Welch Allyn CP 50, CP 50 Plus Directions For Use Manual

CP 50™ and CP 50 Plus™ 12-lead
resting electrocardiograph

Directions for use

© 2016 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication,
the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media
provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted
without written permission from Welch Allyn.

Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that
may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of
intended use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn, Inc. CP 50, CP 50 Plus, and CardioPerfect are trademarks of
Welch Allyn, Inc.

PDI and Sani-Cloth are registered trademarks of PDI, Inc. CaviWipes is a trademark of Metrex Research Corporation.

Patent information

For patent information, please visit

http://www.welchallyn.com/patents.

Software in this product is copyright Welch Allyn or its vendors. 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 incorporated within this instrument as intended in the
operation of the product in which it is embedded. 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 or its vendors.

For information about any Welch Allyn product, contact your local Welch Allyn representative:

http://

www.welchallyn.com/en/other/contact-us.html.

105487

DIR 80020944, Ver. A.
Revision date: 2016-06

Welch Allyn Limited

Navan Business Park

Dublin Road

Navan, County Meath

Republic of Ireland

This manual applies to 901048 ELECTROCARDIOGRAPH

www.welchallyn.com

Contents

Introduction ............................................................................................. 1

iii

About this document ........................................................................................... 1

Intended use ........................................................................................................ 1

Indications for use ................................................................................................ 1

Description ........................................................................................................... 1

About the test types ............................................................................................ 2

Features ............................................................................................................... 3

Configuration options ........................................................................................... 4

Symbols ............................................................................................................... 5

General warnings ................................................................................................. 8

General cautions ................................................................................................ 10

Setup ...................................................................................................... 13

Connecting the patient cable ............................................................................. 13

Loading the thermal paper ................................................................................. 14

Powering the electrocardiograph ....................................................................... 16

About the menu ................................................................................................. 17

Viewing or changing the settings ....................................................................... 17

Viewing the device information ......................................................................... 17

Verifying proper operation .................................................................................. 18

Connecting to an external USB printer (optional - available with CP 50 Plus

only) ................................................................................................................... 19

Connecting to a CardioPerfect workstation (optional, available with CP 50 Plus

only) ................................................................................................................... 19

ECG tests ................................................................................................ 23

Attaching the leads to the patient ...................................................................... 23

Electrode locations ............................................................................................. 25

Performing an ECG test ..................................................................................... 27

Administrative tasks .............................................................................. 29

Turning the security option on or off (optional - available with CP 50 Plus

only) ................................................................................................................... 29

Managing the user list (optional - available with CP 50 Plus only) ..................... 29

Turning the audit trail on or off (optional - available with CP 50 Plus only) ........ 30

Managing the worklist (optional - available with CP 50 Plus only) ..................... 30

Managing the test directory ............................................................................... 31

Maintenance .......................................................................................... 33

Cleaning the equipment ..................................................................................... 33

Inspecting the equipment .................................................................................. 34

Testing the electrocardiograph .......................................................................... 34

Replacing the battery ......................................................................................... 34

iv Contents CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Replacing the AC fuses ...................................................................................... 36

Storing the equipment ....................................................................................... 36

Discarding the equipment .................................................................................. 36

Troubleshooting .................................................................................... 37

Lead-quality problems ........................................................................................ 37

System problems ............................................................................................... 40

Limited warranty ................................................................................................ 41

Service policy ..................................................................................................... 42

Specifications ........................................................................................ 43

Guidance and manufacturer’s declarations ........................................ 47

EMC compliance ................................................................................................ 47

Emissions and immunity information ................................................................. 47

Accessory list ......................................................................................... 51

Introduction

About this document

This document is written for clinical professionals with a working knowledge of medical
procedures and terminology required for monitoring cardiac patients.

Before using the electrocardiograph for clinical applications — or before setting up,
configuring, troubleshooting, or servicing the electrocardiograph — you must read and
understand this document and all other information that accompanies the
electrocardiograph and related options or accessories.

1

Intended use

The Welch Allyn electrocardiography products (subject devices) are intended for use by
trained operators in health facilities. The subject devices provide the following diagnostic
functions:

•

Acquiring, viewing, storing, and printing ECG waveforms using ECG front-end
modules (patient cables) and associated accessories that provide signal acquisition
for up to twelve (12) leads of patient ECG waveforms through surface electrodes
adhered to the body.

• Using optional algorithms to generate measurements, data presentations, graphical
presentations, and interpretative statements on an advisory basis. These are
presented for review and interpretation by the clinician based upon knowledge of the
patient, the result of physical examination, the ECG tracings, and other clinical
findings.

Indications for use

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and
monitor patient cardiac function.

The 12-lead ECG interpretive algorithm provides a computer-generated analysis of
potential patient cardiac abnormalities which must be confirmed by a physician with
other relevant clinical information.

Description

• The electrocardiograph is not suited for direct cardiac application.

• The electrocardiograph allows users to perform 12-lead ECG measurements and

• The electrocardiograph supports STAT, Auto, and Rhythm test types.

analysis.

2 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

• The electrocardiograph provides the ability to print test records on an internal printer.

• The electrocardiograph provides the ability to send test records and analysis directly
to an electronic medical records (EMR) system.

• The electrocardiograph allows storage of test records in device memory, external
storage media, and external software applications.

• The electrocardiograph allows users to enter patient demographic data into the
electrocardiograph memory to be recalled for a test later that day.

About the test types

Auto ECG

Stat ECG

Rhythm ECG

A report typically showing a 10-second acquisition of 12 leads of ECG information combined with
patient data, measurements, and optional interpretation. Auto ECGs can be saved to the
electrocardiograph’s test directory or to a USB mass-storage device. In CP 50 Plus models, auto ECGs
can also be sent to a Welch Allyn CardioPerfect workstation.

Auto ECG report example

An auto ECG that starts instantly without waiting for you to enter patient data or adjust the
waveforms.

WARNING To avoid the risk of associating reports with the wrong patients, make
sure that each test identifies the patient. Do not save a test to the patient record
without patient identification associated with the report.

A continuous, real-time printout of rhythm strips with a user-defined lead configuration. Rhythm ECGs
are printouts only. They cannot be saved.

Rhythm ECG report example

Directions for use Introduction 3

Features

Pacemaker detection

The software detects the possible presence of a pacemaker. If you confirm that the
patient has a pacemaker, the ECG report includes no interpretation, and it indicates that
a pacemaker was detected.

Automatic ECG interpretation (optional)

The optional MEANS interpretation algorithm, developed by the University of Rotterdam
in the Netherlands, provides automatic analysis of ECG tests. For more information, see
the MEANS Physicians’ Manual or the PEDMEANS Physicians’ Manual on the CD that
came with your electrocardiograph. The MEANS algorithm is used for adult patients 18
years and older. The PEDMEANS algorithm is used for pediatric patients from 1 day
through 17 years old.

WARNING A computer-generated interpretation cannot replace sound
medical reasoning by a trained professional. Therefore, a physician should
always review the interpretation.

CP 50 Plus (optional)

The CP 50 Plus consists of the CP 50 device and an optional connectivity feature that is
enabled with a software activation code.

CAUTION Check for the presence of a pacemaker before using ECG with
interpretation.

4 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Configuration options

The device is available in multiple configurations. Use the following to identify a
configuration:

[Device][Feature]-[Cable][Language][PowerCord]

Position Description

[Device] Four characters that indicate the device: CP50.

[Feature]

[Cable]

One or two characters that indicates the added feature:

•

Blank: A basic feature.

•

A: Includes automatic ECG interpretation.

•

P: Includes connectivity.

•

AP: Includes automatic ECG interpretation and connectivity.

A number that specifies the cable type included with the device:

•

1: AHA ECG cable with disposable electrodes.

•

2: IEC ECG cable with disposable electrodes.

•

3: AHA ECG cable with reusable electrodes.

•

4: IEC ECG cable with reusable electrodes.

[Language] Two characters that indicate the language of the manual included with your device:

Code Language Code Language

BR
DA
DE
EN
ES
FR
IT
NL

Brazilian Portuguese
Danish
German
English
Spanish
French
Italian
Dutch

NO
PL
PT
RU
SV
VI
ZH

Norwegian
Polish
Portuguese
Russian
Swedish
Vietnamese
Simplified Chinese

[PowerCord] One number that indicates the power cord packaged with the device.

No. Description No. Description

1
2
3
4
5

North America
Europe
Israel
United Kingdom
Switzerland

6
7
8
9

Australia
China
Denmark
South Africa

Directions for use Introduction 5

Symbols

Documentation symbols

Operation symbols

WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death.

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

Power on/standby

Auto ECG Rhythm ECG

CAUTION The caution statements in this
manual identify conditions or practices
that could result in damage to the
equipment or other property, or loss of
data. This definition applies to both
yellow and black and white symbols.

Search

Accept Close/Cancel

Previous Next

Help Menu

Backspace

6 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Power symbols

(LED off) No AC power is present Battery absent or faulty

(LED green) AC power is present, and
battery is charging. (LED amber) AC
power is present, and battery is charging.

Alternating current Battery is charging

Dangerous voltage Battery door

Fuse Rechargeable battery

Protective earth Nonionizing electromagnetic radiation

Equipotential terminal Lithium ion

Battery is charged to the indicated level

Connectivity symbols

USB

Shipping, storing, and environment symbols

This end up

Fragile Humidity limitation

Temperature limits Atmospheric pressure limitation

Ethernet (RJ-45 )

Keep dry

Directions for use Introduction 7

Separate the battery from other
disposables for recycling

Separate the device from other
disposables for recycling

See www.welchallyn.com/weee.

Miscellaneous symbols

Heartbeats per minute

Manufacturer Date of manufacture

Defibrillation-proof Type CF applied part Serial number

Recycle

China RoHS

Hot surface. Do not touch.

Product identifier Batch code

Reorder number Global Trade Item Number

Do not reuse Software activation code

Meets essential requirements of
European Medical Device Directive
93/42/EEC

8 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

General warnings

Warnings indicate conditions or practices that could lead to illness, injury, or death.

Warnings related to the environment

WARNING To avoid a possible explosion, do not use the
electrocardiograph in the presence of flammable anesthetics: mixtures
containing air, oxygen, or nitrous oxide.

WARNING When transporting the electrocardiograph on a cart, tuck the
patient cable away from the wheels so that it does not present a hazard.

WARNING The power cord is considered the disconnect device for
isolating this equipment from supply mains. Do not position the equipment
so that it is difficult to reach or disconnect.

Warnings related to accessories and other equipment

WARNING For operator and patient safety, peripheral equipment and
accessories that can come in direct patient contact must be in compliance
with all appropriate safety, EMC, and regulatory requirements.

WARNING All signal input and output (I/O) connectors are intended for
connection of only devices complying with IEC 60601-1, or other IEC
standards (for example, IEC 60950), as appropriate to the device.
Connecting additional devices to the electrocardiograph might increase
chassis or patient leakage currents. To maintain operator and patient
safety, consider the requirements of IEC 60601-1-1. Measure the leakage
currents to confirm that no electric shock hazard exists. In the case of a
USB printer, the printer (non-medical electrical equipment) shall be situated
outside the patient environment (reference IEC 60601-1-1). The printer
used should be approved to the appropriate safety standard for non­medical electrical equipment (IEC 60950, or its national variants), and use
of an isolation transformer is recommended. If there is a requirement for
the printer to be situated within the patient environment it is the
responsibility of the user to ensure that the system provides a level of
safety in compliance with IEC 60601-1 and 60601-1-1.

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

WARNING To avoid the risk of electric shock, this equipment must only
be connected to a supply mains with protective earth.

WARNING Defective batteries can damage the electrocardiograph.
Visually inspect the battery at least monthly. If the battery shows any signs
of damage or cracking, it must be replaced immediately and only with a
battery approved by Welch Allyn.

WARNING Improper disposal of batteries may create an explosion or
contamination hazard. Never dispose of batteries in refuse containers.
Always recycle batteries according to local regulations.

Directions for use Introduction 9

WARNING All signal input and output (SIP/SOP) connectors should not be
contacted by the patient directly or indirectly through the user during
operation.

WARNING Use only parts and accessories, including thermal paper, that
were supplied with the device and available through Welch Allyn. The use
of accessories other than those specified may result in degraded
performance or unsafe use of this device, including compromised
defibrillator protection, increased electromagnetic emissions or decreased
electromagnetic immunity.

Warnings related to using the electrocardiograph

WARNING This device captures and presents data reflecting a patient’s
physiological condition. When reviewed by a trained physician or clinician,
this data can be useful in determining a diagnosis. However, the data
should not be used as a sole means for determining a patient’s diagnosis or
prescribing treatment.

WARNING To avoid serious injury or death, take these precautions during
patient defibrillation:

• Avoid contact with the electrocardiograph, patient cable, and patient.

• Verify that the patient leads are properly connected.

• Place defibrillator paddles properly in relation to electrodes.

• After defibrillation, pull each patient lead out of the patient cable and inspect
the tips for charring (black carbon marks). If there is any charring, the patient
cable and individual leads must be replaced. If there is no charring, fully
reinsert the leads into the patient cable. (Charring can occur only if a lead is
not fully inserted into the patient cable before defibrillation.)

WARNING 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.

• Avoid ECG testing for patients with open, infectious sores.

WARNING Avoid positioning any leads or cables so that they could easily
trip someone or become wrapped around a patient’s neck.

WARNING To ensure safe use of the device, follow the documented
maintenance procedures.

WARNING Only qualified service personnel should attempt to repair the
electrocardiograph. In case of a malfunction, call Technical Support.

WARNING Do not perform ST segment analysis on the ECG screen
display, since these ECG representations are scaled. Make manual
measurements of ECG intervals and magnitudes on printed ECG reports
only.

WARNING To maintain diagnostic accuracy and to comply with IEC
60601-02-51, do not scale (re size) when sending a saved ECG to an
external printer.

10 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

WARNING To avoid injury, do not touch the print head immediately after
printing. It might be hot.

WARNING No modification of this equipment is allowed.

WARNING To provide CF protection use only accessories approved by

Welch Allyn. Visit www.welchallyn.com. The use of any other accessories
can result in inaccurate patient data, can damage the equipment, and can
void your product warranty.

WARNING To avoid the risk of associating reports with the wrong
patients, make sure that each test identifies the patient. Do not save a test
to the patient record without patient identification associated with the
report.

General cautions

Cautions indicate conditions or practices that could damage the equipment or other
property.

CAUTION Federal US law restricts sale of the device identified in this
manual to, or on the order of, a licensed physician.

CAUTION When removing the electrocardiograph from storage, allow it to
thermally stabilize to surrounding environmental conditions before using it.

CAUTION To prevent possible damage, do not use sharp or hard objects
to press the touch screen or the buttons. Only use fingertips.

CAUTION Do not expose the patient cable to strong ultraviolet radiation.

CAUTION Do not pull or stretch the patient cable. Doing so could result in

mechanical or electrical failures. Form the patient cable into a loose loop
before storing.

CAUTION Avoid positioning the patient cable where it might get pinched,
stretched, or stepped on. Otherwise, measurements might no longer be
accurate, and repair might be necessary.

CAUTION Using the equipotential terminal for anything but grounding
purposes may contribute to damage of the device.

CAUTION Portable and mobile RF communications equipment can affect
the performance of the electrocardiograph.

CAUTION The electrocardiograph meets the Class A requirements of IEC
60601-1-2 regarding incidental emission of radio frequency interference. As
such it is suitable for use in commercial grade electrical environments. If
the electrocardiograph is used in residential grade electrical environments
and you experience incidental interference with other equipment that uses
radio frequency signals to operate, minimize the interference.

CAUTION 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.

Directions for use Introduction 11

CAUTION The power cord must be disconnected from AC power before
cleaning, maintaining, transporting, or servicing.

CAUTION The requirements of AAMI EC11, Section 3.2.7.2, Frequency
and Impulse Response, for an impulse triangle waveform may be impacted
by up to 5 milliseconds of small amplitude dampened ringing immediately
after the impulse when the muscle filter (35 Hz) is turned on or a small
amplitude offset when the baseline filter (0.5 Hz) is turned on. These filters,
in any combination turned on or off, meet the AAMI requirements.
Measurements performed by the optional interpretation algorithm are
unaffected by any filter selections.

Note The entire patient cable, up to and including the electrodes, are considered

to be an Applied Part.

12 Introduction CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Setup

Connecting the patient cable

13

WARNING Do not allow the conductive parts of the patient cable,
electrodes, or associated connections of defibrillation-proof applied parts,
including the neutral conductor of the patient cable and electrodes, to
come into contact with other conductive parts, including earth ground.
Otherwise, an electrical short might result, risking electric shock to patients
and damage to the device.

WARNING To avoid injury to the patient or damage to the device, never
plug patient leads into any other device or wall outlet.

WARNING To provide CF protection use only accessories approved by
Welch Allyn. Visit www.welchallyn.com. The use of any other accessories
can result in inaccurate patient data, can damage the equipment, and can
void your product warranty.

CAUTION Always connect the patient cable and the leads properly during
defibrillation. Otherwise, the connected leads could be damaged.

14 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Loading the thermal paper

The electrocardiograph prints on z-fold thermal paper or roll thermal paper.

• Store the paper in a cool, dry, dark place.

• Do not expose it to bright light or UV sources.

• Do not expose it to solvents, adhesives, or cleaning fluids.

• Do not store it with vinyls, plastics, or shrink wraps.

To load z-fold thermal paper

Directions for use Setup 15

To load a roll of thermal paper

16 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Powering the electrocardiograph

The electrocardiograph runs on AC or battery power. Plug the electrocardiograph into AC
power as often as possible so that the built-in charger can keep the battery charged.
Regardless of the battery condition, you can use the electrocardiograph whenever it is
plugged in.

WARNING When you use AC power, always plug the electrocardiograph
into a hospital-grade outlet to avoid the risk of shock.

WARNING If the integrity of the building’s safety ground is in doubt,
operate this device on battery power to avoid the risk of shock.

To power up or power down

Press .

Directions for use Setup 17

About the menu

The menu provides access to the saved patient tests, the settings, and the service
functions. From either of the main screens, you can reach the menu by touching the

menu button.

Viewing or changing the settings

Three setting types are available:

•

The ECG settings, which control the content and format of your reports. In CP 50
Plus models, these settings include a second report format (auto report 2),
customizable patient data fields, and auto save options.

• The System settings, which control the overall device.

• The Security settings, which control user login and the audit trail.

To view or change the settings

1.

Touch the menu button.

2. Touch Settings > System > About or Upgrade.

3. Make changes as needed.

Viewing the device information

You can view device information in two places:

The About screen, which lists the model number, serial number, software versions,

•
RAM usage, available NAND.

• The Upgrade screen, which lists the installed options.

18 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

To view the device information

1. Touch the menu button.

2. Touch Settings > System > About or Upgrade.

Verifying proper operation

To ensure the accuracy of test data, you should verify proper operation of the
electrocardiograph before it is used for the first time with patients. You should reverify
proper operation once a year.

To verify proper operation

1. Use an ECG simulator to acquire and print a standard 12-lead ECG of known
amplitude and rate.

2. Look for the following indications of proper operation:

• Printing should be dark and even across the page.

• There should be no evidence of print-head dot failure (no printing breaks forming

horizontal streaks).

• Thermal paper should move smoothly and consistently during printing.

• The waveforms should have no distortion or excessive noise.

• The amplitude and rate of the waveforms should match the input value from the

ECG simulator.

• Z-fold thermal paper should stop with perforations near the tear bar, indicating

proper cue-sensor operation.

3. If you see any indications of improper operation, call Welch Allyn Technical Support.

Directions for use

Setup 19

Connecting to an external USB printer (optional - available with CP 50 Plus only)

You can connect a CP 50 Plus electrocardiograph to an external printer. The printer must
be a USB inkjet or laser printer that supports PCL3 and PCL5 (printer control languages).

No special software is required.

The external printer prints auto ECG reports, always in black and white. (Rhythm ECGs
always print to the internal printer.)

Cables longer than three meters have not been verified for use with the
electrocardiograph. Do not use cables longer than three meters.

To connect to an external USB printer

1. Connect one end of a USB cable to the printer’s USB connector, and connect the
other end to the electrocardiograph’s USB connector.

2. Enable the external printer.

a. Touch the menu button.

b. Touch Settings > ECG > Auto report 1 or Auto report 2.

c. Under Printer, select External.

Connecting to a CardioPerfect workstation (optional, available with CP 50 Plus only)

You can connect a CP 50 Plus electrocardiograph to a Welch Allyn CardioPerfect
workstation via USB cable or via Ethernet cable. Software provided in the Connex
Software Connectivity Kit is required to communicate with the Welch Allyn CardioPerfect
workstation. After you connect, you can perform several functions from the
electrocardiograph, including:

•

Send ECG tests to the workstation.

• Search for patient data in the workstation database.

Cables longer than three meters have not been verified for use with the
electrocardiograph. Do not use cables longer than three meters.

20 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

To connect to a workstation via USB cable

Connect the electrocardiograph to any of the workstation’s USB ports. No software
configuration is required. The electrocardiograph is ready to communicate.

To connect to a network-connected workstation via Ethernet cable

1. Connect the electrocardiograph to the same network as the workstation. If you need
help, consult with your network administrator.

WARNING To reduce the risk of fire and shock hazards,
connect Ethernet cables within the boundaries of a single
building. Ethernet cables that span multiple buildings can
introduce fire or shock hazards unless fiber optic cables or
lightning arrestors are properly installed or other appropriate
safety measures are taken.

2. Go to the CP 50 connectivity screen

a. Touch the menu button.

b. Touch the Settings > System > Network > Device.

3. Fill in the screen.

• If DHCP is enabled for the network, select the DHCP checkbox.

• If DHCP is not enabled, fill in the fields: static IP address, subnet mask, and

default gateway.

4. Touch the Test tab

5. Connect to the network.

a. In the Host Address field, enter the host IP address.

b. Touch Ping Test. The electrocardiograph pings the host.

6. Touch the Server tab.

7. Choose one of these to specify how to get server IP information:

• Obtain server IP information automatically: Select this option if you want the

device to get the IP address, or if you don’t know the server’s IP address.

• Server IP address: Fill in this field if your server IP address is available.

8. Touch Server Test.

The electrocardiograph connects to the server.

Directions for use Setup 21

The electrocardiograph is ready to communicate with the workstation. (To set up the
workstation, see the instructions that came with the workstation connectivity
software.)

22 Setup CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

ECG tests

Attaching the leads to the patient

Proper lead attachment is important for a successful ECG. The most common ECG
problems are caused by poor electrode contact and loose leads. Follow your local
procedures for attaching the leads to the patient. Here are some common guidelines.

23

WARNING Electrodes can cause allergic reactions. To avoid this, follow
the electrode manufacturer's directions.

To attach the leads to the patient

1.

Prepare the patient.

• Describe the procedure. Explain the importance of holding still during the test.

(Movement can create artifact.)

• Verify that the patient is comfortable, warm, and relaxed. (Shivering can create

artifact.)

• Put the patient in a reclining position with the head slightly higher than the heart

and legs (the semi-Fowler’s position).

2. Select the electrode locations. (See the “Electrode locations” chart.)

• Look for flat areas.

• Avoid fatty areas, bony areas, and major muscles.

3. Prepare the electrode locations.

• Shave or clip the hair.

• Thoroughly clean the skin, and lightly rub it dry. You may use soap and water,

isopropyl alcohol, or skin preparation pads.

4. Attach the lead wires to the electrodes.

5. Apply the electrodes to the patient.

24 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Electrode examples, left to right: arm clamp (reusable), Welsh cup (reusable), tab
electrode (disposable), monitoring electrode (disposable).

• For reusable electrodes: Use electrode paste, gel, or cream to cover an area

the size of each electrode but no larger. Secure the arm and leg clamps. Apply
the Welsh cups (suction electrodes) to the chest.

• For disposable tab electrodes: Place the electrode tab between the “jaws” of

the connector. Keep the tab flat. Verify that the metal portion of the connector
makes contact with the skin side of the electrode tab.

• For all disposable electrodes: Lightly tug on the connector to ensure that the

lead is securely attached. If the electrode comes off, replace it with a new
electrode. If the connector comes off, reconnect it.

Directions for use ECG tests 25

Electrode locations

AHA IEC Location

A

B

C

D

E

F

V1

(red)

V2

(yellow)

V3

(green)

V4

(blue)

V5

(orange)

V6

(purple

C1

(red)

C2

(yellow)

C3

(green)

C4

(brown)

C5

(black)

C6

(purple)

Fourth intercostal space at the right sternal border.

Fourth intercostal space at the left sternal border.

Midway between V2 and V4.

Fifth intercostal space to the left of the midclavicular line.

Anterior axillary line at the same horizontal level as V4.

Mid-axillary line at the same horizontal level as V4 and V5.

G

H

LA

(black)

LL

(red)

L

(yellow)

R

(green)

Just above the left wrist on the inside of the arm.

Just above the left ankle.

26 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

AHA IEC Location

I

J

RL

(green)

RA

(white)

N

(black)

R

(red)

Just above the right ankle.

Just above the right wrist on the inside of the arm.

Directions for use ECG tests 27

Performing an ECG test

1. Attach the leads to the patient. Any flashing dots on the lead-status screen indicate
unattached or poorly attached leads.

When all leads have been attached for several seconds, the ECG preview screen
appears.

Leads button

Gain button (size)

Speed button

Filters button

2. If an Artifact message appears, minimize the artifact, as described under
Troubleshooting. You might need to ensure that the patient is comfortably warm,
reprepare the patient’s skin, use fresh electrodes, or minimize patient motion.

3. (Optional) Adjust the waveforms, using the buttons to cycle through the options:

• leads displayed

• gain (size)

• speed

• filters

4. Perform the desired type of test: stat ECG, auto ECG, or rhythm ECG.

For auto ECGs, you can enter patient data automatically if it is available.

28 ECG tests CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

• The Search button gives you access to patient data in the test directory or in

a connected database (CardioPerfect workstation or EMR).

• The Worklist button (CP 50 Plus only) gives you access to patient data in the

worklist.

5. If a Waiting for 10 (or 20) seconds of quality data message appears, at least 10 or
20 seconds of ECG data have been collected with excessive artifact. Time
requirements in the message may vary, based upon selected print format. Minimize
the artifact, as described under Troubleshooting. Then wait for the test to print. If
necessary, you can override the wait time and print the available data immediately,
but the result might be an incomplete or poor-quality test.

6. After the test prints, select the desired option: Reprint, Save, Retest, or Assign
(Any tests that you save to a USB mass-storage device can be retrieved only from a
CardioPerfect workstation.)

WARNING To avoid the risk of associating reports with the
wrong patients, make sure that each test identifies the
patient. If any report does not identify the patient, write the
patient identification information on the report immediately
following the ECG test.

Administrative tasks

Turning the security option on or off (optional - available with CP 50 Plus only)

The electrocardiograph incorporates security features that can keep patient data
confidential. When the security option is off, user login is never required. When the
security option is on, user login is required for the following tasks:

• searching for patient data

• managing the test directory

• managing the worklist

• managing the user list

• managing the audit trail

29

A user’s level of access is either “user” or “administrator,” as determined in the user
list.

To turn the security option on or off

1.

Touch the menu button.

2. Touch Settings > Security.

3. Turn the security option on or off.

Managing the user list (optional - available with CP 50 Plus only)

The user list, which is enabled when the security option is on, identifies all individuals
who are authorized to access patient data.

The user list can hold up to 25 users. After the list reaches 25 users, you can add users
only if some users are set to inactive status. New users replace inactive users. If all 25
users are active, you receive a message that the user list is full.

Two levels of access can be assigned:

User level: User-level users have access to the test directory and the worklist,

•
including searching and editing privileges.

• Administrator level: Administrator-level users have user-level access and can also
create and administer users.

30 Administrative tasks CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

To manage the user list

1. Touch the menu button.

2. Touch Settings > System > Users.

3. Add, edit, delete, activate, or deactivate users.

Turning the audit trail on or off (optional - available with CP 50 Plus only)

An audit trail, a collection of information about user activity, may be helpful or even
required for record-keeping. It records the user identity code and time associated with
each use of the electrocardiograph, including these types of activity:

• accessing the test directory

• searching the worklist

• editing patient data

• accessing administrative functions

When the audit trail is turned on, the electrocardiograph collects this type of information
in a file in its memory.

To turn the audit trail on or off

1.

Touch the menu button.

2. Touch Settings > System.

3. Turn the audit trail on or off.

Managing the worklist (optional - available with CP 50 Plus only)

The worklist is a group of patients whose demographic data has been entered into the
electrocardiograph memory to be recalled for a test later that day. The worklist holds up
to 50 patients.

When you perform an auto ECG, you can fill in the patient’s data from the worklist
automatically by touching the Worklist button.

You can add or delete patients any time. If the electrocardiograph is connected to an
EMR, you can also download a worklist.

To manage the worklist

Touch the menu button.

1.

2. Touch Worklist.

3. Add patients, delete patients, or download a worklist.

Directions for use Administrative tasks 31

Managing the test directory

The test directory is a group of ECG tests that have been saved in the electrocardiograph
memory.

When you perform an auto ECG, you can fill in the patient’s data from the test directory

automatically by touching the search button.

With all electrocardiograph models, you can delete or print saved tests. With CP 50 Plus
models, you can also do the following:

• Edit the patient data in saved tests.

• Send saved tests to a USB mass-storage device or to a Welch Allyn CardioPerfect
workstation. (Any tests that you send to a USB mass-storage device can be retrieved
only from a CardioPerfect workstation.)

To manage the test directory

1. Touch the menu button.

2. Touch Tests.

3. Delete, edit, print, or send saved tests. (Options vary per model.)

32 Administrative tasks CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Maintenance

Cleaning the equipment

WARNING Keep the electrocardiograph, reusable electrodes, and the
patient cable clean. Patient contact with contaminated equipment can
spread infection.

33

CAUTION Never let soap or water come into contact with the
electrocardiograph’s internal printer, connectors, or jacks.

CAUTION Never immerse the electrocardiograph or the patient cable in
liquid. Never autoclave or steam clean the electrocardiograph or the patient
cable. Never pour alcohol directly on the electrocardiograph or the patient
cable, and never soak any components in alcohol. If any liquid enters the
electrocardiograph, remove the electrocardiograph from service, and have
it inspected by a qualified service person before using it again.

Acceptable cleaning solutions:

•

Mild detergent and water, ½ tsp detergent per cup of water

• Bleach and water, 1 part bleach (6.00% sodium hypochlorite) with 9 parts water

• Isopropyl alcohol and water, 70% by volume

•

PDI®Sani-Cloth® Plus wipes (14.85% isopropanol)

• CaviWipes™ (17.2% isopropanol)

To clean the equipment (monthly or more often if needed)

1.

Disconnect the power plug from the AC outlet.

2. Turn off the electrocardiograph. (Press and hold the power button for at least six

seconds until the screen goes blank.)

34

Maintenance CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

3. Dampen a cloth with any of the acceptable cleaning solutions, and wipe the exterior

of the patient cable, reusable electrodes, and electrocardiograph. Dry all
components with a clean, soft cloth, or paper towel.

WARNING The patient cable and reusable elctrodes should be
cleaned between each patient.

4. Before you turn on the electrocardiograph again, wait at least 10 minutes for all

traces of liquid to evaporate.

Inspecting the equipment

Perform the following inspections daily.

• Check for cracked or broken patient cable, patient electrodes, power cord,
communications cables, display, and enclosure.

• Check for bent or missing pins on all cables.

• Check all cable and cord connections; reseat if any connectors are loose.

Testing the electrocardiograph

Welch Allyn recommends verifying proper operation of the electrocardiograph once a
year to ensure reliability. See Verifying proper operation.

Whenever the electrocardiograph is serviced or whenever problems are suspected,
verify continued electrical safety of the device using IEC 60601-1 or ANSI/AAMI ES1
methods and limits.

WARNING Only qualified service personnel should perform leakage
current tests.

Test for the following:

•

Patient leakage current

• Chassis leakage current

• Earth leakage current

• Dielectric strength (AC and patient circuits)

Replacing the battery

Replace the battery under these circumstances:

It loses its charge quickly.

•

• You have charged it, and the electrocardiograph still does not turn on when
unplugged.

The first time that you press the power button after installing a new battery, the
electrocardiograph goes through some diagnostic tests that cause it to take longer than
usual to power up.

Discard the old battery appropriately. Contact your local authorities concerning recycling.

Directions for use Maintenance 35

To replace the battery

Remove the old battery Insert the new battery

36 Maintenance CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Replacing the AC fuses

You might need to replace one or both of the AC fuses if the AC power indicator does
not light up when the electrocardiograph is connected to AC power.

WARNING Failure to unplug could result in electrocution.

To replace the AC fuses

If either fuse is dark or has a broken wire, replace the fuse. Line up the fuse case with
the opening; it goes in only one way.

Storing the equipment

When storing the electrocardiograph, cords, and accessories, observe the environmental
storage conditions that are identified in the product specifications.

Discarding the equipment

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. For more specific disposal information,
see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at [phone].

Troubleshooting

Lead-quality problems

“Artifact” message on the screen

Artifact is signal distortion that makes it difficult to accurately discern the waveform
morphology.

37

Causes

•

The patient was moving.

• The patient was shivering.

• There is electrical interference.

Actions

See actions for wandering baseline, muscle tremor, and AC interference.

Wandering baseline

Wandering baseline is an upward and downward fluctuation of the waveforms.

Causes

•

Electrodes are dirty, corroded, loose, or positioned on bony areas.

• The electrode gel is insufficient or dried.

• The patient has oily skin or used body lotions.

• Rising and falling of chest during rapid or apprehensive breathing.

Actions

Clean the patient’s skin with alcohol or acetone.

•

• Reposition or replace the electrodes.

• Verify that the patient is comfortable, warm, and relaxed.

• If wandering baseline persists, turn the baseline filter on.

38 Troubleshooting CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Muscle tremor

Causes

• The patient is uncomfortable, tense, nervous.

• The patient is cold and shivering.

• The exam bed is too narrow or short to comfortably support arms and legs.

• The arm or leg electrode straps are too tight.

Actions

• Verify that the patient is comfortable, warm, and relaxed.

• Check all electrode contacts.

• If interference persists, turn the muscle-tremor filter on. If interference still persists,
the problem is probably electrical in nature. See the suggestions for reducing AC
interference (in a related troubleshooting tip).

AC interference

AC interference superimposes even-peaked, regular voltage on the waveforms.

Causes

•

The patient or technician was touching an electrode during recording.

• The patient was touching a metal part of an exam table or bed.

• A lead wire, patient cable, or power cord are broken.

• Electrical devices in the immediate area, or lighting, or wiring concealed in walls or
floors are interfering.

• An electrical outlet is improperly grounded.

• The AC filter is turned off or set incorrectly.

Actions

•

Verify that the patient is not touching any metal.

• Verify that the AC power cable is not touching the patient cable.

• Verify that the proper AC filter is selected.

• If interference persists, unplug the electrocardiograph from AC power and run it on
the battery. If this solves the problem, you’ll know that the noise was introduced
through the power line.

• If interference still persists, the noise may be caused by other equipment in the
room or by poorly grounded power lines. Try moving to another room.

Directions for use Troubleshooting 39

Lead alert or square wave

A dot might be flashing on the lead-status screen. Or one or more leads might appear as
a square wave.

Causes

• Electrode contact might be poor.

• A lead might be loose.

• A lead might be defective.

Actions

• Replace the electrode.

• Verify that the patient’s skin has been properly prepared.

• Verify that electrodes have been properly stored and handled.

• Replace the patient cable.

40 Troubleshooting CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

System problems

The electrocardiograph won't turn on when it is plugged in

Causes

• The AC power connection is faulty.

• An AC fuse is blown.

• There is no AC power.

Actions

• Check the AC power source.

• Check the AC fuses.

The electrocardiograph won't turn on when it is unplugged

Causes

• The battery is disconnected or incorrectly connected.

• The battery is low, not charging, depleted, or bad.

Actions

•

Check the battery connections.

• Recharge the battery.

• Replace the battery.

The electrocardiograph shuts down during printing

Causes

•

The battery is low or bad.

Actions

•

Recharge the battery.

• Replace the battery.

The electrocardiograph prints fewer than 10 reports on a full battery charge

Causes

The battery is degraded.

•

Actions

Replace the battery.

•

Directions for use

Troubleshooting 41

The electrocardiograph does not respond when you press buttons or touch the screen

Causes

• The electrocardiograph is frozen.

Actions

• Reset the electrocardiograph by pressing and holding the power button for at least
six seconds until the screen goes blank. Press the power button again. The
electrocardiograph goes through some diagnostic tests that cause it to take longer
than usual to power up.

• Touch the Settings tab. Touch the Advanced tab. Touch the Power down button.
The electrocardiograph goes through some diagnostic tests that cause it to take
longer than usual to power up.

Note For more troubleshooting guidelines, see the service manual.

CAUTION The service manual is for use only by qualified service

personnel who understand technical English.

Limited warranty

Welch Allyn, Inc., warrants that the CP 50 and CP 50 Plus electrocardiographs (the
Products) meet the labeled specifications of the Products and will be free from defects
in materials and workmanship that occur within 1 year after the date of purchase,
exceptthat accessories used with the Products are warranted for 90 days after the date
of purchase. Such accessories include cables, electrodes, and battery.

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, 30 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.

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. If your Product requires
repairs covered by this warranty, upon your request Welch Allyn will loan to you, at no
cost, a substitute Product for use until your repaired Product is returned.

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. Contact Welch Allyn
Technical Support.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILTY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN’S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT

Troubleshooting CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

42

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.

Service policy

All repairs on products under warranty must be performed by Welch Allyn or by a service
provider authorized by Welch Allyn. Unauthorized repairs will void the warranty. In
addition, whether or not covered under warranty, any product repair should be
performed exclusively by Welch Allyn or by a service provider that has been authorized
by Welch Allyn.

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

Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to
ensure that they are not causing the problem. When calling, please be prepared to
provide:

• Product name, model number, and serial number of your product.

• Complete description of the problem.

• 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 orders, the required spare or replacement part numbers.

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 of your product.

In case a 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. An RMA number must be obtained prior to any return.

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

•

Remove all hoses, cables, sensors, power cords, and other accessories (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.

Specifications

Item Specification

43

Dimensions, including
rubber feet (length x height
x width)

Weight 2.0 kg (4.4 lb)

Keyboard type (power,
auto ECG, and rhythm ECG
buttons)

Display

Type

Resolution

Thermal paper

Z-fold

Roll

Thermal printer (internal) Computer-controlled dot array, 8 dots/mm

Thermal-chart-paper
speeds

32.5 x 8 x 18.8 cm (12.8 x 3.1 x 7.4 in.)

Polyester overlay

TFT, 11 cm (4.3 in.) color touch screen

WQVGA, 480 x 272

11.4 cm (4.5 in.) x 250 sheets

11.4 cm (4.5 in.) x 20 m

10, 25, 50 mm/s

Gain settings

Auto ECGs

Rhythm ECGs

Lead configurations Standard, Cabrera

Report formats, internal
printer*

Auto ECGs

Rhythm ECGs

Average cycles

2.5, 5, 10, 20 mm/mV, AUTO

2.5, 5, 10, 20 mm/mV

3x4 @ 25 mm/s, 3x4 @ 50 mm/s, 3x4 + 1R @ 25 mm/s, 3x4 - 5.0s @ 25 mm/s,

3x4 - 5.0s @ 50 mm/s, 2x6 - 1.6s @ 25 mm/s, No print

3 leads

3x4 + 3R @ 25 mm/s, 3x4 + 3R @ 50 mm/s, 2x6 + 1R @ 25 mm/s,

44 Specifications CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Item Specification

2x6 + 1R @ 50 mm/s, No print

Report formats, external
printer*

Auto ECGs

Average cycles

ECG storage (in test
directory)

Patient storage (in
worklist, CP 50 Plus only)

Frequency range 0.3 to 150 Hz

Digital sampling rate > 1,000 samples/second/channel

Pacemaker detection ANSI/AAMI EC11

Power requirement Universal AC power supply 110-240 V~, 50/60 Hz ~, 1.5 A maximum

3x4 @ 25 mm/s, 3x4 @ 50 mm/s, 3x4 + 1R @ 25 mm/s, 3x4 + 3R @ 25 mm/s,

3x4 - 5.0s @ 25 mm/s, 3x4 - 5.0s @ 50 mm/s, 6x2 - 5.0s @ 25 mm/s,

12x1 - 5.0s @ 25 mm/s, No print

3x4 + 3R @ 25 mm/s, 3x4 + 3R @ 50 mm/s, 2x6 + 1R @ 25 mm/s,

2x6 + 1R @ 50 mm/s, 3x4 + 2R @ 25 mm/s, 3x4 + 2R @ 50 mm/s,

6x2 + 2R @ 50 mm/s, No print

At least 25 ECG tests

Up to 50 patients

AC fuses Time-lag type, 2.0-amp 250-V rating, Littlefuse 0218002P or equivalent

Rechargeable battery 10.8V, 1.9Ah minimum, 3-cells Li-ion “smart” battery. A fully charged battery prints up to 25

ECGs with one extra copy per test. Recharge time to 90 percent capacity is 6 hours.

Filters

High-performance
baseline

Muscle tremor

AC interference

Safety, EMC, and
regulatory compliance

Standard connectivity Mini USB client and USB host, Ethernet (optional - available with CP 50 Plus only)

0.5 Hz

35 Hz

50 Hz or 60 Hz

ANSI/AAMI EC11**

CAN/CSA C22.2 No. 601.1

CAN/CSA C22.2 No. 601.1.1

CAN/CSA C22.2 No. 601.1.2

CAN/CSA C22.2 No. 601.1.4

CAN/CSA C22.2 No. 601.2.25

UL60601-1

IEC/EN 60601-1

IEC/EN 60601-1-1

IEC/EN 60601-1-2

IEC/EN 60601-1-4

IEC/EN 60601-1-6

IEC/EN 60601-2-25 ***

IEC/EN 60601-2-51 (2x6 lead arrangement)

Directions for use Specifications 45

Item Specification

Connectivity with
electronic medical records
(CP 50 Plus only)

Electrodes Rigorously tested for conductivity, adhesion, and hypoallergenic qualities, and exceed all

Power cable Meets or exceeds Type SJT.

Environmental operating
conditions

Temperature

Relative humidity

Atmospheric air-pressure
limits

Environmental storage
conditions

Temperature

Relative humidity

Atmospheric air-pressure
limits

Protection against electric
shock

Through the Welch Allyn CardioPerfect workstation software

AAMI standards

+10° C to +40° C (+50° F to +104° F)

15 - 95% noncondensing (30 - 70% for printing)

700 - 1060 hPa

-20° C to +50° C (-4° F to +122° F)

15 - 95% noncondensing

700 - 1060 hPa

Class I, internally powered Type CF

Mode of operation Continuous

* If you print at a high gain setting, the waveform or calibration marks might be clipped. This clipping does not

comply with clause 51.103.1 of the IEC/EN 60601-2-51 standard. Use a lower gain setting to observe the full
waveform.

** Per AAMI EC11:1991/(R)2001 Diagnostic Electrocardiographic Devices, Section 3.1.2.1 Disclosure of cautionary

information/ performance characteristics paragraph c) Accuracy of input signal reproduction, the manufacturer
shall disclose the methods used to establish overall system error and frequency response. Welch Allyn has used
methods A & D, as prescribed in section 3.2.7.2 and 4.2.7.2 of this same standard, to verify overall system error
and frequency response. Because of the sampling characteristics and the asynchronism between sample rate and
signal rate, digital ECG systems such as the CP 50 may produce a noticeable modulating effect from one cycle to
the next, particularly in pediatric recordings. This phenomenon is not physiologic.

*** Disposable electrodes from Welch Allyn shall be used during patient defibrillation.

Specifications are subject to change without notice.

46 Specifications CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Guidance and manufacturer’s declarations

EMC compliance

Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2007.

• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this document and the Welch Allyn website:
http://www.welchallyn.com/apps/products/product_category.jsp?catcode=CARDIO.

• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.

47

The electrocardiograph complies with all applicable and required standards for
electromagnetic interference.

•

It does not normally affect nearby equipment and devices.

• It is not normally affected by nearby equipment and devices.

• It is not safe to operate the electrocardiograph in the presence of high-frequency
surgical equipment.

• However, it is good practice to avoid using the electrocardiograph in extremely close
proximity to other equipment.

Emissions and immunity information

Electromagnetic emissions

The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic
environment specified below. The customer or user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1 The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting

electrocardiograph 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 B

The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low

48 Guidance and manufacturer’s declarations CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Electromagnetic emissions

Harmonic emissions
IEC 61000-3-2

Voltage fluctuations/
flicker emissions

IEC 61000-3-3

Class A

Complies

voltage power supply network that supplies buildings used for domestic
purposes.

WARNING The Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph should not
be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the
Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph should be observed to verify
normal operation in the configuration in which it will
be used.

Electromagnetic immunity

The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph 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

Surge
IEC 61000-4-5

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

IEC 61000-4-11

Powerfrequency (50/60
Hz) magnetic field

IEC 61000-4-8

Note

NOTE UT is the a.c. mains voltage prior to application of the test level.

±2 kV for power supply
lines

±1 kV for input/output
lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<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 s

3 A/m 3 A/m Power frequency magnetic fields should be at

±2 kV for power supply
lines

±1 kV for input/output
lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<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 s

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

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

Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Welch AllynCP 50™ and CP 50 Plus™ 12­lead resting electrocardiograph requires
continued operation during power mains
interruptions, it is recommended that the
Welch AllynCP 50™ and CP 50 Plus™ 12-lead
resting electrocardiograph be powered from an
uninterruptible power supply or a battery.

levels characteristic of a typical location in a
typical commerical or hospital environment.

Directions for use Guidance and manufacturer’s declarations 49

Electromagnetic immunity

The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in the electromagnetic
environment specified below. The customer or the user of the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting
electrocardiograph should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Portable and mobile RF communications
equipment should be used no closer to any part
of the Welch AllynCP 50™ and CP 50 Plus™ 12­lead resting electrocardiograph, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80 MHz

3 V/m 80 MHz to 2.5
GHz

3 V

3 V/m

d= (1.17)

d= (1.17) 80 to 800 MHz

d= (2.33) 800 MHz to 2,5 GHz

whereP is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer 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 rangeb. Interference

may occur in the vicinity of equipment marked
with the following symbol:

Note1: 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 AllynCP 50™ and CP 50 Plus™ 12-lead
resting electrocardiograph is used exceeds the applicable RF compliance level above, the Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Welch AllynCP 50™ and CP 50
Plus™ 12-lead resting electrocardiograph.

b

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

50 Guidance and manufacturer’s declarations CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

Recommended separation distances between portable and mobile RF communications
equipment and the Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

The Welch AllynCP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or user of the Welch AllynCP 50™ and CP
50 Plus™ 12-lead resting electrocardiograph can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Welch AllynCP 50™ and CP
50 Plus™ 12-lead resting electrocardiograph as recommended below, according to the maximum output power of the
communications equipment.

Separation distance according to frequency of transmitter (m)

Rated max. output
power of transmitter
(W)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distanced 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.

150 kHz to 80 MHz

d= (1.17)

80 MHz to 800 MHz

d= (1.17)

800 MHz to 2.5 GHz

d= (2.33)

Accessory list

Options and software upgrades

Part number Description

1000372 CP50 Plus upgrade

1000373 CP50 Interpretive upgrade

51

1000374 CP50 Interpretative Plus upgrade

406814 CP 50/150 connectivity kit

Electrodes, patient cables, and ECG chart paper

Part number Description

715006 ECG multifunction electrode adapter, 10

45008-0000 Resting tab electrodes (box of 1000)

714730 ECG reusable suction cup electrodes, 6

714731 ECG reusable limb clamps, IEC, 4

715992 ECG reusable limb clamps, AHA, 4

719653 10-lead ECG patient cable, AHA, banana (1M/39 inch), CP 50/150

719654 10-lead ECG patient cable, IEC, banana, CP 50/150

721328 10-lead ECG patient cable, AHA, banana (1.5M/5 feet), CP 50/150

406020 CP50 printer paper roll, 4 rolls/case

406021 CP50 printer paper Z fold, 4 packs/case

ECG stand

Part number Description

406815 Roll stand, CP50

52 Accessory list CP 50™ and CP 50 Plus™ 12-lead resting electrocardiograph

ECG stand

Part number Description

715107 Carrying case, CP50

Miscellaneous items

Part number Description

BATT33 Lithium-ion battery assembly 3-Cell

PWCD-B Line cord B, North America

714030 PLFM power cord, North America

PWCD-2 Line cord 2, Europe

PWCD-3 Line cord 3, Israel

PWCD-4 Line cord 4, United Kingdom

PWCD-66 Line cord 66, Australia/New Zealand —Orange

PWCD-C Line cord C, China

PWCD-7 Line cord 7, South Africa

PWCD-A Line cord A, Denmark

PWCD-Z Line cord Z, Brazil

PWCD-5 Line cord 5, Switzerland

713942 Dust cover, CP 50

719685 #2 Phillips screwdriver for battery door