Welch Allyn HR100 Manual

Holter Recorders
HR100/300/1200
Directions for Use
HR100
Recorder
HR300 or HR1200
Recorder

ii Welch Allyn Holter Recorder
Copyright 2006 Welch Allyn. All rights are reserved. No one is permitted to reproduce or duplicate, in any
form, this manual or any part thereof without permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the
product, that may result from failure to use this product in accordance with the instructions, cautions,
warnings, or statement of intended use published in this manual.
Welch Allyn, HR100, HR300, and HR1200 are trademarks of Welch Allyn.
SD is a trademark of Toshiba.
Bluetooth is a trademark of Bluetooth SIG, Inc., USA.
SanDisk is a registered trademark of SanDisk Corporation, USA.
Software in this product is Copyright 2006 Welch Allyn or its vendors. All rights are reserved. The software
is protected by United States of America copyright laws and international treaty provisions applicable
worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with
this instrument as intended in the operation of the product in which it is embedded. The software may not
be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable
form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the
software remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, call Welch Allyn Technical Support:
Manual Material No. 704556
Global Instrumentation part number 004-700-0046 Ver. C
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Manufactured for: Welch Allyn
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Manufactured by: Global Instrumentation, LLC
8104 Cazenovia Road
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01109 Dresden
Germany
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Contact: European Regulatory Manager
E-mail: [e-mail]
www.welchallyn.com

iii
Contents
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Recorder Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Holter Procedure Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Preparing for Electrode Placement on Patient . . . . . . . . . . . . . . . . . . . . . . . 10
Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Cleaning the Recorder and Patient Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Inspecting the Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Testing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Storing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Discarding the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Conformance to Regulatory Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Electromagnetic Emissions and Immunity Information . . . . . . . . . . . . . . . . 22
FCC information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

iv Contents Welch Allyn Holter Recorder

Directions for Use 1
Directions for Use
Intended Use
The Welch Allyn Holter System is intended to be used as a Holter ambulatory
electrocardiograph system for the purpose of screening for ECG rhythm disturbances
over a minimum 24-hour period. The Welch Allyn Holter System is intended for use under
the supervision of a physician or those knowledgeable in all aspects of ECG morphology,
rhythm, and arrhythmia.
This procedure is known as a Holter procedure and captures infrequent or activity
provoked ECG rhythm abnormalities outside of the physician’s office.
The Welch Allyn Holter System is comprised of the Welch Allyn Holter Recorder and the
Welch Allyn Holter System Application.
As the patient wears the recorder component of the system, it records ambulatory
electrocardiograph data. The Welch Allyn Holter System Application analyzes the recorder
data. The Welch Allyn Holter System is not intended for infants weighing less than 10 Kg.
The Welch Allyn Holter System acquires ambulatory ECG waveforms from patients. The
recorder and associated accessories provide signal acquisition for up to three channels
(HR100 and HR300) or up to eight channels (HR1200) of patient ECG waveforms through
surface electrodes adhered to the body.
Caution US Federal law restricts this device to sale by or on the order of a
physician.

2Directions for Use Welch Allyn Holter Recorder
Indications for Use
The Welch Allyn Holter System is intended for acquiring ambulatory ECG signals from
patients. Patients are people with coronary problems or suspected coronary problems.
This ambulatory electrocardiograph, and associated analysis system, can be used on
patients without limitation on patient age or gender.
The Holter Recorder procedure is one of the many tools that clinicians use to capture
infrequent or activity provoked ECG rhythm abnormalities outside of the physician’s
office. Indications for conducting Holter recording are:
•Arrhythmias
•Chestpain
• Unexplained syncope
• Shortness of breath
• Palpitations
• Evaluation of a pacemaker
• Regulation of anti-arrhythmic drugs
• Evaluation of a patient after myocardial infarction
• Family history of heart disease

Directions for Use 3
Symbols
Warning. Read Carefully.
Caution / Notices. Read Carefully.
Attention: See instructions for use.
Patient Activated Event.
Meets or exceeds Council Directive 93/42/EEC, MDD, Class IIb
Type BF Medical Equipment.
Battery Polarity. Use AA (LR6) Alkaline batteries.
Single use. Use materials labeled with this symbol once only.
Secure Digital Memory Card Interface.
Blue Tooth Wireless Communication Technology
Recycling Symbol - Do not dispose of this product as unsorted municipal waste. Prepare this product for reuse or
separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European
Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not
apply. See www.welchallyn.com/weee.
SD

4Directions for Use Welch Allyn Holter Recorder
Temperature range. (see Technical Specifications)
Keep dry. (see Technical Specifications)
This end up.
Fragile, glass.
Serial Number.
Reference Number.
No Latex.
No PVC.
Keep from direct sunlight.
LED light.

Directions for Use 5
Warnings and Cautions
Familiarize yourself with these warnings. Specific warnings and cautions are also found
throughout this manual.
Warnings
A warning statement in this manual identifies a condition or practice which, if not
corrected or discontinued immediately, could lead to patient injury, illness, or death.
Cautions
A caution statement in this manual identifies a condition or practice which, if not
corrected or discontinued immediately, could lead to equipment failure, equipment
damage, or data loss.
WARNING Safety—For patients with a pacemaker, maintain a minimum of 6
inches between the recorder and pacemaker. Turn the recorder off immediately
and provide appropriate patient care if you suspect the recorder affected the
pacemaker.
WARNING Safety—Remove electrodes, patient lead wires, and recorder from
patient before defibrillation.
WARNING Safety—The conductive parts of electrodes and associated
connectors for type BF or CF applied parts, including neutral electrode, should not
contact other conductive parts including earth.
WARNING Safety— Inspect recorder and accessories before each use.
WARNING Safety—peripheral equipment and accessories that touch the patient
must comply with all appropriate safety, EMC, and regulatory requirements.
WARNING Safety— System is not designed for use with high-frequency (HF)
surgical equipment and does not protect against hazards to the patient.
WARNING Safety—Discard electrodes after one use.
WARNING Explosion hazard—Do not use in the presence of a flammable
anesthetic mixture with air or oxygen or nitrous oxide.
WARNING Fire hazard— Replace batteries using AA (LR6) alkaline batteries.
Note polarity.
Caution US Federal law restricts this device to sale by or on the order of a
physician.
Caution Do NOT use acetone, ether, freon, petroleum derivatives, or other
solvents to clean the recorder.
Caution Do NOT let soap or water come into contact with the battery contacts
or patient connector pins.
Caution DO NOT submerse, autoclave, or steam clean the recorder or the
patient cabling.

6Directions for Use Welch Allyn Holter Recorder
Introduction
This manual is written for clinical professionals familiar with monitoring cardiac patients.
You must read and understand this manual and all other information accompanying the
ambulatory electrocardiograph and related options or accessories before:
• using the Welch Allyn Holter Recorder for clinical applications
• setting up, configuring, troubleshooting, or servicing the recorder
Features
All models:
• Lightweight and small size provides comfort for the patient.
• Either of two patient-activated event buttons enables patients to mark times they feel
are significant. (Both event buttons have the same function.)
• System status feedback: LED (HR 100) or LCD window (HR 300 & HR 1200).
• Removable Secure Digital Memory Card for a minimum of 24-hours of ECG storage
and transferring ECG data.
• Holter Analysis system provides real-time ECG data via Bluetooth Wireless
Communication to verify patient electrode placement and electronic transfer of ECG
recordings.
• Operates on AA alkaline (LR6) batteries: one (HR 100) or two (HR 300 & HR 1200).
• Removable patient cable.
HR 300 & HR 1200:
• Navigational keypad — enter, cancel, up, down, right, and left keys.
• LCD window provides ECG waveform views to ensure proper electrode connection.
• Time of day display.