Welch Allyn Cardioperfect PRO ECG Recorder User Manual

CardioPerfect

PRO ECG Recorder - User Manual

Regulatory Affairs Representative

Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland

Welch Allyn, Inc

4341 State Street Road
Skaneateles Falls, NY
13153-0220 USA
www.welchallyn.com

0297

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Caution

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

Caution

Use of accessories other than those recommended by Welch Allyn
may compromise product performance.

Copyright

© Copyright 2012, Welch Allyn. 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.

Welch Allyn®, CardioPerfect® Workstation and SpiroPerfect® are registered trademarks of
Welch Allyn.

Software in this product is Copyright 2012, Welch Allyn. 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 provided on the original distribution medium. 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 remains with 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.

User responsibility

This product is designed to perform in conformity with the description thereof contained in this
manual and accompanying labels and inserts, when assembled, operated, maintained and
repaired in accordance with the instructions provided. A defective product should not be used.
Parts that are broken, plainly worn, missing or incomplete, distorted or contaminated should
be replaced immediately. Should any repair or replacement become necessary, we
recommend that service be performed at the nearest approved service center. The user of the
product shall have the sole responsibility for any malfunction, which results from improper
use, faulty maintenance, improper repair, damage or alteration by anyone other than Welch
Allyn or their authorized service personnel.

Accessories

The Welch Allyn warranty can only be honored if you use Welch Allyn approved accessories
and replacement parts.

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Caution

Radio Frequency (RF) interference between the PRO ECG Recorder or
cardiograph and any existing RF transmitting or receiving equipment at
the installation site, including electrosurgical equipment, in close
proximity to the cardiograph should be evaluated before the equipment is
operated as they may seriously degrade performance.

The CardioPerfect Cardiograph is susceptible to interference from RF
energy sources (lowered RF immunity) which exceed the IEC 60601-1-2
limits, such as power line bursts, other medical devices, cellular products,
information technology equipment and radio/television transmission.

To reduce EMC interference the cardiograph shall be separated from the
emitting source as much as possible. If assistance is needed, call your
local Welch Allyn service representative.

Artifact on the ECG 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.

Like all electronic devices, this cardiograph is susceptible to electrostatic
discharge (ESD). Electrostatic discharge typically occurs when
electrostatic energy is transferred to the patient, the electrodes, or the
cardiograph. ESD may result in ECG artifact that may appear as narrow
spikes on the cardiograph display or on the printed report. When ESD

occurs, the cardiograph’s ECG interpretation may be inconsistent with

the physician’s interpretation.

Welch Allyn assumes no liability for failures resulting from RF
interference between Welch Allyn medical electronics and any radio
frequency generating equipment when these levels exceed those
established by applicable standards.

Patient cables and PC connection cables are intended to be inserted and
removed from the Pro-Recorder in a push / pull motion. Do not twist the
cables. Damage to the cables and the Pro-Recorder will occur.

Safety and Precautions

PRO ECG Recorder - User Manual

Medical Device Directive

The CardioPerfect Pro cardiograph complies with the requirements of the Medical Device
Directive 93/42/EEC and carries the 0297 mark accordingly.

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Warnings

CardioPerfect devices are an integral part of a personal computer
based diagnostic system. The user shall adhere to warnings in order
to ensure safe and reliable performance of the system.

The personal computer, computer peripheral and all accessories (non­medical electrical equipment) connected to the ECG shall be situated
outside the patient environment and the system shall meet the
requirements of IEC 60601-1-1.

The personal computer used should be approved to the

appropriate safety standard for non-medical electrical equipment
(IEC 60950, or its national variants). Also, the use of an additional
protective earth ground or an isolation transformer is required for
the electric power circuit to which the CardioPerfect system is
connected in order to satisfy the IEC 60601-1-1 safety standard.

Power strips (multiple portable socket outlets) are not allowed for

use in connecting the medical electrical equipment or any
accessories to ground unless used in concert with a medical
approved isolation transformer.

Additional equipment that is added to the system may pose a

safety hazard. Use of an additional protective earth ground or an
isolation transformer is required to meet IEC 60601-1-1.

During defibrillation, the ECG signals displayed may show waveform

artifacts and cannot be relied on as a true indication of the patient’s

physical condition.

Accessible metal parts, such as electrode terminations, should not
come in contact with other electrically conductive parts, including earth
ground.

Welch Allyn provides a number of high quality patient leads in varying
termination styles. Use of these approved patient leads is required for
electrical protection of the patient during cardiac defibrillation.

CardioPerfect devices are not intended for direct cardiac application.

An inoperable or damaged electrocardiograph can be identified by
abnormal signals on the ECG waveforms. Abnormal signals are
characterized by flat lines, excess noise, square waves or other non
typical anomalies that appear on the ECG waveform. The
electrocardiograph can be periodically tested by connecting the
CardioPerfect to an ECG simulator. Follow manufacturer’s
instructions.

If there is a requirement for equipment to be connected to a personal
computer or other non-medical rated equipment, it is the responsibility
of the user to ensure that the electric power circuit to which the
CardioPerfect system is connected includes an additional protective
earth ground or an isolation transformer in order to satisfy the IEC
60601-1-1 safety standard.

Other medical equipment—including but not limited to defibrillators,
ultrasound machines, pacemakers, and other stimulators—may be
used simultaneously with the electrocardiograph. However, such

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devices may disturb the electrocardiograph signal.

The electrocardiograph has not been designed for use with high
frequency (HF) surgical equipment and does not protect against
hazards to the patient.

Ensure the location of the electrode and associated cables provides
maximum separation away from all sources of high-frequency energy.
The best way to ensure patient safety is to completely remove all
electrodes and cables from the patient when exposed to high­frequency energy.

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Patient and Operational Safety

The cardiograph isolates all connections to the patient from electrical ground and all other
conductive circuits in the cardiograph. This reduces the possibility of hazardous currents

passing from the cardiograph through the patient’s heart to ground. To ensure the patient’s

safety and your own please observe the following:
When integrating CardioPerfect devices with non-medical rated equipment, such as a

computer, the addition of an additional protective earth ground or the use of a medically
approved isolation transformer is required for compliance to the IEC 60601-1-1 Medical
System Safety Standard.

Any system components (e.g. treadmill, personal computer, ergo meter) that require to be
connected to an outlet socket shall use only grounded power cords (three-wire power cords
with grounded plugs). Also make sure the outlet accepts the plug and is grounded. Never
adapt a grounded plug to fit an ungrounded outlet by removing the ground prong or ground
clip.

Do not connect Multiple Portable Socket Outlets (MPSO’s) or extension cords to the system.

Do not connect items which are not part of the system. The use of multiple portable socket
outlets and other non-medical electrical equipment poses a safety hazard. Refer to the
Medical System Safety Standard IEC 60601-1 for the requirements of such attachments.

Multiple portable outlet sockets shall not be placed on the floor. Multiple portable outlet
sockets or extension cord shall not be connected to the system. Do not connect items which
are not part of the system. The use of multiple (non-) medical electrical equipment connected
to the same patient may pose a safety hazard due to the summation of leakage currents from
each instrument. Any combination of (non-) medical electrical equipment should be evaluated
by local safety personnel before put into service. Multiple portable outlet sockets use without
an isolation transformer is disapproved unless casual access for additional equipment is
impeded or prevented.

Accessories

Use of accessories other than those recommended by Welch Allyn may compromise product
performance. The Welch Allyn warranty can only be honored if you use Welch Allyn approved
accessories and replacement parts.

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PRO ECG Recorder - User Manual

USA

1-800-535-6663

Canada

1-800-561-8797

Latin America

([phone]

South Africa

([phone]

European Call Center

([phone]

Australia

([phone]

United Kingdom

([phone]

Singapore

([phone]

France

([phone]

Japan

([phone]

Germany

([phone]

China

([phone]

Netherlands

([phone]

Sweden

([phone]

Note

Welch Allyn does not accept returned products without an RMA.

Warranty, Service, and Spare Parts

Warranty

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.

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.

Before contacting Welch Allyn it is helpful to attempt to duplicate the problem and to check all
accessories to ensure that they are not the cause of the problem.

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
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
troubleshooting the problem and will make every effort to solve it over the phone, avoiding
potential unnecessary return.

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
If you have to return goods for service, follow these recommended packing instructions:

Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate)

before packing, unless you suspect they are associated with the problem.
Wherever 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.

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Limited Warranty Statement

Welch Allyn, Inc. warrants that the Welch Allyn CardioPerfect Workstation computer based
product 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 use of the Product with any hardware or software that does
not meet the system 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.

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