Edition 1
January 2003
Edition 2
April 2004
Edition 3
November 2007
Applicable to Software Revisions
B.01.00, C.01.02 and higher
Warranty
Philips Medical Systems reserves
the right to make changes to both
this Service Manual and to the
product that it describes. Product
specifications are subject to change
without notice.
Nothing contained within this
Service Manual is intended as any
offer, warranty, promise, or
contractual condition, and must not
be taken as such.
Electronics N.V. All rights are
reserved. All other product names
are the property of their respective
owners.
Reproduction in whole or in part in
any form, or by any means, electrical, mechanical or otherwise, is
prohibited without the written
consent of the copyright holder.
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810 USA
(978) 687-1501
Unauthorized copying of this publication may not only infringe copyright laws, but may also reduce the
ability of Philips Medical Systems
to provide accurate and current
information to users.
Compliance
The Philips Medical Systems PageWriter Touch cardiograph complies
with all relevant international and
national standards and laws. Information on compliance will be
supplied on request by a local
Philips Medical Systems representative, or by the manufacturer.
Intended Use of this
Service Manual
This Philips product is intended to
be operated only in accordance with
the safety procedures and operating
instructions provided in this Service Manual, and in accordance with the
purposes for which it was designed.
Installation, use, and operation of
this product is subject to the laws in
effect in the jurisdiction(s) in which
the product is being used. Users
must only install, use, and operate
this product in such a manner that
does not conflict with applicable
laws or regulations that have the
force of law.Use of this product for
purposes other than the express
intended purpose provided by the
manufacturer, or incorrect use and
operation, may relieve the manufacturer (or agent) from all or some
responsibility for resultant noncompliance, damage, or injury.
United States federal law restricts
this device to use by or on the order
of a physician. THIS PRODUCT IS
NOT INTENDED FOR HOME
USE.
Training
Users of this product must receive
adequate clinical training on its safe
and effective use before attempting
to operate the product as described
in this Service Manual.
Training requirements vary by
country. Users must ensure that
they receive adequate clinical
training in accordance with local
laws or regulations.
For further information on available
training on the use of this product,
please contact a Philips Medical
Systems representative, or the
manufacturer.
Medical Device
Directive
The PageWriter Touch Cardiograph
complies with the requirements of
the Medical Device Directive 93/
42/EEC and carries the
mark accordingly.
PageWriter Touch Cardiograph Service ManualContents-9
Table of Contents
Contents-10PageWriter Touch Cardiograph Service Manual
1
Chapter 1Introduction
This PageWriter Touch Cardiograph Service Manual provides the information needed to
successfully service the PageWriter Touch cardiograph and cart system (Philips part number
860284). This Service Manual provides information on troubleshooting, repairing, and
performance verification and safety testing of the cardiograph and cart system. There is also
information on the theory of operation, maintenance procedures, and ordering parts and
supplies.
This chapter includes general information that needs to be reviewed before servicing the
PageWriter Touch cardiograph. For detailed information regarding controls, operation, and
capabilities of the device, refer to the PageWriter Touch Cardiograph Instructions for Use, Edition 7 on the PageWriter Touch Cardiograph User Documentation CD (Philips part
number 453564053291) or the PageWriter Touch Cardio graph Interactive Training Program
on CD (Philips Part Number 989803127401).
Review the PageWriter Touch Cardiograph Instructions for Use, Edition 7 before servicing
this device. This Service Manual assumes knowledge of all cardiograph controls and basic
features.
This chapter includes the following information:
Who Should Use this Service Manual. . . . . . . . . . . . . . . . . . . . . . . 1-3
Conventions Used in this Service Manual . . . . . . . . . . . . . . . . 1-3
This PageWriter Touch Cardiograph Service Manual provides the information needed to
successfully service the PageWriter Touch cardiograph and cart system (Philips part number
860284). This Service Manual provides information on troubleshooting, repairing, and
performance verification and safety testing of the cardiograph and cart system. There is also
information on the theory of operation, maintenance procedures, and ordering parts and
supplies.
This chapter includes general information that needs to be reviewed before servicing the
PageWriter Touch cardiograph.
Review the PageWriter Touch Cardiograph Instructions for Use, Edition 7 before servicing
this device. This Service Manual assumes knowledge of all cardiograph controls and basic
features.
This chapter includes the following information:
Who Should Use this Service Manual. . . . . . . . . . . . . . . . . . . . . . . 1-2
Conventions Used in this Service Manual . . . . . . . . . . . . . . . . 1-2
Accessing Documentation at the Philips Website . . . . . . . . . 1-20
1-1
IntroductionWho Should Use this Service Manual
Who Should Use this Service Manual
The intended users of this Service Manual are technical personnel trained in the safe and
proper servicing of the PageWriter Touch cardiograph.
Before attempting to service the cardiograph, review the PageWriter Touch Cardiograph Instructions for Use, Edition 7 for software version C.01.02 and higher or Edition 6 for
software version B.01.
Conventions Used in this Service Manual
The Service Manual uses the following typographic conventions.
ItemHow Displayed
Menu item
Button name
Menu items and button names appear in a bold no-serif font.
Example: Touch
Config.
Keyboard keysKeyboard keys, such as Enter, or Tab, appear in italic font.
Example: Press Enter after typing the name.
WARNINGWarning statements describe conditions or actions that may result in a potentially
serious outcome, adverse event, or a safety hazard. Failure to follow a Warning may
result in death or serious injury to the user or to the patient.
CAUTIONCaution statements describe when special care is necessary for the safe and effective use of the
product. Failure to follow a caution may result in minor to moderate personal injury or damage to the
product or other property, a remote risk of more serious injury, or may cause environmental
pollution.
NOTENotes contain additional important information about a topic.
TIPA Tip contains suggested information on using a particular feature.
Menu items and button names appear in bold no-serif font. Example: Touch the Config button.
1-2PageWriter Touch Cardiograph Service Manual
IntroductionSafety Summary
Safety Summary
Safety Symbols Marked on the Cardiograph
SymbolNameDescription
AttentionSee PageWriter Touch Instructions for Use for
Type CFECG physio isolation is type CF, defibrillator proof.
Alternating currentIndicates that the cardiograph is receiving alternating
StandbyPressing the button with this symbol on it puts the
information.
Suitable for all patient applications including direct
cardiac application. System is in continuous operation.
voltages.
cardiograph into Standby (power saving mode).
Equipotential grounding postEquipotential grounding po st used for establishing
FuseCardiograph contains a 1.5 amp (250V) time-delay
InputThe connector near this symbol receives an incoming
Electrostatic DischargeDo not touch exposed pins. Touching exposed pins can
PIM (Patient Interface
Module), Attention
Serial NumberThe number next to this symbol is the serial number of
Product model numberThe number next to this symbol is the product model
common ground between instruments.
fuse.
signal.
cause electrostatic discharge which can damage the
cardiograph.
Attention, see PageWriter Touch Instructions for Use
for information on PIM RJ-11 receptacle.
the cardiograph.
number of the cardiograph
Entry of liquidsCardiograph has ordinary protection against the entry
of liquids.
Entry of liquids
The PIM (Patient Interface Module) is protected
against splashing water. Water splashed against the
PIM from any direction shall have no harmful effect.
PageWriter Touch Cardiograph Service Manual1-3
IntroductionSafety Summary
Safety Symbols Marked on the Cardiograph
SymbolNameDescription
Global Medical Device
Nomenclature Code
Global Medical Device Nomenclature Code is a 5-digit
code providing a brief description of the device, as
defined by EN ISO 15225.
Safety Symbols Marked on the Cardiograph Packaging
SymbolDescription
Keep dry.
o
Ambient temperature range of 15
transport and storage.
Atmospheric pressure range of 466 hPa to 1014 hPa for transport and storage.
C (59o F) to 35 oC (95o F) (non-condensing) for
Relative humidity range of 25% to 80% (non-condensing) for transport and storage.
Made from recycled materials.
Fragile.
Lithium ion battery. Do not dispose of in trash. Follow local regulations for disposing of
as small chemical waste.
This product consists of devices that may contain mercury, which must be recycled or
disposed of in accordance with local, state, or federal laws. (Within this system, the
backlight lamps in the monitor display contain mercury.)
1-4PageWriter Touch Cardiograph Service Manual
IntroductionImportant Patient and Safety Information
Safety Symbols Marked on the Cardiograph Packaging
SymbolDescription
Dispose of in accordance with the requirements of your country.
Important Patient and Safety Information
The PageWriter Touch cardiograph isolates all connections to the patient from electrical
ground and all other conductive circuits in the cardiograph. This reduces the possibility of
hazardous currents passing from the cardiograph through the patient’s heart to ground.
WARNING Failure to follow these warnings could affect both patient and operator safety.
WARNINGDo not connect the modem card to a phone line when the cardiograph is connected to a
patient.
WARNING Do not touch accessible connector pins and the patient simultaneously.
Electrical shock hazard. Keep cardiograph, Patient Interface Module (PIM) and all
cardiograph accessories away from liquids. Do not immerse the cardiograph, PIM, or
other accessories in any liquids.
WARNING When using additional peripheral equipment powered from an electrical source other
than the cardiograph, the combination is considered to be a medical system. It is the
responsibility of the operator to comply with IEC 60601-1-1 and test the medical system
according to the requirements. For additional information contact Philips Medical
Systems.
WARNING Do not use non-medical peripherals within 6 feet of a patient unless the non-medical
peripherals receive power from the cardiograph or from an isolation transformer that
meets medical safety standards.
WARNING The Welsh bulb electrodes (available as an accessory for the cardiograph) do not meet
the requirements of IEC 60601-2-25 for defibrillation recovery time, and cannot be
reliably used for patient diagnosis following defibrillation.
PageWriter Touch Cardiograph Service Manual1-5
IntroductionImportant Patient and Safety Information
When operating the cardiograph on AC power, ensure that the cardiograph and all other
electrical equipment connected to or near the patient are effectively grounded.
Use only grounded power cords (three-wire power cords with grounded plugs) and
grounded electrical outlets. Never adapt a grounded plug to fit an ungrounded outlet by
removing the ground prong or ground clip. If an un gro un ded plu g ad ap ter is r equired, use a
ground strap to connect the equipotential post (rear of the cardiograph, see page 1-13) to the
power source ground. Use the equipotential post when redundant earth ground is necessary
according to IEC 60601-1.
If a safe ground connection is not ensured, operate the cardiograph on battery power only.
The use of equipment that applies high frequency voltages to the patient (including
electrosurgical equipment and some respiration transducers) is not supported and may
produce undesired results.
Periodically inspect the patient data cable, lead wires, and AC power cord for any worn or
cracked insulation.
Keep the patient data cable away from power cords and any other electrical equipment.
Failure to do so can result in AC power line frequency interference on the ECG trace.
The Philips Medical Systems patient data cable (supplied with cardiograph) is an integral
part of the cardiograph safety features. Use of any other patient data cable may compromise
defibrillation protection and degrade cardiograph performance.
Only qualified personnel may service the cardiograph or may open the cardiograph housing
to access internal cardiograph components. Do not open any covers on the cardiograph.
There are no internal cardiograph components that are serviced by the operator.
Do not use this cardiograph near flammable anesthetics. It is not intended for use in
explosive environments or in operating rooms.
The use of the analog ECG output signal port (not supported on cardiograph, see page 1 -13)
should not be used when critical synchronization timing is required.
Do not touch the patient, patient data cable, or cardiograph during defibrillation. Death or
injury may occur from the electrical shock delivered by the defibrillator.
Ensure that the electrodes or lead wires do not come in contact with any other conductive
materials (including earth-grounded materials) especially when connecting or disconnecting
electrodes to or from a patient.
Connecting multiple cardiographs to the same patient may pose a safety hazard due to the
summation of leakage currents. Any combination of instruments should be evaluated by
local safety personnel before being put into service.
Do not pull on the paper while an ECG report is being printed. This can cause distortion of
the waveform and can lead to potential misdiagnosis.
Do not connect any equipment to the cardiograph RS-232 port that does not meet medical
safety requirements and that has not been evaluated by local safety personnel.
1-6PageWriter Touch Cardiograph Service Manual
IntroductionImportant Patient and Safety Information
Equipment connected to the cardiograph RS-232 port can cause ground leakage currents
exceeding the maximum specified in IEC 60601-1 safety standards.
Do not connect any equipment to the cardiograph RS-232 port if a patient is connected to
the cardiograph.
Only use the Philips Medical Systems AC power cord supplied with the cardiograph.
Periodically inspect the AC power cord and AC power connector (rear of cardiograph, see
page 1-13) to ensure that both are in a safe and operable condition. If the AC power cord or
AC power connector is not in a safe or operable condition, operate the cardiograph on
battery power and contact Philips Medical Systems for service.
The cardiograph has been safety tested with the recommended accessories, peripherals, and
leads, and no hazard was found when the cardiograph is operated with cardiac pacemakers
or other stimulators.
Do not connect any equipment or accessories to the cardiograph that are not approved by
Philips Medical Systems or that are not IEC 60601-1 approved. The operation or use of
non-approved equipment or accessories with the cardiograph is not tested or supported, and
cardiograph operation and safety are not guaranteed.
Only install Philips Medical Systems software on the cardiograph. The installation or use of
software not approved by Philips Medical Systems is strictly prohibited and cardiograph
safety and performance are not guaranteed.
Only use Philips Medical Systems replacement parts and supplies with the cardiograph. The
use of non-approved replacement parts and supplies with the cardiograph is strictly
prohibited. Cardiograph safety and performance are not guaranteed when non-approved
replacement parts and supplies are used with the cardiograph.
Manual measurements of ECG intervals and magnitudes should be performed on printed
ECG reports only. Do not make manual measurements of ECG intervals and magnitudes on
the touchscreen display since these ECG representations are scaled.
Only use patient electrodes that are approved by Philips Medical Systems. The use of non-
approved patient electrodes may degrade cardiograph perfo rmance.
The Philips Medical Systems warranty is applicable only if you use Philips Medical
Systems approved accessories and replacement parts. See “Supplies and Ordering
Information” on page 1-24 for more information.
For information on the standard IEC 60601-2-51, please go to the Philips InCenter web site
(
incenter.medical.philips.com). For information on using the Philips InCenter site, see page 1-
29.
Always put the cardiograph in Standby before replacing the Patient Interface Module
(PIM). Do not change the PIM while the cardiograph is in active use.
PageWriter Touch Cardiograph Service Manual1-7
IntroductionThe PageWriter Touch Cardiograph
The PageWriter Touch Cardiograph
This Philips product is intended to be used and operated only in accordance with the safety
procedures and operating instructions provided in this Instructions for Use, and for the
purposes for which it was designed. The purposes for which the product is intended are
provided below. However, nothing stated in this Instructions for Use reduces the
responsibility of the user for sound clinical judgment and best clinical procedures.
Intended Use
The intended use of the cardiograph is to acquire multi-channel ECG signals from adult and
pediatric patients from body surface ECG electrodes and to record, display, analyze, and store
these ECG signals for review by the user. The cardiograph is to be used in healthcare facilities
by trained healthcare professionals. Analysis of the ECG signals is accomplished with
algorithms that provide measurements, data presentations, graphical presentations, and
interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician
on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the
patient, the results of the physical examination, the ECG tracings, and other clinical findings.
A qualified physician is asked to overread and validate (or change) the computer-generated
ECG interpretation.
Indications for Use
The cardiograph is to be used where the clinician decides to evaluate the electrocardiogram of
adult and pediatric patients as part of decisions regarding possible diagnosis, potential
treatment, effectiveness of treatment, or to rule out causes for symptoms.
The Philips 12-Lead Algorithm
The PageWriter Touch Cardiograph software uses the Philips 12-Lead Algorithm. The
algorithm in the software analyzes the morphology and rhythm on each of the 12 leads and
summarizes the results. The set of summarized measurements is then analyzed by the
clinically-proven ECG Analysis Program.
12-lead reports may include or exclude ECG measurements, reasons, or analysis statements.
Intended Use
The intended use of the Philips 12-Lead Algorithm is to analyze multi-channel ECG signals
from adult and pediatric patients with algorithms that provide measurements, data
presentations, graphical presentations, and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician
on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the
patient, the results of the physical examination, the ECG tracings, and other clinical findings.
A qualified physician is asked to overread and validate (or change) the computer-generated
ECG interpretation.
1-8PageWriter Touch Cardiograph Service Manual
IntroductionCardiograph Features
Indications for Use
The Philips 12-Lead Algorithm is to be used where the clinician decides to evaluate the
electrocardiogram of adult and pediatric patients as part of decisions regarding possible
diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.
Cardiograph Features
The PageWriter Touch cardiograph is one of the most advanced cardiographs. It offers touch
screen operation and numerous additional features making it ideal for high-volume
environments. The PageWriter Touch cardiograph is also well suited for hospitals requiring
speed and accuracy to process large volumes of ECGs daily.
The PageWriter Touch cardiograph consists of an electrocardiogr ap h with remote digital
patient module and an optional cart.
Features
The features of the PageWriter Touch cardiograph include:
Battery or AC operation
Remote digital acquisition module with replaceable patient leads with the capability for up
to 12 leads (software version B.01), or up to 16 leads (software ve rsion C.01.02 and
higher)
Three 15 and 16-lead options are available with software version C.01.02 and higher for
both adult and pediatric application
15-inch color liquid crystal touch screen display
Graphical representation of a human torso displaying leads that are loose or not connected
Data transmission between the cardiograph and a TraceMasterVue ECG Management
system in XML format via modem, LAN, WLAN, diskette, or optional PC (PCMCIA)
storage card, or USB memory stick
Software version C.01.02 and higher supports the export of ECG data in XML version
1.03, or XML version 1.04
Optional cart with convenient storage areas for supplies
Software version B.01, and C.01.02 and higher, support bidirectional orders download and
search capability with an OrderVue order handling system
Software version B.01, and C.01.02 and highe r, support algorithm version PH080A and
PH090A; algorithm version PH090A includes new enhancements and features including
heightened detection of atrial arrhythmia, the ability to suppress statements that indicate a
borderline or otherwise normal condition, lead reversal detection feature, ECG warning
statements when a life threatening cardiac event is detected, and the ability to print
Fridericia rate corrected QT interval and RR measurements on the ECG report
Time Sychronization feature that is used with a TraceMasterVue ECG Management
System (version B.01 and higher). Use of this feature helps to ensure the accuracy of the
displayed time on the cardiograph by regularly calibrating it with a configured
TraceMasterVue Remote Site
PageWriter Touch Cardiograph Components
The following sections illustrate the components and connection ports on the cardiograph and
the Patient Interface Module (PIM). Figures 1-1, 1-2, and 1-3 on the following pages show
front, side, and rear views of the PageWriter Touch cardiograph. For additional details, see the
PageWriter Touch Cardiograph Instructions for Use, Edition 7 on the User Documentation
CD.
A Patient Interface Module (PIM) G Magnetic card reader (optional)
BPrinter/paper drawer H Diskette drive
C Touch screen IStorage shelf
D AC power on indicator light JOptional locking drawer
EOn/Standby button K Wheel positioners
FKeyboard
A Fuse door G Serial connector (not supported)
BAC power switch H Barcode scanner connector
C AC power cord IECG out (not supported)
D Reset button JPC card slot
EUSB memory stick connector KPC card eject button
WARNINGDo not connect the modem card to a phone line when the cardiograph is connected to a
CAUTIONDo not insert a USB memory stick into the cardiograph, or remove a USB memory from the
FLAN connector LEquipotential grounding post
patient.
cardiograph when the cardiograph is acquiring ECG data from a patient.
The cardiograph uses a thermal print head to record waveforms and label the ECG report. The
paper supplied with the cardiograph is a thermal paper designed to work with the print head.
The paper drawer accommodates both A and A4 size paper. A separate supplied paper shim is
required for A4 paper use.
Philips guarantees the performance of the cardiograph only when used with Philips supplies,
accessories, and paper that meets or exceeds Philips specifications.
Touch Screen Display
The cardiograph features a 15-inch touch screen color LCD display. Never touch the screen
with sharp objects or you may damage the touch screen surface.
Batteries
The PageWriter Touch is powered by two rechargeable Lithium Ion batteries (Philips part
number 989803129131). The cardiograph is intended to be operated primarily on battery
power. Proper care of the batteries will ensure a long life. For more details see the Care and
Maintenance chapter in the PageWriter Touch Cardiograph Instructions for Use, Edition 7,
included on this Service Documentation CD.
Patient Interface Module (PIM)
The Patient Interface Module (PIM) is a hand-held device that contains all of the
cardiograph’s waveform data acquisition electronics. The PIM connects to the patient data
cable and to the lead wires attached to the patient.The PIM is available in a standard 12-lead,
or an extended 16-lead model. The PIM has an Action button that is used to take ECG
Snapshots from the bedside.
The lead wires and the patient data cable are shipped fully connected to the PIM. For details
about connecting the lead wires to the PIM, see the PageWriter Touch Cardiograph Instructions for Use, Edition 7.
A Action button CLimb and optional extended lead wires
BChest lead wires D Patient data cable (connects to RJ-11 receptacle on right side of
cardiograph)
Configuring the 16-Lead PIM
(software version C.01.02 and higher only)
The optional 16-lead PIM may be configured to support three different 15 and 16-lead options
for adult and pediatric application. The 16-lead PIM is shipped with the optional extended
leads connected to the PIM. The available 15 and 16-lead options are listed in Table 1-1, “15
and 16-Lead PIM Configuration Options,” on page 1-17.