Huntleigh Sonicaid FM800 Series Reference Manual
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Huntleigh Sonicaid FM800 Series Reference Manual

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

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  • Page 1 SonicaidFM800 Reference Manual  Huntleigh Healthcare Ltd 2005 All rights reserved 329000-6 April 2009...
  • Page 2 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.

  • Page 3: Table Of Contents

    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 ........................
  • Page 4 Sonicaid FM800 Series Reference Manual System Settings and Default Alarms ..............34 Overview ...................... 34 Changing the default alarms................35 Printer setup....................35 Audio/graphic settings ................... 37 International settings ..................38 Serial interface ....................39 Monitoring Fetal Parameters .................. 40 Preliminary ....................
  • Page 5 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 ................
  • Page 6 Sonicaid FM800 Series Reference Manual 18 Appendix 3: Transducer Problems ............... 113 19 Appendix 4: Getting Started with T800 ..............115...

  • Page 7: Standards Compliance

    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.

  • Page 8: Indications For Use

    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.

  • Page 9: System Installation

    (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.

  • Page 10: Multiple Portable Socket Outlets

    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).

  • Page 11: Electromagnetic Compatibility

    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.

  • Page 12: Trademarks

    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.

  • Page 13: Addresses

    Sonicaid FM800 Series Reference Manual Addresses 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 www.huntleigh-healthcare.com...

  • Page 14: Introduction

    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.
  • Page 15 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 ●...

  • Page 16: Main Unit: Front Panel

    Sonicaid FM800 Series Reference Manual 1.2 Main unit: front panel 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.

  • Page 17: Connection Sockets For Transducers

    Sonicaid FM800 Series Reference Manual 1.3 Connection sockets for transducers ULT1 1.5 MHz Ultrasound transducer, yellow ULT2/FECG 2.0 MHz Ultrasound transducer, blue Fetal ECG electrode, blue (connected via leg plate) MECG Maternal ECG transducer, blue TOCO/IUP Toco contractions transducer, pink...

  • Page 18: Main Unit: Rear Connectors

    Sonicaid FM800 Series Reference Manual 1.4 Main unit: rear connectors Input socket for the AC mains supply RS232 connector for external NBP, 9-way D-type socket (reserved for future use) RS232 connector for external FspO2, 9-way D-type socket (reserved for future use) RS485 Interface for Axis (1.5kV DC isolation) (not used)

  • Page 19: Connector Module

    Sonicaid FM800 Series Reference Manual 1.5 Connector module FM830 offers additional features via a connector module. Maternal blood pressure Type CF patient TEMP Maternal temperature applied part MSpO Maternal pulse oximetry FM830 The connector module has connectors for maternal blood pressure, maternal oximetry and...

  • Page 20: Event Marker Connection

    Sonicaid FM800 Series Reference Manual 1.6 Event marker connection Event marker connector 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: ●...

  • Page 21: Transducers And Cables

    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 Transducer buckles FECG lead leg belts/electrode pads Fetal movement event marker...

  • Page 22: Fm800 Trolley Or Wall Mounting

    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.

  • Page 23: Fm800 Controls And Display

    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.

  • Page 24: Fm800 Main Screen

    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.

  • Page 25: Software Control Buttons

    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.

  • Page 26: Audio Controls

    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.

  • Page 27: Printer Controls

    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.

  • Page 28: Loading Printer Paper

    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.

  • Page 29: Setup

    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.

  • Page 30: Default Alarms

    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.

  • Page 31: Patient Details

    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 >...

  • Page 32: Timer

    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.

  • Page 33: Actogram Settings

    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.

  • Page 34: System Settings And Default Alarms

    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...

  • Page 35: Changing The Default Alarms

    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 MSpO , and the mode setting for NBP, revert to the hospital defaults. To change the hospital defaults: 1 >...
  • Page 36 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.

  • Page 37: Audio/Graphic Settings

    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.

  • Page 38: International Settings

    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: >...

  • Page 39: Serial Interface

    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.

  • Page 40: Monitoring Fetal Parameters

    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).

  • Page 41: Ultrasound Monitoring

    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.
  • Page 42 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.

  • Page 43: The Fhr Confidence Indicator

    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 FM800 cannot detect and No FHR displayed the fetal heartbeat.

  • Page 44: Ultrasound For Twins

    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.

  • Page 45: Fetal Ecg (Using A Scalp Electrode)

    Sonicaid FM800 Series Reference Manual 5.7 Fetal ECG (using a scalp electrode) Connection For a single fetus: FECG ULT 1 For twins: FECG ULT 1 Note: In the USA and Canada the use of FDA-compliant fetal scalp electrodes is required.
  • Page 46 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.
  • Page 47 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.
  • Page 48 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).
  • Page 49 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:...

  • Page 50: Accidentally Recording The Wrong Signal

    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.

  • Page 51: Monitoring Maternal Parameters

    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.

  • Page 52: Contractions (Using Iup Transducer)

    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.
  • Page 53 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.
  • Page 54 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.
  • Page 55 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:...

  • Page 56: Maternal Blood Pressure

    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).
  • Page 57 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.

  • Page 58: Maternal Oximetry

    Sonicaid FM800 Series Reference Manual Failed measurements (manual and automatic) When an NBP measurement fails: 00/00 ● The NBP display shows ● An error code or message explains why the measurement failed. See Section 13.4. ● An audible alert sounds, if NBP alarms are on.
  • Page 59 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.
  • Page 60 Sonicaid FM800 Series Reference Manual Start and stop monitoring To start monitoring, in the MSpO SETUP screen: > START. After about 5 seconds, the mother’s blood oxygen level appears in the MSpO section of the display, with a pulse amplitude indicator. If you are not monitoring Maternal ECG, the mother’s pulse rate also appears.

  • Page 61: Maternal Temperature

    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).

  • Page 62: Events And Alarms

    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.
  • Page 63 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...

  • Page 64: Responding To Alarms

    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.

  • Page 65: Controlling Alarms

    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. ●...

  • Page 66: Actogram

    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.
  • Page 67 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 Actogram event marks 2 Actogram graph...

  • Page 68: Recording Clinical Events (Easinotes)

    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.

  • Page 69: Setting Alarm Thresholds

    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 Status ULT 1, ULT 2, FECG 160 bpm 110 bpm FHR Signal Loss 30 % None...

  • Page 70: Fhr Thresholds (Ultrasound And Fecg)

    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.
  • Page 71 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: –...
  • Page 72 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.

  • Page 73: Maternal Blood Pressure Thresholds

    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 –...

  • Page 74: Maternal Oximetry Threshold

    Sonicaid FM800 Series Reference Manual 8.5 Maternal oximetry threshold To change the threshold for maternal oximetry: 1 From the main screen: > MSpO > ALARMS. 2 To change the threshold for O SAT: – > LOW LIMIT or LOW LIMIT...

  • Page 75: Sonicaidtrend Intrapartum Analysis

    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.

  • Page 76: Sonicaidtrend Analysis

    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: ●...

  • Page 77: Using Sonicaidtrend Analysis

    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.

  • Page 78: Sonicaidtrend Analysis Results

    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.

  • Page 79: Sonicaidcare Antepartum Analysis

    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...

  • Page 80: The Dawes/Redman Criteria

    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). ●...

  • Page 81: Using Sonicaidcare Analysis

    Sonicaid FM800 Series Reference Manual Event marks for twins SonicaidCare analysis does not take account of fetal movements when analysing twins. Alarms During analysis the Signal Loss alarm is fixed at 30%. In addition, there is a fixed Toco alarm that alerts the user to a constant Toco value for 10 minutes. Once this alarm has been acknowledged, it will not re-alarm during the same analysis.

  • Page 82: Sonicaidcare Analysis Report

    Sonicaid FM800 Series Reference Manual Checking the progress of SonicaidCare analysis To check the key results, after the first analysis: > SETUP > ANTEPARTUM ANALYSIS > ULT 1 RESULTS (or ULT2 RESULTS) FM800 shows the last calculated values for short term variation, number of minutes of high variation and basal heart rate.
  • Page 83 Sonicaid FM800 Series Reference Manual Reasons for not meeting the criteria If the criteria were not met when the analysis was stopped, the reasons are given as coded numbers alongside the CRITERIA NOT MET message: Code Reason Basal heart rate outside normal range...
  • Page 84 Sonicaid FM800 Series Reference Manual A single asterisk indicates one of the following conditions: Short term variation < 4 ms, but ≥ 3ms ● Basal heart rate < 116 bpm or > 160 bpm on a record ≥ 30 minutes ●...

  • Page 85: Using Fm800 With A Pc System

    Sonicaid FM800 Series Reference Manual 11 Using FM800 with a PC System You can connect FM800 to the following PC-based systems: ● Sonicaid FetalCare analysis and replay system ● Sonicaid Axis central review ● Sonicaid System8002 analysis system ● Sonicaid Centrale ●...

  • Page 86: Using Fm800 With Sonicaid Axis

    Sonicaid FM800 Series Reference Manual 11.2 Using FM800 with Sonicaid Axis Connecting FM800 to an Axis central review system 1 Connect the Axis RS485 connecting lead to the RS485 connector on the rear of FM800. See Section 1.4. 2 Connect the lead to the Axis Bed Box (RS485 wall socket) in the Labour Room.
  • Page 87 Sonicaid FM800 Series Reference Manual 3 Indirectly - using RS232 and an RS232 network adaptor Connect an RS232 lead to the RS232 S8002 connector on the rear of FM800. See Section 1.4. Connect the other end of the lead to an RS232 input port on the network adaptor box.

  • Page 88: Telemetry

    Sonicaid FM800 Series Reference Manual 12 Telemetry Full instructions in the use of the telemetry transmitter and receiver are given in the operator’s manual for the telemetry unit. For the availability of this manual in other languages, consult: Rimkus Medizintechnik, Feldkirchenerstrasse 6, D-85599 Parsdorf, Germany Note: Rimkus telemetry is not approved for use with Sonicaid FM800 in the USA or Canada.

  • Page 89: Troubleshooting

    Sonicaid FM800 Series Reference Manual 13 Troubleshooting 13.1 FHR No FHR signal displayed Is FM800 switched on? Is the FHR transducer connected? High % signal loss Check transducer placement. Is the transducer broken? Consider switching from Ultrasound to FECG. No FHR trace printed...

  • Page 90: Maternal Blood Pressure Error Codes

    Sonicaid FM800 Series Reference Manual 13.4 Maternal blood pressure error codes Message Description User action ARTEFACT Irregular pulse or Make sure patient keeps still excessive motion. during measurement. AIR LEAK Reading terminated The cuff is loose or not connected because target pressure properly.

  • Page 91: What To Do Next

    13.6 What to do next? If you cannot solve a problem using this Troubleshooting guide, please contact your Huntleigh Healthcare Ltd representative. If you do this, they may ask you what software version your FM800 is running. To find this out: >...

  • Page 92: Cleaning And Maintenance

    Sonicaid FM800 Series Reference Manual 14 Cleaning and Maintenance WARNING: always switch off FM800 and disconnect the AC supply cable and transducers before attempting to carry out any cleaning or maintenance. 14.1 The FM800 main unit Cleaning after use Wipe the instrument case with a cloth dampened in soap or detergent solution to remove aquasonic gel, blood, saline etc.

  • Page 93: Transducers And Leads: Ultrasound, Fecg, Mecg, Internal Toco And External

    Sonicaid FM800 Series Reference Manual 14.3 Transducers and leads: Ultrasound, FECG, MECG, internal Toco and external Toco Cleaning (Ultrasound, FECG, MECG, and external Toco transducers) After use, wipe the ultrasound transducers, event marker, fetal ECG electrode leg plate and IUP extension cable with a cloth dampened in soap or detergent solution to remove aquasonic gel, blood, saline etc.

  • Page 94: User Maintenance

    3 Look carefully for cracks which may allow the ingress of liquids or gels. 4 Replace any broken or damaged transducers or cables. 5 If there is damage to the main FM800 unit, contact your local Huntleigh Healthcare Ltd representative.

  • Page 95: Technical Maintenance

    Sonicaid FM800 Series Reference Manual 14.5 Technical maintenance The checks below should be performed by a qualified maintenance engineer in the hospital. Fuse check and replacement Every six months: 1 Remove the fuse module using a small screwdriver. 2 Raise the small latch and remove the fuse board for access to the fuses.

  • Page 96: Corrective Maintenance

    The Sonicaid FM800 Service Manual (order part number 329801) is designed as an aid to engineers in maintenance and service of repairable parts. 14.7 Servicing Servicing Servicing should be performed only by Huntleigh Healthcare Ltd or their appointed service agent. If you have difficulty obtaining service for FM800, contact Huntleigh Healthcare Ltd.

  • Page 97: Accessories, Consumables And Spares

    Sonicaid FM800 Series Reference Manual 14.8 Accessories, consumables and spares Accessories FM800 trolley 320501 Intran IUP catheter interconnection lead 8400-6937 Maternal ECG lead 8402-6969 FM800-to-System 8002 lead 8400-6952 Service Manual 329100 Consumables Aquasonic gel: 20gm sterile sachet 1300-0145 60gm tube 1300-0152 0.25 litre bottle...
  • Page 98 Sonicaid FM800 Series Reference Manual Spares 1.5 MHz ultrasound transducer (yellow) (2 metre length) 8400-6919 2.0 MHz ultrasound transducer (blue) (2 metre length) 8400-6920 Temperature sensor 320504 Maternal SpO transducer/lead assy 739088 NBP cuff (large adult) 322806 NBP cuff (small adult)

  • Page 99: Specifications

    Sonicaid FM800 Series Reference Manual 15 Specifications 15.1 Physical and environmental Physical Height (all models) 186mm (7.3in) Length (all models) 358mm (14.1in) Width (FM820) 363mm (14.3in) Width (FM830) 392mm (15.5in) Weight (FM820) Gross weight 18kg (includes transducers etc) Net weight 15kg...

  • Page 100: Transducers

    Sonicaid FM800 Series Reference Manual 15.3 Transducers Ultrasound Range 30 to 240 bpm Accuracy ± 1 bpm over the range 100-180 bpm Alarms High and Low FHR: 30 to 240 bpm Signal Loss: % loss in last 5 minutes Mode Directional pulsed Doppler Repetition rate 3.0KHz...
  • Page 101 Sonicaid FM800 Series Reference Manual Uterine activity (external Toco) Range 0–100 relative units Sensitivity 100% FSD equivalent to 120g Offset range ±100g Auto zero Manual and auto zero facility Safety Type CF protection Uterine activity (internal IUP) Transducers Intran Plus (or any pre-calibrated transducer) Pressure range 0–100 mmHg/1–15 kPa (user selectable)
  • Page 102 Sonicaid FM800 Series Reference Manual Maternal blood pressure Method Oscillometric Measurement ranges Systolic 50–280 mmHg Diastolic 10–260 mmHg Pulse 40–240 bpm Accuracy ±2% or 3mmHg, whichever is greater Modes Manual or automatic User-selectable interval in Auto Mode: 3, 5, 10, 15, 20, 30, 45, 60, 90 or 120 minutes...
  • Page 103 Sonicaid FM800 Series Reference Manual Maternal oximetry Sensor types The following Nellcor probes are suitable for FM830 models equipped with Nellcor™ MSpO modules :  Oxisensor II D-25/D-25L  Oxicliq  Durasensor DS-100A  Dura-Y D-YS Do not use any sensors other than these.

  • Page 104: Controls

    Sonicaid FM800 Series Reference Manual 15.4 Controls Simple functions Control keys on front panel: ● Power on/off ● Volume up/down ● Audio channel select ● Toco/IUP zero ● Printer on/off ● Printer fast forward ● Clinical event mark Higher-level functions 10 ‘soft keys’...

  • Page 105: Connections

    Sonicaid FM800 Series Reference Manual 15.6 Connections Front panel ULT1 (all models) 1.5MHz ultrasound transducer ULT2/FECG (all models) 2.0MHz ultrasound transducer/fetal ECG lead /MECG (all models) Maternal ECG lead TOCO/IUP (all models) Toco transducer/IUP lead MSpO (FM830) Maternal pulse oximetry...

  • Page 106: Display

    Sonicaid FM800 Series Reference Manual 15.7 Display Technology Electroluminescent Size 11.5cm x 8.6cm (4.5in x 3.4in) Resolution ¼ VGA, 320 x 240 Viewing Angle >160° You can also run FM800 with a VGA monitor connected, for training purposes. See note on page 9 before connecting.

  • Page 107: Safety

    The equipment must be serviced only by authorised and qualified personnel. Huntleigh Healthcare Ltd cannot accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorised personnel. Identical replacement parts must be used.

  • Page 108: Ultrasound Safety Considerations

    Sonicaid FM800 Series Reference Manual ix) The nature of the parts in direct or indirect contact with the patient is: Ultrasound transducers ABS plastic External Toco transducer Medical grade polyacetyl Sonicaid FECG electrode Stainless steel Sonicaid FECG electrode lead Stainless steel, rubber...
  • Page 109 Sonicaid FM800 Series Reference Manual Fetal use FM800 is designed for continuous fetal heart rate monitoring during pregnancy and labour. Interpretation of fetal heart rate patterns can diagnose fetal and maternal problems and complications. Minimising patient exposure The acoustic output of FM800 is internally controlled and cannot be varied by the operator.

  • Page 110: Appendix 1: Service And Warranty

    Sonicaid FM800 Series Reference Manual 16 Appendix 1: Service and Warranty Huntleigh Healthcare Ltd (HHC.) provides a comprehensive warranty of 2 years from the date of purchase on hardware products and modules. Transducers have a 12-month warranty, and consumables and accessories (ie disposables and items with no serial number) have a 90-day warranty.

  • Page 111: Appendix 2: External Connections

    Sonicaid FM800 Series Reference Manual 17 Appendix 2: External Connections A2.1 Input/output levels and pin numbers RS485 interface Pluggable cord connector (PCC), isolated to 1.5kV DC. (No longer used). Interface for Sonicaid Axis. (Now Obsolete). Signal Input/Output 0V reference Input/Output...
  • Page 112 Sonicaid FM800 Series Reference Manual RS232 interface: all other RS232 connectors [NB the firmware to support these RS232 sockets is not yet implemented) 9-way D-type socket, isolated to 500V DC. Isolated interface to other monitoring equipment. Signal Input/output Input Output...
  • Page 113 Sonicaid FM800 Series Reference Manual 18 Appendix 3: Transducer Problems The following tests will show whether there is a problem with an Ultrasound transducer. If there is a problem, contact the Service Department of Huntleigh Healthcare Ltd, or their appointed service agent. Preliminary 1 Connect the ultrasound transducer to FM800.
  • Page 114 Sonicaid FM800 Series Reference Manual Ultrasound transducer test The crystal elements in a transducer can be damaged if the transducer is dropped. If one or more crystals have been damaged, this can leave non-receptive areas on the transducer face, reducing the beam coverage.
  • Page 115 Sonicaid FM800 Series Reference Manual 19 Appendix 4: Getting Started with T800 Connecting the T800 Wireless Transducer System 1. Ensure the receiver aerial is fitted and securely fastened to the connector on the rear panel. 2. Connect the power cable from a suitable wall socket to the mains connector on the rear panel.
  • Page 116 Sonicaid FM800 Series Reference Manual Monitoring FHR and Uterine Activity 1. Unplug the T800 transducers. The FM800 display will indicate ‘Wireless Transducers’ in use. 2. To monitor the FHR, determine fetal lie and position. Apply gel to the blue transducer face. Position on the abdomen so as to get optimal fetal heart sounds.
  • Page 117 Sonicaid FM800 Series Reference Manual Monitoring FHR and Uterine Activity During use, the T800 displays the transducer battery life and RF signal quality as indicated below. Transmitter off or out of range (Black) Ultrasound and Toco transducer battery state – GOOD (Green) Ultrasound and Toco transducer battery state –...
  • Page 118 Sonicaid FM800 Series Reference Manual Part No - 329000-6...

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