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

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.

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.

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.

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

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

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