Welch Allyn CP50 ECG User manual

™

CP 50

and CP 50 Plus 12-lead resting electrocardiograph

™

Directions for use

ii Welch Allyn CP 50 resting electrocardiograph

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

Welch Allyn assumes no responsibility for any injury, 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 indications for 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.

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.

Welch Allyn Technical Support

European Customer Care + 35 3 46 906 7790 France + 33 155 69 58 49

Germany + 49 6950 985 132 China + 86 21 6327 9631

Latin America (Miami office) + 1 305 669 9003 Netherlands + 31 202 061 360

Malaysia + 60 3 7875 3341 Sweden + 46 858 536 551

United Kingdom +44 20 7365 6780 Australia + 61 2 9638 3000

Multilanguage CD: 102731

This manual: 80015344, B

Welch Allyn Ltd Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

www.welchallyn.com

Contents

1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

iii

About this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 About the test types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Controls, indicators, and connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 General cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2 - Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Connecting the patient cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Loading the thermal paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Powering the electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 About the menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Viewing or changing the settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Viewing the device information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Verifying proper operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Connecting to an external USB printer (optional, CP 50 Plus only). . . . . . . . . . . 18 Connecting to a CardioPerfect workstation (optional, CP 50 Plus only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3 - ECG testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Attaching the leads to the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Electrode locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Performing an ECG test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

4 - Administrative tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Turning the security option on or off (CP 50 Plus only). . . . . . . . . . . . . . . . . . . . 27 Managing the user list (CP 50 Plus only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Turning the audit trail on or off (CP 50 Plus only) . . . . . . . . . . . . . . . . . . . . . . . . 28 Managing the worklist (CP 50 Plus only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Managing the test directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Cleaning the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Inspecting the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Testing the electrocardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Replacing the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Replacing the AC fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Storing the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Discarding the equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

6 - Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Limited warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Service policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

iv Contents Welch Allyn CP 50 resting electrocardiograph

A - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

B - EMC guidance and manufacturer’s declarations . . . . . . . . . . . . . . 43

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.

2 Introduction Welch Allyn CP 50 resting electrocardiograph

B C

D E

About the test types

Auto 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 massstorage device. In CP 50 Plus models, auto ECGs can also be sent to a Welch Allyn CardioPerfect workstation.

Stat ECG An auto ECG that starts instantly without waiting for you to enter patient data

or adjust the waveforms.

Rhythm ECG A continuous, real-time printout of rhythm strips with a user-defined lead

configuration. Rhythm ECGs are printouts only. They cannot be saved.

Auto ECG report example A: 3 rows, 4 columns. B: Patient data. C: ECG measurements. D: Automatic ECG interpretation (optional). E: Report status label. F: Rhythm leads. G: Gain, speed, AC filter, frequency range, date and time, software version, device ID, practice ID. H: Calibration pulse.

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.

4 Introduction Welch Allyn CP 50 resting electrocardiograph

Power button

Mounting holes for the CP 50 mobile-stand adapter (optional)

AC power indicator

Battery door

Auto ECG button

Rhythm ECG button

Printer-door latch

Ethernet connector (RJ45 for PC), functional on CP 50 Plus only

Patient-cable connector

Mini USB connector (for PC)

USB connector (for mass-storage device, printer)

AC power inlet

Equipotential terminal

AC fuses

Pressure point for closing the printer door

Controls, indicators, and connectors

Directions for use Introduction 5

Symbols

Documentation symbols

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

Consult operating instructions.

Operation symbols

Power on/standby Search

Auto ECG Rhythm ECG

Accept Close

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

Previous Next

Help Menu

Backspace

Power symbols

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

(LED green) AC power is present, and battery is fully charged. (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

Battery is charged to the indicated level.

Equipotential terminal Lithium ion

6 Introduction Welch Allyn CP 50 resting electrocardiograph

-20°C

+50°C

min

Connectivity symbols

USB Ethernet (RJ45)

Shipping, storing, and environment symbols

This end up Keep dry.

Fragile Relative humidity limit

Temperature limits

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 Hot surface. Do not touch.

Manufacturer Date of manufacture

Defibrillation-proof Type CF applied parts Defibrillation-proof Type BF applied parts

Reorder number Serial number

Atmospheric air-pressure limits

Recycle.

China RoHS (restriction of hazardous substances) symbols for control of pollution caused by electronic information products. 5-year environment-friendly use period (EFUP) for batteries. 10-year EFUP for the device. For details, see the accompanying documentation.

Do not reuse. Batch code

Meets essential requirements of European

European community representative

Medical Device Directive 93/42/EEC.

Software activation code

Directions for use Introduction 7

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.

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 non-medical 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 highfrequency (HF) surgical equipment and does not protect against hazards to the patient.

8 Introduction Welch Allyn CP 50 resting electrocardiograph

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

Directions for use Introduction 9

General cautions

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

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 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.

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.

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

10 Introduction Welch Allyn CP 50 resting electrocardiograph

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 requirements are unaffected by any other combination of filters turned on or off. Measurements performed by the optional interpretation algorithm are unaffected by any filter selections.

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.

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

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