Service Manual
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Patient Monitor Menu
Vital Signs Monitor
Service Manual
Copyright © 1995-1999, Protocol Systems, Inc. Protocol® Propaq®, Propaq® CS, Acuity®, Protocol Cordless®, and Flexible Monitoring® are registered trademarks of Protocol Systems, Inc. Protocol Systems, Inc. is protected under various patents and patents pending. NELLCOR® DURASENSOR, C-LOCK and OXISENOSOR are registered trademarks of Mallinckrodt, Incorporated. Mallinckrodt, Incorporated is protected under U.S. patents 4,261,643; 4,653,498; 4,770,179; 4,802,486; 4,869,254; 4,928,692; and 4,934,372. LIFEPAK 5® and LIFEPAK 6s® are registered trademarks of Physio-Control Corporation. The HP Component Monitoring System is a product of Agilent (formerly Hewlett-Packard Company). Copyright Notice: Software in this Product is Copyright® 1999 by Protocol Systems, Inc., or its vendors. All rights are reserved. The software is protected by United States of America Copyright laws, and international treaty provisions applicable all over the world. Under such laws, it may be used as intended in the operation of the product in which it is embedded, but it may not be copied, decompiled, reverseengineered, disassembled, or otherwise reduced to human-perceivable form. Protocol Systems, Inc. will make available specifications necessary for interoperability of this software on request; however, users should be aware that use of Protocol Systems, Inc. hardware and software with devices or software not sold by Protocol or its authorized dealers and affiliates may lead to erroneous results and consequent danger in patient care, and may also void Protocol’s warranty. Disclaimers: Protocol Systems, Inc. cautions the reader of this manual: •
This manual may be wholly or partially subject to change without notice
•
All rights are reserved. No one is permitted to reproduce or duplicate, in any form, the whole or part of this manual without permission from Protocol Systems, Inc.
•
Protocol Systems, Inc. will not be responsible for any injury to the user or other person(s) that may result form accidents during operation of the Propaq CS monitor.
•
Protocol Systems, Inc. assumes no responsibility for usage not in accordance with this manual that results in illegal or improper use of the Propaq CS monitor.
For information concerning this document or any Protocol Systems product, contact: Protocol Systems, Inc. Customer Service 8500 SW Creekside Place Beaverton, Oregon 97008-7107 USA Within USA, toll free: Phone: (800) 289-2500 Phone Technical Services: (800) 289-2501 WorldWide: Phone: Fax: Fax Technical Services:
(503) 526-8500 (503) 526-4200 (503) 526-4910
Internet: http://www.protocol.com Email Technical Services: [email protected] Email Marketing Dept.: [email protected]
Protocol Medical Systems, Ltd.: NW Europe Derby Service Centre St. Georges House Vernon Gate Derby DE1 1UQ, United Kingdom Phone: 44 1332 206208 Fax: 44 1332 206209 Email: [email protected] Protocol Systems, Inc.: Asia/Pacific P.O. Box 29020 Christchurch 5, New Zealand Phone: 64 3 37 94 429 Fax: 64 3 37 92 374
Reorder No: 810-1101-00 Rev. A 11/99 Printed in the U.S.A.
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Contents
Safety Summary Important Safety Considerations ... 7 Definitions ... 8 Symbols ... 9
Section 1 Overview Purpose and Scope ... 11 Other Applicable Documents ... 11 Unpacking Procedure ... 12 Warranty Service ... 12 Technical Support Services ... 12 Recommended Service Intervals ... 13 Identifying Propaq CS monitor Configurations... 14 Monitor Controls ... 15 Self Test and Service Menus... 15
Section 2 Functional Verification Introduction... 17 Self Tests ...17 Required Equipment ...18 Safety Tests ...19 Risk (Leakage) Current Test ...19 Dielectric Strength (Hi-Pot) Test ...20 Functional Verification ... 21 Power System ...21 System Tests ...23 ECG/RESP Channel and Alarm Indicators ...24 IBP Channel ...26 NIBP ...28 Temperature ...30 Nurse Call ...30 SpO2 Checks ...31 Printer Tests ...32
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CO2 Verification Preparation ...33 Mainstream CO2 Verification Procedure ...37 Sidestream CO2 Verification Procedure ...39
Section 3 Calibration Introduction ... 43 Equipment Needed...44 Procedures ...45 Setup ...45 Recharger Supply Adjustments ...46 Main Power Supply Adjustments ... 49 Calibrating Realtime ECG Out ...51 Non-Invasive Blood Pressure Calibration...52 Invasive Blood Pressure...54 MSP Board (MCO2) Calibration ...55
Section 4 Troubleshooting Introduction ... 57 Screen Messages... 57 Non-Recoverable Error Codes ...58 Battery Capacity Check... 59
Section 5 Repair Procedures Introduction ... 61 Propaq CS Monitor Software ... 61 Required Tools ... 62 Propaq CS Monitor Options... 63 Field Replaceable Units in the Monitor ...64 Front Chassis ...64 Interface Chassis ...65 Rear Chassis ...66 Replacing the Power Input Fuse...67 Replacing the Battery Pack ... 68 Removing the Single Battery Pack ...69 Removing the Dual Battery in Expansion Module ...70 Removing the Dual Battery in SpO2 Module ...72 Opening the Monitor... 72 Closing the Monitor...76 Replacing the Analog Board ...77 Replacing the Digital Board or Display...79 Reinstalling the Digital Board or Display ...81 Replacing Recharger Board Fuse (F2)...82
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Propaq CS Service Manual
Replacing Air Tubing...83 Replacing Cables...84 Replacing PROMs... 84 Cuff Fittings ...86 Replacing the Recharger Board ...87 Replacing the Pump ...89 Replacing the Side Panels...90 Removing the Right Side Panel ...90 Removing the Left Side Panel ...91 Installing Side Panels ...91 Expansion Module...94 Opening Expansion Module Rear Panel ...95 Closing Expansion Module ...96 Replacing Expansion Module Front Panel...97 Replacing Expansion Module Button Board and Buttons ...98 Replacing the Printer...99 Removing Printer ...99 Installing Printer ...101 Opening the SpO2 Module ...103 Replacing the SpO2 Boards ...105 Replacing the MSP/SpO2 Boards...106 Replacing the Sidestream CO2 Assemblies... 107 Replacing the Extender Board ...107 Removing the SSP/Stick Board Assembly ...108 Removing the Stick Board from the SSP Board ...109 Replacing Expansion Module Side Panels...110
Section 6 Technical Overview Introduction... 111 System Description... 111 Monitor Options ...112 Power Electronics Description ...118 Monitoring Electronics System Description ...120 NIBP Pneumatics Description ... 123 Cabling Diagrams ... 128 Expansion Module and Printer Description ... 130 Pulse Oximetry Option (SpO2) Description...132 Capnography (CO2) Description...135 Mainstream Board ...136 IPC Expansion ...137 Power Distribution System ...137 CO2 Analysis Chamber (Bench) ...137
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Section 7 Field Replaceable Units (FRUs) List of FRUs ... 139
Appendix A Manufacturable Test Equipment Introduction ... 143
Appendix B Dynatech/Nevada Patient Simulator Modification Introduction ... 145
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Propaq CS Service Manual
Safety Summary
Important Safety Considerations
Safety Summary This Safety Summary should be read by all Propaq CS monitor users. Specific warnings and cautions will be found throughout the documentation where they apply. Caution: Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.
Important Safety Considerations Please consider the following safety points when using the monitor. • Place the monitor and accessories in locations where they cannot harm the patient should they fall from their shelf or mount. • Do not connect more than one patient to a monitor. Do not connect more than one monitor to a patient. • Do not use the monitor in an MRI suite or a hyperbaric chamber. • Do not autoclave the monitor. Autoclave accessories only if the manufacturer's instructions clearly approve it. Many accessories can be severely damaged by autoclaving. • Inspect the power adapter cord periodically for fraying or other damage, and replace the adapter as needed. Do not operate the apparatus from mains power with a damaged power adapter cord or plug. • Make frequent electrical and visual checks on cables and electrode wires. • Avoid electrosurgery burns at monitoring sites by ensuring proper connection of the electrosurgery return circuit so that the return paths cannot be made through monitoring electrodes and probes. • During defibrillation, keep the discharge paddles away from ECG and other electrodes, as well as other conductive parts in contact with the patient. Avoid contact with any accessories connected to the monitor’s left side panel. • To ensure patient safety, the conductive parts of the ECG electrodes (including associated connectors) and other patient-applied parts should not contact other conductive parts, including earth ground, at any time. • Do not operate this product in the presence of flammable anesthetics. Explosion can result.
Note
Within certain governmental jurisdictions, all interconnected accessory equipment must be labeled by an approved testing laboratory. After interconnection with accessory equipment, risk (leakage) current and grounding requirements must be maintained.
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Definitions
Safety Summary
• To ensure conformance to risk (leakage) current requirements when operating from an ac mains power source, use only a Protocol Systems’ 503-0054 series power adapter. • To ensure patient safety, use only accessories recommended or supplied by Protocol Systems, Inc. For a list of those accessories, see the Protocol Products and Accessories book that accompanied this manual (PN 810-0409-XX). Accessories must be used according to your hospital’s standards and the manufacturer’s recommendations. Always refer to the manufacturer’s directions for use. • A product that has been dropped or severely abused should be checked by qualified service personnel to verify proper operation and acceptable risk (leakage) current values. • If the monitor detects an unrecoverable problem, an error message window appears containing an error number and a short message. Report such errors to Protocol Systems. • While under warranty, the monitor should be serviced only by a Protocol Systems service technician.
Definitions Note
NOTE statements in this manual identify information that may be important to the reader. Caution
CAUTION statements in this manual identify conditions or practices that could result in damage to equipment or other property. Warning
WARNING statements in this manual identify conditions or practices that could result in personal injury.
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Propaq CS Service Manual
Safety Summary
Symbols
Symbols The following symbols appear in the monitor documentation and on monitor labels. These internationally recognized symbols are defined by the International Electrotechnical Commission, IEC 878 and IEC 417A.
Off (Standby).
Two way communication port.
On.
Input port to monitor.
For continued fire protection, use only the specified fuse.
Signal output port from monitor.
Direct current or alternating current.
Urgent alarm notification (output to Nurse Call system)
Direct current.
Alternating current.
Caution: Refer to Reference Guide and accompanying documentation.
Temperature sensor input.
Battery charging when green indicator illuminated.
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NRTL/C Evaluated to CSA 601-1 and UL2601-1
IPX1
Enclosure Protection Drip proof: Classification IPX1 per IEC Publication 529.
All patient connections are Type CF, isolated for direct cardiac application, and protected against defibrillation.
For indoor use only (on power adapter only).
All patient connections are Type BF, and protected against defibrillation.
Transformer meets requirements of a short-circuit-proof safety-isolating power transformer.
All patient connections are Type B
Batteries must be separated from other disposables for recycling.
The CE mark and notified body registration number signify Propaq CS Series monitors have met all essential requirements of European medical device directives 93/42/EEC.
The CE mark signifies the device has met all essential requirements of European Medical Device Directive 93/ 42/EEC for a Class 1 product.1
The Canadian Standards Association has evaluated this device according to CSA 601-1 and Underwriters Laboratory Standard UL 2601-1.1
This device has been tested and certified by the Canadian Standards Association International to comply with applicable U.S. and Canadian medical safety standards.
C
US
1. This symbol is on the Universal Power Adapter.
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Symbols
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Safety Summary
Propaq CS Service Manual
Section 1-Overview
Purpose and Scope
Section 1 Overview Purpose and Scope The Propaq CS Service Manual is intended as a reference for monitor maintenance and repair to the field replaceable unit (FRU) level. FRUs are listed in Section 7. This manual provides the technically qualified service person with troubleshooting information, repair procedures, and calibration and performance verification instructions. A technical overview of the monitor subsystems is provided as an introduction to the device’s circuitry and pneumatics. This manual is intended for the technically qualified service person. Service training classes on Protocol Systems’ products are available. Contact Protocol Technical Service for information.
Other Applicable Documents Several other documents are available for the Propaq CS monitor. Refer to those documents for other than maintenance and repair information. Check the Propaq CS Directions For Use for information on other user’s documentation.
Title
Part Number
Propaq CS Directions For Use, English
810-1097-XX
Products & Accessories Booklet
810-0409-XX
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Unpacking Procedure
Section 1-Overview
Unpacking Procedure Use the following guidelines when unpacking the monitor from its shipping carton. 1. Before opening the monitor shipping carton, check it for damage. 2. If damage is apparent, stop unpacking the carton and contact the shipping company for further instructions. If the carton is intact, unpack the monitor. 3. With the monitor out of its carton, check to see that all the items listed on the packing slip (provided with shipment) are in the shipping carton. 4. If an item is missing, first recheck the carton, then check with your receiving department. If necessary, contact Protocol Systems at the address and phone number shown in Technical Support Services on page 12. Note
Save the shipping carton and packing material for repacking the monitor in case it needs to be sent to a repair center or back to Protocol Systems for service.
Warranty Service DO NOT ATTEMPT TO REPAIR the monitor yourself during the warranty period. For fast, convenient service and repair, contact Protocol Systems. See Technical Support Services on page 12.
Technical Support Services Protocol Systems offers a wide range of technical support services including: • 24-hour telephone support • loaner equipment • service contracts • field replaceable units (FRUs) • factory repair
For any of these services, contact Protocol Technical Support at the following numbers: • toll free in the United States (800) 289-2501 • worldwide (503) 526-8500 and ask for Technical Support • facsimile (503) 526-4910
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Propaq CS Service Manual
Section 1-Overview
Recommended Service Intervals
For service outside the United States, contact one of the following service centers near you. United Kingdom and Continental Europe: Protocol Medical Systems Ltd., England Derby Service Centre St. Georges House, Vernon Gate Derby, DE1 1UQ, United Kingdom Phone: 44 1332 206208 Fax: 44 1332 206209 Email: [email protected] Worldwide Internet Access World Wide Web (WWW) URL: http://www.protocol.com/service World Wide E-mail: [email protected]
Recommended Service Intervals At the intervals listed below, check the Propaq CS monitor for normal operation.
Located in this manual
Interval/Condition
Perform
Every 6 months to 2 years (according to hospital protocols).
Complete risk (leakage) current Safety Check followed by a Functional Verification.
Section 2
If battery does not retain a charge.
Check battery pack capacity.
Section 4
Monitor is dropped or suspected of damage or rough handling.
Complete Safety Check followed by Functional Verification.
Section 2
Suspected malfunction with all or part of monitoring parameters.
Functional Verification of suspected parameter(s).
Section 2
Monitor does not pass Functional Verification.
Calibration of monitoring parameter circuits, or repair, followed by Safety Check and Functional Verification.
Section 3 and Section 2
Warning
If the monitor is opened for repair or calibration, a dielectric strength test must be completed to ensure the integrity of the patient isolation barrier. The dielectric strength test procedure is provided in Section 2.
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Identifying Propaq CS monitor Configurations
Section 1-Overview
Identifying Propaq CS monitor Configurations The following table identifies Propaq CS monitor configurations and how they are indicated. The model-option number and serial number are located on the back of the housing. The monitor indicators are located under the handle on the back.
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Option Number
Parameters Included (Acuity Option Is Also Available With Every Model)
Product (Housing)
Model Number
PROPAQ CS MONITOR
242
ECG, NIBP, 2 TEMP., RESP. OPTION, NURSE CALL OPTION, COLOR DISPLAY
244
ECG, NIBP, 2 TEMP., 1 IBP, RESP. OPTION, NURSE CALL OPTION, COLOR DISPLAY
246
ECG, NIBP, 2 TEMP., 2 IBP, RESP. OPTION, NURSE CALL OPTION, COLOR DISPLAY
SPO2-ONLY MODULE
210
SPO2
EXPANSION MODULE
221 223 224 225 226 227 228 229
PRINTER PRINTER SPO2 SPO2, MCO2 PRINTER, SPO2, MCO2 SPO2, SCO2 PRINTER, SPO2, SCO2 SPO2, MCO2, SCO2 PRINTER, SPO2, MCO2, SCO2
Propaq CS Service Manual
Section 1-Overview
Monitor Controls
Monitor Controls
Nurse Call Option
Alarm Light Alarm(s) Off Light
Suspend/ Resume Alarm Suspends alarm tone for 90 seconds or resumes alarm tone (if active) SpO2 Option
Start/ Stop NIBP Starts or stops NIBP reading
Home Mainstream CO2 Option
Returns the display to the Main Menu
Printer Option Printer Buttons Sidestream CO2 Option
Self Test and Service Menus The Propaq CS monitor includes built-in self-tests that verify the integrity of its hardware and software each time you turn it on. If the monitor turns on and displays the Main Menu, all self-tests were passed. If a self-test results in a failure, a message and error code are displayed indicating the failure mode. Refer to Section 4 and contact Protocol Systems Technical Support for help. The Propaq CS monitor contains software routines that make the Functional Verification and Calibration procedures quicker and easier. You access these routines through the Service Menus as indicated in each of the procedures. The figure on page 16 shows the hierarchy of the Service Menus once you enter the top level Service Menu.
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Self Test and Service Menus
Section 1-Overview
The procedures in this manual indicate which buttons to push by separating each button menu name with the (>) character. For example, to access the Service Menu, the procedures would indicate for you to press SETUP > MORE > MORE > SERVICE > YES, which means you press the SETUP button, then the MORE button, then the MORE button, then the SERVICE button, and finally the YES button. Note
The figure illustrates the Service Menu functions. Some of these functions are not available if you do not have the appropriate option.
service menus To access the Service Menu, from the Main Menu press: SETUP>MORE>MORE>SERVICE>YES.
NIBP TEST
IBP TEST
SpO2 TEST
CO2 TEST
MORE
PUMP TEST
AUTO PUMP
NIBP CAL
ZERO
PREVIOUS MENU
TEMP TEST
PIXEL TEST
NET TEST
PCMCIA TEST
MORE
CONTROLLER
MEMORY TEST
WLAN TEST
PREVIOUS MENU
OUT TEST
PREVIOUS MENU
TEST
LOOP TEST
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MAIN CAL
MAIN TEST
SIDE CAL
SETTINGS
SCREEN CAL
SYSTEM
KEY 0
KEY 1
KEY 2
SIDE TEST
PREVIOUS MENU
MORE
KEY 3
KEY 4
Propaq CS Service Manual
Section 2-Functional Verification
Introduction
Section 2 Functional Verification Introduction This functional verification procedure helps to confirm the proper operation of the Propaq CS monitor and options. This procedure supports the requirements of routine preventive maintenance. No monitor disassembly is required to perform this procedure. Section 3 of this manual provides the full calibration procedures. Calibration may be required if the monitor fails certain functional tests or after a circuit board is replaced. Monitor disassembly is required for calibration. Always perform this functional verification procedure after performing any calibration. This procedure contains additional tests that are not included in calibration procedures. The monitor Service Menus provide access to internal software routines that are required during the functional verification procedure. Service Menus provide features to test and verify the NIBP (cuff) channel, display, invasive pressure channel, and printer. Refer to Section 1 for information about the Service Menus.
Self Tests Many functions, such as alarms, waveform and scale sizing, and printer control, are software operations. During the monitor’s power-up self-test, the integrity of all programming is checked first. If software testing is successful, hardware tests are initiated. If all testing is successful, the monitor is ready for use. (See Section 4 for information on error messages.)
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Introduction
Section 2-Functional Verification
Required Equipment You will need the following equipment to verify that all functions of the monitor operate correctly. All test equipment must be calibrated to function within parameters specified by the manufacturer, and must be traceable to a national calibration standard. Some equipment can be manufactured. See Appendix A for information on manufacturable test equipment.
Required Equipment Description Luer connector, male, for use with 1/8" I.D. tubing (Value Plastics, MTLL230-1) Luer connector, female, for use with 1/8" I.D. tubing (Value Plastics, FTLL230-1) Test water trap, Protocol, 008-0370-00 1/8" inside diameter tubing Flow meter, Cole Parmer E 32000-06, 200ml/min. or equivalent 0 to 300 mmHg Mercury-column manometer, or calibrated pressure meter, with inflation squeeze bulb 50 MHz triggered sweep oscilloscope Variable dc power supply, 0-28 V, 3A with voltage and current metering Patient simulator, Dynatech/Nevada 213A, 214A, 215A, or 217A with IBP, Temperature, and EGG Cable/Leads Adult cuff (provided with monitor); Neonatal cuff #3; 3 cm diameter solid cylinder; solid cylindrical object about the size of an adult’s arm Protocol cuff calibration kit, Protocol PN 008-0012-XX Power supply adapter cable, Protocol PN 008-0290-00 Physio-Control LIFEPAK 5 or LIFEPAK 6s with appropriate Protocol Systems Defib Sync adapter to use as Defib Sync Marker pulse source Propaq ac power adapter (provided with the monitor) Safety analyzer, Dynatech/Nevada, 431F-1D or equivalent Rod-L Model M100AVS5 high-voltage potential (hi-pot) tester, or equivalent Static-free work area NELLCOR pocket tester, PT-2500 Test gas source: dry 4% to 10% CO2, balance air (with flow meter). Gas may be between 4% and 10%, but exact CO2 concentration must be certified to ±0.01. (Convert percentage to partial pressure (mmHg) as instructed in Section 2.) Two rubber test tube stoppers, with 1/8" to 1/4" holes drilled through (for CO2 tests)
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Propaq CS Service Manual
Section 2-Functional Verification
Introduction
Safety Tests The following two safety tests, a risk (leakage) current safety check and a dielectric strength integrity (hi-pot) test, must be performed whenever the monitor has been opened for calibration or repair. Note
A hi-pot test is only required if the monitor has been opened.
Risk (Leakage) Current Test A risk (leakage) current test must be performed to verify that the patient remains electrically isolated from the power circuits of the monitor. Check leakage currents using a Dynatech/Nevada 431F-1D safety analyzer or its equivalent. The source current should not exceed 10µA rms. The sink current, measured between the isolated patient connections (ECG) and the dc power input connector of the monitor, should not exceed 20µA rms. See the analyzer's operator's manual for the proper safety check procedure. Note
Because of the all-insulated construction of the monitor, an Enclosure Leakage Current Test to ground is not necessary.
Electrical Connections for Patient Risk (Leakage) Current Safety Tests Safety Test
Power Adapter
Monitor dc Input
Monitor Cable
Safety Analyzer
Source current
Plugged into analyzer outlet (power adapter switch on)
Connected to power adapter
RA LA LL C RL
RA LA LL C RL
Sink current
Not used
Connected to ground connector on analyzer
RA LA LL C RL
RA LA LL C RL
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Introduction
Section 2-Functional Verification
Dielectric Strength (Hi-Pot) Test Because of the close spacings of the monitor's internal components and the critical positioning of the insulation sheet within the monitor, Protocol Systems, Inc. recommends that a dielectric strength test be performed following any procedure in which the monitor is opened. Warning
The Hi-Pot test is extremely hazardous. Only qualified service personnel should perform this test. Conduct the test only on an insulated table top, away from other people and equipment. Use a Rod-L Model M100AVS5 high-voltage potential tester, or equivalent. Refer to the Rod-L instruction manual for operating information and safety recommendations. 1. Set the parameters of the high voltage tester per the ECG input connector specifications in the table below.
Summary of Connection Points and High-Voltage Test Parameters Tester's high-voltage terminal connection
Tester's grounded return connection
High-voltage test parameters
ECG Input Connector: all ECG leads connected together
DC input connector; all pins connected together
Output: 4000 V ac rms Current Limit: 2.5 mA Ramp-up: 8 seconds Dwell: 1 second
Nurse Call Output Connector: Pins 1 and 3 connected together (use 008-0634-XX cable)
DC input connector; all pins connected together
Output voltage: 1500 V ac rms Output Current Limit: 2.5 mA Ramp-up: 8 seconds Dwell time: 1 second
2. Connect the high-voltage output lead of the tester to all ECG leads, using a dedicated patient cable reserved for use only in such tests. 3. Connect the tester's chassis-connected return lead to the monitor's dc input connector, using a suitable plug. 4. Apply the test voltage for one second. The tester must not indicate dielectric breakdown. Warning
If any dielectric breakdown occurs, do not use the monitor. All internal sheet insulation barriers must be properly installed. Check the monitor to determine the cause of dielectric breakdown; then repair the monitor or return the monitor to Protocol Systems for repair. If the monitor has the Nurse Call Option, continue with steps 5 to 8: 5. Remove the ECG connection from the monitor and the tester’s high voltage output lead.
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Propaq CS Service Manual