Huntleigh Sonicaid FM800 Series User manual

Part no. 751321-EN
Issue 9
2008-2010

Huntleigh Healthcare Ltd
All rights reserved
Manufactured in the UK by Huntleigh Healthcare Ltd.
As part of the ongoing development programme the company reserves the right
to modify specifications and materials without notice.
Sonicaid™ and Huntleigh are registered trademarks of Huntleigh Technology
Ltd. 2008.
© Huntleigh Healthcare Ltd. 2008, 2010
The Sonicaid™ FM800 Encore conforms to the Medical Devices
Directive (93/42/EEC) and has been subject to the conformity
assurance procedures laid down in the Council Directive.

Sonicaid FM800 Encore Series Instructions for Use
3
Contents
10BGeneral......................................................................................................................... 7
1.1 20BApplicable products............................................................................................. 7
1.2 20BStandards compliance ........................................................................................ 7
1.3 21BIndications for use............................................................................................... 8
1.4 22BLimitations for use............................................................................................... 9
1.5 23BSystem Installation............................................................................................ 10
1.6 24BCalibration......................................................................................................... 10
1.7 25BMultiple Portable Socket Outlets....................................................................... 11
1.8 26BElectromagnetic compatibility ........................................................................... 12
1.9 27BService & Warranty........................................................................................... 12
1.10 28BTrademarks....................................................................................................... 13
1.11 29BSensors............................................................................................................. 13
1.12 30BResidual Risks.................................................................................................. 13
1.13 31BSymbols ............................................................................................................ 13
21BIntroduction................................................................................................................. 14
2.1 32BThe FM800E series........................................................................................... 14
2.2 33BMain unit: front panel......................................................................................... 16
2.3 34BConnection sockets for transducers ................................................................. 17
2.4 35BMain unit: rear connectors ................................................................................ 18
2.5 36BThe FM800E display......................................................................................... 20
2.6 37BTransducers and cables.................................................................................... 21
2.7 38BHandling and mounting..................................................................................... 22
32BFM800E Controls and Display.................................................................................... 24
3.1 39BControls and on/off indicator............................................................................. 24
3.2 40BFM800E main screen........................................................................................ 25
3.3 41BSoftware control buttons ................................................................................... 26
3.4 42BAudio controls ................................................................................................... 27
3.5 43BPrinter controls.................................................................................................. 28
43BSetup.......................................................................................................................... 29
4.1 44BOverview........................................................................................................... 29
4.2 45BCurrent alarms.................................................................................................. 29
4.3 46BDefault alarms................................................................................................... 29
4.4 47BSystem settings................................................................................................. 29
4.5 48BCCCare Analysis / TREND..................................................................................... 30
4.6 49BTime and date................................................................................................... 30
4.7 50BPatient details.................................................................................................... 30
4.8 51BTimer................................................................................................................. 31
4.9 52BActogram settings ............................................................................................. 32

Sonicaid FM800 Encore Series Instructions for Use
4
54BSystem Settings and Default Alarms.......................................................................... 33
5.1 53BOverview........................................................................................................... 33
5.2 54BChanging the default alarms............................................................................. 34
5.3 55BPrinter setup...................................................................................................... 34
5.4 56BAudio/graphic settings....................................................................................... 36
5.5 57BInternational settings......................................................................................... 37
5.6 58BSerial interface.................................................................................................. 38
65BMonitoring Fetal Parameters...................................................................................... 39
6.1 59BPreliminary........................................................................................................ 39
6.2 60BAudio signal....................................................................................................... 39
6.3 61BUltrasound monitoring....................................................................................... 40
6.4 62BThe FHR confidence indicator .......................................................................... 42
6.5 63BFalse recording of FHR..................................................................................... 42
6.6 64BUltrasound for twins .......................................................................................... 43
6.7 65BFetal ECG (using a scalp electrode)................................................................. 45
6.8 66BAccidentally recording the wrong signal............................................................ 49
76BMonitoring Maternal Parameters................................................................................ 50
7.1 67BContractions (using Toco transducer)............................................................... 50
7.2 68B Contractions (using IUP transducer)................................................................ 51
7.3 69BFetal Event Marker............................................................................................ 52
7.4 70BMaternal ECG ................................................................................................... 52
7.5 71BMaternal Blood Pressure .................................................................................. 56
7.6 72BMaternal Oximetry............................................................................................. 61
87BEvents and Alarms..................................................................................................... 65
8.1 73BWhat is meant by an alarm?............................................................................. 65
8.2 74BWhat is seen and heard?.................................................................................. 65
8.3 75BResponding to alarms....................................................................................... 68
8.4 76BControlling alarms............................................................................................. 69
8.5 77BRecording fetal movements.............................................................................. 69
8.6 78BActogram........................................................................................................... 70
8.7 79BRecording clinical events (EasiNotes) .............................................................. 72
98BSetting Alarm Thresholds........................................................................................... 73
9.1 80BDefault alarm thresholds................................................................................... 73
9.2 81BFHR thresholds (Ultrasound and FECG).......................................................... 74
9.3 82BMaternal blood pressure thresholds.................................................................. 77
9.4 83BMECG thresholds.............................................................................................. 77
9.5 84BMaternal oximetry threshold.............................................................................. 78

Sonicaid FM800 Encore Series Instructions for Use
5
10 9BPrinting ....................................................................................................................... 79
10.1 85BIntroduction ....................................................................................................... 79
10.2 86BPaper options.................................................................................................... 79
10.3 87BPaper care and handling................................................................................... 79
10.4 88BPrint speed and duration................................................................................... 80
10.5 89BChanging paper packs...................................................................................... 80
10.6 90BLoading printer paper........................................................................................ 81
10.7 91BUsing non-Sonicaid paper................................................................................. 81
10.8 92BSample Trace (Sonicaid paper)........................................................................ 83
10.9 93BTrace configurations (only applicable to Sonicaid paper) ................................. 84
11 10BCTG Chart View......................................................................................................... 91
11.1 94BIntroduction ....................................................................................................... 91
11.2 95BScreen Layout................................................................................................... 91
11.3 96BButton Functions............................................................................................... 92
11.4 97BDisplay Buffer.................................................................................................... 93
12 11BSonicaid TREND........................................................................................................ 94
12.1 98BIntroduction ....................................................................................................... 94
12.2 99BSonicaid TREND............................................................................................... 95
12.3 100BUsing Sonicaid TREND..................................................................................... 96
12.4 101BSonicaid TREND results ................................................................................... 97
12.5 102BViewing Sonicaid TREND data ......................................................................... 97
13 12BSonicaid CARE Antepartum Analysis......................................................................... 98
13.1 103BIntended use ..................................................................................................... 98
13.2 104BOverview........................................................................................................... 98
13.3 105BThe Dawes/Redman criteria ............................................................................. 99
13.4 106BSonicaid CARE analysis ................................................................................... 99
13.5 107BUsing Sonicaid CARE analysis....................................................................... 100
13.6 108BSonicaid CARE analysis report....................................................................... 101
14 13BUsing FM800E with a CRS System.......................................................................... 103
14.1 109BUsing FM800E with FetalCare........................................................................ 103
14.2 110BUsing FM800E with Sonicaid Centrale, or other CRS systems...................... 104
15 14BTelemetry – Sonicaid Freedom................................................................................ 105
15.1 111BConnecting the telemetry unit ......................................................................... 105
15.2 112BUsing the telemetry unit .................................................................................. 105
16 15BTroubleshooting........................................................................................................ 106
16.1 113BFHR................................................................................................................. 106
16.2 114BOximetry.......................................................................................................... 106
16.3 115BFetal event marker.......................................................................................... 106
16.4 116BMaternal blood pressure error codes.............................................................. 107
16.5 117BPrinting............................................................................................................ 108
16.6 118BWhat to do next?............................................................................................. 109

Sonicaid FM800 Encore Series Instructions for Use
6
17 Care and Cleaning ................................................................................................... 110
17.1 General Care .................................................................................................. 110
17.2 General Cleaning and Disinfecting (Main unit / non patient applied parts)..... 110
17.3 CCCCleaning and Disinfecting Patient Applied Parts............................................. 111
17.4 122BNBP Cuff & Maternal Oximetry Sensor........................................................... 111
17.5 122BTransducer Belts............................................................................................. 111
18 17B18BMaintenance............................................................................................................. 112
18.1 124BUser maintenance........................................................................................... 112
18.2 125BTechnical maintenance................................................................................... 113
18.3 126BCorrective maintenance.................................................................................. 113
18.4 127BServicing ......................................................................................................... 113
18.5 128BAccessories, consumables and spares .......................................................... 114
19 19BSpecifications........................................................................................................... 115
19.1 129BPhysical and environmental............................................................................ 115
19.2 130BAC supply voltage and fuse values................................................................. 115
19.3 131BTransducers.................................................................................................... 116
19.4 132BControls........................................................................................................... 120
19.5 133BPrinter.............................................................................................................. 120
19.6 134BConnections.................................................................................................... 121
19.7 135BDisplay ............................................................................................................ 122
19.8 136BSafety.............................................................................................................. 123
19.9 137BUltrasound safety considerations.................................................................... 124
295BAppendix 1: Getting Started with Sonicaid Freedom....................................................... 127

Sonicaid FM800 Encore Series Instructions for Use
7
10BGeneral
1.1 20BApplicable products
This manual applies to the following issue status products:
FM820E Issue 04
FM830E Issue 05
The issue status of a unit is shown in characters 6 & 7 of the serial number located on
the rear panel. For example:
Serial no: 751CX041234512
shows this to be an issue status 4 unit.
1.2 20BStandards compliance
Sonicaid FM800 Encore complies with:
EN60601-1, 2006 Medical Electrical Equipment Part 1 General Requirements for Safety
EN60601-1-2, 2007
[collateral standard]
General requirements for safety: Electromagnetic compatibility
IEC60601-1-4, 2000
[collateral standard] General requirements for safety: Programmable electrical medical systems
IEC60601-2-30, 1999 Particular requirements for safety, including essential performance,
of automatic cycling non-invasive blood pressure monitoring
equipment
IEC60601-2-37,
2001+A1,2004+A2,2005
Particular requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
IEC 60601-2-49: 2001 Particular requirements for the safety of multifunction patient
monitoring equipment
ISO9919, 2005 Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use
BSEN980:2008 Symbols for use in the labelling of medical devices
Patient safety
WARNING: DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT
(e.g. COM PORT CONNECTOR PINS ON A PC) AND THE PATIENT
AT THE SAME TIME.
138BCE Mark
Denotes conformity with the European Council
Directive 93/42/EEC concerning medical devices.

Sonicaid FM800 Encore Series Instructions for Use
8
139BClassification
Shock Protection - Class
Class 1 mains powered equipment
Shock Protection – Degree Type CF Applied Parts
Water Ingress Protection
Ordinary equipment
Flammable Gases
Not suitable for use in presence of flammable gases
Operation Mode
Continuous
1.3 21BIndications for use
The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are
indicated for use by trained healthcare professionals in non-invasive and invasive
monitoring of physiological parameters in pregnant adult human females, and fetuses,
during the intrapartum and antepartum periods of pregnancy. The devices are intended
for use in clinical and hospital-type facilities. They are not intended for use in intensive
care units, operating rooms or in transport monitoring applications.
Sonicaid FM820E is suitable for use when there is a need to monitor the following
physiological parameters:
•Single or twin fetal heart rates by means of ultrasound and/or FECG
•Maternal heart rate via ECG
•Uterine activity – externally or internally sensed
•Fetal movement –sensed maternally & externally via ultrasound.
Sonicaid FM830E is suitable for use when there is a need to monitor the following
physiological parameters:
•Single or twin fetal heart rates by means of ultrasound and/or FECG
•Maternal heart rate via ECG
•Uterine activity – externally or internally sensed
•Fetal movement –sensed maternally & externally via ultrasound.
•Maternal heart rate and oxygen saturation via pulse oximetry
•Maternal non-invasive blood pressure
Note
US Federal Law restricts this device to sale by, or on the order of, a physician.

Sonicaid FM800 Encore Series Instructions for Use
9
1.4 22BLimitations for use
Fetal monitors provide just one indicator of fetal condition. This should be assessed as
part of an holistic approach to obstetric care together with other factors. A complete
assessment must be made before taking appropriate action.
FM800E series monitors are intended to show trends in fetal and maternal life signs to
give a “first line” indication. On-screen displays and printouts should not be used as a
basis for clinical diagnosis; always confirm vital sign parameters by other means before
making treatment decisions.
Ultrasound monitoring should be performed in accordance with current guidelines. The
ALARA guideline (AIUM) recommends that ultrasound exposure should be kept As Low
As Reasonably Achievable.
Do not use the maternal 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.
FM800E series monitors are not intended to be used in
conjunction with defibrillator equipment. All transducers
should be removed from the patient prior to using a
defibrillator to avoid possible equipment damage and/or
injury.
FM800E series monitors are not intended for use with
patients fitted with cardiac pacemakers.
FM800E series monitors are not intended for use in water
birth situations. Exposing the unit to water could give rise to
risk of electric shock.
FM800E series monitors are not intended for use in surgical
situations. Disconnect the unit before commencing any
surgical procedures.
FM800E series monitors are not intended for mobile use in
vehicles or in aircraft.
FM800E series monitors are not to be used by untrained
personnel. Users should be alert to the possibility that
machine settings or transducers may be tampered with when
the machine is left unattended.

Sonicaid FM800 Encore Series Instructions for Use
10
1.5 23BSystem Installation
These requirements must be met when an FM800E fetal monitor is connected to any of
the following pieces of equipment:
a central review and archiving system
a PC
Non-medical equipment must comply with the relevant IEC or
ISO safety standard. For Information Technology equipment,
this standard is IEC950/ EN60950
Medical equipment must comply with IEC601-1/EN60601-1, or
equivalent.
The configured system must comply with the system
standard IEC601-1-1/ EN60601-1-1
If non-medical equipment (e.g. the PC or printer) with
enclosure leakage currents greater than those allowed by
IEC601-1/EN60601-1 is to be used in the patient environment
(within 1.5m of the patient), the enclosure leakage currents
must be brought within the limits laid down by IEC601-
1/EN60601-1. This may be done by using an isolating
transformer. Suitable types are available via Huntleigh
Healthcare sales agents
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.
1.6 24BCalibration
There are no special procedures for calibrating FM800E.

Sonicaid FM800 Encore Series Instructions for Use
11
1.7 25BMultiple Portable Socket Outlets
(including isolation transformers)
Note: an isolation transformer is a particular kind of multiple socket outlet.
It is not recommended to power a medical system from a multiple portable socket outlet
which is not supplied from an isolation transformer (IEC601-1-1/EN60601-1-1
Amendment 1).
If such an outlet is in use, it should comply with the requirements of Annex EEE.2 of
IEC601-1-1/EN60601-1-1 Amendment 1.
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
Non-medical electrical equipment situated in the patient
environment (within 1.5 metres of the patient) must be
powered via an isolation transformer, to limit leakage
current.
For more information on the connection and use of isolation transformers, consult the
user manual for the medical system you have purchased.

Sonicaid FM800 Encore Series Instructions for Use
12
1.8 26BElectromagnetic compatibility
Make sure the environment in which FM800E is installed is not
subject to strong sources of electromagnetic interference
(e.g. radio transmitters, mobile phones).
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:
Reorientating the equipment
Relocating the equipment with respect to the source of 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.
1.9 27BService & Warranty
Huntleigh Healthcare's standard terms and conditions apply to all sales. These contain full
details of warranty terms and do not limit the statutory rights of the consumer. A copy is
available on request.
If there is any reason to return the FM800E unit, please:
1. Clean the product, as described in the cleaning section.
2. Pack it in suitable packing.
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.
UK only - For further details refer to the NHS document HSG(93) 26.

Sonicaid FM800 Encore Series Instructions for Use
13
1.10 28BTrademarks
Sonicaid™is a trademark of Huntleigh Healthcare Ltd.
Safelinc™is a trademark of Tyco.
Qwik ConnectTM is a trademark of GE Medical
Koala®is a registered trademark of Clinical Innovations Inc.
Nellcor is a trademark of Covidien AG
1.11 29BSensors
140BCare and disposal
Re-usable probes and sensors: store and maintain in accordance with the instructions
supplied by the manufacturer. Probes and sensors which do not work, or which are no
longer required, should be disposed of in accordance with local regulations.
Single-use probes and sensors: dispose of these after use in accordance with local
regulations.
141BOximeter sensors
The following types of sensor are approved for use with the FM830E:
BCI (Smiths Industries) 3444 Finger Sensor
NELLCOR DS100A
The use of any other sensor may result in erroneous readings.
1.12 30BResidual Risks
The residual risks are those risks that require a warning to
be entered into this manual. They can be identified by the
proximity of the following symbols.
1.13 31BSymbols
Attention, consult accompanying documents/Instructions for Use
This symbol signifies that this product, including its accessories and
consumables is subject to the WEEE (Waste Electrical and Electronic
Equipment) regulations and should be disposed of responsibly in accordance
with local procedures.

Sonicaid FM800 Encore Series Instructions for Use
14
21BIntroduction
2.1 32BThe FM800E series
FM800E series monitors are designed for antepartum and intrapartum monitoring. There
are two monitors in the series:
FM820E Standard monitor
Comprehensive monitoring using twin ultrasound and separate ECG
channels. Gives great flexibility in monitoring multiple pregnancies.
For example:
Twin ultrasound and maternal ECG
Ultrasound, fetal ECG and maternal ECG
Twin ultrasound plus fetal ECG
FM820E also provides external and internal monitoring of uterine activity,
and maternally/automatically sensed fetal movements
FM830E Standard monitor plus
Maternal pulse oximetry
Maternal non-invasive blood pressure
This reference manual covers the whole FM800E range and may describe some facilities
not available in the FM800E you have purchased. Note that FM820E cannot be upgraded to
FM830E.

Sonicaid FM800 Encore Series Instructions for Use
15
143BFM820E: standard features
The following features are available on all monitors in the FM800E range:
Alarms
Annotation
Audio
Display auto dim
Direct FECG via scalp electrode
Fetal event function (Event marker lead supplied as option)
Ethernet connection to Central Review System
Interface to Wireless telemetry
Interface to Sonicaid Fetalcare
Interface to Sonicaid Centrale and other CRS Packages
IUP: internal uterine activity
Maternal Heart Rate via ECG (MECG lead supplied as option)
Toco: external uterine activity
Ultrasound 1: 1.0MHz
Ultrasound 2: 1.0MHz (supplied as option)
Thermal printer
Sonicaid CARE (antepartum) analysis *
Sonicaid TREND (intrapartum) function *
Printing of Mean Arterial Blood Pressure *
Actogram *
* Not approved for sale in USA and Canada
144BFM830E: standard features
In addition to the above, the following features are available on FM830E monitors:
Maternal pulse oximetry (MSpO2)
Maternal non-invasive blood pressure (NBP)

Sonicaid FM800 Encore Series Instructions for Use
16
2.2 33BMain unit: front panel
1 2 1
3 4 5 6
1
Software control buttons
2
Display: see chapter 3
3
Connector module for oximetry and blood pressure (FM830E only)
4
Connection sockets for transducers
5
Printer drawer
6
Controls and on/off indicators: see chapter 3.

Sonicaid FM800 Encore Series Instructions for Use
17
2.3 34BConnection sockets for transducers
ULT1 1.0 MHz Ultrasound transducer, green
ULT2 1.0 MHz Ultrasound transducer, green
MECG/FECG
OR Maternal ECG (3 lead chest electrodes), white
Fetal ECG transducer, white (connected via leg reference
electrode)
TOCO/IUP OR Toco contractions transducer, pink
IUP catheter-transducer, pink
145BClassification symbol
This symbol indicates Type CF applied part.
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.

Sonicaid FM800 Encore Series Instructions for Use
18
2.4 35BMain unit: rear connectors
1 2 3 4 5
1 Input socket for the AC mains supply
2 RS232 connector for connection to our Sonicaid Centrale,
Obstetric Archive & FetalCare CTG viewing and archiving
software systems. Note that other software systems are also
supported.
9-way D-type socket
3 LAN connector for connection to CRS via 10/100Mbps local
area network.
RJ45 socket
4 This symbol denotes Date of Manufacture
5 Connector for Wireless Telemetry
15-way D-type socket
Wireless
Telemetry
Wireless
Telemetry

Sonicaid FM800 Encore Series Instructions for Use
19
Connector module
The FM830E incorporates additional connectors for maternal blood pressure and
maternal oximetry on a connector module.
NBP Maternal blood pressure
Type
CF patient
applied part
MSpO2 Maternal pulse oximetry
Event marker connection
Event
marker
connector

Sonicaid FM800 Encore Series Instructions for Use
20
2.5 36BThe FM800E display
The FM800E’s high-performance colour display combines superior visual performance
with environmental ruggedness, making it suitable for a wide range of environments.
The principal benefits of the FM800E display are:
•High brightness and contrast
•Range of colours helps distinguish between displayed items
•Wide viewing angle
•Display auto-dims when FM800E is used in subdued lighting
•Extremely rugged and durable
•Reliable, long operating life
Note: as with other light-emitting displays, displaying fixed patterns on the screen can
cause a limited degree of burn-in. Some slight variation in luminance, as a result of this, is
perfectly normal.