Welch Allyn PRO ECG Recorder User manual

CardioPerfect
PRO ECG Recorder - User Manual
DIR 80012763 Ver. H Revision date: 2017-09
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 USA
www.welchallyn.com
901047 CARDIOPULMONARY ECG SYSTEM
901095 ECG ACQUISITION MODULE
0297

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Caution
US Federal law restricts this device to sale by or on the order
of a physician.
Copyright
© Copyright 2017, 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 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.
Caution
Use of accessories other than those recommended by Welch Allyn
may compromise product performance.

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Safety and Precautions
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 ECG Recorder in a push / pull motion. Do not
twist the cables. Damage to the cables and the PRO ECG Recorder will
occur.

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Warnings
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.
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 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
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.
Fire and explosion hazard. Do not operate the electrocardiograph in
the presence of a flammable anesthetic mixture with air, oxygen, or
nitrous oxide; in oxygen-enriched environments; or in any other
potentially explosive environment.
To prevent the spread of infection, take these precautions:
•Dispose of single-use components (for example, electrodes)
after using them once.
•Regularly clean all components that come in contact with
patients.
•Consult your facility's equipment cleaning procedures when
performing ECG testing on patients with open, infectious
sores.

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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 high-
frequency energy.
No modification of this equipment is allowed.

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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 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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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
For information about any Welch Allyn product, contact Welch Allyn Technical Support: http://
www.welchallyn.com/support.
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.
Note
Welch Allyn does not accept returned products without an RMA.
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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Table of contents
Safety and Precautions ...................................................................................................... 3
Accessories........................................................................................................................ 6
Warranty, Service, and Spare Parts................................................................................... 7
Limited Warranty Statement............................................................................................... 8
1. About the CardioPerfect PRO Cardiograph....................................................................12
1.1 Accessories.............................................................................................................13
2. Installation..........................................................................................................................15
To connect the cables to the PRO ECG Recorder: ......................................................... 16
To disconnect the cables from the PRO ECG Recorder:................................................. 16
2.1 Connecting the patient cable to the electrode.........................................................17
3. Maintenance.......................................................................................................................19
Clean the equipment........................................................................................................ 19
Clean the PRO ECG Recorder......................................................................................... 19
The following agents are compatible with the PRO ECG Recorder:................................ 19
Clean the cables............................................................................................................... 20
Disinfect the cables .......................................................................................................... 20
Inspecting the equipment................................................................................................. 20
Testing the electrocardiograph......................................................................................... 20
4. Technical Specifications ..................................................................................................21
Safety, EMC, and regulatory compliance......................................................................... 21
Discarding the Equipment................................................................................................ 21
5. Guidance and Manufacturer’s Declarations...................................................................22

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Conventions
A safety symbol used on the device to highlight the fact that
there are specific warnings or precautions associated with
the device, which are not otherwise found on the device label.
A WARNING in this manual indicates conditions or practices
that, if not corrected immediately, could lead to illness, injury
or death.
A CAUTION in this manual indicates conditions or practices
that, if continued or not corrected immediately, could damage
the equipment.
NOTE
A NOTE in this manual contains additional information on
cardiograph usage.
Ingress Protection - Not protected against the ingress of
water
Serial Number
Product Identifier
Defibrillation-Proof Type CF applied part
Manufacture Date
YYYY-MM-DD
CE Mark for Class Is, Im, IIa, IIb & III
Temperature Range
Reorder Number