions
0070-00-0704-02
13 - 3
Alarms
Alarms
HIGH
LOW
PARAMETERS
ADULT
PED
NEONATE
ADULT
PED
NEONATE
HR (bpm)
Except France
150, Off,
60-250
180, Off,
100-300
200, Off,
100-350
50, Off,
30-120
80, Off,
30-150
100, Off,
30-200
HR (bpm)
France
120, Dés,
60-250
150, Dés,
100-300
175, Dés,
100-350
30, Dés,
30-120
50, Dés,
30-150
70, Dés,
30-200
ST Single
Lead (mm)
Off,
+0.5 to
+10.0
Off,
+0.5 to
+10.0
—
Off,
-0.5 to
-10.0
Off,
-0.5 to
-10.0
—
ST Dual
Lead (mm)
Off,
+0.5 to
+10.0
Off,
+0.5 to
+10.0
—
Off,
-0.5 to
-10.0
Off,
-0.5 to
-10.0
—
SpO2 (%)
Off,
80-100
Off,
80-100
Off,
80-100
85,
76-99
90,
76-99
92,
76-99
Desat (%)
—
—
—
80,
75-98
80,
75-98
80,
75-98
Resp (RPM)
Off,
10-100
Off,
15-150
Off,
30-200
Off,
5-30
Off,
5-40
Off,
5-50
NIBP Sys (mmHg)
Off,
70-240
Off,
40-180
Off,
40-180
Off,
50-150
Off,
15-130
Off,
15-130
NIBP Dia (mmHg)
Off,
40-130
Off,
50-100
Off,
50-100
Off,
30-120
Off,
10-50
Off,
10-50
NIBP Mean
(mmHg)
Off,
60-200
Off,
50-180
Off,
40-160
Off,
40-140
Off,
10-100
Off,
10-70
Temp (ºF)
Off,
95-110
Off,
95-110
Off,
95-110
Off,
80-100
Off,
80-100
Off,
80-100
Temp (ºC)
Off,
35-43
Off,
35-43
Off,
35-43
Off,
26-38
Off,
26-38
Off,
26-38
IBP1 Sys (mmHg)
Off,
5-300
Off,
5-240
Off,
5-180
Off,
0-150
Off,
0-130
Off,
0-130
IBP1 Dia (mmHg)
Off,
0-140
Off,
0-100
Off,
0-70
Off,
0-120
Off,
0-100
Off,
0-50
IBP1 Mean
(mmHg)
Off,
5-150
Off,
5-100
Off,
5-100
Off,
2-100
Off,
2-50
Off,
2-50
IBP2 Sys (mmHg)
Off,
5-300
Off,
5-240
Off,
5-180
Off,
0-150
Off,
0-130
Off,
0-130
IBP2 Dia (mmHg)
Off,
0-140
Off,
0-100
Off,
0-70
Off,
0-120
Off,
0-100
Off,
0-50
IBP2 Mean
(mmHg)
Off,
5-150
Off,
5-100
Off,
5-100
Off,
2-100
Off,
2-50
Off,
2-50
ET CO2 (mmHg)
60, Off,
20-80
60, Off,
20-80
60, Off,
20-80
Off,
5-50
Off,
5-50
Off,
5-50
ET CO2 (%)
8.0, Off,
2.0-10.0
8.0, Off,
2.0-10.0
8.0, Off,
2.0-10.0
Off,
1.0-6.0
Off,
1.0-6.0
Off,
1.0-6.0
ET CO2 (kPa)
8.0, Off,
2.0-10.0
8.0, Off,
2.0-10.0
8.0, Off,
2.0-10.0
Off,
1.0-6.0
Off,
1.0-6.0
Off,
1.0-6.0
Insp CO2 (mmHg)
10
Off, 5-30
10
Off, 5-30
10
Off, 5-30
—
—
—
Default values in bold.
13 - 4
0070-00-0704-02
Passport V Operating Instructions
Alarms
Alarms
HIGH
LOW
PARAMETERS
ADULT
PED
NEONATE
ADULT
PED
NEONATE
Insp CO2 (%)
1.0, Off,
1.0-4.0
1.0, Off,
1.0-4.0
1.0, Off,
1.0-4.0
—
—
—
Insp CO2 (kPa)
1.0, Off,
1.0-4.0
1.0, Off,
1.0-4.0
1.0, Off,
1.0-4.0
—
—
—
ET O2 (%)
Off,
40-100
Off,
40-100
Off,
40-100
Off,
10-60
Off,
10-60
Off,
10-60
Insp O2 (%)
Off,
40-100
Off,
40-100
Off,
40-100
18-60
18-60
18-60
ET N2O (%)
Off,
10-80
Off,
10-80
Off,
10-80
Off,
5-70
Off,
5-70
Off,
5-70
Insp N2O (%)
80,
Off,10-80
80,
Off,10-80
80,
Off,10-80
Off,
5-70
Off,
5-70
Off,
5-70
ET Des (%)
Off,
2.0-20.0
Off,
2.0-20.0
Off,
2.0-20.0
Off,
0.5-10.0
Off,
0.5-10.0
Off,
0.5-10.0
Insp Des (%)
Off,
2.0-20.0
Off,
2.0-20.0
Off,
2.0-20.0
Off,
0.5-10.0
Off,
0.5-10.0
Off,
0.5-10.0
ET Hal (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
Insp Hal (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
ET Iso (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
Insp Iso (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
ET Enf (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
Insp Enf (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
ET Sev (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
Insp Sev (%)
Off,
2.0-10.0
Off,
2.0-10.0
Off,
2.0-10.0
Off,
0.5-5.0
Off,
0.5-5.0
Off,
0.5-5.0
Default values in bold.
13.1.3
Auto Set Alarms
The alarm Auto Set function automatically sets High and Low alarm limits for active
parameters as follows:
• +/- 20% of the absolute value for: CO2, Gases, IBP’s and NIBP
• +/- 30% of the value for: HR and Respiration
• +/- 3.0% of the value for: Temperature
When Auto Set is chosen from the Alarm Settings Menu, a Confirmation Dialog is
displayed. Choosing Yes will initiate the alarm Auto Set.
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13 - 5
Alarms
13.1.4
Alarms
Alarm Violations
Passport V alarm violations are classified by severity:
For priority 1 “Warning” alarms,
• The red alarm light flashes.
• The data in violation of the alarm flashes over a red background.
• The priority 1 audio alarm sounds. The priority 1 audio alarm is a pattern of 10 tones
repeated every 10 seconds.
For priority 2 “Caution” alarms,
• The yellow alarm light flashes.
• The data in violation of the alarm flashes over a yellow background.
• The priority 2 audio alarm sounds. The priority 2 audio alarm is a pattern of 3 tones
repeated every 10 seconds.
If the “Print on Alarm” feature has been enabled and a priority 1 or priority 2 alarm violation
occurs,
• The local printer will print a strip of up to two (2) waveforms on a Print on Alarm. The
print length of the strip (16 or 32-seconds) can be set in the Print Setup menu.
• Any other printing in process at the time of the alarm will be aborted.
• An alarm recording is stored in the message queue if the alarm happened when a
recording is preceding.
• An asterisk (*) will be marked after the corresponding parameter value.
For priority 3 “Technical” alarms, SpO2 Sensor Off, and Low Battery:
• The description of the alarm appears over a light blue background in message area A.
• The priority 3 audio sounds:
For Technical alarms: The priority 3 audio alarm is a single tone repeated every 10
seconds.
For SpO2 Sensor Off: When enabled in Installation Mode, the sensor off audio signal is
a pattern of 3 quick tones. The signal may be set to repeat.
For Low battery: The low battery audio signal is a pattern of 2 tones repeated every 20
seconds.
NOTE:
Priority 3 also includes Prompt messages. However, these
are informational messages and not alarm messages.
13 - 6
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Passport V Operating Instructions
Alarms
Alarms
A. Parameter Alarms
Individual alarm levels are adjustable for most of the parameters Passport V is capable of
monitoring. In addition, these alarms may be set by the user to either priority level 1 or 2 as
desired.
NOTE:
The Heart Rate Alarm can be triggered only by the source
identified in the Heart Rate data tile. In some circumstances,
the pulse rate displayed in the SpO2 data tile may differ
from the heart rate displayed in the heart rate data tile.
When the Passport V detects that the SpO2 pulse rate is in
violation of the heart rate limit settings, the pulse rate data
will flash over a red background, but the audio alarm will
not sound.
B. Invalid Heart Rate Alarm
The Invalid Heart Rate Alarm occurs if the selected heart rate source is no longer able to
detect a heart rate. The Passport V may display a message to help identify the cause of the
alarm (e.g., “Lead Off”, “Sensor Off”). The Invalid Heart Rate Alarm is a priority 1
alarm.
C. Apnea Alarm
The Apnea Alarm is active when respiration is being monitored. The Apnea Alarm will be
triggered if respiration is not detected for a time period longer than set in the Alarm Setup
menu. The Apnea Alarm can be set as a “Latched” or “Non-latched” alarm via the
Installation Menu.
When “Apnea Latch” is set to “Off”, the Apnea Alarm will silence and cancel itself if patient
breathing is again detected.
When “Apnea Latch” is set to “On” (default), the Apnea Alarm will not be silenced unless the
operator acknowledges the alarm by pressing the Silence or Silence All keys. The visual
Apnea Alarm indications will not be cancelled unless patient breathing resumes.
The Apnea Alarm is a priority 1 alarm.
D. Arrhythmia Alarms
Arrhythmia Alarms are identified in the upper area of the screen.
“Lethal” Arrhythmia Alarms (“Asystole”, “V-Fib”, and “V-Tach”) are priority 1 alarms that are
latched. Even after the alarming condition is resolved, a latched alarm will continue until it is
acknowledged by pressing the Silence or Silence All key on the front panel keypad. If the
alarm is acknowledged while the lethal condition still exists, the audio portion of the alarm
will be silenced for the duration that is selected from the “Silence For” list in the Alarm
Setup menu, but the alarm message will continue displaying in the message area in the
upper part of the screen. If a new lethal condition occurs while the initial lethal alarm is
silenced, the new lethal alarm will not break through but not be silenced. If the lethal
condition is resolved while the alarm is silenced, the alarm will be terminated.
Passport V Operating Instructions
0070-00-0704-02
13 - 7
Alarms
Alarms
“Non-Lethal” Arrhythmia Alarms are priority 2 alarms by default. These alarms will silence
and cancel automatically if the patient's condition is corrected.
E.
ST Alarms
ST alarms can be set for either single lead alarm or dual lead alarm. The ST single lead
alarm will be initiated if one ST lead has exceeded the set alarm parameters. The ST dual
lead alarm will be initiated if two ST leads have exceeded the set alarm parameters.
ST alarms are latching alarms. They will not be silenced unless the operator acknowledges
the alarm by pressing the Silence or Silence All keys.
F.
Indications of Disabled or Silenced Alarms
ALARM OFF ICON
If any alarm for a monitored parameter is not set, an Alarm Off Icon, a triangle with an
“X” through it, will be displayed in the upper area of the screen.
VOLUME - The audio level of the alarm can be adjusted through the Monitor
Setup Menu.
ALARM SILENCE
One or more alarms can be silenced for a programmable length of time. The following is a
description of how to enable the different silence modes.
Silence - This key silences alarms on parameters for a programmed length of time (default is
2 minutes), or until the alarm condition is no longer present, whichever is shorter. Any new
alarms that occur during the silenced period will disable the silence and the alarm will sound
the tone. An Alarm Silence Icon, a bell with an “X” through it, is displayed in the upper
area of the screen. A message and digital timer counts down in the upper message area.
Pressing Silence again does not re-enable audio alarms.
Silence All - This key suspends alarms on all parameters for a programmed period of time
(default is 2 minutes). An Alarm Silence Icon, a bell with an “X” through it, is displayed in
the upper area of the screen. A message and timer appear in the upper message area
showing the time remaining. Pressing Silence All at any time re-enables audio alarm tones.
If Silence All For is set to Permanent in the Alarm Setup menu, the message All
Alarms Silenced Permanently is displayed. Note that the Permanent selection will be
available only if Enable Silence All Permanent Selection is set to “Yes” in the
Installation Menu.
The time period for Silence and Silence All is adjustable via the Alarm Setup menu.
13.1.5
Verifying Alarm Functionality
Self-Test of Alarm System
The alarm system will perform a self-test of alarm tones and alarm lights after the Passport
V monitor has been powered on.
13 - 8
0070-00-0704-02
Passport V Operating Instructions
Alarms
Alarms
Alarms also can be verified by creating an alarm condition on the Passport V and
verifying the corresponding alarm indicators are present on the monitor.
Alarm Delay
• Apnea Alarm Delay settings are: Adult/Pedatric: 10/15/20/25/30/35/40/45/50/
55 seconds, 1 min
Neonate: 10/15/20 sec
• ST Alarm Delay settings are:
30 seconds/45 seconds/ 1 min/90 seconds/2 min/3 min.
• Alarm delay settings are:
None/1s/2s/3s/4s/5s/6s/7s/8s.
Audio alarm can be delayed for a predetermined time period, with the exception of Apnea,
ST alarm, lethal Arrhythmia alarms, SpO2 Desat and Insp O2 shortage.
When alarm is triggered, the alarm tone will not be presented, but the visual signal will be
presented during delay time.
13.1.6
Alarm Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
High or Low or No Alarm
Sound
Alarm limits not set
Go to Alarm Setup and adjust
alarms
Alarm Silence All, On time has
not expired
Press SILENCE ALL to reactivate
alarms
Arrhythmia option not installed
Call Sales Rep to purchase option
No Arrhythmia
Alarm Sound
Arrhythmia Alarms off
Go to Monitor Setup 〉
Advanced Setup to activate
alarm
Monitor is in learning mode
Wait until learning is concluded
and monitor patient closely
Alarms continue to Sound
despite pressing
SILENCE
More than one alarm is active
Press SILENCE or SILENCE ALL
key to silence
No Alarm printout with
Alarm violation
Print on Alarm is set to
Suspend
Passport V Operating Instructions
Check Patient
0070-00-0704-02
Go to Print Menu and set Print
on Alarm to Active
13 - 9
Alarms
Alarms
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13 - 10
0070-00-0704-02
Passport V Operating Instructions
14.0
Messages
14.1
Physiological Alarm Messages
14.1.1
HR
14.1.2
ALARM MESSAGE
PRIORITY
COMMENTS
High Heart Rate
1
Can occur from ECG, SpO2, or IBP
measurement.
Low Heart Rate
1
Can occur from ECG, SpO2, or IBP
measurement.
Dual ST Elevation
options: 1, 2 (default)
Dual ST Depression
options: 1, 2 (default)
ST Elevation
options: 1, 2 (default)
ST Depression
options: 1, 2 (default)
High PVC/min
options: 1, 2 (default)
Occurs when Arrhythmia analysis is ON,
and PVC/min high alarm limit is not set
to Off.
ARRHYTHMIA MESSAGE
PRIORITY
COMMENTS
Asystole
1
V-Tach
1
V-Fib
1
Arrhythmia
Bigeminy
options: 1,2
Trigeminy
options: 1,2
Couplet
options: 1,2
Passport V Operating Instructions
0070-00-0704-02
14 - 1
Physiological Alarm Messages
14.1.3
Messages
Irregular HR
options: 1,2
Brady (Bradycardia)
options: 1,2
Run
options: 1,2
V-Rhythm (Ventricular Rhythm)
options: 1,2
RESP
ECG (Impedance) module, Internal CO2 module and attached GM can provide Respiration
measurement.
14.1.4
14.1.5
ALARM MESSAGE
PRIORITY
High Respiration
options: 1,2
Low Respiration
options: 1,2
Apnea
1
TEMP
ALARM MESSAGE
PRIORITY
High Temperature
options: 1,2
Low Temperature
options: 1,2
14 - 2
COMMENTS
SpO2
ALARM MESSAGE
PRIORITY
High SpO2
options: 1,2
Low SpO2
options: 1,2
SpO2 Desat
14.1.6
COMMENTS
COMMENTS
1
NIBP
ALARM MESSAGE
PRIORITY
High NIBP Diastolic
options: 1,2
Low NIBP Diastolic
options: 1,2
High NIBP Mean
options: 1,2
Low NIBP Mean
options: 1,2
High NIBP Systolic
options: 1,2
Low NIBP Systolic
options: 1,2
0070-00-0704-02
COMMENTS
Passport V Operating Instructions
Messages
14.1.7
Physiological Alarm Messages
IBP
ALARM MESSAGE
14.1.8
PRIORITY
High <IBP label> Diastolic
options: 1,2
Low <IBP label> Diastolic
options: 1,2
High <IBP label> Mean
options: 1,2
Low <IBP label> Mean
options: 1,2
High <IBP label> Systolic
options: 1,2
Low <IBP label> Systolic
options: 1,2
COMMENTS
CO2
Internal CO2 Module and attached GM can provide EtCO2 and Inspired CO2 measurement.
14.1.9
ALARM MESSAGE
PRIORITY
High Inspired CO2
options: 1,2
High End Tidal CO2
options: 1,2
Low End Tidal CO2
options: 1,2
COMMENTS
GAS
ALARM MESSAGE
PRIORITY
High End Tidal Agent
options: 1,2
Low End Tidal Agent
options: 1,2
High Inspired Agent
options: 1,2
Low Inspired Agent
options: 1,2
High End Tidal N2O
options: 1,2
Low End Tidal N2O
options: 1,2
High Inspired N2O
options: 1,2
COMMENTS
Low Inspired N2O
options: 1,2
High End Tidal O2
options: 1,2
Low End Tidal O2
options: 1,2
High Inspired O2
options: 1,2
Low Inspired O2
options: 1,2
Inspired O2 Shortage
1
GM: Mixed Agents
2
Occurs when more than one anesthetic
agent is detected by the system.
Message will disappear when a single
agent is detected again.
MAC > 3
2
Occurs when a single agent is detected
and MAC > 3.
Passport V Operating Instructions
0070-00-0704-02
14 - 3
Technical Alarm Messages
Messages
14.2
Technical Alarm Messages
14.2.1
ECG Alert Message
14.2.2
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
LA Lead Off
3
LA lead off the
patient.
Connect lead wires.
LL Lead Off
3
LL lead off the patient.
Connect lead wires.
RA Lead Off
3
RA lead off the
patient.
Connect lead wires.
V Lead Off
3
V lead off the patient.
Connect lead wires.
C Lead Off
3
C lead off the patient.
Connect lead wires.
F Lead Off
3
F lead off the patient.
Connect lead wires.
L Lead Off
3
L lead off the patient.
Connect lead wires.
R Lead Off
3
R lead off the patient.
Connect lead wires.
ECG Noise
3
External interference.
Patient movement.
Check patient
Check Electrode Contacts /
reposition electrodes /cable.
Check environment for source
of interference.
ECG Artifact
3
External Interference
Patient movement.
Check patient
Check Electrode Contacts /
reposition electrodes /cable.
Check environment for source
of interference.
HR Overrange
3
Heart rate outside of
measureable range
Check patient.
ST-<X> Overrange
3
ST deviation outside
of measureable
range.
Check patient.
ECG Weak Signal
3
ECG signals are too
weak to be analyzed.
Check ECG leads to see if
there is good contact between
the leads and the patients
skin.
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
CVA
3
Can be caused by
shallow breathing or
an apnea event.
Check the patient.
RESP Alert Message
Adjust scales or leads if
necessary.
Patient HR and
respiratory rate
identical.
14 - 4
0070-00-0704-02
Passport V Operating Instructions
Messages
14.2.3
14.2.4
Technical Alarm Messages
Resp Disturbed
3
Patient Movement
External Interference.
Check patient
For impedance - Check
Electrode Contacts /
reposition electrodes/cable
Check environment for source
of interference.
Resp Rate Overrange
3
Respiration Outside
of measureable range
Check patient.
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
Temp Overrange
3
Temperature Outside
of measureable range
Check patient,
Check sensor
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
SpO2: Sensor Off
3
Sensor Off
Check Patient, Apply Sensor
TEMP Alert Message
SpO2 Alert Message
Note that the alarm is only
active after the sensor has
been on a patient.
14.2.5
SpO2: Overrange
3
SpO2 outside of
measurable range
Check patient
SpO2: PR Overrange
3
PR outside of
measurable range
Check patient
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
NIBP: Systolic Overrange
3
NIBP systolic pressure
exceeds the
measurement range.
Check Patient.
Ensure that the measured
pressure label is within the
measurement range.
NIBP: Diastolic Overrange
3
NIBP diastolic
pressure exceeds the
measurement range.
Check Patient.
Ensure that the measured
pressure label is within the
measurement range.
NIBP: Mean Overrange
3
NIBP mean pressure
exceeds the
measurement range.
Check Patient.
Ensure that the measured
pressure label is within the
measurement range.
NIBP Alert Message
Passport V Operating Instructions
0070-00-0704-02
14 - 5
Technical Alarm Messages
14.2.6
14.2.7
14.2.8
Messages
IBP Alert Message
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
<IBP Label>: Systolic
Overrange
3
IBP systolic pressure
exceeds the
measurement range.
Ensure that the measured
pressure label is within the
measurement range.
<IBP Label>: Diastolic
Overrange
3
IBP diastolic pressure
exceeds the
measurement range.
Ensure that the measured
pressure label is within the
measurement range.
<IBP Label>: Mean
Overrange
3
IBP mean pressure
exceeds the
measurement range.
Ensure that the measured
pressure label is within the
measurement range.
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
CO2: ETCO2 Overrange
3
Et CO2 outside of
measurable range
Check patient
CO2: InspCO2 Overrange
3
Insp CO2 outside of
measureable range
Check patient
CO2: Resp Rate
Overrange
3
The measured RR
value exceeds the
measurement range.
Check Patient.
Check Airway.
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
GM: ETCO2 Overrange
3
The measured
ExpCO2 value
exceeds the
measurement range.
Check Patient.
Check Airway.
GM: InspCO2 Overrange
3
The measured InsCO2
value exceeds the
measurement range.
Check Patient.
Check Airway.
GM: Resp Rate
Overrange
3
The measured RR
value exceeds the
measurement range.
Check Patient.
Check Airway.
GM: Disconnected
2
Appears when the
Ensure Gas Module is turned
on and interface cable is
properly connected. If
problem persists, contact
Technical Support.
CO2 Alert Message
GAS Alert Message
Passport V cannot
detect signals being
sent by the Gas
Module.
14 - 6
0070-00-0704-02
Passport V Operating Instructions
Messages
14.2.9
Technical Alarm Messages
System Level
ALARM MESSAGE
PRIORITY
REASON
SOLUTION
Low Battery
3
The battery capacity
is lower than the set
alarm limit value.
Change the battery, or use the
AC mains.
12V Too High
1
The monitoring of the
internal voltage finds
that 12V voltage is
too high.
Contact Technical Support.
12V Too Low
1
The monitoring of the
internal voltage finds
that 12V voltage is
too low.
Contact Technical Support.
5V Too High
1
The monitoring of the
internal voltage finds
that 5V voltage is too
high.
Contact Technical Support.
5V Too Low
1
The monitoring of the
internal voltage finds
that 5V voltage is too
low.
Contact Technical Support.
3.3V Too High
1
The monitoring of the
internal voltage finds
that 3.3V voltage is
too high.
Contact Technical Support.
3.3V Too Low
1
The monitoring of the
internal voltage finds
that 3.3V voltage is
too low.
Contact Technical Support.
Passport V Operating Instructions
0070-00-0704-02
14 - 7
Prompt Messages
Messages
14.3
Prompt Messages
14.3.1
ECG Prompt Message
14.3.2
14 - 8
ALARM MESSAGE
REASON
SOLUTION
ECG Self Test Error
During Power cycle unit, if ECG
module can not self test
succussfully, this message will
display.
Power cycle unit. If message
reappears, contact Technical
Support.
ECG: Communication Stop
As the ECG module
communication stops, the data
packets sent by the module can
not be received.
Contact Technical Support.
ECG: Communication Error
The ECG module communication
error, the command can not be
send correctly.
Contact Technical Support.
Leads Off
Leads off patient.
Connect lead wires.
ESU-Resp Off
The high frequency
electrosurgery Unit
Interference signal is detected.
Wait that the high frequency
electrosurgery Unit
Interference disappears.
ECG Signal Invalid
Poor leads connection.
Check Patient.
Check Leads and leadlines.
Pacer Rejection On
When Pacer Reject is set to On.
This is normal operation. When
Pace Reject is set to Off, this
message disappears.
Learning
Displayed when a learning cycle
has been requested for
Arrhythmia or ST.
/
No Arrhythmia Detection at
Central
Central Station does not have
arrhythmia Analysis capability.
/
ECG: Initialization Error
During the ECG module poweron,as the ECG module
communication stops,system fails
to communicate with module.
Contact Technical Support.
ALARM MESSAGE
REASON
SOLUTION
Resp: Initialization Error
During the Resp module poweron,as the Resp module
communication stops,system fails
to communicate with module.
Contact Technical Support.
Resp: Communication Error
System can't communicate
correctly with Resp module,and
receive the error data packets.
Restart the monitor.If the error
still appears,please contact
Technical Support.
Resp Prompt Message
0070-00-0704-02
Passport V Operating Instructions
Messages
14.3.3
Prompt Messages
Resp: Communication Stop
As the Resp module
communication stops, the data
packets sent by the module can
not be received.
Contact Technical Support.
Resp: High Impedance
Connections not tight and/or
properly secured.
Electrodes dry or loose.
Cable or lead wires damaged.
Ensure proper connection.
(Electrode to lead, lead to
cable, cable to monitor).
Re-prep skin and apply fresh,
moist electrodes.
Check with continuity tester
CHK LEAD
Increased impedance caused by
one of the following:
Chest hair under electrodes.
Dried electrode gel.
Electrode off.
Lead off.
Cracked lead wires.
Poor skin prep.
Prep chest.
Change electrodes.
Replace electrode.
Replace lead.
Replace lead wires.
Clean and abrade skin before
applying electrodes.
SpO2 Prompt Message
ALARM MESSAGE
REASON
SOLUTION
COMMENTS
SpO2: No Pulse
No pulse.
Low pulse due to
poor perfusion.
External interference.
Check Patient
Reposition sensor.
Check for source of
external interference.
DPM/Nellcor
SpO2: Sensor Fault
Defective sensor
Replace sensor
Masimo/DPM/
Nellcor
SpO2: Board Fault
There is a problem
with the SpO2
measurement board.
Contact Technical
Support.
Masimo
SpO2: Initialization Error
No response after
send order during
initialization.
Contact Technical
Support.
Masimo/DPM/
Nellcor
SpO2: Communication Error
The monitor and the
SpO2 modules are
not communicating
properly.
Contact Technical
Support.
Masimo/DPM/
Nellcor
SpO2: Communication Stop
As the SpO2 module
communication
stops, the data
packets sent by the
SpO2 module can
not be received.
Contact Technical
Support.
Masimo/DPM/
Nellcor
SpO2: Low Perfusion
Low pulse amplitude
Check patient
Reposition sensor
Masimo/DPM
SpO2: Too Much Light
Ambient light
interfering with
signal
Cover sensor site or
reposition sensor
Masimo
SpO2: Unrecognized
Sensor
The sensor is not
recognized by
the Monitor.
Replace the sensor
with a recommended
sensor. Contact
Technical Support
Masimo
Passport V Operating Instructions
0070-00-0704-02
14 - 9
Prompt Messages
14.3.4
14 - 10
Messages
SpO2: Interference
Patient Movement.
External interference.
Noise detected on
the pulse signal
prevents pulse
discrimination.
Decrease patient
motion,check sensor.
Contact Technical
Support.
Masimo/Nellcor
SpO2: No Sensor
No sensor
Apply sensor
Masimo/DPM/
Nellcor
SpO2: Weak Pulse
Low pulse amplitude
Check the condition of
poor perfusion for
patient.
Contact Technical
Support.
Nellcor
SpO2: Low Signal
The SpO2 signal is
too low or too weak.
Check sensor
placement, move as
necessary.
Switch limb / Notify
physician.
Nellcor
SpO2: Weak Signal
The SpO2 signal is
too low or too weak.
Check patient
Reposition sensor
Change sensor
Masimo
SpO2: Check Sensor
Possible Faulty
sensor
Replace Sensor
Nellcor
SpO2: Motion
Patient movement
Check patient
Nellcor
SpO2: Pulse Search
Monitor searching
for pulse.
Sensor just applied
Poor perfusion at
sensor site.
Check patient.
Reposition sensor.
Masimo/DPM/
Nellcor
Temp Prompt Message
ALARM MESSAGE
REASON
SOLUTION
Temp: Communication Stop
As the Temp module
communication stops, the data
packets sent by the Temp module
can not be received.
Contact Technical Support.
Temp: SelfTest Error
Module send out error during
selftest because of some
unspecified reasons.
Contact Technical Support.
Temp: Calibration Error
A calibration failed.
Restart the monitor.
Contact Technical Support.
Temp: Initialization Error
During the Temperature module
power-on,as the Temperature
module communication
stops,system fails to
communicate with module.
Contact Technical Support.
0070-00-0704-02
Passport V Operating Instructions
Messages
14.3.5
Prompt Messages
NIBP Prompt Message
ALARM MESSAGE
REASON
SOLUTION
NIBP: Self Test Error
Failed self-test.
Sensor or A/D sampling may
have an error.
Power cycle unit. If message
reappears, contact Technical
Support.
NIBP: Communication Error
NIBP module communicatuon
error, the command can not be
sent correctly.
Power cycle unit. If message
reappears, contact Technical
Support.
NIBP: System Error
System error. After start-up, the
inflating pump, A/D sampling
unit, pressure sensor have an
error or the pointer has an error
when the software is in running
process.
Power cycle unit. If message
reappears, contact Technical
Support.
Power supply is not stable or
circuit failure leads to voltage
error.
NIBP: Cuff Overpressure
The hardware overpressure limit
has been exceeded.
Overpressure. The cuff pressure
exceeds 297 mmHg in ADU
mode, 240 mmHg in PED mode
or 147 mmHg in NEO mode.
Power cycle unit.
If message reappears, contact
Technical Support.
Pneumatic Leak
Leakage. In Pneumatic check, air
leakage is found in hose.
Change the cuff.
NIBP: Unable to Measure
Unable to make measurement
after three automatic retries.
Check Patient.
Retry measurement. If message
reappears, power cycle unit.
If message reappears, contact
Technical Support.
NIBP: Resetting...
/
NIBP: Reset Failed
Reset has failed.
Power cycle unit.
If message reappears, contact
Technical Support.
NIBP: Idle
Appears when NIBP
measurement is completed and
enters the wait status.
This is normal operation.
Press 'Start' key to start a
measurement, the message is
cleared.
NIBP: Press the START key
Appears when NIBP Interval is
set to anything other than Off or
STAT.
This is normal operation.
Press 'START' key to start
automatic measurement.
NIBP: Manual Mode
Displayed while system is idle.
Note: This is not displayed while
in the interval mode.
Press START to take a single
measurement. Select an
interval and start timed
measurements.
NIBP: Interval
Displayed during the interval
between two timed
measurements.
Press STOP to suspend timed
measurements.
Change timer to OFF to stop
timer.
NIBP: Measuring
Displayed during a
measurement.
Cuff pressure is also displayed.
Press STOP to suspend a
measurement and deflate the
cuff.
Passport V Operating Instructions
0070-00-0704-02
14 - 11
Prompt Messages
Messages
NIBP: STAT
Displayed while the Interval is
set to STAT.
Press START to initiate a STAT
measurement sequence or use
the ‘Interval’ key to change the
setting to Off or a timed
interval value.
NIBP: Warming Up
Warming Up
This is normal operation. Wait
for message to clear.
NIBP: Retry Pump Higher
A measurement has been
attempted but no reading was
possible. This results from
inadequate cuff inflation
pressure.
Retry will be attempted.
Check that appropriate patient
size is set.
Preset initial inflation
pressure.
NIBP: Retry
Cuff is loosely wrapped. The cuff
may be too loosely wrapped or
not attached at all.
Retry will be attempted. Check
for leaks and quality of
peripheral pulses. Decrease
patient movement. Switch cuff
to another limb.
Weak signal. The pulse of the
patient may be too weak or the
cuff is loosely wrapped.
Excessive motion. In
measurement, signals contain
motion artifact or too much
interference.
Timeout. Measurement takes
more than 120 seconds in ADU/
PED mode and 90 seconds in
NEO mode.
Retry Overpressure or bad
measurement.
14 - 12
Accuracy Testing...
Appears when press Accuracy
Test button in Calibrate NIBP
Menu.
/
Accuracy Testing Complete.
During the accuracy testing,
press Stop Accuracy Test button
in Calibrate NIBP Menu, this
message will display.
/
Leakage Testing...
Appears when press Leakage
Test button in Calibrate NIBP
Menu.
/
Leakage Testing Complete
During the leakage testing, press
Stop Leakage Test button in
Calibrate NIBP Menu, this
message will display.
/
Calibrating...
Occurs when NIBP module is
calibrating.
Wait until calibration is
completed
Calibration Failed
During calibration, departure
occurs between the
measurement pressure and
reference pressure due to
improper operation or
measurement error.
Repeat calibration
procedure.
0070-00-0704-02
Passport V Operating Instructions
Messages
14.3.6
14.3.7
Prompt Messages
IBP Prompt Message
ALARM MESSAGE
REASON
SOLUTION
<IBP Label>: Communication
Error
IBP communicatuon error, the
command can not be send
correctly.
Power cycle unit. If message
reappears, contact Technical
Support.
<IBP Label>: Communication
Stop
As the IBP module
communication stops, the data
packets sent by the IBP module
can not be received.
Power cycle unit. If message
reappears, contact Technical
Support.
Pulsatile Pressure. Cannot
Zero!
Input the pulsatile pressure, can
not zero IBP channel.
Input the static pressure, re-zero
IBP channel.
Pressure Overrange. Cannot
Zero!
The pressure is overange, can
not zero IBP channel.
Check the static pressure value,
re-zero IBP channel.
CO2 Prompt Message
ALARM MESSAGE
REASON
SOLUTION
COMMENTS
CO2: Calibration Required
Calibration required
after 4000 operating
hours
Recalibrate
miniMediCO2.
Contact Technical
Support.
Oridion
CO2: Filterline Disconnected
Filterline
disconnected
Connect Filterline to
monitor
Oridion
microstream
CO2: Gas Can Be Removed
CO2 gas can be
removed.
—
Oridion
CO2: Purge
Sample line is
blocked or kinked
Wait several seconds.
The Passport V will
return to monitoring, or
display the message:
“CO2: Occlusion”. If
message is displayed:
Check sample line.
Clear blockage or kink
or replace with a new
sample line.
Oridion
microstream
CO2: Occlusion
Sample line is
blocked or kinked
Check sample line.
Clear blockage or kink
or replace with a new
sample line.
Oridion
microstream
CO2: Sensor High
Temperature
Temperature
overranges high limit
checked by module.
Check,stop using or
replace the sensor.
DPM
CO2: Sensor Low
Temperature
Temperature
overranges low limit
checked by module.
Check,stop using or
replace the sensor.
DPM
CO2: High Airway Press.
Measurement of Flux
Sensor in module is
higer than 790
mmHg.
Check airway's output
and connection.
If problems remain
exist, return it to
factory for
maintaining.
DPM
Passport V Operating Instructions
0070-00-0704-02
14 - 13
Prompt Messages
14 - 14
Messages
CO2: Low Airway Press.
Measurement of Flux
Sensor in module is
less than 400
mmHg.
Check airway's output
and connection.
If problems remain
exist, return it to
factory for
maintaining.
DPM
CO2: High Barometric
Atmospheric pressure
is too high(higher
than 790mmHg).
Check the CO2
connections,make sure
that the monitor
application site meets
the requirements, and
check for special
sources that affect the
ambient pressure.
Restart the monitor.
DPM
CO2: Low Barometric
Atmospheric pressure
is too low(lower than
428mmHg).
Check the CO2
connections,make sure
that the monitor
application site meets
the requirements, and
check for special
sources that affect the
ambient pressure.
Restart the monitor.
DPM
CO2: FilterLine Error
Filterline is leaked or
blocked.
Check if there is a leak
in the CO2 sample line
or the CO2 sample line
has been occluded.
DPM
CO2: Initialization Error
No response after
send order during
initialization.
Contact Technical
Support.
1DPM
2Oridion
CO2: SelfTest Error
Module can not work
because of software
fault,circuit error etc.
Contact Technical
Support.
1DPM
2Oridion
CO2: Communication Error
The monitor receives
wrong responsion
from CO2 module.
Contact Technical
Support.
1DPM
2Oridion
CO2: Communication Stop
Sending out order is
failed during work.
Contact Technical
Support.
1DPM
2Oridion
CO2: Main Board Error
Module has
problems.
Reset the module.
Contact Technical
Support.
Oridion
CO2: Replace Scrubber &
Pump
Module has
problems.
Restart the monitor.
Contact Technical
Support.
Oridion
CO2: 15V Overrange
Power supply to
module is out of
range.
Check power supply.
Restart the monitor.
Contact Technical
Support.
Oridion
CO2: Hardware Error
Module has
problems.
Restart the monitor.
Contact Technical
Support.
DPM
CO2: No Watertrap
Not water trap on
CO2 module
Make sure to plug-in
water trap, and make
sure it is firmly
connected and
fastened.
DPM
0070-00-0704-02
Passport V Operating Instructions
Messages
Prompt Messages
CO2: Temperature
Overrange
Temperature sensor
installed in the gas
cell has read
temperature value
below 0C or above
65C .
Make sure the device
is not working in
extreme hot or cold
condition. Apply
cooling or heating if
possible.
Oridion
CO2: Check Sensor
Possible Faulty
sensor.
Replace the module.
Contact Technical
Support.
Oridion
CO2: Warming up
The CO2 sensor has
not
reached its operating
temperature.
It takes typically 30
seconds for the sensor
to warm up.
Wait for the message
to go away.
DPM/Oridion
CO2: Startup
The CO2 is starting
up.
Wait for the message
to go away.
DPM
Calibration Completed
Successfully
Calibration finished
and successful.
/
DPM/Oridion
Not Ready For Calibration
Module in unable to
initialize calibration.
Repeat calibration
procedure. If problem
persists, contact
Technical
Support.
Oridion
CO2: Zeroing...
The CO2 module is
performing zero.
Wait for zeroing to
complete.
DPM/Oridion
CO2: Zero Failed
Signal cannot be
adjusted to
predefined range
within zeroing
duration.
Check the CO2
connections. After the
sensor's temperature
becomes stabilized,
perform a zero
calibration again.
If problem persists,
contact Customer
Support.
DPM/Oridion
Calibration Error
The actual
concentration of
calibration gas
applied is in wide
discrepancy with the
concentration value
entered by the user in
the Calibration
dialog.
Make sure the
concentration value
entered is the same as
the calibration gas
applied.
Repeat calibration
procedure. If problem
persists, contact
Customer Support.
DPM/Oridion
Caused by no gas or wrong
gas concentration
No gas or wrong gas
concentration.
Check the gas
connections or gas
concentration . Repeat
calibration procedure.
If problem persists,
contact Technical
Support.
Oridion
Passport V Operating Instructions
0070-00-0704-02
14 - 15
Prompt Messages
14.3.8
14 - 16
Messages
Caused by Measurement
Error
Measurement Error
Repeat calibration
procedure. If problem
persists, contact
Technical Support.
Oridion
Caused by no stable gas flow
No stable gas flow
Check the gas
connections or gas
concentration. Repeat
calibration procedure.
If problem persists,
contact Technical
Support.
Oridion
GAS Prompt Message
ALARM MESSAGE
REASON
SOLUTION
GM: Agent Uncalibrated
Appears after an unsuccessful
calibration attempt of the agent
sensor. The numeric data for all
agents will appear as XXX, and
the agent waveform will be a
flatline.
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem
persists, contact Technical
Support.
GM: CO2 Uncalibrated
Appears after an unsuccessful
calibration attempt of the CO2
sensor. The numeric data for
CO2 will appear as XXX, and
the CO2 waveform will be a
flatline.
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem persists,
contact Mindray
Technical Support.
GM: N2O Uncalibrated
Appears after an unsuccessful
calibration attempt of the N2O
sensor. The numeric data for
N2O will appear as XXX, and
the N2O waveform will be a
flatline.
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem persists,
contact Mindray
Technical Support.
GM: O2 Uncalibrated
Appears after an unsuccessful
calibration attempt of the O2
sensor. The numeric data for O2
will appear as XXX, and the O2
waveform will be a
flatline.
Ensure proper gas mixture is
attached tightly and regulator
is on. Repeat calibration
procedure. If problem persists,
contact Mindray
Technical Support.
GM: Agent Zero Error
Appears when the system has
been unable to successfully zero
the anesthetic agent sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Technical Support.
GM: CO2 Zero Error
Appears when the system has
been unable to successfully zero
the CO2 sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Technical Support.
GM: N2O Zero Error
Appears when the system has
been unable to successfully zero
the N2O sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Technical Support.
0070-00-0704-02
Passport V Operating Instructions
Messages
Prompt Messages
GM: O2 Zero Error
Appears when the system has
been unable to successfully zero
the O2 sensor.
Manually start zeroing the
system again. If problem
persists, contact Mindray
Technical Support.
GM: Cannot Zero...Retrying
Appears when the Passport V
requests Zeroing (either on the
automatic cycle or by a user
request) and the Gas Module is
unable to initialize the cycle.
Allow system to retry without
intervention. If problem persist,
contact Mindray Technical
Support
GM: Zero In Progress
Appears when the system is
zeroing all of its channels. This
appears whether initiated by the
user or is automatic.
This is normal operation.
Wait for message to clear.
GM: Warming Up
Appears when the system has
been turned on, and the sensors
have not reached their stable
operating temperature.
Wait for the message to go
away. It takes up to five
minutes for the device to warm
up.
GM: Air Leak
Appears when the system detects
a pneumatic leak.
Turn Gas Module and
Passport V Off.
Also may appear when the Gas
Module has been turned on
without a sample line attached.
Gas Module has been on for a
long period of time without the
Passport V monitor being on.
Install/check sample lines,
filters, water trap and electrical
connections.
Turn off Gas Module.Turn on
Gas Module and Passport V
monitor
GM: Replace Trap
Indicates residue build-up on the
water trap membrane that is
decreasing air flow.
Replace water trap reservoir.
GM: Exhaust Blocked
Appears when the system detects
a blockage at the exhaust gas
outlet, as indicated by an
increase in internal pressure.
Remove waste gas
scavenging assembly, check if
message disappears.
Check exhaust line for
blockage and clear if possible.
If message persists contact
Mindray Technical Support.
GM: Failed
Appears when the Gas Module
detects an unrecoverable error in
its own operation.
Contact Mindray Technical
Support.
GM: Occlusion
Appears when the system detects
an obstruction in the sampling
line or the water trap bottle is
full.
Empty and rinse water trap.
Change water trap if
necessary. Check sampling line
and filter for blockage,
clear sampling line if possible.
Replace sampling line and/or
filter if necessary.
Check exhaust line for
blockage and clear if possible.
If problem persists, contact
Mindray Technical Support.
GM: Pump Off
Appears when the system has
turned off the pump due to a
pneumatic error.
Restart the pump from the Gas
Menu. If problem persists,
contact Mindray Technical
Support.
Passport V Operating Instructions
0070-00-0704-02
14 - 17
Prompt Messages
14.3.9
14 - 18
Messages
GM: Unknown Agent
Appears when the system detects
a gas that does not match the
spectroscopic signatures of the
five known anesthetic agents.
Use recognized agent.
Sampling Error
Appears when a sampling error
occurs on one or more Gas
Module channels during
calibration.
Repeat calibration
procedure. If problem
persists, contact Technical
Support.
Not Ready For Calibration
Appears when the Gas Module
is unable to initialize calibration.
Repeat calibration
procedure. If problem
persists, contact Technical
Support.
Zeroing Error
Appears when the Gas Module
cannot perform a Zeroing
during calibration.
Repeat calibration
procedure. If problem
persists, contact Technical
Support.
GM: Communication Error
System can't communicate
correctly with Resp module,and
receive the error data packets.
Restart the monitor.If the error
still appears,please contact
Technical Support.
GM: Disconnected
Appears when the Passport V
cannot detect signals being sent
by the Gas Module.
Ensure Gas Module is turned
on and interface cable is
properly connected. If problem
persists, contact Technical
Support.
ALARM MESSAGE
REASON
SOLUTION
Power Board Communication
Error
Abnormal power board
communication.
Contact Technical Support.
Main Control System
Power Board Initialization
Error
Contact Technical Support.
Power Board SelfTest Error
Contact Technical Support.
Power Board Communication
Stop
Contact Technical Support.
RT Clock Need Reset
The real time clock need be
reset, as the data read out is the
chip’s default value.
Contact Technical Support.
RT Clock Not Exist
The data written in the real time
clock chip is inconsistent with the
data read out.
Contact Technical Support.
Host Temp Too High
Internal temperature of the host
is too high. This may result from
too high room temperature,
abnormal fan heat dissipation,
or abnormal internal circuits.
Turn off the host until its internal
temperature reduces to the safe
temperature range.
Data Card Error
Data storage card abnormal
Contact Technical Support.
Cooling Fan Failure
The unit running on AC power
and the cooling fan stop work.
Contact Technical Support.
Keyboard Communication
Error
Contact Technical Support.
Keyboard Communication
Stop
Contact Technical Support.
0070-00-0704-02
Passport V Operating Instructions
Messages
14.3.10
14.3.11
Prompt Messages
Keyboard Initialization Error
Contact Technical Support.
Keyboard SelfTest Error
Contact Technical Support.
Defib Sync signal error
Contact Technical Support.
CF card format complete
CF card format complete
successfully.
CF card format error
CF card occur error.
Contact Technical Support.
ALARM MESSAGE
REASON
SOLUTION
12V Too High
The monitoring of the internal
voltage finds that 12V voltage is
too high.
Contact Technical Support.
12V Too Low
The monitoring of the internal
voltage finds that 12V voltage is
too low.
Contact Technical Support.
5V Too High
The monitoring of the internal
voltage finds that 5V voltage is
too high.
Contact Technical Support.
5V Too Low
The monitoring of the internal
voltage finds that 5V voltage is
too low.
Contact Technical Support.
3.3V Too High
The monitoring of the internal
voltage finds that 3.3V voltage is
too high.
Contact Technical Support.
3.3V Too Low
The monitoring of the internal
voltage finds that 3.3V voltage is
too low.
Contact Technical Support.
Power Supply
Data Management
Prompt messages Concerning Patient Data Transfer
MESSAGE
REASON
SOLUTION
Patient data transfer error.
Patient data transfer error.
Check the storage device and
retransfer patient data.
Downloading Patient Data
Remain in the state of patient
data downloading.
No handling needed.
Uploading Patient Data
Remain in the state of patient
data uploading.
No handling needed.
Patient data download
complete.
Patient data downloading
finishes.
No handling needed.
Patient data upload
complete.
Patient data uploading finishes.
No handling needed.
Exported Logs
Passport V Operating Instructions
0070-00-0704-02
14 - 19
Prompt Messages
14.3.12
Messages
MESSAGE
REASON
SOLUTION
Monitor log export error
Exporting log error.
Check the storage device and
retransfer log data.
Exporting Monitor Logs
Remain in the state of exporting
logs..
No handling needed.
Monitor log export complete
Exporting log data finishes.
No handling needed.
Configuration Management
Table of Configuration Transfer Messages
14.3.13
14 - 20
MESSAGE
REASON
SOLUTION
Monitor defaults transfer
error
Configuration data transfer
error.
Check the storage device and
retransfer the configuration
data.
Downloading Monitor
Defaults
Remain in the state of
configuration data
downloading.
No handling needed.
Uploading Monitor Defaults
Remain in the state of
configuration data uploading.
No handling needed.
Monitor defaults download
complete
Configuration data downloading
finishes.
No handling needed.
Monitor defaults upload
complete
Configuration data uploading
finishes.
No handling needed.
Loading configuration failed.
Loading user configuration or
latest configuration failed.
No handling needed.
ALARM MESSAGE
REASON
SOLUTION
IP Address Conflict
The IP address set in the monitor
is same with that set in other
monitors covered in the same
network.
Change the IP address of the
monitor.
Viewed Monitor is Currently
in Demo Mode.
Viewed bed is in demo mode.
No handling needed.
Network
0070-00-0704-02
Passport V Operating Instructions
Messages
14.3.14
Prompt Messages
Print
ALARM MESSAGE
REASON
SOLUTION
Local Printer Comm Error
Contact Technical Support.
Local Printer SelfTest Error
Contact Technical Support.
Thermal Printhead
Overheated
Printer Initializing
Printer Searching...
Local Printer Busy
Printer received multiple print
requests at one time.
Wait until the printer is not
busy.
Local Printer Out Of Paper
Printer out of paper.
Replace with a new roll of
paper.
Local Printer Unable To Print
The system has detected an
unrecoverable printer failure.
Power cycle unit. If message
reappears, contact Mindray
Technical Support.
No printer selected or
available
No printer selected is available
from the network.
Check the selected printer from
the network and make sure the
printer model is supported by
Passport V monitors.
Printing...
The printer is printing.
Printer Buffer Full
The printer buffer is full.
Local Printer Communication
Error
Local Printer communication is
interrupted.
Remote Printer Not Available
This message is displayed in the
case of a printer error.
Printing Complete
The printing is completed.
Passport V Operating Instructions
0070-00-0704-02
Fix the printer.
14 - 21
Prompt Messages
14.3.15
Messages
Alarm Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
High or Low or No Alarm
Sound
Alarm limits not set
Go to Alarm Setup and adjust
alarms.
Alarm Silence All, On time has
not expired
Press SILENCE ALL to reactivate
alarms.
Arrhythmia option not installed
Call Sales Rep to purchase
option.
No Arrhythmia
Alarm Sound
Arrhythmia Alarms off
14 - 22
Go to Monitor Setup 〉
Advanced Setup to activate
alarm.
Monitor is in learning mode
Wait until learning is concluded
and monitor patient closely.
Alarms continue to Sound
despite pressing
SILENCE
More than one alarm is active
Press SILENCE or SILENCE ALL
key to silence.
No Alarm printout with
Alarm violation
Print on Alarm is set to
Suspend.
Check Patient.
0070-00-0704-02
Go to Print Menu and set Print
on Alarm to Active.
Passport V Operating Instructions
15.0
Trends
15.1
Description
Four types of trend displays are available with the Passport V: Quick Trend, List Trend,
Graphic Trend, and OxyCRG (if patient is neonate). All trends are accessed via the TRENDS
key and can be printed via the local printer.
Passport V Operating Instructions
0070-00-0704-02
15 - 1
Quick Trends
15.2
Trends
Quick Trends
The Quick Trend display allows the user to view an abbreviated numeric listing of HR,
SpO2 and NIBP data only. To access this display from the normal monitoring screen, press
the TRENDS key once. This display may also be accessed from the other trend displays via
a menu choice. A maximum of 9 time-stamped entries may be stored. When the maximum
number of entries has been reached, the oldest entry will be deleted from the trend record in
order to allow storage of a new entry.
FIGURE 15-1 Quick Trends
Clearing Trend Data
To manually clear all trend data, including Graphic Trends, choose Clear Trends from the
menu. A confirmation prompt will appear. Once cleared, the data cannot be restored.
• All trend data is automatically cleared when the patient is discharged from the monitor.
• All trend data is also cleared if the monitor’s displayed time or date is changed.
Removing the Quick Trend Display
The Quick Trend display does not automatically time-out and must be manually removed to
return to the normal waveform display. To remove the Quick Trend display, choose
Normal Screen from the menu, or press the NORMAL SCREEN key.
15 - 2
0070-00-0704-02
Passport V Operating Instructions
Trends
15.3
List Trends
List Trends
The List Trend display allows the user to view a tabular list of stored patient vital signs and
anesthetic gas data. To access this display from the normal monitoring screen, press the
TRENDS key twice. To access this display from the Quick Trend display, press the
TRENDS key once. This display may also be accessed from the other trend displays via a
menu choice. When the maximum number of entries has been reached, the oldest entry will
be deleted from the trend record in order to allow storage of a new entry.
FIGURE 15-2 List Trends
The left side of the List Trend display contains menu items for scrolling and access to other
displays. Trend data is listed from newest to oldest. Use the horizontal scroll feature to view
older data. Use the vertical scroll feature to view all the rows of data.
NOTE:
When scrolling vertically, the first row of data (HR) remains
displayed and does not scroll.
Scroll bars along the right and bottom sides of the trend display indicate the position of
viewed data in relation to the rest of the database.
The top row of the List Trend display contains markers which indicate that the entry was
triggered by an alarm violation or by pressing the MARK EVENT key. These markers are
red for priority 1 alarms, time adjusted events, and data transfered events; yellow for priority
2 alarms; and green if initiated by pressing the MARK EVENT key.
Trend data in violation of an alarm is also highlighted according to the priority of the alarm.
The data is red for priority 1 alarms and yellow for priority 2 alarms.
If data for a parameter is not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “XXX”.
Passport V Operating Instructions
0070-00-0704-02
15 - 3
List Trends
Trends
Modification of Parameters Displayed
The parameters displayed always include the currently active parameters and any others
used since the time the patient was admitted to the monitoring system. The default order of
parameters displayed from top to bottom is: HR, SpO2, NIBP, Resp, CO2, O2, Des, N2O,
MAC, P1, P2, Temp, and PVC.
To enable/disable the display (and subsequent ability to print) of specific parameters in List
Trend, select Group Setup from the List Trend menu. From the Group Setup menu,
select one of two custom groups. To change the order in which parameters are displayed in
each of the first 6 rows, set Param 1 through Param 6 to the desired parameters.
Filtering of List Trend Data Displayed
Data corresponding to MARK EVENT key presses, alarms, and NIBP measurements will be
included in the displayed data.
Trend entries triggered by Interval may be filtered out from the displayed List Trend data.
To change the amount of interval entries displayed, select Interval and set as desired.
Transferring List Trend Data Between Different Passport V
Monitors
List and Graphic Trend data, along with patient name and demographics may be
transferred between Passport V monitors with a DPM storage device.
Clearing Trend Data
To manually clear all trend data, including Graphic Trends, choose Clear Trends from the
menu. A confirmation prompt will appear. Once cleared, the data cannot be restored.
• All trend data is automatically cleared when the patient is discharged from the monitor.
• If the monitor's displayed time or date is changed, an event will be marked but not clear
all trend data.
Removing the List Trend Display
The List Trend display does not automatically time-out and must be manually removed to
return to the normal waveform display. To remove the List Trend display, choose Normal
Screen from the menu, or press the Normal Screen key.
15 - 4
0070-00-0704-02
Passport V Operating Instructions
Trends
15.4
Graphic Trends
Graphic Trends
The Graphic Trend display allows the user to view a graphic summary of stored patient
vital signs and anesthetic gas data. To access this display from the normal monitoring screen,
press the TRENDS key three times. To access this display from the Quick Trend display,
press the TRENDS key twice. To access this display from the List Trend display, press the
TRENDS key once. This display may also be accessed from the other trend displays via a
menu choice.
FIGURE 15-3 Graphic Trends
The left side of the Graphic Trend display contains menu items for scrolling, setup and
access to other displays. The Graphic Trend data window contains up to 5 parameter
displays. Use the vertical Scroll feature to view other parameters.
NOTE:
When scrolling vertically, the topmost parameter (HR)
remains displayed and does not scroll.
Time stamps are included in the upper area of the window, with the most recent data
appearing with the cursor at the right end. Use the horizontal Scroll feature to move the
display window through time. Scroll bars along the right and bottom sides of the Graphic
Trend display indicate the position of viewed data in relation to the rest of the database.
The Event feature may be used to scroll quickly between clock adjusted events and data
transfer events (caused by alarm violations and MARK EVENT keypresses).
The Zoom feature may be used to adjust the amount of time shown in the trend window.
The top line of the Graphic Trend display contains markers which indicate if the entry was
triggered by an alarm violation or by pressing the MARK EVENT key. These markers are
red for priority 1 alarms, yellow for priority 2 alarms, and green if initiated by pressing the
MARK EVENT key. Clock adjusted events and data transfer event will be marked as well.
Passport V Operating Instructions
0070-00-0704-02
15 - 5
Graphic Trends
Trends
As the cursor is scrolled horizontally, the digital data corresponding to the points in the graph
is shown at the right side of the window. Trend data in violation of an alarm is highlighted
according to the priority of the alarm.
On color displays:
• Priority 1 alarm data is shown in inverse video with red background.
• Priority 2 alarm data is shown in inverse video with yellow background.
If data for a parameter is not available at the time of the trend entry, the data field will be
dashed. If an NIBP reading could not be obtained or an invasive pressure channel was not
zeroed at the time of the trend entry, the data field will contain “XXX”.
Modification of Parameters Displayed
The parameters displayed always include the currently active parameters and any others
used since the time the patient was admitted to the monitoring system. The default order of
parameters displayed from top to bottom is: HR, SpO2, NIBP, Resp, CO2, O2, Des, N2O,
MAC, P1, P2, Temp, and PVC. To change the order in which parameters are displayed in
each of the top 5 rows, select Group Setup from the Graphic Trend menu. Then, set
Param 1 through Param 6 to the desired parameters.
Modification of Trend Entry Conditions
The Graphic Trend data is the same as that stored for List Trends, arranged graphically.
(If data is not available for time period, it appears as a gap in the Graphic Trend.) Refer to
the previous section (List Trend) for modification of trend entry conditions.
Transferring Graphic Trend Data Between Different Passport V
Monitors
Graphic Trend data is transferred together with List Trend and patient name and
demographics. Refer to the List Trend section for details.
Clearing Trend Data
To manually clear all trend data, including List trends, choose Clear Trends from the menu.
A confirmation prompt will appear. Once cleared, the data cannot be restored.
• All trend data is automatically cleared when the patient is discharged from the
monitor.
• If the monitor’s displayed time or date is changed, an event will be marked but not
cleared of all trend data.
Removing the Graphic Trend Display
The Graphic Trend display does not automatically time-out and must be manually removed
to return to the normal waveform display. To remove the Graphic Trend display, choose
Normal Screen from the menu, or press the Normal Screen key.
15 - 6
0070-00-0704-02
Passport V Operating Instructions
Trends
15.5
OxyCRG
OxyCRG
The OxyCRG function is available for neonatal patients only.
The OxyCRG display allows the user to view a graphic summary of 5 specific patient
parameters, including HR, SpO2, Resp Wave, Temp and IBP1.
To access this display from the normal screen, press the TRENDS key four times (Patient Size
must be set to Neonate to view OxyCRG). This display may also be accessed from the other
trend displays via a menu choice.
FIGURE 15-4 OxyCRG Display
The events that trigger the storage of OxyCRG data are Interval events, Alarm events, and
Manually marked events. The interval for triggering the interval event is 2s maximally.
The parameters stored for the OxyCRG are instantaneous values of HR, SpO2, RR, Resp
Wave, Temp, and IBP1. The time marker is one second. Trended data includes the Time
marker, Parameter value, and Event type.
OxyCRG screen displays the trend graph, parameter values, and events. The rules for
displaying trend graph are as follows:
Passport V Operating Instructions
0070-00-0704-02
15 - 7
OxyCRG
Trends
• The x-axis is time, and the y-axis is parameters.
• The most recent trend data is shown at the rightmost end.
• The time marker is exact to minute.
• Parameters in OxyCRG screen are displayed in the order of HR, SpO2, Resp Wave,
Temp and IBP1.
• The alarmed parameters are marked with different color under the OxyCRG graph to
match the alarm level.
• 1 level alarms: Red
• 2 level alarms: Yellow
• The parameters' trend graph is the same color as the parameter's color.
The rules for displaying parameter values are as follows:
• The color of the alarmed parameter is the same as the color of the alarm priority.
• one level alarms: Red
• two level alarms: Yellow
• The invalid parameter data is shown as “– – –“ in the parameter area of the OxyCRG
screen.
• The IBP parameter value in which the IBP channel isn't zeroed shall be displayed as
“– – –“ in the parameter area of the OxyCRG screen.
The rules for displaying events are as follows:
Manually marked events are marked in green in the Event row.
• Alarm events are marked in different colors in the Event row to match the alarm priority.
• 1 level alarm: red
• 2 level alarm: yellow
• If multiple events happen during a time interval, the color of the event with the highest
priority is shown.
• The order of event priority is: manually marked event, one level alarm, two level alarm.
Viewing Trend Data
The start time for OxyCRG trends is related to the way the user accesses the OxyCRG trends:
• If the user enters the OxyCRG trends by pressing the Trend key 4 times in normal screen,
the start time for the OxyCRG trend display is accurate to the minute of the time when the
user accesses the OxyCRG trends. (The method for obtaining the integrated start time of
the OxyCRG trends is the same with that of the List trends.)
• If the user accesses the OxyCRG trend by pressing the OxyCRG button in the Quick
Trend screen, the cursor time of OxyCRG is accurate to minute of the time of most recent
trend data in the Quick Trends.
• If the user accesses OxyCRG trends by pressing the OxyCRG button in the List Trend
screen, the cursor time of OxyCRG trends is accurate to minute of the time of rightmost
column in the List Trend.
• If the user accesses OxyCRG trends by pressing the OxyCRG button in the Graph Trend
screen, the cursor time of OxyCRG trends is accurate to minute of the time to which the
cursor point in the Graph Trends.
15 - 8
0070-00-0704-02
Passport V Operating Instructions
Trends
OxyCRG
Scrolling the cursor
Scroll the cursor to view the parameter values corresponding to cursor position.The step for
cursor scrolling is one pixel.
Scrolling the events
The objects of Event view are alarm events and manually marked events. The step of event
scroll is a single event.
Zoom Settings
The time span of the OxyCRG screen can be adjusted. Options for Zoom are 8min, 16min,
32min, 64min, and 128min.
Clearing Trend Data
Trend data can be cleared manually.
Refreshing
The OxyCRG display is refreshed according to the Zoom setting of displayed OxyCRG as
follows:
zoom setting
refresh time
8min
2s
16min
4s
32min
8s
64min
16s
128min
32s
Menus and Screens
The OxyCRG screen consists of the following items:
1. Menu area: Allows operations in the OxyCRG display.
2. Event area: Shows events markers.
3. Time area: Shows the time marker of trend entries and cursor in time area:
• There five time markers for trend entries that divide the OxyCRG graph into four equal
sections.
• The time marker of entries is accurate to the minute.
• The time marker of the cursor is accurate to the second.
• The date and time format are consistent with that of the system setting.
4. OxyCRG graph and parameter values area: Displays the trend graphs and parameter
values corresponding to the cursor:
• The graphic trends are blank corresponding to the state of standby.
• For clock adjusted event, the time tag of old trend entry shall be synchronized with
new time start.
Passport V Operating Instructions
0070-00-0704-02
15 - 9
Trends Troubleshooting
15.6
15 - 10
Trends
Trends Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
No Trends displayed
No Trend triggers set
Go to the Monitor Setup
Menu and set NIBP Trend,
Trend Interval or Alarm
Trend as desired
Trend page is scrolled
Use scroll arrows in Trend Menu
to scroll to top of Trend Menu
0070-00-0704-02
Passport V Operating Instructions
16.0
Printing
16.1
Description
Passport V data and waveforms may be printed to the following destinations: local printer,
remote printer, or remote central station.
16.2
Print Setup Menu
FIGURE 16-1 Print Setup Menu
Printing of Waveform Data
The Print Setup Menu allows the user to set up waveforms for printing and gives the user
the ability to change the print destination.
Passport V Operating Instructions
0070-00-0704-02
16 - 1
Print Setup Menu
Printing
Waveforms may be printed at the time of an alarm by selecting Active in response to Print
On Alarm in the Alarm Setup Menu, which can be accessed by pressing the Alarms:
Limits key. Waveforms may also be printed at regular intervals by selecting Print
Interval. Available selections are OFF, 1 min, 5 min, 10 min, 15 min, 20 min, 30
min, 1 hr, and 2 hr.
To choose which waveform will print to the local printer select Waveform 1, 2, or 3 and
then select any of the available choices.
The following printer options may be available: Local, Remote, and Local/Remote. A
default printer or combination of printers can be set.
Local printing will initiate a printout delivered via the local printer.
Remote printing will send a printout to a remote printer (HP1505N, HP4015N) connected
to the Passport V.
During printing, if the operator changes a setting (e.g., scale, lead name), the report will
mark the change at the changed time.
16.2.1
Local Printer (Optional)
The Passport V local printer can provide a printed record of all patient parameters. It is a
three-trace thermal strip chart local printer with an integral paper spool. The local printer uses
plain white thermal paper, 5 cm wide.
NOTE:
All grid patterns and data are printed by the local printer.
Operation of the Local Printer
1. Select the waveforms to print to the local printer via the Print Setup Menu using the
Navigator Knob. To change the waveforms that appear, select Waveform 1, 2, or 3
and choose from the available parameters.
2. To print, select a printer from Print Setup Menu
selection is Local by default.
〉 Select Printer. The printer
3. Press the STRIP key to initiate printing.
4. Press the STRIP key again to abort the printout. Select printouts will also require the use
of alternate menus or keys.
During a waveform printout, tic marks appear at one second intervals, for reference.
Printouts from the Local Printer
Strip Printing
When the STRIP key is pressed a 16 or 32 second strip is printed, acccording to the “Print
Length” setting. The source of the printout is indicated on the strip as REALTIME REPORT.
Continuous ECG Printing
If a real-time, continuous printing of ECG data is required, press the Cont ECG key. To abort
printing, press the Cont ECG, Strip, or Print Trend key.
16 - 2
0070-00-0704-02
Passport V Operating Instructions
Printing
Print Setup Menu
Print on Alarm
If a waveform is initiated by an alarm violation, then the local printer will initiate a 16-second
or 32-second waveform strip. The print length (16 or 32-seconds) can be set in the Print
Setup menu. To activate this feature, from the front panel, select Alarms: Limits 〉 Print On
Alarm
〉 Active. Then select each parameter for which the feature should be enabled.
During an alarm printout, the data for the parameter which violated the alarm will be marked
with an asterisk. The alarm trigger for the printout is indicated on the strip with the name of
the violated alarm.
Interval Printing
To print waveform strips at regular intervals, go to the Print Setup Menu, highlight Print
Interval and select a time interval to print. The selections are Off, 1 min, 5 min, 10
min, 15 min, 20 min, 30 min, 1 hr and 2 hr. The source of the printout is indicated on
the strip as AUTO REALTIME REPORT.
Trend Printing
To print Quick Trend, List Trend, OxyCRG, or Graphic Trend data to the local printer,
press the Print Trend key while the trend is displayed. To abort printing, press the Cont
ECG, Strip, or Print Trend key.
Quick Trend and List Trend print digital data information while Graphic Trend print graphic
representations of the data in the respective menus. Quick Trend entries are only recorded
upon NIBP readings.
FIGURE 16-2 Graphic Trend Format
FIGURE 16-3 List Trend Format
Passport V Operating Instructions
0070-00-0704-02
16 - 3
Print Setup Menu
Printing
FIGURE 16-4 Quick Trend Format
Calculations
IV Drug printouts are initiated in Functions
〉 Drug Calculator by using the Navigator
Knob and scrolling to the Print Units or Print Table function. The printout data will
include patient demographic data, date / time of printout, data used to calculate the
information and the calculated data. Drug Calculations will include the patient weight, IV
fluid infusion rate and medication concentration.
16.2.2
16 - 4
Remote/Local Printer Troubleshooting
MESSAGE/PROBLEM
REASON
SOLUTION
Local Printer report
appears totally blank
Thermal paper may be installed
incorrectly (up-side down).
Remove paper and re-install with
paper feeding off of the spool
from the bottom.
Local Printer Out Of Paper
Printer out of paper or the printer
door is open.
Replace with a new roll of paper
and close the door.
No print on Alarm
Alarm printing not active.
From the front panel, select
Alarms: Limits 〉 Print on
Alarm 〉 Active.
Trends not printing
Print Trend not pressed.
Press PRINT TREND when trend
window is open.
No Trends displayed.
Use scroll feature to scroll to the
top of the trend then press
PRINT TREND.
No paper.
Check / Replace paper.
0070-00-0704-02
Passport V Operating Instructions
17.0
User Maintenance
17.1
Description
This section of the manual outlines routine user maintenance guidelines.
The Passport V monitor is designed for stable operation over long periods of time. Under
normal circumstances the monitor should not require technical maintenance beyond that
described in this section. However, routine maintenance, calibration and safety checks are
recommended at least once a year or more often as required by local statutory or hospital
administration practice.
Passport V Operating Instructions
0070-00-0704-02
17 - 1
Care and Disinfection of the Passport V Monitor
17.2
User Maintenance
Care and Disinfection of the Passport V Monitor
WARNING: Shut down the monitor and disconnect all power cords from
the outlet before cleaning.
The equipment should be cleaned regularly. Please consult your hospital’s policy for the
recommended frequency for cleaning and disinfecting equipment.
The exterior surfaces of the equipment may be cleaned with a clean and soft cloth, sponge or
cotton ball, dampened with either of the following cleaning solutions:
• Mild soap (diluted)
• Sodium hypochlorite bleach (10%)
• Isopropyl alcohol (70%)
• Super sani-cloth (0.5% quaternary ammonia + 55% isopropyl alcohol)
• Virkon
To avoid damage to the equipment:
• ALWAYS use solutions in accordance with the manufacturer's instructions.
• ALWAYS wipe off the excess cleaning solution with a dry cloth after cleaning.
• NEVER submerge the equipment into water or an cleaning solution, or pour or spray
water or any cleaning solution on the equipment.
• NEVER permit fluids to run into the casing, switches, connectors, or any ventilation
openings on the equipment.
17 - 2
0070-00-0704-02
Passport V Operating Instructions
User Maintenance
17.3
Care and Cleaning of SpO2 Sensors
Care and Cleaning of SpO2 Sensors
NOTE:
Refer to the individual instruction sheets that are packaged
with each sensor.
• Check sensors and cables daily for signs of damage. Replace as required.
• Sensors should be cleaned before and after each new patient.
• Wipe the patient contact area using a soft cloth with mild soap and water solution or
isopropyl alcohol. Hydrogen peroxide can be used to remove dried blood.
• Allow the sensor to completely dry before using.
CAUTION:
When cleaning SpO2 sensors, do not use excessive amounts
of liquid. Wipe the sensor surface with a soft cloth,
dampened with cleaning solution. Do not attempt to
sterilize.
Cleaning and Re-use of a Nellcor® Sensor
Sensors may be reattached to the same patient if the emitter and detector windows are clear
and the adhesive still adheres to the skin. The adhesive can be partially rejuvenated by
wiping with an alcohol wipe and allowing the sensor to thoroughly air dry prior to
replacement on the patient.
Do not immerse any Oxisensor®, OxiMax®, Durasensor®, Oxiband®, or Duraform® oxygen
transducers, the Nellcor® RS-10 or Max-Fast® oxygen transducers, or any Nellcor® adhesive
in water or cleaning solution. Clean Durasensor®, Oxiband®, and Duraform® oxygen
transducers, and the Nellcor® RS-10 or Max-Fast® oxygen transducers by wiping with a
disinfectant such as a solution containing 70% alcohol. Do not sterilize by irradiation, steam,
or ethylene oxide. Use a new Oxiband® adhesive wrap or FORM-A adhesive bandage for
each patient. Do not re-sterilize Oxisensor® or OxiMax® oxygen transducers.
17.4
Care and Cleaning of Reusable Temperature Probes
NOTE:
Refer to the individual instruction sheets that are packaged
with each temperature probe for additional information.
• Check temperature probes and cables daily for signs of damage. Replace as required.
• Probes should be cleaned before and after each new patient.
• Wipe the patient contact area using a soft cloth with mild soap and water solution or
isopropyl alcohol.
• Allow the probe to completely dry before using.
Passport V Operating Instructions
0070-00-0704-02
17 - 3
Care and Cleaning of Reusable Cuffs
17.5
Care and Cleaning of Reusable Cuffs
NOTE:
17.5.1
User Maintenance
Accuracy of cuff-pressure transducers/indicators is to be
verified at intervals specified by the manufacturer.
Reusable Cuffs with Bladders
Take out the bladder before cleaning and disinfecting the cuff.
Cleaning
The cuff can be hand washed or machine washed in warm water or with mild detergent. The
bladder can be cleaned with a damp cloth. Air dry the cuff thoroughly after washing.
NOTE:
Machine washing may shorten the service life of the cuff.
Disinfection
The cuff may be disinfected with a damp cloth with 70% isopropanol and water. It may also
be disinfected with ultraviolet. The bladder can only be disinfected with ultraviolet.
NOTE:
Prolonged use of disinfectant may cause discoloration of the
cuff.
Replace the bladder after cleaning and disinfecting the cuff, as follows:
1. Place the bladder on the top of the cuff, as the figure shows.
2. Roll the bladder lengthwise and insert it into the large opening. See the figures below.
3. Hold the hose and the cuff and shake the complete cuff until the bladder is in position.
4. Thread the hose from inside the cuff, and out through the small hole under the internal
flap.
CAUTION:
17 - 4
Do not dry clean the cuff.
Do not press the cuff with a hot iron.
Do not use detergent and disinfectant other than than 70%
ethanol or 70% isopropanol.
Clean and disinfect the cuff according to the instructions.
0070-00-0704-02
Passport V Operating Instructions
User Maintenance
17.5.2
Care and Cleaning of Reusable Cuffs
Reusable Bladderless Cuffs
Clean cuffs with warm water and a mild detergent. Do not use a detergent containing hand
conditioners, softeners, or fragrances.
NIBP cuffs can be sterilized with gamma sterilization without affecting the repeated
performance of the cuff. Steam sterilization is not recommended. Use of a washing liquid
containing bleach is not recommended because chlorine will chemically break down the
urethane on the inside of the cuff.
Antimicrobial Definition
Bladderless cuffs are treated with an antimicrobial coating. Antimicrobial technology
effectively controls a broad spectrum of bacteria, fungi, algae and yeasts on a wide variety
of treated substrates.
Passport V Operating Instructions
0070-00-0704-02
17 - 5
Battery Replacement and Maintenance
17.6
User Maintenance
Battery Replacement and Maintenance
Battery Replacement
1. Open battery compartment door, on left side of unit, by pressing the finger grip area
and sliding the door to the rear.
2. Slide the release located at the top of the installed battery. This will eject the battery.
Slide out and remove battery.
3. Slide in replacement battery until it clicks into place.
4. Close battery compartment door by sliding the door to the right until it firmly clicks into
place.
CAUTION:
Replace lithium-ion batteries with part number M05010001-06 (Mindray) or 0146-00-0099 ONLY.
NOTE:
Mindray PM batteries (0146-00-0069) may fit inside the
Passport V monitor but they will not properly report
charging status.
Battery Maintenance
The batteries may be subject to local regulations regarding disposal. At the end of the
battery life, dispose of the batteries in accordance with any local regulations.
NOTE:
Passport V batteries may only be charged within a Passport V
monitor. Do not attempt to use commercial rechargers.
Lithium-Ion
Storage of the lithium-ion batteries depends on temperature, time period and the degree of
cell charging state. After 6 months of storage at 23oC, fully charged lithium-ion batteries
have a retention capacity of 93%.
17 - 6
0070-00-0704-02
Passport V Operating Instructions
User Maintenance
17.7
Local Printer Paper Replacement
Local Printer Paper Replacement
The instructions below describe the replacement of local printer paper. Use only
recommended local printer paper, P/N 0683-00-0505-02. This ensures that the print quality
is acceptable and reduces print head wear.
1. Open local printer door by pulling the paper eject lever.
2. Remove empty paper spool.
3. Insert new paper roll into the paper holder with the sensitive (shiny) side of the paper
facing the print head at the top of the local printer (paper feeding off of the spool from
the bottom).
4. Unroll approximately 4 inches of paper.
5. Align the paper across the top of the roller.
6. Holding the paper in place, close local printer door.
7. To ensure that the paper is aligned properly and has not been pinched in the door, pull
the loose edge out a couple of inches. If the paper jams, open the door and return to
step 5.
17.8
Care and Storage of Thermal Chart Paper
Thermal Chart Paper is chemically treated and the permanency of a recording is affected by
storage and handling conditions. These conditions are:
• Ultraviolet Light
We recommend storing the recordings in a filing cabinet within a few days of printing.
Long term exposure to natural or artificial U.V. sources is detrimental.
• Storage Temperature and Humidity
Keep the recordings in a cool and dry area for a longer lasting image. Extreme
temperature and humidity (above 80° F/26° C and 80% Humidity) should be avoided.
• Solvent Reactions
Do not store the recordings in plastic bags, acetate sheet protectors, and similar items
made from petroleum products. These products emit a small amount of vapor which will,
over a period of time, deteriorate the image on the chart paper.
• Adhesive Tape
Never place adhesive tape over recordings. The reaction between the adhesive
compound and the chemical/thermal paper can destroy the image within hours.
• Archives
We recommend that if long term archives are required, make a photocopy of the
recordings as back-up. Under normal office filing conditions the recordings should retain
acceptable image quality for about 5 years.
Passport V Operating Instructions
0070-00-0704-02
17 - 7
Care and Cleaning of 3- and 5-lead ECG Cables and Lead wires
17.9
User Maintenance
Care and Cleaning of 3- and 5-lead ECG Cables
and Lead wires
Recommended cleaning method of ECG cables and lead wires is a cloth wipe using ordinary
alcohol-free hand soap or USP green soap tincture. When disinfection is required, a cloth
wipe using disinfectants such as isopropyl alcohol, chlorine bleach in water (1:10 mixture) or
2% Glutaraldehyde solution (i.e., Cidex) is recommended. After cleaning, the ECG cables
and lead wires should be wiped with water using a clean damp cloth then dried with a clean
dry cloth. The ECG cables and lead wires must be allowed to dry thoroughly before use.
17 - 8
CAUTION:
To avoid permanent damage, do not expose metal
components (pins, sockets, snaps) to disinfectants, soaps or
chemicals.
NOTE:
ECG cables and lead wires must never be immersed, soaked
in any fluids, and they should not be cleaned with harsh
chemicals such as acetone or non-diluted bleach.
NOTE:
Do not autoclave, radiation or steam sterilize ECG cables or
lead wires.
NOTE:
Extended exposure to Ethylene Oxide gas may shorten life
of the ECG cables and lead wires, leading to poor signal
quality.
0070-00-0704-02
Passport V Operating Instructions
18.0
Accessories
18.1
ECG
18.1.1
ECG Electrodes
18.1.2
DESCRIPTION
PART NUMBER
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel conductive
adhesive, Box of 60
0681-00-0100-02
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel conductive
adhesive, 1 case of 600 (10 boxes of 60)
0681-00-0100-01
Dual Snap Electrodes (Box of 200)
0683-00-0449-01
Radio Opaque, Neonatal Pre-wired, 3 Lead ECG Electrodes, AAMI, 18"
(45.7cm), Box of 100 packs (each pack contains 3 electrodes)
0681-00-0098-01
Radio Tranlucent, Neonatal Pre-wired, 3 Lead ECG Electrodes, AAMI, 18"
(45.7 cm), Box of 100 Packs (each pack contains 3 electrodes)
0681-00-0098-02
ECG Cables
DESCRIPTION
PART NUMBER
ECG Cable, 3/5 lead, 10’ (3.1 m), Reusable
0012-00-1745-01
ECG Cable, 3/5 lead, 20’ (6.1 m), Reusable
0012-00-1745-02
ECG Cable, 3/5 lead, ESIS, 10’ (3.1 m), Reusable
0012-00-1745-03
ECG Cable, 3/5 lead, ESIS, 20’ (6.1 m), Reusable
0012-00-1745-04
Neonatal ECG Patient Cable, 10’ (3.1 m), Reusable
040-000072-00
Passport V Operating Instructions
0070-00-0704-02
18 - 1
ECG
Accessories
18.1.3
18 - 2
ECG Leadsets
DESCRIPTION
PART NUMBER
ECG Lead Wires, 5 Lead, Snap, 18" (45.7 cm), AAMI, Reusable
0012-00-1503-01
ECG Lead Wires, 5 Lead, Snap, 24" (61.0 cm), AAMI, Reusable
0012-00-1503-02
ECG Lead Wires, 5 lead, Snap, 36" (101.6 cm), AAMI, Reusable
0012-00-1503-03
ECG Lead Wires, 5 lead, Snap, 18" (45.7 cm), IEC, Reusable
0012-00-1503-10
ECG Lead Wires, 5 lead, Snap, 24" (61.0 cm), IEC, Reusable
0012-00-1503-11
ECG Lead Wires, 5 lead, Snap, 36" (101.6 cm), IEC, Reusable
0012-00-1503-12
ECG Lead Wires, 3 lead, Snap, 18" (45.7 cm), AAMI, Reusable
0012-00-1503-04
ECG Lead Wires, 3 lead, Snap, 24" (61.0 cm), AAMI, Reusable
0012-00-1503-05
ECG Lead Wires, 3 lead, Snap, 36" (101.6 cm), AAMI, Reusable
0012-00-1503-06
ECG Lead Wires, 3 lead, Snap, 18" (45.7 cm), IEC, Reusable
0012-00-1503-13
ECG Lead Wires, 3 lead, Snap, 24" (61.0 cm), IEC, Reusable
0012-00-1503-14
ECG Lead Wires, 3 lead, Snap, 36" (101.6 cm), IEC, Reusable
0012-00-1503-15
0070-00-0704-02
Passport V Operating Instructions
Accessories
SpO2
18.2
SpO2
18.2.1
Masimo SpO2 Module
DESCRIPTION
PART NUMBER
LNCS® Adult/Pediatric reusable/single patient adhesive sensor starter kit
(one adult reusable sensor, one adult and one pediatric single patient
adhesive sensor, and one 3.04m/10’ cable)
0020-00-0154
LNCS® Adult/Pediatric single patient adhesive sensor starter kit (one adult
and one pediatric single patient adhesive sensor, and one 3.04m/10’
cable)
0020-00-0156
LNCS® Neonate single patient adhesive sensor starter kit (one neonate and
one neonate pre-term sensor, and one 3.04m/10’ cable)
0020-00-0155
LNCS® DCI Adult Reusable Finger Sensor, patient weight range > 30 kg
(20/box)
0600-00-0126
LNCS® DCIP Pediatric Reusable Finger Sensor, patient weight range 10 to
50 kg (20/box)
0600-00-0127
LNCS® Adtx - Adult Single Patient Adhesive Sensors, patient weight range >
30 kg (20/box)
0600-00-0121
LNCS® Pdtx- Pediatric Single Patient Adhesive Sensors, patient weight
range 10 to 50 kg (20/box)
0600-00-0122
LNCS® INF-L - Infant Single Patient Adhesive Sensors, patient weight range
3 to 20 kg (20/box)
0600-00-0123
LNCS® NEO-L Neonatal single patient adhesive sensors, patient weight
range <3 kg and > 40 kg (20/box)
0600-00-0124
LNCS® NEO PT-L Neonatal preterm single patient adhesive sensors, patient
weight range < 1 kg (20/box)
0600-00-0125
LNC-4, Masimo LNCS SpO2 Patient Cable, 4' (1.22m)
0012-00-1652
LNC-10, Masimo LNCS SpO2 Patient Cable, 10' (3.05m)
0012-00-1599
LNC-14, Masimo LNCS SpO2 Patient Cable, 14' (4.27m)
0012-00-1653
Masimo LNCS® to LNOP® Patient Cable Adapter (Connects LNCS sensors
to LNOP cables)
0012-00-1651
Masimo LNOP MAC-1 Adapter Cable (Connects LNOP Sensors to LNCS
Cables)
0012-00-1656
LNOP® DCI Adult/Pediatric starter kit (one reusable adult sensor, 2 adult
and 1 pediatric single patient adhesive sensors and one 3.66 m/12’ cable)
0020-00-0130
LNOP® DCI-Adult Reusable Finger Sensor (with added "flaps" for ambient
light shielding and 3’ cable), patient weight range > 30 kg
0600-00-0047
LNOP® DCIP-Pediatric/Slender Digit Reusable Finger Sensor, patient weight
range 10 to 50 kg
0600-00-0063
LNOP® TCI Reusable Tip-Clip Ear Sensor, patient weight range > 30 kg
0600-00-0110
Ear Clip, Reusable
0600-00-0086
Ear Hanger (pkg of 5), Reusable
0600-00-0087
Passport V Operating Instructions
0070-00-0704-02
18 - 3
SpO2
18 - 4
Accessories
LNOP® YI Multisite Reusable Sensor, patient weight range > 1 kg
0600-00-0078
Masimo Multisite Wrap (box of 100)
0600-00-0081
Masimo Multisite Foam Wrap (pkg of 12)
0600-00-0083
LNOP® DCSC-Adult Spot Check Reusable Sensor,
patient weight range > 30 kg
0600-00-0077
Masimo LNOP PC08 SpO2 Cable, 8' (2.4m)
0012-00-1099-01
Masimo LNOP PC12 SpO2 Cable, 12’ ( 3.7 m)
0012-00-1099-02
LNOP® Adt-Adult Single Patient Adhesive Sensors, patient weight range
> 30 kg (pkg of 20)
0600-00-0043-01
LNOP® Pdt-Pediatric/Slender Digit Single Patient Sensors, patient weight
range > 10 kg and < 50 kg (pkg of 20)
0600-00-0044-01
LNOP® II Inf-L-Infant L Single Patient Adhesive Sensors,
patient wieght range > 3 kg and < 10 kg (pkg of 20)
0600-00-0100
Masimo Tape, Infant, L-Series (Package of 100)
0600-00-0108
LNOP® Neo-Neonatal Y Single Patient Adhesive Sensors,
patient weight range > 1 kg and < 10 kg (pkg of 20)
0600-00-0045-01
Adhesive Tapes for Neonatal Y Single Patient Adhesive Sensors (pkg of
100)
0600-00-0065
LNOP® II Neo-Neonatal L Single Patient Adhesive Sensors, patient weight
range > 1 kg and < 10 kg (pkg of 20)
0600-00-0099
Adhesive Tapes for Neonatal L Single Patient Adhesive Sensors (pkg of 100)
0600-00-0096
LNOP® NeoPt-Preterm Neonatal Y Single Patient Adhesive Sensors, patient
weight range < than 1 kg (pkg 20)
0600-00-0046-01
Posey Wraps for Preterm Neonatal Y Single Patient Adhesive Sensors
(pkg of 12)
0600-00-0064
LNOP® II NeoPt-L-Preterm Neonatal L Single Patient Adhesive Sensor,
patient weight range < 1 kg (pkg 20)
0600-00-0098
Posey Wraps for Preterm Neonatal L Single Patient Adhesive Sensors
(pkg of 12)
0600-00-0097
LNOP Adult/Pediatric Masimo SpO2 starter kit (two adult and two pediatric
single patient adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-01
LNOP Neonatal Y Masimo SpO2 starter kit (two neonatal and two preterm
neonatal Y single patient adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-02
Clothing Clips (pkg of 5)
0600-00-0084
Adhesive squares, Disposable, 12 cards (12 squares per card)
0600-00-0085
0070-00-0704-02
Passport V Operating Instructions
Accessories
18.2.2
18.2.3
SpO2
Nellcor SpO2 Module
DESCRIPTION
PART NUMBER
Nellcor Durasensor DS100A Adult Reusable Sensor
0600-00-0051
Nellcor OxiMax® DOC-10 SpO2 Cable
0012-00-1464
Disposable Nellcor OxiMax Sensor Kit (2 adult/2 neonatal)
0600-00-0103
DPM SpO2 Module
DESCRIPTION
PART NUMBER
DPM SpO2 518B Reusable Sensor, Neonatal, Foot (Adult/Pediatric,
finger or toe)
518B-30-72107
DPM SpO2 512E Reusable Sensor, Adult Finger with soft cover
512E-30-90390
DPM SpO2 512F Reusable Sensor, Adult, Finger
512F-30-28263
DPM SpO2 512G Reusable Sensor, Pediatric Finger with soft cover
512G-30-90607
DPM SpO2 512H Reusable Sensor, Pediatric, Finger
512H-30-79061
DPM SPO2 Cable, 6 Pin
0010-20-42594
DPM SpO2 520A Single Patient Use sensor, Adult > 30 kg (pkg of 20)
520A-30-64101
DPM SpO2 520I Single patient use sensor, Infant, 3 to 20 kg, 20 pcs/box
520I-30-64301
DPM SpO2 520N Single patient use sensor, Neonatal, <3kg, 20 pcs/box
520N-30-64401
DPM SpO2 520P Single patient use sensor, Pediatric, 10 to 50 kg,
20 pcs/box
520P-30-64201
Passport V Operating Instructions
0070-00-0704-02
18 - 5
NIBP
Accessories
18.3
18 - 6
NIBP
DESCRIPTION
PART NUMBER
Reusable NIBP cuff, Child, 10 to 19cm, quick connect
0683-15-0001-01
Reusable NIBP cuff, Small Adult, 18 to 26cm, quick connect
0683-15-0002-01
Reusable NIBP cuff, Adult, 25 to 35 cm, quick connect
0683-15-0003-01
Reusable NIBP cuff, Large Adult, 33 to 47cm, quick connect
0683-15-0004-01
Reusable NIBP cuff, Thigh, 46 to 66cm, quick connect
0683-15-0005-01
Reusable NIBP Cuff, Adult Long, 25 – 35 cm (limb circumference), latex free
0683-15-0006-01
Reusable NIBP Cuff, Large Adult Long, 33 – 47 cm (limb circumference),
latex free
0683-15-0007-01
Disposable NIBP cuff, Child, 10 to 19cm, quick connect, box of 10
0683-14-0001-01
Disposable NIBP cuff, Small Adult, 18 to 26cm, quick connect, box of 10
0683-14-0002-01
Disposable NIBP cuff, Adult, 25 to 35 cm, quick connect, box of 10
0683-14-0003-01
Disposable NIBP cuff, Large Adult, 33 to 47cm, quick connect, box of 10
0683-14-0004-01
Disposable NIBP cuff, Thigh, 46 to 66cm, quick connect, box of 10
0683-14-0005-01
Disposable NIBP Cuff, Adult Long, 25 – 35 cm, quick connect
0683-14-0006-01
Disposable NIBP Cuff, Large Adult Long, 33 – 47 cm, quick connect,
box of 10
0683-14-0007-01
Neonatal Size 1: limb circumference 3 – 6 cm, box of 10
0683-23-0001-01
Neonatal Size 2: limb circumference 5 – 8 cm, Box of 10
0683-23-0002-01
Neonatal Size 3: limb circumference: 7 – 10 cm, Box of 10
0683-23-0003-01
Neonatal Size 4: limb circumference 9 – 13 cm, Box of 10
0683-23-0004-01
Neonatal Size 5: limb circumference 12 – 17 cm, Box of 10
0683-23-0005-01
NIBP Hose, 5' (1.5 m), Quick Connect to Quick Connect
0683-04-0003
NIBP Hose, 10’ (3.5 m), Quick Connect to Quick Connect
0683-04-0004
0070-00-0704-02
Passport V Operating Instructions
Accessories
Temperature
18.4
Temperature
18.4.1
Disposable 400 Series Temperature Probes
18.4.2
18.4.3
DESCRIPTION
PART NUMBER
Esophageal Stethoscope, 400 Series Disposable Temperature Probe, 12 Fr,
ES 400-12
0206-03-0112-02
Esophageal Stethoscope, 400 Series Disposable Temperature Probe, 18 Fr,
ES 400-18
0206-03-0118-02
Esophageal/Rectal, 400 Series Disposable Temperature Probe, 9 Fr,
ER 400-9
0206-03-0209-02
Esophageal/Rectal, 400 Series Disposable Temperature Probe, 12 Fr,
ER 400-12
0206-03-0212-02
Skin, 400 Series Disposable Temperature Probe, SK 400
0206-03-0300-02
Reusable Instrument Cable, 400 Series
040-000091-00
Reusable DPM Temperature Probes
DESCRIPTION
PART NUMBER
Reusable Temperature Probe, Adult, Esophageal/Rectal,
040-000055-00
Reusable Temperature Probe, Adult, Skin
040-000057-00
Reusable Temperature Probe, Pediatric Esophageal/Rectal
040-000056-00
Reusable Temperature probe, Pediatric/Neonatal, Skin
040-000058-00
Disposable DPM Temperature Probes
DESCRIPTION
PART NUMBER
Reusable Instrument cable for MR411, MR412 disposable probes
040-000224-00
MR411 Disposable Temp probe, Adult/Pediatric/Neonatal, Esophageal/
Rectal, 2-pin
0011-30-90446
MR412 Disposable Temp probe, Adult/Pediatric/Neonatal, Skin, 2-pin
0011-30-90447
Passport V Operating Instructions
0070-00-0704-02
18 - 7
IBP
Accessories
18.5
18 - 8
IBP
DESCRIPTION
PART NUMBER
IBP Cable, BD P10EZ-1, P23XL-1, DTX/Plus, 12ft
040-000053-00
IBP Cable, Edwards Life Sciences TruWave PX, 12ft
040-000054-00
IBP Cable, Hospira Transpac IV, 12ft
040-000052-00
IBP Cable Adapter
040-000096-00
0070-00-0704-02
Passport V Operating Instructions
Accessories
CO2
18.6
CO2
18.6.1
Oridion Microstream CO2 Module
18.6.2
DESCRIPTION
PART NUMBER
Adapter assembly, CO2 Exhaust
0997-00-0648
Calibration Gas
0075-00-0033-01
Microstream CO2 Starter Kit, Adult
0020-00-0188-01
DPM Sidestream CO2 Module and Gas Module 3
DESCRIPTION
PART NUMBER
Nasal Cannula, CO2/O2, 7’ (2.1 m) (box of 10)
0683-00-0452-10
Dryline water trap, Adult/Pediatric, box of 10
9200-10-10530
Dryline water trap, Neonatal, box of 10
9200-10-10574
Sampling line, Adult, 2.5 m, box of 25
9200-10-10533
Sampling line, Neonatal, 2.5 m, box of 25
9200-10-10555
CO2 Nasal sample cannula, Adult with 7' line, box of 25
M02A-10-25937
CO2 Nasal sample cannula, Pediatric with 7' line, box of 25
M02A-10-25938
CO2 Nasal sample cannula, Infant with 7' line, box of 25
M02B-10-64509
Dryline airway adapter, straight, box of 10
9000-10-07486
DPM Sidestream CO2 Kit, Adult (Includes 2 adult/pediatric airway adapter,
2 adult/pediatric watertraps,
2 adult/pediatric airway sampling lines,
2 Adult Nasal Sample Cannula,
2 Pediatric Nasal CO2 Sample Cannula)
6800-30-50618
DPM Sidestream CO2 Kit, Neonate (Includes 2 Airway Adapters, straight
(2 Sampling Line. DRYLINE,Neonate,2.5m,60-15300-00),
2 neonate watetraps, (60-13200-00),
2 Sample Cannula, InfantNasal CO2, with 7'line,
Sidestream CO2 Accessory Specifications
6800-30-50467
Passport V Operating Instructions
0070-00-0704-02
18 - 9
CO2
Accessories
18.6.3
18 - 10
Gas Module 3 Accessories
DESCRIPTION
PART NUMBER
Wall Mount
0436-00-0169
Mounting Plate to Gas Module 3
0386-00-0344
Cable, Serial Port to Gas Module, 12” (30.48 cm)
0012-00-1276-01
Cable, Serial Port to Gas Module, 72” (182.88 cm)
0012-00-1276-02
Power Cord, 120 Volt
0012-00-1081-01
Kit, Acc, Gas Mod / Passport V, 110V
0020-00-0119-10
Kit, Acc, Gas Mod / Passport V, 120V
0020-00-0119-11
Kit, Acc, Gas Mod / Passport V, 240V
0020-00-0119-12
0070-00-0704-02
Passport V Operating Instructions
Accessories
18.7
Mounting Kits, Rolling Stands, and Accessories
Mounting Kits, Rolling Stands, and Accessories
DESCRIPTION
PART NUMBER
Bedrail Mounting Kit
6100-30-86358
Mounting Plate, Gas Module to Rolling Stand
0386-00-0232
Mounting Plate Kit, Bedside to Rolling Stand and Wall Mount
115-003234-00
Quick Release Mounting Kit
115-003237-00
Transport Rolling Stand with Mounting Plate
PASSVROLLSTD
Transport Rolling Stand with Quick Release Mount
PASSVROLLSTDQR
VHM Wall Mount with Mounting Plate
PASSVVHMMT
VHM Wall Mount with Quick Release Mount
PASSVVHMMTQR
Wall Mount with Mounting Plate
PASSVWALLMT
Wall Mount with Quick Release Mount
PASSVWALLMTQR
Mount Kit, Passport V to Gas Module 3
0020-00-0202-01
Passport V Operating Instructions
0070-00-0704-02
18 - 11
Cables and Networking
18.8
Accessories
Cables and Networking
DESCRIPTION
PART NUMBER
12 Port Hub
0992-00-0085-03
Nurse Call Cable
8000-21-10361
IABP Interface Cable
6100-20-86360
Defib Interface Cable
6100-20-86361
Cable, Interface, PC, Serial Port to Serial Port
0012-00-1275-01
Cable, VGA Extension, Male D to Female D, 6’ (1.83 m)
0012-00-0852-01
Cable, VGA Male to Male, 10’ (3.05 m)
0012-00-0994-01
Cable, VGA Male to Male, 25’ (7.62 m)
0012-00-0994-02
Cable, VGA Male to Male, 50’ (15.24 m)
0012-00-0994-03
Cable, VGA Male to Male, 75’ (22.86 m)
0012-00-0994-04
CAT 5 Ethernet Cable, Patch, STP, 6’ (1.83 m)
0012-00-1274-01
CAT 5 Ethernet Cable, Patch, STP, 25’ (7.62 m)
0012-00-1274-02
CAT 5 Ethernet Cable, Patch, STP, 50’ (15.24 m)
0012-00-1274-03
CAT 5 Ethernet Cable, Crossover, STP, 3’ (0.91 m)
0012-00-1392-05
CAT 5 Ethernet Cable, Crossover, STP, 6’ (1.83 m)
0012-00-1392-06
CAT 5 Ethernet Cable, Crossover, STP, 10’ (3.05 m)
0012-00-1392-07
CAT 5 Ethernet Cable, Crossover, STP, 20’ (6.10 m)
0012-00-1392-08
Installation charge per bed
4900-LP-0000
*Networking Installation charge (2-5 beds)
0002-CC-0005
*Networking Installation charge (6-11 beds)
0006-CC-0011
* The Networking Installation charge includes appropriate interface cables, jacks, wall plates, certification
and labor for a certified contractor. Does not include remote printer, hub or comm-ports.
18 - 12
0070-00-0704-02
Passport V Operating Instructions
Accessories
18.9
Battery and Miscellaneous
Battery and Miscellaneous
DESCRIPTION
PART NUMBER
Lithium Ion Battery
M05-010001-06
Lithium Ion Battery
0146-00-0099
Power Cord, 110 Volt
0012-25-0001
Power Cord, 220 Volt
0012-25-0002
Power Cord, 240 Volt (UK)
0012-25-0003
Power Cord, 250 Volt (Brazil)
009-001075-00
SB Storage Device
0992-00-0295-001
Paper, Thermal Strip Local Printer, 12 rolls
0683-00-0505-02
Passport V Operating Instructions
0070-00-0704-02
18 - 13
Battery and Miscellaneous
Accessories
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18 - 14
0070-00-0704-02
Passport V Operating Instructions
19.0
Appendix
19.1
Equipment Environment and Safety Specifications
Passport V Environment
Temperature range
Humidity range
Altitude range
Operating:
0ºC to 40ºC
Non-operating (storage):
-20ºC~+60ºC
Operating:
15% to 95 %, non-condensing
Non-operating (storage):
10% to 95 %, non-condensing
Operating:
(-1,000 to 9,841 feet ASL)
1,051hPa to 700 hPa
(788 mmHg to 525 mmHg)
Non-operating (storage):
(-1,000 to 15,000 feet ASL)
1,051 hPa to 571 hPa
(788 mmHg to 428 mmHg)
GAS Module Environment
Temperature range
Operating:
Non-operating (storage):
Humidity range
Altitude range
Passport V Operating Instructions
10ºC to 40ºC
-40ºC to 70ºC
Operating:
10% to 95 %, non-condensing
Non-operating (storage):
5% to 100 %, condensing
Operating:
Sea Level to 8,000 feet (2438m)
0070-00-0704-02
19 - 1
Equipment Environment and Safety Specifications
Appendix
Transport
Complies with the requirements of ISTA transport test procedure 2A (for shipping cargos in
containers).
Noise Level
• The patient monitor complies with the requirements of ISO 3744 in normal operation.
• Temperature controlled fan is used.
Below and equal to 27 degree ambient temperature, noise ≤ 35 dBA measured at
a distance of one meter from the device.
• Below and equal to 33 degree ambient temperature, noise
distance of one meter from the device.
≤ 40 dBA measured at a
• Below and equal to 40 degree ambient temperature, noise
distance of one meter from the device.
≤ 46 dBA measured at a
• Conditions: NIBP pump and valves not operational, local printer not operational, CO2
not operational.
• SPL range does not include patient heartbeat tone, key-pressing tone and alarm tone.
19 - 2
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.2
Power Specifications
Power Specifications
Power Supply Type
• AC power, battery
• Whole-system consumption:
average consumption of less than 50 W and maximum of 70 W.
AC Mains Power Source
• AC power: 100 - 240VAC (±10%)
• Current: 1.2 - 0.6 Amps
• AC input power frequency: 50 Hz/60 Hz
Internal User-Removable Battery
• Lithium-ion battery (M05-010001-06, Mindray)
• Number of batteries: 2 (maximum), one battery operation supported
Lithium Battery Index
• Voltage: 11.1VDC
• Rated Battery capacity: 4.4 Ah (one battery)
• Battery run time: >270min (two batteries), >130 min (one battery)
Operating conditions: 25ºC for new fully-charged battery. Equipment configuration: 5-lead
ECG, Impedance Repiration, Masimo SpO2, Temperature, IBP1, IBP2, and NIBP in 15-min
Interval mode.
Battery charge time:
• 3.5 hours for 90% charge and 5.5 hours for full charge (equipment powered off)
• 5.5 hours for 90% charge and 8.5 hours for full charge (equipment powered on)
Passport V Operating Instructions
0070-00-0704-02
19 - 3
Clock
19.3
Appendix
Clock
Accuracy
±60 sec/30 days in case of 21±3ºC of operating conditions
Range
Jan. 1, 2001 to Dec 31, 2099
Operating Time
Realtime clock is powered by an independent battery which runs for over 5 years.
19.4
Weight and Dimension
Dimension
<30.0 cm (H) x <18.0 cm (D) x <32.0cm (W)
Weight
< 11 lb. (5.0kg) (standard configuration, including one battery, local printer)
19.5
Display Specifications
Display Type
Color anti-glare TFT display
Rated display Resolution
800×600(Pixels)
Rated display size
12.1” (246 x 184.4 mm)
Data Update Frequency
≥ 60Hz
Accuracy:+/-2Hz
19 - 4
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.6
Sound
Sound
• Power-on self test tone
• Alarm tone
• IEC alarm tone (high, medium, low; complies with the requirements of IEC60601-1-8)
• Provides 1 to 10 levels of alarm tone adjustment.
• Sound Pressure Range: 45 to 85 dB
• Key-pressing prompt tone
• Provides hard key tones
• Systole heartbeat tone/pulse beat tone (Pitch tone)
• Provides 0 to 10 levels of tone adjustment. "0" stands for no sound.
• Provides Pitch Tone based on the SpO2 value
19.7
Marking
Marking complies with the requirements of the following standards:
• UL 969:2006
• 21 CFR 801.1:2007
• ISO 15223:2000+A1:2001+A2:2004
• ISO 7000:2004
Passport V Operating Instructions
0070-00-0704-02
19 - 5
Performance Characteristics
Appendix
19.8
Performance Characteristics
19.8.1
ECG Specifications
Regulations
Complies with the following regulations:
• ANSI/AAMI EC11 / EC13:2001/2002*
• ANSI/AAMI EC57:1998 (R2003)
• IEC 60601-2-27:2005 / EN60601-2-27:2006
• IEC 60601-2-25:1993 + A1:1999 / EN60601-2-25:1995 + A1:1999
* Accuracy of input signal reproduction: Methods A & D were used, as prescribed in section 3.2.7.2 and 4.2.7.2 of
this standard, to establish overall system error and frequency response. Because of the sampling characteristics and the asynchronism between sample rate and signal rate, the Passport V may produce a noticeable
modulating effect from one cycle to the next, particularly in pediatric recordings. * Heart Rate Meter Accuracy and Response to Irregular Rhythm: Ventricular bigeminy: 80 bpm; Slow alternating ventricular bigeminy: 60 bpm; Rapid alternating ventricular bigeminy: 120 bpm; Bidirectional systoles: 90 bpm. * Response
time to HR change: From 80 to 120 bpm: less than 11 s; From 80 to 40 bpm: less than 11 s * Time to alarm for
tachycardia: <11s (measured in accordance with EC 13 and IEC 60601-2-27)
ECG Function and Specifications
Measured Parameters:
• HR
• ST value
• PVCs
• Arrhythmia events
ST Unit
• mm
• The unit conversion of ST value: 10mm/mV
Lead Type (Optional 3- and 5-lead sets)
• 3-lead: displays I, II or III
• 5-lead: displays I, II, III, aVR, aVL, aVF, and V
Intelligent Detection of Lead Sets
• Automatic detection of 3- or 5-lead ECG lead when ECG leads are connected to the
patient.
Waveform Sweep Velocity
• 6.25mm/s, 12.5mm/s, 25.0mm/s, 50mm/s; its accuracy complies with 50.102.7 of
IEC60601-2-27:2005.
19 - 6
0070-00-0704-02
Passport V Operating Instructions
Appendix
Performance Characteristics
Display Size
The accuracy error above is less than ±5%; the change in display sensitivity complies with
50.102.6 of IEC 60601-2-27:2005.
• 1.25mm/mV (×0.125)
• 2.5mm/mV (×0.25)
• 5mm/mV (×0.5)
• 10mm/mV (×1)
• 20mm/mV (×2)
• 40mm/mV (×4)
ECG Signal Range
• +/- 8mV (peak-to-peak value); the output accuracy of signals complies with 50.102.1 of
IEC60601-2-27:2005.
Calibration Signal
• 1mV (peak-to-peak value)
• Accuracy: 5% or 40µV, whichever is greater
Detected RTI Range of Measured ECG Signals
• 4.88 uV, ±8 mV when gain is ×0.125, ×0.25, ×0.5, ×1, ×2, ×4.
ECG Calibration mode
• Manual Calibration
Input Impedance
> 5 Mohms
Bandwidth (-3dB)
• Surgical mode: From 1 to 20 Hz
• Monitor mode: From 0.5 to 40 Hz
• ST Mode: From 0.05 to 40 Hz
• Diagnostic mode: From 0.05 to 150 Hz
Passport V Operating Instructions
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19 - 7
Performance Characteristics
Appendix
Common Mode Rejection Ratio
• Monitor mode: >105 dB measured at 50 and 60 Hz
• Surgical mode: >105 dB measured at 50 and 60 Hz
• ST mode: > 105 dB measured at 50 and 60 Hz
• Diagnostic mode: >90 dB measured at 50 and 60 Hz
Notch Filter
• Notch filter settable to 50 Hz or 60 Hz
Input Bias Current
•
≤ 0.1 µA .
• Complies with 4.2.5 of ANSI/AAMI EC13:2002.
Electrode Offset Potential Tolerance
• +/- 500 mV
• Complies with 4.2.9.1 of ANSI/AAMI EC13:2002
RTI Noise
•
≤ 30 µV (p-v RTI)
• Complies with 4.2.9.3 of ANSI/AAMI EC13:2002.
ESU (Electrosurgical Unit) Interference Suppression
• Incision mode: 300W
• Coagulation mode: 100W
• Recovery time :
≤ 10s
• Complies with 4.2.9.14 of ANSI/AAMI EC13:2002.
RTI Suppression of ESU (Electrosurgical Unit)
• ESIS ECG cable is used.
• ECG lead wires complying with AAMI is used; compared with ECG baseline, the peak-topeak RTI value: ≤ 2mV.
• The testing method complies with 5.2.9.14 of EC13:2002.
ESU Filter Control
• Auto / Off indications:
• Auto: ESU detection shall engage the surgical mode filter if the ESU detection
measures ESU pulses at a rate > 50 Hz or > 50 spikes per second. ESU detection shall
stop the surgical mode filter if the ESU detection measures ESU pulses at a rate < 10
Hz or < 10 spikes per second.
• Off: ESU filter is off.
19 - 8
0070-00-0704-02
Passport V Operating Instructions
Appendix
Performance Characteristics
Baseline Recovery Time
• <5s after defibrillation (in monitor and surgical mode)
Defibrillation Protection
• Withstand discharged current at 360J and keep undamaged.
• Complies with 17h.101.1of IEC 60601-2-27
AC Overload Protection
• 50 Hz/60 Hz, 1Vp-p, lasting10s; when the overload voltage is removed, the monitor will
return back to normal within 3 seconds
Defib. Synchronous Pulse
• The time interval between the peaks of R-waves to the start of synchronous pulses is
35ms.
≤
Multi-leads Display Interruption
•
≤ 5%; Complies with 50.201.5 of IEC60601-2-27:2005.
PACE Pulse Display
• On/Off indications:
• When "Paced" is set to "On", the PACE marker is displayed.
• When "Paced" is set to "Off", the PACE marker is not displayed.
• Pace pulse markers:
• PACE markers are displayed on screen for pulses meeting the following requirements:
• Amplitude: From ±2mV to ±700mV
• Width: From 0.1 ms to 2.0 ms
• Rise time: From 10µs to 100µs
• Pacer tails with amplitudes < 2.0mV and time constants from 4 to 100 ms.
HR Mean Value
• Complies with 4.1.2.1 d of ANSI/AAMI EC13-2002.
• HR mean value is derived from the average RR intervals of the recent 16 beat.
• 4 beat average and 16 beat averages are calculated at all times.
• If 4 beat average is less than 48 BPM, then the 4 beat average is displayed.
• If the 4 beat average is greater than or equal to 48 BPM then the 16 beat average is
displayed.
• Displayed HR value is refreshed every 1 second.
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Performance Characteristics
Appendix
Pace Pulse Rejection
• HR calculation rejects pulses with amplitude between ±2mV to ± 700 mV and width
between 0.1 ms and 2 ms (no tails).
• To enable about 50% pace pulses with fig.5d (EC13, at page 28) waveforms to trigger
pace pulse detector, the minimum input waveform change rate is 50 V/s RTI.
ECG Specifications
Mortara Arrhythmia ( V3.2 )
• HR range
• 15 BPM to 300 BPM Adult,
• 15 BPM to 350 BPM pediatric,
• 15 BPM to 350 BPM neonatal
Accuracy: '+/- 5 % for heart rates between 251 BPM' and 350 BPM, the greater of
'+/- 3 BPM' or 3% for heart rates between 30 BPM and 250 BPM'
Tall T waves Rejection
• Complies with 4.1.2.1 c of ANSI/AAMI EC13-2002.
• HR calculation is not affected for T-waves whose QRS complex is 100ms, QT interval is
350ms, lasting time is 180ms and amplitude less than 1.2mv.
ST Segment Analysis
• Scope: ST analysis is available for Adult and Pediatric patients only.
• ST Measurement Point
• ST measurement point can be manually adjusted: J+60 and J+80 (default: J+60 ms).
• ISO point can be manually adjusted: from 4 to 200 ms before R waves (default: 80ms)
and adjusted interval: 4ms.
• J point can be manually adjusted: from 4 to 200 ms after R waves (default: 48ms).
• Real Time Reference of ST Segment Analysis: Supported.
• Refresh Rate of ST Reference: 16 beats.
Arrhythmia Analysis
• Scope: Arrhythmia analysis is available for Adult and Pediatric patients only.
• Arrhythmia Type: 11 kinds of Arrhythmia events are included:
ASYSTOLE, V-FIB, V-TACH, VRHYTHM, COUPLET, RUN, BIGEMINY, TRIGEMINY,
IRREGULAR HR, BRADY, PVCs per minute
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Performance Characteristics
Screen Display and UI Element
ECG Normal Display
• Lead Set
• 3-, 5-lead set
• Waveform Display
• One ECG waveform is displayed for 3-lead lead set.
• Up to 7 waveforms are optionally viewable using a 5-lead lead set.
Default two waveforms are II, V.
• Displayed Parameters
• HR label
• HR value
• HR source
• HR alarm limit
• PVCs
• ST value and unit
ECG Multi-leads Display
• Lead Set
• 5-lead
• Screen Display
• Full screen display of seven ECG waveforms: I, II, III, aVR, aVL, aVF, and V
Data Storage
Physiological Parameters
• HR
• PVCs
• ST for 3-lead, ST one value of I, II or III is stored.
• For 5-lead, ST values of I, II, III, aVL, aVR, aVF and V are stored.
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Performance Characteristics
19.8.2
Appendix
RESP
Function and Specification
• Measured Parameters: RR, Waveform
• Measurement Method: Trans-thoracic impedance
• Intended Patient: Adult, Pediatric, Neonatal
• Measured Lead: Optional RA-LA or RA-LL; default RA-LL
• Waveform Gain Adjustment: Optional 1, 2, 3, 4, and 5
• Waveform Refresh Velocity: Optional 3.125, 6.25, 12.5 and 25.0mm/s
• Differential Input Impedance: More than 5Mohms
• Excitation Current: < 620 µA RMS
• Baseline Impedance Range: From 200 to 2500 ohms (use the ECG cable with 1 kohms
resistance)
• Respiration Impedance Range: From 0.3 to 5 ohms
• Linear Signal Range: Minimum 3 ohms p-p
• Bandwidth: From 0.2 to 2 Hz (-3 dB)
• RTI Noise: < 0.1 ohms (peak value) (with standard ECG cables and patient impedance
500 ohms)
• RR spec
• Range
• Adult: From 0 to 120 RPM
• Pediatric and neonatal: From 0 to 150 RPM
• Resolution: 1 RPM
• Accuracy: From 6 to 150 RPM: ±2 RPM or ±2%, whichever is greater
• From 0 to 5 RPM: not specified
• Apnea Alarm
• Artifact (CVA) Notification
Screen Display and UI Element
RESP Normal Display
• Waveform Display
• Respiration waveform (thoracic impedance)
• Waveform label
• Waveform gain
• Lead selected
• RR Source
Data Storage
• Respiration Rate
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Appendix
19.8.3
Performance Characteristics
IBP
Regulations
EN60601-2-34 / IEC60601-2-34:2000
Function and Specifications
• Measured Parameters: Systolic pressure, diastolic pressure, means pressure, PR
• Intended Patient: Adult, Pediatric, Neonatal
• Measurement Method: Direct invasive measurement
• Pressure label (default: Art and CVP):
Art
Arterial pressure
PA
Pulmonary artery
CVP
Central venous pressure
RA
Right atrial pressure
ICP
Intracranial pressure
LA
Left artrial pressure
LV
Left ventricular pressure
UA
Umbilical arterial pressure
P1~P2
Unspecified pressure labels
• Pressure Unit: mmHg
• Calibration Accuracy Range: ± 200 mmHg
• Calibration Accuracy: ± 1 mmHg
• RTI: <0.5 mmHg RTI, 300 Ohm source resistance
• Drift: <0.15 mmHg/ºC; less than ± 1 mmHg within 24 hours
• Pressure Transducer:
• Excitation voltage: 5VDC, ±2%
• Sensitivity: 5 uV/mmHg/Volt
• Resistance range: From 300 to 3000 ohms
• Volume displacement in mm3/100 mm Hg may be provided in the transducer
Instructions For Use.
• supplied with the EQUIPMENT.
• Pressure Calibration: Supported
• Pressure Measurement specifications:
• Measurement range: From -50 to +300 mmHg
• ART, UA: From 0 to 300 (mmHg)
• PA: From-6 to 120 (mmHg)
• CVP: From -10 to 40 (mmHg)
• RA, LA, ICP: From -10 to 40 (mmHg)
• LV: From 0 to 60 (mmHg)
• P1~P2: From -50 to 300 (mmHg) (Accuracy: 2% or 1mmHg, whichever is greater
(excluding errors caused by a transducer); Resolution:1 mmHg)
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Performance Characteristics
Appendix
• Refresh Rate: 1s
• Filter: Optional three bandwidths:
• -3 dB point at 8 +/- 1 Hz,
• -3 dB point at 12 +/- 1 Hz,
• -3 dB point at 20 +/- 1 Hz,
• Alarm: Systolic pressure, diastolic pressure, mean pressure.
Automatic Scaling: Supported
• Data Storage: Physiological parameter: Systolic pressure, Diastolic pressure, Mean
pressure
19.8.4
NIBP Performance and Functional Characteristics
The NIBP function is capable of providing systolic, diastolic, and mean blood pressure
measurements in Neonate, Pediatric, and Adult modes non-invasively, using a blood pressure
cuff.
The NIBP function is in accordance with the requirements of EN 60601-2-30, EN 1060-1,
EN 1060-3, and SP 10.
Systolic Pressure Measurement
Accuracy:
Mean error is less than ± 5 mmHg, Standard
Deviation is less than ± 8 mmHg.
Range:
Adult Mode
55 to 235 mmHg
Pediatric Mode
55 to 160 mmHg
Neonatal Mode
45 to 120 mmHg
Diastolic Pressure Measurement
Accuracy:
Mean error is less than ± 5 mmHg, Standard
deviation is less than ± 8 mmHg.
Range:
Adult Mode
30 to 200 mmHg
Pediatric Mode
30 to 150 mmHg
Neonatal Mode
20 to 100 mmHg
Static Pressure Measurement
19 - 14
Range:
0-300 mmHg
Static Accuracy:
± 3 mmHg
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Appendix
Performance Characteristics
Maximum Cuff Pressure
Hardware Maximum Cuff pressure:
Adult Mode:
330 mmHg
Pediatric Mode:
220 mmHg
Neonatal Mode:
165 mmHg
Software Maximum Cuff pressure:
Adult Mode:
300 mmHg
Pediatric Mode:
200 mmHg
Neonatal Mode:
145 mmHg
Cuff Inflation
The Passport V is capable of supplying sufficient air to bring a volume of at least 200 cc
(12 cubic inches) to a pressure of 300 mmHg in no more than 10 seconds, unless otherwise
stated. (ANSI/AAMI SP10A-1996)
If the cuff is not inflated to the desired pressure within 60 seconds then the cuff is vented and
a retry cycle is initiated, up to 3 times.
Maximum Leakage
The maximum allowed pressure drop with the bleed valves closed is 10 mmHg in 10 seconds
as measured with a 500 cc volume at differential pressures of 250 mmHg, 150 mmHg and
50 mmHg (Reference ANSI/AAMI SP10-1992, EN1060-3, 1997).
Vent Rate
A volume of 500 cc, when vented, is reduced from a pressure of 260 mmHg to a pressure of
15 mmHg in a maximum of 10 seconds. For Neonate, from a pressure of 150 mmHg to a
pressure of 5 mmHg in less then 5 seconds (Reference: EN1060-3, 1997).
Initial Conditions
An NIBP Zero is performed automatically before the NIBP can be initiated.
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Performance Characteristics
Appendix
NIBP Start Pressure Settings and Ranges
The Start Pressure is adjustable throughout the following ranges and is set to the following
defaults:
PATIENT SIZE
USER-SELECTABLE START
PRESSURE RANGE
INCREMENT SIZE
DEFAULT
SETTING
Adult Mode
100-280 mmHg
5 mmHg
180 mmHg
Pediatric Mode
60-180 mmHg
5 mmHg
140 mmHg
Neonatal Mode
40-120 mmHg
5 mmHg
100 mmHg
NIBP Measurement Cycle
The Maximum Measurement Cycle Duration is 180 sec for Adult and Pediatric patients
(Reference: EN60601-2-30, 1995).
The Maximum Measurement Cycle Duration is 90 sec for Neonatal patients (Reference:
EN60601-2-30, 1995).
Pulse Rate Range for NIBP Measurement
19.8.5
PATIENT SIZE
RANGE
ACCURACY
Adult Mode
35 - 245 bpm
The greater of ± 3 bpm or ± 3%
Pediatric Mode
35 - 245 bpm
The greater of ± 3 bpm or ± 3%
Neonatal Mode
70 - 245 bpm
The greater of ± 3 bpm or ± 3%
Masimo SET SpO2 Performance Requirements
Sensor Compatibility
LNOP® and LNCS® Series
Measured Parameters
SpO2 and PR
SpO2 Measurement Range
From 1% to 100%
SpO2 Accuracy
A functional tester or patient simulator not used to assess the accuracy of the pulse oximeter
probe or a pulse oximeter monitor.
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Performance Characteristics
No motion conditions1:
SATURATION RANGE
PATIENT SIZE
70% TO 100%
50% TO 69%
1-49%
Adult Mode
± 2%
± 3%
unspecified
Pediatric Mode
± 2%
± 3%
unspecified
Neonatal Mode
± 3%
± 3%
unspecified
During motion conditions2:
SATURATION RANGE
PATIENT SIZE
70% TO 100%
1-69%
Adult Mode
± 3%
unspecified
Pediatric Mode
± 3%
unspecified
Neonatal Mode
± 3%
unspecified
1
2
Masimo SET technology with LNOP and LNCS sensors have been validated for no motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2 against a
laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation, which
encompasses 68% of the population.
Masimo SET technology with LNOP and LNCS sensors have been validated for motion accuracy in human
blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping
motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an
amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation, which encompasses
68% of the population.
Resolution
1%
Average Time
Optional 2-4 seconds, 4-6 seconds, 8 seconds, 10 seconds, 12 seconds, 14 seconds,
16seconds
Refresh Rate
1s
SpO2 Response Time
The response time is 18 seconds to 95% of final step change of % SpO2 value from 60 to
95% at 75 bpm. Post averaging time is set at 8 seconds.
Sensitivity
Normal and high sensitivity modes are optional. The sensitivity mode affects the
measurement of dim signals.
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Performance Characteristics
Appendix
Low Perfusion Performance
LOW PERFUSION CONDITIONS
PULSE
AMPLITUDE
%
TRANSMISSION
SATURATION
ACCURACY
PULSE RATE
ACCURACY
> 0.02%
> 5%
± 2 digits
± 3 digits
Pulse Rate Range and Accuracy
ACCURACY
PATIENT SIZE
PULSE RATE
RANGE
NO MOTION
CONDITIONS
DURING
MOTION
CONDITIONS
Adult / Pediatric / Neonate
25 to 240 bpm
± 3 digits
± 5 digits
Masimo SET® Reference notes
The Masimo SET MS-3 pulse oximeter with LNOP®•Adt sensors has been validated for no
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter with LNOP®•Adt sensors has been validated for
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to
2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced
hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and
ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter with LNOP®•Neo and Neo•Pt sensors has been
validated for neonatal motion accuracy in human blood studies on neonates while moving
the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co-oximeter
and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus
one standard deviation encompasses 68% of the population.
The Masimo SET MS-3 pulse oximeter has been validated for low perfusion accuracy in
bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal
strengths of greater then 0.02% and a % transmission of greater than 5% for saturation's
ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus
or minus on standard deviation encompasses 68% of the population.
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Performance Characteristics
The LNOP ear sensors have an SPO2 accuracy of 70% to 100% ±3.5% for adults during no
motion conditions, however, since the monitor cannot display ½ digits, the accuracy rounded
to ±4 digits. The SPO2 accuracy during motion conditions is not specified for the LNOP ear
sensors.
LNOP & LNCS Sensors with MMS/MS-13/MS-11: Summary of Accuracy Validation (TR14864, DRO-22379, Revision C): With the exception of the LNOP Blue sensor and unless
otherwise noted in CSD-1109 or CSD-1110, the above sensors [LNOP & LNCS Sensors]
were clinically validated for motion and no motion conditions on healthy male and femaile
adults with light to dark skin pigmentation.
Sensor Measurement Wavelengths
The sensor measurement wavelengths are nominally 660 nm for the red LED and 940 nm for
the infrared LED. Maximum optical power output for the LEDs is 4 mW. This information may
be useful to clinicians, such as those performing photodynamic therapy.
19.8.6
DPM SpO2 Performance Requirements
Measured Parameters
SpO2, PR
SpO2 Measurement Range
From 0 to 100%
Accuracy
SATURATION RANGE
PATIENT SIZE
70% TO 100%
0-69%
Adult Mode
± 2% ABS
unspecified
Pediatric Mode
± 2% ABS
unspecified
Neonatal Mode
± 3% ABS
unspecified
Pulse Rate Range and Accuracy
PATIENT SIZE
PULSE RATE RANGE
ACCURACY
(NO MOTION CONDITIONS)
Adult / Pediatric / Neonate
20 to 254 bpm
± 3 digits
Resolution
1%
Sensitivity
High, medium and low sensitivity are provided.
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Performance Characteristics
Appendix
Refresh Rate
1s
Response Time
The maximum update period of saturation and pulse rate are 13s (% SpO2 value from 60 to
95% at 75 bpm) and 12s (bpm value from 60bpm to 100bpm).
SpO2 Pitch Tone Adjustment
The systole beep is generated for each heart beat detection. The source for the trigger may
be from the ECG, IBP (Art, UAP, LV, PAP), or SpO2. The frequency of the tone is determined
by the SpO2 value if it is present.
Low SpO2 Alarm Limit
Exclusive alarm. Alarm limit range is between 76 and 99 and is correlated with SpO2 alarm
low limit.
Alarm Suppression of Monitoring NIBP and SpO2 Simultaneously
When NIBP and SpO2 are monitored on the same limb simultaneously, users can choose this
function to suppress the false alarm during the period of venous block.
Alarm
SpO2 and PR alarms are optional.
DPM SpO2 Module Accuracy
The DPM SpO2 module accuracy has been validated in human studies against arterial blood
sample reference measured with a co-oximeter. Pulse oximeter measurements are statistically
distributed, and about two-thirds of the measurements can be expected to fall within the
specified accuaracy compared to the co-oximeter measurements.
Sensor Measurement Wavelengths
The sensor measurement wavelengths are nominally 660 nm for the red LED and 905 nm for
the infrared LED. Maximum optical power output for the LEDs is 18 mW. The maximum
photic output consumption of the sensor is less than 18 mW. This information may be useful
to clinicians, such as those performing photodynamic therapy.
19.8.7
Nellcor SpO2
Measurement Range
From 0 to 100%
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Passport V Operating Instructions
Appendix
Performance Characteristics
Accuracy
SATURATION RANGE
PATIENT SIZE
70% TO 100%
0-69%
Adult Mode
± 2%
unspecified
Pediatric Mode
± 2%
unspecified
Neonatal Mode
± 3%
unspecified
Pulse Rate Range and Accuracy
PATIENT SIZE
PULSE RATE RANGE
ACCURACY
(NO MOTION CONDITIONS)
Adult / Pediatric / Neonate
20 to 250 bpm
± 3 digits
Response Time
During normal measurement conditions, the averaging time is six to seven seconds.
Refresh Rate
1s
Sat-Seconds
Alarms are triggered only when set Sat-Seconds is violated. Sat-seconds is set by multiplying
the number of percentage points that the SpO2 saturation falls outside the alarm limit with the
number of seconds that it remains outside the limit. Optional threshold value: 0, 10, 25, 50,
or 100
Alarm
Optional SpO2 and PR alarm
Sensor Measurement Wavelengths
SpO2 sensors contain light emitting diodes (LEDs) that emit red light at a wavelength of
approximately 660nm, and infrared light at a wavelength of approximately 900nm. The
total optical output power of the sensor LEDs is less than 15mW. This information may be
useful to clinicians, such as those performing photodynamic therapy.
19.8.8
CO2 Performance Characteristics
The CO2 function is in accordance with the requirements of ISO 21647.
The Passport V is capable of providing CO2 measurements from either a DPM Sidestream
capnography module, or an Oridion miniMediCO2 capnography module.
The Passport V is equipped with automatic barometric pressure compensation.
The CO2 function is in accordance with the requirements of ISO 21647.
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Performance Characteristics
Appendix
miniMediCO2 Microstream®
Range:
0 - 99 mmHg
Accuracy specification of the measured CO2 partial pressure is according to the
following table (This testing is done according to ISO 21647 clauses 51.101.1 and
51.101.2.).
CO2 PARTIAL PRESSURE *
ACCURACY**
0 - 38 mmHg
± 2 mmHg
39 - 99 mmHg
± (5% of reading + 0.08% for every 1 mmHg above 38 mmHg)
*
**
At sea level.
Accuracy applies for respiration rates of up to 80 RPM. For respiration rates above 80 RPM, accuracy is
4 mmHg or ± 12% of the reading, whichever is greater, for EtCO2 values exceeding 18 mmHg. This is
tested according to and is compliant with ISO 21647. To achieve the specified accuracies for respiration
rates above 60 respirations/minute, the Microstream FilterLine H Set for Infant/Neonatal
(p/n 006324) must be used. Above 55 degrees C module temperature, ± 1 mmHg or ± 2.5% (whichever is
greater) has to be added to the tolerance of the accuracy specs.
Accuracy in the presence of interfering gases:
The accuracy specification is maintained to within 4% of the values indicated in the table
above in the presence of interfering gases according to ISO 21647 clauses 51.101.3 and
101.1. The accuracy specification is maintained to within 4% of the values indicated in the
table above in the presence of up to 80% Helium with up to 15% oxygen when tested
according to the procedures defined by ISO 21647.
Flow Rate:
50 ml/min -7.5 + 15 ml/min, flow measured by volume.
Respiration Rate Range:
0 - 150 RPM
Respiration Rate Accuracy:
Respiration Rate
0 to 70 RPM
71 to 120 RPM
121 to 150 RPM
Accuracy
± 1 RPM
± 2 RPM
± 3 RPM
Self Maintenance (SFM) Interval:
Self-Maintenance (SFM) is performed only during measurement mode. The module performs
one or more of the following:
• Ambient pressure measurement
• Auto zero (AZ)
• Flow test
SFM is triggered under the following conditions:
• During the first hour after entering measurement mode, periodically for durations of
typically 10 seconds at a rate which limits the total time consumed by SFMs to less
than 2% of the time in which active measurements are taken. Following the first hour
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Appendix
Performance Characteristics
after entering measurement mode, periodically for durations of typically 10 seconds at
a rate of at most once per hour.
• If a change of 8 °C from the last AZ is detected.
• If a pressure change of 20 mmHg relative to the last ambient pressure measurement
(less than the purge threshold) for a period of 30 seconds is detected. The module will
be able to detect a real change in the ambient pressure and a pressure change due to
partial blockage of the FilterLine.
The module prevents the triggering of an SFM in the following situations:
• In case of purging until the end of this state.
• During a breath absence period which follows a valid breath.
• While waiting a minimum of 20 seconds for host SFM enable command. (After the 20second opportunity given to the host to schedule the SFM passes, the module
schedules the SFM according to a priority determined by current conditions).
System Response Time:
The system response time (with a standard-length FilterLine)
which includes the delay time and rise time (10% to 90%) in
response to a step change in the CO2 concentration is 2.9
seconds typical.
Rise Time (Adult and
190 msec maximum
Neonatal):
Delay Time:
2.7 seconds typical
Pump Calibration Interval:
No routine calibration is required. The module should initially
be calibrated after 1200 operating hours, then once a year
or after 4,000 operating hours, whichever comes first.
Initialization Time:
Time to full accuracy (power on to first reading): Typically 30
seconds for both reading and waveform (max 180 seconds).
At full accuracy when value appears.
DPM CO2
CO2
CO2 measurement range:
0-99 mmHg
Measurement accuracy:
±2mmHg (0-40mmHg)
±5% of reading (41-76mmHg)
±10% of reading (77-99mmHg)
Passport V Operating Instructions
Resolution:
1mmHg
Sampling rate:
50Hz
0070-00-0704-02
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Performance Characteristics
Respiration Rate
Rise Time
Appendix
Measurement range:
0-120 RPM
Measurement accuracy:
±2 RPM
Resolution:
1 RPM
<240ms @150ml/min
<[email protected]/min
<[email protected]/min
<[email protected]/min
Delay Time
<[email protected]/min
<[email protected]/min
<[email protected]/min
<[email protected]/min
Measurement conditions: use a neonatal watertrap and 2.5m
neonatal sampling line.
<[email protected]/min
<[email protected]/min
<[email protected]/min
<[email protected]/min
Measurement conditions: use an adult watertrap and 2.5m adult
sampling line.
Response Time
<[email protected]/min
<[email protected]/min
<[email protected]/min
<[email protected]/min
Measurement conditions: use a neonatal watertrap and 2.5m
neonatal sampling line.
<[email protected]/min
<[email protected]/min
<[email protected]/min
<[email protected]/min
Measurement conditions: use an adult watertrap and 2.5m adult
sampling line.
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Appendix
Performance Characteristics
Quantitative Influence of
Interference gas
Interference Gas
Concentration
Quantitative
Level (%)
Influence
When measuring
under 0~40mmHg,
additional error
introduced due to
gas interference
N2O
60
±1mmHg
HAL
4
±1mmHg
SEV
5
±1mmHg
ISO
5
±1mmHg
ENF
5
±1mmHg
DES
15
±2mmHg
Helium
Unspecified
Xenon
Unspecified
Start Time:
30 s (typical) 60s (maximum)
Warm-up Time:
1 min
Flowrate:
Options are 70ml/min, 100ml/min, 120ml/min and
150ml/min.
Flowrate Accuracy:
19.8.9
±15% or ±15ml/min, whichever is greater
Temperature Performance Characteristics
The Passport V is capable of providing temperature measurements from one channel for
400 series probe.
Measuring range: 0 - 50°C (32 -122°F)
Resolution: 0.1°C (0.1°F)
Scale: °C, °F
Tabular Trend: Yes
Graphic Trend: Yes
Clinical Common Range Default of Graphic Trend: 32 - 43°C (90 - 110°F)
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Performance Characteristics
Appendix
400 Series Probes:
Scale: Celsius or Fahrenheit
Range: 59° F to 113° F
Resolution: 0.1° C (0.1° F)
Accuracy: ± 0.1° C (15° C - 45° C), exclusive of probe errors, ± 0.2° F (59° F - 113° F),
exclusive of probe errors
Accuracy inclusive of 400 Series probes:
± 0.1° C (25° C - 42° C), ± 0.2° C (otherwise),
± 0.2° F (77° F - 108° F), ± 0.4° F (otherwise)
Probe Excitation: < 200 µA, tip to sleeve.
The minimum measuring time required to obtain an accurate reading at the specified body
site is probe-dependent and should be indicated on the probe Instructions For Use.
For each temperature probe, information about the proper environmental conditions of use,
storage, and transport including temperature and humidity should be contained in the probe
Instructions For Use.
19.8.10
Gas Module Performance Characteristics
Technology
NDIR type gas analyzer measuring at 3.9 – 12.8 µm with
paramagnetic oxygen sensor. Pressure, temperature and full
spectral interference correction.
Operating modes
Startup
ISO accuracy
Full accuracy
Measured gases
CO2, N2O, O2, HAL, ENF, ISO, SEV, DES
Measured parameters
Momentary gas concentration
Inspired and expired concentrations of all gases
Breath rate
Resolution
CO2 and agents: 0.01%; O2 and N2O: 0.1%
Warm-up time
ISO accuracy within 45 s, full accuracy within 10 min
ISO Accuracy Specifications1 As Full Accuracy Specifications, but de-rated as follows:
• Add ± 0.3% ABS to inaccuracy for CO2
• Add ± 8% REL to inaccuracy for all Agents
• N2O inaccuracy is ± (8% REL + 2% ABS)
• O2 no addition
Rise times
(t10–90%)2
@200 ml/min
• CO2
250 ms (fall time 200 ms)
• N2O
250 ms
• O2
500 ms
• HAL, ISO, SEV, DES 300 ms
• ENF
19 - 26
0070-00-0704-02
350 ms
Passport V Operating Instructions
Appendix
Performance Characteristics
Rise times (t10–90%)3
• CO2
@120 ml/min
250 ms (fall time 200 ms)
• N2O
250 ms
• O2
600 ms
• HAL, ISO, SEV, DES 300 ms
• ENF
Delay time4 (t0—10%)
350 ms
<4s
Identification
Dual agent
5
Primary agent ID threshold
0.15% (0.4% during ISO accuracy mode)
Secondary agent ID threshold5 0.3% (0.5% during ISO accuracy mode) or 5% REL
(10% REL for Isoflurane) of primary agent if primary
agent >10%
Agent ID time
Three breaths - Typically less than 10 s
Display Update Rate
Breath-by-Breath
Compensation
The Gas Module 3 is equipped with automatic barometric
pressure compensation.
Main Fuse
1
2
3
4
5
2x T0.8A 250V
Includes interference from other gases.
The step rise time specification at 200 ml/min sample flow includes DRYLINE• Water Trap, Adult/Pediatric
and DRYLINE• Sampling Line, Adult/Pediatric 2.5 m.
The step rise time specification at 120 ml/min sample flow includes DRYLINE• Water Trap, Neonate and
DRYLINE• Sampling Line, Neonate 2.5 m.
The delay time specification is valid both for 120 ml/min sample flow (using DRYLINE• Water Trap, Neonate and DRYLINE• Sampling Line, Neonate 2.5 m) and for 200 ml/min sample flow (using DRYLINE•
Water Trap, Adult/Pediatric and DRYLINE• Sampling Line, Adult/Pediatric 2.5 m).
For HAL, add 0.1% ABS to threshold values.
Passport V Operating Instructions
0070-00-0704-02
19 - 27
Input/Output Communications
19.9
Appendix
Input/Output Communications
ECG Analog Output Specification
Bandwidth (-3 dB referenced to 10 Hz):
0.5 to100Hz
Maximum Transmission Delay:
≤25 ms (with notch on)
Sensitivity (referenced to 10 Hz):
1 V/mV of input,
Pacer Enhancement:
Amplitude: +5 V±5 %. Width: 2 ±10 % ms.
± 10%
Arterial Blood Pressure Analog Output Specification
Bandwidth (-3 dB referenced to 1 Hz):
0~12.5Hz
Maximum Transmission Delay:
<25 ms
Sensitivity:
1 V/100 mmHg, ±4%
(reference frequency 1Hz)
Defib Sync Pulse
Connector:
BNC AUX connector (Meets the requirements
of EC60601-1 for short-circuit protection and
leakage current.)
Max time delay:
35 ms (R-wave peak to leading edge of pulse)
Amplitude:
High level: 3.5~5V, providing a maximum of
1 mA output current;
Low level: <0.5V, receiving a maximum of 5
mA input current.
19 - 28
Pulse Width:
100 ms ±10 %
Output Impedance:
50Ω
Limited Current:
15mA rating
Rising and Falling Time:
<2ms
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.10
Communication Protocols
Communication Protocols
DIAP Communication Protocol
The Passport V supports the proprietary DIAP (0070-00-0307).
Gas Module
The Passport V supports the Gas Module Communication Protocol (0084-00-0025).
Alarm Delay Time to Remote Equipment
The alarm delay time from the Passport V to remote equipment is ≤ 2 seconds, measured at
the Passport V signal output connector.
19.11
Data Storage
Monitor Configuration Data Storage and Transfer
Storage
The monitor has the ability to store, in non-volatile memory, the user-selectable configuration.
There is one (1) configuration available for each patient size and the following information is
saved:
• Alarm Values
• Display Configurations
• NIBP Interval
• Parameter Settings, Scaling
• Trace Speed
• Printer Settings
• Trend Configurations
Patient Data Storage and Transfer
Storage
The current patient information and demographics is stored in non-volatile memory.
Passport V Operating Instructions
0070-00-0704-02
19 - 29
Printing
19.12
Appendix
Printing
Integrated Thermal Printer
The integrated printer is a maximum 3-trace thermal strip chart printer with integral
paper spool.
The printer uses plain white thermal paper 5 cm wide.
The printer supports 5 paper speeds: 6.25, 12.5, 25, and 50 mm/sec., each within ± 5%.
The printer sensitivity is
19.13
± 5% on a single trace, and 50% if scale for dual trace, ±5%.
Agency Compliance
Passport V
The Passport V is designed to comply with the following industry standards:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
19 - 30
ANSI/AAMI SP10:1992/A1:1996
ANSI/AAMI EC11:2001
ANSI/AAMI EC13:2002
ASTM E1112-00
CEI/IEC60601-1-6:2006
CEI/IEC60601-1-8:2006
CSA Standard C22.2 No. 601.1M90
EN 60601-1/IEC 60601-1
EN 60601-1-1/IEC 60601-1-1
EN 60601-1-4/IEC 60601-1-4
EN 60601-2-27/IEC 60601-2-27
EN 60601-2-30/IEC 60601-2-30
EN 60601-2-34/IEC 60601-2-34
EN 60601-2-25/IEC 60601-2-25
EN 60601-2-49/IEC 60601-2-49
EN 1060-1:1995 + A1:2002
EN 1060-3:1997+A1 2005
EN 12470-4:2000
IEC 60601-1-2:2001+A1:2004
IEC 60601-1-4:2000
ISO 9919:2005
ISO 14971:2007
ISO 21647:2004+COR.1-2005
UL 2601-1
UL 60601-1
The Passport V has been tested for functionality following ESU (Electrosurgery Unit
Interference) energy exposure as described in the draft Amendment A1 to IEC 60601-225.
0070-00-0704-02
Passport V Operating Instructions
Appendix
Safety Designations
19.14
Safety Designations
19.14.1
Safety Classification
Transportable equipment intended for mobility
Type of Protection Against Electric Shock
Class I equipment
Where the integrity of the external protective earth conductor arrangement is in doubt,
equipment shall be operated from its internal electrical electric power source (battery).
Degree of Protection Against Electric Shock
• ECG/RESP/IBP/TEMP: CF, defibrillation-proof
• SpO2/NIBP/CO2: BF, defibrillation-proof
Mode of Operation
Continuous
Protection Against Hazards of Explosion
• Not protected (ordinary equipment)
• Not for use in the presence of flammable anesthetic mixture, O2 or N2O.
Protection Against Ingress of Liquids
• Complies with the requirements of IEC60529: 2001, IPX1.
• Complies with the requirements of IEC60601-1:1988+A1:1991+A2:1995.
Electrical Connection Between Equipment and Patient
Direct electrical or non-electrical connection with the patient
19.14.2
Safety Performance Index
Shock
Complies with the requirements specified in ISO 9919: 2005, clause 21.101.
Vibration
• Complies with the requirements of ISO9919: 2005, clause 21.101 b).
• Complies with the requirements of IEC60068-2-6:1995, sinusoidal vibration.
Drop
• Main Unit Drop
• Complies with the requirements of ECRI PB-296 892:1979, section AIII 3.3.
• Packaging Drop
• Complies with the requirements specified in ISTA 2A:2006.
Passport V Operating Instructions
0070-00-0704-02
19 - 31
Safety Designations
Appendix
Impact
Complies with the requirements of ECRI PB-296 892, AIII 3.2.3 for Class 3 equipment.
Static Compression
Complies with the requirements specified in ISTA 2A.
Surface Temperature
Complies with the requirements CSA C22.2 No.601.1 M90:2003
Mechanical Stability
Complies with the requirements of IEC 60601-1: 1997, clause 24.1.
Surface, Corner, Edge
Complies with the requirements of IEC60601-1: 1997
Grip Strength
Complies with the requirements of IEC 60601-1: 1997, clause 21.c.
Incompatibility with External Connectors
• Complies with the requirements of IEC 60601-1: 1997, clauses 56.3
• Complies with the requirements of FDA Reviewer Guidance for Premarket Notification
Submission November1993, N2
Rigidity and Strength of Enclosure
• Complies with the requirements of IEC 60601-1: 1997, clauses 21a, 16a and 21b.
• Complies with the requirements of UL 60601-1:2003.
Ball Pressure Test
Complies with the requirements of IEC60601-1: 1997, clause 59.2b.
Impairment of Cooling
Complies with the requirements of IEC 60601-1: 1997, clause 52.5.5
Durability of Markings
Complies with the requirements of IEC60601-1: 1997, clause 6.1.
Leakage Current
Complies with the requirements of CSA C22.2 No.601.1 M90:2003
19 - 32
0070-00-0704-02
Passport V Operating Instructions
Appendix
Safety Designations
Dielectric Strength
• Complies with the requirements of IEC 60601-1: 1997, clause 20.
• AC power to earth(A-a1): 1500VRMS, 1min/5mA
• AC power to applied part (B-a): 4000VRMS, 1min/5mA
• Applied part to earth(B-d): 1500VRMS, 1min/5mA
• Between applied parts(B-b): 1500VRMS, 1min/5mA
Earthing Impedance
• Complies with the requirements of IEC 60601-1: 1997, clause 18.
• The impedance between the protective earth terminal of the power input connector and
any tangible metal part (such as screw and equipotential stud) that is protectively earthed
shall not exceed 0.1 ohms.
Protective Earthing and Potential Equalization
Complies with the requirements of IEC 60601-1: 1997, clause 58.
The protective earth terminal cannot be used for mechanical connections between different
parts of the equipment or for fixing any component irrelevant to protective or functional
earthing.
Anti-power Interference
After interference from ESU/defibrillation/electrostatic discharge
The equipment returns to normal operation mode within 10 seconds. The display is able to
show physiological parameters and waveforms normally. For example, the ECG waveform
data stored are not lost.
Protection Against Power Failure
Requirements of ISO21647: 2005: provides the device to prevent AC power from
disconnection and tension of 10 Kg.
If the power supply is restored after interrupted, saved presets, user settings, and patient data
previous to power failure are retained or can be restored with a DPM storage device.
The monitor stores up to 96 hours of trend information (approximately 6000 trend items)
when powered off. The interval for trend data is 1 minute.
Power Input
Complies with the requirements of IEC60601-1: 1997, clause 7.1.
Limitation of Voltage and (or) Energy
Complies with the requirements of IEC60601-1: 1997, clause 1.5.
Defibrillation-proof Applied Part
Complies with the requirements of IEC60601-1: 1997, clause 17.h.
Passport V Operating Instructions
0070-00-0704-02
19 - 33
Electromagnetic Capability
Appendix
19.15
Electromagnetic Capability
19.15.1
EMC Safety
The Passport V monitor needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in this Instructions For Use.
Portable and mobile RF communications equipment can affect the Passport V monitor.The
Passport V is suitable for use in all establishments other than domestic establishments and
those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Regulation Requirements
Complies with the requirements of IEC 60601-1-2: 2001+A1:2004.
Radiated Emission
Complies with the requirements of CISPR 11 (EN 55011:2007) Group 1, Class A.
Conducted Emission
Complies with the requirements of CISPR 11 (EN 55011:2007) Group 1, Class A.
Immunity Against Conducted Disturbance
Complies with the requirements of IEC 61000-4-6: 2006 for 3Vrms: Level 2, 150 KHz to 80
MHz, 3Vrms, 80% AM @ modulation frequency significant for the equipment under test.
Immunity Against Radiated Electromagnetic Fields
Complies with the requirements of IEC 61000-4-3:2001: 80 MHz to 2.5 GHz, 3V/m, 80%
AM @ 2 Hz or modulation frequency significant for the equipment under test.
Electrostatic Discharge
Complies with the requirements of IEC 61000-4-2:2001 for ESD, namely, minimum of 6 kV
contact discharge or 8 kV air discharge.
Electrical Fast Transient Burst
Complies with the requirements of IEC 61000-4-4:2004 for electrical fast transient burst,
namely, minimum of 2 kV for power cord and 1 kV for I/O cable (more than 3 meters long).
Surge
Complies with the requirements of IEC 61000-4-5:2005 for surge interference, namely, 1 kV
differential mode and 2 kV common mode of AC power.
Power Frequency Magnetic Field
Complies with the requirements of IEC 61000-4-8:2001 for power frequency magnetic field.
3A/m shall be reached based on the requirements of IEC60601-1-2.
19 - 34
0070-00-0704-02
Passport V Operating Instructions
Appendix
Electromagnetic Capability
Voltage Dips and Short Interruptions
Complies with the requirements of IEC 61000-4-11: 2001 for voltage dips and short
interruptions, namely, 0 V for 0.5 cycle, 40% of V for 5 cycles, 70% of V for 25 cycles 0V for
0.5 cycles.
Harmonic Current
Complies with the requirements of EN 61000-3-2:2005 Class A.
Voltage Fluctuations and Flicker
Complies with the requirements of EN 61000-3-3:2005.
19.15.2
Passport V
The Passport V meets the requirements of IEC 60601-1-2/EN 60601-1-2.
NOTE:
The Passport V needs special precautions regarding EMC
and needs to be installed and put into service according to
the EMC information provided below.
NOTE:
Portable and mobile RF communications equipment can
affect the Passport V. See tables 19-1 through 19-4 that
follow.
TABLE 19-1
GUIDANCE AND DECLARATION - ELECTROMAGNETIC EMISSIONS
The Passport V is intended for use in the electromagnetic environment specified below. The
customer or the user of the Passport V should assure that it is used in such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Passport V uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class A
Harmonic
emissions IEC
61000-3-2
Class A
The Passport V is suitable for use in all establishments
other than domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes
Voltage
fluctuations/
Flicker
emissions IEC
61000-3-3
Complies
Passport V Operating Instructions
0070-00-0704-02
19 - 35
Electromagnetic Capability
Appendix
TABLE 19-2
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Passport V is intended for use in the electromagnetic environment specified below. The
customer or the user of the Passport V should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for input/
output lines
±2 kV for power
supply lines ±1
kV for input/
output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV
differential
mode ±2 kV
common mode
±1 kV differential
mode ±2 kV
common mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for
0.5 cycle
<5% UT (>95%
dip in UT) for 0.5
cycle
40% UT (60%
dip in UT) for
5 cycles
40% UT (60%
dip in UT) for
5 cycles
70% UT (30%
dip in UT) for
25 cycles
70% UT (30%
dip in UT) for
25 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
Passport V requires continued
operation during power mains
interruptions, it is recommended that
the Passport V be powered from an
uninterruptible power supply or a
battery.
<5% UT (>95%
dip in UT) for 5
sec
<5% UT (>95%
dip in UT) for 5
sec
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
UT is the A.C. mains voltage prior to application of the test level.
19 - 36
0070-00-0704-02
Passport V Operating Instructions
Appendix
Electromagnetic Capability
TABLE 19-3
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Passport V is intended for use in the electromagnetic environment specified below. The customer or
the user of the Passport V should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF communications
equipment should be used no closer to
any part of the Passport V, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.2 x
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 x
P
80 MHz to 800 MHz
d = 2.3 x
P
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the
compliance level in each frequency
range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE:
At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
NOTE:
The device that intentionally receives RF electromagnetic
energy at the exclusion band (2409.5MHz-2464.5MHz) is
exempt from the wireless performance requirements, but
remains safe.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Passport V is used exceeds the applicable RF compliance level above, the Passport V should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Passport V.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Passport V Operating Instructions
0070-00-0704-02
19 - 37
Electromagnetic Capability
Appendix
TABLE 19-4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE PASSPORT V
The Passport V is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Passport V can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Passport V as recommended below, according to
the maximum output power of the communications equipment.
RATED MAXIMUM
OUTPUT POWER (P)
OF TRANSMITTER
IN WATTS (W)
SEPARATION DISTANCE (d) IN METERS (m) ACCORDING
TO FREQUENCY OF TRANSMITTER
150 kHz to
80 MHz
d = 1.2 x
P
80 MHz to
800 MHz
d = 1.2 x
P
800 MHz to
2.5 GHz
d = 2.3 x
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
P
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined 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.
19 - 38
NOTE:
At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.15.3
Electromagnetic Capability
Radio Regulatory Compliance
RF parameter
TABLE 19-5
DESCRIPTION
ITEM
IEEE 802.11B
IEEE 802.11G
IEEE 802.11N (20M)
Operating Frequency B and
(MHz)
2412-2462
2412-2462
2412-2462
Modulation
DSSS
OFDM-CCK
OFDM
Operating channel
1-11
1-11
1-11
Transmitter Output Power (dBm)
<30
<30
<30
FCC ID: N6C-SDMAN
IC: 4908B-SDMAN
NOTICE
Federal Communication Interference Statement (United States only)
The wireless module of this equipment has been tested and found to comply with the limits for
a class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
• Re-orient or relocate the receiving antenna
• Increase the separation between the equipment and receiver
• Connect the equipment to an outlet on a circuit different from that to which the receiver is
connected
• Consult the dealer or an experienced radio/TV technician for help
This device and its antenna(s) must not be co-located or operation in conjunction with any
other antenna or transmitter.
Canadian Depertment of Communications Industry Canada Notice (Canada
only)
This Class B digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
Passport V Operating Instructions
0070-00-0704-02
19 - 39
Electromagnetic Capability
Appendix
FCC Rules, Part 15./Industry Canadian
This device complies with Part 15 of FCC Rules and Industry Canada licence-exempt RSS
standard(s). Operation is subject to the following two conditions:
• This device may not cause harmful interference, and
• This device must accept any interference, including interference that may cause undesired
operation of this device.
Le présent appareil est conforme aux la partie 15 des règles de la FCC et CNR d'Industrie
Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux
deux conditions suivantes :
• l'appareil ne doit pas produire de brouillage, et
• l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre le fonctionnement.
This equipment complies with FCC/IC radiation exposure limits set forth for an uncontrolled
environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C
to OET65 and RSS-102 of the IC radio frequency (RF) Exposure rules. This equipment should
be installed and operated keeping the radiator at least 20cm or more away from person’s
body (excluding extremities: hands, wrists, feet and ankles).
Cet équipement est conforme aux limites d’exposition aux rayonnements énoncées pour un
environnement non contrôlé et respecte les règles les radioélectriques (RF) de la FCC lignes
directrices d'exposition dans le Supplément C à OET65 et d’exposition aux fréquences
radioélectriques (RF) CNR-102 de l’IC. Cet équipement doit être installé et utilisé en gardant
une distance de 20 cm ou plus entre le dispositif rayonnant et le corps (à l’exception des
extrémités : mains, poignets, pieds et chevilles).
WARNING:
19 - 40
Keep a distance of at least 20cm away from the monitor
when Wi-Fi function is in use.
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.15.4
Electromagnetic Capability
Gas Module 3
The Gas Module 3 meets the requirements of IEC 60601-1-2/EN 60601-1-2.
NOTE:
The Gas Module 3 needs special precautions regarding EMC
and need to be installed and put into service according to
the EMC information provided below.
NOTE:
Portable and mobile RF communications equipment can
affect the Gas Module 3. See tables 19-6 through 19-9 that
follow.
TABLE 19-6
GUIDANCE AND DECLARATION - ELECTROMAGNETIC EMISSIONS
The Gas Module 3 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Gas Module 3 should assure that they are used in such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Gas Module 3 uses RF energy only for their
internal function. Therefore, their RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic
emissions IEC
61000-3-2
Class A
The Gas Module 3 is suitable for use in all
establishments other than domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Voltage
fluctuations/
Flicker
emissions IEC
61000-3-3
Complies
Passport V Operating Instructions
0070-00-0704-02
19 - 41
Electromagnetic Capability
Appendix
TABLE 19-7
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Gas Module 3 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Gas Module 3 should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact ±8
kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for
0.5 cycle
<5% UT (>95%
dip in UT) for
0.5 cycle
40% UT (60%
dip in UT) for
5 cycles
40% UT (60%
dip in UT) for
5 cycles
70% UT (30%
dip in UT) for
25 cycles
70% UT (30%
dip in UT) for
25 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the Gas
Module 3 requires continued
operation during power mains
interruptions, it is recommended that
the Gas Module 3 be powered from
an uninterruptible power supply or a
battery.
<5% UT (>95%
dip in UT) for
5 sec
<5% UT (>95%
dip in UT) for
5 sec
3 A/m
3 A/m
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
UT is the A.C. mains voltage prior to application of the test level.
19 - 42
0070-00-0704-02
Passport V Operating Instructions
Appendix
Electromagnetic Capability
TABLE 19-8
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The Gas Module 3 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Gas Module 3 should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF
communications equipment should be
used no closer to any part of the Gas
Module 3, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.2 x
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2 x
P
80 MHz to 800 MHz
d = 2.3 x P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should be
less than the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE:
At 80 MHz and 800 MHz, the higher frequency range
applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
Gas Module 3 is used exceeds the applicable RF compliance level above, the Gas Module 3 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the or Gas Module 3.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Passport V Operating Instructions
0070-00-0704-02
19 - 43
Electromagnetic Capability
Appendix
TABLE 19-9
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE GAS MODULE 3
The Gas Module 3 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Gas Module 3 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Gas Module 3 as recommended below,
according to the maximum output power of the communications equipment.
RATED MAXIMUM OUTPUT
POWER (P) OF
TRANSMITTER IN WATTS
(W)
SEPARATION DISTANCE (d) IN METERS (m)
ACCORDING TO FREQUENCY OF TRANSMITTER
150 kHz to
80 MHz
d = 1.2 x
0.01
P
0.12
80 MHz to
800 MHz
d = 1.2 x
800 MHz to
2.5 GHz
P
d = 2.3 x
0.12
P
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined 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.
19 - 44
NOTE:
At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
NOTE:
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
0070-00-0704-02
Passport V Operating Instructions
Appendix
19.16
Warranty Statements
Warranty Statements
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. warrants that
components within the monitor unit will be free from defects in workmanship and materials
for the number of years shown on the invoice. Under this extended warranty, Mindray DS
USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. will repair or replace any
defective component at no charge for labor and/or materials. This extended warranty does
not cover consumable items such as, but not limited to batteries, displays, external cables
and sensors.
Recommended preventative maintenance, as prescribed in the Service Manual, is the
responsibility of the user, and is not covered by this warranty.
Except as otherwise provided herein, the terms, conditions and limitations of Mindray DS
USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd.’s standard warranty will
remain in effect.
USA, Canada, Mexico, and Puerto Rico
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. warrants that its
products will be free from defects in workmanship and materials for a period of one (1) year
from the date of purchase except that disposable or one-time use products are warranted to
be free from defects in workmanship and materials up to a date one year from the date of
purchase or the date of first use, whichever is sooner. This warranty does not cover
consumable items such as, but not limited to, batteries, external cables, sensors, cuffs, hoses,
or mounts.
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. will not be liable
for any incidental, special, or consequential loss, damage, or expense directly or indirectly
arising from the use of its products, liability under this warranty and the buyer’s exclusive
remedy under this warranty is limited to servicing or replacing at Mindray DS USA, Inc./
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.’s option at the factory or at an
authorized Distributor, any product which shall under normal use and service appear to the
Company to have been defective in material or workmanship.
No agent, employee, or representative of Mindray DS USA, Inc./Shenzhen Mindray BioMedical Electronics Co., Ltd. has any authority to bind Mindray DS USA, Inc./Shenzhen
Mindray Bio-Medical Electronics Co., Ltd. to any affirmation, representation, or warranty
concerning its products, and any affirmation, representation or warranty made by any agent,
employee, or representative shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty or merchantability or fitness, and of any other obligation on the part of the
seller.
Passport V Operating Instructions
0070-00-0704-02
19 - 45
Warranty Statements
Appendix
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. makes no
warranty whatever in regard to trade accessories, such being subject to the warranty of their
respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Mindray DS USA, Inc./Shenzhen Mindray BioMedical Electronics Co., Ltd., freight prepaid to Mindray DS USA, Inc./Shenzhen Mindray
Bio-Medical Electronics Co., Ltd. Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. shall not have any responsibility in the event of loss or damage in transit.
Calibration may be performed without the need to disassemble the instrument. It is the
responsibility of the purchaser to perform calibration as necessary, in accordance with the
instructions provided in this manual.
International (excluding North America)
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. warrants that its
products will be free from defects in workmanship and materials for a period of two (2) years
from the date of purchase except that disposable or one-time use products are warranted to
be free from defects in workmanship and materials up to a date one year from the date of
purchase or the date of first use, whichever is sooner. This warranty does not cover
consumable items such as, but not limited to, batteries, external cables, sensors, cuffs, hoses,
or mounts.
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. shall not be
liable for any incidental, special, or consequential loss, damage, or expense directly or
indirectly arising from the use of its products, liability under this warranty and the buyer’s
exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA,
Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd.’s option at the factory or at an
authorized Distributor, any product which shall under normal use and service appear to the
Company to have been defective in material or workmanship.
No agent, employee, or representative of Mindray DS USA, Inc./Shenzhen Mindray BioMedical Electronics Co., Ltd. has any authority to bind Mindray DS USA, Inc. /Shenzhen
Mindray Bio-Medical Electronics Co., Ltd. to any affirmation, representation, or warranty
concerning its products, and any affirmation, representation or warranty made by any agent,
employee, or representative shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any
implied warranty or merchantability or fitness, and of any other obligation on the part of the
seller.
19 - 46
0070-00-0704-02
Passport V Operating Instructions
Appendix
Customer Service
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical Electronics Co., Ltd. makes no
warranty whatever in regard to trade accessories, such being subject to the warranty of their
respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to
be defective be returned when authorized by Mindray DS USA, Inc./Shenzhen Mindray BioMedical Electronics Co., Ltd., freight prepaid to Mindray DS USA, Inc./Shenzhen Mindray
Bio-Medical Electronics Co., Ltd. Mindray DS USA, Inc./Shenzhen Mindray Bio-Medical
Electronics Co., Ltd. shall not have any responsibility in the event of loss or damage in transit.
Calibration may be performed without the need to disassemble the instrument. It is the
responsibility of the purchaser to perform calibration as necessary, in accordance with the
instructions provided in this manual.
19.17
Customer Service
Mindray DS USA, Inc. maintains a network of service representatives and factory-trained
distributors. Prior to requesting service, perform a complete operational check of the
instrument to verify proper control settings. If operational problems continue to exist, contact
the Service Department at (800) 288-2121 or (201) 995-8116 for assistance in determining
the nearest field service location.
Please include the instrument model number, the serial number, and a description of the
problem with all requests for service.
Any questions regarding the warranty should be directed to the nearest Mindray DS USA,
Inc. location. A list of international offices, along with their phone numbers, is provided at the
end of this manual.
NOTE:
19.18
Upon request, Mindray DS USA, Inc. will provide circuit
diagrams, component part lists, descriptions, calibration
instructions, or other information which will assist the user’s
appropriately qualified technical personnel to repair those
parts of the equipment which are designated by Mindray DS
USA, Inc. as repairable.
Manufacturer’s Responsibility
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (hereinafter called Mindray) is
responsible for the effects on safety, reliability and performance of the equipment only if:
a. assembly operations, extensions, readjustments, modifications or repairs are carried
out by persons authorized by Mindray; and
b. the electrical installation of the relevant room complies with the appropriate
requirements; and
c. the equipment is used in accordance with the instructions for use.
Passport V Operating Instructions
0070-00-0704-02
19 - 47
ManufacturergS Responsibility
Appendix
This page intentionally left blank.
19 - 48
0070-00-0704-02
Passport V Operating Instructions
20.0
Glossary
20.1
Glossary of Terms
AG
Anesthetic Gas
Agent
Anesthetic agent
Art
Arterial - label for invasive blood pressure
awRR
airway Respiration Rate
CO2
Carbon Dioxide
Compl
Dynamic Compliance
CVA
Cardiovascular Artifact - this is any artifact in the respiratory waveform
due to heartbeats, also message will occur if heart rate and respiration
rate are the same
CVP
Central Venous Pressure - label for invasive blood pressure
Des
Desflurane
ECG
Electrocardiogram
Enf
Enflurane
ET
End - tidal
etCO2
End - tidal CO2 - A patient’s carbon dioxide level measured at endexpiration
Hal
Halothane
HR
Heart rate. Number of heartbeats per minute
ICP
Intracranial pressure - label for invasive blood pressure
IBP
Invasive Blood pressure
Insp
Inspiratory
ISO
Isoelectric point - reference point on ECG waveform for ST analysis
International Organization for Standardization
Iso
Passport V Operating Instructions
Isoflurane
0070-00-0704-02
20 - 1
Glossary of Terms
20 - 2
Glossary
LA
Left atrium - label for invasive blood pressure
LV
Left ventricle - label for invasive blood pressure
MAC
Minimum Alveolar Concentration
N2O
Nitrous oxide
NIBP
Non-invasive Blood Pressure
O2
Oxygen
PA
Pulmonary artery - label for invasive blood pressure
PVC
Premature Ventricular Contractions
RA
Right Atrium - label for invasive blood pressure
Sev
Sevoflurane
SpO2
Oxygen Saturation
ST
ST segment value, indicating the condition of myocardial ischemia
UA
Umbilical Artery - label for invasive blood pressure
0070-00-0704-02
Passport V Operating Instructions
This page intentionally left blank.
0070-00-0704-02
Rev 12.0
November, 2014
Mindray DS USA, Inc. • 800 MacArthur Boulevard • Mahwah, NJ 07430 • USA •
Dom. Customer Service: 1.800.288.2121 • Intl. Customer Service: +1.201.995.8000 •
Dom. Fax: 1.800.926.4275 • Intl. Fax: +1.201.995.8680 • www.mindray.com
Mindray Medical Netherlands B.V.• Drs. W. van Royenstraat 8 • P.O. Box 26 • 3870 CA
Hoevelaken • The Netherlands • Tel: +31 33 25 44 911 • Fax: +31 33 25 37 621
Mindray (UK) Limited • 3 Percy Road • St. John’s Park • Huntingdon • Cambridgeshire PE29 6SZ •
United Kingdom • Tel: 01480 416840 • Fax: 01480 436588
Mindray Medical France SARL • Europarc Créteil •123, Chemin des Bassins •
94035 Créteil Cedex • France • Tel: (0)1.45.13.91.50 • Fax: (0)1.45.13.91.51
Mindray Medical Germany GmbH • Zwischen den Bächen 4 • 64625 Bensheim • Deutschland •
Tel: +49.6251.17524-0 • Fax: +49.6251.17524-20
Mindray Medical International Ltd. • 2813 Office Tower, Convention Plaza • No 1 Harbour Road •
Wanchai • Hong Kong • Tel: +852 2793 5596 • Fax: +852 2344 8824
Medstar Importação e Exportação Ltda • Av. Vereador José Diniz, 3300 • São Paulo, SP • CEP
04804-000 • Brazil • Tel: 55 11 2872-3385 • Fax: 55 11 2872-3385
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