Huntleigh FM800Encore User manual

FM800Encore Service Manual 1
FM800Encore
FM800ENCORE®SERVICE MANUAL

FM800Encore Service Manual 2
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 MSPO
2
(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

FM800Encore Service Manual 3
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
FM800Encore Service Manual 4
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
FM800Encore Service Manual 5
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
FM800Encore Service Manual 6
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
FM800Encore Service Manual 7
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
FM800Encore Service Manual 8
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

Product Specification
FM800Encore Service Manual 9
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
Safety Type CF protection
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
Safety Type CF protection
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%
Safety Type CF protection
4.8 Maternal heart rate and ECG
Range 30-240 bpm
Accuracy ±1 bpm
Alarms High and Low (30-240 bpm)
Rate Signal Loss
Safety Type CF protection

Product Specification
FM800Encore Service Manual 10
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
Nellcor
TM
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
FM800Encore Service Manual 11
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
FM800Encore Service Manual 12

Installation
FM800Encore Service Manual 13
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
FM800Encore Service Manual 14
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
FM800Encore Service Manual 15
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
FM800Encore Service Manual 16
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 100mΩor less.
Protectively earthed parts

Safety Testing
FM800Encore Service Manual 17
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.
1) Configure the electrical safety analyser as recommended by the analyser operating
instructions.
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).
1) Configure the electrical safety analyser as recommended by the analyser operating
instructions.
2) Connect the monitor’s AC plug to the electrical safety analyser as recommended by the
analyser operating instructions.
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
FM800Encore Service Manual 18
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.
Test Condition
Allowable Leakage
Current (µA)
Normal Condition (NC) 10
SFC Open Supply (SFC OS) 50
SFC Open Earth (SFC OE) 50
Normal Condition RM (NCRM) 10
SFC Open Supply RM (SFC OSRM) 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.
Test Condition
Allowable Leakage
Current (µA)
Normal Condition (NC) 50
Normal Condition RM (NCRM) 50

Safety Testing
FM800Encore Service Manual 19
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.
1) Configure the electrical safety analyser as recommended by the analyser operating
instructions.
2) Connect the monitor’s AC plug to the electrical safety analyser as recommended by the
analyser operating instructions.
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.
Test Condition
Allowable Leakage
Current (µA)
Normal Condition (NC) 10
SFC Open Supply (SFC OS) 50
SFC Open Earth (SFC OE) 50
Normal Condition RM (NCRM) 10
SFC Open Supply RM (SFC OSRM) 50
SFC Open Earth RM ( SFC OERM) 50

Performance Verification
FM800Encore Service Manual 20
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
SPO
2
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.