Welch Allyn CP 20 User manual

REF 71305-0000 Rev A
CP 20
12-Lead Resting Electrocardiograph
User
Manual
____________________________________________________________________________
Manufactured by Mortara, Inc. Milwaukee U.S.A.
CAUTION: Federal law restricts this device for sale to or on the order of a physician.

Copyright© 2003
by Welch Allyn, Inc.
7420 Carroll Road
San Diego, California 92121
This document contains confidential information that belongs to Welch Allyn, Inc. No part of this document may be
transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent
of Welch Allyn, Inc. Welch Allyn is a registered trademark of Welch Allyn, Inc. CP 20 is a trademark of Welch
Allyn, Inc.

Technical Support and Service
Headquarters
Welch Allyn, Inc.
4341 State Street Road
P.O. Box 220
Skaneateles Falls, NY 13153-0220
Tel: [phone]
Tel: [phone]
Fax: [phone]
Internet: http://www.welchallyn.com
Service/Technical Support Group
Welch Allyn, Inc.
7420 Carroll Road
San Diego, CA 92121
Tel: [phone]
Service: 800-535-6663
Fax: [phone]
E-mail: [email protected].com
USA 1-800-535-6663
European Call Center ([phone]
United Kingdom 0-207-365-6780
Canada 1-800-561-8797
South Africa ([phone]
Sales Support/Supplies & Accessories
Welch Allyn, Inc.
4341 State Street Road
P.O. Box 220
Skaneateles Falls, NY 13153-0220
Tel: [phone]
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Europe Economic Community
Representatives
Welch Allyn U.K.
Sales & Marketing Office
Cublington Road
Aston Abbotts
Buckinghamshire HP22 4ND
England
Tel: [phone]
Fax: [phone]
Canada
Welch Allyn Canada Ltd.
160 Matheson Blvd. East, Unit #2
Mississauga, Ontario
L4Z 1V4
Canada
Tel: [phone]
Tel: [phone]
Fax: [phone]
South Africa
Welch Allyn Pty Ltd S. Africa
394 Surrey Ave.
Ferndale
Randburg 2194
Zambowie
Africa
Tel: + 27 11 777 7509
Fax: + 27 11 777 7510
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Notices
Manufacturer’s Responsibility
Welch Allyn, Inc., 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, Inc.
• The device (CP 20) is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this product 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, Inc. 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, Inc.
Other Important Information
The information in this document is subject to change without notice.
Welch Allyn, Inc. 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, Inc. assumes no responsibility for
any errors or omissions that may appear in this document. Welch Allyn Inc. makes no commitment to update or to
keep current the information contained in this document.
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Warranty Information
LIMITED WARRANTY
This product is sold by Welch Allyn, Inc. under the warranties set forth in the following paragraphs. These
warranties are extended only to the end user with respect to the purchase of this product directly from Welch Allyn
or Welch Allyn’s authorized distributors.
The electrocardiograph device is warranted to be free from functional defects in materials and workmanship and
to conform in all material respects to the description of the device contained in the Directions For Use or labeling
of the device for a period of 36 months after delivery. Accessories used with the electrocardiograph device are
warranted to be free from functional defects in materials and workmanship and to conform in all material respects
to the description of the accessories contained in the directions for use or labeling of the accessories for a period
of 90 days after delivery.
This warranty is valid only if: (a) the electrocardiograph is used with an approved uninterruptible power supply; (b) all
electrodes, lead wires, cabling, and other accessories used with the electrocardiograph are approved by Welch
Allyn; (c) the device is properly operated under conditions of normal use in accordance with applicable safety and
regulatory requirements; (d) repairs are made by Welch Allyn or by persons expressly authorized by Welch Allyn, in
accordance with Welch Allyn's service procedures; and (e) the device or accessories have not been damaged by
misuse, negligence or accident.
Welch Allyn’s sole and exclusive obligation, and buyer’s sole and exclusive remedy under the above warranties, is
limited to repairing or replacing, free of charge, devices or accessories that are found to be defective during the
warranty period when the defects are reported to Welch Allyn via one of the telephone numbers listed below not
later than seven days after the expiration of the warranty:
Welch Allyn, Inc.
7420 Carroll Road
San Diego, CA 92121
Telephone: [phone]
Telephone: [phone]
Facsimile: 858-621-6610
WELCH ALLYN, INC. SHALL NOT BE OTHERWISE LIABLE FOR ANY DAMAGES INCLUDING, BUT NOT
LIMITED TO, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES.
THERE ARE NO EXPRESS OR IMPLIED WARRANTIES, WHICH EXTEND BEYOND THE WARRANTIES IN THIS
DOCUMENT. WELCH ALLYN MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
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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
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 1-800-535-6663 Canada 1-800-561-8797
Latin America ([phone] South Africa ([phone]
European Call Center ([phone] Australia ([phone]
United Kingdom 0-207-365-6780 Singapore ([phone]
France ([phone] Japan ([phone]
Germany ([phone] China ([phone]
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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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 equipment.
Note: Provides information to further assist in the
use of the device.
Federal law restricts this device for sale to or on the order of a physician.
Warning(s)
•Device (electrocardiograph, Class I) captures and presents data reflecting a patient’s physiological condition
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.
•To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged
into a Hospital Grade outlet.
•To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in
direct patient contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.
• Patient cables intended for use with the CP 20 include series resistance (10 K ohm 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 electrode should not come into contact with other
conductive parts, including earth ground.
•To maintain designed operator and patient safety, only use parts and accessories supplied with the device and
available through Welch Allyn, Inc.
•ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation.
•To prevent possible infection, single use components (e.g., electrodes) should be limited to one-time use only.
•To avoid the possibility of serious injury or death during patient defibrillation, do not come into 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.
• To ensure the safety of both the patient and the device, 1.5 meters (5 feet) of open area should surround the
patient.
•A possible explosion hazard exists; do not use the device in the presence of flammable anesthetics.
•Before attempting to use the device for clinical applications the operator must read and understand the contents
of the manual and any documents accompanying the device.
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• Where the integrity of external protective earth conductor arrangement is in doubt, the CP 20 shall be operated
from its internal electrical power source.
• All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC
60601-1, or other IEC standards (e.g. IEC 60950), as appropriate to the device. Connecting additional devices
to the CP 20 may increase chassis and/or patient leakage currents. To maintain operator and patient safety,
consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be measured
to confirm no electric shock hazard exists.
• The CP 20 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 electrocardiograph may be adversely affected by the use of other
medical equipment, including but not limited to defibrillators and ultrasound machines.
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Caution(s)
•To prevent possible damage to the keypad, do not use sharp or hard objects to depress keys, only use
fingertips.
•Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam
cleaning. Wipe the exterior surfaces with a warm water and mild detergent solution and then dry with a clean
cloth.
• No user serviceable parts inside. Screw removal by qualified service personnel only.
•The rechargeable internal battery is a sealed lead acid type and it is totally maintenance free. If the battery
appears to become defective, refer to Welch Allyn Service Department.
•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.
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Notes
•Excessive patient movement could interfere with the operation of the device.
•Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
• There is no known safety hazard if other equipment, such as pacemakers or other stimulators, are used
simultaneously with the CP 20; however, disturbance to the signal may occur.
• If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the lead(s)
where this condition is present and if the signal is being printed, the respective lead(s) will print out as a square
wave.
• As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
• Class I equipment or internally powered
• Type CF applied parts
• Ordinary equipment
• Not suitable for use in the presence of flammable anesthetics
• Continuous operation
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards / norms, this unit is
declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made along with
mains. The ground terminal on the mains inlet is the only protective earth point in the unit. Exposed
metal accessible during normal operation is double insulated from mains. Internal connections to earth
ground are functional earth.
•The CP 20 will automatically turn off (blank screen) if the batteries have been severely discharged.
•After operating the CP 20 using battery power, always reconnect the power cord. This ensures that the
batteries will be automatically recharged for the next time you use the CP 20. A light will illuminate, next to
the on/off switch, indicating that the unit is charging.
• The CP 20 is a UL Classified Device:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
UL2601-1, IEC60601-1, CAN/CSA CC22.2 No. 601.1, AND
IEC60601-2-25
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