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Huntleigh Sonicaid FM800 Series Instructions For Use Manual Download Page 4

Sonicaid FM800 Encore Series Instructions for Use 

4

 

5

 

4B

System Settings and Default Alarms .......................................................................... 33

 

5.1

 

53B

Overview ........................................................................................................... 33

 

5.2

 

54B

Changing the default alarms ............................................................................. 34

 

5.3

 

55B

Printer setup ...................................................................................................... 34

 

5.4

 

56B

Audio/graphic settings ....................................................................................... 36

 

5.5

 

57B

International settings ......................................................................................... 37

 

5.6

 

58B

Serial interface .................................................................................................. 38

 

6

 

5B

Monitoring Fetal Parameters ...................................................................................... 39

 

6.1

 

59B

Preliminary ........................................................................................................ 39

 

6.2

 

60B

Audio signal ....................................................................................................... 39

 

6.3

 

61B

Ultrasound monitoring ....................................................................................... 40

 

6.4

 

62B

The FHR confidence indicator .......................................................................... 42

 

6.5

 

63B

False recording of FHR ..................................................................................... 42

 

6.6

 

64B

Ultrasound for twins .......................................................................................... 43

 

6.7

 

65B

Fetal ECG (using a scalp electrode) ................................................................. 45

 

6.8

 

66B

Accidentally recording the wrong signal ............................................................ 49

 

7

 

6B

Monitoring Maternal Parameters ................................................................................ 50

 

7.1

 

67B

Contractions (using Toco transducer) ............................................................... 50

 

7.2

 

68B

 Contractions (using IUP transducer) ................................................................ 51

 

7.3

 

69B

Fetal Event Marker ............................................................................................ 52

 

7.4

 

70B

Maternal ECG ................................................................................................... 52

 

7.5

 

71B

Maternal Blood Pressure .................................................................................. 56

 

7.6

 

72B

Maternal Oximetry ............................................................................................. 61

 

8

 

7B

Events and Alarms ..................................................................................................... 65

 

8.1

 

73B

What is meant by an alarm? ............................................................................. 65

 

8.2

 

74B

What is seen and heard? .................................................................................. 65

 

8.3

 

75B

Responding to alarms ....................................................................................... 68

 

8.4

 

76B

Controlling alarms ............................................................................................. 69

 

8.5

 

77B

Recording fetal movements .............................................................................. 69

 

8.6

 

78B

Actogram ........................................................................................................... 70

 

8.7

 

79B

Recording clinical events (EasiNotes) .............................................................. 72

 

9

 

8B

Setting Alarm Thresholds ........................................................................................... 73

 

9.1

 

80B

Default alarm thresholds ................................................................................... 73

 

9.2

 

81B

FHR thresholds (Ultrasound and FECG) .......................................................... 74

 

9.3

 

82B

Maternal blood pressure thresholds .................................................................. 77

 

9.4

 

83B

MECG thresholds .............................................................................................. 77

 

9.5

 

84B

Maternal oximetry threshold .............................................................................. 78

 

Summary of Contents for Sonicaid FM800 Series

Page 1: ......

Page 2: ...the company reserves the right to modify specifications and materials without notice Sonicaid and Huntleigh are registered trademarks of Huntleigh Technology Ltd 2008 Huntleigh Healthcare Ltd 2008 20...

Page 3: ...2 1 32BThe FM800E series 14 2 2 33BMain unit front panel 16 2 3 34BConnection sockets for transducers 17 2 4 35BMain unit rear connectors 18 2 5 36BThe FM800E display 20 2 6 37BTransducers and cables...

Page 4: ...recording the wrong signal 49 7 6BMonitoring Maternal Parameters 50 7 1 67BContractions using Toco transducer 50 7 2 68B Contractions using IUP transducer 51 7 3 69BFetal Event Marker 52 7 4 70BMatern...

Page 5: ...g Sonicaid TREND 96 12 4 101BSonicaid TREND results 97 12 5 102BViewing Sonicaid TREND data 97 13 12BSonicaid CARE Antepartum Analysis 98 13 1 103BIntended use 98 13 2 104BOverview 98 13 3 105BThe Daw...

Page 6: ...nance 112 18 1 124BUser maintenance 112 18 2 125BTechnical maintenance 113 18 3 126BCorrective maintenance 113 18 4 127BServicing 113 18 5 128BAccessories consumables and spares 114 19 19BSpecificatio...

Page 7: ...safety Programmable electrical medical systems IEC60601 2 30 1999 Particular requirements for safety including essential performance of automatic cycling non invasive blood pressure monitoring equipme...

Page 8: ...They are not intended for use in intensive care units operating rooms or in transport monitoring applications Sonicaid FM820E is suitable for use when there is a need to monitor the following physiol...

Page 9: ...esonance 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 FM800E series monitors are not i...

Page 10: ...vironment within 1 5m of the patient the enclosure leakage currents must be brought within the limits laid down by IEC601 1 EN60601 1 This may be done by using an isolating transformer Suitable types...

Page 11: ...o protect against mechanical damage and the ingress of liquids Multiple portable socket outlets supplied with the system must not be used for powering equipment which does not form part of the system...

Page 12: ...uipment with respect to the source of interference Moving the equipment away from the device with which it is interfering Plugging the equipment into a different outlet so that the devices are on diff...

Page 13: ...le use probes and sensors dispose of these after use in accordance with local regulations 141BOximeter sensors The following types of sensor are approved for use with the FM830E BCI Smiths Industries...

Page 14: ...itoring multiple pregnancies For example Twin ultrasound and maternal ECG Ultrasound fetal ECG and maternal ECG Twin ultrasound plus fetal ECG FM820E also provides external and internal monitoring of...

Page 15: ...are Interface to Sonicaid Centrale and other CRS Packages IUP internal uterine activity Maternal Heart Rate via ECG MECG lead supplied as option Toco external uterine activity Ultrasound 1 1 0MHz Ultr...

Page 16: ...2 33BMain unit front panel 1 2 1 3 4 5 6 1 Software control buttons 2 Display see chapter 3 3 Connector module for oximetry and blood pressure FM830E only 4 Connection sockets for transducers 5 Printe...

Page 17: ...Fetal ECG transducer white connected via leg reference electrode TOCO IUP OR Toco contractions transducer pink IUP catheter transducer pink 145BClassification symbol This symbol indicates Type CF app...

Page 18: ...icaid Centrale Obstetric Archive FetalCare CTG viewing and archiving software systems Note that other software systems are also supported 9 way D type socket 3 LAN connector for connection to CRS via...

Page 19: ...r module The FM830E incorporates additional connectors for maternal blood pressure and maternal oximetry on a connector module NBP Maternal blood pressure Type CF patient applied part MSpO2 Maternal p...

Page 20: ...l benefits of the FM800E display are High brightness and contrast Range of colours helps distinguish between displayed items Wide viewing angle Display auto dims when FM800E is used in subdued lightin...

Page 21: ...830E NBP air line 1 NBP adult cuff 1 NBP large adult cuf 1 Maternal SpO2 patient lead 1 Maternal SpO2 re useable probe 1 148BAccessories supplied with all monitors in the FM800E range Ultrasound gel 8...

Page 22: ...is mounted on the purpose designed trolley which is available as an accessory If the unit is seldom moved it is recommended that it is mounted on the purpose designed wall bracket which is also avail...

Page 23: ...fety Follow the instructions provided with the bracket regarding assembly and proper mounting of the FM800E Brackets must be installed by trained personnel using fixings appropriate for the wall const...

Page 24: ...ched on Power on off symbol Note To isolate the FM800E from the mains or line supply disconnect the power cable from the mains inlet at the rear of the unit 153BSwitching on Before switching the unit...

Page 25: ...ive For example Pressing a button brings up a setup screen for that parameter This setup screen allows alarms and thresholds to be set The setup button in the main screen is for general setup procedur...

Page 26: ...Other buttons are inactive When any transducer is connected apart from NBP the button for that parameter becomes active and the parameter name is displayed For example when Ultrasound 1 is connected t...

Page 27: ...ected for audible monitoring For audio see also Sections 6 2 and 7 4 Note If an audio capable transducer is connected when audio is already turned on the audio signal automatically switches to this mo...

Page 28: ...r is switched on Printer fast forward EasiNotes annotation See Section 8 7 157BPrinter setup Printer setup is controlled by the software buttons SETUP NEXT PAGE SYSTEM SETTINGS access code 2755 PRINTE...

Page 29: ...it is desired to change Default Alarms Default alarm settings protected by the access code 2755 Changes made using Default Alarms remain in force when FM800E is switched off and on again System Settin...

Page 30: ...ils are the patient name patient ID and gestation period They are printed on the header of the trace They are not saved when FM800E is switched off 159BEntering patient name and ID To enter or edit th...

Page 31: ...en Sonicaid CARE analysis or Sonicaid TREND analysis is in progress 162BTo set the timer 1 SETUP TIMER ON 2 Use or to set the length of time required 3 EXIT 163BAcknowledging the timer When the set ti...

Page 32: ...OGRAM ACTOGRAM OUTPUT this cycles on each press between GRAPH check MARKS and GRAPH check MARKS 168BChanging the Actogram threshold SETUP NEXT PAGE ACTOGRAM SET ACTOGRAM THRESHOLD use or to set the th...

Page 33: ...llows the operator to Add or change EasiNote descriptions Display or not display the baby graphic Display or not display FECG or MECG waveforms Beep or not beep when a key is pressed Change the printe...

Page 34: ...AULTS 5 3 55BPrinter setup 172BHospital name To enter or edit the hospital name printed on the trace SETUP NEXT PAGE SYSTEM SETTINGS access code 2755 PRINTER HOSPITAL NAME Enter the hospital name in t...

Page 35: ...EM SETTINGS access code 2755 PRINTER FHR GRATICULE 177BFHR scale for twins Sonicaid paper only If twins are being monitored each FHR trace can be printed on its own scale or both on the same scale To...

Page 36: ...h accompanies every key press AUDIO GRAPHIC KEY PRESS 181BAudible event mark To switch on or off the beep which accompanies the marking of an event AUDIO GRAPHIC EVENT MARK 182BECG waveform display To...

Page 37: ...the display INTERNATIONAL LANGUAGE Select the required language 185BDate format To change the date format 1 INTERNATIONAL 2 Press the key opposite the current date format 3 Repeat if necessary The op...

Page 38: ...to the FM800E service manual To select the appropriate serial interface 1 HOST INTERFACE 2 Use the labelled key to select the host interface type For Sonicaid FetalCare make sure the setting is RS232...

Page 39: ...etails if required 6 2 60BAudio signal An audio signal can be obtained for FHR and Fetal ECG For FHR the FM800E gives an audible representation of the Ultrasound signal For FECG the FM800E beeps each...

Page 40: ...heard 5 When a good signal is being obtained FM800E 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 t...

Page 41: ...the fetal heart If the fetus is in the Occiput Anterior 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 m...

Page 42: ...tion of maternal signals particularly in the absence of fetal signals Doubling of the maternal rate can result in a trace looking very like a normal fetal trace If the fetal heart signal has large var...

Page 43: ...fetus 3 Place both ultrasound transducers on the patient s abdomen in the optimum position Use the ULT1 transducer to monitor the first presenting twin Make the transducers secure with belts 4 To hea...

Page 44: ...set 20 bpm from the displayed baseline rate to determine true baseline rate failure to do so may result in misinterpretation of the trace inappropriate clinical management The ULT2 20 flag is printed...

Page 45: ...robe is not connected to the FM800E Use only FECG electrodes supplied with the FM800E or listed in the Accessories Consumables brochure Only Safelinc and Qwik ConnectTM fetal ECG electrodes are specif...

Page 46: ...presenting part 3 Connect the FECG electrode to the FECG lead 4 Allow a few minutes for the signal to stabilise and a clear fetal heart rate to be displayed The signal quality indicator should be a so...

Page 47: ...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 FM800E will display FECG waveforms if there is a...

Page 48: ...eries Instructions for Use 48 194BPrinting the FECG waveform 1 Make sure the FM800E is already printing the trace 2 Make sure the FECG waveform is displayed 3 the EasiNotes annotation button 4 PRINT E...

Page 49: ...t sources If any two rates appear similar within 3bpm for more than three minutes then FM800E beeps The display shows CHECK TRACE FOR SAME HEART RATE Printed trace The message and warning are the same...

Page 50: ...oco transducer to the pink socket on FM800E 3 Place the belt round the abdomen and secure it over the transducer button so that it is retained on the midline over the fundus of the uterus 4 DO NOT USE...

Page 51: ...re to ensure that the catheter is not introduced extraovularly 1 Connect the IUP connecting lead to the pink socket on FM800E 2 Check IUP units of measurement mmHg or kPa Change if required SETUP NEXT...

Page 52: ...er switch and connecting cable assembly ensuring that it is clean and undamaged See section 17 3 for cleaning procedures The Fetal Event Marker must be kept dry Do not immerse or use in the presence o...

Page 53: ...and a clear maternal heart rate to be dis played Check the signal visually by displaying the MECG waveform see below 5 The FM800E carries out its own internal impedance check If the check fails the me...

Page 54: ...or 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 FM800E will display MECG waveforms if there is an MECG t...

Page 55: ...Series Instructions for Use 55 198BPrinting the MECG waveform 1 Make sure the FM800E is already printing the trace 2 Make sure the MECG waveform is displayed 3 EasiNotes annotation button 4 PRINT ECG...

Page 56: ...e cuff size is matched to the patient s arm circumference Two cuff sizes are supplied as standard with the FM830E Adult cuff covering arm circumferences from 23 33cm colour blue Large Adult cuff cover...

Page 57: ...he artery instead of the correct centre point Depending on the cuff size relative to the arm circumference this can result in artificially high pressure readings For correct cuff positioning using the...

Page 58: ...is recommended that local protocols are in place for this method to be used for diagnosing confirming hypertension 200BDisplaying results FM800E displays systolic and diastolic pressure in the format...

Page 59: ...r 3cm min otherwise there will be no room on the paper for every result To stop a particular measurement STOP NBP FM800E remains in Auto Mode and displays 00 00 as the current measurement To avoid har...

Page 60: ...hat as with all auto BP measurement systems results may vary from one make to another and from measurements based on using a manual sphygmomanometer Readings are also subject to the well documented wh...

Page 61: ...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 p...

Page 62: ...ensor DS 100A Use only Sonicaid connecting cables Remove any nail varnish and artificial fingernails before use as they are likely to affect the readings Nail varnish remover contains acetone Contact...

Page 63: ...blood pressure cuff or intravascular line on the same limb Ambient light Excessive patient movement Intravascular dyes or externally applied colouring such as nail polish dye or pigmented cream Artifi...

Page 64: ...plied pre sterilised 19 Caution notes See above for cautions regarding use of compatible sensors and connecting cables 20 Patient population For use on maternal patients only Applied body part Any wel...

Page 65: ...criteria These alarms must not be relied on to detect pathological heart rate patterns Alarms include Signal going outside the user set range Loss of signal Elapsed time counter Failure of the FM800E...

Page 66: ...dia Alarm FECG ULT 1 and ULT 2 F 1 2 FHR Bradycardia Acknowledge FECG ULT 1 and ULT 2 F 1 2 FHR Loss of Signal Alarm FECG ULT 1 and ULT 2 F 1 2 FHR Loss of Signal Acknowledge FECG ULT 1 and ULT 2 F 1...

Page 67: ...EDGE key becomes active The lost parameter and the arrow adjacent to the ALARM ACKNOWLEDGE message flash alternately The Heart symbol flashes The sensor lifted signal may appear if this is the cause o...

Page 68: ...emove transducers from mother 3 If there is an error message make an exact note of what it says 4 Return FM800E to Huntleigh Healthcare Ltd or their local representative 212BAcknowledging alarms To ac...

Page 69: ...alarm thresholds and volume See Chapter 9 8 5 77BRecording fetal movements The mother can record fetal movements using the optional fetal event marker A triangular event mark is printed at the top of...

Page 70: ...ement 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 thr...

Page 71: ...0 Encore Series Instructions for Use 71 218BActogram graph and event marks The following illustration shows Actogram graph and event marks superimposed on the contractions trace Actogram event marks A...

Page 72: ...800E 2 Open a submenu Drugs Position etc 3 Choose an item from the submenu OR To enter a mark MARK Add a handwritten note to the trace if required 4 EXIT 220BTo edit EasiNotes 1 SETUP NEXT PAGE SYSTEM...

Page 73: ...resholds are changed the changes remain in force until FM800E is switched off If the default thresholds are changed the changes remain in force permanently The screens for changing current and default...

Page 74: ...tions which can trigger an alarm High FHR FHR rises above a defined level for a defined period Default 160 bpm for 300 seconds 5 minutes Low FHR FHR falls below a defined level for a defined period De...

Page 75: ...or HIGH DELAY To change the low limit LOW LIMIT or LOW LIMIT To change the low delay LOW DELAY or LOW DELAY When the new alarm levels have been set EXIT 224BAlarm volume To change the volume of the au...

Page 76: ...for the last five minutes has fallen below the alarm threshold 227BSwitching off the Signal Loss alarm From the FHR SETUP screen SIGNAL LOSS OFF 228BFHR alarms and Signal Loss It may happen that the...

Page 77: ...ange the alarm volume use the ALARM VOLUME controls Increase volume Decrease volume 4 To turn the alarm off in the NBP ALARMS screen OFF 5 To return to the NBP SETUP screen EXIT 9 4 83BMECG thresholds...

Page 78: ...hange the threshold for maternal oximetry 1 From the main screen MSpO2 ALARMS 2 To change the threshold for O2 SAT LOW LIMIT or LOW LIMIT 3 To change the alarm volume use the ALARM VOLUME controls Inc...

Page 79: ...mended This has a 25 year rated lifetime Alternatively consider the use of Central Monitoring Software such as Sonicaid Centrale Fetalcare or Obstetric Archive which allow traces to be stored and arch...

Page 80: ...Printer on off button starts to flash and a message is displayed on the screen If the Print Buffer option is enabled see section 5 3 print information will be stored in memory for up to 60 minutes to...

Page 81: ...either side of the printer drawer push the drawer in firmly until it clicks into place diagram A diagram B 10 7 91BUsing non Sonicaid paper We strongly recommend the use of standard Huntleigh paper T...

Page 82: ...rid However it is recognised that some users will have a preference for pre printed paper This section details the procedure for using such papers Users must be aware of and accept the limitations as...

Page 83: ...MHR trace from SpO2 C Maternal oxygen saturation trace from SpO2 D Toco trace E MSpO2 Oxygen Saturation and MHR spot readings F Maternal Blood Pressure spot readings taken automatically G Toco discont...

Page 84: ...le 5 bpm Notes The Ultrasound 1 Ultrasound 2 and ECG MECG or FECG channels are displayed in the upper section with the Toco and MSpO2 trace in the lower section A key is printed to allow the different...

Page 85: ...Sonicaid FM800 Encore Series Instructions for Use 85 Alarm events Easinotes annotations MSpO2 Values FM830E only FHR Scale 20 bpm FHR Graticule 10 bpm FHR Scale 30 bpm FHR Graticule 10 bpm...

Page 86: ...Encore Series Instructions for Use 86 230BSingle scales 2cm min FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Graticule 5 bpm FHR Scale 20 bpm FHR Graticule 10 bpm FHR Scale 30 bpm FHR Gr...

Page 87: ...Encore Series Instructions for Use 87 231BSingle scales 3cm min FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Graticule 5 bpm FHR Scale 20 bpm FHR Graticule 10 bpm FHR Scale 30 bpm FHR Gr...

Page 88: ...0 Encore Series Instructions for Use 88 232BTwin scales 1cm min FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Grat...

Page 89: ...0 Encore Series Instructions for Use 89 233BTwin scales 2cm min FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Graticule 5 bpm FHR Scale 20 bpm FHR Graticule 10 bpm FHR Scale 30 bpm FHR Gra...

Page 90: ...0 Encore Series Instructions for Use 90 234BTwin scales 3cm min FHR Scale 20 bpm FHR Graticule 5 bpm FHR Scale 30 bpm FHR Graticule 5 bpm FHR Scale 20 bpm FHR Graticule 10 bpm FHR Scale 30 bpm FHR Gra...

Page 91: ...n at the far right the screen scrolling from right to left 11 2 95BScreen Layout The current time and date are shown at the top of the screen The chart speed is shown in the bottom right hand corner o...

Page 92: ...rrent selection is shown reversed ULT2 in this case 2 The square block adjacent to this button changes colour to match the source selected above Press this button to toggle the source on off If a sour...

Page 93: ...m min 36 hours at 2cm min 72 hours at 1cm min Beyond this the oldest data is discarded and the buffer then retains the latest 24 36 or 72 hours of trace information The information stored in the Displ...

Page 94: ...ssist not to replace the physician s visual assessment of a trace No guidelines on interpretation or limits of normality are provided but the clinician can use the numeric values to identify and quant...

Page 95: ...inutes Deceleration size beats for the last 15 minutes Note a choice is available as to whether results for the deceleration size parameter are shown or hidden 236BConfidence indicator TREND provides...

Page 96: ...REND 1 Turn TREND on 2 Set up FM800E to record a normal CTG 3 Start printing Note when Sonicaid TREND is running the display shows an I in the lower right corner together with a confidence indicator s...

Page 97: ...minutes before the end of each 60 minute period 60 minute values are available after the first hour Until then the results show NA 242BSignal loss If signal loss is 50 the results show SL 243BDisplaye...

Page 98: ...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 a...

Page 99: ...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 va...

Page 100: ...Sonicaid CARE analysis 1 Set up FM800E as for recording a normal CTG 2 Enter the gestational age SETUP ANTEPARTUM ANALYSIS GESTATION Or enter the gestational age first SETUP PATIENT DETAILS GESTATION...

Page 101: ...t met Whether the Dawes Redman criteria were met at the time the analysis was stopped Abnormalities 251BReasons for not meeting the criteria If the criteria were not met when the analysis was stopped...

Page 102: ...episodes of high variation below the first centile A single asterisk indicates one of the following conditions Short term variation 4 ms but 3ms Basal heart rate 116 bpm or 160 bpm on a record 30 min...

Page 103: ...the listed systems This does not mean that it is incompatible with other systems based on the HP50 communications protocol 14 1 109BUsing FM800E with FetalCare 254BConnecting FM800E to FetalCare 1 Co...

Page 104: ...put port of the Central Review System 2 Indirectly using LAN For full details of PC connections and instructions for using the system see the documentation supplied with the Central Review System At s...

Page 105: ...metry unit 1 Identify the connector of the FM800E to telemetry cable labelled FM800 and plug into the Wireless Telemetry connector on FM800E See Section 2 4 2 Connect the other end of the FM800E to te...

Page 106: ...hen button pressed Beep may be turned off Section 3 2 Alarm not working Alarm may be turned off Section 8 4 16 2 114BOximetry No signal appears when the oximetry sensor is connected OR Signal disappea...

Page 107: ...ched within 60 seconds The cuff is loose or not connected properly OR The cuff bladder or hose has a leak OR The hose is not properly connected to FM800E OVER PRESSURE Cuff over pressurised Measuremen...

Page 108: ...is fully pushed in 3 Try printing again 4 If there is no improvement clean the print head See Section 19 Some NBP measurements are not being printed on the trace When NBP measurements are taken every...

Page 109: ...your FM800E is running To find this out SETUP NEXT PAGE SYSTEM SETTINGS access code 2755 SERVICE CENTRE PRODUCT INFORMATION PRODUCT INFORMATION EXIT MODEL SONICAID FM830E SERIAL NUMBER 751AX0100011 08...

Page 110: ...egarding use and personal protective equipment PPE Do not use abrasive cloths or cleaners Do not use automatic washers or autoclaves Do not use Phenolic detergent based disinfectants solutions contain...

Page 111: ...loth High This procedure should only be used when the part has been contaminated by blood 1 Follow low risk procedure then wipe with a cloth dampened in Sodium Hypochlorite 10 000ppm 2 After two minut...

Page 112: ...socket 3 Look carefully for cracks which may allow the ingress of liquids or gels 4 Replace any broken or damaged transducers or cables 5 If there is damage to the main FM800E unit contact your local...

Page 113: ...ctive maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd The Sonicaid FM800E Service Manual order part number 751339 is designed as an...

Page 114: ...tleigh representatives Available accessories consumables and spares include 263BAccessories Trolley Wall Mounting Bracket FECG Connecting Leads MECG Connecting Leads IUP Catheter Connecting Lead NBP C...

Page 115: ...g includes transducers etc Net weight 16kg 267BRecommended operating storage and transport conditions Operating temperature 10 C to 35 C Storage transport temperature 20 C to 50 C Operating pressure 6...

Page 116: ...Repetition rate 3 0kHz Frequency 1 0MHz green P 30kPa Iob 1mW cm 2 Ispta 3mW cm 2 Resolution 12 bits Safety Type CF protection Ingress Protection IPX7 269BFECG Range 30 to 240 bpm Accuracy 1 bpm over...

Page 117: ...CF protection Ingress Protection IPx7 271BUterine activity internal IUP Transducers Intran Plus 400 Koala IPC5000C Or as detailed in the current FM800E Accessories Consumables Brochure Pressure range...

Page 118: ...45 60 90 or 120 minutes Record display On screen display and printed record of Systolic blood pressure Diastolic blood pressure Pulse rate Mean arterial pressure Note Mean arterial pressure not shown...

Page 119: ...M800E Accessories Consumables Brochure Saturation range 0 99 SpO2 Saturation accuracy 1SD of normal distribution within ranges 70 99 2 digits 0 69 unspecified Pulse rate range 30 240 bpm Pulse rate ac...

Page 120: ...event mark Higher level functions 10 soft keys on the display 19 5 133BPrinter Print head 128mm thick film Resolution 8 dots per mm Printer speeds 1 2 or 3cm per minute user selectable 10 cm per minu...

Page 121: ...odels Toco transducer IUP lead MSpO2 FM830E Maternal pulse oximetry NBP FM830E Maternal non invasive blood pressure 276BSide panel all models Fetal Event Marker button 1 x inch jack plug 277BRear pane...

Page 122: ...display ULT1 and ULT2 Fetal heart rate 30 240 bpm Pulse rate lamp and confidence indicator FECG Fetal heart rate 30 240 bpm Pulse rate lamp MECG Maternal heart rate 30 240 bpm Pulse rate lamp TOCO 0 1...

Page 123: ...hether FM800E is operating correctly when being used on a patient fetal condition must be checked by an alternative diagnostic method without delay vi The protective category against electric shock of...

Page 124: ...use with the Sonicaid FM800 Encore series fetal monitors is summarized in the following tables The values given are based on measurements in water using a calibrated hydrophone and are stated as the...

Page 125: ...MHz 1 0 1 0 1 0 Zsp cm 2 4 2 4 2 4 Beam Dimensions x 6 cm 0 066 0 066 y 6 cm 0 067 0 067 PD S 70 70 PRF Hz 3000 3000 Overall EBD cm2 all eight crystals 7 95 Definition of Terms ISPTA 3 The de rated sp...

Page 126: ...ues Uncertainties The reported uncertainties are based on standard uncertainties multiplied by a coverage factor k 2 providing a level of confidence of approximately 95 Acoustic Parameter Uncertainty...

Page 127: ...cable labelled T840E into the 15 way D socket on the rear panel 4 Plug the other end of the cable labelled FM800 into the 15 way D socket on the rear panel of the FM800E 5 Before operating ensure the...

Page 128: ...se 4 To monitor the FHR determine fetal lie and position Apply gel to the transducer face Position on the abdomen so as to get optimal fetal heart sounds Secure in position with belt 5 Make sure FHR i...

Page 129: ...mpletion of monitoring session 1 Clean the transducers and return them to the Sonicaid Freedom by plugging them into the front panel for charging 2 Return the FM800E to normal wired transducer monitor...

Page 130: ...althcare Ltd Part no 751321 EN 9 Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff CF24 5HN UK Tel 44 0 29 2048 5885 Fax 44 0 29 2049 2520 E mail sales huntleigh diagnostics co uk Web page www hunt...

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