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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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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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 .....................................................................11

1.1 Accessories .............................................................................................................12

2. Installation ..........................................................................................................................14

To connect the cables to the Pro recorder: ...................................................................... 15

To disconnect the cables from the Pro recorder: ............................................................. 15

2.1 Connecting the patient cable to the electrode .........................................................16

3. Maintenance .......................................................................................................................18

Cleaning the CardioPerfect Cardiograph and Battery Pack ............................................. 18

Cleaning the Patient and PC interface Cables ................................................................. 18

Battery LED Indicator ....................................................................................................... 19

Battery Care ..................................................................................................................... 19

Battery Charging .............................................................................................................. 19

Storing the Battery ............................................................................................................ 19

4. Technical Specifications ..................................................................................................21

Discarding the Equipment ................................................................................................ 22

5. Guidance and Manufacturer’s Declarations ...................................................................23

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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

Reference Number

Defibrillation-Proof Type BF Applied Part

Manufacture Date

CE Mark (according to MDD93/42/EEC)

Temperature Range
Direct Current

Conventions

PRO ECG Recorder - User Manual

Electromagnetic Compatibility

When using the CardioPerfect Pro cardiograph, electromagnetic compatibility with
surrounding devices should be considered and evaluated. The CardioPerfect Pro cardiograph
complies with IEC 60601-1-2 limits for EMC.

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Caution

The patient cable supplied with the CardioPerfect cardiograph is an

integral part of the cardiograph’s safety features. Using any other

patient cable may compromise defibrillation protection as well as
cardiograph performance. The patient cable should be routed away
from power cords and any other electrical equipment. Failure to do
so can result in AC power line frequency interference on the ECG
trace.

Warning

Do not touch the patient, patient cable, PC interface cable (Prolink)
or cardiograph during defibrillation. Death or injury may occur from
the electrical shock delivered by the defibrillator. It is recommended
to check the patient cable and PC interface cable (Prolink) for
damage prior to the use of the system. If damage exists do not use
the cable, contact your local Welch Allyn Sales Office or your
authorized Welch Allyn dealer or distributor to have the cable
replaced.

1. About the CardioPerfect Pro Cardiograph

The Welch Allyn CardioPerfect Pro Cardiograph is specifically intended for the recording of
standard 12-lead electrocardiograms of patients. The device is not suitable for direct cardiac
application.

A CardioPerfect Pro system typically comes with the following components:

CardioPerfect Pro Cardiograph (SE-PRO-600, -1200)
Patient Cable (RE-PC or SE-PC)
PC Interface Cable Prolink (PRO-60023, -24, -25)
Battery Pack (PRO-60019)
CardioPerfect Workstation Software (CPWS-SW)

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REF

Component Description

Purpose

CPR-UN-UB-D

PC Based Resting ECG; non interpretive software

The Welch Allyn CardioPerfect
Pro Cardiograph is specifically
intended for the recording of
standard 12-lead electro­cardiograms of patients. The
device is not suitable for direct
cardiac application.

CPR-UI-UB-D

PC Based Resting ECG; interpretive software

CPRL-UN

PC Based Resting ECG; Excludes patient cables

CPR-UN

PC Based Resting ECG; Excludes patient cables

CPR-UN5

PC Based Resting ECG; Excludes patient cables;
5 meter USB cable

CPR-UN-EB

PC Based Resting ECG

CPR-UN-EB-D

PC Based Resting ECG; includes patient cables
and electrode set

CPR-UI-EB-D

PC Based Resting ECG; Adult interpretive
software

CPR-UN-UB

PC Based Resting ECG

CPR-UI-UB

PC Based Resting ECG; Adult interpretive
software, USB cable

CPR-SN

PC Based Resting ECG; Adult interpretive
software, Serial cable

RE-SW-MEANS

CPWS software disk; with interpretation

Software upgrade from normal
resting algorithm to include
indicated data analysis options.
These options allow data
analysis by different methods.
Software enables user to view
and save electro-cardiograms of
patients on a PC.

RE-SW-ECG

CPWS software disk

RE-SW-PEDIA

CPWS software disk; pediatric version with
interpretation

RE-SW-QT

CPWS software disk; dispersion option

RE-SW-VCG

CPWS software disk; vector option

RE-SW-RR

CPWS software disk; interval option

RE-SW-HRV

CPWS software disk; heart rate variability option

UPG-UN-UC-D-T

CPWS software disk; upgrade from resting to
stress

Software upgrade from originally
purchased CPWS. Software
enables user to view and save
electro-cardiograms of patients
on a PC.

CCW-UPCPWR

CPWS software disk; upgrade from DOS
Windows

UPDT-WACPW-CD

CPWS software disk, update from older CPWS
versions

UPDT-WACPW-OW

CPWS software disk; update from older versions,
out of warranty only

CPR-UPG-LTU

CPWS software disk; upgrade from resting ―lite‖
resting ECG to normal ECG functionality

CPR-UPG-POR-1

CPWS software disk; upgrade from POR to
normal resting functionality

CPR-UPG-MD-1

CPWS software disk and cover, upgrade from
MDR to normal resting functionality

45008-0000

Alligator clips attachment (1k box)

Clips allow user to connect
banana jack terminated patient
leads to electrode tabs needing
alligator clip attachment.

58581-0000

Alligator clips attachment (10 pack)

PRO-60023

PROLINK USB CABLE ASSEMBLY (2M)

Cable allows connection of the
Pro-Recorder to the PC USB
connector.

PRO-60024

PROLINK USB CABLE ASSEMBLY (3M)

PRO-60025

PROLINK USB CABLE ASSEMBLY (5M)

RE-PROLINK-SER

SERIAL PRO RECORDER CABLE W/9P SUB D
CONN

Cable allows connection of the
Pro-Recorder to the PC serial
connector.

RE-LINK-SER

UNILINK,RS232 FOR RESTING ECG

SE-PC-IEC-PUSH

Patient Cables;
PUSH style connector, ½ meter

Cable allows connection of the
Pro-Recorder to the electrode

1.1 Accessories

Your CardioPerfect Pro cardiograph allows the use of a broad range of accessories; contact
your local Welch Allyn Sales Office or your authorized Welch Allyn Dealer or Distributor.

NOTE All part numbers may not be available in all countries.

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REF

Component Description

Purpose

SE-PC-IEC-PSHL

SE-PC-AHA-PSHL

PUSH style connector,1.3 meters
PUSH style connector, 1.3 meters

leads, which adhere to the
patient for detection of cardiac

signals.

SE-PC-IEC-CLIP
SE-PC-IEC-CLPL
SE-PC-AHA-CLIP

SE-PC-AHA-CLPL

Patient Cables;
CLIP style connector, 1 meter, CLIP style
connector, 1.3 meters
CLIP style connector, 1 meter
CLIP style connector, 1.3 meters

RE-PC-IEC-BAN

RE-PC-IEC-BANL

RE-PC-AHA-BAN

RE-PC-AHA-BANL

Patient Cables;
Banana style connector, ½ meter
Banana style connector, 2 meters
Banana style connector, ½ meter
Banana style connector, 2 meters

SE-PRO-600-R

CARDIO PERFECT PRO RECORDER 600HZ,
refurbished

Pro-Recorder as sold with normal
resting system, refurbished
model.

08265-0000

UTILITY CART

Plastic cart that the PC and
associated hardware can sit
upon.

RE-SIM

ECG SIMULATOR

Simulator of ECG signals that
allows the user to confirm
operation of the Pro-Recorder
and CPWS system.

RE-ELEC-SET

ELECTRODE SET (6 CUPS,4 CLAMPS,GEL),
suction cups used versus the stick on tabs

Electrodes and accessories allow
connection of the patient cables
to the patient in a variety of
attachment methods.

RE-GEL

ONE BOTTLE OF ELECTRODES GEL (260G)

RE-GEL-12

BOX OF ELECTRODES GEL (12 BOTTLES)

RE-ELEC-CUP

WELCH CUP (individual suction cup)

RE-ELEC-KID

PEDIATRIC WELCH CUP ELECTRODS
(pediatric version of the cup)

RE-ELEC-CLP

LIMB LEAD CLAMPS (IEC)

RE-ELEC

DISP ELECTRODES 50X BANANA CABLE

RE-ELEC-20

DISPOSABLE ELECTRODES FOR BANANA
CABLE

RE-BAN-ADP

ADAPTER SET FOR BANANA TO PUSH STYLE
CLIPS

PRO-60019

BATTERY PACK FOR CP PRO RECORDER;
Output 2.85 – 4.5VDC, 700mA

Battery pack and accessories
allow the Pro-Recorder to be run
on serial connection and on
battery power. Accessories allow
battery to be charged upon
battery removal from Pro­Recorder.

PRO-60039

BATTERY CHARGER. Friwo P/N FW7400/12;
Output 12VDC /1A

PRO-60040

POWER CORD FOR BATTERY CHARGER,USA

PRO-60041

POWER CORD FOR BATTERY
CHARGER,EUROPE

PRO-60042

POWER CORD FOR BATTERY CHARGER,UK

102992

ADDITIONAL PROTECTIVE EARTH
GROUNDING KIT FOR PC AND TREADMILL

Kit allows the CPWS system with
PC and Treadmill to be compliant
with IEC 60601-1-1 from a
system perspective.

08281-0000

LASER PRINTER, CARDIOPERFECT

Printer that is approved for use
with CPWS.

08282-0000

CPU W/MONITOR, CARDIOPERFECT

PC and Monitor that is approved
for use with CPWS.

404008

CPWS FLEX ARM OPTION

Mechanical holder for the Pro­Recorder. Allows better cable
management and support of the
recorder while it is in use.

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DESCRIPTION

EXPLANATION

Patent Cable Connection

Connection for the patient cable

Type BF Symbol

IEC symbol, type BF equipment, defibrillator proof

On/Off Switch

Manual switch to switch on cardiograph

LED

Power indicator, red indicates battery is low and needs to
be recharged immediately, green indicates that sufficient
battery power exists to record an ECG, no LED indicates
ECG recording is not possible.

PC Symbol

Input for computer cable

PC Interface Cable
Connection

Connection for the PC interface cable (Prolink)

Type BF Symbol

On/Off Switch
PC Symbol

PC Interface Cable Connection

Patient Cable Connection
LED

LED

2. Installation

Before using the system, the CardioPerfect Pro cardiograph needs to be connected to the
computer and the software must be properly configured.

Figure 1 Front view CardioPerfect Pro Cardiograph

Figure 1 is a front view of the CardioPerfect Pro. A description of the items indicated is given
in table 1.

Table 1 Description of CardioPerfect Pro Cardiograph front panel.

Before you can start recording ECG’s with the CardioPerfect Pro cardiograph, you
need to:

1. Install the applicable software (refer to the Welch Allyn CardioPerfect Workstation
Installation User Manual)

2. Install the hardware, including the required drivers. (Please refer to the Rest manual
chapters 11 & 12 or Stress manual chapters 10 & 11)

3. Configure the software (Please refer to the Rest manual chapters 11 &12 or Stress
manual chapters 10 & 11)

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Warning

The Pro ECG recorder including connectors and cables should be
handled with care. Improper use could result in inoperable ECG and
or compromising patient safety.

Do not drop the Pro ECG recorder; this may result in
mechanical failure.

Make sure the connectors are properly aligned before
mating with the pro recorder.

Do not use force to insert the cables into the Pro ECG
recorder receptacles.

Never pull the cables, only the latch release.

Caution

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.

Latch release

alignment key

Figure 2 PC interface cable (Prolink)

Figure 3 Patient cable

The Prolink cable has 2 alignment keys and the Patient cable has 1 alignment key.

To connect the cables to the Pro recorder:

1. Hold the Pro recorder in one hand; hold the Cable connector with your other hand.

2. Align the alignment keys with the notches in the corresponding Pro recorder
receptacle.

3. Push the cable gently into the Pro recorder receptacle until it latches.

To disconnect the cables from the Pro recorder:

1. Hold the Pro recorder in one hand; hold the Cable connector with your other hand.

2. Gently pull the latch release away from the Pro recorder.

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Type of connection

Connection to electrode

Resting ECG

Banana

Alligator
clamp

Caution:

Make sure the metal part of the patient
cable connector makes contact with the
skin side of the electrode tab.

Exercise ECG or Resting ECG

Push

2.1 Connecting the patient cable to the electrode

Please refer to the table below for information on connecting the patient cable to the
electrodes.

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Exercise ECG or Resting ECG

Clip

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Caution

Do not clean the patient cable with alcohol. Alcohol can cause the

plastic to become brittle and may cause the cable to fail
prematurely.

Do not autoclave the cable or use ultrasonic cleaners.
Do not immerse the patient cable.
Do not use abrasive materials to clean metal surfaces—scratches

on them can cause artifacts on the ECG.

Do not wet the connectors.

3. Maintenance NOTE

It is recommended to check the performance of the cardiograph regularly. Contact your local
Welch Allyn Sales Office or your authorized Welch Allyn dealer or distributor. Only qualified
personnel may service the cardiograph.

Cleaning the CardioPerfect Cardiograph and Battery Pack

Clean the cardiograph and battery pack with a soft cloth moistened with a recommended
disinfectant or cleaning agent. It is advisable to clean the battery pack and ECG recorder
using moist cloth. Never clean the recorder excessively with water or other substance so that
components inside or connectors on front side of the recorder can be damaged, this may
ultimately lead to decreased performance.

Cleaning the Patient and PC interface Cables

Clean the cables with a soft cloth moistened with a recommended disinfectant or cleaning
agent.

Cleaning cables: patient cables, plugs and power cords should be kept clean using lukewarm
soapy water or a neutral cleaner.

Disinfecting the cables: use chemical disinfectants containing ethanol (70%-80%), propanol
(70%-80%) or aldehydes (2%-4%).

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CardioPerfect

PRO ECG Recorder - User Manual

Warning

Charging must be done outside of the patient environment.

NOTE

The CardioPerfect Pro cardiograph can be powered by a USB connection or through a battery
pack. If you are using a USB connection (dummy battery pack) you do not have to charge the
battery pack. If a battery pack is used with a RS232 connection, you have to charge the
battery pack with a battery charger supplied by Welch Allyn.

Battery LED Indicator

The battery pack is provided with a (green) LED indicator that indicates the performance
status of the battery pack, the following applies:

LED Intermittent – battery pack is charging after complete discharge, it is recommended to
not use the battery pack for use with the cardiograph for diagnostic purpose.
LED On – battery pack is charging and not completely charged but can be used with the
cardiograph for diagnostic purpose.
LED Off – battery pack is completely charged and ready to be used with the cardiograph for
diagnostic purpose.

Battery Care

A fully charged battery will provide a minimum of 8 hours of operation.
The CardioPerfect Pro cardiograph can be powered by a battery pack. This battery pack

contains rechargeable batteries. Battery performance is maintained when recharging takes
place when the battery is almost empty. This can be seen on the recorder when the LED on
the front lights up in red. This is the best time for recharging the battery pack. After the light
has turned red you have still enough power for about ten minutes of recording.

Both the internal gauge measurement and the percentage of battery capacity shown in Welch
Allyn CardioPerfect Workstation become less accurate.

Battery Charging

1. Pull the battery compartment from the recorder by holding the recorder with one hand and pressing on both sides off the battery compartment with your other hand.

2. Connect the battery to an electrical outlet using the power adapter by inserting the charger cable into the top of the battery compartment and charge your battery.

3. Click the battery compartment back into place after the battery is recharged.

Storing the Battery

If the cardiograph will not be used for more than three months, remove the battery pack from
the unit and place it into storage. While in storage, charge the battery to retain the battery life
and capacity. This ensures that the battery does not completely discharge while in storage.

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PRO ECG Recorder - User Manual

Caution

If the battery pack is discharged to a very low level, the "Battery
Time Left" on-screen timer of the CPWS software will not be
accurate.

Caution

Repeated undercharging of the battery will damage the battery and
reduce battery life.

The system must perform a "learning cycle" before accuracy is regained. This "learning cycle"
is achieved by fully charging a battery, fully discharging it through use, and recharging before
the next use.

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CardioPerfect

PRO CARDIOGRAPH

SPECIFICATION

SE-PRO-600
Signal bandwidth
Sampling Rate

0.05 to 150Hz
600 samples/sec

SE-PRO-1200
Signal bandwidth
Sampling Rate

0.05 to 250Hz
1200 samples/sec

Pacemaker Bandwidth

2KHz

Amplitude Quantization

3.75 µV

Skew

72.9uSec

Input impedance

>5MOhms

Gain accuracy

5% RTI

DC dynamic span

±300 mV (95% gain accuracy)

AC dynamic span

±5mV

CMMR

83 dB

Recovery time after defibrillation

80% gain accuracy after 5s

Setup time after power-on

80% gain accuracy after 5s (all leads connected)

Power consumption

<750mW

Enclosure protection against ingress of water

None - IPX0

Degree of protection against electrical shock

BF

PRO BATTERY PACK

SPECIFICATION

Battery output voltage

2.85V - 4.5V

Battery type

Nickel Metal Hydride (NIMH)

Maximum recommended output current

700mA

Battery Capacity

1650mAh nominal

Lifetime battery charge cycles

500 charge-discharge cycles

Supply voltage

9 – 18 VDC

Charger supply rating

4W

Operating temperature

+10˚C to +40˚C, 30% to 70% RH

Charging temperature

0˚C - 35˚C

Storage temperature

-20˚C to + 40˚C

STANDARD

STANDARD

ANSI/AAMI EC11

UL60601-1

CAN/CSA C22.2 No. 601.1

IEC/EN 60601-1

CAN/CSA C22.2 No. 601.1.1

IEC/EN 60601-1-1

CAN/CSA C22.2 No. 601.1.2

IEC/EN 60601-1-2

CAN/CSA C22.2 No. 601.1.4

IEC/EN 60601-1-4

CAN/CSA C22.2 No. 601.2.25

IEC/EN 60601-2-25

IEC/EN 60601-2-51: 2003

4. Technical Specifications

Table 2 CardioPerfect Pro Cardiograph

PRO ECG Recorder - User Manual

Table 3 CardioPerfect Pro Battery Pack

Table 4 Safety, EMC, and regulatory compliance

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CardioPerfect

Discard the old battery appropriately

In the USA, call 1800-SAV-LEAD for instructions on recycling it.

International users, contact your local authorities concerning recycling.
Discard the electrocardiograph, cords, and accessories according to local
laws.

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 or contact Welch
Allyn Customer Service.

Discarding the Equipment

PRO ECG Recorder - User Manual

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CardioPerfect

PRO ECG Recorder - User Manual

Caution

The Welch Allyn CardioPerfect Pro Cardiograph needs special
precautions regarding EMC and needs to be installed and put into
service according to the following EMC information provided.

Portable and mobile RF communications equipment can affect the
Welch Allyn CardioPerfect Pro Cardiograph.

Electromagnetic Emissions

The Welch Allyn CardioPerfect Pro Cardiograph is intended for use in the electromagnetic environment specified

below. The customer or the user of the Welch Allyn CardioPerfect Pro Cardiograph should assure that it is used in

such an environment.

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions
CISPR 11

Group 1

The Welch Allyn CardioPerfect Pro Cardiograph uses RF energy
only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby
electronic equipment.

RF emissions
CISPR 11

Class A

The Welch Allyn CardioPerfect Pro Cardiograph is suitable for
use in all establishments other than domestic, and may be used
in domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes, provided the following warning is
heeded:
WARNING: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the Welch Allyn CardioPerfect
Pro Cardiograph or shielding the location.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions

IEC 61000-3-3

Complies

5. Guidance and Manufacturer’s Declarations

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PRO ECG Recorder - User Manual

Electromagnetic Immunity

The Welch Allyn CardioPerfect Pro Cardiograph is intended for use in the electromagnetic environment specified

below. The customer or the user of the Welch Allyn CardioPerfect Pro Cardiograph should assure that it is used in

such an environment.

Immunity test

IEC 60601

test level

Compliance level

Electromagnetic environment

– guidance

Electrostatic discharge
(ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.

Electrical fast
transient/burst

IEC 61000-4-4

±2 kV for power supply
lines

±1 kV for input/output lines

±2 kV for power
supply lines

±1 kV for input/output
lines

Mains power quality should be
that of a typical commercial or
hospital environment.

Surge
IEC 61000-4-5

±1 kV differential mode
±2 kV common mode

±1 kV differential
mode

±2 kV common mode

Mains power quality should be
that of a typical commercial or
hospital environment.

Voltage dips, short
interruptions and
voltage variations on
power supply input lines

IEC 61000-4-11

<5 % UT
(>95 % dip in UT)
for 0,5 cycle

40 % UT
(60 % dip in UT)
for 5 cycles

70 % UT
(30 % dip in UT)
for 25 cycles

<5 % UT
(>95 % dip in UT)
for 5 sec

<5 % UT
(>95 % dip in UT)
for 0,5 cycle

40 % UT
(60 % dip in UT)
for 5 cycles

70 % UT
(30 % dip in UT)
for 25 cycles

<5 % UT
(>95 % dip in UT)
for 5 sec

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Welch Allyn CardioPerfect
Pro Cardiograph requires
continued operation during
power mains interruptions, it is
recommended that the Welch
Allyn CardioPerfect Pro
Cardiograph be powered from an
uninterruptible power supply or a
battery.

Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

NOTE

UT is the AC mains voltage prior to application of the test level.

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PRO ECG Recorder - User Manual

Electromagnetic Immunity

The Welch Allyn CardioPerfect Pro Cardiograph is intended for use in the electromagnetic environment specified

below. The customer or the user of the Welch Allyn CardioPerfect Pro Cardiograph should assure that it is used in

such an environment.

Immunity test

IEC 60601

test level

Compliance level

Electromagnetic environment –

guidance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to 80 MHz

3 Vrms

Portable and mobile RF communications
equipment should be used no closer to any
part of the Welch Allyn CardioPerfect Pro
Cardiograph, including cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 1 GHz

3 V/m

80 to 800 MHz

800 MHz to 2,5 GHz

where P is the maximum output power
rating of the transmitter in watts (W) and d is
the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following

symbol:

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Welch Allyn
CardioPerfect Pro Cardiograph is used exceeds the applicable RF compliance level above, the Welch Allyn
CardioPerfect Pro Cardiograph should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Welch Allyn
CardioPerfect Pro Cardiograph.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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CardioPerfect

PRO ECG Recorder - User Manual

Recommended separation distances between portable and mobile RF

communications equipment and the Welch Allyn CardioPerfect Pro

Cardiograph

The Welch Allyn CardioPerfect Pro Cardiograph is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the Welch Allyn CardioPerfect Pro Cardiograph

can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the Welch Allyn CardioPerfect Pro Cardiograph as recommended

below, according to the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

W

Separation distance according to frequency of transmitter

m

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0,01

0.12

0.12

0.23

0,1

0.37

0.37

0.74 1 1.2

1.2

2.3

10

3.7

3.7

7.4

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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