Huntleigh Sonicaid FM800 Encore Series Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Huntleigh Manuals
  4. Medical Equipment
  5. Sonicaid FM800 Series
  6. Instructions for use manual

Huntleigh Sonicaid FM800 Encore Series Instructions For Use Manual

Hide thumbs Also See for Sonicaid FM800 Encore Series:
Table of Contents

Advertisement

Quick Links

Download this manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Sonicaid FM800 Encore Series and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Huntleigh Sonicaid FM800 Encore Series

Summary of Contents for Huntleigh Sonicaid FM800 Encore Series

  • Page 2 Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifications and materials without notice. Sonicaid™ and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2008. © Huntleigh Healthcare Ltd. 2008, 2010 The Sonicaid™...

  • Page 3: Table Of Contents

    Sonicaid FM800 Encore Series Instructions for Use Contents 0 B G eneral ......................... 7 2 0 B A pplicable products ..................... 7 2 0 B S tandards compliance ..................7 2 1 B I ndications for use ....................8 2 2 B L imitations for use ....................9 2 3 B S ystem Installation ....................
  • Page 4 Sonicaid FM800 Encore Series Instructions for Use 4 B S ystem Settings and Default Alarms ................33 5 3 B O verview ......................33 5 4 B C hanging the default alarms ................34 5 5 B P rinter setup ...................... 34 5 6 B A udio/graphic settings ..................
  • Page 5 Sonicaid FM800 Encore Series Instructions for Use 10 9 B P rinting ........................79 10.1 8 5 B I ntroduction ....................... 79 10.2 8 6 B P aper options ....................79 10.3 8 7 B P aper care and handling ................... 79 10.4 8 8 B P rint speed and duration ...................
  • Page 6 Sonicaid FM800 Encore Series Instructions for Use 17 Care and Cleaning ....................110 17.1 General Care ....................110 17.2 General Cleaning and Disinfecting (Main unit / non patient applied parts) ..110 17.3 C C C C leaning and Disinfecting Patient Applied Parts ..........111 17.4 1 2 2 B N BP Cuff &...

  • Page 7: G Eneral

    Sonicaid FM800 Encore Series Instructions for Use G eneral A pplicable products 2 0 B This manual applies to the following issue status products: FM820E Issue 04 FM830E Issue 05 The issue status of a unit is shown in characters 6 & 7 of the serial number located on the rear panel.

  • Page 8: 1 B I Ndications For Use

    I ndications for use 2 1 B The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy.

  • Page 9: 2 B L Imitations For Use

    Sonicaid FM800 Encore Series Instructions for Use L imitations for use 2 2 B Fetal monitors provide just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors. A complete assessment must be made before taking appropriate action.

  • Page 10: 3 B S Ystem Installation

    Sonicaid FM800 Encore Series Instructions for Use S ystem Installation 2 3 B These requirements must be met when an FM800E fetal monitor is connected to any of the following pieces of equipment:  a central review and archiving system ...

  • Page 11: 5 B M Ultiple Portable Socket Outlets

    Sonicaid FM800 Encore Series Instructions for Use M ultiple Portable Socket Outlets 2 5 B (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 12: 6 B E Lectromagnetic Compatibility

    S ervice & Warranty 2 7 B Huntleigh Healthcare's standard terms and conditions apply to all sales. These contain full details of warranty terms and do not limit the statutory rights of the consumer. A copy is available on request.

  • Page 13: 8 B T Rademarks

    Sonicaid FM800 Encore Series Instructions for Use 1.10 T rademarks 2 8 B ™ Sonicaid is a trademark of Huntleigh Healthcare Ltd. ™ Safelinc is a trademark of Tyco. Qwik Connect is a trademark of GE Medical ® Koala is a registered trademark of Clinical Innovations Inc.

  • Page 14: I Ntroduction

    Sonicaid FM800 Encore Series Instructions for Use I ntroduction T he FM800E series 3 2 B FM800E series monitors are designed for antepartum and intrapartum monitoring. There are two monitors in the series: FM820E Standard monitor Comprehensive monitoring using twin ultrasound and separate ECG channels.
  • Page 15 Sonicaid FM800 Encore Series Instructions for Use F M820E: standard features 1 4 3 B The following features are available on all monitors in the FM800E range:  Alarms  Annotation  Audio  Display auto dim  Direct FECG via scalp electrode ...

  • Page 16: 3 B M Ain Unit: Front Panel

    Sonicaid FM800 Encore Series Instructions for Use M ain unit: front panel 3 3 B 1 Software control buttons 2 Display: see chapter 3 3 Connector module for oximetry and blood pressure (FM830E only) 4 Connection sockets for transducers 5 Printer drawer...

  • Page 17: 4 B C Onnection Sockets For Transducers

    Sonicaid FM800 Encore Series Instructions for Use C onnection sockets for transducers 3 4 B ULT1 1.0 MHz Ultrasound transducer, green ULT2 1.0 MHz Ultrasound transducer, green MECG/FECG Maternal ECG (3 lead chest electrodes), white Fetal ECG transducer, white (connected via leg reference...

  • Page 18: 5 B M Ain Unit: Rear Connectors

    Sonicaid FM800 Encore Series Instructions for Use M ain unit: rear connectors 3 5 B Wireless Telemetry Input socket for the AC mains supply RS232 connector for connection to our Sonicaid Centrale, Obstetric Archive & FetalCare CTG viewing and archiving software systems.
  • Page 19 Sonicaid FM800 Encore Series Instructions for Use Connector module The FM830E incorporates additional connectors for maternal blood pressure and maternal oximetry on a connector module. Maternal blood pressure Type CF patient applied part MSpO Maternal pulse oximetry Event marker connection...

  • Page 20: 6 B T He Fm800E Display

    Sonicaid FM800 Encore Series Instructions for Use T he FM800E display 3 6 B The FM800E’s high-performance colour display combines superior visual performance with environmental ruggedness, making it suitable for a wide range of environments. The principal benefits of the FM800E display are: •...

  • Page 21: 7 B T Ransducers And Cables

    Sonicaid FM800 Encore Series Instructions for Use T ransducers and cables 3 7 B S upplied with all units 1 4 6 B Ultrasound transducers Green, 1.0MHz (1-off) Toco transducer Pink Transducer belts 3 pairs Fetal ECG lead (5 different types available)

  • Page 22: 8 B H Andling And Mounting

    Sonicaid FM800 Encore Series Instructions for Use H andling and mounting 3 8 B Always ensure that the unit is positioned such that controls and display are readily accessible and visible to the user. H andling 1 5 0 B When moving the unit take care to ensure that proper lifting precautions are taken.
  • Page 23 Sonicaid FM800 Encore Series Instructions for Use Keep hands clear of the trolley wheels while the trolley is in motion. Do not attempt to free trapped cables without stopping the trolley and applying the brakes. W all bracket 1 5 2 B A purpose-designed bracket is available to allow the FM800E to be wall mounted with maximum safety.

  • Page 24: F M800E Controls And Display

    Sonicaid FM800 Encore Series Instructions for Use F M800E Controls and Display C ontrols and on/off indicator 3 9 B Printer on/off switch and indicator. Shows amber light when printer is switched on. Printer fast forward. EasiNotes annotation. See Section 8 .7...

  • Page 25: 0 B F M800E Main Screen

    Sonicaid FM800 Encore Series Instructions for Use F M800E main screen 4 0 B When FM800E 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. The diagram below shows the zones on the screen where the different parameters are displayed.

  • Page 26: 1 B S Oftware Control Buttons

    Sonicaid FM800 Encore Series Instructions for Use S oftware control buttons 4 1 B When the FM800E is switched on, the SETUP button is active. Other buttons are inactive. When any transducer is connected (apart from NBP), the button for that parameter becomes active, and the parameter name is displayed.

  • Page 27: 2 B A Udio Controls

    Sonicaid FM800 Encore Series Instructions for Use A udio controls 4 2 B FM800E can provide an audio signal for one channel at a time (Ultrasound, FECG, MECG or SpO ). The default channel is ULT1. So, if FM800E is switched on with corresponding transducers connected for all the audio channels, and then audio is selected, an audio signal will be reproduced for ULT1.

  • Page 28: 3 B P Rinter Controls

    Sonicaid FM800 Encore Series Instructions for Use P rinter controls 4 3 B There are front panel 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.

  • Page 29: S Etup

    Sonicaid FM800 Encore Series Instructions for Use S etup O verview 4 4 B The Setup procedures are much simpler if the differences between Setup, Current Alarms, Default Alarms and System Settings are understood. Setup User preferences available directly from the Setup screen.

  • Page 30: 8 B C C C Are Analysis / Trend

    Sonicaid FM800 Encore Series Instructions for Use C are Analysis / TREND 4 8 B C C SETUP is also used to select Sonicaid CARE (antepartum) analysis or Sonicaid TREND (intrapartum): Sonicaid TREND See Chapter 12. Sonicaid CARE analysis See Chapter 13.

  • Page 31: 1 B T Imer

    Sonicaid FM800 Encore Series Instructions for Use T imer 5 1 B A timer can be set to provide an alert when a given period of time (1–99 minutes) has elapsed. The timer starts when printing is started. Note: the timer cannot be set when Sonicaid CARE analysis or Sonicaid TREND analysis is in progress.

  • Page 32: 2 B A Ctogram Settings

    Sonicaid FM800 Encore Series Instructions for Use A ctogram settings 5 2 B A ctogram on/off (not available in the USA and Canada) 1 6 5 B To turn the actogram features on or off: > SETUP > NEXT PAGE >...

  • Page 33: S Ystem Settings And Default Alarms

    Sonicaid FM800 Encore Series Instructions for Use S ystem Settings and Default Alarms O verview 5 3 B The System Settings and Default Alarms screens allow preferences to be set which are protected by an access code (2755). These preferences remain in force when you switch the FM800E off, and then on again.

  • Page 34: 4 B C Hanging The Default Alarms

    Sonicaid FM800 Encore Series Instructions for Use C hanging the default alarms 5 4 B When the FM800E is switched on, the alarm settings for FHR, MECG, NBP and MSpO and the mode setting for NBP, revert to the hospital defaults.
  • Page 35 Sonicaid FM800 Encore Series Instructions for Use The default is for the paper-out buffer to be enabled (i.e. FM800E 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: >...

  • Page 36: 6 B A Udio/Graphic Settings

    Sonicaid FM800 Encore Series Instructions for Use A udio/graphic settings 5 6 B B aby graphic 1 7 9 B To display (or stop displaying) the picture of a baby on the main FM800E screen: [ > SETUP > NEXT PAGE > SYSTEM SETTINGS > access code (2755)] >...

  • Page 37: 7 B I Nternational Settings

    Sonicaid FM800 Encore Series Instructions for Use I nternational settings 5 7 B S upply frequency (50Hz or 60Hz) 1 8 3 B To alter the supply frequency: > SETUP > NEXT PAGE > SYSTEM SETTINGS > access code (2755) >...

  • Page 38: 8 B S Erial Interface

    Sonicaid FM800 Encore Series Instructions for Use S erial interface 5 8 B When connecting to a central review system, the appropriate serial interface protocol must be set to match the software system. The ‘RS232 HP 50’ protocol is the most widely used and is recommended for use with Sonicaid Centrale, Obstetric Archive and a range of other CRS systems.

  • Page 39: M Onitoring Fetal Parameters

    Sonicaid FM800 Encore Series Instructions for Use M onitoring Fetal Parameters P reliminary 5 9 B Ensure that the transducers and transducer belts are clean and ready for use. In particular, check the transducers for cracks or signs of damage. See also cleaning instructions in section 17.

  • Page 40: 1 B U Ltrasound Monitoring

    Sonicaid FM800 Encore Series Instructions for Use U ltrasound monitoring 6 1 B 1 Connect the green transducer to the green socket marked ULT1on FM800E. In the FM800E main screen, the ULT 1 button becomes active. 2 Palpate the abdomen to determine fetal lie and position.
  • Page 41 Sonicaid FM800 Encore Series Instructions for Use Toco transducer Ultrasound transducer Transducer positioning for Ultrasound monitoring H ints on monitoring 1 8 7 B  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 42: 2 B T He Fhr Confidence Indicator

    Sonicaid FM800 Encore Series Instructions for Use T he FHR confidence indicator 6 2 B The heart symbol which appears against the FHR display is a confidence indicator, not an indicator of signal strength. If the heart symbol is displayed in outline only, and no FHR is displayed, the FM800E cannot detect the fetal heartbeat.

  • Page 43: 4 B U Ltrasound For Twins

    Sonicaid FM800 Encore Series Instructions for Use 3 Listen to the FM800E Audio signal. The sound will always reflect the true rate of the detected signal and cannot be affected by double rating or half rating. Fetal heart sound should be like a galloping horse, not a swishing sound from maternal vessels.
  • Page 44 Sonicaid FM800 Encore Series Instructions for Use When interpreting a trace to which the +20bpm offset has been applied, the interpreter must subtract this offset (20 bpm) from the displayed baseline rate to determine true baseline rate – failure to do so may result in misinterpretation of the trace &...

  • Page 45: 5 B F Etal Ecg (Using A Scalp Electrode)

    Sonicaid FM800 Encore Series Instructions for Use F etal ECG (using a scalp electrode) 6 5 B C onnection 1 8 9 B The FECG transducer is connected via the white socket on the front panel labelled FECG/MECG. This is used to connect either Fetal or Maternal ECG transducers. It is possible to monitor FECG for a fetus independently of the ultrasound monitoring.
  • Page 46 Sonicaid FM800 Encore Series Instructions for Use Monitoring procedure using Safelinc™ / Qwik Connect™ electrodes 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 47 Sonicaid FM800 Encore Series Instructions for Use D isplaying the FECG waveform 1 9 3 B When FECG is monitored using a scalp electrode, the FM800E 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 48 Sonicaid FM800 Encore Series Instructions for Use P rinting the FECG waveform 1 9 4 B 1 Make sure the FM800E is already printing the trace. 2 Make sure the FECG waveform is displayed. 3 > the EasiNotes annotation button.

  • Page 49: 6 B A Ccidentally Recording The Wrong Signal

    Sonicaid FM800 Encore Series Instructions for Use A ccidentally recording the wrong signal 6 6 B As previously referred to (section 6.6), it is possible when monitoring twins, 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 50: M Onitoring Maternal Parameters

    Sonicaid FM800 Encore Series Instructions for Use M onitoring Maternal Parameters C ontractions (using Toco transducer) 6 7 B Use only Toco transducers supplied with the FM800E, or listed in the FM800E Accessories & Consumables brochure. 1 Ensure that the Toco transducer and belt are clean and ready for use. In particular, check the transducer for cracks or signs of damage.

  • Page 51: 8 B Contractions (Using Iup Transducer)

    Sonicaid FM800 Encore Series Instructions for Use Contractions (using IUP transducer) 6 8 B Use only IUP transducer types supplied with the FM800E, or listed in the FM800E Accessories & Consumables brochure. Always check transducers and their packaging before use to ensure that there is no damage and that sterility has not been compromised.

  • Page 52: 9 B F Etal Event Marker

    Sonicaid FM800 Encore Series Instructions for Use F etal Event Marker 6 9 B The Fetal Event Marker is a pushbutton switch fitted with a captive cable and connector which is available as an optional accessory. It is plugged into the socket on the side of the unit.
  • Page 53 Sonicaid FM800 Encore Series Instructions for Use M ECG monitoring procedure 1 9 6 B 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 Encore Series Instructions for Use D isplaying the MECG waveform 1 9 7 B When MECG is being monitored, the FM800E display 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).
  • Page 55 Sonicaid FM800 Encore Series Instructions for Use P rinting the MECG waveform 1 9 8 B 1 Make sure the FM800E is already printing the trace. 2 Make sure the MECG waveform is displayed. 3 > EasiNotes annotation button. 4 > PRINT ECG.

  • Page 56: 1 B M Aternal Blood Pressure

    Sonicaid FM800 Encore Series Instructions for Use M aternal Blood Pressure 7 1 B FM830E can measure the mother’s systolic and diastolic blood pressure, mean arterial pressure**, and the average pulse rate during the measurement. Measurements can be made manually or automatically (at an interval defined by the user).
  • Page 57 Sonicaid FM800 Encore Series Instructions for Use Artery alignment mark Note: With the Sonicaid FM830E cuffs, the hose is offset towards the end of the bladder. Do not use the hose as the artery position marker, as this will position the end of the bladder over the artery instead of the correct centre point.
  • Page 58 Sonicaid FM800 Encore Series Instructions for Use Other considerations There are many other factors which can effect BP measurement & reflect best practice against national & international guidelines. Key issues that affect accuracy of BP measurements: • The patient should be relaxed & rested – minimum 3 minutes before commencing measurement •...
  • Page 59 Sonicaid FM800 Encore Series Instructions for Use T aking measurements automatically 2 0 2 B 1 Connect the cuff to the NBP socket on the connector module. 2 > NBP > AUTO. – 3 Set the interval between measurements by pressing 4 The alarm symbol informs whether the NBP alarm is on or off.
  • Page 60 Sonicaid FM800 Encore Series Instructions for Use For maternal use only; do not use on neonates. Safety mechanisms are incorporated to prevent over- inflation, or extended period inflation. However, patients should be advised to summon assistance if any discomfort results from the use of the NBP function, and its use discontinued.

  • Page 61: 2 B M Aternal Oximetry

    Sonicaid FM800 Encore Series Instructions for Use M aternal Oximetry 7 2 B FM830E 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.
  • Page 62 Sonicaid FM800 Encore Series Instructions for Use Disconnecting the oximetry sensor To disconnect the oximetry sensor, grip the outer part of the connector and pull to release the locking catches. Do not try to disconnect the oximetry module by pulling on the lead.
  • Page 63 Sonicaid FM800 Encore Series Instructions for Use F urther information 2 0 8 B The following information and warnings are supplied in accordance with the requirements of ISO 9919:2005 clause 6.8.2 (aa): The FM800E MSpO2 system is calibrated to display functional oxygen saturation.
  • Page 64 Sonicaid FM800 Encore Series Instructions for Use Biocompatibility: Refer to probe manufacturer for full details. Sterility: Not applicable. Probes are not supplied pre- sterilised. Caution notes: See above for cautions regarding use of compatible sensors and connecting cables. Patient population: For use on maternal patients only.

  • Page 65: E Vents And Alarms

    Sonicaid FM800 Encore Series Instructions for Use E vents and Alarms W hat is meant by an alarm? 7 3 B 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 66 Sonicaid FM800 Encore Series Instructions for Use Printed Indicators • Fetal alarms • Maternal alarms FHR Tachycardia Alarm (FECG, ULT 1 and ULT 2) F, 1, 2 FHR Tachycardia Acknowledge (FECG, ULT 1 and F, 1, 2 ULT 2) FHR Bradycardia Alarm (FECG, ULT 1 and ULT 2) F,...
  • Page 67 Sonicaid FM800 Encore Series Instructions for Use V isual indicators 2 1 1 B Type of alarm What is seen and heard 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.

  • Page 68: 5 B R Esponding To Alarms

    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 FM800E to Huntleigh Healthcare Ltd or their local representative. A cknowledging alarms 2 1 2 B To acknowledge an alarm: >...

  • Page 69: 6 B C Ontrolling Alarms

    Sonicaid FM800 Encore Series Instructions for Use C ontrolling alarms 7 6 B There are four ways of controlling alarms:  Acknowledge (i.e. silence) it when it occurs. See Section 8.3.  Switch it off, so that it is never triggered.

  • Page 70: 8 B A Ctogram

    Sonicaid FM800 Encore Series Instructions for Use A ctogram 7 8 B Note: the Actogram feature is not available in the USA and Canada. Actogram uses the low-frequency content of the signal from the ULT1 ultrasound transducer to detect fetal movements, and give an activity profile of the fetus.
  • Page 71 Sonicaid FM800 Encore Series Instructions for Use A ctogram graph and event marks 2 1 8 B The following illustration shows Actogram graph and event marks superimposed on the contractions trace. Actogram event marks Actogram graph...

  • Page 72: 9 B R Ecording Clinical Events (Easinotes)

    Sonicaid FM800 Encore Series Instructions for Use R ecording clinical events (EasiNotes) 7 9 B EasiNotes allows clinical events to be recorded as clinical event notes above the fetal heart rate trace. If an attempt is made to record a clinical note when there is not enough room on the trace for one, the FM800E records a clinical event mark instead.

  • Page 73: S Etting Alarm Thresholds

    Sonicaid FM800 Encore Series Instructions for Use S etting Alarm Thresholds D efault alarm thresholds 8 0 B FM800E comes with factory-set alarm thresholds for all parameters: Parameter High Status ULT 1, ULT 2, FECG 110bpm 160 bpm FHR Signal Loss...

  • Page 74: 1 B F Hr Thresholds (Ultrasound And Fecg)

    Sonicaid FM800 Encore Series Instructions for Use F HR thresholds (Ultrasound and FECG) 8 1 B 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.
  • Page 75 Sonicaid FM800 Encore Series Instructions for Use H igh FHR or Low FHR 2 2 3 B 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 76 Sonicaid FM800 Encore Series Instructions for Use S ignal Loss alarm 2 2 6 B To change the defined percentage: 1 > SIGNAL LOSS in the FHR SETUP screen. 2 To increase the percentage: > – To decrease the percentage: >...

  • Page 77: 2 B M Aternal Blood Pressure Thresholds

    Sonicaid FM800 Encore Series Instructions for Use M aternal blood pressure thresholds 8 2 B To change the thresholds for maternal blood pressure: 1 From the main screen: > NBP > ALARMS. 2 To change the Systolic or Diastolic high limit: >...

  • Page 78: 4 B M Aternal Oximetry Threshold

    Sonicaid FM800 Encore Series Instructions for Use M aternal oximetry threshold 8 4 B To change the threshold for maternal oximetry: 1 From the main screen: > MSpO > ALARMS. 2 To change the threshold for O SAT: – > LOW LIMIT...
  • Page 79 Sonicaid FM800 Encore Series Instructions for Use P rinting 10.1 I ntroduction 8 5 B The printer mechanism incorporated into the FM800E is a thermal printing system for use with continuous fan-fold thermal paper. It is virtually silent, rendering it unobtrusive in operation.
  • Page 80 Sonicaid FM800 Encore Series Instructions for Use 10.4 P rint speed and duration 8 8 B Print speed is selectable at 1, 2 or 3 cm/sec according to user preference or local clinical practice. Total running times with a standard 45m pack of Sonicaid paper are as follows:...
  • Page 81 10.7 U sing non-Sonicaid paper 9 1 B We strongly recommend the use of standard Huntleigh paper. There are many advantages to our plain paper including • 100% trace registration accuracy • No risk if inserted the wrong way up (this can result in mis-interpretation and poor outcomes •...
  • Page 82 Sonicaid FM800 Encore Series Instructions for Use IMPORTANT: As paper tracks through a printer mechanism it will move from side to side due to variations in paper and printer mechanism alignment. This is an unavoidable feature of all printers of this type, as used in all makes of fetal monitors. With plain paper, where the grid is printed at the same time as the trace data, any alignment error is eliminated, ensuring 100% print accuracy.
  • Page 83 Sonicaid FM800 Encore Series Instructions for Use 10.8 S ample Trace (Sonicaid paper) 9 2 B The illustration below is of an actual CTG chart. The features highlighted on the chart are as follows: A. FHR trace from Ultrasound channel 1.
  • Page 84 Sonicaid FM800 Encore Series Instructions for Use 10.9 T race configurations (only applicable to Sonicaid 9 3 B paper) The FM800E automatically adjusts the configuration of the printout to make best use of the available space on the paper according to the number and type of channels (transducers) in use.
  • Page 85 Sonicaid FM800 Encore Series Instructions for Use Alarm events Easinotes annotations MSpO2 Values (FM830E only) FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule: 10 bpm FHR Graticule: 10 bpm...
  • Page 86 Sonicaid FM800 Encore Series Instructions for Use S ingle scales, 2cm/min: 2 3 0 B FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule: 5 bpm FHR Graticule: 5 bpm FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule:...
  • Page 87 Sonicaid FM800 Encore Series Instructions for Use S ingle scales, 3cm/min: 2 3 1 B FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule: 5 bpm FHR Graticule: 5 bpm FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule:...
  • Page 88 Sonicaid FM800 Encore Series Instructions for Use T win scales, 1cm/min: 2 3 2 B FHR Scale: 20 bpm FHR Scale: 20 bpm FHR Graticule: 5 bpm FHR Graticule: 5 bpm FHR Scale: 30 bpm FHR Scale: 30 bpm FHR Graticule:...
  • Page 89 Sonicaid FM800 Encore Series Instructions for Use T win scales, 2cm/min: 2 3 3 B FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule: 5 bpm FHR Graticule: 5 bpm FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule:...
  • Page 90 Sonicaid FM800 Encore Series Instructions for Use T win scales, 3cm/min: 2 3 4 B FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule: 5 bpm FHR Graticule: 5 bpm FHR Scale: 20 bpm FHR Scale: 30 bpm FHR Graticule:...
  • Page 91 Sonicaid FM800 Encore Series Instructions for Use C TG Chart View 1 0 B 11.1 I ntroduction 9 4 B FM800E can provide an on-screen trace display, which mimics the paper printout as closely as possible. Switch to this display by pressing > GRAPH, whereupon the screen changes to the format shown below.
  • Page 92 Sonicaid FM800 Encore Series Instructions for Use The other vertical scale also appears every 12, 6 or 4 minutes, interleaved with the first. This uses just the bottom part of the screen and corresponds to TOCO/MSpO2 in the range 0-100%.
  • Page 93 Sonicaid FM800 Encore Series Instructions for Use 11.4 D isplay Buffer 9 7 B The display buffer is the internal memory where the trace information is stored. The length of the buffer is such that it can store: 24 hours of data at 3cm/min.
  • Page 94 Sonicaid FM800 Encore Series Instructions for Use S onicaid TREND 1 1 B 12.1 I ntroduction 9 8 B Sonicaid TREND is a software option available with all FM800E series monitors. It measures fetal heart rate parameters at regular intervals, and describes the trace in a way that is quantitative and not qualitative.
  • Page 95 Sonicaid FM800 Encore Series Instructions for Use 12.2 S onicaid TREND 9 9 B TREND measurements are performed at 15 minutes, and every 15 minutes thereafter. It fits a baseline using the last 60 minutes of fetal heart rate data collected, then calculates the following parameters: ...
  • Page 96 Sonicaid FM800 Encore Series Instructions for Use 12.3 U sing Sonicaid TREND 1 0 0 B T urning Sonicaid TREND on 2 3 7 B By default, Sonicaid TREND is turned on. To turn it on or off: > SETUP >...
  • Page 97 Sonicaid FM800 Encore Series Instructions for Use 12.4 S onicaid TREND results 1 0 1 B P rinted results 2 4 1 B 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 98 Sonicaid FM800 Encore Series Instructions for Use S onicaid CARE Antepartum 1 2 B Analysis 13.1 I ntended use 1 0 3 B The intended use of Sonicaid CARE analysis is to analyse antepartum CTGs in pregnancies from 26 weeks gestation onwards. It can be used on women who are...
  • Page 99 Sonicaid FM800 Encore Series Instructions for Use 13.3 T he Dawes/Redman criteria 1 0 5 B  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 100 Sonicaid FM800 Encore Series Instructions for Use E vent marks for twins 2 4 4 B Sonicaid CARE analysis does not take account of fetal movements when analysing twins. A larms 2 4 5 B During Sonicaid CARE 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.
  • Page 101 Sonicaid FM800 Encore Series Instructions for Use S topping Sonicaid CARE analysis 2 4 9 B Stop printing. FM800E prints the analysis results. T urning Sonicaid CARE analysis off 2 5 0 B > SETUP > ANTEPARTUM ANALYSIS > ANALYSIS OFF The analysis also defaults to OFF when FM800E is switched off, then on again.
  • Page 102 Sonicaid FM800 Encore Series Instructions for Use A bnormalities 2 5 2 B Double asterisks indicate one of the following conditions: ● Fetal heart rate < 116 bpm or > 160 bpm on a record of less than 30 minutes ●...
  • Page 103 Sonicaid Centrale • Obstetric Archive • Other CRS systems which are fully compatible with the Sonicaid, Huntleigh or ‘HP 50’ protocols The FM800E has been designed to work ONLY with the listed systems. This does not mean that it is incompatible with other systems based on the HP50 communications protocol.
  • Page 104 Sonicaid FM800 Encore Series Instructions for Use 14.2 U sing FM800E with Sonicaid Centrale, or other 1 1 0 B CRS systems C onnecting FM800E to Sonicaid Centrale or other CRS systems 2 5 5 B There are a number of ways in which FM800E may be connected to Sonicaid Centrale or other CRS’s.
  • Page 105 Sonicaid FM800 Encore Series Instructions for Use T elemetry – Sonicaid Freedom 1 4 B Please refer to the manual supplied with the Sonicaid Freedom telemetry receiver and transducers before connecting and using the equipment. See also Appendix 1 of this manual - “Getting Started with the Sonicaid Freedom”...
  • Page 106 Sonicaid FM800 Encore Series Instructions for Use T roubleshooting 1 5 B 16.1 F HR 1 1 3 B No FHR signal displayed Is FM800E switched on? Is the FHR transducer connected? High % signal loss Check transducer placement. Is the transducer broken? Consider switching from Ultrasound to FECG.
  • Page 107 Sonicaid FM800 Encore Series Instructions for Use 16.4 M aternal blood pressure error codes 1 1 6 B 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 108 Sonicaid FM800 Encore Series Instructions for Use 16.5 P rinting 1 1 7 B Paper runs out A coloured stripe will appear when the paper pack nears its end (Sonicaid paper). Once the paper has expired, a “PAPER REQUIRED” message is displayed on the screen, the printer LED will flash and an audible alert will sound.
  • Page 109 W hat to do next? 1 1 8 B If a problem cannot be resolved using this Troubleshooting guide, please contact your Huntleigh Healthcare Ltd representative. You may be asked what software version your FM800E is running. To find this out: >...
  • Page 110 CLEAN – DISINFECT – RINSE – DRY All Huntleigh Products have been designed to withstand normal clinical use, however they can contain delicate components which should be handled and treated with care.
  • Page 111 Sonicaid FM800 Encore Series Instructions for Use 17.3 C leaning and Disinfecting Patient Applied Parts C C C Clean the parts before examining a patient using Low Risk cleaning method below. Following patient examination clean and/or disinfect the transducers by the appropriate...
  • Page 112 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 FM800E unit, contact your local Huntleigh Healthcare Ltd representative.
  • Page 113 18.4 S ervicing 1 2 7 B S ervicing 2 6 2 B Servicing should be performed only by Huntleigh Healthcare Ltd or their appointed service agent. If you have difficulty obtaining service for FM800E, contact Huntleigh Healthcare Ltd.
  • Page 114 Please refer to the Accessories & Consumables catalogue included with the monitor for further details of products available for use with the FM800E. The latest issue of this catalogue is available on request from local Huntleigh representatives. Available accessories, consumables and spares include:...
  • Page 115 Sonicaid FM800 Encore Series Instructions for Use S pecifications 1 9 B 19.1 P hysical and environmental 1 2 9 B P hysical 2 6 6 B Height (all models) 186mm (7.3in) Length (all models) 358mm (14.1in) Width (FM820E) 363mm (14.3in) Width (FM830E) 392mm (15.5in)
  • Page 116 Sonicaid FM800 Encore Series Instructions for Use 19.3 T ransducers 1 3 1 B U ltrasound 2 6 8 B Range 30 to 240 bpm Accuracy ± 1 bpm over the range 100-180 bpm Alarms High and Low FHR: 30 to 240 bpm...
  • Page 117 Sonicaid FM800 Encore Series Instructions for Use U terine activity (external Toco) 2 7 0 B Range 0–100 relative units Sensitivity 80% (±5%) scale reading equivalent to 100g Offset range ±100g Auto zero Manual and auto zero facility Safety Type CF protection...
  • Page 118 Sonicaid FM800 Encore Series Instructions for Use M aternal blood pressure 2 7 3 B Method Oscillometric Measurement ranges Systolic 40–260 mmHg Diastolic 20–200 mmHg Pulse 30–220 bpm Accuracy ±2% or 3mmHg, whichever is greater – static only Modes Manual or automatic...
  • Page 119 Sonicaid FM800 Encore Series Instructions for Use M aternal oximetry 2 7 4 B Sensor types BCI (Smiths Industries) 3444 Finger Sensor NELLCOR DS100A Or as detailed in the current FM800E Accessories & Consumables Brochure 0-99% SpO Saturation range Saturation accuracy ±1SD of normal distribution, within ranges:...
  • Page 120 Sonicaid FM800 Encore Series Instructions for Use 19.4 C ontrols 1 3 2 B 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 ●...
  • Page 121 Sonicaid FM800 Encore Series Instructions for Use 19.6 C onnections 1 3 4 B F ront panel 2 7 5 B ULT1 (all models) 1.0MHz ultrasound transducer ULT2 (all models) 1.0MHz ultrasound transducer FECG/MECG (all models) Maternal/fetal ECG lead TOCO/IUP (all models)
  • Page 122 Sonicaid FM800 Encore Series Instructions for Use 19.7 D isplay 1 3 5 B Technology Full Colour TFT Liquid Crystal Display Size 11.5cm x 8.6cm (4.5in x 3.4in) Resolution ¼ VGA, 320 x 240 Viewing Angle 134° D ata display...
  • Page 123 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 124 As Low As Reasonably Achievable. The transmitted acoustic power of the Sonicaid FM800 Encore series fetal monitor is fixed and cannot be adjusted by the operator. Therefore, the user can best observe the ALARA principle by ensuring that each examination is medically indicated and by limiting the duration of the study to the extent appropriate for the clinical objectives.
  • Page 125 Sonicaid FM800 Encore Series Instructions for Use A coustic Output 2 8 1 B The ultrasound transducer used with the Sonicaid FM800 Encore series fetal monitors has a single mode of operation, with fixed acoustic output parameters that are not user adjustable.
  • Page 126 Sonicaid FM800 Encore Series Instructions for Use A dditional Information 2 8 2 B Parameter Value Uncertainty @ transducer face 0.30 mW/cm Note 1 ±24% SATA Note 1: ‘In-situ’ de-rating of 0.3dB/cm/MHz has been applied in order to derive de- rated values.
  • Page 127 Sonicaid FM800 Encore Series Instructions for Use A ppendix 1: Getting Started with 2 9 5 B Sonicaid Freedom C onnecting the Sonicaid Freedom Wireless Transducer System Ensure the receiver aerial is fitted and securely fastened to the connector on the rear panel.
  • Page 128 Sonicaid FM800 Encore Series Instructions for Use M onitoring FHR and Uterine Activity 2 9 0 B 1. Before using the Wireless Telemetry System, check that the fetal heart rate and toco readings can be obtained using the wired transducers as described previously in this manual.
  • Page 129 Sonicaid FM800 Encore Series Instructions for Use O n completion of monitoring session 2 9 2 B 1. Clean the transducers and return them to the Sonicaid Freedom by plugging them into the front panel for charging. 2. Return the FM800E to normal ‘wired’ transducer monitoring by docking the...
  • Page 130 Huntleigh Healthcare Ltd 35 Portmanmoor Road, Cardiff. CF24 5HN. UK. Tel: +44 (0) 29 2048 5885 Fax: +44 (0) 29 2049 2520 E-mail: sales@huntleigh-diagnostics.co.uk Web page: www.huntleigh-diagnostics.com  2008-2010 Huntleigh Healthcare Ltd Part no. 751321-EN-9...

This manual is also suitable for:

Sonicaid fm820eSonicaid fm830e

Table of Contents