Professional Documents
Culture Documents
1 Table of Contents
1 Table of Contents.........................................................................................................................................1
2 General ........................................................................................................................................................3
3 Introduction ..................................................................................................................................................7
4 Product Description......................................................................................................................................8
5 Product Specification ................................................................................................................................ 14
6 Safety Testing ........................................................................................................................................... 17
7 Performance Verification .......................................................................................................................... 23
8 Diagrams................................................................................................................................................... 29
9 Main Unit Assembly Breakdown ............................................................................................................... 32
10 Transducer Repair .................................................................................................................................... 59
11 TOCO Transducer Alignment Procedure ................................................................................................. 71
12 Service Menus .......................................................................................................................................... 72
13 Maintenance Schedules ........................................................................................................................... 80
14 External Connections ................................................................................................................................ 88
15 AU1100 Processor Software Up-Grade.................................................................................................... 90
16 SH2-1(D) and SH2-2(P) Processor Software Up-Grade .......................................................................... 93
17 Flash Option Configuration ..................................................................................................................... 111
18 Spare parts ............................................................................................................................................. 112
19 Trouble Shooting..................................................................................................................................... 114
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,
2014.
© Huntleigh Healthcare Ltd. 2008-2014.
2 General
EN60601-1, 2006 Medical Electrical Equipment Part 1 General Requirements for Safety
EN60601-1-1, 2001
Safety requirements for Medical Electrical Systems
[collateral standard]
EN60601-1-2, 2007
General requirements for safety: Electromagnetic compatibility
[collateral standard]
IEC60601-1-4, 2000
General requirements for safety: Programmable electrical medical systems
[collateral standard]
IEC60601-2-30, 1999 Particular requirements for safety, including essential performance, of automatic
[collateral standard] cycling non-invasive blood pressure monitoring equipment
IEC60601-2-37, 2007 Particular requirements for the safety of ultrasonic medical diagnostic and
[collateral standard] monitoring equipment
Particular requirements for the basic safety and essential performance of pulse
ISO9919, 2005
oximeter equipment for medical use
2.2 CE Mark
2.3 Classification
2.4 Warnings
Warnings are identified by the WARNING symbol shown. Warnings alert users and
technical personnel to potential serious outcomes (death, injury, or adverse events) to
the patient, user or technician
Do not touch live parts of any equipment (e.g. com port connector pins on a pc) and the
patient at the same time.
Do not spray, pour, or spill any liquid on FM800Encore, its connectors, switches, or
openings in the chassis.
Electrical shock hazard. Disconnect the power cord from FM800Encore before
attempting to open or disassemble FM800Encore.
The use of accessories, transducers and cables other than those specified may result in
increased emission and/or decreased immunity of FM800Encore monitor.
Do not silence FM800Encore audible alarm or decrease its volume if patient safety could
be compromised.
During safety tests, AC mains voltage will be present on the applied part terminals.
Exercise caution to avoid electrical shock hazard.
Do not place FM800Encore into operation after repair or maintenance until Performance
and Safety Tests listed in this service manual have been performed.
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'.
2.5 Cautions
Cautions are identified by the Caution symbol shown. Cautions alert users and technical
personnel to exercise care necessary for the safe and effective use of FM800Encore
monitor.
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.
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.
Ferrite Cores are used for electromagnetic compatibility. Do not remove Ferrite Cores
while disassembling or reassembling.
For continued protection against risk of fire, replace only with same type and rating of
fuse.
The accuracy of the readings obtained from this equipment may be affected by the
presence of a pacemaker or by cardiac arrhythmia.
Non-medical equipment must comply with the relevant IEC or ISO safety standard. For
Information Technology equipment, this standard is IEC950/ EN60950
The configured system must comply with the system standard IEC601-1-1/ EN60601-1-1
Anybody who connects additional equipment to signal input or signal output parts of
the system is configuring a medical system, and is therefore responsible for ensuring
that the system complies with IEC601-1-1/ EN60601-1-1. If there is any doubt as to
whether your system does comply, consult the technical service department of your
local Huntleigh Healthcare Ltd representative.
The connection of extra equipment to the patient or FM800E could lead to the summation of leakage currents.
In such circumstances the user must ensure that safe leakage currents are not exceeded.
Do not exceed the power rating for the multiple portable socket outlet.
Do not place multiple portable socket-outlets on the floor. This is to protect against
mechanical damage and the ingress of liquids.
Multiple portable socket-outlets supplied with the system must not be used for powering
equipment which does not form part of the system. This is to prevent increased leakage
currents, and overload of the multiple portable socket outlet.
If the system has been specified for use with an isolation transformer, do not connect
any non-medical electrical equipment which forms part of the system directly to the wall
outlet. This is to prevent excessive leakage currents
Anybody who connects additional equipment to signal input or signal output parts of
the system is configuring a medical system, and is therefore responsible for ensuring
that the system complies with IEC601-1-1/ EN60601-1-1. If there is any doubt as to
whether your system does comply, consult the technical service department of your
local Healthcare Ltd representative.
This equipment generates and uses radio frequency energy. If not installed and used properly, in strict
accordance with the manufacturer's instructions, it may cause or be subject to interference. Type-tested in a fully
configured system, it has been found to comply with IEC601-1-2/EN60601-1-2, the standard intended to provide
reasonable protection against such interference. Whether the equipment causes interference may be determined
by turning the equipment off and on. If it does cause or is affected by interference, one or more of the following
measures may correct the interference:
Moving the equipment away from the device with which it is interfering
Plugging the equipment into a different outlet so that the devices are on different branch circuits
Adding accessories or components to a system, or modifying a medical device or system, may degrade the
immunity performance. Consult qualified personnel before making changes to the system configuration.
3. Attach the decontamination certificate (or other written statement declaring that the product has been
cleaned) to the outside of the package.
4. Mark the package "Service Department – FM800E” and return to the address below.
2.10 Addresses
2.11 UK
Huntleigh Healthcare Ltd
35 Portmanmoor Road, Cardiff.
CF24 5HN. UK.
Tel: +44 (0) 2920 485885
Fax: +44 (0) 2920 492520
E-mail: sales@huntleigh-diagnostics.co.uk
Web page: www.huntleigh-diagnostics.com
3 Introduction
This manual contains information for servicing the FM800Encore monitor. Only qualified service personnel
should service this product. Before servicing FM800Encore, read the products Instructions for Use 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
cannot 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.
To isolate the FM800E from the mains or line supply, disconnect the power cable from
the mains inlet at the rear of the unit
Voltages dangerous to life exist in this unit. Take care when servicing the power supply
and front panel assembly.
4 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.
1 2 1
3 4 5 6
WARNING: Safety and performance are only assured when used in conjunction with the
correct types of transducer. Do not attempt to connect any devices via these sockets other
than those supplied or recommended by your Sonicaid dealer.
4.6 Controls
TOCO Zero
To isolate the FM800E from the mains or line supply, disconnect the power cable from the
mains inlet at the rear of the unit
Type CF patient
applied part
1 2 3 4 5
Event
marker
connector
4.10 Display
The FM800E’s high-performance colour display combines superior visual performance with environmental
ruggedness, making it suitable for a wide range of environments.
5 Product Specification
5.2 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
6 Safety Testing
FM800Encore safety tests meet the standards of, and are performed in accordance with IEC60601-1 and the
guidance of IEC62353:2014 for instruments classed as Class 1, Type CF.
Electrical Safety testing should be performed after the product and its accessories have been inspected for
signs of damage which may compromise the safety of the operator or patient during use. These tests should be
applied as part of a routine service or repair.
Tests marked as MANDATORY must be carried out in accordance with these instructions after repair or as part
of a routine service schedule. Tests marked as OPTIONAL are not deemed as essential but if required must be
carried out as per the following instruction.
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.
Please note due to the design of the electronics within the product deviation from the testing
described below can possibly produce erroneous results.
1
3
4
MECG/FECG
Analyser Input 1
Analyser Input 2
Analyser Input 3
Analyser Input 4
6.4.1 Configure the electrical safety analyser as recommended by the analyser operating instructions.
6.4.2 Connect the monitor’s AC mains plug to the analyser as recommended by the analyser operating
instructions.
6.4.3 Verify that the analyser indicates 300mΩ (as per or IEC62353:2014) or less for the 4 test points
shown in section 6.1
Allowable Leakage
Test Condition
Current (μA)
Normal Condition (NC) 500
Open Supply (OS) 1000
Normal Condition Reverse Mains (NC-RM) 500
Open Supply Reverse Mains (OS-RM) 1000
Table 1
.
6.6.1 Configure the electrical safety analyser as recommended by the analyser operating instructions.
6.6.2 Connect the monitor’s AC plug to the electrical safety analyser as recommended by the analyser
operating instructions.
6.6.3 Connect the Earth Leakage test cable from the safety analyser to the metalwork of the printer shown
in section 6.2
6.6.4 Switch on the unit under test.
6.6.5 Perform test as recommended by analyser operating instructions.
6.6.6 For each condition, the measured leakage current must not exceed that indicated in the Table 2.
6.6.7 Remove the earth leakage test cable from the metal work of the printer and attach a suitable cable
which connects the RS232 and RJ45 socket shown in section 6.2 to the safety analyser.
6.6.8 Repeat tests 6.6.4 to 6.6.6
Allowable Leakage
Test Condition
Current (μA)
Normal Condition (NC) 100
Open Supply (OS) 500
Open Earth (OE) 500
Normal Condition Reverse Mains (NC-RM 100
Open Supply Reverse Mains (OS-RM) 500
Open Earth Reverse Mains (OE-RM) 500
Table 2
Allowable Leakage
Test Condition
Current (μA)
Normal Condition (NC) 10
Open Supply (OS) 50
Open Earth (OE) 50
Normal Condition Reverse Mains (NC-RM) 10
Open Supply Reverse Mains (OS-RM) 50
Open Earth Reverse Mains (OE-RM) 50
Table 3
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 products rated 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.
This test requires the same test cables for MECG/FECG patient connector as illustrated in section 6.3
6.8.1 Configure the electrical safety analyser as recommended by the analyser operating instructions.
6.8.2 Connect the monitor’s AC plug to the electrical safety analyser as recommended by the analyser
operating instructions.
6.8.3 Connect the MECG/FECG socket to the safety analyser as shown in section 6.3
6.8.4 Turn on FM800Encore.
6.8.5 Perform the mains on applied parts test as recommended by the analyser operating instructions.
6.8.6 For each condition, the measured leakage current must not exceed that indicated in Table 4
Allowable Leakage
Test Condition
Current (μA)
Normal Condition (NC) 10
Open Supply (OS) 50
Open Earth (OE) 50
Normal Condition Reverse Mains (NC-RM) 10
Open Supply Reverse Mains (OS-RM) 50
Open Earth RM (OE-RM) 50
Table 5
Analyser Input 1
Analyser Input 2
Analyser Input 3
Analyser Input 4
100Ω
SPO2
Analyser Input 4
Analyser Input 5
Analyser Input 6
Analyser Input 7
Analyser Input 1
Analyser Input 2
Analyser Input 3
6.11 Patient Leakage Current UL1, UL2, TOCO and SPO2 Sockets (OPTIONAL)
The FM800E front panel pulse oximetry, UL1, UL2 and TOCO input connectors are marked as type CF by
adjacent labelling. This labelling applies to these input connections. As the circuitry to these connectors internal
to the FM800E is isolated, leakage currents comply with CF requirements. With the SPO2 Sensor, UL1, UL2
and TOCO transducers connected, none of the cable conductors are accessible. Insulation is provided by
the interface cable and sensor mouldings, limiting patient leakage current to comply with type CF requirements.
Any defects or damage to the insulation of these transducers should be identified during the visual inspection
stage of testing prior to these safety tests.
6.11.1 Isolation Barrier within the FM800Encore (OPTIONAL)
6.11.1.1 Configure the electrical safety analyser as recommended by the analyser operating instructions.
6.11.1.2 Connect the monitor’s AC plug to the electrical safety analyser as recommended by the analyser
operating instructions.
6.11.1.3 Connect the Earth Leakage test cable from the safety analyser to the metalwork of the printer shown
in section 6.2
6.11.1.4 Connect the UL1 socket (and any other of the patient connections if the facility exists) to the safety
analyser as shown in section 6.10
6.11.1.6 Perform the patient leakage current test as recommended by the analyser operating instructions.
6.11.1.7 For each condition, the measured leakage current must not exceed that indicated in Table 3
6.11.1.8 Repeat the tests for UL2, TOCO and SPO2 connections.
6.11.2 Patient Leakage From SPO2, UL1, UL2 and TOCO transducers (OPTIONAL)
6.11.2.1 Configure the electrical safety analyser as recommended by the analyser operating instructions.
6.11.2.2 Connect the monitor’s AC plug to the electrical safety analyser as recommended by the analyser
operating instructions.
6.11.2.3 Connect the Earth Leakage test cable from the safety analyser to the metalwork of the printer shown
in section 6.2
6.11.2.4 Wrap the accessible part of pulse oximeter sensor (SPO2) in metal foil.
6.11.2.5 Make a connection from between the metal foil to the safety analyzer
6.11.2.7 Perform the patient leakage current test as recommended by the analyser operating instructions.
6.11.2.8 For each condition, the measured leakage current must not exceed that indicated in Table 3
6.11.2.9 Repeat the tests for UL1, UL2 and TOCO transducers.
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.
IMPORTANT: As paper tracks through a printer mechanism it will move from side to side due to variations in
paper and printer mechanism alignment. This is an unavoidable feature of all printers of this type, as used in all
makes of fetal monitors. With plain paper, where the grid is printed at the same time as the trace data, any
alignment error is eliminated, ensuring 100% print accuracy. With pre-printed paper, this error cannot be
eliminated and will result in alignment errors between the trace and the grid of ±1.5mm
7.11.1 Connect the SpO2 extension cable and finger clip to the unit under test.
7.11.2 Confirm that the no finger flashing heart symbol is displayed on the unit under test.
7.11.3 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.
7.11.4 When a normal pulse is obtained then an appropriate digital readout will be indicated on the screen.
7.11.5 Remove the finger probe from your finger. Wait 10 seconds.
7.11.6 Configure the SP02 simulator to test either Nellcor or BCI probes. This needs to match the probe used
in the test.
7.11.7 Attach the finger probe to the SpO2 simulator.
7.11.8 Set the simulator to 98% and 80bpm
7.11.9 Whilst observing the SpO2 signal strength indicator displayed on the unit under test adjust the
position of the finger probe on the simulator until a good signal is acquired by the unit.
7.11.10 When the displayed values for SpO2 and bpm have settled on the unit under test, confirm the unit
under test displays the values:
SpO2 98% ± 2%
MHR 80 bpm ±2 bpm or ±2%, whichever is greater
CALIBRATED
MANOMETER Or CALIBRATED
PRESSURE SOURCE
WITH INTEGRAL
MANOMETER
500ml
NIBP CONNECTOR
RIGID
UNIT UNDER TEST
VOLUME
8 Diagrams
Drawing No. Description
Figure 1 FM800E Block Diagram
MSP430: This MSP430 carries out the same processing functions as the MSP430
connected to the ECG front end.
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. This module is isolated by means of a
DC-DC Converter and Opto-Couplers.
DIGITAL BOARD
The digital board manages the overall operation of the system, controlling the printer, display also
communication with the signal processing and module boards.
UART 1: This device routes the data generated by the AU1100 processor to the display CPU.
The device also routes the ECG and user interface key press audio processed by the
display CPU.
EPLD: The EPLD is configured to behave as a multiplexer for the TOCO/IUP and ECG data
received from the SPB PCB and the SPO2 data received from the module pcb for
transfer to the Display and Printer processors. The device also implements address
decoding, generation of an interrupt request for the keyboard, decoding of the address
for the RTC and clock generation.
Shared RAM: The shared RAM is utilized by both the Display and Printer CPU’s for data
exchange.
Clock: This is a high precision RTC module to provide a calendar and clock functions.
Motor Drive: The Motor Drive circuitry provides buffering for the signals generated by the
Printer CPU to drive the printer stepper motor.
UART 2: Provides the means of data interchange between the NIBP module and the display
CPU.
UART 3: Provides the means of data interchange between the SPO2 module and the
SRAM : The Display and Pinter CPU’s are connected to separate block of SRAM which
provides extra data storage space. The display CPU’s SRAM is connected to the
battery supply (VBAT) such that its contents are retained when the power is off.
Printer CPU (SH-P): This processor processes the SPO2,TOCO/IUP data, also controls the printer
stepper motor and provides the data for the thermal printhead.
Display CPU (SH-D): This processor processes the ECG, Ultrasound and NIBP data. It derives the ECG
beep audio from the ECG data and provides the data for the graphics controller.
EEPROM: Used to retain various factory settings (Serial No., date of manufacture … etc).
UART 4: Provides the means of data interchange via opt-couplers for the RS232 and
Ethernet connectors to the Printer CPU
Graphics Controller: The Graphics Controller is a parallel graphics driver containing onboard graphics
memory.
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.
Audio Mixer Control: This is an analogue switch used to select one of the generated audio signals for
speaker output.
User Interface Keys: A total of 17 keys are provided for user interface control.
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
To isolate the FM800E from the mains or line supply, disconnect the power cable from the
mains inlet at the rear of the unit
As several of the boards are stacked one on top of the other you may have to remove other boards to get to the
suspect board. The main difference found in units are the number of modules fitted also the presence or
absence of the Module board will depend on the type of FM8XX unit.
When refitting an assembly, ensure that all screws are replaced, fitted where necessary with the appropriate
washers.
Before removing the cover from the unit, make sure it is switched off and is disconnected from the source of AC
mains.
Ideally, before working on a unit, it should be disconnected and moved well away from the patient environment
and taken to a suitable maintenance area.
The following simple hand tools are required to dismantle and re-assemble the unit. Note that all screws used
are of the Pozidriv™ type and the correct type and size of screwdriver should be used. Failure to use the correct
screwdriver can result in damage to the tip of the screwdriver and to the head of the screw.
Table 6: Tools
Tool Used On
Screwdriver, Pozidriv, Size 0 M2 screws
Screwdriver, Pozidriv, Size 1 M3 screws and No. 2 self-tap screws
Screwdriver, Pozidriv, Size 2 M4 screws
Hex socket or nut spinner, M3 (5.5 mm AF) Earth terminal nuts
17mm Open ended spanner MSPO2 Connector
9.2.3 Remove the 2 off M2.5x12 pozidriv self tapping screws securing the Paper Tray Front Assembly
(SP-715300) to the top of the printer tray. (Fitted to later versions of the paper tray.)
9.2.6 On Reassembly ensure the spacing between Printer Tray and the Paper Tray Front Assembly
(SP-715300) is equidistant along its length.
9.2.9 Remove the M4x6 Pozidriv screw from the back of the Idler Gear (SP-31172) and remove the Idler
Gear (SP-31172) from the Paper Tray Front Assembly (SP-715300). The Idler gear bush is supplied
with the Idler Gear, however, the original bush should not require replacing.
OR
Do Not Unscrew
NIBP HOSE
9.4.3 Lift the NIBP Module (SP-751170) off the spacers
(SP-75156) and disconnect the NIBP hose,
(SP-751184). TUBE SILICON 3MM OD X 1.5 WALL
9.5.2 Lift the locking tabs on the filter PCB connector and
disconnect the 02 LOOM MOLEX TO ODU/SL
Loom Assy (SP-751186)
9.5.3 Remove the cable tie securing the DIG SPO2 (B2)
Module (SP-751518) to the Module PCBA
(SP-751083). Lift the DIG SPO2 (B2) Module
(SP-751518) upwards and away from the Module
PCB (SP-751186).
9.7.3 FM830. Remove the 4 off M3X20-Pozidriv and M3 shake proof washers. Torque screws to
60cN/M on reassembly
9.7.4 FM820. Remove the 6 off M3X20-Pozidriv screws and M3 shake proof washers. On reassembly
torque screws to 60 cN/M.
9.7.5 Remove the cable tie securing the front panel display
earth cable to the mains I/P to PSU loom (SP-751311).
Cable Tie
LIFT
HERE
9.7.10 Disconnect the Molex connectors from the Nicolay Socket Loom Assy (SP-751308) for ULT1, ULT2
MECG/FECG and TOCO inputs from the Signal Process PCBA (SP-751053).
FM820E FM830E
DISCONNECT
EARTH
9.8.5 Unscrew the 8 spacers (SP-751155) securing the Signal Process PCBA (SP-751053) to the NDB
PCB (SP-751144)
9.10.5 Hold the Print Head Assy (SP-751061) and remove the M3 Nyoloc Nuts and M3X14 Pozidriv
screws from each end taking care not to lose the brass spacers.
9.10.6 Move the Print Head Assembly (SP-751061) off the chassis pin.
PIN
9.11.4 Remove the 2 cable ties securing the rubber boot over the Mains Inlet Filter (SP-751407)
marked 1. Remove the cable tie securing the earth leads from the 5 way psu connector of the
Mains I/P to PSU loom (SP-751311) to the earth lead of the Mains Inlet Filter (SP-751407) marked
2. Remove the cable tie which secures both the PSU-DIG Loom (SP-320310), Mains Input to PSU
loom (SP-751311) and the earth lead from the Signal Process PCBA (SP-751053) marked 3.
3 2
SPB EARTH
9.11.5 Remove the M4-Nut and M4 shake proof washer MAINS INPUT EARTH
securing the Signal Process PCBA earth lead and the
Mains Input to PSU loom (SP-751311) earth lead to the PSU EARTH
chassis earth stud.
9.11.8 Slide back the rubber boot covering the Mains Inlet Filter (SP-751407) and disconnect the Brown
and Blue wires of the Mains I/P to PSU Loom (SP-751311) and Green/Yellow earth lead
(SP-320322). Pull the earth lead through the boot first and then pull the remaining wires through
the boot to remove it from the Mains I/P to PSU Loom (SP-751311)
9.12.2 Remove the 2 off cable ties securing the rubber boot
over the Mains Inlet Filter (SP-751407).Remove 1
the cable ties securing the Earth Lead (SP-320322)
to the Mains I/P to PSU Loom (SP-751311) 2
9.12.3 Slide back the rubber boot covering the Mains Inlet Filter (SP-751407).Disconnect the blue and
brown wires from the Mains I/P to PSU Loom (SP-751311) and the green/yellow wire of the earth
lead.
9.12.4 Remove the 2 off M3X6-CSK screws securing the Mains Inlet Filter (SP-751407) to the rear
chassis of the unit. On re-assembly torque screws to 60cN/M
9.13.2 Remove the M4-Nut and M4 shake proof washer PSU EARTH
securing the Signal Process PCBA earth lead
(SP-320322) and the Mains Input to PSU loom
(SP-751311) earth lead to the chassis earth stud.
PSU-DIG Loom
9.13.9 Disconnect the PSU-DIG Loom (SP-320310). (SP-320310).
9.15.3 Disconnect the keyboard to front panel loom. Remove the 6 off 2.2x8 Pozidriv Self Tap
Screws and M2 Nylon Washers. On reassembly Torque to 30cNm.
DISCONNECT
9.15.4 Lift the LCD/Keypad Assy (SP-751162) off the front molding (SP-751164).
9.16 Keytop Gator (SP-321208) and Keytop (part of SP-751050)
9.16.1 Complete cover removal instructions 9.3.1 to 9.3.3
9.16.2 Complete front assembly removal instructions 9.7.2 to 9.7.13.
PUSH
9.16.4 Using either a thin blunt instrument or fingers gently prize out the
Keytop (part of SP-751050) from the Keytop Gator
(part of SP-321208).
9.16.5 Push the Keytop Gator (part of SP-321208) from the front of the Front
Molding (SP-751164) through to the rear of the Front Molding (SP-751164).
UL1
MECG/FECG
UL2
TOCO/IUP
9.17.4 If assembling sockets to new front mouldings SP-751445 or SP-751614 go to section 9.18
9.17.5 On re-assembly ensure solder tags are screwed in the positions as indicated and that all connector
notches are in an upward direction to the top of the Front Molding (SP-751164) and the tags are
positioned as indicated. On reassembly all screws to be torque to 30cNm
NOTCH
NOTCH
NOTCH NOTCH
9.19.1 Secure the Nicolay Loom Assembly to the Mounting Plate (1) using the 8 M3X10 screws (2),M3
washers (3)and M3 nuts (4) in the positions circled in red below.
9.19.2 Ensure the TAGS are position as shown below
9.19.3 Attach the Mounting Plate (1) to the front moulding using the 4 WN1412-KB30-102 (5) screws circled
in blue below. Torque to 80cNm.
1 TAG TAG
9.20.5 Lift the locking tabs on the filter PCB connector and disconnect the
02 LOOM MOLEX TO ODU/SL Loom Assy (SP-751186).
9.20.6 Remove the 5 off cable ties securing the 02 LOOM MOLEX TO ODU/SL Loom Assy
(SP-751186) and TUBE SILICON 3MM OD X 1.5 WALL (SP-751184).
9.20.7 Insert the ferrite opening tool and push down to open the ferrite.
9.20.13 On reassembly
ensure the two flats
on the nut are
aligned vertically in
the moulding.
10 Transducer Repair
This section details how to replace the cable assemblies fitted to the Ultrasound and TOCO transducers.
During the cable replacement process it is also possible to replace the Ultrasound transducers head assembly
and the Toco transducers rubber faceplate assembly.
10.2.3 Remove the 4 screws that hold the metal plate in place.
Gloves must be worn whilst carrying out this operation. Failing to do so could result in
skin being bonded to the product.
10.3.13 At the other end of the inner rubber grommet, bend the cable away from the inner rubber grommet
so that a small gap appears. Apply one spot of glue into the gap created when the cable is bent
away from the inner rubber grommet. Do this twice more around the inner rubber grommet.
10.3.17 Place tie wrap around the loop to secure wires using cable tie
puller.
10.3.18 TOCO TRANSDUCER ONLY: Cut excess tie wrap, cut air tube.
10.3.19 ULTRASOUND TRANSDUCER ONLY: Cut excess tie wrap, cut air
tube. Cut and remove orange wire
4mm 4mm
10.4.1 Secure grommet in place with dots facing upwards. The both “V” of the clamps aligned towards the
top.
10.4.2 Secure grommet in place using M2 Crinkle Washers and M2 x 12 Pozi Pan Screws.
Torque to 20cNm
Solder Tag
Black Red
10.5.1 Secure grommet in place with dots facing upwards. The both “V” of the clamps aligned towards the
top.
10.5.2 Secure grommet in place using M2 Crinkle Washers and M2 x 12 Pozi Pan Screws.
Torque to 20cNm
Before final assembly after repair carry out the following procedure to ensure the TOCO transducer operates
with the specified limits when a 100g weight, part number, SP-742436 100g Test Weight.
2
PR2 PR1
3
11.1.1 Place the transducer face down whilst ensuring there is no pressure applied to the TOCO button.
11.1.2 Connect pin 4 of the TOCO transducer to the Ω input of the DVM.
11.1.3 Connect pin 2 of the TOCO transducer to the common input of the DVM.
11.1.4 Adjust PR1 Anti-clockwise 10 turns; Adjust PR2 clockwise 10 turns.
11.1.5 Observe the reading on the DVM; Adjust/Set the DVM to display 3 decimal places.
Record this result.
11.1.6 Disconnect pin 4 of the TOCO transducer from the DVM.
11.1.7 Connect pin 3 to the Ω input of the DVM.
11.1.8 Adjust PR1 to match the reading recorded in 11.1.5 to within ±1Ω
11.1.9 Adjust PR2 anti-clockwise to achieve a reading 4kΩ ±200Ω.
11.1.10 Disconnect the transducer from the DVM.
11.1.11 Plug the transducer into the Fetal Monitor.
11.1.12 Press the Zero Toco button on the monitor.
11.1.13 Place the 100g test weight in the centre of the transducer faceplate.
11.1.14 Check that the reading on the monitor is 80%±10%.
12 Service Menus
12.1.1 If the NDB PCB (SP-751144) is replaced the parameters for model, serial number and date of
manufacture displayed in the menu will be different from that of the originally supplied PCB.
>SETUP
>NEXT PAGE
>SYSTEM SETTINGS>Enter Code 2755
>SERVICE CENTRE
>DIAGNOSTICS>Enter Code 15351472
>Select the parameter to change MODEL,
SERIAL NUMBER
DATE OF MANUFACTURE
>Use the alphanumeric keypad to enter the changes.
>NEXT PAGE
FOR SERVICE PLEASE CONTACT:
>SYSTEM SETTINGS>Enter Code 2755 A COMPANY NAME
TELEPHONE NUMBER
>SERVICE CENTRE
>SERVICE INFORMATION
IF YOU HAVE DIFFICULTIES,
PLEASE CONTACT
A COMPANY NAME
TELEPHONE NUMBER
>SETUP
DEALER NAME
>NEXT PAGE
>SYSTEM SETTINGS>Enter Code 2755 DEALER PHONE
>SERVICE CENTRE
>DEALERS ONLY>Enter Code 8255
>Select the parameter to change DEALER NAME
DEALER PHONE
>Use the alphanumeric keypad to enter the changes.
To change the details displayed under ‘IF YOU HAVE ANY DIFFICULTIES’
>SETUP
CONTACT DETAILS EXIT
>NEXT PAGE CONTACT NAME
>NEXT PAGE
>SYSTEM SETTINGS>Enter Code 2755 RESET TO FACTORY DEFAULTS
>SERVICE CENTRE
NIBP CALIBRATION NIBP TEST
>DIAGNOSTICS
>SERVICE CENTRE
SERVICE INFORMATION
>DIAGNOSTICS
>RESET FACTORY DEFAULTS
DIAGNOSTICS
DEALERS ONLY
The NIBP Calibration menu is used to assist in the calibration of the NIBP Module (SP-751170). This calibration
should be carried out if the module fails performance tests in Error! Reference source not found. to Error!
Reference source not found..
>SETUP NIBP CALIBRATION EXIT
>NEXT PAGE
PRODUCT INFORMATION
>SYSTEM SETTINGS>Enter Code 2755
>SERVICE CENTRE
CONNECT SPHYGMOMANOMETER
>DIAGNOSTICS SEE SERVICE MANUAL
FOR DETAILS
>NIBP CALIBRATION
PROCEED
12.5.1 Connect the test equipment illustrated in 7.12 to the unit under test and expel any pressures in the
pneumatic hoses to obtain a zero reading on the calibrated pressure indicator.
PRODUCT INFORMATION
CALIBRATING ZERO LEVEL
PROCEED
12.5.2 Once the zero calibration has been completed a request to apply a pressure of 250mmHg is
displayed.
12.5.3 Using the hand bulb increase the pressure to 250mmHg. When the pressure reading on the calibrated
pressure indicator reaches 250mmHg press proceed.
PRODUCT INFORMATION
APPLY 250 mmHg
PRESS PROCEED WHEN READY
PROCEED
12.5.4 Do not de-pressurize the system until the calibration completed message has been displayed.
PRODUCT INFORMATION
CALIBRATION COMPLETED
0 mmHg
>DIAGNOSTICS
>NIBP TEST
12.6.1 Connect the suggested test equipment the NIBP pneumatic coupling and set to 250mmHg. The
displayed value should be 250mmHg ± 3mmHg.
PRODUCT INFORMATION
NIBP TEST PRESSURE
250 mmHg
12.6.2 Repeat the tests for 200mmHg, 150mmHg, 100mmHg and 50mmHg. Ensure all reading are within
± 3mmHg. If not recalibrate the module as per section 12.5
Note: The module will not read back values equal to or less than 20mmHg.
The error reporting display for each module displays two columns of eight rows with 000 00_00_00 00:00:00
The first three digits of the displayed values 000 00_00_00 00:00:00 are the error codes assigned to the
module. The second group of six digits 000 00_00_00 00:00:00 displays the date the error was generated. The
last group of six digits 000 00_00_00 00:00:00 displays the time the error was generated.
>MODULE ERRORS
>NIBP ERRORS
To clear the error logs, select the log you wish to clear.
>SETUP
>NEXT PAGE
>SYSTEM SETTINGS MODULE ERRORS EXIT
>DIAGNOSTIC
>MODULE ERRORS
Select one of the following CLEAR MSPO2 LOG
MSPO2 ERRORS
>CLEAR WD LOG
Clearing the flash options will disable some of the units’ functionality.
>SETUP
0001000010100000 0000000000000000
>NEXT PAGE 0000000000000000 0000000000000000
0000000000000000 0000000000000000
>SYSTEM SETTINGS 0000000000000000 0000000000000000
0000000000000000 0000000000000000
>Enter Code 2755 0000000000000000 0000000000000000
>SERVICE CENTRE 0000000000000000 0000000000000000
0000000000000000 0000000000000000
>DIAGNOSTIC
>SHOW FLASH OPTIONS
The options displayed above are typical for those set for the USA and Canada. Options 3,8 and 10. Option 10 is
used to support original NIBP module fitted to the FM830 Encore. This will not be enabled on units
manufactured from 2012.
The options displayed below are typical for those set for units supplied in Europe and the rest of the world.
Options 1, 2, 3,4,5,8 and 10. Option 10 is used to support original NIBP module fitted to the FM830 Encore. This
will not be enabled on units manufactured from 2012.
0111110010100000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0000000000000000 0000000000000000
0 PRODUCT INFORMATION
>SYSTEM SETTINGS
>Enter Code 2755
>SERVICE CENTRE
>DIAGNOSTIC
>PAPER OUT STATUS
13 Maintenance Schedules
Always switch off the FM800E and disconnect the AC supply cable and transducers
before attempting to carry out any cleaning or maintenance.
The FM800 is designed to require the minimum amount of maintenance. To maintain optimum performance
however, a limited amount of technical maintenance is called for.
Equipment Information:
Fetal Monitor Model:
Serial Number:
Equipment ID Number:
UL1 Serial Number:
UL1 ID Number:
UL2 Serial Number:
UL2 ID Number:
TOCO Serial Number:
TOCO ID Number:
SPO2 Sensor ID:
SPO2 Cable ID:
MECG Cable ID:
FECG Cable ID:
Service
Manual TEST RESULT
Section
6.3 Protective Earth Continuity Test Limit Measured Pass/Fail
Test Point 1 300mΩ
Test Point 2 300mΩ
Test Point 3 300mΩ
Test Point 4 300mΩ
6.5 Earth Leakage Current-Printer Metalwork Limit Measured Pass/Fail
Normal Condition (NC) 500µA
Open Supply (OS) 1000µA
Normal Condition Reverse Mains (NC-RM) 500µA
Open Supply Revers Mains (OS-RM) 1000µA
6.6 Enclosure Leakage Current-Printer Metalwork Limit Measured Pass/Fail
Normal Condition (NC) 100µA
Open Supply (OS) 500µA
Open Earth (OE) 500µA
Normal Condition Reverse Mains (NC-RM 100µA
Open Supply Reverse Mains (OS-RM) 500µA
Open Earth Reverse Mains (OE-RM) 500µA
6.6 Enclosure Leakage Current-RS232 and RJ45 Socket Limit Measured Pass/Fail
Normal Condition (NC) 100µA
Open Supply (OS) 500µA
Open Earth (OE) 500µA
Normal Condition Reverse Mains (NC-RM 100µA
Open Supply Reverse Mains (OS-RM) 500µA
Open Earth Reverse Mains (OE-RM) 500µA
6.7 Patient Leakage Current MECG/FECG Socket Lead 1 Limit Measured Pass/Fail
Normal Condition (NC) 10µA
Open Supply (OS) 50µA
Open Earth (OE) 50µA
Normal Condition Reverse Mains (NC-RM) 10µA
Open Supply Reverse Mains (OS-RM) 50µA
Open Earth Reverse Mains (OE-RM) 50µA
Service
Manual TEST RESULT
Section
Patient Leakage Current: (Mains on applied parts)
6.8 Limit Measured Pass/Fail
MECG/FECG-Lead 3
Single Fault Condition, MAP Normal Polarity 50µA
Single Fault Condition Reverse Mains, MAP Normal Polarity 50µA
Single Fault Condition, MAP Reverse Polarity 50µA
Single Fault Condition Reverse Mains, MAP Reverse
50µA
Polarity
Patient Leakage Current: (Mains on applied parts)
6.8 Limit Measured Pass/Fail
MECG/FECG-Lead 4
Single Fault Condition, MAP Normal Polarity 50µA
Single Fault Condition Reverse Mains, MAP Normal Polarity 50µA
Single Fault Condition, MAP Reverse Polarity 50µA
Single Fault Condition Reverse Mains, MAP Reverse
50µA
Polarity
6.9 Patient Auxiliary Current MECG/FECG-Lead 1 Limit Measured Pass/Fail
Normal Condition (NC) 10µA
Open Supply (OS) 50µA
Open Earth (OE) 50µA
Normal Condition Reverse Mains (NC-RM) 10µA
Open Supply Reverse Mains (OS-RM) 50µA
Open Earth RM (OE-RM) 50µA
6.9 Patient Auxiliary Current MECG/FECG-Lead 2 Limit Measured Pass/Fail
Normal Condition (NC) 10µA
Open Supply (OS) 50µA
Open Earth (OE) 50µA
Normal Condition Reverse Mains (NC-RM) 10µA
Open Supply Reverse Mains (OS-RM) 50µA
Open Earth RM (OE-RM) 50µA
6.9 Patient Auxiliary Current MECG/FECG-Lead 3 Limit Measured Pass/Fail
Normal Condition (NC) 10µA
Open Supply (OS) 50µA
Open Earth (OE) 50µA
Normal Condition Reverse Mains (NC-RM) 10µA
Open Supply Reverse Mains (OS-RM) 50µA
Open Earth RM (OE-RM) 50µA
Service
Manual TEST RESULT
Section
Performance Verification Pass/Fail
7.3 Power
7.4 Display
7.5 Time and Date
7.6 Encore Printer Settings
7.7 FECG-Section
7.8 Maternal ECG
7.9 Ultrasound
7.1 Toco
FM830 Encore Only
7.11 MSPO2-Section
7.12 NIBP
7.14 NIBP Leak Test
7.15 NIBP Transducer Accuracy
7.16 Cuff Inflation
Test Conclusion:
PASS/FAIL
Test Result
Engineers Signature:
Additional Comments:
14 External Connections
14.1 RS-232 Connectors
The left-hand group of 2 9-way D-type connectors are all RS-232 interface connectors, for the connection of
external equipment, System 8002, Dopplex Centrale and other central review systems. The Pin connections are
given in Table 9: RS-232 Connections.
For Sonicaid Fetalcare, select the ‘RS232 Sonicaid’ protocol. Consult the documentation supplied with the
Obstetric Archive or CRS system to identify a suitable communications protocol.
The AU1100 processor requires two files to complete the up-grade. One file will use the extension .tar and the
second file will use a file extension which denotes the version of software. The two software files must be copied
onto a USB memory stick.
Note: Do not try and open or extract any of the files before placing onto the USB Memory stick. The
files must be moved onto the stick as supplied.
15.5.1 Insert the USB memory stick containing the two AU1100
program files (described in section 15.2) into the USB
socket on the Signal Processor PCB.
15.5.2 Connect the FM8X0 Encore to the mains supply and switch on.
15.5.3 After the unit has booted up it may possibly display an “Internal Error Message”, this is normal during
programming.
15.5.4 Leave the unit powered up for 2 minutes.
15.5.5 When 2 minutes have elapsed, switch off the unit.
15.5.6 Remove the USB memory stick from the USB connector on the SPB PCB.
15.5.7 Remove both jumper connectors from the Signal Processing PCB.
15.5.8 Switch on the mains supply.
15.5.9 After the unit has gone into its normal operating screen select
>SETUP
>NEXT PAGE
>SYSTEM SETTINGS>Enter Code 2755
>SERVICE CENTRE
>PRODUCT INFORMATION
15.5.10 Check that the AU1100 software version displayed corresponds to the software version provided for
the up-grade.
16.3.5 Insert the USB to RS232 Converter into a free USB socket.
16.4.5 Left mouse “click” I accept license then left mouse “click”
on NEXT
16.4.6 Select the Clean-up old settings then left mouse “click”
NEXT
16.4.10 Deselect the Launch auto update then left mouse “click”
FINISH.
16.5.1 Left mouse “click” on the program start button bottom left of
the desktop.
16.5.3 If the Flash Development Toolkit hasn’t installed a shortcut select this file with a right mouse “click” then left
mouse “click” on the PROPERTIES option.
16.5.4 Right mouse “click” on the COMPATIBILITY tab and right mouse “click” to select the compatibility mode for
XP.
Software Download
Socket
Key Way
Key Way
16.6.3 Left mouse “click” on the program start button bottom left of the desktop.
16.6.4 Double left mouse “click” on either the Flash Development Toolkit short cut or programme file.
16.6.5 Left mouse “click” on Create a new project workspace then left mouse “click” OK
16.6.6 Type in a meaningful name for the Workspace and left mouse “click” OK
16.6.7 When the “Choose device” dialogue box is displayed left mouse “click” to display the device drop down list
and left mouse “click” on Generic Boot Device listed at bottom drop down list. Left mouse “click” NEXT
16.6.16 Before switching off the FM8X0 Encore left mouse “click”
on the Device menu and left mouse “click” on
DISCONNECT.
An example of the files used to program the SH2-1 and SH2-2 processors are shown below. These file are
referred to as S-Files.
16.8.2 Go to the Project menu and left mouse “click” on Add Files.
16.8.4 Select the required file and left mouse “click” Add.
16.9.4 Go to the Device menu and left mouse “click” on device. If Connect to Device is not greyed out, left mouse
“click” on it to establish connection.
If whilst using the USB to RS232 Converter the device fails to connect, switch off the FM800Encore unit and
remove the USB cable from the PC. Wait 10 seconds and reconnect the cable. Switch on the FM800 unit and
Connect to Device in Device menu.
16.9.6 Select Download File to User Area and right mouse “click”
Left Right
Turn Cable 180o in the Socket
16.10.4 Go to the Device menu and left mouse “click” on device. If Connect to Device is not greyed out, left mouse
“click” on it to establish connection.
If whilst using the USB to RS232 Converter the device fails to connect, switch off the FM800Encore unit
and remove the USB cable from the PC. Wait 10 seconds and reconnect the cable. Switch on the FM800
unit and Connect to Device in Device menu.
16.10.6 Select Download File to User Area and right mouse “click”.
16.10.10 Switch off the FM8X0 Encore and disconnect the software download cable.
16.12 Go to the File menu and left mouse “click” on Save Workspace.
16.12.3 Select the folder named after the workspace and left
mouse “click” OPEN.
16.12.4 Select the workspace file and left mouse “click” OPEN
>SETUP
>NEXT PAGE
>SYSTEM SETTINGS
>Enter Code 2755
>SERVICE CENTRE
>DIAGNOSTIC
>SHOW FLASH OPTIONS
17.1.14 Check that the flash option has been enabled. Refer to section 12.8 for more details.
18 Spare parts
18.1 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.
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.
18.2 Spare Parts
PART NUMBER DESCRIPTION
PRINTER & MOTOR RELATED PARTS
SP-751061 PRINTHEAD ASSEMBLY
SP-320306 FM800E PRINTHEAD-DIG LOOM
SP-320315 FM800E PRINTER TO DIG LOOM
SP-321197 FM800E FB SPRING
SP-751059 FM800E MOTOR GEARBOX ASSY
SP-751160 FM800E PAPER TRAY ASSEMBLY (Spacelabs/Philips/HP)
SP-751060 FM800E PAPER TRAY ASSEMBLY (Standard Assembly)
SP-751300 FM800E PAPER TRAY FRONT ASSY
SP-321172 FM800E IDLE GEAR
NIBP RELATED PARTS
SP-751170 FM830E NIBP MODULE
SP-MV2204 PNEUMATIC PANEL MOUNT COUPLING
SP-751184 TUBE SILICON 3mm OD X 1.5 WALL
SP-751065 FM800E CABLE TO BP ADAPTOR ASSY
SPO2 RELATED PARTS
SP–751186 FM800 02 LOOM MOLEX TO ODU/SL
SP-751518 DIG SPO2 (B2) PCB
DISPLAY RELATED PARTS
SP-321159 FM800E DISPLAY WINDOW
SP-751405 FM800E RIBBON DIGI TO FPB ASSY
SP-751173 FM800E LCD/KEYPAD ASSY
USER INTERFACE PARTS
SP-751309 FM800E KEYBOARD TO FRONT PANEL LOOM
SP-751063 FM800E SUB FUNCTION KEYPAD PCB ASSY
SP-751181 SWITCH, FLAT TOP 12 X 12 TACT
SP-751182 BUTTON MAINS SWITCH
SP-751183 INSULATOR SF KEYBOARD
SP-321208 FM800E KEYTOP GAITOR KIT
SP-751050 FM800E KEYTOP KIT
19 Trouble Shooting