Service Manual
110 Pages
Preview
Page 1
© 2014 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. Software in this product is copyright Welch Allyn. 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 with 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 remain with Welch Allyn. Welch Allyn Technical Support: http://www.welchallyn.com/about/company/locations.htm 105323 (printed copy) Material Number 719489 DIR 80018104 Ver. C
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.com
iii
Contents Symbols ... 1 Safety ... 5
General warnings ... 5 General cautions ... 8 General safety considerations ... 9 Electrostatic discharge (ESD) ... 10
Overview ... 11
Purpose and scope ... 11 Technical support services ... 12 Service loaners ... 12 Service options ... 12 Repairs ... 13 Configuration options for CP150 electrocardiograph ... 14 The Welch Allyn Service Tool ... 15 Returning products ... 15
Controls, indicators, and connectors ... 19 Service menu ... 23
Access the Service screen ... 23 Performing the full-functional tests ... 23 Manage tests and other files ... 31
Troubleshooting ... 33
Symptoms and solutions ... 34 Printer ... 36 User interface ... 38 Post test error messages ... 40 CP 150 spirometry option symptoms and solutions ... 40
EMC guidance and manufacturer’s declarations ... 43
EMC compliance ... 43 Emissions and immunity information ... 43
Disassembly, repair, and reassembly ... 45
Required tools and equipment ... 46 Power down the electrocardiograph ... 48 Remove the battery ... 48 Separate the top housing assembly from the bottom housing assembly ... 49
iv Contents
CP 150 12-lead resting electrocardiograph
Electrical safety testing ... 79 Software updates process ... 81 Update process ... 81 Export and import of the device configuration ... 81
Field replaceable units ... 83
Housing top assembly ... 83 Housing base assembly ... 87 Printer 8 inch assembly tray ... 90 Bottom assembly ... 94 Partners in Care service and support agreements ... 98 Service and repair training ... 99
Appendices ... 101
Decontamination and cleaning requirements ... 101 Cleaning the spirometer and calibration syringe ... 102 Interconnect diagram ... 103
1
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
2
Symbols
CP 150 12-lead resting electrocardiograph
Protective earth
Nonionizing electromagnetic radiation
Equipotential terminal
AC input power
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
Keep away from sunlight
Service manual
Symbols
Expiration date 20XX-XX
IP20
Protected against the ingress of solid foreign objects ≥ 12.5 mm diameter, not protected against the ingress of water.
Miscellaneous symbols Manufacturer
Defibrillation-proof Type CF applied parts
Reference/Model number
Serial number
Reorder/Catalog number
Batch code
Intertek ETL listed
Do not reuse
Type BF applied part
3
5
Safety All users of the device must read and understand all safety information presented in this manual before using or repairing the device. United States federal law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.
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.
6
Safety
CP 150 12-lead resting electrocardiograph
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. 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.
Service manual
Safety
7
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. WARNING To avoid injury, do not touch the print head immediately after printing. It might be hot.
Warnings related to using the spirometry option WARNING Do not perform spirometry tests if any of the following conditions apply to the patient: •
hemoptysis of unknown origin (forced expiratory maneuver may aggravate the underlying condition)
•
pneumothorax
•
unstable cardiovascular status (forced expiratory maneuver may worsen angina or cause changes in blood pressure)
•
recent myocardial infarction
•
pulmonary embolus
•
thoracic, abdominal, or cerebral aneurysms (danger of rupture due to increased thoracic pressure)
•
recent eye surgery (for example, cataract)
•
presence of an acute disease process that might interfere with test performance (for example, nausea, vomiting)
•
recent surgery of thorax or abdomen
WARNING The spirometer 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. WARNING To minimize the chance of a misdiagnosis, it is the physician’s responsibility to assure that spirometry tests are properly administered, evaluated, and interpreted. WARNING To prevent the spread of infection, do not try to clean the flow transducers and nose clips. Discard these items after a single patient use. WARNING Read and observe all safety information provided in the flow transducer instructions.
8 Safety
CP 150 12-lead resting electrocardiograph
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. 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.
Service manual
Safety
Note
The entire patient cable, up to and including the electrodes are considered to be an Applied Part.
General safety considerations •
To ensure patient safety, use only accessories recommended or supplied by Welch Allyn. Always use accessories according to your facility’s standards and according to the manufacturer’s recommendations and instructions. Always follow the manufacturer’s directions for use.
•
Welch Allyn recommends that only Welch Allyn service personnel or an authorized repair center perform warranty service. Performing unauthorized service on a device that is within warranty may void the warranty.
9
10 Safety
CP 150 12-lead resting electrocardiograph
Electrostatic discharge (ESD)
CAUTION Electrostatic discharge (ESD) can damage or destroy electronic components. Handle static-sensitive components only at static-safe workstation. CAUTION Assume that all electrical and electronic components of the device are static-sensitive. 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 staticsensitive 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.
•
Use only grounded tools when inserting, adjusting, or removing static-sensitive components and assemblies.
•
Remove or insert static-sensitive components and assemblies only with device 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.
11
Overview Purpose and scope The purpose of this manual is to assist with some common troubleshooting scenarios you may encounter and to explain the export, import, update and upgrade process. It is intended for use only by trained and qualified service personnel. Corrective service is supported to the level of field-replaceable units. These include circuit-board assemblies and some subassemblies, case parts, and other parts. WARNING When performing a service procedure, follow the instructions exactly as presented in this manual. Failure to do so could damage the device, invalidate the product warranty, and lead to serious personal injury. CAUTION No component-level repair of circuit boards and subassemblies is supported. Use only the repair procedures described in this manual. Find instructions for functional testing and performance verification in the Welch Allyn Service Tool help files (http://www.welchallyn.com/promotions/services/ serviceTool.htm.) This manual applies only to this device. For servicing of any other device, see the service manual for the specific device. Service work not described in this manual must be performed by qualified service personnel at the factory or at an authorized Welch Allyn service center.
Related documents When using this manual, refer to the following: •
CP 150 12-lead resting electrocardiograph Directions for use, software version 2.00 (part number 105313)
•
CP 150 spirometry option Directions for use, software version 2.00 (part number 105555)
•
Welch Allyn Service Tool Install guide (part number 103820)
•
Welch Allyn website: www.welchallyn.com
12
Overview
CP 150 12-lead resting electrocardiograph
Technical support services Welch Allyn offers the following technical support services: •
Telephone support
•
Loaner equipment
•
Service Agreements
•
Service training
•
Replacement service parts
•
Product service
For information on any of these services, contact the Welch Allyn Service Center nearest you.
Service loaners For warranty or non-warranty repairs not covered under a support agreement, loaners are available for a nominal charge, subject to availability. Payment is required prior to shipment for all loaners not covered under a support agreement. The loaner fee can be found on the Welch Allyn loaner price list. Welch Allyn Service Centers that provide repair service for this product can, on request, loan a device for use while the device is being repaired. Loaned devices are provided free of charge for products repaired while under a support agreement that includes a free loaner provision. Loaner equipment for the individual component modules is not available.
Service options Partners in Care service agreements While product warranties provide basic assurance of Welch Allyn hardware quality, they may not include the full range of services and support you need. Welch Allyn offers premium service and support through our Partners in Care program. Whether you service your own devices and require a minimum of support or rely on us to service your device, Welch Allyn provides a program that will meet your needs. For more information visit our web site at www.welchallyn.com or call your sales representative.
Warranty service All repairs on products under warranty must be performed or approved by Welch Allyn. Refer all warranty service to Welch Allyn Product Service or another authorized Welch Allyn Service Center. Obtain a Return Material Authorization (RMA) number for all returns to Welch Allyn Product Service. CAUTION Unauthorized repairs will void the product warranty.
Service manual
Overview 13
Non-warranty service Welch Allyn product 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.
Repairs A Welch Allyn Service Center must perform all repairs on products under warranty, unless you have purchased a Welch Allyn support agreement allowing you to service the device while under warranty. CAUTION Unauthorized repairs will void the product warranty. Qualified service personnel or a Welch Allyn Service Center should repair products out of warranty. If you are advised to return a product to Welch Allyn for repair or routine maintenance, schedule the repair with the service center nearest you. Welch Allyn Technical Support If you have a problem with the device that you cannot resolve, call the Welch Allyn Technical Support Center nearest you for assistance. A representative will assist you in troubleshooting the problem and will make every effort to solve the problem over the phone, avoiding a potential unnecessary return. If your product requires warranty or non-warranty repair service, a Welch Allyn Technical Support representative will record all necessary information to issue an RMA number. The support representative will provide you with the address of the Welch Allyn Service Center to send your device to. An RMA number must be obtained prior to any return. Be sure to note this number on the outside of your shipping box and include a copy of the RMA in the box. Returns without an RMA number will not be accepted for delivery. Technical support is available during local business hours.
14
Overview
CP 150 12-lead resting electrocardiograph
Configuration options for CP150 electrocardiograph Model
Accessories
Language
Power cord
CP150
1 - AHA, disposable
EN - English
2 - Europe
A - Interpretation
2 - IEC, disposable
FR - French
3 - Israel
None
3 - AHA, reusable
DE - German
4 - UK
4 - IEC, reusable
ES - Spanish
5 - Switzerland
NL - Dutch
66 - Australia
BP - Brazilian Portuguese
7 - S. Africa
PT - Portuguese
B - North America
ZH - Simplified Chinese
C - China
RU - Russian
G – Argentina
NO - Norwegian
N – India/UAE
SV - Swedish
Z - Brazil
DA - Danish FI - Finnish IT - Italian
Examples: CP150-1ENB, CP150A-1ENB, CP150A-4DE5
Configurations for CP150 electrocardiograph with spirometry option Model
Accessories
Language
Power cord
CP150
1 - AHA, disposable
EN - English
B - North America
A - Interpretation
2 - IEC, disposable
S - Spirometry
3 - AHA, reusable 4 - IEC, reusable
Note
The spirometry option is only available in English.
Examples: CP150S-1ENB and CP150AS-1ENB
Service manual
Overview
15
The Welch Allyn Service Tool The Welch Allyn Service Tool is available in the Silver edition. Download from Welch Allyn website. Clinicians and technical service personnel can use the service tool to manage and maintain supported Welch Allyn products. You can use the service tool to do the following: •
Review device information. When connected to the device, the service tool lists installed modules, installed firmware and hardware versions, warranty and repair information, status, and usage history.
•
Receive notifications when periodic maintenance is needed. The service tool can help you manage and maintain your entire inventory of supported Welch Allyn products. Through the remote service function, the service tool can connect to Welch Allyn Customer Service. With this functionality you can automatically receive firmware updates and feature upgrades for your supported products, including software upgrades for the service tool.
•
Install updates. The service tool can read the firmware version of the CP 150 and check for available updates or upgrades.
•
Install upgrades. An interpretation option is available for purchase. The CP 150 basic can be upgraded to a CP 150A (with the Interpretation option) through the Welch Allyn Service Tool.
•
Create a work list. The work list provides information about service actions- referred to as work orders-that are waiting for you to perform on your maintained devices. Work orders may include periodic calibrations, upgrades, or license installations.
•
Schedule periodic maintenance. You can use the service tool to set the service interval for each maintained device.
•
View and save logs. You can download and save log files from the device for analysis to help diagnose and identify reported issues.
•
Create user accounts. Administrators can create user accounts and set permission levels to control access to the features, allowing one group to perform administrative tasks and another to perform service tasks. Restricting access prevents the service tool from being used to make unauthorized changes on a connected device.
•
Perform functional verification. The service tool can be used to test the device to ensure that it meets performance specifications.
•
Recover devices. In the rare case where a device can no longer boot because of corrupted firmware, the service tool can connect the device to Welch Allyn Technical Support to reinstall the firmware.
•
Extensible. The device accepts new plug-ins to support future Welch Allyn products.
Returning products When returning a product to Welch Allyn for service, ensure that you have the following information: •
Product name, model number, and serial number. This information may be found on the product and serial number labels on the bottom of the device.
•
A complete return shipping address.
•
A contact name and phone number.
16
Overview
CP 150 12-lead resting electrocardiograph
•
Any special shipping instructions.
•
A purchase-order number or credit-card number if the product is not covered by a warranty.
•
A full description of the problem or service request.
1. Contact Welch Allyn and request an RMA number. Welch Allyn does not accept returned products without an RMA.
Note
2. Ship the device to Welch Allyn, observing these packing guidelines: a.
Remove from the package the battery, all hoses, connectors, cables, sensors, power cords, and other ancillary products and equipment, except those items that might be associated with the problem. Recommendations for returning the Lithium Ion battery •
Use ground transportation to return batteries.
•
If returning multiple batteries, package each battery individually.
•
Do not consolidate multiple batteries in a single package.
•
Use packaging provided by Welch Allyn or the battery manufacturer.
•
Do not pack a defective battery in checked or carry-on baggage if traveling by air.
Packaging •
If you return the battery with the device, remove the battery, seal the battery in an antistatic plastic bag, and place the battery in the position reserved for the battery in the original shipping carton near the device.
•
If you return the battery separately, package the battery in the replacement battery’s plastic bag and shipping box.
If the original shipping carton or replacement battery shipping box is unavailable, consult the manufacturer website for information regarding shipping lithium ion batteries: www.nexergy.com/lithium-shipping.htm WARNING Safety risk. Do not ship any battery that has been physically damaged or shows signs of leakage unless you receive specific instructions which meet the requirements for the shipment of Lithium batteries. Dispose of damaged or leaking batteries in an environmentally safe manner consistent with local regulations. Note
In the United States, the applicable regulations can be found in the Code of Federal Regulations (CFR). Refer to 49 CFR 173.185 for shipping lithium batteries by air or ground. Use 49 CFR 172.102 sections 29, 188, 189, A54, A55, A100, A101, A103, and A104 to find the special provisions for shipping lithium batteries.
b. Clean the device.
Service manual
Overview 17
Note
c.
To ensure safe receipt of your device by the service center and to expedite processing and return of the device to you, thoroughly clean all residues from the device before you ship it to Welch Allyn. For decontamination and cleaning requirements, see “Decontamination and cleaning” in the appendices. If a returned device is found to be contaminated with bodily fluids, it will be returned at the owner’s expense. United States federal regulations prohibit the processing of any device contaminated with blood-borne pathogens. Welch Allyn thoroughly cleans all returned devices on receipt, but any device that cannot be adequately cleaned cannot be repaired.
Put the device, enclosed in a plastic bag with a packing list, into the original shipping carton with the original packing materials or into another appropriate shipping carton.
d. Write the Welch Allyn RMA number with the Welch Allyn address on the outside of the shipping carton.
18
Overview
CP 150 12-lead resting electrocardiograph