Page 1 Serv ic e G u id e Avalon Fetal Monitor FM20/FM30 Rel ease J .3 with So ftware Revisi on J. 3x.xx F e t a l M o n i t o r i n g...
Page 3 Table of Contents 1 Introduction Who Should Read This Guide What to Do Next Repair Strategy Manufacturer’s Information Passwords Safety Information 2 Site Preparation Introduction Site Requirements 3 Installation Instructions Installation Checklist Fetal Monitor Unpacking and Checking the Shipment Fetal Monitors Mounting Instructions Line Voltage Selection Connecting the Monitor to AC Mains...
Page 4 Toco+ Transducer Front-ends Patient Module Front-ends Avalon CTS Interface Cable (TMIF) 5 Interfaces LAN / RS232 Interface Dual PS/2 Interface MIB / RS232 Interface Connection of USB Devices Flexible Nurse Call Relay 6 Connection to a Network Network Infrastructure Requirements Data Privacy and Network Security Requirements Connection Indication Messages 7 Testing and Maintenance...
Page 5 Assembly and Kit Contents 10 Repair and Disassembly Introduction Serial Numbers Top Cover Disassembly/Reassembly Replacing the Display Assembly Recorder Disassembly Bottom Cover Disassembly/Reassembly Transducer Disassembly/Reassembly 11 Upgrades FM20/30 Upgrade Options Installing Upgrade Options Software and Firmware Upgrades 12 Specifications Environmental Specifications Physical Specifications Interface Specification Performance Specifications...
Page 7 Introduction This Service Guide contains technical details for the Avalon FM20 and FM30 fetal/maternal monitors. It provides a technical foundation to support effective troubleshooting and repair. It is not a comprehensive, in-depth explanation of the product architecture or technical implementation. It offers enough information on the functions and operations of the monitoring systems, so that engineers who repair them are better able to understand how they work.
Page 8 For tests that you are required to perform after repairs, refer to “When to Perform Tests” on page 56. WARNING Do not maintain or repair the device in patient vicinity. Manufacturer’s Information © Copyright 2003 - 2014. Koninklijke Philips Electronics N.V. All Rights Reserved. Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2...
Page 9 1 Introduction Passwords In order to access different modes within the monitor a password may be required. The passwords are listed below. Monitoring Mode: No password required Configuration Mode: 71034 Demo Mode: 14432 Service Mode: 1345 Refer to “When to Perform Tests” on page 56 before making any changes to the monitor configuration.
Page 10 1 Introduction Electric Hazards WARNING Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel. • Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket.
Page 11 Use of the devices in such an environment may present an explosion hazard. • Use only Philips batteries part number M4605A with the FM20 or FM30 with battery option. Use of a different battery may present a risk of fire or explosion. Environmental Specifications: •...
Page 12 INOP only Accessories WARNING Philips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance, and cause a potential hazard. Reuse: Never reuse disposable transducers, sensors, accessories, and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance, and cause a potential hazard.
Page 13 Batteries: • Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion. • Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite,...
Page 14 1 Introduction • If battery leakage should occur, avoid contact with skin. • Dispose of used batteries promptly and in an environmentally-responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements.
Page 15 The careful planning of the site for the FM20/FM30 monitor is essential for its safe and efficient operation. A consulting schedule should be established between the customer and Philips' sales and support representatives to ensure that all preparations are completed when the system is delivered.
Page 16 Although considerable effort has been made to ensure the safety of the ceiling mount installation and or mounting guidelines, it is to be understood that the installation itself is beyond the control of Philips Medical Systems. Accordingly, Philips Medical Systems will not be responsible for the failure of any such installation.
Page 17 Installing wall boxes It is the customer's responsibility to provide and install wall boxes to house face plates. The customer must notify the Philips installation coordinator of which size is to be used. Procedures for Philips Personnel Before you begin the procedures in the installation sections, ensure that the customer has completed all necessary preparations outlined in the previous section .
Page 18 2 Site Preparation Environmental Requirements The environment where the FM20/FM30 monitor will be used should be reasonably free from vibration, dust, and corrosive or explosive gases. The ambient operating and storage conditions for the FM20/FM30 monitor must be observed. If these conditions are not met, the accuracy of the system will be affected and damage can occur.
Page 19 2 Site Preparation Safety Requirements (Customer or Philips) The monitor is an electrical Class II device in which the protection against electric shock does not rely on basic insulation and a protective earth conductor, but on double and/or reinforced insulation.
Page 20 2 Site Preparation Measurement Essential Performance Maternal Pulse from Toco (MP) Measurement of the maternal pulse rate within the specified limits. MP is susceptible to movement artifact potentially resulting in signal loss. It is not intended for continuous MHR monitoring. Limit alarms are not provided.
Page 21 2 Site Preparation Measurement Essential Performance After electrostatic discharge, fast transients/bursts, surges and electro surgery interference, the equipment will return to previous operation mode within 10 seconds (SpO 30 seconds) without loss of any stored data. After voltage interruptions the equipment returns to previous state without operator intervention and loss of data.
Page 22 2 Site Preparation Equipment location in the patient vicinity Cabling Options and Requirements for Connection to OB TraceVue/ IntelliSpace Perinatal For cabling options and requirements for connection to an OB TraceVue/IntelliSpace Perinatal system, refer to the OB TraceVue/IntelliSpace Perinatal Site Preparation Guide and the OB TraceVue/IntelliSpace Perinatal Service Guide.
Page 23 2 Site Preparation Mounting Options The following mounting options are available: Part Number 12NC Product Option Description Number M2740-64001 451261009061 M2740A #A01 MECHASY Wall Mount Flush wall mount for flat wall mounting M2740-64002 451261009071 M2740A #A05 MECHASY Wall Mounting arm with tray M2740-64005 451261009101 M2740A #R01...
Page 24 Number M2740A #B01 Bed hanger Refer to “Mounting Instructions” on page 28, or contact your local Philips' representative for advice on mounting the monitor. Input Devices The following table describes the input devices which can be connected to the monitor via the optional USB or PS/2 interface.
Page 25 Installation Instructions Installation should be carried out by authorized and qualified service personnel, by Philips directly, or a Philips certified service partner/dealer. As the first step in preparing the monitor for use, follow the installation instructions given in this chapter.
Page 26 3 Installation Instructions Step Task Check when done Check/set paper speed (see “Checking/Setting Recorder Speed” on page 36 ) Perform system test as necessary (see “Performance Assurance Tests” on page 83) For monitors with the battery option (#E25) confirm that the battery can be charged, and that the monitor can be powered by the battery Test transducers (see “Transducers and Patient Modules;...
Page 27 Repackaging for Shipment or Storage If the instrument is to be shipped to a Philips sales/support office, securely attach a label showing the name and address of the owner, the instrument model and serial numbers, and the repair required (or symptoms of the fault).
Page 28 3 Installation Instructions Mounting Instructions Every type of compatible mounting solution is delivered with a complete set of mounting hardware and instructions. Refer to the “Site Preparation” chapter for a list of mounting options. Refer to the documentation delivered with the mounting hardware for instructions on assembling mounts. WARNING It is the customer's responsibility to have the attachment of the mounting hardware to the ceiling, wall, or mounting rail and the construction of the ceiling, wall, or mounting rail evaluated for structural...
Page 29 3 Installation Instructions Line Voltage Selection You do not need to set the line voltage, as this is done automatically by the power supply. The monitor has a wide-range power supply that allows you to operate the monitor from an AC (alternating current) power source of 100V —...
Page 30 3 Installation Instructions WARNING • Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket. •...
Page 31 3 Installation Instructions Installing the Tympanic Thermometer Insert the communication cable into the connector (1) until it clicks into place. Then route the communication cable through one of the channels (2) in the base station. Attach the mounting plate or mounting clamp to the base station. See “Mounting the Tympanic Thermometer”...
Page 32 3 Installation Instructions Insert the probe covers into the base station. Up to two units of 16 probe covers each can be stored within the base station. Insert the thermometer into the base station until it clicks into place. Insert the other end of the communication cable into the MIB/RS232 (1) port of the monitor. Configure the MIB/R232 port at the fetal monitor to iTemp.
Page 33 3 Installation Instructions Mounting the Tympanic Thermometer The Tympanic Thermometer can be mounted either to the wall using a mounting plate, or to a pole, or rail mount using the universal mounting clamp. The picture below shows as an example, how the mounting clamp is attached to the Tympanic Thermometer base station.
Page 34 3 Installation Instructions Pressing the timer button after the site text display will return you to the installed software version. To exit biotech mode, two options are available: (1) press and hold the °C/°F and timer buttons for one second, or (2) the device will automatically exit biotech mode after about 30 seconds of inactivity. Any changes are saved.
Page 35 3 Installation Instructions Before Using the Monitor WARNING • Before starting monitoring, check that the configuration meets your requirements. • Be aware that the monitors in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring.
Page 36 3 Installation Instructions Checking and Setting Line Frequency Before using the monitor, check that the line frequency setting is correct for your location, and change the setting if necessary in Configuration Mode. WARNING An incorrect line frequency setting can affect the ECG filter, and disturb the ECG measurement. Ensure the line frequency setting is correct.
Page 37 3 Installation Instructions Configuring the Equipment Label OB TraceVue/IntelliSpace Perinatal requires a unique equipment label. In OB TraceVue/IntelliSpace Perinatal it is possible to prevent connection to monitors with specific equipment labels by the means of a filtering mechanism. For more details, see the OB TraceVue/IntelliSpace Perinatal Instructions for Use.
Page 38 3 Installation Instructions...
Page 39 Theory of Operation This chapter describes the functional operation of the monitor and the transducers. It incorporates features of the mechanical design, indicating the physical relationship of the assemblies and components. Monitor Hardware Overview The monitor consists of nine main functional components: •...
Page 40 4 Theory of Operation • Connector Block (1253-8415) • Bus Master Board (M2703-66460) • Main CPU Board (M2705-66510) • Fetal Recorder (Thermal Printer Unit) • Display Assembly (M2703-64503) • Noninvasive Blood Pressure Board (optional, M2703-64502) • Board (optional, M2703-66453) • Input /Output Interface Boards (optional): –...
Page 41 4 Theory of Operation I/O Boards A single MIB/RS232, LAN, PS/2, USB, or Flexible Nurse Call Relay board can be added optionally. An I/O board with three general relays and one dedicated to the power loss condition* . All relays provide both polarities (active closed, or open contact) at their output.
Page 42 4 Theory of Operation LCD Display and Touchscreen The LCD Display Assembly consists of a five-wire resistive touchscreen, a 6.5" TFT panel, and an LED back-light, all connected to the Display Adapter Board (M2703-66440), and fitted into the display housing. The board is connected to the Recorder Adapter Board (M2703-66430) via a 50-pin ribbon cable.
Page 43 4 Theory of Operation Transducer Hardware Overview Transducer Types All transducers that can connect to the fetal sensor sockets can be used. Functional Description of the Transducer CPU The CPU section of the transducers is made up of the following main functional blocks: •...
Page 44 4 Theory of Operation Communication Transceiver (CAN Bus Driver) The communications transceiver (CAN bus driver) communicates directly with the transducer CPU, and allows the transducer to communicate with the Bus Master Board via the CAN bus. EEPROM The serial EEPROM stores all non-volatile data required to operate the transducer (for example, calibration and correction factors for front-end gains and offsets, country-specific information, serial numbers, and error logs).
Page 45 4 Theory of Operation Patient Module Front-ends The patient module shares the same parameter front-ends as the Toco transducer, with the exception of the Toco front-end. Avalon CTS Interface Cable (TMIF) The Avalon CTS Interface Cable contains the Telemetry Module Interface (TMIF). The TMIF shares the signal processing circuitry with the rest of the Avalon transducers, with the exception that it has no front-end board.
Page 46 4 Theory of Operation...
Page 47 Interfaces There are five interface boards available as options for the Avalon fetal monitors: • LAN / RS232 system interface • Dual PS/2 interface • MIB/RS232 interface • Flexible Nurse call • USB port The interfaces are "plug-and-play" boards, and fit into dedicated slots on the underside of the monitor. See “Removing the Interface Boards”...
Page 48 5 Interfaces LAN / RS232 Interface The LAN/RS232 system interface has two fully isolated ports: • The LAN connection can be used for connecting the monitor to a PC for configuration or upgrade using the Support Tool, for connecting the monitor to an OB TraceVue/IntelliSpace Perinatal obstetrical information system on a network, and for future system expansion.
Page 49 5 Interfaces Connection of USB Devices The USB IF board supports the following USB devices: • keyboard • barcode scanner • computer mouse or trackball NOTE • Connect only the above mentioned devices to the USB interface. Other devices are not supported. As the fetal monitor software only supports two input devices, only two input devices can be connected to the USB board.
Page 50 5 Interfaces NOTE Other USB devices, e.g. USB sticks, iPods etc. are not supported by the USB IF board. Do not use USB adapters to connect PS/2 or other devices to the USB board. Flexible Nurse Call Relay The Flexible Nurse Call board contains 2 connectors. A phone jack type connector and a multi-port connector.
Page 51 The customer is responsible for complying with common network configuration rules. If no IP address is entered manually, the Avalon FM20/30 requires a BOOTP service to obtain a valid IP address automatically, therefore DHCP or BOOTP service must be available in each network segment.
Page 52 The customer is responsible for complying with applicable data privacy regulations. Network infrastructure must be protected from unauthorized access. Connection Indication Messages Connection Indication (CI) messages can be sent by the Avalon FM20/FM30 in two ways: by Broadcast or by Unicast. Broadcast...
Page 53 6 Connection to a Network Equipment Label and OB TraceVue/IntelliSpace Perinatal Fetal Monitor Domain Name For connection to an OB TraceVue/IntelliSpace Perinatal system over a network, OB TraceVue/ IntelliSpace Perinatal requires each fetal monitor to have a unique equipment label. When a fetal monitor is configured with an equipment label, this equipment label is sent as part of the CI message.
Page 54 6 Connection to a Network Configuring the MIB/RS232 I/O Board Data Export Setting The configuration of a specific MIB/RS232 port can be viewed in Configuration Mode and altered in Service Mode. can be configured up to two times (on two or more MIB/RS232 boards). Note Data Out that only the first MIB/RS232 port configured to Data Out...
Page 55 Testing and Maintenance Introduction This chapter provides a checklist of the testing and maintenance procedures to ensure the performance and safety of the monitor and accessories. These tests must be performed only by qualified personnel certified by the responsible organization. Qualifications required are: training on the subject, knowledge, experience, and acquaintance with the relevant technologies, standards and local regulations.
Page 56 7 Testing and Maintenance Tests: Safety or Performance Assurance test procedures which may consist of several steps. Recommended Frequency Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements. Tests Frequency Preventive Maintenance Noninvasive Blood Pressure Once every two years, or as specified by local laws Calibration (whichever comes first).
Page 57 7 Testing and Maintenance Service Event Test Block(s) Required - Complete these tests Tympanic Temperature performance testing Tympanic Temperature calibration Other Regular Tests and Tasks Service Event Test Block(s) Required - Complete these tests Visual Inspection Perform Visual Inspection Transducer and Patient Module Testing Recorder Maintenance Regular cleaning and maintenance (see “Transducers and Patient Modules;...
Page 58 It is the responsibility of the facility operator, or their designee, to obtain reference values for recurring safety and system tests. These reference values are the results of the first test cycles after an installation. You may also purchase this service from Philips. Testing Sequence...
Page 59 7 Testing and Maintenance Visual Inspection Before Each Use Check all exterior housings for cracks and damage. Check the condition of all external cables, especially for splits or cracks, and signs of twisting. If serious damage is evident, the cable should be replaced immediately.
Page 60 7 Testing and Maintenance Warnings, Cautions, and Safety Precautions • These tests are well established procedures of detecting abnormalities that if undetected, could result in danger to either the patient or the operator. • Disconnect the device under test from the patient before performing safety tests. •...
Page 61 7 Testing and Maintenance Electrical Isolation Diagram for FM20/30 without battery option Electrical Isolation Diagram for FM20/30 with battery option #E25 Safety Test Procedures Use the test procedures outlined here only for verifying safe installation or service of the product. The setups used for these tests, and the acceptable ranges of values are derived from local and international standards but may not be equivalent.
Page 62 7 Testing and Maintenance The following symbols are used in the diagrams illustrating the safety tests: Supply mains Resistance measuring device L, N Supply mains terminals Protective earth terminal Mains part Applied part F-type applied part Measuring device ..Optional connection Connection to accessible parts CAUTION...
Page 63 7 Testing and Maintenance General Test Setup for the Performance of Safety Tests Connect the detachable power cord of the device under test to the safety analyzer's test mains port. For testing the applied part leakage current, connect all applied parts to the safety analyzer using the appropriate patient lead or adapter cable.
Page 64 7 Testing and Maintenance Applied Part Current Test - Setup Example NOTE The above graphics resemble the Metron QA-90 setup and are protected by copyright. Copyright owned by Fluke (Metron). Safety Test Adapter Cable - Schematics The following graphics provide schematics of safety test (patient lead) adapter cables which can be used for electrical safety testing.
Page 65 7 Testing and Maintenance Tympanic Temperature S(1): Detachable Power Cord Protective Earth Test (optional) This test can be performed upon request by the customer. Test to perform: Use an Ohmmeter to measure the earth wire resistance of the detachable power cord. This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed.
Page 66 7 Testing and Maintenance S(2): Sum of Functional Earth and Equipment Leakage Current Test - Normal Condition Test to perform: Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353 This test measures leakage current of exposed metal parts of the FM20/FM30 monitor and the functional earth leakage current.
Page 67 7 Testing and Maintenance S(3): Sum of Functional Earth and Equipment Leakage Current Test - Single Fault Condition Test to perform: Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353. This test measures leakage current of exposed metal parts of the FM20/FM30 monitor, and the functional earth leakage current.
Page 68 7 Testing and Maintenance NOTE All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated You can find metal parts of the device: • In the top cover (accessed by opening the paper drawer). •...
Page 69 7 Testing and Maintenance Test to perform: Measuring circuit for the measurement of Applied Part Leakage Current - Direct method according to IEC/EN 62353 This test measures applied part leakage current from applied part to earth caused by external main voltage on the applied part of 264 V.
Page 70 7 Testing and Maintenance Insert the two safety test cables as shown below. Cable A (IntelliBridge - 453564127781) and Cable B (Tympanic Temperature - 453564421601) Connect to an appropriate safety tester (e.g. Fluke ESA 620) as shown below. Perform the test:...
Page 71 7 Testing and Maintenance Measuring circuit for the measurement of Applied Part Leakage Current - Direct method according to IEC/EN 62353 This test measures applied part leakage current from applied part to earth caused by external main voltage on the applied part. Each polarity combination possible shall be tested. There are no parts of the equipment that are not protectively earthed.
Page 72 7 Testing and Maintenance inspection, testing or analysis, as specified in the IEC 60601-1:2005+A1:2012/EN 60601- 1:2006+AC:2010 or in this book. Medical electrical equipment must comply with the requirements of the general standard IEC/ EN 60601-1, its relevant particular standards and specific national deviations. Non-medical electrical equipment shall comply with IEC and ISO safety standards that are relevant to that equipment.
Page 73 7 Testing and Maintenance 1:2005+A1:2012/EN 60601-1:2006+AC:2010) that ensures mechanical fixing of the power cords and covering of any unused power outlets. System Installation Requirements • Ensure that the medical electrical system is installed in a way that the user achieves optimal use. •...
Page 74 7 Testing and Maintenance Required Protective Measures at System Installation For any IT equipment (IEC 60950) operated in patient vicinity ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure compliance.
Page 75 7 Testing and Maintenance Case 1: Medical Device Combined with Medical Device If you combine a medical device with another medical device (incl. Philips specified displays) to form a medical electrical system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010, no additional protective measures are required. The medical electrical devices may be located in or outside the patient vicinity in a medically used room.
Page 76 7 Testing and Maintenance Case 2: Medical Device Combined with a Non-Medical Device If you combine a medical device with a non-medical device to form a medical electrical system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010, additional protective measures are required, e.g. usage of a separation device. The medical electrical devices or the IT equipment may be located in or outside the patient vicinity in a medically used room.
Page 77 7 Testing and Maintenance For any IT equipment (IEC 60950) operated in patient vicinity ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current test is required.
Page 78 7 Testing and Maintenance For any IT equipment (IEC 60950) operated in patient vicinity, ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current test is required.
Page 79 7 Testing and Maintenance Case 3: Medical Device Combined with a Medical or Non-Medical Device with one Device in a Non-Medically-Used Room If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 using a common protective earth connection and one of the devices is located in a non-medically used room, additional protective measures are required, e.g.
Page 80 7 Testing and Maintenance If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 using two separate protective earth connections and one of the devices is located in a non-medically used room creating a potential voltage difference, additional protective measures are required, e.g.
Page 81 7 Testing and Maintenance System Test Procedure If the medical electrical device has already been tested as a standalone device e.g. during factory safety testing, an equipment leakage current test must only be performed once the device is connected to another electrical device/system.
Page 82 7 Testing and Maintenance If the devices in the medical electrical system are connected to a multiple portable socket outlet, the resulting protective earth leakage current needs to be determined. All system components must be connected to the multiple portable socket outlet and be switched on during this measurement. Test Expected Test Results Protective Earth Leakage Current of Multiple...
Page 83 7 Testing and Maintenance Performance Assurance Tests Some of the following test procedures must be performed in Service Mode. To enter service mode select in the main menu. Then select and enter the password. Operating Modes Service Mode Basic Performance Assurance Test This section describes the basic performance test procedure.
Page 84 7 Testing and Maintenance Raise the pressure to 280 mmHg with the manometer pump. Wait 10 seconds for the measurement to stabilize. Compare the manometer values with the displayed values. Document the value displayed by the monitor (X1). If the difference between the manometer and displayed values is greater than 3 mmHg, calibrate the noninvasive blood pressure measurement.
Page 85 7 Testing and Maintenance Expected Test Results Test Expected test results Accuracy test x1 = value displayed by monitor Difference ≤3 mmHg Leakage test x2 = leakage test value x2 <6 mmHg Linearity test x3 = value displayed by monitor Difference ≤3 mmHg Valve Test x4 = value <10 mmHg...
Page 86 7 Testing and Maintenance Multi-Port Nurse Call Connector Test (Flexible Nurse Call) This test checks the operation of the Flexible Nurse Call Relay. The Nurse Call Relay test is recommended for customer sites where the nurse call is in use. The following diagram and table show the pins and relay identifiers of the connector: Cable Color Coding Relay...
Page 87 Philips recommends all test results are documented in accordance with local laws. Authorized Philips personnel report the test result back to Philips in a service record. While hospital personnel (biomedical engineers or technicians) do not need to report results to Philips, Philips recommends that they record and store the test results in accordance with local laws.
Page 88 Functional Test (parameters tested): Test and Inspection Matrix Test Block Test or Inspection Expected Test Results Record the Results (mandatory for to be Performed Philips Personnel only) What to Record Actual Results Visual Perform Visual Pass or Fail V:P or V:F...
Page 89 7 Testing and Maintenance Test Block Test or Inspection Expected Test Results Record the Results (mandatory for to be Performed Philips Personnel only) What to Record Actual Results Noninvasive Perform the X1 = value displayed by monitor PN:P/X1 or Blood Pressure Accuracy Test -- see Difference <= 3 mmHg...
Page 90 7 Testing and Maintenance Test Block Test or Inspection Expected Test Results Record the Results (mandatory for to be Performed Philips Personnel only) What to Record Actual Results System Perform the system Equipment Leakage Current: Sys:PSys1/PSys2 or (Sys 1-2) test according to sub Sys1 <= 100 µA (Normal...
Page 91 If the second transducer also fails the tests, contact your Philips Service Engineer or Response Center. Ultrasound Transducer Electrical Check CAUTION Use of ultrasound gel that is not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty.
Page 92 7 Testing and Maintenance To test an ultrasound transducer: Switch on the monitor and the recorder. Connect the transducer to the fetal monitor. Select the fetal heart sound for this channel. Increase the loudspeaker volume to an audible level. The ultrasound transducer contains seven piezoelectric crystals.
Page 93 7 Testing and Maintenance Toco Transducer Electrical Check To test a Toco transducer: Switch on the monitor and the recorder. Connect the transducer to the fetal monitor. Lay the transducer face up on a hard, flat surface for a few seconds. Press the Toco Baseline Key to re-adjust the Toco display to 20±1.
Page 94 7 Testing and Maintenance CAUTION The tip of the spiral electrode is sharp. Take care not to injure your fingers. Cut off the plastic tip of the fetal scalp electrode (containing the spiral and reference electrodes) from the end of the wires. Strip the insulation from the end of the wires, and connect them to a patient simulator.
Page 95 7 Testing and Maintenance Either: attach electrodes to the M1363A adapter cable, and apply the electrodes to the skin (for example on the wrists). attach the M1363A adapter cable to a patient simulator. Note We do not recommend the use of a specific patient simulator. The use of a patient simulator does not allow checking the specification of the ECG-functionality;...
Page 96 7 Testing and Maintenance Attach the IUP adapter cable (989803143931) to the socket on the patient module or Toco transducer. Cut the sensor tip off an IUP catheter (M1333A). Connect the catheter to the IUP adapter cable. Connect the silicone tubing to the test volume chamber and the manometer as shown in the picture.
Page 97 7 Testing and Maintenance Disabling/Enabling Touch Operation To disable touchscreen operation of the monitor, press and hold the Main Screen key for about three seconds. A red padlock will blink on the key. Press and hold the key again for about three Main Screen seconds to re-enable touchscreen operation.
Page 98 7 Testing and Maintenance Fetal Recorder Selftest Report To verify your printer configuration, or if you doubt the performance of the recorder, you may want to print a test report. To print a selftest report, in Service Mode, select Main Setup, Fetal Recorder, Selftest Here is an excerpt from a sample test report to give you an idea what it looks like (the exact appearance may vary slightly): Same data from the trace header...
Page 99 NOTE • Battery Disposal—The battery should be disposed of in an environmentally-responsible manner. Consult the hospital administrator or your local Philips representative for local arrangements. Do not dispose of the battery in normal waste containers. • Battery Storage — The battery should be max. 50% charged for storage.
Page 100 7 Testing and Maintenance The battery LED can be green, yellow, or red depending on the following conditions: Battery LED Colors If the monitor is connected to If the monitor is running on AC power, this means battery power, this means battery full (≥90%) Green battery charging...
Page 101 7 Testing and Maintenance Battery is empty: The capacity of the battery is ≤10 min. Recharge the battery as soon as possible. Temperature outside specified range: The charging of the battery is stopped if the temperature is below 15°C or above 50°C in order to protect the battery. Charging is resumed as soon as the temperature is within this range.
Page 102 7 Testing and Maintenance 5 minutes after beginning the charging cycle. If the battery is charged over 90% Batt full (>90%) displayed until they are charged to 100%. Then Batt fully charged is displayed. Viewing Battery Details To view detailed information for the battery, select the pop-up key Battery Documenting Battery Status To print all battery information in the...
Page 103 7 Testing and Maintenance What Causes the Conditioning Message on the Monitor? In addition to the value for the full capacity, the battery also stores a value for the Max Error. The Max Error tracks the maximum possible deviation of the estimated charge of a battery from the actual charge.
Page 104 7 Testing and Maintenance Conditioning Batteries You must condition the battery when the “battery requires maintenance” symbol shows on the screen. If conditioning is not performed immediately, the monitor will still function according to specifications. However, the displayed time to empty and time to full will show increasing inaccuracy. Do not interrupt the charge or discharge cycle during conditioning.
Page 105 Only qualified and authorized service personnel should open the monitor housing, remove, and replace components, or make adjustments. If your medical facility does not have qualified and authorized service personnel, contact Philips’ Response Center or your local Philips representative. WARNING High Voltage - Voltages dangerous to life are present in the instrument when it is connected to the mains power supply.
Page 106 8 Troubleshooting Checking Revision Information There are various ways to check revision information: • Most of the revision information can be checked from reading the contents of the trace header -- see “Trace Header”. • You can also identify the hardware revision via the Main Setup menu -- see “Hardware Revision Check”...
Page 107 “Parts” on page 125. Taking the recommended actions discussed in this section will correct the majority of problems you may encounter. However, problems not covered here can be resolved by calling Philips Response Center or your local representative. Checks for Obvious Problems...
Page 108 INOP following a monitor software upgrade, it is likely that the Bus Master Malfunc firmware in the bus master board is incompatible with the new software. Check the firmware revision, and upgrade this if necessary with the Support Tool. Contact Philips support for more information regarding software and firmware revisions.
Page 109 The green AC power LED lights for about 1.5 seconds Green AC power LED is turned off, and remains off You hear a ‘pop’ from the loudspeaker Boot screen with the Philips logo appears on the display and a test sound is issued 8-10...
Page 110 8 Troubleshooting Boot Phase Failures Symptoms Possible Causes of Failure Failure Isolation and Remedy Green LED does not light No AC mains connection Check that the power cord is not damaged, up, and no test tone is and is properly connected to the monitor. heard Check that the power cord is correctly connected to a powered AC mains socket.
Page 111 8 Troubleshooting Symptoms Possible Causes of Failure Failure Isolation and Remedy Green LED blinks Hardware failure Connect Support Tool directly to monitor (indicating cyclic reboots) with a crossover cable and start "search for defective devices". If no device is detected, proceed as described above in the section "Green LED stays on continuously".
Page 112 8 Troubleshooting Touchscreen Not Functioning Symptoms Possible Causes of Failure Failure Isolation and Remedy Touchscreen not Touchscreen functionality has been Check if the touchscreen functionality has functioning temporarily disabled been temporarily disabled (padlock symbol key). If yes, press and hold Main Setup Main Setup key to re-enable the...
Page 113 8 Troubleshooting INOP Message Possible Causes of Failure Failure Isolation and Remedy INOP occurs during normal operation, Check the monitor and patient settings Check Settings indicating a possible monitor software before you resume monitoring. If the problem settings are unexpected, there may be a problem with the monitor software.
Page 114 8 Troubleshooting Symptoms Causes of Failure Failure Isolation and Remedy INOP tone The estimated battery-powered Recharge the battery. Batt Low operating time remaining is less than 20 minutes. INOP tone, The monitor cannot determine the Replace the faulty battery. If the condition Battery Malfunct battery LED flashes battery status, or there is a...
Page 115 8 Troubleshooting Icon Explanation LAN cable connected, IP address assigned, monitor connected to OB TraceVue/ IntelliSpace Perinatal. OB TraceVue/IntelliSpace Perinatal may send a prompt message, indicating a possible problem. Alarm Tones Symptoms Possible Causes of Failure Failure Isolation and Remedy INOP Message Speaker cable disconnected Reconnect the speaker cable.
Page 116 8 Troubleshooting Symptom Possible Cause Corrective Action No paper transport. Poor connection. Check all internal connectors. A paper jam occurred. Open the drawer, remove paper, tear off the crumpled section of paper and re-load, or load a new pack of paper. Close the drawer. The motor cable is disconnected.
Page 117 139 and “Parts” on page 125. The rubber roller is dirty. Clean the rubber roller. The paper is not approved by Philips. Use only paper approved by Philips. An inadequate contrast of paper marks. Use only Philips approved paper.
Page 118 8 Troubleshooting Symptom Possible Cause Corrective Action Trace is not printed The Offset needs adjusting. Calibrate the recorder and change the offset correctly with a reference -- see “Setting the Fetal Recorder Offset” to the paper gridlines. on page 97. The wrong paper scale is being used.
Page 119 8 Troubleshooting MIB / RS232 Symptoms Cause of Failure Failure Isolation and Remedy External device not The MIB/RS232 port is not configured for Check the configuration of the MIB/RS232 receiving data data export. ports in Configuration Mode. The wrong data export protocol driver is Check the export protocol required by the configured in the monitor.
Page 120 8 Troubleshooting Tympanic Temperature Problems Symptoms Possible Cause of Failure Failure Isolation and Remedy The Tympanic Thermometer There is no connection either between Verify that the interface cable between the does not function. the base station and the thermometer, base station and the host monitor is or the base station and the host connected correctly.
Page 121 8 Troubleshooting No Video on Remote Display Symptoms Possible Causes of Failure Failure Isolation and Remedy No video on a connected The cable is not properly connected. Check that the video cable is securely remote display. connected at both ends. The remote display has no power.
Page 122 8 Troubleshooting Symptoms Possible Cause Failure Isolation and Remedy The transducer appears Transducer is defective Replace the transducer. not to work, and: EITHER the transducer Finder LED lights up briefly after plugging in the transducer, and INOP Bus Master Malfunc displayed, or the transducer Finder LED lights up briefly after...
Page 123 The following pop-up keys overlay the SmartKeys: Clear Stat Log This key clears the currently displayed Status Log M2703A This key switches to the Monitor Revision Window If an event occurs repeatedly, contact your Philips Service representative.
Page 124 8 Troubleshooting NOTE It is possible, using the Support Tool, to download the Status Log and send it to your Philips Service representative as a file (for example via e-mail). Troubleshooting with the Support Tool Using the Support Tool you can: •...
Page 125 Parts Spare parts, along with part numbers, are listed in the tables that follow. Monitor Part Number 12NC Description M2703-44103 451261010311 AV-FM30 PLAST Cover,Sym wo SpO ,NBP M2703-44105 451261010321 AV-FM30 PLAST Cover, Sym w NBP M2703-44106 451261010331 AV-FM30 PLAST Cover, Sym w SpO ,NBP M2703-44113 451261010341...
Page 126 9 Parts Part Number 12NC Description 1253-8415 451261010261 CONN Block M2703-66530 451261011211 AV-FM30 Recorder Adapter Board 1810-2440 451261010381 THERMAL PRINT HD, 216mm PRNTWDTH, 800Ohm M2703-67501 451261010531 AV-FM30 ASSY LAN / RS232 Interface M8086-67501 453563469651 IV I/F; HIF, Integral, PS/2 M2703-64205 451261010521 AV-FM30 Lever Stop (pack of 5) M2705-64203...
Page 127 9 Parts Part Number 12NC Description M2734A 451261011231 AV-TOCO Transducer M2735A 451261011241 AV-TOCO Toco+ Transducer 453564207971 453564207971 AV-US Ultrasound XDR FDA reg countries 453564203931 453564203931 AV-US Ultrasound XDR 453564204991 453564204991 AV-TOCO Maternal Pulse Transducer M2735-64201 451261010481 AV-Cable Assembly M2703-64204 451261010511 AV-FM30 Belt Button Kit, w tool, 5ea 451261026021 451261026021...
Page 128 9 Parts Part Number 12NC Description 453564180701 453564180701 AV-CTS CBL Cable assy-CTS IF red socket 453564207981 453564207981 AV-CTS CBL CTS Interf. red conn FDA reg. 453564203941 453564203941 AV-CTS CBL CTS Interf. red connector Mounting Hardware Part Number 12NC Description M2740-64001 451261009061 MECHASY Wall Mount M2740-64002...
Page 129 9 Parts Part Number Description Image 453564127781 CBL Safety Test IntelliBridge 453564421601 IM CBL IRTemp test cable 4535 634 84591 MIB cable 1,5 m 4535 634 84601 MIB cable 3,0 m Assembly and Kit Contents The tables in this section provide additional information by listing the contents of assemblies and kits. Assemblies come fully assembled: the contents list details what is contained in the assembly.
Page 130 9 Parts Bottom Housing Assembly Contents Sub-Assembly Contents Support Sub-Assembly Support Pin, DIN 6325, 2.5 x 8 Hinge Support Bracket Screw M3 x 6 Catch, I/O Board Cable Holder Pin for Cable Holder Main Chassis Sub-Assembly Chassis, sheet metal Standoff, M3 x 18 Standoff, M3 x 10 Standoff, M3 x 6 Press Nut, M3...
Page 131 Noninvasive Blood Pressure Assembly Contents Noninvasive Blood Pressure Assembly Isolator Fitting Instructions Top Cover Housing Top Cover Housing Contents Top Cover Handle Paper Drawer Runner Runner End-stop (left) Runner End-stop (right) Screw, Torx M3 x 8 Leaf Spring Label, Avalon FM20 Label, Avalon FM30...
Page 132 9 Parts Stepper Motor Assembly Stepper Motor Assembly Contents Stepper Motor Connector Housing Connector Contact Gearbox Pinion Paper Sensor Assembly Paper Sensor Assembly Contents Paper Sensor, including cable and connectors Nut, press-in M3 Screw, Torx M3 x 6...
Page 133 9 Parts Drawer Assembly Drawer Assembly Contents Paper Drawer Cover Rubber Roller (including bearing, rod, pinion) Platen Holder Chassis Guide Lever Stop Latch Display Assembly Display Assembly Contents Housing, Bottom Housing, Top Clamp Display Holder, left-hand...
Page 134 9 Parts Display Assembly Contents Display Holder, right-hand Back-light Tube Hinge Chassis Guide Cable Guide, rear Board Holder Stop Lever Ribbon Cable PCA Touch Control Inverter Board TFT Display Unit Touchscreen Gasket (1050 mm) Battery Assembly (FM20/FM30 with Battery Option #E25 only) Battery Assembly Contents Charger board Battery metal cover...
Page 135 9 Parts Transducer Cable Assembly Item Cable Assembly Contents Transducer Cable (for all fetal transducers) Sealing Gasket Screw M2.5 Screw Cover (set of 3) Transducer Belt Button Avalon Tool Belt Button Kit Item Belt Button Kit Contents Belt Buttons Avalon Tool (for removing/replacing transducer belt buttons)
Page 136 9 Parts FM Small Parts Kit - Plastic Parts and Labels Item FM Small Parts Kit Contents - Plastic Parts and Labels FM40/50 Insulator, API Board NBP Tubing FM40/50 Silicone ON/OFF Key FM40/50 Light-pipe FM20/30 O-Ring, loudspeaker FM40/50 Mounting Frame for SpO Board FM20/30 Ratchet Lever/Clip FM20/30 Cable Guide, Rear...
Page 137 9 Parts Item FM Small Parts Kit Contents - Plastic Parts and Labels FM40/50 Holder, Bumper Foot FM40/50 Bumper Foot FM Small Parts Kit - Screws and Cables Item FM Small Parts Kit Contents - Screws and Cables Torx M3 x 4 Torx M3 x 6 with washer Torx M3 x 8 with washer Torx M3 x 10 with washer...
Page 138 9 Parts Item FM Small Parts Kit Contents - Screws and Cables FM40/50 Cable assembly, Power Supply FM40/50 PCA, Switch Board FM40/50 Switch Board cable to API Board FM40/50 Sealing Gasket, Top Cover FM40/50 Equipotential grounding bolt...
Page 139 Repair and Disassembly WARNING • Before attempting to open or disassemble the monitor, disconnect it from the AC mains supply. • Energized circuits are accessible with the covers open. Do not work on the monitor with the covers open and AC power connected. Only qualified service personnel should open or disassemble the monitor.
Page 140 80 mm Small flat-head screwdriver, 2.0-3.0 mm Long-nosed pliers Screws Used The following picture shows the range of screws used in the Avalon FM20/30/40/50 fetal monitors: Screw Ejot K30x8, T-10 Screw Ejot 3x10, T-10 Screw Ejot 3x8, T-10 Screw Ejot 2.5x8, T-8...
Page 141 10 Repair and Disassembly Screw M3x6 with washer, T-10 Screw M3x4, T-10 Serial Numbers The serial number of the monitor appears on the device nameplate at the rear of the bottom housing. It is also stored electronically in the power supply. •...
Page 142 10 Repair and Disassembly Carefully place the monitor upside down. To avoid scratches, place the unit on some cloth or other soft surface. Remove the four screws securing the top cover assembly to the bottom housing, using a T-10 Torx driver.
Page 143 10 Repair and Disassembly To gain access to the screw in the rear right hand corner, slide the cable guide aside as illustrated. Holding both top cover and bottom housing assemblies together, place the monitor upright again.
Page 144 10 Repair and Disassembly Separate the top cover from the bottom housing from the front of the monitor as illustrated.
Page 145 10 Repair and Disassembly The top cover assembly is now separated from the bottom housing assembly.
Page 146 10 Repair and Disassembly Removing the Display Assembly The display assembly can be exchanged without removing the top cover of the monitor. Therefore, no additional safety tests are required after exchanging the display assembly. Squeeze the arms of the ratchet clip to remove it from the slots on the rear of the display housing.
Page 147 10 Repair and Disassembly Remove the two plastic hinge pins on either side of the display housing. Release them by turning the slotted head anti-clockwise with a small flat-bladed screwdriver, then pull them straight out. Starting at the hinge end of the display assembly, separate the two halves of the display assembly.
Page 148 10 Repair and Disassembly Open up the two halves of the display assembly and then remove the back of the display unit. If you have the old version with back-light tubes, disconnect the back-light inverter cable after gently releasing it with the help of a small, flat-bladed screwdriver.
Page 149 10 Repair and Disassembly If you have the new version with LED back-light, release the white plastic snap on the display board with a screwdriver. Disengage the cable lock for the display ribbon cable on the display assembly side using a small, flat-bladed screwdriver, then disconnect the ribbon cable.
Page 150 10 Repair and Disassembly Replacing the Display Assembly The new display assembly has the part number, reference (ordering) number, and the serial number printed on the rear. Remove the two plastic hinge pins on either side of the new display housing. Release them by turning the slotted head anti-clockwise with a small flat-bladed screwdriver, then pull them straight out.
Page 151 10 Repair and Disassembly Open up the new display assembly, and remove the rear of the display housing. If you have the old version with back-light tubes, disconnect the back-light inverter cable after gently releasing it with the help of a small, flat-bladed screwdriver.
Page 152 10 Repair and Disassembly Disengage the cable lock for the display assembly ribbon cable with the help of a small, flat-bladed screwdriver. Remove the cable, and discard it. (You will reuse the original ribbon cable, still attached to the monitor, for connecting the new display assembly.) Remove the cable, and discard it.
Page 153 10 Repair and Disassembly Old Version: Reconnect the back-light converter cable, and then slot the PCBs back into position. Use a small, flat-bladed screwdriver to very gently lever the white plastic snap on the display board and move the back-light converter connector outwards (in the direction of the arrow) to guide the PCB back into position.
Page 154 10 Repair and Disassembly Take the new rear housing cover and place it in the position shown.
Page 155 10 Repair and Disassembly Put the two halves of the display assembly together as shown.
Page 156 10 Repair and Disassembly Insert the new plastic hinge pins. Do not apply excessive force when refitting the hinge pins. Turn the head of the hinge pin gently with a small screwdriver. You will feel when the pin is seated correctly, and the head should be flush with the surface.
Page 157 10 Repair and Disassembly The slot in the head of the pin should be pointing in the same plane as the side of the display assembly housing when the display is folded flat. Reattach the ratchet clip to the top cover of the monitor and to the rear of the display housing.
Page 158 10 Repair and Disassembly Recorder Disassembly The recorder consists of the following major sub-assemblies: • Drawer Assembly • Recorder Chassis • Thermal Line Printhead (TLPH) Holder • Recorder Adapter Board • Stepper Motor...
Page 159 10 Repair and Disassembly Removing the Drawer Assembly Press the paper table release to unlock the paper drawer, and then pull the table forward to open it fully.
Page 160 10 Repair and Disassembly Squeeze the two plastic lugs on the underside of the drawer to release the drawer, and then pull to remove the drawer (here shown with the top cover removed).
Page 161 10 Repair and Disassembly Replacing the Drawer Assembly Before replacing the drawer assembly, refer to the previous photographs, and study the detail showing the position of the plastic hooks when the drawer is fixed in position. Slide the drawer into the drawer recess on the top cover, and check that it is located correctly on the runners.
Page 162 10 Repair and Disassembly Removing the Recorder Chassis Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141). Slide open the paper drawer, to gain access to the two countersunk screws (in the following photographs, we have removed the drawer assembly). Remove the two countersunk screws.
Page 163 10 Repair and Disassembly Turn over the top cover assembly and place it top down on a cloth or other soft surface.
Page 164 10 Repair and Disassembly First release the cable lock by moving it in the direction of the arrows, then disconnect the white recorder ribbon cable from the recorder adapter board. Next, disconnect the silver display ribbon cable from the recorder adapter board after releasing the cable lock.
Page 165 10 Repair and Disassembly Disconnect the stepper motor, and the paper sensor cable connectors from the recorder adapter board.
Page 166 10 Repair and Disassembly Remove the two screws (one on each side) fastening the RFI bracket to the recorder chassis. Partially unscrew the screw nearest the recorder adapter board holding the stepper motor to the recorder chassis, until the thread no longer protrudes. This allows the necessary clearance for removing the RFI bracket.
Page 167 10 Repair and Disassembly Remove the four screws holding the recorder chassis.
Page 168 10 Repair and Disassembly Free the RFI bracket on the stepper motor side by applying a little sideways pressure to the recorder chassis, while at the same time pulling the RFI bracket forwards.
Page 169 10 Repair and Disassembly Remove the RFI bracket. Lift out the recorder chassis.
Page 170 10 Repair and Disassembly Replacing the Recorder Chassis The procedure for replacing the recorder chassis is a reversal of the removal procedure. Ensure that the TLPH holder has been fitted to the recorder chassis, as described in the following section. Place the recorder chassis into position, and drive the four fixing screws in lightly.
Page 171 10 Repair and Disassembly Turn over the top cover again, and replace the RFI bracket, reversing the removal procedure. Secure the RFI bracket to the recorder chassis with the two screws. Tighten the stepper motor screw that you loosened to allow removal of the RFI bracket. Now tighten the four screws to secure the recorder chassis.
Page 172 10 Repair and Disassembly Removing the Thermal Line Printhead (TLPH) Remove the recorder chassis as described in the section “Replacing the Recorder Chassis” on page 170. Turn the recorder chassis over. Remove the two screws holding the TLPH to the TLPH holder.
Page 173 10 Repair and Disassembly Turn the chassis assembly over again, and carefully remove the TLPH from the holder as shown. Replacing the TLPH The procedure for replacing the TLPH is a reversal of the removal procedure.
Page 174 10 Repair and Disassembly Removing the Paper Sensor Assembly Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141). Place the top cover assembly top down on a cloth or other soft surface. Disconnect the paper sense cable connector from the recorder adapter board. Turn over the top cover and remove the screw holding the paper sensor to the RFI bracket.
Page 175 10 Repair and Disassembly First release the cable lock by moving it in the direction of the arrows, then disconnect the white recorder ribbon cable from the recorder adapter board. Next, disconnect the silver display ribbon cable from the recorder adapter board after releasing the cable lock.
Page 176 10 Repair and Disassembly Disconnect the stepper motor the record-sense cable connectors from the recorder adapter board.
Page 177 10 Repair and Disassembly With all cables disconnected, remove the recorder adapter board. Replacing the Recorder Adapter Board The procedure to replace the recorder adapter board is a reversal of the removal procedure. Ensure that all cables are firmly reconnected. Removing the Stepper Motor Remove the top cover assembly (see “Removing the Top Cover Assembly”...
Page 178 10 Repair and Disassembly Place the top cover assembly top down on a cloth or other soft surface. Disconnect the stepper motor cable connector from the recorder adapter board.
Page 179 10 Repair and Disassembly Remove the two screws holding the stepper motor to the recorder chassis. Note that the upper screw is secured with a small nut. Remove the stepper motor.
Page 180 10 Repair and Disassembly Replacing the Stepper Motor Refit the stepper motor to the recorder chassis, but do NOT tighten the screws yet! The upper slot on the stepper motor allows fine adjustment when meshing the gears together. Close the drawer assembly. Gently mesh the stepper motor gear with that of the paper roller.
Page 181 10 Repair and Disassembly Place the top cover back to its normal position. Apply a little pressure to seat the multi-pin connector.
Page 182 10 Repair and Disassembly Holding both assemblies together, carefully place the unit upside down on a soft surface to prevent scratching or other damage. Refit the four screws securing the top cover assembly to the bottom housing, using a T-10 Torx driver, as a reversal of the procedure in “Removing the Top Cover Assembly”...
Page 183 10 Repair and Disassembly Bottom Cover Disassembly/Reassembly This section describes disassembly and reassembly operations for the bottom cover and its assemblies. Removing the Power Supply Assembly Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141). Disconnect the power supply cable connector from the main CPU board.
Page 184 10 Repair and Disassembly Lift the cable end of the power supply assembly with one hand, while guiding the power socket/ on/off switch free of the aperture in the bottom housing, then lift out the power supply. Replacing the Power Supply Assembly The procedure to replace the power supply assembly is a reversal of the removal procedure.
Page 185 10 Repair and Disassembly Removing the Battery and the Battery Assembly (FM20/30 Battery option #E25 only) Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141). Remove the screw at the top of the battery assembly. Remove the battery assembly cover by first sliding it to the right, thereby releasing the latches at the left and the bottom of the cover, and then lifting it up.
Page 186 10 Repair and Disassembly Remove the battery carefully, by loosening its connector, sliding the battery to the right and then pulling it out. If you only want to replace the battery, insert a new battery and perform the above steps in reverse order.
Page 187 10 Repair and Disassembly Remove the remaining three screws on the battery assembly. Push in the power button assembly, and then remove the battery assembly and power button assembly together.
Page 188 The procedure to replace the battery assembly is a reversal of the removal procedure. WARNING Use only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion. Removing the Noninvasive Blood Pressure Assembly Remove the top cover assembly (see “Removing the Top Cover Assembly”...
Page 189 10 Repair and Disassembly Disconnect the tubing from the noninvasive blood pressure connector, and the ribbon cable from the main CPU board (after first disengaging the cable lock). Disconnect the grounding cable’s spade connector.
Page 190 10 Repair and Disassembly Remove the two screws holding the noninvasive blood pressure assembly to the bottom housing, then remove the noninvasive blood pressure assembly.
Page 191 10 Repair and Disassembly To separate the noninvasive blood pressure assembly from the noninvasive blood pressure assembly holder, remove the three screws.
Page 192 10 Repair and Disassembly Replacing the Noninvasive Blood Pressure Assembly The new noninvasive blood pressure assembly kit comes with an insulator. Place the insulator on the metal holder as shown. Place the noninvasive blood pressure assembly onto the metal holder, ensuring the insulator is in place.
Page 193 10 Repair and Disassembly Place the noninvasive blood pressure assembly into position, making sure that the insulator is located correctly as shown. Refit the earth strap. Refit the remaining screw to secure the noninvasive blood pressure assembly to the bottom housing.
Page 194 10 Repair and Disassembly Refit the noninvasive blood pressure tubing first (before reconnecting the ribbon cable). When refitting the tubing, also make sure you connect it to the left-hand connector when facing the front of the sockets. Then reconnect the ribbon cable. Make sure the cable lock is firmly closed and the cable is secure. Replace the top cover (see “Replacing the Top Cover Assembly”...
Page 195 10 Repair and Disassembly Removing the SpO2 Assembly Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141). The SpO assembly is identified in the next picture. Remove the two screws holding the SpO assembly. Lift the side of the SpO assembly nearest the SpO socket, carefully disconnecting the multi-pin connector shown.
Page 196 10 Repair and Disassembly To remove the flat brown SpO socket cable from the multi-pin connector on the underside of the board, it is easier to lift the board first to get better access. Remove the SpO assembly.
Page 197 10 Repair and Disassembly Replacing the SpO2 Assembly The procedure to replace the SpO assembly is a reversal of the removal procedure. Hint: When reconnecting the flat brown SpO socket cable to the multi-pin connector on the SpO board, it is easiest to reconnect it while holding the board vertically in line with the cable connector as shown.
Page 198 10 Repair and Disassembly Release the board by pressing the clip that keeps the board in place, as shown. Use a small flat- headed screwdriver to gently pry the board out if it is too tight to pull out with your fingers.
Page 199 10 Repair and Disassembly Pull the board out. Removing the Main CPU Board To remove the main CPU board, proceed as follows: Remove the top cover assembly (see “Removing the Top Cover Assembly” on page 141).
Page 200 10 Repair and Disassembly Remove the screws holding the metal shield. Remove the shield.
Page 201 10 Repair and Disassembly Disconnect the loudspeaker cable (1), the power supply cable (2), the bus master board cable (3), and the noninvasive blood pressure cable (4) from the main CPU board. Remove the main CPU board by lifting it straight up. Replacing the Main CPU Board The procedure to replace the main CPU board is a reversal of the removal procedure.
Page 202 10 Repair and Disassembly Removing the Front End Assembly The front end assembly consists of: • the fetal sensor socket connectors with ribbon cable • the bus master board with ribbon cable • the optional noninvasive blood pressure and SpO socket connectors •...
Page 203 10 Repair and Disassembly Remove the three screws holding the connector block frame to the bottom housing, and the screw holding the bus master board. Lift out the front end assembly. To make the removal easier, apply gentle outward pressure on the bottom housing wall to provide a little more clearance.
Page 204 10 Repair and Disassembly Disassembling the Front End Assembly Remove the front end assembly from the bottom housing (see “Removing the Front End Assembly” on page 200). Release the clip at each end of the connector block frame from the slots in the bus master board. Remove the connector block frame.
Page 205 10 Repair and Disassembly Remove the fetal sensor socket connector block. Remove the optional sockets for noninvasive blood pressure and SpO , if fitted. Note that these sockets slide together.
Page 206 10 Repair and Disassembly All components of the front end assembly are now separated. Reassembling the Front End Assembly The procedure to reassemble the front end assembly is a reversal of the removal procedure. Ensure all the cables are properly reconnected. Exchanging the Bus Master Board Remove the front end assembly -- see “Removing the Front End Assembly”...
Page 207 10 Repair and Disassembly Exchanging the Noninvasive Blood Pressure/SpO2 Sockets Remove the front end assembly -- see “Removing the Front End Assembly” on page 200. Strip the front end assembly down as far as the end of step 6 on under “Removing the Front End Assembly”...
Page 208 10 Repair and Disassembly Transducer Disassembly/Reassembly This section describes the disassembly and reassembly operations for the transducers. Exchanging the Transducer Cable See the “Transducer Cable Assembly” on page 135 section for items that come with the cable. WARNING Transducers are calibrated at the factory, and the calibration data for the measurement is stored on the CPU board.
Page 209 10 Repair and Disassembly Remove the three screws, and remove the transducer top cover. Disconnect the small cable connector, remove the old cable, and fit the new cable (as a reversal of the removal procedure). Remove the sealing gasket from the top cover, and replace it with the new one supplied with the cable.
Page 210 10 Repair and Disassembly new gasket to the top cover, ensuring the gasket is properly seated, replace the top cover and secure it with the three screws.
Page 211 10 Repair and Disassembly Leaving the screw covers attached to the frame, carefully align the screw covers with the screw recesses in the top cover. Next, partially press in two of the covers at the same time, then press in the third one (they detach from the frame as you push them in).
Page 212 10 Repair and Disassembly Exchanging the Transducer Belt Button CAUTION NEVER immerse a transducer in liquid if the belt button has been removed, or is loose, broken or damaged. Remove the belt button using the tool provided with the belt button kit. Dispose of the old belt button.
Page 213 Upgrades This chapter lists the various upgrade options for the monitors, and describes how to carry out these upgrades. FM20/30 Upgrade Options Upgrade options for the FM20 are prefixed with M2702AU. Upgrade options for the FM30 are prefixed with M2703AU. Options B72 and B73 apply to the FM30 only.
Page 214 M4605A Lithium Battery 453564234911 Installation Note (not orderable) NST Trace Interpretation. Customer letter - M8000-9399B Asks customer to contact Philips English Support to arrange a software upgrade Toco MP Triplets Monitoring Capability. Customer letter - M8000-9399B Asks customer to contact Philips English &...
Page 215 11 Upgrades FM20/30 Upgrade Options Parts included with Option Option Option Adds Number Description Part Number Contents/Comments System Interface, 1 x RS232 RS232/LAN I/O card M2703-67501 "Plug & Play" interface port and 1 x LAN port. assembly Rel. J.3 Software Upgrade Fetal Monitoring 453564491101 Documentation DVD-...
Page 216 11 Upgrades Replace the connector block frame, making sure that it snaps securely back into the bus master board. To remove the existing connector cover, release the three snap-fit latches holding the connector cover along its bottom edge with a flat-headed screw-driver with a fairly wide blade. Then remove the cover.
Page 217 11 Upgrades Fit the new connector cover that comes with the upgrade kit. First, locate the three lugs along the top edge of the connector cover in the corresponding recesses in the bottom housing. Then push the bottom of the cover so that the three latches snap securely into position. Replace the front end assembly as described in “Replacing the Front End Assembly”...
Page 218 11 Upgrades Option B72 (FM30 only) Remove the top cover assembly as described “Removing the Top Cover Assembly” on page 141. Remove the noninvasive blood pressure assembly. Remove the front end assembly -- see “Removing the Front End Assembly” on page 200. Remove the connector block frame from the front end assembly (see “Disassembling the Front End Assembly”...
Page 219 11 Upgrades Locate the metal pins and the plastic studs on the underneath of the noninvasive blood pressure/ socket in the corresponding holes in the bus master board. Then replace the connector block frame. Remove the existing connector cover as described in step 6 for Option B71 on, then remove the cover.
Page 220 11 Upgrades Fit the new connector cover that comes with the upgrade kit as described in step 8 for Option B71 Replace the reassembled front end assembly as described in “Setting the Fetal Recorder Offset” on page 97. Fit the SpO board holder to the bottom housing with two screws from the upgrade kit.
Page 221 11 Upgrades Option B73 (FM30 only) Follow steps 1 to 3 inclusive for Option B71. Then follow steps 6 and 7 for Option B72. To remove the existing connector cover, release the three snap-fit latches holding the connector cover at the bottom with a flat-headed screw-driver with a fairly wide blade. Fit the new connector cover that comes with the upgrade kit as described in step 8 for Option B71.
Page 222 When upgrading to a new monitor software revision, we recommend that you check that all system hardware components have the latest firmware revision, and upgrade these if necessary. Refer to the Support Tool Instructions for Use for details of the upgrade procedure. Contact Philips Support for further details.
Page 223 Specifications Specifications for the accuracy of heart rate measurements are given in the Instructions for Use of the fetal monitor. Environmental Specifications The monitor may not meet the given performance specifications if stored and used outside the specified temperature and humidity ranges. Monitor (M2702A/M2703A);...
Page 224 Source Description Patient alarms and INOPs See the sections on Patient Alarms and INOPs, Standard Philips Alarms, and ISO/IEC Standard Audible Alarms in the Instructions for Use. Ultrasound Doppler Direct transmission of Doppler echoes to the speaker of the fetal monitor.
Page 225 12 Specifications Source Description Optional modulation of the QRS tone for changes in the SpO level. NST Timer Tone for Timer expired. Status/Prompt tone Configurable volume tone sounded when status or prompt messages are issued by the fetal monitor. Touch feed back tone Anytime the user touches the display a low beep is issued in response.
Page 226 12 Specifications Battery Specifications The battery lifetime is 3 years from manufacturing date or 500 charge/discharge cycles. M4605A Battery Specifications Physical Specifications W x D x H 149 mm (5.866 in) x 89 mm (3.504 in) x 19.8 mm (0.78 in) Weight 490 g (1.08 lb) per battery Performance Specifications...
Page 227 12 Specifications Interface Specifications RS232 (Standard) Connectors RJ45 (8-pin) Power none Insulation Basic insulation (reference voltage: 250 V; test voltage: 1500 V) RS232 (Independent display Connectors RJ45 (8-pin) interface option) Power none Isolation none Connectors 20 pin MDR (Mini D-Ribbon), active open and closed contacts Flexible Nurse Call Relay Contact <=100 mA, <=24 V DC...
Page 228 8 hours Contents active settings, review alarms, stored trace data Battery Specifications Performance Specifications Avalon FM20/30 Battery Operating Time Basic monitoring configuration: >2 hours Option #E25 (with new, fully charged (Display Brightness: 70%, Recorder: "On" at 3 cm/min,...
Page 229 12 Specifications Performance Specifications US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mW Peak-negative acoustic pressure p_ = (49.1 ± 5.2) kPa Output beam intensity (I = (2.77 ± 0.56) mW/cm sata (= spatial average - temporal average intensity) Spatial-peak temporal average intensity I = (21.1 ±...
Page 230 12 Specifications Performance Specifications Maternal Pulse from Toco Emitted Light Energy ≤15 mW Wavelength Range 780—1100 nm Range 40—240 bpm Resolution 1 bpm Display Update Rate 1 per second Accuracy ± 2% or 1 bpm, whichever is greater Update Rate every 4 seconds Performance Specifications Measurement Method...
Page 231 12 Specifications Performance Specifications Resolution Display 1 bpm (display update rate 1 per second) Recorder 1/4 bpm Wave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/ Accuracy ±1 bpm or 1%, whichever is greater (non- averaging) Beat-to-Beat change (max.) MECG: 28 bpm DECG: 28 bpm (with Artifact Suppression On) Differential Input Impedance...
Page 232 12 Specifications Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Delay Range Bradycardia (low limit) Delay 10—300 seconds in steps of 10 seconds + system alarm delay Default: 240 seconds Tachycardia (high limit) Delay 10—300 seconds in steps of 10 seconds + system alarm delay Default: 300 seconds Signal Loss Delay 10—30 seconds in steps of...
Page 233 12 Specifications Maternal ECG Supplemental Information as required by IEC 60601-2-27 Response Time of Heart Rate M2735A, M2738A HR change from 80—120 bpm Average: 12 seconds meter to Change in Heart Rate HR change from 80—40 bpm Average: 15 seconds CL Toco HR change from 80—120 bpm Average: 10 seconds CL ECG/IUP...
Page 234 12 Specifications • The approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures. • The NBP measurement is suitable for use with pregnant (including pre-eclamptic) patients. Alarm Specifications Range Adjustment...
Page 235 M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3% values and the reference (70%—100%) values Philips Disposable Sensors with M1943A(L): M1131A, M1901B, M1903B, M1904B = 3% (70%—100%) M1133A, M1134A = ±2% (70%—100%) NellcorPB® Sensors with M1943A(L): MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70%—100%)
Page 236 12 Specifications Alarm Specifications Range Adjustment Delay Bradycardia Difference to low limit 0—50 bpm 5 bpm steps max. 14 seconds Clamping at 30—100 bpm 5 bpm steps Tympanic Temperature Complies with: • EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers) •...
Page 237 12 Specifications Displayed Temperature Measurement Range Mode Range °C Range °F Rectal (ear + 1.16°C) 34.2—42.0 93.6—107.6 Caution: ASTM E1965-98 specifies 34.4°C—42.2°C (94°F—108°F) Ambient Temperature Range Mode Range °C Range °F Operating 10%—95% RH, non- 16.0—33.0 60.8—91.4 condensing Storage up to 95% RH, non- -25.0—55.0 -13.0—131.0 condensing...
Page 238 12 Specifications Recorder Specifications Built-in Thermal Array Fetal Trace Recorder Mechanism Thermal Array Recorder Paper & Printing Type Standard Z-fold paper Standard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1 cm/min Fast Print Speed (stored traces) Max. 20 mm/s Print speed is variable and depends on the print load ECG Wave Print Speed Emulated 25 mm/s...
Page 239 12 Specifications Recorder Symbols Symbol Description Beginning of the date/time annotation Warning (INOP) Measurement from a cableless transducer (printed next to measurement label) Measurement from a cableless maternal measurement Pod (SpO or NBP) Pulse from SpO Pulse from Toco MP Pulse from NBP Trace separation +20 bpm (in label) Trace separation -20 bpm (in label)
Page 240 1 and the Avalon CL transducers of this system are class 1 under the scope of the R&TTE Directive. To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given in the “Manufacturer's Information” on page 240 section of this manual.
Page 241 12 Specifications • CAN/CSA C22.2#60601-1-08 • JIS T 1303 2005 • AS/NZS 3200.1.0-1998 The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010. Alarm sounds are compliant with Standard IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2010.
Page 242 12 Specifications Safety Tests Fetal Monitor All the safety tests and procedures required after an installation, or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards, but may not be sufficient to meet local requirements. WARNING •...
Page 243 12 Specifications WARNING The use of accessories, transducers, and cables other than those specified, may result in increased electromagnetic emissions, or decreased electromagnetic immunity of the device. WARNING Do not use cordless/mobile phones, or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.
Page 244 In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with its accessories. The table gives details of the electromagnetic emissions, and how these are classified,...
Page 245 RF emissions CISPR 11 Class B The device is suitable for use in all establishments, including domestic For the Avalon FM20/30 fetal monitor with all establishments and those directly connected to accessories except the IUP/ECG patient the public low-voltage supply network that module M2738A.
Page 246 Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment.
Page 247 12 Specifications (telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.) Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
Page 248 12 Specifications Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Conducted RF Immunity Test EN/IEC 61000-4-6 Electromagnetic Environment Guidance: IEC 60601-1-2 Test Level Recommended Separation Distance (d) Compliance Level over 150 kHz to 80 MHz (in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements 3.0 V 3.0 V...
Page 249 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. If you require further information or assistance, please contact Philips Support. Recommended Separation Distances from Other RF Equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 250 12 Specifications Environment Before operation, make sure that the fetal monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature. Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or explosive gasses, extremes of temperature, humidity, and so forth.
Page 251 12 Specifications Cardiac Pacemakers and Electrical Stimulators WARNING The fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator, or with cardiac pacemakers. Fast Transients/Bursts The equipment will return to the previous operating mode within 10 seconds without loss of any stored data.
Page 252 12 Specifications Fetal Sensor Socket symbol IP 67 Ingress Protection code according to IEC 60529. The IUP/ECG patient module (M2738A) is rated IP 67 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 0.5 meter for 30 minutes).
Page 253 12 Specifications Socket for connecting Indicates location of the date of Avalon CTS interface cable manufacture and/or name and M2732-60001 or Avalon CL address of manufacturer interface cable (with black connector, FM40/FM50) Symbol indication for non- Identifies year and month of ionizing radiation manufacture China RoHS...
Page 254 12 Specifications...
Page 255 Index MECG NIBP drawer assembly accessories SpO2 contents alarm tables disassembly behavior example replacing troubleshooting configuration mode entering tones password troubleshooting connecting power frontend connector block transducer altitude range connectors EEPROM, transducer monitor removing transducers electrical requirements CPU hardware,transducer analyzer, safety enabling/disabling touch assembly contents enclosure leakage current test...
Page 256 NIBP SpO2 initial boot phase paper measurements, troubleshooting failures default speed MECG speed INOPs measurement settings changing individual parameter testing default troubleshooting messages monitor defaults input devices altitude range setting for PS/2 interface connecting to non-medical devices paper sensor inspecting the shipment assembly exchange parts intended readership...
Page 257 NIBP Toco+ monitor accuracy Toco+ (DECG) site preparation Toco+ (IUP) responsibilities leakage Toco+(MECG) local staff linearity ultrasound Philips staff Toco site requirements valve frontend hardware environment patient leakage current Toco+ space performance assurance ECG frontend NIBP software IUP frontend...
Page 258 troubleshooting alarm behavior alarm tones blank screen checks before opening instrument display general INOP messages guide keyboard LAN / RS232 interface measurements mouse obvious problems recorder touchscreen transducers using Support Tool ultrasound electrical check testing a transducer upgrades firmware FM20 FM30 installing Option B71...
Page 260 Part Number 453564541271 Published in Germany 11/14 *453564541271*...

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