Philips Avalon FM40, Avalon FM50 Service manual

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Obstetrical Care

SERVICE GUIDE

Avalon Fetal Monitor

FM40 / FM50

FETAL MONITORING

Printed in Germany

*M2703-9000C*

Part Number M2705-9000A

451261025951

M2705-9000A

1Table of Contents

1 Introduction 1

Who Should Read This Guide 1 What to Do Next 1 Repair Strategy 2 Manufacturer’s Information 2 Passwords 3 Warnings and Cautions 3

2 Site Preparation 5

Introduction 5

Site Planning 5 Roles and Responsibilities 5

Site Preparation Responsibilities 5 Procedures for Local Staff 6 Procedures for Philips Personnel 7

Site Requirements 7

Space Requirements 7 Environmental Requirements 7 Safety Requirements (Customer or Philips) 8 Electrical Requirements (Customer or Philips) 8 Connecting Non-Medical Devices 8 Cabling Options and Requirements for Connection to OB TraceVue 9 Mounting Options 9 PS/2 Input Devices 10 Displays and Touch Devices 10

M8031B: 15” TFT Medical Grade Touch Display 10 M8033C: 17” TFT Medical Grade Touch Display 10 Video Cables for Remote Displays 11

3 Installation Instructions 13

Initial Inspection 13

Visual Inspection 13 Electrical Inspection 13

Claims for Damage 13 Repackaging for Shipment or Storage 14 Mounting Instructions 14 Line Voltage Selection 14 Rear View 15 Connecting the Monitor to AC Mains 15

Connecting the Monitor to Non-Medical Devices 15 Connecting a Remote Display via the MIB/RS232 Interface 16 Installing a Remote Display 16

Mounting Remote Displays 16

Before Using the Monitor 16

Checking and Setting Line Frequency 17 Checking/Setting Paper Scale 17 Checking/Setting Paper Speed 18 Configuring the Equipment Label 18 Configuring SmartKeys 18 PS/2 Keyboard/Mouse 18

4 Theory of Operation 19

Monitor Hardware Overview 19 Power Supply 20 Fetal Sensor Connector Block 20 API (All Peripheral Interfaces) Board 20 Main CPU Board 21 Fetal Recorder (Thermal Printer Unit) 21

Thermal Line Printhead (TLPH) 21 Paper Sensor 21 Stepper Motor 21

LCD Display and Touchscreen 21 Noninvasive Blood Pressure Assembly 21 SpO2 Assembly 21 Input/Output Interface Boards 22 Transducer Hardware Overview 22 Tr a n s d u c e r Ty p e s 23 Functional Description of the Transducer CPU 23

CPU (Micro Controller) 23 Analog-to-Digital Converter 23 Communication Transceiver (CAN Bus Driver) 23 EEPROM 23

Toco Transducer Frontend 23 Ultrasound Transducer Frontend 23 Toco+ Transducer Frontends 24

To co Fr o n te n d 24 IUP Frontend 24 ECG Frontend 24

Patient Module Frontends 24 Avalon CTS Interface Cable (TMIF) 24

5 Rear Interfaces 25

LAN / RS232 Interface 25 Dual PS/2 Interface 26 MIB / RS232 Interface 26

Telemetry Interface 26 VGA Video Out 26

6 Connection to a Network 27

Network Infrastructure Requirements 27 Connection Indication Messages 27

Broadcast 27 Unicast 28 Equipment Label and OB TraceVue Fetal Monitor Domain Name 28

7 Testing and Maintenance 29

Recommended Frequency 29 When to Perform Test Blocks 30 Preventive Maintenance Procedures 31

Noninvasive Blood Pressure Measurement Calibration 31 Fetal Recorder Maintenance 31

Testing Sequence 31 Visual Inspection 32

Before Each Use 32 After Each Service, Maintenance or Repair Event 32

Safety Tests 32

Warnings, Cautions, and Safety Precautions 32 Safety Test Procedures 33

S(1): Protective Earth Resistance Test 34 S(2): Equipment Leakage Current Test - Normal Condition 34 S(3): Equipment Leakage Current Test - Single Fault Condition 35 S(4): Applied Part Leakage Current - Mains on Applied Part 35

System Test 37

What is a Medical Electrical System? 37 General Requirements for a System 37 System Example 37

Performance Assurance Tests 38

Noninvasive Blood Pressure Performance Tests 38

Accuracy Test 38 Leakage Test 39 Linearity Test 39 Valve Test 40 Expected Test Results 40

SpO2 Performance Test 40

Expected Test Results 40 Measurement Validation 40

Reporting of Test Results 41

Carrying Out and Reporting Tests 42

Other Regular Tests 43

Transducers and Patient Modules: Functional Tests 43

Ultrasound Transducer Electrical Check 43

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Toco Transducer Electrical Check 44 Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): DECG Mode 45 Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): MECG Mode 46 Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): IUP Mode 47

To uc h s cr e e n C a l i b ra ti o n 48 Disabling/Enabling Touch Operation 49 Checking the Fetal Recorder Offset 49 Setting the Fetal Recorder Offset 49 Fetal Recorder Selftest Report 50

8 Troubleshooting 53

Who Should Perform Repairs 53 Replacement Level Supported 53 Checking Revision Information 53

Trace Header 54 Hardware Revision Check 54 Software Revision Check 55

Obtaining Replacement Parts 55 Troubleshooting Guide 55

Checks for Obvious Problems 55 Checks Before Opening the Instrument 55

Checks with the Instrument Switched On, AC connected 55 Individual Parameter INOPs 56 Initial Instrument Boot Phase 57

Troubleshooting Tables 57

How to Use the Troubleshooting Tables 57 Boot Phase Failures 58 Screen is Blank 58 Touchscreen not Functioning 59 General Monitor INOP Messages 60 Network Status Icons 61 Alarm Tones 61 Alarm Behavior 61 Fetal Recorder 61 LAN / RS232 64 Keyboard/Mouse not Functioning 64 Remote Touch Display not Responding (MIB/RS232) 65 No Video on Remote Display 65 Tr a n s du c e r s 6 6

Status Log 67 Troubleshooting with the Support Tool 68 Troubleshooting the Individual Measurements or Applications 68

9 Parts 71

Monitor 71 Tr a n s d u c e r s 73

Patient Modules 74 Interface Cables 74 Assemblies and Kits 75

Front Bezel Assembly 75 Main CPU Board 76 API Board Kit 76 Noninvasive Blood Pressure Assembly 76 Recorder Assembly 77 Thermal Line Printhead (TLPH) 77 Loudspeaker Assembly 77 To p C o ve r 78 AC/DC Power Supply 78 SpO2 Board 78 Interface Boards 79 Fetal Sensor Socket Connector Kit 79 Rear (Telemetry) Connector Kit 79 SpO2 Connector Kit 80 Noninvasive Blood Pressure (NBP) Connector Kit 80 Camlock Kit 80 FM Small Parts Kit - Plastic Parts and Labels 81 FM Small Parts Kit - Screws and Cables 83 Transducer Cable Assembly 84 Belt Button Kit 84

10 Disassembly and Reassembly 85

Introduction 85

How to Use this Chapter 85 Tools Required 86 Screws Used 86

Screw Map 87 Serial Numbers 87 Removing the Top Cover 88 Refitting the Top Cover 89 Removing the Power Supply Assembly 90 Refitting the Power Supply Assembly 91 Removing the Loudspeaker Assembly 91 Refitting the Loudspeaker Assembly 92 Removing the Noninvasive Blood Pressure Assembly 92 Refitting the Noninvasive Blood Pressure Assembly 93 Removing the SpO2 Assembly 94 Refitting the SpO2 Assembly 94 Removing the Interface Boards 95 Refitting the Interface Boards 96 Removing the Main CPU Board 96 Refitting the Main CPU Board 98 Removing the Front Bezel Assembly 99

Refitting the Front Bezel Assembly 101 Removing the Telemetry Socket Connector Block 102 Refitting the Telemetry Socket Connector Block 102 Removing the Sensor Socket Connector Block 103 Refitting the Sensor Socket Connector Block Assembly 104 Removing the API Board 105 Refitting the API Board 107 Removing the Recorder Assembly 107 Refitting the Recorder Assembly 110 Removing the Thermal Line Printhead (TLPH) 111 Refitting the TLPH 112 Transducer Disassembly/Reassembly 113

Exchanging the Transducer Cable 113 Exchanging the Transducer Belt Button 115

11 Upgrades 117

FM40/50 Upgrade Options 117 Installing Upgrade Options 118

Option C73 118 Options J22 and J70 118

Software and Firmware Upgrades 118

12 Understanding Configuration 119

What is Configuration Mode? 119 Understanding Settings 120 Entering and Leaving Configuration Mode 120 Storing Changes in the User Defaults 121 Loading the Factory Default 122 Loading the User Defaults 122 Loading Configurations Using the Support Tool 123 About Configuration Files (.cfg) 123 Selecting the Correct Configuration 123

13 Configuration Settings Appendix 125

Documenting Monitor Configurations 125 Using the Configuration Tables 125

Configuration Table Example 126

Understanding Configuration Implications 126 Measurement-Related Settings 127

Color Configuration 127 Configuring FHR (Ultrasound) 127

FHR Configuration Implications 127

Configuring Toco 128 Configuring IUP 128 Configuring DFHR (DECG) 128

DFHR Configuration Implications 128

Configuring MHR (ECG)/Pulse 129

ECG/Pulse Configuration Implications 129

Configuring SpO

Configuration Implications 130

SpO

130

Configuring Noninvasive Blood Pressure (NBP) 132

NBP Configuration Implications 132

Monitor-Related Settings 133

Configuring Alarms 133

Alarm Settings Configuration Implications 133

Configuring the NST Timer 134

NST Timer Configuration Implications 134

Configuring Fetal Recorder Settings 135

Recorder Configuration Implications 135

Configuring User Interface Settings 136

User Interface Configuration Implications 136

Configuring Global SmartKeys 138

Global SmartKeys Configuration Implications 138 Changing the Selection and Sequence of Global SmartKeys 138

Hardware Settings 139 Global Settings 139

Global Settings Configuration Implications 139

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1Introduction

This Service Guide contains technical details for the Avalon FM40 and FM50 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. It covers the physiological measurements and the monitor hardware that acquires and displays them.

The Avalon FM40/FM50 Fetal Monitor Service Guide supplements the maintenance and troubleshooting procedures, carried out by the operator, that are described in the Instructions for Use. Refer to the Instructions for Use for maintenance and troubleshooting procedures that may be performed during normal operation.

Only qualified service personnel should attempt to install the system, disassemble the monitor, remove or replace any internal assemblies, or replace the transducer cable or belt buttons.

Who Should Read This Guide

This guide is for biomedical engineers or technicians responsible for troubleshooting, repairing, and maintaining Philips’ Avalon fetal monitors.

You must:

•understand English

• be familiar with standard medical equipment installation procedures

• be familiar with current conventional technical terms as used throughout this guide

What to Do Next

Familiarize yourself with the contents of this guide and the Instructions for Use before attempting to service or repair the system.

1 Introduction Repair Strategy

Repair Strategy

The Service Support Tool software helps you to determine whether a fault is a hardware or software problem. The main replaceable parts are:

• unit exchange for the transducers

•replacement of –the top cover – the power supply assembly – the loudspeaker assembly – the noninvasive blood pressure assembly –the SpO – the interface boards (RS232/LAN, dual PS/2 and MIB/RS232) –the main CPU board – the front bezel assembly – the telemetry socket connector block – the sensor socket connector block –the API board – the recorder assembly – the thermal line printhead (TLPH) –the transducer cable – the transducer belt button

See Chapter 9, “Parts” for part numbers, and Chapter 10, “Disassembly and Reassembly” for repair details.

assembly

Repair or replacement of individual components on the boards is not supported, and should never be attempted.

For tests that you are required to perform after repairs, refer to “When to Perform Test Blocks” on page 30.

Manufacturer’s Information

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard-Str. 2

71034 Böblingen, Germany

Passwords 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 Chapter 12, “Understanding Configuration” before making any changes to the monitor configuration.

Warnings and Cautions

In this guide:

•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

•A caution alerts you where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

1 Introduction Warnings and Cautions

Introduction

This section describes the procedures you should follow to plan and prepare a site for an Avalon FM40/FM50 fetal monitor installation.

• Site planning.

• Roles and responsibilities for local and Philips personnel.

Site Planning

The careful planning of the site for the FM40/FM50 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.

2Site Preparation

The site planning phases prior to equipment installation are:

Location: Planning the location of the various system components.

Environment: Confirming and correcting, as necessary, the environment of the proposed installation

site(s).

System Capabilities: Explaining the possibilities for system expansion.

Mounting: Referencing the mounting hardware information website for the listing of suitable

mounting hardware recommended for use with the various system components, and all details on the available mounts and accessories.

Cabling: Identifying the requirements for the cabling, conduiting and faceplates for connecting the various system components.

Roles and Responsibilities

This section describes the procedures necessary to prepare a site for a system installation. The procedures are grouped into two parts: procedures that local staff or contractors are responsible for, and procedures that Philips personnel are responsible for.

Site Preparation Responsibilities

Local Staff

• Ensure that all safety, environmental and power requirements are met.

• Provide power outlets.

• Prepare mounts, and consult Philips for detailed mounting requirements.

2 Site Preparation Introduction

• Pull cables, install conduit, install wallboxes.

Philips Personnel

• Provide the customer with the safety, environmental and power requirements.

•Assemble mounts, as necessary.

• Provide requirements for cabling.

Procedures for Local Staff

The following tasks must be completed before the procedures for Philips personnel may be started.

• Providing Power Outlets

Provide a power outlet in the vicinity (1 m or 3 ft) or any peripheral equipment.

WARNING Only the power cables provided with the system may be used. For reasons of safety, power (mains)

extension cables or adapters shall not be used.

• Preparing Mounts

Where ceiling, wall, or shelf mounts are required for mounting the equipment, the customer is responsible for the following:

– Providing and installing all hardware which is required to install the mounting hardware supplied

by Philips as detailed in the installation notes.

– Making sure that all ceilings, walls, and mounting rails that supports mounting hardware are

suitable for their proposed load.

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 integrity and compliance with all local, state and any other required codes by a registered, professional, structural and/or mechanical engineer.

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.

• Providing Conduit

– Providing conduit and/or trunking of a sufficient cross-sectional area for the planned cables and

possible future expansion (for additional components or systems).

– Providing and/or installing suitable wall boxes to accommodate the faceplates.

•Pulling Cables

WARNING NEVER run power cables through the same conduit or trunking used for system cables.

•Installing Wall Boxes

Site Requirements 2 Site Preparation

It is the customer's responsibility to provide and install wallboxes to house faceplates. 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, “Procedures for Local Staff.”

Site Requirements

The site requirements are listed in this section.

Space Requirements

The situating of the monitor should be planned such that the nursing staff are able to monitor the patient with relative ease, with all patient connectors and controls readily available and the displays clearly visible. The location should also allow access to service personnel without excessive disruption and should have sufficient clearance all round to allow air circulation.

Dimensions and weight:

Monitor:

Size (W x H x D): 420 x 172 x 370 mm (16.5 x 6.8 x 14.6 in)

Weight; < 9.0 kg (19.8 lb)

Transducer:

Size (diameter): 83 mm (3.27 in)

Weight (without cable): 190g (6.7 oz.)

Environmental Requirements

The environment where the FM40/FM50 monitor will be used should be reasonably free from vibration, dust and corrosive or explosive gases. The ambient operating and storage conditions for the FM40/FM50 monitor must be observed. If these conditions are not met, the accuracy of the system will be affected and damage can occur.

Monitor (M2704A/M2705A)

Interface Cable for Avalon CTS (M2731-60001/M2732-60001)

Temperature Range Operating 0°C to 45°C (32°F to 113°F)

Storage

Humidity Range Operating <95% relative humidity @ 40°C/104°F

Storage

Altitude Range Operating -500 to 3000 m/-1640 to 9840 ft.

Storage

-20°C to 60°C (-4°F to 140°F)

<90% relative humidity @ 60°C/140°F

-500 to 13100 m/-1640 to 43000 ft.

Transducers (M2734A/M2735A/M2736A/M2738A)

Temperature Range Operating 0°C to 40°C (32°F to 104°F)

Storage

-20°C to 60°C (-4°F to 140°F)

2 Site Preparation Site Requirements

Transducers (M2734A/M2735A/M2736A/M2738A)

Humidity Range Operating <95% relative humidity @ 40°C/104°F

Storage

Altitude Range Operating -500 to 3000 m/-1640 to 9840 ft.

Storage

SpO2 Sensors

Operating Temperature Range 0°C to 37°C (32°F to 98.6°F)

<90% relative humidity @ 60°C/140°F

-500 to 13100 m/-1640 to 43000 ft.

Safety Requirements (Customer or Philips)

The monitor is an electrical Class I device in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution, in that means are provided for the connection of the equipment to a protective earth conductor in the fixed wiring installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation.

WARNING • Always use the supplied power cord with the earthed mains plug to connect the monitor to an

earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket.

• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet without an approved separating transformer is used, the interruption of its protective earthing may result in equipment leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits.

Electrical Requirements (Customer or Philips)

Line Voltage Connection

The FM40/FM50 monitor uses < 60 W.

Line Voltage: the FM20/FM30 monitor may be operated on ac line voltage ranges of 100 to 240V (50/60 Hz).

Connecting Non-Medical Devices

The standard IEC/EN 60601-1-1 applies to any combination of devices, where at least one is a medical device. Therefore IEC/EN 60601-1-1 must still be met after all devices are connected.

WARNING • Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1. The whole

installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-1. Any non-medical device, including a PC running an OB TraceVue system, placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 606011-1) that ensures mechanical fixing of the power cords and covering of any unused power outlets.

• Do not connect any devices that are not supported as part of a system.

Site Requirements 2 Site Preparation

Whenever you combine equipment to form a system, for example, connecting the monitor to an OB TraceVue system, perform a system test according to IEC/EN 60601-1-1 (see “System Test” on page 38).

Figure 1 Equipment Location in the Patient Vicinity

Cabling Options and Requirements for Connection to OB TraceVue

For cabling options and requirements for connection to an OB TraceVue system, refer to the OB TraceVue Site Preparation Guide and the OB TraceVue Service Guide.

Mounting Options

See “Mounting Hardware” on page 61 for a list of mounting options. Refer to “Mounting Instructions” on page 12, or contact your local Philips representative for advice on mounting the monitor.

2 Site Preparation Site Requirements

PS/2 Input Devices

The following table describes the input devices which can be connected to the monitor via the optional PS/2 interface.

Product Option Number

M8024A #A01 862454 989803124741 Slimline Keyboard with integrated Trackball

M8024A #B01 M4046-60104 451261000661 Optical Mouse USB / PS/2

M8024A #C01 M4046-60103 451261000651 Wired Track Ball USB / PS2

M8024A #C02 M4046-60105 451261000671 Wireless Track Ball

M8024A #C03 M4046-60106 451261000681 Wired off table Track Mouse

Part Number 12NC Part

Number

Description

Displays and Touch Devices

The following two tables describe the remote displays that can be connected to the monitor’s video output connector.

For touch operation, the MIB/RS232 interface is required. See “Connecting a Remote Display via the MIB/RS232 Interface” on page 16.

M8031B: 15” TFT Medical Grade Touch Display

Product Number Part Number 12NC Part

Number

M8031B M8031-60001 45121001911 15” Medical Grade Display with Touch

- M8031-68001 451261001941 Exchange 15” Medical Grade Display with Touch

- M8031-60005 451261001921 Power Supply 12V for M8031B Display

- M8031-64001 451261001931 Power Supply Mounting for M8031B Display

- M8031-04701 451261001901 Monitor Desk Stand for M8031B/M8033C

- 2090-0860 453563463201 Backlights for M8031B

Description

M8033C: 17” TFT Medical Grade Touch Display

Product Number Part Number 12NC Part

Number

M8033C M8033-60071 451261009151 17” Medical Grade Display with Touch

- M8033-68071 451261009161 Exchange 17” Medical Grade Display with Touch

- M8031-04701 451261001901 Monitor Desk Stand for M8031B/M8033C

- M8033-64603 451920880311 Backlights for M8033C

Description

Site Requirements 2 Site Preparation

Video Cables for Remote Displays

Product Option Number

M8022 #VA2 M3080-61606 453563484451 1.5 m Analogue Video Cable Kit

M8022 #VA3 M3080-61602 453563334661 3 m Analogue Video Cable Kit

M8022 #VA6 M3080-61603 453563334671 10 m Analogue Video Cable Kit*

Both ends are terminated with HDSUB15 (“VGA”) straight connectors.

*Built on demand

Part Number 12NC Part

Number

Description

2 Site Preparation Site Requirements

3Installation Instructions

The information contained in this chapter, in addition to that given in the Instructions for Use, should enable the monitor to be installed ready for use (the preparation and planning should be adhered to as specified in the “Site Preparation” chapter). Safety checks and inspection procedures for mounts are explained in the “Testing and Maintenance” chapter, and configuration of the system is explained in the “Configuration” chapter.

Please keep the packing materials until you have completed the initial inspection, in case there is a defect on arrival.

Initial Inspection

Inspect the delivery on arrival.

Visual Inspection

Open the shipping container(s) and examine each part of the instrument for visible damage, such as broken connectors or controls, or scratches on the equipment surfaces. If the shipping carton/container is undamaged, check the cushioning material and note any signs of severe stress as an indication of rough handling in transit. This may be necessary to support claims for hidden damage that may only become apparent during subsequent testing.

Electrical Inspection

The instrument has undergone extensive testing prior to shipment. Safety testing at installation is not required (except in situations where devices are interconnected forming a system, see “Connecting Non-Medical Devices” on page 8). An extensive self check may be performed. This recommendation does not supersede local requirements.

All tests are described in the “Testing and Maintenance” chapter of this manual.

Claims for Damage

When the equipment is received, if physical damage is evident or if the monitor does not meet the specified operational requirements of the patient safety checks or the extended self check, notify the carrier and the nearest Philips Sales/Support Office at once. Philips will arrange for immediate repair or replacement of the instrument without waiting for the claim settlement by the carrier.

3 Installation Instructions Repackaging for Shipment or Storage

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). If available and reusable, the original Philips packaging should be used to provide adequate protection during transit. If the original Philips packaging is not available or reusable please contact the Philips Sales/Support Office who will provide information about adequate packaging materials and methods.

Mounting Instructions

Every type of compatible mounting solution is delivered with a complete set of mounting hardware and instructions. Refer to the Site prep 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,

Ensure that this commitment has been met before assembling mounts.

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 100 V to 240 V (± 10%) and 50/60 Hz (± 5%).

Rear View 3 Installation Instructions

Rear View

1 Reserved for future use: protective

earth intended for use in system installations.

2 Equipotential grounding point

3 Power cord connector

4 Loudspeaker

5 Slot 01 for optional LAN / RS232

(A)(B)

system interface (for connection to an obstetrical information and surveillance system)

6 Slot 02 for optional interfaces:

• Either dual PS/2 system interface

(A) for mouse and keyboard connection)

• Or MIB interface (B) for external

touch screen connection

7 Slot 03 reserved for future use

8 Video output (VGA)

9 Telemetry interface. If not using one of

the fetal sensor sockets, one Avalon CTS can be connected at a time to either socket using the M2732-60001 interface cable (with black connector).

Connecting the Monitor to AC Mains

WARNING • Always use the supplied power cord with the earthed mains plug to connect the monitor to an

earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket.

• Do not use AC mains extension cords or multiple portable socket-outlets.

Connecting the Monitor to Non-Medical Devices

Connect the monitor to an obstetrical surveillance system, such as OB TraceVue, via the optional system interface. For cabling requirements, refer to “Cabling Options and Requirements for Connection to OB TraceVue” on page 9. For safety-related information, refer to “Connecting NonMedical Devices” on page 8, and “System Test” on page 38.

3 Installation Instructions Connecting a Remote Display via the MIB/RS232 Interface

Connecting a Remote Display via the MIB/RS232 Interface

The configuration of a specific MIB/RS232 port can be viewed in Configuration Mode and altered in Service Mode. This is required when a remote display with touchscreen is installed. To configure an MIB/RS232 port to support a slave display with touchscreen:

1 Select Main Setup.

2 Select Hardware.

3 Select Interfaces.

4 Select MIB/RS232.

5 Select Touch 1.

NOTE Be aware that if you configure a port, this assignment is retained after a boot up. If the MIB/RS232

board is removed and replaced with a different type of board the settings are deleted. If the MIB/ RS232 board is then refitted, you must reconfigure the MIB/RS232 port. The configuration of MIB/ RS232 is not cloned between monitors.

After loading the Factory Defaults, you will need to reconfigure the MIB/RS232 port to re-enable the touch operation of the connected remote display.

Installing a Remote Display

The monitor is tested and approved for use with the following remote displays:

• Philips M8031B 15” Remote Display

• Philips M8033C 17” Remote Display

The monitor has an analog-only video output signal, with VGA resolution. Use a standard VGA video cable to connect the remote display to the video output on the rear of the monitor.

Mounting Remote Displays

Mounting solutions for the M8031B and M8033C remote displays must be purchased separately. Please refer to the installation instructions which ship with the mounting solution purchased.

Before Using the Monitor

WARNING Before starting monitoring, check that the configuration meets your requirements.

Check that the following configuration settings are suitable:

•Line Frequency

• Paper Scale

•Paper Speed

•Equipment Label

•Configured SmartKeys

Before Using the Monitor 3 Installation Instructions

• Input device configuration (if using an external keyboard or mouse)

• Remote display settings (if using a remote display, see “Connecting a Remote Display via the MIB/ RS232 Interface” on page 16).

If you need to enter configuration mode to change settings:

1 In the Main Setup menu, select Operating Modes.

2 Select Config and enter the passcode.

The passcode for configuration mode is given in the monitor’s service documentation.

The monitor displays Config at the right hand side of the status line and in the center of the Screen while you are in configuration mode.

Before you leave configuration mode, always be sure to store any changes you made. You must store changes made to each Settings Block and to each Profile, individually. As it may be difficult to remember whether the settings you changed belong to a Monitor Settings block or a Measurement Settings block, we recommend that you store each block before you leave configuration mode.

To leave configuration mode:

1 Enter the Main Setup menu.

2 Select Operating Modes.

3 Select Monitoring.

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 Service Mode.

WARNING An incorrect line frequency setting can affect the ECG filter, and disturb the ECG measurement.

Ensure the line frequency setting is correct.

To set the line frequency:

1 Enter the Main Setup menu.

2 Select Global Settings.

3 Select Line Frequency and select 50Hz or 60Hz from the pop-up list.

Checking/Setting Paper Scale

Check the paper Scale Type (US for paper with a scale of 30-240, or Internat’l for paper with a scale of 50-210) in the Fetal Recorder menu. In Monitoring Mode, you can see this setting (grayed out), but you cannot change it. It can be changed in Configuration Mode.

1 Enter the Main Setup menu by selecting the SmartKey .

2 Select Fetal Recorder.

3 Check the current setting for Scale Type. If it is not appropriate, change it in the Fetal Recorder

menu in Configuration Mode:

Select Scale Type to toggle between US and Internat’l.

3 Installation Instructions Before Using the Monitor

Checking/Setting Paper Speed

Check the paper speed before using the monitor. You can choose a paper speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min. In Monitoring Mode, you can see this setting (grayed out), but you cannot change it. It can be changed in Configuration Mode.

As a change in paper speed results in a change in the appearance of a FHR trace, you are advised to ensure ALL monitors in your institution are set to the same speed.

To set the paper speed:

1 Enter the Main Setup menu using the SmartKey .

2 Select Fetal Recorder.

3 In the Recorder menu, you can see the current speed setting. Select Recorder Speed.

4 Select the desired speed from the given choices: 1, 2 or 3 cm/min.

Configuring the Equipment Label

OB TraceVue requires a unique equipment label. In OB TraceVue, is possible to prevent connection to monitors with specific equipment labels by means of a filtering mechanism. For more details, see the OB TraceVue Instructions for Use.

1 Select the Bed Label screen element to call up the Bed Info menu.

2 Select Equipment Label to call up the onscreen keyboard.

3 Enter the system identifier.

Configuring SmartKeys

Check that the configured SmartKeys are suitable. Configure the SmartKeys preferred by the institution from a global list Global Smart Keys. The global list of SmartKeys is stored as a unique monitor setting in the monitor configuration. See the section “Configuring Global SmartKeys” on page 138 for details on how to configure the global SmartKey list.

PS/2 Keyboard/Mouse

Switch off the monitor before connecting any PS/2 compatible device.

Connect the PS/2 connector to the PS/2 Interface board in the monitor at the slot indicated by the appropriate symbol.

The default keyboard language setting for all initial configurations is “US”.

To configure the keyboard language manually, go to Service Mode, select Main Setup -> Hardware -> Keyboard and then select the proper language. Please note that this setting does not clone.

4Theory 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

Standby Button

AC-DC

Power Interrupt Bleeper

Stand-by

Control

Telemetry

Interface

Audio

Amplifier

Telemetry Connector Block

Loudspeaker

Printhead

Main CPU Board

API

(All Peripheral Interfaces Board)

IF Board 1

(LAN/

RS232)

IF Board 2

Printer

Control

Touch

Control

Display

Control

Bus

Master

SpO

Floating

Isolation

Paper

Sensor

Stepper

Motor

Touch

Screen

Display

Adapter

Fetal Sensor Connector Block

Display

Panel

Backlight

Converter

VGA Connector

NBP

optional boards standard boards

4 Theory of Operation Power Supply

The monitor consists of the following main functional components:

•Power supply

• API (All Peripheral Interfaces) Board

• Main CPU Board

• Fetal Recorder (Thermal Printer Unit)

• Fetal Sensor Connector Block

• Noninvasive Blood Pressure Board

•SpO

• Input /Output Interface Boards:

Board

–LAN / RS232

–Dual PS/2 (optional)

– MIB / RS232 (optional)

Power Supply

The power supply is a wide-range input switching unit, with an output of 24V. It is located in the chassis assembly.

Fetal Sensor Connector Block

Any compatible fetal transducer can be connected in any order to the monitor via the sockets on the Connector Block. The Connector Block is located on the Bus Master section of the All Peripheral Interfaces (API) Board, and is exchangeable.

API (All Peripheral Interfaces) Board

The All Peripheral Interfaces (API) Board is connected to the Main CPU Board by a 154-pin 0.5 mm pitch press fit connector.

The recorder is controlled by the Printer Control section of the API Board, which is connected to the Stepper Motor and the Thermal Printer Unit.

The signals from the transducers or sensors are conveyed from the sensor sockets to the Bus Master section of the API Board. The Telemetry Interface is also integrated into the API Board.

The Bus Master section is responsible for transducer detection, communicates with the connected transducers via a CAN bus, and communicates parameter data to the Main CPU Board via a serial link for further processing and display. It has floating power isolation.

The API Board also controls the display panel and the backlight converter, and also controls the touchscreen. The display panel is connected to the API Board. The VGA connector is also connected to the API Board.

The API Board incorporates an audio amplifier which controls the loudspeaker.

Main CPU Board 4 Theory of Operation

Main CPU Board

The Main CPU Board controls the monitor’s human interface, and is responsible for the final processing of data from the Bus Master Board. It sends this data to the TFT display, and to the thermal printer unit for recording traces and other patient data. It also controls the LAN/RS232 interface board, and the optional PS/2 and MIB interface boards.

Fetal Recorder (Thermal Printer Unit)

The fetal recorder is located in the front of the chassis assembly. The recorder consists of the following major parts:

•Thermal Line Printhead (TLPH)

•Paper Sensor

•Stepper Motor

Thermal Line Printhead (TLPH)

The TLPH is located on its own holder in the recorder chassis.

Paper Sensor

The paper sensor hardware consists of a reflective light sensor that detects the black marks on the trace paper, and paper-out. It is attached to the RFI Bracket, and connected to the Recorder Adapter Board via a removable cable connector.

Stepper Motor

The stepper motor is a bipolar motor controlled by a micro-stepping motor driver on the Recorder Adapter Board. The motor is located on the recorder chassis and is connected to the Recorder Adapter Board via a removable cable connector.

LCD Display and Touchscreen

The LCD Display Assembly consists of a five-wire resistive touchscreen, a 6.5” TFT panel, and a backlight inverter, all connected to the API Board and fitted into the front bezel assembly.

Noninvasive Blood Pressure Assembly

The optional Noninvasive Blood Pressure Assembly is located in the rear lefthand corner of the chassis assembly. It is connected via a serial link to the Main CPU Board.

SpO2 Assembly

The optional SpO2 Assembly is physically located on the Bus Master section, but sends data directly to the Main CPU Board via a serial link.

4 Theory of Operation Input/Output Interface Boards

Input/Output Interface Boards

There are three interface boards available:

• LAN/RS232 Interface Board, used for connecting to a PC running the Support Tool and to a surveillance and documentation system such OB TraceVue.

• PS/2 Interface Board (optional), used for connecting an external keyboard or mouse.

• MIB Interface Board (optional), used for connecting external touchscreen displays.

The interface boards plug into the two interface slots on the rear panel of the device, and are controlled by the Main CPU Board.

Transducer Hardware Overview

Analog Signal

Analog/ Digital conversion

Timing and Mode Control

EEPROM

Master Clock recovery

Signal processor

Power supply and reset

Ultrasound frontend board

or alternatively

Transducer cable

Communication Transceiver

Power and Identification

Transducer CPU board

TOCO/ECG frontend board

Transducer Types 4 Theory of Operation

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:

• CPU (micro controller)

• Analog-to-Digital Converter

• Communication Transceiver (CAN bus driver)

• EEPROM

CPU (Micro Controller)

A single-chip processor is used to control the transducer, generate the frontend control signals, control the analog-to-digital signal conversion, and to perform the signal processing.

Analog-to-Digital Converter

Analog-to-digital (A/D) signal conversion is carried out by the 16-bit AD converter. Digital signals are directly communicated from the A/D converter to the CPU.

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 frontend gains and offsets, country-specific information, serial numbers and error logs).

Toco Transducer Frontend

Uterine activity is measured by evaluating the hardness of the mother’s abdomen with a pressure sensitive resistor bridge (strain gauge sensor element). The strain gauge sensor element requires an excitation voltage and its differential output signal is proportional to the pressure applied to it. A DC excitation voltage is used, and the resulting output signal is fed directly to an A/D signal converter before being sent to the processor.

Ultrasound Transducer Frontend

The ultrasound frontend is a pulsed Doppler system with a 1.0 MHz ultrasound frequency, and a pulse repetition rate of 3 kHz. Seven ultrasound crystals are used as transmitter and receiver.

4 Theory of Operation Toco+ Transducer Frontends

Toco+ Transducer Frontends

Several parameter frontends are combined on one board. In addition to the Toco frontend, additional supported parameters are DECG, MECG and IUP.

A seven-pin ‘D-type’ socket carries all parameter related inputs and outputs. An external mode resistor, connected to one of the pins, automatically detects which mode to set when an adapter cable is plugged in (whether it is DECG, MECG, or IUP).

Toco Frontend

See “Toco Transducer Frontend” on page 23.

IUP Frontend

Intrauterine pressure (IUP) is measured via a piezo resistive bridge with AC excitation connected to the RA / LA input pins of the ECG amplifier. A/D conversion of the IUP signal is done by the 16-bit A/D converter.

ECG Frontend

The ECG frontend measures both DECG and MECG, using a 3-lead system (RA, LA and reference electrode). The ECG mode is automatically detected when an adapter cable is attached. Input lines are ESD protected.

Patient Module Frontends

The patient module shares the same parameter frontends as the Toco+ transducer, with the exception of the Toco frontend.

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 frontend board. The TMIF is responsible for converting the analog signals from the parameter frontends of the Avalon CTS transducers into digital signals for transmission to the fetal monitor.

5Rear Interfaces

All the interfaces can be found on the recessed rear panel of the monitor.

There are three interface boards available for the Avalon FM40 and FM50 fetal monitors:

• LAN / RS232 system interface

• Dual PS/2 interface (optional)

• MIB interface (optional)

Slot 02: MIB interface

Dual PS/2 interface

Slot 01: LAN / RS232 system interface

Telemetry interface

The interfaces are “plug-and-play” boards, and fit into dedicated slots on the rear panel of the monitor. See “Removing the Interface Boards” on page 105 for details of how to remove and fit the boards.

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 obstetrical information system on a network, and for future system expansion.

• The RS232 connection can be used for connecting the monitor to an obstetrical information and surveillance system, such as OB TraceVue.

Slot 03: (reserved)

VGA Video Out

5 Rear Interfaces Dual PS/2 Interface

Dual PS/2 Interface

This interface provides two PS/2 ports to enable the monitor to be connected to off-the-shelf, “plug-andplay” input devices:

• Mouse: any specified PS/2 mouse or trackball may be used for navigation and data entry.

• Computer keyboard: a PS/2 computer keyboard can be used for data entry instead of the on-screen

pop-up keyboard.

MIB / RS232 Interface

The MIB interface (IEEE P1073) provides two independently configurable ports for connection to an external touch device.

Telemetry Interface

The telemetry interface is for connecting an Avalon CTS Cordless Fetal Transducer System. If you are not already using the M2731-60001 interface cable (with red connector) to connect to one of the fetal sensor sockets, one Avalon CTS can be connected at a time to either rear socket using the M2732-60001 interface cable (with black connector).

VGA Video Out

This connector is for connecting an external analog display. The video output has VGA resolution.

6Connection to a Network

You can connect the fetal monitor to an OB TraceVue obstetrical information and surveillance system on a network using the LAN connection on the optional LAN / RS232 interface (see “LAN / RS232 Interface” on page 21).

Network Infrastructure Requirements

The Avalon FM40/50 sends Connection Indication messages that OB TraceVue processes to establish an ethernet connection to the fetal monitor. The general requirements for connecting the Avalon FM40/50 to an OB TraceVue obstetrical surveillance system over a network are as follows:

• The fetal monitor and the data acquisition PC must be in the same network segment.

• The Avalon FM40/50 can be allocated a valid IP address either manually, or from a BOOTP service. If no IP address is entered manually, the Avalon FM40/50 requires a BOOTP service to obtain a valid IP address automatically, therefore BOOTP service must be available in each network segment. If the OB TraceVue internal server is part of that network segment, then it can be configured to serve BOOTP requests.

• The ethernet port of the Avalon FM40/50 supports only 10 M-bit half-duplex data transfer.

Connection Indication Messages

Connection Indication (CI) messages can be sent by the Avalon FM40/50 in two ways: by Broadcast or by Unicast.

Broadcast

When CI messages are sent by broadcast, they have the potential to reach any data acquisition PC in the same network segment, and the connection to the fetal monitor is made dynamically by the next available host PC (the data acquisition PC with the least active connections).

Broadcast is the default, and recommended, method for sending CI messages. This is because if there are multiple host PCs available in the same network segment, the broadcast method provides greater availability by allowing load balancing and failure-tolerant functionality. If a particular host PC happens to be unavailable, the next available PC takes over the connection. In the

Server

entry is 0.0.0.0.

Bed Information menu, the IP OB

6 Connection to a Network Connection Indication Messages

Unicast

When CI messages are sent by unicast, the fetal monitor sends a request to a specific target OB TraceVue data acquisition hosting PC in the same network segment. The CI message contains the IP address of the target PC, and only this PC will host the connection.

An example where CI messages are typically sent by unicast is where the fetal monitor and OB TraceVue PC are installed in the same cart, and you therefore always want the fetal monitor to be hosted by the same PC.

To avoid conflicts where there are multiple OB TraceVue systems operating in the same network segment, we recommend that you configure the fetal monitors to send the CI messages by unicast.

To enter the IP address of the target PC:

1 Enter Configuration Mode.

2 Select Main Setup.

3 Select Bed Information.

4 In the Bed Information menu, select IP OB Server.

5 Using the pop-up keypad, enter the IP address of the target server, and press Enter when you are done.

Equipment Label and OB TraceVue Fetal Monitor Domain Name

For connection to an OB TraceVue system over a network, OB TraceVue requires each fetal monitor to have an unique equipment label.

When a fetal monitor is configured with an equipment label, this equipment label is sent as part of the CI message. In OB TraceVue, it is possible to specify a Fetal Monitor Domain Name in the fetal monitor configuration user interface (see OB TraceVue Instructions for Use for details). The OB TraceVue system compares this name with the fetal monitor equipment label. Only if the domain name matches the beginning of the equipment label string is the CI message processed and accepted. Otherwise the CI message is ignored.

Using this filtering process, you can avoid conflicts where there are multiple OB TraceVue systems operating in the same network segment by controlling which monitors connect to a specific OB TraceVue system, and which monitors are excluded.

To enter or change the equipment label:

1 Enter Service Mode.

2 Select Main Setup.

3 Select Bed Information.

4 In the Bed Information menu, select Equipment Label.

5 Enter the desired equipment label for your monitor (up to 12 alphanumeric characters are displayed),

then press

Enter.

7Testing and Maintenance

This chapter contains the testing and maintenance procedures to ensure the proper functioning of the monitor and accessories, covering preventive maintenance, performance assurance and safety.

Carry out the procedures as specified in the following sections.

For detailed instructions on how to clean the monitor, transducers and accessories, see the monitor’s Instructions for Use.

Recommended Frequency

Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements.

Table 1: Suggested Testing Timetable

Te s ts Frequency

Preventive Maintenance

Other Regular Tests

Performance Assurance Te s ts

Safety Tests Visual

Electrical

Noninvasive Blood Pressure Calibration Once every two years, or as specified by

local laws (whichever comes first).

Visual Inspection Before each use.

Recorder Maintenance Once a year, or if the printout is

degraded.

Testing Transducers and Patient Modules Once a year, or if you suspect the

measurement is incorrect.

Noninvasive Blood Pressure Performance Tests Once every two years, or if you suspect

SpO

Performance

Visual Inspection Once every two years and after repairs

Protective Earth

Equipment Leakage Current

Patient Leakage Current

the measurement is incorrect.

where the power supply is removed or replaced, or if the NBP assembly, SpO board, or fetal sensor connector block is removed or replaced, or the monitor has been damaged by impact.

7 Testing and Maintenance When to Perform Test Blocks

When to Perform Test Blocks

This table tells you when to perform specific test blocks. See page 31 for test details.

Table 2: When to perform test blocks

Service Event Test Block(s) Required - Complete these tests

Installation

Installation of standalone monitor Perform Visual Inspection and Power On Test Blocks (see Table 3). Installation of monitor with a display

connected to the video output Installation of networked monitor

(LAN)

Preventive Maintenance

Noninvasive Blood Pressure performance testing

Other Regular Tests and Tasks

Visual Inspection Perform Visual Inspection test block (see Table 3). Transducer and Patient Module

Testing Recorder Maintenance Regular cleaning and maintenance (see “Fetal Recorder Maintenance” on

Perform Visual Inspection, Power On and System test blocks (see Table 3).

Perform Noninvasive Blood Pressure Performance tests blocks (see Table 3).

See “Performance Assurance Tests” on page 38.

page 31

Perform the recorder selftest (see “Fetal Recorder Selftest Report” on page 50).

Repairs

Repairs when the monitor has been damaged by impact.

Repairs where the power supply has been removed or replaced.

All repair events involving any of the following: Noninvasive Blood Pressure connector, SpO board or the red fetal sensor sockets.

All other repair events. Perform Visual Inspection, Power On and Performance test blocks (see

Upgrades

Software upgrades. Perform Visual Inspection and Power On test blocks (see Table 3.)

Combining or Exchanging System Components

All other service events Per form Visual Inspection, Power On and Performance test blocks (see

connector/

Perform Visual Inspection, Power On, Performance and all Safety test blocks (see Table 3).

Perform Visual Inspection, Power On, Performance test blocks and all Safety test blocks (see Table 3).

Table 3).

Perform the System Test (see Table 3 and “System Test” on page 37).

Table 3).

Preventive Maintenance Procedures 7 Testing and Maintenance

Preventive Maintenance Procedures

Noninvasive Blood Pressure Measurement Calibration

Carry out the noninvasive blood pressure measurement performance tests at least every two years, or as specified by local laws (whichever comes first).

Fetal Recorder Maintenance

The recorder platen, thermal printhead and paper sensor should be cleaned at least once a year, or when needed (when traces become faint).

Clean the assemblies as follows:

• Clean the recorder roller with a lint-free cloth using a soap/water solution.

• Wipe the printhead using a cotton swab moistened with 70% Isopropyl alcohol based solution.

• Check the paper sensing mechanism is dust free.

Testing Sequence

Here is a summary of the recommended sequence of testing:

Start

Select the test

Visual Inspection

Safety Tests

Performance Tests

Reporting of Results

Evaluation of Results

See “When to Perform Test Blocks” on page 30.

See ““Visual Inspection” on page 32.

See “Safety Test Procedures” on page 33.

See “Performance Assurance Tests” on page 38.

See “Reporting of Test Results” on page 41.

Check and prepare for normal use

NOTE If any single test fails, testing must be discontinued immediately and the device under test must be

repaired or labeled as defective.

7 Testing and Maintenance Visual Inspection

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. On the Toco not damaged. Check that all mountings are correctly installed and secure. Refer to the instructions that accompany the relevant mounting solution.

After Each Service, Maintenance or Repair Event

Ensure all fuses accessible from the outside comply with the manufacturer’s specification.

Check:

• the integrity of mechanical parts, internally and externally.

• any damage or contamination, internally and externally.

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

transducer and the patient module, ensure that the adapter cable socket is

Safety Tests

Safety test requirements are set according to international standards, their national deviations and specific local requirements. The safety tests detailed in this Service Guide are derived from international standards but may not be sufficient to meet local requirements. We recommend that you file the results of safety tests. This may help to identify a problem early particularly if the test results deteriorate over a period of time.

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.

• You need test equipment (for example, a Safety Analyzer) to perform the tests. Ensure the test equipment is specified to be suitable for the respective test(s). Refer to the documentation that accompanies the test equipment. Only skilled technicians should perform safety testing.

• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step to maintain approval agency status. You can also use the Safety Analyzer as a troubleshooting tool to detect abnormalities of line voltage and grounding plus total current loads.

• During safety testing, high voltage and electrical currents are applied to the device under test. This could result in danger to the safety analyzer operator.

• For Europe and Asia/Pacific, the monitor complies with: IEC60601-1:1988 + A1:1991 + A2:1995 = EN60601-1:1990 +A1:1993 + A2:1995 For USA, the monitor complies with: UL60601-1 For Canada, CAN/CSA C22.2#601.1-M90

Safety Tests 7 Testing and Maintenance

• Additional tests may be required according to local regulations.

• Any device that is connected to the medical device must comply with IEC/EN 60601-1, and UL60601-1:2003 for the USA, if within the patient vicinity and be separately tested at the same intervals as the monitor.

• Perform safety tests as described on the following pages.

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. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using an approved safety tester, perform the tests in accordance with the information provided by the manufacturer of the tester and in accordance with your local regulations, for example IEC/EN 60601-1, UL60601-1 (US), IEC/EN 62353, and IEC/EN 60601-1-1. The safety tester should print results as detailed in this chapter, together with other data.

Please refer to Annex C of IEC/EN 62353 for requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents.

The following symbols are used in the diagrams illustrating the safety tests:

Supply mains Protective earth

L, N

.........

CAUTION After each service, maintenance or repair event:

Ensure all fuses accessible from the outside comply with the manufacturer’s specification.

Check:

• the integrity of mechanical parts, internally and externally.

Supply mains terminals

Mains part Applied part

F-type applied part Measuring device

Resistance measuring device Connection to accessible parts

Optional connection

Protective earth terminal

• any damage or contamination, internally and externally.

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

7 Testing and Maintenance Safety Tests

S(1): Protective Earth Resistance Test

Test to perform:

Measuring circuit for the measurement of Protective Earth Resistance in medical electrical equipment that is disconnected from the supply mains.

This measures the impedance of the Protective Earth (PE) terminal to all exposed metal parts of the Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE).

Measurements shall be performed using a measuring device capable to deliver a current of at least 200 mA.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, and

For measurement limits, refer to test block Safety (1), “Test and Inspection Matrix” on page 42.

Report the highest value (X1).

NOTE If the protective earth resistance test fails, testing must be discontinued immediately and the device

under test must be repaired or labeled as defective.

UL2601-1 Ed. 2/UL60601-1:2003.

S(2): 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.

Safety Tests 7 Testing and Maintenance

This test measures leakage current of exposed metal parts of the FM40/FM50 monitor and the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 closed (Normal Condition).

There are no parts of the equipment that are not protectively earthed.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, and

UL2601-1 Ed. 2/UL60601-1:2003.

For measurement limits, refer to test block Safety (2), “Test and Inspection Matrix” on page 42.

Report the highest value (X1).

S(3): 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.

There are no parts of the equipment that are not protectively earthed.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, and

UL2601-1 Ed. 2/UL60601-1:2003.

For measurement limits, refer to test block Safety (3), “Test and Inspection Matrix” on page 42.

Report the highest value (X2).

S(4): Applied Part Leakage Current - Mains on Applied Part

NOTE During measurement of the Applied Part Leakage Current it is possible that the measured current can

exceed the allowed limit (per IEC/EN 60601-1 or IEC/EN 62353).

This can occur when the safety tester is connected to more than one connector simultaneously, that is, either to two fetal sensor connectors at the same time, or to a fetal sensor connector and the SpO connector at the same time during the applied leakage current measurement.

The connectors for the fetal sensors and for SpO

are independently functioning connectors.

7 Testing and Maintenance Safety Tests

SpO2 Connector Fetal Sensor Connectors

Test one connector at a time! Do not connect the tester to the SpO2 connector at the same time as one of the fetal sensor sockets.

Although there are individual connectors on the front end, internally those parameters use the same electrical insulation interface and are hardwired to each other. This results in an electrical short of those connectors during measurement if a test current is applied simultaneously. Therefore this should be avoided.

Due to the combined insulation interface, it is sufficient to connect to only one parameter interface (that is, one of the fetal sensor connectors or SpO

) of the fetal sensor/SpO2 measurement block. This

avoids a short and the potential of exceeding the limit for the current.

Test to perform:

MECG Electrodes

DECG Electrodes

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 264V. Each polarity combination possible shall be tested. This test is applicable for ECG measurement inputs.

There are no parts of the equipment that are not protectively earthed.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, and

UL2601-1 Ed. 2/UL60601-1:2003.

For measurement limits and test voltage, refer to test block Safety (4), “Test and Inspection Matrix” on page 42.

Report the highest value. (X1).

System Test 7 Testing and Maintenance

System Test

After mounting and setting up a system, perform system safety tests according to IEC/EN 60601-1-1.

What is a Medical Electrical System?

A medical electrical system is a combination of at least one medical electrical device and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

• Devices forming a system must comply with IEC/EN 60601-1-1.

• Any device that is connected to the medical device must comply with IEC/EN 60601-1-1 if outside the patient vicinity and be tested accordingly.

General Requirements for a System

After installation or subsequent modification, a system must comply with the requirements of the system standard IEC/EN 60601-1-1. Compliance is checked by inspection, testing or analysis, as specified in the IEC/EN 60601-1-1 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.

Relevant standards for some non-medical electrical equipment may have limits for equipment leakage currents higher than required by the standard IEC/EN 60601-1-1. These higher limits are acceptable only outside the patient environment. It is essential to reduce equipment leakage currents when nonmedical electrical equipment is to be used within the patient environment.

System Example

This illustration shows a system where both the medical electrical equipment and the non-medical electrical equipment are situated at the patient’s bedside.

Key:

Non-Medical Devices

Distance to patient

must be >= 1.5m

Power cables:

Data cables:

Personal

Computer

Isolation Transformer

Medical Devices

Fetal Monitor

7 Testing and Maintenance Performance Assurance Tests

WARNING • Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple

portable socket-outlet is used, the resulting system must be compliant with IEC/EN 60601-1-1.

• Do not connect any devices that are not supported as part of a system.

• Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-1. Any non-medical device, including a PC running an OB TraceVue system, placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 606011-1) that ensures mechanical fixing of the power cords and covering of any unused power outlets.

Performance Assurance Tests

Some of the following test procedures must be performed in service mode. To enter service mode select Operating Modes in the main menu. Then select Service Mode and enter the password.

Noninvasive Blood Pressure Performance Tests

This section describes noninvasive blood pressure test procedures. The monitor must be in service mode.

Table 3 gives the expected test results for each of the tests.

Accuracy Test

This test checks the performance of the noninvasive blood pressure measurement. Connect the equipment as shown:

Tools required:

• Reference manometer (includes hand pump and valve), accuracy 0.2% of reading.

• Expansion chamber (volume 250 ml +/- 10%)

• Appropriate tubing.

Expansion Chamber

Tubing

Connect to Noninvasive Blood Pressure socket

Manometer

In service mode, the systolic and diastolic readings indicate the noise of noninvasive blood pressure channels 1 and 2 respectively. When static pressure is applied, the reading in noninvasive blood pressure channel 1 should be below 50. The value in parentheses indicates the actual pressure applied to the system.

Performance Assurance Tests 7 Testing and Maintenance

Connect the manometer and the pump with tubing to the noninvasive blood pressure connector

on the monitor and to the expansion chamber.

2 In service mode, select the Setup NBP menu.

3 Select Close Valves: On

4 Raise the pressure to 280 mmHg with the manometer pump.

5 Wait 10 seconds for the measurement to stabilize.

6 Compare the manometer values with the displayed values.

7 Document the value displayed by the monitor (X1).

8 If the difference between the manometer and displayed values is greater than 3 mmHg, calibrate

the noninvasive blood pressure measurement. If not, proceed to the leakage test.

9 To calibrate the noninvasive blood pressure measurement, select Close Valves off then

Calibrate NBP and wait for the instrument to pump up the expansion chamber.Wait a few

seconds after pumping stops until EnterPrVal is highlighted and then move the cursor to the value shown on the manometer. If one of the following prompt messages appears during this step, check whether there is leakage in the setup:

– NBP unable to calibrate–cannot adjust pressure

– NBP unable to calibrate–unstable signal

10 Press Confirm.

If the INOP NBP Equipment Malfunction message occurs in monitoring mode, go back to service mode and repeat the calibration procedure.

Leakage Test

The noninvasive blood pressure leakage test checks the integrity of the system and of the valve. It is required once every two years and when you repair the monitor or replace parts.

1 If you have calibrated, repeat steps 2 to 6 from the accuracy test procedure so that you have 280

2 Watch the pressure value for 60 seconds.

3 Calculate and document the leakage test value (X2).

Linearity Test

1 Reduce the manometer pressure to 150 mmHg.

2 Wait 10 seconds for the measurement to stabilize.

mmHg pressure on the expansion chamber.

X2 = P1 - P2 where P1 is the pressure at the beginning of the leakage test and P2 is the pressure displayed after 60 seconds. The leakage test value should be less than 6 mmHg.

3 After these 10 seconds, compare the manometer value with the displayed value.

4 Document the value displayed by the monitor (X3)

5 If the difference is greater than 3 mmHg, calibrate the noninvasive blood pressure measurement

(see steps 9 to 10 in the accuracy test procedure).

7 Testing and Maintenance Performance Assurance Tests

Valve Test

1 Raise the pressure again to 280 mmHg.

2 Select Close valves: Off.

3 Wait five seconds and then document the value displayed. The value should be less than 10

mmHg.

4 Document the value displayed by the monitor (X4).

Expected Test Results

Te s t Expected test results

Accuracy test x1 = value displayed by monitor

Difference ≤ 3mmHg

Leakage test x2 = leakage test value

x2 < 6 mmHg

Linearity test x3 = value displayed by monitor

Difference ≤ 3mmHg

Valve Test x4 = value < 10 mmHg

SpO2 Performance Test

This test checks the performance of the SpO2 measurement.

Tools required: none

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

Expected Test Results

Te s t Expected test results

SpO2 Per formance Test 95% and 100%

Measurement Validation

The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SaO

The population characteristics for those studies were:

value on your finger (this assumes that you are healthy).

transducer to the SpO2 connector.

were studied.

• Gender: about half female and half male subjects

• Age range: 18 to 45 years

• Skin tone range: from light to very dark

Reporting of Test Results 7 Testing and Maintenance

NOTE

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification.

Reporting of Test Results

Philips recommends all test results are documented in accordance with local laws. Authorized Philips personnel report test result back to Philips to add to the product development database. 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.

Table 3 lists what to record after completing the tests in this chapter. Record the results in the empty column in Table 3.

The following is a guide as to what your documentation should include:

• Identification of the testing body (for example, which company or department carried out the tests).

• Name of the person(s) who performed the tests and the concluding evaluation.

• Identification of the device(s) being tested (serial number, etc.).

• Date of testing and of the concluding evaluation.

• A record of the actual values of the test results, and whether these values passed or failed the tests.

7 Testing and Maintenance Reporting of Test Results

Carrying Out and Reporting Tests

Table 3: Test and Inspection Matrix

Test Block

Visual Inspection Perform Visual

Power On Power on the unit.

Noninvasive Blood Pressure Performance Tests

SpO

Performance Test

Safety (1) Perform Safety Test

Safety (2) Perform Safety Test

Safety (3) Perform Safety Test

Safety (4) Perform Safety Test

System Perform the system

Key: P = Pass, F = Fail, X = test result value to be recorded

Test or Inspection to be Performed

Inspection (see “Visual Inspection” on page 32).

Does the self-test complete successfully?

Perform the Accuracy Test (see page 38).

Performance Leakage Test (see page 39).

Performance Linearity Test (see page 39).

Performance Valve Test (see page 40).

Perform the SpO2 Performance Test (see page 40).

(1): Protective Earth Resistance.

(2): Equipment Leakage Current Normal Condition.

(3): Equipment Leakage Current Single Fault Condition (Open Earth).

(4): Patient Leakage Current - Single Fault Condition, mains on applied part.

test according to sub clause 19.201 of IEC/ EN 60601-1-1, if applicable, after forming a system.

Expected Test Results

Pass or Fail V:P or V:F

If Yes, Power On test is passed. PO:P or PO:F

X1 = value displayed by monitor

Difference <= 3mmHg X2 = leakage test value

X2 < 6 mmHg X3 = value displayed by monitor

Difference <= 3mmHg X4 = value < 10 mmHg PN:P/X4 or

Value should be between 95% and 100%

With mains cable: Maximum impedance (X1): <= 300 mOhms

With mains cable: Maximum leakage current (X1): <= 100μA

With mains cable: Maximum leakage current (X2):

<= 300μA

Maximum leakage current (X1): <= 50μA @ 264V

Equipment Leakage Current: <= 100μA (Normal Condition) <= 300μA (Single Fault Condition)

Protective Earth Leakage Current of Multiple Portable Socket-Outlets: <= 500μA

Patient Leakage Current: <= 10μA (Normal Condition)

Record the Results (mandatory for

Philips Personnel only)

What to Record Actual Results

PN:P/X1 or

PN:F/X1 PN:P/X2 or

PN:F/X2 PN:P/X3 or

PN:F/X3

PN:F/X4 No reporting

necessary

S(1):P/X1 or

S(1):F/X1

S(2):P/X1 or

S(2):F/X1

S(3):P//X2 or

S(3):F/X2

S(4):P/X1 or

S(4):F/X1

System test:P or

System test:F

Other Regular Tests 7 Testing and Maintenance

Other Regular Tests

The care and cleaning requirements that apply to the monitor and its accessories are described in the Instructions for Use. This section details the periodic maintenance recommended for the monitor, transducers and accessories.

Transducers and Patient Modules: Functional Tests

If any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel.

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.

To test an ultrasound transducer:

1 Switch on the monitor and the recorder.

2 Connect the transducer to the fetal monitor.

3 Select the fetal heart sound for this channel.

4 Increase the loudspeaker volume to an audible level.

5 The ultrasound transducer contains seven piezoelectric crystals. Basic functioning of each can be

verified by holding a flat bottomed pencil or similar above each crystal and moving it up and down as shown.

7 Testing and Maintenance Other Regular Tests

A sound should be heard for each crystal tested. The pencil should be held two to three centimeters

from the transducer surface when the test is carried out.

Crystals

7 A sound should also be heard when the transducer is moved back and forth over a solid surface, or

the hand as shown.

Toco Transducer Electrical Check

To test a Toco transducer:

1 Switch on the monitor and the recorder.

2 Connect the transducer to the fetal monitor.

3 Gently apply pressure to the Toco sensor.

Other Regular Tests 7 Testing and Maintenance

Check that the value on the display and paper shows this change in pressure.

5 Lay the transducer face up on a hard, flat surface for a few seconds.

6 Press the Toco Baseline Key to re-adjust the Toco display to 20.

7 Turn the transducer over so that the Toco sensor is resting on the flat surface. You should see a

marked increase in the value of the Toco reading in the Toco display.

Toco display = 20

Toco display = 35 - 45

Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): DECG Mode

1 Switch on the monitor and the recorder.

2 Connect the patient module or Toco

3 Attach the DECG adapter cable M1362B to the socket on the patient module or Toco

4 Ensure that the DFHR channel display on the fetal monitor shows the DECG LEADS OFF

INOP with the DECG adapter cable attached.

5 Take a Fetal Scalp Electrode, and connect it to the DECG adapter cable.

6 EITHER

Hold the reference electrode between the thumb and index finger of one hand, and touch the spiral electrode with the index finger of the other hand, as illustrated below. This makes a short between

transducer to the fetal monitor.

transducer.

7 Testing and Maintenance Other Regular Tests

the spiral electrode and the reference electrode (it is best to wet your fingers first). Use a sterile Fetal Scalp Electrode.

CAUTION The tip of the spiral electrode is sharp. Take care not to injure your fingers.

Spiral Electrode

Reference Electrode

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.

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; it allows only a check of general function.

Result: the DECG LEADS OFF INOP should disappear.

Viewing the ECG wave: when configured, you can view the DECG wave on the screen, and any

noise will be visible as additional verification of the effectiveness of the test.

If the test results are not as outlined above, repeat the test with another ECG transducer. If this does not solve the problem, try the following:

• Check all connections.

•If the DECG LEADS OFF INOP is still displayed, the DECG adapter cable may be defective. Replace the adapter cable.

If the problem persists, replace the transducer.

Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): MECG Mode

1 Switch on the monitor and the recorder.

2 Connect the patient module or Toco

transducer to the fetal monitor.

3 Attach the MECG adapter cable M1363A to the red color-coded socket on the patient module or

transducer

To c o

Other Regular Tests 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; it allows only a check of general function.

Result: You should see MECG values displayed on the maternal display or annotated on the recorder trace.

If the test results are not as outlined above, repeat the test with another ECG transducer. If this does not solve the problem:

• The MECG adapter cable may be defective. Replace the adapter cable, and repeat the test.

• Check all connections.

Testing the Patient Module (M2738A)/Toco+ Transducer (M2735A): IUP Mode

To test the IUP functionality of the patient module or the Toco+ transducer, you need the following:

Toco+ transducer (shown) or patient module

•Manometer.

• Expansion chamber.

Connect to one of the fetal sensor sockets

IUP cable (9898 031 43931)

Cut end of catheter

IUP catheter (M1333A)

Expansion chamber

‘T’ adapter

Manometer

• Three lengths of silicone tubing with a ‘T’ adapter.

1 Switch on the monitor and the recorder.

7 Testing and Maintenance Other Regular Tests

Connect the patient module or Toco+ transducer to the fetal monitor.

3 Attach the IUP adapter cable (989803143931) to the socket on the patient module or Toco

transducer.

4 Cut the sensor tip off an IUP catheter (M1333A).

5 Connect the catheter to the IUP adapter cable.

6 Connect the silicone tubing to the test volume chamber and the manometer as shown in the picture.

7 Connect the cut end of the catheter to the silicone tubing.

8 Apply a pressure of 80 mmHg ± 5 mmHg with the manometer. Check that the value on the display

and on trace corresponds to this pressure. Slowly release the pressure, and check that the value on the display and on trace shows this change in pressure.

Touchscreen Calibration

To access the touchscreen calibration screen:

1 Enter service mode

2 Select Main Setup

3 Select Hardware

4 Select Calibrate Touch

Make sure you complete the calibration procedure without powering off the monitor mid-way. If the monitor is powered off after the first point is touched, the touch panel will be deactivated until the touch calibration is performed again.

Other Regular Tests 7 Testing and Maintenance

If the touchscreen is accidentally mis-calibrated by selecting the wrong spot, you must use another input device to re-enter calibration mode, for instance, a mouse connected to the PS/2 interface. If you have the support tool, you can select Start Touch Calibration and it will create a rough calibration which will allow you to access the calibration menu again via the touchscreen.

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 Main Screen key again for about three seconds to re-enable touchscreen operation.

Checking the Fetal Recorder Offset

To check the recorder offset:

1 Connect a Toco transducer to the monitor.

2 Place the Toco transducer on a flat surface so that it is resting on the belt button, and is therefore

not under any load.

3 Start the recorder, and press the Paper Advance key three times to make sure that at least three

pages of paper have advanced.

4 If the Toco trace is recording exactly on the 20 unit gridline, then the offset is correctly set.

5 If the Toco trace is not recording exactly on the 20 unit gridline, then set the offset as described in

“Setting the Fetal Recorder Offset”.

Setting the Fetal Recorder Offset

To set the fetal recorder offset, you first need to run the fetal recorder calibration:

1 Enter Service Mode.

2 In Main Setup, select Fetal Recorder to enter the Fetal Recorder menu.

The current setting for the recorder offset is shown (but it is still grayed out, and you cannot select it yet).

3 Select Calibration to start the recorder calibration printout.

4 The recorder stops, and the Cal. Offset becomes selectable.

5 Look at the section of the printout entitled “Calibration”.

You will see the numbers 0 to 10, and each number has a line printed below it. See for which number the line best fits the 20 unit gridline (8 in this example).

7 Testing and Maintenance Other Regular Tests

Select Cal. Offset, and select the offset value from 0 to 10 from the list, as determined in step

7 The recorder then finishes the calibration printout. Confirm that the line prints on the 20 unit

gridline.

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 (see “Trace Header” on page 54

Selftest status

Print quality data

Recorder electrical data

Paper-related data (Paper Count is the number of pages detected in this test)

Example of selftest report

This line should print exactly on the 20 unit gridline (Toco baseline) if the recorder is correctly calibrated.

Expected value for PH Volt Min is 0. If value is greater that 0, there may be a TLPH voltage problem.

Speed Value is the tolerance for paper detection. Value should be less than 20. If it is more, there could be a recorder assembly problem. A Paper Value of 2994 is optimal: you may see small variations from this figure.

Other Regular Tests 7 Testing and Maintenance

Check the test pattern to ensure all the heating elements on the printer head are operational. Ensure that:

• No more than 20 dots are missing over the entire printhead.

• No more than 2 adjacent dots are inoperative.

• No dots in the mode annotation (for example, FHR1) are inoperative.

If any of the above conditions are not met, replace the recorder assembly (see “Removing the Recorder Assembly” on page 107).

Ensure that all printed lines are straight. If the lines are not straight, there may be a problem with the paper recorder speed.

7 Testing and Maintenance Other Regular Tests

8Troubleshooting

A list of system error messages and troubleshooting information for common problems you may encounter while using the monitor and its accessories is given in the Instructions for Use. This chapter provides a guide for qualified service personnel for troubleshooting problems that cannot be resolved by the user.

CAUTION If the troubleshooting procedure requires you to disassemble the monitor or transducers, be certain to follow

the disassembly and reassembly procedures given in Chapter 10, “Disassembly and Reassembly”.

Who Should Perform Repairs

Only qualified service personnel should open the monitor housing, remove and replace components, or make adjustments. If your medical facility does not have qualified 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. Do not perform any disassembly procedures with power applied to the instrument. Failure to adhere to this warning could cause serious injury or death.

Replacement Level Supported

The replacement level supported for this product is to the printed circuit board (PCB) and major subassembly level. Once you isolate a suspected PCB, follow the procedures in Chapter 10, “Disassembly and Reassembly” to exchange the PCB with a known good replacement. Check to see if the symptom disappears and that the monitor passes all performance tests. If the symptom persists, swap back the replacement PCB with the suspected malfunctioning PCB (the original PCB that was installed when you started troubleshooting) and continue troubleshooting as directed in this chapter.

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” on page 54).

• You can also identify the hardware revision via the Main Setup menu (see “Hardware Revision Check” on page 54).

8 Troubleshooting Checking Revision Information

• You can also identify the software revision via the Main Setup menu (see “Software Revision Check” on page 55).

Trace Header

The trace header printed when the recorder starts contains useful information about the monitor and its parameters.

1 2

• The first line (marked 1) contains:

–the time.

–date.

–set paper speed.

• The second line (marked 2) contains:

– result of the selftest.

– firmware revision of the FPGA microcontroller, responsible for controlling the recorder, the display

and the ultrasound tone. This revision is always fixed with a particular software revision.

– revision of the internal recorder communication protocol. This revision is always fixed with a

particular software revision.

–paper type (US or INT).

– information on whether the recording is a real-time trace (RT appears), or a stored data/trace

recovery printout (RT is not printed).

– information on the printhead intensity (I).

• The rest of the information (marked 3) contains:

– product serial number and firmware revision.

– Bus Master firmware revision (OB).

– serial number and firmware revision of connected devices.

If a transducer is plugged into the monitor after the recorder started, the serial number and revision information is annotated along the bottom of the trace.

Hardware Revision Check

Some troubleshooting tasks may require that you identify the hardware revision of your monitor’s main board. To check your hardware revision:

1 Enter the Main Setup menu and select Revision.

2 Select Product.

You see the hardware revision in the pop-up window, along with the serial number, part number, and the software revision.

Obtaining Replacement Parts 8Troubleshooting

Software Revision Check

Some troubleshooting tasks may require that you identify the software revision of your monitor. You can find the software revision along with other information, such as the system serial number, in the monitor revision screen.To access the monitor revision screen:

1 Enter the Main Setup menu and select Revision.

2 Select Product.

You see the software revision in the pop-up window, along with the serial number, part number, and the hardware revision.

NOTE The part numbers listed in the monitor revision screen do not necessarily reflect the part numbers required

for ordering parts. Please refer to Chapter 9, “Parts” for the ordering numbers. Photos of the parts are included for swift identification.

NOTE The system serial number can also be found on the rear of the monitor.

Obtaining Replacement Parts

See Chapter 9, “Parts”, for details on replacement parts.

Troubleshooting Guide

Problems with the monitor are separated into the categories indicated in the following sections and tables. Check for obvious problems first. If further troubleshooting instructions are required refer to the Troubleshooting Tables.

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

When first troubleshooting the instrument, check for obvious problems by answering basic questions such as the following:

1 Is the AC power cord connected to the instrument and plugged into an AC outlet?

2 Is the power switch turned on?

Checks Before Opening the Instrument

You can isolate many problems by observing indicators on the instrument before it is necessary to open the instrument.

Checks with the Instrument Switched On, AC connected

When the monitor is connected to AC mains, the green power LED is constantly lit. After switching on, the green power LED blinks during the boot phase, and then remains lit during normal operation. The location of the green LED is shown in the following photograph:

8 Troubleshooting Troubleshooting Guide

Green Power LED

Individual Parameter INOPs

If you see any of the following parameter INOPs:

DECG EQUIP MALF IUP EQUIP MALF

ECG EQUIP MALF NBP EQUIP MALF

FetRec EQUIP MALF OB EQUIP MALF

FHR1 EQUIP MALF SpO

FHR2 EQUIP MALF SpO

FHR3 EQUIP MALF TOCO EQUIP MALF

EQUIP MALF

SENSOR MALF

try exchanging the relevant component (transducer, sensor, patient module or board) with a known good replacement, following the procedures in Chapter 10, “Disassembly and Reassembly”. Check to see if the INOP disappears, and that you can measure the parameter in question normally. If the INOP persists, swap back the original component and continue troubleshooting as directed in this chapter.

If you see the

OB EQUIP MALF INOP following a monitor software upgrade, it is likely that the firmware

in the bus master section of the API 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.

After checking/upgrading the bus master firmware, and you still suspect a defective API Board, first try plugging the transducers into another monitor. If the transducers work properly with the other monitor, then exchange the API Board.

In the case of the INOPs there are two or more ultrasound transducers attached to the monitor,

FHR1 EQUIP MALF, FHR2 EQUIP MALF, and FHR3 EQUIP MALF, when

identify the transducer for which

the INOP was issued, using the blue transducer Finder LED. Touching a numeric on the screen makes the Finder LED light on the transducer providing the measurement. If you cannot identify the suspected transducer directly because the transducer Finder LED does not light due to the defect, identify the other, functioning transducers by activating their Finder LEDs, thus finding the defective one by a process of elimination.

Troubleshooting Guide 8Troubleshooting

Initial Instrument Boot Phase

The following table describes the regular initial boot phase of the monitor. If the boot phase does not proceed as described below, go to Boot Phase Failures for troubleshooting information.

Boot Phase Boot Phase Event

1 Switch the monitor on using the On/Off switch. (Green power light is lit as soon as the

device is connected to AC mains.)

2 The green AC Power LED blinks for about during the boot phase.

3 You hear a ‘pop’ from the loudspeaker.

4 Green AC Power LED stops blinking, and remains lit.

5 Boot Screen with the Philips Logo appears on the display. Test Sound is issued.

6 Boot Screen with the Philips Logo disappears.

Fixed screen elements (for example smart keys, alarm fields) appear on the screen.

7 First measurement information appears on the screen, touchscreen is functional.

Troubleshooting Tables

The following tables list troubleshooting activities sorted according to symptoms.

How to Use the Troubleshooting Tables

The possible causes of failure and the remedies listed in the troubleshooting tables should be checked and performed in the order they appear in the tables. Always move on to the next symptom until the problem is solved.

•Boot Phase Failures

•Screen is Blank

• Touchscreen not Functioning

• General Monitor INOP Messages

•Network Status Icons

•Alarm Tones

•Fetal Recorder

• Keyboard/Mouse Not Functioning

•LAN / RS232

• Remote Touchscreen Display Not Responding

8 Troubleshooting Troubleshooting Guide

Boot Phase Failures

Symptoms Possible Cau ses of

Failure

Green LED does not light up, and no test tone is heard

Green LED does not blink after pressing power On/Off switch

Cyclic reboot:

a) the monitor tries to boot

b) power fails c) LED blinks d) display comes on

briefly, then goes dark e) green LED stays lit f) boot cycle starts again

and sequence repeats

No Test Sound issued or INOP

Speaker

Malfunct.

issued

No AC mains connection Check that the power cord is not damaged and is

Power supply defective

Switch board cable disconnected, or not firmly connected to the API Board connector

Switch board defective

API Board defective

Switch board defective Replace the switch board.

Defective processor on API Board

Hardware failure caused by a short circuit, most likely the result of a NBP board defect

Speaker cable disconnected

Speaker defective

API Board defective

Failure Isolation and Remedy

properly connected to the monitor. Check that the power cord is correctly connected to a powered AC mains socket.

Remove power supply and check if output voltage is within the specifications (24V). Measure on multicolored wired connection between red and black wires.

Exchange power supply if defective.

Check that the switch board cable is firmly connected to API Board connector.

Replace the switch board.

Replace API Board. Add boards in reverse order and try again with each board.

Replace the API Board.

First disconnect the NBP board. Reconnect the NBP board, making sure all cables are connected securely. If the problem persists, replace the NBP assembly.

Check speaker connections.

Check for INOPs and follow instructions

Exchange speaker

Exchange API Board

Screen is Blank

The information listed in this table is only valid if the boot phase has completed without error. See Boot Phase Failures table for a description of the boot phase.

Troubleshooting Guide 8Troubleshooting

Symptoms Possible Ca u ses of

Display is blank or brightness is reduced

Touchscreen not Functioning

Symptoms Possible Causes of

Touchscreen not functioning

Touch Position invalid Possible touch calibration

Failure Isolation and Remedy

Failure

Display flex cable not connected properly

Backlight tubes defective Replace complete Front Bezel Assembly.

Backlight inverter defective

LCD flat panel defective

API Board defective Replace API Board.

Check cable connection is secure at both ends of the display flex cable.

Failure Isolation and Remedy

Failure

Touchscreen functionality has been temporarily disabled

Touch screen cable not connected

Touch controller defective Replace API Board

Tou c h S e n so r d e f e c t iv e Replace Front Bezel Assembly

problem

Check if touchscreen functionality has been temporarily disabled (padlock symbol on Main Screen key). If yes, press and hold the Main Screen key to re-enable touchscreen operation.

Check connection from the Display Assembly to the API Board.

First check the existing calibration offset:

Touch any point on the screen with a suitable plastic pointer (such as a touch stylus from a palm PC).

2 Check offset between the point of contact and

the cursor position.

3 If the offset is greater than 5 mm, perform

touch calibration.

To perform touch calibration:

Enter Service Mode

2 Enter the Main Setup Menu

3 Select Hardware

4 Select Calibrate Touch

See “Touchscreen Calibration” on page 48.

8 Troubleshooting Troubleshooting Guide

General Monitor INOP Messages

INOP Message Possibl e Causes of

Failure Isolation and Remedy

Failure

CheckInternVoltage

Check Monitor Func

Check Monitor Temp The temperature inside the

Check Settings

Internal.Comm.Malf. Main CPU Board defective Replace Main CPU Board.

Settings Malfunc. Problem during cloning

Problem with the voltages (5V) in the monitor

monitor is too high

Main Board defective

INOP occurs during normal operation, indicating a possible monitor software problem

INOP occurs after a software upgrade, indicating a possible incomplete or unsuccessful upgrade

process.

Memory space in which the settings are stored has been corrupted

Main CPU Board defective

Remove all I/O boards and put them back in one at a time to isolate any defective board. If this does not resolve the problem, replace the main board.

Check the environment for possible causes.

Replace Main Board.

Check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software.

1 Silence the INOP.

2 Load the User Defaults (see “Loading the User

Defaults” on page 122).

3 If this is unsuccessful, try loading the Factory

Default (see “Loading the Factory Default” on page 122), and reconfigure the monitor in Configuration Mode, and save the new settings in the User Defaults.

If the INOP persists, there is an unresolved software problem. Report the problem to factory support.

Clone the correct settings via the Support Tool.

Reclone configuration file.

Reclone configuration file. This will reload the memory space.

Replace Main CPU Board.

Troubleshooting Guide 8Troubleshooting

Network Status Icons

Icon Explanation

No Icon LAN cable not connected (monitor does not have a LAN connection).

LAN cable connected, no connection to OB TraceVue.

Alarm Tones

To check whether an IP Address has been assigned, enter

Information

OB TraceVue may send a prompt message, giving the reason why connection to OB TraceVue cannot take place.

LAN cable connected, IP address assigned, monitor connected to OB TraceVue.

OB TraceVue may send a prompt message, indicating a possible problem.

and scroll to IP Address. (0.0.0.0 means no IP address has been assigned.)

Symptoms Possible Causes of

Failure

INOP Message Speaker

Malfunct.

Alarm occurs but no alarm sound is issued

is displayed

Speaker cable disconnected

Speaker defective

Sound amplifier on API Board defective

Vol u me s et t o 0 Increase volume

Speaker defective

Sound amplifier on API Board defective

Main Setup --> Bed

Failure Isolation and Remedy

Reconnect speaker cable

Replace speaker

API Board

Replace speaker

API Board

Alarm Behavior

If your monitor did not alarm in the way in which the end user expected, please consult the Instructions for Use for possible setup issues or configuration settings which could affect alarm behavior.

Fetal Recorder

Symptom Pos sible Cause Corrective Action

Paper empty warning is issued in the status line at the bottom of the screen, but paper is not out.

Drawer is open.

Paper jam. Open the drawer, remove paper, tear off scrumpled

Paper sensor disconnected.

Paper sensor defective.

Close the drawer.

paper and re-load, or load a new pack of paper. Close the drawer.

To minimize the risk of paper transport problems, use the recorder with the paper guide.

Check the paper sensor flex cable connection to the API Board.

Replace Recorder Assembly.

8 Troubleshooting Troubleshooting Guide

Symptom Possible Cause Corrective Action

No paper transport. Drawer is open, or not

properly closed.

Paper jam.

Stepper motor cable is disconnected.

Stepper motor is defective.

The recorder appears to be running normally, but the paper remains blank

No recorder key is available on the screen, and the INOP

FetRec EQUIP

MALF

is issued.

Thermal Printhead is disconnected.

Thermal Printhead is defective.

The wrong side of the paper is facing up.

The recorder has not been calibrated.

EEPROM on the API Board is defective

Recorder Controller on the API Board is defective.

Recorder cable is disconnected.

Close the drawer.

Open the drawer, remove paper, tear off scrumpled section of paper and re-load, or load a new pack of paper. Close the drawer.

To minimize the risk of paper transport problems, use the recorder with the paper guide.

Check that the stepper motor cable is properly connected to the API Board.

To test the functioning of the motor, open the drawer and press the recorder key to start the recorder. A good motor should rotate.

If the motor does not rotate:

Check the stepper motor is connected

Paper Advance

properly to the API Board.

2 If the problem persists, replace the recorder

assembly.

Check the connection. Then run the recorder Selftest to verify correct printing (see “Fetal Recorder Selftest Report” on page 50).

Replace the recorder assembly. Then calibrate the recorder (see “Setting the Fetal Recorder Offset” on page 49).

Load the paper correctly, the right way up.

Calibrate the recorder (see “Setting the Fetal Recorder Offset” on page 49).

Exchange the API Board and calibrate the recorder (see “Setting the Fetal Recorder Offset” on page 49).

Ensure the recorder cable is connected firmly at both ends.

Troubleshooting Guide 8Troubleshooting

Symptom Pos sible Cause Corrective Action

The INOP CHECK PAPER is issued.

The drawer is open and there is paper on the paper

Ensure the paper is loaded correctly, and close the drawer.

sensor.

Paper jam.

Open the drawer, remove paper, tear off scrumpled section of paper and re-load, or load a new pack of paper. Close the drawer.

Paper sensor dirty.

Clean paper sensor (see “Fetal Recorder Maintenance” on page 31).

Paper sensor defective.

The rubber roller is slipping.

Exchange the recorder assembly.

Clean the rubber roller (see “Fetal Recorder Maintenance” on page 31).

Paper is not approved by

Use only paper approved by Philips.

Philips.

The INOP WRONG PAPER

SCALE

is issued.

Inadequate contrast of paper marks, or no paper marks.

Paper with the wrong scale has been loaded (for example, International paper has been loaded instead of

Use only Philips approved paper.

Calibrate the recorder.

Check, and if necessary, replace the paper pack with one with the correct scale. Check, and if necessary, change the paper scale setting to the correct setting for the paper used.

US paper).

The INOP PRINTHEAD

OVERHEAT

is issued.

The printhead is too hot.

Wait for the printhead to cool down, then press the recorder

Start/Stop key or the Silence

key to clear the INOP.

Bad or distorted printout within the first 1 cm of the

Paper drawer was not fully closed.

Always ensure the paper drawer is fully closed before starting recording.

trace.

Poor print quality. Heat setting needs adjusting. Adjust the Thermal Printhead heat setting.

Then run the recorder Selftest to verify correct printing (see “Fetal Recorder Selftest Report” on page 50).

Thermal Printhead dirty (there are partially missing dots on the recorder output).

Clean the Thermal Printhead (see “Fetal Recorder Maintenance” on page 31). Then run the recorder Selftest to verify correct printing (see “Fetal Recorder Selftest Report” on page 50).

Thermal Printhead failure.

Exchange the Recorder Assembly. Then run the recorder Selftest to verify correct printing (see “Fetal Recorder Selftest Report” on page 50).

Paper not feeding properly. Paper incorrectly loaded. Load paper correctly.

The rubber roller is dirty.

Clean the rubber roller (see “Fetal Recorder Maintenance” on page 31 ).

Trace is not printed correctly with reference to the paper gridlines.

Offset needs adjusting. Calibrate the recorder and change the offset (see

“Setting the Fetal Recorder Offset” on page 49).

The wrong paper scale is being used.

Ensure the paper you are using matches the paper scale setting.

8 Troubleshooting Troubleshooting Guide

LAN / RS232

Symptoms Cause of Failure Failure Isolation and Remedy

External device (such as a surveillance system like OB Tr a c e Vu e ) no t r e c e i v i n g data

The LAN/RS232 port is not configured for data export

The cable between the external device and the monitor is not connected correctly or defective

The external device does not support the version of the data export protocol used in the monitor

A terminal concentrator is used in between the device and the monitor and a protocol with dynamic speed negotiation is used

The LAN/RS232 board is in a wrong slot (slot has been changed after software configuration or an additional board has been plugged in)

The LAN/RS232 board is defective

For RS232 connections only: the wrong cable is being used.

Check configuration of the LAN/RS232 ports in configuration mode

Check cable and replace if necessary

Check if the device supports the version of the data export protocol. Upgrade device or monitor if necessary (if matching versions exist).

Some terminal concentrators do not support changing the transmission speed (baud rate) dynamically. Check if the connection works without the concentrator

Verify correct placement of the I/O boards

Check board and replace if necessary

Check that the correct cable is being used.

Keyboard/Mouse not Functioning

Symptoms Possible Causes of

Keyboard/Mouse attached directly to the monitor not functioning

Failure

Keyboard/Mouse not connected properly

Keyboard/Mouse defective

PS/2 I/O board is not properly plugged in

PS/2 I/O board defective

Failure Isolation and Remedy

Check cabling

Replace Keyboard/Mouse

Ensure the PS/2 I/O board is properly plugged in. If necessary, remove the board and plug it in again.

Replace I/O board

Troubleshooting Guide 8Troubleshooting

Remote Touch Display not Responding (MIB/RS232)

Symptoms Possible Causes of

Touch screen operation of connected remote display not possible.

No Video on Remote Display

Symptoms Possible Causes of

No video on a connected remote display.

Failure

Cable not properly connected.

MIB/RS232 port not configured.

Factory Defaults were loaded.

Failure

Cable not properly connected.

Remote display has no power.

Failure Isolation and Remedy

Check cabling at both ends.

Configure the MIB/RS232 port (see “Connecting a Remote Display via the MIB/RS232 Interface” on page 16).

After loading the Factory Defaults, the MIB/ RS232 port assignment settings are no longer valid. Reconfigure the MIB/RS232 port (“Connecting a Remote Display via the MIB/RS232 Interface” on page 16).

Failure Isolation and Remedy

Check video cable is securely connected at both ends.

Ensure the remote display is properly connected to AC mains.

8 Troubleshooting Troubleshooting Guide

Transducers

Note that immediately after plugging in a normally functioning transducer, the Finder LED briefly lights twice.

Symptoms Possible Cause Failure Isolation and Remedy

The transducer Finder LED does not light up after plugging in the transducer, and the transducer appears not to work.

INOP

OB EQUIP MALF

is displayed.

Transducer appears not to work, and:

Defective transducer cable.

Defective connector block.

Transducer or connector block is defective.

API Board is defective.

No power to API Board.

Visually inspect the transducer cable and the cable connector for damage. If there are obvious signs of damage, replace the cable.

Visually inspect the connector block and the sensor sockets for damage. If there are obvious signs of damage, replace the connector block.

Try plugging the transducer into a different sensor socket.

• If the Finder LED works, then the original socket is defective. Replace the connector block.

• If the Finder LED still does not light in any of the other sockets, try using a known good transducer. If the Finder LED lights, the original transducer is defective: replace it.

Try using a known good transducer. If the Finder LED does not light in any of the sockets using a known good transducer, then the API Board is defective. Replace the API Board.

If both the SpO2 board and the API Board are not working, replace the API Board.

If the green power LED does not light, exchange the power supply.

EITHER the transducer Finder LED lights briefly after plugging in the transducer and INOP

EQUIP MALF

OR the transducer Finder LED lights briefly after plugging in the transducer, and there are no parameters on the screen (transducer is not recognized).

INOP

OB EQUIP MALF

is displayed.

All transducers (US, Toco, IUP and ECG) do not work.

INOP

OB EQUIP MALF

is displayed.

Transducer is defective.

API Board is defective.

Replace transducer.

Replace API Board.

Troubleshooting Guide 8Troubleshooting

Symptoms Possible Cause Failure Isolation and Remedy

Status Log

Many events that occur during start-up or regular monitoring are logged in the Status Log. The Status Log can be cleared. Not all entries in the Status Log are errors. You can print the Status Log via the Support Tool.

Transducer is connected, INOP

OB EQUIP MALF

is displayed.

After a transducer software upgrade, the message “Unknown transducer connected” is displayed at the bottom of the screen.

“Unknown transducer connected” is displayed at the bottom of the screen (not following a software upgrade)

Transducer belt button is broken or damaged.

API Board is defective.

Transducer defective.

Transducer is in boot mode, and is not recognized by the monitor.

The transducer is defective.

Mechanical damage. Replace the belt button.

Replace API Board.

Replace transducer.

Try a new software upgrade of the transducer with the Support Tool.

Replace the transducer.

Handle transducers with care.

Never use a transducer with a broken or damaged knob.

Monitor Id. Code No. Date

Time

H 18202 20100 1 4 Dec 07 16:37

C 1721 21050 1 4 Dec 07 15:37

The Status Log window shows logged events which caused a reboot of the monitor.

To enter the Status Log Window, select

Main Setup -> Revision. The following list opens up:

• Status Log

• Product

• Appl. SW

• Config

•Boot

• Language

• Settings

•OB

8 Troubleshooting Troubleshooting Guide

• FetRec

•NBP

•SpO

• List of plugged parameters

Select Status Log.

The first column in the log identifies the event class (“C”: caused a cold start, “H”: caused a hot start, “N”: no restart, for information only). Column 3 and 4 identify the event source and event code. Column 4 counts the number of occurrences of the event. The last column shows the time and date of the last occurrence of the event.

The following pop-up keys overlay the SmartKeys:

Clear StatLog

M2705A

Clear StatLog

This key clears the currently displayed Status Log

M2705A

This key switches to the Monitor Revision Window

If an event occurs repeatedly, contact your Philips Service Representative.

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:

• access the full status log which can be saved as a file

•reload software

• identify defective devices

•start touch screen calibration

For details on how to perform these tasks see the Support Tool Instructions for Use.

Troubleshooting the Individual Measurements or Applications

For problems isolated to an individual parameter or application, please consult the Instructions for Use and configuration information.

If the Instructions for Use did not resolve an individual parameter problem, then another transducer or patient module should be tried.

Troubleshooting Guide 8Troubleshooting

If you are getting questionable readings for individual measurements you may want to do the performance assurance tests in Chapter 7, “Testing and Maintenance”.

The performance of the individual applications are affected by the configuration of the monitor. When contacting Philips support you may be asked about the configuration of the monitor to aid in troubleshooting.

8 Troubleshooting Troubleshooting Guide

Spare parts, along with part numbers, are listed in the tables that follow.

Monitor

9Parts

Ordering Number

Number for New Parts Number for Exchange Parts

Description

Front Bezel Assembly, Text

(picture on page 75)

Front Bezel Assembly, Symbols

(picture on page 75)

Main CPU Board

(picture on page 76)

API Board Kit

(kit contents on page 76)

Noninvasive Blood Pressure Assembly

(picture on page 76)

Recorder Assembly

(picture on page 77)

Thermal Line Printhead (TLPH)

(picture on page 77)

Loudspeaker Assembly

Alternative

Part No.

M2705-64101 451261024941 M2705-68011 451261025131 1

M2705-64100 451261024931 M2705-68010 451261025121 1

M2705-66510 451261024951 M2705-68510 451261024961 1

M2705-64300 451261025021 M2705-68001 451261025111 1

M2703-64502 451261010271 M2703-68502 451261010551 1

M2705-60501 451261025071 M2705-68601 451261025081 1

M2705-60502 451261026321 - -1

M2705-60530 451261024971 - -1

Identifier

Part No.

Alternative

Identifier

Qty

(picture on page 77)

Top Cover

(picture on page 78)

AC/DC Power Supply

(picture on page 78)

M2705-60550 451261024921 - -1

M8105-60001 451261019041 - -1

9Parts Monitor

Ordering Number

Number for New Parts Number for Exchange Parts

Description

SpO2 Board

(picture on page 78)

LAN / RS232 Interface Assembly

(picture on page 79)

Dual PS/2 Interface

(picture on page 79)

MIB / RS232 Interface

(picture on page 79)

Fetal Sensor Socket Connector Kit

(kit contents on page 79)

Rear Connector Kit

(kit contents on page 79)

SpO2 Connector Kit

(kit contents on page 80)

Noninvasive Blood Pressure Connector Kit

Part No.

Alternative

Identifier

Part No.

Alternative

Identifier

Qty

M1020-66513 451261010601 - -1

M2703-67501 451261010531 - -1

M8086-67501 453563469651 - -1

M8081-67001 453563459361 - -1

M2705-64503 451261025001 - -1

M2705-64504 451261025011 - -1

M2705-64502 451261024991 - -1

M2705-64501 451261024981 - -1

(kit contents on page 80)

Camlock Kit

M2705-64400 451261025061 - -1

(kit contents on page 80)

FM Small Parts Kit - plastics and

M2705-64203 451261025031 - -1

labels

FM Small Parts Kit - screws and

M2705-64202 451261025041 - -1

cables

(kit contents on page 83)

Recorder Parts Kit M2705-64600 451261025051 - -1

Transducers 9Parts

Transducers

Toco Transducer (M2734A)

Ultrasound Transducer (M2736A)

Toco+ Transducer with ECG/IUP capability

(M2735A)

Ordering Number

Number for New Parts Number for Exchange Parts

Alternative

Description

Toco Transducer M2734-60501 451261010451 M2734-68501 4512 610 11231 1

Toco+ Transducer M2735-60501 451261010461 M2735-68501 4512 610 11241 1

US Transducer M2736-60501 451261010471 M2736-68501 4512 610 11251 1

Cable Assembly (for all transducers; see page 84)

Belt Button Kit, with tool, pack of 5, “Belt Button Kit” on page 84

Part No.

M2735-64201 4512610 0481 - -1

M2703-64204 451261010511 - -1

Identifier

Part No.

Alternative

Identifier

Qty

9Parts Patient Modules

Patient Modules

Patient module for ECG/IUP

(M2738A)

Ordering Number

Number for New Parts Number for Exchange Parts

Alternative

Description

ECG/IUP Patient Module M2738-60501 451261011261 - -1

Remote Event Marker - 989803143411 - -1

Part No.

Identifier

Part No.

Remote Event Marker

(989803143411)

Alternative

Identifier

Qty

Interface Cables

Avalon CTS Interface Cable (M2731-60001) for front connection

Avalon CTS Interface Cable (M2732-60001) for rear connection

Description

Avalon CTS Interface Cable (M2731-60001), red connector, for connection to the red fetal sensor sockets on the front of the monitor.

Avalon CTS Interface Cable (M2732-60001), black connector, for connection to the black telemetry sockets on the rear of the monitor.

Serial (RS232) Interface Cable to OB Tracevue.

Ordering Number

Number for New Parts Number for Exchange Parts

Alternative

Part No.

M2731-60501 451261016251 - -1

M2732-60501 451261025091 - -1

M1380-61612 453563278111 - -1

Identifier

Part No.

Alternative

Identifier

Qty

Assemblies and Kits 9Parts

Assemblies and Kits

This section contains additional information for quick identification of assemblies and kit contents.

Front Bezel Assembly

Front Bezel Assembly, SYMBOLS

Part number and serial number printed here

A set of labels is included with the assembly

Front Bezel Assembly, TEXT

Front Bezel Assembly, Rear View

9Parts Assemblies and Kits

Main CPU Board

API Board Kit

Item API Board Kit Contents Qty

1API Board 1

2 Connector Block Frame 1

3 Mounting Frame for SpO2 Board 1

Noninvasive Blood Pressure Assembly

Isolator (for FM20/30 only)

Noninvasive Blood Pressure Assembly

Fitting instructions (for FM20/30 only)

Assemblies and Kits 9Parts

Recorder Assembly

Thermal Line Printhead (TLPH)

Loudspeaker Assembly

9Parts Assemblies and Kits

Top Cover

AC/DC Power Supply

SpO2 Board

Assemblies and Kits 9Parts

Interface Boards

LAN / RS232 Interface

MIB / RS232 Interface Dual PS/2 Interface

Fetal Sensor Socket Connector Kit

Item Fetal Sensor Socket Connector Kit Contents Qty

1 Fetal Sensor Socket Connector Block 1

2 Connector Block Frame 1

Interface slot steel blank

Rear (Telemetry) Connector Kit

Item Rear (Telemetry) Connector Kit Contents Qty

1 Rear Socket Connector Block 1

2 Rear Connector Block Frame 1

9Parts Assemblies and Kits

SpO2 Connector Kit

Item SpO2 Connector Kit Contents Qty

1SpO2 Socket Connector Block 1

2 Connector Block Frame 1

Noninvasive Blood Pressure (NBP) Connector Kit

Item Noninvasive Blood Pressure Connector Kit Contents Qty

1 NBP Socket Connector Block 1

2 Connector Block Frame 1

Camlock Kit

Item Camlock Kit Contents Qty

1Cam 1

2 Screws M3 x 10 5

3Feet 4

Assemblies and Kits 9Parts

Item Camlock Kit Contents Qty

4Mounting Plate (for Cam) 4

5 Mounting Plates (for Feet) 4

6 Installation Instructions 1

FM Small Parts Kit - Plastic Parts and Labels

Item FM Small Parts Kit Contents - Plastic Parts and Labels Qty

1 FM40/50 Insulator, API Board 1 2 NBP Tubing (needs to be cut to size) 1 3 FM40/50 Silicone ON/OFF Key 1 4 FM40/50 Lightpipe 1 5 FM20/30 O-Ring, loudspeaker 1 6 FM40/50 Mounting Frame for SpO2 Board 1 7 FM20/30 Ratchet Lever/Clip 2 8 FM20/30 Cable Guide, Rear 1

9 FM20/30 Cable Guide, Front 1 10 FM20/30 Hinge 2 11 FM20/30 Connector Frame 1 12 Label, FM20 1 13 Label, FM30 1 14 Label, FM40 1 15 Label, FM50 1

9Parts Assemblies and Kits

Item FM Small Parts Kit Contents - Plastic Parts and Labels Qty

16 Intrapartum/Triplets Label 1 17 Intrapartum Label 1 18 Triplets Label 1 19 FM40/50 Paper Guide (incorporating tear-off edge) 1 20 FM40/50 Holder, Bumper Foot 4 21 FM40/50 Bumper Foot 4

Assemblies and Kits 9Parts

FM Small Parts Kit - Screws and Cables

Item FM Small Parts Kit Contents - Screws and Cables Qty

1 Torx M3 x 4 5

2 Torx M3 x 6 with washer 10

3 Torx M3 x 8 with washer 10

4 Torx M3 x 10 with washer 10

5 Torx M3 x 12 with washer 5

6 Screw Ejot K30 x 8 3

7 Screw Ejot 3 x 8 8

8 Screw Ejot 2.5 x 8 5

9 Screw Ejot 3 x 10 5

10 Connector for SpO2 Board (all monitors) 1

11 Ribbon cable, Bus Master (all monitors) 2

12 FM20/30 Ribbon cable, Recorder 1

13 Ribbon cable, NBP to Main CPU Board (all monitors) 1

14 FM40/50 Ribbon cable, API Board to Recorder 1

15 FM40/50 Cable assembly, Power Supply 1

16 FM40/50 PCA, Switch Board 1

17 FM40/50 Switch Board cable to API Board 1

18 FM40/50 Sealing Gasket, Top Cover 1

19 FM40/50 Equipotential grounding bolt 1

9Parts Assemblies and Kits

Transducer Cable Assembly

Item Cable Assembly Contents Qty

1 Transducer Cable (for all fetal transducers) 1

2 Sealing Gasket 1

3Screw M2.5 3

4 Screw Cover (set of 3) 1

5 Transducer Belt Button 1

6 Avalon Tool 1

Belt Button Kit

Item Belt Button Kit Contents Qty

1 Belt Buttons 5

2 Avalon Tool (for removing/replacing transducer belt buttons) 1

10Disassembly and Reassembly

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.

• Performance verification: do not place the system into operation after repair or maintenance has been performed, until all performance tests and safety tests listed in Chapter 7, “Testing and Maintenance” have been performed. Failure to perform all tests could result in erroneous parameter readings, and/or patient/ operator injury.

CAUTION Observe ESD (electrostatic discharge) precautions when working within the unit.

Introduction

Remember to store all screws and parts in a safe place for later refitting.

How to Use this Chapter

The disassembly sections detail the step-by-step procedures you use to access replaceable parts of the monitor and the transducers.

All major assemblies are fitted to the chassis assembly.

The chassis assembly consists of the chassis, the power supply assembly, the main CPU board, the All Peripheral Interfaces (API) Board (which includes the Bus Master section), the sensor sockets, the recorder assembly, the front bezel assembly including touchscreen display, the loudspeaker, the noninvasive blood pressure assembly, the SpO interface and the VGA video out connector.

All part numbers of spare parts are listed in Chapter 9, “Parts”.

assembly, the RS232/LAN, dual PS/2 and MIB/RS232 interfaces, the telemetry

10 Disassembly and Reassembly Introduction

Tools Required

CAUTION Do not over-torque the screws. Excessive torque may damage the plastic screw mountings.

You need the following tools:

•Long-nosed pliers.

• Torx-head screwdriver, size T-10, minimum shaft length 80mm.

• Torx-head screwdriver, size T-8.

• Small flat-head screwdriver, 2.0-3.0 mm, for disengaging cable lock, and so on, and for removing the transducer screw covers.

• Flat-head screwdriver, head thickness 0.5 mm to fit transducer screw.

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

• Screw M3x12 with washer, T-10

• Screw M3x10 with washer, T-10

• Screw M3x8 with washer, T-10

• Screw M3x6 with washer, T-10

• Screw M3x4, T-10

Screw Map 10 Disassembly and Reassembly

Screw Map

All internal screws are M3x8 except the following:

Screws, front bezel, M3x6

Screws for plastic holders, Ejot 3x8

Serial Numbers

The serial number of the monitor appears on the rear panel. It is also stored electronically in the power supply.

If you exchange the power supply of the monitor, you may have to re-enter the monitor serial number afterwards. Check the serial number of the monitor in the Support Tool device view to see whether this is necessary: if the sixth digit of a monitor serial number is an “X”, you must re-enter the serial number, which you will find on the nameplate. Refer to the Support Tool Instructions for Use for details of how to change or re-enter a serial number.

10 Disassembly and Reassembly Removing the Top Cover

Removing the Top Cover

The top cover is held by eight screws, six at the rear and one on each side.

1 Remove the six screws from the rear, and one screw from each side of the top cover (all M3 x 6), using a

T-10 Torx driver. The location of the screws to remove are shown here:.

Screws, M3x8

2 With the front of the monitor facing you, hold the sides of the top cover and push sharply away from

you to release the top cover from the chassis.

Refitting the Top Cover 10 Disassembly and Reassembly

Remove the top cover, taking care not to catch the serial number holder with the front edge of the top cover.

NBP Assembly

Interface Cage

Main CPU Board

Loudspeaker Power Supply

API Board

Fetal Recorder

Refitting the Top Cover

Check, and if necessary renew, the top cover sealing gasket before refitting the top cover. The sealing gasket is contained in the FM Small Parts Kit, “Screws and Cables”. For ordering information, see page 83.

Refitting the top cover is a reversal of the removal procedure. Take care not to trap the printer ribbon cable.

10 Disassembly and Reassembly Removing the Power Supply Assembly

Removing the Power Supply Assembly

1 Remove the top cover (see page 87).

2 Disconnect the power supply cable connector.

Remove power

supply cable

3 Remove the three screws securing the power supply

4 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.

Philips Avalon FM40, Avalon FM50 Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

Who Should Read This Guide

What to Do Next

Repair Strategy

Manufacturer’s Information

Passwords

Warnings and Cautions

Introduction

Site Planning

2Site Preparation

Roles and Responsibilities

Site Preparation Responsibilities

Procedures for Local Staff

Procedures for Philips Personnel

Site Requirements

Space Requirements

Environmental Requirements

Safety Requirements (Customer or Philips)

Electrical Requirements (Customer or Philips)

Connecting Non-Medical Devices

Cabling Options and Requirements for Connection to OB TraceVue

Mounting Options

PS/2 Input Devices

Displays and Touch Devices

M8031B: 15” TFT Medical Grade Touch Display

M8033C: 17” TFT Medical Grade Touch Display

Video Cables for Remote Displays

3Installation Instructions

Initial Inspection

Visual Inspection

Electrical Inspection

Claims for Damage

Repackaging for Shipment or Storage

Mounting Instructions

Line Voltage Selection

Rear View

Connecting the Monitor to AC Mains

Connecting the Monitor to Non-Medical Devices

Connecting a Remote Display via the MIB/RS232 Interface

Installing a Remote Display

Mounting Remote Displays

Before Using the Monitor

Checking and Setting Line Frequency

Checking/Setting Paper Scale

Checking/Setting Paper Speed

Configuring the Equipment Label

Configuring SmartKeys

PS/2 Keyboard/Mouse

4Theory of Operation

Monitor Hardware Overview

Power Supply

Fetal Sensor Connector Block

API (All Peripheral Interfaces) Board

Main CPU Board

Fetal Recorder (Thermal Printer Unit)

Thermal Line Printhead (TLPH)

Paper Sensor

Stepper Motor

LCD Display and Touchscreen

Noninvasive Blood Pressure Assembly

SpO2 Assembly

Input/Output Interface Boards

Transducer Hardware Overview

Transducer Types

Functional Description of the Transducer CPU

CPU (Micro Controller)

Analog-to-Digital Converter

Communication Transceiver (CAN Bus Driver)

EEPROM

Toco Transducer Frontend

Ultrasound Transducer Frontend

Toco+ Transducer Frontends

Toco Frontend

IUP Frontend

ECG Frontend

Patient Module Frontends