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 U.S. registered trademark of Masimo Corp.
®
is a U.S. registered trademark of Masimo Corp.
TM
is a trademark of Nellcor Puritan Bennett Inc.
®
is a trademark or registered trademark of Oridion Medical Ltd.
2
®
is a U.S. registered trademark of Oridion Medical Ltd.
®
is a trademark or registered trademark of Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TM
is a U.S. trademark of Mindray DS USA, Inc.
TM
is a U.S. trademark of Nellcor Puritan Bennett Inc.
TM
is a trademark of Oridion Medical Ltd.
Oxiband
OxiMax
Oxisensor
Passport
Velcro
®
is a U.S. registered trademark of Nellcor Puritan Bennett Inc.
TM
is a U.S. trademark of Nellcor Puritan Bennett Inc.
®
is a U.S. registered trademark of Nellcor Puritan Bennett Inc.
®
is a U.S. registered trademark of Mindray DS USA, Inc.
®
is a trademark or registered trademark of Velcro Industries B.V.
0070-00-0704-02Passport V Operating Instructions
Table of Contents
Foreword....................................................................................................................................................... vii
Warnings, Precautions, and Notes.................................................................................................................... vii
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
Front View ..............................................................................................................................................1 - 11
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
Patient Menu ..........................................................................................................................................3 - 2
Discharging a Patient ..................................................................................................................................... 3 - 4
Data Transfer .................................................................................................................................................3 - 5
Transferring User Configuration ................................................................................................................3 - 5
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
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
Menu ..................................................................................................................................................6 - 3
NIBP List Display ....................................................................................................................................7 - 4
NIBP Menu ...................................................................................................................................................7 - 5
Other Factors..........................................................................................................................................7 - 11
User Verification of Passport V Blood Pressure Measurements ...................................................................7 - 11
Temperature Screens .......................................................................................................................................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 Menu ......................................................................................................................................................9 - 5
Menu .................................................................................................................................................. 10 - 3
CO
2
Setup Menu (DPM Sidestream Only) ................................................................................................ 10 - 5
Gas Screens.................................................................................................................................................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
Drug Calculations..................................................................................................................................12 - 1
Auto Set Alarms ....................................................................................................................................13 - 5
GAS ....................................................................................................................................................14 - 3
GAS Alert Message ...............................................................................................................................14 - 6
iv0070- 0-0704-02Passport V Operating Instructions
0
Table of Contents
System Level .........................................................................................................................................14 - 7
GAS Prompt Message............................................................................................................................14 - 16
Main Control System..............................................................................................................................14 - 18
Power Supply........................................................................................................................................14 - 19
Data Management.................................................................................................................................14 - 19
List Trends....................................................................................................................................................15 - 3
Print Setup Menu .........................................................................................................................................16 - 1
Local Printer (Optional)...........................................................................................................................16 - 2
Care and Cleaning of Reusable Temperature Probes .........................................................................................17 - 3
Care and Cleaning of Reusable Cuffs..............................................................................................................17 - 4
Reusable Cuffs with Bladders ..................................................................................................................17 - 4
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
Temperature ................................................................................................................................................ 18 - 7
Oridion Microstream CO2 Module ..........................................................................................................18 - 9
DPM Sidestream CO
Module and Gas Module 3 ....................................................................................18 - 9
2
Gas Module 3 Accessories ..................................................................................................................... 18 - 10
Mounting Kits, Rolling Stands, and Accessories ................................................................................................18 - 11
Cables and Networking.................................................................................................................................18 - 12
Battery and Miscellaneous ............................................................................................................................. 18 - 13
Equipment Environment and Safety Specifications ............................................................................................. 19 - 1
Power Specifications ..................................................................................................................................19 - 3
Communication Protocols...............................................................................................................................19 - 29
Data Storage................................................................................................................................................19 - 29
Customer Service ..........................................................................................................................................19 - 47
Glossary of Terms .......................................................................................................................................20 - 1
vi0070- 0-0704-02Passport V Operating Instructions
0
ForewordIntroduction
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 Instructions0070- 0-0704-02vii
0
IntroductionWarn 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.
viii0070- 0-0704-02Passport V Operating Instructions
0
War nin gsIntroduction
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 Instructions0070- 0-0704-02ix
0
IntroductionWarn 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
2
module. This
2
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.
x0070- 0-0704-02Passport V Operating Instructions
0
War nin gsIntroduction
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
2
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).
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 Instructions0070- 0-0704-02xi
0
IntroductionPrecautions
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
2
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.
xii0070- 0-0704-02Passport V Operating Instructions
0
PrecautionsIntroduction
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
2
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:
2
•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 Instructions0070- 0-0704-02xiii
0
IntroductionPrecautions
•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
2
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
2
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
2
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
2
liquid. Wipe the sensor surface with a soft cloth, dampened
with cleaning solution. Do not attempt to sterilize.
xiv0070- 0-0704-02Passport V Operating Instructions
0
PrecautionsIntroduction
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
2
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 Instructions0070- 0-0704-02xv
0
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
2
xvi0070- 0-0704-02Passport V Operating Instructions
0
Intended UseIntroduction
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)
2
2
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 Instructions0070- 0-0704-02xvii
0
Symbols and Descriptions
SYMBOL DESCRIPTIONSYMBOLDESCRIPTION
Attention, Consult Accompanying
Documents / Refer to Manual
Electrical HazardType BF Equipment
Shock HazardDefibrillator Proof Type BF Equipment
EquipotentialityDefibrillator Proof Type CF Equipment
Alternating Current (AC)
Direct Current (DC)
Power On/Off
Data InputEarth (Ground)
Data OutputProtective Earth (Ground)
Type B Equipment
Alarm Off Icon
Alarm Silence Icon
Alarm Silence Permanently Icon
Data Input/OutputFull Battery
Gas Port InputLow Battery
Gas Port Output No Battery Present
Chart Local Printer OutputBattery Charging
Video Output
NIBP ConnectionManufacturer
Separate treatment from general waste at
end of life
xviii0070- 0-0704-02Passport V Operating Instructions
0
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
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xx0070- 0-0704-02Passport V Operating Instructions
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1.0
General Product Description
FIGURE 1-1 The Passport V Patient Monitor
Passport V Operating Instructions0070- 0-0704-021 - 1
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General Product DescriptionGeneral Product Description
1.1General 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
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 - 20070- 0-0704-02Passport V Operating Instructions
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General Product DescriptionKey Features
1.2Key Features
FEATURESSTANDARDOPTIONAL
Display12.1 inch color liquid crystal
display
Automatic Sensor Detection and
Wave form Displ ay
8-trace erase bar refresh
ECG3 or 5-lead
(I, II, III, aVR, aVL, aVF, V)
ECG CascadeArrhythmia Analysis
ESIS Capability (3 or 5-lead)
Blood PressureNon-Invasive Blood PressureUp to 2 channels of Invasive Blood Pressure
SpO
2
TemperatureOne channel for 400 series
RespirationsLead-selectable ImpedanceDPM CO
TrendTabular and Graphic trends with
PowerInternal isolated power moduleSecond lithium-ion battery
PrintingLocal Printer, Remote Printer
External
Interfaces
CalculationIV drug calculations
OtherSoft Grip HandleMounting kits
Masimo SET
probes
6000 trend data entries
Lithium-ion battery
Gas Module, Nurse Call systems,
DIAP communications,
Defibrillator sync, Ethernet
network
Navigator KnobPatient and monitor data transfer
Dedicated keys
®
External Remote Color Display (SVGA)
ST Analysis
DPM SpO2, Nellcor® OxiMax® SpO
, Microstream® CO
2
Gas Module with Automatic Agent ID
Wireless network
2
2
Multi-language
supported
interface
Passport V Operating Instructions0070- 0-0704-021 - 3
English, French, German, Italian,
Spanish, Brazilian-Portuguese,
Russian,Dutch
0
Keys and Front PanelGeneral Product Description
1.3Keys and Front Panel
The front panel keys are used to access many main functions quickly and easily. The figure
below shows the keys and a brief explanation follows.
1
2
3
5
4
6
7
9
8
10
11
13
12
14
16
15
17
20
18
19
21
FIGURE 1-2 Front panel keys and Navigator Knob
1. Lead
Press this key to select the next ECG lead to display in Waveform 1. Each time you press this
key, the next available ECG lead displays.
2. Size
Press this key to select the next available size of ECG for Waveform 1. Each time you press
this key, the next available ECG size displays. When the largest ECG size is displayed, the
next key press displays the smallest size.
3. View
Press this key to see multiple leads of ECG when using the 5-lead ECG cable. Press this key
repeatedly to toggle between multi-lead view, large numeric display, and normal screen.
4. Start
Press this key to begin an NIBP measurement or to begin or re-start automatic interval
measurements.
5. Interval
Press this key to modify the NIBP interval measurement time. The choices are: Off, STAT, 1
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.
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General Product DescriptionKeys 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 Instructions0070- 0-0704-021 - 5
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Keys and Front PanelGeneral 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.
2
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
2
®
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.
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General Product DescriptionKeys 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 Instructions0070- 0-0704-021 - 7
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