Passport 2 / VAULT COPY

Passport 2 / VAULT  COPY
VAULT COPY
0070-02-0440-01
2/16/05
11:24 AM
Page 1
Passport 2 / Passport 2
®
Operating Instructions
TM
Microstream® and FilterLine® are U.S. registered trademarks of Oridion Medical Ltd.
MediCO2® is a registered trademark of Oridion Medical Ltd.
CapnoLine™ and NIV Line™ are trademarks of Oridion Medical Ltd.
Nellcor®, Oxismart®, Oxiband®, and Durasensor® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.
OxiMax® and Max-Fast® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.
Oxisensor® is a U.S. registered trademark of Nellcor Puritan Bennett Inc.
Masimo SET®, LNCS® and LNOP® are U.S. registered trademarks of Masimo Corporation.
PatientNet® is a U.S. registered trademark of GE Medical Systems Information Technologies.
Passport 2® is a U.S. registered trademark of Datascope Corp.
Navigator™, Auto-Set™, and View 12™ are U.S. trademarks of Datascope Corp.
Panorama™ is a U.S. trademark of Datascope Corp.
Velcro® is a registered trademark of Velcro Industries B.V.
Copyright© Datascope Corp., 2005. Printed in U.S.A. All rights reserved. Contents of this publication may not be
reproduced in any form without permission of Datascope Corp.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Table of Contents
Foreword ....................................................................................................................................................... vii
Warnings, Precautions And Notes .................................................................................................................... vii
Warnings ...................................................................................................................................................... viii
Precautions .................................................................................................................................................... xi
Notes ............................................................................................................................................................ xv
Intended Use .................................................................................................................................................. xv
Unpacking ..................................................................................................................................................... xvi
Symbols and Descriptions ................................................................................................................................ xvii
General Description .......................................................................................................... 1 - 1
Controls, Indicators and Connectors .................................................................................. 2 - 1
Front Panel..................................................................................................................................................... 2 - 2
Display .......................................................................................................................................................... 2 - 6
Menus ........................................................................................................................................................... 2 - 9
Patient.................................................................................................................................................... 2 - 9
Monitor Setup ......................................................................................................................................... 2 - 11
Print Setup .............................................................................................................................................. 2 - 14
Parameters ............................................................................................................................................. 2 - 15
Functions Menu ....................................................................................................................................... 2 - 16
Left Side Panel ................................................................................................................................................ 2 - 17
Right Side Panel ............................................................................................................................................. 2 - 19
Rear Panel ..................................................................................................................................................... 2 - 20
Remote Color Display (Passport 2 Only) ............................................................................................................ 2 - 21
Gas Module - Front Panel (Optional Passport 2).................................................................................................. 2 - 22
Gas Module - Rear Panel (Optional Passport 2) .................................................................................................. 2 - 24
Comm-Port (Optional Passport 2) ...................................................................................................................... 2 - 25
Operation......................................................................................................................... 3 - 1
Getting Started ............................................................................................................................................... 3 - 1
Installation Mode ............................................................................................................................................ 3 - 3
Installation Menu ..................................................................................................................................... 3 - 3
System Information Menu.......................................................................................................................... 3 - 6
Non-Invasive Blood Pressure Measurements (NIBP).............................................................................................. 3 - 8
The NIBP Menu ....................................................................................................................................... 3 - 8
Manual NIBP Measurements ..................................................................................................................... 3 - 8
Automatic NIBP Measurements.................................................................................................................. 3 - 10
Automatic Adjustment in the Interval Mode ......................................................................................... 3 - 10
Suspension of NIBP Measurements .................................................................................................... 3 - 11
NIBP Pressure Limit Fail Safe ..................................................................................................................... 3 - 11
Cuff Inflation Time.................................................................................................................................... 3 - 11
START and STOP Functions ....................................................................................................................... 3 - 11
NIBP Auto Time Out Functions................................................................................................................... 3 - 12
ECG Measurements ........................................................................................................................................ 3 - 13
Electrocardiogram (ECG) Monitoring ......................................................................................................... 3 - 13
Skin Preparation ............................................................................................................................. 3 - 13
Electrode Patch Location ................................................................................................................... 3 - 14
Lead Placement ............................................................................................................................... 3 - 14
The ECG Menu ....................................................................................................................................... 3 - 22
3 Lead or 5 Lead ECG Measurements ........................................................................................................ 3 - 23
“ECG Lead Fault” Message ...................................................................................................................... 3 - 24
12-Lead ECG Monitoring (Optional Passport 2)........................................................................................... 3 - 24
12-lead ECG Analysis (Optional Passport 2) ...................................................................................... 3 - 25
Invasive Blood Pressure (IBP1, IBP2) (optional Passport 2) .................................................................................... 3 - 27
SpO2 Pulse Oximetry ...................................................................................................................................... 3 - 28
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Table of Contents
SpO2 Menu ............................................................................................................................................ 3 - 28
SpO2 Measurements................................................................................................................................ 3 - 28
Performance Considerations ..................................................................................................................... 3 - 30
Calibration ..................................................................................................................................... 3 - 30
Auto Scaling ................................................................................................................................... 3 - 30
Masimo® Sensors and Patient Cable.......................................................................................................... 3 - 30
Masimo Sensors and Accessories ...................................................................................................... 3 - 31
Selecting a Sensor ........................................................................................................................... 3 - 31
Cleaning and Re-use ........................................................................................................................ 3 - 32
Nellcor® Sensors and Patient Cable........................................................................................................... 3 - 32
Selecting a Sensor ........................................................................................................................... 3 - 32
Cleaning and Re-Use ....................................................................................................................... 3 - 32
ST Monitoring (Optional Passport 2).................................................................................................................. 3 - 33
ST Setup ................................................................................................................................................. 3 - 34
Arrhythmia Algorithm (Optional Passport 2) ....................................................................................................... 3 - 35
ST Segment Analysis (Optional Passport 2) ........................................................................................................ 3 - 38
Arrhythmia Alarms (Optional Passport 2) ........................................................................................................... 3 - 39
Lethal Arrhythmia Alarms.......................................................................................................................... 3 - 39
Non-Lethal Arrhythmia Alarms................................................................................................................... 3 - 40
Arrhythmia Analysis (Optional Passport 2) ......................................................................................................... 3 - 43
Temperature Menu .......................................................................................................................................... 3 - 45
List Trends (Passport 2 Only)............................................................................................................................. 3 - 46
Modification of Parameters Displayed ........................................................................................................ 3 - 47
Modification of Trend Entry Conditions....................................................................................................... 3 - 47
Filtering of List Trend Data Displayed ......................................................................................................... 3 - 47
Printing List Trend Data............................................................................................................................. 3 - 48
Transferring List Trend Data Between Different Passport 2 Monitors ................................................................ 3 - 48
Transfer Notes......................................................................................................................................... 3 - 48
Clearing Trend Data ................................................................................................................................ 3 - 48
Removing the List Trend Display................................................................................................................. 3 - 48
Graph Trends (Passport 2 Only)........................................................................................................................ 3 - 49
Modification of Parameters Displayed ........................................................................................................ 3 - 50
Modification of Trend Entry Conditions....................................................................................................... 3 - 50
Printing Graph Trend Data........................................................................................................................ 3 - 50
Transferring Graph Trend Data Between Different Passport 2 Monitors ........................................................... 3 - 50
Clearing Trend Data ................................................................................................................................ 3 - 50
Removing the Graph Trend Display............................................................................................................ 3 - 51
OXY CRG Display Menu (Passport 2 only) ......................................................................................................... 3 - 52
Parameters Displayed .............................................................................................................................. 3 - 52
Printing OXY CRG Data ........................................................................................................................... 3 - 52
Transferring OXY CRG Data Between Different Passport 2 Monitors............................................................... 3 - 52
Clearing Trend Data ................................................................................................................................ 3 - 53
Removing the OXY CRG Display ............................................................................................................... 3 - 53
Respiration Monitoring .................................................................................................................................... 3 - 54
Resp Menu ............................................................................................................................................. 3 - 54
Thoracic Impedance................................................................................................................................. 3 - 54
CO2 Waveform (Passport 2 only) .............................................................................................................. 3 - 55
Respiration Monitoring on the Passport 2.................................................................................................... 3 - 55
Thoracic Impedance ........................................................................................................................ 3 - 55
CO2 Waveform (requires optional Microstream® CO2 or Gas Module) (Passport 2 only) ........................ 3 - 55
Microstream® CO2 Monitoring (Optional Passport 2).......................................................................................... 3 - 56
Microstream CO2 .................................................................................................................................... 3 - 56
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Passport 2®/Passport 2 LT™ Operating Instructions
Table of Contents
Microstream® CO2 Calibration ................................................................................................................. 3 - 57
Gas Module (optional Passport 2)..................................................................................................................... 3 - 60
Sequence for Monitoring Anesthetic Gases, O2, N2O and/or CO2............................................................... 3 - 60
Gas Monitor Calibration .......................................................................................................................... 3 - 61
Alarms........................................................................................................................................................... 3 - 64
Setting Parameter Alarm Limits .................................................................................................................. 3 - 64
Alarm Limits ............................................................................................................................................ 3 - 65
Auto-Set Alarms....................................................................................................................................... 3 - 66
Alarm Violations...................................................................................................................................... 3 - 67
Beep Tones ............................................................................................................................................. 3 - 69
Recorder (Optional) ........................................................................................................................................ 3 - 71
Print Setup Menu ..................................................................................................................................... 3 - 71
Operation of Recorder ............................................................................................................................. 3 - 71
Printer Formats ........................................................................................................................................ 3 - 72
Laser Printing 12 Lead ECG (optional - Passport 2 only)....................................................................................... 3 - 76
Printing 12 Lead to the Laser printer........................................................................................................... 3 - 76
Laser Printing 12 Lead Format: (Passport 2 only).......................................................................................... 3 - 77
Status Messages ............................................................................................................................................. 3 - 78
NIBP Measurement Messages ................................................................................................................... 3 - 78
SpO2 Messages ...................................................................................................................................... 3 - 79
Recorder Messages (only units equipped with recorder) ............................................................................... 3 - 80
CO2 Messages (only units equipped with CO2) .......................................................................................... 3 - 80
Passport 2 / Gas Module Messages (only observed when Gas Module is installed)......................................... 3 - 80
Cooling Fan Message .............................................................................................................................. 3 - 83
Monitor Problem Solving.................................................................................................................................. 3 - 84
Connection to Visa or PatientNet Central Stations ............................................................................................... 3 - 87
Connection to Panorama™ Central Station ......................................................................................................... 3 - 88
Connection to Panorama™ Gateway ................................................................................................................. 3 - 89
User Maintenance ............................................................................................................. 4 - 1
Introduction .................................................................................................................................................... 4 - 1
Care and Cleaning of Monitor ......................................................................................................................... 4 - 1
Decontamination of Monitor ............................................................................................................................. 4 - 2
Care and Cleaning of SpO2 Sensors................................................................................................................. 4 - 2
Sterilization and Cleaning of Reusable Bladderless Cuffs ..................................................................................... 4 - 2
Battery Replacement and Maintenance .............................................................................................................. 4 - 3
Battery Replacement ................................................................................................................................ 4 - 3
Battery Maintenance ................................................................................................................................ 4 - 3
Recorder Paper Replacement............................................................................................................................ 4 - 4
Care and Storage of Thermal Chart Paper ......................................................................................................... 4 - 4
Care and Cleaning of Gas Module ................................................................................................................... 4 - 5
Care and Cleaning of 3 Lead and 5 Lead ECG Cables and Leadwires.................................................................. 4 - 6
Care and Cleaning of View 12™ ECG Cables and Leadwires .............................................................................. 4 - 6
Accessories ....................................................................................................................... 5 - 1
Optional Accessories ...................................................................................................................................... 5 - 1
NIBP Accessories..................................................................................................................................... 5 - 1
Oximetry Sensors and Accessories............................................................................................................. 5 - 2
Pulse Oximetry-Masimo SET® LNOP® SpO2 ....................................................................................... 5 - 2
Pulse Oximetry-Masimo Set® LNCS® SpO2 ......................................................................................... 5 - 3
Pulse Oximetry-Nellcor® OxiMax® SpO2* ......................................................................................... 5 - 4
Oridion CO2 Accessories ......................................................................................................................... 5 - 4
Gas Module Accessories .......................................................................................................................... 5 - 5
Reusable Temperature Probes.................................................................................................................... 5 - 5
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Table of Contents
Disposable Temperature Probes................................................................................................................. 5 - 5
ECG Accessories ..................................................................................................................................... 5 - 6
ECG Cables ................................................................................................................................... 5 - 6
ECG Leadwires ............................................................................................................................... 5 - 6
12 Lead ECG Accessories ................................................................................................................ 5 - 7
Electrodes ...................................................................................................................................... 5 - 7
IBP Accessories ....................................................................................................................................... 5 - 7
Comm-Port Accessories ............................................................................................................................ 5 - 7
Base Station Accessories .......................................................................................................................... 5 - 8
Miscellaneous Accessories........................................................................................................................ 5 - 9
Mounting Kits and Accessories .................................................................................................................. 5 - 9
Upgrade Kits........................................................................................................................................... 5 - 9
Central Station Accessories....................................................................................................................... 5 - 10
Appendix ......................................................................................................................... 6 - 1
Safety Designations......................................................................................................................................... 6 - 1
Safety designations per IEC 601-1 Standard............................................................................................... 6 - 1
Performance Specifications .............................................................................................................................. 6 - 3
ECG ...................................................................................................................................................... 6 - 3
ECG Performance Requirements ........................................................................................................ 6 - 3
Analog Output Specifications.................................................................................................................... 6 - 6
3 Lead and 5 Lead ECG .................................................................................................................. 6 - 6
Arterial Blood Pressure ..................................................................................................................... 6 - 7
Sync Pulse for Cardioversion ............................................................................................................ 6 - 7
Systole Detector and Heart Rate Meter ....................................................................................................... 6 - 7
ECG Derived Heart Rate Meter Performance Requirements ................................................................... 6 - 7
IBP Derived Heart Rate Meter Performance ......................................................................................... 6 - 9
SpO2 Derived Heart Rate Meter Performance ..................................................................................... 6 - 9
NIBP Derived Heart Rate Meter ......................................................................................................... 6 - 9
S-T Segment Analysis ............................................................................................................................... 6 - 9
S-T Segment Analysis Performance Requirements ................................................................................. 6 - 9
Arrhythmia Analysis ................................................................................................................................. 6 - 10
12-Lead ECG Interpretation .............................................................................................................. 6 - 11
NIBP Sub-System Performance Characteristics ............................................................................................. 6 - 11
Pressure Measurement System ........................................................................................................... 6 - 12
Pulse Rate ....................................................................................................................................... 6 - 12
Maximum Cuff Pressure .................................................................................................................... 6 - 12
Cuff Inflation ................................................................................................................................... 6 - 12
Maximum Leakage .......................................................................................................................... 6 - 13
Vent Rate ....................................................................................................................................... 6 - 13
NIBP Sub-System Functional Requirements .................................................................................................. 6 - 13
Initial Conditions ............................................................................................................................. 6 - 13
NIBP Starting Pressure Settings and Ranges ........................................................................................ 6 - 13
NIBP Measurement Cycle ................................................................................................................. 6 - 13
IBP Parameter Sub-System Performance Characteristics................................................................................. 6 - 14
IBP Performance Requirements .......................................................................................................... 6 - 14
IBP Connector Type ......................................................................................................................... 6 - 14
IBP Transducer Performance .............................................................................................................. 6 - 14
IBP Heart Rate Meter ....................................................................................................................... 6 - 14
Temperature Parameter Performance Characteristics .................................................................................... 6 - 15
Connector Type .............................................................................................................................. 6 - 15
Temperature Performance Requirements ............................................................................................. 6 - 15
Respiration ............................................................................................................................................. 6 - 16
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Table of Contents
ECG Respiration Performance Requirements ....................................................................................... 6 - 16
CO2 Respiration Performance Requirements ....................................................................................... 6 - 17
SpO2 ..................................................................................................................................................... 6 - 17
Masimo® SpO2 Performance Requirements ........................................................................................ 6 - 17
Masimo® Pulse Rate Performance ...................................................................................................... 6 - 18
Nellcor SpO2 Performance Requirements ........................................................................................... 6 - 19
Nellcor SpO2 Pulse Rate Performance Requirements ............................................................................ 6 - 19
CO2 ...................................................................................................................................................... 6 - 20
Microstream® CO2 (Passport 2 Only) ................................................................................................ 6 - 20
Physical Characteristics ............................................................................................................................ 6 - 21
Printer .................................................................................................................................................... 6 - 21
Comm-Port .............................................................................................................................................. 6 - 21
Physical Characteristics .................................................................................................................... 6 - 21
Communication Characteristics ......................................................................................................... 6 - 21
Normal Operating Noise ......................................................................................................................... 6 - 22
Battery ................................................................................................................................................... 6 - 23
Sealed Lead Acid Battery (P/N 0146-00-0043) .................................................................................. 6 - 23
Lithium-Ion Battery (P/N 0146-00-0069) ............................................................................................ 6 - 23
AC Power............................................................................................................................................... 6 - 24
Real Time Clock ...................................................................................................................................... 6 - 24
Power Selection....................................................................................................................................... 6 - 24
Fan Control............................................................................................................................................. 6 - 24
Trend Storage ......................................................................................................................................... 6 - 24
Transferring Monitor Default Settings.......................................................................................................... 6 - 25
Installation and Use of “Extended Trend” feature ......................................................................................... 6 - 25
Display................................................................................................................................................... 6 - 25
Gas Module................................................................................................................................................... 6 - 26
Environmental Conditions................................................................................................................................. 6 - 28
Storage .................................................................................................................................................. 6 - 28
Agency Compliance........................................................................................................................................ 6 - 29
Electromagnetic Capability .............................................................................................................................. 6 - 30
Indirect Blood Pressure Measurements And Associated Errors ............................................................................... 6 - 34
Precautions While Making Automatically Cycled Blood Pressure Measurements...................................................... 6 - 35
Cuff Size ................................................................................................................................................ 6 - 35
Other Factors .......................................................................................................................................... 6 - 35
User Verification Of Passport 2 Measurements.................................................................................................... 6 - 35
Newborn NIBP Technique................................................................................................................................ 6 - 36
How To Get Help............................................................................................................................................ 6 - 36
Warranty....................................................................................................................................................... 6 - 37
USA, Canada, Mexico, and Puerto Rico..................................................................................................... 6 - 37
Datascope’s Responsibility ............................................................................................................................... 6 - 38
Extended Warranty......................................................................................................................................... 6 - 38
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Foreword
Introduction
Foreword
The Passport 2/Passport 2 LT Operating Instructions are intended to provide
information for proper operation.
General knowledge of monitoring and an understanding of the features and functions of the
Datascope Passport 2/Passport 2 LT Monitor are prerequisites for its proper use.
Do not operate this monitor before reading these instructions.
Information for servicing this instrument is contained in the Passport 2/Passport 2 LT
Operation/Service Manual, Part No. 0070-00-0513-01. For additional information or
assistance, please contact an authorized Datascope 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 may differ based on the monitoring device
configuration, licenses available, parameters selected and
patient configuration of the Passport 2/ Passport 2 LT
Monitor.
Patents: This device is covered under one or more of the following U.S. Patents 4,621,643,
4,653,498, 4,700,708, 4,770,179, 4,869,254, 4,911,167, 4,928,692, 4,934,372,
5,078,136, 5,351,685, 5,368,026, 5,368,224, 5,482,036, 5,490,505, 5,533,507,
5,632,272, 5,685,299, 5,758,644, 5,769,785, 5,823,950, 6,002,952, 6,036,642,
6,067,462, 6,157,850, 6,206,830, 6,247,674, 6,377,845, 4,802,486, 4,960,126,
5,485,847, 5,743,263, 5,865,736, 6,011,986, 6,035,223, 6,263,222, 6,298,252,
6,463,310, 6,501,975, 6,591,123, 6,675,031, 6,708,049, 6,801,797, Re.35,122 and
foreign equivalents. 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 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
vii
Introduction
Warnings
Warnings
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: 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: 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: For continued protection against a fire hazard, replace all
fuses with the specified type and rating. See the Passport 2
Service Manual, P/N 0070-00-0513-01.
WARNING: Do not clean the monitor while it is on and/or plugged in.
WARNING: This unit uses a common isolation path for the ECG leads
and the Invasive Pressure Channels. Ensure that conductive
parts of the ECG electrodes do not contact other conductive
parts including earth ground. Do not connect any nonisolated accessories to the Passport 2 or to the ECG or
invasive pressure channel inputs when connected to a
patient. Insure that the total chassis leakage currents of all
connected units does not exceed 300µA. Use an IEC 601-1
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: The AC line cord and interface cables (ie non-patient cables)
may utilize the same ground. Therefore, removal of the AC
line cord does not necessarily isolate the Passport 2, if nonpatient 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: Microstream® waste material and CO2 filter should be
treated as biohazard material.
WARNING: Do not incinerate battery, possible explosion may occur.
WARNING: Do not put MPSO (Multiple Portable Socket Outlets ie.
Multiple outlet extension cords) used with the Passport 2/
Passport 2 LT or its accessories on the floor. Connect only
Passport 2/Passport 2 LT accessories to the same MPSO as
the Passport 2/Passport 2 LT. Do not overload the MPSO
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Passport 2®/Passport 2 LT™ Operating Instructions
Warnings
Introduction
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: 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.
WARNING: Computerized ECG Analysis should be reviewed by qualified
medical personnel. It should not be used exclusively for
treatment or non-treatment of patients.
WARNING: ST segment measurements may be affected by one or more
of the following ECG rhythm morphologies: wide complex
QRS such as bundle branch blocks, ventricular pacemaker
rhythm, left ventricular hypertrophy or Wolff-ParkinsonWhite Syndrome. Consult with qualified medical personnel
prior to treatment or non-treatment.
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
WARNING: Route cables neatly. Ensure cables, hoses and wires are
away from a patient’s neck to avoid strangulation. Keep
floors and walkways free of cables to reduce risk to
hospital personnel, patients and visitors.
WARNING: The arrhythmia analysis feature is intended to detect
ventricular rhythms, however, due to physiologic differences
in patient populations, the Passport 2/Passport 2 LT may
occasionally sound a false alarm or may not recognize
some arrhythmia patterns.
WARNING: Operation of the Passport 2/Passport 2 LT 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 2/Passport 2 LT. It can also cause
delayed recovery after the discharge of a cardiac
defibrillator.
WARNING: The Passport 2/Passport 2 LT should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use
is necessary, the Passport 2/Passport 2 LT should be
observed to verify normal operation in the configuration in
which it will be used.
Passport 2®/Passport 2 LT™ Operating Instructions
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ix
Introduction
Warnings
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
WARNING: Ensure that the ECG leadwires are neatly secured in a
manner that will prevent them from encircling the patient’s
neck, creating a strangulation hazard.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenge 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 using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min. This device should not be
used on patients whose breathing could be impaired by this
vacuum flow rate.
WARNING: When using Microstream® CO2 Monitoring, the maximum
sampling rate at the nasal cannula is 50 ml/min. This device
should not be used on patients whose breathing could be
impaired by this vacuum flow rate.
WARNING: Perform the decontamination process with the unit powered
down and power cord removed.
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Passport 2®/Passport 2 LT™ Operating Instructions
Precautions
Introduction
Precautions
CAUTION:
Only use the Abbreviated Operating Check List (0070-000493) if you are already familiar with this product. If not,
please use the Detailed Operating Instructions.
CAUTION:
Always place the monitor on a rigid, flat surface or on
approved mounts. Do not block the vents.
CAUTION:
Never place fluids on top of this monitor. In case of
accidental wetting, wipe clean immediately and have the
monitor serviced to ensure no hazard exists.
CAUTION:
Do not operate the Passport 2/Passport 2 LT with a frayed
or damaged power cord.
CAUTION:
This unit must only be operated with Datascope approved
software.
CAUTION:
NIBP cuffs must be used with the correct Datascope hoses.
See chapter 5.0 for part numbers.
CAUTION:
Use only Datascope accessories with this product.
CAUTION:
When cleaning SpO2 sensors, do not use excessive amounts
of liquid. Wipe the sensor surface with a soft cloth,
dampened with the cleaning solution.
CAUTION:
Dispose of single use items in accordance with hospital
policy.
CAUTION:
Do not use a damaged or broken unit or accessory.
CAUTION:
Do not operate the Passport 2/Passport 2 LT with the
ventilation or speaker vents obstructed.
CAUTION:
To prevent condensation, allow the Passport 2/
Passport 2 LT to warm up and dry if it is moved from a cold
area to a warm one.
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:
Substitution of a component different from that supplied
might result in measurement error.
CAUTION:
The Passport 2/Passport 2 LT 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.
Datascope cannot be responsible for injury or damage
resulting from improper or inadequate support of the
monitor.
Passport 2®/Passport 2 LT™ Operating Instructions
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Introduction
xii
Precautions
CAUTION:
To assure successful triggering of a Datascope Intra-Aortic
balloon pump from the Passport 2/Passport 2 LT monitor,
set the “ECG Filter” to “Extended” and set “Pacer
Enhancement” to “On”. Both of these settings are located in
the ECG setup menu of the Passport 2/Passport 2 LT.
CAUTION:
The Analog Output on the Passport 2/Passport 2 LT
supports triggering the Intra-Aortic Balloon Pump (IABP) for
3 Lead and 5 Lead ECG cable monitoring only. Invasive
Blood Pressure triggering is not supported. ECG analog
output is disabled when 12 Lead ECG analysis is enabled.
CAUTION:
Use only Datascope supplied power cords, or if a substitute
is necessary, use only hospital grade power cords.
CAUTION:
Removal of the View 12™ ECG Analysis Module without first
disabling the 12-Lead ECG card may cause a temporary
disruption in patient monitoring.
CAUTION:
The 2.4 GHz radio optionally used in this device must be at
least 20 cm away from the user and/or patient during
normal operating conditions.
CAUTION:
Only connect NIBP Luer fittings to Blood Pressure Cuff or
Monitor.
CAUTION:
To avoid possible damage to the Passport 2/Passport 2 LT,
use only ECG cables and accessories available from
Datascope.
CAUTION:
Line Isolation Monitor transients may resemble actual
cardiac waveforms, thus inhibiting heart rate alarms. Check
leadwires for damage and ensure good skin contact prior to
and during use. Always use fresh electrodes and follow
proper skin preparation techniques.
CAUTION:
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
CAUTION:
Thoracic impedance monitoring may affect rate responsive
pacemakers.
CAUTION:
Do not clean the Gas Module while it is on and/or plugged
in.
CAUTION:
If the dust filter for the Gas Module fan cannot be cleaned or
is damaged, replace it with the replacement dust filter P/N
0378-00-0040. Use of another type of filter may decrease
the cooling effectivity and cause damage to the Gas Module.
CAUTION:
Recharge batteries in the Passport 2/Passport 2 LT.
CAUTION:
Remove the batteries if the Passport 2/Passport 2 LT is not
likely to be used for an extended period of time.
CAUTION:
Replace sealed lead acid batteries with Datascope P/N
0146-00-0043 ONLY. Replace lithium-ion batteries with
Datascope P/N 0146-00-0069 ONLY.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Precautions
Introduction
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:
Observe caution on all patients (Neonates, Pediatrics, and
Adults) when NIBP is set to the Continuous Mode and the 1
minute interval. When the NIBP “continuous” interval is
chosen, the Passport 2/Passport 2 LT will continually take
back to back blood pressure readings. As a safety
precaution, a limit is placed on continuous and 1 minute
interval measurements. In continuous mode, after 5
minutes, the NIBP interval will automatically switch to one
measurement taken every 5 minutes. In 1 minute mode,
after 10 minutes the NIBP interval automatically switches to
measurements taken once every 10 minutes. Reports have
been made of nerve injury occurring during use of
automatically cycled blood pressure cuffs. See the
Appendix, “Cautions when Using Automatically Cycled
Blood Pressure Cuffs”.
CAUTION:
When equipped with Masimo® SpO2, use only Masimo
oxygen transducers including Masimo LNOP® patient
dedicated adhesive sensors and Masimo PC Series Patient
Cable. 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:
Tissue damage or inaccurate measurements may be caused
by incorrect SpO2 sensor application or use, such as
wrapping it too tightly, applying supplemental tape, failing
to inspect the sensor site periodically, or failing to position it
appropriately. Carefully read the sensor directions for use,
the Passport 2/Passport 2 LT operating instructions, and all
precautionary information before use.
CAUTION:
Excessive ambient light may cause inaccurate
measurements. In such cases, cover the SpO2 sensor site
with opaque material.
CAUTION:
Inaccurate measurements may be caused by incorrect SpO2
sensor application or use; significant levels of dysfunctional
hemoglobins, (e.g., carboxyhemoglobin or methemoglobin);
or 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 direct sunlight; excessive patient movement; venous
pulsations; electro-surgical interference; and placement of a
sensor on an extremity that has a blood pressure cuff,
arterial catheter, or intra-vascular line.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
xiii
Introduction
xiv
Precautions
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 an
inability to acquire physiological data.
CAUTION:
The site should be checked at least every eight (8) hours
(every four (4) hours with the Adult re-usable SpO2 finger
sensor). Ensure proper adhesion, skin integrity, and proper
alignment. Nail polish and fungus may affect readings.
Exercise extreme caution with poorly perfused patients.
Skin erosion and pressure necrosis can be caused when
sensors are not frequently monitored. Assess the site every
two (2) hours with poorly perfused patients.
CAUTION:
If the SpO2 sensor or patient cable is damaged in any way,
discontinue use immediately. To prevent damage do not
soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize.
CAUTION:
Vacuum (negative pressure) should not exceed 1 mmHg at
the Passport Pump Exhaust fitting. Excessive scavenge
vacuum may result in an “OCCLUSION” message or
damage to the Passport 2’s internal pump. The scavenge
system must be on during calibration.
CAUTION:
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Notes
Introduction
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 ausculatory
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 Datascope Technical Support (800) 288-2121,
ext. 8116.
NOTE:
Potential hazards due to errors in software or hardware
have been minimized by actions taken in accordance with
IEC 60601-1-4.
Intended Use
The intended use for the Passport 2® includes the monitoring of the following human
physiological parameters:
• ECG waveform derived from 3, 5 or 12 lead measurements
• Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
• Blood Oxygenation (SpO2) measurement/waveform
• ST Segment Analysis derived from 5 to 12 lead measurements
• Lethal Arrhythmia Detection derived from 5 to 12 lead measurements
• Non Invasive Blood Pressure (NIBP) measurement
• Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Respiration Rate/ waveform derived from ECG or CO2
• CO2, Inspired and end tidal microstream/waveform
• Temperature measurement via YSI 400/700 series probes
• Interpretation of Resting 12 lead ECG
The target populations are adult, pediatric and neonate with the exception of the:
• Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations
are adult and pediatric only, and
• Interpretation of Resting 12 Lead ECG, for which the target population is adult only.
The monitor is intended for use in the health care facility setting.
The device has the capacity of interfacing with Datascope’s Gas Module SE, displaying the
measurements of Anesthetic Gases, O2, N2O, and CO2.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
xv
Introduction
Unpacking
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
Datascope Service Department (800) 288-2121, ext. 8116 for prompt assistance in
resolving shipping problems.
xvi
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Symbols and Descriptions
Introduction
Symbols and Descriptions
SYMBOL DESCRIPTION
SYMBOL
DESCRIPTION
Attention, Consult
Accompanying Documents /
Refer to Manual
Type B Equipment
Dangerous Voltage
Type BF Equipment
Equipotentiality
Defibrillator Proof Type BF
Equipment
Alternating Current (AC)
Defibrillator Proof Type CF
Equipment
Direct Current (DC)
Alarm Off Icon
On (only for a part
of the equipment)
Alarm Mute Icon
OFF (only for a part
of the equipment)
Earth (Ground)
Data Input
Protective Earth (Ground)
Data Output
Battery Charging
Data Input / Output
Full Battery
Gas Port Input
Low Battery
Gas Port Output
No Battery Present
NIBP Connection
IABP
Analog ECG and IBP output for
communication to an Intra-Aortic
Balloon Pump
Latex-free product
DEFIB
Analog ECG out and Sync Pulse for
connection to a defibrillator
Crossed out wheelie bin
indicates separate treatment
from general waste at end of
life
Interference may occur in the
vicinity of equipment marked with
this symbol
Conformité Européenne (CE) Marking of Conformity to European Medical Device
Directive. CEXXXX represents the Notified Body number
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
xvii
Introduction
Symbols and Descriptions
This page intentionally left blank.
xviii
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
1.0
General Description
Passport 2
Passport 2
NIBP
IBP
ALARMS
PRINT
LEAD
ECG
START
ZERO
ALL
LIMITS
STRIP
STANDBY
TRENDS
SIZE
INTERVAL
MUTE
ALL
CONT
ECG
DISCHARGE
FREEZE
VIEW
STOP
MUTE
PRINT
TREND
MARK
EVENT
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
DISPLAY
NORMAL
SCREEN
1-1
General Description
The Datascope Passport 2/Passport 2 LT is a vital signs monitor intended for
intrahospital use on human patients. The Passport 2 is a six (6) trace monitor, the
Passport 2 LT is a three (3) trace monitor. The unit has many features and functions, yet is
very easy to use through an integrated keypad, Navigator™ Control Knob and intuitive menu
system. The patient parameters that can be monitored with the Passport 2/Passport 2 LT
are: ECG, Masimo SET® SpO2, Nellcor® Oxismart® or OxiMax® SpO2, Non-invasive
Blood Pressure, Respiration Rate and Temperature. Parameters optional for the Passport 2
are: 3 lead or 12 lead ST analysis with adjustable ISO and J points, Arrhythmia analysis,
Invasive Blood Pressure, Gases, Microstream® CO2 and 12 Lead ECG Interpretation.
The Passport 2/Passport 2 LT Monitor can be mounted on a rolling stand, a wall mount
bracket, gas machine arm, Bedrail or operated as a tabletop instrument. The Passport 2
monitor can be mounted to a Gas Module. The keypad contains dedicated primary
functions. The menu buttons provide access to setting up patient information, waveforms, and
parameters.
The Passport 2 comes with a color TFT LCD or a monochrome display. The Passport 2 LT
comes with a passive color or monochrome display. Digital displays are provided for Heart
Rate, Non-invasive Blood Pressure (NIBP), Pulse Oximetry (SpO2), Respiration Rate and
Temperature (T1). Additional digital areas present for the Passport 2 are Invasive Blood
Pressure (IBP1 and IBP2) (optional), Anesthetic Agents (optional), O2 and NO2 (optional), ST
(optional), and CO2 (optional). The optional built-in recorder provides hard copies of all
digital data and waveforms as well as Tabular Trend information.
The View 12™ ECG Analysis Module for the Passport 2 enables 12-Lead Acquisition,
Continuous 12-Lead ST Analysis and Arrhythmia Analysis with print capability. The View
12™ ECG Analysis Module consists of a PCMCIA card for insertion into the Passport 2
with 12 Lead software, an M-12 cable and a detachable leadwire set.
The Passport 2 has the capability of interfacing with Datascope’s Central Stations, Gas
Module, IABP Systems, Remote Displays and Nurse Call Systems.
The Passport 2 LT has the capability of interfacing with Datascope’s IABP Systems, Remote
Displays and Nurse Call Systems.
The optional Gas Module can be used on an anesthesia cart or mounted on a rolling stand
or wall mounted.
The Passport 2/Passport 2 LT monitor is powered from an AC connection or internal
batteries. Batteries can be purchased separately as optional equipment. See Chapter 5.0.
The Passport 2/Passport 2 LT monitor can operate with either battery removed so that
fresh batteries can be installed during monitor operation.
1-2
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
General Description
Key features of the Passport 2/Passport 2 LT are:
• 3 or 5 Lead (I, II, III, aVR, aVL, aVF, V) ECG
• 12 Lead (I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6) ECG
(optional Passport 2)
• ECG Cascade
• ESIS Capability (3 or 5 Lead ECG only)
• 2 invasive blood pressure channels (optional Passport 2)
• 3 or 12 Lead ST Analysis with adjustable ISO and ST points
(optional Passport 2)
• Arrhythmia Analysis (optional Passport 2)
• 12 Lead ECG Interpretation (optional Passport 2)
• Non-invasive Blood Pressure (NIBP)
• Lead Selectable Impedance Respiration
• Masimo SET® SpO2
• Nellcor® Oxismart® and OxiMax® SpO2 (optional)
• Microstream® CO2 (optional Passport 2)
• Gas Module Connectivity (optional Passport 2)
• 1 YSI 400/700 temperature channel
• Automatic sensor detection and waveform display
• Automatic Heart Rate source selection
• Auto-Set™ Alarms
• Dual channel thermal array recorder (optional)
• Color TFT LCD display or Monochrome display (Passport 2)
• Monochrome display (Passport 2 LT)
• Battery operation (optional)
• Tabular 120 entries (500 entries optional)
• Graphic Trend display (Passport 2)
• Extended Trend Display, 500 entries (optional)
• OXY CRG display, 6 minutes (12 hours optional) (Passport 2)
• 6 trace erase bar refresh (Passport 2)
• 3 trace erase bar refresh (Passport 2 LT)
• Navigator™ Control Knob
• Internal isolated power module
• External Remote Color Display Available with Color TFT LCD Equipped Monitor (optional
Passport 2)
• External Interfaces with Datascope’s Central Stations, Gas Module, IABP Systems, Remote
Displays, Nurse Call Systems and Serial Communications (Passport 2)
• External Interfaces with Datascope’s IABP Systems (Passport 2 LT)
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
1-3
General Description
• Communication with hospital CIS (Clinical Information Systems) through DIAP (Datascope
Improved ASCII Protocol, manual P/N 0070-00-0307) (Passport 2)
• Inter-Monitor Patient Data Transfer (with optional accessories)
• Inter-Monitor System Set-up Transfer (with optional accessories)
• Mounting Kits (optional accessory)
• Soft-Grip Handle
• Comm-Port (optional Passport 2)
• Dual PCMCIA Interface
1-4
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
2.0
Controls, Indicators and Connectors
This section of the Operating Instructions identifies and describes each control and display of
the Datascope Passport 2/Passport 2 LT Monitor.
Refer to the paragraph and page numbers listed below for the location of specific controls
and displays.
Step-by-step instructions for operation of the monitor are provided in Section 3.0
“Operation”.
The following is a list of all the controls, connectors and indicators and their item numbers.
The item number refers to the call outs on the drawings within this chapter of the manual. If
looking for a particular item, locate it on this list and then use the table below to determine
the page where it can be found.
PARAGRAPH
NUMBER
DESCRIPTION
CONTROL/
DISPLAY NUMBER
PAGE
NUMBER
2.1
Front Panel
1-23
2-2
2.2
Display
24-29
2-6
2.3
Menus
2.4
Left Side Panel
30-38
2-17
2.5
Right Side Panel
39-43
2-19
2.6
Rear Panel
44-48
2-20
2.7
Remote Color Display (Passport 2
Only)
2.8
Gas Module - Front Panel
(Optional Passport 2)
49-53
2-22
2.9
Gas Module - Rear Panel
(Optional Passport 2)
54-59
2-24
2.10
Comm-Port (Optional Passport 2)
61-63
2-25
Passport 2®/Passport 2 LT™ Operating Instructions
2-9
0070-10-0649-01
2-21
2-1
Front Panel
2.1
Controls, Indicators and Connectors
Front Panel
The front panel keys are used to access many main functions quickly and easily.
Figure 2-1 below shows the keys and a brief explanation of each key.
1
5
2
8
7
4
9
12
13
15
16
18
ECG
NIBP
IBP
ALARMS
PRINT
LEAD
START
ZERO
ALL
LIMITS
STRIP
STANDBY
TRENDS
SIZE
INTERVAL
MUTE
ALL
CONT
ECG
DISCHARGE
FREEZE
VIEW
STOP
MUTE
PRINT
TREND
MARK
EVENT
19
20
DISPLAY
NORMAL
SCREEN
6
3
10
14
17
21
22
23
11
FIGURE 2-1 Front Panel Controls
1. (ECG) 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. (ECG) 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. (ECG) VIEW
Press the VIEW key to see 6 leads of ECG at once when using the View 12™ ECG Analysis
Module or the 5 Lead ECG cable. With a View 12™ ECG Analysis Module installed, press
the VIEW key once to see the first 6 leads of ECG, press again to view another 6 ECG
leads. Pressing a third time will return to normal display view. With a 5 lead ECG cable,
press the VIEW key once to see 6 leads of ECG, press again to return to normal display
view.
NOTE:
Pressing the VIEW key does not affect the waveforms being
transmitted to the Central Station.
4. (NIBP) START
Press this key to begin an NIBP measurement or to begin or re-start automatic interval
measurements.
2-2
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
Front Panel
5. (NIBP) INTERVAL
Press this key to modify the NIBP interval measurement time. The choices are: Off, Cont, 1
min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hrs or 4 hrs. The
“Off” selection means that NIBP measurements can only be initiated manually. The “Cont”
selection means that measurements will be continuous (one right after the other). The
continuous measurement interval will only last for 5 minutes and then automatically change
to a 5 minute interval. The 1 minute interval will last for 10 minutes and then automatically
change to a 5 minute
6. (NIBP) 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. If a Press STOP to clear. message is displayed, pressing this
key will clear a Cuff Overpressure condition.
7. (IBP) ZERO ALL
Press this key to set the current pressure of all the invasive pressure channels to zero provided
the channel(s) do not have an existing pressure being monitored. During the zeroing process,
the message Zeroing is displayed. The message Zero Complete displays when the
zeroing process is successful. If the zero process is not successful, the message Unable to
Zero is displayed. Available with Passport 2 monitor only.
8. (ALARMS) LIMITS
Press this key to display the Alarm menu. The Alarm menu provides you access to view or
change alarm values.
9. (ALARMS) MUTE 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 Alarms Setup menu. While the
alarms are suspended, an Alarm Mute icon is displayed next to each silenced parameter.
Also, the message All Alarms Muted for XX:XX mins displays. XX: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, the message All
Alarms Permanently Muted displays.
10. (ALARMS) MUTE
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 Alarms Setup Menu or
when 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 Mute icon is displayed next to each silenced parameter.
11. (Alarms) LED Indicators
A set of 2 LED’s used to indicate that an alarm has been tripped. The WARNING (or Priority
1) LED is red and the CAUTION (or Priority 2) LED is yellow.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2-3
Front Panel
Controls, Indicators and Connectors
12. (PRINT) STRIP
Press this key to initiate a 16 second print out of selected waveforms on the internal printer.
Press this key during the printing to stop the printer. With a View 12™ ECG Analysis Module
installed, press the VIEW key, then press the STRIP key to initiate a 12-lead Interpretative
report that will be printed at either the internal recorder or a laser printer. If the print
destination is a remote Central Station, then pressing this key will initiate a printout at the
Central Station.
13. (PRINT) CONT ECG
Press this key to initiate a continuous ECG 1 and 2 waveform printout on the internal printer.
Press this key during the printing to stop the printer.
14. (PRINT) PRINT TREND
Press this key to initiate the printing of the desired trend. By default, the monitor’s stored trend
information will be printed by the internal printer. Press this key during the printing to stop the
printer.If the print destination is a remote Central Station, then pressing this key will initiate a
trend report at the Central Station.
15. STANDBY
Press this key to place the Passport 2/Passport 2 LT 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. When in the STANDBY mode, the message STANDBY. TO BEGIN
MONITORING, PRESS STANDBY is displayed. Press the STANDBY key again to exit
the STANDBY mode and return to the normal screen.
NOTE:
Trend data is not cleared in the STANDBY mode. When the
STANDBY mode is released, NIBP INTERVAL is in IDLE MODE
and requires re-activation via the START key. The CO2 pump
automatically reactivates if the Microstream® sensor is in
place.
16. DISCHARGE
Press this key to initiate the process of discharging the patient from the monitor. A menu titled
Patient Discharge will be displayed. Depending on the monitor’s configuration, the
Normal Screen menu choice will be provided along with one or more of the following
selections: Discharge From Monitor, Discharge From Central and Discharge
From Both. If any discharge option is selected, a confirmation box will be displayed.
(Discharging a patient from the monitor deletes all patient trend and demographic data and
places the monitor in STANDBY mode.) An onscreen message will display as follows:
• For Main Module Software Versions Y.xx and earlier, the message STANDBY. TO
BEGIN MONITORING, PRESS STANDBY is displayed.
• For Main Module Software Versions AA.xx and later, the message PATIENT
DISCHARGED. MONITOR IN STANDBY MODE - TO BEGIN MONITORING,
PRESS STANDBY is displayed.
Upon exiting STANDBY mode, the monitor configuration reverts to currently saved settings.
Selecting Normal Screen from the menu aborts the discharge.
2-4
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
Front Panel
17. MARK EVENT
Press this key to cause a time stamp event marker to be noted in the trend memory. If
connected to a Panorama Central Station, a time stamp event marker will also be noted in
the Central Station’s trend memory.
18. (DISPLAY) TRENDS
Press this key to display the List Trend screen. Press this key a second time to display the
Graph Trend screen. Press this key a third time to return to the Normal Display. If Neonate or
Pediatric is selected as the patient size, a third press will display the OXY CRG display. A
fourth press will then return the monitor to normal display.
19. (DISPLAY) FREEZE
Press this key to freeze the waveform display. When waves are frozen, the message WAVES
FROZEN is displayed. Digital data will continue to be updated.
20. NORMAL SCREEN
Press this key at any time to return the screen to the normal monitoring mode. All menus are
closed.
21. Battery Charging LED
A green LED located below 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
type (sealed lead acid vs. lithium-ion) and 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.
22. AC Power LED
A green LED beside the Battery Charging LED that is used to indicate that the unit is
connected to the AC Power within the facility.
23. Navigator™ Control Knob
Rotate this knob to highlight the various menus on the display. Press the center of the knob to
display the highlighted menu. Once a menu is displayed, rotate the knob to highlight the
items within the menu. Press the center of the knob to select a highlighted item.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2-5
Display
2.2
Controls, Indicators and Connectors
Display
The display of the Passport 2/Passport 2 LT provides menus, waveforms, parameter
information, and messages. Figure 2-2 below shows the layout of the screen. The display can
be a color LCD or monochrome flat panel for the Passport 2 monitor. The display for the
Passport 2 LT is a monochrome panel. The number of waves displayed can vary from 3 to
6 (Passport 2 LT is limited to 3). The default operation follows these basic rules:
a. If a wave and related parameter tile are displayed, they are horizontally linked and
have the same color for easy and clear reading. The ECG parameter may violate
this rule since multiple vectors can be viewed at one time.
b. NIBP and Temperature data is displayed only in the lower row of boxes. With the
Passport 2 monitor, as the fourth, fifth and sixth waves are sensed they will
automatically insert and fill the bottom waveform areas.
c. Font size for parameter data vary with the amount of data on the screen to maximize
the size of the numbers.
The monitor also includes a display set-up function that allows the user to customize the
display. User preferred set-ups can be programmed and saved.
Menu Headings
27
Pat ient
Monit or Setup
Print Set up
Parameters
Functions
07/27/04
6:55 PM
LASTNAME, FIRST
Adult
HR
bpm
170
P
A
S
55
PVC/min: 45
Source: A ut o
Lead
II
I
V
mm
+ 2.2
-2.1
-3.0
PR
bpm
OFF
%
94
Insp
mmHg
14
Exp
rpm
Source: CO2
24
mmHg
Waveform
Area
Des%
T1
Insp
F
Exp
O2%
120 (100)
80
N2O%
mmHg
4.0 48 60
1.1 46 58
Int erval: ON
ET: 13 min
NIBP: Idle
29
25
Parameter Menu
Headings
Radio
Icon
26
28
Parameter
Areas
Battery
Indicator
30
Panorama
Icon
FIGURE 2-2 Display
2-6
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
Display
24. Waveform Area
The waveform area is used to display the windows that contain parameter waveforms. Up to
6 waveforms can be displayed. The top window is always set to display the ECG waveform
and cannot be changed. By default, SpO2 (Pleth) will appear as the second waveform, if
connected. Respiration or CO2 will appear as the third waveform. If pressure transducers are
plugged into IBP connectors, the screen will reformat to display additional waveforms, and
IBP will appear as the fourth and fifth waveforms. Except for the top window that is reserved
for ECG, the windows can be changed to display any of the available parameters and
waveforms. Each window contains a menu heading, which can be selected with the
Navigator™ Control Knob.
25. Parameter Menu Heading
Using the Navigator™ Control Knob, select a parameter menu heading, change the
waveform and / or set specific information for the parameter. See the next section for a
description of each menu.
26. Parameter Area
The parameter areas contain the digital data for each available parameter.
27. Menu Headings
Using the Navigator™ Control Knob, select a menu to set or review specific information. See
the next section for a description of each menu.
28. Battery Indicator
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
(Lithium-Ion batteries only)
If the monitor is configured for lithium-ion batteries, when there are no batteries installed, the
battery indicator will be displayed with an “X” through it as shown in the example.
When the battery charge is low, but not below the cutoff voltage, the battery indicator will
begin to flash and a low pitched double beep will be generated every minute.
NOTE:
When the battery indicator begins to flash, less than 15
minutes of operating time remains, depending upon the
number of functions that are operational.
NOTE:
The internal recorder may not be operational when the
battery charge is low.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2-7
Display
Controls, Indicators and Connectors
29. Radio Icon
If a Panorama Instrument Radio - 608 is installed and “WMTS Enabled” is set to “Yes” (in the
Installation Menu), this icon will be displayed.
30. Panorama Icon 1 or V
This icon will display in one of two possible formats as follows:
• If the Passport 2 608 radio is sending data but it is not being displayed at a
Panorama Central Station, then this icon will display the number “1”.
• If the Passport 2 data is being displayed at a Panorama Central Station, then this
icon will display the capital letter “V”.
2-8
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.3
Menus
Menus
The Main Menu system of the Passport 2/Passport 2 LT is available through the Menu
headings, which are always displayed on the screen. The headings are accessed using the
Navigator™ Control Knob. Turning the Control Knob highlights the Menu headings one at a
time. When the Menu heading that you would like to access is highlighted, press the center
of the Control Knob to display the menu. Turn the Control knob again to highlight items
within the Menus headings and press the Control Knob to select the highlighted item. If
selecting the highlighted item displays more selections, continue using the Control Knob in
the same manner (turn to highlight, press to select) to set the options as desired. The Menu
headings are:
2.3.1
Patient
FIGURE 2-3 Patient Menu
NOTE:
Changes that are made in the Patient Menu do not become
effective until the menu is closed.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2-9
Menus
Controls, Indicators and Connectors
Patient
MENU ITEM
SELECTIONS
DEFAULT/COMMENTS
Patient Size
Adult, Pediatric,
Neonate
Adult
Gender
Unspecified, Male,
Female
Default is Unspecified. Use Navigator Control Knob to
select patient’s gender.
Date of Birth
Default is Unspecified. Use Navigator Control Knob to
select patient’s date of birth.
Last Name
A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s LAST name.
First Name
A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s FIRST name.
ID #1
A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s ID #.
Bed #2
A keyboard displays. Use the NavigatorTM Control
Knob to enter the patient’s Bed #.
Height
8" to 120"
(20 cm to 305 cm)
Adult - 70"
Pediatric - 30"
Neonate - 20"
Weight
0.1 lbs to 1100 lbs
(0.1 kg to 500 kg)
Adult - 150 lbs
Pediatric - 15 lbs
Neonate - 6 lbs
Admit Patient3
Yes, No
Default is No. Select Yes to admit patient to the central
station.(This selection appears only when connected to
a VISA or PatientNet® Central Station.)
1
2
The “ID #” field can accept a maximum of 15 characters. If a Passport 2 608 radio is communicating
with a Panorama Central Station, only the first 10 characters will be displayed in the “ID” field at the
Central Station.
The “Bed #” field can accept a maximum of 15 characters. However, since only the first 5 characters will
be displayed in the “Bed” field at a Panorama Central Station if a Passport 2 608 radio is communicating
with the Central Station, the following standard format for this demographic is recommended:
NOTE:
3
2 - 10
•
Start the string with a room # 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 # 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 the
maximum number of digits that is used in numbering the rooms is 4) would be
identified as 0513B.
If the monitor is communicating with the EMR (Electronic Medical Records) system through a Panorama Gateway, any changes to patient demographics made at the monitor will not be sent to the
EMR system. For further explanation, refer to section 3.26, “Connection to Panorama™ Gateway”.
Passport 2 only.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.3.2
Menus
Monitor Setup
FIGURE 2-4 Monitor Setup
Monitor Setup Menu
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
Normal Screen
Select to return to normal screen.
Save Current
A confirmation prompt appears. Select Yes to save
the current settings as the “monitor” defaults.
Display Setup
Open an additional menu which allows you to
change the positions of the parameters and
waveforms.
View ECG Setup
Open an additional menu which allows you to
change the ECG leads viewed when you press the
VIEW key.
Rescale Waves
Select to auto-scale all waveforms.
Alarm Volume
Variable from
Minimum to
Maximum
Mid-Scale / Displays a slide bar to adjust the setting
of the alarm volume. Use the Navigator™ Control
Knob to adjust the volume.
Beep Volume
Variable from Off to
Maximum
Mid-Scale / Displays a slide bar to adjust the setting
of the systole beep volume. Use the Navigator™
Control Knob to adjust the volume.
ECG Speed
6.25, 12.5, 25,
50 mm/sec
25 mm/sec / Select to change trace speed of ECG &
Pleth waveforms.
IBP Speed
6.25, 12.5, 25,
50 mm/sec
25 mm/sec / Select to change trace speed of
pressure waveforms.
*
Passport 2 only.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 11
Menus
Controls, Indicators and Connectors
Monitor Setup Menu (Continued)
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
Resp/Gas Speed
3.125, 6.25, 12.5,
25 mm/sec
12.5 mm/sec / Select to change trace speed.
Advanced Setup
*
Select to set these menu items:
•
Set Date
•
Set Time
•
Trend Interval
•
NIBP Trend
•
Alarm Trend
•
Nurse Call*
•
Arrhythmia Menu*
•
NIBP Start Mode
•
Apnea Latch
Passport 2 only.
Advanced Setup Menu
MENU ITEM
SELECTIONS
Previous Menu
Select to return to previous menu.
Set Date
Select to change date. Changing the date will clear
the trend information. A confirmation message will
display.
Set Time
Select to change time. Changing the time will clear the
trend information. A confirmation message will
display.
Trend Interval
Off, 1, 2.5, 5,10,
15, 20, 30 min,
1 hr, 2 hrs
Off / Select to change time of trend data collection.
NIBP Trend
On, Off
On / Select to save numeric data to trend on NIBP
measurements.
Alarm Trend
On, Off
Off / Select to save numeric data to trend on Alarms.
Nurse Call
Off, 1 second,
Continuous
Off / Select to choose the Nurse Call activation time.
Arrhythmia Menu*
This selection will open the Arrhythmia Menu.
NIBP Start Mode
Interval Mode, Timer
Mode
Interval Mode / Select the Interval mode to
synchronize NIBP start with the integral clock. Select
Timer Mode to synchronize NIBP start with the interval
selected in relation to the real time clock.
Apnea Latch
On, Off
On / Select to turn apnea alarm latching on or off.
*
2 - 12
FACTORY DEFAULT/COMMENTS
Passport 2 only.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
Menus
Arrhythmia Menu (Optional)
MENU ITEM
SELECTIONS
FACTORY DEFAULT/
COMMENTS
Use Navigator™ Control knob to
return to the previous menu.
Previous Menu
Arrhythmia
All On, All Off,
Non-lethals Off
Factory default is All On. Use
Navigator Control knob to turn
arrhythmia analysis on or off.
Irregular HR**
On, Off
Factory default is On. Use Navigator
Control knob to turn Irregular HR on
or off.
V-Tach Threshold
3 to 15 beats
Factory default is 3 beats. Use
Navigator Control knob to select
how many ventricular beats in a row
will constitute V-Tach.
V-Tach Rate
100 to 180 bpm
Factory default is 120 bpm. Use
Navigator Control knob to select the
heart rate threshold which must be
reached to constitute V-Tach.
Asystole Delay
3 to 10 seconds (3/5 lead)
3 to 8 seconds (12 lead)
Factory default is 4 seconds. Use
Navigator Control knob to select the
number of seconds with an absence
of an R wave that will constitute
asystole.
Relearn
ECG Noise Delay**
**
Use Navigator Control knob to select
to relearn Arrhythmia and ST.
3 to 30 seconds
Factory default is 5 seconds. Use
Navigator Control knob to select the
number of seconds to delay the ECG
Noise Alarm.
Only available with 3-lead or 5-lead.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 13
Menus
2.3.3
Controls, Indicators and Connectors
Print Setup
FIGURE 2-5 Print Setup
Print Setup Menu
MENU ITEM
SELECTIONS
DEFAULT/COMMENTS
Waveform 1
ECG 1-6, IBP1,* IBP2,*
Pleth, Resp, CO2,* O2,*
Agent,* N2O*
ECG 1 / Select to choose Waveform 1 on the
printer.
Waveform 2
Off, ECG 1-6, IBP1,*
IBP2,* Pleth, Resp, CO2,*
O2,* Agent,* N2O*
ECG 2 / Select to choose Waveform 2 on the
printer.
Select Printer
Local, Remote, Local &
Remote, Local & Laser**,
Laser & Remote**, Laser**
Select printer source for printing waveforms /
trends. A default printer or combination of
printers can be set.
Print on alarm
Yes, No
No / Select to print data on an alarm
occurrence.
Format
Leader, Wave
Leader / Select to format strip with all digital
data in the leader or top / bottom of wave.
Print Every
Off, 1, 5, 10, 15, 20, 30,
minutes, 1 hr, 2 hrs
Off / Select to set a time interval for automatic
printing.
Average ST Complex**
*
**
2 - 14
This selection will print the Average ST
Complex for this patient to the Local Printer.
Passport 2 only.
Passport 2 only with View 12™ ECG Analysis Module.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.3.4
Menus
Parameters
FIGURE 2-6 Parameters
Parameters Menu
MENU ITEM
DEFAULT/COMMENTS
ECG
ST*
NIBP
IBP1*
IBP2*
SpO2
CO2*
Resp
Gases*
Temperature
Select to open the respective menu. These can also be selected
through the individual parameter menus.
*
Passport 2 only.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 15
Menus
2.3.5
Controls, Indicators and Connectors
Functions Menu
FIGURE 2-7 Functions Menu
Functions Menu
MENU ITEM
DEFAULT/COMMENTS
Select to return to normal screen
Copy patient data to
card
Select to copy the patient data to a data
transfer card.
Copy patient data from
card
Select to copy the patient data from a data
transfer card.
12-Lead ECG*
*
2 - 16
SELECTIONS
Normal Screen
Disable / Enable
Use Navigator Control knob to disable or
enable 12-Lead ECG.
Passport 2 only with View 12™ ECG Analysis Module. NOTE: If “Enable Network” is set to “Wireless” in the
“System Information” menu, 12-Lead ECG will not be listed as a choice in the Functions Menu.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.4
Left Side Panel
Left Side Panel
CO2 Output
CO2 Input
31
39
T1
IBP 1
IBP 2
32
ECG
33
SpO2
38
34
35
36
37
FIGURE 2-8 Left Side Panel
31. CO2 Exhaust Connector (Optional Passport 2)
This connector is used to attach an exhaust line which can be used to connect to a gas
scavenger system.
32. T1 Connector
A standard three wire phone jack used to mate with either the YSI series 400 or 700
temperature probes. The monitor automatically detects which probe is connected.
33. IBP 1 Connector (Optional Passport 2)
A six-pin male connector used for Channel 1 Pressure Transducer connection. Datascope
specified pressure transducers are listed in Chapter 5, Accessories.
34. IBP 2 Connector (Optional Passport 2)
A six-pin male connector used for Channel 2 Pressure Transducer connection. Datascope
specified pressure transducers are listed in Chapter 5, Accessories.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 17
Left Side Panel
Controls, Indicators and Connectors
35. SpO2 Connector
A 14-lead Mini-D ribbon type female connector used to attach the SpO2 sensor to the
monitor. See Chapter 5 for the complete listing of approved SpO2 accessories.
36. Battery Compartment
This compartment houses the two optional, user replaceable, rechargeable batteries (sealed
lead acid or lithium-ion). These batteries provide power to the unit when it is not connected to
an AC receptacle. The batteries can be independently removed and replaced while the unit
is operating.
37. NIBP Rectus Connector
This connector is used to attach the NIBP hose to the unit.
38. ECG Connector
This connector is used to attach ECG cables. Use Datascope cables listed in Chapter 5.0,
Accessories.
39. CO2 Input Connector (optional Passport 2)
This connector is used to attach the Microstream® CO2 FilterLine®, listed in Chapter 5.0,
Accessories, to the unit.
2 - 18
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.5
Right Side Panel
Right Side Panel
44
40
41
42
43
FIGURE 2-9 Right Side Panel
40. PCM1 and PCM2 Card Slots
These sockets are used for extended trend memory, software download to the CPU, patient
data transfer, monitor set-up transfers, View 12™ ECG Analysis Module and Panorama
Instrument Radio - 2.4.
41. Power Switch
A momentary switch that turns power ON or puts the unit in STANDBY 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.
42. DEFIB Connector
Used to connect a defibrillator sync cable.
43. IABP Connector
Used for triggering an Intra-Aortic Balloon Pump from the Passport 2/Passport 2 LT ECG
signal only when using a 3-lead or 5-lead ECG cable.
44. Recorder (Optional)
A two trace thermal strip chart recorder with integral paper spool.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 19
Rear Panel
2.6
Controls, Indicators and Connectors
Rear Panel
47
49
Passport2
Passpo
Model No. DT-5000
™
FCC ID:BQI95DT-5000
This Device Complies With Part 15 Of The FCC Rules.
Operation Of This Device Is Subject To The Following Two
Conditions: (1) This Device May Not Cause Harmful
Interference, And (2) This Device Must Accept Any
Interference That May Be Received, Including
This product may be
protected under one or
more of the following
U.S. patents:
46
4,621,643
4,700,708
4,770,179
4,869,254
4,653,498
4,911,167
4,928,692
4,934,372
45
5,078,136
5,368,224
5,482,036
5,490,505
5,632,272
5,685,299
5,758,644
5,769,785
S/W
P/N
S/N
8888 - 00 - 1234 - 12345
8888 - 00 - 1234 - 12345
8888 - 00 - 1234 - 12345
Datascope Corp. Paramus, NJ 07652 USA
0044
V
A
Hz
100-120~
100-120
.75
60
/
/
/
¨
220-240~
220-240
.35
50
IEC 601-1:1988
CSA - C22.2 No. 601.1 - M90
UL 2601-1:1997
48
FIGURE 2-10 Rear Panel
45. AC Receptacle
Insert an AC power cord into this connector.
CAUTION:
Use only Datascope supplied power cords, or if a substitute
is necessary, use only hospital grade power cords.
46. Equipotential lug
Provides Equipotential grounding of hospital equipment
47. Soft Grip Handle
Use for carrying the monitor.
48. Main I/O Connector Port (DM1)
Area dedicated for the use of an optional communication port.
49. Expansion Slot
Used for connecting an optional Panorama Instrument Radio - 608.
2 - 20
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.7
Remote Color Display (Passport 2 Only)
Remote Color Display (Passport 2 Only)
Passport 2 (with Comm Port), rear view
Remote Color Display, rear view
1. Connect Interface Cable
to the Analog Input
Connector on the Remote
Color Display.
Remote Color Display Interface Cable
2. Connect Passport 2
Monitor Remote Color
Display interface cable.
FIGURE 2-11 Remote Color Display
NOTE:
Passport 2 monitors equipped with EL (electro-luminescent)
displays do not support remote display capabilities.
For instructions on mounting the remote display to a wall, see the Passport 2 Service
Manual, Installation Guide.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 21
Gas Module - Front Panel (Optional Passport 2)
2.8
Controls, Indicators and Connectors
Gas Module - Front Panel (Optional Passport 2)
Passport 2
®
Patient/ADT
Monitor Setup
Alarms
Trend
Record
11/9/98
10:28 am
Juan Valdez /Room 1420 / BED 2
+1
E
C
G
S
T
mV
-1
HR
125
P
S
D
PVC/min: 45
A Source: Auto
Lead
mm
II
+2.2
aVR
-2.1
V1
-3.0
ST Pt: 80/60
RPM
40
R
E
S
P
10
18
Source: ECG
40
Insp Exp
C
0
2
mmHg
0
8
S
P
0
2
T1
ECG
mmHg
RR (CO2 )
14 rpm
SpO2
0
T
E
M
P
1 /38
36.7
A
G
T
C
1
98
PR
%
Sys
Insp
Exp
O2
41
36 %
Des
7.6
5.2 %
N2O
51
54 %
N
I
B
P
81
bpm
Dia
120 / 80
Mean (93)
Interval: ON
NIBP
IBP
ALARMS
LEAD
START
ZERO
ALL
LIMITS
STRIP
STANDBY
TRENDS
SIZE
INTERVAL
MUTE
ALL
CONT
ECG
DISCHARGE
FREEZE
VIEW
STOP
MUTE
PRINT
TREND
MARK
EVENT
ET: 13min
DISPLAY
PRINT
NORMAL
SCREEN
Gas Module SE™
50
55
51
52
53
54
FIGURE 2-12 Gas Module Front Panel
NOTE:
This manual refers to the Gas Module II and the Gas Module
SE as Gas Module. All illustrations represent the Gas Module
SE. Any parts or descriptions unique to either product will be
identified as such.
50. Input Port
This port is used to connect the sampling tubing to the Gas Module.
51. Water Trap Assembly (includes Water Trap Reservoir)
The Water Trap Assembly (P/N 0202-00-0129) is used to capture moisture drawn in with
the patient sample. The Water Trap Reservoir must be emptied and rinsed (with water only)
whenever more than half full or whenever changing patients. To remove push latch to left.
Refer to Section 4.9 for more details.
52. Dust Filter
The Dust Filter (P/N 0378-00-0040) protects the Gas Module from airborne dust. It should
be removed and cleaned on a regular basis. Refer to Section 4.9 for more details.
53. Dust Filter Cover
The Dust Filter Cover is removed to access the filter.
2 - 22
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
Gas Module - Front Panel (Optional Passport 2)
54. Power Indicator Lamp
This lamp illuminates when power is applied to the Gas Module and the power switch is
turned on.
55. Power Switch
A switch used to power the unit on and off. It is located on the front of the Gas Module SE
and on the back of the Gas Module II.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 23
Gas Module - Rear Panel (Optional Passport 2)
2.9
Controls, Indicators and Connectors
Gas Module - Rear Panel (Optional Passport 2)
TM
Model No. DT-5000
This product may be
protected under one or
more of the following
U.S. patents:
4,621,643
4,700,708
4,770,179
4,869,254
4,653,498
4,911,167
4,928,692
4,934,372
5,078,136
5,368,224
5,482,036
5,490,505
5,632,272
5,685,299
5,758,644
5,769,785
FCC ID:BQI95DT-5000
This Device Complies With Part 15 Of The FCC Rules.
Operation Of This Device Is Subject To The Following
Two Conditions: (1) This Device May Not Cause
Harmful Interference, And (2) This Device Must
Accept Any Interference That May Be Received, Including
Interference That May Cause Undesired Operation.
S/W
8888 - 00 - 1234 - 12345
P/N
8888 - 00 - 1234 - 12345
S/N
8888 - 00 - 1234 - 12345
Datascope Corp. Mahwah, NJ 07430 USA
0044
V 100-120~ /
A
.75
/
Hz
60
/
220-240~
.35
50
¨
RD1
NC1
IEC 601-1:1988
CSA - C22.2 No. 601.1 - M90
UL 2601-1:1997
SP1
60
56
59
57
58
FIGURE 2-13 Gas Module Rear Panel
56. AC Power Input
This input is used to attach the special “Y” Shaped Power Cord.
57. Exhaust Port
This panel mount coupling is used for attaching a gas scavenging system (P/N 0997-000923 or P/N 0997-00-0984) to the Gas Module.
58. Reference Port
This port is used only to measure room air. This port is not to be connected to anything. Do
not block this port.
59. External Interface Port
A communication interface port used to connect the Gas Module to the Passport 2.
60. Equipotential lug
Provides Equipotential grounding of hospital equipment
2 - 24
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Controls, Indicators and Connectors
2.10
Comm-Port (Optional Passport 2)
Comm-Port (Optional Passport 2)
NOTE:
Figures 2-15 to 2-18 depict four distinct sub-models of the
Comm-Port that have different interface capabilities. Only
one sub-model at a time can be connected to the Passport 2.
61 Main I/O Connector
FIGURE 2-14 Comm-Port Main Connector
61. Comm-Port to Main I/O Connector (DB1)
This is the female connector that will engage the equivalent male connector when connected
to the Passport 2.
!
CS1
MB1
62
63
RD1
65
FIGURE 2-15 Comm-Port 2
62. Ethernet Connector (CS1)
Ethernet connection port used for networking connections or devices requiring ethernet
communication such as the Panorama™ Central Station or a Laser Printer.
63. Module Bus Connector (MB1)
Port used to connect to future enhancements.
64. Serial Port Connector (SP1 or SP2)
Proprietary serial port used to connect to the Visa or Patient Net Central Station, Gas
Module, or other devices.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
2 - 25
Comm-Port (Optional Passport 2)
Controls, Indicators and Connectors
RD1
65
NC1
66
SP1
64
FIGURE 2-16 Comm-Port 3
65. Remote Display Connector (RD1)
Port used to connect a color remote display to the Passport 2 monitor
66. Nurse Call Connector (NC1)
Port used to connect a Nurse Call Cable to the Passport 2 monitor
TX
LINK
CS1
MB1
64
63
62
SP1
FIGURE 2-17 Comm-Port 4
SP1
NC1
66
64
SP2
64
FIGURE 2-18 Comm-Port 5
2 - 26
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
3.0
Operation
3.1
Getting Started
The Passport 2/Passport 2 LT 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.
1. Initial Monitor Set-Up
a. Attach the Line cord to the Passport 2/Passport 2 LT and to the AC outlet,
respectively.
b. Attach any peripheral equipment, e.g., Central Station, Remote Color Display,
before turning the unit ON.
c. Plug the unit into a hospital grade AC receptacle. If battery operation is required,
ensure that two fully charged batteries are installed.
d. Press the power switch to turn the unit ON. Internal self-tests will run and the display
will come on.
2. Setting the Date and Time
The date and time are set in the Monitor Setup Menu.
a. Using the Navigator™ Knob, highlight Monitor Setup. Press the Navigator Knob
to open the menu.
b. Use the Navigator Knob to select Advanced Setup, then select either Date or
Time.
c. Turn the Navigator Knob to select a new setting. Once the desired choice is
highlighted, press the Navigator Knob.
d. This setting is saved when Yes is selected via the confirmation prompt.
Passport 2®/Passport 2 LT™ Operating Instructions
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3-1
Getting Started
Operation
NOTE:
Patient trend data is cleared if the Time and/or Date are
changed on the monitor.
If the Passport 2 is connected to a Panorama Central Station, the Time and Date settings of
the Central Station will be acquired by the Passport 2 in one of three ways as follows:
• the Time and/or Date are changed on the Passport 2
• “Clear Trends” is chosen from the List Trend or Graph Trend menus
• the patient is discharged
3. Transferring Monitor Default Settings (Optional)
When installing several Passport 2/Passport 2 LT monitors with identical display
and alarm settings, it is not necessary to set each unit separately. A “Transfer Card” (P/N
0996-00-0051-01) may be used to copy the settings from monitor to monitor.
a. Ensure that the source monitor is powered OFF.
b. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
c. Power ON the source monitor while holding down the DISCHARGE key to enter
into its Installation Mode.
d. From the Installation Menu, select “Copy monitor defaults to card.” A status
message will indicate when the process is complete. Remove the Transfer Card.
e. Ensure that the receiving monitor is powered OFF.
f. Insert the Transfer Card into the PCM2 slot on the right side of the receiving monitor.
g. Power ON the receiving monitor while holding down the DISCHARGE key to enter
into its Installation Mode.
h. From the Installation Menu, select “Copy monitor defaults from card.” A status
message will indicate when the process is complete.
i. Select “Save Current” and then restart the receiving monitor to enter normal
monitoring mode.
4. Installation and Use of “Extended Trend” Feature (Optional)
This feature is added to the Passport 2/Passport 2 LT by inserting the “Extended
Trend” card (P/N 0996-00-0052-01) into the PCM1 slot on the right side of the monitor.
The card is to be inserted before monitor power-up, and never removed during monitor
operation. In order to guard against accidental removal, the card slot is designed so that
a tool is required to eject the card after insertion.
The “Extended Trend” feature is automatically enabled when the unit is powered-up
following card insertion.
5. Patient Set-Up
a. Power ON the monitor. Clear the previous patient’s data by pressing the
“DISCHARGE” key and then selecting “Discharge From Monitor” or
“Discharge From Both” from the Patient Discharge menu.
b. Connect the patient to the monitor, apply appropriate accessories such as ECG
electrodes, NIBP cuff, SpO2 probe, CO2 Filterline®, etc.
c. Open the Patient Menu and enter the patient demographic data. Ensure that the
correct patient size is chosen.
d. If an NIBP cuff has been applied, press the START key to initiate a non-invasive
blood pressure measurement.
3-2
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Installation Mode
3.2
Installation Mode
3.2.1
Installation Menu
FIGURE 3-1 Installation Menu
The Installation Mode is accessed by pressing and holding the DISCHARGE key during
power on. See the table that follows for descriptions of the Installation Menu choices.
To enter Installation Mode proceed as follows:
1. Power up the Passport 2/Passport 2 LT while holding down the DISCHARGE key.
2. Set each item as necessary. To save all of the chosen settings, choose “Save current”
before leaving this menu. To return to normal operating mode, power the unit Off and
On again.
Passport 2®/Passport 2 LT™ Operating Instructions
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3-3
Installation Mode
Operation
The following table describes the Installation Mode menu structure:
MENU TITLE ON
SCREEN
MENU CHOICES
DEFAULT
Save Current
Select to save current
settings as defaults.
Select Language
Set up at factory
Select to change
language.
Select Country
Set up at factory
Select to change
country.
Date Format
M/D/Y, D/M/Y,
Y/M/D
Per country
Select to change date
format.
Time Format
12, 24 hour
Per country
Select to change time
format.
NIBP Timeout
15, 30, 45, 60 mins
15 min.
Select to change NIBP
display time out.
Temperature units
°F, °C
°F - USA
°C - All others
Select to change
temperature units.
Weight Units
lbs, kg
lbs - USA
kg - All others
Select to change
weight units.
Height Units
ft/ inches, cm
ft/ inches - USA
cm - All others
Select to change height
units.
CO2 Units
mmHg,%, kPa
mmHg
Select to change CO2
units.
Copy monitor defaults
from card.
Select to copy the
monitor defaults and
settings from a data
transfer card inserted
into PCM2.
Copy monitor defaults
to card.
Select to copy the
monitor defaults and
settings to a data
transfer card.
Set Up Serial Port 14
None, Visa with
admit1, DIAP,
Accutorr2, Gas
Module, PatientNet1
None
Select to set up a serial
output protocol port.
An item enabled in
SetUp Serial Port 1 will
be removed from the
selections in SetUp
Serial Port 2.
Set Up Serial Port 24
None, Visa with
admit1, DIAP,
Accutorr2, Gas
Module, PatientNet1
None
Select to set up a serial
output protocol port.
An item enabled in
SetUp Serial Port 2 will
be removed from the
selections in SetUp
Serial Port 1.
WMTS Enabled4
No, Yes
No
Set to “YES” to enable
the use of the
Panorama Instrument
Radio - 608.
1
2
3
4
3-4
ACTIONS/
COMMENTS
“Visa with admit” and “PatientNet” will not be available as menu choices if “WMTS Enabled” is set to
“Yes” or if “Enable Network” is set to “Wired” in the System Information menu.
“Accutorr” will not be available as a menu choice if “WMTS Enabled” is set to “Yes”
Country, language and system information are not affected by restoring defaults.
Passport 2 only
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Installation Mode
MENU TITLE ON
SCREEN
MENU CHOICES
DEFAULT
Re-boot in demo mode
No, Yes
No
ACTIONS/
COMMENTS
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
defaults3
Select to restore factory
defaults.
System Information
Select to set up owners
screen.
Options
Select to add/view
options.
1
2
3
4
“Visa with admit” and “PatientNet” will not be available as menu choices if “WMTS Enabled” is set to
“Yes” or if “Enable Network” is set to “Wired” in the System Information menu.
“Accutorr” will not be available as a menu choice if “WMTS Enabled” is set to “Yes”
Country, language and system information are not affected by restoring defaults.
Passport 2 only
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3-5
Installation Mode
3.2.2
Operation
System Information Menu
FIGURE 3-2 System Information Menu
The System Information menu is accessed by rotating the cursor to the System Information
selection on the Installation Menu and pressing the Navigator™ Control Knob. Each item on
this screen is accessed in the same manner as the other menus on the monitor. Some items
provide menu choices while others require information to be entered via a keypad-like entry
screen. To enter information, rotate to the desired letter or number and then press the
Navigator™ Control Knob to select. When finished, rotate to the Previous Menu tag and
press the Navigator™ Control Knob. See the table that follows for descriptions of the System
Information menu choices.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Installation Mode
MENU TITLE ON
SCREEN
MENU
CHOICES
DEFAULT
TEXT STRINGS
Previous Menu
Select to return to Previous Menu
Property Of
Select to set up Property name
Location
Select to set up Location
Department
Select to set up Department
Contact
Select to set up Contact
Phone
Select to set up Phone
Accutorr Baud Rate5
1200, 9600
9600
Select to change the Accutorr protocol
baud rate
DIAP Baud Rate5
9600, 19200
9600
Select to change the DIAP protocol
baud rate
Enable Network1,5
No, Wired,
Wireless2
No
Select to enable Panorama
communications
IP Address:3,5
Subnet Mask ID:
Select to set up IP Address
3,5
Select to set up Subnet Mask ID
Wireless IP Address3,5
Select to set up Wireless IP Address
Wireless Subnet Mask
ID3,5
Select to set up Wireless Subnet Mask
ID
Laser Printer
IP Address5
Select to set up Laser Printer IP Address
Network Name:3,5
Select to set up Network name
Device ID4,5
1
2
3
4
5
If a serial port is set to “Visa with admit” or “PatientNet”, or if “WMTS Enabled” is set to “Yes” in the
Installation Menu, “Enable Network” will not be available as a menu choice.
If “Wireless” is selected, the ability to enable 12-Lead ECG will be locked out of the Functions Menu.
Refer to the Panorama Service Manual for information on network settings.
Device ID is an information field that displays a unique, factory defined, device ID number.
It is not user selectable.
Passport 2 only
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3-7
Non-Invasive Blood Pressure Measurements (NIBP)
Operation
3.3
Non-Invasive Blood Pressure Measurements (NIBP)
3.3.1
The NIBP Menu
FIGURE 3-3 NIBP Menu
3.3.2
Manual NIBP Measurements
1. Select a pressure cuff that is appropriate for the size of the patient. See “Optional
Accessories” in Section 5.1 for a detailed list of available cuffs.
3-8
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 your 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 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,
insure that the cuff is properly applied.
NOTE:
The skin is sometimes fragile (i.e., on pediatrics, geriatrics,
etc.). In these cases, a longer timer 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.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Non-Invasive Blood Pressure Measurements (NIBP)
2. Attach cuff hose to NIBP Connector.
3. Apply the cuff to the patient. To reduce errors, the cuff should be fitted snugly, with little
or no air 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 as described in
Section 2.3. Choices are Adult, Pediatric or Neonate.
5. If necessary, change the initial cuff inflation pressure through the NIBP Menu.
Initial cuff inflation pressures depend on the patient size setting. The choices of cuff inflation
are:
PATIENT SIZE
SETTING
INITIAL CUFF
INFLATION VALUES
DEFAULT
SETTING
MAXIMUM
INFLATION VALUES
Adult
100 - 280 mmHg
180 mmHg
300 mmHg
Pediatric
60 - 180 mmHg
140 mmHg
200 mmHg
Neonate
40 - 120 mmHg
100 mmHg
150 mmHg
6. Press START to begin an NIBP measurement.
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.
The cuff begins to inflate to the selected cuff pressure. After reaching the selected value the
cuff begins to slowly deflate and the Datascope Passport 2/Passport 2 LT Monitor
collects oscillometric pulsations.
If the initial cuff inflation is found to be inadequate, the unit retries with a higher inflation
pressure (+50 mmHg in the adult mode; +40 mmHg in the pediatric and neonate modes).
Have the patient 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.
If NIBP is the only parameter being measured with the Passport 2/Passport 2 LT, a heart
rate can be derived from NIBP. The HR source menu selection must be in the Auto mode (i.e.,
not selected for ECG, IBP or SpO2) with no heart rate alarm limits set. (See “Alarms”
Section 3.19 for details). If another heart rate source is available, the NIBP heart rate will be
replaced by the heart rate from the selected source.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3-9
Non-Invasive Blood Pressure Measurements (NIBP)
Operation
If NIBP is a selected trend source, then NIBP data will be recorded in the trend with the time
stamp of the reading. If NIBP is not a selected trend source, then NIBP data will be recorded
in the trend with the next entry into the trend caused by another trigger (i.e. Alarm, Interval
Entry, or Mark Event key press). The time stamp will be that of the trigger causing the trend
entry. (See Section 3.12 for details on trend triggers).The NIBP measurement and NIBP heart
rate 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.
3.3.3
Automatic 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 an interval that
measurements will be taken. 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.
Follow Steps 1 - 5 in Manual NIBP Measurement, Section 3.3.2.
7. Select the Interval Mode or the Timer Mode in the Monitor Setup menu.
8. Press INTERVAL until the desired time displays. The choices are: Off, Cont, 1 min, 2
min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hrs or 4 hrs.
9. Press START to begin taking interval measurements.
3.3.3.1
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.
NOTE:
When the NIBP “continuous” interval is chosen, the
Passport 2/Passport 2 LT will continually take back to back
blood pressure readings. As a safety precaution, a limit is
placed on continuous and 1 minute interval measurements.
In continuous mode, after 5 minutes, the NIBP interval will
automatically switch to one measurement taken every 5
minutes. In 1 minute mode, after 10 minutes the NIBP
interval automatically switches to measurements taken once
every 10 minutes.
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 and +40 mmHg in the pediatric and
neonate mode.
3 - 10
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.3.3.2
Non-Invasive Blood Pressure Measurements (NIBP)
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.
3.3.4
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 the Continuous Mode and the 1
minute interval. When the NIBP “continuous” interval is
chosen, the Passport 2/Passport 2 LT will continually take
back to back blood pressure readings. As a safety
precaution, a limit is placed on continuous and 1 minute
interval measurements. In continuous mode, after 5
minutes, the NIBP interval will automatically switch to one
measurement taken every 5 minutes. In 1 minute mode,
after 10 minutes the NIBP interval automatically switches to
measurements taken once every 10 minutes. Reports have
been made of nerve injury occurring during use of
automatically cycled blood pressure cuffs. See the
Appendix, “Cautions when Using Automatically Cycled
Blood Pressure Cuffs”.
NIBP Pressure Limit Fail Safe
If the cuff is over-pressurized, the cuff will automatically vent to atmosphere and the NIBP
message window will alternately read “cuff over pressure” and “unable to measure”. Power
the system off and then on again.
3.3.5
Cuff Inflation Time
If the cuff pressure does not attain 20 mmHg within 40 seconds of the start of inflation or if
the target pressure is not reached within another 60 seconds, then the cuff is vented and the
“RETRY” or “UNABLE TO MEASURE” message will display in the NIBP message window.
3.3.6
START and STOP Functions
The START and STOP functions have the following effects on the timed measurement
sequence (Interval or Timer Mode).
• INTERVAL is set and you press START:
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.
• INTERVAL is set and you press STOP during the measurement:
The cuff deflates and interval measurements are suspended.
• INTERVAL 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.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 11
Non-Invasive Blood Pressure Measurements (NIBP)
3.3.7
Operation
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 (See
Section 3.2)
• If a measurement is unsuccessful, the display values are replaced with “XXX” and a
tone sounds.
3 - 12
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
3.4
ECG Measurements
3.4.1
Electrocardiogram (ECG) Monitoring
ECG is a continuous waveform of a patient's cardiac electrical activity. The ECG waveform
will display in the first waveform area of the Passport 2/Passport 2 LT.
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 2, ECG can be obtained by using a 3 Lead, 5 Lead or 12 Lead ECG
cable in conjunction with a lead set and skin electrodes. With the Passport 2 LT, ECG can
be obtained by using a 3 Lead or 5 Lead ECG cable in conjunction with a lead set and skin
electrodes. For best performance and safety, inspect the ECG cables and electrodes daily.
WARNING: Ensure that the conductive parts of ECG electrodes do not
contact other conductive parts, including earth ground.
3.4.1.1
CAUTION:
To avoid possible damage to the Passport 2/Passport 2 LT,
use only ECG cables and accessories available from
Datascope.
CAUTION:
Line Isolation Monitor transients may resemble actual
cardiac waveforms, thus inhibiting heart rate alarms. Check
leadwires for damage and ensure good skin contact prior to
and during use. Always use fresh electrodes and follow
proper skin preparation techniques.
NOTE:
This device is not intended for direct cardiac application.
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:
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.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 13
ECG Measurements
3.4.1.2
Operation
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.
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:
If using the snap type electrode wires, attach the electrode
patch to the leadwire before placing patch on the patient.
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 leadwires to the patient according to hospital practice. For additional
information see section 3.4.1.3, “Lead Placement”.
WARNING: Ensure that the ECG leadwires are neatly secured in a
manner that will prevent them from encircling the patient’s
neck, creating a strangulation hazard.
NOTE:
3.4.1.3
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.
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.
This section outlines lead placement according to the guidelines of the American Heart
Association (AHA).
3 - 14
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
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
LA
Red
LL
FIGURE 3-4 3-wire Lead Placement (AHA)
• Place the RA (white) 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 LL (red) electrode on the patient’s lower left abdomen within the rib
cage frame.
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3 - 15
ECG Measurements
Operation
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.
White
Black
RA
LA
Brown
V Lead
(any position)
V
Green
Red
RL
LL
FIGURE 3-5 5-wire Lead Placement (AHA)
• Place the RA (white) electrode under the patient’s right clavicle, at the mid-clavicular line
within the rib cage frame.
• Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular 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 RL (green) 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.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
View 12™ Card (Optional Passport 2)
A View 12™ card utilizes a 10-wire ECG lead set that can monitor 12 ECG vectors (I, II, III,
aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6) simultaneously. The recommended lead
placement for a View 12™ card is as follows.
LA
RA
V1
V6
V5
V4
RL
V2
V3
LL
FIGURE 3-6 View 12™ Card Lead Placement (AHA)
• Place RA (white) electrode under the right clavicle, mid-clavicular line within the rib cage
frame.
• Place LA (black) electrode under the left clavicle, mid-clavicular line within the rib cage
frame.
• Place LL (red) electrode on the lower left abdomen within the rib cage frame.
• Place RL (green) electrode on lower right abdomen within the rib cage frame.
• Place V1 (brown) chest lead in the fourth intercostal space, right sternal border.
• Place V2 (brown) chest lead in the fourth intercostal space, left sternal border.
• Place V3 (brown) chest lead midway between V2 and V4 on a straight line.
• Place V4 (brown) chest lead in the fifth intercostal space, mid-clavicular line.
• Place V5 (brown) chest lead in the fifth intercostal space, anterior axillary line.
• Place V6 (brown) chest lead in the fifth intercostal space, mid-axillary line.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 17
ECG Measurements
Operation
Lead II Monitoring
The recommended lead placement for Lead II monitoring is as follows.
White
Black
RA
LA
Red
LL
FIGURE 3-7 Lead II Monitoring (AHA)
• Place the RA (white) electrode under the patient’s right clavicle, at the mid-clavicular line
within the rib cage frame.
• Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular line
within the rib cage frame.
• Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.
Select ECG Lead II on the monitor. Lead II is the direct electrical line between the RA (white)
electrode and the LL (red) electrode.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
Modified Chest Lead (MCL) Monitoring
The recommended lead placement for MCL monitoring is as follows.
White
RA
Black
Red
LA
LL
FIGURE 3-8 MCL Monitoring with a 3-wire Lead Set (AHA)
• Place the RA (white) electrode under the patient’s left clavicle, at the mid-clavicular 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 LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.
Select ECG Lead I for MCL1 monitoring. Lead I is the direct electrical line between the RA
(white) electrode and the LA (black) electrode.
Select ECG Lead II for MCL6 monitoring. Lead II is the direct electrical line between the RA
(white) electrode and the LL (red) electrode.
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ECG Measurements
Operation
Neonatal Electrode Placement
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
White
RA
LA
Red
LL
FIGURE 3-9 Neonatal 3-wire Lead Placement (AHA)
• Place the RA (white) electrode under the patient’s right clavicle, at the mid-clavicular line
within the rib cage frame.
• Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular line
within the rib cage frame.
• Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
Monitoring a Pacemaker Patient
The recommended lead placement for monitoring a pacemaker patient is as follows.
White
Pacer
White
Pacer
V
Brown
Black
Black
Red
Green
FIGURE 3-10 3-wire Lead Placement for a
Pacemaker Patient (AHA)
Red
FIGURE 3-11 5-wire Lead Placement for a
Pacemaker Patient (AHA)
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 (white)
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:
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
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.
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3 - 21
ECG Measurements
3.4.2
Operation
The ECG Menu
FIGURE 3-12 ECG Menu
The ECG Menu provides the following choices: Normal Screen, ECG 1 — ECG 6,
Arrhythmia Menu, Relearn, ST Menu, ECG Sizes Menu, ECG Setup and Resp
Menu.
• The Normal Screen selection returns the view to the normal screen.
• The ECG 1 — ECG 6 selections define the ECG labels for printing and trends.
• The Arrhythmia Menu selection opens the Arrhythmia Menu.
• The Relearn selection is only available if the ST or Arrhythmia options are installed and
is used to manually initiate the learning process for ST measurements or Arrhythmia
analysis.
• The ST Menu selection opens the ST Menu.
• The ECG Sizes Menu selection opens the ECG Sizes Menu.
• The ECG Setup selection opens the ECG Setup Menu that is detailed in the following
table.
• The Resp Menu selection opens the Resp Menu.
ECG Setup Menu
MENU ITEM
SELECTIONS
Previous Menu
Filter
FACTORY DEFAULT/COMMENTS
Returns to the previous menu.
Monitor, Extended,
ST
Select to change the filter mode for ECG. Extended or
ST must be used for ST analysis. The filter setting
affects both the display output and the printer output.
Monitor = 0.5 - 40 Hz
Extended, 3 or 5-lead = 0.05 - 100 Hz
Extended, 12-lead = 0.05 - 150 Hz
ST = 0.05 - 40 Hz
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
ECG Setup Menu (Continued)
MENU ITEM
SELECTIONS
FACTORY DEFAULT/COMMENTS
HR Source
Auto, ECG, <IBP1
Label>, <IBP2
Label>, <IBP3
Label>, <IBP4
Label>, SpO2
Dependent on current settings, the IBP Label
selections may remain as numbered or may be
substituted with one of the following: Art, PA, CVP,
ICP, RA, UA, LV, LA, IABP.
Pacer Reject
On, Off
When set to On, pacers are eliminated from the
display.
Pacer
Enhancement
On, Off
When set to On, all detected pacemaker spikes are
displayed.
Notch Filter
Off, 50 Hz, 60 Hz
This menu item is used to filter out AC line noise from
the ECG waveform. The Off selection is not saved
with the Save Current function and will be reset when
the monitor is power cycled.
ESU Filter
Auto, Disable
This menu item is used to filter out high frequency
electrosurgical noise from the ECG waveform. The
Disable selection is not saved with the Save Current
function and will be reset when the monitor is power
cycled. This function is not supported in 12 lead
mode.
ECG Cable
Auto Detect, 3 lead,
5 lead
This menu item is used to manually set the mode of
operation for the chosen ECG cable type.
NOTE: When using Datascope cables, the Auto
Detect selection will automatically detect the cable
type and switch the mode of operation accordingly.
3.4.3
Grid
On, Off
Select to turn the ECG grid On or Off.
Color
List of 16 colors
Select to change the display color for all ECG waves
and for the HR and ST parameters.
3 Lead or 5 Lead ECG Measurements
NOTE:
If an electro-surgical device is to be used on the patient, use
the ESIS cable. Respiration from ECG is not available if the
ESIS cable is used.
1. Plug patient cable into the ECG connector. An ECG waveform will be present on the
screen. The heart rate appears to the right of the waveform.
2. Select desired lead setting by pressing the front panel ECG LEAD key. Lead II is
automatically selected at power-up.
3. Select desired ECG size by pressing the front panel ECG SIZE key. An ECG of 1 cm/
mV is automatically selected at power-up.
4. If cascaded ECG is desired in waveform 2, use the Monitor Setup menu (see section
2.3.2), to choose this option.
5. If desired, choose an alternative source for heart rate. Choices are: ECG, IBP1, IBP2,
SpO2, or AUTO. AUTO selects the source from a hierarchy (ECG, IBP1, IBP2, SpO2,
NIBP) of what is currently monitored.
CAUTION:
To assure successful triggering of a Datascope Intra-Aortic
balloon pump from the Passport 2/Passport 2 LT monitor,
set the “ECG Filter” to “Extended” and set “Pacer
Enhancement” to “On”. Both of these settings are located in
the ECG setup menu of the Passport 2/Passport 2 LT.
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ECG Measurements
Operation
CAUTION:
3.4.4
The Analog Output on the Passport 2/Passport 2 LT
supports triggering the Intra-Aortic Balloon Pump (IABP) for
3 Lead and 5 Lead ECG cable monitoring only. Invasive
Blood Pressure triggering is not supported. ECG analog
output is disabled when 12 Lead ECG analysis is enabled.
“ECG Lead Fault” Message
A lead fault message will be displayed if an ECG lead becomes disconnected from the
patient.
A “CHECK LEAD CONNECTION” message will be displayed if 3 lead or 5 lead ECG has
an intermittent or poor connection. See section 3.4.1.1 for proper skin preparation for
electrode placement.
3.4.5
NOTE:
If a 3 or 5 Lead ECG cable and the View 12™ ECG Analysis
Module are both in use, and 12 Lead ECG is enabled, then
“Lead Fault” messages refer to the 12 Lead cable only.
NOTE:
When monitoring 12-Lead ECG, a “Lead Fault” message will
not be displayed if RL (Right Leg lead) becomes disconnected
from the patient.
12-Lead ECG Monitoring (Optional Passport 2)
This feature is added to the Passport 2 by inserting the View 12™ ECG Analysis Module
into slot PCM 1 on the right side of the monitor.
All Passport 2 monitors used with a View 12™ ECG Analysis Module on a hardwired
Panorama Central Station must comply with the following software requirements. Failure to
do so may cause inaccurate information to be printed at the Panorama Central Station laser
printer.
• Panorama software version 8.1.6 requires Passport 2 software version W.18
• Panorama software version 8.2 or higher requires Passport 2 software version
W.28 or higher
WARNING: The View 12™ ECG Analysis Module is not intended for use
during electrosurgery. If the electrosurgical ground
connection is not satisfactory, there exists a possibility of
patient burns at the ECG electrode sites.
1. Prep patient’s skin as indicated in Section 3.4.1.1 prior to placement of electrodes. See
“View 12™ Card (Optional Passport 2)” on page 3-17. for proper electrode placement.
2. Insert View 12™ ECG Analysis Module with cable attached into PCM slot 1 on right side
of Passport 2, turn monitor on.
3. To enable 12-Lead (if function is disabled), with the 12-Lead card inserted into PCM slot
1, go to the Functions menu and select “Enable 12-Lead ECG” using the Navigator
Control Knob.
4. To view multiple leads of ECG, press the VIEW key. Press the VIEW key once to view
the first 6 ECG leads, press again to view another 6 leads. Pressing a third time will
return to normal viewing.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
ECG Measurements
5. Select desired leads to view in the View ECG Setup menu within the Monitor Setup
menu.
6. To change sizes of displayed waveforms, go to the ECG Sizes Menu within the ECG
menu.
7. To remove the View 12™ ECG Analysis Module, turn monitor off or go to the Functions
menu and select “Disable 12 Lead ECG”, then use the Navigator Control knob to select
“Yes”.
CAUTION:
3.4.5.1
Removal of the View 12™ ECG Analysis Module without first
disabling the 12-Lead ECG card may cause a temporary
disruption in patient monitoring.
12-lead ECG Analysis (Optional Passport 2)
With a View 12™ ECG Analysis Module installed and enabled, the Passport 2 is capable
of providing ECG Analysis on printouts. To print this analysis, press the VIEW key (to view
multiple ECG leads), then press STRIP. If all conditions for analysis have been met, the
recorder will include it on the printed strip. The analysis will consist of an interpretive
statement, a condition statement, and a rhythm statement as specified in the Physician’s
Guide to Computerized ECG Analysis (Datascope P/N 0070-00-0524-01 English, 0070-000524-50 all other languages).
The conditions for printing the ECG analysis are:
1. The Passport 2 patient size must be set to “Adult”.
2. The patient’s gender and date of birth must be entered via the Patient menu.
3. The patient must be at least 18 years old. (The monitor calculates the patient age from
the date of birth entered.
WARNING: Computerized ECG Analysis should be reviewed by qualified
medical personnel. It should not be used exclusively for
treatment or non-treatment of patients.
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ECG Measurements
Operation
WARNING: ST segment measurements may be affected by one or more
of the following ECG rhythm morphologies: wide complex
QRS such as bundle branch blocks, ventricular pacemaker
rhythm, left ventricular hypertrophy or Wolff-ParkinsonWhite Syndrome. Consult with qualified medical personnel
prior to treatment or non-treatment.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.5
Invasive Blood Pressure (IBP1, IBP2) (optional Passport 2)
Invasive Blood Pressure (IBP1, IBP2)
(optional Passport 2)
1. Plug the pressure transducer into the PRESSURE TRANSDUCER connector on the left side
panel.
2. To establish a monitoring site, introduce an arterial pressure catheter into the patient’s
artery in accordance with standard hospital procedures. “Best practice,” as determined
by the medical community, should be observed.
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 or an SpO2 sensor.
3. Connect catheter line with flushing device to the pressure transducer.
4. Zero pressure transducer as follows:
a. Open transducer vent to atmosphere.
b. Press ZERO ALL.
After the automatic zero process is complete, the pressure display should indicate zeros.
NOTE:
If the transducer offset should exceed 120 mmHg, it will not
be possible to automatically zero the transducer. Pressure
values will be xxx and an “UNABLE TO ZERO” message will
be displayed.
5. Close the pressure transducer vent from atmosphere.
6. The IBP1 waveform will appear by default as the fourth waveform on the display with its
associated data to the right of the waveform. The waveform may be displayed in
another location or turned off by accessing the “Display Setup” menu. The IBP2
waveform and/or data will not appear unless a location has been designated in the
“Display Setup” menu.
7. Select the desired pressure scale in the IBP Menu.
8. Flush arterial line at regular intervals per standard hospital procedure.
NOTE:
Pressure transducers are protected against the effects of
defibrillation and electrocautery.
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SpO2 Pulse Oximetry
Operation
3.6
SpO2 Pulse Oximetry
3.6.1
SpO2 Menu
Nellcor® equipped unit
Masimo® equipped unit
FIGURE 3-13 SpO2 Menus
3.6.2
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.
3 - 28
NOTE:
Do not place the sensor on an extremity with an IV catheter
or blood pressure cuff in place.
NOTE:
Ensure proper routing of patient cable to avoid
entanglement and/or strangulation.
CAUTION:
When equipped with Masimo® SpO2, use only Masimo
oxygen transducers including Masimo LNOP® patient
dedicated adhesive sensors and Masimo PC Series Patient
Cable. 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:
Tissue damage or inaccurate measurements may be caused
by incorrect SpO2 sensor application or use, such as
wrapping it too tightly, applying supplemental tape, failing
to inspect the sensor site periodically, or failing to position it
appropriately. Carefully read the sensor directions for use,
the Passport 2/Passport 2 LT operating instructions, and all
precautionary information before use.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
SpO2 Pulse Oximetry
CAUTION:
Excessive ambient light may cause inaccurate
measurements. In such cases, cover the SpO2 sensor site
with opaque material.
CAUTION:
Inaccurate measurements may be caused by incorrect SpO2
sensor application or use; significant levels of dysfunctional
hemoglobins, (e.g., carboxyhemoglobin or methemoglobin);
or 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 direct sunlight; excessive patient movement; venous
pulsations; electro-surgical interference; and placement of a
sensor on an extremity that has a blood pressure cuff,
arterial catheter, or intra-vascular line.
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 an
inability to acquire physiological data.
CAUTION:
The site should be checked at least every eight (8) hours
(every four (4) hours with the Adult re-usable SpO2 finger
sensor). Ensure proper adhesion, skin integrity, and proper
alignment. Nail polish and fungus may affect readings.
Exercise extreme caution with poorly perfused patients.
Skin erosion and pressure necrosis can be caused when
sensors are not frequently monitored. Assess the site every
two (2) hours with poorly perfused patients.
CAUTION:
If the SpO2 sensor or patient cable is damaged in any way,
discontinue use immediately. To prevent damage do not
soak or immerse the sensor in any liquid solution. Do not
attempt to sterilize.
3. The Pleth waveform and digital SpO2 value will be displayed by default in the second
waveform and parameter area.
4. Enter the display set-up menu as described previously in this manual, to display Pleth
waveform and data in an alternative location.
5. Set the “Sensor -Off Audio”, in the SpO2 menu to the desired setting. Set to OFF, the
Passport 2/Passport 2 LT will not give an audio beep when the SpO2 sensor is off
the patient. Set to “ON”, the Passport 2/Passport 2 LT will sound a series of 5
triple beeps.
6. Color - menu selectable, multi-color.
7. Grid - menu selectable On or Off.
8. Masimo® Sensitivity Mode and Post Average Time
Passport 2/Passport 2 LT monitors equipped with Masimo SpO2 allow the user to
adjust Sensitivity and Post Averaging Time. The user should choose the sensitivity mode
depending upon signal quality and patient motion. In most cases, the normal setting will be
appropriate. If the patient motion is limited, high sensitivity can be used.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 29
SpO2 Pulse Oximetry
Operation
It is also possible to change the averaging time of the Saturation and Pulse Rate
measurements. The post average time can be changed to 6, 8, 10, 12, 14 or 16 seconds.
3.6.3
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 any 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.
Nail polish and fungus should be removed.
3.6.3.1
Calibration
The oximetry sub-system incorporates automatic calibration mechanisms. No other
calibration is required.
3.6.3.2
Auto Scaling
The Pleth waveform is automatically scaled. There is no adjustment that can be made to the
Pleth waveform size.
3.6.4
Masimo® Sensors and Patient Cable
Masimo 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:
1. indicated for continuous non invasive monitoring of arterial oxygen saturation (SpO2)
and pulse rate
2. non-sterile
3. usable during patient movement
The LNOP®• DCSC Adult Reusable Spot Check Sensor is used for “spot check” applications.
The LNOP®•DCI Adult Re-usable Finger Sensor 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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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.6.4.1
SpO2 Pulse Oximetry
Masimo Sensors and Accessories
Masimo Sensors Family
PART
NUMBER
PATIENT
SIZE
DISPOSABLE/
REUSABLE
LNOP®•Adt Adult Disposable Finger
Sensor
0600-00-0043-01
> 30 kg.
Disposable
LNOP®•Pdt Pediatric/Slender Digit
Disposable Sensor
0600-00-0044-01
10 to 50 kg.
Disposable
LNOP®•Neo Neonatal Disposable
Sensor
0600-00-0045-01
< 10 kg.
Disposable
LNOP® DC-12 Adult Finger Sensor
0600-00-0120
> 30 kg.
Re-usable
LNCS™ Adtx Adult Adhesive Sensors
0600-00-0121
> 30 kg.
Disposable
0600-00-0122
10 to 50 kg.
Disposable
LNCS™ Inf-L Infant Adhesive Sensors
0600-00-0123
3 to 20 kg.
Disposable
LNCS™ Neo-L Neonatal Adhesive
Sensors
0600-00-0124
> 40 kg.
Disposable
LNCS™ NeoPt –L Neonatal PreTerm
Adhesive Sensors
0600-00-0125
< 1 kg.
Disposable
LNCS™ DC-I Adult Reusable Sensor
0600-00-0126
> 30 kg.
Re-usable
LNCS DC-IP Pediatric Reusable
Sensor
0600-00-0127
10 to 50 kg.
Re-usable
LNOP®•Neo Pt Neonatal Pre-term
Disposable Sensor
0600-00-0046-01
< 1 kg.
Disposable
LNOP®•DCI Adult Reusable Finger
Sensor
0600-00-0047
> 30 kg.
Re-usable
LNOP®•DCSC Adult Reusable Spot
Check Sensor
0600-00-0077
> 30 kg.
Re-usable
SELECTION
™
LNCS Pdtx Pediatric Adhesive
Sensors
™
3.6.4.2
LNOP®•YI Multisite Reusable Sensor
0600-00-0078
> 1 kg.
Re-usable
LNOP®•EAR Reusable Ear Sensor
0600-00-0079
> 30 kg.
Re-usable
LNC-4, Patient Cable, 4 feet)
0012-00-1652
All
Re-usable
LNC-10, Patient Cable, 10 feet
0012-00-1599
All
Re-usable
LNC-14, Patient Cable, 14 feet
0012-00-1653
All
Re-usable
LNCS™ Series to LNOP® PC Series,
Patient Cable
0012-00-1651
All
Re-usable
Masimo SET® AC-1 Adapter Cable
0012-00-1656
All
Re-usable
PC Series Patient Cable
0012-00-1099-02
All
Re-usable
Selecting a 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 and the anticipated duration of monitoring.
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SpO2 Pulse Oximetry
3.6.4.3
Operation
Cleaning and Re-use
The sensor 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.
3.6.5
Nellcor® Sensors and Patient Cable
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 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 to
forehead or temple.
All Nellcor accessories and sensors must be purchased from Nellcor Puritan Bennett Inc. To
contact Nellcor Puritan Bennett Inc., call 1-800-635-5267.
3.6.5.1
Selecting a 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.
Only Nellcor® oxygen transducers should be used with the Passport 2 or Passport 2 LT
monitors with Nellcor® Oxismart® or OxiMax® pulse oximetry.
3.6.5.2
Cleaning and Re-Use
Do not immerse any Oxisensor®, OxiMax®, Durasensor® or Oxiband® oxygen transducers,
the Nellcor® RS-10 or Max-Fast® oxygen transducers, or any Nellcor® adhesive in water or
cleaning solution. Clean Durasensor® and Oxiband® oxygen transducers, and the Nellcor®
RS-10 or Max-Fast® oxygen transducers by wiping with a disinfectant such as 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.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.7
ST Monitoring (Optional Passport 2)
ST Monitoring (Optional Passport 2)
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 3-14 ST Monitoring
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 3-11). ST
measurements are available on a maximum of three user selected ECG leads at a point
situated 80 msec (heart rate 120 bpm or less) or 60 msec (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 ST segment.
Ventricular paced beats are also rejected from the analysis of the ST segment, because pacer
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:
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.
The Passport 2 initiates the Learning process for ST measurements after one of the
following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling ST 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.
It is recommended that a Relearn be initiated after one or more of the following:
Passport 2®/Passport 2 LT™ Operating Instructions
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ST Monitoring (Optional Passport 2)
Operation
• ECG electrodes have been repositioned
• Eight hours have passed since the last Relearn
• Any significant changes to the patient QRS complex
• The observed ST measurement mode has been changed (Delta or Absolute - 12 Lead
only)
• A clinician has observed clinically questionable arrhythmia calls
A Relearn must be initiated if “Learning” occurred during a “Leads Off” condition.
3.7.1
ST Setup
Select the waves to be used for ECG. ST analysis is performed on the leads chosen as ECG
1, ECG 2 and ECG 3 on the ECG Menu. ST analysis begins when the feature is turned on
from the ST Menu. By default, ST data will appear in the Heart Rate Tile.
To display the ST data in the second tile, set waveform 2 to display any ECG wave (i.e.
ECG2, ECG3, or ECG1 Cascade), then set “Combine ST/HR” to OFF.
Once waveform 2 has been set to display an ECG wave, the learned ST patterns or ST trend
data may be displayed in place of the ECG wave.
Set “View ST” to “Minitrends” to view the trended data for each analyzed lead. Set “View
ST” to “Averaged ST” view the learned and current ST complex for each analyzed lead.
When View 12™ ECG Analysis Module is installed, continuous 12-lead ST monitoring will be
enabled when “ST analysis” is set to “On”. 12-lead ST analysis may be viewed in 2 modes:
Delta and Absolute. Delta ST is the ST segment change between the learned ST segment and
the present ST segment. Absolute ST is the ST segment change between the “O” baseline
point of the ST and the present ST segment.
To display 12-lead ST data in a tile, set Waveform 2 to display any ECG wave, ST minitrends
or Averaged ST.
FIGURE 3-15 ST Setup (3/5 lead)
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.8
Arrhythmia Algorithm (Optional Passport 2)
Arrhythmia Algorithm (Optional Passport 2)
The Passport 2 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
S
40 to 80 msec
ST Segment
FIGURE 3-16 Sample Waveform
Noise and Artifact
The presence of noise or artifact in an ECG waveform makes the accurate detection and
classification of heart beats 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 leadwires, and patient movement. The algorithm
uses several techniques to differentiate a patient’s QRS complexes from noise sources.
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 when ECG noise is detected in one or more ECG
leads. If ECG noise continues beyond the configured noise delay, an alarm is triggered,
and ECG rhythm analysis is stopped.
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Arrhythmia Algorithm (Optional Passport 2)
Operation
Heart Rate Meter
Heart Rate is computed using the 16 most recent R-R intervals for heart rates above 48 beats
per minute. If the 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.
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. Pacer pulses are
shown on the Passport 2 as exaggerated vertical lines.
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.
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.
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
VIEW 12™ CARD
Leads used for Beat
Detection
Determined by
viewed lead
II and V
V1 and V5
Leads used for Beat
Typing
Determined by
viewed lead
II, V, and I
V1, V5, and II
Leads used for
V-Fib Detection
Determined by
viewed lead
II and V
V1 and V5
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 heart beat to reference templates that were
previously stored in the system. A beat typing algorithm classifies the beats.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Arrhythmia Algorithm (Optional Passport 2)
• 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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ST Segment Analysis (Optional Passport 2)
3.9
Operation
ST Segment Analysis (Optional Passport 2)
The ST segment of an ECG waveform (shown in FIGURE 3-16) represents the period from the
end of ventricular de-polarization, to the beginning of ventricular re-polarization, or the end
of the QRS complex (the J point) and the beginning of the T-wave. ST Segment analysis is
used to monitor the oxygen supply and the viability of the heart muscle.
ST deviation is the vertical distance between the isoelectric (ISO) point level and signal level
at ST point. The ST point is located 40 to 80 milliseconds beyond the J-point.
The ISO point is located between the end of the P-wave and the onset of the QRS complex.
The ISO point provides the baseline for this measurement.
The ST point is a fixed distance from the J point at the end of the QRS complex. The ST point
can be configured to 40, 60, or 80 milliseconds past the J-point, independent of the heart
rate. By default, the ST point is positioned as follows:
• at 80 milliseconds for heart rates less than or equal to 120 beats per minute
• at 60 milliseconds for higher heart rates
ST data is calculated on the averaged beat, and not on individual beats. The reliability of ST
measurements is lowered with the presence of atrial fibrillation, flutter, and erratic baseline
changes.
All available ECG leads are analyzed to measure deviations in the ST segment.
Learning
The process of learning is used to establish normal beat templates or a stable baseline for
accurate ST analysis. To establish this baseline, the system evaluates the first sixteen normal
beats based on readings from leads I, II and V.
To establish an accurate baseline, it is recommended that learning be done when the patient
is in stable condition, not moving, and has an ECG rhythm that is free of artifact. Learning
should not be initiated during a primarily ventricular rhythm or other ECG rhythm irregularity
because an ectopic beat may be established as normal.
ECG Filters
The ST segment of an ECG waveform often contains low amplitude signals with low
frequency content. To preserve low frequency signal content, the high pass filter is set to 0.05
Hz when ST analysis is turned on.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.10
Arrhythmia Alarms (Optional Passport 2)
Arrhythmia Alarms (Optional Passport 2)
Arrhythmia alarms are activated based on the patterns in the patient ECG waveform rhythms.
Beat detection for a 5-wire lead set is determined by using a combination of leads II and V.
When using a 3-wire lead set, beat detection is determined by using the lead being viewed.
The following lethal and non-lethal arrhythmia alarms may be detected by the arrhythmia
algorithm.
NOTE:
3.10.1
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.
NOTE:
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 MUTE or MUTE 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 muted for the duration
that is selected from the “Mute 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 muted, the new lethal alarm will not
break through and will be muted for the remainder of the
mute duration. If the lethal condition is resolved while the
alarm is muted, 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.
For 3-Lead and 5-Lead ECG – The time period range for an Asystole alarm is user
selectable from 3 to 10 seconds.
For 12-Lead ECG – The time period range for an Asystole alarm is user selectable from 3 to
8 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.
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.
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Arrhythmia Alarms (Optional Passport 2)
Operation
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.
Ventricular Tachycardia (V-TACH) Alarm
A V-TACH alarm is activated when a set number of consecutive PVCs is reached at a rate
exceeding the set V-TACH rate.
• The V-TACH rate may be set between 100 and 180 beats per minute.
• The number of consecutive PVCs may be set between 3 and 15 beats.
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.
3.10.2
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, Pause, PVC/min, Run, Trigeminy, and
Ventricular Rhythm (V-Rhythm) alarms are classified as non-lethal arrhythmia alarms.
NOTE:
Non-lethal arrhythmia alarms are not latched alarms and
can be acknowledged at any time. To acknowledge a nonlethal arrhythmia alarm, press the MUTE 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 a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A BIGEMINY text message above the ECG1 waveform area.
Bradycardia (Brady) 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.
NOTE:
The Bradycardia alarm is not available when using a View
12™ card.
The Brady alarm is an alarm event that produces:
• Alarm Priority 1 visual and audio alarm indicators.
• A Brady text message above the ECG1 waveform area.
Couplet Alarm
The Couplet alarm is activated when two consecutive PVCs are detected between normal
beats.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Arrhythmia Alarms (Optional Passport 2)
The Couplet alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A COUPLET text message above the ECG1 waveform area.
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.
NOTE:
The Irregular Heart Rate alarm is not available when using
a View 12™ card.
The Irregular Heart Rate alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• An IRREGULAR HR text message above the ECG1 waveform area.
Pause Alarm
The Pause alarm is activated when no beat is detected during an interval that is greater
than 1.8 R-R and the next beat is not a PVC.
NOTE:
The Pause alarm is only available when using a View 12™
card.
The Pause alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A PAUSE text message above the ECG1 waveform area.
PVC/minute Alarm
The 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 PVC alarm has priority settings of 1 or 2, and behaves as follows:
• If the High PVC alarm priority is set to 1, Alarm Priority 1 visual and audio alarm
indicators are produced.
• If the High PVC alarm priority is set to 2, Alarm Priority 2 visual and audio alarm
indicators are produced.
NOTE:
PVC/min will not be displayed during periods of Ventricular
Rhythms, V-TACH, V-FIB and Asystole.
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.
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Arrhythmia Alarms (Optional Passport 2)
Operation
The Run alarm is a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A RUN text message above the ECG1 waveform area.
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 a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
A TRIGEMINY text message above the ECG1 waveform area.
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 a Priority 2 alarm event that produces:
• Alarm Priority 2 visual and audio alarm indicators.
• A VENTRICULAR RHYTHM text message above the ECG1 waveform area.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.11
Arrhythmia Analysis (Optional Passport 2)
Arrhythmia Analysis (Optional Passport 2)
WARNING: The arrhythmia analysis feature is intended to detect
ventricular rhythms, however, due to physiologic differences
in patient populations, the Passport 2/Passport 2 LT may
occasionally sound a false alarm or may not recognize
some arrhythmia patterns.
The Passport 2 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.
FIGURE 3-17 Arrhythmia Menu
(3/5 lead)
FIGURE 3-18 Arrhythmia Menu
(12 lead)
Arrhythmia alarm calls are classified as Priority 1 or Priority 2.
Asystole, Ventricular Tachycardia, Ventricular Fibrillation and Bradycardia 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 MUTE or MUTE ALL key,
regardless of whether the patient’s condition has improved.
The other arrhythmia alarms are classified as Priority 2 by factory default. The
characteristics and priority level of the “PVC/min” alarm can be changed at the user’s
discretion via the Alarm Limits Setup menu.
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, and Trigeminy.
For 3-lead or 5-lead ECG, the following additional calls can be made:
• Irregular HR and Bradycardia
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Arrhythmia Analysis (Optional Passport 2)
Operation
For 12-lead ECG, the following additional call will be made:
• Pause
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.
The Passport 2 initiates the Learning process for Arrhythmia measurements after one of the
following:
• Unit Power-Up
• Return to normal monitoring from Standby mode
• Enabling 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.
It is recommended that a Relearn be initiated after one or more of the following:
• The ECG electrodes have been repositioned
• Sufficient time has passed since the last Relearn
• Any significant changes to the patient QRS complex
• Any 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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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.12
Temperature Menu
Temperature Menu
FIGURE 3-19 Temperature Menu
The Temperature measurement function of the Passport 2/Passport 2 LT is designed to
take temperature readings from YSI 400 or YSI 700 or compatible probes. To display the
Temp Menu, turn the Navigator™ Control Knob to the Parameters tile along the top of the
screen. Rotate the Navigator Control Knob to highlight the Temperature selection. Press the
Navigator Control Knob and the Temperature Menu will appear.
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List Trends (Passport 2 Only)
3.13
Operation
List Trends (Passport 2 Only)
FIGURE 3-20 List Trends
The List Trend display allows the user to view a tabular list of stored patient vital signs and
anesthetic gas data. Press the TRENDS key to access this display. A maximum of 120 timestamped entries may be stored. If the “Extended Trend” option is installed, a maximum of
500 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.
The left side of the List Trend display contains menu items for scrolling, setup, and access to
other displays. Trend data is listed from newest to oldest. Use the Vertical Scroll feature to
view older data. Use the Horizontal Scroll feature to view all the columns of data.
NOTE:
When scrolling horizontally, the first column of data 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. Upon reopening of the trend screen, the
last viewed data position will be displayed at the top of the trend screen.
The leftmost column of the List Trend display contains markers which indicate if the entry was
triggered by an alarm violation or MARK EVENT keypress. On color displays these markers
are red for priority 1 alarms, yellow for priority 2 alarms, and green for MARK EVENT
keypresses. On monochrome displays these markers are bold for priority 1 alarms, halfbrightness for priority 2 alarms, and normal brightness for MARK EVENT keypresses.
Trend data in violation of an alarm is also highlighted according to the priority of the alarm.
On color displays this data is red for priority 1 alarms and yellow for priority 2 alarms. On
monochrome displays this data is bold for priority 1 alarms and half-brightness for priority2
alarms.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
List Trends (Passport 2 Only)
If data for a parameter was 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”.
3.13.1
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 left to right is: HR, NIBP, SpO2, Resp, CO2, IBP1, IBP2, T1, O2,
Agent, N2O, and PVC. To change the order of the parameters displayed, select “Setup” from
the List trend menu. Once in the Setup Menu, change the Format selection from “Auto” to
“Manual”. The parameters to be displayed in each of the first 6 columns may then be
specified.
3.13.2
Modification of Trend Entry Conditions
Trend entry conditions may be modified via the Advanced Setup Menu. The Advanced Setup
Menu is accessed from the Monitor Setup Menu. Any combination of Trend Input triggers
may be used.
TREND ENTRY TRIGGER
DEFAULT
COMMENT
Interval
Off
Trend entries will occur at the selected time
interval
Alarm
Off
Trend entries will occur when an alarm violation
occurs
NIBP
On
Trend entries will occur whenever an NIBP
measurement is made
Pressing the MARK EVENT key will always cause a Trend entry.
3.13.3
Filtering of List Trend Data Displayed
Data corresponding to MARK EVENT keypresses will always be included in the displayed
data. If the Trend Entry Triggers for Alarms and/or NIBP have been set to “On”, this data will
also always be included.
Trend entries triggered by the Interval setting above may be filtered out from the displayed
List trend data. To change the amount of interval entries displayed, select “Setup” from the
List trend menu. Once in the Setup Menu, select “Display Interval” and set as desired. The
choices available for the “Display Interval” depend on the setting of the “Trend Entry
Interval” setting above. (If the “Trend Entry Interval” is set to “Off”, there will be no choices
available for “Display Interval”.)
NOTE:
If the “Display Interval” remains set to “Off” while the
“Trend Entry Interval” has been set to something other than
“Off”, the trend may appear to clear itself or to have
disappeared. This is because the trend has reached it’s
maximum number of entries and new interval data
(although not displayed) is causing older trend entries to be
deleted from the database.
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List Trends (Passport 2 Only)
3.13.4
Operation
Printing List Trend Data
To print, press the PRINT TREND key while the List Trend is displayed. The recorder will
print the data for all parameters from the first line displayed to the last line of the trend
record. Use the Vertical Scroll feature to position the first line to be printed at the top of the
List Trend display. Press the PRINT TREND key again to stop printing at any time.
3.13.5
Transferring List Trend Data Between Different Passport 2 Monitors
List and Graph Trend data, along with patient name and demographics may be transferred
between Passport 2 monitors with a “Datascope Transfer Card” (P/N 0996-00-0051-01).
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Access the Functions Menu of the source monitor, and select “Copy patient data to card”
from the menu. A status message will report completion of the transfer. (This section is
grayed-out if a transfer card is not plugged into the PCMCIA slot A.)
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Access the Functions menu of the receiving monitor, and select “Copy patient data from
card”. A status message will report completion of the transfer.
3.13.6
Transfer Notes
1. If the source monitor is equipped with the “Extended Trend” option and the receiving
monitor is not, only the latest 120 trend entries will be transferred from the card.
2. If the latest trend data stored on the card has a time stamp newer than the time
displayed on the receiving monitor, data transfer will be prohibited. (This is possible
when the time and date settings on the monitors have not been correctly set.)
3.13.7
Clearing Trend Data
To manually clear all trend data, including Graph and OXY CRG 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.
3.13.8
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 Trend display, choose “Normal
Screen” from the menu, or press the NORMAL SCREEN key.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.14
Graph Trends (Passport 2 Only)
Graph Trends (Passport 2 Only)
Graph Trend
Normal Screen
Scroll
Scroll
Event
Events
11:40
300
11:45
11:50
List Trends
Setup
12:00 Cursor 11:46
HR
162 bpm
0
100
Zoom
Rescale Waves
Clear Trends
11:55
SP02
96%
0
100
Resp
76
80
50
bpm
C02
1 / 38
mmhg
0
Select to return to the Normal Screen
FIGURE 3-21 Graphing Trends
The Graph 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 twice. To access this display from the List Trends display, press the
TRENDS once. This display may also be accessed from the other trend displays via menu
selection.
The left side of the Graph Trend display contains menu items for scrolling, setup, and access
to other displays. The Graph Trend data window contains up to 4 parameter displays. Use
the Vertical Scroll feature to view other parameters.
NOTE:
When scrolling vertically, the topmost parameter remains
displayed and does not scroll.
Time stamps are included at the top of the window, with the most recent data appearing at
the right end. Use the Horizontal Scroll feature to move the cursor though time. 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 Event Scroll feature may be used to scroll quickly
between events (caused by Alarm entries and MARK EVENT key presses).
The Rescale Waves feature automatically rescales the viewed parameters’ graphs so all data
is displayed. The Zoom feature may be used to adjust the amount of time shown in the trend
window.
The top line of the Graph Trend display contains markers which indicate if the entry was
triggered by an alarm violation or MARK EVENT keypress. On color displays these markers
are red for priority 1 alarms, yellow for priority 2 alarms, and green for MARK EVENT
keypresses. On monochrome displays these markers are bold for priority 1 alarms, halfbrightness for priority 2 alarms, and normal brightness for MARK EVENT keypresses.
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Graph Trends (Passport 2 Only)
Operation
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.
On monochrome displays:
• Priority 1 alarm data is shown in inverse video with background at full brightness.
• Priority 2 alarm data is shown in inverse video with background at half brightness.
If data for a parameter was 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”.
3.14.1
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, NIBP, SpO2, Resp, CO2, IBP1, IBP2, ST1,
ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9, ST10, ST11, ST12, T1, O2, Agent, N2O, and
PVC/min. To change the order of the parameters displayed, select “Setup” from the Graph
trend menu. Once in the Setup Menu, change the Format selection from “Auto” to “Manual”.
The parameters to be displayed in each of the top 5 rows may then be specified.
3.14.2
Modification of Trend Entry Conditions
The Graph 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 Graph trend.) Refer to the previous
section (List Trend) for modification of trend entry conditions.
3.14.3
Printing Graph Trend Data
To print, press the PRINT TREND key while the Graphic Trend is displayed. The recorder
will print the displayed trends. Use the Vertical Scroll feature and the Zoom feature to display
the parameters and time span desired to be printed. Press the PRINT TREND key again to
stop printing at any time.
3.14.4
Transferring Graph Trend Data Between Different Passport 2
Monitors
Graph Trend data is transferred together with List Trend and patient name and
demographics. Refer to the List Trend section for details.
3.14.5
Clearing Trend Data
To manually clear all trend data, including List and OXY CRG trends, choose “Clear Trends”
from the menu. A confirmation prompt will appear. Once cleared, the data cannot be
restored.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Graph Trends (Passport 2 Only)
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.
3.14.6
Removing the Graph Trend Display
The Graph Trend display does not automatically “time-out” and must be manually removed to
return to the normal waveform display. To remove the Graph Trend display, choose “Normal
Screen” from the menu, or press the NORMAL SCREEN key.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 51
OXY CRG Display Menu (Passport 2 only)
3.15
Operation
OXY CRG Display Menu (Passport 2 only)
OxyCRG
Normal Screen
Scroll
Scroll
Event
Rescale Waves
Clear Trends
List Trends
Graph Trends
Events
11:40
300
12:00 Cursor 11:46
HR
162 bpm
0
100
SP02
96%
0
100
Resp
76
bpm
80
Select to return to return to Normal Screen
FIGURE 3-22 OXY CRG Display Menu
The OXY CRG (Oxygen Cardiorespirogram) display allows the user to view a continuously
updated graphic summary of 5 specific patient vital signs. This display is available for
Neonate and Pediatric patient sizes only. To access this display from the normal monitoring
screen, press the TRENDS key 3 times. To access this display from the List Trends display,
press the TRENDS key twice. To access this display from the Graph Trends display, press the
TRENDS key once. This display may also be accessed from the other trend displays via
menu selection. A maximum of 6 minutes of data may be stored. If the “Extended Trend”
option is installed, a maximum of 12 hours of data may be stored. When the maximum
storage time has been reached, the oldest data will be deleted from the database in order to
allow storage of new data.
The general operation and format of the OXY CRG menu items and display is the same as for
Graph Trend display described previously.
3.15.1
Parameters Displayed
The parameters displayed are Heart Rate (from ECG source only), SpO2, Condensed
thoracic impedance respiration wave (with digital rate data), IBP1, and Temperature.
3.15.2
Printing OXY CRG Data
To print, press the PRINT TREND key while the OXY CRG Trend is displayed. The recorder
will print the 5 OXY CRG parameters. Press the PRINT TREND key again to stop printing at
any time.
3.15.3
Transferring OXY CRG Data Between Different Passport 2 Monitors
OXY CRG data may not be transferred between monitors.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.15.4
OXY CRG Display Menu (Passport 2 only)
Clearing Trend Data
To manually clear all trend data, including List and Graph 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.
3.15.5
Removing the OXY CRG Display
The OXY CRG display does not automatically “time-out” and must be manually removed to
return to the normal waveform display. To remove the Graph Trend display, choose “Normal
Screen” from the menu, or press the NORMAL SCREEN key, or press the TRENDS key
once.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 53
Respiration Monitoring
3.16
Operation
Respiration Monitoring
The Passport 2 Monitor offers two kinds of respiratory monitoring: Thoracic impedance
and CO2 (optional). Both methods offer certain benefits and limitations. A respiration source
may be selected. The choices are Auto, CO2 or ECG. When the Respiration source is set to
AUTO, the unit will search for a source in the following order: CO2 waveform from the
optional Gas Module or from the optional Microstream® CO2 (depending on settings in the
Installation Menu), then ECG. The Passport 2 LT monitor offers Thoracic impedance
respiratory monitoring. When the respiration source is ECG, either Lead I or Lead II may be
selected. Lead II is the default.
3.16.1
NOTE:
When 12 Lead ECG is enabled, Respirations can be acquired
from the 3 Lead or 5 Lead ECG cables as well as CO2.
CAUTION:
Some pacemakers may contain a respiratory sensor that
may produce artifact on an ECG waveform.
Resp Menu
FIGURE 3-23 Resp Menu
3.16.2
Thoracic Impedance
The Passport 2/Passport 2 LT Monitor presents a small electrical signal across the RA
and LA (or RA & LL) 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 non-invasively and without any extra cost. It is important to use cables
with internal resistors for Thoracic Impedance, see Section 5.1.7 for a list of cables.
CAUTION:
Thoracic impedance monitoring may affect rate responsive
pacemakers.
Choke blocks are electrical filters that may be used in electro-cautery environments where
ECG interference can be substantial. These filters remove the electro-cautery noise, but also
block the signal used by the Passport 2/Passport 2 LT Monitor to measure respiration.
3 - 54
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Respiration Monitoring
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 2/Passport 2 LT warns the operator when the respiration value
equals the heart rate by displaying the CVA message.
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:
3.16.3
To avoid possible damage to the Passport 2/Passport 2 LT,
use only ECG cables and accessories available from
Datascope.
CO2 Waveform (Passport 2 only)
When used with the optional Microstream® CO2 or optional Gas Module the Passport 2
may use the end tidal CO2 waveform to report the respiration rate by measuring the actual
breaths per unit time. The advantage of the CO2 waveform method is that the signal is a
direct result of respiration and can only occur if the patient is actually breathing. Refer to
Section 3.16 for more details on the above options for CO2 monitoring.
3.16.4
Respiration Monitoring on the Passport 2
The respiration wave appears by default in the third waveform area. An alternative location
can be set by accessing the Display Setup Menu.
3.16.4.1
Thoracic Impedance
Select lead to be used as Respiration Source on the Resp Menu. Lead II is the default setting.
Thoracic impedance respirations can only be acquired from a 3 Lead or 5 Lead, non ESIS
ECG cable.
3.16.4.2
CO2 Waveform (requires optional Microstream® CO2 or
Gas Module) (Passport 2 only)
If the RESP SOURCE is set to “AUTO”, the source will switch to CO2 source when a filterline
is connected to the unit. If a filterline is not connected, the source will be ECG.
This source will switch to CO2 if a Gas Module has been setup in the Installation Mode and
is connected to the Passport 2. If the Gas Module has not been connected, the source will
be ECG.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 55
Microstream® CO2 Monitoring (Optional Passport 2)
3.17
Operation
Microstream® CO2 Monitoring (Optional Passport 2)
The Passport 2 offers the MediCO2® Microstream® CO2 module. The Microstream CO2
modules provides ETCO2, Inspired CO2 and respiration rate monitoring utilizing a small
lumen filterline. Microstream capnography can be acquired via a nasal cannula (nonintubated) or through a sampling line connected to a breathing circuit (intubated).
Microstream can be used on adult, pediatric, and neonatal patients.
WARNING: When using Microstream® CO2 Monitoring, the maximum
sampling rate at the nasal cannula is 50 ml/min. This device
should not be used on patients whose breathing could be
impaired by this vacuum flow rate.
WARNING: Connection of the Passport 2’s exhaust port to the hospital’s
waste gas scavenge system is recommended to prevent
exposure of hospital personnel to the patient’s respiratory
sample.
3.17.1
Microstream CO2
1. Connect one end of an exhaust line to the exhaust port on the Passport 2 and the
other end to the hospital gas scavenging system.
2. Select CO2 or AUTO as the Resp. Source in the Resp Menu.
CAUTION:
Vacuum (negative pressure) should not exceed 1 mmHg at
the Passport Pump Exhaust fitting. Excessive scavenge
vacuum may result in an “OCCLUSION” message or
damage to the Passport 2’s internal pump. The scavenge
system must be on during calibration.
3. Open spring loaded door and connect the proper filterline to the Monitor. Connect the
opposite end to the patient.
NOTE:
Ensure all tubing connections are secure. Ensure that the
nasal cannula is away from all sources of CO2 (including the
patient’s and your own exhaled breath and ventilator
exhaust valves) during the warm up period.
4. When the Passport 2 has detected valid breaths, numbers will display for ETCO2,
Inspired CO2 and Respiratory Rate.
5. The CO2 respiration waveform and data will automatically replace the ECG Respiration
waveform and data on the display. If respiration wave or data is not displayed, use the
DISPLAY Setup Menu, to select RESP or CO2 to be displayed on Waveform 2, 3 or 4.
6. If desired, the CO2 waveform scale can be changed through the CO2 menu.
NOTE:
See “Installation Mode” Section 3.2, for CO2 Units selection.
NOTE:
See “CO2 Messages (only units equipped with CO2)”
Section 3.22.4 for more details on messages.
WARNING: Microstream® waste material and CO2 filter should be
treated as biohazard material.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Microstream® CO2 Monitoring (Optional Passport 2)
Operation
3.17.2
Microstream® CO2 Calibration
Accuracy verification of the Microstream CO2 is recommended at 1 year intervals, or
whenever the readings appear to be in error. The date of the last successful calibration
appears on the CO2 Calibration Menu.
Use Calibration Gas, P/N 0075-00-0033-01 and a Microstream FilterLine®, P/N 0683-00468-01.
NOTE:
For maximum accuracy, a 20 minute warm-up time is
recommended.
1. Connect the tubing that comes with the Calibration Gas to the gas canister and to the
filterline. Attach the calibration gas / tubing assembly to the Microstream® port on the
Passport 2.
2. Select the CO2 parameter tile by rotating Navigator™ Control Knob clockwise and
pressing the Knob after the CO2 button is highlighted. (The same menu can be accessed
by using the “PARAMETERS” tile and rotating to CO2 and pressing the Knob.)
3. Select the CALIBRATE option and press the button on the gas canister to begin
releasing the gas mixture.
CO2 Menu
Calibration Menu
Previous Menu
Start
Date and Time of last successful Calibration
3/15/99 at 11:44 AM
Return to previous menu
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 57
Microstream® CO2 Monitoring (Optional Passport 2)
Operation
4. Select the START option in the Calibration Menu. Once the “START” option has been
selected, no CO2 waveform data will be displayed.
CO2 Menu
Calibration Menu
Previous Menu
Start
Date and Time of last successful Calibration
3/15/99 at 11:44 AM
Select to start calibration, apply 5% CO2
before pressing start.
5. CALIBRATING, CONTINUE TO APPLY 5% CO2 will appear in the message area of
the Calibration Menu.
NOTE:
If no gas is being delivered, or the mixture does not contain
5% CO2, the message “Calibration error. Caused by no gas
or wrong gas concentration” will appear. Obtain a new gas
canister and begin again with Step 1.
6. With the proper gas mixture being applied, the message “Calibrating, continue to apply
5% CO2” will remain in the menu. When the message changes to “Calculating,
calibration gas can be removed”. Release the button and remove the connector from the
canister.
CO2 Menu
Calibration Menu
Previous Menu
Start
Calibrating, continue to apply 5% CO2
Date and Time of last successful Calibration
3/15/99 at 11:44 AM
Select to stop calibration
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Microstream® CO2 Monitoring (Optional Passport 2)
Operation
CO2 Menu
Calibration Menu
Previous Menu
Start
Calculating, calibration gas can be removed.
Date and Time of last successful Calibration
3/15/99 at 11:44 AM
Select to stop calibration
7. After a moment, the message will change to “Calibration Completed Successfully”. The
date and time of the successful calibration will appear in the body of the Calibration
Menu.
8. Rotate the Navigator™ Control Knob to the selection for “Previous Menu” and press to
select.
CO2 Menu
Calibration Menu
Previous Menu
Start
Calibration Completed Successfully
Date and Time of last successful Calibration
3/15/99 at 11:44 AM
Select to stop calibration
9. Rotate the Navigator Control Knob to select the “Normal Screen” and press to return to
the monitors normal display screen.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 59
Gas Module (optional Passport 2)
3.18
Operation
Gas Module (optional Passport 2)
The Gas Module option allows for the measurement of anesthetic gases, O2, N2O and CO2
levels. Measurement can be acquired via a nasal cannula (non-intubated) for oxygen and
CO2 only, or through a sampling line connected to a breathing circuit (intubated). For a
complete listing of accessories, refer to Chapter 5.0.
NOTE:
The Passport 2 will interface to the Gas Module via the SP1
Connector on the Comm-Port mounted onto the Passport 2.
WARNING: When using the Gas Module, the maximum sampling rate at
the nasal cannula is 200 ml/min. This device should not be
used on patients whose breathing could be impaired by this
vacuum flow rate.
3.18.1
Sequence for Monitoring Anesthetic Gases, O2, N2O and/or CO2
1. Turn on the Gas Module and Passport 2, and configure the Passport 2 Serial Port to
be used with the Gas Module. Set alarms as necessary.
®
7 Foot Nasal Cannula, CO2/O2
P/N 0683-00-0452-10
Pa ssp ort 2
Patient/ADT
Monitor Setup
Alarms
Trend
Th i s i s app ro xi matl y where th e to p l evel i nfo . woul d appear
11 /9/98
1 0:2 8 am
Juan Valdez /Room 1 420 / BED 2
Record
HR
Lead
mm
II
+ 2 .2
S
aVR
-2 .1
D
PVC/mi n: 45 V1
-3 .0
A So urce: Auto ST Pt: 80 /60
RPM
P
R
E
S
P
C
0
2
18
Sou rc e : ECG
Ins p Ex p
1/3
8
mmHg
14 rp m
RR (CO2 )
8
S
P
0
2
T
E
M
P
T1
36 . 7
C
A
G
T
1
In sp
O2
41
Exp
36 %
Des
7 .6
5 .2 %
N 2O
51
54 %
Sp O2
Sy s
N
I
B
P
PR
%
8 1 bpm
Di a
120/ 80
M e an (9 3)
Interval : ON
ET: 1 3mi n
or
7 Foot Nasal Cannula, CO2
P/N 0683-00-0424-10
10 Foot Sample Line, Patient
P/N 0683-00-0451-10
Adapter, Straight Tee ET
P/N 0683-00-0242-22
Gas Scavenging Adapter Assy.
P/N 0997-00-0923
or
P/N 0997-00-0984
Adapter, Mask Elbow ET
P/N 0683-00-0242-12
FIGURE 3-24 Gas Module Airway Adapter
2. 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
packets.
3. Connect the other end of the nasal cannula or sample line to the Gas Module at the
Input Port. Refer to Figure 3-19. Do not connect anything to Reference Port on the rear of
the unit. This port is used to monitor the room air only. Ensure all tubing connections are
tight.
WARNING: Connection of the Gas Module exhaust port to the hospital’s
waste gas scavenge 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.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Gas Module (optional Passport 2)
4. Check for a clean water trap. If cleaning is necessary, consult Section 4.9 for details.
5. Select Gas Module CO2 or AUTO as the Resp. Source in the Resp Menu.
6. Observe the capnogram on the monitor’s display. On Passport 2/Passport 2 LT
powerup, O2, Agent and N2O numbers will display. CO2 numbers will be displayed
when a valid breath is detected.
NOTE:
The Gas Module must be warmed up a minimum of two
minutes for accurate CO2, O2 and N2O readings and five
minutes for agent readings.
7. If not already set, use the Monitor Setup Menu to select the gas waveforms to be
displayed in Waveform area 2, 3 or 4.
8. If desired, the Gas waveform scale and speed can be changed by entering the Gases
menu. See Section 2.3 for “Menus” details.
NOTE:
3.18.2
See “Passport 2 / Gas Module Messages (only observed
when Gas Module is installed)” in Section 3.22.5 for more
details on messages.
Gas Monitor Calibration
Accuracy verification of the Gas Module is recommended at six (6) month intervals or
whenever gas readings appear to be in error. The date of the last successful mixture
calibration appears at the bottom of the “Gas Calibration” menu. During the calibration
session gas readings and all other gas functions are not available. Span calibration is a set
of prompted commands that enables the operator to align the gas display(s) to specific gas
concentration(s) within the Datascope Calibration Gas canister. Span calibration can be
initiated by the operator any time the gas module’s readings are suspected to be inaccurate.
Always verify accuracy using a full canister of Datascope approved precision calibration
gas, after calibration is performed (See Chapter 5.0, Accessories for the Datascope Part
Number). Never use calibration gas that has expired, has a different concentration, or a
canister that is indicating low pressure. The pressure indicator on the Datascope gas
regulator must operate in the green zone during the entire calibration session.
NOTE:
The Gas Module must be fully warmed up before
performing a gas calibration. For maximum accuracy, a
warm-up time of 30 minutes is recommended.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 61
Gas Module (optional Passport 2)
Operation
1. Select Calibrate from the Gas Menu. The menu shown will appear
2. Select the calibration gas type from the choices, and START to begin calibration.
Start
3. At the start of the calibration, the Gas Module will zero the gas channels. After a
successful zeroing, the Gas Module will request the calibration gas.
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0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Gas Module (optional Passport 2)
NOTE:
If the Gas Module cannot zero, a “zeroing error” will be
displayed and the previous calibration data will be
restored. Repeat the calibration procedure from step 1. If
problems persist, call for service.
4. The message “Feed Calibration Gas” will appear. At this point, attach the calibration
gas canister to the regulator and turn it on. Increasing gas values will appear in the
window as the Gas Module samples the calibration gas.
5. When sampling is complete, the “Feed Calibration Gas” message will disappear,
“Adjusting” will appear next to each value and an “Accept” menu item will appear. If
the values are acceptable, select “Accept”. If for any reason, it is desired to cancel
calibration, press Abort to re-install the previous calibration values. The entire
calibration must be accepted as a whole or not at all.
NOTE:
To avoid premature emptying of the gas canister, always
remove the regulator at the end of the procedure.
NOTE:
If any channel cannot be calibrated due to a sampling error,
the “Sampling Error” message will appear. Selecting
“ACCEPT” will calibrate only those channels that do not
have a sampling error. If any channel fails calibration, the
gas value will be “XXX”. These channels will appear as
“XXX” in the normal run mode as well. Repeat procedure
from Step 1. If problems persist, call for service.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 63
Alarms
3.19
Operation
Alarms
FIGURE 3-25 Alarms
The Passport 2/Passport 2 LT provide high and low alarm limits for heart rate (HR),
Systolic, Diastolic, and Mean Pressure (NIBP), respiration rate, SpO2 and temperature. The
Passport 2 monitor also provides alarms for ST level, ventricular arrhythmia, low and high
alarm limits for Systolic, Diastolic and Mean Pressure (IBP1 and IBP2), inspired/expired
CO2, O2 and N2O. Alarms for apnea delay time are available within the Passport 2/
Passport 2 LT.
3.19.1
Setting Parameter Alarm Limits
1. To access the Alarms Limits menu press the ALARMS LIMITS key. The main Alarm
Settings menu displays.
2. Using the Navigator™ Control Knob (as described in 2.3, Menus) set parameter limits as
desired.
FIGURE 3-26 Alarms
NOTE:
3 - 64
Alarms can be set for any active parameter through the
main Alarm limits menu. To set other parameter’s alarms,
enter the Alarms Setup option. Alarm limits can be set
separately for each patient size from the Alarm Limits Menu.
Alarm limits are not saved when the monitor is turned off,
unless you select “Save Current” in the Monitor Setup menu.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Alarms
NOTE:
3.19.2
Alarm limits can be set using the “Auto-Set” function. Alarm
limits can be saved in the Monitor Setup Menu. The “Save
Current” option must be selected in order to save the current
parameters.
Alarm Limits
All of the alarm limits have an “OFF” position with the exception of low SpO2, high inspired
N2O and low inspired O2. A separate table of alarm limit settings is maintained for each
patient size. When the patient size is changed, the appropriate selections are automatically
used. See table below for alarm ranges.
Alarm Parameters
HIGH
LO
PARA
METERS
ADULT
PED
NEONATE
ADULT
PED
NEONATE
Heart Rate
(bpm)
Off,
60-250
Off,
100-300
Off,
100-350
Off,
30-120
Off,
30-150
Off,
30-200
PVC/ min
Off, 1-30
Run**
4 / 4-8
ST Single
Lead (mm)
Off, +0.5 - +10.0 (Elevation)
Off, -0.5 - -10.0 (Depression)
ST Dual
Lead (mm)
Off, +0.5 - +10.0 (Elevation)
Off, -0.5 - -10.0 (Depression)
NIBP Sys
(mmHg)
Off,
70-240
Off,
40-180
Off,
40-180
Off,
50-150
Off,
15-130
Off,
15-130
NIBP Mean
(mmHg)
Off,
60-200
Off,
50-180
Off,
40-160
Off,
40-140
Off,
10-100
Off,
10-70
NIBP Dia
(mmHg)
Off,
40-130
Off,
50-100
Off,
50-100
Off,
30-120
Off,
10-50
Off,
10-50
IBP1/IBP2
Sys (mmHg)
Off,
5-300
Off,
5-240
Off,
5-180
Off,
0-150
Off,
0-130
Off,
0-130
IBP1/IBP2
Mean
(mmHg)
Off,
5 - 150
Off,
5 -100
Off,
5 - 100
Off,
2-100
Off,
2 - 50
Off,
2-50
IBP1/IBP2
Dia (mmHg)
Off,
0-140
Off,
0-100
Off,
0-70
Off,
0-120
Off,
0-100
Off,
0-50
SpO2 (%)
Off,
80-100
Off,
80-100
Off,
80-100
50-99
50-99
50-99
Off,
5-40
Off,
5-50
T1 (°F)
Off, 95-110
Off, 80-100
T1 (°C)
Off, 35-43
Off, 26-38
Resp Rate
(rpm)
Off,
10-100
ET CO2
(mmHg)
Off, 20-80
Off,
15-150
Off,
30-200
Off,
5-30
Off, 5-50
ET CO2 (%)
Off, 2.0-10.0
Off, 1.0-6.0
ET CO2 (kPa)
Off, 2.0-10.0
Off, 1.0-6.0
Insp CO2
(mmHg)
Off, 5-30
**
Passport 2 only with 3-lead or 5-lead.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
3 - 65
Alarms
Operation
Alarm Parameters (Continued)
HIGH
PARA
METERS
ADULT
PED
LO
NEONATE
ADULT
PED
NEONATE
Off,
10-60
Off,
10-60
Off,
10-60
Insp CO2 (%)
Off, 1.0 - 4.0
Insp CO2
(kPa)
Off, 1.0 - 4.0
ET O2
Off,
40-100
Off,
40-100
Off,
40-100
Insp O2
Off,
40-100
Off,
40-100
Off,
40-100
ET N2O
Off,
10-80
Off,
10-80
Off,
10-80
Insp N2O
Apnea Delay
(seconds)
**
10-80
10-60
10-80
10-20
18-60
10-80
18-60
18-60
Off,
5-70
Off,
5-70
Off,
5-70
Off,
5-70
Off,
5-70
Off,
5-70
10-20
Passport 2 only with 3-lead or 5-lead.
Alarm Parameters (Gas Module Only)
PARAMETERS
HIGH SETTINGS
LOW SETTINGS
DEFAULT
Insp. Hal
Off, 2-10
Off, 0.5-5
Off
ET Hal
Off, 2-10
Off, 0.5-5
Off
Insp. Iso
Off, 2-10
Off, 0.5-5
Off
ET Iso
Off, 2-10
Off, 0.5-5
Off
Insp. Enfl
Off, 2-10
Off, 0.5-5
Off
ET Enfl
Off, 2-10
Off, 0.5-5
Off
Insp. Sevo
Off, 2-10
Off, 0.5-5
Off
ET Sevo
Off, 2-10
Off, 0.5-5
Off
Insp. Des
Off, 2-20
Off, 0.5-10
Off
ET Des
Off, 2-20
Off, 0.5-10
Off
All Gas Module alarms are in units of % and increment in units of 0.5.
3.19.3
Auto-Set Alarms
To automatically set alarms, choose “Auto Set” in the Alarms Menu. Auto Set will cause auto
alarm limit functions to be set for active parameters at the time of activation as follows:
• +/- 20% of absolute value for: CO2, Gases, IBP’s and NIBP
•
HR and Resp. Rate: +/- 30%
•
Temp: +/- 3.0%.
Press YES to confirm the Auto-Set in the Confirmation window when it appears.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.19.4
Alarms
Alarm Violations
Alarms are classified by severity: Warnings (Priority 1) and Cautions (Priority 2).
Warnings are HIGH priority and activate a red LED. Cautions are lower priority and activate
a yellow LED on the keypad.
A. Parameter Alarms
An alarm condition exists if the parameter is equal to or is outside the high/low limit range.
When an alarm limit is violated, the following actions occur:
• The red or yellow alarm LED flashes, according to the priority of the alarm.
• An alarm tone is sounded (unless it is muted with the MUTE ALL key), according to
the priority of the alarm.
• The recorder prints the currently selected waveform (if Record On Alarm is selected
from the Recorder menu).
NOTE:
On the waveform printouts that are caused by alarm
situations, a bar is printed above the alarming area. On
trend printouts, the value that has caused an alarm is
printed with square brackets around it. If the recorder is
printing a waveform and an alarm situation occurs, the
currently printing waveform will be aborted and the new
alarm waveform printout will be printed.
The data for the violated parameter is displayed in reverse graphics in the parameter
window.
The display indicates the priority of the alarm as follows:
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.
On monochrome displays:
• Priority 1 alarm data is shown in inverse video with background at full brightness.
• Priority 2 alarm data is shown in inverse video with background at half brightness.
If a parameter is being monitored but data is not being displayed, an alarm message will be
posted at the top of the display.
B. Heart Rate Fault Alarm
The Heart Rate Fault Alarm occurs if the selected heart rate source is no longer able to detect
a heart rate. This may be due to an ECG lead fault, a problem with an SpO2 sensor, or
various other reasons. This alarm is only active if a low heart rate limit is set. The alarm
operation is the same as for a parameter alarm. A further message from a lead fault or SpO2
fault may be present to help diagnose the problem. The heart rate alarm is a Priority 1 alarm.
NOTE:
Only the value displayed in the heart rate window is used
to determine heart rate alarm conditions.
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Alarms
Operation
C. Apnea Alarm
The Apnea Alarm is active when respiration is being monitored. The Apnea alarm is violated
when breathing is not detected for a longer period of time than the apnea delay specified in
the Alarms Menu. When the alarm is silenced by pressing MUTE or MUTE ALL, the alarm
tone will cease to be heard. The mute period, as set in the Alarms Menu, will now begin to
count down. If normal breathing occurs during the selected time frame for “MUTE”, the
Alarms Muted for... message will disappear. Apnea is a Priority 1 alarm.
D. Arrhythmia Alarms (Passport 2 only)
Arrhythmia alarms are defined in section 3.10.
Non-lethal arrhythmia conditions are defined as:
• Bradycardia, Irregular Heart Rate (3/5-Lead ECG only)
• Pause (View 12™ ECG Module only)
• Ventricular Rhythm (V-Rhythm), Couplet, Bigeminy, Trigeminy, PVC’s per minute, and
Run.
Once an alarm condition has been triggered for any of these non-lethal arrhythmias, it can
be silenced by pressing MUTE or MUTE ALL. During the muted period, as established in the
Alarms Menu, if a second non-lethal arrhythmia condition occurs, it will be identified in the
message area of the Passport 2 but will not sound an alarm until the preset, mute period of
time has elapsed. Non-lethal arrhythmia conditions are Priority 2 alarms.
Lethal arrhythmia conditions are defined as Asystole, Ventricular Tachycardia, and
Ventricular Fibrillation. Once V-Tach, V-Fib, or Asystole occurs, the alarm is latched. Even
after the alarming condition is resolved, a latched alarm will continue until it is
acknowledged by pressing the MUTE or MUTE 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 muted for the duration that is selected from the “Mute 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 muted, the new lethal alarm will not break through and will be
muted for the remainder of the mute duration. If the lethal condition is resolved while the
alarm is muted, the alarm will be terminated.
E.
General Alarms
ALARMS OFF ICON
- If both high and low alarms are not set for a parameter, an
alarm off icon, resembling a crossed bell, will be displayed next to the numerical data for
that parameter.
VOLUME KEY - The loudness of the alarm can be adjusted through the Monitor Setup
Menu.
ALARM MUTES - One or more alarms can be muted for a programmable length of time.
The following is a description of how to enable the different mute modes.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Alarms
MUTE
- This key is a single action button, which when pressed, silences the alarm
whose parameters have been violated for a programmed length of time (Default 2 minutes),
or until the alarm condition is no longer present, which ever is shorter. Any new alarms that
occur during the silenced period will disable the silence and the alarm will sound the tone.
An Alarm Mute icon, resembling a crossed speaker, is displayed next to each muted
parameter. A message and digital timer counts down in the upper message area. Pressing
MUTE again does not re-enable audio alarms
MUTE ALL
- This is a single action button, which when pressed, suspends alarms on
all parameters for a programmed period of time. (Default is 2 minutes). An Alarm Mute icon
(resembling a crossed speaker) is displayed next to each parameter. A message and timer
appear in the upper message area showing the time remaining. Pressing MUTE ALL at any
time re-enables audio alarm tones. If MUTE ALL was permanently selected a message is
posted stating All alarms muted permanently.
The time period for MUTE and MUTE ALL is adjustable via the ALARMS SETUP Menu.
3.19.5
Beep Tones
The following chart describes the beep tones of the Passport 2 monitor:
POWER ON
Normal Operation
1 beep
Runtime Stack Failure
2 beeps
DRAM Memory Failure
3 beeps
PCMCIA Boot Checksum Failure
4 beeps
PCMCIA Image Checksum Failure
5 beeps
Flash Checksum Failure
6 beeps
Flash Programming Error
7 beeps
DRAM Checksum Error
8 beeps
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Alarms
Operation
POWER ON
ALARMS
High Priority
3 beeps followed by 2 beeps,
repeated every 5 seconds
Low Priority
3 beeps, repeated every 30 seconds
NORMAL OPERATION
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CO2 Occlusion
2 beeps repeated every 4 seconds
NIBP Unable to Measure
1 beep
Low Battery
2 beeps every minute
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.20
Recorder (Optional)
Recorder (Optional)
The Passport 2/Passport 2 LT Recorder can provide a printed record of all of a patients
monitored parameters. It is a two trace thermal strip chart recorder with an integral paper
spool and uses plain white thermal paper, 5 cm wide. (see Section 4.7 for replacement
instructions).
NOTE:
3.20.1
All grid patterns and data are printed by the recorder.
Print Setup Menu
FIGURE 3-27 Print Setup Menu
3.20.2
Operation of Recorder
1. Select the waveforms to print on the recorder via the Print Setup menu using the
Navigator™ Control Knob.
2. Select the printer destination (local), in the Print Setup menu. The default destination is
LOCAL; the print will be produced by the local printer
3. Press the STRIP key to initiate a printing or stop a printing when one is in progress.
When STRIP is pressed to initiate a printing, a 16 second strip is printed. The 16 second
strip consists of waveforms 8 seconds prior to and 8 seconds after the time STRIP is pressed.
If a continuous printing of ECG1 and ECG2 is required, press the CONT ECG key. (Cont
ECG produces a real-time strip: It does not include 8 seconds of data accumulated prior to
the key press.) Press CONT ECG again to stop printing.
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Recorder (Optional)
Operation
NOTE:
When the waveforms are frozen and STRIP is pressed, the
recorder prints 8 seconds of the frozen displayed
waveforms.
The data and waveforms printed at a remote printer are
determined by the setup of that device.
Press the PRINT TREND key while the List Trend is displayed,
to print a list trend report. See Section 4.7 for “Recorder
Paper Replacement” .
3.20.3
Printer Formats
Single waveform format
FIGURE 3-28 Sample Printout, Single Waveform
The waveform for rule-scaled waveforms (i.e. ECG) will be an exact rendering. However,
non-rule scaled waveforms will be transformed to fit the full excursion of the 40mm waveform
window at the selected scale. The baseline of printed waveforms will follow that of the
displayed waveform
Two waveforms separate field format
FIGURE 3-29 Sample Printout, Two Waveform
The two waveforms are printed in a separate field format with two centimeters assigned to
each waveform. The waveforms do not overlap. Grids are printed as for one waveform.
The upper and lower borders are printed as for the single waveform.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Recorder (Optional)
Trend list Format
FIGURE 3-30 Sample Printout, Trend List Format
The list trend data is printed with text running along the length of the strip. If more than one
page of data is available then all additional pages are printed along the length of the strip.
NOTE:
On waveform printouts that are caused by alarm situations
(Record on Alarm must be selected YES in the Print Set-Up
menu), a bar is printed above the alarming area. On trend
printouts and in annotations, the value that has caused an
alarm is printed with square brackets around it. If the
recorder is printing a waveform and an alarm situation
occurs, the currently printing waveform will be aborted and
then the alarm waveform printout will be printed.
NOTE:
IBP1, IBP2, CO2, and Gas Module data is printed only when
models are equipped with these options.
NOTE:
The print format can be changed via the PRINT SET UP Menu.
Digital parameter data can be placed either in the leader or
the top and bottom of the waveform.
Graph Trend Format: (Passport 2 only)
FIGURE 3-31 Graph Trend Format
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Recorder (Optional)
Operation
OXY CRG Format: (Passport 2 only)
FIGURE 3-32 OXY CRG Format
12 Lead Format: (Passport 2 only)
FIGURE 3-33 12 Lead Format
To print 12 Lead ECG data and analysis on the internal thermal recorder, press the VIEW
key, then press STRIP. The recorder will print the patient’s demographic data vital sign data
(as for a normal waveform printout) followed by a 2 ½ second sample of each of the 12
ECG vector waveforms. The waveform samples represent the 2 ½ seconds prior to pressing
STRIP. These waveforms will be followed by ECG measurement data (Ventricular rate, PR
interval, QRS duration, QT/QTc and P-QRS-T axes). If all conditions have been met for ECG
analysis, the recorder will add this following the ECG measurement data. The analysis will
consist of an interpretive statement, a condition statement, and a rhythm statement as
specified in the Physician’s Guide to Computerized ECG Analysis (Datascope P/N’s 007000-0524-01 English, 0070-00-0524-50 all other languages).
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Recorder (Optional)
The conditions for printing the ECG analysis are:
1. The Passport 2 patient size must be set to Adult.
2. The patient’s gender and date of birth must be entered via the Patient menu.
3. The patient must be at least 18 years old. (The monitor calculates the patient age from
the date of birth entered.
Average ST Complex Format: (Passport 2 Only)
FIGURE 3-34 Average ST Complex Format
To print the Average ST Complex, use the Navigator Control knob to select the Print Setup
menu, then scroll and select Average ST Complex.
NOTE:
This menu selection is only available when ST analysis has
been enabled and the “learning” cycle completed.
The recorder will print the patient’s demographic data, followed by the average ST complex
for each of the 12 ECG vectors, then followed by the current ST data for each of the 12 ECG
vectors.
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Laser Printing 12 Lead ECG (optional - Passport 2 only)
3.21
Operation
Laser Printing 12 Lead ECG
(optional - Passport 2 only)
The Passport 2 may be connected to a laser printer to print 12 Lead ECG data and
interpretation. Please refer to P/N 0070-00-0441-02 for Laser Printer setup instructions and
refer to section 5.1.9 for the approved printer(s).
3.21.1
Printing 12 Lead to the Laser printer
1. To select the destination for your 12 Lead ECG data, go to the Print Setup menu and
ensure “Select Printer” is set to Laser, Laser/Local or Laser/Remote.
2. To print 12 Lead ECG data to the laser printer, the View 12 Lead ECG Analysis Module
must be installed and enabled within the Passport 2.
3. Enter patient's Date of Birth and Gender into the Patient menu to print the 12 Lead
interpretation.
4. Press the VIEW key to display View All ECG mode.
5. Press the STRIP key to print 12 Lead ECG to the destination of choice.
The laser printer will print the patient's demographic data, vital sign data (as for a normal
waveform), and ECG measurement data (Ventricular rate, PR interval, QRS duration, QT/
QTC and P-QRS-T axes) in the upper left portion of the printout. If all conditions are met for
ECG analysis, the 12 Lead interpretation will be printed in the upper right portion of the
printout. Analysis consists of an interpretive statement, a condition statement and a rhythm
statement as specified in the Physician's Guide to Computerized ECG Analysis (Datascope
P/N 0070-00-0524-01).
Below the digital information and interpretation are 2-½ second samples of each of the 12
ECG vector waveforms displayed in standard 12-Lead format. The waveform samples
represent the 2-½ seconds prior to pressing the STRIP key. Beneath the 12 ECG waveform
samples is a 10-second rhythm strip of ECG Lead II.
The conditions for printing the ECG analysis are:
1. The Passport 2 patient size must be set to “Adult.”
2. The patient's Gender and Date of Birth must be entered via the Patient menu.
3. The patient must be at least 18 years old. (The monitor calculates the patient's age from
the Date of Birth entered).
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.21.2
Laser Printing 12 Lead ECG (optional - Passport 2 only)
Laser Printing 12 Lead Format: (Passport 2 only)
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Status Messages
3.22
Operation
Status Messages
The monitor uses the Message Display Area to provide messages to the user relating to
monitor status. The following is a list these messages and a description of the message. The
messages are grouped by function.
3.22.1
NIBP Measurement Messages
MESSAGE
REASON
ACTION
NIBP: Idle
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: Deflate
Displayed when a
measurement that is in process
is stopped by pressing the
STOP key.
Press START to take an
immediate measurement and
resume 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: Failure
The system has detected an
unrecoverable failure of the
NIBP system.
Power cycle unit. If message
reappears, call Service.
NIBP: Measuring
Displayed during a
measurement. Cuff pressure is
also displayed.
Press STOP to suspend a
measurement and deflate the
cuff.
NIBP: Retry Pump Higher
A measurement has been
attempted but no reading was
possible. This results from
inadequate cuff inflation.
Retry will be attempted. Check
that appropriate patient size is
set. Preset initial inflation
pressure.
NIBP: Retry
A measurement has been
attempted but no reading was
possible and the retry limit has
not been reached.
Retry will be attempted. Check
for leaks and quality of
peripheral pulses. Decrease
patient movement. Switch cuff
to another limb.
NIBP: Unable To Measure*
An unsuccessful measurement
cycle has been completed.
Switch cuff to another limb.
Decrease patient movement.
Press START to retry. Be
prepared to auscultate BP
manually.
NIBP: Cuff Overpressure
The hardware overpressure
limit has been exceeded.
Power cycle unit. If message
reappears, call Datascope
Service.
NIBP: Cuff Overpressure/Press
STOP to clear.
The hardware overpressure
limit has been exceeded.
Press STOP to clear the
hardware overpressure. If
message reappears, call
Datascope Service.
NIBP: Check Calibration
The software has detected that
the overpressure transducer is
out of calibration.
Have the unit calibrated. If
problem persists call
Datascope service.
*
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The presence of arrhythmias may increase the time required to complete a measurement and may
extend this time to a point where a measurement cannot be completed.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Status Messages
• Always have an alternate method of BP verification available.
• On vasoconstricted patients, failure to evacuate air from the cuff can distort BP
measurement.
• Do not place cuff on extremity that has an IV.
• Cuff should be at heart level.
3.22.2
SpO2 Messages
The following messages pertain to SpO2 Operation.
MESSAGE
REASON
ACTION
SpO2: No Sensor
Sensor is not plugged in to the
Passport 2.
Plug the sensor into the monitor
SpO2: Sensor Off (Masimo
Only)
Sensor may not be connected
to the patient.
Check patient connection.
SpO2: Interference
Noise detected on the pulse
signal prevents pulse
discrimination.
Decrease patient motion, check
sensor.
SpO2: Pulse Search
Hardware settings are being
adjusted in order to
discriminate a pulse waveform.
Change to site where pulse is
stronger if patient is
vasoconstricted. Change or
readjust sensor if loose.
SpO2: No Pulse (Nellcor Only)
No detectable pulse is
measured.
Check to patient connection
and patient status.
SpO2: Failure
The system has detected an
unrecoverable failure of the
SpO2 system.
Power cycle unit. If message
reappears, call Datascope
Service.
SpO2: Low Perfusion
(Masimo Only)
Patient perfusion is low.
Check to patient connection
and patient status.
SpO2: Too Much Light
(Masimo Only)
There is too much ambient
room light for the sensor to
function properly.
Minimize the room light
around the patient. Check
sensor.
SpO2: Unrecognized Sensor
(Masimo Only)
The sensor is not recognized
by the Monitor.
Replace the sensor with a
Datascope recommended
sensor.
SpO2: Communication Error
The monitor and the SpO2
modules are not
communicating properly.
Power the unit OFF / ON. If
problem persists, contact
Datascope Service.
SpO2: Board Fault
Masimo board failed to
operate properly.
Contact Datascope Customer
Support.
SpO2: Sensor Fault
Defective Sensor.
Replace sensor.
SpO2: Motion (Nellcor Only)
Motion is detected.
Decrease patient motion, check
sensor.
SpO2: Check Sensor (Nellcor
Only)
The SpO2 module has sensed
a poor connection or a bad
sensor.
Reconnect the same sensor. If
problem persists, replace
sensor.
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Status Messages
3.22.3
3.22.4
3.22.5
3 - 80
Operation
Recorder Messages (only units equipped with recorder)
MESSAGE
REASON
ACTION
Local Printer Door Open
The door of the printer is not
closed.
Close the printer door.
Local Printer Out Of
Paper
The roll of printer paper is used
up.
Replace with a new roll of paper.
Printer Busy
Printer received multiple print
requests at one time.
Wait until the printer is not busy.
Local Printer Unable To
Print
The system has detected an
unrecoverable printer failure.
Power cycle unit. If message
reappears, call Datascope
Service.
CO2 Messages (only units equipped with CO2)
MESSAGE
REASON
ACTION
CO2: Filterline
Disconnected
The filterline is not connected to the
monitor.
Connect the filterline.
CO2: Warming
Up
The CO2 sensor has not reached its
operating temperature. (The monitor
was just turned on)
Wait for the message to go away. It
takes typically 30 seconds for the
sensor to warm up.
CO2: Auto-zero In
Progress
The CO2 sensor is performing an
auto-zero.
Wait for the auto-zero to complete.
CO2: Auto-zero
Requested
An Auto-Zero was automatically
requested by the system.
Wait for the auto-zero to complete.
CO2: Failure
CO2 system failure.
Contact Datascope Technical
Support.
CO2: Occlusion
The CO2 hardware is indicating the
sampling pump line is blocked while
the CO2 sidestream pump is on.
Check sampling line and filter for
blockage, clear sampling line if
possible. Replace sampling line if
necessary.
Disconnect and reconnect the filterline
from the Passport 2 in order to
clear this message.
CO2: Purge
The system has detected a blocked
filterline and attempts to unblock it by
temporarily increasing the flow rate.
Check filterline and replace if
necessary.
Passport 2 / Gas Module Messages
(only observed when Gas Module is installed)
MESSAGE
REASON
ACTION
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 two minutes
for the device to warm up.
GM: Agent
Warming Up
This message appears after the GMII:
Warming Up message disappears. It
indicates that the Agent ID Bench is
warming up and readings will not be
available.
Wait for the message to go
away. It takes ups to five
minutes from power-up for the
Agent ID Bench to warm up.
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Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Status Messages
MESSAGE
REASON
ACTION
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,
call Datascope service.
GM: Mixed Agents
Appears in Inverse Video when more
than one anesthetic agent is detected by
the system.
Message will disappear when a
single agent is detected again.
GM: Air Leak
Appears when the system detects a
pneumatic leak. Also may appear when
the Gas Module has been turned on
without a sample line attached or if the
Gas Module has been on for a long
period of time without the Passport 2
Monitor being on.
Turn Gas Module and
Passport 2 Off. Install/check
sample lines, filters, water trap
and electrical connections. Turn
on Gas Module and
Passport 2 Monitor.
GM: Replace Trap
Indicates residue build-up on the water
trap membrane. This decreases air flow.
Replace water trap reservoir.
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. If problem persists,
call Datascope service.
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: 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, call Datascope service.
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 call for service.
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 call for service.
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 call for service.
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, call
for service.
GM: Agent
Mismatch - HAL
Appears when the system detects
Halothane as the primary agent and the
manually selected agent is not
Halothane.
Match the Agent administered
with the Agent selected, or
select Agent Auto ID.
GM: Agent
Mismatch - ISO
Appears when the system detects
Isoflurane as the primary agent and the
manually selected agent is not Isoflurane.
Match the Agent administered
with the Agent selected, or
select Agent Auto ID.
GM: Agent
Mismatch - ENF
Appears when the system detects
Enflurane as the primary agent and the
manually selected agent is not Enflurane.
Match the Agent administered
with the Agent selected, or
select Agent Auto ID.
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Status Messages
3 - 82
Operation
MESSAGE
REASON
ACTION
GM: Agent
Mismatch - SEV
Appears when the system detects
Sevoflurane as the primary agent and the
manually selected agent is not
Sevoflurane.
Match the Agent administered
with the Agent selected, or
select Agent Auto ID.
GM: Agent
Mismatch - DES
Appears when the system detects
Desflurane as the primary agent and the
manually selected agent is not
Desflurane.
Match the Agent administered
with the Agent selected, or
select Agent Auto ID.
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.
GM: Cannot Zero...
RETRYING
Appears when the Passport requests a
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 persists
call for service.
GM: ET CO2 High
Appears when the End Tidal CO2
measurement is greater than or equal to
the value set for the ET CO2 High Alarm.
Check patient.
GM: ET CO2 Low
Appears when the End Tidal CO2
measurement is less than or equal to the
value set for the ET CO2 Low Alarm.
Check patient.
GM: INSP CO2
High
Appears when the FiCO2 measurement is
greater than or equal to the value set for
the INSP CO2 High Alarm.
Check patient.
GM: ET O2 High
Appears when the End Tidal O2
measurement is greater than or equal to
the value set for the ET O2 High Alarm.
Check patient.
GM: ET O2 Low
Appears when the End Tidal O2
measurement is less than or equal to the
value set for the ET O2 Low Alarm.
Check patient.
GM: INSP O2 High
Appears when the FiO2 measurement is
greater than or equal to the value set for
the INSP O2 High Alarm.
Check patient.
GM: INSP O2 Low
Appears when the FiO2 measurement is
less than or equal to the value set for the
INSP O2 Low Alarm.
Check patient.
GM: INSP N2O
High
Appears when the Inspired N2O
measurement is greater than or equal to
the value set for the INSP N2O High
Alarm.
Check patient.
GM: ET Agent High
Appears when the End Tidal Anesthetic
Agent measurement is greater than or
equal to the value set for the ET Agent
High Alarm.
Check patient.
GM: ET Agent Low
Appears when the End Tidal Anesthetic
Agent measurement is less than or equal
to the value set for the ET Agent Low
Alarm.
Check patient.
GM: INSP Agent
High
Appears when the Inspired Agent
measurement is greater than or equal to
the value set for the INSP Agent High
Alarm.
Check patient.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.22.6
Status Messages
MESSAGE
REASON
ACTION
GM: INSP Agent
Low
Appears when the Inspired Agent
measurement is less than or equal to the
value set for the INSP Agent Low Alarm.
Check patient.
GM: CO2
Uncalibrated
Appears after an unsuccessful calibration
attempt of the CO2 sensor. The numeric
data for CO2 will appear as - - -, 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,
call for service.
GM: O2
Uncalibrated
Appears after an unsuccessful calibration
attempt of the O2 sensor. The numeric
data for O2 will appear as - - -, 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,
call for service.
GM: N2O
Uncalibrated
Appears after an unsuccessful calibration
attempt of the N2O sensor. The numeric
data for N2O will appear as - - -, 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,
call for service.
GM: Agents
Uncalibrated
Appears after an unsuccessful calibration
attempt of the Agent sensor. The numeric
data for all agents will appear as - - -,
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,
call for service.
GM: Failed
Appears when the Gas Module detects
an unrecoverable error in its own
operation.
Call for Service.
GM: Disconnected
Appears when the Passport 2 cannot
detect signals being sent by the Gas
Module.
Ensure Gas Module is turned on
and interface cable is properly
connected. If problem persists,
call for service.
Sampling Error
Appears when a sampling error occurs
on one or more Gas Module channels
during calibration.
Repeat calibration procedure. If
problem persists, call for
service.
Calibration Not
Started
Appears when the Gas Module is unable
to initialize calibration.
Repeat calibration procedure. If
problem persists, call for
service.
Calibration Error,
Sampling Error
Appears when a sampling error occurs in
all four Gas Module channels during
calibration.
Repeat calibration procedure. If
problem persists, call for
service.
Calibration Error,
Zeroing Error
Appears when the Gas Module cannot
perform a Zero during calibration.
Repeat calibration procedure. If
problem persists, call for
service.
Cooling Fan Message
MESSAGE
REASON
ACTION
Cooling Fan Failure
Either an over-temperature condition exists
or the unit is running on AC Power and a
fan failure has been deleted.
Call for service.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 83
Monitor Problem Solving
3.23
Operation
Monitor Problem Solving
This guide is provided to establish the possible causes and solutions to some monitoring
problems.
PROBLEM
REASON
ACTION
No trace for a desired
parameter
Improper attachment of
transducer to monitor
Check transducer connection
Faulty transducer
Try a different transducer
Wandering ECG
Respiration artifact
Try a different base line lead
configuration
Noisy ECG traces
Loose or dry electrodes
Apply new electrodes
Defective electrode wires
Replace wires as necessary
Patient cable or leads are routed
too close to other electrical
devices
Eliminate 60Hz interference
Electrode could be positioned
over a bone or muscle mass
Reposition electrodes
Excessive Electro-surgical
Interference
Inadequate skin prep prior to
application of electrode
Repeat skin prep and electrode
placement procedures
Intermittent Signal
Connections not tight and
properly secured
Ensure proper connection
(Electrode to lead, lead to cable,
cable to monitor)
Electrodes dry
Re-prep skin and apply fresh moist
electrodes
Cable or leadwires 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 be twice the amplitude of
other part of waveform
Excessive patient movement or
muscle tremor
Reposition electrodes and secure
with tape if necessary
Gain set too low. (Set through
SIZE key.
Readjust as required
Skin improperly prepared
Abrade skin
Possibly not patient's normal
complex
Check with 12 lead electrocardiogram
Electrode could be positioned
over a bone or muscle mass
Reposition electrodes
Trace Not Moving
FREEZE key may have been
pressed.
Press the FREEZE key to unfreeze
the trace
Temperature Probes not
Working
Poor contact from probes to body
Check the body surface contact at
the probe tip. Reposition or apply
thermoconductive gel.
Low Amplitude ECG
Use ECG cable with built-in filter
block
Press ECG SIZE key
Add additional gel to electrodes
Excessive alarms: heart
rate, lead fault
Low Amplitude ECG
Signal
3 - 84
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
Monitor Problem Solving
PROBLEM
REASON
ACTION
Display Appears to be
Off
Mains power switch may not be
on
Check 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 hours is
required for a full charge of
lithium-ion batteries. A period of
16 hours is required for a full
charge of sealed lead acid
batteries.
Disabled Alarm Tone,
QRS Tone, or Other
Function
MUTE key pressed
Check for alarm mute symbol and
message
Beep volume low
Increase beep volume
ECG Base Line With No
Waveform
Gain control not set high enough.
Set through SIZE key
Readjust as required
Leadwires and patient cable not
fully inserted into proper
receptacle
Check insertion
Cable or leadwires damaged
Check with lead continuity tester
Patient moving excessively
Secure leadwires and cable to
patient
Patient's respiration
Reposition electrodes
Electrodes dry
Re-prep skin and apply fresh moist
electrodes
Static build up around patient
Check with hospital engineer
Base Line Wander
Damped Invasive
Waveform
Air bubbles in tubing
Eliminate air from tubing
Kinked catheter
Slightly alter position of catheter
Catheter against wall of blood
vessel
Check for leaks at connector
Blood in tubing
Pump pressure bag up to 300
mmHg
Recorder 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
Resp. Waveform Too
Large
Scales set inappropriately
Change lead selection
Resp. Waveform Too
Small
Patient breathing shallow or
turned on side
Change lead selection
Scale set inappropriately
False Apnea Alarm
Apnea delay may be improperly
set
Choose another apnea delay
Patient may be having frequent
episodes of CVA
Reposition electrodes to better
detect respirations
Scale size may be too low
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 85
Monitor Problem Solving
Operation
PROBLEM
REASON
ACTION
“CHK Lead” Message
Due to increased impedance
Prep chest
Chest hair under electrodes
Dried electrode gel
3 - 86
Change electrodes
Electrode off
Replace electrode
Lead off
Replace lead
Cracked leadwires
Replace leadwires
Poor skin prep
Clean and abrade skin before
applying electrodes
“CVA” Message
Can be caused by shallow
breathing or an apnea event
Check the patient adjust scales or
leads if necessary
No Resp. Waveform or
Rate Displayed
Patient not connected to a patient
safety cable
Turn respiration on (OFF will be
displayed in Resp. window).
Check that proper patient cable is
used
Patient connected using Patient
ESIS Choke/Cable
Use 3-lead Patient Cable - non
ESIS. (See Accessories, Section
5.1.)
“BAD CARD” Message
The option card is not the correct
version or the card data has
become corrupt.
Obtain replacement card
“Artifact” Message
The 12 Lead ECG is detecting
muscle artifact, or electrical
interference from auxiliary
devices.
Check leads, follow skin
preparation procedure (see 3.5.2)
0070-10-0649-01
Check for electrical interferences,
replace wires as necessary
Passport 2®/Passport 2 LT™ Operating Instructions
Operation
3.24
Connection to Visa or PatientNet Central Stations
Connection to Visa or PatientNet Central Stations
The Passport 2 can be connected to the VISA or PatientNet Central Stations via direct
hardwire or telemetry connection with the COMM Port. Access the “Installation Menu” (See
section 3.2.1) and set a serial port to “Visa with admit” in order to enable the VISA Interface
or “PatientNet” to enable PatientNet.
The interface allows the Passport 2 waveforms and data to be displayed at the VISA or
PatientNet Central Stations. The interface also enables the Passport 2 to admit to,
discharge from, and print at the VISA or PatientNet Central Stations.
NOTE:
See the VISA Operating Instructions for more details on VISA
operation.
NOTE:
See the PatientNet Operating Instructions for more details
on PatientNet Operation.
NOTE:
See the Administrative Guide for the PatientNet Central
Station for more details on PatientNet Operation.
Passport 2®/Passport 2 LT™ Operating Instructions
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3 - 87
Connection to Panorama™ Central Station
3.25
Operation
Connection to Panorama™ Central Station
The Passport 2 will communicate with the Panorama Central Station via direct hardwire to
an appropriate Comm-Port or via a wireless network. The “Enable Network” option in the
System Information menu must be set to “Wired” when using a hardwire Passport 2.
“Enable Network” must be set to “Wireless” for communication between the Passport 2
and the Panorama via the 2.4 GHz wireless Symbol radio card. “WMTS Enabled” must be
set to “Yes” to allow for communication between the Passport 2 and the Panorama via the
Panorama Instrument Radio - 608.
Refer to the Panorama Operating Instructions Manual for a list of supported parameters.
The Passport 2 is capable of transmitting a discharge command to a Panorama Central
Station. It is also capable of bi-directional transmission of patient demographics and patient
alarm settings with a Panorama Central Station.
When the Panorama Central is selected for operation, the Patient Discharge menu selections
will vary as follows:
• For Main Module Software Versions Y.xx and earlier, “Discharge From Central” and
“Discharge From Both” will be displayed.
• For Main Module Software Versions AA.xx and later, “Discharge From Both” will be
displayed.
When “Discharge From Central” or “Discharge From Both” are selected from the Patient
Discharge menu, the Panorama will discharge the patient.
If Trend is cleared or the patient is discharged at the Passport 2, the Passport time and date
will be synchronized with the Panorama Central Station time and date.
NOTE:
3 - 88
If a Passport 2 608 radio is communicating with a
Panorama Central Station, Gas Module data and alarms, V2
- V6 waveform data and ST templates are not displayed at
the Central Station.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Connection to Panorama™ Gateway
Operation
3.26
Connection to Panorama™ Gateway
The Passport 2 can communicate with an EMR system through a Panorama Gateway via a
hardwired network connection to a Comm-Port with a CS1 port or via wireless connection
through a Panorama Central Monitoring System. The “Enable Network” option in the
Passport 2 System Information menu must be set to “Wired” when using a hardwire
Passport 2. “Enable Network” must be set to “Wireless” to allow for wireless
communication through a Panorama Central Station via the 2.4 GHz wireless Symbol radio
card. “WMTS Enabled” must be set to “Yes” to allow for wireless communication through a
Panorama Central Station via the Panorama Instrument Radio - 608.
For the Passport 2 to be recognized by the EMR system, certain demographics content,
referred to as the “Patient Key”, must be entered from its Patient Menu. Each facility has its
own unique “Patient Key” that must be entered before making a connection to the EMR. The
“Patient Key” consists of the required ID # and, optionally, one or more of the following
Patient Menu demographics fields:
• First name
• Last name
• Bed #
Once the “Patient Key” has been entered, communication with the EMR system must be
verified. Since the Panorama Gateway can be purchased with ADT messaging only, Results
messaging only or ADT messaging with Results messaging, this verification differs as follows:
ADT messaging
For a Panorama Gateway that has ADT messaging, verify that communication with the EMR
system has been established as follows:
• After entering the “Patient Key” in the Patient Menu, select Normal Screen to close the
menu.
• If demographics information corresponding to the following fields was not part of the
“Patient Key” but is entered into the EMR system, these fields in the Patient Menu should
auto-populate upon re-opening the menu:
• First name
• Last name
• Date of Birth
• Gender
• Bed #
• In addition, the First Name and Last Name should populate in the upper right of the
display.
• If the fields do not auto-populate, verify that the “Patient Key” has been correctly entered
and that the patient demographics have been entered in the EMR system. If the fields still
do not auto-populate, contact the EMR administrator.
Results messaging
For facilities with a Panorama Gateway that has Results messaging, verify that
communication with the EMR system has been established by checking the charting system to
ensure that vital signs data has been uploaded. If the charting system is not displaying the
information, contact the EMR administrator.
Passport 2®/Passport 2 LT™ Operating Instructions
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Connection to Panorama™ Gateway
Operation
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3 - 90
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
4.0
User Maintenance
4.1
Introduction
This section of the manual outlines routine maintenance that should be performed by the user.
The Passport 2/Passport 2 LT Monitor is designed for stable operation over long
periods of time and under normal circumstances should not require technical maintenance
beyond that described in this section. However, it is recommended that routine maintenance
calibration and safety checks be performed at least once a year or more often as required by
local statutory or hospital administration practice.
4.2
Care and Cleaning of Monitor
The monitor enclosure may be cleaned with a mild soap and water solution or ammoniated
window cleaner. Apply cleaning solution to the cloth, not directly onto the monitor. DO NOT
apply large amounts of liquid. DO NOT use abrasive cleaning agents or organic solvents.
WARNING: Do not clean the monitor while it is on and/or plugged in.
To prevent scratches on the front panel display screens, blow or carefully brush dust and dirt
particles with a soft sponge moistened with cleaner solution; or a fine, soft-hair brush. DO
NOT use abrasive cleaning materials. Fingerprints and stains may be removed by using a
liquid lens cleaner and a soft cloth. DO NOT wipe a dry screen or use alcohol or chlorinated
hydrocarbon solvents.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
4-1
Decontamination of Monitor
4.3
User Maintenance
Decontamination of Monitor
WARNING: Perform the decontamination process with the unit powered
down and power cord removed.
Decontamination of a unit that has come in contact with a biological material can be
performed using LpH SE Germicidal detergent. Apply a small amount of detergent to a
disposable wipe (paper based) and wipe down the outside of the unit. Discard the wipe
appropriately. After waiting 10 minutes, use a clean dry wipe to dry the unit.
CAUTION:
4.4
During the decontamination process, do not get the LpH SE
Germicidal detergent into any vent openings.
Care and Cleaning of SpO2 Sensors
NOTE:
Refer to the individual instruction sheets that are packaged
with each sensor.
• Daily, check the sensors and cables for signs of damage. Replace as required.
• The sensors should be cleaned before and after each patient’s use.
• 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 on all
accessible surfaces.
• Let the sensor completely dry before using.
CAUTION:
4.5
When cleaning SpO2 sensors, do not use excessive amounts
of liquid. Wipe the sensor surface with a soft cloth,
dampened with the cleaning solution.
Sterilization and Cleaning of 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 effecting 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
Datascope 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.
4-2
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
User Maintenance
Battery Replacement and Maintenance
4.6
Battery Replacement and Maintenance
4.6.1
Battery Replacement
1. Open battery compartment door, on left side of unit, by pressing the finger grip area
and sliding the door to the left.
2. Press the release button, located on the right side of the installed battery. This will eject
the battery. Slide out old 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:
4.6.2
Replace sealed lead acid batteries with Datascope P/N
0146-00-0043 ONLY. Replace lithium-ion batteries with
Datascope P/N 0146-00-0069 ONLY.
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.
CAUTION:
Recharge batteries in the Passport 2/Passport 2 LT.
CAUTION:
Remove the batteries if the Passport 2/Passport 2 LT is not
likely to be used for an extended period of time.
Sealed Lead Acid
Due to the self-discharge characteristics of sealed lead acid batteries, it is imperative that
they are charged after 3 months of storage (or unit not in use). If not, permanent loss of
capacity may occur as a result of sulfation. Charge retention at 20oC is 6 months to 83%.
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%.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
4-3
Recorder Paper Replacement
4.7
User Maintenance
Recorder Paper Replacement
The instructions below describe the replacement of recorder paper. Use only recommended
recorder paper, P/N 0683-00-0422-XX. This ensures that the print quality is acceptable and
reduces print head wear.
1. Open recorder door by pressing the paper eject button.
NOTE:
If the recorder door does not open completely, carefully pull
it until it is completely open.
2. Remove empty paper spool by pulling it out gently.
3. Insert new paper roll between the two rounded tabs of the paper holder with the
sensitive (shiny) side of the paper facing the print head at the top of the recorder (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 metal bar.
6. Holding the paper in place, close recorder 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.
4.8
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 may be 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 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.
4-4
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
User Maintenance
4.9
Care and Cleaning of Gas Module
Care and Cleaning of Gas Module
1. The Gas Module enclosure may be cleaned with a mild soap and water solution or
ammoniated window cleaner. Apply cleaning solution to the cloth, not directly onto the
Gas Module. DO NOT apply large amounts of liquid. DO NOT use abrasive cleaning
agents or organic solvents.
CAUTION:
Do not clean the Gas Module while it is on and/or plugged
in.
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.
2. The fan dust filter should be checked and cleaned on a regular basis, at least once every
two months.
• Locate fan on front panel. Remove the filter by pulling the dust filter cover. Remove the
dust from the filter.
• Let the filter soak in a mild detergent solution.
• Rinse the filter and let dry completely before re-installing.
CAUTION:
If the dust filter for the Gas Module fan cannot be cleaned or
is damaged, replace it with the replacement dust filter P/N
0378-00-0040. Use of another type of filter may decrease
the cooling effectivity and cause damage to the Gas Module.
3. The Water Trap Reservoir must be checked and emptied whenever changing patients or
if it is more than half full.
• To remove the water trap, push the water trap latch to the right. The water trap is
spring loaded and will pop out. An “Air Leak” message will be displayed. The monitor
will suspend sampling.
• Detach the reservoir from the water trap assembly by pulling it down carefully.
• Empty the reservoir and rinse with water only.
• Re-attach the reservoir to the assembly tightly.
• Re-install the whole unit into the Gas Module making sure the latch is set. Check that
the “Air Leak” message disappears and monitoring resumes.
NOTE:
Do not disinfect or open the water trap. Do not If an
“occlusion” message appears it may be necessary to
replace the water trap assembly P/N 0202-00-0129.
4. The Water Trap Assembly must be replaced every two months.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
4-5
Care and Cleaning of 3 Lead and 5 Lead ECG Cables and Leadwires
4.10
User Maintenance
Care and Cleaning of 3 Lead and 5 Lead ECG Cables
and Leadwires
Recommended cleaning method of ECG cables and leadwires 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 leadwires should be wiped with water using a clean damp cloth then dried with a clean
dry cloth.
4.11
CAUTION:
To avoid permanent damage, do not expose metal
components (pins, sockets, snaps) to disinfectants, soaps or
chemicals.
NOTE:
ECG cables and leadwires 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
leadwires.
NOTE:
Extended exposure to Ethylene Oxide gas may shorten life
of the ECG cables and leadwires, leading to poor signal
quality.
Care and Cleaning of View 12™ ECG Cables
and Leadwires
Clean cables and leadwires using a cloth wipe and warm water. Use a dry, clean cloth to
dry leadwires and cables before placing them on a patient. Do not use alcohol to clean the
View 12™ ECG Analysis Module. Alcohol or other harsh chemicals will cause the cables and
leadwires to become brittle or harden, causing damage.
NOTE:
The View 12™ ECG Analysis Module must never be
immersed or soaked in any fluids.
If the M-12 cable or PC card require maintenance or service, please contact the Datascope
Service department at 1-800-288-2121.
4-6
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
5.0
Accessories
5.1
Optional Accessories
5.1.1
NIBP Accessories
Hoses/Adapters
DESCRIPTION
PART NUMBER
NIBP Hose, 60” (1.5 m), Female Rectus to Female Rectus
0683-04-0003
NIBP Hose, 138” (3.5 m), Female Rectus to Female Rectus
0683-04-0004
NIBP Hose, Neonate 60” (1.5 m), Female Luer to Female Rectus
(for use with disposable neonate cuffs)
0683-04-0005
Color Coded Reusable Cuffs (with Quick-Connect fittings)
DESCRIPTION
PART NUMBER
Variety Kit I, 6 cuffs [(1) Small Child, (1) Child, (1) Small Adult, (1) Adult,
(1) Large Adult, (1) Adult Thigh]
0020-00-0082-31
Variety Kit II, 6 cuffs [(1) Small Adult, (2) Adult, (2) Large Adult,
(1) Adult Thigh]
0020-00-0082-33
Variety Kit III, 6 cuffs [(1) Small Child, (2) Child, (3) Small Adult]
0020-00-0082-32
Adult Thigh, Brown (45 - 56.5 cm circumference)
0998-00-0003-56
Large Adult Long, Burgundy (35.5 - 46 cm arm circumference)
0998-00-0003-58
Large Adult, Burgundy (35.5 - 46 cm arm circumference)
0998-00-0003-55
Adult Long, Navy Blue (27.5 - 36.5 cm arm circumference)
0998-00-0003-57
Adult, Navy Blue (27.5 - 36.5 cm arm circumference)
0998-00-0003-54
Small Adult, Light Blue (20.5 - 28.5 cm arm circumference)
0998-00-0003-53
Child, Green (13.8 - 21.5 cm arm circumference)
0998-00-0003-52
Small Child, Orange (9 - 14.8 cm arm circumference)
0998-00-0003-51
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
5-1
Optional Accessories
Accessories
Disposable Cuffs (with Quick-Connect fittings)
DESCRIPTION
PART NUMBER
Adult Thigh, White/Brown (5/box) (45 - 56.5 cm circumference)
0683-07-0036-01
Large Adult Long, White/Burgundy (10/box)
(35.5 - 46 cm arm circumference)
0683-07-0038-01
Large Adult, White/Burgundy (10/box)
(35.5 - 46 cm arm circumference)
0683-07-0035-01
Adult Long, White/Navy Blue (10/box)
(27.5 - 36.5 cm arm circumference)
0683-07-0037-01
Adult, White/Navy Blue (10/box)
(27.5 - 36.5 cm arm circumference)
0683-07-0034-01
Small Adult, White/Light Blue (10/box)
(20.5 - 28.5 cm arm circumference)
0683-07-0033-01
Child, White/Green (10/box)
(13.8 - 21.5 cm arm circumference)
0683-07-0032-01
Small Child, White/Orange (10/box)
(9 - 14.8 cm arm circumference)
0683-07-0031-01
Disposable Neonatal Cuffs (with Luer fittings)* (Clear/Blue)
DESCRIPTION
APPROXIMATE LIMB CIRCUMFERENCE:
BOX OF 10
BOX OF 50
Neo Size 1: 3 – 6 cm
0683-03-0005-01
0683-03-0005-02
Neo Size 2: 5 – 8 cm
0683-03-0004-01
0683-03-0004-02
Neo Size 3: 7 – 10 cm
0683-03-0001-01
0683-03-0001-02
Neo Size 4: 9 – 13 cm
0683-03-0002-01
0683-03-0002-02
Neo Size 5: 12 – 17 cm
0683-03-0003-01
0683-03-0003-02
*
5-2
PART NUMBER
Cuffs have Male Luer Connectors. Adapter 0004-00-0060-02 or Hose P/N 0683-04-0005 is required.
5.1.2
Oximetry Sensors and Accessories
5.1.2.1
Pulse Oximetry-Masimo SET® LNOP® SpO2
DESCRIPTION
PART NUMBER
LNOP® DCI Adult/Pediatric starter kit (one reusable adult
sensor, 2 adult and 1 pediatric single patient adhesive
sensors and one 12’ cable)
0020-00-0130
LNOP® DCI-Adult reusable finger sensor (with added “flaps”
for ambient light shielding and 3’ cable)
0600-00-0047
LNOP® DC-12 Adult direct connect reusable finger sensor
with attached 12' cable
0600-00-0120
LNOP® DCIP-Pediatric/slender digit reusable finger sensor
0600-00-0063
LNOP® TCI Tip Clip Ear Sensor
0600-00-0110
Ear Clip
0600-00-0086
Ear Hanger (pkg of 5)
0600-00-0087
LNOP® YI-Multisite reusable sensor
0600-00-0078
Multisite wrap (box of 100)
0600-00-0081
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Accessories
Optional Accessories
DESCRIPTION
PART NUMBER
Multisite wrap, foam (pkg of 12)
0600-00-0083
®
5.1.2.2
LNOP DCSC-Adult spot check reusable sensor
0600-00-0077
PC08-SpO2 cable (2.44 m./8’)
0012-00-1099-01
PC12-SpO2 cable (3.66 m./12’)
0012-00-1099-02
LNOP® Adt-Adult single patient adhesive sensors for patients
more than 30 kgs. (pkg of 20)
0600-00-0043-01
LNOP® Pdt-Pediatric/slender digit single patient sensors for
patients more than 10 kgs. and less than 50 kgs. (pkg of 20)
0600-00-0044-01
LNOP® II Inf-L-Infant L single patient adhesive sensors for
patients more than 3 kgs. and less than 10 kgs. (pkg of 20)
0600-00-0100
Tape, Infant, L-Series (Package of 100)
0600-00-0108
LNOP®
Neo-Neonatal Y single patient adhesive sensors for
patients more than 1 kg. and less than 10 kgs. (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 for
patients more than 1 kg. and less than 10 kgs. (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-for patients less 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
sensors-for patients less than 1 kg. (pkg 20)
0600-00-0098
Posey wraps for Preterm neonatal L single patient adhesive
sensors (pkg of 12)
0600-00-0097
Adult/Pediatric starter kit (two adult and two pediatric single
patient adhesive sensors and one 3.66 m./12’ cable)
0020-00-0123-01
Neonatal Y 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 (12 cards/12 squares per card)
0600-00-0085
Pulse Oximetry-Masimo Set® LNCS® SpO2
DESCRIPTION
PART NUMBER
LNCS DC-I Adult finger reusable sensor
0600-00-0126
LNCS DC-IP Pediatric finger reusable sensor
0600-00-0127
LNCS ADTX Adult single patient adhesive sensors (20/Box)
0600-00-0121
LNCS PDTX Pediatric single patient adhesive sensors
(20/Box)
0600-00-0122
LNCS INF-L Infant single patient adhesive sensors (20/Box)
0600-00-0123
LNCS NEO-L Neonatal single patient adhesive sensors
(20/Box)
0600-00-0124
LNCS NEO PT-L Neonatal preterm patient adhesive sensors
(20/Box)
0600-00-0125
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
5-3
Optional Accessories
5.1.2.3
Accessories
DESCRIPTION
PART NUMBER
LNC-4 SpO2 Patient cable, 4'
0012-00-1652
LNC-10 SpO2 Patient cable, 10'
0012-00-1599
LNC-14 SpO2 Patient cable, 14'
0012-00-1653
LNCS to LNOP PC series adapter
0012-00-1651
Masimo SET AC-1 LNCS adapter cable
0012-00-1656
Kit, Masimo, LNCS Reusable/Disposable,
Adult/Pediatric Sensors
0020-00-0154
Kit, Masimo, LNCS Disposable, Neonatal Sensors
0020-00-0155
Kit, Masimo, LNCS Disposable, Adult/Pediatric Sensors
0020-00-0156
Pulse Oximetry-Nellcor® OxiMax® SpO2*
DESCRIPTION
PART NUMBER
Reusable sensor
0600-00-0051
SpO2 cable, DOC-10, OxiMax
0012-00-1464
Disposable OxiMax Sensor Kit (2 adult/2 neonatal)
0600-00-0103
*
5.1.3
Oximetry-Nellcor® OxiMax® SpO2 Replacement sensors are available from Nellcor-Puritan Bennett.
Phone: 1 800 NELLCOR or WWW.NELLCOR.COM
Oridion CO2 Accessories
DESCRIPTION
PART NUMBER
Filterline Set (short term), Adult/Pediatric (box of 25)
0683-00-0470-25
Filterline Set, High Humidity, Infant/Neonatal (box of 25)
0683-00-0490-25
Filterline Set, High Humidity, Adult/Pediatric (box of 25)
0683-00-0469-25
Smart CapnoLine™ Nasal/Oral Cannula, Pediatric (box of 25)
0683-00-0495-25
Smart CapnoLine™ O2/CO2 Oral Nasal Cannula Adult (box of 25)
0683-00-0496-25
Smart CapnoLine™ O2, Nasal/Oral Cannula, Pediatric (box of 25)
0683-00-0498-25
Smart CapnoLine Plus™ O2/CO2 Oral Nasal Cannula with O2 tubing,
Adult/Intermediate (box of 25)
0683-00-0516-25
Smart CapnoLine Plus™ O2/CO2 Oral Nasal Cannula with O2 connector,
Adult/Intermediate (box of 25)
0683-00-0517-25
NIV Line™, Adult (box of 25)
0683-00-0506-25
NIV Line™, Pediatric (box of 25)
0683-00-0507-25
CapnoLine™ H, Adult (box of 25)
0683-00-0508-25
CapnoLine™ H, Pediatric (box of 25)
0683-00-0509-25
CapnoLine
™
H, Infant/Neonatal (box of 25)
CapnoLine™ H O2, Adult (box of 25)
™
CapnoLine
5-4
H O2, Pediatric (box of 25)
0683-00-0510-25
0683-00-0511-25
0683-00-0512-25
Calibration Gas
0075-00-0033-01
CO2 Exhaust Connector, Male
0008-00-0332-01
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Accessories
5.1.4
5.1.5
Optional Accessories
Gas Module Accessories
DESCRIPTION
PART NUMBER
Calibration Gas
0075-00-0028
Calibration Gas Regulator
0119-00-0166
Gas Module Rolling Stand Kit
0040-00-0232-01
Gas Module Wall Mount Kit
0040-00-0232-02
Y-Power Cord, North America, 120V
0012-00-1081-01
Dust Filter
0378-00-0040
Nasal Cannula, CO2, 7’ (box of 10)
0683-00-0424-10
Nasal Cannula, CO2/O2, 7’ (box of 10)
0683-00-0452-10
Adapter, Straight Tee ET (box of 12)
0683-00-0242-22
Adapter, Mask Elbow ET (box of 12)
0683-00-0242-12
Sample Line, Patient, 10’ (box of 10)
0683-00-0451-10
Water Trap Assembly (box of 10)
0202-00-0129
Gas Scavenging Adapter Assembly, Quick Connect
0997-00-0923
Gas Scavenging Adapter Assembly, Luer
0997-00-0984
Passport 2/Gas Module Mounting Kit
0040-00-0287-03
Reusable Temperature Probes
YSI 400
DESCRIPTION
PART NUMBER
Adult Rectal / Esophageal
0206-02-0001
Pediatric Rectal / Esophageal
0206-02-0002
Skin Surface
0206-02-0003
YSI 700
DESCRIPTION
5.1.6
PART NUMBER
Adult Rectal / Esophageal
0206-00-0701
Pediatric Rectal / Esophageal
0206-00-0702
Skin Surface
0206-00-0709
Disposable Temperature Probes
400 Series Probes (boxes of 20)
DESCRIPTION
PART NUMBER
Esophageal Stethoscope, 12 Fr, ES 400-12
0206-03-0112-02
Esophageal Stethoscope, 18 Fr, ES 400-18
0206-03-0118-02
Esophageal/Rectal, 9 Fr, ER 400-9
0206-03-0209-02
Esophageal/Rectal, 12 Fr, ER 400-12
0206-03-0212-02
Skin, SK 400
0206-03-0300-02
Instrument Cable, 400 Series
0012-00-0975
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
5-5
Optional Accessories
Accessories
5.1.7
ECG Accessories
5.1.7.1
ECG Cables
3/5 Lead ECG Cables
DESCRIPTION
PART NUMBER
10’ Straight
0012-00-1255-01
20’ Straight
0012-00-1255-02
10’ Right Angle
0012-00-1255-03
20’ Right Angle
0012-00-1255-04
10’ Straight, ESIS
0012-00-1255-05
20’ Straight, ESIS
0012-00-1255-06
10’ Right Angle, ESIS
0012-00-1255-07
20’ Right Angle, ESIS
0012-00-1255-08
10’ Neonate Cable, AAMI
0012-00-1265-01
Panorama Mobility Cable (ESIS and Non ESIS)
5.1.7.2
DESCRIPTION
PART NUMBER
Non-ESIS, 10’ (3.1 m), AAMI
0012-00-1502-01
Non-ESIS, 20’ (6.1 m), AAMI
0012-00-1502-02
ESIS, 10’ (3.1 m), AAMI
0012-00-1502-03
ESIS, 20’ (6.1 m), AAMI
0012-00-1502-04
ECG Leadwires
ECG Leadwires - 3 Lead
DESCRIPTION
PART NUMBER
3 Lead, Snap 18" (45.7 cm), AAMI
0012-00-1261-07
3 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1261-08
3 Lead, Snap 40" (101.6 cm), AAMI
0012-00-1261-09
3 Lead, Pinch Clip 18" (45.7 cm), AAMI
0012-00-1262-07
3 Lead, Pinch Clip 24" (61.0 cm), AAMI
0012-00-1262-08
3 Lead, Pinch Clip 40" (101.6 cm), AAMI
0012-00-1262-09
ECG Leadwires - 5 Lead
5-6
DESCRIPTION
PART NUMBER
5 Lead, Snap 18" (45.7 cm), AAMI
0012-00-1261-01
5 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1261-02
5 Lead, Snap 40" (101.6 cm), AAMI
0012-00-1261-03
Snap, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), AAMI
0012-00-1261-13
5 Lead, Pinch Clip 18" (45.7 cm), AAMI
0012-00-1262-01
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Accessories
Optional Accessories
ECG Leadwires - 5 Lead (Continued)
DESCRIPTION
PART NUMBER
5 Lead, Pinch Clip 24" (61.0 cm), AAMI
0012-00-1262-02
5 Lead, Pinch Clip 40" (101.6 cm), AAMI
0012-00-1262-03
Pinch, Extended Leg, 3/40" (3/101.6 cm), 2/60" (2/152.4 cm), AAMI
0012-00-1262-13
ECG Leadwires - 12 Lead
DESCRIPTION
PART NUMBER
12 Lead, AAMI
0012-00-1411-02
12 Long Lead, AAMI, 63”
0012-00-1588
Panorama Mobility Lead Wires
5.1.7.3
5.1.7.4
5.1.8
DESCRIPTION
PART NUMBERS
5 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1503-02
3 Lead, Snap 24" (61.0 cm), AAMI
0012-00-1503-05
12 Lead ECG Accessories
DESCRIPTION
PART NUMBER
View 12 Kit for version 8.2 & higher Panorama/Passport 2 Customers and
standalone Passport 2 Customers
VIEW12DOMP2SP
View 12 Kit for version 8.1.6 Panorama Hardwire/
Passport 2 Customers
VIEW12DOM8.1.6P2
Electrodes
DESCRIPTION
PART NUMBER
Neo Pre-wired (3 Lead Combiner Clip) 18", AAMI,
box of 100 Pks of 3 Ea: Radio Opaque Set
0681-00-0098-01
Neo Pre-wired (3 Lead Combiner Clip) 18", AAMI,
box of 100 Pks of 3 Ea: Radio Translucent Set
0681-00-0098-02
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel conductive
adhesive, 1 case of 600/10 boxes of 60
0681-00-0100-01
Disposable pre-gelled ECG Electrodes, foam base and Hydrogel conductive
adhesive, 1 case of 60
0681-00-0100-02
IBP Accessories
IBP
DESCRIPTION
PART NUMBER
P10EZ Miniature (Reusable)
0682-00-0085
P23XL-1 Transducer (Reusable)
0682-00-0084
Cable, Interface, Transducer
0012-00-1245
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
5-7
Optional Accessories
5.1.9
Accessories
Comm-Port Accessories
Comm-Port
DESCRIPTION
FUNCTION
PART NUMBER
Comm-Port 2
CS1, MB1, RD1
0998-00-0178-03
Comm-Port 3
RD1, NC1, SP1
0998-00-0178-05
Comm-Port 4
CS1, MB1, SP1
0998-00-0178-04
Comm-Port 5
SP1, NC1, SP2
0998-00-0178-06
CS = Ethernet Port, MB = Module Bus, SP = Serial Port, RD = Remote Display, NC = Nurse Call
Nurse Call (NC1)
DESCRIPTION
PART NUMBER
Unterminated Cable, 9’
0012-00-1277-02
Serial Port (SP1)
DESCRIPTION
PART NUMBER
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
Cable, Interface, PC, Serial Port to Serial Port
0012-00-1275-01
Cable, Serial Port to VISA, 10’ (3.05 m)
0012-00-1299-01
Ethernet (CS1)
5-8
DESCRIPTION
PART NUMBER
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, Patch, STP, 1’ (0.30 m)
0012-00-1274-04
CAT 5 Ethernet Cable, Patch, STP, 2’ (0.61 m)
0012-00-1274-05
CAT 5 Ethernet Cable, Patch, STP, 3’ (0.91 m)
0012-00-1274-06
CAT 5 Ethernet Cable, Patch, STP, 10’ (3.05 m)
0012-00-1274-07
Laser Printer, Laserjet 4200N
0992-00-0091-04
Paper, Laser Printer, View 12
0683-00-0503
ECS, HUB, 12 Port
0992-00-0085-01
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
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Accessories
5.1.10
Optional Accessories
Base Station Accessories
DESCRIPTION
5.1.11
5.1.12
5.1.13
PART NUMBERS
Base Station kit with 110V line cord
BASESTATION110
Base Station 110V line cord
0012-25-0001
Base Station power supply
0014-00-0070
Base Station mounting kit
0386-00-0259
Base Station Operator's manual multilanguage
0073-00-1292
Miscellaneous Accessories
DESCRIPTION
PART NUMBER
Recorder Chart Paper (10 Rolls)
0683-00-0422-02
Battery, Lithium-Ion
0146-00-0069
Battery, Sealed Lead Acid
0146-00-0043
AC Power Cord, 120V
0012-25-0001
Cable Assy, DPD Defibrillator, 8” (20.32 cm)
0012-00-1301-01
Cable Assy, DPD Defibrillator, 10’ (3.05 m)
0012-00-1301-02
Cable Assy, Analog Output (ECG only), 15’ (4.57 m)
CABLEANALOGOUT
Transfer Card
0996-00-0051-01
Extended Trend Card
0996-00-0052-01
Abbreviated Operator’s Manual
0070-00-0493
12 Lead ECG Physician’s Reference Guide, English Version
0070-00-0524-01
Mounting Kits and Accessories
DESCRIPTION
PART NUMBER
Rolling Stand with mounting bracket
TRANSLBRKT
Rolling Stand with quick release plate
TRANSQRMTG
Wall Mount Kit
0040-00-0287-02
VHM Wall Mount
0040-00-0287-04
Bedrail Mount Kit
0040-00-0293
Quick Release Mounting Plate Kit
0040-00-0299-01
Stationary Mounting Bracket Kit
0040-00-0299-02
Gas Module Mounting Kit
0040-00-0287-03
12 Lead ECG Mounting Kit
0040-00-0311-01
Upgrade Kits
DESCRIPTION
PART NUMBER
CO2 Upgrade Kit with Masimo SpO2
®
0040-00-0353-01
®
CO2 Upgrade Kit with Nellcor Oxismart SpO2
0040-00-0353-02
CO2 Upgrade Kit with Nellcor® OxiMax® SpO2, Nell-3
0040-00-0353-03
IBP Upgrade Kit (Add IBP1 and IBP2)
0040-00-0268-01
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
5-9
Optional Accessories
5.1.14
5 - 10
Accessories
DESCRIPTION
PART NUMBER
AR42 Recorder Upgrade Kit (serial number tailcode - F3 or lower)
0040-00-0267-01
Xena Recorder Upgrade Kit (serial number tailcode - G3 or higher)
0040-00-0267-02
ST Software Option Enable Kit - 1 License
0040-00-0300-01
ST Software Option Enable Kit - 5 Licenses
0040-00-0300-02
ST Software Option Enable Kit - 10 Licenses
0040-00-0300-03
Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-11
Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-12
Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-13
ST & Arrhythmia Software Option Enable Kit - 1 License
0040-00-0300-21
ST & Arrhythmia Software Option Enable Kit - 5 Licenses
0040-00-0300-22
ST & Arrhythmia Software Option Enable Kit - 10 Licenses
0040-00-0300-23
Central Station Accessories
DESCRIPTION
PART NUMBER
Transmitter Mounting Kit
0040-00-0296
Kit, Telemetry, 2.4 GHz
0040-00-0327-XX
Kit, Mounting, Transmitter, DT-7000, PatientNet
0020-00-0458-01
Kit, Instrument Radio, Panorama, 608 MHz
0040-00-0361-01
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
6.0
Appendix
6.1
Safety Designations
6.1.1
Safety designations per IEC 601-1 Standard
Type of protection against electrical shock:
Class 1 and Internal Electric Power Source.
Where the integrity of the external protective
earth in the installation or its conductor
arrangement is in doubt, equipment shall be
operated from its internal electric power
source.
Degree of protection against electric shock:
ECG and IBP, Type CF defibrillation
protected. NIBP, Type BF defibrillation
protected. SpO2, CO2, and Temperature,
Type BF
Supply Connection:
100V - 240VAC
50 or 60 Hz.
1.2 - 0.7 A
12 VDC Sealed Lead Acid Internal Battery
or
11.1 VDC Lithium-Ion Internal Battery
Mode of Operation:
Continuous
Protection Against Hazards of Explosion:
Not Protected (Ordinary)
Protection Against Ingress of Liquids:
Not Protected (Ordinary)
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6-1
Safety Designations
6-2
Appendix
Degree of Electrical Connection between
Equipment designed for direct electrical and
Equipment and Patient:
non-electrical connection to the patient
Degree of Mobility:
Transportable, Intra-Hospital
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Performance Specifications
6.2
Performance Specifications
6.2.1
ECG
The 3/5 Lead ECG function is in accordance with the requirements of EN 60601-2-27.
The 12 Lead ECG function is in accordance with the requirements of EN 60601-2-25.
6.2.1.1
ECG Performance Requirements
Leads
Three Lead Displayable Leads:
I, II, III
Five Lead Displayable Leads:
I, II, III, aVR, aVL, aVF, V (n)
Twelve Lead Displayable Leads:
I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6
3 Lead and 5 Lead Connector Types:
Standard AAMI six pin or HP cable
compatible.
12 Lead Connector Type:
Type II PCMCIA card with integrated
processor electronics and cable assembly.
3 Lead or 5 Lead Cable Detection:
Automatic detection of three wire or five wire,
with Datascope auto-detecting cables.
12 Lead Card Enabling:
12 Lead processing and analysis will be
enabled and disabled through button
toggling, located in the Function menu.
Defibrillator Overload Protection:
No damage from 360 Joule discharge. Meets
all requirements of IEC 60601-2-27,51.101.1
AC Overload Protection:
Withstands 60 Hz, 1V p-p for 10 seconds
(ANSI/AAMI EC13-1992,3.2.2.1 or ANSI/
AAMI EC 11-1991, 3.2.14.1)
Recovery:
Recovers from defibrillator overload or lead
fault to within 1mV, referred to input, in < 8
seconds automatically. (< 5 seconds 12 Lead
ECG). Recovers from a 1 V p-p 60 Hz
overload within 3 seconds.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6-3
Performance Specifications
Appendix
ESU Protection:
3 Lead and 5 Lead ECG shall meets standard
IEC 601-2-25, clause 36.202.7 for
functionality following ESU energy exposure.
The 12 Lead ECG function provides no ESU
protection.
Electro Surgical Unit
Noise Suppression: Peak noise is less than ±
2mV from ECG baseline when used with
AAMI compatible cables. Noise level is
unspecified when the monitor is used with HP
cables. The 12 Lead ECG function provides
no ESU protection or noise suppression.
ESU Withstand:
3 Lead and 5 Lead ECG shall withstand ESU
stress from a High Frequency Surgical Units
operating at 300 Watts in cut mode and 100
Watts on coagulate mode. The 12 Lead ECG
function provides no ESU protection.
Input Bias Current:
< 100 nA per lead, excluding driven lead
(ANSI/AAMI EC13-1992, 3.2.5 or ANSI/
AAMI EC 11-1991 3.2.10).
Input Signal Range:
± 5.0 mV, minimum
DC Offset:
± 300 mV minimum (ANSI/AAMI EC131992, 3.2.9.1 or ANSI/AAMI EC 11-1991,
3.2.3).
Input Impedance:
> 2.5 MΩ single ended at 10Hz per ANSI/
AAMI EC13-1992, 3.2.9.2 or ANSI/AAMI
EC11-1991, 3.2.9.
Noise:
Less than 30 µV p-p, referred to input, through
shielded 51KΩ resistors in parallel with 47nF
capacitors (ANSI/AAMI EC13-1992, 3.2.9.3
or ANSI/AAMI EC 11-1991, 3.2.12.1).
Overall System Error:
5% or 40uV, whichever is greater (ANSI/
AAMI EC-13-1992, 3.2.9.8 or ANSI/AAMI
EC 11-1991, 3.2.7.1)
Gain Stability:
Per ANSI/AAMI EC13-1992, 3.2.9.5 (d) or
ANSI/AAMI EC 11-1991, 3.2.4.4.
6-4
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Performance Specifications
Multichannel Crosstalk:
Maximum of 2%, per ANSI/AAMI EC131992, 3.2.12.2 or ANSI/AAMI EEC) 111991, 3.2.12.2.
3 Lead and 5 Lead Drift Rate:
10 µV/s maximum, referred to input, with all
leads shorted through 25KΩ resistors. Total
drift shall be less than 500 µV over a 1 hour
period per ANSI/AAMI EC 13-1992,
3.2.9.11.
12 Lead Drift Rate:
10 µV/s maximum, referred to input with all
leads shorted through 25KΩ resistors. Total
drift shall be less than 500 µV over a 2 minute
period per ANSI/AAMI EC 11-1991,
3.2.13.2.
Frequency & Impulse Response 3 Lead and 5 Lead configuration
AAMI:
0.5 to 40 Hz (-3dB) in the Monitor mode,
0.05 to 100 Hz in the extended mode and
0.05 to 40 Hz in the ST Mode. Meets the
Extended low frequency response and impulse
response requirements (with the ESU filter
disabled) of ANSI/AAMI EC13-1992,
3.2.9.8 (c).
HP:
0.55 to 35 Hz (-3dB) in the Monitor mode,
0.005 to 90 Hz in the extended mode and
0.005 to 35 Hz in the ST Mode. Meets the
Extended band width and impulse response
requirements (with the ESU filter disabled) of
ANSI/AAMI EC13-1992, 3.2.9.8 (c).
Frequency & Impulse Response 12 Lead
Meets the frequency response and impulse
configuration:
response requirements of ANSI/AAMI EC111991, 3.2.7.2, A and D (0.67 to 40 Hz
sinusoidal and -10% for 20 msec triangle).
Notch Filter Selections:
Passport 2®/Passport 2 LT™ Operating Instructions
Off, 50 Hz, or 60 Hz.
0070-10-0649-01
6-5
Performance Specifications
Appendix
CMRR:
90 dB min., Maximum, output of 1mV p-p
(RTI) over a 60 second period at 50/60 Hz,
with a parallel combination 51KΩ and
0.047uF imbalance and ± 300 mV DC offset
per AAMI EC13-1992 3.2.9.10 or ANSI/
AAMI EC 11-1991,3.2.11.
Lead resistance ≤ 51KΩ in parallel with
Lead Fault:
0.047µF shall not cause a lead fault
condition. Also, a ± 300 mV offset shall not
cause a lead fault condition.
Pacer Enhancement:
Pacer signals with amplitudes within the range
± 2mV and ± 700 mV (RTI) amplitude with a
maximum rise time of 100usec and with
duration in the 0.1ms to 2.0ms range shall be
enhanced when the Pacer Mode is turned
ON.
ESIS Filtering:
Greater than 90 dB attenuation at 500 kHz.
(3 Lead and 5 Lead ECG configuration):
ESU Noise Detection:
An ESU noise declaration will be asserted if
signals detected as pacers are detected at a
rate greater than 50 Hz. No noise declaration
will be asserted if pacer-like signals are
detected at a rate less than 10 Hz. Applies to
3 Lead and 5 Lead ECG configurations only.
6.2.2
Analog Output Specifications
6.2.2.1
3 Lead and 5 Lead ECG
Propagation Delay (Delay of QRS complex): 25 ms maximum.
Sensitivity (referenced to 10Hz:
1 V/mV of input, ± 10%.
Pacer Enhancement:
Pacer is summed at the output when pacer
enhance mode is turned ON. Pacer Amplitude
signal is a minimum of 2.5V Pacer width is 10
ms, with a 5% tolerance. Pacer rise and fall
times are 100 ms, maximum.
6-6
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Appendix
6.2.2.2
Performance Specifications
Arterial Blood Pressure
(Only in monitors with serial number prefix “TS” and software versions AC.X and higher.)
6.2.2.3
Bandwidth (-3 dB referenced to 10 Hz):
DC to 15 Hz minimum.
Propagation Delay:
25 ms, maximum.
Sensitivity:
1 V/100 mmHg, ± 10%.
Sync Pulse for Cardioversion
Propagation Delay:
35 ms maximum, between QRS peak and the
rising edge of the Sync Pulse.
Amplitude:
2 V min.
Width:
7 ms (3 Lead and 5 Lead ECG) 11 ms
(12 Lead ECG)
Source:
The Sync Pulse is derived from the active ECG
source.
6.2.3
CAUTION:
The Analog Output on the Passport 2/Passport 2 LT
supports triggering the Intra-Aortic Balloon Pump (IABP) for
3 Lead and 5 Lead ECG cable monitoring only. Invasive
Blood Pressure triggering is not supported. ECG analog
output is disabled when 12 Lead ECG analysis is enabled.
CAUTION:
To assure successful triggering of a Datascope Intra-Aortic
balloon pump from the Passport 2/Passport 2 LT monitor,
set the “ECG Filter” to “Extended” and set “Pacer
Enhancement” to “On”. Both of these settings are located in
the ECG setup menu of the Passport 2/Passport 2 LT.
Systole Detector and Heart Rate Meter
The heart rate (HR) meter data source is automatically selected from the available monitored
parameters. The selection priority is: (1) ECG; (2) IBP1; (3) IBP2; (4) SpO2; (5) NIBP
6.2.3.1
ECG Derived Heart Rate Meter Performance Requirements
Range:
30 to 300 bpm Adult / Pediatric
30 to 350 bpm Neonatal
(3-Lead or 5-Lead ECG)
30 to 300 bpm Neonatal (12-Lead ECG)
Resolution:
Passport 2®/Passport 2 LT™ Operating Instructions
1 bpm.
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Performance Specifications
Appendix
Accuracy:
± 3 bpm or ± 3% at 30 to 250 bpm,
whichever is greater.
± 5% 251 to 350 bpm.
Alarm Response Time:
< 10 seconds for 60 bpm low limit alarm to
sound when stepping from heart rate of 80 to
0 bpm and 80 to 40 bpm (ANSI/AAMI
EC13-1992, 3.2.8.4 and 5).
< 10 seconds for 100 bpm high limit alarm to
sound when stepping from a heart rate of 80
to 120 bpm (ANSI/AAMI EC13-1992,
3.2.8.6).
Trigger Threshold:
Does not trigger on signals less than 0.15 mV
in amplitude or less than 10m seconds wide
(ANSI/AAMI EC13-1992, 3.2.6.1) in ADULT
mode.
Detectable QRS Width:
70 to 120 ms, minimum, for Adults.
40 to 120 ms, minimum, for Pediatric and
Neonate patients (ANSI/AAMI EC13-1992,
3.2.6.1)
60 Hz Voltage Tolerance:
Tolerates 60 Hz sinusoidal voltage less than
or equal to 0.1 mV p-p RTI per ANSI/AAMI
EC13-1992, 3.2.6.2.
Drift Tolerance:
Tolerates triangular wave of 0.1 Hz, 4 mV p-p
RTI superimposed on the ECG per ANSI/
AAMI EC13-1992, 3.2.6.3.
Tall T-Wave Rejection:
Rejects T-waves less than 120% of 1mV QRS,
and Q-T interval of 350 ms per AAMI EC131992, 3.1.2.1 (c).
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Appendix
Performance Specifications
Pacemaker Pulse Rejection:
Rejects pulses of amplitude ± 2.0 mV to ± 700
mV and duration 0.1 ms to 2 ms with no tail
(ANSI/AAMI EC13-1992, 3.1.4.1).
3/5 Lead ECG:
Rejects all pacer pulses ± 2.0 mV to ± 700
mV and duration 0.1 ms to 2 ms with 4 ms
time constant tail of less than 2.0 mV.
12 Lead ECG:
Does not reject pacer pulses with tails
(overshoot/undershoot).
Trigger Indication:
Audible beep on every beat captured.
Heart Rate Averaging:
3/5/12 Lead ECG: The average heart rate is
calculated as follows:
Mean R to R interval in the last 16 R to R
intervals (HR > 48 bpm).
Mean R to R interval in the last 4 R to R
intervals (HR ≤ 48 bpm).
6.2.3.2
IBP Derived Heart Rate Meter Performance
Refer to Section 6.2.8.4
6.2.3.3
SpO2 Derived Heart Rate Meter Performance
Refer to Section 6.2.11.2 and 6.2.11.4
6.2.3.4
NIBP Derived Heart Rate Meter
Refer to Section 6.2.6.2
6.2.4
S-T Segment Analysis
6.2.4.1
S-T Segment Analysis Performance Requirements
Enabling:
Available in ADULT and PEDIATRIC modes
only.
ST Deviation Range:
9.9 mm to + 9.9mm
(3-Lead and 5-Lead ECG)
(-990µV to + 990µV RTI)
Resolution:
0.1 mm (10 µV)
Default ST Measurement Point:
80 ms after J point for heart rates ≤ 120 bpm.
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Performance Specifications
Appendix
Enabling:
Available in ADULT and PEDIATRIC modes
only.
60 ms after the J point for heart rates > 120
bpm.
User Selectable ST Measurement Points:
40, 60 and 80 ms after J point (heart rate
independent) or 60/80 Heart Rate
Dependent.
Default ISO Point:
Is located between the P and Q waves. Is user
adjustable from “R peak” - 10 ms to “R peak”
- 200 ms in increments of 12 ms.
Default J Point:
The end of the QRS complex. Is user
adjustable from “R peak” + 10 ms to “R peak”
+ 200 ms in increments of 12 ms.
Excluded beats:
Ectopic beats and paced beats are excluded
from ST measurement.
Invalid ST:
During 3 Lead and 5 Lead ECG modes ST
data is invalidated when paced rhythm,
Ventricular Rhythm, or Ventricular
Tachycardia persists for more than 45
seconds, and/or during detected episodes of
Asystole and Ventricular Fibrillation.
During 12 Lead ECG mode ST data shall be
invalidated when the paced rhythm or
Ventricular Rhythm persists for more than 30
seconds, and/or during detected episodes of
Asystole, Ventricular Fibrillation and
Ventricular Tachycardia.
6.2.5
Arrhythmia Analysis
• Arrhythmia analysis can be enabled in Adult and Pediatric modes.
• Arrhythmia analysis identifies ventricular arrhythmias only.
• The following arrhythmia calls are made during 3 Lead and 5 Lead mode:
Asystole, Irregular Heart Rate, Couplet, Bigeminy, Trigeminy, Ventricular Tachycardia,
Ventricular Fibrillation, Ventricular Rhythm, PVCs per minute, Run, Bradycardia.
• The following Arrhythmia calls are made during 12 Lead ECG mode:
Asystole, Pause, Couplets, Runs, Bigeminy, Trigeminy, Ventricular Tachycardia,
Ventricular Fibrillation, PVCs per minute, Ventricular Rhythm.
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Appendix
Performance Specifications
• Optionally, non-lethal or all arrhythmia alarms are capable of being disabled.
• In 3 Lead and 5 Lead ECG modes: PVCs per minute are invalidated and the PVC counter
is reset to 0 during periods of Ventricular Rhythm, Ventricular Tachycardia, Ventricular
Fibrillation or Asystole.
• In 12 Lead ECG mode: PVCs per minute are invalidated and the PVC counter is reset to 0
during periods of Ventricular Rhythm, Ventricular Tachycardia, and Ventricular
Fibrillation. During periods of Asystole, the PVC counter is reset to 0.
6.2.5.1
12-Lead ECG Interpretation
The Passport 2, equipped with optional 12-Lead ECG, has the ability to make
Interpretation, Rhythm and Condition statements in accordance with the Physician’s Guide to
Computerized ECG Analysis (Datascope P/N 0070-00-0524-01 English, 0070-00-0524-50
all other languages).
• Interpretive statements are disabled in neonatal and pediatric modes.
• Interpretive statements are disabled in adult mode for ages less than 18 years old.
6.2.6
NIBP Sub-System Performance Characteristics
This function calculates the patient blood pressure non-invasively, using a blood pressure
cuff. There are three pressure readings available: systolic, diastolic, and mean pressures.
Systolic Pressure Measurements
Accuracy1,2:
Mean error is less than ± 5 mmHg
Standard Deviation shall be less than ± 8
mmHg.
Range:
55 to 235 mmHg in Adult mode
55 to 160 mmHg in Pediatric mode.
45 to 120 mmHg in Neonatal mode.
Diastolic Pressure Measurements
Accuracy1,2:
Mean error is less than ± 5 mmHg,
Standard deviation is less than ± 8 mmHg.
Range:
30 to 200 mmHg in Adult mode
30 to 150 mmHg in Pediatric mode.
20 to 100 mmHg in Neonatal mode.
1Adult
and Pediatric - Blood pressure measurements determined with this device 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.
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Performance Specifications
2
Appendix
Neonate - Blood pressure measurements determined with this device are equivalent to those
obtained by an intraarterial blood pressure measurement device, within the limits prescribed
by the American National Standard, Electronic or automated sphygmomanometers.
NOTE:
6.2.6.1
Mean Arterial Pressure (MAP) is defined as:
Mean Pressure 1 = Mean Pressure determined from the
oscillometric profile
Mean Pressure 2 = (2*diastolic + systolic) /
3 Mean Pressure Displayed = (Mean Pressure 1 + Mean
Pressure 2) / 2
Pressure Measurement System
Connector:
Rectus pneumatic fitting.
Range:
0-300 mmHg.
Static Accuracy:
± 3 mmHg or 2% whichever is greater in the
range of 20 to 275 mmHg.
6.2.6.2
Pulse Rate
Pulse Rate Range:
35-245 bpm, for Adults/Ped
70– 245 bpm, for Neonate.
6.2.6.3
Pulse Rate Resolution:
1 bpm
Pulse Rate Accuracy:
± 3 bpm or ± 3%, whichever is greater.
Maximum Cuff Pressure
Software Over Pressure Limits:
Adult: ≤300 mmHg
Pediatric: ≤200 mmHg
Neonate: ≤150 mmHg
Hardware Over Pressure Limits:
Adult: ≤330 mmHg
Pediatric: ≤220 mmHg
Neonate: ≤65 mmHg
6.2.6.4
Cuff Inflation
The inflation source is capable of supplying sufficient air to bring a volume of 500 cc’s to a
pressure of 300 mmHg in no more than 35 seconds (reference 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.
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Appendix
6.2.6.5
Performance Specifications
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).
6.2.6.6
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).
6.2.7
6.2.7.1
NIBP Sub-System Functional Requirements
Initial Conditions
The NIBP System performs a zero calibration adjustment at power-up.
6.2.7.2
NIBP Starting Pressure Settings and Ranges
Range of Adjustment:
Adult Patients, 100-280 mmHg
Pediatric Patients, 60-180 mmHg
Neonatal Patients, 40-120 mmHg
Default Start Pressure:
Adult Patients, 180 mmHg.
Pediatric Patients, 140 mmHg.
Neonatal Patients, 100 mmHg.
Pressure Increment:
6.2.7.3
5 mmHg, regardless of patient size.
NIBP Measurement Cycle
There are two different modes of measurement operation: manual and interval modes. The
manual mode requires the operator to initiate the measurement cycle. The interval mode
follows a configured plan of automatically initiated measurement cycles.
The Maximum Measurement Cycle Duration shall be 180 sec for Adult and Pediatric patients
(reference EN601-2-30, 1995).
The Maximum Measurement Cycle Duration shall be 90 sec for Neonatal patients (reference
EN601-2-30, 1995).
During a measurement, if the initial cuff inflation pressure is found to be inadequate, the unit
shall retry with a higher inflation pressure (+50 ±10 mmHg in Adult and Pediatric modes and
+40 ±10 mmHg in Neonatal mode).
In interval mode only, the unit shall adjust the inflation pressure according to the previous
systolic pressure. After the first successful measurement is made, the subsequent inflation
pressure becomes +50 ±10 mmHg in the Adult and Pediatric modes and +40 ±10 mmHg in
Neonatal mode.
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Performance Specifications
6.2.8
Appendix
IBP Parameter Sub-System Performance Characteristics
The IBP function is in accordance with the requirements of EN 60601-2-34.
6.2.8.1
IBP Performance Requirements
Accuracy:
± 2 mmHg or 2% which ever is greater
(excluding transducer error).
6.2.8.2
IBP Connector Type
AAMI standard six pin.
Configurations of the patient monitor which include IBP have two (2) identical IBP connectors.
Either or both may be used at a given time.
6.2.8.3
IBP Transducer Performance
Excitation:
5 Volts DC, ± 2% Minimum load resistance
shall be 300 ohms per transducer.
Transfer Function:
Compatible with 5uV/mmHg/Volt excitation
nominal transducers.
Zero Offset Range:
± 120 mmHg
Zero Accuracy:
± 1 mmHg
Linear Input Range:
-30 to +300 mmHg, after zeroing.
Noise:
< 0.5 mmHg RTI, DC to 15 Hz, 300 W
source impedance
6.2.8.4
Drift:
< 0.15 mmHg / °C.
Frequency Response:
DC to 16 Hz ± 1 Hz, -3db
IBP Heart Rate Meter
Range:
30 to 300 bpm Adult / Pediatric 30 to 350
bpm Neonatal
6 - 14
Resolution:
1 bpm
Accuracy:
± 3 bpm or ± 3% at 30 to 250 bpm
Trigger Threshold:
18mm ± 9mmHg
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Appendix
Performance Specifications
Step Change Response Time:
less then 10 sec, 80 to 120 bpm Adult/
Pediatric/Neonatal
less then 11 sec, 80 to 40 bpm Adult/
Pediatric/Neonatal
6.2.9
Temperature Parameter Performance Characteristics
6.2.9.1
Connector Type
The temperature parameter sensor cable connects with a 3 circuit 0.25 inch phonejack as a
standard feature.
YSI 400:
Tip:
Thermistor
Ring:
Short to Sleeve
Sleeve:
Common/Ground
YSI 700:
6.2.9.2
Tip:
Thermistor 1
Ring:
Thermistor 2
Sleeve:
Common/Ground
Temperature Performance Requirements
Scale:
Selectable °C or °F
Range:
15°C to 45°C, 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
Inclusive Accuracy, 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)
Inclusive Accuracy, 700 Series Probes:
± 0.2°C (25°C - 42°C), ± 0.4°F (77°F 108°F)
Probe Excitation - 400 Series
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< 200 µA, Tip to Sleeve
6 - 15
Performance Specifications
Appendix
Scale:
Selectable °C or °F
Probe Excitation - 700 Series
< 200 µA, Tip to Sleeve and < 30 µA
maximum, Ring to Sleeve
6.2.10
Respiration
6.2.10.1
ECG Respiration Performance Requirements
Leads:
Primary lead shall be II. User selectable to
lead I.
Source:
When 12 Lead ECG is enabled, the
Passport 2 is capable of acquiring
respiration while using a 3 Lead or 5 Lead
ECG cable.
Range:
4 to 199 breaths per minute
Accuracy:
± 2% or ± 2 breaths per minute, whichever is
greater from 4 to 150.
± 4%, from 151 to 199.
Excitation:
≤ 550 µA RMS max.
Bandwidth:
0.1 Hz to 3 Hz (-3 dB) for Adults.
0.2 Hz to 3 Hz (-3 dB) for Pediatric and
Neonatal patients
Baseline Impedance Range:
200Ω to 2000Ω at patient with 1k resistor in
the ECG cable.
High Impedance Indication:
>2.2 kΩ at patient
Resp Scale:
1, 2, 3, 4, or 5 with standard ECG cable.
Linear Signal Range:
8W p-p minimum.
Noise:
< 0.05Ω at 500Ω patient impedance, using a
standard ECG cable.
Min. Breath Height Detected:
Is a function of respiration scale. Waveform
needs to be greater than 0.1Ω in order for
breathes to be accurately detected.
Cardiovascular Artifact Rejection:
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Will be detected by algorithm.
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
6.2.10.2
Performance Specifications
CO2 Respiration Performance Requirements
MediCO2 Microstream® (Only in monitors with serial numbers
below TS10000.)
Respiration Rate Range:
0 - 150 RPM.
Respiration Rate Accuracy:
± 1 RPM from 0 to 40 RPM
± 2 RPM from 41 to 70 RPM
± 3 RPM from 71 to 100 RPM
± 5 RPM from 101 to 150 RPM
MiniMediCO2 Microstream® (Only in monitors with serial number
TS10000 and higher.)
Respiration Rate Range:
0 - 150 RPM.
Respiration Rate Accuracy:
± 1 RPM from 0 to 70 RPM
± 2 RPM from 71 to 120 RPM
± 3 RPM from 121 to 150 RPM
6.2.11
SpO2
• SpO2 is a non-invasive measurement of the functional oxygen saturation.
• The SPO2 function is in accordance with the requirements of EN 865.
6.2.11.1
Masimo® SpO2 Performance Requirements
Sensor Compatibility:
Masimo:
LNOP® Series.
Connector Type:
14-lead “Mini D-Ribbon” Receptacle (Masimo
PC-12).
Measurement Technique:
Masimo Sensors:
Masimo proprietary algorithm (SET).
SpO2 Accuracy Saturation during No Motion Conditions1:
Adults / Pediatrics:
70% to 100% ± 25, 0 to 69% unspecified.
Neonates:
70% to 100% ± 3, 0% to 69% unspecified.
SpO2 Accuracy Saturation during Motion Conditions6:
Adults / Pediatrics2:
Passport 2®/Passport 2 LT™ Operating Instructions
70% to 100% ± 3, 0 to 69% unspecified.
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Performance Specifications
Appendix
Sensor Compatibility:
Neonates3:
70% to 100% ± 3, 0% to 69% unspecified.
SpO2 Response Time:
18 seconds to 95% of final step change of %
SpO2 value from 60 to 95% at 75bpm.
NOTE:
This time was measured with post average time set at 8
seconds.
Low Perfusion Performance4:
>0.02% Pulse Amplitude and % Transmission
>5%.
Saturation (%SpO2) ± 2 digits, Pulse ± 3
digits.
Wavelengths Emitted:
660 nm and 905 nm.
Maximum Emitted Energy:
30 mW at 50 mA pulsed.
Interfering Substances:
Carboxyhemoglobin may erroneously
increase readings. The level of increase is
approximately equal to the amount of
carboxyhemoglobin present. Dyes, or any
substance containing dyes, that change usual
arterial pigmentation may cause erroneous
readings.
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6.2.11.2
Performance Specifications
Masimo® Pulse Rate Performance
Pulse Rate During No Motion Conditions4:
Adult/Pediatric/Neonates:
30 to 235 bpm ± 3 digits
Pulse Rate During Motion Conditions 2,3:
Adult/Pediatric/Neonates:
30 to 235 bpm ± 5 digits
Update Rate:
Every 2 seconds
1
The Masimo MS-3 pulse oximeter with LNOP®•Adt 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% 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.
2The
Masimo 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.
3The
Masimo MS-3 pulse oximeter with LNOP®•Neo and LNOP®•NeoPt sensors has been
validated for motion accuracy in human blood studies on neonates while moving the
neonates 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.
4The
Masimo 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 than 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 one
standard deviation encompasses 68% of the population.
5
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 1/2 digits, the accuracy
shall be rounded to ± 4 digits.
6The
SpO2 accuracy during motion conditions is not specified for the LNOP•Ear Sensors.
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Performance Specifications
6.2.11.3
Appendix
Nellcor SpO2 Performance Requirements
Complies with the following Nellcor specifications:
046095 Rev. C. (MP304 OEM product specification)
068107 Rev. D/1 (NELL-3 OEM product specification)
Sensor Compatibility:
Nellcor types: D-25/D-25L, R-15, N-25, I-20,
D-20, RS-10, OxiCliq A, OxiCliq N, OxiCliq P,
OxiCliq I, Oxiband A/N, Oxiband P/I,
DS-100A, DY-S, Max-Fast
Measurement Technique:
Saturation Accuracy
SpO2 Response Time:
6.2.11.4
6 - 20
Nellcor proprietary algorithm.
Patient Size
Range
Adult 70% to 100%,
± 2 digits
Adult Below 70%,
unspecified
Neonate 70% to 100%,
± 3 digits
Neonate Below 70%,
unspecified
5 to 7 seconds averaging
Nellcor SpO2 Pulse Rate Performance Requirements
Pulse Rate Range:
20 to 249 bpm
Pulse Rate Accuracy:
± 3 bpm
Update Rate:
Every 2 seconds
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Appendix
6.2.12
Performance Specifications
CO2
The Passport 2 is capable of providing CO2 measurements from either an Oridion
MediCO2 capnography module, or an Oridion MiniMediCO2 capnography module.
The CO2 performance is in accordance with the requirements of EN 864 (MediCO2) or ISO
21647:2004 (MiniMediCO2).
6.2.12.1
MediCO2 Microstream® (Only in monitors with serial numbers
below TS10000.)
Range*:
0 - 99 mmHg
Accuracy:
The accuracy specification of the measured
CO2 partial pressure is according to the
following table:
TIME
CO2 CONCENTRATION*
0 - 20 min.
20 min. and up
*
**
ACCURACY**
0 - 38mmHg
± 4 mmHg
39 - 99 mmHg
± 12% Reading
0 - 38 mmHg
± 2 mmHg
39 - 99 mmHg
± 5% Reading + 0.08% for every 1
mmHg above 40 mmHg
At sea level (760 mmHg)
Accuracy applies for respiration rates of up to 80 RPM. For respiration rates above 80 RPM, accuracy
complies with EN864 / ISO9918 (4 mmHg or • 12% of reading whichever is greater) for EtCO2 values
exceeding 19 mmHg. To achieve the specified accuracies for respiration rates above 60 RPM an endotracheal tube adapter with low dead-space must be added in neonatal mode.
The accuracy specification is maintained to within 4% for the following gas mixtures (all
values are in Vol. %)
CO2
N2
O2
N2O
H2 0
ANESTHETIC
AGENTS
0 to 13
0 to 97.5
0 to 100
0 to 80
Dry to
Saturated
According to
EN864
Above 80% O2, 1mmHg has to be added to the upper tolerance of the accuracy
specifications.
Sampling Rate:
50 ml/minute, ± 7.5 ml/min.
Auto Zero:
≤ 15 seconds Auto Zero occurs as required
during warm up. Auto zero also occurs if the
temperature changes by more than 80C or the
pressure changes by more than 5mmHg from
the last zero.
Readings are calculated at BTPS:
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
CO2 = 0.97 x CO2 (STPD).
6 - 21
Performance Specifications
Appendix
≤ 190 msec. to display 10 to 90% step
Rise Time:
change with a 5% CO2 balance air test gas at
10 liters per minute flow through an airway
adapter
≤ 190 m sec. to display 90 to 10% step
Fall Time
change with a 5% CO2 balance air test gas at
a 10 liters per minute flow through an airway
adapter.
Delay Time:
6.2.12.2
< 3 Seconds.
MiniMediCO2 Microstream® (Only in monitors with serial number
TS10000 and higher.)
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 EN 864 and 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.
Flow Rate:
50 ml/min -7.5 + 15 ml/min, flow measured by volume.
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
6 - 22
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Performance Specifications
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
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.
6.2.13
Physical Characteristics
Maximum Size:
11.9”W x 9.5”H x 7.4”D
Maximum Weight:
11.4 lbs without batteries
15.0 lbs with 2 Sealed Lead Acid batteries
13.0 lbs with 2 Lithium-Ion batteries
6.2.14
Printer
The printer is a two trace maximum thermal strip chart printer with integral paper spool. The
number of traces are user selectable. The printer uses plain white thermal paper 5 cm wide
and supports 5 paper speeds: 3.125, 6.25, 12.5, 25, and 50 mm/sec.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6 - 23
Performance Specifications
6.2.15
Appendix
Comm-Port
Communication with external devices (i.e. VISA or Patient Net Central Station, Remote
Display, Gas Module and Nurse Call System) is accomplished via the Comm- Port. The
Comm-Port is permanently mounted in a recess on the under side of the monitor.
6.2.15.1
Physical Characteristics
Maximum Size:
Has no impact on the size of the
Passport 2/Passport 2 LT.
Maximum Weight:
6.2.15.2
0.5 lbs.
Communication Characteristics
The Comm Port supports the following connections:
• Remote VGA Display - Connection to a medical grade VGA monitor for remote repeater
display P/N 0160-00-0022. The display mimics the main display (15 pin D-subminiature
female connector).
• Nurse Call - The Nurse Call function interfaces to hospital nurse call systems. The
connector is a 3-pin DIN connector. The monitor activates a relay, which resides in an
interface cable P/N 0012-00-1277-02. The cable interfaces with “normal open”
signaling systems with a minimum of 1,500VAC isolation.
• Serial Communication Channel Supports Passport 2 to Visa (with Admit) protocol,
PatientNet protocol, Datascope Improved ASCII Protocol (DIAP)1, Accutorr
Communications Protocols2 and Gas Module. The interface is proprietary.
• Ethernet Communications Port - Supports Passport 2 interface to Panorama Central
Station or to laser printer using 100 BASE-TX Ethernet.
1The
Passport 2 supports the DIAP (P/N 0070-00-0307) with the following exceptions:
• The NIBP elapsed time is set to “—-” when the elapsed time is greater than 999
minutes.
• Though not specified in the protocol, the alarm limit values are at the same resolution
as the parameter value. Example, temperature is 10X, therefore, the alarm limit values
are also 10X.
• Baud rate is 9600 or 19200.
2The
Passport 2 supports the Accutorr Communication Protocol (P/N 0070-00-0304) with
the following exceptions:
• Baud rate is 9600 or 1200.
• The “Show patient data” command fields not supported are:
• “f” Status Byte 0
• “g” Status Byte 1
• “h” Status Byte 2
• “I” Status Byte 3
6 - 24
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Performance Specifications
• The bits of Status Byte 1 not supported are:
• Bit 1, SpO2 Uncalibrated
• Bit 2, SpO2 Alarm Overlapped
• Bit 3, SpO2 RAM Test Failure
• Bit 4, SpO2 ROM Test Failure
• Bit 5, SpO2 OFFSET Mismatch
• Bit 6, SpO2 FILTER Mismatch
• Bit 7, SpO2 System Test in Progress
• The bits of Status Byte 2 not supported are:
• Bit 1, NIBP indicating Motion Artifact
• Bit 2 through 7 not used
6.2.16
Normal Operating Noise
The SPL produced by the unit during normal operating conditions shall be 60 dBA at 1 meter
when measured in accordance with ISO 3744. Maximum SPL shall be measured with no
alarms sounding, but all internal mechanical devices (i.e., pumps) running.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6 - 25
Performance Specifications
6.2.17
Appendix
Battery
The monitor will operate from AC Mains power with or without the internal batteries
installed.
6.2.17.1
Sealed Lead Acid Battery (P/N 0146-00-0043)
Battery Type:
Sealed Lead Acid
Number of Batteries:
2 (the unit is capable of operation with one
battery for the sole purpose of changing
batteries while in the normal operating mode.)
Minimum Battery Run Time:
1 hour and 50 minutes from two fully charged
new batteries at 25°C with 3 Lead or 5 Lead
ECG, SpO2, no CO2, no printing, and the
NIBP running at the 15 minute interval.
Battery Recharge Time:
16 hours maximum.
Charging Method:
Parallel and independent.
Time to Shutdown from Low Battery:
>10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries with no
CO2 and printer.
6.2.17.2
Lithium-Ion Battery (P/N 0146-00-0069)
Battery Type:
Lithium-ion
Number of Batteries:
2 (the unit is capable of operation with one
battery for the sole purpose of changing
batteries while in the normal operating mode.)
Minimum Battery Run Time:
5 hours from two fully charged new batteries
at 25°C with 3 Lead or 5 Lead ECG, SpO2,
no CO2, no printing, and the NIBP running at
the 15 minute interval.
Battery Recharge Time:
5 hours maximum.
Charging Method:
Parallel and independent.
Time to Shutdown from Low Battery:
>10 minutes but < 20 minutes after indication,
with 2 new, fully charged batteries with no
CO2 and printer.
6 - 26
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
6.2.18
Performance Specifications
AC Power
• 100 – 240 VAC (+/-10%), 50 or 60 Hz (± 3 Hz)
• 1.2 – 0.7 Amps
6.2.19
Real Time Clock
Display Resolution:
1 minute
Accuracy:
± 1 minute/month (30 days) @ 21± 3°C.
Clock Display Format:
12 or 24 hour, user selectable
The Real Time Clock keeps time whether the rest of the system has power or not. A dedicated
battery provides standby power for the clock circuit.
6.2.20
Power Selection
The Monitor auto-selects its power source from those available. The monitor uses the
following priority in choosing the power source:
1. AC Mains Power
2. External DC from base station
3. Internal battery power
6.2.21
Fan Control
• The cooling fan is ON when the unit is powered from external power.
• The cooling fan is OFF when the unit is powered from the internal batteries.
6.2.22
Trend Storage
• The Passport 2 monitor is capable of storing, in non-volatile memory, up to 120 trend
values for each parameter and up to 6 minutes of OXY CRG data.
• With the addition of the Extended Trend Option (P/N 0996-00-0052-01), the
Passport 2 is capable of storing up to 500 trend values for each parameter, and up to
12 hours of OXY CRG data.
Passport 2®/Passport 2 LT™ Operating Instructions
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6 - 27
Performance Specifications
6.2.23
Appendix
Transferring Monitor Default Settings
When installing several Passport 2/Passport 2 LT monitors and identical display
settings and alarm settings are desired on each, a “Transfer Card” (P/N 0996-00-0051-01)
can be used to copy the settings from monitor to monitor.
1. Insert the Transfer Card into the PCM2 slot on the right side of the source monitor.
2. Access the Functions menu, and select “Copy monitor defaults to card” from the menu. A
status message will report completion of the transfer.
3. Remove the card and insert it into the PCM2 slot of the receiving monitor.
4. Enter Installation Mode on the receiving monitor (Press and hold the DISCHARGE key
during power-up.), and select “Copy monitor defaults from card”. A status message will
report completion of the transfer.
5. Select “Save Current” and power-cycle the receiving monitor to enter normal monitoring
mode.
6.2.24
Installation and Use of “Extended Trend” feature
• This feature is added to the Passport 2/Passport 2 LT by inserting the “Extended
Trend” card (P/N 0996-00-0052-01) into slot PCM1 on the right side of the monitor. The
card is to be inserted before monitor power-up, and never removed during monitor
operation. In order to guard against accidental removal, the card slot is designed so that
a tool is required to eject the card after insertion.
• The “Extended Trend” feature is automatically enabled when the unit is powered-up
following card insertion.
NOTE:
6.2.25
The Extended trend card must be removed prior to using the
12-Lead ECG features.
Display
Size:
10.4” (diagonal) active matrix TFT
Resolution:
640 x 480 pixels
Sweep Speeds:
3.125 mm/, 6.25 mm/s, 12.5 mm/s, 25
mm/s, 50 mm/s
6 - 28
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
6.3
Gas Module
Gas Module
Gas Module Power Input Ratings:
90 - 250 VAC
Sampling Rate:
180 ± 20 ml/min (with sampling line 120" ±
4", under normal conditions)
Sampling Delay:
2.5 seconds (with a 120" ± 4" sampling line)
Total System Response Time:
2.9 seconds (with a 120" ± 4" sampling line,
including sampling delay and rise time)
Display Update Rate:
Breath-by-Breath
Compensation:
Automatic for pressure, CO2-N2O and CO2O2 collision broadening effect
Warm-up Time:
Maximum 2 minutes to operation with CO2,
O2, and N2O 5 minutes to operation of
anesthetic agents 30 minutes for full accuracy
specifications
Auto-zeroing Interval:
At startup and at 5, 10, 15, 30, and 60
minutes of operations. Every 60 minutes
thereafter.
CO2
Measurement Range:
0-14.8 vol%
0-14.8 kPa
0-111 mmHg
Measurement Rise Time:
< 400 ms
Accuracy:
± (0.2 vol% + 2% of reading)
Cross Effects:
0.2 vol% for O2, N2O and anesthetic agents
Threshold:
0.1 vol% (if value is less than 0.1%, 0.0% is
displayed)
Respiration Rate:
Breath Detection
1% change in CO2 level
Measurement Range
4 to 60 breaths/min
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6 - 29
Gas Module
Appendix
Accuracy
± 2 bpm
O2 Measurement Range:
0-100 vol%
Measurement Rise Time:
< 400 ms
Accuracy:
± (1 vol% + 2% of reading)
Cross Effects:
< 2 vol% for N2O
< 1 vol% for anesthetic agents
O2 Fi-Et Difference:
0.1 vol% resolution
N2O Measurement Range:
0 - 100% N2O
Measurement Rise Time:
< 450ms
Accuracy:
± (2 vol% + 2% of reading)
Gas Cross Effects:
< 2 vol% anesthetic agents
Anesthetic Measurement Range:
HAL, ENF and ISO - 0 to 5.8 vol%
SEV - 0 to 7.8 vol%
DES - 0 to 20 vol%
Measurement Rise Time:
< 400ms
Accuracy:
± (0.15 vol% +5% of reading)
Gas Cross Effects:
< 0.15 vol% N2O
Resolution:
Two digits for Anesthetic Agent concentrations
< 1.0 vol%
Threshold:
0.15 vol%
Identification Time:
< 20 seconds (for single agents)
Mixture Identification Threshold for
0.2 vol% +10% of total concentration
second agent:
6 - 30
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Environmental Conditions
6.4
Environmental Conditions
6.4.1
Storage
Temperature:
-20°C to +60°C
Humidity:
10 to 95%, Non-condensing
Altitude:
-1250 to 9,889 feet ASL
1060hPa to 700 hPa
795 mmHg to 525 mmHg
Operating Altitude:
-1250 to 9,889 feet ASL
1060 hPa to 700 hPa
795mmHg to 525 mmHg
Operating Temperature:
5°C to 40°C
Operating Humidity:
15% to 95%, maximum, non-condensing
Gas Module Operating Humidity:
10 to 95%RH, non-condensing
Shipping:
ISTA shipping procedure 1A
Shock:
15g, 11msec, half sine shock pulse
Vibration:
FDA Reviewer Guidance for Pre-market
Notification Submission, November 1993,
paragraphs n4ii and n4iii.
Drop:
ECRI PB-296 892 Section AIII 3.3 for Class 3
devices.
Impact:
ECRI PB-296 892, Section AIII 3.2 for Class 3
devices.
Spillage and Ingress of Fluids:
Non-protected Equipment (IPX0) as specified
in IEC 529.
≥ 70 dBA but ≤ 85 dBA for Priority 1 and
Sound Pressure Level:
Priority 2 alarms per EN 475.
Passport 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6 - 31
Agency Compliance
6.5
Appendix
Agency Compliance
The Passport 2/Passport 2 LT was designed to comply with the following industry
standards:
• EN 60601:1990 +A1:1992 +A2:1995 +A13:1995 / IEC 601-1:1988 +A1:1991
+A2:1995 +corrigendum June, 1995
• UL 2601-1:1997
• CSA Standard C22.2 No. 601.1M90
• EN 60601-1-1:1993 +A1:1995 / IEC 601-1-1:1992 +A1:1995
• EN 60601-1-4:1996 / IEC 601-1-4:1996
• EN 60601-2-27:1994 / IEC 601-2-27:1994
• EN 60601-2-30:1995 / IEC 601-2-30:1995
• EN 60601-2-34:1995 / IEC 601-2-34:1994
• EN 60601-0-25:1993 / IEC 601-2-25:1993
The View 12™ ECG Analysis Module with AAMI EC 11:1991 for Diagnostic
Electrocardiographic Devices.
The Passport 2/Passport 2 LT has been certified by CSA for compliance with the
standards listed above.
The Passport 2/Passport 2 LT has been tested for functionality following ESU
(Electrosurgery Unit Interference) energy exposure as described in the draft Amendment A1
to IEC 60601-2-25, dated 18 December 1998.
6 - 32
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
6.6
Electromagnetic Capability
Electromagnetic Capability
The Passport 2/Passport 2 LT meets the requirements of IEC 60601-1-2:2001/
EN 60601-1-2:2001.
NOTE:
The Passport 2/Passport 2 LT 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 2/Passport 2 LT. See tables 6-1 through
6-4 that follow.
TABLE 6-1
GUIDANCE AND DATASCOPE CORP. DECLARATION - ELECTROMAGNETIC EMISSIONS
The Passport 2/Passport 2 LT is intended for use in the electromagnetic environment specified
below. The customer or the user of the Passport 2/Passport 2 LT should assure that it is used in
such an environment.
EMISSIONS
TEST
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions
CISPR 11
Group 1
The Passport 2/Passport 2 LT 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 2/Passport 2 LT 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 2®/Passport 2 LT™ Operating Instructions
0070-10-0649-01
6 - 33
Electromagnetic Capability
Appendix
TABLE 6-2
GUIDANCE AND DATASCOPE CORP. DECLARATION - ELECTROMAGNETIC IMMUNITY
The Passport 2/Passport 2 LT is intended for use in the electromagnetic environment specified
below. The customer or the user of the Passport 2/Passport 2 LT 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 2/Passport 2 LT requires
continued operation during power
mains interruptions, it is recommended
that the Passport 2/Passport 2 LT
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.
6 - 34
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Electromagnetic Capability
TABLE 6-3
GUIDANCE AND DATASCOPE CORP. DECLARATION - ELECTROMAGNETIC IMMUNITY
The Passport 2/Passport 2 LT is intended for use in the electromagnetic environment specified
below. The customer or the user of the Passport 2/Passport 2 LT 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 2/Passport 2 LT,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
P
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
3 Vrms
d = 1.2 x
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 Passport 2/Passport 2 LT is used exceeds the applicable RF compliance level above, the Passport 2/
Passport 2 LT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Passport 2/Passport 2 LT.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Passport 2®/Passport 2 LT™ Operating Instructions
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6 - 35
Electromagnetic Capability
Appendix
TABLE 6-4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE PASSPORT 2/PASSPORT 2 LT
The Passport 2/Passport 2 LT is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Passport 2/Passport 2
LT can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Passport 2/Passport 2
LT 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.
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.
NOTE:
The Passport 2/Passport 2 LT is intended for use in the
electromagnetic environment specified below. The customer
or the user of the Passport 2/Passport 2 LT should assure
that it is used in such an environment.
The Passport 2/Passport 2 LT meets the additional FDA electromagnetic compatibility
requirements of the FDA Reviewer Guidance for Premarket Notification Submission
(November 1993) listed below:
AC Voltage Dropout: < 10 ms
NOTE:
6 - 36
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the Passport 2/
Passport 2 LT requires continued operation during power
mains interruptions, it is recommended that the Passport 2/
Passport 2 LT be powered from an uninterruptible power
supply or a battery.
0070-10-0649-01
Passport 2®/Passport 2 LT™ Operating Instructions
Appendix
Indirect Blood Pressure Measurements And Associated Errors
AC Slow Sags and Surge: 90 V to 150 V for 500 ms
AC Steady State Voltage: 95 – 132 VAC/battery backup below 85 VAC
Quasi-static Fields: 500 – 2000 V/m sweep at 0.5 Hz sine
Magnetic Emissions: MIL-STD-461D, RE101, 30 Hz to 100 kHz @ 7 cm
6.7
Indirect Blood Pressure 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 has weight and it is this weight that influences these 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
so no adjustment of the NIBP readings will be necessary.
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Precautions While Making Automatically Cycled Blood Pressure Measurements
6.8
Appendix
Precautions While Making Automatically Cycled
Blood Pressure Measurements
Reports have been made of nerve injury occurring from automatically cycled 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.
6.8.1
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. Too much
force per unit area is exerted. This requires less pressure to collapse the artery.
6.8.2
Other Factors
An accurate determination of blood pressure by the Passport 2/Passport 2 LT can be
difficult if cardiac rhythm is very irregular. Irregular cardiac rhythm changes the stroke
volume from beat to beat. This changing stroke volume may increase the time it takes the
Passport 2/Passport 2 LT, to make a measurement. The Passport 2/Passport 2 LT
makes up to four successive attempts to obtain a measurement. If a measurement cannot be
made after four tries, the numeric displays are zeroed.
6.9
User Verification Of Passport 2 Measurements
Regular service to blood pressure equipment will help insure accurate measurements. Consult
your service manual for appropriate information.
If you question the accuracy of the Passport 2/Passport 2 LT check it (the Passport 2/
Passport 2 LT) with a manometer. See the Calibration Section of the Passport Service
Manual.
Auscultatory verification can be made at the same time the Passport 2/Passport 2 LT 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.
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Appendix
6.10
Newborn NIBP Technique
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.
• Try to measure infants when they are calm. A kicking/crying baby may disturb or jiggle
the cuff, causing noise within the system and, as a result, yielding unstable blood pressure
readings. If necessary, hold the cuffed limb steady, but do not impede circulation; do not
hold onto the cuff and do not “pat” the cuffed limb to comfort the child.
• 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.
• Use the correct size cuff. Datascope offers Newborn and Infant size cuffs. When
applying, verify the cuff’s “Index” line falls between the “Range” lines.
• Try disposable cuffs. Disposable cuffs are more pliant than the reusable ones. They
generally fit really tiny infants better.
• 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.
Remember NIBP cannot be taken under all conditions. Even manual methods, employing a
sphygmomanometer and stethoscope, will not work on unstable or active patients.
6.11
How To Get Help
Datascope 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 Datascope
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 Datascope location.
A list of international offices, along with their phone numbers, is provided at the end of this
manual.
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Warranty
Appendix
6.12
Warranty
6.12.1
USA, Canada, Mexico, and Puerto Rico
Datascope Corp. 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.
Datascope Corp. 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 Datascope Corp’s option at the factory or at an authorized Datascope
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 Datascope Corp. has any authority to bind
Datascope Corp. 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.
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.
Datascope Corp. 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 Datascope, freight prepaid to Datascope
Corp., Mahwah, New Jersey 07430. Datascope Corp. 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.
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Appendix
6.13
Datascope’s Responsibility
Datascope’s Responsibility
Datascope 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 Datascope; 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.
6.14
Extended Warranty
Datascope Corp. warrants that components within the monitor unit will be free from defects
in workmanship and materials for the number of years shown on the Datascope invoice.
Under this extended warranty, Datascope Corp. 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 Datascope
Corp.’s standard warranty shall remain in effect.
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Extended Warranty
Appendix
Declaration of Conformity
European Community Council Directive 93/42/EEC
0044
Datascope Corp. declares that the products listed below comply with the requirements of
the Medical Device Directive 93/42/EEC. The Technical file required by this Directive is
maintained at the manufacturer’s address below.
Equipment type:
Patient Monitor –
Class IIb device
Models:
Passport 2, Passport 2LT
Quality System:
ISO9001 / EN46001
Notified Body:
RWTÜV Essen
Passport 2 conforms to the following models
Safety:
EN 60601-1:1990 + A1:1992+A2:1995 + A13:1995 /
IEC 601-1:1988 + A1:1991+A2:1995;
EN 60601-1-1:1993 + A1:1995 / IEC 601-1-1:1992 + A1:1995;
EN 60601-1-4:1996 / IEC 601-1-4:1996;
IEC 601-2-25:1993; IEC 601-2-27:1994
IEC 601-2-30:1995; IEC 601-2-34:1994;
UL 2601:1997
CSA C22.2 No.601.1-M90;
QSR 21CFR 820
EMC:
EN60601-1-2:1995 / IEC 601-1-2:1993
Performance:
EN 475:1995;
EN 864:1996;
EN 865:1997;
EN 1060-1:1995;
EN 1060-3:1997;
EN 1441:1997
Biocompatibility: ISO 10993:1997
Review by:
Prepared by:
Place:
Michael Gusel
Principal Engineer
Russell Olsen
Director, Quality Assurance
and Regulatory Affairs
Datascope Corp.
Approval Date:
800 MacArthur Blvd.
Mahwah, NJ 07430-0619, USA
January 30, 2002
month/date/year
EU contact: Datascope B.V., Drs. W van Royenstraat 8, 3871 AN Hoevelaken, The Netherlands
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Appendix
Extended Warranty
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Printed in U.S.A.
0070-10-0649-01
Rev G
July 3, 2007
Datascope Corp.• Patient Monitoring • Worldwide Headquarters • 800 MacArthur Boulevard •
Mahwah, NJ 07430-0619 • USA • Dom. Customer Service: 1.800.288.2121 •
Dom. Fax: 1.800.926.4275 • Intl. Customer Service: 201.995.8000 •
Intl. Fax: 201.995.8680 • E-Mail Address: [email protected]
Datascope Europe & Africa Office • Drs. W van Royenstraat 8 • P.O. Box 26 • 3870 CA •
Hoevelaken • The Netherlands • Tel: 31.33.2544911 • Fax: 31.33.2537621
Datascope Asia-Pacific Office • Unit A, 30th Floor, Morrison Plaza • 9 Morrison Hill Road •
Wanchai • Hong Kong • Tel: 852.2793.5596 • Fax: 852.2344.8824
Datascope Middle East Office • 9z Ahmad Kamel Street • From El-Laselky Street • New Maadi
Cairo • Egypt • Tel: 20.2.753.8633 • Fax: 20.2.753.8644
Datascope GmbH • Fabrikstrasse 35 • 64625 Bensheim • Germany • Tel: 06251.17050 •
Fax: 06251.67877
Datascope Medical Co., Ltd. • Lakeview Court • Ermine Business Park • Huntingdon •
Cambridgeshire PE29 6XR • United Kingdom • Tel: 01480.423600 • Fax: 01480.423638
Datascope SARL • Z.I. Athelia 1 • 13705 La Ciotat • Cedex • France • Tel: 04.42.08.77.50 •
Fax: 04.42.08.57.08
Datascope Sprl/Bvba • Woluwe Garden C • Woluwedal 26 • 1932 St. Stevens-Woluwe •
Belgium • Tel: 32.2.216.8000 • Fax: 32.2.216.3333
0002-08-8918
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