Philips Medical Systems North America M2601B Medical Telemetry Transmitter User Manual tele6
Philips Medical Systems North America Co. Medical Telemetry Transmitter tele6
Instructions for Use
Instructions for Use
Philips Telemetry System
with the M2601B Transmitter and
Telemetry Functions
at the IntelliVue Information Center
Part Number: M2600-92201
Printed in the U.S.A. November 2004
First Edition
Notice
Operation of this equipment requires the prior coordination
with a frequency coordinator designated by the FCC for the
Wireless Medical Telemetry Service.
ii
Notice
Equipment specifications are subject to alteration without notice. All changes
will be in compliance with regulations governing manufacture of medical
equipment.
Printed in the USA.
Document number: M2600-92201
© Copyright 2004 Koninklijke Philips Electronics N.V. All Rights Reserved.
OxiCliq and OxiMax are registered trademarks of Nellcor Incorporated.
Printing History
New editions of this document incorporate all material updated since the
previous edition. Update packages may be issued between editions and contain
replacement and additional pages to be merged by a revision date at the bottom
of the page. Pages that are rearranged due to changes on a previous page are not
considered revised.
The documentation printing date and part number indicate its current edition.
The printing date changes when a new edition is printed. (Minor corrections and
updates which are incorporated at reprint do not cause the date to change.) The
document part number changes when extensive technical changes are
incorporated.
First Edition................................................................ November 2004
Philips Telemetry System, model M2600B is compatible with:
M2604A Philips Mainframe, #01D or #0EU, revision E.00.19
Philips Information Center, revisions F.00, E.01, E.00, D.01, D.00
M2636B TeleMon Companion Monitor, Options A02/A03
Philips Transmitter, model M2601A
Philips Transmitter, model M1400A/B/J
Note—Some features are not available on all products.
About this Book
iii
About this Book
This book contains operating instructions for use of the M2601B Transmitter, a
part of the Philips Telemetry System. It also includes operational information for
the telemetry functions of the IntelliVue Information Center. The intended
audience is the clinician who uses and/or teaches others to use the equipment in
a healthcare environment. For operating information on other functionality of
the Information Center, see the IntelliVue Information Center Instructions for
Use (order number M3150-9001F). For preventive maintenance, repair, and test
methods for verification of device performance, refer to the M2600B Philips
Telemetry System Service Guide in the M2600B Documentation Kit, shipped
with the product (order number M2600-90323).
This book does not address Philips IntelliVue TRx transceivers or the Philips
IntelliVue Telemetry System. For information on those products, refer to the
manual Philips IntelliVue Telemetry System Instructions for Use (order number
M4841-91001).
Note—Standard and EASI M2601A Transmitters can be used with the Philips
Telemetry System and can operate simultaneously with M2601B Transmitters.
“What’s New” on page 1-2 summarizes the differences between the M2601B
and M2601A transmitters.
About this Book
iv
Document
Conventions
Procedures
Procedures are indicated in text by the heading Task Summary followed by the
following table:
Bold Typeface
Objects of actions in procedures appear in bold typeface. Note the following
example:
Click the Standby button.
Warnings
WarningWarning
Warnings are information you should know to avoid injuring patients and
personnel.
Cautions
Caution
Cautions are information you should know to avoid damaging your equipment
and software.
Notes
Note—Notes contain additional information on Philips Telemetry System usage.
Step Action
1
2
3
Product Safety Information
v
Product Safety Information
The warnings below refer to the following devices:
• Philips M2601B Transmitter
• Philips Telemetry System
• IntelliVue Information Center
WarningWarning
For continued safe use of this equipment, it is necessary that the listed
instructions are followed. Instructions in this manual in no way supersede
established medical procedures.
WarningWarning
Do not touch the patient, or table, or instruments during defibrillation. The
battery door must be closed during defibrillation. These steps protect the
clinician from high defibrillator voltage.
WarningWarning
This device is not to be used in the vicinity of electrosurgery units because
use may interrupt or interfere with the transmission of signals from the
transmitter.
WarningWarning
This equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
Product Safety Information
vi
WarningWarning
Do not use patient cables with detachable lead wires that have exposed male
pins. Electrocution could result if these pins are plugged into AC power.
WarningWarning
Use of product accessories (e.g., ECG lead sets, SpO2 sensors) other than
those prescribed by Philips could lead to patient injury.
WarningWarning
Strangulation Hazard! Under no circumstances should any pouch be tied
solely around a patient’s neck.
WarningWarning
ECG SAFETY FOR ALL PATIENTS
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
Every lead must be secured to an electrode on the patient.
Conductive parts of electrodes must not contact earth or other conductive
parts.
Philips recommends that you change the lead label only to reflect the
physical placement of electrodes. This will ensure a match between the
monitored lead and the label, and prevent any possible confusion.
When switching between EASI and Standard monitoring, there is a loss of
data for 30 seconds.
Product Safety Information
vii
WarningWarning
ECG SAFETY FOR PACED PATIENTS
The output power of the M2601B Transmitter and other sources of radio
frequency energy, when used in the proximity of a pacemaker, can be
sufficient to interfere with pacemaker performance. Due to the shielding
effects of the body, internal pacemakers are somewhat less vulnerable than
external pacemakers. However, caution should be exercised when
monitoring any paced patient.
In order to minimize the possibility of interference, position electrodes,
electrode wires, and the transmitter as far away from the pacemaker as
possible.
Consult the pacemaker manufacturer for information on the RF
susceptibility of their products and the use of their products with the
Philips Telemetry System. See the IntelliVue Information Center
Instructions for Use for additional information on monitoring paced
patients.
Product Safety Information
viii
WarningWarning
ST/AR ARRHYTHMIA SAFETY FOR ALL PATIENTS
During complete heart block or pacemaker failure (to pace or capture), tall
P-waves (greater than 1/5 of the average R-wave height) can be erroneously
counted by the arrhythmia algorithm, resulting in missed detection of
cardiac arrest.
Learning/Relearning
--If you initiate learning during ventricular rhythm, the ectopics can be
incorrectly learned as the normal QRS complex. This can result in missed
detection of subsequent events of V-Tach and V-Fib.
--When using EASI ECG monitoring, Relearn happens automatically when
there is a LEADS OFF technical alarm. If learning takes place during
ventricular rhythm, the ectopics can be incorrectly learned as the normal
QRS complex. This can result in missed detection of subsequent events of
V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to
correct. Therefore, when a technical alarm is generated:
1. Respond to the technical alarm [for example, reconnect the electrode(s)].
2. Ensure that the arrhythmia algorithm is labeling beats correctly.
Product Safety Information
ix
WarningWarning
ST/AR ARRHYTHMIA SAFETY FOR PACED PATIENTS
It is possible that pacemaker pulses will not be detected when the ECG
analog output of a defibrillator or telemetry unit is plugged into a bedside
monitor. This can result in the arrhythmia algorithm’s failure to detect
pacemaker non-capture or asystole.
Some pace pulses can be difficult to reject. When this happens, the pulses
are counted as a QRS complex, and could result in an incorrect HR and
failure to detect cardiac arrest or some arrhythmias. Keep pacemaker
patients under close observation.
-- During complete heart block or pacemaker failure (to pace or capture),
tall P-waves (greater than 1/5 of the average R-wave height) can be
erroneously counted by the arrhythmia algorithm, resulting in missed
detection of cardiac arrest.
-- When arrhythmia monitoring paced patients who exhibit only intrinsic
rhythm, the monitor can erroneously count pace pulses as QRS complexes
when the algorithm first encounters them, resulting in missed detection of
cardiac arrest.
For patients who exhibit intrinsic rhythm only, the risk of missing cardiac
arrest can be reduced by monitoring these patients with the low heart rate
limit at or slightly above the basic/demand pacemaker rate. A low heart
rate alarm alerts you when the patient begins pacing. Proper detection and
classification of the paced rhythm can then be determined.
-- When an external pacemaker is being used on a patient, arrhythmia
monitoring is severely compromised due to the high energy level in the
pacer pulse. This can result in the arrhythmia algorithm’s failure to detect
pacemaker non-capture or asystole.
Product Safety Information
x
Contents
Contents-1
1. Introduction to the Philips Telemetry System. . . . . . . . . . . . . . . . . . . . . . . . . 1-1
What’s New. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
New Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Connection to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
M2601B Transmitter Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Transmitter Controls - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Transmitter Controls - Back. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Transmitter Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Securing the Pouch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Showering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Making Monitoring Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Turning the Transmitter On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Turning Telemetry Monitoring On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Transmitter Auto Shutoff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Turning Nurse Call On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Use with TeleMon B, Options A02/A03. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Operation with TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Testing the Transmitter Functionality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Status Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Battery Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Inserting/Removing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Checking the Battery Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32
Receiver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34
Receiver Mainframe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Antenna System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Contents-2
2. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Pause/Suspend Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Alarm Behavior with Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Physiologic (Patient) Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
3. ECG & ST/AR Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
EASI ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
ECG Lead Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
ECG Leads Monitored . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Setting Up for ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7
Positioning ECG Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-14
Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Making ECG Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18
Changing Lead/Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Adjusting Wave Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Monitoring During Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19
Lead Fallback. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Extended Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Relearning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Using EASI Leads to Troubleshoot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Optimizing System Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
The Telemetry Signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Troubleshooting Signal Disturbance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Dropouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Muscle and Movement Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
ST/AR Arrhythmia Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28
ECG and ST/AR Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
ST/AR Arrhythmia Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
4. ST/AR ST Segment Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
ST/AR ST Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
The Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
How the Algorithm Works. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Contents-3
Displayed ST Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
EASI ST Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Adjusting Measurement Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Establishing ST Reference Beats (Baseline) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Turning ST On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
ST Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
ST Alarm Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9
5. SpO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
About the Pulse Oximetry Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Pulse Indication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
SpO2 Information for the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Preparing for Telemetry SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
SpO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Disposable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Selecting an SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Applying the Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Adult Finger Sensor (M1191A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14
Small Adult/Pediatric Finger Sensor (M1192A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-15
Ear Clip Sensor (M1194A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Connecting the SpO2 Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Making SpO2 Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
SpO2Measurement when Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
Making a Spot Check Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
Monitoring SpO2 Continuously . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Turning SpO2 Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Turning the SpO2 Parameter On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21
SpO2 Parameter Auto ON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22
Turning SpO2 Alarms On/Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22
Turning the Pulse Parameter On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-23
Measurement Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-24
Optimizing Sensor Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-25
SpO2 Alarms and Technical Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-25
Contents-4
6. Maintenance and Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Basic Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Testing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention . . . . . . . . . . . . . . . . . . . . . . . 6-4
Cleaning the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4
Disinfecting the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Cross-Infection Prevention for the Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Receiver Mainframe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Configuration Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
M2604A Mainframe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Philips M2601B Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
Changing the Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
7. System Safety and Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Product Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
System Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
Philips Telemetry System Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
M2600B Philips Telemetry System Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
FCC Compliance (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Canadian Radio Equipment Compliance (Canada Only) . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
System Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Type CF Defibrillation Proof. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Installation and Maintenance Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Preventive Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
End of Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
Additional Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-19
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Battery Life Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
Electrical Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
Antenna System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26
Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30
Contents-5
A. Optional Patient Monitor/Holter Interface (Analog Output) . . . . . . . . . . . A-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Correct Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Analog Output Bedside Monitor Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Lead Placement and Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Using Non-Standard Lead Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Controls for Telemetry Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Functionality with Paced Waves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Technical Alarms (Inoperative Conditions). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
Holter Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8
B. Accessory List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Accessory Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
ECG Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
SpO2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
C. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Contents-6
Introduction to the Philips Telemetry System 1-1
Introduction
1
Introduction to the
Philips Telemetry System
This chapter introduces the Philips Telemetry System. It includes the following
sections:
• What’s New. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
• Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
• System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
• Transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
• Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
• Making Monitoring Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
• Use with TeleMon B, Options A02/A03. . . . . . . . . . . . . . . . . . . . . . . 1-25
• Testing the Transmitter Functionality. . . . . . . . . . . . . . . . . . . . . . . . . 1-27
• Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
• Receiver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34
• Receiver Mainframe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
• Antenna System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
What’s New
1-2 Introduction to the Philips Telemetry System
What’s New
This section highlights the differences between the M2600B Philips Telemetry
System, utilizing the M2601B Transmitter and the Philips M2600A Telemetry
System, Release C, utilizing the M2601A Transmitter.
New
Transmitter
The main difference between the two systems is the introduction of the new
M2601B transmitter.
Differences
Between
Transmitters
The following table summarizes the differences between the two transmitters.
M2601B M2601A
Function One transmitter for both Standard and
EASI monitoring -- clinician simply
changes the ECG lead set position
Separate Standard or EASI versions of
transmitter
FAST (Fourier Artifact Suppression
Technology) SpO2 algorithm
Traditional (not motion tolerant) SpO2
algorithm
Continuous and Spot Check (Manual)
SpO2 measurements
Continuous, Spot Check (Manual), and
Intermittent (1- and 5-minute) SpO2
measurements
What’s New
Introduction to the Philips Telemetry System 1-3
Controls &
Indicators
Spot Check SpO2 initiated by inserting
sensor cable
Manual measurement initiated by
button push on transmitter
Auditory feedback for Spot Check and
self test
N/A
Two electrode placement diagrams
show both Standard and EASI
placement
One electrode placement diagram
appropriate for the transmitter: either
Standard or EASI placement
Check button for verifying transmitter
status: lead set type, battery level,
EASI indicator (if in use)
N/A
Battery gauge to indicate power level N/A
Audible volume/mute configurations N/A
Audible pulse detection during Spot
Check measurement
N/A
Unit designator label on battery
compartment
N/A
Physical Smaller and lighter ECG-only
transmitter
ECG/SpO2 transmitter approximately
same size as the M2601A
One-size transmitter (ECG-only or
ECG/SpO2)
Power Source Battery Type: 2 AA Alkaline Battery Types: 1 9-volt Alkaline,
Lithium, Zinc Air
No Support for Battery Extender Compatible with Battery Extender
Accessories New 5-wire lead sets, with color-
coded lead wires available
M2601B M2601A
What’s New
1-4 Introduction to the Philips Telemetry System
Connection
to TeleMon
The M2601B Transmitter also has a different method of connecting to the
TeleMon Companion Monitor:
• M2601B: Transmitter is connected to the outside of TeleMon via a 3-
meter tether cable.
• M2601A: Transmitter is docked in TeleMon.
Own Bed
Overview
The system supports the concept of Own Bed Overview, the pairing of a
telemetry bed and an IntelliVue Patient Monitor (Release B.1 or higher) for a
single patient. Own Bed Overview provides the telemetry-monitor data
(waveforms, parameters, and alarms) in an integrated form both on the bedside
monitor and at the IntelliVue Information Center.
Own Bed Overview is available with both the M2601B and M2601A
transmitters.
Information on Own Bed Overview can be found in the IntelliVue Patient
Monitor Instructions for Use and the IntelliVue Information Center Instructions
for Use. In this book, “Alarm Behavior with Own Bed Overview” on page 2-3
summarizes alarm functionality with Own Bed Overview.
Indications for Use
Introduction to the Philips Telemetry System 1-5
Indications for Use
The paragraphs below are the elements of the indications for use statement for
the Philips Telemetry System.
Condition The licensed clinician decides that the Philips Telemetry System should be used
to monitor the patient.
Prescription
Versus Over-
the-Counter
The Philips Telemetry System is a prescription device.
Part of the
Body or Type
of Tissue with
which the
Device
Interacts
The ECG signal is obtained from accessory electrodes in contact with the
patient’s skin. The SpO2 signal is obtained from an accessory sensor in contact
with the patient’s skin.
Frequency of
Use
As prescribed by a licensed physician.
Physiological
Purpose
To monitor the ECG and SpO2 of patients on the order of a licensed physician.
Patient
Population
Adult and pediatric patients.
Indications for Use
1-6 Introduction to the Philips Telemetry System
Intended Use The Philips Telemetry System is a comprehensive ambulatory system solution
for the intermediate care unit for adult and pediatric patients. The foundation of
the system is a transmitter that can capture and transmit ECG signals and SpO2
values (if available) that are then processed and displayed on the IntelliVue
Information Center. The Information Center generates alarms and recordings,
thus notifying clinicians of changes in patients' conditions. The Telemetry
System communicates with other devices via the Philips patient care system.
WarningWarning
United States law restricts this device to sale by or on the order of a
physician. This product is intended for use in health care facilities by
trained health care professionals. It is not intended for home use.
Regulatory
Information
This device is not for use with infant or neonatal patients.
The transmitter and related accessories are in compliance with the relevant
requirements of EN ISO 10993-1 for Biocompatibility. The transmitter is not
designed for direct contact with the patient’s skin. The accompanying pouch is
the appropriate means for holding the transmitter.
Use of the transmitter is restricted to one patient at a time.
The system is not intended to be connected to public mains as defined in
CISPR 11.
System Overview
Introduction to the Philips Telemetry System 1-7
System Overview
The Philips Telemetry System is used with the IntelliVue Information Center to
provide multi-parameter measurements for transitional care and other
ambulatory monitoring environments for adult and pediatric patients. The
system:
• Enunciates patient monitoring alarms.
• Monitors adult and pediatric patients’ ECG.
• Provides ST/AR arrhythmia detection.
• Measures pulsatile arterial oxygen saturation (SpO2) and pulse rate, if
available.
• Enables viewing of ECG and SpO2 measurements and waveforms at the
patient’s side when connected to the TeleMon Companion Monitor.
• Makes ST segment measurements.
The Philips Telemetry System consists of:
• A transmitter for each patient.
• An antenna system.
• A receiver for each transmitter.
• A mainframe housing up to eight receivers.
Other possible items include:
• The TeleMon Companion Monitor: TeleMon can be used to view
waveforms and heart rate and SpO2 numerics as well as measure NBP.
For more information see the Philips TeleMon B A02/A03 Companion
Monitor Instructions for Use.
See the Philips Telemetry System Service Guide or your local trained service
professional for assistance.
System Overview
1-8 Introduction to the Philips Telemetry System
Philips Telemetry System
Dual-Band
Operation
The Philips Telemetry System (M2600B) can operate in both the 406-480 MHz
and 590-614 MHz ranges. The exact operating frequency for each transmitter/
receiver pair is set so as to meet specific customer needs, while maintaining
compliance with local and international radio regulations.
For United States operation, the M2600B will operate only in the protected,
dedicated Wireless Medical Telemetry Service (WMTS) band (608-614 MHz).
EASI, 3
5
M2601B
Transmitters
Introduction to the Philips Telemetry System 1-9
Transmitters
The following Philips transmitters can be used with the Philips Telemetry
System:
• ECG-only transmitter
•ECG/SpO
2 transmitter
Standard and EASI M2601A transmitters can also be used. These transmitters
can operate simultaneously with M2601B transmitters. For operating
information, refer to the Instructions for Use for the Philips Telemetry System
(part number M2600-9001C).
Note—“What’s New” on page 1-2 summarizes the differences between
the M2601B and M2601A transmitters.
The M2601B Transmitter models are illustrated on the following pages in this
chapter. Subsequent tables describe the controls, indicators, markings, and
audible sounds respectively.
If your hospital uses both the M2601B Transmitter and IntelliVue
TRx devices
The M2601B Transmitter and M4841A TRx Transceiver are similar in
appearance. You can distinguish between them by:
• Name on the front of the device
• Label color (dark gray for M2601B and pale gray for TRx)
Transmitters
1-10 Introduction to the Philips Telemetry System
M2601B
Transmitter
Features
• Clinician-selectable Standard or EASI leads in same transmitter, at the
bedside.
• Powered by two AA Alkaline batteries.
• Spot Check SpO2 without using any control buttons.
•FAST-SpO
2 (Fourier Artifact Suppression Technology) for improved
motion artifact rejection and low-perfusion performance.
• Simultaneous operation in system with M2601A Transmitter.
• Two sizes - smaller ECG-only version and larger ECG-SpO2 version.
• Battery gauge on transmitter.
• Designed to be ergonomic and comfortable for patients to wear.
• Colored labels provide clinical unit identifiers.
• Lead sets are optimized for ambulating patients, with a cable length of
79 cm (30 in).
• Gunk guards prevent dirt from accessing unused ECG and SpO2 cable
ports and the unused TeleMon/Service port, thus simplifying cleaning.
• New pouches with clear front and flaps.
.
M2601B Transmitter - ECG only
Front View
EASI, 3
5
M2601B
EASI
S
IA
E
!
0123
FCCID: XXXXXXXX
CANADA IC: XXXX
i
Back View
Transmitters
Introduction to the Philips Telemetry System 1-11
Transmitter
Controls -
Front
ECG/SpO2 Transmitter - Front View
The labeled items in the diagram above include:
• Transmitter controls (A-C)
• Indicators (a-d)
• Labels (1-3)
• Ports (i-iii)
These items are defined on subsequent tables.
EASI, 3
5
M2601B
3
2
A
B
a
b
c
dC
1
iii
i
ii
Transmitters
1-12 Introduction to the Philips Telemetry System
Controls
Callout Control Definition
ATelemetry Button: Depending on the
configuration, this multi-function button directs
the Information Center to generate a Nurse Call,
central recording, both, or none.
If desired, you can turn Nurse Call off for
individual patients at the Information Center by
using the Telemetry Setup Window. See
“Turning Nurse Call On/Off” on page 1-23 for
additional information.
Note—Recordings generated by the telemetry
button are stored in Alarm Review at the
Information Center.
Note—If the installation includes a paging
system and if the Information Center is
configured for paging upon receipt of Nurse
Call, a Nurse Page signal will be initiated.
BCheck Button. Checks the status of the
transmitter. When pressed, the battery gauge,
lead set type, and EASI (if in use) indicators
illuminate.
CPower On/Off Battery Compartment. Battery insertion turns
power on; battery removal turns power off.
Transmitters
Introduction to the Philips Telemetry System 1-13
Indicators
Callout Indicator Definition
aLead Indicator.
• Lights momentarily to display leads
attached when lead set is inserted or when
the Check button is pressed.
• When a Leads Off condition occurs, the
light(s) indicate the lead(s) that need to be
reapplied. The light(s) remain on until the
Leads Off condition ends.
Note—The 6th indicator (left-most LED) is not
used for the M2601B Transmitter.
bEASI Indicator. Illuminates momentarily upon
insertion of lead set in EASI position. Lit by
Check button when EASI is in use.
cAlarms Pause/Suspend Indicator. Inactive.
Note—If the transmitter is connected to the
TeleMon Companion Monitor this indicator is
lit during 3 minute alarm pause period initiated
at TeleMon.
dBattery Gauge. When the Check button is
pressed, indicates the amount of power
remaining in the batteries. Valid only for
recommended battery type.
Note—See “Checking the Battery Power Level”
on page 1-32.
EASI
Transmitters
1-14 Introduction to the Philips Telemetry System
Front Labels
Ports
Callout Label Definition
1Lead Set Insertion Guide. See
“Connecting the ECG Cable” on page 3-
14.
2Device Identification Label
3Unit Identification Label. (one of
seven colors). Color-coded sticker.
EASI, 3
5
M2601B
Callout Definition
iECG Lead Set Port. Connection for 3-wire or 5-wire lead set.
ii SpO2 Sensor Port. Connection for SpO2 sensor.
iii TeleMon/Service Port. Connection for cable to TeleMon
Companion Monitor or to Service Tool.
Transmitters
Introduction to the Philips Telemetry System 1-15
Transmitter
Controls -
Back
ECG/SpO2 Transmitter - Back View
TO TRANSLATORS: use appropriate graphic showing electrode colors
(IEC graphics are in "13 August graphics IEC").
The labeled items in the diagram above include:
• Labels (A)
• Safety symbols and other markings (1-11)
These items are defined on subsequent tables.
7
5
1
4
A
8-11 not shown
(inside battery
compartment)
3
5
6
2
EASI
i
EASI
EASI
S
IA
E
!
0123
FCCID: XXXXXXXX
CANADA IC : XXXX
Transmitters
1-16 Introduction to the Philips Telemetry System
Back Labels
Safety
Symbols and
Other
Markings
Callout Definition
AElectrode Placement Diagrams (See “Positioning ECG
Electrodes” on page 3-8.)
Callout Label Definition
1Considered Class 2 radio equipment per
Directive 1999/5/EC for which Member States
may apply restrictions on putting the device
into service or placing it on the market. This
device is intended to be connected to the
publicly available interfaces (PAI) for use
throughout the EEA.
2Compliance to Council Directive 93/42/EEC
(MDD).
3The transmitter patient connections are
protected against defibrillation
(DEFIBRILLATION-PROOF) and are a
TYPE CF APPLIED PART.
4Prescription device.
5Follow operating instructions.
!
Rx
i
Transmitters
Introduction to the Philips Telemetry System 1-17
6Non-Ionizing Radiation. Interference to
electronic equipment may occur in the vicinity
of devices marked with this symbol.
7Complies with all applicable Canadian and
American standards.
8Serial Number. Needed to identify the
equipment during a call to the Response
Center.
9Philips Catalog Number.
10 MAC Address of device.
11 Date of manufacture.
Callout Label Definition
SN
REF
MAC
Transmitters
1-18 Introduction to the Philips Telemetry System
Sounds The transmitter produces auditory information signals to inform you of
measurement and battery conditions. The main tone, which can be set to one of
5 different volume settings or turned off, is configurable. In addition, a lower
pitched tone is used to identify a pulse beat occurring during an SpO2 Spot
Check measurement.
Transmitter
Safety
Information WarningWarning
If another radio medical device is operating at the same frequency as the
transmitter, it is possible that either device will not function properly.
WarningWarning
Although the transmitter is shielded against Electromagnetic Interference
(EMI), avoid the use of other electrically radiating devices in close
proximity to the transmitter, which might interfere with transmitter
operation.
WarningWarning
Place the transmitter in a pouch or over clothing, or both, during patient
use. The transmitter should not touch the patient’s skin during use.
Auditory Information
Signal Definition
Beep Power On Self Test Passed
SpO2 Spot Check Measurement Complete
Beep Beep Power On Self Test Failed
SpO2 Spot Check Measurement Failed
Boop Boop signal corresponding to detected Pulse
(during SpO2 Spot Check measurement only)
Briefing the Patient
Introduction to the Philips Telemetry System 1-19
Briefing the Patient
WarningWarning
Patients should be instructed not to open the battery cover while the
transmitter is in use.
If the Telemetry button has been configured to generate a Nurse Call, recording
at the Information Center, or both, instruct the patient to use the button when
needed.
Note—If desired, the clinician can turn off patient use of the button at the
Information Center. See “Turning Nurse Call On/Off” on page 1-23.
Pouch Use The transmitter is not designed for direct contact with the patient’s skin. During
normal use, the transmitter should be worn over clothing, in a pocket or,
preferably, in a pouch. The carrying pouch is an appropriate means for holding
the transmitter.
Briefing the Patient
1-20 Introduction to the Philips Telemetry System
Securing
the Pouch
Task Summary
Step Action
1 Secure the pouch on the patient with upper ties around the patient’s
head and arm, and lower ties around the patient’s lower torso.
WarningWarning
To avoid strangulation, do not tie a pouch solely around the
patient’s neck.
2 Insert the transmitter into the pouch with lead wires and SpO2
sensor cable, if used, exiting from the same side.
Important—Do not coil the cables inside the pouch. They are part of
the antenna system and need to be freely exposed.
Briefing the Patient
Introduction to the Philips Telemetry System 1-21
Showering
WarningWarning
Signal quality and leads off detection may be compromised when showering
due to significant patient movement. Appropriate clinical precautions must
be taken.
The transmitter can be used to monitor a patient in the shower, but only when
placed inside a Philips carrying pouch with the flap closed and the snaps
secured. The combination of the transmitter and pouch will withstand showering
for up to 10 minutes.
3 Fold the flap down and snap closed.
4 Check that the patient is comfortable wearing the pouch with
transmitter.
Step Action
Making Monitoring Adjustments
1-22 Introduction to the Philips Telemetry System
Drying the
Transmitter
after
Showering
After showering, perform the following steps to continue monitoring:
1. Pat dry the lead set connections at the electrodes.
2. Wipe the lead wires with care.
3. If wet, dry the outside of the transmitter with a non-lint-producing cloth.
4. If wet, wipe the inside of the battery compartment dry. Dry the batteries.
5. If wet, disconnect the ECG lead block and shake out any water. Dry the
connector pin area with a cotton swab.
Note—The transmitter should not be used for monitoring if the battery
compartment is wet. Remove the batteries and wipe the compartment dry before
continued monitoring use.
Accidental
Wetting
If the transmitter is accidentally immersed in liquid for up to 5 minutes, no
damage to the device and no electrical safety issues for the patient will result.
Remove the device, dry it off, and follow the procedure for cleaning/disinfection
or cleaning/cross-infection prevention under “Transmitter Cleaning,
Disinfection, & Cross-Infection Prevention” on page 6-4 as appropriate.
Making Monitoring Adjustments
Turning the
Transmitter
On/Off
The transmitter is powered by two AA alkaline batteries. To turn the transmitter
on, insert both batteries. Remove the batteries to turn the power off.
Note—Transmitter settings (SpO2 mode, audible tone volume, etc.) set using the
Service Tool/TeleMon are retained indefinitely after battery removal.
Making Monitoring Adjustments
Introduction to the Philips Telemetry System 1-23
Turning
Telemetry
Monitoring
On/Off
Telemetry monitoring can be turned on or off in one of two ways:
• Manually, by activating Monitoring Standby at the IntelliVue Information
Center (see “Standby Mode” on page 1-24).
• Automatically, if Auto Shutoff is enabled at the transmitter and if all leads
are off for 10 minutes (see “Transmitter Auto Shutoff” on page 1-23).
Note—Turning telemetry monitoring off does not turn the transmitter off. Turn
the transmitter off by removing the batteries.
Transmitter
Auto
Shutoff
A service feature of the transmitter is RF Automatic Shutoff, which causes the
transmitter to stop broadcasting a radio signal if all leads are off for 10 minutes.
This prevents interference with other transmitters in use. The technical alarm
message at the Information Center is TRANSMITTER OFF. To restart
monitoring, attach leads to the patient. Automatic Shutoff can be configured off.
Batteries must be removed when the transmitters are not in use to prevent RF
interference and unnecessary battery drain.
Note—Automatic Shutoff does not save battery life. In order to allow an
automatic turn-on when the leads are reattached, transmitter functions are
not completely disabled in this mode. To extend battery life, remove the
batteries when the transmitter is not in use.
Turning
Nurse Call
On/Off
If the Telemetry button on the transmitter is configured for a Nurse Call alarm,
you can inhibit the alarm for individual patients by using the Telemetry Setup
Window on the Information Center. If your system is configured for both a
Nurse Call alarm and a recording, only the Nurse Call alarm is inhibited by
turning it off: recordings are still made.
Task Summary Turn the Telemetry button on the transmitter on or off by performing the
following steps:
Step Action
1On the Patient Window click the All Controls button.
Making Monitoring Adjustments
1-24 Introduction to the Philips Telemetry System
Standby
Mode
When a patient is temporarily off the unit or out of antenna range you can
suspend monitoring by placing telemetry in Standby mode. Standby suspends
monitoring, and you won’t get any waveforms or alarms.
Note—If you remove the leads before putting a patient into Standby, you’ll get a
LEADS OFF technical alarm, and reminders if configured.
WarningWarning
If you put telemetry in Standby mode, you must remember to turn
monitoring back on when the patient returns to the unit.
Note—When you take an EASI transmitter out of Standby, the lead settings
revert back to the central’s default lead settings (i.e., II and V2).
Task Summary Place a patient in Standby by performing the following steps:
2On the All Controls Window click Telemetry Setup.
3On the Telemetry Setup Window turn the Telemetry button on or off
by clicking in the Telemetry Button Allow Calls checkbox. A
check mark in the checkbox indicates that the Telemetry button is
on.
Step Action
Step Action
1On the Patient Window click the Standby button.
2Select the patient’s location from the pre-defined list.
Use with TeleMon B, Options A02/A03
Introduction to the Philips Telemetry System 1-25
Use with TeleMon B, Options A02/A03
The M2601B Transmitter can employ the full functionality of the TeleMon B
(Options A02 orA03) Companion Monitor, including NBP measurement and
local display of alarms. Connection is made through an interface cable at the
TeleMon/Service port. Please refer to the Philips TeleMon B A02/A03
Companion Monitor Instructions for Use for operating instructions.
Note—Option A02 can be used with either the M2601B transmitter tethered to
the monitor or the M2601A transmitter docked to it. Option A03 can be used
only with the M2601B transmitter tethered to the monitor. (TeleMon B Options
A02/A03 units are distinguished by a gray front bezel; while Option A01 units
have a dark green front bezel.)
Operation
with
TeleMon
When the transmitter is tethered to TeleMon:
• Standby mode is not available.
• 3-minute alarm pause/suspend is available from TeleMon. The alarm
pause indicator on the transmitter will accurately reflect the current state
of alarm pause at TeleMon.
3Click the Suspend Monitoring button. This suspends all monitoring
and displays the following message in the Patient Sector
TELEMETRY STANDBY and the location (for example, X-Ray).
Note—Be sure to take the bed out of Standby before discharging.
Since Standby is associated with the equipment assigned to a bed, if
a patient is discharged and the bed is in Standby mode, that
equipment will be in Standby for the next patient, and monitoring
will continue to be interrupted.
4When the patient comes back, restart monitoring by clicking on
Resume Monitoring in the Patient Sector.
Step Action
Use with TeleMon B, Options A02/A03
1-26 Introduction to the Philips Telemetry System
• After a change in lead set or SpO2 sensor, TeleMon returns to the default
ECG settings. Be sure to check the monitoring leads after you switch
leads or sensor.
• Arrhythmia relearn will occur at TeleMon automatically if the lead set is
changed.
• When the Check button is pressed, the transmitter battery gauge indicates
full regardless of battery state.
• The transmitter receives operating power from TeleMon when tethered/
docked.
Note—Batteries are not being charged when the transmitter is tethered/
docked.
SpO2
Operation
• When the transmitter is connected to TeleMon, SpO2 operation is always
switched to Continuous mode unless SpO2 is turned off.
• TeleMon can also be used to change the SpO2 operating mode when the
transmitter is tethered. See “SpO2Measurement when Connected to
TeleMon” on page 5-18.
Defibrillation In the event of patient defibrillation, it may take several seconds for the ECG
trace to appear on the screen.
Testing the Transmitter Functionality
Introduction to the Philips Telemetry System 1-27
Testing the Transmitter Functionality
There are two tests of the transmitter functionality:
•Self Test - performed automatically each time the transmitter is turned on.
•Status Check - initiated manually by the clinician.
Self Test
WarningWarning
Do not use the transmitter for patient monitoring if it fails the Power On
Self Test.
A self test of the transmitter functions is automatically performed each time that
the transmitter is turned on (that is, batteries are inserted).
In Case of
Failure
If any portion of the self test fails, the transmitter will attempt to report the
failure to the monitoring system. In case of failure, use another transmitter, and
contact your Service Provider.
Self Test Status Auditory Signal (if
configured on) Visual Indicators
Passed Single beep All LEDs illuminate
for 3 seconds
Failed Double beep tone One or more indicators
do not light up.
Testing the Transmitter Functionality
1-28 Introduction to the Philips Telemetry System
Status
Check
You can check the status of the transmitter indicators at any time.
Task Summary To initiate a Status Check, use the following instructions.
Step Action
1Press the
Check button.
2 The following indicators should illuminate for as long as the Check
button is depressed.
• Battery gauge
• Type of lead set
• EASI (if in use)
3 If one or more of the expected indicators do not light up, check the
following:
• Make sure the lead set block is correctly inserted in the
transmitter and the orange line at the base of the cable is not
visible (see “Connecting the ECG Cable” on page 3-14)
• Power and position of batteries (see “Checking the Battery
Power Level” on page 1-32)
• Lead positions and connections (see “Verifying Electrode
Connections” on page 3-17)
4 If there is still a problem, contact your Service Provider for
assistance.
Battery Information
Introduction to the Philips Telemetry System 1-29
Battery Information
Battery
Safety
Information WarningWarning
Use Duracell MN 1500 AA 1.5V Alkaline batteries to ensure specified
performance. Outdated, mismatched, or poor-quality batteries can give
unacceptable performance (e.g., insufficient Battery-Weak warning time).
The use of fresh high-quality alkaline batteries is strongly recommended.
Batteries should be removed from the transmitter at the end of the
battery’s useful life to prevent leakage.
If battery leakage should occur, use caution in removing the batteries. The
leaked substance may cause eye or skin irritation. Avoid contact with skin.
Clean the battery compartment according to instructions in “Chapter 6.
Maintenance and Configuration”. Wash hands.
Certain failure conditions, such as short circuits, can cause a battery to
overheat during normal use. High temperatures can cause burns to the
patient and/or user. If the transmitter becomes hot to the touch, place it
aside until it cools. Then remove the batteries and discard them. Have the
transmitter operation checked by your Service Provider to identify the
cause of overheating.
The battery door must be closed during defibrillation.
If you receive a BATTERY WEAK alarm, the batteries must be promptly
replaced. A "Battery Weak" condition that is not corrected will result in
transmitter shutdown and cessation of monitoring.
Be careful not to short circuit the battery. Short circuiting is caused when a piece
of metal connects both positive and negative terminals together. More than a
momentary short circuit will generally reduce the battery life.
Battery Information
1-30 Introduction to the Philips Telemetry System
Disposal of
Batteries
Caution
The battery must be removed if a transmitter will be stored for an extended
period of time.
Important—When disposing of batteries, follow local laws for proper disposal.
Dispose of batteries in approved containers. If local regulations require you to
recycle batteries, recycle batteries in accordance with regulations.
Battery Life Battery life is dependent upon:
• Condition of the batteries.
• Parameters being monitored - ECG only, ECG and Spot Check SpO2, or
ECG and Continuous SpO2.
By observing the following guidelines, you can optimize battery life in the
Philips transmitter:
• REMOVE THE BATTERIES when the transmitter is not in use.
• If using TeleMon, see the Philips TeleMon B A02/A03 Companion
Monitor Instructions for Use, page 3-7.
Note—Automatic Shutoff of the transmitter does not eliminate battery
usage. In order to allow an automatic turn-on, the transmitter ECG and
SpO2 functions are not completely disabled in this mode.
Note—The Battery Extender for the M2601A Transmitter cannot be used with
the M2601B Transmitter to extend battery life.
Battery Information
Introduction to the Philips Telemetry System 1-31
Inserting/
Removing
Batteries
The battery compartment is located at the bottom of the transmitter and
accommodates a pair of AA 1.5V Alkaline batteries. Only this type of
disposable battery shall be used.
Important—Do not use rechargeable batteries. Use of this type of battery will
adversely affect:
• Battery gauge performance.
• Battery low warnings.
• Battery life performance.
Task Summary Insert batteries into the transmitter using the following procedure.
Step Action
1 Open battery compartment by swinging the compartment door 90o
into an open hinged position.
2 Insert two disposable AA 1.5V Alkaline batteries, matching the
polarity with the +/- indications inside the compartment.
3 Close the battery compartment door.
+
+
Both batteries are inserted with
the + ends in the same direction.
Battery Information
1-32 Introduction to the Philips Telemetry System
Batteries should be changed in sets, that is, if you change one battery, change
them both.
If you remove good batteries to turn off the transmitter, keep them together as a
set for later re-use so that both batteries will have the same level of power
remaining.
Batteries should be removed when the transmitter is not in use or is being stored.
DO NOT STORE BATTERIES BY LEAVING THEM IN THE INCORRECT
POLARITY POSITION INSIDE THE TRANSMITTER.
Be careful not to short circuit the batteries. Short circuits are caused when a
piece of metal touches both the positive and negative terminals simultaneously
(for example, by carrying batteries in a pocket with loose change). More than a
momentary short circuit will generally reduce the battery life. In case of a short
circuit, discard both batteries in a pair, or just the shorted one if the batteries are
new.
Checking
the Battery
Power Level
When the Check button is pressed, the battery gauge on the transmitter indicates
the battery power level.
The approximate battery life remaining indicated by the gauge is given in the
table below. The percentages and times are for ECG operation only.
Note—The battery life times are based on Duracell MN 1500 batteries. Battery
life for other brands may be different.
Battery
Gauge
Approximate
Battery Life
Remaining (ECG
Only)
Approximate
Operating
Time
Remaining
Functionality
4 green
indicators
>75% >30.4 hours
Japanese
version: >33
hours
Normal
operation
3 green
indicators
>50% >20.3 hours
Japanese
version: >22
hours
Normal
operation
Battery Information
Introduction to the Philips Telemetry System 1-33
Task Summary To check the power level, use the following instructions.
2 green
indicators
>25% >10.1 hours
Japanese
version: >11
hours
Normal
operation
1 green
indicator
25% to BATTERY
WEAK level
>15 minutes Normal
operation
1 red indicator BATTERY WEAK
level to REPLACE
BATTERY level
<15 minutes SpO2 disabled
no indicator REPLACE
BATTERY level
(Check batteries for
correct polarity)
Transmitter
shutdown
Battery
Gauge
Approximate
Battery Life
Remaining (ECG
Only)
Approximate
Operating
Time
Remaining
Functionality
Step Action
1 Insert batteries if the transmitter is not already on.
2Press the Check button to determine the level. (See “Checking the
Battery Power Level” on page 1-32.):
3If no indicators flash:
1. Check that the batteries are inserted properly.
2. Replace both batteries.
3. If there are still no indicators on the battery gauge, contact your
Service Provider.
If the indicators illuminate but do not behave as described in
Step 2 above, the transmitter has malfunctioned. Contact your
Service Provider.
Receiver Module
1-34 Introduction to the Philips Telemetry System
Receiver Module
The Philips receiver modules are housed in the receiver mainframe. Each
receiver module is dedicated to a specific transmitter by an internal identity
code. This prevents another patient's waveform from being erroneously
transmitted and displayed. The receiver acquires the ECG and SpO2 signals
from the transmitter and sends them to the receiver mainframe.
Front Cover
Receiver Module
Receiver Mainframe
Receiver Mainframe
Introduction to the Philips Telemetry System 1-35
Receiver Mainframe
The Philips receiver mainframe houses up to eight receiver modules. For each
receiver, the receiver mainframe calculates the heart rate, and sends the
waveform, patient alarms, technical alarms, and status messages over the Philips
patient care system to the IntelliVue Information Center for display and
recording. If SpO2 is available, the transmitter processes the data and sends it to
the IntelliVue Information Center via the network as well.
Turning the
Receiver
Mainframe On
or Off
The receiver mainframe must be turned on for individual transmitters and
receivers to work. To turn the receiver mainframe on, the power cord must be
attached and connected to an AC outlet. A green LED on the rear of the
Mainframe will light then.
If the receiver mainframe is turned off, the light and all receiver modules are off.
Receiver
Mainframe
Malfunction
Light
A red light on the front panel of the mainframe illuminates when either the
mainframe or one of the receivers has malfunctioned. Depending on the
problem, you may see the message, NO DATA FROM BED or RECEIVER
MALF, in single or multiple patient sectors. Contact your Service Provider.
When the mainframe is first turned on, the red light flashes. If no problems are
detected, the flashing stops and the light turns off.
Channel
Frequencies
The frequency of Philips transmitters and receivers are programmable, thus
enabling changes in frequency if interference is detected. In case of interference,
contact service.
Retaining
Telemetry
Settings
If power to the receiver mainframe is interrupted or turned off, settings
controlled by the mainframe such as leads may be affected.
• If the receiver mainframe is turned off for less than three hours, your
settings should still be in effect.
• If the mainframe is turned off for more than three hours, your settings
revert to default, that is, to the configured settings at installation.
Antenna System
1-36 Introduction to the Philips Telemetry System
Antenna System
The telemetry antenna system is custom-designed for your unit to ensure
adequate coverage, therefore the telemetry signal can only be received where
there are receiving antennas. After it is received by the antenna system, it is sent
to the receiver which recovers the patient's ECG and optional SpO2. This
information is then sent to a monitoring display.
Alarms 2-1
Introduction
2
Alarms
This chapter describes alarm behavior and lists Physiologic Alarms (Patient
Alarms) and Technical Alarms (Inoperative Conditions). Both types of alarms
are listed alphabetically.
• Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Pause/Suspend Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Alarm Behavior with Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . 2-3
• Physiologic (Patient) Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
• Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Alarm Indicators
2-2 Alarms
Alarm Indicators
A description of visual and auditory information signals for patient and technical
alarms on the Information Center is located in the IntelliVue Information Center
Instructions for Use and the Online Help. The Information Center
documentation also includes the default alarm settings and physiological alarm
limit ranges.
Pause/Suspend Alarms
All alarms for a patient can be paused/suspended from the Information Center,
or from the TeleMon Companion Monitor, if connected. See the Instructions for
Use for the Information Center or TeleMon for directions.
If connected to TeleMon, alarms can be suspended only from TeleMon, and not
from the Information Center. If alarms are suspended from TeleMon, the Alarms
Suspend icon on the transmitter is lit (see “Transmitter Controls - Front” on page
1-11) and an ALARMS SUSPENDED message appears at TeleMon and the
Information Center.
Alarm Behavior with Own Bed Overview
Alarms 2-3
Alarm Behavior with Own Bed Overview
Both the IntelliVue Patient Monitor and the telemetry system source alarms. The
following tables summarize alarm behavior when Own Bed Overview is used.
For detailed information, see the IntelliVue Patient Monitor Instructions for Use
and the IntelliVue Information Center Instructions for Use.
Alarm Pause/Suspend
When alarms are paused/suspended, the messages and types of alarms affected
depend on where the pause/suspend was initiated.
If alarms are
paused/
suspended
from....
these alarms are
paused/
suspended
and this message appears
Information
Center
both bedside and
telemetry
measurements
Information Center: ALARMS
PAUSED or ALARMS
SUSPENDED
Bedside: ALARMS OFF in
Overview window and ALARMS
PAUSED or ALARMS OFF on the
monitor (depending on
configuration)
IntelliVue
Patient Monitor
bedside
measurements only
Information Center: BED
ALARMS OFF or BED ALARMS
SUSPEND (depending on
configuration)
Bedside: ALARMS PAUSED or
ALARMS OFF
Alarm Behavior with Own Bed Overview
2-4 Alarms
Alarm Silence
When an active alarm is silenced, the types of alarms that are silenced depend on
the alarm source and where the silence was initiated.
Note—If tethered to TeleMon, silencing an active alarm at TeleMon silences the
alarm at TeleMon only. It has no effect on the paired bedside monitor or the
Information Center.
Alarm
Source
Where
Silenced
Effect at
Paired
Bedside
Effect at
Information
Center
Bedside alarm Bedside Alarm is
silenced
Bedside alarm is
silenced. There is
no effect on
telemetry alarms
Telemetry
alarm
Bedside No effect on
telemetry
alarms
No effect on
telemetry alarms
Bedside and/or
telemetry alarm
Overview
Silence Control
Bedside or
telemetry alarm
is silenced
Bedside alarm is
silenced (if
Silence
Overview
Alarms is
configured)
Bedside and/or
telemetry alarm
Information
Center
Bedside or
telemetry alarm
is silenced
Bedside or
telemetry alarm
is silenced
Alarm Behavior with Own Bed Overview
Alarms 2-5
Alarm/INOPs at the Information Center
The alarms and INOPs that are displayed, recorded and stored at the Information
Center depend on the type of alarm.
Type of Alarm/INOP Effect at Information Center
All ECG telemetry alarms and
INOPs
Note—ECG is generated from
telemetry when paired.
Displayed, recorded (if
configured), and stored
Bedside ECG INOPs and RESP
INOPs
Ignored. Not displayed, recorded,
or stored
Bedside non-ECG alarms and
non-ECG INOPs
Displayed, recorded (if
configured), and stored
Physiologic (Patient) Alarms
2-6 Alarms
Physiologic (Patient) Alarms
There are no physiologic (patient) alarm signals generated by the transmitter. All
physiologic alarms are generated at the IntelliVue Information Center, and
all alarm signals must be acknowledged at the Information Center.
Arrhythmia alarm chaining and other aspects of alarm behavior, such as alarm
levels, setting alarm limits, customizing arrhythmia alarm settings on a per
patient basis, switching individual measurement alarms on/off, and reviewing
alarm messages, are described in IntelliVue Information Center Instructions for
Use.
If arrhythmia is turned off at the Information Center, the cardiotach is available
on the telemetry mainframe for the following alarms: Asystole, V-fib, High HR,
Low HR.
There are two levels of arrhythmia analysis available at the Information Center:
Basic and Enhanced. Enhanced analysis includes Basic alarms.
In the table Red (***) alarms are listed alphabetically, followed by the Yellow
(**) alarms, then Yellow (*) arrhythmia alarms.
Note—In Release D.00/D.01/E.00/E.01 of the IntelliVue Information Center,
yellow ST/AR arrhythmia alarms are indicated by (**) rather than (*).
Physiologic (Patient) Alarms
Alarms 2-7
Physiologic (Patient) Alarms
Alarm Text Priority Condition Source
***ASYSTOLE Red Asystole. No QRS for 4
consecutive seconds
ST/AR Basic and
Enhanced
Arrhythmia
Mainframe
cardiotach
*** BRADY yyy <xxx Red Extreme Bradycardia. HR <
extreme Brady HR Limit
ST/AR Enhanced
Arrhythmia
*** EXTREME BRADY Red Extreme Bradycardia. HR <
extreme Brady HR Limit
ST/AR Basic and
Enhanced
Arrhythmia
*** EXTREME TACHY Red Extreme Tachycardia. HR >
extreme Tachy HR Limit
ST/AR Basic and
Enhanced
Arrhythmia
*** TACHY yyy < xxx Red Extreme Tachycardia. HR >
extreme Tachy HR Limit
ST/AR Enhanced
Arrhythmia
*** VFIB Red Ventricular Fibrillation.
Fibrillatory waveform for 4
consecutive seconds
Mainframe
cardiotach
*** V-FIB/TACH Red Ventricular Fibrillation.
Fibrillatory waveform for 4
consecutive seconds
ST/AR Basic and
Enhanced
Arrhythmia
*** V-TACH Red Ventricular Tachycardia.
Sustained run of PVCs
accompanied by a high heart rate
ST/AR Basic and
Enhanced
Arrhythmia
** HIGH HR Yellow High Heart Rate. HR > high HR
Limit
Mainframe
cardiotach
Physiologic (Patient) Alarms
2-8 Alarms
** LOW HR Yellow Low Heart Rate. HR < low HR
Limit
Mainframe
cardiotach
** NURSE CALL Yellow Telemetry button press on the
transmitter (when configured for
Nurse Call operation)
Clinician/patient-
initiated at the
transmitter
** SpO2 yyy > xxx Yellow High SpO2. SpO2 value greater
than high SpO2 Limit
SpO2
** SpO2 yyy < xxx Yellow Low SpO2. SpO2 value less than
low SpO2 Limit
SpO2
* HR yyy > xxx Yellow High Heart Rate. HR > high HR
Limit
ST/AR Enhanced
Arrhythmia
* HR yyy < xxx Yellow Low Heart Rate. HR < low HR
Limit
ST/AR Enhanced
Arrhythmia
* IRREGULAR HR Yellow Irregular Heart Rate. Constantly
irregular HR.
ST/AR Enhanced
Arrhythmia
* LOW HR Yellow Low Heart Rate. HR < low HR
Limit
ST/AR Basic and
Enhanced
Arrhythmia
* MISSED BEAT Yellow Missed Beat. Beat omitted ST/AR Enhanced
Arrhythmia
* MULTI ST Ld X, Ld Y Yellow Multi ST Leads exceeding Limit
(EASI mode or when selected).
Two ST leads (Ld X, Ld Y)
exceed elevation or depression
for > 60 seconds
ST/AR
Arrhythmia
* MULTIFORM PVCs Yellow Multiform PVCs ST/AR Enhanced
Arrhythmia
Physiologic (Patient) Alarms
Alarm Text Priority Condition Source
Physiologic (Patient) Alarms
Alarms 2-9
* NON-SUSTAIN VT Yellow Non-Sustained VT. Non-
Sustained Ventricular
Tachycardia
ST/AR Enhanced
Arrhythmia
* PACER NOT CAPT Yellow Pacer Not Capture. Missed beat
with pace pulse (paced patient).
ST/AR Basic and
Enhanced
Arrhythmia
* PACER NOT PACE Yellow Pacer Not Pacing. Missed beat
without pace pulse (paced
patient).
ST/AR Basic and
Enhanced
Arrhythmia
* PAIR PVCs Yellow Pair of PVCs. ST/AR Enhanced
Arrhythmia
* PAUSE Yellow Pause. No QRS for > x seconds ST/AR Enhanced
Arrhythmia
* PVC > xx/min Yellow PVCs > xx/min. PVCs > Rate
Limit
ST/AR Basic and
Enhanced
Arrhythmia
* R-ON-T PVCs Yellow R-on-T PVCs ST/AR Enhanced
Arrhythmia
* RUN PVCs Yellow Run PVCs. Run of PVCs length
>= 2
ST/AR Enhanced
Arrhythmia
* ST lead > xxx Yellow STx > Elevation limit. ST
segment is elevated
ST/AR
Arrhythmia
* ST lead < xxx Yellow STx < Depression limit. ST
segment is depressed.
ST/AR
Arrhythmia
* SVT Yellow Supra Ventricular Tachycardia.
SVT for > 15 seconds
ST/AR Enhanced
Arrhythmia
Physiologic (Patient) Alarms
Alarm Text Priority Condition Source
Physiologic (Patient) Alarms
2-10 Alarms
* VENT BIGEMINY Yellow Ventricular Bigeminy.
Predominant Bigeminy rhythm
present.
ST/AR Enhanced
Arrhythmia
* VENT RHYTHM Yellow Ventricular Rhythm. Ventricular
rhythm present.
ST/AR Enhanced
Arrhythmia
* VENT TRIGEMINY Yellow Ventricular Trigeminy.
Predominant Trigeminy rhythm
present.
ST/AR Enhanced
Arrhythmia
Physiologic (Patient) Alarms
Alarm Text Priority Condition Source
Technical Alarms (INOPs)
Alarms 2-11
Technical Alarms (INOPs)
Technical Alarms, or INOPs, are sourced at the transmitter or TeleMon
Companion Monitor, and identify inoperative conditions. There are three types
of Technical Alarms. Severe technical alarms must be acknowledged by a
clinician. A Hard technical alarm indicates that monitoring and alarms are
disabled and generates an audible tone at the Information Center. With a Soft
technical alarm, monitoring and alarms remain active, and no audible tone is
generated.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
##nnn/nnn(nnn)nnn
(RF technical alarm)
Soft Used by service in
troubleshooting the radio
signal
Contact Service Provider.
ARRHY REQUIRED Hard Arrhythmia monitoring was
turned off for an EASI
transmitter.
Turn arrhythmia monitoring
on or move lead set to the
Standard ECG position if
arrhythmia monitoring is not
desired.
BATTERY WEAK Soft Weak batteries Replace batteries promptly to
avoid transmitter shutdown
and cessation of monitoring.
CANNOT ANALYZE
ECG
Hard Arrhythmia algorithm
cannot reliably analyze the
ECG data on any
monitored leads.
Assess the lead selections,
initiate relearn, and validate
analyzed rhythm.
Note—See “Optimizing
System Performance” on
page 3-22.
Technical Alarms (INOPs)
2-12 Alarms
CANNOT ANALYZE ST Soft ST algorithm cannot
reliably generate any valid
ST values on any
monitored lead.
Assess the lead selections.
Note—See “Optimizing
System Performance” on
page 3-22.
ECG EQUIP MALF Hard Failure of the ECG
equipment or failure to
calibrate ECG
Replace transmitter or
calibrate ECG with Service
Tool.
INTERFERENCE Hard Interference due to outside
source
Check that there are no
transmitters stored with
batteries inserted.
Change the Philips
transmitter and receiver
frequency.
Contact Service Provider.
INVALID LEADSET Hard Bad lead selection switches
in transmitter
Replace transmitter case.
Use supported lead set.
INVALID SIGNAL E01 Hard Receiver is picking up a
duplicate frequency.
When the transmitter is not
being used, turn telemetry
monitoring off for the bed. If
the situation continues,
contact Service.
If this is a new transmitter,
the system must learn the
new transmitter ID code -
contact Service Provider.
LEADS OFF Hard Single or multiple leads off Reattach ECG leads to
patient.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
Technical Alarms (INOPs)
Alarms 2-13
NO RECEIVER Hard Receiver absent or
malfunctioning
This message appears after
the mainframe is turned on
and indicates the absence of
a receiver or a receiver is
faulty. Contact Service
Provider.
NO SIGNAL Hard Patient is out of range,
radio board has failed, no
batteries in transmitter, or
batteries inserted
incorrectly.
Make sure that the
transmitter is in range. Check
batteries for correct insertion.
Replace transmitter if Power
On Self Test fails, and notify
Service Provider.
RECEIVER MALF Hard Receiver is malfunctioning. Contact Service Provider.
REPLACE BATTERY Hard, Latched
Message
remains until
acknowledged
by clinician.
Batteries are unable to
power the transmitter, or
batteries are inserted
backwards.
No monitoring is occurring.
Replace batteries/check
batteries for correct insertion.
SpO2 EQUIP MALF Hard Malfunction in the SpO2
hardware
SpO2 board needs to be
replaced. Call Service
Provider.
SpO2 ERRATIC Hard Erratic SpO2
measurements, often due to
a faulty sensor or invalid
SpO2 measurements, or
incorrect sensor position
Repeat measurement,
reposition sensor on patient,
or finally, replace sensor.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
Technical Alarms (INOPs)
2-14 Alarms
SpO2 INTERFERENCE Hard Level of ambient light or
level of electrical
interference are so high that
the SpO2 sensor cannot
measure SpO2 and pulse
rate.
Reduce ambient light to
sensor or electrical noise
sources.
Conceal/cover sensor with
opaque non-white cover.
SpO2 NO TRANSDUCER Hard No sensor attached to SpO2
device
Attach SpO2 sensor.
SpO2 NOISY SIGNAL Hard Excessive patient
movements or electrical
interference are causing
irregular pulse patterns
Reduce movement or
electrical noise sources.
SpO2 NON-PULSATILE Hard Pulse is too weak or not
detectable
Check connection to patient.
Change sensor site. Avoid
site distal to BP cuff or intra-
arterial line.
SpO2 TRANS MALF Hard Malfunction of the SpO2
sensor/adapter-cable
Replace sensor.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
Technical Alarms (INOPs)
Alarms 2-15
TEL CANNOT
ANALYZE
Hard INOP Shorts bursts of data
corruption inhibiting an
accurate HR count. (Often
accompanied by WEAK
SIGNAL, NO SIGNAL, or
INTERFERENCE INOPs.)
Check that there are no
transmitters stored with
batteries.
Check to see if the patient is
in the coverage area, and
return patient if needed.
If the patient is in the
coverage area and is
stationary, move the
transmitter or patient about 6
inches (15 cm.).
If the situation persists,
contact Service Provider.
TRANSMITTER MALF Hard Transmitter malfunction Replace transmitter and
notify Service Provider.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
Technical Alarms (INOPs)
2-16 Alarms
TRANSMITTER OFF Soft RF shut off after 10
minutes of leads off
Reattach ECG leads to
patient.
WEAK SIGNAL Soft Weak RF signal received at
Telemetry Mainframe from
transmitter
Move transmitter into RF
coverage area and re-check
transmitter. If condition
exists in close proximity to
the antenna, replace
transmitter.
Check to see if the patient is
in the coverage area, and
return patient if needed.
If the patient is in the
coverage area and is
stationary, move the
transmitter or patient about 6
inches (15 cm.).
If the situation persists,
contact Service Provider.
Technical Alarms (INOPs)
Alarm Text Priority Condition What to do
ECG & ST/AR Measurement 3-1
3
ECG & ST/AR Measurement
This chapter covers the specifics of ECG measurement, as well as arrhythmia
monitoring using the ST/AR algorithm. It includes the following sections:
• Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Setting Up for ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
• Connecting the ECG Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
• Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
• Making ECG Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
• Monitoring During Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
• Optimizing System Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
• ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
• ST/AR Arrhythmia Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
TO TRANSLATORS for geographies where IEC ECG lead sets are used:
Please use the graphics showing IEC electrode colors (see "13 August
graphics IEC.fm").
Also, if needed, change the electrode colors in the text to conform to the
IEC colors.
Note that the graphics and text in this chapter say "V1, V2, V3....." for the
chest lead designations. For IEC please substitute "C2, C2, C3, etc.".
Measuring ECG
3-2 ECG & ST/AR Measurement
Measuring ECG
The electrocardiogram (ECG) measures the electrical activity of the heart and
displays it on the Information Center as a waveform and a numeric.
There is no cardiotach within the transmitter: cardiotach analysis resides in the
telemetry mainframe. The type of ECG analysis depends on whether or not
arrhythmia analysis is on or off at the Information Center.
• When arrhythmia is turned on at the Information Center, the cardiotach is
included as part of arrhythmia analysis in the Information Center for
standard lead placement.
• When arrhythmia is turned off at the Information Center, the cardiotach is
available on the telemetry mainframe.
Note—Arrhythmia analysis must be turned on at the Information Center
when using EASI mode.
ECG Lead
Sets
The M2601B Transmitter supports two different lead sets (see “Connecting the
ECG Cable” on page 3-14). It detects the inserted lead set type and
automatically determines the ECG measurement and transmitted leads. The
Lead Set Insertion Guide on the device will assist you in ensuring the correct
measurement during transmitter usage (see “Connecting the ECG Cable” on
page 3-14). The 5-wire lead set can be used for either Standard or EASI
electrode configurations. The lead sets are compatible with the 5- and 3-wire
lead sets used with the IntelliVue family of monitors.
Important—M2601B Transmitter lead sets are not compatible with M2601A
Transmitters.
The electrode placements for the illustrations in this chapter use the AAMI
labels and colors. 5-wire lead sets are available with the lead-wire color option.
The following table lists the AAMI and IEC electrode locations and colors.
Measuring ECG
ECG & ST/AR Measurement 3-3
Electrode Locations and Colors
Lead Set Type Electrode
Location
AAMI
Electrode
Color
IEC Electrode
Color
3-wire LA
RA
LL
Black
White
Red
Yellow
Red
Green
5-wire
(in Standard Mode) LA
RA
LL
RL
V
Black
White
Red
Green
Brown
Yellow
Red
Green
Black
White
(in EASI Mode) S
I
A
N
E
Black
White
Red
Green
Brown
Yellow
Red
Green
Black
White
Measuring ECG
3-4 ECG & ST/AR Measurement
ECG Leads
Monitored
Depending on the lead set connected to the transmitter, a different set of
viewable leads are available at the Information Center. The transmitter can
source up to four raw ECG waves. The transmitter automatically recognizes the
lead set connected.
If you are using ... these leads are available
3-wire If Lead Select is configured off:
• Default is II.
• To monitor a different lead, change the
electrode placement to the lead you want. Then,
at the Information Center, select the lead label
that reflects the electrode placement.
• Choices are I, II, or III.
Note—The raw ECG is received on
Channel 1 as II.
If Lead Select is configured on:
• Default is II.
• If tethered to TeleMon, you can select a
different lead at TeleMon without moving the
electrodes. Choices are I, II, or III.
Note—The raw ECG is received on
Channel 1 as I, II, or III, depending on which
lead is selected.
Measuring ECG
ECG & ST/AR Measurement 3-5
5-wire (Standard Mode) I, II, III, aVR, aVL, aVF, MCL, and V
Defaults are II, V, III
In Standard mode, the raw ECG waves are
received as:
• Channel 1 = Lead II
• Channel 2 = Lead III
• Channel 3 = Lead MCL
Lead selection is available at the Information
Center.
Important—Do not set the primary and secondary
channels to the same lead.
5-wire (EASI Mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
EASI 12-lead selection is available at the
Information Center.
In EASI mode, the sourced waves are received as:
• Channel 1 = Vector 1 (A-I)
• Channel 2 = Vector 2 (A-S)
• Channel 3 = Vector 3 (E-S)
Although you can view and perform ST analysis
on all 12 EASI derived leads, arrhythmia
monitoring is performed only on the primary and
secondary leads selected at the Information Center.
If you are using ... these leads are available
Measuring ECG
3-6 ECG & ST/AR Measurement
Reconstructed
Leads
Reconstruction of 3 and 5 leads from the sourced wave is defined by the
calculations in the following table. EASI reconstructed leads are a linear
combination of all three raw EASI leads. Default labels/leads are shown in bold.
ECG Lead Reconstruction
ECG Lead Clinical Calculations
in terms of electrodes3-wire 5-wire
Standard
IILA-RA
II II LL-RA
III III LL-LA
-MCL Va-LA, C=Va
-aVR RA-(LA+LL)/2
-aVL LA-(RA+LL)/2
-aVF LL-(LA+RA)/2
-VC-(RA+LA+LL)/3, C=Va
Setting Up for ECG Monitoring
ECG & ST/AR Measurement 3-7
Setting Up for ECG Monitoring
Task Summary
Step Action
1 Prepare the patient’s skin. Good electrode-to-skin contact is
important for a good ECG signal, as the skin is a poor conductor of
electricity.
• Select sites with intact skin, without impairment of any kind.
• Clip or shave hair from site, as necessary
• Wash site with soap and water, leaving no soap residue.
Note—Philips does not recommend using ether or pure
alcohol, because they dry the skin and increase the resistance.
• Dry thoroughly.
• Use ECG skin preparation paper (abrasive) to remove dead
skin cells and to improve the conductivity of the electrode
site.
2 Check electrodes for moist gel, and attach to the clips/grabbers. If
you are not using pre-gelled electrodes, apply electrode gel to the
electrodes before placement.
Note—Gel must be moist to provide a good signal.
3 Place the electrodes on the patient according to the lead placement
you have chosen (see “Electrode Placement” on page 3-8). Place the
edge down, then "roll down" the rest of the pad. Press firmly around
the adhesive edge toward the center.
Note—When placing electrodes, choose a flat, non-muscular site
where the signal will not be interfered with by either movement or
bones. Correct lead placement is always important for accurate
measurement, especially in the precordial leads, which are close to
the heart. QRS morphology can be greatly altered if an electrode is
moved away from its correct location.
Setting Up for ECG Monitoring
3-8 ECG & ST/AR Measurement
Positioning
ECG
Electrodes WarningWarning
Do not mix and match electrodes of different types. In particular, do not use
electrodes of dissimilar metals. This helps ensure optimal signal quality.
WarningWarning
When you are connecting the electrodes or the patient cable, make sure that
the connectors never come into contact with other conductive parts, or with
earth. In particular, make sure that all of the ECG electrodes are attached
to the patient, to prevent them from contacting conductive parts or earth.
This helps maintain maximum electrical patient safety.
WarningWarning
Non-manufacturer supplied accessories and supplies can corrupt the
performance of the equipment. Use only AAMI EC-12 compliant electrodes
with this device. Use of electrodes that are non-compliant may provide
erroneous results.
Caution
To protect the transmitter from damage during defibrillation, to ensure accurate
ECG information, and to provide protection against signal noise and other
interference, use only ECG electrodes and cables specified by Philips.
Electrode
Placement
Diagrams for Standard 5-wire and EASI electrode placement are located on the
back of the transmitter. Additional lead placement information is available in the
Online Help in the IntelliVue Information Center.
Philips recommends that electrodes be changed every 24 hours.
Setting Up for ECG Monitoring
ECG & ST/AR Measurement 3-9
Locating the
Fourth
Intercostal
Space
For accurate chest electrode placement and measurement, it is important to first
locate the fourth intercostal space. This can be done using the Angle of Lewis.
1. Locate the second intercostal space by first palpating the Angle of Lewis
(the bony protuberance where the body of the sternum joins the
manubrium). This rise in the sternum is where the second rib is attached,
and the space just below this is the second intercostal space.
2. Palpate and count down the chest until you locate the fourth intercostal
space.
Angle of Lewis
Setting Up for ECG Monitoring
3-10 ECG & ST/AR Measurement
5-wire
Placement
(Standard
Mode)
Lead Placement
RA directly below the clavicle and near the right
shoulder
LA directly below the clavicle and near the left
shoulder
RL on the right lower abdomen
LL on the left lower abdomen
V on the chest, the position depends on your
required lead selection. The default position is V2.
V1 on the fourth intercostal space at the right sternal
border
V2
V3
V4 V5 V6
V1
Setting Up for ECG Monitoring
ECG & ST/AR Measurement 3-11
V2 on the fourth intercostal space at the left sternal
border
V3 midway between the V2 and V4 electrode
positions
V4 on the fifth intercostal space at the left
midclavicular line
V5 on the left anterior axillary line, horizontal with
the V4 electrode position
V6 on the left anterior axillary line, horizontal with
the V4 electrode position
Lead Placement
Setting Up for ECG Monitoring
3-12 ECG & ST/AR Measurement
5-wire
Placement
(EASI Mode) WarningWarning
EASI derived 12-lead ECGs and their measurements are approximations to
conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not
exactly identical to the 12-lead conventional ECG obtained from an
electrocardiograph, it should not be used for diagnostic interpretations.
EASI lead placement is supported for adult patients only
Lead Corresponds to
Standard Lead Placement
E V on the lower sternum at the level of
the fifth intercostal space
A LL on the left midaxillary line at the
same level as the E electrode
S LA on the upper sternum
I RA on the right midaxillary line at the
same level as the E electrode
N Reference can be anywhere, usually below the
sixth rib on the right hip
IA
E
S
N
Setting Up for ECG Monitoring
ECG & ST/AR Measurement 3-13
3-wire
Placement
Lead Placement
RA directly below the clavicle and near the right
shoulder
LA directly below the clavicle and near the left
shoulder
LL on the left lower abdomen
Connecting the ECG Cable
3-14 ECG & ST/AR Measurement
Connecting the ECG Cable
Task Summary Note—Your transmitters may have alignment guides that assist lead set
insertion.
Step Action
1 Match the arrow on the ECG cable with the arrow on the Lead Set
Insertion Guide according to the lead type you have chosen, and
insert the ECG cable into transmitter.
Important—Make sure that the cable is pushed completely into
the transmitter. When correctly inserted, the orange line at the
base of the cable is not visible.
3-wire:
Match the arrow on the
cable with the left arrow
(labeled EASI, 3) on the
Lead Set Insertion Guide.
EASI, 3
5
M2601B
Orange
line
Connecting the ECG Cable
ECG & ST/AR Measurement 3-15
5-wire
Note—If you are using the 5-wire lead set in both Standard and
EASI modes, insert the protective plug into the open lead port with
the wide lip facing the leads. Then, press down firmly so that the
plug is securely under the lead set and the orange line is not visible.
Standard Mode:
EASI Mode:
Step Action
Match the arrow on the
cable with the right arrow
(labeled 5) on the Lead
Set Insertion Guide.
EASI, 3
5
M2601B
Orange
line
Match the arrow on the
cable with the left arrow
(labeled EASI, 3) on the
Lead Set Insertion Guide.
EASI, 3
5
M2601B
Orange
line
Connecting the ECG Cable
3-16 ECG & ST/AR Measurement
Cable
Disconnection
When disconnecting the lead set from the transmitter, grasp the lead block
firmly and pull free. Do not pull on the lead wires.
2 Check that the correct lead indicators are lit for the lead set you are
using, and that the EASI indicator light is illuminated appropriately.
See “Verifying Electrode Connections” on page 3-17.
Important—When using 5-wire Standard, note that the EASI
indicator does not illuminate.
When using EASI, the EASI indicator should illuminate for 5
seconds after the lead set is inserted (as well as when the Check
button is pressed).
Step Action
Verifying Electrode Connections
ECG & ST/AR Measurement 3-17
Verifying Electrode Connections
The electrode indicator LEDs (Light Emitting Diodes) enable you to verify that
the leads are available for the desired monitoring. Each electrode is color-coded.
Pressing and holding the Check button enables you to view the lead set status.
During routine use of the transmitter for monitoring, all LEDs are off.
Task Summary To verify electrode connections, use the following procedure:
Step Action
1 Press and hold the Check button for 2 seconds
2Expected Response:
• If 3-wire cable is attached: Red, White and Black LEDs
illuminate, then all turn off.
• If 5-wire cable in Standard mode is attached: Red, White,
Black, Green & Brown LEDs illuminate, then all turn off.
• If using EASI: Red, White, Black, Green & Brown LEDs
illuminate, then all turn off. The EASI indicator also
illuminates briefly.
• If no lead set is attached: all LEDs are off.
3Unexpected Response:
Any other response indicates a problem. Check the lead block
connection and/or use a new lead set. If the problem is not
corrected, contact your Service Provider.
Making ECG Adjustments
3-18 ECG & ST/AR Measurement
During routine monitoring, the electrode indicators also notify you if one or
more leads are not functioning. When a LEADS OFF condition occurs, the
transmitter automatically illuminates the indicator corresponding to the missing
lead.
Making ECG Adjustments
You can make the following adjustments from the IntelliVue Information
Center:
• Change the lead or the lead label.
• Change the wave size.
With 5-wire lead sets, you can monitor two leads. With a 3-wire lead set you can
monitor one lead. When monitoring two leads, the first lead is the primary lead.
Singlelead arrhythmia analysis uses this lead. It is also the lead used for alarm
and delayed recordings. Multilead analysis uses both leads.
If you are not receiving a good ECG wave and the electrodes are securely
attached, you should try changing the lead in which you are monitoring.
Bandwidth Bandwidth is not user adjustable, but is assigned automatically by the
Information Center. The settings are:
Changing
Lead/Label
To change the lead/label place your cursor over the wave in the Patient Window.
• For a 3-wire lead set, apply the electrodes to monitor the lead you want
and select the label from the pop-up box to match the placement.
Setting Bandwidth
ST off Monitor (0.5 to 40 Hz)
ST on ST (0.05 to 40 Hz)
Monitoring During Leads Off
ECG & ST/AR Measurement 3-19
Note—If the TeleMon Companion Monitor is available, you can change
the lead on a 3-wire lead set (if configured for Lead Select). See “ECG
Leads Monitored” on page 3-4.
• For a 5-wire lead set, you can change the lead without moving the
electrodes.
Adjusting
Wave Size
To change the amplitude of the ECG wave on the display or for recordings,
place your cursor over the wave in the Patient Window and select the size you
want from the pop-up box. There are five sizes available: 1/4 (smallest), 1/2, 1,
2, and 4 (largest).
You can use the 1 mV cal bar on the Patient Window to check the height of the
R-wave. If the wave is not at least 0.5 mV high (one-half the size of the cal bar),
change the lead.
Monitoring During Leads Off
ECG Fallback and Extended Monitoring occur when the primary and/or
secondary leads are in a Leads Off condition for >10 seconds. The system
performs this action in an attempt to maintaining monitoring and arrhythmia
analysis.
Lead Fallback is used if the primary or secondary lead is available. Extended
Monitoring is used if neither is available.
Lead
Fallback
Lead Fallback is configured on or off by your Service Provider.
0.5 mV
1 mV
Monitoring During Leads Off
3-20 ECG & ST/AR Measurement
Multilead
Analysis
If the system is using multilead analysis, the active secondary lead becomes the
primary lead, and the arrhythmia algorithm switches the leads on the display.
When the Leads Off condition is corrected, the leads are switched back to their
original state. Arrhythmia Relearn does not occur.
Singlelead
Analysis
For singlelead analysis, if there are two leads available, the other lead is made
the primary lead until the Leads Off condition is corrected. The arrhythmia
algorithm performs a Relearn.
Fallback for
EASI
If one of the derived EASI leads is in a technical alarm condition, a flat line is
displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead,
depending on which is available, is displayed with the label "ECG" and is
analyzed by the arrhythmia algorithm. Arrhythmia Relearn occurs with
transition to/from EASI Lead Fallback.
Extended
Monitoring
When both the primary and secondary leads have a Leads Off condition, if
another lead is available it becomes the primary lead and the system does a
Relearn. This is called Extended Monitoring.
Extended Monitoring applies if:
• Telemetry is configured for Extended Monitoring ON.
• The lead set provides more than two leads (i.e., when using a 5-wire lead
set).
Relearning Whenever there is a Leads Off condition, the arrhythmia algorithm performs a
Relearn, using the available leads.
WarningWarning
Since Relearn happens automatically, if learning takes place during
ventricular rhythm, the ectopics can be incorrectly learned as the normal
QRS complex. This can result in missed detection of subsequent events of
V-Tach and V-Fib. For this reason, you should:
1. Respond promptly to any technical alarm.
2. Ensure that the arrhythmia algorithm is labeling beats correctly.
Monitoring During Leads Off
ECG & ST/AR Measurement 3-21
Using EASI Leads to Troubleshoot
If there is artifact in the ECG waves or a CANNOT ANALYZE ECG technical
alarm condition, you can use the three EASI leads to troubleshoot:
1. Click 12-Lead ECG on the Patient Window, then on 3 EASI Leads.
2. The three directly acquired EASI leads will be displayed so that you can
determine which electrodes are causing the problem and need to be
replaced.
Optimizing System Performance
3-22 ECG & ST/AR Measurement
Optimizing System Performance
While telemetry monitoring offers many advantages, it can be a challenge. The
reliability and quality of the signal transmission through the air and hospital
walls is governed by a number of variables which can be difficult to control. A
telemetry system cannot be as dependable as a hardwired bedside monitor that
transmits its signal through a wire.
The effect of interference on the telemetry system ranges from a momentary loss
of ECG to complete inoperability, depending on the situation. The strength,
frequency, and proximity of the source of interference to transmitters or the
antenna system are factors that determine the degree of severity. In cases where
the source of interference is known - for example, cellular phones, magnetic
equipment such as MRI, other radio or motorized equipment - removing or
moving away from the source of interference will increase the system's
dependability.
WarningWarning
The Philips Telemetry System should not be used for primary monitoring
in applications where the momentary loss of the ECG is unacceptable.
In this section, we'll investigate some of the problems affecting ECG signal
clarity and when possible, show you how you can greatly enhance performance.
Note—The Philips Telemetry System also emits radio frequencies (defined in
Chapter 7, “System Safety and Specifications”) that may affect the operation of
other devices. Contact the manufacturer of other equipment for possible
susceptibility to these frequencies.
The
Telemetry
Signal
The transmitter worn by the patient acquires the patient's physiological data,
amplifies and digitizes it, detects pace pulses and broadcasts this information via
radio waves to the antenna system. Since the signal passes through the air, it is
susceptible to interference from many sources.
Optimizing System Performance
ECG & ST/AR Measurement 3-23
Troubleshooting Signal Disturbance
Dropouts Because the telemetry system is a wireless system, under certain conditions RF
“dropouts” can occur. Dropouts result from a weak signal or RF interference.
There will be signal drops to the bottom of channel for a minimum of 200 ms to
indicate to the clinical user that it is a non-physiological event. If dropouts are
frequent enough to affect the heart rate count, the TEL CANNOT ANALYZE,
as well as CANNOT ANALYZE ECG or CANNOT ANALYZE ST technical
alarms occur.
The following recording strip is an example of dropouts.
If frequent dropouts are occurring, the following section describes some steps
you can take to improve performance.
Signal
Strength
The antenna system is custom designed for your unit, so reliable signal reception
is only possible where there are receiving antennas. When the signal is too low,
the following technical alarms occur:
• TEL CANNOT ANALYZE
• CANNOT ANALYZE ECG
• CANNOT ANALYZE ST
• WEAK SIGNAL
• NO SIGNAL
To correct, first check the location of the patient. If not in the coverage area, do
one of the following.
• Return the patient to the specified antenna coverage area.
• Put telemetry in Standby mode. See “Standby Mode” on page 1-24.
Optimizing System Performance
3-24 ECG & ST/AR Measurement
WarningWarning
If you put telemetry in Standby mode, you must remember to turn
monitoring back on when the patient returns to the unit.
• If the patient is in the coverage area and is stationary, try moving the
location of the transmitter or patient about 6 inches (15 cm.).
Radio
Frequency
Interference
Radio frequency (RF) interference is caused by anything that intrudes into the
transmitted electrical signal, such as paging transmitters. We are all familiar
with electrical interference in our homes and cars when it causes signal loss or
static on a cell phone. These same types of interference can occur with the
transmitted telemetry signal. Even though the Philips Telemetry System is
designed to resist these effects, interference can occasionally be seen in the form
of "dropouts”. To improve performance, the source of the interference must be
identified and eliminated.
Muscle and
Movement
Artifact
Muscle and movement artifact differ from radio frequency interference since
you can prevent much of the occurrence. Noise on the ECG signal can be caused
by many sources, such as interference from other electrical equipment, muscle
artifact and respiration variation. It is up to the clinician to use certain
techniques to minimize these types of noise.
Optimizing System Performance
ECG & ST/AR Measurement 3-25
Use the following table to help you troubleshoot the most common sources of
ECG noise.
Problem Cause Remedy
60-Cycle (AC) Interference Poor electrode placement.
Possible non-grounded
instrument near patient.
Re-apply electrodes
Disconnect electrical appliances near
patient (one at a time) by pulling wall
plugs, to determine faulty grounding.
Have engineering check grounding.
Muscle Artifact Tense, uncomfortable
patient.
Poor electrode placement.
Tremors.
Diaphoresis.
Make sure patient is comfortable.
Check that electrodes are applied on flat
non-muscular areas of the torso; re-apply
the electrodes if necessary, using good
skin preparation (see “Setting Up for ECG
Monitoring” on page 3-7).
Irregular Baseline Poor electrical contact.
Respiratory interference.
Faulty electrodes.
Dry electrodes.
Re-apply electrodes, using good skin
preparation (see “Setting Up for ECG
Monitoring” on page 3-7).
Move electrodes away from areas with
greatest movement during respiration.
Optimizing System Performance
3-26 ECG & ST/AR Measurement
Baseline Wander Movement of patient.
Improperly applied
electrodes.
Respiratory interference.
Make sure patient is comfortable.
Re-apply electrodes, using good skin
preparation (see “Setting Up for ECG
Monitoring” on page 3-7). Check that
patient cable is not pulling electrodes.
Move electrodes away from areas with
greatest movement during respiration.
Poor Electrode Contact Loose electrodes.
Defective cables.
Lead set not firmly
connected.
Change electrodes, using good skin
preparation (see “Setting Up for ECG
Monitoring” on page 3-7).
Replace cables.
Problem Cause Remedy
ECG Safety Information
ECG & ST/AR Measurement 3-27
ECG Safety Information
WarningWarning
FOR ALL PATIENTS
Always confirm Information Center observations with clinical observation
of the patient before administering interventions.
Every lead should be secured to an electrode on the patient.
Conductive parts of electrodes should not contact earth or other conductive
parts.
Philips recommends that you change the lead label only to reflect the
physical placement of electrodes. This will ensure a match between the
monitored lead and the label, and prevent any possible confusion.
When switching from EASI to Standard monitoring, there is a loss of data
for 30 seconds.
ST/AR Arrhythmia Analysis
3-28 ECG & ST/AR Measurement
WarningWarning
FOR PACED PATIENTS
The output power of the transmitter and other sources of radio frequency
energy, when used in the proximity of a pacemaker, can be sufficient to
interfere with pacemaker performance. Due to the shielding effects of the
body, internal pacemakers are somewhat less vulnerable than external
pacemakers. However, caution should be exercised when monitoring any
paced patient.
In order to minimize the possibility of interference, position electrodes,
electrode wires, and the transmitter as far away from the pacemaker as
possible.
Consult the pacemaker manufacturer for information on the RF
susceptibility of their products and the use of their products with the
Philips Telemetry System. See the IntelliVue Information Center
Instructions for Use for additional information on monitoring paced
patients.
ST/AR Arrhythmia Analysis
For information on arrhythmia detection and ST monitoring, refer to the
following:
• IntelliVue Information Center Instructions for Use and Online Help
•ST/AR Algorithm - Arrhythmia Monitoring Application Note (4522 981
93051).
•ST/AR Algorithm - ST Segment Monitoring Application Note (4522 981
92851).
The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor
the patient’s ECG for heart rate and ventricular arrhythmias and to produce
events/alarms simultaneously for one or more ECG leads. The arrhythmia
ST/AR Arrhythmia Analysis
ECG & ST/AR Measurement 3-29
algorithm is effective when monitoring both paced and non-paced patients in a
clinical environment.
ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the
conditions listed in the table below. There are two levels: Basic and Enhanced.
Enhanced includes the Basic alarms. See “Physiologic (Patient) Alarms” on
page 2-6 for arrhythmia alarm text and descriptions.
Basic & Enhanced Arrhythmia Detection
Basic Arrhythmia
Detection Enhanced Arrhythmia Detection
Asystole Tachy yyy > xxx Vent Bigeminy
V Fib/Tach Brady yyy < xxx Vent Trigeminy
V Tach Non-Sustain VT Multiform PVCs
Extreme Brady Vent Rhythm HR yyy > xxx
Extreme Tachy Run PVCs HR yyy < xxx
High HR Pair PVCs Irregular HR
Low HR Pause
PVCs > xx/min Missed Beat
Pacer Not Capturing SVT
Pacer Not Pacing R-on-T PVCs
ST/AR Arrhythmia Analysis
3-30 ECG & ST/AR Measurement
Beat classification determined by the ST/AR algorithm is shown on the primary
delayed wave in Arrhythmia Analysis at the Information Center. To access the
waves with beat annotations, select Arrhythmia Analysis from the Patient
Window.
The annotation requires clinical validation of the analyzed heart rhythm. If the
analysis is inaccurate, perform a Relearn of the rhythm.
When monitoring is initiated, when the Channel 1 lead is changed, or if Relearn
is selected, a question mark (?) is displayed next to HR and the annotation “L”
appears on the annotated wave until the HR is calculated and the rhythm is
learned.
ECG and ST/
AR Alarms
See Chapter 2, “Alarms” for a list of all ECG and arrhythmia alarms.
Annotation Beat Classification Color
A
I
L
M
N
P
S
V
?
‘
Artifact
Inoperative
Learning
Missed Beat
Normal
Paced Beat
Supraventricular Premature
Ventricular Premature
Questionable
Pacer Mark
Blue
Red
Red
Red
Blue
Blue
Blue
Red
Red
Blue
ST/AR Arrhythmia Analysis
ECG & ST/AR Measurement 3-31
ST/AR
Arrhythmia
Safety
Information WarningWarning
FOR ALL PATIENTS
During complete heart block or pacemaker failure (to pace or capture), tall
P-waves (greater than 1/5 of the average R-wave height) can be erroneously
counted by the arrhythmia algorithm, resulting in missed detection of
cardiac arrest.
Learning/Relearning
--If you initiate learning during ventricular rhythm, the ectopics can be
incorrectly learned as the normal QRS complex. This can result in missed
detection of subsequent events of V-Tach and V-Fib.
--When using EASI ECG monitoring, Relearn happens automatically when
there is a LEADS OFF technical alarm. If learning takes place during
ventricular rhythm, the ectopics can be incorrectly learned as the normal
QRS complex. This can result in missed detection of subsequent events of
V-Tach and V-Fib. Be sure to check the beat labels and initiate a Relearn to
correct.
1. Respond to the technical alarm [for example, reconnect the electrode(s)].
2. Ensure that the arrhythmia algorithm is labeling beats correctly.
ST/AR Arrhythmia Analysis
3-32 ECG & ST/AR Measurement
WarningWarning
FOR PACED PATIENTS
It is possible that pacemaker pulses will not be detected when the ECG
analog output of a defibrillator or telemetry unit is plugged into a bedside
monitor. This can result in the arrhythmia algorithm’s failure to detect
pacemaker non-capture or asystole.
Some pace pulses can be difficult to reject. When this happens, the pulses
are counted as a QRS complex, and could result in an incorrect HR and
failure to detect cardiac arrest or some arrhythmias. Keep pacemaker
patients under close observation.
--During complete heart block or pacemaker failure (to pace or capture),
tall P-waves (greater than 1/5 of the average R-wave height) can be
erroneously counted by the arrhythmia algorithm, resulting in missed
detection of cardiac arrest.
--When arrhythmia monitoring paced patients who exhibit only intrinsic
rhythm, the monitor can erroneously count pace pulses as QRS complexes
when the algorithm first encounters them, resulting in missed detection of
cardiac arrest.
For patients who exhibit intrinsic rhythm only, the risk of missing cardiac
arrest can be reduced by monitoring these patients with the low heart rate
limit at or slightly above the basic/demand pacemaker rate. A low heart
rate alarm alarms you when the patient begins pacing. Proper detection
and classification of the paced rhythm can then be determined.
--When an external pacemaker is being used on a patient, arrhythmia
monitoring is severely compromised due to the high energy level in the
pacer pulse. This can result in the arrhythmia algorithm’s failure to detect
pacemaker non-capture or asystole.
ST/AR ST Segment Monitoring 4-1
Introduction
4
ST/AR ST Segment Monitoring
This chapter describes the ST/AR ST algorithm for telemetry of the IntelliVue
Information Center. It includes the following sections:
• ST/AR ST Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
• Adjusting Measurement Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
• Establishing ST Reference Beats (Baseline) . . . . . . . . . . . . . . . . . . . . 4-7
• Turning ST On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
• ST Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
ST/AR ST Algorithm
4-2 ST/AR ST Segment Monitoring
ST/AR ST Algorithm
Intended
Use
The intended use of the ST/AR ST algorithm for the IntelliVue Information
Center is to monitor ST segment elevation or depression for each available
telemetry ECG lead and produce events/alarms simultaneously. ST values
update with every measurement period and enunciate, depending upon the
severity of the change, events and alarms as they are detected.
Patient
Population
You can perform ST analysis on both non-paced and atrially paced patients. The
ST/AR ST algorithm is approved only for adult telemetry-monitored patients.
With EASI monitoring, ST analysis is performed on up to 12 leads.
Note—Studies have validated the maximal EASI derived ST measurements on
male and female patients with ages from 33 to 82, heights 147 to 185 cm (58 to
73 in), weights 53 to 118 kg (117 to 261 lb) and height-to-weight ratios of 1.41
to 2.99 cm/kg (0.25 to 0.54 in/lb).
ST/AR ST Algorithm
ST/AR ST Segment Monitoring 4-3
The
Measurement
The ST measurement for each beat complex is the vertical difference between
two measurement points. The isoelectric point provides the baseline for the
measurement and the ST point provides the other measurement point. It is
positioned with reference to the J point.
WarningWarning
This device provides ST level change information; the clinical significance
of the ST level change information should be determined by a physician.
R-WAVE PEAK
AT 0 MSEC
J POINT
ISO ELECTRIC
POINT
DEFAULT =
-80 MSEC
MEASUREMENT
POINT
DEFAULT =
J+60 MSEC
DIFFERENCE =
ST VALUE
P
Q
S
ST
T
ST/AR ST Algorithm
4-4 ST/AR ST Segment Monitoring
How the
Algorithm
Works
When ST analysis is being performed on two leads, the averaged derived and
reconstructed ST waves and associated ST segment values are given for up to
six leads, depending on the type of patient cable:
• 3-wire: one lead
• 5-wire: up to two leads if monitoring a chest and a limb lead
• 5-wire: up to six leads if monitoring two limb leads with the Philips
transmitter (without EASI monitoring)
• 5- wire: up to 12 leads if monitoring using EASI
Note—No ST analysis is done on a patient if an electrode falls off.
ST analysis uses the ST/AR arrhythmia beat classification to select only normal
and atrially paced beats for its analysis.
The ST/AR ST algorithm processing includes special ST filtering, beat selection
and statistical analysis, calculation of ST segment elevations and depressions,
and lead reconstruction and wave generation.
Displayed
ST Data
ST data displays as values in the Patient Sector and Patient Window. A positive
value indicates ST segment elevation; a negative value indicates depression.
You can view ST data in ST Review, Trend Review, and Event Review
windows.
EASI ST
Analysis
ST/AR ST analysis for EASI derived transmitters is done on all 12 leads. The
value presented in the patient sector and Patient Window is “STindx”. STindx is
a summation of three ST segment measurements, using the leads that can
indicate ST segment changes in the different locations of the heart:
• anterior lead V2
• lateral lead V5
• inferior lead aVF
Caution
Be sure not to duplicate the lead labels. This can result in incorrect ST values
being displayed for those leads.
Adjusting Measurement Points
ST/AR ST Segment Monitoring 4-5
Adjusting Measurement Points
The ST Setup Window allows you to adjust the ST measurement points to
ensure accurate data.
There are three measurement cursors:
• The ISO measurement cursor positions the isoelectric point in relation to
the R-wave peak.
• The J-point cursor positions the J point in relation to the R-wave peak.
The purpose of the J point is to correctly position the ST measurement
point.
• The ST measurement cursor positions the ST point a fixed distance from
the J point.
Note—The ST measurement points may need to be adjusted if the patient's heart
rate or ECG morphology changes significantly.
Task Summary Perform the following steps to adjust the ST measurement points:
Step Action
1Access the ST Setup window by clicking on the All Controls button
in the Patient Window then clicking on the ST Setup button.
2If you need to adjust the ISO (isoelectric) point, place the cursor
over the ISO button to access the adjustment arrows. Then use the
arrows to position the bar in the middle of the flattest part of the
baseline (between the P and Q waves or in front of the P wave).
T
R
P
ISO
point QS
Adjusting Measurement Points
4-6 ST/AR ST Segment Monitoring
3Adjust the J point, if necessary, by placing the cursor over the J-
point button to access the adjustment arrows. Then use the arrows to
position the bar at the end of the QRS complex and the beginning of
the ST segment.
4Adjust the ST point, if necessary, by using the J point as an
“anchor” and place the bar at the midpoint of the ST segment.
Choices are J + 0, J + 20, J + 40, J + 60, or J + 80).
Step Action
T
R
P
S
QJ point
T
R
P
S
QST point
Establishing ST Reference Beats (Baseline)
ST/AR ST Segment Monitoring 4-7
Establishing ST Reference Beats (Baseline)
After adjusting the measurement points, you can establish baseline reference
beats for all available leads in the ST Review window at the IntelliVue
Information Center. Reference beats enable you to compare waveform changes,
for example from admission, or prior to or after treatment. The reference
continues to be saved beyond the 24 hour review window, but you can update it
to any beat within the last 24 hours. Please refer to the IntelliVue Information
Center Instructions for Use or Online Help for directions.
Turning ST On/Off
The ST Setup Window allows you to turn ST monitoring on/off for all available
ECG leads. You would turn ST monitoring off if:
• You are unable to get any lead that is not noisy.
• Arrhythmias such as atrial fib/flutter cause irregular baseline.
• The patient is continuously ventricularly paced.
• The patient has left bundle branch block.
Task Summary To turn ST monitoring on/off perform the following steps:
Step Action
1Access the ST Setup Window by clicking the All Controls button on
the Patient Window then clicking the ST Setup button.
2If you want to turn all ST monitoring on/off click ST On.
ST Alarms
4-8 ST/AR ST Segment Monitoring
ST Alarms
All IntelliVue Information Center alarm settings (limits and on/off status) have
unit default settings. The Information Center however, lets you set the high and
low ST alarm limits for individual patients based on:
• Your assessment of the patient's clinical condition.
• Unit protocols.
• Physician orders or medication specified limits.
You can make the following adjustments to ST alarm limits to accommodate the
clinical condition of individual patients:
• Turn all alarms off/on.
• Adjust the alarm limits:
– to specific high and low limits.
– to Smart Limits (see the IntelliVue Information Center Instructions
for Use for information on Smart Limits).
– back to unit default settings.
You adjust the ST alarm limits in the ST Alarms Window. Each ST parameter
has its own alarm limit. The alarm is triggered when the ST value exceeds its
alarm limit for more than 1 minute. The alarm will be a yellow alarm.
When more than one ST parameter is in alarm, only one alarm message displays.
For multilead alarms when using an EASI transmitter, an alarm is generated if
two or more ST leads exceed the alarm limits. The default setting is +/-1.0. The
alarm message indicates the two leads that are in greatest violation of the limits,
for example, “**MULTI ST AVR, V6”. If another lead becomes deviant, the
message changes but it is considered the same alarm (no new alarm sounds and
it is not listed as a new event).
See Chapter 2, “Alarms” for a list of all ST alarms.
Note—See the IntelliVue Information Center Instructions for Use for specifics
on alarm management and behavior.
ST Alarms
ST/AR ST Segment Monitoring 4-9
ST Alarm
Adjustments
Task Summary Make adjustments to ST alarms on the ST Alarms window.
Step Action
1Access the ST Alarms window by clicking on the All Controls
button in the Patient Window then clicking the ST Alarms button
under Alarm Management and Setup.
2Make the adjustments on the ST Alarms window. Choices for setting
the ST alarm limits are:
Unit Settings—Click on this button if want to have the specific
limits that are pre-set for your unit.
Smart Limits—Click on this button to set high and low limits around
your patient's current ST value. The difference above and below the
patient's ST value are pre-set for your unit.
Note—Smart Limits can be configured to automatically be activated
when the patient is connected. See the IntelliVue Information Center
Instructions for Use for additional information on using smart limits.
Specified limits—Use these to set the high and low alarm limits
based on your assessment of the patient's clinical condition, unit
protocols, or physician orders or medication specified limits. A good
guideline is + 1.0 mm or - 1.0 mm from the patient's ST, or follow
your unit protocol.
ST Alarms
4-10 ST/AR ST Segment Monitoring
SpO2 Monitoring 5-1
Introduction
5
SpO2 Monitoring
This chapter provides an introduction to the SpO2 measurement and its
application. It includes the following sections:
• About the Pulse Oximetry Measurement . . . . . . . . . . . . . . . . . . . . . . . 5-2
• Preparing for Telemetry SpO2 Monitoring. . . . . . . . . . . . . . . . . . . . . . 5-7
•SpO
2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
• Selecting an SpO2 Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
• Applying the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
• Connecting the SpO2 Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
•Making SpO
2 Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
• Measurement Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24
• Optimizing Sensor Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
•SpO
2 Alarms and Technical Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
About the Pulse Oximetry Measurement
5-2 SpO2 Monitoring
About the Pulse Oximetry Measurement
The M2601B transmitter supports an SpO2 sensor connection using Fourier
Artifact Suppression Technology (FAST). The FAST algorithm provides
superior motion artifact rejection and low-perfusion performance. SpO2 can be
measured continuously, where a value is sent to the Information Center every
second, or as a single, individual measurement (Spot Check). The Spot Check
measurement will be removed from the Information Center display after 24
hours. If 1-minute or 5-minute sampling is selected at TeleMon, the M2601B
Transmitter will provide Continuous SpO2 measurement (see
“SpO2Measurement when Connected to TeleMon” on page 5-18).
The SpO2 parameter measures the arterial oxygen saturation. That is, the
percentage of oxygenated hemoglobin in relation to the total hemoglobin.
If, for example, a total of 97% of the hemoglobin molecules in the red blood
cells of the arterial blood combine with oxygen, then the blood has an oxygen
saturation of 97%. The SpO2 numeric that appears on the monitor will read
97%. The SpO2 numeric indicates the percentage of hemoglobin molecules
which have combined with oxygen molecules to form oxyhemoglobin.
• The oxygen saturation is measured using the pulse oximetry method. This
is a noninvasive method of measuring the arterial hemoglobin oxygen
saturation. It measures how much light, sent from light sources on one
side of the sensor, travels through patient tissue (such as a finger or an
ear), to a receiver on the other side.
• The amount of light getting through depends on many factors, most of
which are constant, such as tissue or venous blood. However one of the
factors, the blood flow in the arterioles, varies with time - because it is
pulsatile.
This measurement principle is used to derive the SpO2 measurement. The
numeric that is displayed at the Information Center is the oxygen
saturation of the arterial blood - the measurement of light absorption
during a pulsation.
About the Pulse Oximetry Measurement
SpO2 Monitoring 5-3
Pulse
Indication
During Spot Check measurement, the pulse signal is detected and communicated
to you via an auditory signal. The indicator is a single low-pitched tone for each
pulse detected. The tone (volume, mute) is configured. The pulse indication
stops when a measurement is complete. However, since it is possible to have a
strong pulse but fail an SpO2 measurement, you should listen for the successful
completion of a measurement (single beep), or a double beep if the measurement
fails.
The pulse indicator is for information only; it should not be used an indication
for treatment. The indicator is not functional in Continuous measurement mode.
Clinical Note: If you are in Spot Check mode and the sensor light is illuminated
but you do not hear a pulse indication sound synchronized with the pulse,
readjust the sensor, or move the sensor to another site to find better detection.
About the Pulse Oximetry Measurement
5-4 SpO2 Monitoring
SpO2
Information
for the User1
The pulse oximeter is calibrated to indicate fractional oxyhemoglobin, and
displayed results can range from 0 to 100%.
A 10 second averaging filter is used in the calculation of the result. Displayed
results are typically updated every second, but the update period can be
automatically delayed by up to 30 seconds in the presence of noise.
Physiological SpO2 alarm signals will be generated at the Information Center.
The SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments.
The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1%
increments. The maximum delay between the physiological alarm condition and
alarm signal generation at the Information Center is 10 seconds.
Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed
results can range from 30 to 300 b/min. There is no alarm function for pulse rate.
The pleth wave (on the TeleMon Companion Monitor, if available) is auto-
scaled to maximum display size. It decreases only when the signal quality
becomes marginal. Pleth wave size is NOT directly proportional to the pulse
volume.
1. A functional tester cannot be used to assess the accuracy of a pulse oximeter sensor or a pulse oximeter monitor. If
there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse
oximeter monitor and a pulse oximeter sensor, then a functional tester can measure the contribution of a monitor to
the total error of a monitor/sensor system. The functional tester can then measure how accurately a particular pulse
oximeter monitor is reproducing that calibration curve.
About the Pulse Oximetry Measurement
SpO2 Monitoring 5-5
SpO2 Safety
Information
WarningWarning
Prolonged, continuous monitoring can increase the risk of changes in skin
characteristics, such as irritation, reddening, blistering or pressure
necrosis, particularly on patients with impaired perfusion and varying or
immature skin morphology. Specific attention must be given to sensor site
inspection for changes in skin quality, proper optical path alignment and
attachment. Check the application site at regular intervals and change the
site if any compromise in skin quality should occur. More frequent
checking can be required due to an individual patient's condition.
Using a sensor during MR imaging can cause severe burns. To minimize
this risk, ensure that the cable is positioned so that no inductive loops are
formed. If the sensor does not appear to be operating properly, remove it
immediately from the patient.
Do not use disposable sensors on patients who exhibit allergic reactions to
the adhesive.
Avoid placing the SpO2 sensor on any extremity with an arterial catheter,
or intravascular venous infusion line.
Injected dyes such as methylene blue or intravascular dyshemoglobins such
as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-
estimated) measurements.
Interference leading to inaccurate measurements can be caused by:
- High levels of ambient light (Hint: cover application site with opaque
material)
- Electromagnetic interference
- Excessive patient movement and vibration.
About the Pulse Oximetry Measurement
5-6 SpO2 Monitoring
WarningWarning
Removal of the SpO2 sensor during Continuous SpO2 monitoring results in
a SpO2 NO TRANSDUCER technical alarm. There is no technical alarm
for a "No sensor" condition in Spot Check mode.
Preparing for Telemetry SpO2 Monitoring
SpO2 Monitoring 5-7
Preparing for Telemetry SpO2 Monitoring
The Philips Telemetry System provides remote monitoring of SpO2
measurement for adult and pediatric patients. You need to prepare your
telemetry patient and perform setup tasks for the measurement to display at the
IntelliVue Information Center or the TeleMon Companion Monitor.
Task Summary Perform the following steps to set up for telemetry SpO2 monitoring:
Step Action
1Select the site and appropriate sensor (see “Selecting an SpO2
Sensor” on page 5-9).
2Attach the sensor cable to the transmitter (see “Connecting the
SpO2 Cable” on page 5-17
3Attach the transducer cable to the transmitter.
Plug reusable transducers directly into the transmitter.
Plug disposable transducers into the adapter cable, then plug the
adapter cable into the transmitter. Remove the protective backing.
Attach the sensor to the appropriate part of the patient's body.
4If connected to TeleMon, use the pleth wave to check the signal
quality.
5Adjust SpO2 alarms in the Patient Window.
6Make other adjustments in the Telemetry Setup Window.
SpO2 Sensors
5-8 SpO2 Monitoring
SpO2 Sensors
Disposable
Sensors
Only use disposable sensors once and then discard. However, you can relocate
them to a different patient-site if the first location does not give the desired
results. Do not reuse disposable sensors on different patients. Disposable sensors
are not available as Philips Medical Systems parts in the USA or Canada.
Contact Nellcor® Incorporated at 1-800-635-5267 or 1-888-744-1414.
Reusable
Sensors
You can use reusable sensors on different patients after cleaning and disinfecting
them. For care and cleaning instructions, see the instructions accompanying the
sensors. Reusable sensors should be changed to another site regularly. See the
Directions for Use supplied by Nellcor® Incorporated for instructions on
preparation and application of disposable sensors.
WarningWarning
When the specified Nellcor® sensors are used, the application must be
consistent with the sensor manufacturer's own guidelines.
Selecting an SpO2 Sensor
SpO2 Monitoring 5-9
Selecting an SpO2 Sensor
Philips reusable sensors in adult, pediatric and infant models can be used, as
well as Philips and Nellcor disposable sensors.
Use only specified sensors (probes) and cables.
“Selecting an SpO2 Sensor” on page 5-10 is a guide in selecting the correct
sensor type. To use the figure, find the patient’s weight on the vertical axis. On
the horizontal axis at this weight, the shaded areas indicate that the sensor is a
"best choice" for the patient. Unshaded areas indicate a "good choice." For
example, the best reusable sensor for a 50 kg patient is the M1191A, applied to
the finger or toe. Alternatively, you could use M1194A applied to the ear
Selecting an SpO2 Sensor
5-10 SpO2 Monitoring
Selecting an SpO2 Sensor
Preferred sensor types
Alternative sensor types
Reuseable
sensor
Disposable
sensor
M1192A M1191A M1194A
Philips Part #
M1901B
N-25
N
M1903B
D-20
P
M1904B
D-25
A
110
88
66
44
33
22
7
Infant
Pedi Adult
Patient
Weight
( kg )
50
40
30
20
15
10
3
Pedi
Adult Adult
Pedi
Adult
Patient
Weight
( lb )
Pedi
Infant
Pedi
Pedi
Adult
Neo
Oxisensor
OxiCliq/OxiMax
Selecting an SpO2 Sensor
SpO2 Monitoring 5-11
Caution
Do not use OxiCliq disposable sensors in a high humidity environment, or in the
presence of fluids. These can contaminate sensor and electrical connections, and
thereby cause unreliable or intermittent measurements.
Do not use disposable sensors on patients who have allergic reactions to the
adhesive.
Applying the Sensor
5-12 SpO2 Monitoring
Applying the Sensor
Sensor Application Safety Information
WarningWarning
Failure to apply a sensor properly can reduce the accuracy of the SpO2
measurement.
Loose/Tight sensor: If a sensor is too loose, it can compromise the optical
alignment or fall off. If it is too tight, for example because the application site is
too large or becomes too large due to edema, excessive pressure can be applied.
This can result in venous congestion distal from the application site, leading to
interstitial edema, hypoxia and tissue malnutrition. Skin irritations or ulcerations
can occur as a result of the sensor being attached to one location for too long.
To avoid skin irritations and ulcerations, inspect the sensor application site every
2-3 hours, and change the application site at least every 4 hours or according to
clinical practice guidelines.
Venous Pulsation: Do not apply sensor too tightly as this results in venous
pulsation and can severely obstruct circulation and lead to inaccurate
measurements.
Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures
from above 37 oC (99 oF) because this can cause severe burns after prolonged
application.
Extremities to Avoid: Avoid sites distal to BP cuff or intra-arterial line.
A minimum pulsatile flow must be present at the application site of your patient
to obtain measurements.
Applying the Sensor
SpO2 Monitoring 5-13
Select an appropriate sensor and apply the sensor properly to avoid incorrect
measurements. Applying a small amount of pressure at the application site can
improve the measurement. Use one of the preferred application sites for your
sensor. Selecting the most suitable sensor and application site will help you to
ensure that:
• The light emitter and the photodetector are directly opposite each other
and that all the light from the emitter passes through the patient's tissues,
• The application site is of the correct thickness for light to pass through. If
the application site is too thick or too thin, an SpO2 NON-PULSATILE
technical alarm will occur. You should then select another site as
appropriate.
Positioning of the Light Emitter and Photo Detector
Inspect the application site every 2 to 3 hours or according to clinical practice
guidelines to ensure skin integrity and correct optical alignment. If skin integrity
changes, move the sensor to another site.
Light Emitter
Photo Detector
Applying the Sensor
5-14 SpO2 Monitoring
Adult Finger
Sensor
(M1191A)
Place the sensor over the fingertip in such a way that the fingertip touches but
does not protrude from the end of the sensor. The fingertip must be uppermost
and the cable must lie on the back of the hand. This ensures that the light sources
cover the base of the fingertip giving the best measurement results. The cable
can be held in place by the accompanying wristband.
WarningWarning
Failure to apply the sensor properly may cause incorrect measurement of
SpO2. For example, not placing the sensor far enough over the finger can
result in inaccurate SpO2 readings. Placing the sensor too far, so that the
finger protrudes from the sensor, can pinch the finger, resulting in
inaccurately low SpO2 readings.
Applying the Sensor
SpO2 Monitoring 5-15
Small Adult/
Pediatric
Finger
Sensor
(M1192A)
Place the sensor over the fingertip in such a way that the fingertip touches but
does not protrude from the end of the sensor.
Applying the Sensor
5-16 SpO2 Monitoring
Ear Clip
Sensor
(M1194A)
Clip the probe onto the fleshy part of the ear lobe as shown in the diagram
below. The plastic fixing mechanism helps to minimize artifact generated by
patient motion. Do not position the probe on cartilage or where it presses against
the head.
The clip sensor can be used as an alternative if the adult finger sensor does not
provide satisfactory results. The preferred application site is the ear lobe,
although other application sites with higher perfusion (such as the nostril) can be
used. Due to the physiologically lower perfusion in the ear lobe, you should be
aware of the reduced accuracy of the measurement and more frequent technical
alarms.
Connecting the SpO2 Cable
SpO2 Monitoring 5-17
Connecting the SpO2 Cable
Task Summary
Caution
Extension cables: Do not use extension cables with the transmitter.
Electrical Interference: Position the sensor cable and connector away from
power cables, to avoid electrical interference.
Step Action
1 Connect the sensor cable to the transmitter.
If you are using a disposable sensor, plug the sensor into the adapter
cable and plug this cable into the transmitter. Plug reusable sensors
directly into the transmitter
2 Ensure that the sensor and connector are positioned away from
power cables, to avoid electrical interference.
Making SpO2 Measurements
5-18 SpO2 Monitoring
Making SpO2 Measurements
SpO2 measurements can be made continuously, or manually on an as-needed
basis (Spot Check). The SpO2 parameter is turned on/off by inserting/removing
the sensor cable into the transmitter. SpO2 monitoring consumes considerable
electrical energy. If the battery power is not at least 25% full, no measurements
of SpO2 can be made.
Setting the mode at Continuous or Spot Check is done at TeleMon or is
configured using the Service Tool.
SpO2Measurement when Connected to TeleMon
When the M2601B transmitter is connected to TeleMon:
• The measurement mode is always Continuous.
• You can change the mode. Changes to the mode take effect when the
transmitter is disconnected from TeleMon. The following settings will be
used:
Note—When using the M2601A Transmitter, 5-minute and 1-minute settings are
available when disconnected from TeleMon.
If the transmitter had been set to Continuous or Spot Check before connection to
TeleMon, it returns to the setting it had when the transmitter is disconnected
(provided that it wasn’t changed when connected).
Mode Setting at TeleMon Mode at Disconnected Transmitter
Continuous Continuous
5-minute Continuous
1-minute Continuous
Manual Spot Check
Making SpO2 Measurements
SpO2 Monitoring 5-19
Making a Spot Check Measurement
When the transmitter is configured for Spot Check measurement, use the
following instructions to take an individual, manual SpO2 reading from the
transmitter.
Task Summary
Step Action
1 Attach the sensor to the patient.
2 Connect the SpO2 cable to the transmitter, and check that:
•The SpO
2 sensor light turns on.
• A low-pitched tone detecting each pulse is audible (unless
sounds are muted).
3 After approximately 30 seconds, a tone from the transmitter
indicates that a measurement has been completed successfully
(single beep), or failed (double beep). If failed, you must retake the
measurement. The value, with the measurement time, is displayed at
the Information Center, and the sensor light extinguishes.
Note—The SpO2 value and time stamp will remain on the
Information Center for 24 hours or until another measurement is
taken, with one exception. If the batteries are removed from the
transmitter, the Spot Check measurement will be erased from the
display, but the SpO2 measurements will be available in Trend
Review.
4 To repeat a Spot Check measurement at the bedside, disconnect then
reconnect the SpO2 cable to the transmitter.
Making SpO2 Measurements
5-20 SpO2 Monitoring
Monitoring SpO2 Continuously
When the transmitter is configured for Continuous SpO2 measurement, use the
following directions to initiate Continuous SpO2 monitoring.
Task Summary
Turning
SpO2
Monitoring
Off
To turn SpO2 monitoring off, disconnect the sensor cable from the transmitter.
SpO2 enters a power-down mode after the cable is disconnected from the
transmitter, thereby conserving battery life.
SpO2 should also be turned off at the Information Center. If the transmitter is
configured for Continuous SpO2 measurement and the sensor is removed
without turning SpO2 off, a SpO2 NO TRANSDUCER technical alarm will
result.
Important—It is important to disconnect the sensor from the transmitter.
Unplugging the sensor from an adapter cable that is connected to the transmitter
does NOT provide SpO2 power-down mode.
Step Action
1 Insert the SpO2 cable to the transmitter, and check that the sensor
light turns on.
2 Attach the sensor to the patient.
3 After approximately 15 seconds, the value, with the measurement
time, is displayed at the Information Center.
Note—There are no sounds associated with Continuous SpO2
measurement.
4 To discontinue monitoring, set SpO2 mode to off at the Information
Center. If TeleMon is available, connect and change the setting to
Spot Check.
Making SpO2 Measurements
SpO2 Monitoring 5-21
Turning the
SpO2
Parameter
On/Off
You can turn the SpO2 parameter on/off at the Information Center by using the
Telemetry Setup Window.
Note—If SpO2 is turned on, the Patient Sector and Patient Window of the
Information Center display the numeric with "T" (for example, SpO2 T 90%) to
indicate that the measurement was made via telemetry.
Turning the SpO2 parameter off at the Information Center also turns off:
•SpO
2 alarms
•SpO
2 display of numerics
•SpO
2 trending
If the transmitter is connected to the TeleMon Companion Monitor, after you
turn SpO2 on, you should adjust the sample rate to match your patient’s acuity.
Note—After you turn SpO2 off, setting the sample rate to Spot Check at
TeleMon will help you conserve the transmitter’s battery life.
Task Summary Turn the SpO2 parameter on or off manually by performing the following steps:
Step Action
1On the Patient Window click the All Controls button.
2On the All Controls Window click the Telemetry Setup button.
3On the Telemetry Setup Window, under SpO2, turn the parameter on
or off by clicking in the Parameter ON checkbox. A check mark in
the checkbox indicates that SpO2 monitoring is on.
Making SpO2 Measurements
5-22 SpO2 Monitoring
SpO2
Parameter
Auto ON
The SpO2 parameter is automatically turned on at the IntelliVue Information
Center if a manual SpO2 measurement is initiated at the transmitter while in
Spot Check mode or the SpO2 sensor is inserted into the transmitter while the
transmitter is in Continuous SpO2 mode.
When a patient is discharged and the transmitter is in Continuous mode, the
SpO2 parameter is turned off. To reactivate the SpO2 parameter Auto ON
feature from the transmitter, remember to do one of the following when a patient
is discharged:
– remove the SpO2 cable from the transmitter, wait 15 seconds, then
reinsert the cable
or
– if using TeleMon, reset the transmitter to Spot Check mode.
Note—The SpO2 parameter Auto ON feature only needs to be reactivated when
the transmitter is in Continuous mode at discharge.
Note— SpO2 can always be turned on and off at the IntelliVue Information
Center.
Turning
SpO2
Alarms On/
Off
You can turn SpO2 alarms on or off by using the Telemetry Setup Window.
Task Summary Turn SpO2 alarm on or off by performing the following steps:
Step Action
1On the Patient Window click the All Controls button.
2On the All Controls Window click the Telemetry Setup button.
3On the Telemetry Setup Window, under SpO2, turn alarms on or off
by clicking in the Alarm ON checkbox. A check mark in the
checkbox indicates that SpO2 alarms are on.
Making SpO2 Measurements
SpO2 Monitoring 5-23
Turning the
Pulse
Parameter
On/Off
If monitoring SpO2 continuously, the Pulse parameter is available at the
IntelliVue Information Center. You can turn the SpO2 pulse parameter on or off
by using the Telemetry Setup Window.
Task Summary Turn the pulse parameter on or off by performing the following steps:
Note—If pulse is turned on, the Patient Sector and Patient Window of the
Information Center display the label with "T" (for example, Pulse T) to indicate
that the measurement was made via telemetry.
Step Action
1On the Patient Window click the All Controls button.
2On the All Controls Window click the Telemetry Setup button.
3On the Telemetry Setup Window, under Pulse, turn parameter on or
off by clicking in the Parameter ON checkbox. A check mark in the
checkbox indicates that pulse monitoring is on.
Measurement Limitations
5-24 SpO2 Monitoring
Measurement Limitations
Refer to this section on problem situations if you have difficulty getting a signal
or obtaining accurate measurements.
Distortion
Ambient light, motion, perfusion or incorrect sensor placement may affect the
accuracy of the derived measurements.
Arterial Blood Flow
The measurement depends on the pulsatile nature of blood flow in the arteries
and arterioles; with the following conditions arterial blood flow may be reduced
to a level at which accurate measurements cannot be made:
• shock
• hypothermia
• use of vasoconstrictive drugs
• anemia
Wavelength Absorption
The measurement also depends on the absorption of particular light wavelengths
by the oxyhemoglobin and reduced hemoglobin. If other substances are present
which absorb the same wavelengths, they will cause a falsely high, or falsely
low SpO2 value to be measured. For example:
• carboxyhemoglobin
• methemoglobin
• methylene blue
• indocyanine green*
• indiocarmine*
*These chemicals are used in dye dilution cardiac output calculations.
Ambient Light
Very high levels of ambient light can also affect the measurement; an SpO2
INTERFERENCE message will appear on the display. The measurement quality
can be improved by covering the sensor with suitable opaque material.
Care and Cleaning
For care and cleaning instructions, see the instructions accompanying the
sensors.
See Appendix B, “Accessory List” for ordering information.
Optimizing Sensor Performance
SpO2 Monitoring 5-25
Optimizing Sensor Performance
To get the best results from your SpO2 reusable sensor:
• Always handle the sensor and cable with care. The soft finger sleeve
houses a sensitive electronic device that can be damaged by harsh
treatment. Always protect the cable from sharp-edged objects.
• Use the wristband that is supplied with your M1191A sensor. By keeping
the cable between the finger sensor and the wristband fairly loose, you
will maintain good monitoring conditions.
Normal wear and tear associated with patient movement and regular sensor
cleaning naturally mean that your sensor will have a limited lifetime. However,
provided you handle the sensor and its cable with care, you can expect useful
service from it for up to two years. Harsh treatment will drastically reduce the
lifetime of the sensor. Moreover, Philips Medical Systems’ warranty agreement
shall not apply to defects arising from improper use.
SpO2 Alarms and Technical Alarms
SpO2 alarms are non-latching. That is, when an SpO2 limit is exceeded, if the
alarm is not silenced, it will reset automatically if the patient’s alarm condition
returns within the limits. This reduces the number of times you will need to reset
alarms at the Information Center when an alarm condition has been corrected at
the patient’s side (for example, movement-induced artifact alarms).
See Chapter 2, “Alarms” for a list of all SpO2 alarms.
SpO2 Alarms and Technical Alarms
5-26 SpO2 Monitoring
Maintenance and Configuration 6-1
Introduction
6
Maintenance and Configuration
This chapter describes how to maintain the telemetry equipment and configure
the system. It includes the following sections:
• Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
• Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
• Transmitter Cleaning, Disinfection, & Cross-Infection Prevention . . . . 6-4
• Receiver Mainframe Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
• Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
• Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Troubleshooting
6-2 Maintenance and Configuration
Troubleshooting
Basic Troubleshooting
Testing
Alarms
Visual and auditory alarms appear at the Information Center. One method of
verifying visual and auditory alarms at the Information Center is to connect the
transmitter to an ECG or ECG/SpO2 simulator. By varying the ECG rate and
SpO2 value, alarms can be generated and confirmed for proper operation.
For problems with... refer to
• ECG measurement “Optimizing System Performance” on page 3-22
“Technical Alarms (INOPs)” on page 11
•SpO
2 measurement “Measurement Limitations” on page 5-24
“Technical Alarms (INOPs)” on page 11
• Batteries “Battery Information” on page 1-29
“Status Check” on page 1-28
• Nurse Call Alarm Nurse Call may have been turned off for the
patient. See “Turning Nurse Call On/Off” on
page 1-23.
Maintenance
Maintenance and Configuration 6-3
Maintenance
Before beginning monitoring on a patient:
• Check for any mechanical damage.
• Check all the external leads, plug-ins and accessories.
• Check all the functions of the instrument which are needed to monitor the
patient.
• Ensure that the instrument is in good, working order.
• Ensure that any needed gunk guards are in place.
Important—Do not use the Philips Telemetry Monitoring System for any
monitoring procedure on a patient if you identify features which demonstrate
impaired functioning of the instrument. Contact the hospital biomedical
engineer, or your Service Provider.
WarningWarning
Failure on the part of the responsible individual hospital or institution
employing the use of this equipment to implement a satisfactory
maintenance schedule may cause undue equipment failure and possible
health hazards.
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
6-4 Maintenance and Configuration
Transmitter Cleaning, Disinfection, & Cross-Infection
Prevention
The procedures in this section keep the transmitter clean and provide protection
against infectious agents and bloodborne pathogens. Both the outside of the
transmitter and the inside of the battery compartment must be kept free of dirt,
dust, and debris. The procedures in this section cover the following activities:
•Cleaning: removing visible surface decontamination from the device
•Disinfection: protecting cleaned devices against infectious agents and
bloodborne pathogens by a chemical agent.
•Cross-Infection Prevention: using ETO gas treatment to decontaminate
cleaned equipment.
Important—After exposure, the transmitter must be cleaned, followed by
either Disinfection or Cross-Infection Prevention procedures according to
hospital protocols, before continued use in monitoring.
Cleaning the Transmitter
Caution
Do not use any abrasive cleaning materials or overly vigorous cleaning actions
on any part or component of the transmitter. Use of abrasive cleansers and
abrasive cleaning actions will damage the components.
Task Summary Perform the following steps to clean the transmitter of visible surface
contamination.
Step Action
1 Remove the batteries and any cables or accessories.
2 Soak the transmitter in water for up to 5 minutes to soften any dried
debris, if necessary.
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
Maintenance and Configuration 6-5
Disinfecting the Transmitter
WarningWarning
To prevent fire, provide adequate ventilation and do not permit smoking
when disinfecting the device with a flammable liquid, such as alcohol.
Caution
Remove the batteries and any cables or accessories before you disinfect the
transmitter.
The transmitter can be disinfected by two methods: wiping or soaking. If the
device has areas that are difficult to disinfect, soaking for up to five minutes is
recommended. The approved disinfection agents are:
• Isopropryl Acohol, >70%
• Sodium Hypochlorite, 10% solution prepared within 24 hours (for wiping
only)
Equipment must be cleaned (see “Cleaning the Transmitter” on page 6-4) before
this procedure is performed.
3 Rinse the transmitter in water.
4 Flush device orifices with a forceful water stream to remove any
residue in the openings.
5 Allow to air-dry, or dry with a non-lint producing cloth.
6 Continue with either Disinfection or Cross-Infection Prevention
procedure, according to your hospital’s protocol.
Step Action
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
6-6 Maintenance and Configuration
Wiping the
Transmitter
Soaking the
Transmitter
Caution
Do not soak the equipment in cleansers other than Isopropyl Alcohol, or soak
longer than five minutes. Soaking the transmitter for longer than five minutes or
in cleansers other than Isopropyl Alcohol can severely damage the device.
Step Action
1 Remove the batteries and any cables or accessories.
2 Wipe the transmitter clean by using a cloth dampened modestly with
one of the following approved cleaning agents:
• Isopropyl Alcohol (> 70%)
• Sodium Hypochlorite (chlorine bleach), 10% solution
prepared within 24 hours.
3 Wipe all disinfected surfaces with distilled water to remove any
residue.
4 Allow to air-dry, or dry with a non-lint producing cloth.
Step Action
1 Remove the batteries and any cables or accessories.
2 Soak the device in Isopropyl Alcohol (> 70%) for up to five
minutes.
Note—The battery compartment can be closed or open during
soaking.
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
Maintenance and Configuration 6-7
Cross-Infection Prevention for the Transmitter
The transmitter can be subjected to one ETOH cross-infection prevention
process four times per year for 2 years. Completion of this procedure achieves a
cross-infection prevention assurance level of 10E-6.
Equipment must be cleaned (see “Cleaning the Transmitter” on page 6-4) before
this procedure is performed.
Note—If there is concern over cross-contamination due to leadsets or sensors,
new lead sets or sensors should be used.
Equipment and
Materials
WarningWarning
EO is highly explosive, toxic, and a potential occupational carcinogenic and
reproductive hazard. Handle it with extreme care, following U.S.
Occupational Safety and Health Administration (OSHA) standards for EO
(29 CFR 1910.1047)*. Personnel exposure and/or room air must be
monitored per OSHA standards.
Vent sterilizer gas outdoors or to a suitable, evacuated container for
reprocessing, depending upon state, provincial, or country environmental
regulations. Do not vent sterilant indoors.
Vent aerator exhaust only to the outdoors.
* See “References” on page 6-12.
3 Dip all cleaned surfaces in bowl of distilled water to remove any
residue.
4 Dry the equipment with a non-lint producing cloth.
Step Action
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
6-8 Maintenance and Configuration
Use the following equipment and material to process the transmitter:
1. Ethylene Oxide (Allied Signal Oxyfume-2002™), heretofore referred to
as EO.
2. Gas sterilizer, made by American Sterilizer Company or other
manufacturers.
3. Mechanical aerator. The intake air for the aeration chamber must be
routed through bacterial filters, and the exhaust air must be vented outside
the building.
Note—Available combination sterilizer/aerators bypass the problem of personnel
exposure to EO during transfer of treated material to a separate aeration cabinet.
Cross-
Infection
Process
The following generic procedure can be used to supplement the sterilizer and
aerator manufacturers’ instructions, although the processing times, temperatures,
and pressure must be the same as those given in this procedure.
Important—In order to complete this stage of the process safely, harmful residue
gas must be dissipated through aeration.
Task Summary
Step Action
1Remove any obvious contamination from the equipment to be
processed using approved cleaners.
2Individually package each transmitter in standard central supply
room (CSR) wrapping material secured with EO color-change indi-
cator tape.
3Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the empty
sterilizer chamber two times, to remove any residual EO or mois-
ture. Vent the vacuum pump to the outdoors to avoid toxic hazards
to personnel.
4Insert the equipment to be processed into the gas sterilizer.
5Heat the chamber and its contents to 54.4 +/- 2.8oC (130 +/- 5oF).
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
Maintenance and Configuration 6-9
6Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer
chamber.
7Humidify the chamber at 50% +/- 10% relative humidity for 20 to
30 minutes.
8Taking a minimum of five minutes, slowly introduce EO sterilant
until the sterilizer unit pressure gauge reaches 11 +/- 1 psig.
Note—At this pressure, the concentration of sterilant in the chamber
will be 600 +/- 50 mg/liter, regardless of the chamber size.
9Process the equipment to be processed as follows:
Pressure: 11 +/- 1 psig (established in the preceding step).
Time: 2-3 hours
Temperature: 54.4 +/- 2.8oC (130 +/- 5oF)
10 Extract the gas mixture from the sterilizer as follows:
WarningWarning
Comply with OSHA standards*. Do not vent sterilizer gas to the
room, but vent only outdoors or to a suitable, evacuated
container, depending upon state, provincial, or country environ-
mental regulations. (If the mixture is captured, it can be sepa-
rated commercially and the component gases re-used.)
* See “References” on page 6-12.
a. Pump the gas mixture out of the chamber until you ob-
tain a vacuum of -26 inHg +/- 1 (-12.77 psig +/-.49), re-
turning the mixture to a suitable evacuated container.
b. Return the sterilizer chamber to ambient pressure by in-
troducing air that has been bacterially filtered.
Step Action
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
6-10 Maintenance and Configuration
Aeration
Procedure
WarningWarning
To avoid chemical burns and toxic effects, the equipment must be aerated
after sterilization, as described. The aerator must have bacterial filters and
outdoor venting.*
See “References” on page 6-12.
11 Air-wash the chamber and material as follows:
a. Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the
chamber and processed material again, to remove residu-
al EO. The vacuum pump must be vented to the out-
doors.
b. Return the sterilized chamber to ambient pressure by in-
troducing air that has been bacterially filtered.
12 Continue with the "Aeration Procedure" (following).
Step Action
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
Maintenance and Configuration 6-11
Task Summary Aerate the processed equipment by performing the following steps:
1 These values will produce EO and Ethylene Chlorohydrin residual levels in the
transmitter and patient cable plastic that meet ISO 10993-7 in conjunction with
AAMI Technical Information Report 19, that the FDA currently endorses.
References OSHA: Standard for acceptable levels of personnel exposure to Ethylene Oxide
Gas: 1 ppm on an eight-hour time-weighted average basis.
Reference: U.S.A. Federal Regulations 49 FR 25734/29 CFR Part 1910.1047,
June 22, 1984; final approval 50 FR 9800/2- CFR Part 1910.1047, March 12,
1985.
Test Procedure
Caution
You must perform this test each time you put a transmitter through the cross-
infection prevention procedure.
This test allows you to verify that patient information for both ECG and SpO2 (if
you are monitoring pulse oximetry) appear at the Information Center and at the
bedside. You can use this procedure with a patient simulator.
Step Action
1To dissipate residual EO, aerate the processed equipment with air
that has been bacterially filtered, using a mechanical aerator or
combination sterilizer/aerator as follows:1
Time: 8-9 hours
Temperature: 54.4 +/- 2.8oC (130 +/- 5oF)
Ventilation Frequency: At least 30 air exchanges per hour.
2 Continue with the Test Procedure (following).
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
6-12 Maintenance and Configuration
Note—This test assumes that the telemetry system and Information Center are
fully installed, and that you have performed the procedure to learn the
transmitter identity code.
Task Summary Test the transmitter by performing the following steps. If the test indications do
not appear, refer to your Service Provider.
Step Action
1Perform a mechanical inspection of the transmitter (connectors,
battery door opening and closing, Telemetry and Check buttons).
2At the Information Center, select the telemetry bedside you are
testing.
Transmitter Cleaning, Disinfection, & Cross-Infection Prevention
Maintenance and Configuration 6-13
3Test the transmitter:
a. Put fresh batteries in the transmitter and close the battery
door.
Result: All indicator lights on the front of the transmitter
light momentarily, and you will hear a single beep.
b. Attach a lead set to the ECG port, and attach an SpO2
sensor to the SpO2 port. If an ECG simulator is avail-
able, attach the ECG leads to the simulator and the
SpO2sensor to yourself. At TeleMon, set the SpO2 sam-
ple rate to Continuous.
Result: An ECG trace and SpO2 information should be
visible on the Information Center display. All transmit-
ter lights should be off.
c. Disconnect the Right Arm lead for standard ECG or the
“I” electrode for EASI.
Result: The RA LED or the “I” lead LED should turn
on, and a Leads Off INOP should appear on the display
at the Information Center.
d. Reconnect the electrode.
4a. Connect the transmitter to TeleMon and observe the
ECG waveform and SpO2 numerics on the TeleMon dis-
play.
Result: The ECG waveform and SpO2 numerics should
be displayed on the TeleMon screen.
Step Action
Receiver Mainframe Cleaning
6-14 Maintenance and Configuration
Receiver Mainframe Cleaning
The receiver mainframe should be kept free of dust and dirt. You can only clean
the outside of the receiver mainframe. Wipe the outside of the receiver
mainframe clean by wetting a damp cloth or rag with one of the following
approved cleaning agents:
• Soap and Water
• Isopropyl Alcohol (> 70%)
• Ethyl Alcohol (> 70%)
• Hydrogen Peroxide
• Sodium Hypochlorite (chlorine bleach), 5% solution
• Sodium Hypochlorite (chlorine bleach), 10% solution prepared within
24 hours
•Cidex®
• Windex®
• Lysol®
Wipe all cleaned surfaces with distilled water to remove any residue. Allow to
air-dry, or dry with a non-lint producing cloth before use.
Configuration
Maintenance and Configuration 6-15
Configuration
How your telemetry system performs depends in large part on the configuration
choices made during system installation. This chapter provides a summary of the
factory-set defaults and the alternative configuration choices that relate to
clinical practice. Configuration for the telemetry system is performed at the
receiver mainframe, except for Philips transmitters, which are configured at the
TeleMon Companion Monitor or using the Service Configuration Tool. All
receiver settings, except frequency, pertain to all receivers in the mainframe.
Two of the most frequently performed configuration procedures are also
included in this chapter.
For complete configuration information, including the impact of individual
choices, refer to the Philips Telemetry System Installation and Configuration
Guide in the M2600B Documentation Kit (M2600-90323).
Configuration Settings
6-16 Maintenance and Configuration
Configuration Settings
M2604A
Mainframe
The following table lists the mainframe configuration settings used by the
IntelliVue Information Center.
Note—The IntelliVue Information Center does not use the following settings:
• HR Alarm Limits
• Lead Fallback
•Bandwidth
• ST Settings
Item Factory Default User Choices
GENERAL ALARM PARAMETERS
Alarm Suspend 3 Minutes 3 Minutes, Infinite
Alarm Reminder
only applies to:
–SpO
2
– ECG if not arrhythmia
monitored
ON ON, OFF
GENERAL ECG PARAMETERS
Extended Monitoring ON ON, OFF
Configuration Settings
Maintenance and Configuration 6-17
For configuration of the following items, see the Philips Telemetry System
Installation and Configuration Guide in the M2600B Documentation Kit.
• Auto Self Test
• Self-test Strip
• SDN Unit Number
• SDN Branch Number
• Country Code
• Locale Code
• Frequencies
M2601X SERIES TRANSMITTERS ECG PARAMETERS
Lead Selection - 5 Electrode Primary = II
Secondary = V
Primary = I, II, III, aVR, aVL, aVF, MCL, V
Secondary = I, II, III, aVR, aVL, aVF, MCL,
V, OFF
Note—The ECG primary and secondary must
be different lead types, and the primary
cannot be OFF.
Lead Labelling - 3 Electrode Primary = II Primary = I, II, III, MCL
SpO2 PARAMETERS
SpO2 Alarm Limits High: 100 percent
Low: 90 percent
High Range = 51-100 percent
Low Range = 50-99 percent (increment of 1)
GENERAL PARAMETERS
Telemetry Button Function Nurse Call and
Record
Nurse Call, Record, Both, Disabled
Language English English, German, French, Dutch, Spanish,
Swedish, Italian, Japanese, Norwegian,
Danish, Finnish, Portuguese
Item Factory Default User Choices
Configuration Settings
6-18 Maintenance and Configuration
Philips
M2601B
Transmitter
The following table lists the configuration settings for the Philips M2601B
Transmitter.
For configuration of the following items, see Philips Telemetry System
Installation and Configuration Guide
• Country Code
• Locale Code
• Frequencies
Changing the Configuration
Configuration changes require the TeleMon Companion Monitor or the Service
Configuration Tool. If configuration is required (for example to match a
replacement Philips transmitter to others in the unit or to change the frequency
in case of excessive interference) contact the Service Provider or consult the
TeleMon Service Manual.
Item Factory Default User Choices
Lead Selection 3-wire lead set No Yes, No
Automatic Shutoff (after 10 minutes) Yes No, Yes
System Safety and Specifications 7-1
Introduction
7
System Safety and Specifications
This chapter provides information on regulatory requirements compliance for
patient safety, safety-oriented installation and maintenance procedures, and
specifications for the Philips Telemetry System. It includes the following
sections:
• Product Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
• Philips Telemetry System Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
• Electromagnetic Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
• System Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
• Installation and Maintenance Safety. . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
• Additional Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
• System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20
Product Safety
7-2 System Safety and Specifications
Product Safety
The M2600B Philips Telemetry System, complies with the requirements of the
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and
carries CE-marking accordingly. ( )
The following symbol means that this device is considered Class 2 radio
equipment per Directive 1999/5/EC for which Member States may apply
restrictions on putting the device into service or placing it on the market. This
system is intended to be connected to the publicly available interfaces (PAI) for
use throughout EEA.
The Philips Telemetry System also complies with the following international
safety requirements for medical electrical equipment:
• IEC 601-1:1998 + A1:1991 +A2:1995 General Requirements for Safety
(with worldwide deviations, including U.S. deviations)
• IEC 60601-1-1:2000 System Safety
• IEC 60601-1-2:2001 Electromagnetic Interference
• IEC 60601-1-4:1996 Safety for Programmable Electrical Medical Systems
• IEC 60601-2-49:2001 Multi-parameter Monitor Safety
• EN 865:1997 Particular Requirements for Pulse Oximeters
• AAMI Voluntary Performance Standards for Cardiac Monitors: EC 13:
2002, Clauses 4.2.8 and 5.2.8
The system is protected against the effects of defibrillation.
This system provides continuous operation when in use.
The following accessories and system components are independently CE marked
to the Medical Device Directive. They are not covered by the CE marking of the
Philips Telemetry System:
•All SpO
2 accessories and equipment
• ECG electrodes
• ECG lead sets
0123
!
0123
!
Product Safety
System Safety and Specifications 7-3
Authorized EU Representative:
Philips Medizinsysteme Boeblingen GmbH
Hewlett-Packard Str. 2
D-71034 Boeblingen
Germany
System Classification
Class I Equipment
M2604A Receiver Mainframe
Class II Equipment
453563647161 Universal Power Converter (UPC)
Characteristic Definition
Internally Powered
Equipment
The M2601B Transmitter is an internally powered
device.
Continuous Operation All equipment is Ordinary Equipment, IPX0, and
provides continuous operation.
Type CF
Defibrillation Proof
The M2601B Transmitter is Type CF
Defibrillation Proof relative to ECG and SpO2
patient applied parts.
Water Resistance When placed inside a Philips carrying pouch with
the flap closed and snaps secured, the transmitter
is rated IPX3,as per IEC 60529:1989 (+A1:1999):
Protected against splashing water.
The combination of the transmitter and pouch will
withstand showering for up to 10 minutes.
The transmitter will not be damaged if it is
accidentally immersed in liquid for up to 5
minutes.
Philips Telemetry System Warnings
7-4 System Safety and Specifications
Essential Performance
The Philips Telemetry System provides Essential Performance (EP) under
normal operating conditions (includes EMC exposure) only as a complete
Medical Electrical System, consisting of the M2601B Patient-Connected
Device, M2636B TeleMon (opt. A02, A03) Companion Monitor (Optional),
M2603A/M2604A Receiver/Mainframe, and M3150A IntelliVue Information
Center.
The system achieves its Essential Performance exclusively through alarm
generation at the Information Center.
The system protects the patient from unacceptable immediate clinical risk by
generating specific Physiological Alarms when appropriate. If the system cannot
generate Physiological Alarms, then relevant Technical Alarms (INOPs) will be
created.
Philips Telemetry System Warnings
The warnings and cautions described below refer to the following devices:
• Philips M2601B Transmitter
• Philips Telemetry System
• IntelliVue Information Center
WarningWarning
Do not touch the patient, or table, or instruments during defibrillation. The
battery door must be closed during defibrillation. These steps protect the
clinician from high defibrillator voltage.
Electromagnetic Compatibility
System Safety and Specifications 7-5
WarningWarning
Do not install or use power modules for analog output and antennas within
a 2.44 m (8 ft.) radius of the patient. This helps ensure patient electrical
safety.
Caution
Installation and setup must be performed by a Philips Medical Systems service
representative or designee according to the instructions in Philips Telemetry
Installation & Configuration Guide, which can be found in the M2600B
Documentation Kit (order number M2600-90323).
Electromagnetic Compatibility
M2600B
Philips
Telemetry
System
Testing
The electromagnetic compatibility (EMC) validation of the Philips M2600B
Telemetry System included testing performed according to the international
standard for EMC with medical devices. See the Manufacturer’s Declaration for
details.
Medical electrical equipment can either generate or receive electromagnetic
interference. This product has been evaluated for electromagnetic compatibility
(EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the
international standard for EMC for medical electrical equipment. This IEC
standard has been adopted in the European Union as the European Norm, EN
60601-1-2:2001.
Radio frequency (RF) interference from nearby transmitting devices can degrade
performance of the product. Electromagnetic compatibility with surrounding
devices should be assessed prior to using the product.
Fixed, portable, and mobile radio frequency communications equipment can also
affect the performance of medical equipment. See your Service Provider for
Electromagnetic Compatibility
7-6 System Safety and Specifications
assistance with the minimum recommended separation distance between RF
communications equipment and the product.
The cables, sensors/transducers, and other accessories for which compliance is
claimed are listed in “Appendix B. Accessory List” in this Instructions for Use
and in the Philips Telemetry System Service Guide.
WarningWarning
The use of accessories, transducers and cables other than those specified in
the Philips Telemetry System service and user documentation can result in
increased emissions or decreased immunity of the product.
WarningWarning
The product should not be used next to or stacked with other equipment. If
you must stack the product, you must check that normal operation is
possible in the necessary configuration before the product is used.
Reducing Electromagnetic Interference
The system and associated accessories can be susceptible to interference from
other RF energy sources and continuous, repetitive, power line bursts. Examples
of other sources of RF interference are other medical electrical devices, cellular
products, information technology equipment, and radio/television transmission.
If interference is encountered, as demonstrated by artifact on the ECG or
dramatic variations in physiological parameter measurement values, attempt to
locate the source. Assess the following:
• Is the interference due to misplaced or poorly applied electrodes or
sensors? If so, re-apply electrodes and sensors correctly according to
directions in “Chapter 3. ECG & ST/AR Measurement”.
• Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
• Does the interference occur only when in close proximity to certain
medical electrical equipment?
• Do parameter measurement values change dramatically when the AC line
cord is unplugged?
Electromagnetic Compatibility
System Safety and Specifications 7-7
Once the source is located, attempt to attenuate the interference by distancing
the product from the source as much as possible. If assistance is needed, contact
your local Service Provider.
Restrictions
for Use
Artifact on ECG and other physiological waveforms caused by electromagnetic
interference should be evaluated by a physician or physician authorized
personnel to determine if it will negatively impact patient diagnosis or treatment.
FCC
Compliance
(USA only)
Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
The FCC requires the following statement for this device:
The Philips M2600B Telemetry System complies with Part 15 of the Federal
Communications Commission (FCC) Rules. Operation is subject to the
following two conditions:
• This device may not cause harmful radio frequency interference to a
primary licensed user (radio and television stations), and
• This device must accept any interference received from a primary licensed
user, including interference that may cause undesired operation.
Pursuant to Part 15.21 of the FCC Rules, any changes or modifications to this
equipment not expressly approved by Philips Medical Systems may cause
harmful radio frequency interference, and void your authority to operate this
equipment.
Canadian
Radio
Equipment
Compliance
(Canada
Only)
For operation in 608-614 MHz
This telemetry device is only permitted for installation in hospitals and health
care facilities. This device shall not be operated in mobile vehicles (even
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 (e.g., 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 is Tel: 250-493-2277; FAX: 250-493-7767.
Electromagnetic Compatibility
7-8 System Safety and Specifications
For operation outside 608-614 MHz
Contact your local Industry Canada offices as licensure is required.
To provide maximum RF shielding and minimum RF interference to the
licensed service, this device should be operated indoors and away from
windows.
System Symbols
System Safety and Specifications 7-9
System Symbols
The following is an explanation of the symbols found on the hardware
components of the Philips Telemetry System:
Symbol Explanation
AC Line Current.
Active Antenna Combiner.
Antenna Input.
Attention. See Instructions for Use.
Bandpass Filter
Battery Polarity
Catalog Number
REF
System Symbols
7-10 System Safety and Specifications
Class 2 Equipment
Data In
Data In, Data Out
Data Out
Date of Manufacture
DC Voltage
Do Not Reuse. Use Only Once.
Dispose of properly after use in accordance with
local regulations.
Electrical Input
Symbol Explanation
2
System Symbols
System Safety and Specifications 7-11
Electrical Output.
Equipotential Grounding System.
Follow Operating Instructions.
Frequency Converter
Fuse Input.
Grounding system.
Indoor Use Only
Line Amplifier
MAC Address of Device
Symbol Explanation
i
MAC
System Symbols
7-12 System Safety and Specifications
Non-ionizing Radiation
Power On/Off
Product Option
Protective Earth (Ground)
Power Tee
Receiver Mainframe Malfunction
Receiver Mainframe. For future use.
Serial Number
Type CF Defibrillation Proof
Symbol Explanation
SN
System Symbols
System Safety and Specifications 7-13
IPX0
The M2600B is rated IPXO in degrees of
protection by enclosures; not protected against
ingress of water.
Complies with applicable Canadian and
American medical safety standards.
Compliance to Council Directive 93/42/EEC
(Medical Device Directive)
Class 2 Radio equipment identifier (1999/5/EC):
Member states may apply restrictions on putting
this device into service or placing on the market.
This device is intended to be connected to the
publicly available interfaces (PAI) for use
throughout the EEA
Federal Law restricts this device in the United
States to sale by or on the order of a physician.
Symbol Explanation
0123
!
Rx
Installation and Maintenance Safety
7-14 System Safety and Specifications
Type CF Defibrillation Proof
The following symbol identifies a device that is Type CF Defibrillation Proof.
Type CF Defibrillation Proof equipment is protected against defibrillation
(DEFIBRILLATION-PROOF) and is a TYPE CF APPLIED PART.
Installation and Maintenance Safety
Caution
Installation and setup must be performed by a Philips Medical Systems service
representative or designee, except for transmitters purchased individually. These
can be installed by hospital personnel according to instructions in the
Installation and Configuration Guide included in the M2600B Documentation
Kit.
Installation
Environment Follow the instructions below to ensure a completely safe electrical installation.
The environment where the Philips Telemetry System will be used should be
relatively free from vibration, dust, corrosive or explosive gases, extremes of
temperature, humidity, and so on. For a cabinet mounted installation, allow
sufficient room at the front for operation and sufficient room at the rear for
servicing with the cabinet access door open.
The Philips Telemetry System operates within specifications at ambient
temperatures between 0ºC (32oF) and 55ºC (131oF). The transmitter ambient
temperature specification is between 0ºC (32oF) and 37oC (99oF). Ambient
temperatures which exceed these limits could effect the accuracy of the
TYPE CF
DEFIBRILLATION PROOF
Installation and Maintenance Safety
System Safety and Specifications 7-15
instrument and cause damage to the components and circuits. Allow at least 5
cm (2 inches) clearance around the instrument for proper air circulation.
Grounding To protect hospital personnel, the cabinet of the Philips Telemetry System must
be grounded. Accordingly, the system is equipped with a detachable 3-wire
cable which grounds the instrument to the power line ground (protective earth)
when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not
available, consult the hospital electrician.
WarningWarning
Do not use a 3-wire to 2-wire adapter with this instrument. This ensures
optimal electrical safety.
Condensation Make sure that during operation, the instrument is free of condensation.
Condensation can form when equipment is moved from one building to another,
thus being exposed to moisture and difference in temperature.
WarningWarning
Possible explosive hazard if used in the presence of flammable anesthetics.
Installation and Maintenance Safety
7-16 System Safety and Specifications
Receiver
Mainframe
Rear Panel
The rear panel of the receiver mainframe is shown below.
The back of the mainframe should be removed only by qualified service
personnel. To remove the protective cover, unfasten screws, remove tab(s) from
slot(s), and lift the cover section off.
Connectors
The connectors on the rear panel of the receiver mainframe are:
Connector Description
AC Power 3-pin connector, used to input the local line
voltage. Mainframe plug is a standard IEC mains
inlet receptacle.
Analog Output (Patient
Monitor/Holter Interface)
- optional
High-density 50-pin SCSI connector to send
analog signal to output connector box
Antenna Input Signal BNC coaxial connector. Max voltage +25V DC
Not AC Power
Antenna Input
Signal Connector
Used Connector
Power Supply
Protective Equipotential
Grounding Lug
Earth
Green ON
CPC
Analog
Output
Connector
Board
SDN
Connectors
CPC Configuration
Connector
Cover
(optional)
(Ground)
Installation and Maintenance Safety
System Safety and Specifications 7-17
Secondary Ground Wire
A secondary ground wire is provided with this instrument to comply with IEC-
60601-1-1. This wire ensures against excessive chassis leakage current in the
event of a single fault in the health care facility's primary grounding means.
It is recommended that the secondary ground wire be used to connect the
Equipotential Grounding Lug to a ground source separate from the primary
grounding source found in the instrument's power source.
Note—After servicing, be certain to reconnect the secondary ground wire.
WarningWarning
Removal of the secondary grounding wire from the rear of the product
voids the IEC approval.
Lifting the Receiver Mainframe
The weight of the receiver mainframe is 13.8 kg (30.5 lb.). When carrying the
mainframe, please use proper lifting techniques
Antenna
Amplifiers
The antenna amplifiers must be operated only with the Power Supply (AC/DC
Adapter), and must be operated at a minimal distance of 2.43 meters (8 feet)
from the patient.
M26XXA/M14XX Series Antenna Components
For all voltages, use part number 453563647161.
Patient
Monitor/Holter
Interface
Option
If using the optional Patient Monitor/Holter Interface (Analog Output), the
connector box must only be operated with the appropriate power supply) and
must be operated at a minimum distance of 2.43 meters (8 feet) from the patient.
Equipotential Grounding
Lug
Grounding stud connector, used to equalize the
grounding potential between products (see
“Secondary Ground Wire”, below)
SDN Upstream and downstream connectors that connect
to the Philips monitoring network
Connector Description
Installation and Maintenance Safety
7-18 System Safety and Specifications
For all voltages, use Universal Power Converter (UPC), part number
453563647161.
Preventive Maintenance
Preventive maintenance should be performed by a qualified service person. The
Safety and Performance Tests, and what to do if the equipment does not meet
these specifications, are described in the Philips Telemetry System Service Guide
in the M2600B Documentation Kit. Contact your biomedical department if your
equipment needs testing for safety or performance.
End of Life There is no specific, predetermined end of life to the Philips Telemetry System
or any of its component products. Philips Medical Systems provides service,
support and replacement parts and assemblies throughout the support life of the
products that allow them to be repaired should any component of the system fail.
Please refer to the Philips Telemetry System Service Guide for instructions on
how to obtain service or replacement parts and for instructions on preventative
maintenance. Your local Philips Medical Systems sales or service representative
can provide you information regarding the support life of your products.
Additional Safety Information
System Safety and Specifications 7-19
Additional Safety Information
WarningWarning
The equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
WarningWarning
This device is not to be used in the vicinity of electrosurgery units because
use may interrupt or interfere with the transmission of signals from the
transmitter.
WarningWarning
Do not touch the patient, or table, or instruments during defibrillation. The
battery door must be closed during defibrillation. These steps protect the
clinician from high defibrillator voltage.
WarningWarning
Strangulation Hazard! Under no circumstances should any pouch be tied
solely around a patient’s neck.
WarningWarning
Do not use patient cables with detachable lead wires that have exposed male
pins. Electrocution could result if these pins are plugged into AC power.
Software
Hazard
Prevention
The minimization of hazards arising from errors in the software program is
documented in the following reports:
TO TRANSLATORS: text will follow.
System Specifications
7-20 System Safety and Specifications
System Specifications
This section lists the specifications for battery life, environmental and electrical
power specifications for the hardware components of the system, and
measurement specifications.
For complete specifications, see the M2600B Documentation Kit.
Battery Life Specifications
Note—The battery life times listed below are based on Duracell MN 1500
batteries. Battery life for other brands may be different.
Equipment Specification
Battery Type 2 fresh disposable AA alkaline batteries
Operating Mode Battery Life Battery Life
Japanese Version
ECG Only 39.6 hours, typically 44.71 hours, typically
ECG/SpO2 Continuous 16.7 hours, typically 17.01 hours, typically
ECG/SpO2 Spot Check between 14 hours and 41
hours, depending on usage
rate
between 15 hours and 45
hours, depending on usage
rate
System Specifications
System Safety and Specifications 7-21
Environmental Specifications
For all hardware components of the Philips Telemetry System except Philips
transmitters and reusable pulse oximetry sensors
Operating
Temperature Range: 0 to 55ºC (32 to 131ºF)
Altitude Range: Up to 4570 m (15,000 ft.)
Humidity Range: 15 to 95% relative humidity
Storage
Temperature Range: -40 to +70ºC (-40 to +158ºF)
Altitude Range: Up to 4570 m (15, 000 ft.)
Humidity Range: 90% relative humidity maximum
For Philips
Transmitters
Operating Temperature: 0 to 37 oC (32 to 99 oF)
Operating Humidity: < 95% RH at 40 oC (104 oF) non-condensing
Storage Temperature: -40 oC to 60 oC (-40 to 120 oF) without batteries
Storage Humidity: < 90% RH at 60 oC (120 oF) without batteries
Altitude, Operating and Non-operating: 0 to 3048 m (10,000 ft.)
For Philips
Reusable
Pulse
Oximetry
Sensors
Operating
Temperature Range: 15-37ºC (50-98.6º F)
Altitude Range: Up to 4570 m (15,000 ft.)
Humidity Range: 95% relative humidity at 37º C (98.6º F) maximum
Storage
Temperature Range: -40 to 70º C (-40 to 158º F)
Altitude Range: Up to 4570 m (15,000 ft.)
Storage Humidity: 95% relative humidity at 65º C (150º F) maximum
Water
Resistance
The transmitter can be used to monitor a patient in the shower for up to 10
minutes only when placed inside a Philips carrying pouch with the flap closed
and snaps secured. The transmitter will not be damaged if it is accidentally
immersed in liquid for up to 5 minutes.
System Specifications
7-22 System Safety and Specifications
After showering, perform the following steps to continue monitoring:
4. Pat dry the lead set connections at the electrodes.
5. Wipe the lead wires with care.
6. If wet, dry the outside of the transmitter with a non-lint producing cloth.
7. If wet, wipe the inside of the battery compartment dry. Dry the batteries.
8. If wet, disconnect the ECG lead block and shake out any water. Dry the
connector pin area with a cotton swab.
Note—The transmitter should not be used for monitoring if the battery
compartment is wet. Remove the batteries and wipe the compartment dry before
continued monitoring use.
WarningWarning
If the transmitter is used while showering a patient or is accidentally
immersed in liquid, detection of "leads off" conditions may be
compromised. Appropriate clinical precautions should be taken.
Electrical Power Specifications
Note—Specifications for earlier releases of the product may vary slightly.
M2601B
Transmitters
Frequency Range
406-480 MHz and 590-614 MHz, depending on option
Synthesizer Step Size
12.5 KHz
RF Output Power @ 25oC
Non-Japan transmitter: option #001 to option # 008: 6.5 dBm, +1.6/-2.0 dB (2.8
mW to 6.5 mW) not to exceed 10 dBm into Antenna load
Japan only: +0.8/-3.0 dBm (0.5 mW to 1.2 mW) into Antenna load
RF Output Power @ 0 - 45oC
RF Output Power @ 25oC +/- 1.25 dB into Antenna load
Adjacent Channel Power
< - 65 dBm at 25 KHz offset
Harmonic Levels (into Antenna)
For ETSI & CISPR-11 standards
System Specifications
System Safety and Specifications 7-23
47 - 118 MHz: < -54 dBm
118 - 174 MHz: < -46 dBm
174 - 230 MHz: < -54 dBm
230 - 470 MHz: < -38 dBm (excluding channel output)
470 - 862 MHz: < -54 dBm (excluding channel output)
862 - 1000 MHz: < -38 dBm
> 1000 MHz: < -30 dBm
Frequency Accuracy
Frequency @25oC +/- 2.5 ppm @ (0 - 45oC)
Occupied Bandwidth
< 10 KHz
Data Rate
9600 bits per second
Modulation Type
GMSK
RF Specifications in 608-614 WMTS Band
Frequency Ranges
Option Band #037: 608 - 614 MHz (WMTS)
RF Output Power @ 25oC
6.5 dBm, +1.6/-2.0 dB (2.8 mW to 6.5 mW) not to exceed 10 dBm into Antenna
load
RF Output Power @ 0 - 45oC
RF Output Power @ 25oC +/- 1.25 dB into Antenna load
Adjacent Channel Power
< - 65 dBm at 25 KHz offset
Harmonic Levels (into Antenna)
For FCC & Canadian standards
30 - 88 MHz: < -56 dBm (< 50 dBm in US)
88 - 174 MHz: < -52 dBm (< 50 dBm in US)
174 - 230 MHz: < -54 dBm (< 50 dBm in US)
230 - 960 MHz: < -50 dBm (excluding channel output)
> 960 MHz: < -42 dBm
System Specifications
7-24 System Safety and Specifications
Defibrillator Protection
Transmitter ECG input protected against 400 joules discharge into 50 Ohm load
Batteries
Two disposable 1.5V Alkaline batteries
M2604A
Receiver Main
Frame with
453563489161
Power Supply
Input Voltage
100-240 VAC
Frequency Range
50 to 60 Hz
Power Consumption
For M2604A: 110 VA maximum, average with 8 M2603A receiver modules
Controls
Front Panel: none
Rear Panel: none
Indicators
Front Panel: Green Instrument Power On LED
Red Instrument Malfunction LED
Rear Panel: Green Power Supply On LED
Connections (rear)
AC Power connector
Analog Output connector
Antenna Input Signal connector
Grounding lug
Downstream SDN connector
Upstream SDN connector
CPC Configuration connector
Radiated Immunity
3 Volts/Meter outside of operating receiver bands
System Specifications
System Safety and Specifications 7-25
M2603A
Receiver
Module
Frequency Tuning
Programmable, synthesizer, PLL controlled.
Channel Spacing
25 kHz.
Carrier Frequency Range
Frequency range depends on transmitter option
Patient
Monitor Holter
Recorder
Interface
(Analog
Output)
Option J01
Power Module
453563647161
Input Voltage
100-240 VAC +/- 10%
Frequency Range
47 - 63 Hz.
Power Consumption
33 VA maximum
Analog Output Gain (from output of receiver module)
High-level outputs: 500 + 5%
Low-level outputs: 1 +7%/-6%
Inoperative Mode (Technical Alarm Condition) Output Level
High-level output: 10.8 volts + 1.2 volts
Low-level output: >100 megohms with respect to reference electrode
Delay from Transmitter Input to Analog Output
400 milliseconds max -- Philips transmitter
Not intended for use with synchronized cardioversion due to processing delay.
Indicators
Output Connector Box; Status and Power LEDs
Connections
Output Connector Box: Input (50-pin jack); Input (Power Module); Output (8
pairs of 9-pin D connectors)
Analog Output Card: Output (50-pin jack)
System Specifications
7-26 System Safety and Specifications
Bedside Attenuator: Output (3-conductor phone jack)
Holter Attenuator: Output (set of 5-button connectors)
ECG Bandwidth
M2601B: 0.5 - 40 Hz
Antenna System Specifications
M2606A Line
Amplifier
Input Voltage
19-32 VDC
Current Requirements
38 mA, maximum
Power Consumption
0.75 Watts, average
RF Frequency Range
406-650 MHz
RF Gain
12.0 dB typical at 406 MHz
12.7 dB typical at 465 MHz
13.3 dB typical at 611 MHz
13.2 dB typical at 650 MHz
Indicators
Green LED indicates DC power is applied to the RF Output connector.
Yellow LED indicates DC power is applied to the RF Input connector.
To ensure proper operation, installation and
setup must be performed by a Philips Medical
Systems service representative or designee
according to the instructions in Patient Monitor/
Holter Recorder Interface (Analog Output)
Installation Note (part number M2600-90194).
System Specifications
System Safety and Specifications 7-27
M2607A
Multiple Unit
Power Supply
Note—M2607A specifications cover both power module and power tee.
Input Voltage
CE Mark Power Module 453563647161: 100-240 VAC +/- 10%
Frequency Range
47-63 Hz
RF Frequency Range
406-650 MHz
Power Consumption
33 VA maximum
Output Voltage
23 VDC nominal
Output Current
1 Amp maximum (Limited by the circuit breaker in the power tee)
Indicators
Green LED is on when power is present.
M2608A Active
Antenna/
Combiner
Input Voltage
19 - 32 VDC
Input Current
62 mA maximum
Power Consumption
1.1 Watts average (2.0 Watts maximum)
RF Frequency Range
406-650 MHz
RF Gain
Indicators
Green LED indicates DC power/signal cable connected correctly.
Antenna Port 9.7 dB +/- 1.0 dB at 406 MHz
10.2 dB +/- 1.0 dB at 465 MHz
9.7 dB +/- 1.0 dB at 611 MHz
9.7 dB +/- 1.5 dB at 650 MHz
Line Port 3.2 dB +/- 0.7 dB at 406 MHz
3.5 dB +/- 0.3 dB at 465 MHz
3.9 dB +/- 0.7 dB at 611 MHz
4.0 dB +/- 0.7 dB at 650 MHz
System Specifications
7-28 System Safety and Specifications
Red LED indicates DC power/signal cable connected incorrectly.
M2609A
Attenuator
Current Carrying Capacity
Maximum DC Voltage: +30 VDC maximum
Maximum DC Current: 1 A maximum
RF Frequency Range:
406-650 MHz
RF Attenuation
1-9 dB in increments of 1 dB, based on option
M2612A
Bandpass
Filter
Current Carrying Capacity
Maximum DC Voltage: 32 Volts
Maximum DC Current: 1 A
Power Requirements
Negligible
RF Frequency Range
#004 430-440 MHz
#005 440-450 MHz
#006 450-460 MHz
#007 460-470 MHz
#034 590-596 MHz
#035 596-602 MHz
#036 602-608 MHz
#037 608-614 MHz
Indicators
Green LED is ON when power is present.
M2616A
External
Frequency
Converter
Input Voltage
CE Mark Power Module 453563647161: 100-240 VAC +/- 10%
Frequency Range
47-63 Hz
System Specifications
System Safety and Specifications 7-29
Power Consumption
14.0 VA maximum
RF Input Frequency Range
590-632 MHz
RF Output Frequency Ranges
#130 460-502 MHz
#136 454-496 MHz
#142 448-490 MHz
#148 442-484 MHz
#154 436-478 MHz
#160 430-472 MHz
#166 424-466 MHz
Indicators
Green LED is ON when power is present.
System Specifications
7-30 System Safety and Specifications
Measurement Specifications
ECG ECG channel transmitted leads
3 electrodes
Channel #1: I, II, or III
5 electrodes
Channel #1: II
Channel #2: III
Channel #3: MCL
5 electrodes, EASI
Channel #1: Vai
Channel #2: Vas
Channel #3: Ves
Resolution
5 µV
ECG Input
Differential, defibrillator protected against 400 joules discharge into a 50 ohm
load
Input Impedance
> 5 megohms (@ 10 Hz
Input Dynamic Range
+/- 9 mmV (EASI mode, +/-4.7mV)
DC Offset Range
+/- 320 mV
CMRR
+/- 90 dB @ 50, 60 Hz
Bandwidth +/- 3 dB
0.05 to 40 Hz
Gain Accuracy
+/- 5% at 25oC (77oF)
Noise Referred to ECG Input
AAMI: 30 µV
System Specifications
System Safety and Specifications 7-31
Lead Wires
3 or 5-wire set. 5-lead compatible with IntelliVue Patient Monitor, AAMI or
IEC color code
Time to baseline from Defibrillator
AAMI: 5 s max (until ECG wave is on display but not yet centered, monitoring
bandwidth)
Pacer Rejection Performance (pace pulses with no tails)
Positive pacers
Amplitude Width
+2 to +700 mV 0.1, 0.2, 0.5, and 1.0 ms
+2 to +500 mV 1.5 ms
+2 to +400 mV 2 ms
Negative pacers
Amplitude Width
-2 to -700 mV 0.1, 0.2, 0.5, and 1.0 ms
-2 to -500 mV 1.5 ms
-2 to -400 mV 2 ms
EMC Performance limits, radiated immunity
Meets Essential Performance, No HR, PVC or Alarm error. But may observe
some waveform disturbance in the range 45.00 to 65.00 MHz at levels greater
than 2.0 Vrms.
Cardiotach Alarm (Standard ECG only)
Information Center selectable, in 5 b/min. increments.
High: 20 - 250 b/min.
Low: 15 - 245 b/min.
Cardiotach Display (Standard ECG only): 15 - 300 b/min.
Accuracy
Gain: +/- 5% at 25o C (77o F)
Cardiotach (Standard ECG only): +/- 3 beats plus +/- 2% of heart rate for
constant rate input.
At fewer than 15 b/min., the heart rate indication is 0.
Cardiotach Alarm (Standard ECG only): +/- 1 b/min., of displayed value
Display
Displayed values are presented in whole numbers.
System Specifications
7-32 System Safety and Specifications
SpO2Measurement Range (Calibration and Display)
0-100%
Display of SpO2Numerics
SpO2 values are displayed as xxx % SpO2 to meet ISO/EN standard EN 865
Accuracy
See tables, following
Resolution
1%
SpO2 Numerics Averaging
10 seconds
SpO2 & Pulse Numerics - Update Rate
Transmitted once per second
Pleth Wave - Sampling Rate
125 sps
Technical Alarms
Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is
noisy, if light interference is detected, if the sensor is defective, if the
measurement is erratic, or if the module is malfunctioning
Pulse Rate Measurement (available only with Continuous SpO2)
Range: 30 - 300 b/min.
Accuracy: +/- 2%
Resolution: 1 b/min.
Calibration
Automatic self-calibration when device is turned on. The pulse oximeter is
calibrated to display functional saturation.
System Specifications
System Safety and Specifications 7-33
Sensor
Accuracy
.
Type Description Model
Number
Accuracy%
Arms (70-100%
Range)
Philips
Reusable
Sensors
Adult Finger M1191A 2.0
Adult Finger M1191AL 2.0
Adult Finger M1191NL 2.0
Pediatric Finger M1192A 2.0
Pediatric Finger M1192N 2.0
Adult/Pediatric Ear M1194A 3.0
Adult/Pediatric Ear M1194N 3.0
Type Description Model
Number
Accuracy%
Arms (70-100%
Range)
Philips
Disposable
Sensors
Adult Finger M1901B 3.0
Pediatric Finger M1903B 3.0
Adult Finger M1904B 3.0
System Specifications
7-34 System Safety and Specifications
Nellcor
Disposable
Sensors (not
available
from Philips)
OxiCliq A, Adult N/A 3.0
OxiCliq N, Adult >40 kg (88
lb)
N/A 3.0
OxiCliq P, Pediatric N/A 3.0
OxiMax MAX-A, Adult >30
kg (66 lb)
N/A 3.0
OxiMax MAX-AL, Adult >30
kg (>66 lb)
N/A 3.0
OxiMax MAX-N, Adult >40
kg (>88 lb)
N/A 3.0
OxiMax MAX-P, Pediatric N/A 3.0
Oxisensor II D-20, Pediatric
10-50 kg (22-110 lb)
N/A 3.0
Oxisensor II D-25, Adult >30
kg (>66 lb)
N/A 3.0
Oxisensor II N-25, Adult >40
kg (>88 lb)
N/A 3.0
Type Description Model
Number
Accuracy%
Arms (70-100%
Range)
A-1
Introduction
A
Optional Patient Monitor/
Holter Interface (Analog
Output)
This chapter describes the optional Patient Monitor/Holter Interface (Analog
Output). It includes the following sections:
• Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2
• Analog Output Bedside Monitor Cables. . . . . . . . . . . . . . . . . . . . . . . .A-3
• Lead Placement and Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5
• Controls for Telemetry Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6
• Functionality with Paced Waves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6
• Technical Alarms (Inoperative Conditions) . . . . . . . . . . . . . . . . . . . . .A-7
• Holter Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-8
Overview
A-2
Overview
The optional Patient Monitor/Holter Interface (Analog Output) gives the Philips
Telemetry System the capability of providing ECG outputs to bedside monitors,
holter monitors, and other recording devices. This option is not available for
telemetry systems with EASI monitoring.
WarningWarning
The Patient Monitor/Holter Interface (Analog Output) Option is intended
for display and recording purposes only. The following should not be used
with this option:
- Synchronized cardioversion
- Intra-aortic balloon pump
Inherent delays in the telemetry transmitter, receiver, and the analog
output processing cause significant time lags between actual ECG
occurrence and the signal required to trigger the defibrillator or intra-
aortic balloon pump. Failure to adhere to this warning could cause serious
injury to the patient.
Correct
Labeling
To ensure correct lead labeling at the bedside monitor, the following should be
used:
• Correct bedside monitor cable. See the table on page A-4.
• Standard lead placement
• Valid lead selection at the bedside monitor. See “Lead Placement and
Selection” on page A-5.
Not adhering to these recommendations may result in mislabeled leads or an
invalid display.
Analog Output Bedside Monitor Cables
A-3
Analog Output Bedside Monitor Cables
To connect the telemetry transmitter to the bedside monitor via the optional
Patient Monitor/Holter Interface (Analog Output), you will need an analog
output bedside monitor cable.
The end of the cable that connects to the bedside monitor will have either a
small 12-pin connector or a larger 8-pin connector (See the illustration below).
The other end of the cable has a phone plug connector, and it plugs into the
wallplate.
Note—When using the analog output option for the Philips Telemetry System,
this cable will replace the bedside monitor patient cable.
There are four different analog output bedside monitor cables. The cable you use
depends upon whether the input connector on your bedside monitor is 8-pin or
12-pin and whether your transmitter lead set is 3- or 5-wire.
The table on page A-5 summarizes the proper cable selection. The 3-wire cables
can be distinguished from the 5-wire cable by the attached label (see page A-5).
The lead set type also determines which are the valid leads to be selected at the
bedside. Appropriate use of each cable type is illustrated on a label attached to
the cable (see page A-5).
8 Pin
12 Pin
Analog Output Bedside Monitor Cables
A-4
The following table shows all available analog output bedside monitoring
cables.
Caution
To ensure correct lead labeling at the bedside monitor, it is important that you
use the correct bedside monitor cable.
Lead Set Bedside Monitor
Cable Connector
Analog Output Bedside
Monitor Cable
3-wire lead set 8-pin (large)
12-pin (small)
HP78599AI-#K71
HP78599AI-#K72
5-wire lead set 8-pin (large)
12-pin (small)
HP78599AI-#K73
HP78599AI-#K74
Lead Placement and Selection
A-5
Lead Placement and Selection
To ensure valid waves with the correct lead label, you must remember to use the
following:
• Standard lead placement (shown on the telemetry transmitter case and in
further detail in IntelliVue Information Center or TeleMon On-line Help).
• Valid lead selection (performed at the bedside monitor)
The following table summarizes recommended lead placement and selection.
Caution
To ensure correct lead labeling at the bedside monitor, standard lead placement
and valid lead selection must be used. Not adhering to these
recommendations may result in mislabeled leads or an invalid
display.
Using Non-
Standard
Lead
Placement
With the 3- and 5-wire lead set, you can use non-standard lead placement, but
you must still use a valid lead label selection at the bedside monitor.
This will give you the desired waveform, but it will result in a mislabeled lead at
the bedside monitor.
Lead Set Lead Placement Valid Lead Selection on
Bedside Monitor
3-wire Standard II
5-wire Standard II, MCL
Controls for Telemetry Setup
A-6
Controls for Telemetry Setup
The interaction with ECG depends on how the system is installed. If it is
installed so that you can make changes from the IntelliVue Information Center,
the interface for lead and size selection is the same as described in “Changing
Lead/Label” on page 3-18. If not, make adjustments at the bedside monitor.
Functionality with Paced Waves
In order for paced waves to be processed correctly by bedside monitors using the
analog outputs, the pace pulses must be artificially reconstructed and inserted
into the analog output signals. The synthesized pace pulse is very narrow and
may not be visible at the bedside display, depending on the type of monitor
used.
WarningWarning
To ensure proper cardiotach performance, diagnostic bandwidth (filter off)
should be selected at the bedside monitor when monitoring paced patients
with a transmitter.
Technical Alarms (Inoperative Conditions)
A-7
Technical Alarms (Inoperative Conditions)
With the Patient Monitor/Holter Interface (Analog Output) Option, the
following telemetry technical alarms (inoperative conditions) will appear as a
LEADS OFF message at the bedside monitor.
1. LEADS OFF
2. NO SIGNAL
3. TEL CANNOT ANALYZE
4. REPLACE BATTERY
5. INTERFERENCE
6. RECEIVER MALF
7. NO RECEIVER
8. TRANSMITTER MALF
9. ECG EQUIP MALF
10. TRANSMITTER OFF
11. INVALID LEAD SET
If telemetry controls are located at the bedside monitor, (see “Controls for
Telemetry Setup” on page A-6, these technical alarms appear as a LEADS OFF
message at the IntelliVue Information Center.
Note—See Chapter 2, “Alarms” for information about the specific alarm
messages.
Holter Interface
A-8
Holter Interface
If you are using a holter monitor, it should be connected to a holter wallplate.
WarningWarning
Using a holter wallplate to interface to a bedside monitor could result in
mislabeled leads.
B-1
Introduction
B
Accessory List
This appendix lists all ECG and SpO2 accessories that can be used with the
transmitter.
For additional information on connecting and using these accessories, see the
individual parameter chapters.
Note—Accessories are subject to change. To get the latest accessories,
visit the Philips Medical Supplies website located at the following
address: http://shop.medical.philips.com.
Accessory Safety
WarningWarning
Reuse: Never reuse disposable sensors, accessories and so forth that are
intended for single use, or single patient use only.
Philips’s approval: Use only Philips-approved accessories.
Packaging: Do not use a sterilized accessory if the packaging is damaged.
ECG Accessories
B-2
ECG Accessories
Electrodes
Lead Sets
Order Number Description
M2202A 60 packages of 5 radio translucent foam electrodes (300
per box)
40489E 10 packages of 30 paper tape electrodes (300 per box)
40493D 60 packages of 5 foam electrodes (300 per box)
40493E 10 packages of 30 foam electrodes (300 per box)
Order Number Description
989803133831 3-wire, patient cable set, 79 cm (30”), AAMI, Snap
989803133841 3-wire, patient cable set, 79 cm (30”), AAMI, Grabber
989803133851 3-wire, patient cable set, 79 cm (30”), IEC, Snap
989803133861 3-wire, patient cable set, 79 cm (30”), IEC, Grabber
989803133871 5-wire, patient cable set, 79 cm (30”), AAMI, Snap
989803133881 5-wire, patient cable set, 79 cm (30”), AAMI, Grabber
989803133891 5-wire, patient cable set, 79 cm (30”), IEC, Snap
989803133901 5-wire, patient cable set, 79 cm (30”), IEC, Grabber
989803137241 Colored 5-wire, patient cable set, 79 cm (30”), AAMI,
Snap
989803137251 Colored 5-wire, patient cable set, 79 cm (30”), AAMI,
Grabber
ECG Accessories
B-3
Skin Prep
Paper
Alignment
Guides
Gunk Guards
989803137261 Colored 5-wire, patient cable set, 79 cm (30”), IEC,
Snap
989803137271 Colored 5-wire, patient cable set, 79 cm (30”), IEC,
Grabber
Order Number Description
Order Number Description
989803134771 Skin preparation sheets, 10 preps/sheet, 10 sheets/
package
Order Number Description
989803140401 Single, package of 10
989803140411 Single tethered, package of 10
989803140421 Double, package of 10
Order Number Description
989803140431 ECG, package of 10
989803140441 SpO2, package of 10
SpO2 Accessories
B-4
Pouches
Trunk Cable
SpO2 Accessories
Reusable
Sensors
Order Number Description
989803137831 Telemetry pouch, box of 50
989803140371 Telemetry pouch, case of 200
Order Number Description
989803137841 5-wire ECG trunk cable
Order Number Description
M1191A Philips Adult finger, 2 m (6.6 feet)
M1191AL Philips Adult finger, 3 m (9.8 feet)
M1191NL Philips Adult finger, 3 m (9.8 feet)
M1192A Philips Pediatric finger 1.5 m (4.9 feet)
M1192N Philips Pediatric finger, 1.5 m (4.9 feet)
M1194A Philips Adult & Pediatric ear, 1.5 m (4.9 feet)
M1194N Philips Adult & Pediatric ear, 1.5 m (4.9 feet)
SpO2 Accessories
B-5
Disposable
Sensors -
Single Use
Note—OxiCliq, OxiMax and Oxisensor II sensors are not available from Philips
in the USA or Canada. Adapter cables are not available from Philips in Canada
or Japan. In those countries, contact Nellcor Incorporated directly.
Order Number Description
M1901B Philips Adult >40 kg (>88 lb)
M1903B Philips Pediatric 10-50 kg (22-110 lb)
M1904B Philips Adult >30 kg (>66 lb)
N/A from Philips *Nellcor Adhesive OxiCliq A, Adult
N/A from Philips *Nellcor Adhesive OxiCliq N, Adult >40kg (>88 lb)
N/A from Philips *Nellcor Adhesive OxiCliq P, Pediatric
N/A from Philips *Nellcor OxiMax MAX-A, Adult >30 kg (>66 lb)
N/A from Philips *Nellcor OxiMax MAX-AL, Adult >30 kg (>66 lb)
N/A from Philips *Nellcor OxiMax MAX-N, Adult >40 kg (>88 kg)
N/A from Philips *Nellcor OxiMax MAX-P, Pediatric 10-50 kg (22-110
lb)
N/A from Philips *Nellcor Oxisensor II D-20, Pediatric 10-50 kg (22-
110 lb)
N/A from Philips *Nellcor Oxisensor II D-25, Adult >30 kg (>66 lb)
N/A from Philips *Nellcor Oxisensor II N-25, Adult >40 kg (>88 lb)
M1943A Adapter cable for Nellcor SpO2 sensor, 2 m (6.6 ft)
M1943AL Adapter cable for Nellcor SpO2 sensor, 3 m (9.8 ft)
* Uses reusable OC-3 Sensor Cable.
SpO2 Accessories
B-6
Wristband
Order Number Description
M1627A 10 bands per pack
C-1
Introduction
C
Sales and Support Offices
For more information, please call your local Philips Medical Systems sales
office listed in your telephone directory or a Philips Medical Systems regional
office listed below for the location of your nearest sales office.
Corporate Headquarters:
Philips Medical Systems
Netherlands B.V.
Postbus 10.000
5680 DA Best
Netherlands
United States
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
(800) 934-7372
Canada
Philips Medical Systems Canada
281 Hillmount Road
Markham, ON
L6C 2S3
(800) 291-6743
Europe, Middle East and Africa
Philips Medizinsysteme Böblingen GmbH
Cardiac and Monitoring Systems
Hewlett-Packard Str. 2
71034 Boeblingen
Germany
Fax: (+49) 7031 463 1552
C-2
Latin America Headquarters
Philips Medical Systems
5200 Blue Lagoon Drive
9th Floor
Miami, FL 33126
(305) 267-4220
Asia Pacific Headquarters
Philips Medical Systems
24F Cityplaza One
1111 King’s Road
Taikoo Shing, Hong Kong
(+852) 3197 7777
1
A
accessories
ECG, B-2
ordering information, B-1
SpO2, B-4
alarms
behavior with Own Bed Overview, 2-3
list of physiologic, 2-6
list of technical (INOPs), 2-11
pause/suspend, 2-2
SpO2, turn on/off, 5-22
testing, 6-2
ambient light
effect on SpO2, 5-24
analog output, 7-17
bedside monitor cables, A-3
INOPs, A-7
lead labeling, A-2
lead placement and selection, A-5
making adjustments, A-6
use with paced waves, A-6
antenna amplifiers, 7-17
arrhythmia
ST/AR algorithm, 3-28
artifact, muscle and movement, 3-24
auditory signals
definition, 1-18
automatic shutoff
transmitter, 1-23
B
batteries
disposal, 1-30
gauge indicators, 1-32
life, 1-30
power level, 1-32
safety information, 1-29
C
Check Button, 1-12
classification information, 7-3
cleaning
receiver mainframe, 6-15
system, 6-3
compliance
Canadian radio equipment, 7-7
FCC, 7-7
system, 7-2
configuration
changing, 6-19
settings, 6-17
connectors
receiver mainframe, 7-16
continuous SpO2 measurement, 5-20
D
defibrillation
type of proof against, 7-14
dropouts, 3-23
E
EASI
sourced waves, 3-5
ST, 4-2
ECG
changing lead/labels, 3-18
lead sets, 3-2
leads available, 3-4
measurement, 3-2
minimizing artifact (noise), 3-24
reconstructed leads, 3-6
RF interference, 3-24
safety information, 3-27
signal too low, 3-23
ECG monitoring
electrode site preparation, 3-7
optimizing performance, 3-22
preparation for, 3-7
Index 2
ECG noise
troubleshooting, 3-24
ECG waves
changing size, 3-19
electromagnetic compatibility, 7-5
essential performance, 7-4
EU representative, address, 7-3
Extended Monitoring, 3-20
F
fallback
EASI, 3-20
multilead/singlelead analysis, 3-20
FAST SpO2 algorithm, 5-2
G
grounding, telemetry, 7-15
H
Holter Interface option
see analog output
I
indications for use, 1-5
instructions to patient, 1-19
IntelliVue TRx transceiver, 1-9
L
labels
changing ECG, 3-18
lead sets, 3-2
capabilities, 3-18
leads
changing, 3-18
leads off
monitoring during, 3-19
M
M2600B Philips Telemetry System
new functionality, 1-2
maintenance
preventive, 7-18
system, 6-3
measurement points, ST, 4-3
N
noise
eliminating, 3-24
Nurse Call
turn on/off, 1-23
O
Own Bed Overview
alarm behavior, 2-3
description, 1-4
P
paced patients
safety, 3-32
using analog outputs, A-6
patient
instructions to, 1-19
skin preparation, 3-7
Patient Monitor/Holter Interface option
see analog output
pause/suspend alarms, 2-2
pouch
how to use, 1-20
securing, 1-20
power
specifications, 7-22
pulse
audio signal, 5-23
turn on/off, 5-23
R
receiver mainframe, 1-35
cleaning, 6-15
connectors, 7-16
rear panel, 7-16
3
retaining settings, 1-35
turning on/off, 1-35
RF interference, 3-23, 3-24
reducing, 7-6
restrictions for use, 7-7
S
safety
accessories, B-1
installation, 7-14
maintenance, 7-14
pacing, 3-32
pouch, 1-20
ST/AR arrhythmia, 3-31
safety information, 7-19
sensors
adult finger, 5-14
application safety information, 5-12
applying, 5-12
ear clip, 5-16
positioning, 5-13
selecting, 5-25
small adult/pediatric, 5-15
showering
drying transmitter, 1-22
use of transmitter, 1-21
signal too low (ECG)
action to take, 3-23
Smart Limits
ST, 4-9
sounds
description of, 1-18
specifications
analog output, 7-25
antenna system, 7-26
battery life, 7-20
ECG measurements, 7-30
environmental, 7-21
environmental, SpO2 sensors, 7-21
environmental, transmitter, 7-21
mainframe, 7-24
Patient Monitor or Holter Interface, 7-25
power, 7-22
receiver module, 7-25
SpO2 measurements, 7-32
SpO2 sensors, 7-33
transmitter, power, 7-22
SpO2
alarm behavior, 5-25
alarms, turn on/off, 5-22
ambient light, effect of, 5-24
applying sensors, 5-12
auto on/off, 5-22
continuous measurement, 5-20
FAST algorithm, 5-2
measurement limitations, 5-24
measurement method, 5-2
obtaining accurate measurements, 5-24
preparation for monitoring, 5-7
reusable sensors, 5-8
selecting sensors, 5-12
spot check measurements, 5-19
troubleshooting, 5-24
turn on/off, 5-20
turn parameter on/off, 5-21
types of measurements, 5-18
types of sensors
SpO2
disposable sensors,5-8
spot check measurements, 5-19
ST
alarm adjustments, 4-9
analysis, 4-2
EASI analysis, 4-4
intended use, 4-2
measurement, 4-3
patient population, 4-2
smart limits, 4-9
turn on/off, 4-7
viewing data, 4-4
Index 4
ST/AR arrhythmia analysis, 3-28
standby mode, 1-24
symbols
explanation of, 7-9
system
classification, 7-3
compliance, Canadian radio equipment, 7-7
components, 1-7
diagram of, 1-8
electromagnetic compatibility, 7-5
environmental specifications, 7-21
essential performance, 7-4
FCC compliance, 7-7
indications for use, 1-5
intended use, 1-6
regulatory information, 1-6
RF interference, 7-6
safety compliance, 7-2
symbols, 7-9
transmitters used with, 1-9
warnings, 7-4
T
technical alarms
analog output, A-7
telemetry
changing lead/label, 3-18
dropouts, 3-23
grounding, 7-15
muscle and movement artifact, 3-24
noise, 3-24
on/off, 1-34
Patient Monitor/Holter Interface option, 7-17
receiver mainframe, 7-16
retaining settings, 1-35
RF INOPs, 3-23
standby mode, 1-24
suspending monitoring, 1-24
Telemetry button, 1-12, 1-23
TeleMon
operation when connected, 1-25
SpO2 measurement modes, 5-18
use with M2601A/B transmitter, 1-25
transmitter
automatic shutoff, 1-23
battery disposal, 1-30
battery life, 1-30
controls on back, 1-15
controls on front, 1-11
M2601A, 1-9
M2601B and M2601A comparison, 1-2
M2601B features, 1-10
pouch use, 1-19
safety warnings, 1-18
sounds, 1-18
turning on/off, 1-22
use in shower, 1-21
wetting, 1-22
where worn, 1-19
troubleshooting, 6-2
ECG noise, 3-24
SpO2, 5-24
turn on/off
pulse parameter, 5-23
SpO2, 5-20
SpO2 alarms, 5-22
SpO2 parameter, 5-21
ST, 4-7
transmitter, 1-22
W
warnings
system, 7-4
waves
changing size on display/recordings, 3-19
wetting
use of transmitter, 1-22