Edition 1, October 2008
Software Revision
A.01.00 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.
Philips 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 TC70
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 the 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 TC70
Cardiograph complies
with the requirements of
the Medical Device Directive 93/42/EEC and carries
the
ingly.
PageWriter TC 70 Cardiograph Service ManualContents-5
1
1Introduction
This PageWriter TC 70 Service Manual provides the information you need to successfully
service the PageWriter TC 70.
This Service Manual includes information on:
Maintenance procedures
Troubleshooting procedures and diagnostic tests
Performance verification and safety testing
Ordering parts and supplies
Software Installation
Cart replacement kits and procedures
Theory of operation
Specifications
Before servicing the PageWriter TC 70 cardiographs, review the PageWriter TC70
Cardiograph Instructions for Use located on the User Documentation CD shipped with the
cardiograph, or download the file from the Philips InCenter site (
incenter.medical.philips.com).
This service manual assumes you are familiar with the controls, basic cardiograph operations,
and capabilities of the device as described in these documents.
This chapter provides information on:
Who Should Use this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
This manual is intended for users who handle preventive maintenance, periodic operational
checks, and basic troubleshooting for PageWriter TC 70 cardiographs.
Before attempting to service the cardiographs, you must review the following documentation
and training materials:
PageWriter TC70 Cardiograph Instructions for Use
This Service Manual
This PageWriter TC 70 Cardiograph Service Manual is intended to assist users in the safe and
effective use of the product.
Before attempting to operate this product, read this Service Manual, and note and strictly
observe all Warning and Cautions as described in this document.
Pay special attention to all of the safety information provided in the Safety Summary section.
The following conventions are used in this document.
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.
CAUTION Caution 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.
NOTE Notes contain additional important information about a topic.
TIP A 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.
Internal software components or file directories appear in regular no-serif font. Example:
ECGs are stored to the
RubyArchiveInternal directory.
PageWriter TC 70 Cardiograph Service Manual1-3
IntroductionUsing the Philips InCenter Site
Using the Philips InCenter Site
The Philips InCenter site provides frequent updates to all Philips Cardiac Systems product
documentation and product software, including the PageWriter TC 70 cardiograph.
The Philips InCenter site requires an active registration and password. To register, go to the
InCenter site at:
On the following page, click the
side of the page. The Cardiac Systems InCenter Registration page appears. Complete all of the
information fields on the page to receive a login and password for the InCenter site.
Registration for the InCenter site requires the serial number(s) for all PageWriter TC 70
cardiographs in active use at your facility. The serial number is found on the product
identification label. The product identification label is located on the rear panel of the
cardiograph, next to the AC power cord connector.
About Adobe Acrobat Versions
Adobe Acrobat Reader version 8.0 must be installed on the PC that is used to access the
Philips InCenter site. Previous versions of Acrobat Reader are not compatible with the Philips
InCenter site, and attempting to access InCenter with a previous version of Acrobat Reader
will result in error messages when opening documents. Uninstall all previous versions of
Acrobat Reader, and then proceed for a free install of Acrobat Reader 8.0 at:
incenter.medical.philips.comand click on the Need help? link on the main page.
Click here for account registration link located on the right
www.adobe.com.
Any version of Adobe Acrobat Professional or Acrobat Elements are also not compatible with
the Philips InCenter site, and error messages will appear when opening documents with these
applications. Acrobat Reader 8.0 must be installed in addition to Acrobat Professional or
Acrobat Elements.
Follow this procedure when accessing documents on the Philips InCenter site.
To access documents on the Philips InCenter site:
Exit Acrobat Professional or Acrobat Elements (if open).
1
2Start Acrobat Reader 8.0.
3Open Internet Explorer, and go to the Philips InCenter site. Keep Acrobat Reader 8.0 open
the entire time while accessing the InCenter site.
1-4PageWriter TC 70 Cardiograph Service Manual
Safety SummaryIntroduction
Safety Summary
Symbols Marked on the Cardiograph
SymbolNameDescription
Attention; read the Instructions
for Use
Type CFECG physio isolation is type CF, defibrillator proof.
Direct currentIndicates that the equipment is suitable for direct
DisposalDispose of in accordance with the requirements of
ECG output signalThe connector near this symbol provides access to an
Local Area Network (LAN)
Connector
See the PageWriter TC70 Cardiograph Instructions for Use.
Suitable for all patient applications including direct
cardiac application. System is in continuous operation.
current only.
your country.
analog ECG signal that can be used as a
synchronization signal for external devices, such as an
imaging device. This analog ECG signal is not
diagnostic quality and should not be used for ECG
analysis purposes.
Connect the Ethernet RJ45 LAN cable to the connector
directly beneath this symbol to establish LAN
connectivity.
Modem ConnectorConnect an analog phone line to the connector directly
beneath this symbol.
Attention; read the Instructions for Use
See the PageWriter TC70 Cardiograph Instructions for Use.
PageWriter TC 70 Cardiograph Service Manual1-5
IntroductionSafety Summary
Symbols Marked on the Cardiograph
SymbolNameDescription
Patient Interface Module (PIM)
Connector
Connect the PIM patient data cable to the connector
located directly beneath this symbol.
PCMCIA iconInsert the wireless LAN card into the slot located
directly beneath this symbol.
PS/2 ConnectorConnect the Magnetic Card Reader or Barcode Reader
to the connector located directly beneath this symbol.
Option NumberThe number next to this symbol is the serial number of
the cardiograph.
StandbyPressing the button with this symbol on it puts the
cardiograph into Standby (power saving mode).
USB ConnectorThe connector near this symbol is used with a USB
device.
Non-ionizing electromagnetic
radiation
Interference may occur in the vicinity of equipment
marked with this symbol.
1-6PageWriter TC 70 Cardiograph Service Manual
Safety SummaryIntroduction
Safety Symbols Marked on the Cardiograph Packaging
SymbolDescription
Keep dry.
o
Ambient temperature range of -20
transport and storage.
Atmospheric pressure range of 4572 meters (15,000 feet), 572 hPA above sea level for
transport and storage.
Relative humidity range of 10% to 90% (non-condensing) for transport and storage.
C (-4o F) to 50 oC (122o F) (non-condensing) for
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.)
Dispose of in accordance with the requirements of your country.
PageWriter TC 70 Cardiograph Service Manual1-7
IntroductionSafety Summary
Safety and Regulatory Symbols Marked on the Cart
SymbolNameDescription
Cart TransportDo not transport the cart with the drawer open.
Cart Drawer Weight
Limit
Cart Storage Bin Weight
Limit
AC power connector
input
Do not place more than 3 kilograms or 6.6
pounds of weight into the cart drawer.
Do not place more than 3 kilograms or 6.6
pounds of weight into the cart storage bin.
Indicates the location of the cardiograph AC
power connector.
1-8PageWriter TC 70 Cardiograph Service Manual
Safety SummaryIntroduction
Safety and Regulatory Symbols Marked on the AC Power Adapter
SymbolNameDescription
No serviceable parts
inside
Indoor, dry location use
only
Attention; read the
Instructions for Use
There are no serviceable parts inside the AC
adapter. Do not open the AC adapter case.
The AC adapter is only intended for indoor use in
a dry location.
See the PageWriter TC70 Cardiograph Instructions for Use for information on the AC
power adapter.
AC adapter disposalDispose of in accordance with the requirements
of your country.
PageWriter TC 70 Cardiograph Service Manual1-9
IntroductionImportant Patient and Safety Information
Important Patient and Safety Information
The PageWriter TC70 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.
Accessories and Supplies
WARNING Always clean and disinfect reusable electrodes before patient use. Failure to properly
clean and disinfect reusable electrodes before patient use may cause infectious materials
to be transferred between patients.
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 immediately following defibrillation.
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.
CAUTIONThe Welsh bulb electrodes contain natural rubber latex which may cause allergic reactions.
When using additional peripheral equipment powered by an electrical source other than the
cardiograph, the combination of
Using accessories, peripherals, or cables that are not supplied with the cardiograph or that
are not recommended by Philips Medical Systems can result in increased emissions or
decreased immunity of the cardiograph.
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.
1-10PageWriter TC 70 Cardiograph Service Manual
Important Patient and Safety InformationIntroduction
Connect other equipment in accordance with IEC 60601-1-1 Medical Electrical Systems
Standard or IEC 60601-1: 2005 (3rd Edition) Medical Electrical Equipment Standard
Clause 16 Medical Electrical Systems.
When connecting the cardiograph to other AC powered equipment, only connect equipment
approved to IEC 60601-1 Medical Electrical Equipment or IEC 60950-1 Information
Technology Equipment.
Only use patient electrodes that are approved by Philips Medical Systems. The use of non-
approved patient electrodes may degrade cardiograph performance.
To prevent burns to the patient, remove all ECG electrodes and lead wires prior to the use of
high frequency surgical equipment (including electrosurgical equipment and some
respiration transducers).
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.
AC Power Adapter and AC Power Cord
CAUTION The power supply could feel warm to the touch.
The PageWriter TC70 cardiograph external power supply, part number 453564094411 is
designed with a three wire supply system. The ground only serves a functional purpose for
EMC and not protective earth for electrical safety. Use of an appropriate three-wire power
cord is necessary to provide proper EMC operation.
Only use the AC power adapter designed to be used with the PageWriter TC70 cardiograph,
part number 453564094411, in order to ensure continued compliance with the requirements
of IEC 60601-1.
Only use the external power supply with part number 453564094411 with the PageWriter
TC70 cardiograph to prevent electrical safety hazards. The use of any other power supply is
not approved by Philips Medical Systems.
To disconnect the cardiograph from AC power, unplug the cardiograph AC power cord
from the mains power supply.
This equipment complies with the earth leakage current limits as specified in UL 60601-
1:2003 Medical Electrical Equipment - General Requirements for Safety, only when
connected to a 120 Volt mains power supply.
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.
Periodically inspect the patient data cable, lead wires, and AC power cord for any worn or
cracked insulation. Ensure that no exposed wires are visible on the AC power cord.
PageWriter TC 70 Cardiograph Service Manual1-11
IntroductionImportant Patient and Safety Information
Only use the Philips Medical Systems AC power supply (part number 453564094411)
supplied with the cardiograph. Use of any other power supply has not been verified and may
lead to operator or patient harm, including electrical shock. Periodically inspect the AC
power cord and AC power connector 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.
Analog ECG Output Signal Port
Do not use the analog ECG output signal port (not supported on cardiograph) for diagnostic
purposes and do not use this signal for critical synchronization timing.
Do not connect any equipment to the cardiograph analog ECG output signal port that does
not meet medical safety requirements and that has not been evaluated by local safety
personnel.
Batteries
CAUTION When removing the batteries from the cardiograph, the batteries could feel warm to the touch.
The PageWriter TC70 cardiograph is designed to be operated with two batteries installed,
and the battery operational time listed in this Instructions for Use is based upon cardiograph
operation with both batteries installed. Operation with a single battery is not supported or
recommended as it will shorten operational time and decrease overall battery life.
Only use the batteries designed to be used with the PageWriter TC70 cardiograph, part
number 989803144631, in order to ensure continued compliance with the requirements of
IEC 60601-1.
Cart
Ensure that the cardiograph is securely attached to the cardiograph cart before use.
Defibrillation
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.
Diagrams
Upon customer request, Philips Medical Systems will make available circuit diagrams,
component part lists, descriptions, calibration instructions and other technical information.
1-12PageWriter TC 70 Cardiograph Service Manual
Important Patient and Safety InformationIntroduction
Display Accuracy
The accuracy of the ECG signals are within +/- 5% (or +/- 40 uV whichever is greater), over
a range of 0 to 5 mV, in the presence of differential and common mode DC offset voltages
of +/- 300 mV. The cardiograph performance is tested to comply with the accuracy
requirements over the dynamic ranges and frequency ranges specified in the IEC 60601-251 and AAMI EC-11 standards.
For additional details regarding accuracy and precision, refer to the Physician's Guide and
the Manufacturer's Disclosure Statement.
ECG Interpretation
CAUTION Always enter accurate patient information (including age and gender) if using the Philips ECG
Algorithm for ECG interpretation.
Electrodes
Philips recommends the use of disposable electrodes at all times for all patient applications.
Choose either adult or pediatric disposable electrodes based on the age and size of the
patient. See “Disposable and Reusable Electrodes” on page 5-8 for information on ordering
disposable electrodes.
Faxed ECGs
CAUTION No guarentee is made as to the suitability of a faxed ECG for any particular purpose, due to the
variability inherent in fax technology.
General Cardiograph Use
Do not use this cardiograph near flammable anesthetics. It is not intended for use in
explosive environments or in operating rooms. The disconnection or connection of AC
power, or electrostatic discharge (ESD) may result in an electrical spark.
The cardiograph may generate electromagnetic interference (EMI) that may cause nearby
equipment to fail.
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.
IEC 60601-2-51
For information on the standard IEC 60601-2-51, please go to the Philips InCenter web site
(
incenter.medical.philips.com).
PageWriter TC 70 Cardiograph Service Manual1-13
IntroductionImportant Patient and Safety Information
Lead Wires
WARNING Electrical shock hazard. Do not touch accessible connector pins and the patient
simultaneously.
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.
Main Waveform Display Screen
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 main waveform display screen since these ECG representations are scaled.
Modem Card and Fax Feature
WARNINGDo not connect the modem card to a phone line when the cardiograph is connected to a
patient.
No guarantee is made as to the suitability of a faxed ECG report for any particular purpose,
due to the variability inherent in fax technology.
Pacemaker
Pace pulses may not be visible on a printed ECG report that uses simultaneous acquisition.
Patient Data Cable
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.
Periodically inspect the patient data cable for any cracks or breaks in the cable insulation. If
the integrity of the patient data cable is not assured, replace the patient data cable. Contact
Philips Medical Systems for further assistance.
1-14PageWriter TC 70 Cardiograph Service Manual
Important Patient and Safety InformationIntroduction
Patient Interface Module (PIM)
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.
If using the optional, 16-lead PIM, always ensure that the leads connected to the Patient
Interface Module (PIM) are the same leads that are displayed on the cardiograph screen.
Printer
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.
Servicing the Cardiograph
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.
The Philips Medical Systems warranty is applicable only if you use Philips Medical
Systems approved accessories and replacement parts. See “Parts and Supplies” on page 5-1
for more information.
Software
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.
Touch Screen
Do not use sharp objects with the touch screen or apply excessive force to the touch screen.
Applying excessive force to the touch screen may result in breaking the touch screen
display and can cause sharp, jagged parts to expel to persons nearby.
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.
CAUTION Only use the USB memory stick that is available for purchase as an optional accessory from Philips
Medical Systems with the PageWriter TC cardiograph.
Do not insert a USB memory stick into the cardiograph, or remove a USB memory stick from the
cardiograph when the cardiograph is acquiring ECG data from the patient.
Only use the USB memory stick to transfer data between the cardiograph and a computer. Do not use
the USB memory stick with other devices.
Do not import ECGs into the cardiograph from another cardiograph, or from other devices
to the cardiograph using a USB memory stick.
PageWriter TC70 Cardiograph Components
The following sections include a description of all of the components of the cardiograph,
including the connection ports on the cardiograph, the Patient Interface Module (PIM), and
optional accessories available with the cardiograph.
Figure 1-1Cardiograph (left front view)
H
G
A
B
DEC
F
A Touch screen FECG button
B Audio speakerG Paper tray
C AC power on indicator lightH Keyboard
A Modem connectorG Wireless LAN card slot (with protective
cover installed)
B LAN connectorH AC power connector
C Barcode reader or magnetic card reader
connector
D Analog ECG output signal connector (not
supported)
EUSB connector
FPIM connector
H
G
F
E
WARNINGDo not connect the modem card to a phone line when the cardiograph is connected to a
patient.
CAUTIONDo not insert a USB memory stick into the cardiograph, or remove a USB memory from the
cardiograph when the cardiograph is acquiring ECG data from a patient.
1-18PageWriter TC 70 Cardiograph Service Manual
Patient Interface Module (PIM)Introduction
Patient Interface Module (PIM)
The Patient Interface Module (PIM) is a hand-held device that connects to the patient data
cable. The PIM is available in a standard 12-lead, or an optional 16-lead model. The PIM is
shipped with the patient data cable fully connected to the PIM.
Figure 1-416-lead (left) and 12-lead (right) Patient Interface Module (PIM)
PageWriter TC 70 Cardiograph Service Manual1-19
IntroductionInstalling the Batteries
Installing the Batteries
The cardiograph is shipped with two batteries that are used to power the cardiograph when AC
power is not available.
CAUTIONInsert the batteries into the cardiograph before plugging the cardiograph into AC power.
To install the batteries:
1
Open the battery door.
2Locate the two gold pull tabs inside of the battery compartment. Pull the tabs straight out
of the battery compartment and ensure that both are pulled taut.
1-20PageWriter TC 70 Cardiograph Service Manual
Installing the BatteriesIntroduction
3Insert the battery with the external connector facing the bottom rear of the compartment.
4Ensure that the battery is fully inserted into the slot. The pull tab will insert along with the
battery. Insert the second battery following the same procedure.
PageWriter TC 70 Cardiograph Service Manual1-21
IntroductionInstalling the Batteries
5Reinstall the battery door.
6Connect the AC power cord to the cardiograph. Charge the batteries for five hours before
operating the cardiograph on battery power only.
Charging the Batteries
Charge the batteries for five hours prior to initial use. Plug the cardiograph into AC power
whenever possible, and fully charge the batteries. Proper battery maintenance and care,
including frequent and full charging of the batteries, will help to prolong battery life.
There are configurable power saving features available on the cardiograph. These features are
used to help prolong overall battery life, and to optimize battery power use between battery
charges.
CAUTION When removing the batteries from the cardiograph, the batteries could feel warm to the touch.
1-22PageWriter TC 70 Cardiograph Service Manual
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