HUNTLEIGH HEALTHCARE SONICAID FM820 (01) PDF MANUAL


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PDF Content Summary: SonicaidFM800 Reference Manual ♥ Huntleigh Healthcare Ltd 2005 All rights reserved 329000-5 September 2007 Sonicaid FM800 Series Reference Manual 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. 2 Sonicaid FM800 Series Reference Manual 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 2 FM800 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 3 Setup.......................................................................................................................... 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 3 Sonicaid FM800 Series Reference Manual 4 System 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 5 Monitoring Fetal Parameters...................................................................................... 40 5.1 Preliminary........................................................................................................ 40 5.2 Audio 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 6 Monitoring 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 7 Events 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 8 Setting 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 9 SonicaidTrend 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 4 Sonicaid FM800 Series Reference Manual 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 5 Sonicaid FM800 Series Reference Manual 18 Appendix 3: Transducer Problems .......................................................................... 113 19 Appendix 4: Getting Started with T800 .................................................................... 115 6 Sonicaid FM800 Series Reference Manual 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. 7 Sonicaid FM800 Series Reference Manual 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. 8 Sonicaid FM800 Series Reference Manual 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. 9 Sonicaid FM800 Series Reference Manual 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. 10 Sonicaid FM800 Series Reference Manual 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. 11 Sonicaid FM800 Series Reference Manual 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. 12 Sonicaid FM800 Series Reference Manual Addresses UK Huntleigh Healthcare Ltd 35 Portmanmoor Road, Cardiff. CF24 5HN. UK. Tel: +44 (0) 2920 485885 Fax: +44 (0) 2920492520 E-mail: sales@huntleigh-diagnostics.co.uk Web page huntleigh-healthcare.com 13 Sonicaid FM800 Series Reference Manual 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. 14 Sonicaid FM800 Series Reference Manual 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. 15 Sonicaid FM800 Series Reference Manual 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. 16 Sonicaid FM800 Series Reference Manual 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. 17 Sonicaid FM800 Series Reference Manual 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. 18 Sonicaid FM800 Series Reference Manual 1.5 Connector module FM830 offers additional features via a connector module.

NBP TEMP MSpO2 FM830 Maternal blood pressure Maternal temperature Maternal pulse oximetry Type CF patient applied part

The connector module has connectors for maternal blood pressure, maternal oximetry and maternal temperature. The fetal oximetry connector is blanked off. 19 Sonicaid FM800 Series Reference Manual

1.6 Event marker connection 1.7 The FM800 display Event marker connector

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. 20 Sonicaid FM800 Series Reference Manual 1.8 Transducers and cables Supplied with all units Ultrasound transducers Yellow, 1.5MHz (primary) Blue, 2.0MHz (secondary) Fetal ECG lead Blue Toco transducer Pink Transducer belts 3 Transducer buckles 3 FECG lead leg belts/electrode pads 2 Fetal movement event marker 1 Mains lead 1 Supplied with FM830 NBP air line 1 NBP adult cuff 1 Maternal SpO2 patient lead 1 Maternal SpO2 re-useable probe 1 Maternal temperature probe 1 TempHearts™ (for maternal temperature) 1 Supplied as options (with any monitor in the FM800 range) IUP lead Pink IUP single-use transducers Maternal ECG lead Blue NBP small adult cuff NBP large adult cuff Trolley Wall-mounting kit Accessories supplied with all monitors in the FM800 range Ultrasound gel 8oz Printer paper 2 packs Reference Manual 1 Getting Started card 1 Mother’s guide to FM800 card 1 21 Sonicaid FM800 Series Reference Manual 1.9 FM800 trolley or wall mounting FM800 can be mounted on a trolley or wall mounting. A purpose-designed trolley is available. If FM800 is used with a trolley or wall mounting, then it must be attached to the trolley or wall mounting with the securing screw. Otherwise there is a danger of its falling off the trolley or wall mounting accidentally. To assemble the trolley or wall mounting, follow the instructions supplied by the manufacturer. To attach FM800 to the trolley or wall mounting: 1 Position FM800 on the trolley or wall mounting top so that the securing screw is in line with the threaded boss in the centre of the FM800 base. 2 Reach under the trolley or wall mounting top, and locate the securing screw. 3 Gently push up and secure the screw tightly. WARNING: if you use FM800 on a trolley, make sure the trolley brakes are applied at all times, except when the trolley is being moved. 1 4 2 5 3 1 FM800 unit 2 Spacer 3 Securing screw 4 Threaded boss 5 Top of trolley or wall mounting unit 22 Sonicaid FM800 Series Reference Manual 2 FM800 Controls and Display 2.1 Controls and on/off indicator Printer on/off switch and indicator. Shows amber light when printer is switched on. Audio volume down. Audio volume up. Printer fast forward. Audio channel select. See Sections 5.2 and 6.3. EasiNotes annotation. See Section 7.6. Toco zero. Power on/off switch and indicator. Shows green light when FM800 is switched on. Power on/off symbol. Switching on To switch on, press the Power on/off switch. If FM800 beeps rapidly and continuously, it has failed its power-up self-test routine. Contact your local Huntleigh Healthcare Ltd representative. 23 Sonicaid FM800 Series Reference Manual 2.2 FM800 main screen When FM800 is monitoring, fetal parameters are displayed down the left-hand side of the display, maternal parameters down the right-hand side. Each parameter is always displayed in the same position on the display. See diagram below. Buttons are not active until a transducer is connected. A triangular pointer indicates that a button is active. For example: Pressing a button takes you into a setup screen for that parameter. This setup screen allows you to set alarms and thresholds. The setup button in the main screen is for general setup procedures (setting the time and date, altering the default thresholds, and so on). Stop beep or make it quieter FM800 beeps when you press a button or key. The loudness of the beep depends on the loudness of the fetal or maternal alarm, whichever is louder. So to make FM800 beep more quietly or loudly, change the volume of the fetal and/or maternal alarms. See Section 8.2. To stop FM800 beeping when you press a button or key: > SETUP > SYSTEM SETTINGS > access code (2755) > AUDIO/GRAPHIC > KEY PRESS 24 Sonicaid FM800 Series Reference Manual 2.3 Software control buttons When you switch FM800 on, the SETUP button is active. Other buttons are inactive. When you connect any transducer (apart from NBP), the button for that parameter becomes active, and the parameter name is displayed. For example, when you connect Ultrasound 1, the display shows: When the FM800 detects the fetal heart rate, it displays the rate and a confidence indicator (the heart symbol). See Section 5.4. 25 Sonicaid FM800 Series Reference Manual 2.4 Audio controls FM800 can give you an audio signal for one channel at a time (Ultrasound, FECG or MECG). The default channel is ULT1 (1.5MHz Ultrasound). So if you switch on FM800 with transducers connected for all the audio channels, and then select audio, you will get an audio signal for ULT1. If you are in any doubt, the FM800 display shows you which channel currently has the audio signal. For audio, see also Sections 5.2 and 6.3. Note: in FM800s with firmware version 1.4.0 or later, if you connect an audio-capable transducer when audio is already turned on, the audio signal automatically switches to this most recently connected transducer. The audio controls on FM800 allow you to: ● change the audio volume ● change the audio channel Volume control To change the audio volume, press Audio Volume Up or Audio Volume Down. Audio Volume Down Audio Volume Up Changing the audio channel To change the audio channel, press the Audio Channel Select button on the front panel of FM800 until the channel you want is selected. Audio Channel Select 26 Sonicaid FM800 Series Reference Manual 2.5 Printer controls There are hardware controls for printer on/off, printer fast forward, and EasiNotes: Printer On/Off switch and indicator. Shows amber light when printer is switched on. Printer Fast Forward. EasiNotes annotation. See Section 7.6. Printer setup Printer setup is controlled by the software buttons ( > SETUP > SYSTEM SETTINGS > access code (2755) > PRINTER). The options are: Twin FHR Print header Hospital name Paper speed FHR vertical scale FHR graticule Paper out buffer See Section 4.3. EasiNotes setup > SETUP > SYSTEM SETTINGS > access code (2755) > EasiNotes. See Section 7.6. 27 Sonicaid FM800 Series Reference Manual 2.6 Loading printer paper Note: the printer uses a thermal paper pack (part number 8400-8003), with no pre-printed graticule. If the paper pack shows a procedure for loading paper, this should be ignored, since it is relevant to Sonicaid Team, and not to the FM800. 1 Pull the FM800 paper drawer as far out as it will come (diagram A). 2 Remove the paper from its plastic wrapping. Make sure the words ‘THIS SIDE UP’ are visible, and that the arrow points to the back of the paper drawer. 3 Lift the first fold of paper towards you. 4 Place the paper pack centrally in the paper tray, with the first sheet centrally positioned over the roller (diagram B). 5 With a thumb on either side of the printer drawer, push the drawer in firmly until it clicks into place. diagram A diagram B 28 Sonicaid FM800 Series Reference Manual 3 Setup 3.1 Overview The Setup procedures are much simpler if you understand the differences between Setup, Current Alarms, Default Alarms and System Settings. Setup User preferences available directly from the Setup screen. Current Alarms Allows you to set alarms before connecting transducers. Settings remain in force until you switch off FM800. When you switch on again, the FM800 reverts to the default alarms. You can set alarms for: FHR, Maternal temperature, MECG, NBP, MSpO2 You can also set alarms from the main screen by pressing the key beside the parameter whose alarm you want to change. Default Alarms Default alarm settings protected by the access code (2755): Changes you make using Default Alarms remain in force when you switch FM800 off and on again. System Settings User preferences protected by the access code (2755): Changes you make using System Settings remain in force when you switch FM800 off and on again. 3.2 Current alarms This option allows you to alter the alarms for a monitoring session before connecting transducers. The changes you make using this option do not remain in force when you switch off the FM800. See Chapter 8. 29 Sonicaid FM800 Series Reference Manual 3.3 Default alarms This option allows you to alter the default alarms for the FM800. The changes you make using this option do remain in force when you switch off the FM800. See Chapter 8. 3.4 System settings See Chapter 4. 3.5 Analysis Use SETUP also if you want to choose SonicaidCare* (antepartum) or SonicaidTrend* (intrapartum) analysis: SonicaidTrend analysis See Chapter 9. SonicaidCare analysis See Chapter 10. * not approved for sale in USA and Canada 3.6 Time and date To reset the date or time in FM800: 1 > SETUP > TIME AND DATE. 2 > SETUP beside the time or date. 3 Use + and – to make the necessary changes. 4 > EXIT. To change the date format, see Section 4.5, International Settings. 30 Sonicaid FM800 Series Reference Manual 3.7 Patient details Patient details are the patient name, patient ID and gestation period. They are printed on the header of the trace. They are not saved when FM800 is switched off. Entering patient name and ID To enter or edit the patient name and ID: 1 > SETUP > PATIENT DETAILS. 2 > ADD/EDIT beside Name or Number. 3 For each character of the name or ID: Press the key for the character group (eg ABCDEFGH). Then press the key for the character. To move the cursor: > LEFT or RIGHT. NB For non-standard characters: > NEXT PAGE. 4 When the name or ID is complete: > EXIT. Gestation To enter the gestational age of the fetus: 1 > SETUP > PATIENT DETAILS. 2 > ADD/EDIT beside Gestation. 3 > + or – as necessary. To remove patient details Switch FM800 off, then on. 31 Sonicaid FM800 Series Reference Manual 3.8 Timer You can set a timer to tell you when a given period of time (1–99 minutes) has elapsed. The timer starts when you start printing. Note: you cannot set the timer when SonicaidCare analysis or SonicaidTrend analysis is in progress. To set the timer 1 > SETUP > TIMER > ON. 2 Use + or – to set the length of time required. 3 > EXIT. Acknowledging the timer When the set time has elapsed, FM800 beeps repeatedly, if the beep is turned on. In the main screen, the Alarm Acknowledge key shows the message: TIMER FINISHED To stop the beep: > ALARM ACKNOWLEDGE. To turn the timer off > SETUP. > TIMER. > OFF. 32 Sonicaid FM800 Series Reference Manual 3.9 Actogram settings Actogram on/off (not available in the USA and Canada) To turn the actogram features on or off: > SETUP > NEXT PAGE > ACTOGRAM Press ACTOGRAM IS OFF/ON to turn the actogram feature on or off. To increase or decrease the sensitivity of Actogram > SETUP > NEXT PAGE > ACTOGRAM > SET ACTOGRAM GAIN ULT1 > use + or – to set the gain required. Changing the Actogram display setting > SETUP > NEXT PAGE > ACTOGRAM > ACTOGRAM OUTPUT [this cycles on each press between graph, checkmarks and graph + checkmarks] Changing the Actogram threshold > SETUP > NEXT PAGE > ACTOGRAM > SET ACTOGRAM THRESHOLD > use + or – to set the threshold as required. [the required threshold may depend on whether the trace is showing a high incidence of artefact. It is recommended to set the threshold between 40 and 60%.] Observe the Actogram trace for a short period to see if the setting is satisfactory. 33 Sonicaid FM800 Series Reference Manual 4 System Settings and Default Alarms 4.1 Overview The System Settings and Default Alarms screens allow you to set preferences which are protected by an access code (2755). These preferences remain in force when you switch the FM800 off, and then on again System settings The System Settings screen allows you to: ● Add or change EasiNote descriptions ● Display or not display the baby graphic ● Display or not display FECG or MECG waveforms ● Beep or not beep when a key is pressed ● Change the printer setup ● Change the international setup ● Beep or not beep when an Event Mark is recorded ● Select the host interface (eg Sonicaid FetalCare, System8002, Dopplex Centrale, Philips TraceVue) You can also use System Settings to access Service information. To get into the System Settings screen: > SETUP. > SYSTEM SETTINGS. > access code (2755). Default alarms The Default Alarms screen allows you to change the default alarms for: ● FHR ● Maternal temperature ● MECG ● NBP ● MSpO2 34 Sonicaid FM800 Series Reference Manual 4.2 Changing the default alarms When you switch the FM800 on, the alarm settings for FHR, maternal temperature, MECG, NBP and MSpO2, and the mode setting for NBP, revert to the hospital defaults. To change the hospital defaults: 1 > SETUP > DEFAULT ALARMS > access code (2755). 2 Press the key for the parameter whose default setting you want to change. 3 Change the alarm settings. See Section 8.1. Resetting to factory defaults To restore FM800 configuration, as originally delivered from the factory: > SETUP. > SYSTEM SETTINGS. > enter access code (2755). > SERVICE CENTRE. > DIAGNOSTICS. > RESET TO FACTORY DEFAULTS. 4.3 Printer setup Print header The header (hospital name, patient name, gestation) is printed at the start of the trace. To switch header printing on or off: [> SETUP > SYSTEM SETTINGS > access code (2755)] > PRINTER. > PRINT HEADER once or twice, as required. Hospital name To enter (or edit) the hospital name printed on the trace: > PRINTER. > HOSPITAL NAME. Enter the hospital name in the same way as for Patient Details. See Section 3.7. 35 Sonicaid FM800 Series Reference Manual Paper speed To change the paper speed: > PRINTER. > PAPER SPEED once or twice, as required. FHR vertical scale The FHR vertical scale can be 20 bpm/cm or 30 bpm/cm. At 20 bpm/cm the range is 50- 210 bpm. At 30 bpm/cm it is 30–240 bpm. To change the vertical scale: > PRINTER. > FHR SCALE. FHR scale for twins If you are monitoring twins, you can print each FHR trace on its own scale, or both on the same scale. To alter the vertical scale for twins: > PRINTER. > TWIN FHR. FHR graticule The FHR graticule can be printed at intervals of 5 bpm or 10 bpm. To alter the FHR graticule: > PRINTER. > FHR GRATICULE. 36 Sonicaid FM800 Series Reference Manual Paper-out buffer If the paper runs out, FM800 can store data for up to 10 minutes, and then fast print when the paper is refilled until it catches up with the real-time incoming data. When this happens, the stored data is held in the paper-out buffer. The default is for the paper-out buffer to be enabled (ie FM800 will store data if the paper runs out). To switch off the paper-out buffer, or switch it on again after it has been switched off: > PRINTER. > PAPER OUT BUFFER. 4.4 Audio/graphic settings Baby graphic To display (or stop displaying) the picture of a baby on the main FM800 screen: [> SETUP > SYSTEM SETTINGS > access code (2755)] > AUDIO/GRAPHIC. > BABY GRAPHIC. Audible key press To switch on (or off) the beep which accompanies every key press: > AUDIO/GRAPHIC. > KEY PRESS. Audible event mark To switch on (or off) the beep which accompanies the marking of an event: > AUDIO/GRAPHIC. > EVENT MARK. ECG waveform display To display (or stop displaying) ECG waveforms when Maternal ECG or Fetal ECG is being recorded: > AUDIO/GRAPHIC. > ECG WAVEFORM. Note: the waveforms appear only if an ECG signal is connected. But if you switch the instrument off, and then later switch it on again, it remembers whether you asked for ECG waveforms to be displayed. 37 Sonicaid FM800 Series Reference Manual 4.5 International settings Supply frequency (50Hz or 60Hz) To alter the supply frequency: [> SETUP > SYSTEM SETTINGS > access code (2755)] > INTERNATIONAL. > SUPPLY FREQUENCY. Language To change the language appearing on the display: > INTERNATIONAL. > LANGUAGE. Select the language you want. Date format To change the date format: 1 > INTERNATIONAL. 2 Press the key opposite the current date format. 3 Repeat if necessary. If you want day, month and year separated by ‘.’: > ‘/ ’. Contractions units of measurement For Toco, the contractions scale is 0–100%, relative units. For IUP, the units of measurement are mmHg (0–100) or kPa (0–15). To select mmHg or kPa for the IUP transducer: > INTERNATIONAL. > IUP UNITS. Temperature units of measurement (°C or °F) To select °C or °F for the temperature transducer: > INTERNATIONAL. > TEMP UNITS. 38 Sonicaid FM800 Series Reference Manual 4.6 Serial interface When connecting to a central review system, you need to tell the FM800 whether the central review system is a Sonicaid system or a non-Sonicaid system which recognises the Philips Series 50 fetal monitors digital interface protocol. FM800 has been tested with Sonicaid Centrale, Philips TraceVue and GMT Argus. For other central review systems, consult the description of the Serial Interface Protocol in the Sonicaid FM800 Service Manual, part number 329801, issue 3 or later. To select the appropriate serial interface: 1 > SERIAL INTERFACE. 2 Use the key opposite ‘RS232 S8002’ to select the serial interface. For Sonicaid FetalCare or Sonicaid System8002, make sure the setting is ‘Sonicaid’. For Sonicaid Centrale, Philips TraceVue or GMT Argus, make sure the setting is ‘HP’. 3 > EXIT. 4 Switch off FM800. Wait for about 10 seconds. 5 Switch FM800 on again. See also Chapter 11. Note: GMT Argus is not approved for use with Sonicaid FM800 in the USA or Canada. Note: Sonicaid Centrale can also support the ‘Sonicaid’ protocol option. 39 Sonicaid FM800 Series Reference Manual 5 Monitoring Fetal Parameters 5.1 Preliminary 1 Have the transducers and transducer belts ready. 2 Switch on FM800. 3 Check the printer: Is there sufficient paper for the monitoring session? Is the drawer fully pushed in? 4 Check the printer setup (graticule, scale, paper speed etc). 5 Enter patient details, if required. 5.2 Audio signal You can get an audio signal for FHR and Fetal ECG: ● For FHR the FM800 gives an audible representation of the Ultrasound signal. ● For FECG the FM800 beeps each time it detects a fetal heartbeat. The volume control and channel select buttons are on the front panel of FM800. The channel select button selects the eligible channels in turn. The eligible channels are those which: a) can produce an audio signal, and b) have a transducer connected. To select Audio for a channel, press Channel Select until the Audio symbol appears by that channel. To turn Audio off, press Channel Select until the Audio symbol does not appear at all. Channel Select Audio symbol 40 Sonicaid FM800 Series Reference Manual 5.3 Ultrasound monitoring 1 Connect the yellow transducer to the yellow socket on FM800. In the FM800 main screen, the ULT 1 button becomes active. 2 Palpate the abdomen to determine fetal lie and position. 3 Make the patient comfortable in a semi-recumbent or sitting position. Place the belt around the abdomen, and secure it with the buckle. Transducer buckle and belt attachment 4 Apply Aquasonic coupling gel liberally to the face of the transducer. Position the transducer on the abdomen over the fetal site. Move it slowly until you hear the characteristic hoof-beat sound of the fetal heart. 5 When you are getting a good signal, FM800 displays the FHR. Check that the fetal heart pulse lamp flashes with each fetal heartbeat, and that the FHR is distinct from the maternal pulse rate taken at the mother’s wrist. Make a note of the maternal pulse on the chart paper. 6 Clip the transducer through one of the three positioning holes on the buckle. 7 Connect the fetal event marker to the socket on the side panel. Explain to the mother how and when to use it. 8 Adjust the sound level with the volume controls on the front panel of FM800. 9 To start printing, press the printer on/off button. Note: FM800 displays a schematic diagram of a fetus (or fetuses, if two transducers are connected) These diagrams do not show the actual position of the fetus. You can stop displaying this graphic, if you want. See Section 4.4. 41 Sonicaid FM800 Series Reference Manual Toco transducer Ultrasound transducer Transducer positioning for Ultrasound monitoring Hints on monitoring ● Make sure the transducer is placed in the optimum position. Avoid positions with strong placental sounds (swishing) or the fetal cord pulse at the same rate as the fetal heart. ● If the fetus is in the occipitoanterior presentation and the mother is supine, the clearest heart sound will normally be found on the midline below the umbilicus. ● It is not possible to monitor the fetal heart rate unless an audible fetal heart signal is present. It is important to distinguish the fetal pulse from the maternal pulse. To do this, feel the mother’s pulse during the examination, or monitor Maternal ECG. 42 Sonicaid FM800 Series Reference Manual 5.4 The FHR confidence indicator The heart symbol which appears against the FHR display is a confidence indicator, not an indicator of signal strength. See table below: Display shows Interpretation

No heart symbol and No FHR displayed Heart symbol in outline only and No FHR displayed Small heart symbol inside outline heart symbol and FHR displayed Alternate small and large filled heart symbol (‘beating’ heart) and FHR displayed FM800 cannot detect the fetal heartbeat. FM800 can detect a fetal heartbeat, but cannot determine the fetal heart rate. FM800 can detect the fetal heartbeat, and can establish a fetal heart rate, but not with a high degree of confidence. FM800 can detect the fetal heartbeat, and can establish the fetal heart rate with confidence.

5.5 False recording of low baseline FHR When monitoring a low baseline FHR using Doppler ultrasound, the heart rate may be falsely reported. This effect is known as double-counting, and is characteristic of ultrasound fetal monitoring. In normal circumstances the atrium and ventricle beat almost simultaneously. The ultrasound reflected from these two chambers is used by fetal monitors to calculate the FHR. When the FHR is low, at 70-80bpm, there is a longer time interval between the atrial and ventricular contractions. A fetal monitor may take the reflection from each chamber as a separate beat and therefore falsely calculate the FHR. It can also happen, though very rarely, that the monitor double counts signals which are maternal in origin. 43 Sonicaid FM800 Series Reference Manual The Sonicaid FM800’s heart rate detection system separates movements of the heart away from the transducer from those towards the transducer. This helps to correct some instances of double-counting, but does not entirely prevent it. How to minimise the chances of double counting occurring 1 Always palpate the abdomen and listen to the fetal heart with a Pinard stethoscope or hand-held Doppler unit before applying the ultrasound transducers. This helps to verify the fetal heart and to locate the area where best signal quality can be expected. 2 Palpate the maternal pulse for one minute simultaneously and record it on the printed output. 3 Recording a signal for maternal ECG will help to identify any cross-correlation between maternal and fetal heart rates. 4 Listen to the fetal heart rate using the FM800 Audio signal. The sound should be like a galloping horse, not a swishing sound from maternal vessels. 5.6 Ultrasound for twins 1 Set FM800 to TWIN SCALES or SINGLE SCALE. [ > SETUP > SYSTEM SETTINGS > access code (2755) > PRINTER > TWIN FHR] 2 Palpate the abdomen and ascertain the lie of each fetus. 3 Place both ultrasound transducers on the patient’s abdomen in the optimum position. Use the blue ultrasound transducer to monitor the first, presenting twin. Make the transducers secure with belts and buckles. 4 Check that the two heart rates are different. If the heart rates appear similar: FM800 beeps The display shows !CHECK TRACE FOR SAME HEART RATE The printer prints this symbol on the trace Make sure you have positioned the transducers correctly. 44 Sonicaid FM800 Series Reference Manual 5 To hear the audio signal for each twin, press the Channel Select on the front of FM800. The Audio symbol shows which is the active audio channel. Channel Select Audio symbol 6 Connect the fetal event marker to the socket on the side panel. Explain to the mother how and when to use it. 5.7 Fetal ECG (using a scalp electrode) Connection For a single fetus: FECG or ULT 1 For twins: FECG + ULT 1 Note: In the USA and Canada the use of FDA-compliant fetal scalp electrodes is required. 45 Sonicaid FM800 Series Reference Manual Monitoring procedure using Sonicaid electrodes 1 Gel the base of the electrode leg plate, then strap the electrode leg plate to the front of the thigh. Secure with the belt. 2 Connect the electrode leg plate to either of the blue sockets on FM800. Caution: read the instructions for use supplied with the fetal ECG scalp electrode 3 Attach the fetal scalp electrode to the fetal scalp or the presenting part as described in the electrode instructions. 4 Connect the electrode leads to the leg plate. The polarity of these connections is not important. Make sure a good signal is maintained. 5 Allow a few minutes for the signal to stabilize and a clear fetal heart rate to be displayed. The signal quality indicator should be a solid, filled heart. Check the signal visually by displaying the FECG waveform (see below). 6 The FM800 carries out its own internal impedance check. If the check fails, you see the message: CHECK FECG CONNECTIONS. 7 Adjust the volume control as necessary. FECG socket: pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key: 1 FECG socket on FM800 2 Red 3 Green 4 M REF 5 Red 6 Black 7 FECG electrode 8 ECG REF 46 Sonicaid FM800 Series Reference Manual Monitoring procedure using Safelinc electrodes Caution: follow the instructions for use supplied with the fetal ECG scalp electrode 1 Following the manufacturer’s instructions, attach the FECG lead to the mother’s leg, using the adhesive pad. 2 Following the manufacturer’s instructions, attach the FECG electrode to the fetal presenting part. 3 Connext the FECG electrode to the FECG lead. 4 Allow a few minutes for the signal to stabilize and a clear fetal heart rate to be displayed. The signal quality indicator should be a solid, filled heart. Check the signal visually by displaying the FECG waveform (see below). 5 The FM800 carries out its own internal impedance check. If the check fails, you see the message: CHECK FECG CONNECTIONS. 6 Adjust the volume control as necessary. FECG socket: pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key: 1 FECG socket on FM800 2 M REF 3 FECG REF 4 FECG electrode 47 Sonicaid FM800 Series Reference Manual Displaying the FECG waveform When you monitor FECG using a scalp electrode, the FM800 monitor shows the fetal heart rate in the same way as it shows the ultrasound heart rate: as a numerical rate together with the confidence indicator (the flashing heart symbol). There is also an option to display the FECG waveform. The factory default is to display the waveform. So a brand new FM800 will display FECG waveforms if there is an FECG transducer connected. From then on the FM800 remembers the on/off setting from the last time it was used. To switch the display on: > SETUP. > SYSTEM SETTINGS. > access code (2755). > AUDIO/GRAPHIC. > ECG WAVEFORM. > EXIT > EXIT. The FECG waveform now appears in place of the baby graphic: Note: if you are monitoring MECG and FECG, and ECG waveform display is switched on, the FM800 displays the MECG waveform. To see the FECG waveform displayed, disconnect the MECG transducer from the FM800. 48 Sonicaid FM800 Series Reference Manual Printing the FECG waveform 1 Make sure the FM800 is already printing the trace. 2 Make sure the FECG waveform is displayed. 3 > the EasiNotes annotation button. 4 > PRINT ECG. FECG trace printout: 49 Sonicaid FM800 Series Reference Manual 5.8 Accidentally recording the wrong signal We have seen (section 5.6) that when you are monitoring twins, it is possible to pick up the signal for the ‘wrong’ twin. It is also possible, if the ultrasound transducer is incorrectly placed, for it to pick up the maternal heart instead of the fetal heart. Similarly it is possible for the maternal ECG to be mistaken for the fetal ECG. To help guard against these possibilities, the FM800 routinely compares the heart rates obtained from different sources. If any two rates appear similar (within 3bpm), for more than three minutes, then: FM800 beeps The display shows !CHECK TRACE FOR SAME HEART RATE The printer prints this symbol on the trace The message and warning are the same no matter what two rates are similar. If the rates continue to match, the warning is repeated every 2 minutes 30 seconds. If the FM800 gives you this warning, you should check that the signals you are recording are what you think they are. The following pairs of rates are compared: ULT1 with ULT2 ULT1 with FECG ULT1 with MECG ULT1 with MSpO2 (heart rate) ULT2 with MSpO2 (heart rate) FECG with MSpO2 (heart rate) FECG with MECG ULT2 with MECG 50 Sonicaid FM800 Series Reference Manual 6 Monitoring Maternal Parameters 6.1 Contractions (using Toco transducer) 1 Connect the Toco transducer to the pink socket on FM800. 2 Place the belt round the abdomen, and secure it with the buckle. 3 DO NOT USE COUPLING GEL. Wipe off any gel present on abdomen around this area. 4 Clip the Toco transducer through one of the three positioning holes on the buckle so that it is retained on the midline half-way between the mother’s fundus and the umbilicus. 5 Contractions activity is measured as a % of full scale deflection. The contractions measurement automatically zeroes to 10%. If you suspect the transducer is not zeroed correctly, press the pink Toco Zero button on the front of FM800, at a moment when the mother is not experiencing a contraction. 51 Sonicaid FM800 Series Reference Manual 6.2 Contractions (using IUP transducer) FM800 is designed for use with an Intran disposable catheter transducer. 1 Connect the IUP connecting lead to the pink socket on FM800. Caution: read the instructions for use supplied with the intrauterine catheter. 2 Set IUP units of measurement, if required. [SETUP > SYSTEM SETTINGS > access code (2755) > INTERNATIONAL > IUP UNITS] 3 Insert the catheter as described in the instructions. 4 Zero the transducer as described in the instructions supplied with it. Zero FM800 by pressing the pink Toco Zero control on the front panel. Or > IUP, then > ZERO. 5 To confirm placement and function of the transducer, ask the patient to cough. You should observe a spike in the contractions measurement. 6 Connect the fetal event marker to the socket on the side panel. Explain to the mother how and when to use it. 6.3 Maternal ECG Monitoring MECG allows you to check that the fetal heart rate being recorded does in fact belong to the fetus and not the mother. Audio signal You can get an audio signal for MECG. If you select Audio for MECG, the FM800 beeps each time it detects a maternal heartbeat. The volume control and channel select buttons are on the front panel of the FM800. To select Audio for MECG, press Channel Select until the Audio symbol appears by the MECG display. To turn Audio off completely, press Channel Select until the Audio symbol does not appear at all. Channel Select Audio symbol 52 Sonicaid FM800 Series Reference Manual MECG monitoring procedure 1 Use self-adhesive disposable electrodes. Placement of the electrodes is not critical, though it is a good idea to have the lower electrode placed clear of the diaphragm, as the muscles here are very active in contraction. A recommended arrangement might be:

W B R

2 Connect the MECG lead (blue) to the MECG socket on FM800. 3 Clip the three flying leads of the MECG lead to the electrodes. They are colour-coded white, black and red (W, B and R in the diagram above). 4 Allow a few minutes for the signal to stabilize and a clear maternal heart rate to be dis played. Check the signal visually by displaying the MECG waveform (see below). 5 The FM800 carries out its own internal impedance check. If the check fails, you see the message: CHECK MECG CONNECTIONS. 6 If you have selected audio for the MECG channel, adjust the volume control as necessary. If the maternal and fetal heart rates appear similar: ● FM800 beeps ● The display shows !CHECK TRACE FOR SAME HEART RATE Confirm the source of the fetal heart rate you are monitoring. 53 Sonicaid FM800 Series Reference Manual Displaying the MECG waveform When you monitor MECG, the FM800 monitor shows the maternal heart rate in the same way as it shows the ultrasound heart rate: as a numerical rate together with the confidence indicator (the flashing heart symbol). There is also an option to display the MECG waveform. The factory default is to display the waveform. So a brand new FM800 will display MECG waveforms if there is an MECG transducer connected. From then on the FM800 remembers the on/off setting from the last time it was used. To switch the display on: > SETUP. > SYSTEM SETTINGS. > access code (2755). > AUDIO/GRAPHIC. > ECG WAVEFORM. > EXIT > EXIT. The MECG waveform now appears in place of the baby graphic: Note: if you are monitoring MECG and FECG, and ECG waveform display is switched on, the FM800 displays the MECG waveform. 54 Sonicaid FM800 Series Reference Manual Printing the MECG waveform 1 Make sure the FM800 is already printing the trace. 2 Make sure the MECG waveform is displayed. 3 > the EasiNotes annotation button. 4 > PRINT ECG. MECG trace printout: 55 Sonicaid FM800 Series Reference Manual 6.4 Maternal Blood Pressure The FM830 can measure the mother’s systolic and diastolic blood pressure, mean arterial pressure**, and the average pulse rate during the measurement. You can take measurements manually or automatically (at an interval defined by the user). An alarm is triggered if the mother’s blood pressure goes above or below certain limits, or if the measurement fails. You can switch the alarm off, if you prefer. ** This feature not available in the USA or Canada Note: in countries where mean arterial pressure is not used, the value for mean arterial pressure is not shown on the FM800 printout. Any obstetric data management system connected to FM800 should be configured not to display the mean arterial pressure. Attaching the cuff 1 Place the cuff around the mother’s arm, approximately 5cm above the elbow. 2 Connect the cuff hose to the FM800 air hose. 3 Connect the FM800 air hose to the NBP connector on the FM800 patient module. Displaying results FM800 displays systolic and diastolic pressure, in the format 135/75, beside the NBP button. This result is displayed for an hour, or until the next NBP measurement. If you are not monitoring maternal ECG or maternal oximetry, FM800 also displays the average pulse rate during the last NBP measurement. This value is displayed beside the MECG button for 10 minutes, or until the next NBP measurement. Note: if you are taking NBP measurements every 3 minutes, set print speed to 2cm/min or 3cm/min; otherwise there will not be room on the paper for every result. 56 Sonicaid FM800 Series Reference Manual Taking measurements manually 1 Connect the cuff to the NBP socket on the connector module. 2 > NBP. The NBP SETUP screen tells you whether you are in Manual Mode or Auto Mode. 3 To change from Auto to Manual: > MANUAL. 4 The ALARMS symbol tells you whether the alarm is on or off. Alarm on Alarm off To turn the alarm on or off: > ALARMS > ON or OFF. If you set the alarm on, you can reset the alarm limits and volume, if necessary. See Chapter 8. 5 Attach the cuff to the mother. See above. 6 To take a measurement: > NBP > START MEASUREMENT. To stop a measurement, after it has started: > STOP NBP. Taking measurements automatically 1 Connect the cuff to the NBP socket on the connector module. 2 > NBP > AUTO. 3 Set the interval between measurements by pressing + or –. 4 The alarm symbol tells you whether the NBP alarm is on or off. Alarm on Alarm off To turn the alarm on or off: > ALARMS > ON or OFF. If you set the alarm on, you can reset the alarm limits and volume, if necessary. See Chapter 8. 5 Attach the cuff to the mother. See above. 6 > START AUTO CYCLE to start taking measurements. 7 To take a non-automatic measurement, while remaining in Auto Mode: > NBP > MEASURE NOW. 8 To stop taking measurements: > NBP > STOP AUTO CYCLE. To stop a particular measurement: > STOP NBP. FM800 remains in Auto Mode, and displays 00/00 as the current measurement. 57 Sonicaid FM800 Series Reference Manual Failed measurements (manual and automatic) When an NBP measurement fails: ● The NBP display shows 00/00. ● An error code or message explains why the measurement failed. See Section 13.4. ● An audible alert sounds, if NBP alarms are on. If there is an error condition in Auto Mode, the Auto cycle is halted, but FM800 remains in Auto Mode. To restart automatic measurements: > NBP > START AUTO CYCLE. Note: if the error is over-pressure (code 906), the alert always sounds. 6.5 Maternal Oximetry The FM830 can measure the mother’s blood oxygen saturation and pulse rate. An alarm sounds if the mother’s oxygen saturation drops below a certain level, or if her pulse rate goes above or below certain limits. If you are monitoring Maternal ECG, the MECG heart rate overrides the pulse rate from the oximeter. Caution 1 Use only maternal oximetry sensors which have been approved and licensed by the manufacturer. Always follow the instructions for use supplied with the maternal oximetry sensor. 2 The maternal oximetry sensor will not give accurate results if the mother is wearing nail varnish. 3 Nail varnish remover contains acetone. Contact with acetone will damage the maternal oximetry sensor. 58 Sonicaid FM800 Series Reference Manual 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. Procedure 1 Connect the maternal oximetry sensor to the maternal oximetry module. 2 Connect the oximetry module to the FM800 connector module. Align the red dot on the oximeter lead with the red dot on the MSpO2 socket on the FM800 connector module. Push the connector straight in until it locks. Do not twist. 3 Attach the sensor to the mother. See the instructions supplied with the sensor. 4 The ‘searching’ symbol appears while the sensor looks for an oximetry signal. 5 When it finds a signal, the ‘searching’ symbol disappears, and is replaced by the ‘pulse amplitude’ and ‘signal quality’ symbols. 6 Reset the alarm limits and alarm volume, if necessary. See Chapter 8. 7 If you want an audible pulse tone, press Channel Select until the Audio symbol appears by the MSpO2 display. Channel Select Audio symbol 8 Start monitoring. Check the pulse tone volume, if Audio is selected. Note: if FM800 does not display the ‘Searching’ symbol in step 4, make sure the oximetry sensor is connected to the oximetry module. Guide to MSpO2 symbols

Searching Signal Quality: good Signal Quality: poor Pulse Amplitude

59 Sonicaid FM800 Series Reference Manual Start and stop monitoring To start monitoring, in the MSpO2 SETUP screen: > START. After about 5 seconds, the mother’s blood oxygen level appears in the MSpO2 section of the display, with a pulse amplitude indicator. If you are not monitoring Maternal ECG, the mother’s pulse rate also appears. If you have selected Audio for MSpO2, the pulse beat is indicated by an audible ‘pulse tone’, which sounds with each beat of the mother’s pulse. Disconnecting the oximetry sensor When the oximetry module is connected to FM800, the connection is secured by two catches. These catches are released when you pull the knurled metal sleeve of the oximetry module connector (this sleeve is the part with the red dot on it). So when you disconnect the oximetry module from FM800, be sure to hold it by the knurled metal sleeve. Caution If you try to disconnect the oximetry module by pulling on the lead, then a) you won’t succeed, and b) you may damage the connector module. 60 Sonicaid FM800 Series Reference Manual 6.6 Maternal temperature 1 Position the temperature probe on the mother (a position on the inside of the upper arm is recommended). 2 Secure the probe with a TempHeart (TempHearts are heart-shaped silver stickers). 3 Set the temperature alarms, if required. See Section 8.7. 4 Connect the temperature probe lead to the TEMP input on the FM800 connector module. FM800 starts taking readings for Maternal Temperature as soon as you attach the Temperature probe to the mother. 5 Wait about 5 minutes for the displayed temperature reading to stabilise. To change the units of measurement: > SETUP > SYSTEM SETTINGS > access code (2755). > INTERNATIONAL. > TEMP UNITS. 61 Sonicaid FM800 Series Reference Manual 7 Events and Alarms 7.1 What is meant by an alarm? During most monitoring sessions things occur which are to some extent unexpected or outside normal routine. These are referred to collectively as alarms, even though many of them are not in the least alarming. They include: ● Signal going outside the normal range ● Loss of signal ● Elapsed time counter ● Failure of the FM800 unit Of these, the first requires the attention of a midwife or doctor. The signal going outside the normal range is sometimes cause for alarm and sometimes not. Other so-called alarms are unlikely to be cause for alarm at all. 7.2 What do you see and hear? Audible indicators FM800 has five different beep tones. These indicate: ● Fetal alarms (highest tone) ● Maternal alarms ● Key presses, general warnings, fetal event by marker button or Actogram ● Fetal pulse rate from FECG ● Maternal pulse rate from MECG or MSpO2 (lowest tone) 62 Sonicaid FM800 Series Reference Manual Visual indicators Type of alarm What you see and hear Signal outside range The alarm beeps sound and the ALARM ACKNOWLEDGE key becomes active. The value which is out of range, and the arrow adjacent to the ALARM ACKNOWLEDGE message, flash alternately

Signal loss, Ultrasound/FECG Signal loss, contractions/MECG Signal loss, oximetry Signal loss, blood pressure Coincidence alarms (see section 5.6) The alarm beeps sound and the ALARM ACKNOWLEDGE key becomes active. The ‘lost parameter’, and the arrow adjacent to the ALARM ACKNOWLEDGE message, flash alternately. The Heart symbol flashes and an alarm beep sounds (Fetal Oximetry only). The sensor lifted signal may appear if this is the cause of the signal loss. No NBP value An alarm beeps 5 times, and a message explains why (eg ‘movement’, ‘air leak’) A single warning beep and the message: ‘!CHECK TRACE FOR SAME HEARTRATE’

Fetal events Triangular marker at the top of the FHR trace

Clinical events OR printed on FHR trace, with space for manual annotation Clinical event notes above the FHR trace

Timer Message: Alarm Acknowledge TIMER FINISHED FM800 failure EITHER a blank screen OR an error message 63 Sonicaid FM800 Series Reference Manual 7.3 Responding to alarms Type of alarm Recommended user response Signal outside range Acknowledge alarm Doctor or midwife to decide what action to take Loss of signal Acknowledge alarm, if appropriate For FHR: reposition the transducer For other parameters: check transducer attachment and connections Timer Depends on why you set the timer in the first place FM800 failure 1 Stop monitoring. 2 Remove transducers from mother. 3 If there is an error message, make an exact note of what it says. 4 Return FM800 to Huntleigh Healthcare Ltd or their local representative. Acknowledging alarms To acknowledge an alarm: > ALARM ACKNOWLEDGE in the main screen. This turns off the audible alarm and resets the counters on which the calculation of alarm states is based. The visual indication continues – ie the value which is out of range continues to flash. If more than one alarm has been triggered, ALARM ACKNOWLEDGE turns them all off. 64 Sonicaid FM800 Series Reference Manual 7.4 Controlling alarms There are four ways you can control an alarm: ● Acknowledge it (ie silence it) when it occurs. See Section 7.3. ● Switch it off, so that it is never triggered. ● Alter thresholds so that it occurs more frequently or less frequently. ● Alter the volume of the audio alarm. Switching alarms off To switch an alarm off, press the parameter key, then OFF, then EXIT. Altering alarm thresholds and volume See Chapter 8. 7.5 Recording fetal movements The mother can record fetal movements using the fetal event marker. A triangular event mark is printed at the top of the fetal heart rate trace, and FM800 beeps, if the audible beep is switched on. 1 Connect the event marker to the jack socket on the side of FM800. 2 Give the event marker to the mother. Tell her to press the button every time she feels a fetal movement. To turn the audible beep off or on 1 > SETUP > SYSTEM SETTINGS > access code (2755). 2 > AUDIO/GRAPHIC > EVENT MARK. 3 > EXIT. 65 Sonicaid FM800 Series Reference Manual 7.6 Actogram Note: the Actogram feature is not available in the USA and Canada. Actogram uses the low-frequency content of the signal from the 1.5 MHz ultrasound transducer to detect fetal movements, and give an activity profile of the fetus. WARNING: ACTOGRAM IS NOT INTENDED FOR USE DURING LABOUR. Recorded activity represents fetal movements (breathing, limb and trunk movement) or non-fetal movements (transducer movement, maternal coughing or other movement). The Actogram value can be printed as a line graph on the contractions trace, or as fetal event marks above the trace, or both. An event mark is printed every time the amplitude goes above a set threshold. The default threshold is 40% of full scale deflection, but it can be set to any value in the range 0–99%. In a study of 14 near-term normal fetuses with the threshold set at 40%, the sensitivity and specificity of the Actogram function (compared with scanner-identified breathing, limb movement and trunk movement) were 96% and 68% respectively. This data is published with the kind permission of Professor David James of the Department of Obstetrics and Gynaecology, Queens Medical Centre, Nottingham. Data storage FM800 does not store the Actogram event marks, activity graph or threshold value. Twins Actogram works from information collected only from the 1.5 MHz transducer, but it may also sometimes detect fetal movements from the other twin. To minimise this effect, position the 1.5 MHz and 2.0 MHz transducers as far apart as possible and advise the mother to remain as still as she can. 66 Sonicaid FM800 Series Reference Manual Actogram graph and event marks The following illustration shows Actogram graph and event marks superimposed on the contractions trace. 1 2 1 Actogram event marks 2 Actogram graph 67 Sonicaid FM800 Series Reference Manual 7.7 Recording clinical events (EasiNotes) EasiNotes allow you to record clinical events as clinical event notes above the fetal heart rate trace. If you try to record a clinical note when there is not enough room on the trace for one, the FM800 records a clinical event mark instead. To enter a clinical event note or mark 1 Press the EasiNotes button on the front panel of FM800. 2 Open a submenu (Drugs, Position, etc). 3 Choose an item from the submenu. OR To enter a mark: > MARK. [Add a handwritten note to the trace, if required] 4 > EXIT. To edit EasiNotes 1 > SETUP > SYSTEM SETTINGS > access code (2755). 2 > EasiNotes. 3 Open a submenu (Drugs, Position, etc), then edit the notes using the same text editing procedure as for Patient Details (see Section 3.7). 4 When you have finished editing: > EXIT. To restore the default EasiNotes 1 Set the screen display to a language other than the one currently displayed. [SETUP > SYSTEM SETTINGS > access code (2755) > INTERNATIONAL > LANGUAGE] 2 Then reset the screen display to your own language. 68 Sonicaid FM800 Series Reference Manual 8 Setting Alarm Thresholds 8.1 Default alarm thresholds FM800 comes with factory-set alarm thresholds for all parameters: Parameter High Low Status ULT 1, ULT 2, FECG 160 bpm 110 bpm Off FHR Signal Loss 30 % None Off MECG 120 bpm 50 bpm On

Maternal Blood Pressure, Systolic Maternal Blood Pressure, Diastolic 160 mmHg 90 mmHg 90 mmHg 50 mmHg On On

Maternal Oximetry None 94 % On Temperature 37.5°C 34.0°C Off Changing thresholds If you change the current thresholds, the changes you make remain in force until you switch off FM800. If you change the default thresholds, the changes you make remain in force permanently. The screens for changing current and default thresholds are the same. The only difference is the option you need to select to access the screen. To access the current alarm thresholds screen: > SETUP > CURRENT ALARMS To restore the default thresholds, switch FM800 off and on again. To access the default alarm thresholds screen: > SETUP > DEFAULT ALARMS > access code (2755) Changing FHR thresholds is explained in some detail. The procedure for changing other thresholds is so similar that it is explained much more briefly. 69 Sonicaid FM800 Series Reference Manual 8.2 FHR thresholds (Ultrasound and FECG) To change the thresholds for FHR (Ultrasound 1, Ultrasound 2 or FECG), press ULT 1, ULT 2 or FECG in the main screen. The FHR SETUP screen appears. There are three conditions which can trigger an alarm: High FHR FHR rises above a defined level for a defined period. Default: 160 bpm for 30 seconds or longer. Low FHR FHR falls below a defined level for a defined period. Default: 110 bpm for 10 seconds or longer. Signal Loss More than a given percentage signal loss in a defined period. Default: 30% in the last 5 minutes. For High and Low FHR you can change the defined level and the duration. For Signal Loss you can change the defined percentage. 70 Sonicaid FM800 Series Reference Manual High FHR or Low FHR To change the limit or delay for High or Low FHR, press FHR: To change the high limit: > HIGH LIMIT + or HIGH LIMIT – To change the high delay: > HIGH DELAY + or HIGH DELAY – To change the low limit: > LOW LIMIT + or LOW LIMIT – To change the low delay: > LOW DELAY + or LOW DELAY – When you have set the new alarm levels: > EXIT. 71 Sonicaid FM800 Series Reference Manual Alarm volume To change the volume of the audio alarm, use the ALARM VOLUME controls in the FHR SETUP screen: Increase volume Decrease volume Switching off the High FHR and Low FHR alarm In the FHR SETUP screen: > OFF. Note: this does not turn off the Signal Loss alarm. Signal Loss alarm To change the defined percentage: 1 > SIGNAL LOSS in the FHR SETUP screen. 2 To increase the percentage: > + To decrease the percentage: > – 3 > EXIT. The Signal Loss alarm state ends when a continuous minute of signal has been received since the last alarm, or when the percentage signal loss for the last five minutes has fallen below the alarm threshold. Switching off the Signal Loss alarm From the FHR SETUP screen: > SIGNAL LOSS > OFF. FHR alarms and signal loss It may happen that the FHR goes beyond the FHR threshold, and then into signal loss, and that the next rate received is again beyond the FHR threshold. The episode of signal loss is treated as: Beyond the threshold if signal loss < 50% of time period Signal loss if signal loss > 50% of time period In the first case an alarm is triggered. In the second case an alarm is not triggered. 72 Sonicaid FM800 Series Reference Manual 8.3 Maternal blood pressure thresholds To change the thresholds for maternal blood pressure: 1 From the main screen: > NBP > ALARMS. 2 To change the Systolic or Diastolic high limit: > SYSTOLIC or DIASTOLIC > HIGH LIMIT + or HIGH LIMIT – To change the Systolic or Diastolic low limit: > SYSTOLIC or DIASTOLIC > LOW LIMIT + or LOW LIMIT – 3 To change the alarm volume, use the ALARM VOLUME controls: Increase volume Decrease volume 4 To turn the alarm off, in the NBP ALARMS screen: > OFF. 5 To return to the NBP SETUP screen: > EXIT. 8.4 MECG thresholds To change the thresholds for maternal ECG: 1 From the main screen: > MECG > ALARMS. 2 To change the Bradycardia threshold (low limit): > LOW LIMIT + or LOW LIMIT – To change the Tachycardia threshold (high limit): > HIGH LIMIT + or HIGH LIMIT – 3 To change the alarm volume, use the ALARM VOLUME controls: Increase volume Decrease volume 4 To turn the alarm off: > OFF. 5 To return to the main screen: > EXIT. 73 Sonicaid FM800 Series Reference Manual 8.5 Maternal oximetry threshold To change the threshold for maternal oximetry: 1 From the main screen: > MSpO2 > ALARMS. 2 To change the threshold for O2 SAT: > LOW LIMIT + or LOW LIMIT – 3 To change the alarm volume, use the ALARM VOLUME controls: Increase volume Decrease volume 4 To turn the alarm off: > OFF. 5 To return to the main screen: > EXIT. 8.6 Temperature thresholds To change the thresholds for maternal temperature: 1 From the main screen: > TEMP. 2 To change the threshold for Temperature: > LOW LIMIT + or LOW LIMIT – 3 To change the alarm volume, use the ALARM VOLUME controls: Increase volume Decrease volume 4 To turn the alarm off: > OFF. 5 To return to the main screen: > EXIT. 74 Sonicaid FM800 Series Reference Manual 9 SonicaidTrend Intrapartum Analysis 9.1 Introduction SonicaidTrend intrapartum analysis is a software option available with all FM800 series monitors. It measures fetal heart rate parameters at regular intervals, and describes the trace in a way that is quantitative and not qualitative. The analysis is not intended as a replacement for skilled visual interpretation of the trace, but it does help you to assess long-term changes in the fetal heart rate pattern. Caution: the analysis is valid only during the first stage of labour. No guidelines on interpretation or limits of normality are provided, but the clinician can use the numeric values to identify and quantify the relative changes in fetal heart rate parameters over a period of time. Numerical description of the trace allows direct comparison between traces. It also provides training support for trace interpretation, and readily available data for clinical research projects. IMPORTANT SonicaidTrend analysis describes the fetal heart rate on the CTG (NST) record. Inter pretation and diagnosis of the record remain the responsibility of the appropriately qualified medical staff. Note: Sonicaid Trend analysis is not approved for sale in the USA and Canada. 75 Sonicaid FM800 Series Reference Manual 9.2 SonicaidTrend analysis Analysis is performed at 15 minutes, and every 15 minutes thereafter. The analysis fits a baseline using the last 60 minutes of fetal heart rate data collected, then calculates the following parameters: ● Baseline heart rate (bpm) for the last 60 minutes ● Baseline heart rate (bpm) for the last 15 minutes ● Short-term variation (msecs) for the last 60 minutes ● Deceleration size (beats) for the last 60 minutes ● Deceleration size (beats) for the last 15 minutes Note: you can choose to show or hide results for the deceleration size parameter. Confidence indicator The analysis provides a confidence indicator showing the reliability of the baseline fit, and hence the fetal heart rate parameters. Confidence is shown as High, Medium or Low (H, M or L). If the confidence indicator is Medium or High, the analysis results reliably reflect the fetal heart rate pattern. If the confidence indicator is Low, interpret the results in relation to the appearance of the trace. Use them only if you think they are a sensible reflection of the visually assessed pattern. 76 Sonicaid FM800 Series Reference Manual 9.3 Using SonicaidTrend analysis Turning SonicaidTrend analysis on By default, SonicaidTrend analysis is turned off. To turn it on: > SETUP > INTRAPARTUM ANALYSIS > ANALYSIS ON. Starting SonicaidTrend analysis 1 Turn the analysis on. 2 Set up FM800 to record a normal CTG (NST). 3 Start printing. Note: when SonicaidTrend analysis is running, the display shows an I in the lower right corner, together with a confidence indicator (see previous page) for each channel. Stopping SonicaidTrend analysis Press the printer on/off button to stop the printer. Deceleration size parameter To print and display deceleration size: > SETUP > INTRAPARTUM ANALYSIS > DECELERATION PRINTING IS OFF 77 Sonicaid FM800 Series Reference Manual 9.4 SonicaidTrend analysis results Printed results The parameter values and confidence indicator are printed on the contractions section of the trace. A key to the parameters is printed on the trace header, and again three minutes before the end of each 60-minute period. 60-minute values are available after the first hour. Until then the results show ‘NA’. Signal loss If signal loss is > 50%, the results show ‘SL’. Displayed results To display results: > SETUP > INTRAPARTUM ANALYSIS > RESULTS (for ULT1, ULT2 or FECG) To return to the main screen: > EXIT 9.5 Viewing trend data To see a trend of the analysis results for up to the last four hours: > SETUP > INTRAPARTUM ANALYSIS > ULT1 TREND (or ULT2 TREND or FECG TREND) To return to the main screen: > EXIT 78 Sonicaid FM800 Series Reference Manual 10 SonicaidCare Antepartum Analysis 10.1 Intended use The intended use of Sonicaid Care analysis is to analyse antepartum CTGs (NSTs) in pregnancies from 26 weeks gestation onwards. It can be used on women who are experiencing Braxton-Hicks contractions, but is not intended for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, and epidural anaesthesia. The analysis provided by the Sonicaid Care is intended to assist, not to replace, the physician's visual assessment of a trace. As such, Sonicaid Care is not a diagnosis, but an aid to clinical management. Diagnosis remains the responsibility of an appropriately qualified physician. Indeed, both the physician's visual assessment of the trace and the analysis provided by Sonicaid Care should be considered within the context of a full clinical assessment before decisions are made regarding management. Such a clinical assessment may include further tests such as umbilical blood flow velocity waveforms or biophysical profiling. Note: Sonicaid Care analysis is not approved for sale in the USA and Canada. 10.2 Overview SonicaidCare antepartum analysis is a software option available with all FM800 series monitors. The software tests fetal heart rate parameters against the criteria which define a normal record. Abnormalities are highlighted. IMPORTANT The analysis describes fetal heart rate, toco and fetal movements. Interpretation and diagnosis of the CTG (NST) record remain the responsibility of the appropriately qualified medical staff. WARNING The analysis is valid for admission testing, but is not valid during labour. 79 Sonicaid FM800 Series Reference Manual 10.3 The Dawes/Redman criteria ● An episode of high variation, above the first centile for gestational age. ● No decelerations > 20 lost beats (> 100 lost beats on records longer than 30 minutes). ● Basal heart rate between 116 and 160 bpm, though a slightly lower or higher rate may be acceptable after 30 minutes, if all other parameters are normal. An asterisk on the analysis results shows that the fetal heart rate is low or high, but that in the context of the rest of the record, it is acceptable. ● At least one fetal movement or three accelerations. ● No evidence of a sinusoidal fetal heart rate rhythm. ● Short-term variation should be 3 ms or greater. ● Either an acceleration Or variability in high episodes > the tenth centile and fetal movements > 20. ● No errors or decelerations at the end of the record. 10.4 Care analysis Analysis is performed at 10 minutes, and every 2 minutes thereafter up to a maximum of 60 minutes. The analysis fits a baseline to the fetal heart rate data collected so far, and from this measures accelerations and decelerations. Short-term variation is calculated, and episodes of high and low variation looked for. The system then compares the calculated results with the Dawes/Redman criteria. If the record appears normal, the message CRITERIA MET appears, and FM800 gives a single beep. Otherwise, CRITERIA NOT MET is shown. You can stop the analysis once the criteria have been met. FM800 produces a report of the analysis results at the end of the trace. Abnormalities are highlighted. If you do not stop the analysis, it is possible for the results to change to CRITERIA NOT MET. As more data is received, a subsequent analysis may re-fit the baseline so that, for example, an episode of high variation is no longer above the first centile. If you stop FM800 before 10 minutes, the first analysis is not performed. After 60 minutes, the analysis stops, even if you continue monitoring. The results printed will be those from the final analysis at 60 minutes. 80


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