Philips Medical Systems North America M2600 Biomedical Transmitter User Manual Part 1

Philips Medical Systems North America Co. Biomedical Transmitter Users Manual Part 1

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Users Manual Part 1

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Document ID166622
Application ID8VnymlNoeDyT6gvaHWY1kA==
Document DescriptionUsers Manual Part 1
Short Term ConfidentialNo
Permanent ConfidentialNo
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Document TypeUser Manual
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Date Submitted2001-08-27 00:00:00
Date Available2001-10-22 00:00:00
Creation Date2001-08-24 09:46:25
Document Lastmod0000-00-00 00:00:00
Document TitleUsers Manual Part 1
Document CreatorHP 9100C Digital Sender
Document Author: JONATHAN

User’s Reference Manual
HP Viridia Telemetry System
[413 2535.15
HP Part No. M2600~90039
Printed in U.S.A. May 1997
First Edition
Notice HEWLETT-PACKARD MAKES NO WARRANTY OF
ANY KIND WITH REGARD TO THIS MATERIAL,
INCLUDING, BUT NOT LIMITED TO, THE
IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE.
Hewlett-Packard shall not be liable for errors contained
herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of
this material.
This document contains proprietary information, which
is protected by copyright. All rights are reserved. No
part of this document may be photocopied, reproduced
or translated to another language without prior written
consent of Hewlett-Packard Company. The information
contained in this document is subject to change without
notice.
Responsibility of the Hewlett-Packard only considers itself responsible for
manufacturer any effects on safety, reliability and performance of the
equipment if:
assembly operations, extensions, re-adjustments,
modifications or repairs are carried out by persons
authorized by HP, and
the electrical installation of the relevant room complies
with national standards, and
the instrument is used in accordance with the
instructions for use.
© Hewlett-Packard Company 1992, 1993, 1994, 1996,
1997. All rights reserved.
rhfle—wm . .. “W." . ,,__.__.‘________M¥,,,..,m.__, ,, c _. ,r..,..c_r..,,s._n-.,,.__,__._____....
Intended Use
The HP Viridia Telemetry System (M2600A) is a
comprehensive ambulatory system solution for the
intermediate care unit. The foundation of the solution is
a transmitter that can capture and transmit ECG signals
and SpOz values which are then processed and displayed
on the HP OmniCare Component Central Monitor. The
central monitor generates alarms and recordings, thus
notifying clinicians of changes in patients’ conditions.
The Telemetry System communicates with other devices
via the HP Viridia monitoring network (SDN). The HP
Viridja Wave Viewer is intended for use at the patient’s
side for assistance in ECG electrode and 51302 sensor
positioning.
_——_—‘——-———“_
Patient Population
The HP Viridia Telemetry System provides monitoring
for adult and pediatric patients.
Environment
Caution ‘
The HP Viridia Telemetry System is designed for use in
health care facilities by trained health care professionals.
It is not for home use.
United States law restricts this device to sale by or on
the order of a physician.
This device provides ST level change information; the
clinical significance of the ST level change information
should be determined by a physician.
System Safety
Standards
The HP Viridia Telemetry System (except the HP
Viridia Wave Viewer) complies with the following
international safety requirements for medical electrical
equipment:
I UL2601-1
l CSA 22.2 601.1
| IEC 601-1
I IEC 606-1-1
- AAMI Voluntary Performance Standards for Cardiac
Monitors: Sections 3.1.2.1.c, 3.2.6.1.a—c, 3.2.6.2,
3.2.6.3, 3.2.7, 3.2.8.3, 3.2.8.4, 3.2.8.7, 3.2.9.2, 3.2.9.3,
and 3.1.4.1
The system is protected against the effects of
defibrillation and electrosurgery.
The HP Viridia Wave Viewer complies with UL General
Safety requirements.
Conventions Used
in This Manual
Warning 0
Caution '
Note 6
iv
A “warning” calls attention to the user of imminent hazard
to people it proper procedures are not followed.
A “caution” calls attention to a condition or possible
situation that could cause injury to the user.
Notes contain additional information on HP Viridia
Telemetry System usage.
Warnings
Warning 6
Warning 6
The following warnings apply to the HP Viridia
Telemetry System.
General System
I DO NOT TOUCH THE PATIENT, BED, OR INSTRUMENT
DURING DEFIBRILLATION.
I A possible explosive hazard exists it the system is
used in the presence of flammable anesthetics.
I Do not use a 3-w'l'e to 2-wire adapter with this
instrument.
- Removal of the secondary g’ounding wire from the rear
of the product voids the EC approval.
- Power modules for analog output, antennas, and
palmtop personal computers (wave viewer) must not be
installed or used within an 8’ radius of the patient.
ECG Monitoring
I ll you are using a 3-wire cable (or the S-wire cable
with the M1400A/B transmitter), Hewlett-Packard
recommends you do not use Change Label except
to select the correct labels which reflect the physical
placement of the electrodes. This will ensue that the
monitored lead and the label match, and prevent any
possible contusion.
I Hewlett-Packard recommends you do not turn
telemetry oft when a patient leaves the area. Instead,
acknowledge the INOP when the patient leaves
the telemetered range. Monitoring will resume
automatically when the patient returns. However, it you
do turn telemetry monitoring oft, you must remember to
turn it back on when the patient returns to the area.
l The Exercise bandwidth should not be used on
ECG-CHf for paced patients. The pace pulse may be
sufficiently distorted and be inadvertently detected as 5
QRS complex which could lead to missed detection of
cardiac arrest.
I The Exercise bandwidth should not be used when
arrhythmia monitoring is turned on.
a Do not touch the patient, bed or instrument during
defibrillation.
I Pacemakers can be susceptible to radio frequency
(RF) interference which may temporarily impa'n' their
performance.
The output power of telemetry transmitters and other
sources of radio frequency energy, when used in
the proximity of a pacemaker, may be sufficient to
interfere with the pacemaker’s 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.
Consult the pacemaker manufacturer for information on
the RF susceptibility of the: products and the use of
their products with the telemetry transmitters.
In order to minlmize the possiblity of interference.
position electrodes, electrode wires, and transmitter as
far away from the pacemaker as possible.
- Du‘ing complete heart block or pacemaker failure to
pace/capture, tall P-waves (greater than 1/8 of the
average R-wave height) may be erroneously counted
by the monitor, resulting in missed detection of cardiac
arrest.
l The monitor may continue to count pacemaker pulses
or pace pulse repolarization tails, resulting in a false
Warning 6
, e.-. . . A . , _. Mme,”
heart rate during cardiac arrest or some arrhythmias.
Keep pacemaker patients under close observation.
I 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 tailure and possible health
hazards.
I If you are cleaning the transmitter or receiver
mainframe with a flammable liquid, prevent fire by
providing adequate ventilation, and avoid smoking.
Disconnect the power from the the receiver mainframe
to prevent electrical shock and accidental turn-on.
SpOz Transducer Application
I Failure to apply the transducer properly may cause
incorrect measu'ement of Spoz.
I 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 it any
compromise in skin quality should occur.
I Using a transducer during MR imaging can cause
severe burns. To minimize this risk, ensure that the
cable is positioned so that no inductive loops are
formed. It the transducer does not appear to be
operating properly, remove it immediately from the
pafienL
I Using a transducer in the presence of bright lights may
result in inaccurate measurements. ln such cases,
cover the site with opaque material.
I Injected dyes, such as methylene blue, or mtravascular
dyshemoglobins, such as methemoglobin, may lead to
inaccurate measurements.
vii
Warning a
I Performance may be compromised by excessive
motion. This can lead to inaccurate Spoz readings.
I Avoid placing the Spoz transducer on any extremity
with an arterial catheter, or intravascular venous
infusion line.
I Do not use disposable transducers on patients who
exhibit allergic reactions to the adhesive.
For Specific SpOz Transducers
I When the specified NELLCOR® transducers are
used, the application must be consistent with the
manufacturer’s own guidelines.
HP Reusable Adult Finger Transducer (M1191A): Failure
to apply the transducer property may cause incorrect
measurement of Spoz. For example, not pushing the
transducer far enough over the finger can result in
inaccurate Spoz readings. Pushing the transducer too
far, so that the finger protrudes from the transducer,
can pinch the finger, resulting in inaccurately low Spoz
readings.
HP Reusable Pediatric Finger Transducer (M1192A):
FaiIu'e to apply the transducer property may reduce the
accuracy of the Spoz measurement.
HP Reusable Clip Transducer (M1194A): FaiIu-e to
apply the clip transducer property may reduce the
accuracy of the Spoz measurement.
SpOz Monitoring
I Prolonged, continuous monitoring may increase the risk
at changes in skin characteristics, such as irritation,
reddening, blistering or pressure necrosis, particularly
on patients with impaired perfusion and varying or
e, .__..__....__.___,.._.._.. , , W , A#A_.___4-
immature skin morphology. Specific attention must be
given to sensor site inspection lor changes in skin
quality, proper optical path alignment and attachment.
Check the application site at regular intervals and
change the site it any compromise in skin quality should
occur. More frequent checking may be required due to
an individual patient’s condition.
Setting the high Spoz alarm limit to 100% is equivalent
to switching off the high alarm limit. Therefore the
upper alarm limit for oxygen saturation must be
carefully selected in accordance with accepted clinical
practices.
I Pulse oximetry can overestimate the Sp02 value in the
presence of Hb-CO, Mel-Hb or dye dilution chemicals.
Cautions The following cautions apply to the HP Viridia
Telemetry System.
HP M2604A and M1401A Receiver Mainframes
The following cautions can be found on the HP M2604A
Receiver Mainframe.
Caution ' I
CAUTION-
SHOCK HAZARD
DO NOT REMOVE COVERS
SERVICE BY QUALIFIED PERSONNEL
CAUTION
METRIC & INCH HARDWARE
CONSULT SERVICE MANUAL
This device complies with Part 15 of the
FCC Rules. Operation is subject to the
condition that this device does not cause
harmful interference.
ix
Caution '
- CAUTION
REMOVAL OR INSERTION
OF RECEIVER MODULES
WITH POWER ON MAY
CAUSE DAMAGE TO
INSTRUMENT
HP M1407A Power Supply
The following caution can be found on the HP M1407A
Power Supply.
CAUTION
INDOOR USE ONLY
TO REDUCE THE RISK OF FIRE OR
ELECTRICAL
SHOCK, CONNECT DIRECTLY TO A
GROUNDING RECEPTABLE (3-PRONG)
Contents
1.
Introducing the HP Viridia Telemetry System
System Introduction .........
Transmitter .............
ECG Signal Processing .......
Integrated 51302 Processing .....
Transmitter Button .........
Batteries .............
Automatic Shutoff .........
Lead Sets .............
Leads Off Lights ..........
Transmitter Durability .......
Receiver Module ...........
Receiver Mainframe ..........
Turning the Receiver Mainframe On or
Ofl' ..............
Receiver Mainframe Malfunction Light
Channel Frequencies ........
Retaining Telemetry Settings .....
Antenna System ...........
ECG Monitoring
Optimizing Your System’s Performance
Understanding the Telemetry Signal
Antenna. System ..........
Frequent Signal Strength and RF IN OPS
Signal Strength ..........
Radio Frequency Interference .....
Getting the Best ECG Signal for Telemetry
Monitoring ............
More About Bandwidths ......
1»1
1-3
1-3
1-4
1-4
1-4
1-5
1-6
1-6
1-6
1—7
1-8
1-8
1-9
1-9
1—9
1—9
2—1
2—2
2-2
2—2
2-3
2—4
2—4
2-6
Contents-1
Contents-2
r" i"
Heart Rate Limit Adjustment
Monitoring Paced Patients ......
Optimizing Pace Pulse Detection with
the HP Viridia Transmitter . l .
Preparing the Patient ........
Preparing the Patient for Telemetry
Monitoring ..........
Applying the Electrodes ......
Selecting a Lead ...........
The HP Viridia Transmitter .....
HP Viridia Transmitter, 3-Wire Lead
Set/ Standard Electrode Placement
Viridia Transmitter, 3—Wire Lead
Set / Standard Electrode Placement
Viridia Transmitter, 5-Wire Lead
Set/ Standard Electrode Placement
The HP M1400A/B Transmitter . .
M1400A/B Transmitter and 4-Wire
Lead Set ...........
M1400A/B Transmitter and 3-Wire
Lead Set ...........
M1400A/B Transmitter and 5-Wire
Lead Set ...........
Lead Placement for Telemetry Monitoring
3-wire Lead Set ..........
4-Wire Lead Set (M1400A/B transmitter
only) ..............
S-Wire Patient Lead Set .......
Characteristics of a Good ECG Signal . .
Characteristics of a Good ECG for
Arrhythmia Monitoring .....
Tips for ECG Telemetry Monitoring
2-8
2—9
2—10
2-13
2-13
2-13
2-14
2-14
244
2—15
2-15
2-16
2—16
2-16
2-17
2-18
2-18
2-21
2—22
2-24
2-25
2-26
3.
5.
SpOz Monitoring
Introduction to SpOg Monitoring . . . .
What does SpO; Measure? .......
Measurement Limitations .......
SpOg Transducers ..........
Transducers and Accessories .....
Transducer Selection ........
Transducer Application .......
Application of the HP Reusable Adult
Finger Transducer (M1191A) . .
Application of the HP Reusable Small
Adult / Pediatric Finger Transducer
(M1192A) ..........
Application of the HP Reusable Ear
Clip Transducer (M1194A) . . .
Preparation and Application of
Disposable Transducers .....
Optimizing Transducer Performance
HP Viridia Wave Viewer
Installation of Wave Viewer ......
Exiting from Wave Viewer .......
Configuration Screens .........
Setup Screens ............
Demo Mode ............
Batteries ..............
Battery Status ...........
Palmtop Power Save Mode .......
Care and Cleaning ..........
Inoperative Conditions
Monitoring During Inoperative Conditions
(INOPS) .............
Fallback Mode without Arrhythmia
Monitoring ...........
Fallback Mode with Arrhythmia
Extended Monitoring Mode .....
3-1
3-1
3-3
3-4
3-4
3-6
3-7
3-9
3—10
3-11
3—12
3-12
4-2
4-3
4-3
4-4
4-5
4-5
5-1
5-1
5-3
5-3
Contents-3
Contents-4
6.
Configuration
Configuration Choices .........
Changing the Configuration ......
To Configure a Replacement HP Viridia
Transmitter ...........
To Change the Frequency: ......
Installation and Patient Safety
Installation Information ........
Environment ............
Power Source Requirements .....
Grounding the HP Viridia Telemetry
System .............
Condensation ...........
Explanation of symbols .......
Maintenance Checks .........
Cleaning and Disinfection
Cleaning the Receiver Mainframe . . . .
Cleaning the HP Viridia Transmitter
Wiping the Outside of the Transmitter
Wiping the Battery Compartment
Soaking the Transmitter .......
Sterilization ............
Cleaning ECG Patient Cables .....
Cleaning ..............
Cleaners .............
Disinfecting ............
Disinfectants ...........
Sterilization ............
Cleaning SpOg Transducers ......
HP Adapter Cable (M1943A)
HP Reusable Transducers (M1191A,
M1192A, M1194A) ........
M1400A/B Transmitter Sterilization
Cleaning the Palmtop .........
6-1
6-5
6-5
6-7
7-1
7-2
7-2
7-2
7—3
7-5
8—1
8~2
8-3
8-4
8-4
8-4
8-5
8-5
8-6
8-6
8-6
8-7
8-8
A.
Specifications and Ordering Information
System Classification .........
Transportation & Storage Specifications .
Power Specifications .........
HP M2601A Viridia Transmitter . . .
HP M1400A/ B Transmitters .....
HP M2604A/M1401A Receiver
Mainframe ...........
HP M2603A Receiver Module . . . .
Analog Output Option (301) .....
HP M1402A Receiver Module .
Antenna System Specifications . . . .
HP M1408A Active Antenna
Combiner ...........
HP M1406A Line Amplifier . .
HP M1407A Multiple Unit Power
Supply ............
Accessories Ordering Information . . . .
Analog Output Option
Analog Output Bedside Monitor Cables .
Lead Placement and Selection .....
Using N on-standard Lead Placement .
Controls for Telemetry Setup ......
Functionality with Paced Waveforms . .
Inoperative (INOP) Conditions .....
Holter Interface ...........
Index
A-2
A—3
A-3
A-3
A-4
A-5
A—G
A—6
A—6
A—6
Contents-5
Introducing the HP Viridia Telemetry System
This chapter describes the individual parts of the HP
Viridia Telemetry System, including transmitters,
receiver modules, receiver mainframe, and antenna
system. The wave viewer is described in Chapter 4.
System
|ntroduction
The HP Viridia Telemetry System provides remote
monitoring of ECG (and optional ST segment) and
integrated SpOz.
The HP Viridia Telemetry System consists of:
l a transmitter for each patient
I a receiver for each transmitter
I a receiver mainframe housing up to eight receivers
I an antenna system
If the Central Monitor includes the Patient Locator
Interface option, patient location information tracked
by Fisher Berkeley’s SmartLinkTM system of infrared
badges and receivers can be displayed at central. For
information on this capability, refer to Appendix B of
the HP OmniCare Component Central Monitor User’s
Reference Manual.
Introduction 1-1
5.
2:
D.
HP Component
Central Momtor
HP Compahble
Bedsxde Mennors
HP Viridla
Tetemetry System
1-2 |ntroduction
Transmitter
Note 6
ECG Signal
Processing
Note 6
The following transmitters can be used with the HP
Viridia Telemetry System:
- HP Viridia Transmitter (ECG/SP02 or ECG only)
I HP M1400A/B Transmitter (ECG only)
See Chapter 1 in the User’s Guide for illustrations of
the transmitters, information about the transmitter
button, and directions for removing and inserting the
battery and connecting and disconnecting the ECG lead
set and 51302 sensor.
The transmitter acquires the patient’s ECG signal,
amplifies and digitizes it, detects pace pulses, then sends
the signal via an Ultra High Frequency (UHF) radio
channel to a receiver in the receiver mainframe.
Depending on the lead set used, the transmitter
transmits up to three ECG leads. Up to seven leads are
displayed on the Central Monitor. The clinician can
make adjustments to only two channels of the signal,
ECG-CH] and ECG-CH2. ECG—CHI is always the
cardiotach ECG, that is, it is used by the monitor to
count the heart rate.
See Chapter 2 in this manual for more information on
monitoring ECG.
Introduction 1-3
Warning 6
lntegrated Spoz
Processing
Transmitter Button
Batteries
Warning 6
1-4 Introduction
Pacemakers can be susceptible to radio frequency (RF)
interference from devices such as telemetry transmitters.
See “Monitoring Paced Patients” in Chapter 2 for
additional information.
Algorithm processing for integrated SpOz occurs in the
HP Viridia transmitter. Measurements can be made on a
continuous basis, periodically at l-minute or 5-minute
intervals, or manually on demand. Adjustments to the
sample rate are made at the HP Wave Viewer.
See Chapter 3 in this manual for more information on
setting up and monitoring SpOg, and SpOz transducers.
The compatible SpOg sensors are listed in Appendix A,
“Specifications and Ordering Information.”
The transmitter button can be configured to produce an
ECG recording, set off the nurse call alarm, do both, or
neither.
The battery compartment is capable of accommodating
most standard 8.4 volt or 9 volt batteries. The life
expectancy of the battery depends on the transmitter
configuration and the type of battery used.
HP recommends that the battery be removed when the
transmitter is not in use.
The battery must be removed if a transmitter will be
stored for an extended period of time.
. ”NAM“
Note i
Automatic Shutofl‘
., m .. ~mer her. “flaw“
Battery Life Expectancy
Battery Type ECG Only ECG 84 SpOz ECG L: SpOz
Continuous Intermittent
Lithium 3 days 6 hours 16 hours 1.5 - 2.5 days
1 day 8 hours 8 hours
1 Tested with DURACELL battery
If you have a transmitter with Sp02 that is not in use,
HP recommends setting the SpOg measurement mode to
manual at the wave viewer to conserve battery power.
The message BATTERY WEAK appears in the patient’s
sector to warn when the battery has approximately 15
minutes left (HP Viridia transmitter) or one hour left
(M1400A/B transmitter).
If you are making a STAT SP02 measurement or
changing the SpOg sample rate out of Manual when the
BATTERY HEAK message appears, it may be necessary to
replace the battery immediately in order to continue
monitoring.
Automatic Shutoff enables an HP Viridia transmitter to
stop broadcasting if there is no signal from any electrode
for 10 minutes. This saves battery Life and prevents
interference with other powered transmitters in close
proximity. Automatic Shutdown can be configured to
off. When configured off, batteries must be removed
when the tranmitters are not in use to prevent RF
interference.
Automatic Shutoif is not availabale on M1400A/ B
transmitters.
Introduction 1-5
Lead Sets The HP Viridia transmitter uses M259X series 3-
and 5
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