CP 100 and 200 Service Manual Rev A

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Welch Allyn CP 100 and CP 200 Electrocardiograph

Copyright 2012, 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., and CP 200, CP100, and CardioPerfect are trademarks of Welch Allyn, Inc. SD is a trademark of Toshiba. Software in this product is Copyright Welch Allyn, Inc., 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, please call Welch Allyn Technical Support: USA

+ 1 315 685 4560 800 535 6663

Australia

+ 61 2 9638 3000

Canada

800 561 8797

China

+ 86 216 327 9631

European Call Center

+ 35 3 46 906 7790

France

+ 33 1 55 69 58 49

Germany

+ 49 7477 92 71 86

Japan

+81 42 703 6084

Latin America

+ 1 305 669 9003

Netherlands

+ 31 202 061 360

Singapore

+ 65 6419 8100

South Africa

+ 27 11 777 7555

United Kingdom

+ 44 20 7365 6780

Sweden

+ 46 8 58 53 65 51

Part Number (manual only): 718439 Rev. A Welch Allyn PO Box 220 Skaneateles Falls, NY 13153-0220 www.welchallyn.com Printed in USA

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Contents 1 - Safety Summary... 1 Introduction... 2 Symbols... 2 Servicing the Electrocardiograph Safely... 4 General Warnings... 4 Electrostatic Discharge (ESD)... 5 General Cautions... 6

2 - Overview... 7 Purpose and Scope... 8 Service Options... 8 Warranty Service... 8 Non-Warranty Service... 8 Technical Support Services... 9 Returning Products... 9 Product Configurations... 10 Recommended Service Intervals... 10 Controls, Indicators, and Connectors... 11 “System Settings” Menu Tree... 16 About the Main Menu... 17 Moving Through the Menus... 18 Reviewing the Device Information... 19 CP 100 and CP 200 Electrocardiograph... 20 Service Menus... 20 Entering the Service Info Screen... 20 Print Log... 21 Battery Life Test... 22 Printer Test... 22 Export Files... 23 Import Files... 24 Delete Files... 24 Serial Number... 25 Lead Off Threshold... 25 Service Tests... 25

3 - Functional Verification... 29 Functional Verification Overview... 30 Full Functional Check... 30 Equipment Required... 30

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Contents

Welch Allyn CP 100 and CP 200 Electrocardiograph

Operating/Non-Printing Mode Current Test... 30 Battery Accuracy Test... 31 Sleep/Standby Mode Current Test... 31 Charger Detect Test... 31 LED Test... 32 LCD Test... 32 Set Unit Initial Configuration/SD Slot Test... 32 ECG Communication Test (ECG Input test and lead off)... 33 Spirometer Communication Test... 33 USB Communications Test... 34 Beeper Test... 34 Keyboard Test... 35 Printer Test... 35 Dielectric Strength Test... 38 Hi-Pot Test Connections... 39 Chassis, Earth and Patient Leakage Current Tests... 39 Checklist and Test Results Report Form... 40

4 - Troubleshooting... 41 Problem-Solving Suggestions... 42 Limited Warranty... 45 Service Policy... 46

5 - Disassembly and Repair Procedures... 47 Introduction... 48 Screws... 48 Torque Specs... 48 Disassembly Procedures... 49 Opening the Unit... 49 Replacing the Printer Assembly... 50 Replacing the Paper Tray Cover... 52 Replacing the Platen Roller... 54 Replacing the Printhead... 55 Replacing the Stepper Motor and Gear Box... 57 Replacing the Battery or Fuse... 58 Replacing the Battery (DC) Fuse... 60 Replacing the Main Board... 61 Replacing the Power Supply... 62 Replacing the IEC (AC input) Connector... 63 Replacing the LCD Inverter and LCD Assembly (CP 200)... 64 Replacing the Function Keypad Assembly (CP 200)... 65 Replacing the Keyboard Assembly (CP 200)... 66 Replacing the LCD Assembly (CP 100)... 67 Replacing the Keyboard Assembly (CP 100)... 68

6 - Field Replaceable Parts... 69 Introduction... 69 Field Replacement Parts... 70

Service Manual

CP 100 and CP 200 Electrocardiograph

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A - Specifications... 77 B - EMC Guidance and Manufacturer’s Declarations... 79 C - Software Updates... 83 D - Interconnect Diagrams... 85 CP 200 Interconnect Diagram... 86 CP 100 Interconnect Diagram... 87

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Contents

Welch Allyn CP 100 and CP 200 Electrocardiograph

1

1 Safety Summary Introduction... 2 Symbols... 2 Servicing the Electrocardiograph Safely... 4

2

Safety Summary

CP 100 and CP 200 Electrocardiograph

Introduction The safety summary, and all additional specific warnings and cautions located throughout the documentation, must be read and understood by all users of the CP 100 and CP 200 Electrocardiograph.

Symbols The symbols illustrated on the following pages may appear on the electrocardiograph, the packaging, the shipping container, or in this manual. Documentation Symbols

WARNING Indicates conditions or practices that could lead to illness, injury, or death. Caution In the manual, indicates conditions or practices that could damage the equipment or other property. Caution On the product, means “Consult accompanying documentation.”

Shipping, Storing, and Environment Symbols

+49C

This end up

Keep dry

Fragile

Altitude limits

Temperature limits

Relative humidity limit

-20C

Certification Symbols

EC REP

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

Complies with applicable U.S. and Canadian medical safety standards

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

Australian registered importer N344

Directions for Use

Safety Summary

Operation Symbols For details on the keys, see “Keyboard Functions” on page 14. On/standby (off)

Help

Navigation arrows

Backspace

Enter

Shift

Auto ECG

Menu

Rhythm ECG

Stop/Cancel

SD memory card slot

Com port A (for patient cable)

Alternating current

Battery charge level

Dangerous voltage

Direct current

Defibrulation-proof type CF applied parts (while the electrocardiograph is safety-rated “CF” for direct cardiac contact it is not intended to be connected directly to the patient’s heart; only surface contact with the patient’s skin is intended).

Ground equipotential

Do not reuse.

Sealed lead-acid battery

Type BF Defibrillator proof

Recycle

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.

AC fuse replacement information T2.0A/250V

For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.

Additional Operation Symbols for CP 200 Spirometry Key

OK

Spirometry port

Com port B (for USB cable)

3

4

Safety Summary

CP 100 and CP 200 Electrocardiograph

Servicing the Electrocardiograph Safely Before using or servicing the electrocardiograph, you must read and understand the following safety-related information.

General Warnings The following warning statements apply to electrocardiograph use in general. Warning statements that apply specifically to particular procedures, such as connecting the patient cable or performing an ECG test, appear in the corresponding sections of the manual. Warning statements 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. 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 Do not use the CP 100 and CP 200 Electrocardiograph in an MRI suite or hyperbaric chamber. WARNING Do not autoclave the CP 100 and CP 200 Electrocardiograph or patient cable. 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. See “EMC Guidance and Manufacturer’s Declarations” on page 79 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 may 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. WARNING The electrocardiograph has not been designed for use with highfrequency (HF) surgical equipment and does not protect against hazards to the patient.

Directions for Use

Safety Summary

5

Warnings Related to Using the Electrocardiograph WARNING Avoid positioning any leads or cables so that they could easily trip someone. WARNING Satisfactory maintenance procedures must be implemented, or equipment failure and health hazards may result. Warnings Related to Repairing the Electrocardiograph WARNING Only qualified service personnel should attempt to repair the electrocardiograph. In case of a malfunction, call Technical Support and precisely describe the problem. For phone numbers, see page ii. WARNING While under warranty, the electrocardiograph must be serviced only by a Welch Allyn service technician. WARNING Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at static-safe workstation. WARNING Consider all electrical and electronic components of the monitor as static-sensitive.

Electrostatic Discharge (ESD)

Electrostatic discharge is a sudden current flowing from a charged object to another object or to ground. Electrostatic charges can accumulate on common items such as foam drinking cups, cellophane tape, synthetic clothing, untreated foam packaging material, and untreated plastic bags and work folders, to name only a few. Electronic components and assemblies, if not properly protected against ESD, can be permanently damaged or destroyed when near or in contact with electrostatically charged objects. When you handle components or assemblies that are not in protective bags and you are not sure whether they are static-sensitive, assume that they are static-sensitive and handle them accordingly. •

Perform all service procedures in a static-protected environment. Always use techniques and equipment designed to protect personnel and equipment from electrostatic discharge.

•

Remove static-sensitive components and assemblies from their static-shielding bags only at static-safe workstations-a properly grounded table and grounded floor mat- and only when you are wearing a grounded wrist strap (with a resistor of at least 1 megohm in series) or other grounding device.

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Safety Summary

CP 100 and CP 200 Electrocardiograph

•

Use only grounded tools when inserting, adjusting, or removing static-sensitive components and assemblies.

•

Remove or insert static-sensitive components and assemblies only with monitor power turned off.

•

Insert and seal static-sensitive components and assemblies into their original staticshielding bags before removing them from static-protected areas.

Always test your ground strap, bench mat, conductive work surface, and ground cord before removing components and assemblies from their protective bags and before beginning any disassembly or assembly procedures.

General Cautions The following caution statements apply to electrocardiograph use in general. Caution statements that apply specifically to particular procedures, such as connecting the patient cable or performing an ECG test, appear in the corresponding sections of the manual. Caution statements 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 to the keypad, do not use sharp or hard objects to press keys. Only use fingertips. Caution Do not expose the patient cable to strong ultra-violet 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 or stepped on. If the cable’s impedance is altered, 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 supplied with the device and available through Welch Allyn. The use of accessories other than those specified may result in degraded performance of this device. Caution Portable and mobile RF communications equipment can affect the performance of the electrocardiograph. 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.

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2 Overview Purpose and Scope... 8 Service Options... 8 Product Configurations... 10 Recommended Service Intervals... 10 Controls, Indicators, and Connectors... 11 “System Settings” Menu Tree... 16 About the Main Menu... 17 Moving Through the Menus... 18 Reviewing the Device Information... 19 CP 100 and CP 200 Electrocardiograph... 20

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Overview

Welch Allyn CP 100 and CP 200 Electrocardiograph

Purpose and Scope The service manual is a reference for periodic preventive maintenance and corrective service procedures for the Welch Allyn CP 100 and CP 200 Electrocardiograph. Corrective service is supported to the level of field-replaceable units. This includes some circuit-board assemblies and some subassemblies, case parts, and other parts. See “Field Replaceable Parts” on page 69 for complete list of user-replaceable service parts. Note

Repair and replacement of the main board is not supported. All service work on the main board must be performed by certified and qualified service personnel at an authorized Welch Allyn service center. Caution No component-level repair of circuit boards and subassemblies is supported. Use only the repair procedures described in this manual. WARNING When performing a service procedure, follow the instructions exactly as presented in this manual. Failure to do so could damage the monitor, invalidate the product warranty, and lead to serious personal injury.

This guide provides troubleshooting information, assembly procedures, and instructions for functional testing and performance verification. It is intended for use only by technically qualified service personnel.

Service Options Warranty Service All repairs on products under warranty must be performed and/or approved by Welch Allyn. Refer all warranty service to Welch Allyn Factory Service or another authorized Welch Allyn Service Center. Obtain an RMA number for all returns to Welch Allyn Factory Service – see Returning Products (page 9). Caution Unauthorized repairs will void the product warranty.

Non-Warranty Service Welch Allyn Factory Service and authorized Service Centers support non-warranty repairs. Contact any Welch Allyn regional service center for pricing and service options. Welch Allyn offers modular repair parts for sale to support non-warranty service. This service must be performed only by qualified end-user biomedical/clinical engineers using this service manual. The Welch Allyn Electrocardiograph Service Information supports certain service functions. For information about any Welch Allyn product, please call Welch Allyn Technical Support: (page ii).

Service Manual

CP 100 and CP 200 Electrocardiograph

9

Technical Support Services Welch Allyn offers the following technical support services: Telephone support Loaner equipment Service agreements Replacement service parts Factory Service For information on any of these services, contact Welch Allyn at the numbers listed on page ii

Returning Products To return a product for service, contact Welch Allyn Technical Support and request a Return Material Authorization (RMA) number. Note

Welch Allyn does not accept returned products without an RMA.

•

When requesting an RMA, please have the following information available:

•

Product name, model number, and serial number

•

A complete return shipping address, including a contact name and phone number; include any special shipping instructions

•

A purchase-order number or credit-card number if the product is not covered by warranty

•

A full description of the problem or service request

To ship the unit, please observe these packing guidelines: •

Remove from the package all hoses, connectors, cables, sensors, power cords, and other ancillary products and equipment, except those items that might be associated with the problem.

•

Use the original shipping carton and packing materials, or as close an approximation as possible.

•

Include a packing list.

•

Write the Welch Allyn RMA number with the Welch Allyn address on the outside of the shipping carton.

United States federal regulations require that any unit received by Factory Service must be free from blood-borne pathogens before processing. All incoming products are cleaned as well as possible, but products that cannot be effectively cleaned cannot be accepted for repair. Please thoroughly clean all organic residues from the product before shipment. This will ensure safe receipt, processing and repair, and will help expedite the return of your device.

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Overview

Welch Allyn CP 100 and CP 200 Electrocardiograph

Product Configurations Model numbers for the configurations are as follows:

Model Number

Description

CP 1

CP 100 Electrocardiograph

CP 1A

CP 100 Electrocardiograph w/Interpretation

CP 2

CP 200 Electrocardiograph

CP 2A

CP 200 Electrocardiograph w/Interpretation

CP 2S

CP 200 Electrocardiograph w/Spirometry

CP 2AS

CP 200 Electrocardiograph w/Interpretation & Spirometry

Recommended Service Intervals Interval or Condition Every 6 – 24 months (per hospital protocols)

Action Recommended Complete Functional test

Procedure Functional Verification (page 29)

Battery does not hold a charge Check battery capacity Replace battery

Battery Accuracy Test (page 31) Replacing the Battery or Fuse (page 58)

Unit has been dropped or otherwise damaged

Complete Functional test

Functional Verification (page 29)

Unit malfunctioning

Complete Functional test

Functional Verification (page 29)

Unit does not pass Functional Verification

Troubleshooting and repair followed by functional test

Troubleshooting (page 41) Disassembly and Repair Procedures (page 47) Functional Verification (page 29)

Return to authorized service center

Returning Products (page 9)

Service Manual

CP 100 and CP 200 Electrocardiograph

Controls, Indicators, and Connectors This section describes the controls, indicators, and connectors that are part of the electrocardiograph. Figure 1. Top of CP 200 Electrocardiograph

Softkeys and functions keys See Figure 10 on page 15.

Keyboard See Figure 8 on page 14.

Figure 2. Top of CP 100 Electrocardiograph

Keyboard See Figure 9 on page 14.

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12

Overview

Welch Allyn CP 100 and CP 200 Electrocardiograph

Figure 3. Back of Electrocardiograph

AC power inlet

Equipotential stud

AC fuses

Figure 4. Right Side of Electrocardiograph

Com port B (for USB cable)

SD memory card slot

(Not functional on CP 100)

Figure 5. Left Side of Electrocardiograph

Paper tray latch

Spirometry port

(Not functional on CP 100)

Reset Button

Service Manual

CP 100 and CP 200 Electrocardiograph

Figure 6. Front of CP 200 Electrocardiograph

Com port A (for patient cable)

Figure 7. Front of CP 100 Electrocardiograph

Com port A (for patient cable)

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14

Overview

Welch Allyn CP 100 and CP 200 Electrocardiograph

Keyboard Functions Figure 8. Keyboard for CP 200 Electrocardiograph

On/Off See “ Powering the Electrocardiograph” in the Directions of Use manual.

Menu See “About the Main Menu” on page 17.

Backspace Deletes the character to the left of the cursor.

Green LED Lights up when the electrocardiograph is connected to AC power.

Help See the Directions For Use manual.

Tab Moves through the data-entry fields.

Shift Capitalizes letters.

Space Enters a space.

Enter See “Moving Through the Menus” on page 18.

Navigation arrows See “Moving Through the Menus” on page 18.

Figure 9. Keyboard for CP 100 Electrocardiograph

Green LED Lights up when the electrocardiograph is connected to AC power.

On/Off See “ Powering the Electrocardiograph” in the Directions of Use manual.

Backspace Deletes the character to the left of the cursor.

Menu See “About the Main Menu” on page 17.

Tab Moves through the data-entry fields.

Auto ECG Begins Auto ECGs, normal and stat.

Rhythm ECG Begins a Rhythm ECG. .

Help See the Directions for Use manual.

Shift Capitalizes letters.

Space Enters a space.

Stop/Cancel Stops any current activity. See “Moving Through the Menus” on page 18.

Enter See “Moving Through the Menus” on page 18.

Navigation arrows See “Moving Through the Menus” on page 18.