Welch Allyn H12+ User Manual

Welch Allyn

®

H12+™

12-lead Holter

User Manual

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

© Copyright 2019, Welch Allyn. All rights are reserved. To support the intended use of the product
described in this publication, the purchaser of the product is permitted to copy this publication, for internal
distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of
this publication, or any part of it, is permitted without written 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. Unauthorized copying of this publication may not only
infringe copyright but also reduce the ability of Welch Allyn to provide accurate and up-to-date information
to users and operators alike. Software: 2019 v5.0.0

Welch Allyn®, H12+™ and HScribe® are registered trademarks of Welch Allyn.
The information contained in this manual is subject to change without notice.

All changes will be in compliance with regulations governing manufacture of medical equipment.

For patent information, please visit www.welchallyn.com/patents
For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-

us/locations.html
Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html

1.888.667.8272, [e-mail]

80025606 Ver. A
Revision date: 2019-07

901141 HOLTER RECORDER

EU IMPORTER

Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA

welchallyn.com

Welch Allyn Limited
Navan Business Park, Dublin Road,
Navan, Co. Meath C15 AW22
Ireland

i

TABLE OF CONTENTS

SERVICE AND SPARE PARTS ................................................................................................................................... 1

ASSISTANCE AND PARTS ................................................................................................................................................... 1

REPAIRS ........................................................................................................................................................................ 1

PACKING INSTRUCTIONS: .................................................................................................................................................. 1

NOTICES ................................................................................................................................................................. 3

MANUFACTURER’S RESPONSIBILITY .................................................................................................................................... 3

RESPONSIBILITY OF THE CUSTOMER .................................................................................................................................... 3

EQUIPMENT IDENTIFICATION ............................................................................................................................................. 3

COPYRIGHT AND TRADEMARK NOTICES ............................................................................................................................... 3

OTHER IMPORTANT INFORMATION ..................................................................................................................................... 3

WARRANTY INFORMATION ................................................................................................................................... 5

LIMITED WARRANTY STATEMENT ....................................................................................................................................... 5

USER SAFETY INFORMATION ................................................................................................................................. 7

EQUIPMENT SYMBOLS AND MARKINGS .............................................................................................................. 11

GENERAL CARE .................................................................................................................................................... 13

PRECAUTIONS .............................................................................................................................................................. 13

INSPECTION ................................................................................................................................................................. 13

CLEANING AND DISINFECTION ......................................................................................................................................... 13

ELECTROMAGNETIC COMPATIBILITY (EMC) ......................................................................................................... 15

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGENTIC EMISSIONS .................................................................. 16

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ................................................................... 16

GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY ................................................................... 17

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT

................................................................................................................................................................................. 18

INTRODUCTION ................................................................................................................................................... 19

MANUAL PURPOSE ....................................................................................................................................................... 19

AUDIENCE ................................................................................................................................................................... 19

INDICATIONS FOR USE ................................................................................................................................................... 19

H12+ RECORDER DESCRIPTION ....................................................................................................................................... 20

RECORDER SETUP ......................................................................................................................................................... 21

USING THE KEYPAD ....................................................................................................................................................... 22

LEADFORM PATIENT CABLE ............................................................................................................................................ 22

H12+ RECORDER IN CARRYING CASE ................................................................................................................................ 23

PART NUMBERS ........................................................................................................................................................... 24

SPECIFICATIONS ............................................................................................................................................................ 25

PATIENT PREPARATION ....................................................................................................................................... 27

PATIENT HOOKUP ......................................................................................................................................................... 27

USING THE RECORDER ......................................................................................................................................... 29

TABLE OF CONTENTS

ii

INSERTING AND REMOVING SD CARDS .............................................................................................................................. 29

ATTACHING THE PATIENT CABLE ...................................................................................................................................... 29

MAIN MENU OPTIONS .................................................................................................................................................. 30

STARTING A RECORDING SESSION .................................................................................................................................... 31

ENDING A RECORDING SESSION ....................................................................................................................................... 34

CONFIGURING THE RECORDER ............................................................................................................................. 35

CONFIGURATION .......................................................................................................................................................... 35

SETTING DATE AND TIME ............................................................................................................................................... 37

SETTING LANGUAGE ...................................................................................................................................................... 37

VIEWING SOFTWARE VERSION NUMBER ........................................................................................................................... 37

CHANGING SAMPLE RATE (HIGH-FIDELITY SD CARD ONLY) ................................................................................................... 38

CHANGING DURATION ................................................................................................................................................... 38

MAINTENANCE .................................................................................................................................................... 39

PERIODIC MAINTENANCE ............................................................................................................................................... 41

PRODUCT LIFE .............................................................................................................................................................. 41

DISPOSAL OF WASTE MATERIALS ..................................................................................................................................... 41

TROUBLESHOOTING............................................................................................................................................. 43

TABLE OF MESSAGES ..................................................................................................................................................... 43

TRANSLATIONS .................................................................................................................................................... 45

TABLE OF TRANSLATIONS ............................................................................................................................................... 45

1

SERVICE AND SPARE PARTS

Assistance and Parts

If the product fails to function properly or if assistance, service or spare parts are required, contact the
nearest Welch Allyn Technical Support Center.

USA
Latin America
European Call Center
Italy
United Kingdom
France
Germany
Netherlands

1-800-535-6663
([phone]
([phone]
([phone]
([phone]
([phone]
([phone]
([phone]

Canada
South Africa
Australia
Singapore
Japan
China
Sweden

1-800-561-8797
([phone]
([phone]
([phone]
([phone]
([phone]
([phone]

When calling, please be prepared to provide:

 Product name and model number and complete description of the problem
 The serial number of your product (if applicable)
 The complete name, address and phone number of your facility
 For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number
 For parts order, the required spare or replacement part number(s)

Repairs

All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized
repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall
exclusively be performed by Welch Allyn certified service personnel.

If your product requires warranty, extended warranty, or non-warranty repair service, please call first the
nearest Welch Allyn Technical Support Center. A representative will assist you in troubleshooting the
problem and will make every effort to solve it over the phone, avoiding potential unnecessary returns.

In case the return cannot be avoided, the representative will record all necessary information and will
provide a Return Material Authorization (RMA) number, as well as the appropriate return address. A
Return Material Authorization (RMA) number must be obtained prior to any return.

Packing Instructions:

Remove patient cable, battery, and Secure Digital memory card (as appropriate) prior to packing, unless
you suspect they are associated with the problem.

Whenever possible, use the original shipping carton and packing materials.
Include a packing list and the Welch Allyn Return Material Authorization (RMA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product must be

initiated by the sender.

SERVICE AND SPARE PARTS

2

3

NOTICES

Manufacturer’s Responsibility

Welch Allyn is responsible for the effects on safety and performance only if:

• Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by
persons authorized by Welch Allyn.

• The device is used in accordance with the instructions for use.

Responsibility of the Customer

The user of this device is responsible for ensuring the implementation of a satisfactory maintenance
schedule. Failure to do so may cause undue failure and possible health hazards.

Equipment Identification

Welch Allyn equipment is identified by a serial and reference number on the back of the device. Care
should be taken so that these numbers are not defaced.

Copyright and Trademark Notices

This document contains information that 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 Welch Allyn.

Other Important Information

The information in this document is subject to change without notice.
Welch Allyn makes no warranty of any kind with regard to this material including, but not limited to,

implied warranties of merchantability and fitness for a particular purpose. Welch Allyn assumes no
responsibility for any errors or omissions that may appear in this document. Welch Allyn makes no
commitment to update or to keep current the information contained in this document.

NOTICES

4

5

WARRANTY INFORMATION

Limited Warranty Statement

Welch Allyn warrants that the Welch Allyn H12+ Holter recorder you have purchased meets the labeled
specifications of the product and will be free from defects in materials and workmanship that occur within
1 year after the date of purchase. Accessories used with the Product are warranted for 90 days after the
date of purchase.

The date of purchase is: 1) the date specified in our records, if you purchased the Product directly from
us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3) if you don’t
return the warranty registration card, 120 days after the date on which the Product was sold to the dealer
from whom you bought the Product, as documented in our records.

This warranty does not cover damage caused by: 1) handling during shipping, 2) use or maintenance
contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4)
accidents.

You assume all responsibility for the use of the Product with any accessory that does not meet the
requirements described in the Product documentation.

If a product or accessory covered by this warranty is determined to be defective because of defective
materials, components, or workmanship, and the warranty claim is made within the warranty period
described above, Welch Allyn will, at its discretion, repair or replace the defective Product or accessory
free of charge.

You must obtain a return authorization from Welch Allyn to return your Product before you send it to
Welch Allyn’s designated service center for repair.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE. WELCH ALLYN’S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO
REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT
RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A
PRODUCT DEFECT COVERED BY THE WARRANTY.

WARRANTY INFORMATION

6

7

USER SAFETY INFORMATION

WARNING:

Means there is the possibility of personal injury to you or others.

Caution:

Means there is the possibility of damage to the device.

Note:

Provides information to further assist in the use of the device.

WARNING(S)

This manual gives important information about the use and safety of this device. Deviating from
operating procedures, misuse or misapplication of the device, or ignoring specifications and
recommendations could result in increased risk of harm to users, patients and bystanders, or damage to
the device.

Any serious incident that has occurred in relation to the H12+ should be reported to Welch Allyn and the
competent authority of the Member State in which the user or patient is established.

Caretakers must closely supervise an infant or child who is wearing a Holter recorder to ensure the
recorder is intact and the patient cable is properly secured.

Device stores data reflecting a patient’s physiological condition to a properly equipped analysis system
that when reviewed by a trained physician or clinician can be useful in determining a diagnosis; however,
the data should not be used as a sole means for determining a patient’s diagnosis.

 Users are expected to be licensed clinical professionals knowledgeable about medical procedures

and patient care, and adequately trained in the use of this device. Before attempting to use this
device for clinical applications, the operator must read and understand the contents of the user
manual and other accompanying documents. Inadequate knowledge or training could result in
increased risk of harm to users, patients and bystanders, or damage to the device. Contact Welch
Allyn service for additional training options.

 To maintain designed operator and patient safety, peripheral equipment and accessories that can

come in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601­2-47. Only use parts and accessories supplied with the device and available through Welch Allyn.

 Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each

lead for defibrillation protection. Patient cables should be checked for cracks or breakage prior to
use.

 Conductive parts of the patient cable, electrodes, and associated connections of type CF applied

parts, including the neutral conductor of the patient cable and electrodes, should not come into
contact with other conductive parts including earth ground.

 ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or

inflammation.

 To avoid the possibility of serious injury or death during patient defibrillation, do not come in contact

with device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the
electrodes is required to minimize harm to the patient.

 Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of

this device may alter defibrillator protection.

USER SAFETY INFORMATION

8

 This device was designed to use the electrodes specified in this manual. Proper clinical procedure

must be employed to prep the electrode sites and to monitor the patient for excessive skin irritation,
inflammation, or other adverse reactions.

 Carefully route cables to reduce any possibility of patient entanglement or strangulation.
 Simultaneous connection to other equipment may increase leakage current.
 To avoid potential for spread of disease or infection, single-use disposable components (e.g.,

electrodes) must not be reused. To maintain safety and effectiveness, electrodes must not be used
beyond their expiration date.

 FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party

responsible for compliance could void the user’s authority to operate the device.



A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic

mixture.

 The device has not been designed for use with high-frequency (HF) surgical equipment and does not

provide a protective means against hazards to the patient.

 The quality of the signal produced by the device may be adversely affected by the use of other

medical equipment, including but not limited to defibrillators and ultrasound machines.

 There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is

used simultaneously with the device; however, disturbance to the signal may occur.

 Operations may be affected in the presence of strong electromagnetic sources such as

electrosurgery equipment.

 The device is restricted to use on one patient at a time.
 The performance of the device may be compromised by excessive motion.
 Use only recommended battery cells. Use of other cells may present a risk of fire or explosion.

USER SAFETY INFORMATION

9

Caution(s)

 The H12+ recorder is not waterproof. It may be placed in an optionally available sealed, clear pouch

that will protect it from moisture, but should not be submerged in water.

 To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only

use fingertips.

 To prevent pinching, press down on the battery door latch when removing and replacing the battery

door.

 Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam

cleaning as this may damage equipment or reduce its usable life. Use of unspecified
cleaning/disinfecting agents, failure to follow recommended procedures, or contact with unspecified
materials could result in increased risk of harm to users, patients and bystanders, or damage to the
device. Do not sterilize the device or patient cables with Ethylene Oxide (EtO) gas.

 The device and patient cable should be cleaned between each use. Inspect cable and connection for

damage or excessive wear prior to each use. Replace cable if damage or excessive wear is noted.

 Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures.

Patient cables should be stored after forming them into a loose loop.

 The device will only work with devices that are equipped with the appropriate option.
 Do not format the SD Card using standard Microsoft Windows formatting conventions on the

computer. This will cause the SD card to be non-functional for Holter recording.

 When removing the SD card from the system card reader, it is recommended to use the “Safely

Remove Hardware and Eject Media” feature on the computer to reduce the possibility of SD card

errors.

 No user-serviceable parts are inside. Damaged or suspected inoperative equipment must be

immediately removed from use and must be checked/repaired by qualified service personnel prior to
continued use.

 This device is not recommended for use in the presence of imaging equipment such as Magnetic

Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.

 When necessary, dispose of the device, its components and accessories (e.g., batteries, cables,

electrodes), and/or packing materials in accordance with local regulations.

 AA batteries are known to leak their contents when stored in unused equipment. Remove battery

from device when not used for an extended period of time.

To prevent possible damage to the device, the following environmental conditions must be adhered to:

Operating Temperature: +10 to +45C
Storage Temperature: -40 to +70C
Relative Humidity: 10 to 95%, non-condensing
Ambient Air Pressure: 700 to 1060 millibars

USER SAFETY INFORMATION

10

Note(s)

Proper patient preparation is important to proper application of ECG electrodes and operation of the
device.

If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is
damaged, display will indicate a lead fault for the lead(s) where the condition is present.

The device is set to the U.S. Central Time Zone when shipped from the factory. If a change is required,
set the correct date and time prior to using the recorder. Refer to the instructions within this user manual.

 The patient cable life expectancy is six months continuous use with proper care.
 Complete lead fail will cause a greater draw on battery power which may cause the recording period

to end early due to low-battery voltage.

 If during power up the battery voltage is below 1.45V, the recorder will display a low battery message

and will not continue.

The device will automatically turn off (blank screen) if the batteries have been severely discharged.
 No preliminary or ongoing scheduled periodic calibration by the user or Welch Allyn personnel is

required. The design for the device is such that the system contains no elements requiring
calibration.

 The device conforms to the following standards:

IEC 60601-1: Edition 3.1 2012-08 General requirements for basic Safety and essential

performance

IEC 60601-2-47: Edition 2.0 2012-02* Particular requirements for safety, including essential

performance, of ambulatory electrocardiographic

systems
IEC 60601-1-2: Third Edition 2007-03 Electromagnetic Compatibility
IEC 62304:2006/A1:2015 Software life-cycle processes
IEC 62366:2015 Application of usability engineering
93/42/EEC Medical Device Directive (MDD)
2012/19/EU Waste Electrical and Electronic Equipment
ISO 10993-1:2009/Cor. 1:2010 Biological evaluation of medical devices

* Pacemaker spikes < 0.1 milliseconds may not always be detected.

 The device is UL classified:

MEDICAL — PATIENT-MONITORING EQUIPMENT AS TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH

ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1 (2012), CAN/CSA
C22.2 No. 60601-1 (2014) AND IEC 60601-2-47 (2012).

11

EQUIPMENT SYMBOLS AND MARKINGS

WARNING The warning statements in this manual identify
conditions or practices that could lead to illness, injury, or death. In
addition, when used on a patient applied part, this symbol indicates
defibrillation protection is in the cables. Warning symbols will
appear with a grey background in a black and white document.

CAUTION The caution statements in this manual identify conditions
or practices that could result in damage to the equipment or other
property, or loss of data.

Warning: Do not use this equipment in the MRI scan room.

Follow instructions/directions for use (DFU) -- mandatory action. A
copy of the DFU is available on this website. A printed copy of the
DFU can be ordered from Welch Allyn for delivery within 7 calendar
days.

Defibrillator-proof type CF applied part

Do not dispose as unsorted municipal waste. Requires separate
handling for waste disposal according to local requirements.

Device Manufacturer

Device is UL classified.

Indicates compliance to applicable EEC directives.

Model Identifier

Reorder Number

Serial Number

EQUIPMENT SYMBOLS AND MARKINGS

12

Global Trade Item Number

Battery orientation and size

Medical Device