Propaq encore Service Manual Rev A March 1998

Contents

Contents

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 ... 14 Identifying Propaq Encore Configurations... 15 Self Test and Service Menus... 15

Section 2 Functional Verification Introduction... 17 Self Tests ...17 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 & Alarm Indicators ...24 IBP ...26 NIBP ...28 Temperature ...30 SpO2 Checks ...30 Printer Tests ...31 CO2 Verification Preparation ...32 Mainstream CO2 Verification Procedure ...36

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Contents

Section 3 Calibration Introduction ... 43 Equipment Needed... 44 Procedures ... 45 Setup ...45 Recharger Supply Adjustments ... 46 Display Voltage Adjustments ... 49 Main Power Supply Adjustments ... 50 Calibrating Realtime ECG Out ... 52 Non-Invasive Blood Pressure Calibration... 53 EMI Null Adjustment... 55 Invasive Blood Pressure... 55 MSP Board (MCO2) Calibration ...56

Section 4 Troubleshooting Introduction ... 57 Screen Messages... 57 Non-Recoverable Error Codes ...58 Battery Capacity Check... 59

Section 5 Repair Procedures Introduction ... 61 Propaq Encore Software... 61 Required Tools ... 62 Propaq Encore Options ...63 Field Replaceable Units in the Monitor ... 63 Replacing the Power Input Fuse... 66 Replacing the Battery Pack ... 67 Removing the Single Battery Pack ...68 Removing the Dual Battery in Expansion Module ...69 Removing the Dual Battery in SpO2 Module ...71 Opening the Monitor... 71 Closing the Monitor... 75 Replacing the Analog Board ... 76 Replacing the Digital Board ... 78 Replacing the EL Display Module... 81 Removing Front Panel Buttons ... 84 Replacing Recharger Board Fuse (F2)... 86 Replacing Air Tubing ... 87 Replacing Cables... 87 Replacing PROMs ... 88 Cuff Fittings ...89

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Propaq Encore Service Manual

Contents

Replacing the Recharger Board ... 90 Replacing the Pump ... 93 Replacing the Side Panels... 94 Removing the Right Side Panel ...94 Removing the Left Side Panel ...95 Installing Side Panels ...95 Expansion Module... 97 Opening Expansion Module Rear Panel ...98 Closing Expansion Module ...99 Replacing Expansion Module Front Panel... 100 Replacing Expansion Module Button Board and Buttons ... 102 Replacing the Printer... 102 Removing Printer ...102 Installing Printer ...104 Opening the SpO2 Module... 106 Replacing the SpO2 Circuit Boards... 109 Replacing the MSP/SpO2 Circuit Boards ... 110 Replacing the Sidestream CO2 Assemblies ... 112 Replacing the extender board ...112 Removing the SSP/Stick board assembly: ...112 Removing the Stick board from the SSP board: ...113 Replacing Expansion Module Side Panels... 115

Section 6 Technical Overview System Description... 117 Power Electronics Description ...124 Monitoring Electronics System Description ...126 NIBP Pneumatics Description ...128 Cabling Diagrams ... 133 Expansion Module and Printer Description ... 135 Pulse Oximetry Option (SpO2) Description ... 137 Capnography (CO2) Description ... 140 Mainstream Board ...141 IPC Expansion ...142 Power Distribution System ...142 CO2 Analysis Chamber (Bench) ...142

Section 7 Field Replaceable Units (FRUs) List of FRUs ... 143

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Contents

Appendix A Manufacturable Test Equipment Introduction ... 149

Appendix B Dynatech/Nevada Patient Simulator Modification Introduction ... 151

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Propaq Encore Service Manual

Safety Summary

Important Safety Considerations

Safety Summary This Safety Summary should be read by all Propaq Encore 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 Propaq. • Place the Propaq Encore 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 Propaq Encore in an MRI suite or a hyperbaric chamber. • Do not autoclave the Propaq Encore. 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 Propaq’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. • The Propaq Encore should be serviced only by a Protocol Systems service technician while under warranty.

Definitions note... NOTE statements in the service manual, which look like this, identify information that may be important to the reader.

ALARM

ALARM(S) OFF

ALARMS

FREEZE/ UNFREEZE

10 SUSPEND/ RESUME

NIBP

MAIN MENU START / STOP

CAUTION

CAUTION statements in the service manual, which look like this, identify conditions or practices that could result in damage to equipment or other property.

WARNING

WARNING statements in the service manual, which look like this, identify conditions or practices that could result in personal injury.

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Propaq Encore Service Manual

Safety Summary

Symbols

Symbols The following symbols appear in the Propaq documentation and on Propaq 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.

Alternating current.

Caution: Refer to Reference Guide and accompanying documentation.

Temperature sensor input.

Battery charging when green indicator illuminated.

0123

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 TypeBF, and protected against defibrillation.

Transformer meets requirements of a short-circuit-proof safety-isolating power transformer.

All patient connections are TypeB

Batteries must be separated from other disposables for recycling.

The CE mark and notified body registration number signify Propaq Encore 200 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

1. This symbol is on the Universal Power Adapter.

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Symbols

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Safety Summary

Propaq Encore Service Manual

Section 1-Overview

Purpose and Scope

Section 1 Overview Purpose and Scope The Propaq Encore 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.

note... Configurations vary nationally. Some early versions of the Propaq Encore do not include impedance pneumagraphy (RESP) in some countries. 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 Encore monitor. Refer to those documents for other than maintenance and repair information. Check the Encore Reference Guide for information on other user’s documentation.

Title

Part Number

Propaq Encore Reference Guide, English Language, U.S.

810-0639-XX

Propaq Encore Reference Guide, English Language, International

810-0640-XX

Propaq Encore Reference Guide, German Language

810-0641-XX

Products & Accessories Book

810-0409-XX

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Unpacking Procedure

Section 1-Overview

Unpacking Procedure Use the following guidelines when unpacking the Encore monitor from its shipping carton. 1. Before opening the Encore 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 Encore monitor. 3. With the Encore 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 Encore 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 Encore 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 Encore Service Manual

Section 1-Overview

Technical Support Services

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 Continental Europe: Protocol Systems, GmbH., Germany Berliner Strasse 106 D-66424 Homburg, Germany Phone: 49 89 462 34 30 Fax: 49 89 460 70 87 Worldwide Internet Access World Wide Web (WWW) URL: http://www.protocol.com/service World Wide E-mail: [email protected]

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Recommended Service Intervals

Section 1-Overview

Recommended Service Intervals At the intervals listed below, check the Encore 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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Propaq Encore Service Manual

Section 1-Overview

Identifying Propaq Encore Configurations

Identifying Propaq Encore Configurations The following table identifies Propaq Encore 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.

Product (Housing)

Model Number

Option Number

PROPAQ ENCORE MONITOR

202-EL

ECG, NIBP, 2 TEMP., RESP., EL DISPLAY

204-EL

ECG, NIBP, 2 TEMP., 1 IBP, RESP., EL DISPLAY

206-EL

ECG, NIBP, 2 TEMP., 2 IBP, RESP., EL DISPLAY

Defining Parameters

Serial Number Prefix DA/EA

SPO2-ONLY MODULE

210

SPO2

DB/EB

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

DC/EC

Self Test and Service Menus The Encore 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 Encore 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 all Service Menu functions. Some of these functions are not available if you do not have the appropriate option.

service menus NIBP TEST

IBP TEST

SpO2 TST

CO2 TEST

MORE

PUMP TEST

AUTO PMP

NIBP CAL

ZERO

PREV MENU

TEMP TEST

PIXL TEST

NET TST

CYCLE

CHECKER 1

CHECKER 2

LOOP TEST

16

MORE

BORDER

OUT TEST

MAIN CAL

MAIN TEST

SIDE CAL

SETTINGS

KEY TEST

SYSTEM

KEY 0

KEY 1

KEY 2

PREV MENU

PREV MENU

SIDE TEST

PREV MENU

MORE

KEY 3

PREV MENU

Propaq Encore Service Manual

Section 2-Functional Verification

Introduction

Section 2 Functional Verification Introduction The functional verification procedures ensure proper operation of the Encore monitor and its options. These procedures should be performed following module-level repairs, calibration, or whenever there is a question about the accuracy or safety of the patient functions. The calibration procedures in Section 3 should be used to return the monitor to operation within its performance specifications. If the monitor does not pass the functional verification, or when it is time to do a routine calibration, see Section 3.

WARNING

Whenever the monitor is opened for calibration or repair, a risk (leakage) current safety check as well as a dielectric strength integrity (hi-pot) test must be performed as described in this section. The Encore’s service menu facilitates the functional verification. It has several features for testing and verifying the NIBP (cuff) channel, display, invasive pressure channel, and printer. Refer to Section 1 for information about the Service Menu.

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 Encore 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 Encore) 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 Encore Service Manual

Section 2-Functional Verification

Safety Tests

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 Encore 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 Encore. 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

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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Safety Tests

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 high voltage potential of the tester as specified in the table below.

Summary of Connection Points and High-Voltage Test Potentials Tester's high-voltage terminal connection All ECG leads on patient cable connected together

Tester's grounded return connection DC input connector; all pins connected together

High-voltage test parameters Output: 4000 V ac rms Current Limit: 2.5mA Ramp-up: 8 seconds Dwell: 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.

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Propaq Encore Service Manual

Section 2-Functional Verification

Functional Verification

Functional Verification The functional verification must be done only when the monitor is fully assembled. If the monitor has been stored for longer than one month without the monitor connected to the ac adapter (for recharging), the battery voltage must be checked. The battery must be replaced if it cannot hold a charge. Refer to Section 4 for a battery capacity test.

note... Some configurations of the Encore monitor do not include impedance pneumography (RESP) and other neonatal monitoring parameters. In these versions, RESP does not appear in menus or on the screen displays. You can ignore RESP and other terms relating to neonatal monitoring when indicated in the following instructions. If you plan to use a Dynatech/Nevada model 213A, 215A, or 217A Patient Simulator to simultaneously simulate ECG and invasive blood pressure, see Appendix B for important information. Before starting the verification procedures, charge the battery for at least 8 hours with the monitor turned off. (Charge for 12 hours if a Printer or SpO2 module is attached.)

Power System The following steps check the integrity of the Encore’s power system. 1. Turn the ac power adapter’s power switch off. 2. Plug the ac power adapter into an ac mains receptacle and connect it to the Encore’s right side panel dc power connector. 3. Check that the green LED charging indicator on the monitor’s right side panel is off. 4. Turn on the power adapter’s power switch. 5. Check that the green LED on the power adapter turns on and that the green LED charging indicator on the monitor’s right side panel turns on. 6. Disconnect the power adapter from the monitor. Check that the monitor’s green LED charging indicator on the right side panel turns off.

ALARM

ALARM(S) OFF

ALARMS

FREEZE/ UNFREEZE

10 SUSPEND/ RESUME

NIBP

MAIN MENU START / STOP

CAUTION

In the next steps, carefully check for the proper polarity of the connection between the power supply and the monitor. If voltage is applied with the wrong polarity, it will open the right side panel fuse (F1). Refer to the figure on page 22 to verify proper polarity. 7. Set the dc power supply meter to Volts and turn the power switch on; set it for 15.0V ± 0.1V. 8. Turn off the dc power supply.

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