StressVue 3.00.04 Wireless Patient Module, Rev.B - English

StressVue
Wireless Patient Module

INSTRUCTIONS FOR USE
Notice Responsibility of the Customer CAUTION
The user of this product is responsible for Use of accessories other than those
About This Edition ensuring the implementation of a recommended by Philips Medical
PN 453564103061 satisfactory maintenance schedule. Failure Systems may compromise product
Edition 2 to do so may cause undue failure and performance.
Printed in USA possible health hazards.
IN THE U.S., FEDERAL LAW
Edition History Equipment Identification RESTRICTS THIS PRODUCT TO SALE
ON OR BY THE ORDER OF A
Edition 2, July, 2008 Philips Medical Systems equipment is PHYSICIAN.
Appropriate for the wireless patient identified by serial numbers on the back
or bottom of the device. Care should be THIS PRODUCT IS NOT INTENDED
modules model 608 and model 2500, used
taken so that these numbers are not FOR HOME USE.
with StressVue software version 3.00.04
and later. defaced.
Philips Medical Systems shall not be European Directives

liable for errors contained herein or for This product consists of hardware and
incidental or consequential damages in software. The hardware carries the CE
connection with the furnishing, mark based on the declarations provided
performance, or use of this material. in the User’s Guide for the IT hardware.
Copyright The Philips Wireless patient module,
Copyright © 2008 model 2500, is a class IIa medical device
Koninklijke Philips Electronics N.V. All under the Medical Device Directive 93/
rights are reserved. 42/EEC and carries the
Andover, MA 01810-1099 USA 0123 mark accordingly.
(978) 687-1501 Authorized EU Representative:
Permission is granted to copy and Philips Medizin Systeme
distribute this document for educational Böblingen GmbH
purposes. Hewlett Packard Str. 2
71034 Böblingen
Warranty Germany
Philips Medical Systems makes no
warranty of any kind with regard to this WARNING
material, including, but not limited to, the As with all electronic equipment, Radio
implied warranties or merchantability and Frequency (RF) interference between the
fitness for a particular purpose. StressVue system and any existing RF
transmitting or receiving equipment at the
Responsibility of Manufacturer installation site, including electrosurgical
Philips Medical Systems only considers equipment, should be evaluated carefully
itself responsible for any effects on safety, and any limitations noted before the
reliability, and performance of the equipment is placed in service.
Wireless Patient Modules if:
Radio frequency generation from
– assembly operations, extensions, re- electrosurgical equipment and close
adjustments, modifications or repairs proximity transmitters may seriously
are done by persons authorized by degrade performance.
Philips Medical Systems, and
Philips Medical Systems assumes no
– the electrical installation of the liability for failure resulting from RF
relevant room or vehicle complies with interference between Philips Medical
the IEC or national requirements, and Systems medical electronics and any radio
frequency generating equipment at levels
– the instrument is used according to the
exceeding those established by applicable
instructions for use presented in this
standards.
manual.
Warranty It is expressly agreed that the liability of
Philips Medical Systems hereby warrants Philips is limited and that Philips does not
that the Wireless Patient Modules function as an insurer. A purchaser of a
(hereinafter referred to as “Products”) product, by its acceptance and purchase
shall be free from defects in material and thereof, acknowledges and agrees that
workmanship under normal use, service Philips is not liable for loss, harm or
and maintenance for one year of such damage due directly or indirectly to an
product from Philips or an authorized occurrence or consequence therefrom
distributor or representative of Philips. relating to the products.
Normal use, service and maintenance If Philips should be found liable to anyone
means operation and maintenance in under any theory (except the expressed
accordance with appropriate instructions warranty set forth herein) for loss, harm or
and/or information guides. damage, the liability of Philips shall be
This Warranty does not apply to damage limited to the lesser of the actual loss,
to the Products caused by any or all of the harm or damage, or the original purchase
following circumstances or conditions: price of the Product when sold.
– Freight damage. Excluded from the limited warranty set

forth above are consumable items such as
– Parts and/or accessories of the paper, batteries, electrodes, patient cables,
Products not obtained from or lead wires and magnetic storage
approved by Philips. mediums.except as set forth herein with
– Misapplication, misuse, abuse and respect to reimbursement of labor charges,
failure to follow the product instruction A purchaser’s sole exclusive remedy
sheets and/or information guides. against Philips for claims relating to the
– Accident, a disaster affecting the products for any and all losses and
Products. damages resulting from any cause shall be
the repair or replacement of defective
– Alterations or modifications to the products to the extent that the defect is
products not authorized by Philips. noticed and Philips is notified within the
– Other events outside of Philips warranty period.
reasonable control or not arising under In no event, including the claim for
normal operating conditions. negligence, shall Philips be liable for
THE REMEDY UNDER THIS incidental, special or consequential
WARRANTY IS LIMITED TO THE damages, or for any other loss, damage or
REPAIR OR REPLACEMENT expense of any kind, including loss of
WITHOUT CHARGE FOR LABOR OR profits, whether under tort, negligence or
MATERIALS, OR ANY PRODUCTS strict liability theories of law, or
FOUND UPON EXAMINATION BY otherwise. This warranty is expressly in
PHILIPS TO HAVE BEEN lieu of any other warranties, express or
DEFECTIVE. implied, including, but not limited to the
implied warranty of merchant ability and
This remedy shall be conditioned upon
the warranty of fitness for a particular
receipt of notice by Philips of any alleged
purpose.
defects promptly after discovery thereof
within the warranty period. Philips’
obligations under the foregoing warranty
will further be conditioned upon the
assumption by the purchaser of the
products (i) of all carrier charges with
respect to any Products returned to
Philips’ principal place or any other place
as specifically designated by Philips or an
authorized distributor or representative of
Philips, and (ii) all risk of loss in transit.
Contents
Safety Summary
Wireless Patient Module Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Safety Symbols Marked on the Wireless Patient Module Packaging . . . . . . . . . . . . . . . . . . . . vi
Disposal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Conventions Used in the Instructions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Warnings about the Wireless Patient Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Additional Wireless Patient Module Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Caution Statements for the Wireless Patient Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Important Notes about the Wireless Patient Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
FCC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xii
Industry Canada Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
The Wireless Patient Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Chapter 1. Getting Started Using the Wireless Patient Module

About the Wireless System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
About the Wireless Patient Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Supported Channels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
About the USB Interface Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Preparing the Wireless Patient Module for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Attaching the Patient Cable to the Patient Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Lead Wire Placement on Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Ordering Parts and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
About StressVue and Wireless Patient Module Documentation. . . . . . . . . . . . . . . . . . . . . . 1-8
Available Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
How to Use this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Ordering Options and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Wireless Patient Module Instructions for Use i

Table of Contents
Chapter 2. Configuring and Using the Wireless Patient Module

Powering the Patient Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Installing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Turning the Patient Module On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
About the Battery Voltage Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Navigating the Patient Module Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Keypad Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
The Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Menu Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Configuring the Patient Module for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Setting the Transmission Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Setting the Number of Patient Cable Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Setting the Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Viewing the Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Viewing the Battery Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Starting a Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Attaching the Patient Cable to the Patient Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Preparing the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Instructing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Attaching the Electrodes/Lead Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Checking Signal Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Inspecting Signal from Individual Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Chapter 3. Maintaining the Wireless Patient Module

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Cleaning the Patient Module, Patient Data Cable, and Lead Wires . . . . . . . . . . . . . . . . . . . 3-2
Maintaining the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Appendix A. Specifications and Requirements

Wireless Patient Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Options and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Accessories and Cables Warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions . . . . . . . . . . . . . A-4
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity . . . . . . . . . . . . . A-5
Recommended Separation Distances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
ii Wireless Patient Module Instructions for Use

Table of Contents
Appendix B. Patient Module Messages and Channel Assignments

Wireless Patient Module Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Channel Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Troubleshooting Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7
System Information Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
Contacting Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
Philips Response Center Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
North America. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
South America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11
Asia Pacific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12
Appendix C. ASHE Registration

Registering the Wireless 608 System with ASHE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Coordinating Frequencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Appendix D. Translations
Wireless Patient Module Instructions for Use iii

Safety Summary
This chapter provides important safety information related to the use of the Philips Wireless
Patient Modules, models 608 and 2500. They are referred to collectively as the wireless
patient module.
NOTE For safety and labeling information about the Wireless USB connector box, refer to the StressVue
Instructions for Use.
US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF

A PHYSICIAN.
Wireless Patient Module Equipment Symbols
Symbol Description
Attention. See the StressVue Instructions for Use and other product
documentation for information.
ECG physio isolation is type CF, defibrillator proof.
CE mark.
Do not dispose as unsorted municipal waste. Dispose of in

accordance with the requirements of your country.
v
Safety Summary
Safety Symbols Marked on the Wireless Patient Module

Packaging
Symbol Description
Keep dry.
Keep out of direct sunlight.
Acceptable temperature range.

-20° to 65° C
-4° to 149° F
Move and store packaging this end up.
Fragile.
Recycle the packaging materials after use.
Disposal Information
The wireless modules use one alkaline battery and disposable monitoring electrodes. Disposal
must be in accordance with the following procedures:
Battery — applicable disposal or recycling standards
Electrodes — normal waste
vi Wireless Patient Module Instructions for Use

Conventions Used in the Instructions for Use
Conventions Used in the Instructions for Use

The following conventions are used in the Wireless Patient Module Instructions for Use, this
guide.
WARNING Warning statements describe conditions or actions that may result in personal injury or
loss of life.
CAUTION Caution statements describe conditions or actions that may result in damage to equipment or
software.
NOTE Notes contain additional important information about a topic.
Important Patient and Safety Information

For information about electromagnetic compatibility (EMC) with surrounding devices, see of
“Electromagnetic Compatibility (EMC)” on page A-3.
The following safety information applies to both the Philips Wireless 608 Patient Module and
the Philips Wireless 2500 Patient Module.
Warnings about the Wireless Patient Module

WARNING Failure to follow these warnings could affect both patient and operator safety.
The wireless patient module device transmits data reflecting a patient’s physiological
condition to a properly equipped system and when reviewed by a trained physician or
clinician can be useful in determining a diagnosis. However, the data should not be used
as a sole means for determining a patient’s diagnosis.
To maintain designed operator and patient safety, peripheral equipment and accessories
used that can come in direct patient contact must be in compliance with UL 2601-1,
IEC 60601-1, and IEC 60601-2-25.
FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.
(United States only)
To maintain designed operator and patient safety, only use parts and accessories supplied
with the device and available through Philips Medical Systems.
Wireless Patient Module Instructions for Use vii

Safety Summary
To avoid the possibility of serious injury or death during patient defibrillation, do not
come into contact with device or patient cables. Additionally, proper placement of
defibrillator paddles in relation to the electrodes is required to minimize harm to the
patient.
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.
WARNING Failure to follow these warnings could affect both patient and operator safety.
A possible explosion hazard exists. Do not use the device in the presence of flammable
anesthetics, or flammable mixtures with air, oxygen, or nitrous oxide.
In some countries, the use of the wireless patient module (2500 MHz version) has been
limited as follows:
E Spain: Use is limited to channels in the range 8B to E6 (inclusive).
F France: Use is limited to channels in the range 8E to A5 (inclusive).
Connecting multiple medical electrical instruments 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.
The channel setting of the wireless patient module, when used in the above listed
countries, must be set accordingly.
viii Wireless Patient Module Instructions for Use

In the United States and Canada, use of the wireless patient module (608 MHz version) is
regulated by Federal Communications Commission (FCC) rules, Part 15.
– The wireless patient module must be used solely on the premises of health care
facilities (see Part 15, section 15.242a).
– A health care facility operating the wireless patient module must coordinate with the
directors of existing nearby TV stations and Radio Astronomy Observatories to ensure
compatible use. Minimum separation distances from such facilities may apply. It may
be necessary to obtain written authorization from such facilities prior to installation
and use of the transmitter (Part 15, section 15.242d,e).
– Under U.S. Federal Communications Commission (FCC) rules, authorized health care
providers must register their WMTS devices with an authorized Frequency
Coordinator designated by the FCC. The American Society for Healthcare
Engineering (ASHE) is the current designated Frequency Coordinator.
Additional Wireless Patient Module Warnings

Defibrillation protection is guaranteed only if the original patient cable is used.
– La protection contre la défibrillation n'est garantie qu'à la condition exclusive
d'utiliser le câble patient original.
– La protezione dal defibrillatore è garantita solo se si utilizza il cavo paziente originale.
– Defibrillationsschutz wird nur sichergestellt, wenn das Original-Patientenkabel verwendet
wird.
– Sólo se garantiza la protección contra desfibrilación si se utiliza el cable de paciente
original.
Simultaneous connection to other equipment may increase leakage current.
– Toute connexion simultanée à d'autres appareils peut augmenter le courant de fuite.
– Il collegamento simultaneo ad altre apparecchiature può aumentare la corrente
di dispersione.
– Der gleichzeitige Anschluss an andere Geräte kann den Ableitstrom erhöhen.
– Una conexión simultánea a otro equipo puede aumentar las probabilidades de que se
produzca una fuga de corriente.
Wireless Patient Module Instructions for Use ix

Safety Summary
To ensure safety and prevent damage to the system, only connect the patient data cable to
the connector on the patient module.Do not connect the patient data cable into any other
connector or port on the StressVue computer.
– Pour garantir la sécurité et éviter d'endommager le système, brancher le câble de
données patient uniquement sur le connecteur du module patient. Ne pas le brancher
sur aucun autre connecteur ni sur le port de l'ordinateur de l'application StressVue.
– Per garantire una protezione adeguata ed evitare di danneggiare il sistema, collegare
il cavo dati paziente esclusivamente al connettore sul modulo paziente. Non collegare
il cavo dati paziente ad altri connettori o porte del computer di StressVue.
– Aus Sicherheitsgründen und zur Vermeidung von Schäden am System darf das
Patientendatenkabel nur in den Anschluss des Patientenmoduls eingesteckt werden.
Stecken Sie das Patientendatenkabel nicht in einen anderen Anschluss oder Eingang
des StressVue-Computers.
– Para garantizar la seguridad y evitar cualquier daño en el sistema, el cable del paciente
sólo puede conectarse al conector del módulo de paciente. No conecte el cable de
datos de paciente en ningún otro conector o puerto del StressVue.
Caution Statements for the Wireless Patient Module

CAUTION Failure to heed these caution statements may result in damage to equipment or software.
To prevent possible damage to the keypad, do not use sharp or hard objects to depress
keys; only use fingertips.
Do not attempt to clean the device or patient cables by submersing into a liquid,
autoclaving, or steam cleaning.
Wipe the exterior surface of the device and patient cables with a non-alcohol sterilizing
disinfectant, then dry with a clean cloth.
Conductive parts of the patient cable, electrodes and associated Type CF connections,
including the neutral conductor of the patient cable and electrode, should not come into
contact with other conductive parts, including earth ground.
The wireless patient module and patient cable should be cleaned between each use.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical
failures. Patient cables should be stored after forming them into a loose loop.
The wireless patient module only works with systems that are equipped with the
appropriate option.
No user-serviceable parts are inside. Any modification of this device may alter
defibrillator protection. Any modification to any part of this device is to be performed by
qualified service personnel only.
The following equipment may cause interference with the RF channel: microwave ovens,
diathermy units with LANs (spread spectrum), amateur radios, and government radar.
x Wireless Patient Module Instructions for Use

To prevent possible damage to the device during transport and storage (while in the
original packaging), the following environmental conditions must be adhered to:
Ambient Temperature Range:
-20°C to 65°C (-4°F to 149°F)
Relative Humidity Range:
5% to 95% (non-condensing)
Atmosphere Pressure:
700 hPa to 1060 hPa
Allow the device to stabilize within its intended operating environment for a minimum of
two hours prior to use. The allowable operating environment is as follows:
Ambient Temperature Range:
0°C to 45°C (32°F to 113°F)
Relative Humidity Range:
5% to 95% (non-condensing)
Atmosphere Pressure:
700 hPa to 1060 hPa
Important Notes about the Wireless Patient Module

Proper patient preparation is important to proper application of ECG electrodes and
operation of the device.
Patient cables should be checked for cracks or breakage in its exterior properties prior to
use.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
– Internally powered
– Type CF applied parts
– Ordinary equipment
– Not suitable for use in the presence of flammable anesthetics or flammable mixtures
of air, oxygen, or nitrous oxide
– Continuous operation
The wireless patient module is a UL-classified device.
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE, AND
MECHANICAL HAZARDS ONLY, IN ACCORDANCE WITH
UL 2601-1, CAN/CSA C22.2 No. 601.1, IEC60601-1,
AND IEC60601-2-25.
5P35
To comply with WMTS, only use channels 0-63 with the wireless 608 module.
Wireless Patient Module Instructions for Use xi

Safety Summary
FCC Compliance
In the United States, use of the wireless patient module is regulated by Federal
Communications Commission (FCC).
FCC ID: HJR-X12-600-15
FCC ID: HJR-X12P-2500
These devices comply with Part 15 of the FCC rules.
Operation is subject to the following conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause
undesired operation.
The wireless 608 patient module must be used solely on the premises of health care
facilities (see Part 15, section 15.242a).
A health care facility operating the wireless 608 patient module must coordinate with the
compatible use. Minimum separation distances from such facilities may apply. It may be
necessary to obtain written authorization from such facilities prior to installation and use
of the wireless patient module (Part 15, section 15.242d,e).
Under U.S. Federal Communications Commission (FCC) rules, authorized health care
providers must register their WMTS devices with an authorized Frequency Coordinator
designated by the FCC. The American Society for Healthcare Engineering (ASHE) is the
current designated Frequency Coordinator.
xii Wireless Patient Module Instructions for Use

Industry Canada Compliance Statement
Industry Canada Compliance Statement

This device complies with RSS-210 of the Industry Canada rules. Operation is subject to the
following two conditions:
1 This device may not cause interference, and
2 This device must accept any interference, including interference that may cause undesired
Wireless 608 module Certification Number: 3758A - 104616
This telemetry device is only permitted for installation in hospitals and health care
facilities. Devices shall not be operated in mobile vehicles (including ambulances and
other vehicles associated with health care facilities).
The installer/user of this device shall ensure that it is at least 80 km from the Penticton
radio astronomy station (British Columbia latitude: 49° 19' 12" N, longitude: 118° 59'
56" W).
For medical telemetry systems not meeting this 80 km separation (for example, the
Okinagan valley, British Columbia), the installer/ user must coordinate with, and obtain
the written concurrence of, the Director of the Penticton radio astronomy station before
the equipment can be installed or operated.
The Penticton contact information is (telephone) 250-493-2277, (fax) 250-493-7767.
The Wireless Patient Module

For information about electromagnetic compatibility (EMC) with surrounding devices, see
“Electromagnetic Compatibility (EMC)” on page A-3.
Indications for Use

The device is indicated for use as follows:
For use to acquire, process, record, and output electrocardiographic data obtained during
physiologic stress exercise testing.
For use in a clinical setting, by a physician or by trained personnel who are acting on the
orders of a licensed physician. It is not intended as a sole means of diagnosis.
For use on adult populations, typically symptomatic.
The device is not intended to be used as a vital signs physiological monitor.
For use as a radio frequency physiological signal transmitter, receiving and delivering
real-time acquisition and RF transmission of simultaneous 12-lead ECG data, while
allowing the patient to be ambulatory.
Wireless Patient Module Instructions for Use xiii

1
Chapter 1Getting Started Using the Wireless
Patient Module
The Philips wireless patient module allows you to acquire and transmit 12-lead ECG without
direct connections to a stress exercise test system.
Design innovations implemented in the wireless patient module achieve real-time acquisition,
RF transmission of simultaneous 12-lead ECG data with diagnostic quality to the StressVue
system while allowing the patient to be ambulatory. In addition, by using a very high
monitoring frequency to transmit cardiac signals, the diagnostic bandwidth of the signals is
maintained.
This guide describes configuration and use of these patient modules. It shows how to
configure the patient module, as well as how to acquire and transmit 12-lead ECG signals to a
receiving device
This chapter provides the following information:
About the Wireless System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
About the Wireless Patient Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Supported Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
About the USB Interface Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Preparing the Wireless Patient Module for Use . . . . . . . . . . . . . . . . . . . . . . . .1-6
Attaching the Patient Cable to the Patient Module. . . . . . . . . . . . . . . . . . .1-6
Lead Wire Placement on Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
Ordering Parts and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7
About StressVue and Wireless Patient Module Documentation. . . . . . . . . . . .1-8
Available Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
How to Use this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Ordering Options and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
1-1
Getting Started Using the Wireless Patient Module
About the Wireless System

Wireless ECG acquisition for the StressVue system includes the following communication
components:
Patient cable
One of the following acquisition modules:
– Wireless 608MHz RF module (PN 989803145521) (North America, Australia and
China only)
– Wireless 2500MHz RF module (PN 989803145531) (outside of North America,
Australia, and China)
USB interface connector and antennas
This is the connection box that provides the ECG signal to the StressVue PC via the USB
port on the PC, along with providing an analog and TTL output for use by other medical
equipment.
One 1.5V AA alkaline battery
For details about assembling the system, see the StressVue Installation and Getting Started
Guide. For details about using the system and about the rest of the system components, see the
StressVue Instructions for Use.
About the Wireless Patient Modules

Figure 1-1 Wireless patient module (shown with patient data cable attached), front
view
Patient data cable
LCD display
Navigation key pad
1-2 Wireless Patient Module Instructions for Use

Figure 1-2 Wireless patient modules, rear view (without battery cover)
2500 model 608 model
The transmitter will generally maintain a connection with the USB interface connector as long
as the devices are within approximately 45 feet (15 meters) of each other. This number is an
approximate figure; the distance may vary depending upon the local area network at your site,
any wireless networks, telemetry units in the area, and other associated RF usage.
Supported Channels
The Wireless 608 patient module, for use in North America, Australia, and China supports the
64 channels in the Wireless Medical Telemetry System (WMTS), which includes the 608-614
frequency band (channels 00-3F on the patient module). WMTS is the only frequency
spectrum designated exclusively for wireless medical telemetry systems.
The WMTS has been established by the FCC in response to concerns about interference
resulting from new digital television transmitters, low power television transmitters, and
greater use of Private Land Mobile Radio equipment. In addition, the FCC also appointed
ASHE (American Society for Healthcare Engineering) as the Frequency Coordinator for the
WMTS bands.
Hospitals deploying telemetry systems in the WMTS bands must register the device before the
equipment is operational. Registration is required to ensure interference-free operation. For
registration information, see Appendix C, “ASHE Registration.” This information is also
available in the StressVue Installation and Getting Started Guide.
The Wireless 2500 patient module, for use in regions other than the two listed above, can
operate in any of the 256 available channels.
Wireless Patient Module Instructions for Use 1-3

About the USB Interface Connector

WARNING To maintain designed operator and patient safety, equipment connected via the TTL or
analog cable must be IEC 60601-1 compliant.
The USB interface connector provides a convenient and simple interface to transmit data from
the patient module to the StressVue PC. This interface is used both for direct connect and
wireless transmitters. Figure 1-3 on page 1-5 illustrates the wireless option. For ordering
information, see the StressVue Instructions for Use.
The transmitter will generally maintain a connection with the USB interface connector as long
as the devices are within approximately 45 feet (15 meters) of each other. This number is an
approximate figure; the distance may vary depending upon the local area network at your site,
any wireless networks, telemetry units in the area, and other associated RF usage.
The interface connector does not require a battery or separate power cord; it draws power from
the StressVue PC, via the USB cable. The analog output, together with TTL, is standard on all
StressVue systems.
For additional information about the TTL and analog outputs, see Appendix C, “TTL and
Analog Export for Echo” in the StressVue Instructions for Use.

Figure 1-3 USB interface connector for wireless connection

Front view
Antennas attached
Unused
Rear view
TTL Analog
output output
USB connector
Antenna ECG
connectors
The wireless interface connector has two BNC-type antenna connectors for direct connection
of antennas. These antenna are used to provide diversity and increase signal throughput.
For details on attaching the antennas and connecting the interface connector to the PC, see the
StressVue Installation and Getting Started Guide. These steps are performed once, when
setting up the system.

Preparing the Wireless Patient Module for Use

Preparing the patient module for use comprises the following activities:
NOTE If you are just starting to use the Wireless 608 system, check with your StressVue administrator to
ensure that the device is registered with ASHE. For details, see Appendix C, “ASHE Registration.”
Attach the patient data cable. See the next section.
Configure the patient module for your needs.
See Chapter 2, “Configuring and Using the Wireless Patient Module.”
Ensure the USB interface connector is connected to the StressVue system.
This step is performed when the system is first set up. If you have any problems with
transmission of ECG data, check that the connections are secure. For details, see the
StressVue Installation and Getting Started Guide.
Follow these procedures to properly attach and detach the cable from the patient module.
Attaching the Patient Cable to the Patient Module

To attach the patient cable to the patient module
1 Check the leads on the patient cable to ensure they are free of damage and cracks.
2 Align the pins on the cable with the connector pins on the transmitter, and gently push the
cable-end connector in until it is firmly seated.
CAUTION Be sure the connector on the patient cable is properly aligned with the connector on the patient
module, and that you push the connector straight into or pull it straight out of the patient module.
Inserting the connector at an angle may bend and damage the connector pins on the patient
module.
Pins inserted straight in
To detach the patient cable from the patient module

X Pull the patient cable connector straight out from the patient module. See Caution above.

Ordering Parts and Supplies
Lead Wire Placement on Patient

The following illustrations show you where to place the lead wires. For detailed information
on connecting the patient, see the StressVue Instructions for Use.
Figure 1-4 Patient cable and 12-Lead electrode placement (AAMI/IEC)
Place near the

waist
Place near the shoulders
LA/L
RA/R
RL/N V4/C4
V5/C5
V1/C1 V6/C6
V2/C2
V3/C3
LL/F
Ordering Parts and Supplies

For detailed information, see Chapter 4, “Ordering Options and Parts.”

About StressVue and Wireless Patient Module

Documentation
Philips Medical Systems provides detailed instructional and reference materials to help you
get the most out of your StressVue system.
Available Documentation
The following documentation is available with the wireless patient module and StressVue
system:
Wireless Patient Module Instructions for Use
This guide. Provides information about how to set up and maintain the wireless patient
module.
StressVue Instructions for Use
A reference that provides detailed information about StressVue functionality, including
how to configure the system, as well as run the StressVue application. This guide also
includes troubleshooting and maintenance information.
This manual is written for clinical professionals. They are expected to have a working
knowledge of medical procedures and medical terminology as required for monitoring
potential cardiac patients.
StressVue Installation and Getting Started Guide
Describes how to set up the StressVue hardware and software, and provides an overview
of StressVue components and operation.
StressVue System Cart Setup Guide
Describes how to set up the StressVue hardware and cart.
StressVue tutorial
HTML-based training program teaches you how to configure and use StressVue.

About StressVue and Wireless Patient Module Documentation
Conventions Used in this Guide

The documentation and training materials for StressVue use the following typographic
conventions.
Item How Displayed
Menu item Menu items and button names appear in a bold no-serif font.
Button name
Example: Click Settings.
Field names and list Field names and list items appear in a no-serif font.
items Example: Select the appropriate format from the Format dropdown
list.
WARNING Warning statements describe conditions or actions that may result in injury to the
patient.
CAUTION Caution statements describe conditions or actions that may result in damage to equipment or
software.
NOTE Notes provide additional important information about a topic.
How to Use this Guide

This guide is intended to help you use and configure the Philips Wireless Patient Module,
models 608 and 2500. It also provides maintenance and troubleshooting information, as well
as product specifications.
This guide is organized as follows:
Safety Summary. Lists the warning and caution statements, as well as

important notes, that apply to using the wireless patient module. Read this
chapter before operating any of the equipment.
1 Getting Started Using the Wireless Patient Module. This chapter. Provides
an overview of the StressVue system.
2 Configuring and Using the Wireless Patient Module. Describes all aspects of
the patient session, from getting started through the four phases of the test.
3 Maintaining the Wireless Patient Module. Describes how to clean and

maintain the wireless patient module.

A Specifications and Requirements. Describes wireless patient module

specifications and EMC information.
B Patient Module Messages and Channel Assignments. Describes messages

that may appear on the patient module, shows usable frequency channels, and
provides the system information log.
C ASHE Registration. Describes how to register your wireless device with

ASHE before operation.
Ordering Options and Supplies

For detailed information about accessories, options, and other supplies, refer to the StressVue

2
Chapter 1 Configuring and Using the Wireless
Patient Module
CAUTION Any changes or modifications not expressly approved by Philips Medical Systems can void your
authority to operate the equipment.
The Philips Wireless 608 and 2500 patient modules comply with part 15 of the FCC rules.
Operation is subject to the following conditions:
The device may not cause harmful interference.
The device must accept any interference received, including interference that may cause
undesired operation.
The device must be used solely on the premises of health care facilities (see Part 15,
section 15.242a).
A health care facility operating the wireless patient module must coordinate with the
compatible use. Minimum separation distances from such facilities may apply. It may be
necessary to obtain written authorization from such facilities prior to installation and use
of the wireless patient module (Part 15, section 15.242d,e).
Operating frequencies are 608.48-631.52 MHz or 2400.96-2452.96 MHz operating frequency
range.
FCC ID: HJR-X12P-2500
FCC ID: HJR-X12-600-15
This device is defibrillator-protected in compliance with AAMI standards and IEC 601-2-25.
2-1
Configuring and Using the Wireless Patient Module

Powering the Patient Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Installing the Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Turning the Patient Module On and Off. . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
About the Battery Voltage Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Navigating the Patient Module Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Keypad Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
The Main Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Configuring the Patient Module for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Setting the Transmission Channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Setting the Number of Patient Cable Leadwires . . . . . . . . . . . . . . . . . . .2-10
Setting the Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Viewing the Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Viewing the Battery Capacity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Starting a Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
Attaching the Patient Cable to the Patient Module . . . . . . . . . . . . . . . . .2-14
Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Instructing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Attaching the Electrodes/Lead Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-15
Checking Signal Impedance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Inspecting Signal from Individual Leads . . . . . . . . . . . . . . . . . . . . . . . . .2-19
Figure 2-1 The wireless patient module
Patient data cable
LCD display
Navigation key pad

Powering the Patient Module
Installing the Battery

The wireless patient module runs on a single AA 1.5V alkaline battery. The typical life of the
battery is approximately 30 hours.
To remove and/or install the battery

1 Hold the transmitter with the back side containing the battery door facing you.
2 Press down on the battery door arrow symbol and slide the battery cover out.
3 If a battery is present, pull it out and dispose of it properly.

4 Insert one AA alkaline battery into the battery compartment.
Align the positive (+) and negative (-) indicators of the battery with the symbols in the
battery compartment.

5 Replace the battery cover and slide it back until it snaps into place.
The wireless patient module turns itself on as soon as you insert a fresh battery.
Turning the Patient Module On and Off

The wireless patient module turns itself on as soon as you insert a a battery with a minimum of
1 volt.
To turn on the patient module

X Do either of the following:
– Remove and reinsert the battery.
– Press the Up/Right arrow key on the front of the patient module.
The patient module powers up and displays the main screen within three seconds. For
details, see “The Main Screen” on page 2-6
Battery voltage indicator

To turn off the patient module

X Do either of the following:
– Remove the battery.
– Press and hold the Left arrow key (called the Enter key) for three seconds.
You are prompted to confirm shutting off the patient module.
a Press the Down arrow key to select Yes.
b Press the Enter key again.
The patient module powers off.
For details about navigating the patient module menus, see “Navigating the Patient Module
Screens” on page 2-6.
About the Battery Voltage Indicator

When the battery contains sufficient voltage, the main menu screen displays a picture
representing the current battery voltage, in the following increments: 100%, 75%, 50% and
25%.
Battery Indicator Description
Full battery
Battery at 75%
Battery at 50%
Battery at 25%
Low battery
If a battery with unknown voltage is inserted and the main menu does not appear, replace the
battery.
NOTES If the battery voltage is less than 1V, the patient module will not power on. Replace with a fresh
battery to continue operation.
When the battery voltage indicator shows 25%, we recommend you discard the battery and replace
it with a new one.

Navigating the Patient Module Screens

When you power on the patient module, the main screen appears. This section describes:
Keypad Buttons (below)
The Main Screen (below)
Menu Options (page 2-7)
Keypad Buttons
The key pad buttons are used as follows. Note that, during transmission, you can press any key
to send a Call signal.
Table 2-1 Wireless patient module navigation buttons
Button Name Icon Function
Up/Right arrow Used to display the menu and navigate through the
options.
Down arrow Used to navigate through menu options.
Left arrow, called Enter Used to select the displayed option.
In general, use the Up/Right arrow to display the menu, use the Down arrow to navigate through
the options, and the Enter key to select the option and save your settings.
The Main Screen

Figure 2-2 Patient module main screen
Channel indicator Battery voltage indicator
Failing leads
Press Enter (Left arrow) to
Press the Up/Right
power off the patient
arrow to display
module
menu options

Navigating the Patient Module Screens
The main screen displays the following information:
Screen Item Description See...
CH: Transmission channel “Setting the

Transmission Channel”
on page 2-9
Battery power Shows how much charge is left in the “About the Battery
indicator battery, in 25% increments Voltage Indicator” on
page 2-5
Menu Access to configuration options. All “Menu Options” on
wireless configuration and operation is page 2-7
controlled through the Menu entry. The
top-level menu offers options for
checking leads, viewing individual lead
details, and configuring the patient
module.
Off Power off access “Turning the Patient
Module On and Off” on
page 2-4
Lead list Shows leads that are failing “Starting a Patient
Session” on page 2-13
Menu Options
The patient module menu provides the following options:
Lead Check
Used to verify signal impedance. See “Checking Signal Impedance” on page 2-18.
Display ECG
Lets you scroll through each lead and examine the waveform. See “Inspecting Signal from
Individual Leads” on page 2-19.
Configure
Provides options for configuring the channel and cables used, as well as verifying patient
module information and selecting the display language. See “Configuring the Patient
Module for Use” on page 2-8.
Done
Press Enter to exit the menu and return to the main screen.
Figure 2-3 on page 2-8 shows a flow chart illustrating the menu options.

Figure 2-3 Menu options
DONE
LEAD CHECK DISPLAY ECG CONFIGURE
Return to Main
menu
CHANNEL CABLE LANGUAGE VERSION BATTERY DONE
Select a channel Select 10-wire, Select language Software version Show real-time Return to
(page 2-9) 5-wire, 4-wire (page 2-11) information voltage Configure menu
(page 2-10) (page 2-12) (page 2-12)
Configuring the Patient Module for Use

The following configuration tasks are typically set before the first patient session using the
wireless patient module, and do not need to be changed on a per-patient basis. These tasks are
all available within the Configure menu option.
To access options in the Configure menu

1 With the main screen displayed, hold down the Up/Right arrow key for a few seconds to
access the menu.
The Lead Check menu item appears.

2 Press the Down arrow to move through menu selections, until the Configure menu item is
displayed.
3 Press the Enter key to select the Configure menu item.

The Channel menu item appears.
4 Press the Down arrow to move through menu selections.
5 When the desired item is displayed, press the Enter key to select it.
Setting the Transmission Channel

The wireless patient module transmits the patient’s cardiac signals to the StressVue system
using a specific channel number. Select channels within the following ranges:
For the Wireless 608 patient module, use any of the 64 channels within the WMTS band
(between 00 and 3F, hexadecimal) that is set aside by the FCC for medical wireless
transmissions.
For the Wireless 2500 patient module, you can select any of the available 256 channels
between 00 and FF (hexadecimal).
If the patient module loses ECG signal, try changing the transmission channel.
NOTE The transmission channel you select on the patient module must match the channel set on the
StressVue system.
To set the transmission channel

1 Conduct an RF scan first on the StressVue system and determine which channel offers the
least amount of interference.
For details, see the section, “Setting the RF Channel” in Chapter 5, “Configuring
StressVue,” of the StressVue Instructions for Use.
2 Access the Configure menu as described in “To access options in the Configure menu” on
page 2-8.

3 When the Channel option appears, press Enter to select it.
Editable channel fields
You specify channel settings using hexadecimal values.

4 Press the Up/Right arrow key to move the cursor to the right or left alphanumeric character
field.
In the image above, pressing the arrow key moves the cursor from the 1 to the E and back
again.
5 Press the Down arrow key to scroll through letters and digits in each field.
When you have reached the end of the list, the list starts again at the first character. You
can only scroll through characters going forward (for example, A to B to C); you cannot
move backward through the list (for example, C to B to A).
For example, to change the channel to 3B, with the cursor over the 1, press the Down arrow
key until 3 is displayed. Then press the Up/Right arrow key so the cursor moves to the E,
and press the Down arrow until you cycle through the list and B is displayed.
6 When finished making changes, press Enter to exit the channel settings and return to the
Configure menu.
7 Ensure that you configure the same channel on the StressVue system.
For details, see the section “Configuring Wireless Mode” in Chapter 5, “Configuring
StressVue,” of the StressVue Instructions for Use.
Setting the Number of Patient Cable Leadwires

Use the Cable menu option to set the number of leadwires to display from the patient cable.
NOTE When 4-wire or 5-wire cable is selected, only the limb leads (and a V lead with the 5-wire cable)
appear in Lead Check, Display ECG, and Lead Fail messages. When 10-wire cable is selected, all but
the three augmented leads are displayed.
To set the number of lead wires

page 2-8.
2 When the Cable option appears, press Enter to select it.

You can choose from three options. The first one to appear is 10-wire.
3 Press the Down arrow key to scroll through the three options.
4 When the desired option is displayed, press Enter to select it and return to the Configure
menu.
Setting the Language

Use the Language menu option to select the patient module display language. Options are
English, Spanish, French, Italian, and German.
To set the language

page 2-8.
2 When the Language option appears, press Enter to select it.
3 Press the Down arrow key to scroll through the options.

4 When the desired option is displayed, press Enter to select it and return to the Configure
menu.

Viewing the Software Version

Use the Version option to see the current software version installed in the patient module.
To see version information

page 2-8.
2 When the Version option appears, press Enter to select it.
The current version and model number is displayed on the screen.

3 Press Enter again to return to the Configure menu.
Viewing the Battery Capacity

Use the Battery option to see the actual voltage of the installed battery.
To see battery voltage information

page 2-8.
2 When the Battery option appears, press Enter to select it.
The current voltage is displayed on the screen.

3 Press Enter again to return to the Configure menu.

Starting a Patient Session
Starting a Patient Session

After configuring the basic patient module settings as described in the previous sections, there
are a number of configuration and verification tasks to perform to ensure the best quality
signal and ECG at the beginning of each patient session. These tasks include:
1 Attaching the patient cable to the patient module.
For details, see “Attaching the Patient Cable to the Patient Module” on page 2-14.
2 Positioning electrodes on the patient.
Proper positioning is critical for a good reading. For details, see “Preparing the Patient”
on page 2-14.
3 Checking signal impedance.
This task uses the Lead Check menu option. For details, see “Checking Signal
Impedance” on page 2-18.
4 Verifying signal quality for each lead.
This task uses the Display ECG menu option. For details, see “Inspecting Signal from
Individual Leads” on page 2-19.
5 Starting the test.
During normal operation, the wireless patient module screen shows the selected channel
and current battery voltage. If the battery fails during a patient session, transmission stops.
NOTE During a patient session, if a lead fails, the affected lead appears on the patient module display, as
well as on the StressVue monitor. See Appendix B, “Patient Module Messages and Channel
Assignments” for details on lead failure messages.
For detailed information about conducting a stress test, see the StressVue Instructions for
Use.
6 Ending transmission.
Turn off the patient module after the patient session to save battery power. For details, see
“Turning the Patient Module On and Off” on page 2-4.

Attaching the Patient Cable to the Patient Module

The LeadForm patient cable consists of a connector block, main cable, and leadwires
connected to the main cable. Each leadwire terminates in a snap connector. The leadwires are
positioned on the main cable to follow the contour of the torso.
To attach the patient cable to the patient module

X Insert the cable connector block into the input connector on the top of the wireless patient
module.
CAUTION Be sure the connector on the patient cable is properly aligned with the connector on the patient
module, and that you push the connector straight into or pull it straight out of the patient module.
Inserting the connector at an angle may bend and damage the connector pins on the patient
module.
Correct alignment
To remove the patient cable from the patient module

X Pull the cable connector block straight out of the input connector on the top of the wireless
patient module.
See the caution and images above for proper technique.
Preparing the Patient

Good ECG technique is very important to achieve the best quality results.
TIP The leads are attached to the patient cable, which connects to the patient module that the patient
wears during the exercise test. If your facility has multiple patient cables, you can streamline the testing
process by prepping multiple patients before the actual test. Once it is each patient’s time for the test,
you can simply plug the patient cable into the patient module and begin the test.
Instructing the Patient

Before attaching the electrodes, greet the patient and explain the procedure. Explaining the
procedure decreases anxiety and informs the patient about what to expect.
Privacy is important to relaxation. When possible, prepare the patient in a quiet room or
area where others cannot see the patient.

Reassure the patient that the procedure is painless.

Make sure the patient is comfortable. The patient’s arms and hands must be relaxed.
Instruct the patient to rest their hands on the handrails and not grasp the handrails tightly.
The more relaxed the patient, the less the ECG will be affected by noise.
Preparing the Skin

Thorough skin preparation is very important. The skin is a poor conductor of electricity and
frequently creates artifact that distorts the ECG signal. By performing methodical skin
preparation, you greatly reduce the potential for myographic noise and baseline wander,
ensuring high-quality printouts and displayed data. There is a natural resistance on the skin
surface due to dry, dead epidermal cells, oils, and dirt.
To prepare the skin

1 Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.
2 Use an abrading pad to lightly scratch an “X” pattern into the skin, taking care to avoid
excessive abrading.
3 Wash the area thoroughly with soap and water.
4 Dry the skin vigorously with a gauze pad to increase capillary blood flow to the tissues
and to remove the dead, dry skin cells and oil.
Attaching the Electrodes/Lead Wires

Attach the electrodes to the lead wires on the patient cable before attaching them to the patient.
The patented LeadForm patient cable, available in standard and large sizes, is lightweight and
conforms to the patient’s torso. This further enhances the patient’s comfort and freedom
during testing. The absence of heavy wires reduces the amount of artifact.
When the patient cable is properly draped over the right shoulder of the patient, the order in
which to connect the wires to the electrodes is easily apparent, and is described in Table 2-2 on
page 2-17.
To attach the electrodes to the patient

1 Firmly attach each lead wire to an electrode.
2 With the patient standing, drape the patient cable over the right shoulder of the patient,
with the connector on the bottom end and the RA and LA leads at the shoulder.

Figure 2-1 Patient cable and 12-Lead electrode placement (AAMI/IEC)
Place near the waist
Place near the shoulders
LA/L
RA/R
RL/N V4/C4
V5/C5
V1/C1 V6/C6
V2/C2
V3/C3
LL/F
3 Place the gel area of the electrode over the center of the prepared area, using the
positioning described in Table 2-2, below, and illustrated on the previous page; then press
the adhesive ring into place.
– Avoid pressing the center of the gel area; this might hinder conduction.
– Place the electrodes on flat, fleshy parts of the arms and legs, avoiding muscle. See
limb lead placement notes below.
– For female patients, place the precordial electrodes on top of the breast (not
underneath the breast tissue).
Lead placement is similar to standard 12-Lead ECG placement; however, limb leads are
modified, as follows:
– Right Arm and Left Arm leads should be placed close to the shoulders on the clavicle
bone, away from muscular areas to avoid muscle interference.
– The Right Leg lead is typically placed on the sternum midway between the arm leads
and V1 and V2 leads.

– The Left Leg lead should be placed on a rib, below V6 by about 2 fingers, in the lower
left area of the patient’s chest (avoiding flabby areas and the belt). This may need
adjustment depending on body habitus.
4 Ensure the electrodes are firmly attached.
A good test for firm electrode contact is to try to move it. If it moves easily, the electrode
connection is too loose. Do not allow the electrodes to move in any way.
5 Have the patient raise their arms over their head. This will help verify good lead
placement and no strain on the electrodes.
Review the following lead wire labeling and electrode placement information to
ensure a quality ECG.
Table 2-2 Leads and positioning
AAMI Lead IEC Lead Electrode Position
Right side of the sternum in the 4th intercostal space
Left side of the sternum in the 4th intercostal space
Midway between V2 and V4
Left midclavicular line in the 5th intercostal space
Between V4 and V6
5th intercostal space, left midaxillary
Place the limb electrodes for the arm directly on the

clavicle bones (away from major muscles)
Below V6 on the ribcage
On the sternum, midway between the clavicle and the 4th

intercostal space

Figure 2-2 12-Lead electrode placement, internal view (AAMI/IEC)
RA/R
LA/L
RL/N
V1/C1 V4/C4
V5/C5
V2/C2 V6/C6
V3/C3
LL/F
Checking Signal Impedance

The Lead Check option is a valuable tool for verifying and optimizing signal quality before
starting a patient session.
To check impedances
access the menu.
2 Press Enter to select this option.
A graph depicting the impedance measured at the Right Arm (RA), Left Arm (LA), Left
Leg (LL), and V1 through V6 electrodes is displayed from left to right in vertical columns
on the screen. The higher the bar, the better the contact is between the skin and the
electrode.

A full-bar graph (6 bars) means optimal high quality and good electrode contact. For good
quality transmissions, the bars should be at least 4 bars high.
A low-bar graph means poor quality and high electrode impedance. Re-prep the skin, and,
if necessary, replace the electrode(s).
3 After verifying acceptable impedance levels, press Enter to return to the top-level menu.
Inspecting Signal from Individual Leads

The Display ECG option is useful for visually inspecting leads I, II, III, V1, V2, V3, V4, V5,
and V6 before starting a transmission session. This option allows you to check the signal
quality and lead amplitude for each lead.
To view the signal for each lead

access the menu.
2 Press the Down arrow to scroll through the menu options until Display ECG appears.
3 Press Enter to select this option.

Lead I is the first lead displayed on the screen.
4 Press the Down arrow to scroll through each lead. Lead II is displayed below.
5 After visually verifying each lead, press Enter to return to the top-level menu.
NOTE During a patient session, if a lead fails, the affected lead appears on the display. See Appendix B,
“Patient Module Messages and Channel Assignments” for details on lead failure messages.

3
Chapter 1 Maintaining the Wireless Patient
Module
This chapter describes routine maintenance and cleaning of your StressVue system. It
provides the following information:
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1
Cleaning the Patient Module, Patient Data Cable, and Lead Wires . . . . . . . . .3-2
Maintaining the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2
Precautions
Before cleaning any equipment, remove the battery from the patient module.
Do not attempt to clean the device or patient cables by submersing into a liquid,
autoclaving, or steam cleaning.
Wipe the exterior surface of the device and patient cables with a non-alcohol sterilizing
disinfectant, and then dry with a clean cloth.
Conductive parts of the patient cable, electrodes, and associated Type CF connections,
including the neutral conductor of the patient cable and electrode, should not come into
contact with other conductive parts, including earth ground.
Do not pull or stretch patient cables as this could result in mechanical and/or electrical
failures. Patient cables should be stored after use by forming them into a loose loop.
Proper patient preparation is important for proper application of ECG electrodes and
Patient cable exteriors should be checked for cracks or breakage prior to use.
3-1
Maintaining the Wireless Patient Module
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
– Class IIa equipment
– Type CF applied parts
– Ordinary equipment
– Not suitable for use in the presence of flammable anesthetics
– Continuous operation
CAUTION Dispose of waste material according to local regulations and laws regarding medical and battery waste.
Cleaning the Patient Module, Patient Data Cable, and

Lead Wires
To clean the patient module and patient data cable/lead wires
1 Dampen a soft cloth with one of the disinfectants or cleaning agents listed below.
Clean the patient data cable and lead wires with any of the following:
– Cidex Ortho Phthaladehyde
– Cetylcide
– Vesphene 2 Aqueous Phenolic Germicidal Agent
CAUTION Do not:
Use isopropyl alcohol
Autoclave the patient module, patient data cable/lead wires, or use ultrasonic cleaners
Immerse
Use abrasive materials
Wet the connectors
2 Wring excess moisture from the cloth before cleaning.
Maintaining the Equipment

Visually inspect the patient module, data cable, lead wires, and electrodes every day for
damage, cracks, or breakage. Replace components as necessary.
TIP You can streamline the testing process at your facility by maintaining multiple patient cable and lead set
combinations. You can prep patients ahead of time, and get them hooked up. Then, once it is each
patient’s time for the test, you can simply plug the patient cable into the patient module and begin the
test. Be sure to inspect all the equipment every day for wear and damage.

A
Appendix A Specifications and Requirements
NOTE No user serviceable parts are inside. ANY modification of this device may alter defibrillator
protection. Any modification to any part of this device is to be performed only by qualified service
personnel. See also Chapter 3, “Maintaining the Wireless Patient Module.”
Wireless Patient Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Options and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Accessories and Cables Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions. A-4
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity . A-5
Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
A-1
Specifications and Requirements
Wireless Patient Module Specifications
Table A-1 Wireless Patient Module Specifications
608 Wireless 2500 Wireless
Feature Specifications
Instrument type 12-lead ECG transmitter 12-lead ECG transmitter

Input channels Continuous 12-lead signal Continuous 12-lead signal
acquisition and transmission acquisition and transmission
Standard leads I, II, III, aVR, aVL, aVF, V1, I, II, III, aVR, aVL, aVF, V1,
transmitted V2, V3, V4, V5, and V6 V2, V3, V4, V5, and V6
Frequency range 608.48 MHz to 631.52 MHz 2400.96 MHz to 2482.56 MHz
Special functions Lead impedance check, ECG Lead impedance check, ECG
display, lead fail, low battery display, lead fail, low battery
notification, multi-purpose call, notification, multi-purpose
10-wire, 5-wire, and 4-wire call, 10-wire, 5-wire, and 4-
options wire options
Defibrillator In compliance with AAMI In compliance with AAMI
protection standards and IEC 60601-2-25 standards and IEC 60601-2-25
Number of channels For WMTS compliance, 64, user 256, user selectable
selectable, between channels 00
and 3F
Function keys Up/Right arrow, Down arrow, and Up/Right arrow, Down arrow,
Left arrow (Enter) keys for and Left arrow (Enter) keys for
powering the patient module on powering the patient module
and off, and navigating the menu on and off, and navigating the
menu
Device classification Type CF, battery operated Type CF, battery operated
Weight 4 ounces (125 g) without battery 4 ounces (125 g) without
battery
Dimensions 2.5 x 3.5 x .98 inches 2.5 x 3.5 x .98 inches
(64 x 91 x 25 mm) (64 x 91 x 25 mm)
Battery 1 AA alkaline, 30 hour typical 1 AA alkaline, 30 hour typical
life life
NOTE Operating range performance is 15 meters with no barriers. The manufacturer does not supply
accessories for direct cardiac applications.
A-2 Wireless Patient Module Instructions for Use

Electromagnetic Compatibility (EMC)
Options and Supplies

For detailed information about available accessories, options, and supplies, see the StressVue

Electromagnetic compatibility with surrounding devices should be assessed when using the
Philips Wireless Patient Module, models 608 and 2500.
An electronic device can either generate or receive electromagnetic interference. Testing for
electromagnetic compatibility (EMC) has been performed on the wireless patient module
according to the international standard for EMC for medical devices (IEC 60601-1-2) and
other relevant standards. This IEC 60601-1-2 standard has been adopted in Europe as the
European Norm (EN 60601-1-2).
The wireless patient module should not be used adjacent to, or stacked on top of other
equipment. If the wireless patient module must be used adjacent to or stacked on top of other
equipment, verify that the wireless patient module operates in an acceptable manner in the
configuration in which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the
performance of medical equipment. See Table A-5 on page A-7 for recommended separation
distances between the radio equipment and the wireless patient module.
Accessories and Cables Warning

The use of accessories and cables other than those specified in Chapter 4, “Ordering Options
and Parts” may result in increased emissions or decreased immunity of the wireless patient
module.
Wireless Patient Module Instructions for Use A-3

Guidance and Manufacturer’s Declaration:

Electromagnetic Emissions
The wireless patient module is intended for use in the electromagnetic environment specified
in the table below. The customer or the user of the wireless patient module should assure that
it is used in such an environment.
Table A-2 Guidance and Manufacturer’s Declaration: Electromagnetic emissions
Emissions Test Compliance Electromagnetic Environment Guidance
RF Emissions CISPR 11 Group 2 The wireless patient module must emit electromagnetic
energy in order to perform its intended function. Nearby
electronic equipment may be affected.
RF Emissions CISPR 11 Class B The wireless patient module is suitable for use in all
establishments other than domestic and those directly
Harmonic Emissions not applicable connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic
purposes.
Voltage fluctuations/ not applicable
flicker emissions
IEC 61000-3-3

Guidance and Manufacturer’s Declaration:

Electromagnetic Immunity
The wireless patient module is intended for use in the electromagnetic environment specified
in the following tables. The customer or the user of the wireless patient module should assure
that it is used in such an environment.
Table A-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
Emissions Test Compliance Compliance Level Electromagnetic Environment

Guidance
Electrostatic +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete, or

Discharge (ESD) +/- 8 kV air +/- 8 kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical Fast +/- 2 kV for not applicable

transient/burst power supply line
IEC 61000-4-4 +/- 1 kV for input/
output lines
Surge +/- 1 kV not applicable

IEC 61000-4-5 differential mode
+/- 2 kV common
mode
Voltage dips, short <5% UT not applicable

interruptions and (>95% dip in UT)
voltage variations on for 5 cycles
power supply input 40% UT
lines (60% dip in UT)
IEC 61000-4-11 for 0.5 cycles
Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60 Hz) magnetic should be at levels characteristic of a
field typical location in a typical
commercial or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.

Table A-4 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
Emissions IEC 60601 Compliance Electromagnetic Environment Guidance

Test Test Level Level
Conducted 3 Vrms 3 Vrms Portable and mobile RF communications equipment

RF 150 kHz to 150 kHz to should be used no closer to any part of the wireless
IEC 80 MHz 80 MHz patient module, including cables, than the
61000-4-6 recommended separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance:
⎡ 3.5 ⎤
d=⎢ P
⎣ 3Vrms ⎥⎦
Radiated RF 3 Vrms 3 Vrms ⎡ 3.5 ⎤

d=⎢ P
⎣ 3V / m ⎥⎦
80 MHz to 800 MHz
IEC 80 MHz to 80 MHz to
61000-4-3 2.5 GHz 2.5 GHz
⎡ 7 ⎤
d=⎢ ⎥ P 800 MHz to 2.5 GHz
⎣ 3V / m ⎦
Where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment
marked with the following symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, am-
ateur radios, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the elec-
tromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the wireless patient module is used exceeds the applicable RF compliance level above, the
wireless patient module should be observed to verify normal operation. If abnormal performance is observed, additional mea-
sures may be necessary, such as reorienting or relocating the wireless patient module.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

Recommended Separation Distances

The wireless patient module is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the wireless patient
module can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the wireless
patient module as recommended below, according to the maximum output power of the
communications equipment.
Table A-5 Recommended Separation Distances
Rated Maximum Output Separation Distance According to Frequency of

Power of Transmitter (W) Transmitter (m)
150 KHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 P d = 2.3 P
0.01 0.1 m 0.2 m
0.1 0.4 m 0.7 m
1 1.2 m 2.3 m
10 4.0 m 7.0 m
100 12.0 m 23.0 m
NOTES For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
At 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by the
absorption and reflection from structures, objects, and people.

B
Appendix A Patient Module Messages and Channel
Assignments
This appendix describes the messages and channel assignments. It also provides the system
information log to record system information, and Response Center contact information.
This appendix provides the following information:
Wireless Patient Module Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
Channel Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
Troubleshooting Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7
System Information Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-9
Contacting Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11
Philips Response Center Contact Information . . . . . . . . . . . . . . . . . . . . .B-11
North America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11
South America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11
Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11
Asia Pacific . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-12
Wireless Patient Module Messages

The following table describes messages that are displayed on the wireless patient module
during a patient session.
Table B-1 Patient module messages
Message Description/Solution
CH: XX The transmission channel set for the patient module.

RA RA lead failure. Check whether the lead is off or the
electrode needs to be replaced.
RL RL lead failure. Check whether the lead is off or the
LA LA lead failure. Check whether the lead is off or the
LL LL lead failure. Check whether the lead is off or the
B-1
Patient Module Messages and Channel Assignments
Table B-1 Patient module messages (continued)
Message Description/Solution
A combination of any of the One or more limb leads failed. Check whether the leads are
limb leads (e.g., RA/LL) off or the electrodes need to be replaced.
V1 V1 lead failure. Check whether the lead is off or the
A combination of any of the One or more chest leads failed. Check whether the leads
chest leads (e.g., V1/V3) are off or the electrodes need to be replaced.
Channel Assignments
Table B-2 shows channel assignments for the Wireless 608 system; the table shows the UHF
TV channel occupying the same frequency range.
Table B-3 on page 4 shows the hexadecimal/decimal channel mapping for the 64 channels in
the WMTS band that is set aside by the FCC for medical wireless transmissions.
Table B-4 on page 5 shows channel assignments for the Wireless 2500 system; the table
shows the UHF TV channel occupying the same frequency range.
Table B-2 Wireless 608 channel assignments (FCC Part 15 compliant)
CH # MHz CH # MHz CH # MHz
00 608.48 01 608.56 02 608.64

03 608.72 04 608.8 05 608.88
06 608.96 07 609.04 08 609.12
09 609.2 0A 609.28 0B 609.36
0C 609.44 0D 609.52 0E 609.6
0F 609.68 10 609.76 11 609.84
B-2 Wireless Patient Module Instructions for Use

Channel Assignments
Table B-2 Wireless 608 channel assignments (FCC Part 15 compliant) (continued)
CH # MHz CH # MHz CH # MHz
12 609.92 13 610 14 610.08

15 610.16 16 610.24 17 610.32
18 610.4 19 610.48 1A 610.56
1B 610.64 1C 610.72 1D 610.8
1E 610.88 1F 610.96 20 611.04
21 611.12 22 611.2 23 611.28
24 611.36 25 611.44 26 611.52
27 611.6 28 611.68 29 611.76
2A 611.84 2B 611.92 2C 612
2D 612.08 2E 612.16 2F 612.24
30 612.32 31 612.4 32 612.48
33 612.56 34 612.64 35 612.72
36 612.8 37 612.88 38 612.96
39 613.04 3A 613.12 3B 613.2
3C 613.28 3D 613.36 3E 613.44
3F 613.52
Wireless Patient Module Instructions for Use B-3

The following table shows channel numbers for the Wireless 608 system in hexadecimal and
the corresponding decimal number. The channels shown are the 64 channels in the WMTS
(medical) band.
Table B-3 Hexadecimal/Decimal channel assignments
00 = 0 0A = 10 14 = 20 1E = 30 28 = 40 2 = 50 3C = 60
01 = 1 0B = 11 15 = 21 1F = 31 29 = 41 33 = 51 3D = 61
02 = 2 0C = 12 16 = 22 20 = 32 2A = 42 34 = 52 3E = 62
03 = 3 0D = 13 17 = 23 21 = 33 2B = 43 35 = 53 3F = 63
04 = 4 0E = 14 18 = 24 22 = 34 2C = 44 36 = 54
05 = 5 0F = 15 19 = 25 23 = 35 2D = 45 37 = 55
06 = 6 10 = 16 1A = 26 24 = 36 2E = 46 38 = 56
07 = 7 11 = 17 1B = 27 25 = 37 2F = 47 39 = 57
08 = 8 12 = 18 1C = 28 26 = 38 30 = 48 3A = 58
09 = 9 13 = 19 1D = 29 27 = 39 31 = 49 3B = 59

Channel Assignments
The following table shows channel assignments for the Wireless 2500 system; the table shows
the UHF TV channel occupying the same frequency range.
Table B-4 Wireless 2500 channel assignments (FCC Part 15 compliant)
CH# MHz CH# MHz CH# MHz CH# MHz
00 2400.96 40 2421.44 80 2441.92 C0 2462.4
01 2401.28 41 2421.76 81 2442.24 C1 2462.72
02 2401.6 42 2422.08 82 2442.56 C2 2463.04
03 2401.92 43 2422.4 83 2442.88 C3 2463.36
04 2402.24 44 2422.72 84 2443.2 C4 2463.68
05 2402.56 45 2423.04 85 2443.52 C5 2464
06 2402.88 46 2423.36 86 2443.84 C6 2464.32
07 2403.2 47 2423.68 87 2444.16 C7 2464.64
08 2403.52 48 2424 88 2444.48 C8 2464.96
09 2403.84 49 2424.32 89 2444.8 C9 2465.28
0A 2404.16 4A 2424.64 8A 2445.12 CA 2465.6
0B 2404.48 4B 2424.96 8B 2445.44 CB 2465.92
0C 2404.8 4C 2425.28 8C 2445.76 CC 2466.24
0D 2405.12 4D 2425.6 8D 2446.08 CD 2466.56
0E 2405.44 4E 2425.92 8E 2446.4 CE 2466.88
0F 2405.76 4F 2426.24 8F 2446.72 CF 2467.2
10 2406.08 50 2426.56 90 2447.04 D0 2467.52
11 2406.4 51 2426.88 91 2447.36 D1 2467.84
12 2406.72 52 2427.2 92 2447.68 D2 2468.16
13 2407.04 53 2427.52 93 2448 D3 2468.48
14 2407.36 54 2427.84 94 2448.32 D4 2468.8
15 2407.68 55 2428.16 95 2448.64 D5 2469.12
16 2408 56 2428.48 96 2448.96 D6 2469.44
17 2408.32 57 2428.8 97 2449.28 D7 2469.76
18 2408.64 58 2429.12 98 2449.6 D8 2470.08
19 2408.96 59 2429.44 99 2449.92 D9 2470.4
1A 2409.28 5A 2429.76 9A 2450.24 DA 2470.72
1B 2409.6 5B 2430.08 9B 2450.56 DB 2471.04
1C 2409.92 5C 2430.4 9C 2450.88 DC 2471.36

1D 2410.24 5D 2430.72 9D 2451.2 DD 2471.68
1E 2410.56 5E 2431.04 9E 2451.52 DE 2472
1F 2410.88 5F 2431.36 9F 2451.84 DF 2472.32
20 2411.2 60 2431.68 A0 2452.16 E0 2472.64
21 2411.52 61 2432 A1 2452.48 E1 2472.96
22 2411.84 62 2432.32 A2 2452.8 E2 2473.28
23 2412.16 63 2432.64 A3 2453.12 E3 2473.6
24 2412.48 64 2432.96 A4 2453.44 E4 2473.92
25 2412.8 65 2433.28 A5 2453.76 E5 2474.24
26 2413.12 66 2433.6 A6 2454.08 E6 2474.56
27 2413.44 67 2433.92 A7 2454.4 E7 2474.88
28 2413.76 68 2434.24 A8 2454.72 E8 2475.2
29 2414.08 69 2434.56 A9 2455.04 E9 2475.52
2A 2414.4 6A 2434.88 AA 2455.36 EA 2475.84
2B 2414.72 6B 2435.2 AB 2455.68 EB 2476.16
2C 2415.04 6C 2435.52 AC 2456 EC 2476.48
2D 2415.36 6D 2435.84 AD 2456.32 ED 2476.8
2E 2415.68 6E 2436.16 AE 2456.64 EE 2477.12
2F 2416 6F 2436.48 AF 2456.96 EF 2477.44
30 2416.32 70 2436.8 B0 2457.28 F0 2477.76
31 2416.64 71 2437.12 B1 2457.6 F1 2478.08
32 2416.96 72 2437.44 B2 2457.92 F2 2478.4
33 2417.28 73 2437.76 B3 2458.24 F3 2478.72
34 2417.6 74 2438.08 B4 2458.56 F4 2479.04
35 2417.92 75 2438.4 B5 2458.88 F5 2479.36
36 2418.24 76 2438.72 B6 2459.2 F6 2479.68
37 2418.56 77 2439.04 B7 2459.52 F7 2480
38 2418.88 78 2439.36 B8 2459.84 F8 2480.32
39 2419.2 79 2439.68 B9 2460.16 F9 2480.64
3A 2419.52 7A 2440 BA 2460.48 FA 2480.96

Troubleshooting Issues
3B 2419.84 7B 2440.32 BB 2460.8 FB 2481.28
3C 2420.16 7C 2440.64 BC 2461.12 FC 2481.6
3D 2420.48 7D 2440.96 BD 2461.44 FD 2481.92
3E 2420.8 7E 2441.28 BE 2461.76 FE 2482.24
3F 2421.12 7F 2441.6 BF 2462.08 FF 2482.56
Troubleshooting Issues
When you encounter a problem working with the wireless patient module, address the issue in
the following order:
1 Review Table B-5, “Troubleshooting wireless patient module issues,” on page B-8 to see
whether your issue is addressed.
2 Review the Troubleshooting information in the StressVue Instructions for Use.
3 Contact your StressVue administrator.
4 Contact the Philips Response Center.
For phone numbers, see “Philips Response Center Contact Information” on page B-11.
The Philips Response Center can assist with product troubleshooting and provide
technical expertise to help with any issue with the StressVue system or patient modules.
For details, visit the following URL on the Web:
www.medical.philips.com/main/services/response_center

Table B-5 Troubleshooting wireless patient module issues
Wireless Patient Module Issues
Packet errors/ signal Signal on the StressVue screen Review any messages in the upper right
drop shows artifact and/or square corner of the display. A lead failure
waves intermittently. message (Battery Low) indicates the
system is not receiving ECG signals.
Check that no 2.4 GHz or 608MHz
network units operate in the proximity of
the StressVue system.
Perform an RF Scan to locate the source
of the interference and to change to the
optimal channel for the wireless patient
module. See Chapter 5, “Configuring
StressVue” of the StressVue Instructions
for Use.
No waveform signal on With the patient (or simulator) Check the StressVue Miscellaneous
the StressVue screen. connected, no waveforms are settings, as well as the wireless patient
displayed on the StressVue module settings to ensure that the two
screen; only the square waveform units are set to the same channel.
and lead-fail indicator appear.
Check patient module for leads off
indication.
NOTE: If neither the signal nor the
squared waveform is present, click For details about the patient module settings,
Abort and start a new exam from see “Setting the Transmission Channel” on
the Main window. page 2-9.
For details about setting the receiving
channel settings on the StressVue PC, see
Chapter 5, “Configuring StressVue” of the
StressVue Instructions for Use.

System Information Log
System Information Log

The system information log on the following page is provided for your convenience. You will
need this information to set up your system if it needs servicing. Be sure to add notes to your
log when you add options or your system has been serviced.
NOTE It is strongly recommended that you make a copy of this log and file it after you enter the information.
Record the model and serial number of all components, dates of removal, and/or replacement
of components, and the name of the vendor from whom the component was purchased and/or
installed.
In addition to having records of this information, the system information provides a warranty
record of when your system was placed in service. A warranty card is also included with the
system documentation. It is imperative that it is filled out and returned to Philips Medical
Systems.
The serial and part numbers for the wireless patient module are located under the battery in the
battery compartment. The model number is on the label on the back of the patient module.
Part number
Serial number
Have the model number, serial number, and other system information available when calling
with questions and service requests.

StressVue System Information Log Sheet
Manufacturer
Manufacturer Philips Medical Systems

3000 Minuteman Rd
Andover, MA 01810-1099
USA
Telephone Numbers (978) 687-1501 (North America)
Product Information
Name of Unit/Product Philips Wireless Patient Module, Model ___________
Date of Purchase / /
Purchased Unit from
Serial Number
(under the battery in the
patient module)
Software Version

Contacting Technical Support
Contacting Technical Support

Philips Response Center Contact Information
North America
Country Telephone Number
Canada (800) 323 2280

United States (800) 722-9377, press option 3
Miami 954 835 2650
(Spanish speaking)
South America
Argentina 54 11 4546 7698

Brazil 0800 701 7789
Chile 0800 22 3003
Mexico 01 800 710 8128
Columbia 01 8000 11 10 10
Peru 51 1620 6440
Puerto Rico 787 754 6811
Europe
United Kingdom 07 002 432 58 472 or

07 002 HEALTHRC
Austria 01 25125 333
Belgium 32 2 525 7102 (French)
32 2 525 7103 (Flemish)
Finland 010 855 2455
France 0803 35 34 33
Germany 0180 5 47 5000

Europe
Italy 0800 8256087

Netherlands 31 4 027 87630
Spain 34 90 230 4050
Sweden 08 5064 8830
Switzerland 0800 80 10 23
Asia Pacific
Australia 1800 251 400

China 800 810 0038
Hong Kong 852 2876 7578
India
New Delhi 011 2695 9734
Mumbai 022 5691 2643/2431
Calcutta 2485 3718
Chennai 044 555 01000
Bangalore 080 5091 911
Hyderabad 040 5578 7974
Indonesia 021 794 7542
Japan 0120 381 557
Korea 080 372 7777 (toll free)
Seoul 02 3445 9010
Macau 0800 923
Malaysia 1800 886 188
New Zealand 0800 251 400
Philippines 02 845 7875
Singapore 1 800 Philips
Taiwan 0800 005 616
Thailand 02 614 3569

C
Appendix A ASHE Registration
Frequency coordination is a registration and coordination process for wireless medical
telemetry devices used in the U.S.A. that operate in the FCC-allocated, protected Wireless
Medical Telemetry Service bands (608-614 MHz, 1395-1400 MHz, 1427-1432 MHz).
The Philips Wireless 608 system operates in the 608-614 MHz band.
NOTES It is the customer’s responsibility, as the user of the wireless system, to register the applicable
wireless devices.
Registration is not required for the Philips Wireless 2500 system.
Registration/coordination is a two-step process comprising:
Registration
Frequency registration and coordination
This step involves logging the equipment and frequencies used into the FCC’s database, to
identify any existing potential interference and to help prevent potential future
interference.
Registering the Wireless 608 System with ASHE

Register the system online as described next.
To register the wireless 608 system

1 In a web browser, access the following URL: http://www.ashe.org/ashe/wmts/index.html
The Wireless Telemetry Services home page appears.
2 Click the link to register: Online Registration Form
Follow the directions on the web site. You will need to fill out registration details, and pay
the associated fee as directed. Once registration is complete, you will receive
confirmation, as well as access information to register the frequencies.
You must receive the confirmation before you can proceed to the next step, frequency
coordination.
C-1
ASHE Registration
Coordinating Frequencies
Before proceeding, have available the following information:
Registration confirmation and site access information from the registration process
described in the previous section.
County in which the facility using the devices is located.
Latitude and longitude that represents the center of the area where the transmitting devices
will be deployed. Comsearch, the third-party that provides the frequency coordination
services, can help provide this information through their website, www.comsearch.com.
Names of the clinical units using the wireless devices (for example, Diagnostic Cardiology
department, 4th floor, Building One, and so on).
Radius of deployment, expressed in meters. Imagine drawing a circle around the center of the
clinical unit that encloses/encompasses the unit. What is its radius?
Number of the highest floor on which a transmitting device will operate.
Number of transmitting devices in use; that is, the number of Philips wireless patient modules in
use.
Effective Radiating Power: < 1 mW
Equipment Manufacturer: Manufactured by Mortara Instruments for Philips Medical Systems.
Equipment Model: 989803145521
Frequency range to be used: Select all frequencies in the range of 608.0 through 632 MHz.
To register the frequencies used

X The Wireless Telemetry Services home page provides links to the Frequency Coordination
database. Follow directions provided on the site.
There is a separate fee for this coordination process.
When you have successfully registered your devices, the StressVue Wireless 608 MHz system
can be activated.
C-2 Wireless Patient Module Instructions for Use

D
Appendix A Translations
The following table lists the wireless patient module’s user interface in English, French,
Italian, German and Spanish.
English Italian Spanish German French

ITALIANO ESPAÑOL DEUTSCH Français
CH: CH: C: KAN: CH:
Menu Menu Menu Menu Menu
CALL CHIAMA LLAMAR RUF APPEL
Off Off Off Aus Off
POWER OFF? SPEGNERE? ¿APAGAR? AUSSCHALTEN? ETEINDRE?
NO NO NO NEIN NON
YES SI’ SI JA OUI
LEAD CHECK DERIVAZIONI TEST ELECT ABL.TEST DÉRIVATIONS
DISPLAY ECG MOSTRA ECG MOSTRAR ECG EKG-ANZEIGE AFFICH. ECG
CONFIGURE CONFIGURA CONFIGURAR EINSTELLUNG CONFIGURER
CHANNEL CANALE CANAL KANAL CANAL
CABLE CAVO CABLE KABEL CÀBLE
4-Leadwire 4 Elettrodi 4 Electrodos 4-Elektroden 4 Électrodes
VERSION VERSIONE VERSION VERSION VERSION
BATTERY BATTERIA BATERIA BATTERIE BATTERIE
Battery Voltage Livello Batteria Voltaje Bateria Batterie-Spannung Capacité Batt.
DONE FINE OK FERTIG FIN
LANGUAGE LINGUA IDIOMA SPRACHE LANGUAGE
D-1
Index
A P T
AAMI electrode placement 2-15 patient cables technical support
attaching electrodes 2-15 approved cleaning solutions 3-2 how to contact B-8
cleaning 3-1, 3-2 system information log B-9
connecting to patient module 1-6 technical support, contacting B-11
C detaching from patient module 1-6
patient instructions
cables, cleaning 3-2 before taking ECG 2-14 W
cleaning patient interface module (PIM)
approved cleaning solutions 3-2 wireless transmitter
cleaning 3-2
cables 3-2 connecting to direct connect cable 1-6 safety iii-vii
electrodes 3-2 detaching from direct connect troubleshooting B-8
lead wires 3-2 cable 1-6
patient cables 3-1, 3-2 patient session
precautions 3-1 multiple patients 2-14
preparing patients 2-14
E multiple patients 2-14
skin preparation 2-15
ECGs preparing the skin 2-15
quality 2-14
electrodes
attaching to the patient 2-15
R
cleaning 3-2 response center, contacting B-11
placement 2-15
I S
safety
IEC electrode placement 2-15
wireless transmitter iii-vii
Instructions for Use
shaving. See patient
conventions used in 1-9
skin preparation before taking ECG 2-15
organization of 1-9
StressVue
cleaning 3-1
L maintenance 3-1
system information log B-9
lead wires, cleaning 3-2
log. See system information log
M
maintenance precautions 3-1
multiple patients, preparing 2-14
Index-1
Copyright © 2006
Koninklijke Philips Electronics N.V.
All rights are reserved. Permission is granted to copy
and distribute this document for educational purposes.
Printed in the U.S.A.
July 2008
Edition 2
453564103061
*453564103061*
*2*

StressVue 3.00.04 Wireless Patient Module, Rev.B - English

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StressVue

Wireless Patient Module

Philips Medical Systems shall not be European Directives

– Freight damage. Excluded from the limited warranty set

Chapter 1. Getting Started Using the Wireless Patient Module

Wireless Patient Module Instructions for Use i

Chapter 2. Configuring and Using the Wireless Patient Module

Chapter 3. Maintaining the Wireless Patient Module

Appendix A. Specifications and Requirements

ii Wireless Patient Module Instructions for Use

Appendix B. Patient Module Messages and Channel Assignments

Appendix C. ASHE Registration

Wireless Patient Module Instructions for Use iii

US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF

Wireless Patient Module Equipment Symbols

ECG physio isolation is type CF, defibrillator proof.

Do not dispose as unsorted municipal waste. Dispose of in

Safety Symbols Marked on the Wireless Patient Module

Keep out of direct sunlight.

Acceptable temperature range.

Move and store packaging this end up.

Recycle the packaging materials after use.

vi Wireless Patient Module Instructions for Use

Conventions Used in the Instructions for Use

NOTE Notes contain additional important information about a topic.

Important Patient and Safety Information

Warnings about the Wireless Patient Module

Wireless Patient Module Instructions for Use vii

E Spain: Use is limited to channels in the range 8B to E6 (inclusive).

F France: Use is limited to channels in the range 8E to A5 (inclusive).

viii Wireless Patient Module Instructions for Use

Additional Wireless Patient Module Warnings

Wireless Patient Module Instructions for Use ix

Caution Statements for the Wireless Patient Module

x Wireless Patient Module Instructions for Use

Important Notes about the Wireless Patient Module

Wireless Patient Module Instructions for Use xi

xii Wireless Patient Module Instructions for Use

Industry Canada Compliance Statement

The Wireless Patient Module

Indications for Use

Wireless Patient Module Instructions for Use xiii

About the Wireless System

About the Wireless Patient Modules

Patient data cable

Navigation key pad

1-2 Wireless Patient Module Instructions for Use

2500 model 608 model

Wireless Patient Module Instructions for Use 1-3

About the USB Interface Connector

1-4 Wireless Patient Module Instructions for Use

Figure 1-3 USB interface connector for wireless connection

Wireless Patient Module Instructions for Use 1-5

Preparing the Wireless Patient Module for Use

Attaching the Patient Cable to the Patient Module

Pins inserted straight in

To detach the patient cable from the patient module

1-6 Wireless Patient Module Instructions for Use

Lead Wire Placement on Patient

Place near the

Place near the shoulders

Ordering Parts and Supplies

Wireless Patient Module Instructions for Use 1-7