Welch Allyn Holter System User Manual

Holter System
Directions for Use
ii Welch Allyn Holter System
Copyright 2006 - 2013 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 or its vendors assume 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.
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Software in this product is Copyright 2006 - 2013 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:
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+1 315 685 4560
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Reorder Number: 705874
Global Instrumentation part number 006-700-0035 Version H
Refer to WEB Site “www.WelchAllyn.com” for device directions for use and supporting documentation. To obtain a paper copy of the device directions for use, please contact Welch Allyn.
Manufactured for: Welch Allyn
4341 State Street Road Skaneateles Falls, NY 13153 USA
Manufactured by: Manufacturer:
Global Instrumentation, LLC 8104 Cazenovia Road Manlius, NY 13104 USA
Australia +61 2 9638 3000
+800 074 793
Printed in USA
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Directions for Use Table of Contents iii
Table of Contents
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Inspection upon Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Before you begin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Optional Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operator Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Holter System Application Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Activating the Welch Allyn Holter Software . . . . . . . . . . . . . . . . . . . . . . . . . 10
Recorder Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Holter Procedure Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Preparing for Electrode Placement on Patient . . . . . . . . . . . . . . . . . . . . . . . 13
Starting the Welch Allyn Holter System Application. . . . . . . . . . . . . . . . . . . 19
Starting a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Test Report Review, Editing and Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Physician’s Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Welch Allyn Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Cleaning the Recorder and Patient Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Inspecting the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Testing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Storing the Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Discarding the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Electromagnetic Emissions and Immunity Information . . . . . . . . . . . . . . . . 53
FCC information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
iv Table of Contents Welch Allyn Holter System
Directions for Use 1

Directions for Use

Intended Use

Caution US Federal law restricts this device to sale by or on the order of a physician.
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 up to a 48-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 (22 lbs).
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.
The subject devices provide the following diagnostic functions:
Acquire, view, store, and print ambulatory ECG waveforms from patients. The recorder and associated accessories provide signal acquisition for up to 12 leads of patient ECG waveforms through surface electrodes adhered to the patient.
Using optional Holter algorithms to generate measurements, data presentations and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
Using optional interpretive algorithms to generate measurements, data presentations, graphical presentations, and interpretive statements on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
2 Directions for Use Welch Allyn Holter System

Indications for Use

WARNING Safety—Computer assisted ECG data acquisition and interpretation is a valuable tool when used properly. However, no automated interpretation is completely reliable and a qualified physician shall review the interpretations before treatment, or non-treatment, of any patient.
The Welch Allyn Holter System is intended for acquiring ambulatory ECG signals from patients. Patients are people with coronary problems or people with suspected coronary problems. This ambulatory electrocardiograph, and associated analysis system, can be used on patients without any 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
•Chest pain
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

Contraindications

Computer assisted ECG data acquisition and interpretation is a valuable tool when used properly. However, no automated interpretation is completely reliable and interpretations should be reviewed by a qualified physician before treatment, or non-treatment, of any patient.
The Welch Allyn Holter System is not intended for infants weighing less than 10 Kg (22 lbs).
Using optional interpretive algorithms to generate measurements, data presentations, graphical presentations, and interpretive statements on an advisory basis for patients.
Directions for Use 3

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.
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 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.
WARNING Using non-approved cables and accessories may affect the EMC performance.
WARNING Stacking of devices or storage near other equipment is not recommended.

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.
Caution US Federal law restricts this system 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.
Caution Welch Allyn-certified components are required.
4 Directions for Use Welch Allyn Holter System
SD

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.
Temperature range. (see Technical Specifications)
Directions for Use 5
Keep dry. (see Technical Specifications)
This end up.
Fragile, glass.
Serial Number.
Reference Number.
No Latex.
No PVC.
Keep from direct sunlight.
LED light.
Non-ionizing radiation.
6 Directions for Use Welch Allyn Holter System
Temperature range. (see Technical Specifications).
Pressure range. (see Technical Specifications).
Serial Number.
Directions for Use 7

Introduction

This manual is written for clinical professionals with a working knowledge of medical procedures and terminology as required for 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 and the accompanying Welch Allyn Holter software for clinical applications
before setting up, configuring, troubleshooting, or servicing the recorder

Inspection upon Delivery

Your new Holter System Application was carefully inspected before shipment. Please inspect all components upon delivery for any damage which may have occurred in transit. If you notice any damage, please contact your shipping agent. If items are missing, contact technical support.

Before you begin

Your system must meet the recommended requirements to function properly. Please review the System Requirements before attempting to install or use the system.

System Requirements

300MHz Pentium class processor or faster
Windows XP (32-Bit), Windows Vista (32-Bit/64-Bit), Windows 7 (32/64-Bit) with all major service pack updates, Windows 8 (32/64-Bit)
256Mb RAM minimum
40GB hard drive minimum
Mouse and keyboard
Compact Disc (CD) Reader
Secure Digital Card Reader
Printer with resolution greater than 300 dpi
Monitor with screen resolution set to 1024 x 768
Hard Drive Space Required
Hard drive space required for program installation:
30Mb for Holter System Application
8Mb for electronic manuals (optional)
8 Directions for Use Welch Allyn Holter System

Typical Hard Drive Usage

Caution Windows® requires a minimum 250Mb of free hard drive space available at all times for virtual memory, print spooling and caching. Failing to comply will degrade system performance or crash the system.
1Gb for sixteen 24-hour patient reports @ 200 samples per second with full disclosure

Storage requirements examples

24-hour patient report @ 200 samples per second with full disclosure requires 64Mb of hard drive space
48-hour patient report @ 200 samples per second with full disclosure requires 128Mb of hard drive space

Optional Requirements

Requirements for backup
Caution Backup on Windows Vista or Windows 7 cannot be restored on Windows XP.
CD Writer to write Holter report files to CD
Requirements for Bluetooth Communications
Caution Welch Allyn-certified components are required.
Support for Universal Serial Bus (USB) 1.1 or 2.0
Bluetooth Communications Device (Welch Allyn Part Number 704555)
Caution The PCH100 and PCH200 application will not run under any Windows Compatibility Modes (ie. Windows 95, 98, NT 4.0, 2000).

Operator Requirements

Operator of the PCH100 and PCH200 Holter System application shall have the following level of experience:
Knowledge of operating a Windows based PC system, including mouse and
keyboard.
For the reviewer of the analysis information - operator shall be proficient in
reviewing ECG’s and understanding various beat classifications. Refer to the physicians guide.
For operators performing subject hookup to the HR100 and HR300 recorders shall
have experience on how to properly perform an electrode preparation.
For operators performing maintenance operation on the software, database and
data files should have previous experience in those specific operations
Directions for Use 9

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: LCD and LED (HR 100) or LCD (HR 300 & HR 1200).
Removable Secure Digital Memory Card up to 48-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.
LCD window provides ECG waveform views to ensure proper electrode connection.
Time of day display.
Navigational keypad - enter, cancel, up, down, right, left keys (HR300 & HR1200).
10 Directions for Use Welch Allyn Holter System

Holter System Application Directions for Use

Activating the Welch Allyn Holter Software

You must activate your Holter software within 30 days, or the software will lock itself. The activation message displays each time you launch the software until you activate. The best way to activate your software is through the Internet.
Activating through the Internet
1. Click the Holter icon. The activation message displays.
2. Select Ye s or No.
If you select No, a message displays reminding you that you must activate within 30 days. (Caution: after 30 days, the software will not launch.)
If you select Ye s , the system automatically activates itself and the activation screen will not display again. This completes the activation requirement.
Activating Manually (No Internet Connection)
If the software cannot detect an Internet connection, you must activate the application manually.
1. Launch the Holter System software. The activation message displays.
2. Select Ye s or No.
If you select No, a message displays reminding you that you must activate within 30 days. (Caution: after 30 days, the software will not launch.)
If you select Ye s , the Manual Activation dialog displays. Click the Print button. Contact Welch Allyn Technical Support (see page ii). You will be asked to provide the information displayed on the printout:
•User name
Password
PC Serial Number 1
PC Serial Number 2
3. Once you receive the Activation Code, type it into the Activation Code box and click Activate. The application launches and the activation screen will not display again. This completes the activation requirement.
Directions for Use 11
LED
Patient Cable
Battery
Compartment
Secure Digital Card Interface
Patient-Activated Event Buttons
Secure Digital (SD) Card Interface
LCD
Patient-Activated
Event Buttons
Patient Cable
Batteries

Recorder Illustrations

Figure 1. HR 100 Holter Recorder
Figure 2. HR 300 & HR 1200 Holter Recorder
Caution Inserting the Secure Digital Card in backwards or up side down may damage Secure Digital Card Interface.
12 Directions for Use Welch Allyn Holter System

Operation

To Set the Time (HR100)

Batteries must to stay in the recorder for a minimum of 10-minutes to charge the clock backup cell.
1. Remove the battery cover from the recorder (see Figure 1 on page 11).
2. Remove the Secure Digital Card from the Secure Digital port located at the rear of the device (see Figure 1 on page 11).
3. Insert one new, AA alkaline (LR 6) batteries into the recorder battery compartment. Note the polarity.
4. The LCD window shows the time after the recorder self-diagnostics is complete (approximately 10 seconds). Time is displayed in 24-hour time format and Date is shown in Year Month Day format.
5. Enter time set mode by pressing the Top and Bottom Event switches simultaneously for 2-seconds.,the hour digit starts blinking
6. Increase the value shown with the Top Event switch. Use the Bottom Event switch to toggle between Hours, Minutes, Year, Month and Day.
7. Press the Top and Bottom Event switches to save time and date shown. Remove the batteries.

To Set the Time (HR 300 & HR 1200)

Batteries must to stay in the recorder for a minimum of 10-minutes to charge the clock backup cell.
1. Remove the battery cover from the recorder (see Figure 2 on page 11).
2. Remove the Secure Digital Card from the Secure Digital port located at the rear of the device (see Figure 2 on page 11).
3. Insert two new, AA alkaline (LR 6) batteries into the recorder battery compartment. Note the polarity.
4. Slide and secure the battery cover onto the recorder. The LCD window shows the time after the recorder self-diagnostics is complete (approximately 10 seconds). Time is displayed in 24-hour time format and Date is shown in Year Month Day format.
5. Press the <Right> function key, the hour digit starts blinking
6. Increase the hour shown with the up arrow key or decrease the hour shown with the down arrow key. Use the right and left arrow keys to toggle between Hours, Minutes, Seconds, Year, Month and Day.
7. Press the <Right> function key to save time and date shown. Remove the batteries.
Directions for Use 13

Patient Preparation

Holter Procedure Patient Preparation

When making the appointment, tell the patient:
Do not remove any electrodes or disconnect lead wires.
Do not swim, bathe, or shower during the recording period.
Do wear loose fitting, comfortable clothing to the appointment (shirt-and-pants or blouse-and-skirt combinations are better than one-piece garments.)

Preparing for Electrode Placement on Patient

WARNING Safety—Leave 5 feet (1.5 meters) of open area around the patient during recorder hookup and removal.
WARNING Safety—Do not connect external devices to the recorder. Connect patient lead wires only to the patient electrodes.
WARNING Safety—Keep the recorder and patient cable clean, especially the components that touch patients.
Caution Verify that dates on applicable accessories have not expired.
Table 1. Recommended accessories
Accessory Quantity
Electrodes 5 or 7
AA Alkaline Batteries (LR6) 1 for HR 100
2 for HR 300 & HR 1200
Disposable Safety Razor 1
Abrading pad 1
Alcohol Prep Pads 2
Pouch 1
Patient Diary 1
14 Directions for Use Welch Allyn Holter System
To Prepare the Patient and Place Electrodes
Caution Always ensure that the appropriate electrode placement is employed
for the lead configuration selected.
Caution ECG electrodes can cause skin irritation. Examine the skin for signs of irritation or inflammation and avoid placement of the electrode in those areas. If skin irritation occurs during the procedure advise the patient to remove the electrodes and contact the health service provider as soon as possible.
Help the patient get comfortable. Patient preparation is important for a successful Holter procedure.
1. Describe the procedure to the patient.
2. Prepare electrode locations. See Figure 4 on page 15 for 5-lead placement, Figure 5 on page 16 for 7-lead placement, Figure 8 on page 18 for 12-lead placement.
3. Shave the area for electrode placement, if necessary.
4. Clean electrode sites with alcohol.
5. Allow electrode site to dry.
6. Attach the electrodes to the lead wires before attaching to patient.
7. Secure each lead wire. Loop each lead wire into a 1- to 2-inch diameter loop, position it approximately two inches from each sensor site, and tape it to the skin (see
Figure 3 on page 14). This reduces movements that cause signal artifact.
Figure 3. Patient Lead Wire Stress Loop
Evaluating the Signal Quality from Each Lead
Refer to the Holter System Application Directions for Use.
Clinician tasks
Explain to the patient:
the recording procedure
how to record information in the patient diary
how to use the Patient Event Button
to avoid contact with water
Directions for Use 15
Table 2. 5-Lead Placement (HR100 only)
Lead AHA Color IEC Color Placement
Ch1+ Red Green 4th intercostal space at left border of sternum
Ch1- White Red Left clavicle, lateral of sternum border
Ch2+ Brown White 6th intercostal space at the anterior axillary's line
Ch2- Black Yellow Right clavicle, lateral to the mid-clavicle line
RL Green Black Lowest rib on right side of chest
Figure 4. 5-Lead Placement (HR100 only)
16 Directions for Use Welch Allyn Holter System
Table 3. 7-Lead Placement (all models)
Lead AHA Color IEC Color Placement
Ch1+ Red Green 4th intercostal space at left border of sternum
Ch1- White Red Left clavicle, lateral of sternum border
Ch2+ Brown White 6th intercostal space at the anterior axillary's line
Ch2- Black Yellow Right clavicle, lateral to the mid-clavicle line
Ch3+ Orange Orange 6th intercostal space on left mid-clavicular line
Ch3- Blue Blue Manubrium sternum
RL Green Black Lowest rib on right side of chest
Figure 5. 7-Lead Placement (all models)
Directions for Use 17
Figure 6. AHA lead cables
Figure 7. IEC lead cables
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