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1. 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 0088 Sonicaid FM800 Series Reference Manual Contents OIA aA E EIE A AA A A be eet Rea eet A etki te uae de oe ie 3 Standards COMPIiANcCe cccccceecccceeeeecenceceeeeeceneeeeeeeeeeaeeeeaeeeeseeeeeeereeeeseeeseeeeeseeeeeeeeeteees 7 InidiGAtiONS fOF USE wiz A ee a es E A AA 8 System Installation cccccceeeecceeeceeceeeeeesececeeeeeceeeceaceeseaeeseaeeseacececaeeessaeeessaeetsaeeeesneeeess 9 Calibratione ke tak tei CAR eee ee oS athe ke Be ee 9 Multiple Portable Socket Outlets 2 0 2 2 ccccccecccceeeeeeeeeeeeeeeeeeeeeeecaeeeeceeesecaeeeeeeeeseeeeeseeeeees 10 Electromagnetic Compatibility ceeeceecccccceeeeeeeeeseeennaeeeeeeeeeesesecseeaeeeeeeeeeseesseseneeeeees 11 TRAGSMArKS A tected eis eee ete ed ee ee ee A 12 SENSOMS asst Ae Meera Teac ed ok EA Tec ase eis Bote paced ook we TR Tae deca choos 12 Addres OS ici ait dt ee Sh Siva eis Se ee Se ee ak 13 AaLi golo LOTO ON AeA E E AEE E E cece euts EEA A ETE 14 1 1 The FM800 SEri S cece ceccececcceceeeeceeccceceeceeeceeeeeesceeceeeeeseceeeesueeseeeeeeeaeeeees 14 1 2 Main unit front panel cc cccessseecssseeeeecssneeeeeseeeeeesssnsaeeees
2. Sonicaid FM800 Series Reference Manual 2 5 Printer controls There are hardware controls for printer on off printer fast forward and EasiNotes Vv R O Printer On Off switch and indicator Shows amber light when printer is switched on y T O Printer Fast Forward O EasiNotes annotation See Section 7 6 Printer setup Printer setup is controlled by the software buttons gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt 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
3. gt SET ACTOGRAM THRESHOLD gt 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 34 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 e Add or change EasiNote descriptions e Display or not display the baby graphic e Display or not display FECG or MECG waveforms e Beep or not beep when a key is pressed e Change the printer setup e Change the international setup e Beep or not beep when an Event Mark is recorded e 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 Default alarms The Default Alarms screen allows you to change the default alarms for e FHR e Maternal temperature e MECG e NBP e MSpO2 Sonicaid FM800 Series Reference Manual 4 2 Changing the default
4. Signal loss contractions MECG Signal loss oximetry Signal loss blood pressure Coincidence alarms see section 5 6 Fetal events Clinical events Timer FM800 failure Sonicaid FM800 Series Reference Manual What you see and hear 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 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 Triangular marker at the top of the FHR trace printed on FHR trace with space for manual annotation OR Clinical event notes above the FHR trace Message lt Alarm Acknowledge TIMER FINISHED EITHER a blank screen OR an error message 63 Sonicaid FM800 Series Reference Manual 64 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
5. 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 gt 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 gt 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 e For FHR the FM800 gives an audible representation of the Ultrasound signal e For FECG the FM800 beeps each time
6. 2 Remove the paper pack 3 Using a lint free cloth and pure alcohol wipe along the full width of the print head which is beneath the plastic edge of the paper compartment 4 Replace the paper tray and paper pack Check NBP cuffs and hose Once a month 1 Check the NBP hose Straighten out any kinks and distortions 2 Check the cuff s for wear and damage Check oximetry and temperature sensors Once a month Check the oximetry and temperature sensors for any signs of wear or damage 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 3 Check the AC supply fuses are of the correct value 1A for 2 200V systems 2A for lt 200V systems Functional check Every six months 1 Connect the AC supply the transducers and the accessories 2 Switch ON 3 Check that FM800 can perform the functions described in this Reference Manual Check oximetry and temperature sensors Check the sensors every three months gt SYSTEM SETTINGS gt SERVICE CENTRE gt DIAGNOSTICS Follow the instructions on screen 95 Sonicaid FM800 Series Reference Manual 96 Check NBP pressure Every twelve months check NBP pressure gt SYSTEM SETTINGS gt SERVICE CEN
7. HHC e Defective consumables will be replaced Any problems should be reported immediately to the supplier of the equipment or your local HHC service department The warranty is valid in all circumstances provided that a the goods have been used in accordance with the operating instructions and solely for the purpose for which they were intended b the defect has not been caused by misuse or accident unauthorised alteration repair or maintenance or the use of sub standard consumables c kit products have been fitted in accordance with the installation instructions d repair of the goods has not been attempted by a person or company which is not an approved Huntleigh Healthcare Ltd representative e the purchaser shall be liable for any costs incurred by HHC or its appointed agent in responding to claims caused by operator error or incorrect application 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 OV reference Tx Not connected Bed resistor Rx Bed resistor Input Output Input Output Input Input Input Output RS232 interface RS232 S8002 9 way D type socket isolated to 500V DC Isolated interface to a PC running System 8002 FetalCare etc From units at modification state 4 or greater isol
8. Manual 44 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 Palpate the maternal pulse for one minute simultaneously and record it on the printed output Recording a signal for maternal ECG will help to identify any cross correlation between maternal and fetal heart rates 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 6 Ultrasound for twins Set FM800 to TWIN SCALES or SINGLE SCALE gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt PRINTER gt TWIN FHR Palpate the abdomen and ascertain the lie of each fetus 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 Check that the two heart rates are different If the heart rates appear similar FM800 beeps The display sho
9. Printing Poor print quality Some NBP measurements are not being printed on the trace 90 wo OR OR User action Make sure patient keeps still during measurement The cuff is loose or not connected properly The cuff bladder or hose has a leak The hose is not properly connected to FM800 Make sure the patient does not press the cuff or bend her arm too much Check cuff and hose then try another measurement If the problem persists note the error message and contact Huntleigh Healthcare Ltd or their representatives Make sure you have the right paper loaded FM800 uses Sonicaid paper part number 8400 8003 Make sure the paper tray is fully pushed in Try printing again If there is no improvement clean the print head See Section 14 4 When NBP measurements are taken every 3 minutes and print speed is set to 1cm min there is not room on the paper for every result Either take measurements every 5 minutes or increase the print speed Sonicaid FM800 Series Reference Manual 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt SERVICE CENTRE gt PRODUCT INFORMATION PRODUCT INFORMATION Model SONICAID FM830 Serial Number FM800 1
10. 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 gt PRINTER gt TWIN FHR FHR graticule The FHR graticule can be printed at intervals of 5 bpm or 10 bpm To alter the FHR graticule gt PRINTER gt FHR GRATICULE 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 gt PRINTER gt 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt AUDIO GRAPHIC gt BABY GRAPHIC Audible key press To switch on or off the beep which accompanies every key press gt AUDIO GRAPHIC gt KEY PRESS Audible event mark To switch on or off the beep which accompanies the marking of an event gt AUDIO GRAPHIC gt EVENT MARK ECG waveform display To display or stop displaying ECG waveforms when Maternal ECG or Fetal ECG is
11. 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 12 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 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 www huntleigh healthcare com 13 Sonicaid FM800 Series Reference Manual 14 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
12. alarms When you switch the FM800 on the alarm settings for FHR maternal temperature MECG NBP and MSpOzg and the mode setting for NBP revert to the hospital defaults To change the hospital defaults 1 gt SETUP gt DEFAULT ALARMS gt 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 gt SETUP gt SYSTEM SETTINGS gt enter access code 2755 gt SERVICE CENTRE gt DIAGNOSTICS gt 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt PRINTER gt PRINT HEADER once or twice as required Hospital name To enter or edit the hospital name printed on the trace gt PRINTER gt HOSPITAL NAME Enter the hospital name in the same way as for Patient Details See Section 3 7 35 Sonicaid FM800 Series Reference Manual 36 Paper speed To change the paper speed gt PRINTER gt 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 gt PRINTER gt FHR
13. 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 00000 LLL When the FM800 detects the fetal heart rate it displays the rate and a confidence indicator the heart symbol See Section 5 4 TILI TILL 25 Sonicaid FM800 Series Reference Manual 26 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 e change the audio volume e change the audio channel Volume control To change the audio volume press Audio Volume Up or Audio Volume Down O Audio Volume Down q Q 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 O O Audio Channel Select
14. gt EXIT 71 Sonicaid FM800 Series Reference Manual 72 Alarm volume To change the volume of the audio alarm use the ALARM VOLUME controls in the FHR SETUP screen f Increase volume d Decrease volume Switching off the High FHR and Low FHR alarm In the FHR SETUP screen gt OFF Note this does not turn off the Signal Loss alarm Signal Loss alarm To change the defined percentage 1 gt SIGNAL LOSS in the FHR SETUP screen 2 To increase the percentage gt To decrease the percentage gt 3 gt 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 gt SIGNAL LOSS gt 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 lt 50 of time period Signal loss if signal loss gt 50 of time period In the first case an alarm is triggered In the second case an alarm is not triggered Sonicaid FM800 Series Reference Manual 8 3 Maternal blood pressure thresholds To change the thresholds for maternal blood pressure 1 From the main screen gt NBP gt ALARMS 2 To change the S
15. 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 Sonicaid FM800 Series Reference Manual FM820 standard features The following features are available on all monitors in the FM800 range e Alarms e Annotation e Audio e Display autodim e Direct FECG via scalp electrode e Fetal event marker e Interface to Rimkus telemetry e Interface to Sonicaid Axis e Interface to Sonicaid System 8002 Fetalcare e Interface to Sonicaid Centrale and other CMS packages e IUP internal uterine activity e Maternal Heart Rate via ECG MECG lead supplied as option e Toco external uterine activity e Ultrasound 1 1 5MHz e Ultrasound 2 2 0MHz e Thermal printer e SonicaidCare antepartum analysis e SonicaidTrend intrapartum analysis Not approved for sale is USA and Canada 15 Sonicaid FM800 Series Reference Manual 1 2 Main unit fr
16. 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 e ULTRASOUND 1 EXTERNAL 1 5 MHZ TOCO OR IUP e ULTRASOUND 2 MATERNAL e 2 MHZ ECG FECG SCALP MATERNAL ELECTRODE NBP MATERNAL SPO2 ACKNOWLEDGE ALARM ETC SETUP 00000 TII Buttons are not active until a transducer is connected A triangular pointer indicates that a button is active For example SETUP o O 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt AUDIO GRAPHIC gt KEY PRESS 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
17. 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 ata ar moment when the mother is not experiencing a contraction O 51 Sonicaid FM800 Series Reference Manual 52 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 gt SYSTEM SETTINGS gt access code 2755 gt INTERNATIONAL gt IUP UNITS 3 Insert the catheter as described in the instructions 4 Zero the transducer as described in the instructions supplied with it ar Zero FM800 by pressing the pink Toco Zero control on the front panel O Or gt IUP then gt ZERO 5 To confirm placement and function of the transducer ask the patient to cough You should observe a spike in the contractions measurement
18. on the screen can cause a limited degree of burn in Some slight variation in luminance as a result of this is perfectly normal 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 22 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
19. 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 Sonicaid FM800 Series Reference Manual 10 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
20. 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 wo To change the units of measurement gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt INTERNATIONAL gt TEMP UNITS 61 Sonicaid FM800 Series Reference Manual 62 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 MSpO 2 lowest tone Visual indicators Type of alarm Signal outside range Signal loss Ultrasound FECG
21. the printer drawer push the drawer in firmly until it clicks into place sr diagram A diagram B 28 3 Setup 3 1 Overview Sonicaid FM800 Series Reference Manual The Setup procedures are much simpler if you understand the differences between Setup Current Alarms Default Alarms and System Settings Setup Current Alarms Default Alarms System Settings User preferences available directly from the Setup screen 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 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 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 30 3 3 Default alarms This option allows you to alter the defaul
22. 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 FM800 unit 2Spacer 3 Securing screw 4 Threaded boss 5 Top of trolley or wall mounting unit Sonicaid FM800 Series Reference Manual 2 FM800 Controls and Display 2 1 Controls and on off indicator RY Printer on off switch and indicator Shows amber light when printer is switched on O Audio volume down O Audio volume up Fv O Printer fast forward O Audio channel select See Sections 5 2 and 6 3 tO EasiNotes annotation See Section 7 6 a O Toco zero Power on off switch and indicator Shows green light when FM800 is switched on D 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 24 2 2 FM800 main screen When FM800 is
23. 0017 Date of Manufacture 24 06 2000 Version SH2 1 1 7 0 SH2 2 1 7 0 PIC 1 1 4 PIC 2 1 3 EPLD 1 0 Make a note of the numbers listed for SH2 1 SH2 2 PIC 1 PIC 2 and EPLD 91 Sonicaid FM800 Series Reference Manual 92 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 Wipe dry with a clean cloth Caution do not use isopropyl alcohol to clean the FM800 main unit Do not expose metal components eg snap connectors to chemicals Sterilising the case The only method of sterilisation for the FM800 main unit is by using Ethylene Oxide gas up to 5 5 bar Low temperature steam is NOT permissible Note sterilisation is not normally required 14 2 Transducers NBP cuff maternal oximetry sensor temperature probe For cleaning disinfection sterilization and maintenance of these transducers read the instructions supplied by the manufacturer of the transducers 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 electr
24. 3 Nail varnish remover contains acetone Contact with acetone will damage the maternal oximetry sensor 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 MSpOz2 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 MSpOz2 display ag O 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 symbo
25. 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 a O Channel Select d Audio symbol 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 Connect the MECG lead blue to the MECG socket on FM800 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 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 The FM800 carries out its own intern
26. 7 n S 180 160 140 4 CM MIN 49 Sonicaid FM800 Series Reference Manual 50 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 ICHECK TRACE FOR SAME HEART RATE The printer prints this 4 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 Sonicaid FM800 Series Reference Manual 6 Monitoring Maternal Parameters 6 1 Contractions using Toco transducer 1 Connect the Toco transducer to the pink socket
27. 800 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 1 Basal heart rate outside normal range Large decelerations No episodes of high variation No movements and fewer than 3 accelerations Baseline fitting is uncertain Short term variation is less than 3ms Possible error at the end of the record Deceleration at the end of the record High frequency sinusoidal rhythm OAN DO BW DY 10 Suspected sinusoidal rhythm 11 Long term variation in high episodes below acceptable level 12 No accelerations Abnormalities Double asterisks indicate one of the following conditions e Fetal heart rate lt 116 bpm or gt 160 bpm on a record of less than 30 minutes e Decelerations gt 100 lost beats gt 20 lost beats on record of less than 30 minutes e No moves and fewer than 3 accelerations e No episodes of high variation e Short term variation lt 3ms e No accelerations and either lt 21 movements per hour or long term variation in episodes of high variation below the tenth centile e Long term variation in episodes of high variation below the first centile 83 Sonicaid FM800 Series Reference Manual 84 A single asterisk indicates one of the following conditions e Short term variation lt 4 ms but 3ms e Basal heart rate lt 116 bpm or gt 160 bpm on a record 2 30 minutes
28. BP 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 Sonicaid FM800 Series Reference Manual Taking measurements manually 1 2 Connect the cuff to the NBP socket on the connector module gt NBP The NBP SETUP screen tells you whether you are in Manual Mode or Auto Mode To change from Auto to Manual gt MANUAL The ALARMS symbol tells you whether the alarm is on or off A Alarm on as Alarm off To turn the alarm on or off gt ALARMS gt ON or OFF If you set the alarm on you can reset the alarm limits and volume if necessary See Chapter 8 Attach the cuff to the mother See above To take a measurement gt NBP gt START MEASUREMENT To stop a measurement after it has started gt STOP NBP Taking measurements automatically 1 2 3 4 Connect the cuff to the NBP socket on the connector module gt NBP gt AUTO Set the interval between measurements by pressing or The alarm symbol tells you whether the NBP alarm ison or off x Alarm on LA Alarm off To turn the alarm on or off gt ALARMS gt ON or OFF If you set the alarm on you can reset the alarm limits and volume if necessary See Chapter 8 Attach the cuff to the mother See above gt START AUTO CYCLE to start tak
29. C to 35 C 20 C to 50 C 68 to 106 kPa 680 to 1060 mB 68 to 106 kPa 680 to 1060 mB 10 to 75 RH non condensing 10 to 90 RH non condensing 15 2 AC supply voltage and fuse values Rated AC supply voltage Fuse values Power rating 100 120V 220 240V 50 60Hz T1A L 250V for nominal input voltage 2 200V T2A L 250V for nominal input voltage lt 200V 100VA 99 15 3 Transducers Ultrasound Range Accuracy Alarms Mode Frequency P lob Ispta Resolution Safety FECG Range Accuracy Alarms Common mode rejection Input impedance Input range DC offset Common mode range Noise Safety Sonicaid FM800 Series Reference Manual 30 to 240 bpm 1 bpm over the range 100 180 bpm High and Low FHR 30 to 240 bpm Signal Loss loss in last 5 minutes Directional pulsed Doppler Repetition rate 3 0KHz 1 5MHz yellow 2 0MHz blue lt 1Mpa lt 20mW cm lt 100mW cm 12 bits Type CF protection 30 to 240 bpm 1 bpm over the range 100 180 bpm As Ultrasound Better than 66db within the signal bandwidth 10M Ohm gt 30uV to gt 500uV peak to peak 2V common mode 300mV differential 20V mains frequency lt 10uV peak to peak referred to input Type CF protection Sonicaid FM800 Series Reference Manual Uterine activity external Toco Range Sensitivity Offset range Auto zero Safety Uterine activity internal IUP Transducers Pressure range Sensiti
30. EEE EEA 29 3 3 Default AAS a a a a 30 3 4 System Settings eee ceccccecceececeeeeeeeeeeeeeeceeeeeeeaeesesaeeseeeeseceeeeseaeeeeeeeeeeeeeeseeeeee 30 Bid EINA AEAEE sols Leceseacectns Sate baaecateccdet tia taaeherns ace EET 30 3 6 IMG and dt ura eis ee a Reese ks A ead ee 30 3 1 Patient detalls E EEEE eae eta eee abt aed ee 31 Fo Fo EE TIa A Pen RSE RA oe Ene EATE So er i Se ec EO RE mE a oe 32 3 9 Actogram Setting nresnani tees cient cineeianiin E EE EE 33 Sonicaid FM800 Series Reference Manual 4 System Settings and Default Alarms ccccccceceeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeneeeeeeetees 34 2s BY A eee cer ey ae eae ee ee ee eee ee eee 34 4 2 Changing the default alarMs 2 ccceceeceeceeeeeceeeeeeeeeeeeseaeeeseaeeseseeenseeeeesaees 35 43 gt PYINtSh SOUP ite edessccte gt iite eeeestecceas ates te iacte cateate T 35 4 4 Audio graphic settings ccccceeeeceeeeeceeeeceeeeeeeeeeeeeceseeeceaeeceeaeeesseeeesseeessaees 37 4 5 International Settings isisisi da o a aides 38 4 6 Serial interface cccccecescceeeecccenceeeeeeeceeeeeeeeeececeeeeceaeeceaeeseaaeceseeesseeesseeessaees 39 5 Monitoring Fetal Parameters cececcceceeeeeeceeeeeeeeeeeeeeenaaeeeeseeeeeeeeeeaaaeeeeseeeeeeeneaaa 40 OFT 2 PPC UIMUMARY tes atten toc ces ce VTi canted ad pact od ca Utes oaths cee Ae aaa a aa Dace 40 O52 AUDIO SIGNAL sr cirei cagteatadeeracuevcacasea TSE 40 5 3 Ultrasound MOnit
31. FM800 Before operating ensure the transducers are plugged in and fully charged takes 3 to 4 hours Battery Fully Charged Green o ol Battery Charging Amber 115 Sonicaid FM800 Series Reference Manual 116 Monitoring FHR and Uterine Activity Unplug the T800 transducers The FM800 display will indicate Wireless Transducers in use 9 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 Secure in position with belt Make sure FHR is clear and distinct from the maternal pulse taken from the patient s wrist FHR signal quality is shown by the flashing heart symbol Adjust the volume of the fetal heart sounds to your O O desired level To monitor uterine activity position the grey Toco transducer halfway between the fundus and the umbilicus and secure with belt Zero the Toco Make sure the uterus is relaxed then press a the pink Toco zero button 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 LOW Amber Ultrasound and Toco transducer battery state EMPTY Red Transducer battery low or out of
32. STATION Or you can enter the gestational age first gt SETUP gt PATIENT DETAILS gt GESTATION 3 Start printing Note when SonicaidCare analysis is running the display shows an A in the lower right corner together with the status for each channel being analysed and an elapsed time indicator Status indicators are v Criteria met x Criteria not met N Not applicable ie no results yet 81 Sonicaid FM800 Series Reference Manual Checking the progress of SonicaidCare analysis To check the key results after the first analysis gt SETUP gt ANTEPARTUM ANALYSIS gt 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 An asterisk beside a figure indicates an abnormal result See Abnormalities in Section 10 5 Stopping SonicaidCare analysis Stop printing FM800 prints the analysis results Turning SonicaidCare analysis off gt SETUP gt ANTEPARTUM ANALYSIS gt ANALYSIS OFF The analysis also defaults to OFF when FM800 is switched off then on again 10 6 SonicaidCare analysis report When the analysis is stopped the printer produces a report of the analysis results at the end of the trace The report shows e Values for the calculated parameters e When the Dawes Redman criteria were first met e Whether the Dawes Redman criteria were met at the time the analysis was stopped e Abnormalities 82 Sonicaid FM
33. TRE gt DIAGNOSTICS gt NBP CALIBRATION Follow the instructions on screen Note for calibration to be effective you need to remove the link on J6 on the NBP module This involves removing the equipment cover and then the module Replace the link on J6 after calibration 14 6 Corrective maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd Sonicaid Products 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 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 1300 0153 5 litre container 1300 0154 Membrane for Toco transducer 50 1300 0216 Transducer belts 1 5 m pack of 2 8400 8026 Transducer belt buckle 8400 6208 Sonicaid fetal ECG scalp electrode spiral Box of 50 1400 0160 Belt for Sonicaid fetal ECG electrode leg plate 7481 6101 Safelinc fetal ECG scalp ele
34. al impedance check If the check fails you see the message CHECK MECG CONNECTIONS 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 ICHECK TRACE FOR SAME HEART RATE Confirm the source of the fetal heart rate you are monitoring 53 Sonicaid FM800 Series Reference Manual 54 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt AUDIO GRAPHIC gt ECG WAVEFORM gt EXIT gt EXIT The MECG waveform now appears in place of the baby graphic ILLL 0000 Note if you are monitoring MECG and FECG and ECG waveform display is switched on the FM800 displays the MECG waveform Sonicaid FM800 Series Reference Manual Printing the MECG waveform 1 2 3 4 Make sure the FM800 is already printing the trace Make sure the MECG waveform is display
35. alCare User Guide or the Sonicaid System8002 Operating Handbook Setting up FM800 for use with FetalCare or System8002 1 gt SETUP gt SYSTEM SETTINGS gt access code 2755 2 gt SERIAL INTERFACE 3 Make sure the RS232 S8002 button says Sonicaid If it says HP then press it to change to Sonicaid 4 gt EXIT Switch off FM800 Wait for about 10 seconds 6 Switch FM800 on again oO 85 Sonicaid FM800 Series Reference Manual 86 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 Note for full details of PC connections and instructions for using the Axis system see the Sonicaid Axis User Guide and the Sonicaid Axis Installation Guide Annotations on Axis If you connect FM800 to an Axis central review system any annotations entered will be displayed in the Axis Notepad See the Sonicaid Axis User Guide On an Axis system annotations appear in the Axis Notepad Note Sonicaid Axis is no longer offered as a supported product 11 3 Using FM800 with Sonicaid Centrale Philips TraceVue or GMT Argus Connecting FM800 to Sonicaid Centrale Philips TraceVue or GMT Argus There are a number of ways in which FM800 may be connected to Sonicaid Centrale or other CMS s like TraceVue
36. analysis is not approved for sale in the USA and Canada 15 Sonicaid FM800 Series Reference Manual 76 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 e Baseline heart rate bpm for the last 60 minutes e Baseline heart rate bpm for the last 15 minutes e Short term variation msecs for the last 60 minutes e Deceleration size beats for the last 60 minutes e 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 Mor 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 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 gt SETUP gt INTRAPARTUM ANALYSIS gt ANALYSIS ON Starting SonicaidTre
37. ard e Clinical event mark 10 soft keys on the display 128mm thick film 8 dots per mm 1 2 or 3cm per minute user selectable 10 cm per minute fast forward Plain thermal paper z fold 45m length 30 240 bpm or 50 210 bpm user selectable e Hospital name time date paper speed monitoring modes signal loss e Mothers name and ID number optional 15 6 Connections Front panel ULT1 all models ULT2 FECG all models MECG all models TOCO IUP all models MSpOo2 FM830 NBP FM830 MTEMP FM830 Rear panel all models RS232 RS485 Auxiliary VGA Interfaces Telemetry System External maternal monitors Sonicaid FM800 Series Reference Manual 1 5MHz ultrasound transducer 2 0MHz ultrasound transducer fetal ECG lead Maternal ECG lead Toco transducer IUP lead Maternal pulse oximetry Maternal non invasive blood pressure Maternal temperature 4 isolated NB the RS232 S8002 connector will also accept an RS232 to RS422 adaptor lead for connection to Philips TraceVue 1 isolated not used 1 for telemetry system 1 Rimkus Telemetry Sonicaid Centrale Sonicaid Fetalcare Sonicaid Axis central review Sonicaid System 8002 FHR analysis Philips TraceVue central review system GMT Argus central review system Not available GMT Argus is not approved for use with Sonicaid FM800 in the USA or Canada 105 Sonicaid FM800 Series Reference Manual 106 15 7 Display Techn
38. asiNotes 1 gt SETUP gt SYSTEM SETTINGS gt access code 2755 2 gt 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 gt EXIT To restore the default EasiNotes 1 Set the screen display to a language other than the one currently displayed SETUP gt SYSTEM SETTINGS gt access code 2755 gt INTERNATIONAL gt LANGUAGE 2 Then reset the screen display to your own language 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 160 mmHg 90 mmHg On Maternal Blood Pressure Diastolic 90 mmHg 50 mmHg 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 gt SETUP gt CURRENT ALARMS To restore the default thresholds
39. ated current limited supplies of 10 volts are available to power an RS232 to RS422 converter pin Signal Input output 1 2 3 4 5 6 7 8 9 Isolated 10V Rx Tx Isolated OV Isolated 10V Output power 232 to 422 converter Input Output Reference Output power 232 to 422 converter 111 Sonicaid FM800 Series Reference Manual 112 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 pin Signal Input output Rx Input Tx Output Isolated OV Reference OONDOARWNDH Fetal event marker connector 1 4 jack socket Pin Signal 1 Tip Switch 2 Ring Signal ground via switch 3 Sleeve Chassis ground via anti static network 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 2 Turn on FM800 3 Select the required audio channel 4 Adjust the volume to the required level System test 1 Hold the ultrasound transducer in one hand with the transducer face against the palm 2 Stroke the back of the hand repeatedly with one finger See d
40. being recorded gt AUDIO GRAPHIC gt 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 38 4 5 International settings Supply frequency 50Hz or 60Hz To alter the supply frequency gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt INTERNATIONAL gt SUPPLY FREQUENCY Language To change the language appearing on the display gt INTERNATIONAL gt LANGUAGE Select the language you want Date format To change the date format 1 gt INTERNATIONAL 2 Press the key opposite the current date format 3 Repeat if necessary If you want day month and year separated by gt T 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 gt INTERNATIONAL gt IUP UNITS Temperature units of measurement C or F To select C or F for the temperature transducer gt INTERNATIONAL gt TEMP UNITS 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
41. cccceccccccnsessscceceeececeseeecensaaaeeeeeeeeeeenenees 96 14 275 SERVICING REAA EEE EE secede eck tats alae EAA Rete e Riese 96 14 8 Accessories consumables and Spares cccccceeeeeceeeeeeeeeeceeeeeeeeeeeeeeeeeess 97 15 Sp cifications ees fesse tecse leer aa ee e ont be hava otek ae tate ett bert a eat act 99 15 1 Physical and environmental ccceccceceeeeeeeeeeeseeeeeeeeeeaaeeeeseeeeeeesteaaeeeeeeeeeees 99 15 2 AC supply voltage and fuse values cccceceecceeeeceeeeeeeeeeeeeeeeeeteeeeeeeeteeeees 99 15 32 TranSGucCels w2 2 sis i seeioeiechessceei ses odie bodee es 205251 x05 Seb A E A TT 100 15 4 Controls 6 38025 oe even eh et natok Be ote at 104 oo ae ALA ILE eee ace ee err ee ee ie nce ee ey Oe eee ee 104 15 6 CONNEC NS e ce 105 15 7 Displaying a notes A A ee 106 e NEST AAEE E EET A O ae ee Te 107 15 9 Ultrasound safety considerations cccccceeceeeseeeeneeceeeeeceeeeeeeeeeeseeeeaees 108 16 Appendix 1 Service and Warranty cesecceeeecceeeceeeeeeeeeeeeeeceeeeceeeeeeneeetseetees 110 17 Appendix 2 External COnnections ccccsceccccsscceesseneeecescsaeeeeseeeeeeesesaeeeessesaees 111 Sonicaid FM800 Series Reference Manual 18 Appendix 3 Transducer Problems 19 Appendix 4 Getting Started with T800 Sonicaid FM800 Series Reference Manual Standards compliance SonicaidFM800 complies with EN60601 1 1990 Medical Electrical Equipment Part 1 Ge
42. chenerstrasse 6 D 85599 Parsdorf Germany Note Rimkus telemetry is not approved for use with Sonicaid FM800 in the USA or Canada 12 1 Connecting the telemetry unit 1 Connect one end of the FM800 to telemetry cable to the telemetry receiver See the operator s manual for the telemetry unit Connect the other end of the FM800 to telemetry cable to the Rimkus connector on FM800 See Section 1 4 Connect the telemetry receiver to the main power supply See the operator s manual for the telemetry unit 12 2 Using the telemetry unit 1 Connect the telemetry unit to the main power supply and to FM800 Switch on the telemetry unit Check that the transmitter is fully charged See the operator s manual for the telemetry unit With the transducers connected to FM800 not to the telemetry transmitter examine the mother and establish the best position for the transducers Attach the transducers securely to the mother Disconnect the transducers from FM800 and connect them to the telemetry transmitter Leave the transmitter in the receiver unit for the time being Explain to the mother that she should take the transmitter with her when she wants to walk around Demonstrate the Patient Recall signal to her See Getting Started with the T800 Appendix 4 Sonicaid FM800 Series Reference Manual 13 Troubleshooting 13 1 FHR No FHR signal displayed High signal loss No FHR trace printed Only one trace twin
43. computer Make sure the TraceVue computer is connected to the local area network The computer and all its peripherals should be powered via a mains isolating transformer If in doubt consult the administrator of your central review system or your electrical safety department For full details of PC connections and instructions for using the system see the docu mentation supplied with the central review system Note GMT Argus is not approved for use with Sonicaid FM800 in the USA or Canada Setting up FM800 for use with Sonicaid Centrale Philips TraceVue or GMT Argus 1 2 3 ol gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt SERIAL INTERFACE Make sure the RS232 S8002 button says HP If Sonicaid is displayed then press the RS232 S8002 button to change to HP gt EXIT Switch off FM800 Wait for about 10 seconds Switch FM800 on again If you connect FM800 to a Philips TraceVue system you can annotate the trace on FM800 using the TraceVue system See the documentation supplied with the Philips TraceVue system Note Sonicaid Centrale can also support the Sonicaid protocol option 87 Sonicaid FM800 Series Reference Manual 88 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 Feldkir
44. ctrode FDA compliant Box of 50 900X259 Safelinc fetal ECG leg plate attachment pad Box of 50 900X260 Intran disposable IUP catheter transducer Box of 10 8400 8011 Printer paper 45m 8400 8003 Adult ECG electrodes pack of 25 ED 25 Adult ECG electrodes pack of 50 ED 50 97 Sonicaid FM800 Series Reference Manual 98 Spares 1 5 MHz ultrasound transducer yellow 2 0 MHz ultrasound transducer blue Temperature sensor Maternal SpO2 transducer lead assy NBP cuff large adult NBP cuff small adult External Toco transducer Sonicaid fetal ECG electrode leg plate Safelinc fetal ECG connector lead Event marker lead Fuse 2A 100 120V supply Fuse 1A 200 240V supply contact Huntleigh Sales Dept 8400 6919 8400 6920 320504 739088 322806 322804 8400 6921 8400 6922 017D065 7775 6901 FUSE22 1000 0247 15 Specifications Sonicaid FM800 Series Reference Manual 15 1 Physical and environmental Physical Height all models Length all models Width FM820 Width FM830 Weight FM820 Weight FM830 186mm 7 3in 358mm 14 1in 363mm 14 3in 392mm 15 5in Gross weight 18kg includes transducers etc Net weight 15kg Gross weight 19kg includes transducers etc Net weight 16kg Recommended operating storage and transport conditions Operating temperature Storage transport temperature Operating pressure Storage transport pressure Operating humidity Storage transport humidity 10
45. dicator not an indicator of signal strength See table below Display shows No heart symbol No FHR displayed Heart symbol in outline only No FHR displayed Small heart symbol inside outline heart symbol FHR displayed Alternate small and large filled heart symbol beating heart FHR displayed Interpretation 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
46. duration of exposure however is fully under his or her control The examination techniques we have recommended will help the user to get the maximum amount of diagnostic information with the minimum amount of exposure Acoustic output Sonicaid FM800 is exempt from the declaration of acoustic output information in accordance with clause 4 of IEC 1157 EN 61157 This is because the maximum probable levels of the following three parameters are below the limits specified in clause 6 namely peak negative pressure lt 1MPa output beam intensity lt 20mW cm spatial peak temporal average intensity lt 100mW cm Power measurements were made by the National Physical Laboratory Teddington Middlesex UK in accordance with NEMA UD 2 1998 109 Sonicaid FM800 Series Reference Manual 110 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 The warranty covers parts and labour necessary to rectify any faults in the product hardware If within the warranty period any of the goods supplied prove defective due to faulty design workmanship or materials HHC will adjust repair or replace them free of charge as follows e Monitors will be repaired or replaced at the discretion of
47. e Decelerations present but not meeting the criteria for size or record length A single asterisk does not necessarily mean that the record cannot pass the criteria If all other parameters are normal at the 30 minute point the abnormality could be considered to be within acceptable limits to meet the analysis criteria Basal heart rate warnings A basal heart rate of 115 bpm or lower triggers a printed warning WARNING LOW BASAL FHR CHECK THAT FHR DOES NOT CONTINUE TO FALL FETAL MOVEMENTS PRESENT SINUSOIDAL RHYTHM Sonicaid FM800 Series Reference Manual 11 Using FM800 with a PC System You can connect FM800 to the following PC based systems e Sonicaid FetalCare analysis and replay system e Sonicaid Axis central review e Sonicaid System8002 analysis system e Sonicaid Centrale e Hewlett Packard Philips TraceVue central review e GMT Argus central system not approved for use with Sonicaid FM800 in the USA or Canada 11 1 Using FM800 with FetalCare or System8002 Connecting FM800 to FetalCare or System8002 1 Connect the Sonicaid FetalCare or Sonicaid System8002 connecting lead to the RS232 S8002 connector on the rear of FM800 See Section 1 4 2 Connect the lead to the COM1 port on the rear of the Sonicaid FetalCare PC or the Sonicaid System8002 PC 3 Make sure the FM800 has the Sonicaid interface enabled See Section 4 6 Note for full details of PC connections and instructions for using the system see the Sonicaid Fet
48. e ee eee 75 9 2 SonicaidTrend analySis ccccecccceeccceeeeeeeeeeeeeeeeeeeeeeeeeeeeseceeeeeneeeeeneeeseeeeees 76 9 3 Using SonicaidTrend analysis ccecccccesceeeeseeeeeeeeeeeeeeeeeeeeeeeeeeesneeeeseeeees 77 9 4 SonicaidTrend analysis results ccecccceecceeeeseeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeneeeees 78 9 5 Viewing trend datas sioen a aiaiaaeo hekia daaa 78 Sonicaid FM800 Series Reference Manual 10 SonicaidCare Antepartum Analysis ccccecceeeseeeeeeeeeeceeeeceeeeeeeeeeeeeeeeeeeeeeaeeeees 79 Out IMeNE SO USC esis tees su fedestet che a seth pda eisd te UTED ea eee e dh aad 79 FOZ SOVOIVIOW sie Ee rrea wah ce erp vnc a eaaa ae ateit den devin Ma seein 79 10 3 The Dawes Redman Criteria ccc ccceecccececeeeeeeeeeeceeceeeeseaeeceeaeeseeeeeessseeenaees 80 10 4 Care anay S e pede Gat eo ees es etc dole te ne ate ad cette 80 10 5 Using SonicaidCare analySis cccecceeeeceeeeeceeeeceeceeeeceaeeeesaeeesneeeeeseeeeenes 81 10 6 SonicaidCare analysis repoOrt ccccccccccessssceeesesseeeecsseeeeeseeseeeeessaeeesssseaees 82 11 Using FM800 with a PC System cceccccceceeeeeeeeeeeeeeeeeeeeeesesaeeeseaeeeeeeeseeeseeneeeees 85 11 1 Using FM800 with FetalCare or System8002 cccceeeeeceeeeteeeeeeeeeenees 85 11 2 Using FM800 with Sonicaid AXis cccccceeeeeceeeeeeeeeeceeeeeeeeseeeeceeeeeteneeeesaees 86 11 3 Using FM800 with Sonicaid Centra
49. ed gt the EasiNotes annotation button xO gt PRINT ECG MECG trace printout MECG PRINT 27mn S 1 CM MIN 55 Sonicaid FM800 Series Reference Manual 56 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 N
50. eeceeeeeeeeeeeeeeeeeeeeeeeeteeceeeeseeeeeeeetees 62 7 2 What do you see and N ar ccccessscccesssseceeecsnsseeeesecneeeeecsssseeescceneeeeeestaeeenss 62 7 3 ReSPONCING tO AlALMS cece ee eeeeee a a E E Ea 64 7 4 Controlling Alarm cececcceecceeeceeeeceeeeceeeeecaeeeesaeeseeeeeeeeeeeseeeeeeneeeeeeeeeeeeeeee 65 7 5 Recording fetal movements ccceccceceeeeeeseeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeesteeeeeeeeees 65 T6 AClOQrAM eiiieitnoeeeei ieee aetna a O a es roes 66 7 7 Recording clinical events EasSiNotes ccccccccccssceeeessssseeeeeesseeeeesssteeeeess 68 8 Setting Alarm Thresholds ssni e a e aaa ee 69 8 1 Default alarm thresholds ccecccecccceeeeeceeeeeeeeeeeeeeeeeseceeeeeeeeeeeeeeeeeeeeeeseeeees 69 8 2 FHR thresholds Ultrasound and FECG 2 cccccccescceeeeeeeeeeeeeeeeeeeeeeeeeeteeesees 70 8 3 Maternal blood pressure thresholds ceeeeceeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeenaeeeeess 73 8 4 MECG thresholds 2 22 22 400eccecheiyeie hese ce pieeede sien fase eeeebieesncgedecieeslecieete 73 8 5 Maternal oximetry threshold cceeeceeeeeeeeeeeeeceeeeeeeeeeeeeeeaeeeeeeeeeeesssseeenneees 74 8 6 Temperature thresholds ccccessccceeeessseeeeeeeeeeeeeesesaeeeeeeseaeeeeeessaeeeeeeseaeaeetes 74 9 SonicaidTrend Intrapartum AnalySis ccececceeeeceeeeeeeeeeeeeceeeeeseeeeeeeseeesneeeeeeneees 75 O A MinthOdu Ctlon PAPAE E eed bat teh Atte Be ha
51. ended 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 reco
52. essary To remove patient details Switch FM800 off then on 31 Sonicaid FM800 Series Reference Manual 32 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 gt SETUP gt TIMER gt ON 2 Use or to set the length of time required 3 gt 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 gt ALARM ACKNOWLEDGE To turn the timer off gt SETUP gt TIMER gt OFF 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 gt SETUP gt NEXT PAGE gt ACTOGRAM Press ACTOGRAM IS OFF ON to turn the actogram feature on or off To increase or decrease the sensitivity of Actogram gt SETUP gt NEXT PAGE gt ACTOGRAM gt SET ACTOGRAM GAIN ULT1 gt use or to set the gain required Changing the Actogram display setting gt SETUP gt NEXT PAGE gt ACTOGRAM gt ACTOGRAM OUTPUT this cycles on each press between graph checkmarks and graph checkmarks Changing the Actogram threshold gt SETUP gt NEXT PAGE gt ACTOGRAM
53. ew 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 The FM800 carries out its own internal impedance check If the check fails you see the message CHECK FECG CONNECTIONS Adjust the volume control as necessary FECG socket pin 1 M REF pin 2 FECG REF pin 3 FECG electrode SS lt Key 1 FECG socket on FM800 Red Green M REF Red Black FECG electrode ECG REF AN ODOR WD 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 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 ow FECG socket pin 1 M REF pin 2 FECG REF pi
54. gh one of the three positioning holes on the buckle Connect the fetal event marker to the socket on the side panel Explain to the mother how and when to use it Adjust the sound level with the volume controls on the front panel of FM800 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 42 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 and and and and Sonicaid FM800 Series Reference Manual 5 4 The FHR confidence indicator The heart symbol which appears against the FHR display is a confidence in
55. hreshold for Temperature gt 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 gt OFF 5 To return to the main screen gt EXIT 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
56. ia 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 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 Fetal ECG Since the analysis is not valid during labour it does not run on the FECG channel 10 5 Using SonicaidCare analysis Starting SonicaidCare analysis 1 Setup FM800 as you would to record a normal CTG NST 2 Enter the gestational age gt SETUP gt ANTEPARTUM ANALYSIS gt GE
57. iagrams below If necessary use water or gel to obtain good contact between the palm and transducer 3 Check that the audio output pulse lamp heart rate display and printer trace on FM800 are synchronised with the finger movement 113 Sonicaid FM800 Series Reference Manual 114 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 The positions of the crystals behind the transducer face are shown below 1 Squeeze a small amount of Aquasonic gel on to the transducer face over each crystal 2 Move the gel tube rapidly up and down over each crystal keeping the tip of the gel tube in contact with the transducer Check that you get an audio signal synchronised with the tube movement Sonicaid FM800 Series Reference Manual 19 Appendix 4 Getting Started with T800 Connecting the T800 Wireless Transducer System N wo a Ensure the receiver aerial is fitted and securely fastened to the connector on the rear panel Connect the power cable from a suitable wall socket to the mains connector on the rear panel Plug the end of the data cable labelled T800E into gt gt CTG the 15way D socket on the rear panel Plug the other end of the cable labelled FM800 into the 15way D socket on the rear panel of the
58. ing measurements To take a non automatic measurement while remaining in Auto Mode gt NBP gt MEASURE NOW To stop taking measurements gt NBP gt STOP AUTO CYCLE To stop a particular measurement gt STOP NBP FM800 remains in Auto Mode and displays 00 00 as the current measurement 57 Sonicaid FM800 Series Reference Manual 58 Failed measurements manual and automatic When an NBP measurement fails e The NBP display shows 00 00 e Anerror code or message explains why the measurement failed See Section 13 4 e 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 gt NBP gt 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
59. 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 ag O 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 Palpate the abdomen to determine fetal lie and position 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 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 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 Clip the transducer throu
60. ker 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 2 gt AUDIO GRAPHIC gt EVENT MARK 3 gt EXIT 65 Sonicaid FM800 Series Reference Manual 66 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 Ob
61. le Philips TraceVue or GMT Argus 86 12 Telemetry nrnna tii aaa eel Arn i tae 88 12 1 Connecting the telemetry Unit ccccceeccceeeeeceeeeeeeeeeeeceaeeceeeeeeseeeeessneeetenes 88 12 2 Using the telemetry Unit eee eee cecceeeeeseeceeeeeeseeeeeesaeeeeeeessaeeeesseceneeeensaaees 88 13 Troubleshooting 225 002 chit ised ai eens ete ee econ ete 89 OSS RR E EE k Bele re T acct A ee ieee a AE 89 13 2 Oximetty Aisa scone eee Rie eevee pele EEEN AEE a eases 89 13 3 Fe tal event Markeriic c cnisdiiiaichsh deed ides wa le ee 89 13 4 Maternal blood pressure error CODES ceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeteeaeeeeeeeneeees 90 4325 PANINO i ives ative ecient ent ees 90 43 6 Whatto do next cc heal ecl ee E ce age bk te 28 ot 91 14 Cleaning and Maintenance ce cccceccceeeceeeeeeeeeeeeeeeceeeeeeaeeeeeeeecaeeeeeeeeseeeeseneeeees 92 14 1 The FM800 main Unit cececeecceeeeceeeeeecececeeeceeeeceeeeceaceeceaeeeesseeessaeeeenseeeeiees 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 cccccccccccccccccsssssessesseecseeeeceeeeceeeceeeeceesseeesaeseeeasseasesseeeseees 94 14 5 Technical Maintenance ccccccccescseseesesscsseeccseceeccecceeeceeesaeesuaassaaassasseeseeeeeess 95 14 6 Corrective Maintenance ccccccecsec
62. lity and performance if modifications or repairs are carried out by unauthorised personnel Identical replacement parts must be used If there is doubt whether FM800 is operating correctly when being used on a patient fetal condition must be checked by an alternative diagnostic method without delay The protective category against electric 7 shock of all patient applied parts is Type CF Installation is the responsibility of the vendor via a competent person approved by Huntleigh Healthcare Ltd This equipment is not protected against a the effects of defibrillator shocks or discharge b the effects of high frequency currents c the effects of bistoury either TENS Transcutaneous Electrical Nerve Stimulation or electro surgery 107 Sonicaid FM800 Series Reference Manual 108 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 Safelinc FECG electrode Stainless steel Intran IUP catheter Polyurethane plastic Temperature probe Stainless steel MSpO 2 probe Biocompatible plastics Transducer belts Latex free fabric ECG leg plate belt Fabric 15 9 Ultrasound safety considerations General Diagnostic ultrasound has been in use for over 35 years with no confirmed adverse effects on patients or instr
63. ls D Searching Pulse Amplitude aati Signal Quality good PTTL Signal Quality poor 59 Sonicaid FM800 Series Reference Manual Start and stop monitoring To start monitoring in the MSpO2 SETUP screen gt START After about 5 seconds the mother s blood oxygen level appears in the MSpOz2 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 MSpOzg 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 Set the temperature alarms if required See Section 8 7 4 Connect the
64. n 3 FECG electrode 017D065 VA Key 900X260 1 FECG socket on a a FM800 2 M REF 3 FECG REF 4 FECG electrode 900X259 47 Sonicaid FM800 Series Reference Manual 48 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 gt SETUP gt SYSTEM SETTINGS gt access code 2755 gt AUDIO GRAPHIC gt ECG WAVEFORM gt EXIT gt EXIT The FECG waveform now appears in place of the baby graphic LLL 0000 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 Sonicaid FM800 Series Reference Manual Printing the FECG waveform 1 2 3 4 Make sure the FM800 is already printing the trace Make sure the FECG waveform is displayed gt the EasiNotes annotation button xO gt PRINT ECG FECG trace printout FECG PRINT 2
65. nd 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 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 gt SETUP gt INTRAPARTUM ANALYSIS gt DECELERATION PRINTING IS OFF 77 Sonicaid FM800 Series Reference Manual 78 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 gt 50 the results show SL Displayed results To display results gt SETUP gt INTRAPARTUM ANALYSIS gt RESULTS for ULT1 ULT2 or FECG To return to the main screen gt EXIT 9 5 Viewing trend data To see a trend of the analysis results for up to the last four hours gt SETUP gt INTRAPARTUM ANALYSIS gt ULT1 TREND or ULT2 TREND or FECG TREND To return to the main screen gt EXIT Sonicaid FM800 Series Reference Manual 10 SonicaidCare Antepartum Analysis 10 1 Int
66. neral 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 C Denotes conformity with the European Council 0088 Directive 93 42 EEC concerning medical devices Classification symbol y Indicates Type CF applied part 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
67. ode leg plate and IUP extension cable with a cloth dampened in soap or detergent solution to remove aquasonic gel blood saline etc Wipe dry with a clean cloth Caution do not expose metal components eg snap connectors to chemicals Disinfection Ultrasound FECG external Toco transducers and all re usable leads After use clean the transducers as described above Then wipe the transducers and leads with an alcohol solution 70 ethanol or isopropranol in accordance with instructions provided by the disinfectant manufacturer Care of ultrasound transducers Ultrasound transducers should be kept dry and preferably below 45 C Gel must be wiped from the ultrasound transducers after use and before placing on the storage area on the side panel 93 Sonicaid FM800 Series Reference Manual 94 14 4 User maintenance The checks below can be performed by any user of the equipment Mechanical inspection Every three months 1 Inspect the AC supply cable transducers and all other assemblies and connectors for loose or broken parts or any other damage Pay particular attention to the AC supply socket Look carefully for cracks which may allow the ingress of liquids or gels Replace any broken or damaged transducers or cables If there is damage to the main FM800 unit contact your local Huntleigh Healthcare Ltd representative aR WD Cleaning the print head on the printer 1 Pull the paper tray out as far as it will go
68. ology Size Resolution Viewing Angle Data display ULT1 and ULT2 FECG MECG TOCO IUP MSpO2 NBP MTEMP Electroluminescent 11 5cm x 8 6cm 4 5in x 3 4in 4 VGA 320 x 240 gt 160 You can also run FM800 with a VGA monitor connected for training purposes See note on page 9 before connecting Fetal heart rate 30 240 bpm Pulse rate lamp and confidence indicator Fetal heart rate 30 240 bpm Pulse rate lamp Maternal heart rate 30 240 bpm Pulse rate lamp 0 100 relative units 0 100mmHg or 1 15 kPa Oxygen saturation Pulse amplitude Pulse rate Systolic and diastolic pressures Pulse rate Temperature C or F Sonicaid FM800 Series Reference Manual 15 8 Safety i ii ii vi vii viii FM800 is designed to comply with EN60601 1 1990 FM800 is Class 1 equipment with protective earth via the AC mains input FM800 must be connected to an earth supply complying with local safety standards The installation engineer must check the correctness of the supply voltage label and the fuse ratings for the local supply This equipment is not explosion proof and must not be used in the presence of flammable anaesthetics It is ordinary equipment not drip proof or splash proof designed for continuous operation The equipment must be serviced only by authorised and qualified personnel Huntleigh Healthcare Ltd cannot accept responsibility for safety compliance reliabi
69. on to Philips Trace Vue RS232 connector for external MSpO2 9 way D type socket reserved for future use 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 RS232 NBP lt RS232 FSPO2 lt RS232 8002 lt RS232 MSPO2 lt J Sonicaid FM800 Series Reference Manual 1 5 Connector module FM830 offers additional features via a connector module NBP Maternal blood pressure v Type CF patient applied part TEMP Maternal temperature MSpO2 Maternal pulse oximetry FM830 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 20 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 High brightness and contrast Wide viewing angle gt 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
70. ont panel Sonicaid 800 1 00000 Software control buttons Display see chapter 2 Connector module for oximetry blood pressure and temperature Connection sockets for transducers Printer drawer Controls and on off indicators see chapter 2 ook WRN 16 Sonicaid FM800 Series Reference Manual 1 3 Connection sockets for transducers ULT2 O Yy ULTI TOCO C C ULT1 1 5 MHz Ultrasound transducer yellow ULT2 FECG 2 0 MHz Ultrasound transducer blue OR Fetal ECG electrode blue connected via leg plate MECG Maternal ECG transducer blue TOCO IUP Toco contractions transducer pink OR IUP catheter transducer pink Classification symbol y This symbol indicates Type CF applied part 17 Sonicaid FM800 Series Reference Manual 18 1 4 Main unit rear connectors 4 5 1 2 T00 120V 220 240V ason imava Y w S232 St 2 xTRALBSOV 108 120V 3002 St 2 xTtaLasev 228 240V 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 Connector for Rimkus Telemetry 15 way D type socket 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 connecti
71. or FM830 models equipped with Nellcor MSpO2 modules Oxisensor II D 25 D 25L Oxicliq A Durasensor DS 100A Dura Y D YS Do not use any sensors other than these b The following BCI probes are suitable for use with FM830 models equipped with BCI Smith Industry maternal pulse oximetry technology 3444 Finger Sensor WARNING Do not use the 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 Saturation range 1 100 SpO2 Saturation accuracy 1SD of normal distribution within ranges 70 100 2 digits 50 69 3 digits 0 49 unspecified Pulse rate range 20 250 bpm Pulse rate accuracy 3 bpm Record display On screen display and printed record of Maternal SpO2 Heart rate Alarms High and low saturation 0 100 SpO2 Signal loss Pulse or ECG Maternal temperature Measurement ranges 32 42 C 90 104 F Accuracy 0 2 C between 32 and 40 C Sensor types YSI 400 Series Do not use any sensor other than this 103 Sonicaid FM800 Series Reference Manual 104 15 4 Controls Simple functions Higher level functions 15 5 Printer Print head Resolution Printer speeds Paper FHR scales Annotation Control keys on front panel e Power on off e Volume up down e Audio channel select e Toco IUP zero e Printer on off e Printer fast forw
72. or Argus Some of the combinations are described below but the list is not exhaustive For other ways of connecting consult the administrator of your central monitoring system 1 Directly using RS232 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 a spare RS232 input port of the central monitoring system 2 Directly using RS422 Connect an RS232 to RS422 conversion lead to the RS232 S8002 connector on the rear of FM800 See Section 1 4 Connect the other end of the lead to a spare RS422 input port of the central monitoring system Note that the plug with the converter inside the larger plug must go at the FM800 end 3 Sonicaid FM800 Series Reference Manual 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 Make sure the network adaptor box is connected to the local area network The network adaptor should be powered by a medically approved power supply If in doubt consult the administrator of your central review system or your electrical safety department Indirectly using RS232 and a TraceVue computer with the FM800 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 TraceVue
73. oring ccceeeceeeeneeeeeeeeeeeeeeesaeeeeeeeeeeeeeesaaeeeeeeeeeeeeeeesseeeeees 41 5 4 The FHR confidence indicator ccccccceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneeeees 43 5 5 False recording of low baseline FHR cccceccceeeeeeeeeeeeeeeeeeeeeeeeeseeeeeseeeees 43 5 6 Ultrasound for twin ccccceccceeceeceeeeeeeeeeeeeceeeeeeeeseeeeeeceeeeeceeeeseeeeeceeeeeeeeeees 44 5 7 Fetal ECG using a scalp electrode ccccccccsssceceessseeeeessesseeeesseeeeeeeessteeeeees 45 5 8 Accidentally recording the wrong signal ceeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeees 50 6 Monitoring Maternal Parameters cccccceeeeeeeeeeeeeeceeeeeeeeeeeeeeeeaeeeeeeeeeeeeeeeenaaeeeees 51 6 1 Contractions using Toco transducer cccccceeeceeeeeeeeeeeeeeseeeeeeeeeeeeeeeseneees 51 6 2 Contractions using IUP transducer cccccceecceeeeceeeeeeeeeeseeeeeeeeeeeeetenneees 52 6 3 Maternal ECG srsiss estas cade ened ddd ens cede ies 52 6 4 Maternal Blood Pressure eccccceeeeeeeeeeeeeneeeeeeeenaeeeeeeaaeeeeeeeeaeeeeseaeeeeeeneaees 56 6 5 Maternal Oximetry cccecccceececeeeceeeeseeeeeeeeeeeeeeeeeeeeeeseeeeeeeeescaeeeseeeeteeeeeeeeeees 58 6 6 Maternal temperature eeccccceeesseeeeeeeeececeeesenceeeseeeeaeeeessaaeeeeeeseeseeeentseees 61 OB Vents and sAlarims ccces2 sees facets AE A omexaeunaeeahce 62 7 14 What is meant by an alarm cceeccceeeccc
74. oximeter may affect the MRI image and the MRI unit may affect the accuracy of oximetry measurements 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 e acentral review and archiving system e aPC e aVGA 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 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 wo The connection of extra equipment to the
75. 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 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 e Reorienting the equipment e Relocating the equipment with respect to the source of interference e Moving the equipment away from the device with which it is interfering e Plugging the equipment into a different outlet so that the devices are on different branch circuits Adding
76. range Red Transducers in range Green Weak RF signal Amber On completion or monitoring session Clean the transducers and return them to the T800 by plugging them into the front panel for charging Return the FM800 to normal wired transducer monitoring by pressing the button adjacent to the X N III 117 Sonicaid FM800 Series Reference Manual Part No 329000 5 118
77. rd 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 80 10 3 The Dawes Redman criteria e Anepisode of high variation above the first centile for gestational age e No decelerations gt 20 lost beats gt 100 lost beats on records longer than 30 minutes e 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 e Atleast one fetal movement or three accelerations e No evidence of a sinusoidal fetal heart rate rhythm e Short term variation should be 3 ms or greater e Either an acceleration Or variability in high episodes gt the tenth centile and fetal movements gt 20 e 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 criter
78. s OR Traces superimposed twins No beep when you press a button Alarm not working 13 2 Oximetry No signal appears when you connect the oximetry sensor Signal disappears after you have been monitoring for some time 13 3 Fetal event marker No mark appears on the trace when the mother presses the event marker FM800 does not beep when the mother presses the event marker Is FM800 switched on Is the FHR transducer connected Check transducer placement Is the transducer broken Consider switching from Ultrasound to FECG Have you pressed the Print button Is there paper in the paper tray Is the paper tray fully pushed in Correct FHR scale for twins in Printer setup See Section 4 3 Beep may be turned off Section 2 2 Alarm may be turned off Section 7 4 Is the oximetry module connected to FM800 MSpOz Is the oximetry module connected to FM800 Is the event marker connected Note it is possible to connect the event marker to the temperature socket by mistake Is the event marker connected Is the beep turned off Section 7 5 89 Sonicaid FM800 Series Reference Manual 13 4 Maternal blood pressure error codes Message Description ARTEFACT Irregular pulse or excessive motion AIR LEAK Reading terminated because target pressure was not reached within 60 seconds OVER Cuff over pressurised PRESSURE Measurement terminated automatically MALFUNCTION No reading reported 13 5
79. seseeeessssaeeeesseeeees 16 1 3 Connection sockets for transducers cccccecccccccccccceccseecessuessuuusueeeeueeeeeeeeeeeess 17 1 4 Main unit rear connectors 0 cece ccceeeecccececeeeeeccceeeeeeceeceeeeeeeceeeeeaeeeeeeeuseaeesees 18 1 5 Connector Module xicccic ts ceetete wie be tek eta hn a a tet Mean states iaai 19 1 6 Event marker connection cccccccceceeccecccceceeeceeceeeeeeeceeceeueuseceeeeseeereceeensaeeseees 20 1 7 The FM800 display s cccccis cecccecssercevs eesti oe xdeciiieenseteeeicdes T 20 1 8 Transducers and Cables cccccccccceeccecccceceeececceeeeeeeceeceeeeeseceeeuseueeeeeeeauaeeeees 21 1 9 FM800 trolley or wall MOUNtING 0 cece eee eeeeeeeeeeeeeeeeeeeaeeeeeteeeeeeeeeeaeeeeeeeaeeees 22 2 FM800 Controls and Display cc cceceeeceeeeceeeeeeeeeeeeeseaeeceaeeeceaceeeeeeesseeessneeeeenes 23 2 1 Controls and on off indicator cccccessessecseeecececeeeeceeceseeceeuueeeuaasaanenees 23 22 FMB00 Main Screo Niron a aa a a e ne reece deers 24 2 30 Software control DUtONS esna A N E E 25 2A AUO CON OE a e a os san ar aaa a aa EE 26 2 5 PAME CONTOS tontes aan a e o a e en 27 2 6 Loading printer Ppaper ccecccecesccccececeeeeeeeeeenenneeeeeeeeeeeeeeeeeeesnnnneeeeeeeeeeeeses 28 wD i o ates te eas acetate A ae ee ek ee acta E E ates 29 Bali OVervi Wa L fe s ccceh ah te he a a cok th RS th eb oe ek ak ak he ea 29 322 GURENtAlAMMS e225 ci E EEEE EEE A E TE E
80. stetrics 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 Sonicaid FM800 Series Reference Manual Actogram graph and event marks The following illustration shows Actogram graph and event marks superimposed on the contractions trace Sonicaid m l 9 ULT Y 1 CM MIN 14 10 ULT Y 1 CM MIN 1420 ULT Y 16 18 93 26 08 93 0 SL 26 08 93 O SL 0 00 tt tt t 1 Actogram event marks 2 Actogram graph 67 Sonicaid FM800 Series Reference Manual 68 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 xO 2 Open a submenu Drugs Position etc 3 Choose an item from the submenu OR To enter a mark gt MARK Add a handwritten note to the trace if required 4 gt EXIT To edit E
81. switch FM800 off and on again To access the default alarm thresholds screen gt SETUP gt DEFAULT ALARMS gt 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 70 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 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 gt HIGH LIMIT or HIGH LIMIT To change the high delay gt HIGH DELAY or HIGH DELAY To change the low limit gt LOW LIMIT or LOW LIMIT To change the low delay gt LOW DELAY or LOW DELAY When you have set the new alarm levels
82. t 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 gt SETUP gt TIME AND DATE 2 gt SETUP beside the time or date 3 Use and to make the necessary changes 4 gt EXIT To change the date format see Section 4 5 International Settings 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 gt SETUP gt PATIENT DETAILS 2 gt 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 gt LEFT or RIGHT NB For non standard characters gt NEXT PAGE 4 When the name or ID is complete gt EXIT Gestation To enter the gestational age of the fetus 1 gt SETUP gt PATIENT DETAILS 2 gt ADD EDIT beside Gestation 3 gt or as nec
83. 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 gt 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 Sonicaid FM800 Series Reference Manual 7 4 Controlling alarms There are four ways you can control an alarm e Acknowledge it ie silence it when it occurs See Section 7 3 e Switch it off so that it is never triggered e Alter thresholds so that it occurs more frequently or less frequently e 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 mar
84. ument operators at the intensities typical of present diagnostic instruments However available data are not wholly conclusive and the possibility remains that biological effects may be identified in the future It is therefore deemed desirable by medical and scientific authorities that exposure to ultrasound be limited to the duration and intensity appropriate for the clinical objective Because fetal tissue could be more sensitive to biological effects by reason of rapid cell division it is particularly desirable that ultrasound exposure of pregnant subjects be kept to a minimum At present there is a clear consensus that the benefits to patients of prudent use of diagnostic ultrasound outweigh the risks if any that may be present See a Report No 24 National Council on Radiation and Protection biological effects of ultrasound clinical effects and observations b Ziskin M C in World Policies on the Use of Diagnostic Ultrasound in Obstetrics The American Institute of Ultrasound Policy and Statement on Safety Ultrasound in Medicine and Biology 12 711 714 1986 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 The
85. vity Accuracy Safety Maternal heart rate and ECG Range Accuracy Alarms High and Low Rate Signal Loss Safety 0 100 relative units 100 FSD equivalent to 120g 100g Manual and auto zero facility Type CF protection Intran Plus or any pre calibrated transducer 0 100 mmHg 1 15 kPa user selectable 5yuV V mmHg 5 Type CF protection 30 240 bpm 1 bpm 30 240 bpm Type CF protection 101 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 Record display On screen display and printed record of e Systolic blood pressure e Diastolic blood pressure e Pulse rate Printed record of e Mean arterial pressure Note Mean arterial pressure not shown in the USA or Canada Alarms Systolic High 55 255 mmHg Systolic Low 50 250 mmHg Diastolic High 35 220 mmHg Diastolic Low 30 215 mmHg System air leaks movement overpressure etc Safety Type CF protection Hardware and software controls to limit e Inflation max 300 mmHg e Measurement time max 160 secs Standards ANSI AAMI SP10 1992 102 Sonicaid FM800 Series Reference Manual Maternal oximetry Sensor types a The following Nellcor probes are suitable f
86. ws ICHECK TRACE FOR SAME HEART RATE The printer prints this symbol on the trace Make sure you have positioned the transducers correctly 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 C O 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 wees cy ie 5 A N SA sm YA ae a CO Sag ow Yay ei Soy Note In the USA and Canada the use of FDA compliant fetal scalp electrodes is required 45 Sonicaid FM800 Series Reference Manual 46 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 Connect the electrode leg plate to either of the blue sockets on FM 800 Caution read the instructions for use supplied with the fetal ECG scalp electrode Attach the fetal scalp electrode to the fetal scalp or the presenting part as described in the electrode instructions Connect the electrode leads to the leg plate The polarity of these connections is not important Make sure a good signal is maintained Allow a f
87. ystolic or Diastolic high limit gt SYSTOLIC or DIASTOLIC gt HIGH LIMIT or HIGH LIMIT To change the Systolic or Diastolic low limit gt SYSTOLIC or DIASTOLIC gt LOW LIMIT or LOW LIMIT 3 To change the alarm volume use the ALARM VOLUME controls Increase volume d Decrease volume 4 To turn the alarm off in the NBP ALARMS screen gt OFF 5 To return to the NBP SETUP screen gt EXIT 8 4 MECG thresholds To change the thresholds for maternal ECG 1 From the main screen gt MECG gt ALARMS 2 Tochange the Bradycardia threshold low limit gt LOW LIMIT or LOW LIMIT To change the Tachycardia threshold high limit gt HIGH LIMIT or HIGH LIMIT 3 To change the alarm volume use the ALARM VOLUME controls Increase volume d Decrease volume 4 To turn the alarm off gt OFF 5 To return to the main screen gt EXIT 73 Sonicaid FM800 Series Reference Manual 74 8 5 Maternal oximetry threshold To change the threshold for maternal oximetry 1 From the main screen gt MSpO2 gt ALARMS 2 Tochange the threshold for O2 SAT gt 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 gt OFF 5 To return to the main screen gt EXIT 8 6 Temperature thresholds To change the thresholds for maternal temperature 1 From the main screen gt TEMP 2 Tochange the t

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