Huntleigh Sonicaid FM800 Series User manual

SonicaidFM800
Reference Manual

Huntleigh Healthcare Ltd 2005
All rights reserved
329000-6
April 2009

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The Sonicaid™ FM800 is in conformity with the Medical Device
Directive (93/42/EEC) and has been subject to the conformity
assurance procedures laid down in the Council Directive.

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Contents
Contents.........................................................................................................................3
Standards compliance.....................................................................................................7
Indications for use...........................................................................................................8
System Installation..........................................................................................................9
Calibration ......................................................................................................................9
Multiple Portable Socket Outlets...................................................................................10
Electromagnetic compatibility .......................................................................................11
Trademarks ..................................................................................................................12
Sensors ........................................................................................................................12
Addresses.....................................................................................................................13
1 Introduction................................................................................................................14
1.1 The FM800 series.........................................................................................14
1.2 Main unit: front panel ....................................................................................16
1.3 Connection sockets for transducers...............................................................17
1.4 Main unit: rear connectors.............................................................................18
1.5 Connector module.........................................................................................19
1.6 Event marker connection ..............................................................................20
1.7 The FM800 display........................................................................................20
1.8 Transducers and cables ................................................................................21
1.9 FM800 trolley or wall mounting......................................................................22
2FM800 Controls and Display..................................................................................23
2.1 Controls and on/off indicator .........................................................................23
2.2 FM800 main screen ......................................................................................24
2.3 Software control buttons................................................................................25
2.4 Audio controls...............................................................................................26
2.5 Printer controls..............................................................................................27
2.6 Loading printer paper....................................................................................28
3Setup.....................................................................................................................29
3.1 Overview ......................................................................................................29
3.2 Current alarms..............................................................................................29
3.3 Default alarms...............................................................................................30
3.4 System settings.............................................................................................30
3.5 Analysis ........................................................................................................30
3.6 Time and date...............................................................................................30
3.7 Patient details...............................................................................................31
3.8 Timer ............................................................................................................32
3.9 Actogram settings .........................................................................................33

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4System Settings and Default Alarms......................................................................34
4.1 Overview ......................................................................................................34
4.2 Changing the default alarms..........................................................................35
4.3 Printer setup..................................................................................................35
4.4 Audio/graphic settings...................................................................................37
4.5 International settings.....................................................................................38
4.6 Serial interface..............................................................................................39
5Monitoring Fetal Parameters..................................................................................40
5.1 Preliminary....................................................................................................40
5.2Audio signal ..................................................................................................40
5.3 Ultrasound monitoring...................................................................................41
5.4 The FHR confidence indicator.......................................................................43
5.5 False recording of low baseline FHR.............................................................43
5.6 Ultrasound for twins.......................................................................................44
5.7 Fetal ECG (using a scalp electrode)..............................................................45
5.8 Accidentally recording the wrong signal.........................................................50
6Monitoring Maternal Parameters............................................................................51
6.1 Contractions (using Toco transducer)............................................................51
6.2 Contractions (using IUP transducer)..............................................................52
6.3 Maternal ECG...............................................................................................52
6.4 Maternal Blood Pressure...............................................................................56
6.5 Maternal Oximetry ........................................................................................58
6.6 Maternal temperature....................................................................................61
7Events and Alarms.................................................................................................62
7.1 What is meant by an alarm? .........................................................................62
7.2 What do you see and hear? ..........................................................................62
7.3 Responding to alarms ...................................................................................64
7.4 Controlling alarms.........................................................................................65
7.5 Recording fetal movements ..........................................................................65
7.6 Actogram ......................................................................................................66
7.7 Recording clinical events (EasiNotes) ...........................................................68
8Setting Alarm Thresholds.......................................................................................69
8.1 Default alarm thresholds ...............................................................................69
8.2 FHR thresholds (Ultrasound and FECG)........................................................70
8.3 Maternal blood pressure thresholds...............................................................73
8.4 MECG thresholds..........................................................................................73
8.5 Maternal oximetry threshold..........................................................................74
8.6 Temperature thresholds ................................................................................74
9SonicaidTrend Intrapartum Analysis.......................................................................75
9.1 Introduction...................................................................................................75
9.2 SonicaidTrend analysis.................................................................................76
9.3 Using SonicaidTrend analysis .......................................................................77
9.4 SonicaidTrend analysis results......................................................................78
9.5 Viewing trend data ........................................................................................78

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10 SonicaidCare Antepartum Analysis........................................................................79
10.1 Intended use.................................................................................................79
10.2 Overview ......................................................................................................79
10.3 The Dawes/Redman criteria..........................................................................80
10.4 Care analysis................................................................................................80
10.5 Using SonicaidCare analysis.........................................................................81
10.6 SonicaidCare analysis report.........................................................................82
11 Using FM800 with a PC System.............................................................................85
11.1 Using FM800 with FetalCare or System8002.................................................85
11.2 Using FM800 with Sonicaid Axis ...................................................................86
11.3 Using FM800 with Sonicaid Centrale, Philips TraceVue™or GMT Argus......86
12 Telemetry ..............................................................................................................88
12.1 Connecting the telemetry unit........................................................................88
12.2 Using the telemetry unit ................................................................................88
13 Troubleshooting.....................................................................................................89
13.1 FHR..............................................................................................................89
13.2 Oximetry.......................................................................................................89
13.3 Fetal event marker........................................................................................89
13.4 Maternal blood pressure error codes .............................................................90
13.5 Printing .........................................................................................................90
13.6 What to do next?...........................................................................................91
14 Cleaning and Maintenance.....................................................................................92
14.1 The FM800 main unit....................................................................................92
14.2 Transducers: NBP cuff, maternal oximetry sensor, temperature probe..........92
14.3 Transducers and leads: Ultrasound, FECG, MECG, internal Toco and external
Toco 93
14.4 User maintenance.........................................................................................94
14.5 Technical maintenance .................................................................................95
14.6 Corrective maintenance................................................................................96
14.7 Servicing.......................................................................................................96
14.8 Accessories, consumables and spares..........................................................97
15 Specifications ........................................................................................................99
15.1 Physical and environmental ..........................................................................99
15.2 AC supply voltage and fuse values................................................................99
15.3 Transducers................................................................................................100
15.4 Controls ......................................................................................................104
15.5 Printer.........................................................................................................104
15.6 Connections................................................................................................105
15.7 Display........................................................................................................106
15.8 Safety .........................................................................................................107
15.9 Ultrasound safety considerations.................................................................108
16 Appendix 1: Service and Warranty.......................................................................110
17 Appendix 2: External Connections .......................................................................111

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18 Appendix 3: Transducer Problems .......................................................................113
19 Appendix 4: Getting Started with T800.................................................................115

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Standards compliance
SonicaidFM800 complies with:
EN60601-1, 1990 Medical Electrical Equipment Part 1
General Requirements for Safety
EN60601-1-1, 1993 Safety Requirements for Medical
[collateral standard] Electrical Systems
Patient safety
WARNING: DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT (eg COM
PORT CONNECTOR PINS ON A PC) AND THE PATIENT AT THE SAME TIME.
CE Mark
Denotes conformity with the European Council
Directive 93/42/EEC concerning medical devices.
Classification symbol
Indicates Type CF applied part.

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Indications for use
Huntleigh Healthcare Ltd Sonicaid FM800 series fetal monitors are indicated for use in
monitoring fetal and maternal vital signs during the intrapartum and antepartum periods.
Sonicaid FM820 provides comprehensive fetal monitoring facilities, offering twin
ultrasound fetal heart rate, separate fetal and maternal ECG channels, external and
internal uterine activity monitoring and maternally sensed fetal movements.
Sonicaid FM830 provides additional maternal monitoring with facilities for simultaneous
monitoring of maternal pulse oximetry, blood pressure and temperature without the need
for additional stand-alone devices.
Notes
US Federal Law restricts this device to sale on or by the order of a physician.
Sonicaid Care analysis and Sonicaid Trend analysis are not approved for sale in the USA
and Canada.
Warning: 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.

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System Installation
These requirements must be met when you connect an FM800 fetal monitor to any of the
following pieces of equipment:
●a central review and archiving system
●a PC
●a VGA monitor:
1 Non-medical equipment must comply with the relevant IEC or ISO safety standard.
For Information Technology equipment, this standard is IEC950/EN60950.
2 Medical equipment must comply with IEC601-1/EN60601-1.
3 The configured system must comply with the system standard IEC601-1-1/EN60601-1-1.
4 If non-medical equipment (eg 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), you must bring the enclosure leakage currents within the
limits laid down by IEC601-1/EN60601-1. This may be done by using an isolating
transformer such as the one supplied by Huntleigh Healthcare
Ltd.
5 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 you are
in any doubt 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 FM800 could lead to the summation
of leakage currents. In such circumstances the user must ensure that
safe leakage currents are not exceeded.
Calibration
The NBP module should be calibrated every 12 months. See Section 14.5. Apart from
this, there is no special procedure for calibrating FM800.

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Multiple 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 Annexe EEE.2 of
IEC601-1-1/EN60601-1-1 Amendment 1.
WARNINGS
1 Do not exceed the power rating for the multiple portable socket outlet.
2 Do not place multiple portable socket-outlets on the floor. This is to
protect against mechanical damage and the ingress of liquids.
3 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.
4 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.
5 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.

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Electromagnetic compatibility
Make sure the environment in which FM800 is installed is not subject to strong sources of
electromagnetic interference (eg 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:
●Reorienting 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.

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Trademarks
Sonicaid™is a registered trademark of Huntleigh Healthcare Ltd.
TempHearts™is a registered trademark of YSI Corporation.
TraceVue™is a registered trademark of Philips.
Safelinc™is a registered trademark of Tyco.
Sensors
Care 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.
Oximeter sensors
The use of original oximetry sensors supplied by the manufacturer is strongly
recommended.

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Addresses
UK
Huntleigh Healthcare Ltd
35 Portmanmoor Road, Cardiff.
CF24 5HN. UK.
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Web page www.huntleigh-healthcare.com

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1 Introduction
1.1 The FM800 series
FM800 series monitors are designed for antepartum and intrapartum monitoring. There
are four monitors in the series:
FM820 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
FM820 also provides external and internal monitoring of uterine activity,
and maternally sensed fetal movements
FM830 Standard monitor plus
Maternal pulse oximetry
Maternal non-invasive blood pressure
Maternal temperature
This reference manual covers the whole FM800 range and may describe some facilities
not available in the FM800 you have bought. Note that FM820 can be upgraded to FM830.

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FM820: standard features
The following features are available on all monitors in the FM800 range:
●Alarms
●Annotation
●Audio
●Display autodim
●Direct FECG via scalp electrode
●Fetal event marker
●Interface to Rimkus telemetry
●Interface to Sonicaid Axis
●Interface to Sonicaid System 8002 / Fetalcare
●Interface to Sonicaid Centrale and other CMS packages
●IUP: internal uterine activity
●Maternal Heart Rate via ECG (MECG lead supplied as option)
●Toco: external uterine activity
●Ultrasound 1: 1.5MHz
●Ultrasound 2: 2.0MHz
●Thermal printer
●SonicaidCare (antepartum) analysis*
●SonicaidTrend (intrapartum) analysis*
* Not approved for sale is USA and Canada.

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1.2 Main unit: front panel
1 2 1
3 4 5 6
1
Software control buttons
2
Display: see chapter 2
3
Connector module for oximetry, blood pressure and temperature
4
Connection sockets for transducers
5
Printer drawer
6
Controls and on/off indicators: see chapter 2.

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1.3 Connection sockets for transducers
ULT1 1.5 MHz Ultrasound transducer, yellow
ULT2/FECG
OR 2.0 MHz Ultrasound transducer, blue Fetal ECG electrode, blue (connected via leg plate)
MECG Maternal ECG transducer, blue
TOCO/IUP
OR
Toco contractions transducer, pink
IUP catheter-transducer, pink
Classification symbol
This symbol indicates Type CF applied part.

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1.4 Main unit: rear connectors
1 2 3 4 5
6 7 8
1 Input socket for the AC mains supply
2 RS232 connector for external NBP,
9-way D-type socket (reserved for future use)
3 RS232 connector for external FspO2,
9-way D-type socket (reserved for future use)
4* RS485 Interface for Axis (1.5kV DC isolation) (not used)
5* Connector for Rimkus Telemetry**
15-way D-type socket
6 RS232 connector for Sonicaid Centrale, FetalCare, Philips
TraceVue™, GMT Argus** 9-way D-type socket
NB this connector will also accept an RS232 to RS422
adaptor lead for connection to Philips TraceVue™
7 RS232 connector for external MSpO2
9-way D-type socket (reserved for future use)
8 VGA connector, 15-way compact D-type socket
See notes on page 9
This symbol means Date of Manufacture
*For pin connections, see Appendix 2.
** Not approved for use with Sonicaid FM800 in the USA or Canada.

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1.5 Connector module
FM830 offers additional features via a connector module.
NBP
TEMP
MSpO2
Maternal blood pressure
Maternal temperature
Maternal pulse oximetry
Type CF patient
applied part
FM830
The connector module has connectors for maternal blood pressure, maternal oximetry and
maternal temperature. The fetal oximetry connector is blanked off.

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1.6 Event marker connection
1.7 The FM800 display
The FM800’s high-performance display combines superior visual performance with
environmental ruggedness, making it suitable for a wide range of environments.
The principal benefits of the FM800 display are:
●High brightness and contrast
●Wide viewing angle: >160°
●Display auto-dims when FM800 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.
Event
marker
connector