CP 150 Directions for Use sw ver 2.00.XX Ver B

© 2013 Welch Allyn, Inc. 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. 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 150, and CardioPerfect are trademarks of Welch Allyn, Inc. Patent information For patent information, please visit 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. Welch Allyn Technical Support: http://www.welchallyn.com/about/company/locations.htm 105755 (CD) DIR 80018007 Ver. B

Material Number 720157, DIR 80018007 Ver. B

Regulatory Affairs Representative Welch Allyn 4341 State Street Road

Welch Allyn Limited

Skaneateles Falls, NY 13153-0220 U.S.A

Dublin Road

www.welchallyn.com

Navan Business Park Navan, County Meath Republic of Ireland

iii

Contents Introduction ... 1

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

Setup ... 11 Connecting the patient cable ... 11 Loading the thermal paper ... 11 Powering the electrocardiograph ... 12 Verifying proper operation ... 12 Connecting to a CardioPerfect workstation ... 13 To connect to a network-connected workstation via Ethernet cable ... 13

ECG home screen ... 15 ECG home screen ... 15

ECG tests ... 19

Attaching the leads to the patient ... 19 Electrode locations ... 21 Viewing electrode placement ... 22 Performing an Auto ECG test ... 22

Assigning an Auto ECG test to the worklist ... 27

Assign an Auto ECG test to the worklist ... 27

Saved tests ... 29 Searching for saved tests ... 29 Managing the saved tests ... 29 Saving a test as a PDF ... 30 Managing the worklist ... 30

Settings ... 31

Viewing or changing the ECG settings ... 31 Selecting the device information ... 33

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Contents

CP 150 12-lead resting electrocardiograph

Maintenance ... 35

Cleaning the equipment ... 35 Inspecting the equipment ... 36 Testing the electrocardiograph ... 36 Replacing the battery ... 37 Replacing the AC fuses ... 37 Storing the equipment ... 38 Discarding the equipment ... 38

Troubleshooting ... 39 Lead-quality problems ... 39 System problems ... 42 Limited warranty ... 44 Service policy ... 45

EMC guidance and manufacturer’s declarations ... 47

EMC compliance ... 47 Emissions and immunity information ... 47

Specifications ... 49

1

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.

Contraindications The electrocardiograph has no known contraindications.

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Introduction

CP 150 12-lead resting electrocardiograph

Description •

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

•

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

•

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

•

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.

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

Directions for use

Introduction

Controls, indicators, and connectors

No. Feature

Description

1

LCD screen

800 x 480 pixels color touchscreen provides a graphical user interface.

2

Power switch and LED

Power-on/Standby switch. The LED indicates the charging status when connected to AC power: • Green: The battery is charged. • Amber: The battery is charging.

3

Patient cable connector

Provides connection for patient cable.

4

Printer

Printer provides a printout of patient Auto ECG, Stat ECG, or Rhythm ECG.

3

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Introduction

CP 150 12-lead resting electrocardiograph

Back view No. Feature

Description

1

Ethernet connector

Provides a hardwired connection to the computer network. The LEDs indicate active network status when the ethernet cable is connected to a network.

2

Clients USB

USB, type "mini B." Provides connection to an enabled host.

3

Host USB

USB, type "A." Provides four host USB connections for optional accessories.

4

Power connection

Provides an external AC power connection.

5

AC fuse

Provides access to AC fuse.

6

Ground lug (equipotential terminal)

Provided for electrical safety testing and as a means for connection of a potential equalization conductor.

7

Battery compartment (behind cover)

Houses the Li-ion battery.

Directions for use

Introduction

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

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.

Consult Directions for Use, Electronic version available at Welchallyn.com, or Hard copy DFU available from Welch Allyn within 7 days.

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

Power symbols Power on/standby

(LED off) No AC power is present

The battery is absent or faulty

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

The battery is charged to the indicated level

Alternating current

Battery is charging

Dangerous voltage

Battery door

Fuse

Rechargeable battery

Protective earth

Nonionizing electromagnetic radiation

Equipotential terminal

AC input power

5

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Introduction

CP 150 12-lead resting electrocardiograph

Connectivity symbols USB

Ethernet (RJ-45 )

Shipping, storing, and environment symbols This end up

Keep dry

Fragile

Relative humidity limit

Temperature limits

Atmospheric air-pressure limits

Separate the battery from other disposables for recycling

Recycle

Separate the device from other disposables for recycling.

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.

See www.welchallyn.com/weee.

Lithium ion battery

Miscellaneous symbols Manufacturer

Defibrillation-proof Type CF applied parts

Reference/Model number

Serial number

Reorder/Catalog number

Batch code

Directions for use

Introduction

Intertek ETL listed

7

Do not reuse

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

Warnings related to the environment 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. 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 to keep them clear of the wheels and to minimize trip hazards.

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

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Introduction

CP 150 12-lead resting electrocardiograph

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

Warnings related to using the electrocardiograph WARNING No modification of this equipment is allowed. 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 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 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 and IEC 60601-02-25, do not scale (re size) when sending a saved ECG to an external printer.

Directions for use

Introduction

9

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

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 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.

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Introduction

CP 150 12-lead 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 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.

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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.

Loading the thermal paper The electrocardiograph prints on z-fold 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.

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Setup

CP 150 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 turn on or turn off

Press

.

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.

Directions for use

Setup

13

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, contact Welch Allyn Technical Support.

Connecting to a CardioPerfect workstation You can connect a 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 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 3 meters have not been verified for use with the electrocardiograph. Do not use cables longer than 3 meters.

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 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.

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Setup

CP 150 12-lead resting electrocardiograph

2. Go to the Network screen a.

Touch the Settings tab.

b. Touch the Device tab. c.

Touch the Network button.

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: Network IP address, Subnet mask, and Default gateway.

4. Touch the Test with ping button. 5. Connect to the network. a.

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

b. Touch the Ping Test button. The electrocardiograph pings the host. 6. Choose one of these to specify how to get DCP 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.

•

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

•

Fill in the UDP broadcast port field.

7. Touch Test connection. 8. Fill in the Remote file server address, User ID, and password. 9. Touch Test remote folder. The electrocardiograph connects to the remote file server. The electrocardiograph is ready to send tests to the remote file server. (To set up the workstation, see the instructions that came with the workstation connectivity software.

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ECG home screen ECG home screen The ECG home screen includes the following areas:

Item

Area

1

Device status

2

Content

3

Navigation

Device status area The Device status area, located at the top of the ECG home screen, displays: •

Time and date

•

Battery status

•

Error or information messages. These items are displayed until the condition has been resolved.

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ECG home screen

CP 150 12-lead resting electrocardiograph

Content area The Content area includes 3 test selection buttons and a preview selection button: •

Auto ECG

•

Rhythm ECG

•

Stat ECG

•

Electrode Placement

The content area also provides shortcuts to several controls.

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 mass-storage device.

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.

Stat ECG

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

Navigation area The Navigation area includes the following tabs: •

ECG home: Displays ECG test types and provides shortcuts to several controls.

•

Manage worklist : Includes patient data entered manually or orders downloaded when connected to a hospital information system.

•

Saved tests: Accesses the patient ECG tests.

•

Settings: Accesses device configuration settings.

To navigate to a tab, touch the tab in the Navigation area with the corresponding name. The active tab is highlighted.