fm800e service manual reviewed by gn & gb - eol

FM800Encore Service Manual 1

FM800Encore

FM800ENCORE® SERVICE MANUAL


Table of Contents 1 Quality, Reliability and Safety ..................................................................................................... 4

2 Introduction .................................................................................................................................. 6

3 Product Description...................................................................................................................... 7

4 Product Specification ................................................................................................................... 8

4.1 Physical Specification .......................................................................................................... 8

4.2 Environmental ...................................................................................................................... 8

4.3 AC supply voltage and fuse values ...................................................................................... 8

4.4 Ultrasound Transducer ......................................................................................................... 8

4.5 Foetal ECG (FECG) ............................................................................................................. 9

4.6 Uterine activity (external Toco) ........................................................................................... 9

4.7 Uterine activity (internal IUP) ............................................................................................. 9

4.8 Maternal heart rate and ECG ............................................................................................... 9

4.9 Maternal blood pressure ..................................................................................................... 10

4.10 Maternal oximetry .............................................................................................................. 10

5 Installation .................................................................................................................................. 11

5.1 Surface Mounting ............................................................................................................... 11

5.2 Trolley Mounting ............................................................................................................... 11

5.3 Wall Mounting ................................................................................................................... 13

6 Safety Testing ............................................................................................................................ 16

6.1 Protective Earth Continuity ................................................................................................ 16

6.2 Earth Leakage Current ....................................................................................................... 17

6.3 Patient Leakage Current ..................................................................................................... 17

6.4 Patient Leakage Current (Mains on applied parts) ............................................................. 18

6.5 Patient Auxiliary Current ................................................................................................... 19

7 Performance Verification ........................................................................................................... 20

7.1 Introduction ........................................................................................................................ 20

7.2 Equipment Needed ............................................................................................................. 20

7.3 Performance Tests .............................................................................................................. 20

7.3.1 Power ......................................................................................................................... 20

7.3.2 Display ....................................................................................................................... 20

7.3.3 Patient Information .................................................................................................... 20

7.3.4 Language .................................................................................................................... 20

7.3.5 Time and Date ............................................................................................................ 21

7.3.6 FECG Test.................................................................................................................. 21

7.3.7 MSPO2 (for FM830E only) ........................................................................................ 21

7.3.8 NIBP (for FM830E only) ........................................................................................... 21

7.3.9 Ultrasound .................................................................................................................. 22

7.3.10 TOCO ......................................................................................................................... 22

8 Diagrams .................................................................................................................................... 23

9 Disassembly ............................................................................................................................... 26

10 Maintenance ............................................................................................................................... 31

11 Troubleshooting Guide .............................................................................................................. 33

12 Spare parts .................................................................................................................................. 34

12.1 Ordering Spare Parts .......................................................................................................... 34

12.2 Recommended Spare Parts................................................................................................. 34

13 End-of-Life Disposal.................................................................................................................. 35

14 Warranty..................................................................................................................................... 36


Service Agreements

Periodic inspection and preventative maintenance are essential to ensure continued effective operation. Contact the Company or its approved agents or distributors for further

information on service contracts.

Although every care has been taken to ensure that the information in this manual is accurate, continuous development may result in equipment changes. The Company

reserves the right to make such changes without prior notification, and resulting manual inaccuracies may occur. This manual and any changes are protected by copyright.

FM800Encore®, Huntleigh and 'H' logo are registered trademarks of Huntleigh Technology Ltd. 2008.

© Huntleigh Healthcare Ltd. 2008

Quality, Reliability and Safety


1 Quality, Reliability and Safety This equipment has been manufactured using quality components and designed to operate safely and reliably. Huntleigh Healthcare Limited can accept responsibility only if the following conditions are observed:

The equipment is used in accordance with the instructions for use provided by Huntleigh Healthcare.

The equipment is used in a building whose electrical installations conform to the standards specified by the country in which the building is situated.

All modifications and repairs to the equipment are carried out by service engineers, agents or hospital technicians authorised by Huntleigh Healthcare Limited.

CE MARKING

This equipment carries a CE mark but this is only fully valid if it is used in conjunction with cables and other accessories approved by Huntleigh Healthcare Limited.

Warnings

Warnings are identified by the WARNING symbol shown above.

Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user.

WARNING: Explosion hazard. Do not use FM800Encore in the presence of flammable anesthetics or gases.

WARNING: Do not spray, pour, or spill any liquid on FM800Encore, its connectors, switches, or openings in the chassis.

WARNING: Electrical shock hazard. Disconnect the power cord from FM800Encore before attempting to open or disassemble FM800Encore.

WARNING: The use of accessories, transducers and cables other than those specified may result in increased emission and/or decreased immunity of FM800Encore monitor.

WARNING: Do not silence FM800Encore audible alarm or decrease its volume if patient safety could be compromised.

WARNING: During safety tests, AC mains voltage will be present on the applied part terminals. Exercise caution to avoid electrical shock hazard.

WARNING: Do not place FM800Encore into operation after repair or maintenance until Performance and Safety Tests listed in this service manual have been performed.

WARNING: This product contains sensitive electronics; strong radio frequency fields could interfere with the operation of the system. In the event where this occurs, we suggest that the source of interference is identified and the equipment is used 'out of range'.

If any doubt exists concerning the use of this equipment, an alternative method should be used.

Quality, Reliability and Safety


Cautions

Cautions are identified by the Caution symbol shown above.

Cautions alert the user to exercise care necessary for the safe and effective use of FM800Encore monitor.

CAUTION: Do not mount the equipment directly above the patient. Place the equipment in a location where it cannot harm the patient should it fall from its shelf or other mount

CAUTION: Do not operate the equipment using damaged cables and wires, or loose snap fittings, which may cause interference or loss of signal. A frequent electrical and visual inspection on cables and wires is advisable.

CAUTION: Observe ESD (electrostatic discharge) precautions when working within the unit and/or when disassembling and reassembling FM800Encore monitor and when handling any of the components of FM800Encore monitor.

CAUTION: Ferrite Cores are used for electromagnetic compatibility. Do not remove Ferrite Cores while disassembling or reassembling.

CAUTION: For continued protection against risk of fire, replace only with same type and rating of fuse.

CAUTION: The accuracy of the readings obtained from this equipment may be affected by the presence of a pacemaker or by cardiac arrhythmia.

Introduction


2 Introduction

This manual contains information for servicing the FM800Encore monitor. Only qualified service personnel should service this product. Before servicing FM800Encore, read the user’s manual carefully for a thorough understanding of safe operation.

Read and understand all safety warnings and service notes printed in this service manual and the user’s manual.

The fault finding described is only intended to identify boards, modules or major components that need to be replaced. This document is not intended as a full diagnostic tool because many of the boards and modules can not be satisfactorily repaired in the field and must be returned to Huntleigh Healthcare if faulty.

If any warranty claim is intended then it is important to ensure that any security seals are intact on the items to be returned if the warranty is not to be invalidated.

To reduce the risk of electric shock, do not remove the cover or back. Refer servicing to qualified service personnel.

Only trained service technicians should perform all unit repairs.

Voltages dangerous to life exist in this unit. Take care when servicing the power supply and front panel assembly.

Product Description


3 Product Description The Sonicaid FM800Encore range of monitors is designed to provide flexible solutions for intrapartum monitoring needs, both for today and in the future. A choice of two models allows for the selection of the facilities required, from standard intrapartum fetal monitoring capabilities to high-risk fetal or maternal care.

Sonicaid FM820Encore: Designed to help with the management and care of all pregnancies, where comprehensive and adaptable fetal monitoring facilities are needed, the Sonicaid FM820Encore offers twin ultrasound, fetal and Maternal ECG channel, external and internal uterine activity monitoring, and maternally sensed fetal movements.

Sonicaid FM830Encore: To closely monitor the mother as well as the foetus, the Sonicaid FM830Encore is a fully integrated fetal/maternal monitor with the facilities for simultaneous monitoring of pulse oximetry and blood pressure without the need for additional stand-alone devices.

System Controls

Product Specification


4 Product Specification

4.1 Physical Specification

Height (all models) 186mm (7.3in)

Length (all models) 358mm (14.1in)

Width (FM820E) 363mm (14.3in)

Width (FM830E) 392mm (15.5in)

Weight (FM820E) Gross weight 13.5kg (includes transducers etc) Net weight 9.5kg

Weight (FM830E) Gross weight 15.5kg (includes transducers etc) Net weight 10.5kg

4.2 Environmental

Operating temperature +10°C to +35°C

Storage/transport temperature -20°C to +50°C

Operating pressure 68 to 106 kPa (680 to 1060 mB)

Storage/transport pressure 68 to 106 kPa (680 to 1060 mB)

Operating humidity 10% to 75% RH, non-condensing

Storage/transport humidity 10% to 90% RH, non-condensing

4.3 AC supply voltage and fuse values

Rated AC supply voltage 100-120V, 220-240V, 50-60Hz

Fuse values T2.5A L 250V for nominal input voltage ≥ 200V T2.5A L 250V for nominal input voltage < 200V

Power rating 100VA

4.4 Ultrasound Transducer

Range 30 to 240 bpm

Accuracy ± 1 bpm over the range 100-180 bpm

Alarms High and Low FHR: 30 to 240 bpm Signal Loss: % loss in last 5 minutes

Mode Directional pulsed Doppler Repetition rate 3.0KHz

Frequency 1.0MHz (green)

P- <1Mpa

Iob <20mW/cm2

Ispta <100mW/cm2

Resolution 12 bits

Safety Type CF protection



4.5 Foetal ECG (FECG)

Range 30 to 240 bpm

Accuracy ± 1 bpm over the range 100-180 bpm

Alarms As Ultrasound

Common mode rejection Better than 66db within the signal bandwidth

Input impedance 10M Ohm

Input range >30µV to >500µV peak to peak

DC offset ±2V common mode ±300mV differential

Common mode range ±20V @ mains frequency

Noise <10µV peak-to-peak referred to input


4.6 Uterine activity (external Toco)

Range 0-100 relative units

Sensitivity 100% FSD equivalent to 120g

Offset range ±100g

Auto zero Manual and auto zero facility


4.7 Uterine activity (internal IUP)

Transducers Intran Plus (Use only approved types)

Pressure range 0-100 mmHg/0-15 kPa (user selectable)

Sensitivity 5µV/V/mmHg

Accuracy ±5%


4.8 Maternal heart rate and ECG

Range 30-240 bpm

Accuracy ±1 bpm

Alarms High and Low (30-240 bpm) Rate Signal Loss




4.9 Maternal blood pressure

Method Oscillometric

Measurement ranges Systolic 50–280 mmHg Diastolic 10–260 mmHg Pulse 40–240 bpm

Accuracy ±2% or 3mmHg, whichever is greater

Modes Manual or automatic User-selectable interval in Auto Mode: 3, 5, 10, 15, 20, 30, 45, 60, 90 or 120 minutes

Record/display

On-screen display and printed record of: Systolic blood pressure. Diastolic blood pressure. Pulse rate.

Printed record of: Mean arterial pressure.

[Note: Mean arterial pressure not shown in the USA or Canada]

Alarms Systolic High: 55–255 mmHg Systolic Low: 50–250 mmHg Diastolic High: 35–220 mmHg Diastolic Low: 30–215 mmHg System: air leaks. movement, overpressure etc

Safety Type CF protection Hardware and software controls to limit:

Inflation (max. 300 mmHg) Measurement time (max. 160 secs)

Standards ANSI/AAMI SP10-1992

4.10 Maternal oximetry

Sensor types

(a) The following probe is suitable for FM830Encore equipped with BCI-B1 MSpO2 modules: Smiths Medical 3444 singer sensor Do not use any sensors other than these.

(b) The following probes are suitable for use with the FM830Encore models equipped with BCI-B2 Maternal pulse oximetry technology:- 3444 Finger Sensor NellcorTM

Durasensor® DS-100A

Do not use the oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could cause burns. The oximeter may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements.

Saturation range 1-99% SpO2

Saturation accuracy ±2 digits (70-100%) Less than 70% is undefined.

Pulse rate range 30-254 bpm

Pulse rate accuracy ±3 bpm

Record/display On-screen display and printed record of: Maternal % SpO2 Heart rate

Alarms High and low saturation: 0-100% SpO2 Signal loss: Pulse or ECG

Installation


5 Installation FM800Encore series of monitors have the following mounting options:

Surface mounted.

Trolley mounted.

Or wall mounted.

What ever mounting method is chosen there must be adequate ventilation around the unit and air vents should not be obstructed.

5.1 Surface Mounting

The FM800Encore series units can be free-standing on any suitable stable surface. The unit should not overhang the surface. There are four high-adhesion rubber feet attached to the base of the unit these should help prevent the unit moving on the surface. If required the front of the Monitor can be tilted up by hinging down the front feet extensions. Care should be taken to avoid the monitor from being pulled or knocked off the surface.

5.2 Trolley Mounting

When used on the Huntleigh Healthcare trolley the Monitor must be securely attached to the top of the trolley using the hardware provided.

Installation


Installation


5.3 Wall Mounting

Due to the size weight of the unit we advise that only the approved wall mounting kit should be used. The approved kit comes with comprehensive manufacturers instructions on securely fitting and using the bracket, these should be read and followed. When the approved wall mounting kit is correctly assembled and attached to the wall, the Monitor must be securely attached to the shelf section of the wall mounting kit using the hardware provided.

STEP (1):

Fit the mounting plate (item 1) as shown in figure below,

Installation


STEP (2):

Adjust the pivot arm to the required height.

STEP (3):

Slide the unit onto the carrier plate.

Note: Make sure the locking pin is fully engaged.

Installation


Item Description Quantity

1 MOUNTING PLATE 1

2 M3x14 SCREW 4

3 GCX M-SERIES 12" PIVOT ARM 1

4 GCX UTILITY BASKET 1

Locking pin must be fully engaged

Safety Testing


6 Safety Testing FM800Encore safety tests meet the standards of, and are performed in accordance with IEC60601-1, for instruments classed as Class 1, Type CF.

Please note that Dielectric strength testing as per clause 20 of EN60601-1 is carried out before the units leave the factory. These Dielectric strength tests must not be repeated in the field. This is because repeated Dielectric strength tests may degrade the insulation.

6.1 Protective Earth Continuity

This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground. A current of 1A from a current source with a frequency of 50Hz or 60Hz and with a no-load voltage not exceeding 6V, passed for 5s to 10s through the protective earth pin in the mains plug and each protectively earthed pat.

1) Configure the electrical safety analyser as recommended by the analyser operating instructions.

2) Connect the monitor’s AC mains plug to the analyser as recommended by the analyser operating instructions.

3) Verify that the analyser indicates 100mΩ or less.

Protectively earthed parts

Safety Testing


6.2 Earth Leakage Current

This test is in compliance with IEC60601-1 earth leakage current. The applied voltage for IEC60601-1 is 264 Volts AC (110% of the highest rated mains voltage) 50 to 60Hz.


2) Connect the monitor’s AC plug to the electrical safety analyser as recommended by the analyser operating instructions.

3) Perform test as recommended by analyser operating instructions.

Test Condition Allowable Leakage

Current (µA) Normal Condition (NC) 500

SFC Open Supply (SFC OS) 1000

Normal Condition RM (NCRM) 500

SFC Open Supply RM (SFC OSRM) 1000

Note: Earth leakage current is measured under various conditions of the AC mains and protective earth conductor. For each condition, the measured leakage current must not exceed that indicated in the table above.

Note: NC-Normal Condition / SFC-Single Fault Condition / RM - Reverse Mains/Line Voltage / OS- Open Supply.

Note: All measurements shall be made with the power switch in ‘ON’ position.

6.3 Patient Leakage Current

This test measures patient leakage in accordance with IEC60601-1, clause 19, for Class1, Type CF equipment. Patient leakage current in this test is measured from any individual patient connection to earth (power ground).



3) Wrap NIBP cuff tightly around appropriate metal cylinder (for FM830Encore only).

4) Connect a test cable between the cylinder and an input connector on analyser.

5) Turn on FM8x0Encore.

6) Perform the patient leakage current test as recommended by the analyser operating instructions.

7) Repeat the patient leakage current test for all patient connections, using the appropriate test cables.

Note: Contractions transducer (TOCO/IUP) socket has no direct patient connections. The patient leakage current can be measured by wrapping the transducer in aluminium foil and then attaching the test cable to the foil.

Safety Testing


Note: Patient leakage current is measured under various conditions of the AC mains and protective earth conductor. For each condition, the measured leakage current must not exceed that indicated in the table below.

Note: Note: This test requires a test cable for each patient connector. Test cables can be configured by wrapping each sensor end individually in aluminium foil filled with conductive gel, (enough to ensure conductivity only). Attach a wire to the foil that is connected to a test lead from the electrical safety analyser. For ECG, measurements are made to each patient connection.


Current (µA)

Normal Condition (NC) 10


SFC Open Earth (SFC OE) 50



SFC Open Earth RM ( SFC OERM) 50

6.4 Patient Leakage Current (Mains on applied parts)

AC mains voltage will be present on the applied part terminals during this test. Exercise caution to avoid electrical shock hazard.

Do not touch the patient lead clips or the simulator parts connected to patient leads during this test, as an electrical shock will occur.

This test measures patient leakage in accordance with IEC60601-1, Class1, Type CF equipment. In this test, 110% of mains voltage is applied between each patient connection and earth (power ground). Patient leakage current in this test is measured from any individual patient connection to earth.

Note: Keep the patient test cable length as short as possible during the leakage test.

Note: This test requires the same test cables for each patient connector as described in ‘Patient Leakage Current’ section 6.3.

1) Repeat No’s 1-7 as shown in ‘Patient Leakage Current’ section 6.3.

Note: Patient leakage current is measured with normal and reverse mains polarity. For each condition, the measured leakage current must not exceed that indicated in the table below.


Current (µA)



Safety Testing


6.5 Patient Auxiliary Current

This test measures auxiliary current in accordance with IEC60601-1, Class1, Type CF equipment. Patient auxiliary current is measured between each cable for all possible connections.

Note: Keep the patient test cable length as short as possible during the leakage test.

Note: This test requires the same test cables for each patient connector as described in ‘Patient Leakage Current’ section 6.3.



3) Turn on FM8x0Encore.

4) Perform the patient auxiliary current test per table below, as recommended by the analyser operating instructions.

5) Repeat the patient auxiliary current test for each lead combination as listed in the table below, and measure each patient auxiliary current.


Current (µA)



SFC Open Earth (SFC OE) 50



SFC Open Earth RM ( SFC OERM) 50

Performance Verification


7 Performance Verification

7.1 Introduction

This section discusses the tests used to verify performance following repairs or during routine maintenance. All tests can be performed without removing FM800Encore cover. All tests must be performed as the last operation before the monitor is returned to the user. If FM800Encore fails to perform as specified in any test, repairs must be made to correct the problem before the monitor is returned to the user.

7.2 Equipment Needed

Equipment Description

ECG Simulator Metron PS-320 or equivalent

NIBP Simulator Metron QA-1290 or equivalent

SPO2 Simulator Metron QA-510 or equivalent

Safety Analyser Metron QA-90 or equivalent

7.3 Performance Tests

7.3.1 Power

1. Connect the monitor to AC power source using proper power cord.

2. Press the ON switch.

3. Verify Green power LED is lit.

4. Verify Amber printing LED is flashing (for approx 2 seconds).

7.3.2 Display

1. Check the display for any visible damage or scratches.

2. Connect the monitor to AC power source using proper power cord.

3. Press the ON switch.

4. Press SETUP SYSTEM SETTINGS and enter 2755 for password.

5. Navigate to AUDIO/GRAPHIC SCREEN BRILLIANCE.

6. Cycle through the available options and verify that the screen backlight is changing from “LOW”, “MEDIUM”, “HIGH” and “AUTO-DIM”.

7.3.3 Patient Information

1. Press SETUP PATIENT DETAILS.

2. Press ADD on the screen, next to Name.

3. Enter some text using the keypad.

4. When finished, press EXIT button.

5. Verify the patient details are displayed in the Info Box.

7.3.4 Language

1. Press SETUP SYSTEM SETTINGS INTERNATIONAL.

2. Press the LANGUAGE button.

3. Verify that the language selection changes.

4. Set the unit back to its original language.



7.3.5 Time and Date

1. Press SETUP TIME AND DATE.

2. Verify that the time and date settings can be altered.

3. Correct the time and date settings.

7.3.6 FECG Test

Equipment Setup: Connect the ECG cable to the unit under test. Connect the patient connectors to the simulator.

1. Set the simulator to 120BPM, 100µV (Fetal ECG mode).

2. Verify the monitor displays BPM of 120 ± 1bBPM.

3. Disconnect the RED patient lead.

4. Verify the monitor displays “CHECK FECG CONNECTION” and alarms.

5. Reconnect the RED patient lead.

7.3.7 MSPO2 (for FM830E only)

1. Attach the finger probe to your finger as shown on the probe; allow the cable to lay on top on the fingers parallel to the arm.

2. When a normal pulse is obtained then an appropriate digital readout will be indicated on the screen.

3. Remove the finger probe.

4. Verify that after maximum 13 seconds the SpO2 will flash and the alarm will sound. The digital readout must indicate no reading and the HEART SYMBOL should flash.

5. Attach the finger probe to a QA-510 simulator and set the simulator to the following predetermined settings, set to the corresponding technology, i.e. BCI or Nellcor:-

Make: USER-1 Preset: Manual

OPER: MANUAL Sp02: 96% (Increment or decrement this value)

Amb.L: 50HZ Rate:60BPM

Pigm : Medium P.Amp1: 100%

6. Repeat the test for 92% and 98% oxygen saturation.

7. Verify the displayed values are within the following limits:-

96% the reading should be between 94% - 98%



7.3.8 NIBP (for FM830E only)

1. Make sure that the Adult Cuff is wrapped around the Plastic tube with an outside diameter of 350mm.

2. Connect the Cuff to the outlet of the QA-1290 simulator then connect NIBP Module to the INLET of the analyser.

3. Switch on the analyser and press BP test.

4. On the simulator select Adult cuff then the setting of 80/48, HR: 80 then press start.



5. Press NIBP START MEASUREMENT button on the unit under test.

6. The BP test should start soon after.

7. The unit should display systolic/diastolic readings similar to the analyser setting ±5mmHg.

8. Repeat the test for 120/80 and 200/140.

NOTE: If problems are seen with the NIBP measurements, then 5 readings may be taken and the average systolic/diastolic results calculated. The unit is a PASS if all the readings taken are within 5 of the average values.

7.3.9 Ultrasound

1. Connect the ultrasound transducer to the unit under test, ULT1.

2. Input a signal by placing the transducer in the palm of the hand and stroke the back of the hand approximately twice per second (see figure below).

3. The display should indicate a rate of around 120 BPM after a few seconds. Continue this for one minute and check for a corresponding line on the fetal heart rate trace.

4. Repeat the above test for UL2 socket.

7.3.10 TOCO

1. Place the TOCO transducer on a solid surface with the rubber surface uppermost and level.

2. Press the zero button on the front panel.

3. Depress the TOCO rubber surface gently and release, repeat this several times. Check that the TOCO display registers the change and returns to zero (10%) after a short delay.

4. With the rubber surface still uppermost and level, reset the zero then place a 100g weight in the centre of the boot.

5. The shape of this weight is important and the contact area on the rubber boot should be 12mm diameter maximum. The TOCO display should indicate 80% ±10%.

Diagrams


8 Diagrams

Drawing No. Description

Figure 1 FM800E Block Diagram

Diagrams


The monitor is divided into four functional blocks:

Digital board assembly.

Signal processing board assembly.

Front panel board assembly.

Module board assembly (FM830E only).

The following is a brief description for the various functional blocks:

DIGITAL BOARD

The digital board will manage the overall operation of the system, controlling the printer, display and communication with the signal processing and module boards.

• UARTs: The UARTs are responsible for handling communication channels between the various functional blocks. Additionally two uart blocks were implemented to provide three electrically isolated data ports.

• Audio MUX: Used for selecting between Analog or Digital audio source.

• SRAM: Each CPU is connected to a static RAM. These devices are 512k by 16 bits. The display CPU’s SRAM is connected to the battery supply (VBAT) such that its contents are retained when the power is off.

• Real Time Clock: This is a high precision RTC module to provide a calendar and clock functions.

• EEPROM: Used to retain various factory settings (Serial No., date of manufacture … etc).

• ALTERA EPLD: This is to implement address decoding, generation of an interrupt request for the keyboard, decoding of the address for the RTC, synchronous serial interfaces, and clock generation.

• Shared RAM: This is to provide a means by which the two CPUs communicate data with each other.

SIGNAL PROCESSING BOARD

The signal processing board (SPB) provides the following functions: (a) Two ultrasound channels, (b) TOCO/IUP and (c) FECG/MECG.

• RMI AU1100 CPU: This is a serial interface to the isolated micro-controllers for ECG and Toco. a MIPS32 processor intended to perform the main ultrasound signal processing.

• FLASH ROMs: Flash ROMs contain the start-up code for the AU1100 CPU. The flash ROMs are compliant with the Common Flash Memory Interface standard. This standard provides a common access method for writing and reading flash ROMs that is largely independent of size and manufacturer.

• Actel ProAsic+ FPGA: These devices use internal flash memory to retain their configuration when switched off. The internal design of the FPGA provides:

Control of the main ultrasound A-D converter and its signal multiplexers.

Generation of the ultrasound carrier frequencies and gating signals.

Buffering the averaged samples in the FPGAs internal FIFOs.

A read port to allow this data to be transferred to the Au1100.

A serial interface to the isolated micro-controllers for ECG and Toco.

Diagrams


• ADC: This is to digitize the demodulated ultrasound data. The device is used in parallel output mode, and controlled by signals from the FPGA. The FPGA also controls the input multiplexer to select the source of the A-D converters input.

• CODEC: This is to provide software enhanced audio output.

• ECG/TOCO Microcontrollers: A Texas Instruments MSP430 16 bit RISC micro-controller is used to digitize the ECG/TOCO signals and transfer it under software control to the digital board. Also, the digitized data is processed to provide 50/60Hz filtering.

• ULTRASOUND FRONTEND: Provides a low noise analog signal conditioning for the ultrasound data.

• ANALOG AUDIO: This contains receive gating, filtering and amplification, frequency doubling and more filtering.

• ECG FRONT END: This is to provide signal amplification and filtering using a high input impedance high common-mode rejection amplifier. Also, provides impedance checking circuit which has been designed to operate continuously.

• TOCO FRONT END: This is to provide signal amplification for two different types of transducer: Toco (monitoring contractions externally to the mother) and IUP (monitoring inside the mother).

MODULE BOARD

The module board provides the necessary supply rails and isolation for the OEM modules.

• Suntech NIBP: Provides a non-invasive blood pressure measurement.

• BCI MSpO2: Provides non-invasive maternal pulse oximetry.

FRONT PANEL BOARD

This board provides a keypad interface intended for user interaction, also a 5.7” LCD interface.

• LED backlight control: This is to vary the LCD output intensity by adjusting the current in the backlight LEDs. The light can be adjusted by software or can be set to automatic.

• USER INTERFACE KEYS: A total of 17 keys are provided for user interface control.

Disassembly


9 Disassembly

Removing the chassis cover

The chassis cover is held by a total of 11 screws, 7 at the rear panel and 4 on the side rails.

Torque = 60cN/M

Gently slide the lid to the back and lift upward. Disconnect the speaker loom from CON12.

Disassembly


Removing NIBP Module

Detach the air tube from the module as shown below.

Remove the four mounting screws.

Detach the NIBP loom from the module PCB.

M3 Screws and Shake-proof Washers

NIBP Module Loom

Press down

Disassembly


Module PCB

The module PCB is held by 8 M3 screws as shown below.

BCI MSPO2 Module

Top view Rear view

TOP VIEW

Disassembly


Front panel disassembly

Signal processing board (SPB)

FM820E or FM830E FM830E side pod FM820E

Pod bracket

Plastic Cover Strip

Ultrasound 1 (CON7) Ultrasound 2 (CON8) FECG/MECG (CON9) TOCO (CON11)

Paper out sensor Print head interface

FM830E Front panel FM820E or FM830E front panel

Screws and washers in these positions (FM820E)

Nylon Pillars (FM830E)

Disassembly


Digital board (NDB)

Push the PCB this way

8 off Pillars

M3 Screw

Paper out sensor

Print head interface

Remove tie bar screw

Unplug event marker connectors Unplug power connectors

Unplug stepper motor connector

Maintenance


10 Maintenance

Always switch off the FM800E and disconnect the AC supply cable and transducers before attempting to carry out any cleaning or maintenance.

The Monitor

The unit and power lead should be kept clean and checked for signs of damage. It is recommended that it is wiped clean with a cloth or tissue dampened with water and detergent. Check mains power connections weekly and examine outer sheath of power lead for signs of damage. If signs of damage are found, consult or refer to a qualified technician for repair.

SpO2 Equipment Cleaning

Unplug the device before cleaning or disinfecting. Do not autoclave or ethylene oxide sterilise, or immerse in any liquid. Clean with soapy water and dry.

Patient ECG leads

The patient leads should be cleaned with warm water or a neutral cleaner and wiped dry. To disinfect use chemical disinfectants containing ethanol (70% - 80%), propanol (70% - 80%) or alderhydes (2% - 4%).

NOTE: Do not autoclave the patient cable. Electrical connectors must not be immersed in any fluid

Transducer Care

Transducers should be kept dry and preferably below 45°C. Gel must be wiped from the ultrasound transducers after use and before stowing.

Cleaning the Print head

If the print quality of the chart recording is poor, check first that the paper tray is correctly inserted and that the drive gears are meshed. If still poor, clean the print head as follows:

i. 1 Withdraw the paper tray and remove the paper pack.

ii. 2 Using a lint-free cloth and pure alcohol, wipe along the full width of the print head, which is above the paper tray compartment.

iii. 3 Re-fit the paper pack and return the paper tray.

Maintenance


Battery Replacement

Follow instructions in section 9 to disassemble the unit. Remove LK1 as shown below. Desolder the battery terminals and remove the old battery. Place the replacement battery in the designated position and solder both terminals (make sure the battery is fitted with the right polarity). Reconnect LK1 and assemble the init. Set the correct time and date values.

CAUTION: Discarded battery may explode during incineration. Recycle used batteries properly. Do not dispose of batteries in refuse containers.

Further Maintenance

Huntleigh Healthcare recommends that preventative maintenance checks are carried out on the unit under a Huntleigh Healthcare Service Contract at 6-monthly intervals. Alternatively, the maintenance may be carried out by suitably qualified personnel.

Remove link before removing the battery

FM800E Digital PCB (NDB)

Troubleshooting Guide


11 Troubleshooting Guide

SYMPTOM POSSIBLE CAUSE

No FHR signal displayed Is FM800E switched on? Is the FHR transducer connected?

High % signal loss Check transducer placement. Is the transducer broken? Consider switching from Ultrasound to FECG.

No FHR trace printed Has the Print button been pressed? Is there paper in the paper tray? Is the paper tray fully pushed in?

Only one trace (twins) OR Traces superimposed (twins)

Correct "FHR scale for twins‟ in Printer setup.

No beep when button pressed. Beep may be turned off.

Alarm not working Alarm may be turned off.

Spare parts


12 Spare parts

12.1 Ordering Spare Parts

Due to developments improving the product, over the years certain spare parts may not be readily interchangeable between early and late production units. Always quote the serial number of the unit and date of purchase, if known. This information is in addition to the circuit reference and the reference number and issue of the PCB required.

Items returned for replacement under guarantee should be labelled with the unit type, serial number, date of purchase, if known, and written details of the symptoms or fault found. Orders for spare parts may be sent by post, telex, fax or telephoned to Huntleigh Healthcare or approved agents or distributors.

12.2 Recommended Spare Parts

Part No. Description Quantity

SP-751053 FM800E Signal Processing Board Assembly 1

SP-751054 FM800E Digital Board Assembly 1

SP-751083 FM800E Module Board Assembly 1

SP-751061 FM800E Print Head Assembly 1

SP-751059 Printer Motor Assembly 1

SP-751062 FM800E Front panel Assembly 1

SP-320601 FM800E new PSU 1

SP-MI1194 NIBP Module 1

SP-WW3711 BCI MSPO2 Module 1

SP-751060 FM800E Printer Tray Assembly 1

SP-SL350P SL350P, 3.6V Lithium battery. 1

End-of-Life Disposal


13 End-of-Life Disposal

Definition: this symbol indicates that this product comes under the provisions of EU Directive 2002/96/EC on waste electrical and electronic equipment (WEEE) and that this unit was placed on the market after 12 August 2005. This directive covers EOL (end-of-life) disposal.

Rules for the User: within the EU, at end-of-life, this product may be disposed

of only through a government approved collection scheme or treatment facility.

If in doubt contact your local Huntleigh Healthcare Ltd representative.

Warranty


14 Warranty

Huntleigh Healthcare Ltd (HHC.) provides a comprehensive warranty of 2 years from the date of purchase on hardware products and modules. Transducers have a 12-month warranty, and consumables and accessories (i.e. disposables and items with no serial number) have a 90-day warranty.

The warranty covers parts and labour necessary to rectify any faults in the product hardware. If within the warranty period any of the goods supplied prove defective due to faulty design, workmanship or materials, HHC will adjust, repair or replace them free of charge, as follows:

Monitors will be repaired or replaced at the discretion of HHC.

Defective consumables will be replaced.

Any problems should be reported immediately to the supplier of the equipment or your local HHC. service department. The warranty is valid in all circumstances provided that:

a) The goods have been used in accordance with the operating instructions, and solely for the purpose for which they were intended;

b) The defect has not been caused by misuse or accident, unauthorised alteration, repair or maintenance, or the use of sub-standard consumables;

c) Kit products have been fitted in accordance with the installation instructions;

d) Repair of the goods has not been attempted by a person or company which is not an approved Huntleigh Healthcare Ltd representative;

e) e) the purchaser shall be liable for any costs incurred by HHC. or its appointed agent in responding to claims caused by operator error or incorrect application.

fm800e service manual reviewed by gn & gb - eol

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