Edition 1, June 2009
Software Revision
A.03.00 and higher
Edition 2, March 2010
Software Revision
A.04.01 and higher
Warranty
Philips Medical Systems
reserves the right to make
changes to both this
Instructions for Use and to
the product that it
describes. Product specifications are subject to
change without notice.
Nothing contained within
this Instructions for Use 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 and PageWriter TC50 cardiograph
comply 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
Instructions for Use
This Philips product is
intended to be operated
only in accordance with
the safety procedures and
operating instructions
provided in this Instruc-tions for Use, 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 Instructions for Use.
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 and PageWriter TC50 cardiograph
comply with the requirements of the Medical
Device Directive 93/42/
EEC and carries the
Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph Cart. . . i-v
Safety and Regulatory Symbols Marked on the PageWriter TC50 Cardiograph Cart. . . i-v
Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph AC
PageWriter TC70/TC50 Cardiograph Instructions for Use Contents-7
Table of Contents
Contents-8PageWriter TC70/TC50 Cardiograph Instructions for Use
1About the PageWriter TC70 and
PageWriter TC50 Cardiographs
About the Instructions for Use
This PageWriter TC70 and PageWriter TC50 Cardiograp h Instructions for Use is intended to
assist users in the safe and effective use of the product.
Before attempting to operate this product, read this Instructions for Use, 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.
For more information, see page i-i.
WARNING Warning 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 Setup button.
Safety Summary
Symbols Marked on the Cardiograph or Patient Interface Module (PIM)
SymbolNameDescription
Attention; read the Instructions
for Use
Type CF
Defibrillator Proof
DC PolarityIndicates the polarity of the DC power connector.
See the PageWriter TC70 and PageWriter TC50 Cardiograph Instructions for Use.
ECG physio isolation is type CF, defibrillator proof.
Suitable for all patient applications including direct
cardiac application. System is in continuous operation.
i-i
Safety SummarySymbols Marked on the Cardiograph or Patient Interface Module (PIM)
Symbols Marked on the Cardiograph or Patient Interface Module (PIM)
SymbolNameDescription
Direct Current Indicates that the equipment is suitable for direct
current only.
DisposalDispose of in accordance with the requirements of
your country.
ECG output signalThe connector near this symbol provides access to an
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.
Local Area Network (LAN)
Connector
Connect the Ethernet RJ45 LAN cable to the connector
directly above this symbol to establish LAN
connectivity.
Modem ConnectorConnect an analog phone line to the connector d irectly
above this symbol.
Attention; read the Instructions for Use
Patient Interface Module (PIM)
Connector
See the PageWriter TC70 and PageWriter TC50 Cardiograph Instructions for Use.
Connect the PIM patient data cable to the connector
located directly above this symbol.
PCMCIA iconInsert the wireless LAN card into the slot located
directly above this symbol.
PS/2 ConnectorConnect the Magnetic Card Reader or Barcode Reader
to the connector located directly above this symbol.
Serial 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).
i-iiPageWriter TC50/TC70 Cardiograph Instructions for Use
Symbols Marked on the Cardiograph or Patient Interface Module (PIM)Safety Summary
Symbols Marked on the Cardiograph or Patient Interface Module (PIM)
SymbolNameDescription
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.
Equipotential Grounding PostEquipotential grounding post used for establishing
common ground between instruments.
Class IIProtection against electric shock (PageWriter TC70
Cardiograph only).
Fuse The PageWriter TC50 Cardiograph contains a 1 .6 amp
(250V) time-delay fuse.
PageWriter TC50/TC70 Cardiograph Instructions for Usei-iii
Safety SummarySafety Symbols Marked on the Cardiograph Packaging
Safety Symbols Marked on the Cardiograph Packaging
SymbolDescription
Keep dry.
o
Ambient temperature range of -20
transport and storage.
Note: the batteries will discharge at a rapid rate if the cardiograph is stored at a high
temperature.
Atmospheric pressure range of 0 to 4572 meters (15,000 feet), 572 hPA above sea level
for transport and storage.
C (-4o F) to 50 oC (122o F) (non-condensing) for
Relative humidity range of 10% to 90% (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.)
Dispose of in accordance with the requirements of your country.
i-ivPageWriter TC50/TC70 Cardiograph Instructions for Use
Safety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph CartSafety Summary
Safety and Regulatory Symbols Marked on the PageWriter TC70
Cardiograph Cart
SymbolNameDescription
Cart TransportDo not transport the cart with the drawer open.
Cart Drawer Weight
Limit
Cart Storage Bin Weight
Limit
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.
Safety and Regulatory Symbols Marked on the PageWriter TC50
Cardiograph Cart
SymbolNameDescription
Cart Storage Bin Weight
Limit
Do not place more than 3 kilograms or 6.6
pounds of weight into the cart storage bin.
Optional Patient Cable
Arm
PageWriter TC50/TC70 Cardiograph Instructions for Usei-v
Do not transport the cart with the patient
cable arm positioned to the side. Only
transport the cart with the patient cable
arm positioned to the front of the cart.
Safety SummarySafety and Regulatory Symbols Marked on the PageWriter TC70 Cardiograph AC Power Adapter
Safety and Regulatory Symbols Marked on the PageWriter TC70
Cardiograph 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 and PageWriter TC50 Cardiograph Instructions for Use for information
on the AC power adapter.
AC adapter disposalDispose of in accordance with the requirements
of your country.
i-viPageWriter TC50/TC70 Cardiograph Instructions for Use
Accessories and SuppliesImportant Patient and Safety Information
Important Patient and Safety Information
The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph isolate 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.
CAUTION 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.
CAUTION 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.
PageWriter TC50/TC70 Cardiograph Instructions for Usei-vii
Important Patient and Safety InformationAC Power Adapter and AC Power Cord
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.
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 equipmen t, only connect e quipment
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.
T o prevent burns to the pat ient, remove all ECG electrodes and lead wires prior to the use of
high frequency surgical equipment (including electrosurgical equipment and some
respiration transducers).
AC Power Adapter and AC Power Cord
WARNING Only use the external power supply with part number 453564094411 with the
PageWriter TC70 cardiograph in order to prevent electrical safety hazards. The use of
any other power supply is not approved by Philips Medical Systems.
WARNING Whenever the AC power cord is connected to a live power outlet, ensure that it is also
securely attached to the cardiograph. Always disconnect the AC power cord from the
power outlet when it is not connected to the cardiograph.
WARNING Only use grounded power cords (three-wire power cords with grounded plugs) and
grounded electrical outlets that are labeled as Hospital Only or Hospital Grade. NEVER adapt a
grounded plug to fit an ungrounded outlet by removing the ground prong. Use the
equipotential post when redundant earth ground is necessary according to IEC 60601-1-
1.
CAUTION The power supply could feel warm to the touch.
.The PageWriter TC70 cardiograph external po wer 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.
i-viiiPageWriter TC50/TC70 Cardiograph Instructions for Use
Analog ECG Output Signal PortImportant Patient and Safety Information
Only use the AC power adapter designed to be used with the PageWriter TC70 cardiograph,
part number 453564094411 , in order to ensure continue d compliance with the requirements
of IEC 60601-1.
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.
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.
Only use the Philips Medical Systems AC power cord (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 cardio graph) for diagno stic
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
CAUTIONS Before removing and replacing batteries from the cardiograph, press down and hold the On/
Standby button () (located on the front of the cardiograph), to shut down the cardiograph.
Ensure that the cardiograph is shut down. When the cardiograph is fully shut down, the screen is
black, and the On/Standby button is not illuminated. Once the cardiograph is shut down, proceed
to remove and replace the batteries.
When removing batteries from the cardiograph, the batteries could feel warm to the touch.
The battery capacity for the PageWriter TC50 cardiograph with a single battery installed
using the battery with Philips part number 989803170371, is 30 minutes of continuous
Rhythm printing, or 30 total ECG reports.
When operating the PageWriter TC50 cardiograph with one battery installed, only use the
Philips battery with part number 989803170371. Do not use the battery with Philips part
number 989803160981 for one battery operation.
When operating the PageWriter TC70 or the PageWriter TC50 cardiograph with two
batteries installed, ensure that both batteries contain the same Philips part number. The
PageWriter TC50/TC70 Cardiograph Instructions for Usei-ix
Important Patient and Safety InformationPageWriter TC50 Cardiograph One Battery Operation
battery part number identification label is found on the bottom of the battery. The
cardiograph cannot operate with two batteries that contain different part numbers. If the
cardiograph is operated with two batteries with different part numbers, the cardiograph will
display an error message and will not operate.
PageWriter TC50 Cardiograph One Battery Operation
The PageWriter TC50 cardiograph with inst alled software version A.04.00 and h igher can
operate on a single battery with Philips part number 989803170371.
The battery capacity for the PageWriter TC50 cardiograph with a single battery installed
using the battery with Philips part number 989803170371, is 30 minutes of continuous
Rhythm printing, or 30 total ECG reports.
When operating the PageW riter TC50 cardiograph with one battery installed, only use the
Philips battery with part number 989803170371. Do not use the battery with Philips part
number 989803160981 for one battery operation.
When operating the PageWriter TC50 cardiograph with one battery installed, the single
battery may be inserted into either battery compartment.
Cart
Ensure that the cardiograph is securely attached to the cardiograph cart before use.
Defibrillation
WARNING Do not touch the patient, patient data cable, leads, or the 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.
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.
i-xPageWriter TC50/TC70 Cardiograph Instructions for Use
ECG InterpretationImportant Patient and Safety Information
ECG Interpretation
CAUTION Always enter accurate patient information (including age and gender) if using the Philips DXL ECG
Algorithm or Philips 12-Lead Algorithm for ECG interpretation.
Electrodes
Philips recommends the use of disp osable elec trodes 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 1-48 for information on
ordering disposable electrodes.
Faxed ECGs
CAUTION No guarantee is made as to the suitability of a faxed ECG for any particular purpose, due to the
variability inherent in fax technology.
CAUTION Faxed ECGs should only be sent to secure recipient fax machines.
General Cardiograph Use
WARNING Electrical shock hazard. Keep the 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 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.
CAUTION The cardiograph may generate electromagnetic interference (EMI) that may cause nearby equipment
to fail.
CAUTION 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.
Disconnect the patient data cable from the cardiograph, or detach the leads from the patient prior to
performing any procedure that uses high frequency surgical equipment.
PageWriter TC50/TC70 Cardiograph Instructions for Usei-xi
Important Patient and Safety InformationIEC 60601-2-51
The use of non-Philips equipment connected to, or operating with, the PageWriter TC70
cardiograph or the PageWriter TC50 cardiograph is not tested or supported, and may
produce undesired results.
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). For information on using the Philips InCenter site, see page 1-
5.
Lead Wires
WARNING Electrical shock hazard. Do not touch accessible connector pins and the patient
simultaneously.
WARNING Do not touch any loose or exposed leads during defibrillation. Death or injury may occur
from the electrical shock delivered by the defibrillator.
WARNING 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 printe d
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
WARNING Do not connect the modem card to a phone line when the cardiograph is connected to a
patient.
i-xiiPageWriter TC50/TC70 Cardiograph Instructions for Use
PacemakerImportant Patient and Safety Information
WARNING Only connect the phone line to the modem connector () located on the rear panel
of the cardiograph. Never attach the phone line to the LAN connector ().
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
WARNING 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 lead to
the distortion or corruption of patient ECG data, may compromise defibrillation
protection and degrade cardiograph performance, and overall cardiograph safety may be
seriously degraded.
WARNING Ensure that the patient data cable is securely connected to the PIM Connector ()
on the rear panel of the cardiograph.
The PageWriter TC50 cardiograph with installed software version A.03.00 and higher are
only compatible with the Class B patient data cable (Philips part number 989803164281).
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.
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, see "Contacting a Philips Response
Center" on page 1-51.
Patient Interface Module (PIM)
WARNING Always clean and disinfect the Patient Interface Module (PIM) after patient use, if the
PIM comes into direct contact with the patient’s skin. Failure to properly clean and
disinfect the PIM after direct contact with the patient’s skin may cause infectious
materials to be transferred between patients.
PageWriter TC50/TC70 Cardiograph Instructions for Usei-xiii
Important Patient and Safety InformationPrinter
CAUTION 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.
The PageWriter TC50 cardiograph with installed software version A.03.00 and higher is
only compatible with the Class B 12-lead PIM (Philips part number 453564150741, AAMI
and 453564150761, IEC) or the Class B 16-lead PIM (Philips part number 453564150751,
AAMI and 453564150771, IEC).
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.
Printer
CAUTION 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 “Supplies and Ordering
Information” on page 1-45 for more information.
Software
WARNING 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
WARNING 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 printe d
ECG reports only . Do not make manual measurements of ECG intervals and magnitudes on
the touchscreen display since these ECG representations are scaled.
i-xivPageWriter TC50/TC70 Cardiograph Instructions for Use
USB Memory StickThe PageWriter TC70 Cardiograph and PageWriter TC50 Cardiograph
USB Memory Stick
WARNING Do not use the USB memory stick to import ECGs from other cardiographs, or other
non-Philips devices onto the PageWriter TC70 cardiograph or PageWriter TC50
cardiograph.
CAUTIONS 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.
Keep all USB memory sticks that contain patient data in a secure location where they cannot be
accessed by unauthorized personnel. Always delete patient data from a USB memory stick promptly
after use.
Affix a label to all USB memory sticks that contain patient data notifying users that unauthorized
access of patient data on the USB memory stick is punishable by law.
Periodically inspect the USB connectors (side and rear of cardiograph) for any cracks or
breaks. If the integrity of a USB connectors is not assured, do not use the USB connector,
and contact Philips Medical Systems for further assistance, see "Contacting a Philips
Response Center" on page 1-51.
The PageWriter TC70 Cardiograph and PageWriter
TC50 Cardiograph
These Philips products are 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.
PageWriter TC50/TC70 Cardiograph Instructions for Usei-xv
The Philips ECG AlgorithmIndications for Use
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 ECG Algorithm
The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph software uses the
Philips ECG Algorithm. The algorithm in the software analyzes the morphology and rhythm
on each of the 16 leads and summarizes the results. The set of summarized measurements is
then analyzed by the clinically-proven ECG Analysis Program.
16-lead reports may include or exclude ECG measurements, reasons, or analysis statements.
Intended Use
The intended use of the Philips ECG 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.
Indications for Use
The Philips ECG 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.
i-xviPageWriter TC50/TC70 Cardiograph Instructions for Use
1
1Getting Started
Welcome to the PageWriter TC70 and TC50 cardiographs, a versatile and powerful addition
to your cardiac care patient workflow. The PageWriter TC cardiographs help to simplify
patient cardiac care through easy-to-use 1-2-3 touch screen operation, color-coded signal
quality indicators, and integrated connectivity with the TraceMaster ECG Management
System for one touch patient order download and ECG transmission. The PageWriter TC70
and TC50 cardiographs also support integrated connectivity with an ADT Order Update
system. Powerful clinical features include the Philips DXL ECG Algorithm that provides
comprehensive measurement and interpretive analysis for up to 16 leads, and includes full
pediatric interpretation, enhanced pacemaker pulse detection, lead reversal detection
notification, and the Critical Values feature that provides an alert to caregivers of a silent MI
or other conditions that require immediate treatment, an integral tool for acute care
environments. Other time-sensitive clinical tools include ST Map reports that indicate ST
elevation, along with optional culprit artery identification that locates the probable anatomical
site of a coronary artery occlusion responsible for an ischemia. Support for up to 16 leads
assists in the precise detection of right sided or posterior myocardial injury in adults,
conditions that are difficult to diagnosis or detect in standard 12-lead ECGs. For pediatric
patients, the use of 15 leads provides full information on the electrical activity of the right
ventricle of the heart, crucial information for the accurate diagnosis of pediatric patients.
This PageWriter TC70 and PageWriter TC50 Cardiograph Inst ruct ions for Use and the other
components provided in the Learning Kit describe all aspects of setting up, using, and
maintaining your cardiograph.
NOTE Read and complete the materials included in the PageWriter TC70/TC50 Cardiograph Learning Kit
before using the cardiograph. Pay close attention to all warnings and cautions.
About the PageWriter TC70/TC50 Cardiograph Learning
Kit
Getting Started Guide (A)
This fold out guide Guide provides out-of-the-box instructions for setting up the
cardiograph. It is intended to be used with the instructions provided in this chapter.
1-2PageWriter TC70/TC50 Cardiograph Instructions for Use
The user documentation and training DVD includes many useful files including:
–Philips DXL ECG Algorithm Physician’s Guide
This Physician’s Guide provides a comprehensive description of the Philips DXL
ECG Algorithm version PH100B, and lists all of the interpretive statements included
in the 0B criteria.
–Philips 12-Lead Algorithm Physician’s Guide
This Physician’s Guide provides a comprehensive description of the Philips 12-Lead
Algorithm version PH090A, and lists all of the interpretive statements included in the
0A criteria.
–PageWriter TC Cardiograph Network Configuration Guide (only available in
English)
This Network Configuration Guide provides detailed instructions on installing and
configuring wired or wireless network connectivity between the cardiograph and the
TraceMaster ECG Management System (including the OrderVue order handling
option), or other third party ECG management system.
–PageWriter TC Cardiograph Service Manual (only available in English)
This document provides comprehensive information on product troubleshooting,
performance verification and safety tests, using the Service Utilities accessed from the
Setup menu, and installing software upgrades.
–Metrologic Scanner Instructions for Use (only available in English)
This document provides comprehensive information on using and configuring the
optional barcode scanner available with the cardiograph, and also provides detailed
calibration sequences for configuring the barcode scanner for use with extended Code
39 barcode standards.
–PageWriter TC70 and PageWriter TC50 Cardiograph Interactive Training Program
for software version A.02.00 (only available in English)
This training program provides detailed information on the purpose of 12 and 16-lead
ECGs, the different views of the heart that the ECG represents, electrode placement
for 12 or 16 leads, effective patient preparation, basic cardiograph operation, and how
to troubleshoot various ECG signal quality problems. The training program also
includes interactive, hands-on training exercises to test users on information provided
in the training program. Updates to this training program will be available on a
periodic basis, and may be downloaded from the Philips InCenter site. For more
information on accessing and using the Philips InCenter site, see “Using the Philips
InCenter Site" on page 1-5.
To open the User Documentation and Training DVD:
1
Insert the DVD into a DVD-compatible drive on a standard PC.
The main menu opens automatically. Click on a blue button or on the file name to
open a file.
NOTEIf you save PDF files from the DVD to a PC hard drive, Acrobat Reader 9.0 will need to be
installed on the PC in order to view the files. For a free install, go to: www.adobe.com.
2
If the main menu does not automatically appear, open the DVD in W indows Explorer.
PageWriter TC70/TC50 Cardiograph Instructions for Use1-3
Getting StartedPhilips ECG XML Information
3Double-click the file menu.pdf on the DVD. The main menu appears. Any of the files
on the DVD may be printed or saved to a PC hard drive
User Skills Checklists (C) (only available in English)
These checklists provide a comprehensive list of all of the tasks associated with patient
preparation, taking an ECG, and using the cardiograph features. These checklists provide
the basis for all critical tasks recommended for inclusion in a clinical training program.
These checklists can be copied as necessary, and retained as an official record of clinical
training at your facility. The checklists are also included as PDF files on the User
Documentation and Training DVD.
Quick HelpGuide (D)
The Quick Help Guide is presented as an easy-to-use flip book that can be left at the
cardiograph in order to provide clear and simple instructions to users on using cardio graph
features. Included are instructions on proper patient preparation and electrode placement,
signal quality indicators, taking STAT or urgent ECGs, how to retrieve orders, and using
other cardiograph features. The guide is included as a PDF file on the User Documentation
and Training DVD, and additional copies may be printed if necessary. The PDF file is
sized appropriately for printing on standard sized paper.
Philips ECG XML Information
The PageWriter TC70 cardiograph and PageWriter TC50 cardiograph export ECG data in
XML (Extensible Markup Language) format. There are th ree avai lable XML sch ema versio ns
on the cardiograph: version 1.03, version 1.04, and version 1.04.01. Version 1.03 exports E CG
data in 12-lead format only, version 1.04 exports ECG data for up to 16 leads, and version
1.04.01 exports ECG data for up to 16 leads and includes full interpretation from the Philips
DXL Algorithm.
Information regarding the Philips ECG XML schema can be obtained directly from Philips
Medical Systems by sending an email request to:
name, facility, and the serial number of your PageWriter TC cardiograph in the email request.
NOTE The default XML version setting on the cardiograph must be coordinated with the XML version
compatibility of the TraceMaster ECG Management System, or other third party ECG management
system used by your facility. For more information on configuring your cardiograph for use with an
external ECG management system, see the PageWriter TC Network Configuration Guide included on the
User Documentation and Training DVD, or download the file from the Philips InCenter site.
ecg@philips.com. Please include your
1-4PageWriter TC70/TC50 Cardiograph Instructions for Use
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