Mindray Passport V Operating Instructions Manual

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Operating Instructions

Passport

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Operating Instructions

Passport

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CapnoLine® is a U.S. registered trademark of Oridion Medical Ltd.

DRYLINE

Durasensor

Edwards

FilterLine

LNCS

LNOP

Masimo SET

Max-Fast

miniMediCO

Microstream

Mindray

Navigator

Nellcor

NIV Line

is a trademark of Artema Medical AB

is a U.S. registered trademark of Nellcor Puritan Bennett Inc.

is a U.S. registered trademark of Edwards Lifesciences Corporation.

is a U.S. registered trademark of Oridion Medical Ltd.

is a U.S. registered trademark of Masimo Corp.

is a trademark of Nellcor Puritan Bennett Inc.

is a trademark or registered trademark of Oridion Medical Ltd.

is a U.S. registered trademark of Oridion Medical Ltd.

is a trademark or registered trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

is a U.S. trademark of Mindray DS USA, Inc.

is a U.S. trademark of Nellcor Puritan Bennett Inc.

is a trademark of Oridion Medical Ltd.

Oxiband

OxiMax

Oxisensor

Passport

Velcro

is a U.S. registered trademark of Nellcor Puritan Bennett Inc.

is a U.S. trademark of Nellcor Puritan Bennett Inc.

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is a U.S. registered trademark of Mindray DS USA, Inc.

is a trademark or registered trademark of Velcro Industries B.V.

0070-00-0704-02 Passport V Operating Instructions

Table of Contents

Foreword....................................................................................................................................................... vii

Warnings, Precautions, and Notes.................................................................................................................... vii

Warnings ......................................................................................................................................................viii

Precautions ....................................................................................................................................................xii

Notes ............................................................................................................................................................xvi

Intended Use .........................................................................................................................................xvii

Unpacking .................................................................................................................................................... xvii

Symbols and Descriptions ............................................................................................................................. xviii

General Product Description.............................................................................................. 1 - 1

General Product Description .........................................................................................................................1 - 2

Key Features ..................................................................................................................................................1 - 3

Keys and Front Panel ....................................................................................................................................1 - 4

Display..........................................................................................................................................................1 - 8

Physical Views ..............................................................................................................................................1 - 11

Front View ..............................................................................................................................................1 - 11

Rear View...............................................................................................................................................1 - 12

Left Side Panel.........................................................................................................................................1 - 13

Right Side Panel ......................................................................................................................................1 - 14

Top View................................................................................................................................................1 - 15

System Configuration........................................................................................................ 2 - 1

Installation Menu ............................................................................................................................................2 - 1

Advanced Installation Setup Menu (Network) .....................................................................................................2 - 4

Monitor Setup Menu........................................................................................................................................ 2 - 6

Advanced Setup ............................................................................................................................................. 2 - 7

How to Set the Clock/Date and Time.........................................................................................................2 - 8

Transferring Monitor Default Settings..........................................................................................................2 - 8

Configuration Management .............................................................................................................................2 - 9

Patient Management ........................................................................................................ 3 - 1

Description..................................................................................................................................................... 3 - 1

Setting-up Patients ...........................................................................................................................................3 - 2

Patient Menu ..........................................................................................................................................3 - 2

Discharging a Patient ..................................................................................................................................... 3 - 4

Data Transfer .................................................................................................................................................3 - 5

Transferring User Configuration ................................................................................................................3 - 5

Remote View ................................................................................................................................................3 - 6

Monitor/Display Troubleshooting ....................................................................................................................3 - 11

ECG Monitoring ................................................................................................................ 4-1

Description .................................................................................................................................................... 4 - 1

ECG Screens..................................................................................................................................................4 - 2

Numeric Tile: ECG .................................................................................................................................4 - 2

Waveform: ECG .....................................................................................................................................4 - 3

Front Panel: ECG Keys ....................................................................................................................................4 - 5

Menus: ECG Main and Submenus ....................................................................................................................4 - 6

ECG Menu ............................................................................................................................................4 - 6

Arrhythmia Menu (optional) ......................................................................................................................4 - 8

ST Menu ................................................................................................................................................4 - 10

ECG Sizes Menu .....................................................................................................................................4 - 12

ECG Setup Menu ...................................................................................................................................4 - 12

Preparation and Lead Placement.......................................................................................................................4 - 15

Skin Preparation......................................................................................................................................4 - 15

Electrode Patch Location........................................................................................................................... 4 - 15

Lead Placement ..................................................................................................................................... 4 - 16

Passport V Operating Instructions 0070- 0-0704-02 i

Table of Contents

Description .....................................................................................................................................4 - 16

Setting Lead Naming Standard .........................................................................................................4 - 16

Lead Placement: Standard 3-wire Lead Sets ........................................................................................4 - 17

Lead Placement: Standard 5-wire Lead Sets ........................................................................................4 - 18

Lead Placement: Lead II Monitoring ................................................................................................... 4 - 19

Lead Placement: Modified Chest Lead (MCL) Monitoring ...................................................................... 4 - 20

Lead Placement: Neonates ...............................................................................................................4 - 21

Lead Placement: Pacemaker Patients .................................................................................................. 4 - 22

Arrhythmia Algorithm ...................................................................................................................................... 4 - 23

Noise and Artifact ...................................................................................................................................4 - 23

Heart Rate Average ................................................................................................................................ 4 - 23

Filtering Pacer Signals.............................................................................................................................. 4 - 24

ECG Amplitude .......................................................................................................................................4 - 24

Learning.................................................................................................................................................4 - 24

Beat Detection and Typing........................................................................................................................4 - 24

Arrhythmia Alarms (optional)............................................................................................................................4 - 25

Lethal Arrhythmia Alarms .........................................................................................................................4 - 25

Asystole Alarm ................................................................................................................................4 - 25

Ventricular-Fibrillation (V-FIB) Alarm ...................................................................................................4 - 25

Ventricular Tachycardia (V-TACH) Alarm ...........................................................................................4 - 26

Non-Lethal Arrhythmia Alarms ..................................................................................................................4 - 26

Bigeminy Alarm ..............................................................................................................................4 - 26

Brady (Bradycardia) Alarm ...............................................................................................................4 - 26

Couplet Alarm ................................................................................................................................4 - 26

Irregular Heart Rate Alarm ............................................................................................................... 4 - 27

PVC/minute Alarm ..........................................................................................................................4 - 27

Run Alarm ......................................................................................................................................4 - 27

Trigeminy Alarm ..............................................................................................................................4 - 27

Ventricular Rhythm (V-Rhythm) Alarm .................................................................................................4 - 27

Arrhythmia Analysis (Optional) ........................................................................................................................4 - 28

Arrhythmia Analysis Setup .......................................................................................................................4 - 29

ST Analysis (Optional) ....................................................................................................................................4 - 30

Numeric Tile: ST .....................................................................................................................................4 - 31

ST Analysis Setup .................................................................................................................................... 4 - 31

Adjusting the ISO and J/ST Point ......................................................................................................4 - 32

Adjusting ST Measurement Points .....................................................................................................4 - 32

Relearning ST or Arrhythmia Analysis ................................................................................................................4 - 33

ECG Troubleshooting .....................................................................................................................................4 - 34

Respiration Monitoring ..................................................................................................... 5 - 1

Description ....................................................................................................................................................5 - 1

Resp Screens.................................................................................................................................................. 5 - 2

Numeric Tile: Resp................................................................................................................................... 5 - 2

Waveform: Resp .....................................................................................................................................5 - 2

Resp Menu.....................................................................................................................................................5 - 3

Thoracic Impedance.................................................................................................................................5 - 4

Respiration and CO

Troubleshooting ...............................................................................................................5-5

SpO2 Monitoring............................................................................................................... 6 - 1

Description ....................................................................................................................................................6 - 1

Screens ................................................................................................................................................6 - 2

SpO

Numeric Tile: SpO Waveform: SpO

Menu ..................................................................................................................................................6 - 3

SpO

.................................................................................................................................6 - 2

....................................................................................................................................6 - 2

ii 0070- 0-0704-02 Passport V Operating Instructions

Table of Contents

SpO2 Pulse Oximetry ......................................................................................................................................6 - 5

Masimo SET Nellcor DPM SpO

Troubleshooting and SpO2 Menu Performance Considerations ...................................................................6 - 11

SpO

SpO2.................................................................................................................................6 - 6

SpO2........................................................................................................................................6 - 7

.............................................................................................................................................6 - 9

NIBP Monitoring ............................................................................................................... 7 -1

NIBP Description ............................................................................................................................................7 - 1

Displaying Measured Pressure ............................................................................................................... 7 - 1

Display Time-out for NIBP Measurement ....................................................................................................7 - 1

Measurement Modes ............................................................................................................................. 7 - 2

NIBP Screens .................................................................................................................................................7 - 3

NIBP Numeric Tile ................................................................................................................................... 7 - 3

NIBP List Display ....................................................................................................................................7 - 4

NIBP Menu ...................................................................................................................................................7 - 5

NIBP Measurements ........................................................................................................................................ 7 - 7

Manual NIBP Measurements .....................................................................................................................7 - 7

Automatic Interval NIBP Measurements.......................................................................................................7 - 8

Suspension of NIBP Measurements ............................................................................................................7 - 9

Retry measurement .................................................................................................................................. 7 - 9

Reset .....................................................................................................................................................7 - 9

NIBP Pressure Limit Fail Safe ..................................................................................................................... 7 - 9

Cuff Inflation Timeout ...............................................................................................................................7 - 10

Start and Stop Keys .................................................................................................................................7 - 10

NIBP Auto Time Out Functions...................................................................................................................7 - 10

Indirect BP Measurements and Associated Errors .........................................................................................7 - 10

Recommendations for Automatic Blood Pressure Measurements ..................................................................... 7 -11

Cuff Size ................................................................................................................................................7 - 11

Other Factors..........................................................................................................................................7 - 11

User Verification of Passport V Blood Pressure Measurements ...................................................................7 - 11

Newborn NIBP Technique ........................................................................................................................7 - 11

NIBP List Tile ...........................................................................................................................................7 - 12

Adaptive Inflation Pressure .......................................................................................................................7 - 12

NIBP Troubleshooting ......................................................................................................................................7 - 13

Temperature Monitoring ................................................................................................... 8 - 1

Description ................................................................................................................................................. 8 - 1

Temperature Screens .......................................................................................................................................8 - 2

Numeric Tile: Temp..................................................................................................................................8 - 2

Temperature Probes ........................................................................................................................................8 - 3

Skin Temperature Sensor with 400 Series Thermistor....................................................................................8 - 3

Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor .......................................................8 - 4

Esophageal/Rectal Temperature Probe with 400 Series Thermistor ................................................................8 -6

Reusable DPM Temperature Probes............................................................................................................ 8 - 7

Temperature Troubleshooting ...........................................................................................................................8 - 8

IBP Monitoring (optional) .................................................................................................. 9 - 1

IBP Description ..............................................................................................................................................9 - 1

Pressure Labels........................................................................................................................................ 9 - 1

IBP Screens ...................................................................................................................................................9 - 3

IBP Numeric Tile...................................................................................................................................... 9 - 3

IBP Waveform......................................................................................................................................... 9 - 4

IBP Menu ......................................................................................................................................................9 - 5

Measuring IBP ...............................................................................................................................................9 - 7

IBP Troubleshooting.........................................................................................................................................9 - 8

Passport V Operating Instructions 0070- 0-0704-02 iii

Table of Contents

CO2 Monitoring (optional)............................................................................................... 10 - 1

Description ..................................................................................................................................................10 - 1

Screens ...............................................................................................................................................10 - 2

Numeric Tile: CO

Waveform: CO

Menu .................................................................................................................................................. 10 - 3

Setup Menu (DPM Sidestream Only) ................................................................................................ 10 - 5

Microstream

Troubleshooting ....................................................................................................................................10 - 8

................................................................................................................................10 - 2

...................................................................................................................................10 - 2

CO2 Monitoring (Optional) ................................................................................................10 - 7

Gas Monitoring (optional) ............................................................................................... 11 - 1

Description ..................................................................................................................................................11 - 1

Gas Screens.................................................................................................................................................11 - 3

Numeric Tile ................................................................................................................................11 - 3

Gas Numeric Tile .................................................................................................................................11 - 3

Gas Waveform .....................................................................................................................................11 - 4

Gas Menu ..................................................................................................................................................11 - 5

Measure Unit .......................................................................................................................................11 - 6

Automatic identification of Anesthetic Agents ...........................................................................................11 - 6

Gas Module 3 Pre-use Test .....................................................................................................................11 - 8

Gas Module Troubleshooting .........................................................................................................................11 - 8

Drug Calculations............................................................................................................ 12 -1

Description................................................................................................................................................... 12 - 1

Drug Calculations..................................................................................................................................12 - 1

Alarms ........................................................................................................................... 13 - 1

Alarms..................................................................................................................................................... 13 - 1

Adjusting Alarms ..................................................................................................................................13 - 1

Alarm Limits ........................................................................................................................................13 - 3

Auto Set Alarms ....................................................................................................................................13 - 5

Alarm Violations ...................................................................................................................................13 - 6

Verifying Alarm Functionality ................................................................................................................13 - 8

Alarm Troubleshooting ...........................................................................................................................13 - 9

Messages ....................................................................................................................... 14 - 1

Physiological Alarm Messages .......................................................................................................................14 - 1

HR....................................................................................................................................................... 14 - 1

Arrhythmia............................................................................................................................................ 14 - 1

RESP ....................................................................................................................................................14 - 2

TEMP ...................................................................................................................................................14 - 2

...................................................................................................................................................14 - 2

SpO

NIBP ....................................................................................................................................................14 - 2

IBP.......................................................................................................................................................14 - 3

....................................................................................................................................................14 - 3

GAS ....................................................................................................................................................14 - 3

Technical Alarm Messages.............................................................................................................................14 - 4

ECG Alert Message ............................................................................................................................... 14 - 4

RESP Alert Message............................................................................................................................... 14 - 4

TEMP Alert Message ..............................................................................................................................14 - 5

Alert Message..............................................................................................................................14 - 5

SpO

NIBP Alert Message............................................................................................................................... 14 - 5

IBP Alert Message.................................................................................................................................. 14 - 6

Alert Message ...............................................................................................................................14 - 6

GAS Alert Message ...............................................................................................................................14 - 6

iv 0070- 0-0704-02 Passport V Operating Instructions

Table of Contents

System Level .........................................................................................................................................14 - 7

Prompt Messages..........................................................................................................................................14 - 8

ECG Prompt Message ............................................................................................................................14 - 8

Resp Prompt Message ............................................................................................................................14 - 8

Prompt Message .......................................................................................................................... 14 - 9

SpO

Temp Prompt Message ...........................................................................................................................14 - 10

NIBP Prompt Message............................................................................................................................14 - 11

IBP Prompt Message ..............................................................................................................................14 - 13

Prompt Message............................................................................................................................14 - 13

GAS Prompt Message............................................................................................................................14 - 16

Main Control System..............................................................................................................................14 - 18

Power Supply........................................................................................................................................14 - 19

Data Management.................................................................................................................................14 - 19

Configuration Management .................................................................................................................... 14 - 20

Network............................................................................................................................................... 14 - 20

Print..................................................................................................................................................... 14 - 21

Alarm Troubleshooting ...........................................................................................................................14 - 22

Trends ............................................................................................................................ 15 - 1

Description................................................................................................................................................... 15 - 1

Quick Trends................................................................................................................................................15 - 2

List Trends....................................................................................................................................................15 - 3

Graphic Trends............................................................................................................................................. 15 - 5

OxyCRG...................................................................................................................................................... 15 - 7

Trends Troubleshooting.................................................................................................................................. 15 - 10

Printing .......................................................................................................................... 16 - 1

Description................................................................................................................................................... 16 - 1

Print Setup Menu .........................................................................................................................................16 - 1

Local Printer (Optional)...........................................................................................................................16 - 2

Remote/Local Printer Troubleshooting....................................................................................................... 16 - 4

User Maintenance...........................................................................................................17 - 1

Description................................................................................................................................................... 17 - 1

Care and Disinfection of the Passport V Monitor............................................................................................17 - 2

Care and Cleaning of SpO

Sensors............................................................................................................... 17 - 3

Care and Cleaning of Reusable Temperature Probes .........................................................................................17 - 3

Care and Cleaning of Reusable Cuffs..............................................................................................................17 - 4

Reusable Cuffs with Bladders ..................................................................................................................17 - 4

Reusable Bladderless Cuffs .....................................................................................................................17 - 5

Battery Replacement and Maintenance ............................................................................................................17 - 6

Local Printer Paper Replacement .....................................................................................................................17 - 7

Care and Storage of Thermal Chart Paper ....................................................................................................... 17 - 7

Care and Cleaning of 3- and 5-lead ECG Cables and Lead wires ......................................................................17 - 8

Accessories .....................................................................................................................18 - 1

ECG............................................................................................................................................................ 18 - 1

ECG Electrodes .....................................................................................................................................18 - 1

ECG Cables .........................................................................................................................................18 - 1

ECG Leadsets ....................................................................................................................................... 18 - 2

.........................................................................................................................................................18 - 3

SpO

Masimo SpO

Nellcor SpO

DPM SpO

NIBP ...........................................................................................................................................................18 - 6

Temperature ................................................................................................................................................ 18 - 7

Module...........................................................................................................................18 - 3

Module............................................................................................................................ 18 - 5

Module ...............................................................................................................................18 - 5

Passport V Operating Instructions 0070- 0-0704-02 v

Table of Contents

Disposable 400 Series Temperature Probes .............................................................................................. 18 - 7

Reusable DPM Temperature Probes ..........................................................................................................18 - 7

Disposable DPM Temperature Probes .......................................................................................................18 - 7

IBP .............................................................................................................................................................. 18 - 8

............................................................................................................................................................ 18 - 9

Oridion Microstream CO2 Module ..........................................................................................................18 - 9

DPM Sidestream CO

Module and Gas Module 3 ....................................................................................18 - 9

Gas Module 3 Accessories ..................................................................................................................... 18 - 10

Mounting Kits, Rolling Stands, and Accessories ................................................................................................18 - 11

Cables and Networking.................................................................................................................................18 - 12

Battery and Miscellaneous ............................................................................................................................. 18 - 13

Appendix ......................................................................................................................19 - 1

Equipment Environment and Safety Specifications ............................................................................................. 19 - 1

Power Specifications ..................................................................................................................................19 - 3

Clock ..........................................................................................................................................................19 - 4

Weight and Dimension.................................................................................................................................. 19 - 4

Display Specifications ...................................................................................................................................19 - 4

Sound ....................................................................................................................................................... 19 - 5

Marking ......................................................................................................................................................19 - 5

Performance Characteristics ...........................................................................................................................19 - 6

ECG Specifications................................................................................................................................19 - 6

RESP .................................................................................................................................................... 19 - 12

IBP.......................................................................................................................................................19 - 13

NIBP Performance and Functional Characteristics .....................................................................................19 - 14

Masimo SET SpO2 Performance Requirements ......................................................................................... 19 - 16

DPM SpO2 Performance Requirements .....................................................................................................19 - 19

Nellcor SpO2........................................................................................................................................19 - 20

Performance Characteristics ............................................................................................................19 - 21

Temperature Performance Characteristics ...............................................................................................19 - 25

Gas Module Performance Characteristics .................................................................................................19 - 26

Input/Output Communications ......................................................................................................................19 - 28

Communication Protocols...............................................................................................................................19 - 29

Data Storage................................................................................................................................................19 - 29

Printing........................................................................................................................................................ 19 - 30

Agency Compliance......................................................................................................................................19 - 30

Safety Designations ......................................................................................................................................19 - 31

Safety Classification ..............................................................................................................................19 - 31

Safety Performance Index ....................................................................................................................... 19 - 31

Electromagnetic Capability ............................................................................................................................ 19 - 34

EMC Safety .........................................................................................................................................19 - 34

Passport V.........................................................................................................................................19 - 35

Radio Regulatory Compliance..................................................................................................................19 - 39

Gas Module 3 ...................................................................................................................................... 19 - 41

Warranty Statements ....................................................................................................................................19 - 45

Customer Service ..........................................................................................................................................19 - 47

Manufacturer's Responsibility ........................................................................................................................19 - 47

Glossary......................................................................................................................... 20 - 1

Glossary of Terms .......................................................................................................................................20 - 1

vi 0070- 0-0704-02 Passport V Operating Instructions

Foreword Introduction

Foreword

The Passport V Operating Instructions are intended to provide information for proper operation.

General knowledge of monitoring and an understanding of the features and functions of the

Passport V monitor are prerequisites for its proper use.

NOTE: Do not operate this monitor before reading these instructions.

Information for servicing this instrument is contained in the Passport V Service Manual, part number 0070-00-0705. For additional information or assistance, please contact an authorized service representative in your area.

CAUTION: U.S. Federal Law restricts this device to sale by or on the order

of a physician or other practitioner licensed by state law to use or order the use of this device.

NOTE: Figures in this manual are provided for reference purposes

only. Screens will likely differ based on the monitoring device configuration, licenses available, parameters selected and patient configuration of the Passport V monitor.

Patents: This device is covered under one or more of the following U.S. Patents: 5,300,859; 5,485,847; 5,657,750; 5,676,141; 5,743,263; 5,758,644; 5,823,950; 5,857,461; 6,011,986; 6,035,223; 6,157,850; 6,226,539; 6,263,222; 6,411,833; 6,422,240; 6,437,316; 6,463,310; 6,501,975; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847; 7,400,919; foreign equivalents; and Masimo patents (www.masimo.com/ patents.htm). Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Warnings, Precautions, and Notes

Please read and adhere to all warnings, precautions and notes listed here and in the appropriate areas throughout this manual.

A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user.

A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects.

A NOTE is provided when additional general information is applicable.

Passport V Operating Instructions 0070- 0-0704-02 vii

Introduction Warn ings

Warnings

WARNING: Use of the Passport V is restricted to one patient at a time.

WARNING: This device is not intended for direct cardiac application.

WARNING: Internal Electrical Shock Hazard - This unit does not contain any

user-serviceable parts. Do not remove instrument covers. Refer Servicing to qualified personnel.

WARNING: Do not use this monitor during MRI (Magnetic Resonance

Imaging) scanning. Induced current could potentially cause burns. Accuracy of measurements on this unit and the MRI unit may also be affected.

WARNING: To reduce the hazard of burns in the high-frequency surgical

neutral electrode connection, the electrodes should not be located between the surgical site and the electro-surgical unit return electrode.

WARNING: Ensure that conductive parts of the ECG electrodes do not

contact other conductive parts including earth ground. Do not connect any non-isolated accessories to the Passport V or to the ECG or invasive pressure channel inputs when connected to a patient. Ensure that the total chassis leakage currents of all connected units does not exceed 300µA. Use an IEC 60601-1 approved isolation / separation transformer if required. Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment.

WARNING: Electrode polarization: some electrodes may be subject to large

offset potentials due to polarization. Use only electrodes as recommended by Mindray. Recovery time after application of defibrillator pulses may be especially compromised. Squeeze bulb electrodes commonly used for diagnostic ECG recording may be particularly vulnerable to this effect. Electrodes of dissimilar metals should not be used unless the amplifier can handle polarization potentials as high as 1 volt (V).

WARNING: The AC line cord and interface cables (i.e. non-patient cables)

may utilize the same ground. Therefore, removal of the AC line cord does not necessarily isolate the Passport V if non-patient interface cables are attached.

WARNING: Observe extreme caution when a defibrillator is used on a

patient. Do not touch any part of patient, table, or monitor when a defibrillator is in use.

WARNING: Do not incinerate battery; possible explosion may occur.

viii 0070- 0-0704-02 Passport V Operating Instructions

War nin gs Introduction

WARNING: To ensure that alarms can sound if the Gas Module/Passport V

loses power, at least one charged battery must be installed in the Passport V at all times.

WARNING: Do not put MPSO (Multiple Portable Socket Outlets, i.e. Multiple

outlet extension cords) used with the Passport V or its accessories on the floor. Connect only Passport V accessories to the same MPSO as the Passport V. Do not overload the MPSO. Do not connect other equipment to the same MPSO with the Passport V, as it may increase system leakage current.

WARNING: Reliably attach Potential Equalization connector to the safety

ground when interconnecting Passport V with other medical or non-medical electrical equipment to minimize the risk of excessive leakage current and/or shock hazard.

WARNING: Do not reuse disposable accessories. Dispose of single use items

in accordance with hospital policy.

WARNING: Compressed gasses are considered Dangerous Goods/

Hazardous Materials per I.A.T.A. And D.O.T. regulations. It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and/or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information.

WARNING: Route cables neatly. Ensure cables, hoses and wires are kept

away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients and visitors.

WARNING: Do not use a damaged or broken unit or accessory. Periodically,

check all cables (e.g., AC line cord and patient connection cables) for damage that may occur through normal use. Replace cable if damaged in any way.

WARNING: Ensure that the conductive parts of ECG electrodes do not

contact other conductive parts, including earth ground.

WARNING: Pacemaker patients’ rate meters may continue to count the

pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See the Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument.

Passport V Operating Instructions 0070- 0-0704-02 ix

Introduction Warn ings

WARNING: Due to physiologic differences in the patient population, the

Passport V may occasionally not alarm or may sound a false alarm for some arrhythmia patterns. The arrhythmia analysis feature is intended to detect ventricular rhythms only. High-risk patients should be kept under close surveillance.

WARNING: Trace Gas Hazard - When using the optional Gas Module, a

health hazard exists when trace amounts of vaporized anesthetic agents are chronically inspired by operating room personnel. See Appendix A in NFPA 56A on Inhalation Anesthetics. During any procedure where such agents are employed, the Gas Module exhaust output should be connected to a medical gas-scavenging system.

WARNING: Connection of the Gas Module exhaust port to the hospital’s

waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. Vacuum (negative pressure) should not exceed 1 mmHg at the Gas Module Pump Exhaust fitting. Excessive scavenge vacuum may result in damage to the Gas Module’s internal pump.

WARNING: When monitoring CO

nasal cannula is 150ml/min with the DPM CO

, the maximum sampling rate at the

module. This

device should not be used on patients whose breathing could be impaired by these vacuum flow rates.

WARNING: When monitoring an anesthesized patient in an operating room

environment, connection from the exhaust port of the Passport V to the hospital’s waste gas scavenging system is recommended to prevent exposure of hospital personnel to the patient’s respiratory sample.

WARNING: When using the Gas Module, the maximum sampling rate at

the nasal cannula is 200 ml/min (120 ml/min for Gas Module 3 with a neonatal water trap). This device should not be used on patients whose breathing could be impaired by this vacuum flow rate.

WARNING: Operation of the Passport V below the minimum amplitude or

value of PATIENT physiological signal may cause inaccurate results.

WARNING: Use of ACCESSORIES, transducers and cables other than those

specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Passport V. It can also cause delayed recovery of the monitor after the discharge of a cardiac defibrillator.

x 0070- 0-0704-02 Passport V Operating Instructions

War nin gs Introduction

WARNING: Use of the Passport V in the vicinity of explosive anesthetics

and in the presence of electromagnetic interference or power overloads caused by electrosurgical or diathermy instruments could create a potential hazard or could damage the monitor.

WARNING: The use of gas sampling accessories in Gas Module 3 other than

those specified may cause significant measurement errors and patient risk.

WARNING: Use of accessories, transducers and cables other than those

specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Gas Module 3.

WARNING: With the exception of stacking on a Gas Module with the

appropriate mounting brackets, the Passport V should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Passport V and Gas Module should be observed to verify normal operation in the configuration in which they will be used.

WARNING: If the water trap breaks or becomes damaged during

operation, there is a risk that bacteria and/or mucus may contaminate the Gas Module.

WARNING: The Gas Module must not be used with flammable anesthetic

agents.

WAR N ING: SpO

sensors, SpO2 accessories, and temperature probes

should be disposed of in accordance with local regulations.

WARNING: Shut down the monitor and disconnect all power cords from the

outlet before cleaning.

™

WARNING: Connect only DRYLINE

gas sampling lines to the water trap. Note that there may be other compatible tubes present that must not be used (e.g. IV lines).

™

WARNING: Do not use DRYLINE

nuts) with DRYLINE

™

DRYLINE

Adult/Pediatric sampling lines (colorless Luer lock

nuts) with DRYLINE

Neonatal sampling lines (blue Luer lock

™

Adult/Pediatric water traps. Do not use

™

Neonatal water traps. These

configurations could result in incorrect measurement data.

WARNING: Do not use Adult/Pediatric type water traps and/or sampling

lines with neonates to avoid high sampling flow.

WARNING: The contents of the Gas Module water trap should be handled

as a potential infection hazard. The water trap, sampling line and airway adapter should be disposed of in accordance with local regulations for contaminated and biologically hazardous items.

Passport V Operating Instructions 0070- 0-0704-02 xi

Introduction Precautions

WAR N ING: CO

WARNING: Use the recommended cleaning methods for the DRYLINE

WARNING: A hazard can exist if different alarm presets are used for the

WARNING: The user should check that the current alarm settings on the

FilterLines® should be treated as biohazardous waste and

disposed of in accordance with local regulations for contaminated and biologically hazardous items.

™

water traps. Do not clean or wash the filter housing of the water trap. Never allow alcohol to enter the filter housing. Never force air through the water trap.

same or similar equipment in any single area.

Passport V monitor are appropriate prior to use on each patient.

Precautions

CAUTION: Always place the monitor on a rigid, flat surface or on

approved mounts. Do not block ventilation or speaker vents.

CAUTION: Do not carry the Passport V using the integrated grip handle if

the unit is mounted to another item (e.g., a rolling stand or Gas Module 3).

CAUTION: Never place fluids on top of this monitor. In case of accidental

spillage, wipe clean immediately and have the monitor serviced to ensure no hazard exists.

CAUTION: To avoid possible damage to the Passport V, and to provide

protection against the effect of the discharge of a cardiac defibrillator and against burns, use only approved ECG cables and approved accessories listed in the Accessories chapter.

CAUTION: To prevent condensation, allow the Passport V to warm up and

dry if it is moved from a cold to warm location.

CAUTION: The Passport V may not meet its performance specifications if

stored or operated outside of specified temperature and humidity ranges.

CAUTION: Prior to use, be sure the rail supporting the bed rail mounting

hook can support the weight of the monitor. Consult the bed manufacturer’s specifications if necessary. The Company is not responsible for injury or damage resulting from improper or inadequate support of the monitor.

CAUTION: Use the power cord provided with the product. If a substitute is

necessary, use only hospital grade power cords.

xii 0070- 0-0704-02 Passport V Operating Instructions

Precautions Introduction

CAUTION: Line Isolation Monitor transients may resemble actual cardiac

waveforms, thus inhibiting heart rate alarms. Check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques.

CAUTION: Blood pressure cuffs must be used with the manufacturer’s

correct and approved hoses.

CAUTION: Please consult a physician for interpretation of blood pressure

measurements.

CAUTION: A blood pressure measurement can be affected by the position

of the patient, and his / her physiological condition as well as other factors, such as patient movement.

CAUTION: Observe caution on all patients (Neonates, Pediatrics, and

Adults), when NIBP is set to STAT Mode or the 1-minute interval, to minimize the possibility of nerve injury occurring during use of automatically cycled blood pressure cuffs.

CAUTION: Observe caution when NIBP measurement is performed on

patients suffering from sickle cell disease, or are expected to have skin injuries.

CAUTION: Observe caution when NIBP measurement is performed on a

patient’s limb with venous transfusion or catheters.

CAUTION: Tissue damage or inaccurate measurements may be caused by

incorrect SpO

sensor application or use, such as wrapping too

tightly, applying supplemental tape, failing to inspect the sensor site periodically, or failing to position appropriately. Carefully read the sensor directions for use, the Passport V Operating Instructions, and all precautionary information before use.

CAUTION: Inaccurate SpO

measurements may be caused by:

• Incorrect sensor application or use

• Significant levels of dysfunctional hemoglobins, (e.g.,

carboxyhemoglobin or methemoglobin)

• Intra-vascular dyes such as indocyanine green or

methylene blue

• Exposure to excessive illumination such as surgical

lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or excessive ambient light. In such cases, cover the sensor site with opaque material

• Excessive patient movement

• Venous pulsations

• Electro-surgical interference

Passport V Operating Instructions 0070- 0-0704-02 xiii

Introduction Precautions

• Placement of a sensor on an extremity that has a blood

pressure cuff, arterial catheter, or intra-vascular line

• Nail polish or fungus

CAUTION: In certain situations in which perfusion and signal strength are

low, such as in patients with thick or pigmented skin, inaccurately low SpO

readings will result. Verification of

oxygenation should be made, especially in preterm infants and patients with chronic lung disease, before instituting any therapy or intervention.

CAUTION: Many patients suffer from poor peripheral perfusion due to

hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.

CAUTION: Prolonged and continuous monitoring may increase the risk of

skin erosion and pressure necrosis at the site of the sensor. Check the SpO

sensor site frequently to ensure proper

positioning, alignment and skin integrity at least every eight (8) hours; with the Adult and Pediatric re-usable finger sensor, check every four (4) hours; for neonates and patients of poor perfusion or with skin sensitive to light, check every 2 - 3 hours; more frequent examinations may be required for different patients. Change the sensor site if signs of circulatory compromise occur.

CAUTION: When equipped with Masimo SET

Oxygen Transducers including Masimo SET LNOP

SpO2, use only Masimo SET

and LNCS® Patient Dedicated Adhesive Sensors and Masimo SET PC Series Patient Cables. Use of other oxygen transducers may cause improper oximeter performance.

CAUTION: When equipped with Nellcor

transducers including Nellcor Oxisensor

SpO2, use only Nellcor oxygen

and OxiMax® patient dedicated adhesive sensors. Use of other oxygen transducers may cause improper oximeter performance.

CAUTION: When equipped with DPM SpO

, use only DPM oxygen sensors

and cables. Use of other oxygen sensors may cause improper oximeter performance.

CAUTION: Vacuum (negative pressure) should not exceed 1 mmHg at the

Passport V Pump Exhaust fitting. Excessive scavenge vacuum may result in an Occlusion message or damage to the Passport V’s internal pump. The scavenging system must be on during calibration.

CAUTION: When cleaning SpO

sensors, do not use excessive amounts of

liquid. Wipe the sensor surface with a soft cloth, dampened with cleaning solution. Do not attempt to sterilize.

xiv 0070- 0-0704-02 Passport V Operating Instructions

Precautions Introduction

CAUTION: Some disinfectants may cause skin irritation. Please rinse cuff

thoroughly with water to remove any residual disinfectants.

CAUTION: The internal sampling system of the Gas Module does not need

to be cleaned or sterilized. There is no reverse flow back to the patient. If the internal sampling system is suspected to be clogged or dirty, the module should be serviced by an authorized service person only.

CAUTION: To avoid permanent damage, do not expose metal components

(pins, sockets, snaps) to disinfectants, soaps or chemicals.

CAUTION: Do not connect NIBP Luer fittings to Blood Pressure Cuff or

Monitor.

CAUTION: Some pacemakers may contain a respiratory sensor that may

produce artifact on an ECG waveform.

CAUTION: The monitor display provides data and waveform information

over its entire area. Do not cover any part of the monitor display with tape or labels.

CAUTION: A functional tester cannot be used to assess the accuracy of the

pulse oximeter probe or a pulse oximeter monitor.

CAUTION: Replace lithium-ion batteries with part number

M05-010001-06 (Mindray) or 0146-00-0099 ONLY.

CAUTION: Gas Module 3 must be moisture protected whenever

transported. This can be done with a protective plastic bag in which water-absorbing materials (e.g. silica gel) have been included.

CAUTION: Contamination with CO

, N2O or Anesthetic Agent in the air

surrounding the Gas Module may cause significant measurement errors. The Gas Module exhaust output should be connected to a medical gas-scavenging system.

CAUTION: The Passport V monitor is not compatible with 700 Series

temperature probes.

CAUTION: Do not unplug the storage device from any of the SB ports on

the Passport V while transferring data, as indicated on the menu or prompt areas of the monitor. Data may be lost or corrupted and the storage device may become damaged.

Passport V Operating Instructions 0070- 0-0704-02 xv

IntroductionAvoid simultaneous contact with the patient and the SP1 and SP2 ports on the Passport V to avoid excessive leakage current.

CAUTION: Devices connected to the Passport V must meet the

requirements of the applicable IEC standards (e.g., IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. Any personnel who connects devices to the signal input/output port of the Passport V is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1-1. Please contact Technical Support if you have any questions about connecting devices to the data port.

CAUTION: The Gas Module must be power cycled if the Passport V monitor

is powered off.

Avoid simultaneous contact with the patient and the SP1 and SP2 ports on the Passport V to avoid excessive leakage current.

Notes

NOTE: This unit is not designed to be used with a peripheral pulse

sensor. SpO used to obtain a plethysmograph waveform and heart rate.

NOTE: The comparison testing conducted via the auscultatory method

used both Phase 4 and Phase 5 Korotkoff sounds. Reports of study findings for both the auscultatory method as well as the intra-arterial methods are available by contacting Technical Support (800) 288-2121, ext. 8116 or (201) 995-8237.

NOTE: Potential hazards due to errors in software or hardware have

been minimized by actions taken in accordance with IEC 606011-4.

is a standard function in this monitor, and may be

xvi 0070- 0-0704-02 Passport V Operating Instructions

Intended Use Introduction

Intended Use

The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V monitor include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3- or 5-lead measurements

• Heart Rate derived from selected sources (ECG, IBP, SpO2)

• Pulse Oximetry (SpO2)

• ST Segment Analysis derived from 3 or 5 ECG lead measurements

• Arrhythmia Detection derived from 3 or 5 ECG lead measurements

• Non Invasive Blood Pressure (NIBP)

• Invasive Blood Pressure (IBP) - up to two (2) channels

• Respiration Rate/waveform derived from ECG or CO

•CO2, inspired and end tidal waveform

• Anesthetic agents, O

•Temperature

• IV Drug Calculations The target populations are adult, pediatric, and neonate; except Arrhythmia Detection and

ST Segment Analysis for which the target populations are adult and pediatric only; and IV Drug Calculations for which the target population is adult only.

(inspired and expired)

Unpacking

Remove the instrument from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Service Department at (800) 288-2121 or (201) 995-8237 (U.S.A and Canada), or (201) 265-8800 (outside U.S.A. and Canada) for prompt assistance in resolving shipping problems.

Passport V Operating Instructions 0070- 0-0704-02 xvii

Symbols and Descriptions

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Electrical Hazard Type BF Equipment

Shock Hazard Defibrillator Proof Type BF Equipment

Equipotentiality Defibrillator Proof Type CF Equipment

Alternating Current (AC)

Direct Current (DC)

Power On/Off

Data Input Earth (Ground)

Data Output Protective Earth (Ground)

Type B Equipment

Alarm Off Icon

Alarm Silence Icon

Alarm Silence Permanently Icon

Data Input/Output Full Battery

Gas Port Input Low Battery

Gas Port Output No Battery Present

Chart Local Printer Output Battery Charging

Video Output

NIBP Connection Manufacturer

Separate treatment from general waste at end of life

xviii 0070- 0-0704-02 Passport V Operating Instructions

Interference may occur in the vicinity of equipment marked with this symbol

For single-patient use only, do not reuse. Manufacturer’s reference/catalogue

number

For Neonatal use Manufacturer’s batch number

Not for Neonatal use Serial number

Classified by Underwriters Laboratories

Inc. with respect to electric shock, fire Conformité Européenne (CE) Marking of Conformity to European Medical Device Directive. CE Body number

represents the Notified

XXXX

and mechanical hazards, only in

accordance with UL 60601-1, CAN/

CSA C22.2 NO.601-1, IEC 60601-1-1,

IEC 60601-2-25, IEC 60601-2-27, IEC

60601-2-30, IEC 60601-2-34, IEC

60601-2-49.

CS1 Port Connection

Wireless Enabled and not communicating

The wireless status icon indicates that the

2.4 GHz radio is activated.

SB Storage Device Connection

Passport V Operating Instructions 0070- 0-0704-02 xix

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xx 0070- 0-0704-02 Passport V Operating Instructions

1.0

General Product Description

FIGURE 1-1 The Passport V Patient Monitor

Passport V Operating Instructions 0070- 0-0704-02 1 - 1

General Product Description General Product Description

1.1 General Product Description

The Passport V is a vital signs monitor intended for intrahospital use on human patients.

The Passport V is a three (3) to eight (8) trace monitor. The unit has many features and functions, yet is easy to use through an integrated keypad, Navigator Knob and an intuitive menu system.

The Passport V has a 12.1 inch color display and comes standard with 3 or 5-lead ECG, Masimo SET IV Drug Calculations, and support for Gas Module 3 connectivity.

The Passport V may be configured to suit your department by adding software and hardware optional features. Optional software features include ST and Arrhythmia analysis. Optional hardware features include up to 2 Invasive Blood Pressure Channels, DPM CO MicroStream Local Printer, and 2.4 GHz wireless networking.

Digital displays are provided for Heart Rate, Non-invasive Blood Pressure (NIBP), Pulse Oximetry (SpO2), Respiration Rate, and Temperature. Optional digital areas provided for Invasive Blood Pressure (up to two), Anesthetic Agents, O The optional local printer provides hard copies of all digital data and waveforms as well as trend information.

SpO2, Non-invasive Blood Pressure, Respiration, Continuous Temperature and

CO2, Anesthetic Gases, DPM SpO2, Nellcor® OxiMax® SpO2, three-trace

and N2O, ST, CO2, and MAC.

When powered on, the self-check feature of the Passport V provides verification of proper operation.

The Passport V monitor can be mounted on a rolling stand, a wall mount bracket, gas machine arm, bedrail, Gas Module or operated as a tabletop instrument.

The Passport V has the capability of interfacing with Gas Modules, Remote Displays, Defibrillators, and Nurse Call Systems.

The Passport V monitor is powered by an AC connection or internal batteries.

The Passport V provides Remote View. This feature enables the user to view the numeric and waveform data of another patient who is being monitored at a remote location.

1 - 2 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Key Features

1.2 Key Features

FEATURES STANDARD OPTIONAL

Display 12.1 inch color liquid crystal

display Automatic Sensor Detection and

Wave form Displ ay 8-trace erase bar refresh

ECG 3 or 5-lead

(I, II, III, aVR, aVL, aVF, V) ECG Cascade Arrhythmia Analysis

ESIS Capability (3 or 5-lead) Blood Pressure Non-Invasive Blood Pressure Up to 2 channels of Invasive Blood Pressure SpO

Temperature One channel for 400 series

Respirations Lead-selectable Impedance DPM CO

Trend Tabular and Graphic trends with

Power Internal isolated power module Second lithium-ion battery

Printing Local Printer, Remote Printer External

Interfaces

Calculation IV drug calculations Other Soft Grip Handle Mounting kits

Masimo SET

probes

6000 trend data entries

Lithium-ion battery

Gas Module, Nurse Call systems,

DIAP communications,

Defibrillator sync, Ethernet

network

Navigator Knob Patient and monitor data transfer

Dedicated keys

External Remote Color Display (SVGA)

ST Analysis

DPM SpO2, Nellcor® OxiMax® SpO

, Microstream® CO

Gas Module with Automatic Agent ID

Wireless network

Multi-language supported interface

Passport V Operating Instructions 0070- 0-0704-02 1 - 3

English, French, German, Italian,

Spanish, Brazilian-Portuguese,

Russian,Dutch

Keys and Front Panel General Product Description

1.3 Keys and Front Panel

The front panel keys are used to access many main functions quickly and easily. The figure below shows the keys and a brief explanation follows.

FIGURE 1-2 Front panel keys and Navigator Knob

1. Lead

Press this key to select the next ECG lead to display in Waveform 1. Each time you press this key, the next available ECG lead displays.

2. Size

Press this key to select the next available size of ECG for Waveform 1. Each time you press this key, the next available ECG size displays. When the largest ECG size is displayed, the next key press displays the smallest size.

3. View

Press this key to see multiple leads of ECG when using the 5-lead ECG cable. Press this key repeatedly to toggle between multi-lead view, large numeric display, and normal screen.

4. Start

Press this key to begin an NIBP measurement or to begin or re-start automatic interval measurements.

5. Interval Press this key to modify the NIBP interval measurement time. The choices are: Off, STAT, 1

min, 2 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hr, 2 hr, or 4 hr.

If Off is selected, NIBP measurements can be performed manually only. If STAT is selected, measurements will be continuous for a period of 5 minutes. Afterward, the monitor will switch to 5-minute intervals.

6. Stop

Press this key to stop any NIBP measurement. If the interval mode is activated, pressing this key disables the interval mode measurements. An NIBP: Idle message displays until the interval mode is restarted.

1 - 4 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Keys and Front Panel

7. Zero All (with IBP option)

Press this key to set the current pressure for all invasive pressure channels to zero. This key does not affect any channels monitoring pressure. If the zero process is not successful, one of the following messages is displayed: Pulsatile Pressure. Cannot Zero! or Pressure

Overrange. Cannot Zero!

8. Limits

Press this key to display the Alarm Settings Menu. The Alarm Settings Menu provides access to view or change alarm values.

9. Silence All

Press this key to suspend audio alarms on all parameters. The alarms remain suspended for a user selected amount of time. This amount of time is set in the Alarm Setup Menu. While the alarms are suspended, an Alarm Silence icon and message All Alarms Silenced For X:XX mins display in the upper area of the screen. X:XX is the time remaining in minutes and seconds. Press this key again during the suspended alarm time to re-enable the audio alarm. If the suspend time was set to Permanent in the Alarm Setup Menu, the message All Alarms Silenced Permanently is displayed. Note that the Permanent selection will be available only if Enable Silence All Permanent Selection is set to “Yes” in the

Installation Menu.

10. Silence

Press this key to suspend audio alarms on all currently alarming parameters. The alarms remain suspended for a user selected amount of time as set in the Alarm Setup Menu or until the alarm condition is no longer present. Any new alarms that occur while the alarm tone is silenced will disable the silence and sound the alarm tone. While the alarms are suspended, an Alarm Silence icon and message Alarm Silenced For X:XX mins display in the upper area of the screen.

11. Strip

Press this key to initiate a printout to the selected device.

• If the print destination is the local printer, then pressing this key will produce a print strip of up to three (3) waveforms. The print length (16 or 32-seconds) can be set in the Print Setup menu. Pressing this key during a print job will abort the strip printout.

• If the print destination is a remote Central Station, then pressing this key will initiate a printout at the Central Station.

• If the print destination is a remote printer, then pressing this key will initiate a printout at the remote printer.

12. Cont ECG

Press this key to initiate a continuous ECG 1, 2, or 3 waveform printout from the internal printer. Press this key again to abort printing. The first three ECG waveforms displayed on the screen are printed continuously in real-time. If only one or two ECG waveforms are displayed on the screen, they will be printed.

Passport V Operating Instructions 0070- 0-0704-02 1 - 5

Keys and Front Panel General Product Description

13. Print Trend

Press this key to initiate printing of the displayed trend. By default, the monitor’s stored trend information will be printed by the internal printer. Pressing this key during a print job will abort printing.

• If the print destination is a remote Central Station, then pressing this key will initiate a trend report at the Central Station.

• If the print destination is a remote printer, then pressing this key will initiate a trend report at the remote printer.

14. Standby

Press this key to place the Passport V into a STANDBY mode. While in STANDBY mode, monitoring is discontinued and the alarms are in permanent suspension, interval NIBP measurements are placed in idle mode, CO The monitor notifies the central station and other monitors.

pump is shut off, and the display shuts down.

Except for the power on/off switch

and the STANDBY key, all the other hard keys on the front panel are disabled. When in the STANDBY mode, the message To Begin Monitoring, press Standby. is displayed.

NOTE: Trend data is not cleared in the STANDBY mode. When the

STANDBY mode is released, NIBP INTERVAL is in IDLE MODE and requires reactivation via the START key. The CO automatically reactivates if the DPM or Microstream is in place.

pump

sensor

Press the Standby key to exit the STANDBY mode and return to the normal screen. When exiting from the standby mode to the monitoring mode, the monitor responds as follows:

• Restores parameter measurement: Start arrhythmia relearning. Gas modules recover the working status before the standby mode. NIBP measurement will not start automatically.

• Restores normal data storage.

• All the alarms are activated.

• The screen becomes the one displayed before the standby mode.

• The function of auxiliary output is restored.

• The functions of input devices (such as the hard keys on the front panel) are activated.

• The monitor notifies the central station and other monitors.

15. Discharge

Press this key to discharge a patient.

16. Mark Event

Press this key to cause a time stamp event marker to be noted in the trend memory.

17. Trends

Press this key repeatedly to toggle through the following screens: Quick Trend, List Trend, Graphic Trend, and normal screen (or OxyCRG, if the patient size is set to Neonate).

18. Normal Screen

Press this key at any time to return the screen to the normal monitoring mode. All menus are closed.

1 - 6 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Keys and Front Panel

19. Navigator Knob

Rotate this knob to highlight the various menus or functions on the display. Press the center of the knob to select the highlighted item. Selecting the item may open a menu, perform a function, or select an option.

20. Battery Charging LED

A green LED located above the battery icon indicates that the battery charger is active. The charger will not always be active when AC power is present. It is dependent on the battery charge condition. The LED is not an indication of the condition of the batteries or their charge level. Charged batteries must be installed in the monitor to ensure uninterrupted operation while switching from AC to battery power.

21. AC Power LED

A green LED located above the AC present icon is used to indicate that the unit is connected to the AC power.

Passport V Operating Instructions 0070- 0-0704-02 1 - 7

Display General Product Description

1.4 Display

The display of the Passport V provides menus, waveforms, parameter information, and messages. The Passport V includes a display setup function that allows customization of the display. Preferred setup details can be programmed and saved.

The operator of the Passport V should be positioned in front of the monitor at a comfortable distance to view all displayed waveforms and text.

Main Menus

Message

Area A

Waveform

Area

Message

Area B

Parameter

Menus

Numeric

Tiles

Status Icon

Area

FIGURE 1-3 Normal Screen Display

1. Waveform Area

The waveform area is used to display windows which contain parameter waveforms. Up to 8 waveforms may be displayed. The top waveform is always set to display the ECG waveform and cannot be changed. By default, SpO

(Pleth) waveform will appear as the second

waveform. Respiration will appear as the third waveform. If pressure transducers are plugged into the P1 and P2 ports, the screen will reformat to display the additional waveforms. CO

will display as the fourth waveform; IBP will appear as the fifth and sixth

waveform. The setup can be changed to display any of the available parameters and waveforms.

1 - 8 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Display

2. Main Menus

The Main Menus of the Passport V are always displayed in the upper area of the screen and are accessed using the Navigator Knob. The Main Menu headings are Patient, Monitor Setup, Print Setup, Parameters, and Functions. These menus enable the user to enter patient specific data, customize the monitor, setup printing or transfer patient data.

The Functions Menu provides the following choices: Normal Screen, Remote View,

Drug Calculator, Copy Patient Data to Storage Device, Copy Patient Data from Storage Device, and System Information.

The Normal Screen selection returns the view to the normal screen.

There are two options for data transfer. Copy patient data to Storage Device and Copy patient data from Storage Device options allow for the transfer of patient specific data from monitor to monitor.

3. Parameter Menus

The Parameter Menus enable the user to review and customize various parameter display and alarm attributes. Use the Navigator Knob to access these menus. Parameters supported include: ECG, ST, ART, CVP, SpO

, NIBP, Resp, CO2 (optional), and Gas (optional).

4. Numeric Tiles

The numeric tiles display digital data for each available parameter.

5. Status Icon Area

Battery Status Icon: When batteries are installed and the monitor is functioning on battery power, the battery indicator provides a visual reference for the approximate charge level of the batteries. See the following examples.

Full Battery Low Battery No Battery Present

When the battery charge is low, but not below the cutoff voltage, a flashing low battery icon is displayed and a special low battery sound is activated.

WARNING: To ensure that alarms can sound if the Gas Module/Passport

V loses power, at least one charged battery must be installed in the Passport V at all times.

NOTE: At least 15 minutes is available to turn off the monitor or

insert a new battery after the low battery alarm occurs.

Passport V Operating Instructions 0070- 0-0704-02 1 - 9

Display General Product Description

CS Status Icon: If displayed, the CS status icon indicates that the CS1 port is connected to another device.

CS1 Port Connection

Wireless Status Icon: If displayed, the wireless status icon indicates that the 2.4 GHz radio is activated.

2.4 GHz Radio Activated

If displayed, the wireless status icon indicates that wireless enabled and NOT communicating.

Wireless Enabled

NOTE: It applies to Version 01.04.00 and higher.

SB Status Icon: If displayed, the SB status icon indicates that a storage device has been connected to the SB port.

SB Storage Device Connection

6. Message Area A

This message area is located above the ECG waveform window. Messages regarding the ECG/heart rate, alarm status, physiological alarms, and technical alarms are displayed here.

• Physiological alarms are located on the left side.

• Technical alarms are located on the right side.

• ECG prompts are located at the top of waveform 1.

7. Message Area B

This message area is located below the last row of numeric tiles. Messages regarding NIBP, IBP, printer status, system status, SpO

, CO2, and Gas Module are displayed here.

8. Alarm Status Icon Area

This area displays an Alarm Off icon if any alarm for a monitored parameter has been set to Off. This area will display an Alarm Silence icon if an alarm has been silenced.

1 - 10 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Physical Views

1.5 Physical Views

1.5.1 Front View

FIGURE 1-4 Front Panel

1. Front Panel Hard Keys

Provides access to most main functions.

2. Navigator Knob

Rotates clockwise and counter-clockwise to navigate through menu selections. It also can be pressed to select a highlighted item.

3. Display

Displays all waveforms and numeric data.

4. Alarm Light

Indicates that an alarm has been activated.Alarm Light (not shown). The WARNING (or Priority 1) LED is red. The CAUTION (or Priority 2) LED is yellow.

Passport V Operating Instructions 0070- 0-0704-02 1 - 11

Physical Views General Product Description

1.5.2 Rear View

MP1

SB1 SB2

RD1

CS1

SP1

SP2

FIGURE 1-5 Rear Panel

1. Soft Grip Handle

Provides a secure method to carry the monitor.

2. AC Receptacle (with an integrated cord retension clip)

Provides an inlet for an AC power cord.

3. Equipotential Lug

Provides equipotential grounding of hospital equipment.

4. Main I/O Connector Ports

Area dedicated for the use of an optional communication port.

• MP1: Allows connectivity to one of the following: Nurse Call or Defibrillator.

• SB1, SB2: Allows copying and transferring of patient data and user settings.

• RD1: Allows duplicate display of the main display on an SVGA-compatible monitor.

• CS1: Allows connectivity via an RJ45-based network.

• SP1, SP2: Allows connectivity to Gas Module 3 and DIAP.

1 - 12 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Physical Views

1.5.3 Left Side Panel

FIGURE 1-6 Left Side Panel

1. P1 Connector (optional)

2. P2 Connector (optional)

3. T1 Connector

4. ECG/EKG Connector

5. SpO2 Connector (Masimo or Nellcor shown in figure)

6. NIBP Rectus Connector

7. Battery Compartment

8. CO

9. CO

Input (Optional DPM CO2 shown in figure)

Exhaust Connector

Passport V Operating Instructions 0070- 0-0704-02 1 - 13

Physical Views General Product Description

1.5.4 Right Side Panel

FIGURE 1-7 Right Side Panel

1. Power Switch

A momentary switch that turns power ON or OFF but does not prevent charging of the batteries. Press the top of the switch once to turn the unit ON. Press the top of the switch again to turn the unit OFF.

2. Local Printer (optional)

A thermal strip chart local printer with integral paper spool.

1 - 14 0070- 0-0704-02 Passport V Operating Instructions

General Product Description Physical Views

1.5.5 Top View

FIGURE 1-8 Top Vie w

1. Soft Grip Module Handle

This integrated grip handle is used for carrying the Passport V.

WARNING: Do not carry the Passport V using the integrated grip handle

if the unit is mounted to another item (e.g., a rolling stand or Gas Module 3).

Passport V Operating Instructions 0070- 0-0704-02 1 - 15

Physical Views General Product Description

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1 - 16 0070- 0-0704-02 Passport V Operating Instructions

2.0

System Configuration

2.1 Installation Menu

The Installation Menu allows the user to change and save default configuration settings for the Passport V, such as date format, time format, and temperature units. All the hard keys are disabled (except the Navigator Knob) in Installation Mode.

FIGURE 2-1 Installation Menu

Passport V Operating Instructions 0070- 0-0704-02 2 - 1

Installation Menu System Configuration

To access the Installation Menu:

1. Turn off the Passport V.

2. Press and hold the Discharge key on the front panel.

Simultaneously, power up the Passport V monitor.

3. Release the Discharge key when the Installation Menu is displayed.

4. Set each item as necessary using the Navigator Knob.

5. To save all of the chosen settings, choose “Save Current” before leaving this menu.

6. To return to normal operating mode, cycle power to the Passport V monitor.

The following table describes the Installation Menu structure:

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Save Current Select to save current

settings as defaults.

Select Language ENGLISH

Date Format Y/M/D

Time Format 12 hour

NIBP Timeout 15 min

Temperature Units °F

Weight Units lbs

Height Units inches

Units mmHg

ECG Standard AHA

FRENCH GERMAN ITALIAN SPANISH PORTUGUESE RUSSIAN DUTCH

M/D/Y D/M/Y

24 hour

30 min 45 min 60 min

°C

% kPa

IEC

Set up at factory Select to change language.

M/D/Y Select to change date

12 hour Select to change time

15 min Select to change NIBP time

°F Select to change

lbs Select to change weight

inches Select to change height

mmHg Select to change CO

AHA Select to change standard

format.

out.

temperature units. Changing temperature units will cause temperature alarm limits to be restored to default values.

units.

units. Changing CO will cause CO to be restored to default values.

for ECG.

units

alarm limits

2 - 2 0070- 0-0704-02 Passport V Operating Instructions

System Configuration Installation Menu

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Notch Filter 50 Hz

60 Hz

60 Hz Select to change notch filter

for ECG.

Off

ESU Filter Auto

Disable

SpO Audio

Sensor Off

Off Once Repeat

Tones Standard Tones

SpO

Enable Arrhythmia All Off Selection

Alternate Tones Yes

Auto Select to change the ESU

filter.

Off Select to change the SpO2

Sensor Off Audio alert type.

Standard Tones Select to change the SpO2

tones.

No Select to enable or disable

the Arrhythmia All Off menu selection.

Apnea Latch On

Off

Enable Silence All Permanent Selection

Yes No

On Select to turn apnea alarm

latching on or off.

No Select to enable or disable

the Permanent Audio Off menu selection.

Auxiliary Output Nurse call

Analog Output Defib Sync

Nurse Call Mode Normally Open

Normally Close

Set up Serial Port 1 None

Nurse Call Select to change the

function of the Auxiliary Output interface.

Normally Open Select to change the type

of Nurse Call system

None Select to set up comm port. DIAP Gas Module

Set up Serial Port 2 None

None Select to set up comm port. DIAP Gas Module

Copy Monitor Defaults to Storage Device

Copy Monitor Defaults from Storage Device

Select to copy monitor defaults to Storage Device.

Select to copy monitor defaults from Storage Device.

Re-boot in demo mode No

Yes

No Set to “YES” to start the

monitor in demonstration mode on next power-up. Normal monitoring will resume after cycling power in demonstration mode.

Restore factory defaults

Advanced Installation Setup

Select to restore factory defaults

Select to access Advanced Installation Setup Menu.

Change Password Select to change

password.

Options Select to add/view

options.

Passport V Operating Instructions 0070- 0-0704-02 2 - 3

Advanced Installation Setup Menu (Network) System Configuration

2.2 Advanced Installation Setup Menu (Network)

Use the Advanced Installation Setup Menu for network configuration of the Passport V.

FIGURE 2-2 Advanced Installation Setup Menu

To access the Advanced Installation Setup Menu:

1. Turn off the Passport V.

2. Press and hold the Discharge key on the front panel. Simultaneously, power up the Passport V monitor.

3. Release the Discharge key when the Installation Menu is displayed.

4. Rotate the Navigator Knob to navigate and select the Advanced Installation Setup Menu.

5. Set each item as necessary using the Navigator Knob.

6. To save all of the chosen settings, select Previous Menu

7. To return to normal operating mode, cycle power to the Passport V monitor.

The following table describes the Advanced Installation Setup Menu structure:

〉 Save Current.

2 - 4 0070- 0-0704-02 Passport V Operating Instructions

System Configuration Advanced Installation Setup Menu (Network)

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Previous Menu Select to return to previous

menu.

DIAP Baud Rate 9600

19200

Enable Network Wired

Wireless

Connect To Central Station

IP Address 7.6.6.50 Select to set up the IP

Subnet Mask ID 255.255.255.0 Select to set up subnet

Configure Wireless AP Press to enable or disable

Search Printer Select to search for printers

Select Printer Select to change the target

Paper Size Select to change the printer

Device ID Set at the factory. Not user-

Yes No

9600 Select to change DIAP

protocol baud rate.

Wired Select to change the type

of communications with Panorama.

Wireless is always displayed as an option, but will function only if the wireless option is installed.

No Select No to disable

communication with the Central Station.

Select Yes to enable communication with the Central Station. If communication has failed, the message “No Arrhythmia Detection at Central” is displayed.

address.

mask ID.

the operation of configuring wireless AP.

on the network.

printer already found.

paper size.

selectable.

Passport V Operating Instructions 0070- 0-0704-02 2 - 5

Monitor Setup Menu System Configuration

2.3 Monitor Setup Menu

Select the Monitor Setup Menu to configure audio and display settings.

FIGURE 2-3 Monitor Setup Menu

To access the Monitor Setup Menu:

1. Power up the Passport V. The normal screen is displayed.

2. Rotate the Navigator Knob to Monitor Setup. Press the knob to select it.

3. Configure the settings as desired.

4. To exit, press the Normal Screen key on the front panel.

The following table describes the Monitor Setup Menu selections:

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Normal Screen Select to return to Normal Screen (or

Display Setup Select to make changes to the display

Alarm Volume low to high volume Mid-level Select to change alarm volume. Beep Volume silence to high volume Mid-level Select to change systole beep volume. Color Select to access Color Setup Menu. Advanced Setup Select to access Advanced Setup

press the Normal Screen key on the front panel).

format. Save as defaults if desired.

Menu.

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System Configuration Advanced Setup

2.4 Advanced Setup

Select the Advanced Setup to configure date, time and other settings.

FIGURE 2-4 Advanced Setup

To access the Advanced Setup:

1. Power up the Passport V. The normal screen is displayed.

2. Rotate the Navigator Knob to Monitor Setup

select it.

3. Configure the settings as desired.

4. To exit, press the Normal Screen key on the front panel.

The following table describes the Advanced Setup selections:

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Previous Menu Select to return to the

Set Date Select to set date. Set Time Select to set time. NIBP Start Mode Interval Mode

Timer Mode

〉 Advanced Setup. Press the knob to

previous menu.

Interval Mode Select Interval mode to

synchronize NIBP Start with the integral clock. Select Timer Mode fo synchronize the NIBP start with the interval selected in relation to the real time clock.

Passport V Operating Instructions 0070- 0-0704-02 2 - 7

Advanced Setup System Configuration

MENU TITLE ON SCREEN MENU CHOICES DEFAULT COMMENTS

Nurse Call Off

1 second Continuous

Arrhythmia Menu Select to open the

Restore User Defaults Select to load user defaults

Save Current Select to save current

Off Select to choose nurse call

activation time.

Arrhythmia Menu.

as current settings.

settings as defaults. Enter password.

2.4.1 How to Set the Clock / Date and Time

The date and time are set in the Monitor Setup Menu 〉 Advanced Setup

1. Using the Navigator Knob, highlight Monitor Setup. Press the Navigator Knob to

open the menu.

2. Use the Navigator Knob to select Advanced Setup, then select either Set Date or Set Time.

3. Turn the Navigator Knob to select a new setting. Once the desired choice is highlighted,

press the Navigator Knob.

4. This setting is saved when Ye s is selected via the confirmation prompt.

2.4.2 Transferring Monitor Default Settings

When installing several Passport V monitors with identical display and alarm settings it is not necessary to set each unit separately. A DPM storage device may be used to copy the settings from monitor to monitor.

NOTE: Use only storage devices supplied by Mindray.

CAUTION: Do not unplug the storage device from any of the SB ports

on the Passport V while transferring data, as indicated on the menu or prompt areas of the monitor. Data may be lost or corrupted and the storage device may become damaged.

2 - 8 0070- 0-0704-02 Passport V Operating Instructions

System Configuration Configuration Management

2.5 Configuration Management

If the monitor is inadvertently powered down (due to power failure or battery depletion), monitor settings are recovered as follows:

• If the monitor is restarted within 60 seconds, the latest user-settings will be restored.

• If the monitor is restarted after 60 but before 120 seconds, the settings restored may be

either the latest user-settings or the user-saved settings.

• If the monitor is restarted after 120 seconds, the user-saved configurations will be

restored.

Passport V Operating Instructions 0070- 0-0704-02 2 - 9

Configuration Management System Configuration

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3.0

Patient Management

3.1 Description

The Passport V comes with default factory settings which enable you to begin monitoring without setting any of the waveforms, parameters, alarms, or functions. However, all of these settings can be changed for specific patient or departmental needs.

Certain operating characteristics are based on the selected patient size (e.g. NIBP start pressure). The patient size selection should be matched to the actual patient before monitoring begins.

Passport V Operating Instructions 0070- 0-0704-02 3 - 1

Setting-up Patients Patient Management

3.2 Setting-up Patients

1. Turn the monitor on using the ON/OFF switch. Ensure the previous patient’s data has been removed from the monitor by discharging previous patient.

2. Connect the patient to the monitor, apply appropriate accessories such as ECG electrodes, blood pressure cuff, etc.

3. Enter patient information into the Passport V via the Patient Menu, check patient size.

4. If desired, press the START key to initiate a non-invasive blood pressure measurement.

3.2.1 Patient Menu

To display the Patient Menu:

1. On the front panel: Press the Normal Screen key to return to the normal screen.

2. On the normal screen: Select Patient by rotating the Navigator Knob.

3. Use the Navigator Knob to enter patient information. Monitor settings are stored for each patient size.

NOTE: Verify monitoring settings when the patient size is changed.

FIGURE 3-1 Patient Menu

3 - 2 0070- 0-0704-02 Passport V Operating Instructions

Patient Management Setting-up Patients

Patient Menu

MENU ITEM SELECTIONS COMMENTS

Normal Screen — Select to return to Normal Screen (or press the

Normal Screen key on the front panel).

Patient Size Adult (default)

Pediatric Neonate

Gender Unspecified (default)

Male

Female Date of Birth Unspecified (default) Select to enter or change date of birth. First Name Select to enter or change patient’s first name. Last Name Select to enter or change patient’s last name. ID # Select to enter or change Patient ID. Bed # Select to enter or change patient bed number. Height Unspecified (default) Select to enter or change patient height. Weight Unspecified (default) Select to enter or change patient weight. Drug Calculator Select to open Drug Calculation Menu. Discharge Select to discharge patient from monitor.

Note: When changing Patient Size, some patient info may need to be re-entered.

Select to enter or change patient gender.

Entering a Patient’s First / Last Name, ID Number and Bed Number

To enter the patient’s First Name, Last Name, ID Number and Bed Number complete the following steps:

1. Open the Patient Menu and scroll down through the menu using the Navigator Knob.

2. Select the patient data you wish to enter or change.

3. Press the Navigator Knob and a keypad will appear on the screen.

4. To enter patient information highlight the appropriate characters.

5. When finished entering the data select Done and press the Navigator Knob to close

the keypad.

6. The patient information will appear in the upper right hand corner of the display. This data will also appear on printouts.

NOTE: Since Remote View requires selecting a “Bed #”, a unique

number for each bed should be used. The following standard format for this demographic is recommended:

Passport V Operating Instructions 0070- 0-0704-02 3 - 3

Discharging a Patient Patient Management

• Start the Bed # with a room number that has a fixed number of digits. For example, if the maximum number of digits that is used in numbering the rooms is 4, then for room 102, a leading zero would be added to get the 4th digit - 0102.

• Follow the room number with a letter to identify the particular bed within the room. For example, a room with 2 beds would have bed A and bed B.

• An example of a complete “Bed #”: Bed B in room 513 (in a facility where there are up to 4 digits in a room number) would be identified as 0513B.

Entering a Patient’s Date of Birth

To enter the patient’s Date of Birth complete the following steps:

1. Open the Patient Menu and scroll down through the menu using the Navigator

Knob.

2. Select Date of Birth from the menu. Press the Navigator Knob and a pop-up window will emerge with day, month and year choices for Date of Birth.

3. To enter the patient’s Date of Birth, turn the Navigator Knob and scroll until you reach the desired dates.

4. When finished with the Date of Birth, press the Navigator Knob to return to the Patient Menu.

3.3 Discharging a Patient

To discharge a patient from the Passport V:

1. On the front panel:

Press the Discharge key or On the normal screen: Select Patient

Discharging a patient from the Passport V clears the following:

• Patient information (except Patient Size and Bed No.)

• Physiological alarms and technical alarms

• Prompt messages irrelevent with the patient management

• Corresponding history data (includes Trend data, Events, OxyCRG Trend data, Dose calculations)

• Operations in process (includes local printing and NIBP measurement)

〉 Discharge

3 - 4 0070- 0-0704-02 Passport V Operating Instructions

Patient Management Data Transfer

3.4 Data Transfer

3.4.1 Transferring User Configuration

Patient configuration and data can be transferred to and from the Passport V via a DPM storage device inserted into the SB1 or SB2 port, located in the back of the unit. The maximum time of data download or upload is about 1 min.

The transferred patient data includes the following:

• Patient demographics (not including Bed No.)

• Trend & Event Data

NOTE: Newly generated trend or event data, or on-going changed

patient demographics may not be transferred during the downloading process.

CAUTION: Do not unplug the storage device from any of the SB ports

on the Passport V while transferring data, as indicated on the menu or prompt areas of the monitor. Data may be lost or corrupted and the storage device may become damaged.

Passport V Operating Instructions 0070- 0-0704-02 3 - 5

Remote View Patient Management

3.5 Remote View

The Remote View selection enables the user to view the numeric and waveform data of another patient monitored by a different Passport V at a remote location.

To display Remote View:

On the normal screen: Select Functions

The Remote View feature allows the simultaneous display of data from two patients on a single monitor. The monitor at the user’s current location is defined as the host monitor. While maintaining visibility of the primary patient at the host monitor, the Remote View Menu enables the user to view the numeric data and two selectable waveforms of another patient who is being monitored at a remote location. The monitor at the remote location is defined as the remote monitor. Visual and audio alarms occurring at the remote monitor are also received through the Remote View Menu at the host monitor

〉 Remote View.

FIGURE 3-2 Remote View Menu on Main Display

The “Enable Network” option in Installation Menu Menu must be set to “Wired” or “Wireless” for Remote View capability to be available. Only Passport V monitors on an approved hardwired or wireless network can be viewed remotely.

NOTE: Unstable wireless signals may be caused by the monitor

operating beyond the network coverage, interference from nearby equipment, or by exceeding network capacity limit.

3 - 6 0070- 0-0704-02 Passport V Operating Instructions

〉 Advanced Installation Setup

Patient Management Remote View

NOTE: Remote View function is not available between wireless

monitors, nor for wireless monitors to view wired monitors. Remote View function is available between wired monitors, or for wired monitors to view wireless monitors.

All Remote View controls are contained within the Remote View Menu. Opening other menus from the monitor’s keypad, or pressing the Normal Screen key, will close the Remote View Menu.

The Remote View Menu displays data as follows:

• The waveforms that are displayed are user-selectable through the Remote View

Setup Menu, as described in the table on page 3-8. Corresponding numeric tiles are displayed to the right of the waveforms. The numeric data for a maximum of fifteen (15) parameters that are not related to the waveforms is displayed in the “Numeric Data Area” located directly below the waveforms.

• The colors of the waveforms and all numeric data correspond to the settings of the host

monitor (not the remote monitor).

• When numeric data for a particular parameter is unavailable, dashes (– – –) are

displayed.

• If a high or low alarm limit has not been set, an Alarm Off icon is displayed.

• Remote View alarms follow the alarm settings at the remote monitor, displaying in a

priority-appropriate, reverse-video color.

• If the remote monitor is placed into Standby mode, the message “In Standby” is

displayed in the Remote View Window.

NOTE: Respiration alarm text messages are also displayed in the

displayed in the message area (upper part) of the Remote View Menu window as follows:

• If Apnea is detected, the message “APNEA” is displayed.

• If CVA is detected, the message “CVA” is displayed.

• If high impedance is detected from the ECG electrodes, the message “CHK LEAD” is displayed.

The Remote View Menu also provides the following menu choices: Normal Screen,

Select Beds, Setup, Remote Silence, Remote Silence All, and Remote Print.

1. Normal Screen — this selection removes the Remote View Menu from the display.

2. Select Beds — this selection opens the Select Beds menu from which beds may be

selected to be included in the care group. All networked beds will be in que but only 8 can be selected.

Passport V Operating Instructions 0070- 0-0704-02 3 - 7

Remote View Patient Management

3. Setup — this selection opens the Remote View Setup Menu shown in FIGURE 3-3. This menu enables the user to configure the display and functionality of the Remote

View Menu.

FIGURE 3-3 Remote View Setup Menu

The following table provides a listing of the Remote View Setup Menu items:

Remote View Setup Menu

MENU ITEM SELECTIONS COMMENTS

Previous Menu Select to return to previous menu. Waveform 1 All waveforms available

on the remote monitor.

Waveform 2 All waveforms available

Remote Silence For 1 min

Remote Silence All For

* These selections will not be available if the language chosen in the Installation Menu is French.

on the remote monitor.

2 min (default) 3 min* 5min* 10 min*

Permanent* 1 min 2min (default) 3 min* 5min* 10 min*

Only waveforms available on the remote monitor will be listed as selections for this menu item. The menu selections for Wave 1 will not include the waveform that is currently selected as Wave 2.

Only waveforms available on the remote monitor will be listed as selections for this menu item. The menu selections for Wave 2 will not include the waveform that is currently selected as Wave 1.

Select to choose duration of Remote Silence.

Select to choose duration of Remote Silence All.

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Patient Management Remote View

4. Remote Silence / Remote Silence All — this selection silences the audio portion of a remote alarm for the duration that is selected from the Remote Silence For / Remote Silence All For list in the Remote View Setup Menu. The factory default is 2 minutes. While the audio alarm is silenced:

• The visual alarm indicators remain displayed.

• The message ALARMS SILENCED FOR X:XX mins is displayed in the message area of the Remote View Menu. The X:XX in the message is a digital timer for the silence time remaining.

• If a new remote alarm occurs during this time, the current alarm will remain silenced while its digital timer continues to count down, and the new alarm tone will sound.

• An Alarm Silence icon is displayed in the top left of the Remote View window.

•If Remote Silence is selected again, the digital timer is reset.

NOTE: The Remote Silence selection silences only the alarms

indicated in the Remote View Menu. It does not silence the primary patient's alarms or alarm sounds at the remote location.

5. Remote Print – Select to request a remote print.

6. Remote Silence All — this selection silences the audio alarm tones of all remote alarms for the duration that is selected from the Remote Silence All For list in the Remote View Setup Menu. The factory default is 2 minutes. While the audio alarms

are silenced:

• the visual alarm indicators remain displayed

• the message All Alarms Silenced For X:XX mins is displayed in the message area of the Remote View Menu. The X:XX in the message is a digital timer for the silence time remaining

NOTE: If “Permanent” is selected from the Remote Silence All For

list, “All Alarms Silenced Permanently” is displayed in the message area of the Remote View Menu.

• an Alarm Silence icon (a crossed bell) is displayed in the numeric tiles and in the “Numeric Data Area”

If Remote Silence All is selected again, the audio alarm tones are re-enabled.

NOTE: The Remote Silence All selection silences only the alarms

indicated in the Remote View Menu. It does not silence the primary patient's alarms or alarm sounds at the remote location.

7. Remote Print — this selection sends a print request to the remote monitor. The printout will be as configured in the Print Setup menu of the remote monitor.

NOTE: When a Remote Print is requested, there is no indication that

the printout was completed as requested. The user should verify the successful print at the printer.

Passport V Operating Instructions 0070- 0-0704-02 3 - 9

Remote View Patient Management

Remote View Message Area

• If more than one message is being received, they are alternately displayed.

• All arrhythmia alarms, priority one alarms, and priority two alarms generate the appropriate audio alerts at the host monitor, and the associated alarm text messages are displayed in the Remote View Message Area. See section 4.7 (pg. 4-25) "Arrhythmia Alarms (optional)" for the specific arrhythmia alarm text messages that can be displayed.

NOTE: The Lethal Arrhythmia alarms (V-Tach, V-Fib, and Asystole)

are latched alarms. They cannot be acknowledged by selecting "Remote Silence "or "Remote Silence All" in the "Remote View Menu". If an alarm is acknowledged while a lethal condition still exists, the audio alert of the alarm will be silenced for XX minutes, where XX is the number minutes selected in “Remote View Menu” 〉 “Setup” 〉 “Remote Silence For” or “Remote Silence All For”. However, the visual alert of the alarm and the alarm message will continue to remain active in the Remote View Message Area.

If a new lethal condition occurs while the initial lethal alarm is silenced, the new lethal alarm will not break through but not be silenced. If the lethal condition is resolved while the alarm is silenced, the alarm will be terminated.

• All alarm messages for parameters are displayed in the Message Area of the Remote View Menu window.

• If Apnea is detected, the message “Apnea” is displayed.

• If CVA is detected, the message “CVA” is displayed.

• Remote View displays Technological Alarm messages and Physiological Alarm messages.

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Patient Management Monitor/Display Troubleshooting

3.6 Monitor/Display Troubleshooting

MESSAGE/PROBLEM REASON SOLUTION

No trace for a desired parameter

Display Appears to be Off Mains power switch may not be

Disabled Alarm Tone Silence key pressed. Check for alarm silence symbol

Cooling Fan Failure The unit running on AC power

Patient Information did not appear on display

Incorrect Date or Time Data not entered or entered

Improper attachment of transducer or cable to monitor.

Faulty transducer or cable. Try a new transducer or cable.

on. Unit may not be plugged into an

AC outlet. If used as a portable, battery

pack may be drained.

Monitor or display is damaged. Contact Customer Support.

Beep volume low. Increase beep volume.

and the cooling fan is not operational.

No data entered. Enter proper patient data. Done was not selected from

keypad after entering data.

incorrectly.

Check transducer / cable connection.

Press mains power switch on side panel.

Check power cord (Is it plugged in?)

If battery pack is drained, plug into an AC outlet to recharge the battery. A period of 5.5 hours (monitor OFF) or 8.5 hours (monitor ON) is required for a full charge of lithium-ion batteries.

and message.

Contact Customer Support.

Go to the proper keypad enter data, select Done when finished.

Follow instructions from “How

to Set the Clock / Date and Time”.

Passport V Operating Instructions 0070- 0-0704-02 3 - 11

Monitor/Display Troubleshooting Patient Management

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4.0

ECG Monitoring

4.1 Description

ECG is a continuous waveform of a patient's cardiac electrical activity. An ECG waveform will display in the first waveform area of the Passport V.

The quality of an ECG signal is directly affected by electrode site skin preparation, electrode patch quality and ECG lead placement. If artifact is present on the ECG waveform, then the arrhythmia processing, alarm processing, and quality of the monitoring function may be affected. The presence of artifact can prevent the monitor from establishing an accurate ECG reference waveform, increasing the difficulty experienced in assessing the ECG rhythm.

Optimizing the ECG signal is imperative for accurate monitoring. Use high quality electrodes, designed to acquire the ECG with excellent base line stability, recovery from defibrillation and minimum artifact from patient movement.

With the Passport V, ECG can be obtained by using a 3- or 5-lead ECG cable in conjunction with a 3- or 5-lead set and skin electrodes. For best performance and safety, inspect the ECG cables and electrodes daily.

Features:

• Provides the function of ECG1 cascade display on the normally monitored screen.

•The Passport V supports the Mortara algorithm (V3.2.8).

• Supports 3- and 5-lead configuration and automatic identification of lead configuration.

• The ECG algorithm includes up to three parts: HR calculation, ST analysis (if installed) and ARR analysis (if installed).

• Displays HR, PVCs and ST segment parameters and ECG waveforms (if installed).

• The ECG waveforms can be displayed normally or in All ECG View (via View key) when a 5-lead leadset is in use.

• When using a 5-lead cable, 3-lead configuration will be selected automatically if the RL lead becomes detached from the patient.

Passport V Operating Instructions 0070- 0-0704-02 4 - 1

ECG Screens ECG Monitoring

4.2 ECG Screens

4.2.1 Numeric Tile: ECG

The ECG numeric tile displays the following:

• ECG label

• HR value, HR unit, HR alarm limits

• PVCs parameter name, PVCs value (not displayed when arrhythmia is OFF or not installed)

• ST segment value (not displayed when ST segment analysis is OFF and Combine HR/ST is set to Off or not installed)

•HR source

NOTE: In Large Numeric Screen, ST values and PVC/min are not

displayed in the ECG numeric tile.

ECG Label HR Unit

High Alarm Limit

Low Alarm Limit

HR Measured Value

PVCs Measured Value

HR Source

FIGURE 4-1 ECG numeric tile without ST displayed

ECG Label HR Unit

High Alarm Limit

Low Alarm Limit

HR Measured Value

ST Unit

PVCs Measured Value

HR Source

ST Values

FIGURE 4-2 ECG numeric tile with ST displayed

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ECG Monitoring ECG Screens

4.2.2 Waveform: ECG

The ECG waveform tile displays the following:

• Every ECG waveform area displays ECG lead name, ECG scale, and filter mode.

• A pacer marker is displayed when an external pace pulse is detected.

• ECG Prompt Messages are displayed in the top of ECG1 waveform area: Message "Pacer Reject On" is displayed in the right top of waveform area. Other ECG prompt messages are displayed in the middle top of ECG1 waveform area.

FIGURE 4-3 ECG waveform, 3-lead normal monitoring (cascade is turned on)

FIGURE 4-4 ECG waveform, 5-lead normal monitoring (2 channel)

Passport V Operating Instructions 0070- 0-0704-02 4 - 3

ECG Screens ECG Monitoring

FIGURE 4-5 ECG waveform, 1mV scale overrange

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ECG Monitoring Front Panel: ECG Keys

4.3 Front Panel: ECG Keys

ECG Keys (Front Panel)

KEY COMMENTS

LEAD Press to change ECG1 lead selection.

The ECG1 menu selection in ECG Menu has the same function. In All ECG View, this key is disabled.

SIZE Press to change ECG1 waveform size.

VIEW Press to display the All ECG View screen. In All ECG View, the order of the

The ECG1 Size menu option in the ECG Sizes Menu has the same function. In All ECG View, this key is disabled.

waveforms displayed is I, II, III, aVR, aVL, aVF, V.

Press this key repeatedly to toggle between multi-lead view, large numeric display, and normal screen.

When returning to Normal Screen from All ECG View, the order of the ECG waveforms is displayed as configured in the ECG Menu.

Passport V Operating Instructions 0070- 0-0704-02 4 - 5

Menus: ECG Main and Submenus ECG Monitoring

4.4 Menus: ECG Main and Submenus

4.4.1 ECG Menu

FIGURE 4-6 ECG Menu

To display the ECG Menu:

1. On the front panel:

Press the Normal Screen key to return to the normal screen.

2. On the normal screen:

Select Parameters or Select the ECG tile.

3. To exit, press the Normal Screen key on the front panel.

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〉 ECG

ECG Monitoring Menus: ECG Main and Submenus

ECG Menu

MENU ITEM SELECTIONS COMMENTS

Normal Screen — Select to return to Normal Screen (or press the

Normal Screen key on the front panel).

ECG 1 ECG 2 ECG 3 ECG 4 ECG 5 ECG 6

Speed

Arrhythmia Menu Select to open the Arrhythmia Menu.

ST Menu Select to open the ST Menu.

Relearn — Select to manually initiate the relearning process for

For 3-lead leadset: I, II, III

For 5-lead leadset: I, II, III, aVR, aVL, aVF, V

Defaults: ECG 1 = II ECG 2 = I ECG 3 = V ECG 4 = aVR ECG 5 = aVL ECG 6 = aVF

6.25 mm/s

12.5 mm/s 25 mm/s (default) 50 mm/s

Select to change ECG lead to be analyzed.

When a 3-lead configuration is detected, only ECG1 is displayed.

When a 5-lead configuration is detected, ECG1 to ECG6 can be displayed.

In Normal screen, the ECG lead displayed can be selected as required.

In All ECG View, the ECG1 to ECG6 options can be selected as required.

The effect of 3-lead and 5-lead switchover: 5-lead to 3-lead: If ECG1 is I/II/III, then ECG1 is unchanged. Otherwise, automatically change to II. 3-lead to 5-lead: ECG1to ECG6 are unchanged from the previous 5-lead setting.

Select to change the trace speed (mm/s) of the ECG waveform. Applies to all ECG leads.

Available only if Arrhythmia option is installed. Disabled if Patient Size = Neonate.

Available only if ST option is installed. Disabled if Patient Size = Neonate.

ST Measurements or Arrhythmia Analysis.

Relearn is disabled if at least one of the following:

• Patient Size = Neonate.

• ST Analysis and Arrhythmia = Off.

• ST Analysis and Arrhythmia are not configured.

After relearning is started, arrhythmia relearning and ST relearning are performed simultaneously. The arrhythmia and ST analysis templates are recreated and the message “Relearning...” is displayed. During relearning, ST and PVCs are displayed as “– – –“.

Arrhythmia relearning should be automatically started when:

• Lead type is changed.

• ECG lead wires are reconnected to the patient.

• Analysis lead is changed.

• Patient size is changed.

• Arrhythmia analysis is turned on.

• Module is turned on.

• Exiting Standby mode.

Passport V Operating Instructions 0070- 0-0704-02 4 - 7

Menus: ECG Main and Submenus ECG Monitoring

ECG Menu

MENU ITEM SELECTIONS COMMENTS

ECG Sizes Menu 0.125 cm/mV

0.25 cm/mV

0.5 cm/mV 1 cm/mV (default) 2 cm/mV 4 cm/mV

ECG Setup Select to open the ECG Setup Menu.

Resp Menu Select to open the Respiration Menu.

Select to open the ECG Sizes Menu.

Sets the ECG size (waveform gain) for:

• ECG1 only if using 3-lead

• ECG1 to ECG6 if using 5-lead

All ECG waveforms are displayed with 1cm/mV gain in the All ECG View (via View key).

All ECG waveforms are displayed with the user-selected gain after exiting the All ECG View.

All ECG waveform gains remain unchanged after switchover between 3-lead and 5-lead modes.

NOTE: The SIZE key on the front panel is used to change ECG1 waveform size. The “ECG1 Size” menu option in the ECG Sizes Menu has the same function. (In All ECG View, this key is disabled.)

See section 4.4.4 (pg. 4-12) "ECG Sizes Menu".

See section 4.4.5 (pg. 4-12) "ECG Setup Menu".

4.4.2 Arrhythmia Menu (optional)

FIGURE 4-7 Arrhythmia Menu

NOTE: The Arrhythmia Menu is disabled if Patient Size = Neonate.

4 - 8 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Menus: ECG Main and Submenus

To display the Arrhythmia Menu:

1. On the front panel, press the Alarms: Limits key to display the Alarm Settings

Menu, and select Arrhythmia Menu

or On the normal screen: Select Monitor Setup or Select Parameters or Select the ECG tile

2. To exit, press the Normal Screen key on the front panel.

Arrhythmia Menu

MENU ITEM SELECTIONS COMMENTS

Previous Menu — Select to return to previous menu. Arrhythmia Setup Asystole

All On — Select to set all arrhythmia alarms to On. Non-lethals off — Select to set all non-lethal arrhythmia alarms to Off. All Off — Select to set all arrhythmia alarms to Off.

〉 Advanced Setup 〉 Arrhythmia Menu

〉 ECG 〉 Arrhythmia Menu

〉 Arrhythmia Menu.

Select to set individual arrhythmia alarm V-Tach V-Fib PVC/min V-Rhythm Couplet Run Bigeminy Trigeminy Irregular HR Brady

characteristics.

For each arrhythmia selection, choose:

Alarm: On or Off

Priority: 1 or 2

Print: On or Off

Lethal arrhythmias (Asystole, V-Tach, and V-Fib) are

Priority 1 and cannot be changed. The factory default

for all arrhythmia alarms is On.

“All Off” is displayed only if “Enable Arrhythmia All

Off Selection” = Yes in the Installation Menu.

Relearn — Select to manually initiate the relearning process for ST

PVC/min 1 to 30

default = 10

Passport V Operating Instructions 0070- 0-0704-02 4 - 9

Measurements or Arrhythmia Analysis.

Disabled if Arrhythmia = Off.

After relearning is started, arrhythmia relearning and

ST relearning are performed simultaneously. The

arrhythmia and ST analysis templates are recreated

and the message “Relearning...” is displayed. During

relearning, ST and PVCs are displayed as “– – –“.

Arrhythmia relearning should be started when:

• Lead type is changed.

• ECG lead wires are reconnected to the patient.

• Analysis lead is changed.

• Patient size is changed.

• Arrhythmia analysis is turned on.

• Module is turned on.

• Exiting Standby mode.

Select to change the High PVC/min alarm rate limit.

The PVC/min parameter is displayed when PVC/min

arrhythmia alarm is set to On.

Menus: ECG Main and Submenus ECG Monitoring

Arrhythmia Menu

MENU ITEM SELECTIONS COMMENTS

Asystole Delay 3 to 10 seconds

default = 5

V-Tach Rate 100 to 180 BPM

default = 130

V-Tach PVC 3 to 15

default = 3

Select to change the Asystole Delay Time.

Select to change the V-Tach alarm rate limit.

Select to change the required number of PVCs detected

in a continuous sequence before V-Tach is detected and

labeled.

4.4.3 ST Menu

FIGURE 4-8 ST Menu

NOTE: The ST Menu is disabled if Patient Size = Neonate.

4 - 10 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Menus: ECG Main and Submenus

To display the ST Menu:

1. On the front panel: Press the Normal Screen key to return to the normal screen.

2. On the normal screen: Select Parameters or Select the ECG tile

3. To exit, press the Normal Screen key on the front panel.

ST Menu

MENU ITEM SELECTIONS COMMENTS

Normal Screen — Select to return to Normal Screen (or press the Normal

ST Analysis On

Combine ST/HR On (default)

〉 ST Menu

〉 ST Menu.

Off (default)

Off

Screen key on the front panel). Select to turn ST analysis on or off.

On: ST analysis is active. ST values are displayed. Off: ST analysis is inactive. ST values are not displayed.

Note: If Filter is set to Surgery or Monitor when ST Analysis is set to On, the ST analysis automatically uses the ST filter without changing the user-selected filter setting. The user can select Diagnostic Filter setting. If Filter is set to ST or Diagnostic when ST Analysis is set to On, the ST analysis uses the Filter setting. The filter displayed in ECG waveform areas is coincident with actual filter mode.

Select to determine location of ST values. Combine moves ST to heart rate window.

On: ST values are displayed in the HR numeric tile. Off: ST values are displayed in the ST numeric tile.

Relearn — Select to manually initiate the relearning process for ST

ISO -200 to -4 msec Select to adjust isoelectric point.

Measurements or Arrhythmia Analysis.

Disabled if ST Analysis = Off.

After relearning is started, arrhythmia relearning and ST relearning are performed simultaneously. The arrhythmia and ST analysis templates are recreated and the message “Learning...” is displayed. During relearning, ST and PVCs are displayed as “– – –“.

Arrhythmia relearning should be started when:

• Lead type is changed.

• ECG lead wires are reconnected to the patient.

• Analysis lead is changed.

• Patient size is changed.

• Arrhythmia analysis is turned on.

• Module is turned on.

• Exiting Standby mode.

Adjustable in 8 msec increments.

Passport V Operating Instructions 0070- 0-0704-02 4 - 11

Menus: ECG Main and Submenus ECG Monitoring

ST Menu

MENU ITEM SELECTIONS COMMENTS

J/ST 4 to 200 msec Select to adjust J and ST measurement points.

ST -pt 40 msec

60 msec (default) 80 msec 60/80 msec

Adjustable in 8 msec increments. Select to adjust distance of ST point to the J point.

4.4.4 ECG Sizes Menu

FIGURE 4-9 ECG Sizes Menu

To display the ECG Sizes Menu:

1. On the front panel: Press the Normal Screen key to return to the normal screen.

2. On the normal screen: Select Parameters 〉 ECG 〉 ECG Sizes Menu or Select the ECG tile

3. To exit, press the Normal Screen key on the front panel.

4.4.5 ECG Setup Menu

〉 ECG Sizes Menu.

FIGURE 4-10 ECG Setup Menu

4 - 12 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Menus: ECG Main and Submenus

To display the ECG Setup Menu:

1. On the front panel: Press the Normal Screen key to return to the normal screen.

2. On the normal screen: Select Parameters or Select the ECG tile

3. To exit, press the Normal Screen key on the front panel.

ECG Setup Menu

MENU ITEM SELECTIONS COMMENTS

Previous Menu — Select to return to previous menu. Filter Surgery

〉 ECG 〉 ECG Setup Menu

〉 ECG Setup Menu.

Select to change filter mode for ECG. Diagnostic or ST Monitor (default) ST Diagnostic

must be used for ST analysis.

Channel Bandwidth:

Surgery = 1 to 20 Hz

Monitor = 0.5 to 40 Hz

ST= 0.05 to 40 Hz

Diagnostic = 0.05 to 150 Hz

HR Source Auto (default)

ECG Art UA LV PA SpO

Pacer Reject On

Off (default)

Pacer Enhancement

Off (default)

Note: If Filter is set to Surgery or Monitor when ST

Analysis is set to On, the ST analysis automatically uses

the ST filter without changing the user-selected filter

setting. If Filter is set to ST or Diagnostic when ST

Analysis is set to On, the ST analysis uses the Filter

setting. The filter displayed in ECG waveform areas is

coincident with the actual filter mode.

Select to change heart rate source.

The selections are available if the corresponding

parameters are configured. The selections are in order

of priority from high to low: Auto, ECG, ART, UA, LV,

PA, SpO2.

If Auto is selected, the monitor will switch to the current

highest-priority measuring module, and will display the

actual heart rate source in the numeric tile. If the

module for the selected HR source becomes

unavailable, the monitor will switch to the next

available source.

Select to turn pacer reject on (pacer artifact blanked

from display) or off (pacer artifact displayed).

On: Rejects the pacing pulse, and filters the pacing

pulse from the ECG waveforms. The message "Pacer

Reject On" is displayed on the top right of the ECG1

waveform area.

Off: Pacing pulse is not rejected.

Select to turn pacer enhancement on or off.

On: If there is pacing pulse, a short, straight vertical

line is used on all ECG waveforms to mark pacing

pulse.

Off: Pacing pulse is not rejected

Passport V Operating Instructions 0070- 0-0704-02 4 - 13

Menus: ECG Main and Submenus ECG Monitoring

ECG Setup Menu

MENU ITEM SELECTIONS COMMENTS

ECG Cable Auto (Default)

3 Lead 5 Lead

ECG Noise Audio On (Default)

Off

ECG Noise Delay 3 to 30 seconds

Default = 5 seconds

Select to change the ECG cable type being used.

Select to turn ECG Noise audio signal on or off.

On: An audio alarm tone is triggered when ECG

Noise is detected.

Select to change the number of seconds to delay the

ECG Noise Alarm.

WARNING: Ensure that the conductive parts of ECG electrodes do not

CAUTION: To avoid possible damage to the Passport V, and to provide

CAUTION: Line Isolation Monitor transients may resemble actual

WARNING: This device is not intended for direct cardiac application.

contact other conductive parts, including earth ground.

protection against the effect of the discharge of a cardiac defibrillator and against burns, use only approved ECG cables and approved accessories listed in the Accessories chapter.

cardiac waveforms, thus inhibiting heart rate alarms. Check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques.

4 - 14 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Preparation and Lead Placement

4.5 Preparation and Lead Placement

4.5.1 Skin Preparation

Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites should be clean and dry and should provide a smooth flat surface. Incidental electrical activity and inaccurate readings may arise from incorrect skin preparation.

The following procedure is recommended for secure electrode patch application:

1. Shave the chest hair from the electrode sites in a circular area with a diameter of 2 – 4 inches.

2. Use a dry gauze pad to remove excess skin oils, skin cells and residue from the electrode sites. Never rub the skin until it is raw or bleeding.

NOTE: 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.

4.5.2 Electrode Patch Location

NOTE: Store electrode patches at room temperature and open just

NOTE: Avoid more than one type of electrode on a patient because

NOTE: Avoid placing electrode patches directly over bone

NOTE: Using a Transcutaneous Electrical Nerve Stimulator (TENS):

prior to use.

of variations in electrical resistance.

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.

Since a TENS unit transmits electrical impulses, avoid placing ECG electrode patches near the TENS electrodes. ECG electrode patches may need to be repositioned and the ECG lead viewed may need to be adjusted until the optimum ECG tracing is obtained.

1. To prevent evaporation of the contact gel medium, peel the backing off of the electrode

patch only when it is ready for use. Visually inspect the contact gel medium for moistness. If the gel medium is not moist, do not use the electrode patch. Dry electrode patches are not conductive.

NOTE: If using the snap type electrode wires, attach the electrode

patch to the lead wire before placing patch on the patient.

Passport V Operating Instructions 0070- 0-0704-02 4 - 15

Preparation and Lead Placement ECG Monitoring

2. Attach the electrode patch to the skin at the prepared site. Smooth the electrode patch down in a circular motion to ensure proper skin contact. If using soft gel electrodes, never push down directly over the contact gel medium as this may displace the gel and cause monitoring artifact. If using hard gel electrodes, it is recommended that during application, the center of the electrode should be slightly pressed onto the skin to ensure direct contact. Consult the electrode patch manufacturer’s instructions for specific use.

3. Secure the lead wires to the patient according to hospital practice. For additional information see section NOTE:, “It is recommended that electrode patches be changed at least every 24 – 36 hours to maintain proper contact with the skin. Some patients may require electrodes to be changed more often. Electrode patches are disposable and should be applied only once. Try to avoid reusing the exact same electrode site during reapplication. If an electrode becomes wet with fluid, change the electrode patch.”.

WARNING: Route cables neatly. Ensure cables, hoses and wires are

NOTE: It is recommended that electrode patches be changed at least every

kept away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients and visitors.

24 – 36 hours to maintain proper contact with the skin. Some patients may require electrodes to be changed more often. Electrode patches are disposable and should be applied only once. Try to avoid reusing the exact same electrode site during reapplication. If an electrode becomes wet with fluid, change the electrode patch.

4.5.3 Lead Placement

4.5.3.1 Description

For lead placement, the computerized arrhythmia algorithm works best when the patient’s R wave is significantly larger than the P wave or the T wave. If the R wave is not significantly larger than other lower voltage waves on the ECG tracing, the computer may have some difficulty in identifying the appropriate waves. On some patients, electrode patch placement and/or the viewed ECG lead may need to be adjusted in order to obtain a significant R wave.

4.5.3.2 Setting Lead Naming Standard

This manual presents lead placement according to the guidelines of the American Heart Association (AHA) and the International Electro-Technical Commission (IEC).

LEAD NAMING STANDARDS

LEAD POSITION AHA IEC

CHEST V C LEFT LEG LL F RIGHT LEG RL N LEFT ARM LA L RIGHT ARM RA R

4 - 16 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Preparation and Lead Placement

The Passport V provides two lead naming standards in the Installation Menu: IEC and AHA.

To set the lead naming standard on the Passport V:

1. Press and hold the Discharge key on the front panel. Simultaneously, power up the Passport V monitor.

2. Release the Discharge key when the Installation Menu is displayed.

3. Select ECG Standard.

4. Choose AHA or IEC.

5. Cycle power to the Passport V monitor.

4.5.3.3 Lead Placement: Standard 3-wire Lead Sets

A 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3-wire lead placement is as follows.

White

Black

Red

FIGURE 4-11 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.

Red

Yellow

Green

FIGURE 4-12 3-wire Lead Placement

(IEC)

• Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.

• Place the L (yellow) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.

Passport V Operating Instructions 0070- 0-0704-02 4 - 17

Preparation and Lead Placement ECG Monitoring

4.5.3.4 Lead Placement: Standard 5-wire Lead Sets

A 5-wire lead set can monitor seven ECG vectors (I, II, III, aVR, aVL, aVF, and V) simultaneously. The recommended 5-wire lead placement is as follows.

White

Green

Black

Brown V Lead (any V position)

Red

FIGURE 4-13 5-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.

• 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.

Yel low

White C Lead (any C position)

Green

Black

Red

FIGURE 4-14 5-wire Lead Placement

(IEC)

• Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.

• Place the L (yellow) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.

• Place the N (black) electrode on the patient’s lower right abdomen within the rib cage frame.

• Place the C (white) electrode in one of the C-lead (C1 – C6) positions depicted in the following section.

4 - 18 0070- 0-0704-02 Passport V Operating Instructions

ECG Monitoring Preparation and Lead Placement

4.5.3.5 Lead Placement: Lead II Monitoring

The recommended lead placement for Lead II monitoring is as follows.

White

Black

Red

Yellow

Green

FIGURE 4-15 Lead II Monitoring (AHA) FIGURE 4-16 Lead II Monitoring (IEC)

• Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.

• Place the 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.

• Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.

• Place the L (yellow) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.

Select ECG Lead II on the monitor. Lead II is the direct electrical line between the RA (white) electrode and the LL (red) electrode.

Select ECG Lead II on the monitor. Lead II is the direct electrical line between the R (red) electrode and the F (green) electrode.

Passport V Operating Instructions 0070- 0-0704-02 4 - 19

Preparation and Lead Placement ECG Monitoring

4.5.3.6 Lead Placement: Modified Chest Lead (MCL) Monitoring

The recommended lead placement for MCL monitoring is as follows.

White

Red

Black

FIGURE 4-17 MCL Monitoring with a

3-wire Lead Set (AHA)

• Place the RA (white) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the LA (black) electrode on the right sternal border, at the fourth intercostal space within the rib cage frame.

• Place the LL (red) electrode on the patient’s lower left abdomen within the rib cage frame.

Yellow

Red

Green

FIGURE 4-18 MCL Monitoring with a

3-wire Lead Set (IEC)

• Place the R (red) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the L (yellow) electrode on the right sternal border, at the fourth intercostal space within the rib cage frame.

• Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.

Select ECG Lead I for MCL

monitoring.

Lead I is the direct electrical line between the RA (white) electrode and the LA (black) electrode.

Select ECG Lead II for MCL

monitoring.

Lead II is the direct electrical line between the RA (white) electrode and the LL (red) electrode.

4 - 20 0070- 0-0704-02 Passport V Operating Instructions

Select ECG Lead I for MCL Lead I is the direct electrical line between the R (red) electrode and the L (yellow) electrode.

Select ECG Lead II for MCL Lead II is the direct electrical line between the L (red) electrode and the F (green) electrode.

monitoring.

ECG Monitoring Preparation and Lead Placement

4.5.3.7 Lead Placement: Neonates

Using a 3-wire lead set, ECG lead placement on a neonate is usually directed towards obtaining the best possible respiration data through the ECG thoracic impedance technique. Thoracic impedance is usually measured between the Right Arm and Left Arm electrode patches. These patches should be placed on the chest directly across from each other to optimize the measuring of the neonate’s chest movement. The recommended lead placement for neonate monitoring is as follows.

Black

White

Red

FIGURE 4-19 Neonatal 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.

Yellow

Red

Green

FIGURE 4-20 Neonatal 3-wire Lead

Placement (IEC)

• Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.

• Place the L (yellow) electrode under the patient’s left clavicle, at the midclavicular line within the rib cage frame.

• Place the F (green) electrode on the patient’s lower left abdomen within the rib cage frame.

Passport V Operating Instructions 0070- 0-0704-02 4 - 21

Preparation and Lead Placement ECG Monitoring

4.5.3.8 Lead Placement: Pacemaker Patients

The recommended lead placement for monitoring a pacemaker patient is as follows.

White

Pacer

Black

Red

FIGURE 4-21 3-wire Lead Placement for a

Pacemaker Patient (AHA)

White

Brown

Green Red

Pacer

Black

Red

Pacer

Yellow

Green

FIGURE 4-22 3-wire Lead Placement for a

Pacemaker Patient (IEC)

Red

Black

V White

Pacer

Yellow

Green

FIGURE 4-23 5-wire Lead Placement for a

Pacemaker Patient (AHA)

FIGURE 4-24 5-wire Lead Placement for a

Pacemaker Patient (IEC)

A pacemaker patient usually requires a different electrode patch placement configuration than a non-pacemaker patient.

Do not place an ECG electrode directly over the pacemaker generator. Place the electrode patches 3 – 5 inches away from the pacemaker generator area. For example, if the pacemaker generator is located in the right subclavian area, relocate the Right Arm electrode closer in towards the center of the chest.

WARNING: Pacemaker patients’ rate meters may continue to count the

CAUTION: Some pacemakers may contain a respiratory sensor that

may produce artifact on an ECG waveform.

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ECG Monitoring Arrhythmia Algorithm

4.6 Arrhythmia Algorithm

The Passport V uses an arrhythmia algorithm to monitor ECG waveform data. The algorithm creates ECG waveform templates based on a patient’s normal ECG data and uses them to analyze newly received data. The algorithm verifies that data is free from noise and artifact, and that it does not deviate from the patient’s normal ECG rhythms.

A normal ECG waveform typically includes consistent spacing between R waves, a sharp and well defined QRS complex, and an ECG baseline that is free of noise and artifact.

ST deviation

(Depression or Elevation)

ISO Point

FIGURE 4-25 Sample Waveform

4.6.1 Noise and Artifact

The presence of noise or artifact in an ECG waveform makes the accurate detection and classification of heartbeats difficult. To best optimize performance, all leads should be free of noise.

Some of the causes of ECG noise include poor skin preparation, improperly attached electrodes, dried electrode gel, defective lead wires, and patient movement. The algorithm uses several techniques to differentiate a patient’s QRS complexes from noise sources.

If noise levels are too high for a particular lead, a message is posted, and the data is dropped from analysis until the signal quality is re-established.

If noise levels are too high, the following will occur until the signal quality is re-established:

• Beat detection is suspended

J Point

ST Segment

ST Point

40 to 80 msec

• All rhythm calls are suspended

•An ECG Noise message is displayed

4.6.2 Heart Rate Average

The heart rate average is computed using the 16 most recent R-R intervals for heart rates above 48 beats per minute. If the heart rate calculated using the last 4 beats is less than 48 beats per minute, then this rate is used. All detected beats are used to compute the heart rate. A separate ventricular rate is used in the algorithm to determine rhythms like ventricular tachycardia and ventricular run.

Passport V Operating Instructions 0070- 0-0704-02 4 - 23

Arrhythmia Algorithm ECG Monitoring

4.6.3 Filtering Pacer Signals

In order to prevent pacer pulses from being mistaken for QRS complexes, they are removed from the ECG data that is sent to the arrhythmia algorithm for analysis.

4.6.4 ECG Amplitude

The QRS detection threshold algorithm setting is fixed between 0.15 and 0.45 mV to avoid detecting noise spikes or P-waves as valid beats. Changing the display gain on the monitor does not affect the signal that is used by the algorithm for beat detection. For optimal performance, the leads selected for monitoring should have an amplitude of 0.5 to 1 mV or more.

4.6.5 Learning

The process of learning is used to establish a normal beat template for a patient. The learn period is dependent on the heart rate and the dominant pattern. Learning should not be initiated during a primarily ventricular rhythm because an ectopic beat may be established as normal.

A learn should be initiated when beats are not being properly detected, or when they are being erroneously classified. However, if a signal is not strong enough, or lead data is extremely noisy, better signal quality must be established before a learn can be effective.

4.6.6 Beat Detection and Typing

The following table describes the leads that are used to measure beat detection and beat typing.

DESCRIPTION 3-WIRE LEAD SET 5-WIRE LEAD SET

Leads used for Beat Detection Determined by viewed lead II and V Leads used for Beat Typing Determined by viewed lead II, V, and I Leads used for V-Fib Detection Determined by viewed lead II and V

The search for the next beat begins after a refractory period to avoid detecting T- waves as valid QRS complexes. For all patient sizes, the minimum QRS amplitude that can be detected is between 0.15 and 0.45 mV depending on the width of the QRS complexes.

Beat typing aligns and compares each new heartbeat to reference templates that were previously stored in the system. A beat typing algorithm classifies the beats.

• If an incoming beat matches a template that has already been classified, it is given the same label as the template. The template parameters are updated with the features from this new beat.

The real time ECG analysis library incorporates ventricular ectopic beat detection as a part of arrhythmia analysis.

• Beats are measured for compensatory pause, QRS width, QRS positive and negative areas, and R wave positive and negative amplitudes. This process uses multiple leads when available.

• A scoring algorithm is then applied to those measurements to determine whether or not a beat is ectopic.

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ECG Monitoring Arrhythmia Alarms (optional)

4.7 Arrhythmia Alarms (optional)

Arrhythmia alarms are activated based on the patterns in the patient ECG waveform rhythms. Beat detection for a 5-lead wire set is determined by using a combination of leads II and V. When using a 3-lead wire set, beat detection is determined by using the lead being viewed.

The lethal and non-lethal arrhythmia alarms in this section may be detected by the arrhythmia algorithm.

NOTE: Arrhythmia alarms are not available for the Neonate patient size.

4.7.1 Lethal Arrhythmia Alarms

A lethal arrhythmia is an arrhythmia that can be life threatening to a patient if left untreated. Ventricular Tachycardia (V-Tach), Ventricular Fibrillation (V-Fib), and Asystole alarms are classified as lethal arrhythmia alarms. These alarms automatically default to Alarm Priority 1 and cannot be changed.

NOTE: Lethal arrhythmia alarms are latched alarms. Even after the

alarming condition is resolved, a latched alarm will continue until it is acknowledged by pressing the “Silence” or “Silence All” key on the front panel keypad. If the alarm is acknowledged while the lethal condition still exists, the audio portion of the alarm will be silenced for the duration that is selected from the “Silence For” list in the “Alarm Setup” menu, but the alarm message will remain in message area A. If a new lethal condition occurs while the initial lethal alarm is silenced, the new lethal alarm will not break through but not be silenced. If the lethal condition is resolved while the alarm is silenced, the alarm will be terminated.

4.7.1.1 Asystole Alarm

An Asystole alarm is activated when no QRS complexes are detected for the configured time period in the absence of Ventricular Fibrillation.

The time period range for an Asystole alarm is user-selectable from 3 to 10 seconds. The Asystole alarm is a Priority 1 alarm event that produces:

• Alarm Priority 1 visual and audio alarm indicators.

•An Asystole text message above the ECG1 waveform area.

4.7.1.2 Ventricular-Fibrillation (V-FIB) Alarm

A V-FIB alarm is activated when a fibrillated waveform (P, QRS or T waves can no longer be identified) is detected. V-FIB is defined as “irregular, disorganized electrical activity of the heart”. The V-FIB detection algorithm runs in parallel to the beat detection algorithm and continuously examines the incoming data.

The V-FIB alarm is a Priority 1 alarm event that produces:

• Alarm Priority 1 visual and audio alarm indicators.

•A V-FIB text message above the ECG1 waveform area.

Passport V Operating Instructions 0070- 0-0704-02 4 - 25

Arrhythmia Alarms (optional) ECG Monitoring

4.7.1.3 Ventricular Tachycardia (V-TACH) Alarm

A V-TACH alarm is activated as follows:

• The range of the V-TACH rate is between 100 to 180 beats per minute.

AND

• The V-TACH lethal arrhythmia alarm is activated when the configured number of

consecutive PVCs is reached. The range for the V-TACH threshold is 3 – 15 beats per minute.

A V-TACH alarm is a Priority 1 alarm event that produces:

• Alarm Priority 1 visual and audio alarm indicators.

•A V-TACH text message above the ECG1 waveform area.

4.7.2 Non-Lethal Arrhythmia Alarms

A Non-Lethal Arrhythmia is an arrhythmia that is most likely not life threatening to a patient. Bigeminy, Bradycardia, Couplet, Irregular Heart Rate, PVC/min, Run, Trigeminy, and Ventricular Rhythm (V-Rhythm) alarms are classified as non-lethal arrhythmia alarms. All other Non-Lethal Arrhythmias default to Alarm Priority 2. The Alarm Priority for non-lethal Arrhythmia is user-selectable between 1 and 2.

NOTE: Non-lethal arrhythmia alarms are not latched alarms and

can be acknowledged at any time. To acknowledge a nonlethal arrhythmia alarm, press the “Silence” key on the keypad.

4.7.2.1 Bigeminy Alarm

The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one normal beat are detected.

The Bigeminy alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•A BIGEMINY text message above the ECG1 waveform area.

4.7.2.2 Brady (Bradycardia) Alarm

The Brady alarm is activated when the heart rate falls to a value 10% lower than the user selected value for low heart rate alarm.

The Brady alarm is an alarm event that produces:

• Alarm visual alarm indicator. Since Bradycardia is always accompanied by a low

heart rate alarm, the Priority 1 audio alarm will sound.

•A Brady text message above the ECG1 waveform area.

4.7.2.3 Couplet Alarm

The Couplet alarm is activated when two consecutive PVCs are detected between normal beats.

The Couplet alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•A COUPLET text message above the ECG1 waveform area.

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ECG Monitoring Arrhythmia Alarms (optional)

4.7.2.4 Irregular Heart Rate Alarm

The Irregular Heart Rate alarm is activated when the measured variations in the R-R interval over a period of time exceeds a preset limit established by the arrhythmia algorithm.

The Irregular Heart Rate alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•An IRREGULAR HR text message above the ECG1 waveform area.

4.7.2.5 PVC/minute Alarm

The High PVC alarm is activated when the number of PVCs detected per minute exceeds the configured threshold. The PVC limit can be set to Off, or 1 to 30 PVCs per minute.

The High PVC alarm is an alarm event that produces :

• Alarm visual and audio alarm indicators.

•A High PVC text message above the ECG1 waveform area.

NOTE: PVC/min will not be displayed during periods of Ventricular

Rhythms, V-TACH, V-FIB and Asystole.

4.7.2.6 Run Alarm

The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals or exceeds the user defined V-Tach Rate. The number of consecutive PVCs that constitute a Run is one beat less than the minimum used to identify V-Tach.

The Run alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•A RUN text message above the ECG1 waveform area.

4.7.2.7 Trigeminy Alarm

The Trigeminy alarm is activated when three or more cycles of one PVC coupled to two normal beats are detected. This rhythm could also cause an Irregular HR alarm.

The Trigeminy alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•A TRIGEMINY text message above the ECG1 waveform area.

4.7.2.8 Ventricular Rhythm (V-Rhythm) Alarm

The V-Rhythm alarm is activated when more than 2 consecutive PVCs occur at a rate that is less than the user defined V-Tach Rate.

The V-Rhythm alarm is an alarm event that produces:

• Alarm visual and audio alarm indicators.

•A VENTRICULAR RHYTHM text message above the ECG1 waveform area.

Passport V Operating Instructions 0070- 0-0704-02 4 - 27

Arrhythmia Analysis (Optional) ECG Monitoring

4.8 Arrhythmia Analysis (Optional)

NOTE: Arrhythmia analysis is available for Adult and Pediatric

patients only.

WARNING: Due to physiologic differences in the patient population, the

The Passport V is capable of identifying ventricular arrhythmia patterns in Adult and Pediatric size patients. Arrhythmia analysis may be enabled or disabled via the

Arrhythmia Menu. By default, arrhythmia analysis is enabled if the option is installed.

FIGURE 4-26 Arrhythmia Menu

Arrhythmia alarm calls are classified as Priority 1 or Priority 2.

Asystole, Ventricular Tachycardia, and Ventricular Fibrillation are classified as Priority 1 and the priority level cannot be changed by the user. In addition, these alarms will sound continuously until the user presses the Silence or Silence All key, regardless of whether the patient’s condition has improved.

The other arrhythmia alarms (listed below) are classified as Priority 2 by default. The characteristics and priority level of all non-lethal alarms can be changed at the user’s discretion via the Arrhythmia Setup menu option.

The following alarm calls can be made when Arrhythmia Analysis is set to “All On” (default setting):

• Asystole, Ventricular Tachycardia, Ventricular Fibrillation, Ventricular Rhythm, Run,

PVC/Min, Couplet, Bigeminy, Trigeminy, Irregular HR and Bradycardia.

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ECG Monitoring Arrhythmia Analysis (Optional)

The following alarm calls will be made when Arrhythmia analysis is set to “Non-lethals Off”:

• Asystole, Ventricular Tachycardia, and Ventricular Fibrillation.

When Arrhythmia analysis is set to “All Off,” no arrhythmia alarm calls will be made.

NOTE: The “All Off” selection in the “Arrhythmia Menu” is only

available if “Enable Arrhythmia All Off Selection” is set to “Yes” in the Installation Menu.

4.8.1 Arrhythmia Analysis Setup

ARR TYPE OPTION DESCRIPTION

Asystole Asystole Delay No QRS complex is detected within the set "Asystole Delay",

V-Tach V-Tach Rate

V-Tach PVC

Brady Brady Low When HR is 10% less than the HR low alarm limit , it is

which is judged as one Asystole event. HR is greater than or equal to the set "V-Tach Rate" and the

number of continuous PVCs is greater than or equal to the set "V-Tach PVC" threshold, which is judged as one V-Tach event.

judged as one Bradycardia event.

Passport V Operating Instructions 0070- 0-0704-02 4 - 29

ST Analysis (Optional) ECG Monitoring

4.9 ST Analysis (Optional)

NOTE: ST analysis is available for Adult and Pediatric patients only.

ST deviation

(Depression or Elevation)

ST Point

ISO Point

J Point

40 to 80 msec

FIGURE 4-27 ST Monitoring

The formula for calculating ST segment offset value is: ST segment offset value = VST-VISO. If 3-lead is detected, analysis provides one ST value from one ECG waveform (ECG1). If 5-lead is detected, analysis provides all seven ST values.

The depression or elevation of the ST segment is measured as the vertical distance between the isoelectric (ISO) point which provides the baseline, and the ST point (See figure above). ST measurements are available on a maximum of three user selected ECG leads at a point situated 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from the algorithmically determined end point of the QRS (J Point). In addition, the user can also select from three (3) different settings for the ST measurement point (80, 60, or 40 ms) from the J-point and independent of heart rate. These measurements are valid only on normal beats. Abnormal beats, like ventricular beats, are excluded from the analysis of the ST segment. Ventricular paced beats are also rejected from the analysis of the ST segment, because pacemaker tails distort the shape of the ST segment.

ST segment changes are continuously measured by the monitor, but update of the displayed ST data is different depending on the ECG cable in use. When using a 3 or 5-lead ECG cable, the displayed ST data is updated approximately every 10 seconds.

NOTE: The ST algorithm has been tested for accuracy of the ST

segment data. The significance of the ST segment changes must be determined by a clinician.

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ECG Monitoring ST Analysis (Optional)

4.9.1 Numeric Tile: ST

The ST numeric tile displays the following:

•ST label

•ST unit

• Lead name and corresponding ST measured value

ST Label

Lead

Val ues

Unit

FIGURE 4-28 ST numeric tile. ECG1, ECG2, and ECG3 are displayed from top to bottom

with the corresponding ST values. ST values are rounded off to 1 decimal place.

4.9.2 ST Analysis Setup

ST analysis begins when the feature is turned on from Parameters 〉 ST Menu. By default, ST data will appear in the Heart Rate Tile, when using a 3-lead or 5-lead leadset.

When using a 3-lead leadset, ST Analysis is performed on the lead chosen as ECG1. With a 5-lead leadset, ST Analysis is performed on all seven leads.

To display ST data in a separate tile, set a waveform to display any ECG wave (i.e., ECG2, ECG3, etc.), then set Combine ST/HR to OFF.

FIGURE 4-29 ST Menu

Passport V Operating Instructions 0070- 0-0704-02 4 - 31

ST Analysis (Optional) ECG Monitoring

4.9.2.1 Adjusting the ISO and J/ST Point

1. Open the ST Menu by using the Navigator Knob to select the ST parameter heading.

ST Menu can also be accessed through the ECG Menu.

2. Ensure the ST Analysis selection in the ST Menu is On. The Passport V will learn

the patient's QRS complexes (one for a 3-lead leadset or 3 for a 5-lead leadset). These learned complexes will appear in the ST Menu with the monitor-selected ISO and J/ST points displayed.

3. Scroll to the ISO selection to adjust the isoelectric point on the learned QRS complex.

The isoelectric point is the area of the QRS complex following the P-wave and before the start of the Q-wave.

4. Adjust the ISO point by pressing the Navigator Knob and turning to adjust the white

ISO reference line. Press the Navigator Knob when the ISO point is satisfactory.

5. Scroll to the J/ST point heading. Adjust the J/ST point by pressing the Navigator Knob

and turning to adjust the orange and green J/ST reference lines. Press the Navigator Knob when the J/ST points are satisfactory.

6. To adjust the ST-pt, scroll to the ST-pt heading and press the Navigator Knob to display

a list of ST measurement point settings. Select the appropriate setting, then press the Navigator Knob when the ST-pt choice is satisfactory.

4.9.2.2 Adjusting ST Measurement Points

ST measurement points refer to ISO point (isoelectric reference point) and ST point. The Mortara algorithm uses the J+X method to position the ST point, which is located at X position on the right of J point.

The following table describes the range of ST measurement points and their steps.

POINT OPTION/RANGE STEP

ISO -200 to -4ms 8ms J/ST 4 to 200ms 8ms ST-pt 40ms, 60ms, 80ms,

60/80ms

ST-pt is set to 60 or 80ms from the J point. When HR is greater than 120 bpm, the distance between ST point and J point is set at 60ms; when HR is lower or equal to 120 bpm, the distance between ST point and J point is set at 80ms.

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ECG Monitoring Relearning ST or Arrhythmia Analysis

4.10 Relearning ST or Arrhythmia Analysis

Automatic Relearning

The Passport V initiates the learning process for ST measurements or Arrhythmia analysis after one of the following:

• Unit Power-Up

• Return to normal monitoring from Standby mode

• Enabling ST or Arrhythmia analysis

• The lead has been changed in ECG 1 waveform (3-lead only)

• Patient Size is changed

• Whenever the Relearn function is selected from the ST, ECG or Arrhythmia

Menus

• The monitor switches between 3-lead and 5-lead mode

Manual Relearning

To initiate a manual relearn, select Relearn from the ECG Menu, Arrhythmia Menu, or ST Menu.

It is recommended to initiate a manual Relearn after one or more of the following:

• The ECG electrodes have been repositioned

• Sufficient time has passed since the last Relearn

• After significant changes to the patient QRS complex

• After significant changes to the patient ECG rhythm

• A clinician has observed clinically questionable arrhythmia calls

A Relearn must be initiated if “Learning” occurred during a “Leads Off” condition.

Passport V Operating Instructions 0070- 0-0704-02 4 - 33

ECG Troubleshooting ECG Monitoring

4.11 ECG Troubleshooting

MESSAGE/PROBLEM REASON SOLUTION

Noisy ECG traces Loose or dry electrodes. Apply fresh, moist electrodes.

Defective electrode wires. Replace wires as necessary. Patient cable or leads are

routed too close to other electrical devices.

Eliminate 50-60 Hz interference.

Excessive Electro-surgical Interference

Muscle Noise Inadequate skin preparation

Intermittent Signal Connections not tight and/or

Excessive alarms: heart rate, lead fault

Low Amplitude ECG Signal Gain set too low. Readjust as required -

No ECG Waveform Gain set too low. Readjust as required -

Wrong ECG cable used. Use ESIS ECG cable with

prior to application of electrode, tremors, tense subject, and/or poor electrode placement.

properly secured.

Electrodes dry or loose. Re-prep skin and apply fresh,

Cable or lead wires damaged. Check with continuity tester. Electrodes dry. Re-prep skin and apply fresh,

Alarm limits set too close to patient's normal heart rate.

R-wave wrong size. Must have a higher amplitude

Excessive patient movement or muscle tremor.

Electrodes dry / old. Apply fresh, moist electrodes. Skin improperly prepared. Abrade skin. This could be the patient’s

normal QRS complex. Electrode could be positioned

over a bone or muscle mass.

Lead wires and patient cable not fully or properly inserted.

Cable or lead wires damaged. Check with lead continuity

internal filter block. NOTE: Respiration monitoring via the ECG electrodes will not be available when using the cable.

Repeat skin preparation and electrode location procedures. Apply fresh, moist electrodes. Avoid areas of the torso that are very muscular.

Ensure proper connection. (Electrode to lead, lead to cable, cable to monitor).

moist electrodes.

moist electrodes. Readjust.

than the other ECG waves, like the P and T waves.

Reposition electrodes and secure with tape, if necessary.

(Set via the SIZE key).

Verify with a 12-lead electrocardiogram.

Move ECG patches closer towards each other.

(Set via the SIZE key). Check for proper insertion.

tester.

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ECG Monitoring ECG Troubleshooting

MESSAGE/PROBLEM REASON SOLUTION

Base Line Wander Patient moving excessively. Secure lead wires and cable to

Patient's respiration. Reposition electrodes. Electrodes dry or loose. Re-prep skin and apply fresh,

Static build up around patient. Check with local biomedical

ECG Filter set to “ST” or “Diagnostic” mode.

patient.

moist electrodes.

personnel. Set ECG Filter to “Monitor”

mode.

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ECG Troubleshooting ECG Monitoring

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5.0

Respiration Monitoring

5.1 Description

Intended patient types: Adult, Pediatric, Neonate.

Respirations, or the amount of breaths per minute, are measured by two methods in the Passport V:

The first method is thoracic impedance through the ECG signal. The respiration signal is measured between two ECG electrodes:

• RA and LA of ECG Lead I, or

• RA and LL of ECG Lead II

The second is by CO

5.3.1 discusses the monitoring of CO2 with thoracic impedance. Chapter 10.0 discusses the

monitoring of CO

exchange via internal CO2 or via the external Gas Module. Section

with Sidestream and Microstream capnography.

Passport V Operating Instructions 0070- 0-0704-02 5 - 1

Resp Screens Respiration Monitoring

5.2 Resp Screens

5.2.1 Numeric Tile: Resp

The Resp numeric tile displays the following:

• Parameter name: Resp

• Measured value (RR is ” – – –” for CVA or Apnea)

• Respiration Source: ECG

• Alarm limits

• RR unit: RPM

Resp Label Resp Unit

FIGURE 5-1 Resp Numeric Tile

5.2.2 Waveform: Resp

• The Resp waveform tile displays the following: Resp waveform

• Waveform size

RR Value

High Alarm Limit

Low Alarm Limit

FIGURE 5-2 Resp Waveform Tile

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Respiration Monitoring Resp Menu

5.3 Resp Menu

To disp lay t h e Resp Menu:

On the normal screen: Select Parameters 〉 Resp or Select the ECG tile or Select the Resp tile

〉 Resp Menu

FIGURE 5-3 Respiration Menu

Resp Menu

MENU ITEM SELECTIONS COMMENTS

Normal Screen — Select to return to Normal Screen (or press the

Normal Screen key on the front panel).

Resp Lead I

II (default)

Resp On (default)

Passport V Operating Instructions 0070- 0-0704-02 5 - 3

Off

Select to change respiration lead for ECG. When the current Resp Lead drops, the Resp waveform will be a straight line.

Select to turn respiration on or off. On: Opens the Resp Module to start respiratory measurement. Off: Closes the Resp Module to stop respiratory measurement. Displays "OFF" in Resp numeric tile.

Mindray Passport V Operating Instructions Manual

Specifications and Main Features

Frequently Asked Questions

User Manual