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- Frank`s Hospital Workshop

1. WARNING Do not use In the presence of flammable anaesthetic LOT US Federal Law restricts this device to sale cn or by the ordar of a physician RA A 1 5 Ez ip 1 H 3456 wee dq CG is 3E D000 kr pe Mag ot 1 2 Key 1 Printer setting switches See below 2 Connector to main unit 7 pin DIN Connect to the printer AN connector on the Team main unit 1 5MHz DUO Printer switch settings Paper speed Switch 5 Switch 6 1 cm min Down Down 2 cm min Up Down 3 cm min Up Up Scale Switch 4 20 bpm cm Down 30 bpm cm Up Dual monitoring Switch 3 Side by side Up Full width Down 30 bpm cm Graticule Switch 2 1 cm min 5 bpm Up 2 cm min 10 bpm Down 3 cm min Note switch 1 should always be Up 20 Diagram on printer Sonicaid Team Operator s Manual 1 7 Team printer wedge assembly option For Team fetal monitors there is a wedge which can be fitted between the Team base unit and the Team printer unit to improve the visibility of the trace To assemble 1 2 Remove the centre blanking plug if fitted from the Team base unit top Position the printer wedge on top of the base unit with the feet of the printer wedge in the depressions on the rear of the base unit top Using a screwdriver secure the screw supplied in centre hole of the wedge top surface down into the Team base unit with approximately 4 turns Remove the printer platen Lift the paper pack for access to
2. Huntleigh HEALTHCARE Ltd 2006 All rights reserved 738311 A February 2006 Sonicaid Team Operator s Manual Sonicaid Team isin conformity with the Medical Device C C Directive 93 42 EEC and has been subject to the conformity 0088 assurance procedures laid down in the European Council Directive Sonicaid Team Operator s Manual Contents Gsap sg com p ETE 3 Standards compliance ccce tte t ee eee ntn ee ee o ER nee REL ee n 6 Indications FOF USES renis a e a ie eel Aovaad wed ted ode 7 System InstallatiOn z ii eot a Pete bia PEU le ai cae arn 8 ie e ez de cL 8 Multiple Portable Socket Outlets sess enne 9 Electromagnetic compatibility ssessssseeseeen ener nennen nnns 10 GO PYM n pL 11 WAC 1 18 e REERRMRIECE 11 Note on terminology nce ctr c eaa e dare ee dee a aeaa 12 e gcurp M 12 Addresses ioseph uas RR ctum ai attin tete 13 1 SIMEFOGUCHON ssa he eerte rr dicii 15 11 Teamfetal monitors eesssessssessssseeeesee enne enne nennen tenentes teens 15 12 Main unit front panel sse nennen trennen nnns 16 L3 Main unit rear panel c cn e er Ee eee Rea 17 14 Contrast controle iene anaa ena Dot eripe o Bedi deeded 18 15 Team printer front panel sssessssssessseeeneneen nennen nennen 19 16 Team printer rear panel sess enne nennen n
3. Set up the Team on the patient 1 Turnthe Team base unit on 2 Connect the transducers and event marker to the Team base unit 3 Attach the transducersto the patient Start recording Press TO BEGIN RECORDING PRESS Team starts storing data and a timer in the display message bar showsthe preset store time counting down Team stops storing the record at the end of the preset time Sending the record Team automatically dials FetalCare or System8002 and transfers the data When the transfer is completed switch off Team To put the Team into Manual mode Next time the Team isturned on it will still be in Home mode To set the Team up for the next patient you need to put it into Manual mode 1 With Team turned off press and hold down the M ENU button on the keypad 2 Switch on Team while continuing to hold down the MENU button 3 Release the button when the logo dearsfrom the display Team Operator s manual issue number 738311 A Appendix 3 Sonicaid Team distance monitoring Home Mode problems sending a record You may sometimes encounter problems sending the record For example System 8002 may be busy at the hospital The Team display shows if the modem fails to get a reply and gives you a preset voice contact phone number for assistance If you wish to try sending the record again use one of the following methods Home mode re try With Team and the modem still connected to the telephone socket 1 Switch off
4. 1 Press MENU twice 2 Select REVIEW 3 A list of stored records is displayed the most recent at the top To the left of the list is a selection arrow gt You can move this down then up the list by pressing the button with v next to it P to the left of a record means it has been printed S means it has been transferred to Sonicaid FetalCare or System8002 4 Highlight the record for review with the selection arrow then press SELECT 5 The patient detailsfor the selected record appear on the Review Options menu From here choose to display print or transfer the record to Sonicaid FetalCare or System8002 You can also edit the patient details or delete the record when you have finished with it 5 3 Displaying a stored record Once a stored record has been selected you can review it on the Team display 1 Fromthe Review Options Menu press DISPLAY 2 To scroll through the display press v To change the displayed range press 1 5 4 Printing a stored record Once a stored record has been selected see Section 5 2 above you can print it on the Team printer The printer runs faster than for on line printing at a speed of 10cm per minute 1 Fromthe Review Options menu press FAST PRINT 2 Team asks PRINT THIS DATA To print press FAST PRINT Otherwise press EXIT 3 To stop printing press STOP PRINTING Sonicaid Team Operator s Manual 5 5 Transferring a stored record to Sonicaid Feta
5. amp A Nn NJ UJ NJ 4 RS232 interface to a PC running Sonicaid FetalCare Sonicaid System8002 or a central review system 500V DC isolation 9 way D type connector 5 Modem connection for distance monitoring 25 way D type Connect only modems which comply with EN60950 Same connector used for the Rimkus Telemetry system 6 Team printer connector 8 way DIN type 7 Fetal event marker socket 1 4 stereo jack socket Date of manufacture symbol Rope 6f amp for detailsof pin connections see Appendix 1 not available on Teams sold in the USA or Canada 17 Sonicaid Team Operator s Manual Rear panel label The label on the rear of the Team unit shows the manufacturing serial number the Team frequency and the date of manufacture Serial number Team frequency TEAM FREQUENCY MHz ESSE Date of manufacture 1 4 Contrast control In the base of the Team main unit is a display Q contrast control marked with this symbol lt This control is for the use of service engineers only 18 Sonicaid Team Operator s M anual 1 5 Team printer front panel Sonicaid Team Key 1 Printer control button Press once for on off Press and hold down for fast forward Kt lt 2 Printer on indicator 9 19 Sonicaid Team Operator s Manual 1 6 Team printer rear panel
6. 3 Place the blue transducer over twin one again ensuring a good fetal heart rate signal Secure the transducer with a belt 4 Check carefully that the two heart rates are different If you have not positioned the transducers correctly it is possible to record the same FHR twice Hints on use e Make sure the transducer is placed in the optimum position Avoid positions with strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate e Ifthefetusisin the cephalic presentation and the mother is supine the clearest heart sound will normally be found on the midline below the umbilicus e It isnot possible to monitor the fetal heart rate unless an audible fetal heart signal is present To distinguish the fetal pulse from the maternal pulse feel the mother s pulse during the examination or use the Team s Maternal ECG facility optional on Team IP only Not available in the USA and Canada Sonicaid Team Operator s Manual False recording of low baseline FHR When monitoring a low baseline FHR using Doppler ultrasound the heart rate may be falsely reported This effect isknown 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 monitorsto calculate the FHR When the FHR is low at 70 80bpm there isa longer time interval between the atrial an
7. Troubleshooting iie ee eer E t Rene e n eer Enn 88 9X General questions pd tg Ee dte erit e ge ett 88 9 2 Problems when you first switch on sssssseeeeeennennenn nnns 89 9 3 Problems replaying or printing traces esee 90 9 4 Team cycling from Logo screen to off ssssssssssssssseeeeenens 90 10 User Maintenance ues een eror ait gedaan pais 91 10 1 Cleaning and sterilisation 0 cee eeeeececsceeeeeneeceeeeeeeeeeeeeeeeteeeseeeseeeseaeesaeeseaes 91 10 2 Printer paper scsi idees e e Bead hei eee ee eed etis 92 10 3 Technical MAINTENANCE eee cece eee ceee cee eee tees eae eeae ceases nennen nennen nennen 92 10 4 Corrective maintenance eect eeeeeetee eee eee eae eae eae enne nennen nennen nennen 93 10 5 Accessories consumables and spares 94 10 6 Servicing and guarantee ssssssssssseeseeeenneen nene nnn nennen nes 95 ll Specifications eee e ede ed e t dee ERR ees 96 11 1 Physical and environmental seen 96 11 2 AC supply voltage and fuse values 96 11 3 Printer eee ree Pe ea re aeter He Ee aer Potes 97 II Transducersc uei D tre aia rg 97 11 5 Satetycas io Sire rie tere tb ent ate eh enhn titu desis 99 11 6 Ultrasound safety considerations ssssssseeenes 101 Appendix 1 External Connections sssssseseseeeseneeenne enne nennen nnne 103 Appendix 2 Transducer Problems sse enn
8. RESULTS gt gt gt in the display message bar The Team 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 6 6 For twins the results shown are for the fetus on the currently selected audio channel This is confirmed on the display with either ULT Y or ULT B If no audio channel is selected the default is the yellow channel To turn the analysis off To record a trace without the analysis 1 Press the printer button once to start the printer 2 When Team asks you to enter the gestational age select ANALYSIS OFF 3 The printer then starts without the analysis Or 1 Press M ENU once 2 Select TURN ANALYSIS OFF 3 Pressthe printer button to start recording By default the analysisis ON if it was on the last time Team was used and OFF if it was off the last time Team was used Analysing a stored trace A stored trace can be analysed when it is printed on a Team Care printer The patient details for the stored trace must indude the gestational age 65 Sonicaid Team Operator s Manual 66 6 6 The 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 criteria for normality were first met e Whether the
9. t hear the 1 5M Hz transducer Problem When I try and reprint a stored trace the CTG trace is blank Problem The Toco channel of the CTG graph is scratchy and distorted have tried using a different Toco transducer but it displays the same symptom Remedy Use the loudspeaker enable button on the MENU left hand side of the display Remedy On Team Duo and Team IP you must select which transducer you wish to store It may be that you are using the yellow transducer but have selected the blue transducer for storage Remedy You may have enabled Actogram and be unaware of the effect it has on the trace Try turning Actogram off in the MENU 9 4 Team cycling from Logo screen to off TEAM is cycling from the Logo screen to off The microprocessor can rarely get confused To resolve the problem 1 Remove one end of the battery 2 Short out the battery contacts 3 Resolder the battery back again The unit will then function properly Sonicaid Team Operator s Manual 10 User Maintenance WARNING ALWAYS SWITCH OFF THE TEAM AND DISCONNECT THE AC SUPPLY CABLE AND TRANSDUCERS BEFORE ATTEMPTING TO CARRY OUT ANY CLEANING OR MAINTENANCE 10 1 Cleaning and sterilisation Cleaning general Wipe the instrument case transducers event marker fetal ECG electrode leg plate and IUP extension cable with a cloth dampened in soap or detergent solution to remove aquasonic gel blood saline etc Wipe dry
10. Dawes Redman criteria were met at the time the analysis was stopped e Abnormalities 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 2 Large decelerations 3 No episodes of high variation 4 No movements and fewer than 3 accelerations 5 Baseline fitting is uncertain 6 Short term variation is less than 3ms 7 Possible error at the end of the record 8 Deceleration at the end of the record 9 High frequency sinusoidal rhythm 10 Suspected sinusoidal rhythm 11 Long term variation in high episodes below acceptable level 12 No accelerations Sonicaid Team Operator s Manual Abnormalities Double asterisks indicate one of the following conditions Fetal heart rate 116 bpm or gt 160 bpm on a record of less than 30 minutes Decelerations gt 100 lost beats 7 20 lost beats on record of less than 30 minutes No moves and fewer than 3 accelerations No episodes of high variation Short term variation 3ms No accelerations and either 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 A single asterisk indicates one of the following conditions e Short term variation 4 ms but gt 3ms e Basal heart rate 116 bpm or gt 160 b
11. WARNING the analysis is valid only during the first stage of labour 75 Sonicaid Team Operator s Manual 76 7 2 Team Trend analysis Analysis is performed at 15 minutes and then 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 Baseline heart rate bpm for the last 15 minutes Short term variation msecs for the last 60 minutes Deceleration size beats for the last 60 minutes Deceleration size beats for the last 15 minutes Note the user may choose to show or hide results for deceleration size Confidence indicator The analysis provides a confidence indicator showing the reliability of the baseline fit and hence the fetal heart rate parameters Confidence is indicated as High Medium or Low shown asH M or L If the confidence indicator is Medium or High the analysis results will reliably reflect the fetal heart rate pattern If the confidence indicator is Low the results should be interpreted in relation to the appearance of the trace and only used if it isthought that they are a sensible reflection of the visually assessed pattern Analysing twins When monitoring twins both channels are analysed simultaneously Sonicaid Team Operator s Manual 7 3 Using the analysis Starting the analysis 1 Set up Team as you would to record a normal trace 2 P
12. are not included but are available as options 1 Apply self adhesive disposable electrodes to the mother Asit is only necessary to pick up the maternal pulse and not the ECG complex placement of the electrodes is not critical but it isa good idea to have the third lower electrode placed dear of the diaphragm asthe muscles here are very active in contraction 47 Sonicaid Team Operator s Manual 48 A recommended arrangement of the lectrodes might be 2 Connect the MECG lead plug blue to the blue socket on Team 3 Clipthethree flying leads of the MECG lead to the electrodes They are colour coded white black and red W B and R in the diagram above 4 Allow a few minutes for stabilisation and a dear maternal heart rate to be displayed 5 Adjust the volume control as necessary The audio signal in this mode is a bleep If the maternal and fetal heart rates appear similar e Team bleeps e The display shows CHECK TRACE FOR SAME HEART RATE Confirm the source of the fetal heart rate you are monitoring 3 7 Team connected to FetalCare or System8002 Sonicaid FetalCare and Sonicaid System8002 are PC based antepartum analysis systems Sonicaid FetalCare isthe replacement for Sonicaid System8002 The analysis measuresfetal heart rate parameters and performs a test against criteria that define a normal record You can store a record on the Team monitor then transfer it to FetalCare or System 8002 for analysis Or you ca
13. fit the paper pack and platen To reassemble 1 2 A 22 Remove the centre blanking plug if fitted from the Team base unit top Position the printer unit on top of the base unit The feet of the printer unit will locate in depressions on the base unit top Remove the platen and lift the paper pack for accessto the screw head beneath Using a screwdriver push down and secure the screw with approximately 4 turns Re fit the paper pack and platen m Printer platen shown removed Centre fixing screw 3 Release button N Sonicaid Team Operator s Manual 1 9 Team base unit to Team trolley assembly A purpose designed trolley isan option on Team To attach Team to the trolley 1 Position the Team unit on the trolley top so that the securing screw isin line with the threaded boss in the centre of the base unit 2 Reach under the trolley top and locate the securing screw 3 Gently push up and secure the screw with three or four turns Threaded Team unit m AR Trolley top Securing 23 Sonicaid Team Operator s Manual 1 10 Transducers and cables Ultrasound transducer Used for non invasive monitoring of the fetal heart rate Two transducers are available Primary yellow 1 5MHz Secondary blue 2 0MHz The 2 0MHz transducer can only be used on a Team Duo or Team IP base unit External Toco transducer Gives a subjective indication of contractions pressure Used for non
14. hour so the second annotation may not print for up to 19 minutes Signal loss is expressed as a percentage over the period between annotations 33 Sonicaid Team Operator s Manual 2 4 Loading printer paper 1 Press the release button beneath the left edge of the printer platen 2 Lift the platen to the left and off the top of the printer 3 Placethe pack of paper in the compartment beneath The top side of a new pack of paper is identified by the message LOAD PACK and an arrow pointing to the right For a partly used pack align the blue marks on the pack with the blue marks on the compartment 4 Pull two folds dear of the chart printer to the right 5 Then fold them back to the left acrossthe top of the platen asit isfitted at a downwards angle to the right 6 If necessary adjust the paper positioning between the sides of the paper channel and press down on the left edge of the platento latch it If after a period of use the print quality is poor check that the platen is closed If still poor dean the print head as detailed in the Technical Maintenance section 34 Sonicaid Team Operator s Manual 2 5 Printer operation Make sure the printer has sufficient paper for the monitoring session Ensure the printer platen is securely closed Turning the printer on 1 Press the printer button once 2 The indicator in the button lights up and the printer starts 3 Thetrace header is fast printed
15. invasive monitoring of the timing duration and co ordination of contractions Colour coded pink can be used on all Team base units Sonicaid fetal ECG lead Strapped to the thigh of the patient it is used for interconnection between Team and a fetal ECG scalp electrode Colour coded blue can only be used on a TeamlP base unit The Sonicaid fetal ECG lead is not available in the USA or Canada 24 Sonicaid Team Operator s Manual Safelinc fetal ECG lead Attached to the mother s leg it is used for interconnection between Team and a fetal ECG scalp electrode Colour coded blue can only be used on a TeamIP base unit Fetal movement event marker The patient uses this hand held push button lead to record fetal movement events It can be used on all Team base units Interconnection lead for intrauterine pressure catheter Used for interconnection between Team and an intrauterine pressure catheter Colour coded pink can only be used on a Team IP base unit It isnot included with the unit but is available as an option Maternal ECG lead option Used for monitoring the maternal heart rate to check that the heart rate being recorded belongsto the fetus and not the mother Colour coded blue can only be used on a Team IP base unit Not included with the unit but available as an option The Maternal ECG option is not available in the USA or Canada Transducer storage When not in use the ultrasound and extern
16. the Team base unit 2 Switch on the Team base unit 3 The Team automatically triesto re dial and transfer the data Manual mode Auto Dial Put Team into Manual mode With Team switched off press and hold down the MENU button on the keypad Switch on Team while continuing to hold down the MENU button Release the button when the logo clears from the display Follow the procedure titled Manual Mode sending a record using Auto Dial U AUNE Return to base and direct data transfer If problems persist take the Team back to the hospital Transfer the stored record to FetalCare or System8002 by direct cable connection See the Sonicaid Team Operator s Manual Team Operator s manual issue number 738311 A Appendix 3
17. the screw head beneath Position the printer unit on top of the printer wedge with the feet of the printer in the depressions on the printer wedge top Using a screwdriver push down and secure the screw with approximately 4 turns Re fit the paper pack and platen To disassemble 1 UJ Pressthe release button beneath the left edge of the printer platen and lift the platen to the left and off the top of the printer Remove the paper pack Using a screwdriver release the centre fixing screw approximately 4 turns Remove the printer from the printer wedge Using a screwdriver release the screw in the centre hole of the wedge top surface that secures the wedge to the Team base unit Remove the printer wedge from the Team base unit Position the printer unit on top of the base unit with the feet of the printer unit in the depressions on the base unit top Using a screwdriver push down and secure the screw with approximately 4 turns Re fit the paper pack and platen 21 Sonicaid Team Operator s Manual 1 8 Team printer to Team base unit assembly The Team base unit is supplied already assembled to the Team printer To disassemble AU BWN H Press the release button beneath the left edge of the printer platen Lift the platen to the left and off the top of the printer Remove the paper pack Using a screwdriver release the centre fixing screw approximately 4 turns Remove the printer unit from the main unit Re
18. top scale the secondary channel ULT B or FECG below In full width printing the primary channel ULT Y is printed asa solid line the secondary channel ULT B or FECG as a dotted line Sonicaid Team Operator s Manual 3 5 Intrauterine pressure catheter contractions Available only on the Team IP base unit The interconnecting lead between the base unit and the intrauterine catheter is not included but is available as an option Team is designed for use with an Intran disposable catheter 1 Connect the intrauterine pressure IUP connecting lead to the pink socket on Team Caution read the instructions for use supplied with the intrauterine pressure catheter 2 Once the membranes are ruptured insert the catheter as described in the instructions The catheter can be supported with a tape or belt 3 Zero the transducer as described in the instructions then zero the Team by pressing TOCO ZERO top left on Team keypad 4 Ask the patient to cough to confirm optimal placement and function of the transducer You should observe a spike in the contractions measurement To set IUP units of measure 1 Press MENU three times 2 Select kPa mmHg 3 Choose kPa or mmHg 3 6 Maternal Heart Rate monitoring not available in the USA and Canada Allows you to check that the heart rate being recorded belongsto the fetus and not the mother Available only on the Team IP The maternal ECG MECG lead and disposable electrodes
19. with a clean cloth Disinfecting the maternal ECG lead 1 Wipe with a cloth soaked in a solution of chlorine bleach in water no stronger than 1 10 mixture or in a 2 Glutaraldehyde solution such as Cidex 2 Wipe the lead with a clean damp cloth then a clean dry cloth Caution do not use isopropyl alcohol Do not expose metal components eg snap connectors to chemicals Disinfection general Clean the instrument case transducers etc as described above Then wipe with an alcohol impregnated wipe 70 ethanol or isopropranol Sterilisation The only method of sterilisation for case and transducers is by using Ethylene Oxide gas up to 5 5 bar Low temperature steam is NOT permissible Note sterilisation is not normally required Transducer care 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 91 Sonicaid Team Operator s Manual 92 10 2 Printer paper Use only Sonicaid paper Use of non approved paper may result in poor quality printing or damage to the printer and could invalidate the printer warranty 10 3 Technical maintenance The checks below should be carried out at intervals of three months to a year dependent on equipment use and environmental conditions Fuse check and replacement 1 Remove the fuse module using a small screwdriver 2 Raise the small latch and remove the fus
20. 4 10 ULT Y 1 CM MIN 14 20 ULT Y 1 18 93 26 08 93 O SL 26 08 93 OXSL LL 9 1731 ttt tat ttt 100 fM 100 E tt 1 TUN hr Ee eo rA a 1 Actogram event marks 2 Acogram graph Sonicaid Team Operator s Manual 4 3 Recording clinical events Clinical events can be recorded either as a solid square event mark printed at the bottom of the fetal heart rate trace or asa clinical event note printed at the top of the fetal heart rate trace Event notes are selected from topicrelated menus on the Team display They can only be entered when the printer is active To enter a clinical event note 1 Pressthe Clinical Event button 7 on the Team keypad 2 Selec a note topic from the note main menu DRUGS OTHER gt gt gt lt lt lt POSITION ANTENATAL gt gt gt lt lt lt MEMBRANES REASON PROCEDURES EXIT 3 Select a note from the topic sub menu To enter a clinical event mark 1 Press the Clinical Event button 7 on the Team keypad 2 Select EXIT from the note main menu Note when Team Care analysis is being run on twins the Clinical Event button is used to record movement of the second fetus as this is required for the analysis In this case pressing the Clinical Event button prints a solid triangular fetal event mark 53 Sonicaid Team Operator s Manual 54 4 4 Alarms Alarm setup menu 1 Press MENU once 2 Select ALARM lt lt lt SIGNAL LOSS lt lt lt LOW FHR
21. CORRECT If it is correct press ACCEPT If not press RE ENTER Team displays the patient details entered If they are correct press ACCEPT If not press RE ENTER To edit patient details 1 2 3 Press MENU once Press ANNOTATE Team displays the patient details To edit press RE ENTER To remove patient details Switch the Team unit off then on 39 Sonicaid Team Operator s Manual 40 3 Monitoring 3 1 Ultrasound transducers 1 Connect the yellow transducer to the yellow socket on Team 2 Place the belt around the abdomen and secure it with the buckle 3 Apply Aquasonic coupling gel liberally to the face of the transducer Palpate the fetus and position the transducer on the abdomen over the fetal site Move it slowly until the characteristic hoof beat sound of the fetal heart is heard 4 Check that the signal quality indicator showsat least two bars and preferably three Check that the fetal heart pulse lamp flashes with each fetal heartbeat 5 Clip the ultrasound transducer through one of the three positioning holes on the buckle so that it is retained in the optimum fetal heart signal position 6 Adjust the sound level with the volume control buttons at the left side of the display Procedure for twins Team Duo IP 1 Palpate the abdomen and ascertain the lie of each fetus 2 Placethe yellow transducer on twin two ensuring a good fetal heart rate signal Secure the transducer with a belt
22. Care or System8002 by direct cable connection or by modem Team DM only Team can store only one fetal heart rate channel at a time together with the contrac tions information and fetal event marks You can select which channel to store Storage space There are two limitations on the space available for storing records number of records and total recording time Number of records the maximum number of records Team can store is 14 Total recording time Team can store up to 6 hours worth of recordings Since the maximum length of a record is 65 minutes this means there may be space for fewer than 14 records if there are several long records If there isnot enough space for a record Team deletes the oldest record or records until there is enough space Team can delete a record only if it has already been printed or transferred to Sonicaid FetalCare or or System8002 If no records are avail able for deletion Team displays the message STORE FULL in the display message bar Use the REVIEW menu to decide which records to delete Patient details When you store a record you should enter patient details so that the stored record can be identified with that patient Before storing Team asks you to enter these details see Entering Patient Details All stored records have time and date details saved Note Team can have a 13 character patient reference number Sonicaid FetalCare and System8002 store only the first 8 characters of th
23. Care or System8002 it can be deleted 1 From the Review Options Menu press DELETE 2 Team asks ARE YOU SURE YOU WANT TO DELETE THIS 3 Press DELETE 60 Sonicaid Team Operator s Manual 6 Care Printer option The Care printer isthe printer supplied when you purchase TeamCare 6 1 Overview The Team Care printer has an analysis system for use during the antepartum period The analysis measures fetal heart rate parameters and performsa test against criteria that define a normal record Abnormalities are highlighted The analysis is based on more than 48 000 records which have been compared with outcome and originates from work carried out by Professor G S Dawes and Professor C W G Redman at the Nuffield Department of Obstetrics and Gynaecology The John Raddiffe Hospital Oxford England See 6 8 References 6 2 Intended use The intended use of Sonicaid Care analysis isto 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 asthe fetusisthen 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 Assuch Sonicaid Care is not a diagnosis but an aid to dinical management Diagnosis remainsthe respon
24. FECG or ULT Y and MECG Sonicaid Team Operator s Manual FHR Trace Display mode CTG mode OB WN H 02 11 05 CTGI gt Heart rate range beats per minute indicates the range currently displayed Heart rate lamp heart shaped flashing indicator Channel mode indicates heart rate channel on display Display message bar used for display of interactive messages Heart rate trace Displaysthe active audio channel or channel 1 yellow if no audio is selected If monitoring twin heart rates only one channel can be displayed at a time 6 Contractions trace compressed 7 CTG gt this menu pointer changes title and function See below Scrolling the trace and returning to the alphanumeric display below Scrolling the trace and returning to the alphanumeric display The fetal heart rate trace is initially displayed over the range 110 150bpm The menu pointer in the display message bar reads CTG v gt To scroll the display vertically 1 Pressthe Enter button next to the menu pointer The display will show the trace over the range 80 120bpm The menu pointer will then read CTG 2 Pressthe Enter button next to the menu pointer The display will show the trace over the range 140 180bpm The menu pointer will then read ALPHA gt Press the Enter button next to the menu pointer The display will return to Alphanumeric display mode To scroll the display horizontically press the Clinical Event marker bu
25. FETAL MOVEMENT HIGH FHR EXIT Signal loss alarm You can set a signal loss threshold above which an alarm will occur Thisthreshold is a percentage of the last 5 minute period With a setting of 2096 for example one minute of signal loss in 5 minutes will trigger the alarm This alarm is only active when the printer or store is active To set a signal loss alarm 1 Fromthe Alarm setup menu press SIGNAL LOSS 2 Select ALARM ON SILENT or ALARM ON AUDIBLE If you set a silent alarm and the alarm istriggered a notification appearson the display message bar but the Team does not beep 3 Enter the signal loss required 4 Team asks IS THIS CORRECT If it is correct press ACCEPT If it isnot correct press RE ENTER To turn the signal loss alarm off 1 Fromthe Alarm setup menu press SIGNAL LOSS 2 Select ALARM OFF Low and high FHR alarms You can set fetal heart rate thresholds such that an alarm occurs if the signal remains above or below the threshold for a specified time known as the delay time These alarms are only active when the printer or store is active Sonicaid Team Operator s Manual To set an FHR alarm 1 From the Alarm setup menu press either LOW FHR or HIGH FHR 2 Select ALARM ON SILENT or ALARM ON AUDIBLE If you set a silent alarm and the alarm is triggered a notification appears on the display message bar but the Team does not beep 3 Enter the heart rate thre
26. INACA T 8801 TOTS HIH Fl k x d S801 TWHOIS HJJH FIOK A TOWEL J3ATIVEST3UIO LYTI x CA x F5 DT at a ETO HP FE S30T HALIY 340439 Mdd ININ S1vd8 HIH TWNOIS JIH NOTIVTHVA HOM HL NJT 1507 FHIL T sIg38 1907 ns 4 SHOIIVHTTAT3 4 Ndi PEE 9 I I gDr x b Ney in SISOH OVI Y 108 SI SIME Angay ONT OETA LON SISATUNU NIM SE oiv 13H ION VISSLIDI NULOSH SIAVO 0D SHIH LT AY 130 ION VIH3li4o HWulgiss3mg CA SED MDIIVIZUA LL dons NID 22008143 AGT MOIIVIHVA 537 309H 335 033 JO HES SHA bE LY C8 HIM 3d68 d3 Hor 81938 ASOT OF SNOLLIHTT323U 998 SE Ug SEX 25 SE Udg OF SHOLIMuITIOOV S4934 ROLLS NDA WMG JIYE LUSH 938 MH did SEMSHAOM TELITI 5071 TeHadis Example printout of TeamCare twins analysis results 69 Sonicaid Team Operator s Manual 70 6 7 Plotting trend data Pre printed Trend Graph forms are available in packs of 50 part number 8902 8002 These enable you to produce a plot manually of the key values given in the analysis report With other clinical information these graphs may allow a trend of fetal health to be discerned The forms allow plotting of e Movesper hour e Short term variation e Basal heart rate e Dedarative trace mark a D on the graph to indicate this This is normally done after four or more records are taken in a 28 day period 6 8 Analysis parameters and calculations The baseline The analysis uses pul
27. Printer speed Set the printer setting switches as follows Speed Switch 5 Switch 6 1 cm min Down Down 2 cm min Up Down 3 am min Up Up Turning the printer off 1 Pressthe printer button once 2 The printer fast forwards a little way to allow the paper to be torn 3 Theindicator in the button turns off and the printer stops Fast forward Press and hold the printer button The printer fast forwards for as long as you hold the button down 35 Sonicaid Team Operator s Manual 36 2 6 Team menu system To see the menu press MENU top right on the Team keypad lt lt lt TIME DATE NEXT gt gt gt lt lt lt ALARM lt lt lt ANNOTATE ELAPSED TIME gt gt gt EXIT gt gt gt Using the Team Menu Each menu item has arrows gt gt gt pointing at the the buttons on the Team keypad To select a menu item press the keypad button indicated by the arrows Using a menu to enter data An example data entry screen is shown below lt lt lt 123456 OPQRSTU 7890 VWXYZ gt gt gt lt lt lt ABCDEFG EXIT HIJKLMN SAVE gt gt gt Numbers and letters are arranged in groups To enter a character 1 Press the button for the group that contains the character 2 The display now showsthis group with one character against each keypad button 3 Select the required character Sonicaid Team Operator s Manual 2 7 User name You can enter a hospital or dinic name maximum 13 charact
28. al toco transducer can be stored by dipping the stud on the back of the transducer into the rack on the right hand side of the Team base unit 25 Sonicaid Team Operator s Manual 26 1 11 Team display panel The display panel on the Team base unit has two modes for the display of monitored information alphanumeric display and trace display referred to by Team as CTG Alphanumeric display mode 1 1 2 3 Key to alphanumeric display 1 2 Heart rate in beats per minute Channel mode indicates source of monitored information ULT Y 1 5 MHz ultrasound transducer yellow ULT B 2 0 MHz ultrasound transducer blue FECG Fetal ECG scalp electrode MECG Maternal ECG electrodes not available in the USA or Canada TOCO External Toco transducer IUP Intra uterine pressure catheter Contractions measurement Percentage full scale deflection when using an external Toco transducer Pressure mmHg kPa when using an intrauterine pressure catheter Display Message Bar includes date time and patient name if entered Also used for display of interactive messages Heart rate lamp a heart shaped flashing indicator The active audio channel indicated by highlight on channel mode Signal quality indicator No bars no signal Two bars average One bar poor Three bars good CTG gt press this key to change to Trace Display mode Note this facility is not available on a Team IP when monitoring two heart rates using either ULT Y and
29. al zero Protection Category B Nominal Sensitivity 150g full scale 97 Sonicaid Team Operator s Manual 98 Fetal ECG input Direct FECG protection category Scalp minimum signal threshold Patient leakage current Sampling rate Heart rate Maternal ECG input Direct FECG protection category Scalp minimum signal threshold Patient leakage current Sampling rate Heart rate Contractions internal IUP Protection category Input connections Pressure range IUP Breakdown voltage Transducer sensitivity IUP Accuracy BF 30 uV 100 uA max 240V 1ms Calculated to 0 25 bpm BF 30 uV 100 uA max 240V 1ms Calculated to 0 25 bpm BF Fully isolated 0 100 mmHg amp 0 15 0 kPa 2 5kV rmsto ground 5 mV V mmHg 5 nominal transducer Sonicaid Team Operator s Manual 11 5 Safety i iii vi Team is designed to comply with IEC601 Part 1 1988 BS5724 Part 1 1989 Team is Class 1 equipment with protective earth via the AC mains input Team 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 qua
30. as a software version of Automatic Gain Control AGC This enables it to detect a wider range of input signals and extract the best FHR When first switched on the algorithm selects a high gain and low threshold and attempts to count any signal it can find amongst the noise until the average level of the noise pushes the threshold up As soon as a recognizable periodic signal is present the gain and threshold are set above the noise floor and the spurious signals are less likely to be detected Answer STV is measured using the valid one minute sections of the heart rate trace A valid section does not contain any decelerations or parts of decelerations or high signal loss or artifact An intrapartum trace is quite likely to have decelerations and signal loss and artifacts and many one minute sections of the trace will be discarded as not valid by the analysis when calculating the STV A15 minute section might contain only a small amount of valid data and STV measurement would not be reliable A 60 minute period provides a more significant amount of valid data for the measurement of STV and therefore produces a more reliable measurement of heart rate variability Sonicaid Team Operator s Manual 9 2 Problems when you first switch on Problem The Team Menu does not appear when you switch on Problem The Team Menu does appear when you switch on but in a different language from the one you expected Problem O
31. asound transducer If there isa problem contact the Service Department of Sonicaid Products or their appointed service agent Preliminary 1 Connect the ultrasound transducer to the Team 2 Turnon the Team 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 diagrams 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 the Team are synchronised with the finger movement Sonicaid Team Operator s Manual Ultrasound transducer test The crystal elementsin 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 107 Sonicaid Team Operator s Manual 108 Appendix 3 Procedures for Distance Monitoring In the hospital The proc
32. ath the clear plastic edge of the paper compartment 3 Re fit the paper pack and platen 10 4 Corrective maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd Sonicaid Products The Sonicaid Team Service Manual order part number 8909 8540 is designed as an aid to engineers in maintenance and service of repairable parts 93 Sonicaid Team Operator s Manual 10 5 Accessories consumables and spares Accessories Team trolley 8900 6990 Carrying bag for base unit 8900 8003 Carrying bag for base unit and printer 8900 8006 Intran IUP catheter interconnection lead Team IP 8400 6937 Maternal ECG lead Team IP 8402 6969 Team to System8002 lead 8400 6952 Service Manual 8909 6914 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 Transucer belt buckle 8400 6208 Fetal ECG scalp electrode spiral 1400 0160 Belt for fetal ECG electrode leg plate 7481 6101 Intran disposable IUP catheter transducer 8400 8011 Printer paper 45m 8400 8003 Adult ECG electrodes pack of 25 ED 25 Trend graph pad 8902 8002 Spares 1 5 MHz ultrasound transducer 8400 6919 2 0 MHz ultrasound transducer 8400 6920 External Toco transducer 8400 6921 Fetal ECG electrode leg plate 8400 6922 Event marker lead 7775 6901 Team to pri
33. atient s thigh Secure with the belt Connect the FECG lead to the Team Once the membranes are ruptured attach the electrode to the fetus as described in the electrode instructions Connect the electrode leads to the leg plate Make sure a good signal is maintained Wait for the signal to stabilize and a clear fetal heart rate to be displayed on the Team base unit display Then adjust the volume control Using a Safelinc electrode 1 2 Attach the FECG lead to the mother s leg Once the membranes are ruptured attach the FECG electrode to the fetal pre senting part Connext the FECG electrode to the FECG lead Wait for the signal to stabilize and a clear fetal heart rate to be displayed on the Team base unit display Then adjust the volume control See also Section 3 3 Sonicaid Team Operator s Manual 2 2 The Team printer There are three Team printers available Standard Thermal printer for a continuous paper record of monitored data Care With analysis for use during the antepartum period The analysis measures fetal heart rate parameters performs a test against criteria that define a normal record and highlights any abnormalities Trend With analysis for use during the intrapartum period The analysis measures fetal heart rate parameters at regular intervals identifying suspicious fetal heart rate trends Sonicaid Trend is not available for sale in the USA and Canada The procedures described here on
34. brane on the front face of the Toco transducer is present and undamaged Connect the Toco transducer to the pink socket on Team Place the belt round the abdomen and secure it with the buckle DO NOT use coupling gel Wipe off any gel present on abdomen around this area 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 Contractions activity is measured as a percentage of full scale deflection The con tractions measurement automatically zeroes to 10 This can take up to 3 minutes To set the zero more quickly if the mother is not experiencing a contraction press TOCO ZERO top left on Team keypad Replacing the membrane on the Toco transducer 1 2 Remove damaged membrane Wipe the transducer face lightly with a cleaning solvent if necessary 3 Strip the backing paper from a new membrane and press it centrally in place Self adhesive membrane 43 Sonicaid Team Operator s Manual 44 3 3 Fetal ECG scalp electrode TeamIP only Fetal scalp electrodes Sonicaid Products supplies two types of fetal scalp electrode Safelinc electrodes FDA compliant and Sonicaid electrodes not FDA compliant In the USA and Canada the use of FDA compliant electrodes is required by law In the rest of the world the choice of lectrodes may depend on local legislation FDA compliant non FDA compl
35. caid Team display CTG cardiotocograph EFM electronic fetal monitoring NST non stress test FHR fetal heart rate 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 Addresses UK Sonicaid Products Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN UK Telephone 44 0 2920 485885 Fax 44 0 2920 492520 E mail sales huntleigh diagnostics co uk Web page www huntleigh healthcare com Sonicaid Team Operator s Manual 13 Sonicaid Team Operator s Manual Addresses 14 Sonicaid Team Operator s Manual 1 Introduction 1 1 Team fetal monitors Sonicaid Team fetal monitors provide accurate and reliable monitoring throughout the antepartum and intrapartum periods The fetal monitor consists of a base unit which collects the monitored information and a printer unit Four base unit models are available Team Standard Monitoring of single fetal heart rate with an ultrasound trans ducer and uterine activity with an external toco transducer Team Duo As Team above but with a second ultrasound transducer for monitoring twin fetal heart rates Team IP Twin fe
36. ct For each remaining interval the maximum to minimum variation in the fetal heart rate within that minute is calculated The peak to peak variation is defined as the maximum positive to maximum negative excursion from the fitted baseline Fetal movements Fetal movements recorded by the mother are counted and quantified per hour This number is given on the analysis report In a normal trace movements will be more frequent during episodes of high variation than in episodes of low variation Fetal movements are recorded for twins traces but not divided between twin 1 and twin 2 Contractions The analysis defines a contraction as a rise in relative uterine pressure measurement to greater than 16 from the baseline for 30 seconds or more A count of contrac tions meeting this definition is made on the analysis report Signal loss The system monitorsthe loss of fetal heart rate signal Where there isa gap in the trace due to signal loss the analysis interpolates a straight line through the missing section when fitting the baseline When the analysis is running the signal loss alarm isfixed at 30 The signal loss as a percentage of the whole record is given on the analysis report The analysisisnot able to interpret the data if there is signal loss 8096 If there is signal loss gt 50 during either an acceleration or a deceleration of greater than 20 lost beats the acceleration or deceleration is not counted Errors Signal artefact
37. d buckle Check that the fetal heart rate is clear and distinct from the maternal pulse rate taken at the mother s wrist Note the maternal pulse rate on the chart paper Optimum signal quality for the fetal heart rate is shown by 3 bars on the display with a flashing heart at each beat Adjust the volume using the volume up and down keys Conned the fetal event marker to the socket on the rear panel Show the patient how to use it 29 Sonicaid Team Operator s Manual 30 Using the printer 1 2 3 To switch the printer on press the button on the printer front panel To fast forward the paper press and hold down the printer button To stop the printer press the printer button again Using the second ultrasound transducer for twins 1 Connect the second ultrasound transducer blue to the Team The display switches to twin heart rate display 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 sure each fetal heart rate is from a separate fetus See Section 3 4 If in doubt ask for assistance Secure the ultrasound transducers with belts and buckles To select Audio press the bottom left button on the keypad The active audio channel is highlighted on the display Monitoring fetal ECG Using a Sonicaid scalp electrode 1 Put electrode gel on the base of the leg plate then strap the leg plate to the p
38. d 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 The Sonicaid FM 800 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 stetho scope or hand held Doppler unit before applying the ultrasound transducers This helps to verify the fetal heart and to locate the area where best signal quality can be expected 2 Palpate the maternal pulse for one minute simultaneously and record it on the printed output 3 Recording a signal for maternal ECG will help to identify any cross correlation between maternal and fetal heart rates 4 Listen to the fetal heart rate using the FM 800 Audio signal The sound should be like a galloping horse not a swishing sound from maternal vessels 41 Sonicaid Team Operator s Manual Transducer buckle and belt attachment Toco transducer Ultrasound transducer Transducer positioning 42 Sonicaid Team Operator s Manual 3 2 External Toco contractions transducer 1 U AUN Check that the plastic mem
39. down for 10 bpm Fetal heart rate scale Set printer switch 4 down for 20 bpm cm range 50 210 bpm or up for 30 bpm cm range 30 240 bpm Sonicaid Team Operator s Manual Twin fetal heart rates Set switch 3 down to print twin fetal heart rate traces superimposed on a full width fetal heart rate scale or up to print side by side on two separate fetal heart rate scales In side by side printing the primary channel ULT Y is printed on the top scale the secondary channel ULT B or FECG or MECG below The FHR range depends on the scale setting 20 bpm cm 30 bpm cm 100 180 bpm 60 180 bpm In full width printing the primary channel ULT Y is printed as a solid line the secondary channel ULT B or FECG or M ECG asa dotted line MECG is not available in the USA and Canada Contractions scales When using an external Toco transducer the contractions scale is 0 10096 relative units When using an intrauterine pressure catheter the contractions scale is 0 100 mmHg or 0 15 kPa depending on the units of measure selected Trace annotation The printer automatically annotatesthe trace with the following information Heart rate scale Contractions scale Monitoring mode Date and time Paper speed Signal loss 96 Annotation occurs when the printer is switched on and then at 10 minute intervals at 1 cm min or 5 minute intervals at 2 or 3 cm min Each hour is divided into 5 minute or 10 minute segments starting on the
40. e Sonicaid Team fetal monitors are indicated for use during labour and delivery Intrapartum and to monitor fetal and maternal vital signs during the antepartum period Sonicaid Team Standard monitors one channel of fetal heart rate with an ultrasound transducer and uterine activity with an external toco transducer Sonicaid Team Duo offers two channels of fetal heart rate monitoring using ultra sound transducers and uterine activity with an external toco transducer Sonicaid Team IP monitors twin fetal heart rates either by two ultrasound trans ducers or invasively by a fetal ECG scalp electrode and an ultrasound transducer Uterine activity can be measured either with an external toco transducer or an intra uterine catheter pressure transducer Team IP can also measure the maternal heart rate thisfeature not currently available in the USA Sonicaid Team DM Distance Monitoring is for use in a remote clinic or the patient s home It provides the same facilities as Team but includes a modem for transmitting stored data Note US Federal Law restricts this device to sale on or by the order of a physician Sonicaid Team Operator s Manual System Installation The following requirements must be met when you connect a Sonicaid Team fetal monitor to a central review and archiving system or to a PC 1 Non medical equipment must comply with the relevant IEC or ISO safety standard For Information Technology equipment this sta
41. e board for access to the fuses 3 Check the AC supply fuses are of the correct value T315mA for 110 120V systems T160mA for 220 240V systems Mechanical inspection 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 If necessary repair or replace faulty parts Functional check 1 Connect the AC supply the transducers and the accessories 2 Switch ON 3 Check that Team can perform the functions described in this User Guide Sonicaid Team Operator s Manual Printer self check facilities To run the Team printer self test facility Set all the DIP switches on the rear panel of the printer to the On positon down Switch the Team printer on The printer prints a 20 bpm scale grid at 3 cm min Check that the paper feeds out correctly and at the correct speed Check the quality of the printing Reset the switches to their required positions see Section 1 6 U APUNE Cleaning the print head on the chart printer If the print quality of the chart recording is poor check first that the platen is secure fully clipped down If sill poor clean the print head as follows 1 Remove the platen and the paper pack See Section 2 4 2 Using a lint free cloth and pure alcohol wipe along the full width of the print head which is bene
42. e enne nennen nnns 106 Appendix 3 Procedures for Distance Monitoring eene 108 Sonicaid Team Operator s Manual Standards compliance Sonicaid Team complies with EN60601 1 1990 Medical Electrical Equipment Part 1 General Requirements for Safety EN60601 1 1 1993 Safety Requirements for Medical Electrical Systems collateral standard EN60601 1 2 1993 Medical Electrical Equipment Part 1 General require ments for safety Section 1 2 Collateral standard Electro magnetic compatibility Requirements and tests EN61157 1995 Requirements for the declaration of the acoustic output I EC61157 1992 of medical diagnostic ultrasonic equipment Notes Some features on the Team monitor have not been approved for sale in the USA and Canada The following features are therefore not available on Team monitors sold in those countries e Maternal ECG e Rimkus Telemetry e Useof Team with GMT Argus central review e Sonicaid Trend analysis In addition for FECG the use of FDA compliant fetal scalp electrodes is required in the USA and Canada Patient safety WARNING DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT eg COM PORT CONNECTOR PINS ON A PC AND THE PATIENT AT THE SAME TIME CE Mark Denotes conformity with the European Council C oos8 Directive 93 42 EEC concerning medical devices THIS FETAL MONITORING SYSTEM IS A PRESCRIPTION DEVICE IN THE USA Sonicaid Team Operator s Manual Indications for us
43. e the sensitivity of Actogram s detection of fetal movement use the SENSITIVITY button ULTRASOUND ACTIVITY MARKS ARE OFF ULTRASOUND ACTIVITY GRAPH IS OFF SET ACTOGRAM THRESHOLD SENSITIVITY Changing the Actogram display setting From the Actogram setup menu 1 Press ACTOGRAM ACTIVITY MARKS to turn event mark printing on and off 2 Press ULTRASOUND ACTIVITY GRAPH to turn graph printing on and off Changing the Actogram threshold From the Actogram setup menu 1 Press SET ACTOGRAM THRESHOLD 2 Entera new value The required threshold may depend on whether the trace is showing a high incid ence of artefact It is recommended to set the threshold between 40 and 60 3 Observe the Actogram trace for a short period to see if the setting is satisfactory 51 Sonicaid Team Operator s Manual 52 Data storage Team stores Actogram event marks when it stores an FHR record It does not store the Actogram activity graph and 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 Actogram graph and event marks The following illustration shows Actogram graph and event marks superimposed on the contractions trace 9 ULT Y 1 CM MIN 1
44. edion O Z 11 Audio forte 12 Nouerconedion 13 Nouerconedion O 14 Nouerconedion 15 Nouerconedion 16 Nouerconedion 17 Nouerconedion 18 Nouserconnection 19 Nouerconedion 20 DTR ntued O 21 Nousrcomedion 22 Nouserconnection O 23 Nousrcomedion 24 Nouserconnection 25 Nouserconnection 103 Sonicaid Team Operator s Manual RS485 interface Pluggable cord connector PCC isolated to 1 5kV DC Interface for Sonicaid Axis OV reference TX Not connected Bed resistor Rx Bed resistor fro fe fe fo fo RS232 interface 9 way D type socket isolated to 500V DC Isolated interface to a PC running Sonicaid System8002 etc Pm signa Inputioutput 1 2 Rx Input E P Tx Output Oooooo Isolated OV Reference g 6 7 8 9 104 Sonicaid Team Operator s Manual Fetal event marker connector 1 4 jack socket 1Tip Switch 2 Ring Signal ground via switch 3 Sleeve Chassis ground Team Printer connector 8 pin D type connection to the Team printer module 30V nominal 5V 48V nominal Not connected Ground Ground 1 2 3 4 5 6 7 8 105 Sonicaid Team Operator s Manual 106 Appendix 2 Transducer Problems The following tests will show whether there is a problem with an Ultr
45. edure required by the operator of the System8002 is titled Home Mode preliminary set up At the remote location The procedures required at the remote location are titled Manual Mode storing a record Manual Mode sending a record using Auto Dial Home Mode storing and sending a record Home Mode problems sending a record Sonicaid Team distance monitoring Home Mode preliminary setup Check storage space 1 Press MENU then NEXT then NEXT then VERSION 2 Make sure there is enough storage space in the Team 3 Delete old records if necessary Enter patient details 1 Press M ENU then ANNOTATE 2 Enter patient details Note Team can have a 13 character patient reference number System8002 stores only the first 8 characters of this number Set up the store time Press M ENU then NEXT then NEXT then START UP MODE Press CHANGE Start up mode changesto HOME Press SET STORE TIME Enter the store time required This must be between 12 and 65 minutes Team asks IS THIS CORRECT If it is correct press ACCEPT If it is not correct press RE ENTER U APUNE Put the Team into Home mode 1 Press EXIT twice to leave the Start up Mode Menu 2 Turn off the Team base unit Team is now ready for use at the remote site The next time it isturned on it will be in Home mode ready to store and send a record To put the Team into Manual mode 1 With the Team unit turned off press and hold the Men
46. ennen 20 17 Team printer wedge assembly option 21 18 Team printer to Team base unit assembly sssseseseeeeee 22 19 Team base unit to Team trolley assembly sse 23 110 Transducers and cables ssssssssseeeenneee nennen nnne 24 111 Team display panel essssesesseseseeee enne nennen nnnm nnne 26 12 The Team Keypad sii aves headed hs d etre rd re itt edes 28 2 Getting Started adit c Ra de e de e d te te 29 2 1 Summary of recording procedure ssssseeeeeenennennnnnns 29 2 2 The Teampribter sioe ce eee eee pter tere brise 31 2 3 Trace annotation eg ee te Gass ee dene ded e ed e E ed 32 2 4 Loading printer paper enne enn nnns 34 2 5 IPrinteroperatlon s ete e eret ie dette kiere De te tes 35 26 Team Men System ect tte ine pete See er RR FRE HER ep La peni a Ea i 36 2J Username a an ott e di eit Lese etras 37 2 8 Date andtlme onines hne ehe 37 2 9 MetslODi sepe eid enun he ia cae indie tette 38 2 10 Changing language sssssesesesssseeeeseeenneennn enne nnt nennen nnns 38 2 11 Entering Patient Details ssssssssseseeeneeeeneenn enne nnne 39 Sonicaid Team Operator s Manual Contents 3 Monitoring netta pee Goan es A agen aie 40 3 1 Ultrasound transducer eceececs cece eeeeeeeeeeeeeeeeeeeeeesaeesaaeeaaeseaeeeaeenaeseaeenaeeas 40 3 2 External Toco contractions transduc
47. er ccccccccseesseeseesecsseeeeuseessesssseeanes 43 3 3 Fetal ECG scalp electrode TeamlP only seeseeeenenen 44 3 4 Twin heart rate monitoring nennen 46 3 5 Intrauterine pressure catheter contractions 47 3 6 Maternal Heart Rate monitoring not available in the USA and Canada 47 3 7 Team connected to FetalCare or System8002 sse 48 4 Eventsand Alarms iioii eres a fue eto eere regeln telae earn an ITE E de Lo En aa ede roges dades 50 4 1 Recording fetal movement events ssssssseeeenenneen nenne 50 42 Aog AMan a ete eese tse n ie eterne 50 4 3 Recording Clinical events eene ener nennen 53 OAs AlartriSus iie ere e cto cote to ete itte p vadit tei ie dte pies 54 5 Storing Records diei de e UE LU Rd De EUER iaaa EENT 56 Bele SSEOFIIg i eiecit ed eto bid o rt t ot dete tinet dettes 56 5 2 Selecting a stored record for review s sss 58 5 3 Displaying a stored record ssssssssssssseseseenen enne 58 5 4 Printing a stored record ssssssssseseseseeeee enne en nennen nnne 58 5 Transferring a stored record to Sonicaid FetalCare or System8002 59 5 6 Deleting a stored record ssssssssseseeeeneee nennen 60 6 Care Printer OPIO iann nara aa a Saa aa aeea a a Pa einen snaielateesuens 61 6L OVENI NO DEM 61 6 2 Intended USE i a a end Eee nnn ned Ene aaaea Aai a e AY Dr rna 61 6 3 The Daw
48. erm variation should be 3 ms or greater Either an acceleration or variability in high episodes gt the tenth centile and fetal movements gt 20 e Noerrorsor decelerations at the end of the record 6 4 Care analysis option The maximum record length is 60 minutes Analysis is performed at 10 minutes and every 2 minutes thereafter If you stop the printer before 10 minutes no analysis is performed You are asked either to confirm that you want to stop or to continue 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 compares the calculated results with the Dawes Redman criteria criteria for normality If the record appears normal CRITERIA MET appears on the Team message bar and Team gives a single beep At this point you can stop the analysis and the printer will produce a report of the analysis results Sonicaid Team Operator s Manual If the criteria are not met CRITERIA NOT MET isshown and you should allow the analysis to continue If the analysis is still running at 60 minutes Team ends this analysis prints the results on the trace and then starts a new analysis The printer continues printing throughout In the results any abnormalities showing why the trace did not meet the criteria are highlighted with asterisks See Abnormalities in Secti
49. ers to be printed on the header of the trace Entering a User Name U AUNE Press M ENU three times Press USER NAME Enter the hospital or dinic name When done press SAVE Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER 2 8 Date and time Time and date are printed on the trace and shown on the Team display message bar To reset the date and time 1 2 3 6 Press M ENU once Press TIM E DATE Press NEXT to move the cursor to the right and highlight the digit you want to change Press DELETE to move the cursor to the left Enter the required time When done press NEXT until Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER Enter the date in the same way The date format European or USA depends on the language selected See Section 2 10 Changing Language 37 Sonicaid Team Operator s Manual 38 2 9 Version Provides information about the software version and facilities installed in your Team 1 Press MENU three times 2 Press VERSION At the top of the display Team shows the version of software fitted and the amount of data storage available in minutes For an explanation of RECONFIGURE see Changing language below 3 Press EXIT 2 10 Changing language CAUTION if you reconfigure Team any records held in the store are deleted and all defaults are reset to factory set defaults Team
50. es Redman criteria sessssssssssseseee eene 62 6 4 GCare analysisoptlOn nier tree te Pt re e er Ree in e 62 6 5 USING the analyiS irsinin eiei aae aan ar a enana tnn enn enn 64 6 6 Theanalysis report sessessssssssseesese enne enne nennen nennen entes tenes 66 6 7 Plotting trend data nuce e tec tere 70 6 8 Analysis parameters and calculations esse 70 6 9 References itis n I M UEAEEL Mt di ure cide 74 7 Trend Printer Option suasit tente rene err m i cites acticin aere e Te dab aas 75 Vs EM aj roro Ure o nre EP EE 75 7 2 Team Trend analysis sessi ennt enn entren nnns 76 7 3 Using the analysis cea teen tectae a Re e e a 77 T s Analysisresults iecit ceste dost devs nieve eda Hi Rhe detest ns 78 AS Viewing trend data utente cit clase MERE 80 7 6 Analysis parameters and calculations essen 80 Sonicaid Team Operator s Manual Contents 8 Team DM Distance Monitoring cccccccesscecsssecsessecssreessseesceecsersescsaeeseeesssneessaees 83 81 Description etaed eet ERE ne e Deed Re Le EE dne aa 83 8 2 Manual mode setup esses ennt i a E nnn nens 83 8 3 iHomemode set p abe eR a me bae vert 84 84 Modem ssetup eiii eei a d e e ed 85 8 5 Team DM connedtions sssssssssssseeeeeeene enne ennt enn nnns 86 8 6 iProcedires uias dee een tae RU re ad ERES fees hee 87 9
51. eset length 12 65 minutes 1 Fromthe Home Mode Setup Menu press SET STORE TIM E 2 Enterthe time required 3 Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER Entering the voice phone number The Voice Phone telephone number should be a different telephone number from the one used for the modem transfer and is used for voice contact if problems occur 1 Fromthe Home Mode Setup Menu press VOICE PHONE NO 2 Enterthe telephone number required 3 Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER Sonicaid Team Operator s Manual 8 4 Modem setup Modem Setup Menu 1 Press MENU three times 2 Select MODEM SET UP Setting up for Auto Dial You can get the Team to dial a preset phone number for the receiving FetalCare or System8002 system System8002 must be in Auto Answer mode 1 Fromthe Modem Setup Menu press NEW PHONE NUMBER 2 Enter the telephone number required 3 Team asks IS THIS CORRECT If it iscorrect press ACCEPT If not press RE ENTER Setting up the modem Check that the modem is set up for your type of telephone system 1 Fromthe Modem Setup Menu press CHANGE TO USA MODEM STANDARD or press again to CHANGE TO CCIT MODEM STANDARD 2 Press CHANGE TO PULSE DIAL or press again to CHANGE TO TONE DIAL 85 Sonicaid Team Operator s Manual 86 8 5 Team DM connections BRWN ul Remove the telephone handset connector
52. from the telephone socket Plug the dual adaptor into the telephone socket Reconnect the telephone handset to the dual adaptor Connect the modem into the modem connector on the rear of the Team base unit Connect the modem lead between the modem and the dual adaptor Check that the telephone is working by listening for a dialling tone 4 a Connecting Team DM to the telephone line 1 Dual adaptor 2 Wall socket 3 Telephone 4 Team monitor Sonicaid Team Operator s Manual 8 6 Procedures Appendix 3 contains procedures for Distance Monitoring using a Team DM base unit and Sonicaid FetalCare or System8002 These pages can be removed and copied so that users operating a Team in a remote location can carry the relevant procedures with them The procedure required by the operator of the FetalCare or System8002 istitled Home Mode preliminary set up The procedures required at the remote location are titled Manual Mode storing a record Manual Mode sending a record using Auto Dial Home Mode storing and sending a record Home Mode problems sending a record 87 Sonicaid Team Operator s Manual 88 9 Troubleshooting 9 1 General questions Question Why when Team is turned on do you initially get a rate with the transducers in air Question Why is STV measured only over a 60 minute period when the other parameters on the Team IP Trend analysis are also measured over a 15 minute period Answer Team h
53. ght line through the missing section when fitting the baseline If signal loss is greater than 50 the analysis will not be able to calculate the parameter values The signal loss also affects the reliability of the baseline fit 82 Sonicaid Team Operator s Manual 8 Team DM Distance Monitoring 8 1 Description The Team DM base unit hasa modem for sending records from a remote site to a Sonicaid FetalCare or System8002 for analysis FetalCare and System8002 provide a printed trace similar to that provided by a Team printer so there is no need to take the Team printer to the examination site Team DM can be used in Manual mode or Home mode Manual mode On Team storage review and modem transfer are carried out using the menus On System8002 the data is received manually This requires interaction between the Team user and the System8002 user On FetalCare the data is received automatically by the FetalCare system Home mode Storage review and modem transfer are automated to a great degree System8002 is used in Auto Answer mode This means it can receive data without user intervention but you cannot use the system for anything else while it remainsin Auto Answer mode On fetalCare since the system receives data automatically you can use the system for other things while it is receiving data 8 2 Manual mode setup Manual start up mode For normal use or to set up Home mode for a different patient you need to have Tea
54. gnetic 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 isinterfering e Plugging the equipment into a different outlet so that the devices are on different branch circuits Adding accessories or components to a system or modifying a medical device or system may degrade the immunity performance Consult qualified personnel before making changes to the system configuration Sonicaid Team Operator s Manual Copyright All rights reserved This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Huntleigh Healthcare Ltd The copyright and the foregoing restrictions on the copyright use extend to a
55. he signal quality indicator should be lit Adjust the volume control as necessary Sonicaid Team Operator s Manual Connection diagram for Sonicaid electrodes FECG socket pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key 7481 6101 1 FECG socket on FM 800 Red Green M REF Red Black FECG electrode ECG REF OnNoa uu BW NJ FECG socket pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key 1 FECG socket on FM 800 2 M REF 3 FECG REF 4 FECG electrode 45 Sonicaid Team Operator s Manual 46 3 4 Twin heart rate monitoring Simultaneous monitoring of twins can be done with Team Duo or Team IP base units The recommended protocols are Twin 1 Twin 2 Team Duo 2 0M Hz transducer 1 5 MHz transducer Team IP 2 0MHz transducer 1 5 MHz transducer or Scalp electrode 1 5 MHz transducer Monitoring To hear the audio signal for each twin press CHANNEL SELECT bottom left on the Team keypad The active audio channel is highlighted on the Team display If the two heart rates appear similar e Team bleeps e The display shows CHECK TRACE FOR SAM E HEART RATE e The printer printsthis symbol on the trace Confirm the source of the heart rates you are monitoring Chart printing in dual monitoring mode The Team printer can print the heart rate traces side by side or superimposed See Section 1 6 Printer switch settings In side by side printing the primary channel ULT Y is printed on the
56. iant electrodes electrodes North America USA and Canada Y X Europe and the rest of the world Y Y Caution follow the instructions for use supplied with the fetal ECG scalp electrode 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 plug blue to the blue socket on Team 3 Once the membranes are ruptured attach the fetal scalp electrode 1400 0160 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 connectionsis not important Make sure a good signal is maintained Allow a few minutes for the signal to stabilize and a dear fetal heart rate to be displayed on the Team base unit display 2 or 3 bars of the signal quality indicator should be lit Adjust the volume control as necessary Monitoring procedure using Safelinc electrodes 1 Following the manufacturer s instructions attach the FECG lead to the mother s leg using the adhesive pad Once the membranes are ruptured attach the FECG electrode to the fetal pre senting part following the manufacturer s instructions Connect the FECG electrode to the FECG lead Allow a few minutes for the signal to stabilize and a dear fetal heart rate to be displayed on the Team base unit display 2 or 3 bars of t
57. ied from an isolation transformer IEC601 1 1 EN60601 1 1 Amendment 1 If such an outlet isin use it should comply with the requirements of Annexe EEE 2 of IEC601 1 1 EN60601 1 1 Amendment 1 Note an isolation transformer isa particular kind of multiple socket outlet WARNINGS 1 2 Do not exceed the power rating for the multiple portable socket outlet Do not place multiple portable socket outlets on the floor This is to 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 This is to prevent increased leakage currents and overload of the multiple portable socket outlet If the system has been specified for use with an isolation transformer do not connect any non medical electrical equipment which forms part of the system directly to the wall outlet This is to prevent excessive leakage currents 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 Team Operator s Manual 10 Electromagnetic compatibility Make sure the environment in which Sonicaid Team is installed is not subject to strong sources of electroma
58. inter 2 5kg approx Recommended operating and storage conditions Operating temperature 10 C to 35 C 50 F to 96 F Storage temperature 20 C to 60 C 4 F to 140 F Storage pressure 68 to 106 kPa 680 to 1060 mB Storage humidity 10 to 100 RH 11 2 AC supply voltage and fuse values Rated AC supply voltage 110V 120V 220V 240V 10 50Hz 60Hz maximum rating 30VA Fuse values T160mA for 220 240V nominal input voltage T315mA for 110 120V nominal input voltage 96 Sonicaid Team Operator s Manual 11 3 Printer High resolution 5 chart printer with automatic annotation signal loss date time and chart speed Dot matrix thermal 1024 elements Print width 128mm Paper type Heat sensitive z fold plain coated paper Paper length 45m per pack representing 75 hours at 1 cm min 25 hours at 3 cm min Chart speeds 1 2 3 cm min and fast feed FHR scale user selectable 30 240 bpm 30 bpm cm 50 210 bpm 20 bpm cm 11 4 Transducers Ultrasound Wide angle multi crystal monitoring transducer watertight with clip for attaching patient belt Pulsed Doppler system with directional facility Protection category B Operating frequencies 1 5 MHz yellow and 2 0 MHz blue Sampling rate 5 ms Heart rate Calculated to 0 25 bpm Accuracy 1 bpm over the range 100 180 bpm Protection against water IPX7 Contractions external toco Smythe guard ring tocodynamometer with clip for attaching patient belt Auto zero and Manu
59. is number Sonicaid Team Operator s Manual Auto Store details A record can be stored without entering patient details Team labels the record with the number ASNN where NN isa 2 digit number starting at 01 and counting up as new records are stored Patient details can be added to these records after stopping storage Note you must enter full patient details if you wish to transfer the record to Sonicaid FetalCare or System8002 Selecting which channel to store Press MENU twice Select SELECT STORE Team shows the current channel selected Select the required channel When done press EXIT U AUNE Start storing 1 Press MENU twice 2 Select STORE 3 Team asks DO YOU WISH TO ANNOTATE To use Auto Store annotation press STORE To enter patient details press ANNOTATE 4 Enter patient details 5 When done press STORE Stop storing 1 Press MENU twice 2 Select STOP STORING 3 If you used Auto Store annotation Team asks DO YOU WISH TO ANNOTATE To enter patient details now press ANNOTATE Otherwise press EXIT 4 Enter patient details 5 When done press EXIT 57 Sonicaid Team Operator s Manual 58 5 2 Selecting a stored record for review Stored records can be reviewed on the Team display printed or transferred to Sonicaid FetalCare or Sonicaid or System8002 by direct cable connection Using Team DM you can also transfer records via a modem To select a record for review
60. kelihood of metabolic ms acidaemia or intrauterine death gt 4 0 3 5 4 0 8 3 0 3 5 29 2 5 3 0 33 2 5 72 STV has been shown to be an excellent indicator of fetal well being Episodes of high and low variation An episode of high variation is defined asa section of the trace where the one minute peak to peak variation is above a given threshold for 5 out of 6 consecutive minutes An episode of low variation is defined as a section of the trace where the one minute peak to peak variation is below a given threshold for 5 out of 6 consec utive minutes The threshold for high is defined by a pulse interval of 32 ms and the threshold for low by a pulse interval of 30 ms The variability for each episode is expressed in beats per minute and isindependent of the basal heart rate High variation occurs when the fetus isin an active sleep phase and low variation when it isin quiet sleep Asthe fetus matures episodes of high variation increase and episodes of low variation decrease One of the Dawes Redman criteria is for there to be an episode of high variation where the peak to peak variation for the episode is greater than the first centile when corrected for gestational age Sonicaid Team Operator s Manual Calculating peak to peak variation The fetal heart rate record is analysed in one minute intervals Intervals containing a deceleration or part of a deceleration are discarded as are intervals with high signal loss or artefa
61. lCare or System8002 You can transfer a selected record to a Sonicaid FetalCare or Sonicaid System8002 for analysis either by direct cable connection or using Team DM by modem This section describes direct cable connection For transfer by modem see Chapter 8 Team DM Distance Monitoring Connecting Team to FetalCare or System8002 Use the Team to System8002 interconnecting lead 1 Connect the lead to the RS232 interface on the rear of the Team base unit 2 Connect the lead to the COM 1 interface on the rear of the PC running the FetalCare or System8002 software For full details of PC connections see the Sonicaid FetalCare User Guide or the Sonicaid System8002 User Guide Transferring a stored record to System8002 1 System8002 from the MainMenu select Receive Direct Data 2 From the Team Review Options M enu press DIRECT DATA 3 Datatransfer starts 4 When the transfer is complete On Team press PRESS RETURN TO CONTINUE On the PC running the FetalCare or System8002 software confirm that the patient details are correct 5 System8002 analyses the record On a Team DM base unit the DIRECT DATA option on the Review Options Menu is replaced by a SEND option Press SEND then DIRECT DATA Transferring a stored record to Sonicaid FetalCare See the Sonicaid FetalCare online help 59 Sonicaid Team Operator s Manual 5 6 Deleting a stored record Once a record has been printed or transferred to Sonicaid Fetal
62. lified personnel Sonicaid Products cannot accept responsibility for safety compliance reliability and performance if modifications or repairs are carried out by unauthorised personnel Identical replacement parts must be used If there is doubt whether Team is operating correctly when being used on a patient fetal condition must be checked by an alternative diagnostic method without delay The protective categories of the patient connections against electric shock are 5 1 Fetal ECG electrode lead BF 2 IUP catheter interconnection lead 3 Maternal ECG lead Ultrasound transducers External Toco transducer Nr B Type BF protection includes isolated supplies and is intended for direct conductive connection to the patient fetus ECG or vaginal contact when using an IUP catheter Type BF protection will withstand mains voltage between the patient connection and earth There is a possible risk of BF partstouching conductive parts Type B protection meansthese patient connections comply with permitted leakage currents dielectric strengths and protective earthing limits of BS5724 IEC 601 1 99 Sonicaid Team Operator s Manual 100 vii Installation is the responsibility of the vendor via a competent person approved by Sonicaid Products viii This equipment is not protected against xi a the effects of defibrillator shocks or discharge b the effects of high frequency currents c the effects of bistoury ei
63. ll media in which this information may be preserved This copy of the Operator s M anual shall be used only in accordance with the conditions of sale of Huntleigh Healthcare Ltd or its distributors Huntleigh Healthcare Ltd makes no representations or warranties of any kind whatsoever with respect to this document Huntleigh Healthcare Ltd disclaims all liabilities for loss or damage arising out of the possession sale or use of this document Sonicaid is a registered trademark of Huntleigh Healthcare Ltd in the UK and other countries Microsoft Office and Microsoft Windows are registered trademarks of Microsoft Corporation Intel Pentium is a registered trademark of INTEL Corporation Trademarks Sonicaid is a registered trademark of Huntleigh Healthcare Ltd in the UK and other countries Safelinc is a registered trademark of Tyco 11 Sonicaid Team Operator s Manual 12 Note on terminology The Sonicaid Team fetal monitor was developed in the UK where CTG is a recognised abbreviation for cardiotocograph In the USA and some other countries the terms EFM and NST are more commonly used When the Sonicaid Team display refers to CTG this means the printed or recorded trace showing the fetal heart rate and contractions In this manual the trace showing the fetal heart rate and contractions is referred to simply as the trace Where the manual refers to CTG it does so because CTG is what appears on the Soni
64. lt To turn the audible beep off or on 1 Press MENU once 2 Select ALARM 3 Press FETAL MOVEMENT 4 Select SILENT EVENT or AUDIBLE EVENT 4 2 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 move ment The Actogram value can be printed asa 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 Sonicaid Team Operator s Manual In a study of 14 near term normal fetuses with the threshold set at 40 the sensi tivity and specificity of the Actogram function compared with scanner identified breathing limb movement and trunk movement were 96 and 68 respectively This data is published with the kind permission of Professor David James of the Department of Obstetrics and Gynaecology Queens Medical Centre Nottingham Actogram setup menu 1 Press MENU twice 2 Select ACTOGRAM 3 To increase or decreas
65. m in Manual start up mode If it isin Home mode With the Team unit turned off hold down the MENU button on the keypad Switch on Team while continuing to press MENU Release the MENU button when the logo clears from the display Press M ENU three times Select START UP MODE The start up mode is shown as HOME Press CHANGE The start up mode now shows MANUAL OU U0UN N Hn 83 Sonicaid Team Operator s Manual 84 8 3 Home mode setup Home start up mode You should put the Team base unit into Home start up mode before sending it out for use at a remote site Press MENU three times Select START UP MODE The start up mode is shown as MANUAL Press CHANGE The start up mode now shows HOME and the Home Mode Setup Menu appears Press EXIT twice Switch off the Team base unit OU UN H Team is now ready for use at the remote site The next time it isturned on it will be in Home mode ready to store and send a record To put the Team into Manual mode With the Team unit turned off press and hold M ENU on the keypad Turn on the Team while continuing to press M ENU Release the MENU button when the logo clears from the display Press M ENU three times Select START UP MODE The start up mode is shown as HOME Press CHANGE The start up mode now shows MANUAL OU U0NK amp N HD Setting up the store time In Home mode Team stores a record of pr
66. menus are available in different languages To change the choice of language 1 Fromthe VERSION Menu select RECONFIGURE 2 Team displays a message EXIT THEN TURN UNIT OFF TO RECONFIGURE 3 Select EXIT 4 Switch off Team then switch on again 5 Team now showsthe available languages Select the language you want Use the button V gt gt gt to scroll through the list and see more choices Note if a selected language is not available the Team defaults to English Sonicaid Team Operator s Manual 2 11 Entering Patient Details You can enter the Gestation Period Patient Name and Patient Reference Number into the Team These details are then printed on the header of the trace The details are not saved when the Team unit is switched off To add patient details 1 2 3 Press MENU once Select ANNOTATE Enter the Gestation Period asthe number of weeks followed by the number of days If you enter weeks only 0 days is assumed Press NEXT to move the cursor to the right Press DELETE to move the cursor back to the left When done press NEXT until Team asks IS THIS CORRECT If it is correct press ACCEPT If it isnot correct press RE ENTER Enter the Patient Name maximum 13 characters When done press SAVE Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER Enter the Patient Reference Number maximum 13 characters When done press SAVE Team asks IS THIS
67. n a Team Telemetry unit the Telemetry menu option does not appear in the Team Menu when you switch on Problem On TeamDM when you switch on you see the message TO BEGIN RECORDING PRESS J Remedy 1 2 3 4 Switch the Team unit off Switch on again holding down the M ENU key Wait for the Team unit to beep then release the MENU key The Team Menu will now appear Remedy 1 2 3 4 Switch the Team unit off Switch on again holding down the v key Wait for the Team unit to beep then release the 7 key Choose the correct language for the Team menus If you use this shortcut instead of RECONFIGURE you will not lose any stored traces Remedy 1 2 3 4 Switch the Team unit off Switch on again holding down the key Wait for the Team unit to beep then release the key The Telemetry menu option will now appear Remedy 1 2 3 4 Switch the Team unit off Switch on again holding down the MENU key Wait for the Team unit to beep then release the MENU key The Team Main Menu will now appear When this happens it is not a fault in the unit It merely means the unit has been left in Home Mode ready to switch on and begin recording rather than in Manual Mode The menu system is available in Manual Mode but not available in Home Mode 89 Sonicaid Team Operator s Manual 90 9 3 Problems replaying or printing traces Problem On Team Duo can
68. n connect Team directly to FetalCare or System8002 for real time analysis of monitored data Sonicaid Team Operator s Manual Note analysing twins Team can send real time FHR data for twinsto a Sonicaid FetalCare system If you have System8002 Team can send real time FHR data from the yellow channel only In that case you can store the FHR data from the blue channel while you are monitoring and later transfer it to the FetalCare or System8002 for retrospective analysis See Section 5 Storing Records Connecting Team to FetalCare or System8002 Use the Team to System8002 interconnecting lead 1 Connect the lead to the RS232 connector on the rear of the Team base unit 2 Connect the lead to the COM1 port on the rear of the FetalCare or System8002 PC Note for full details of PC connections and instructions for using the system see the Sonicaid FetalCare User Guide or the Sonicaid System8002 User Guide 49 Sonicaid Team Operator s Manual 50 4 Events and Alarms 4 1 Recording fetal movement events Fetal movements are recorded by the mother operating a hand held push button event marker When an event is noted a solid triangular event mark is printed at the top of the fetal heart rate trace The Team beeps if the audible beep is switched on 1 Connect the event marker to the jack socket on the rear of the Team base unit 2 Give the event marker to the mother Tell her to press the button every time a fetal movement is fe
69. ndard is IEC950 EN60950 Medical equipment must comply with IEC601 1 EN60601 1 medical safety standard The configured system must comply with the system standard IEC601 1 1 EN60601 1 1 medical safety standard 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 asthe one supplied by Sonicaid Products 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 Sonicaid Products representative The connection of extra equipment to the patient or to Sonicaid Team could lead to the summation of leakage currents In such circumstances the user must ensure that safe leakage currents are not exceeded Calibration There isno special procedure for calibrating Sonicaid Team Sonicaid Team Operator s Manual Multiple Portable Socket Outlets including isolation transformers It isnot recommended to power a medical system from a multiple portable socket outlet which is not suppl
70. nter lead 8900 6955 Fuse T315mA 100 120V supply 1000 0270 Fuse T160mA 200 240V supply 1000 0240 94 AND Sonicaid Team Operator s Manual 10 6 Servicing and guarantee Servicing Servicing should be performed only by Sonicaid Products or their appointed service agent If you have difficulty obtaining service for Team contact Sonicaid Products Guarantee Team is guaranteed against defects in materials or workmanship for 12 months from the date of purchase Any system which is proven to be defective within this period shall at the discretion of Sonicaid Products be either repaired or replaced free of charge provided that 1 The system has not been damaged by misuse mishandling or attempted repair by unapproved personnel 2 The goodsare returned to Sonicaid Products or their appointed agent from whom the system was purchased secured in the original packaging with the carriage paid On component parts which are not manufactured by Sonicaid Products this guarantee is limited to extending to the purchaser the same guarantee that is given by the supplier of any such goods Under no circumstances shall Sonicaid Products have any liability for loss or indirect damage or consequential damages 95 Sonicaid Team Operator s Manual 11 Specifications 11 1 Physical and environmental Physical Dimensions base unit W275 x H83 x D275mm Weight base unit 3kg approx Dimensions printer W275 x H83 x D236mm Weight pr
71. of hourly signal loss For the third analysis at 45 minutes Two points are allocated e For the second analysis at 30 minutes Baseline heart rate The baseline heart rate is calculated asthe mean of the fitted baseline over 60 and 15 minute periods Short term variation The record is examined minute by minute Any one minute interval containing a deceleration or part of a deceleration is discarded as are one minute intervals with high signal loss or artefact Each remaining valid one minute interval is divided into 16 epochs of 3 75 seconds The mean fetal heart rate for each epoch is determined and expressed as a pulse interval in msecs The difference between adjacent epochs is calculated The short term variation is calculated as the mean of these adjacent epoch pulse intervals during all valid minutes over a 60 minute period Deceleration size The size of a deceleration is determined by calculating the area of the deceleration trough under the baseline expressed in lost beats The analysis reports the sum of the deceler ation areas over 60 and 15 minute periods The analysis defines a deceleration as being a trough 10 bpm below the baseline for more than 1 minute or 20 bpm below the baseline for more than 30 seconds 81 Sonicaid Team Operator s Manual Signal loss The system monitors the loss of fetal heart rate signal Where there isa gap in the trace due to signal loss the analysis interpolates a strai
72. ogram Event marks recorded by the Actogram facility are not used by the Team Care analysis Alarms During analysis the Signal Loss alarm is fixed at 30 In addition there isa 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 mode Since the analysis is not valid during labour it does not run on the secondary channel if this is using a fetal ECG scalp electrode 6 5 Using the analysis Starting the analysis 1 Set up Team as you would to record a normal trace 2 Press MENU once Check that the display says ANALYSIS IS ON If it says ANALYSIS IS OFF then select TURN ANALYSIS ON Pressthe printer button once to start the printer Team beeps and asks you to enter the gestational age of the fetus Enter the gestational age The Team stops beeping and the printer starts OU Uu Stopping the analysis 1 Pressthe printer button once to stop the printer 2 Thetrace fast forwards and the analysis results are printed If you stop the printer before 10 minutes Team says CANNOT ANALYSE LESS THAN 10 MINUTES DATA and asks CONTINUE PRINT amp ANALYSIS Select either HALT PRINTER or CONTINUE PRINT Sonicaid Team Operator s Manual Checking analysis progress After the first analysis has been performed at 10 minutes you can check the key results by pressing the return button on the keypad indicated by
73. on 6 6 Note if the criteria are met but for some reason you do not stop the analysis it can very rarely happen that the results then 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 Such a change is extremely rare but can occur in a high risk unit with a baby which is on the borderline between normality and abnormality If this happens the recommendation isto continue monitoring until the criteria are met again Analysing twins When monitoring twins using two ultrasound transducers both channels are analysed simultaneously The results for each fetus are identified by the channel mode and colour ULT Y Yellow ULT B Blue Fetal movement events The mother should try to mark events for each fetus If she is not sure which fetus is moving she should make no marks at all The conventional fetal event marker lead marks events on the primary channel yellow The Clinical Event marker button on the Team keypad marks events on the secondary channel blue The usual Clinical Event facility is not available in these circumstances Gestational age The analysis takes the gestational age of the fetusinto account Team asks you to enter this information when you start the analysis Or you may use Annotation to pre enter this and other patient details 63 Sonicaid Team Operator s Manual 64 Act
74. output of FM800 isinternally controlled and cannot be varied by the operator The duration of exposure however isfully 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 101 Sonicaid Team Operator s Manual 102 Acoustic output Sonicaid FM 800 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 20mW cme spatial peak temporal average intensity lt 100mMW cm Power measurements were made by the National Physical Laboratory Teddington Middlesex UK in accordance with NEMA UD 2 1998 Sonicaid Team Operator s Manual Appendix 1 External Connections Input output levels and pin numbers All input and output voltages are system earth referred and not isolated Only signal voltage up to 1V maximum should be used Logic levels up to 5V are permitted on data lines Modem socket 25 way Canon type Connection from Team DM to modem for distance monitoring an Sorat memes 1 Nouserconnection 5 Nousrcometin No user connetion f O 7 S Nouserconnecion f O No user connetion f O 10 Nouercon
75. patients or instrument operators at the intensities typical of present diagnostic instruments Although the absence of adverse effects to human subjects after extensive use at diagnostic power levels is gratifying available data are not conclusive and the possibility remains that biological effects may be identified in the future It istherefore deemed desirable by medical and other scientific authorities that exposure to ultrasound should be limited to a duration and intensity appropriate to the dinical objective Since 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 dinical 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 Fetal use Team 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
76. pm on a record gt 30 minutes e Decelerations present but not meeting the criteria for size or record length A single asterisk does not necessarily mean that the record cannot passthe 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 on the analysis report WARNING LOW BASAL FHR CHECK THAT FHR DOES NOT CONTINUE TO FALL FETAL MOVEMENTS PRESENT SINUSOIDAL RHYTHM 67 Sonicaid Team Operator s Manual ISONOMIC V LON SI SIHI unogwi SHIGA CITA LON SYSATUNN SNIH OF IV JIH YIII HVLRg3H S3NVd ASH HOILUIHUA MAXI LYOHS Mv ANOU S3008Id3 AOT NOTLVINVA SSTT JAH SISTMLAd GO HESS SO E id HJA PET B RIM Sauosrd3 BOTH i GIVAE 1801 07 lt SMOI1VHITHD30 F 998 ST Hall st lt T cus Si HdE OT SHOTLYYTTIONY I Said NOlLOVUENDO HJD TIVE 1593H SYA og ROH Wad SINAHIADH WI ESOT HOTS dace i KHH Y ALTA BEBE ENTIS S8 TD 60 E E t D6 4027 ET HIIWS ASI VPE NOILVI539 CH I9EVSSE ees LEHI IWI m ier 96 78 60 AWG irg AUWHALANT IVAOM TUVOWWEL abe Example printout of TeamCare trace and analysis report 68 d Team Operator s Manual icai Son eHBIAM THITOSAHIS LIMIS344 S3N383A2H 719114 9 TIA OL 3INIIHO2 JON 530 YHA IVHL X23H2 D SHI T SV0 ADI DR
77. r ULT Y Yellow ULT B or FECG Blue Displayed results After each analysis the results are also shown on the Team base unit The display returns to the fetal heart rate display after two minutes or when you press EXIT TIME 21 06 60 MIN BASELINE seem 139 15 MIN BASELINE usuamauamu 144 60 MIN STV BHEHBHBHEBEEBESBHEHESs 7 8 60 MIN DECEL seen 15 MIN DECEL BEEBE eee CONFIDENCE seeps lt lt lt TREND ULT Y EXIT gt gt gt If you are analysing twins the results shown are for the fetus on the currently selected audio channel shown on the display as ULT Y or ULT B FECG If no audio channel is selected the display defaults to the primary yellow channel Sonicaid Team Operator s Manual SS6py y H 1 W H 30N30LJNO2 S d 061 NI T 3 3 p du 1 1 a Uu i R f i 5 R E i i 1 1 ib B i NIN 09 l FALS OvT 2h NIW ST Tol HIBI NIW 09 aNITaSva 9924 x 00I 991i x001 TS 0 86 10 51 TS 0 86 10 ST NIN WO 1 9934 02 51 NIN W9 1 9914 OT ST 00T bt 4 M gh ft EM uet 091 EN RENE NEM NEM NEN EL m wa pleajuos 79 Printout showing Team Trend analysis results Sonicaid Team Operato
78. r s Manual 80 7 5 Viewing trend data To see a trend of the analysis results for up to the last four hours press TREND in the results display screen The Trend display screen returns to the fetal heart rate display after two minutes or when you press EXIT TIME 60 MIN BASELINE 60 MIN STV 60 MIN DECEL CONFIDENCE EXIT For twins the results shown are for the fetus on the currently selected audio channel ULT Y or ULT B FECG If no audio channel is selected the default is ULT Y 7 6 Analysis parameters and calculations The baseline The analysis fits a baseline to the fetal heart rate trace through data points Data points are pulse intervals averaged over 1 16 minute The baseline isfitted in such a way as to follow slow but not rapid changesin the fetal heart rate The baseline is re fitted at every analysis asfurther information becomes available Confidence indicator The confidence measure for baseline fit is based on points for possible errors Points Confidence Oor1 High 20r3 Medium 4 Low Note the confidence indicator defaultsto Low for the first analysis at 15 minutes Sonicaid Team Operator s Manual One point is allocated e For every 5 minutes the heart rate is away from the baseline e f the commonest heart rate is 196 of the total number of heart rates e f the current 60 minute baseline value differs from the previous 60 minute value by more than 20 bpm For every 20
79. ress the printer button once to start the printer This starts the analysis as well Stopping the analysis To stop the printer press PRINTER then HALT If you press PRINTER by accident press CONTINUE to resume Turning the analysis off To record a trace without the analysis 1 Press M ENU once 2 Select TURN ANALYSIS OFF 3 When done press EXIT 4 Pressthe printer button to start recording Turning the analysis on To turn the analysis on again 1 Press MENU once 2 Select TURN ANALYSIS ON 3 When done press EXIT Deceleration size parameter The default isfor deceleration size results not to be printed or displayed To print and display the deceleration size 1 Press MENU three times 2 Select TURN DECEL ON 3 When done press EXIT 77 Sonicaid Team Operator s Manual 78 7 4 Analysis results Printed results When an analysis has been performed 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 See the example in Figure 7 1 The 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 Twins results Both channels are analysed simultaneously The results for each fetus are identified by the channel mode and colou
80. s are detected by the analysis and counted as signal loss 73 Sonicaid Team Operator s Manual 74 6 9 References Some publications on computerised fetal heart rate analysis Street P Dawes GS Moulden M Redman CWG Short term variation in abnormal antenatal fetal heart rate records American Journal of Obstetrics and Gynecology 1991 165 515 523 Nijhuis IJ M ten Hof J Mulder EJH NijhuisJG Narayan H Taylor DJ Westers P Visser GHA Numerical fetal heart rate analysis nomograms minimal duration of recording and interfetal consistency Prenatal and Neonatal Medicine 1998 3 314 322 Burch D Computerised measurement of fetal heart rate variation in a case of fetomaternal haemorrhage British Journal of Obstetrics and Gynaecology 1994 101 1089 1090 Pardey J Moulden M Redman CWG A computer system for the numerical analysis of nonstress tests American Journal of Obstetrics and Gynecology 2002 186 1095 1103 Brown R Patrick J The nonstress test how long is enough American Journal of Obstetrics and Gynecology 1981 141 646 651 Blumofe KA Broussard PM Walla CA Platt LD Computerized versus visual analysis of fetal heart rate a reduction in testing time American Journal of Obstetrics and Gynecology 1992 166 415 Sonicaid Team Operator s Manual 7 Trend Printer option The Trend printer is the printer supplied if you purchase TeamlP Trend Note Sonicaid Trend analysisi
81. s not approved for sale in the USA and Canada 7 1 Introduction The Team Trend printer incorporates an analysis system for use during the intra partum period The analysis which provides measurement of fetal heart rate para meters at regular intervals offers a new way of describing the attributes of the trace that is quantitative and not qualitative It is not intended as a replacement for skilled visual interpretation of the trace Used with continuous fetal monitoring it allows you to assess long term changes in the fetal heart rate pattern No guidelines on interpretation or limits of normality are provided Instead the clinician can use the numeric values to identify and quant ify the relative changes in fetal heart rate parameters over a period of time A numerical description of the trace enables direct comparison between different traces It also providestraining support for trace interpretation and readily available data for clinical research projects The analysis isan extension of the antepartum analysis work originated by Professor G S Dawes Professor C W G Redman and M Moulden at the Nuffield Department of Obstetrics and Gynaecology John Radcliffe Hospital Oxford England IMPORTANT The analysis provided by the Team Trend printer generates parameters describing the fetal heart rate on the record The interpretation and diagnosis of the record remains the responsibility of the appropriately qualified medical staff
82. se intervals averaged over 1 16 minute to fit a baseline to the fetal heart rate trace Accelerations and decelerations are measured from this base line The baseline follows slow but not rapid changesin the fetal heart rate It is re fitted at every analysis as further information becomes available Basal heart rate The basal heart rate is the mean rate averaged over all periods of low variation If no low variation is present it is derived from a statistical analysis The basal heart rate should be between 116 160 bpm A basal heart rate of 160 170 bpm is not sinister antepartum provided that the mean range of the fetal heart rate variation is within normal limits and there are no large decelerations A basal heart rate greater than 170 bpm suggeststhe possibility of fetal infection Sonicaid Team Operator s Manual A basal heart rate less than 105 bpm requires further investigation at once A few normal fetuses at 38 42 weeks gestation have a basal heart rate of 110 115 bpm The threshold of 115 bpm at which a warning is given is chosen conservatively to give warning of a compromised fetus in which the fetal heart rate may be falling progressively It is likely that fewer than 196 of analysed records in dinical practice will come in this category Accelerations The analysis defines an acceleration as being a rise of 10 bpm or 15 bpm above the baseline for more than 15 seconds The Dawes Redman criteria criteria for normality u
83. se the first of these definitions A count of accelerations meeting both definitions is made on the analysis report Decelerations The analysis defines a deceleration as being a trough 10 bpm below the baseline for more than 1 minute or 20 bpm below the baseline for more than 30 seconds The area of each deceleration is calculated and expressed in lost beats A deceleration gt 20 lost beatsis regarded as large A count of decelerations is made on the report Any deceleration gt 50 lost beats is described in detail on the report and the mean variation for 3 minutes before and after the deceleration is given Short term variation The record is divided into one minute intervals Intervals containing a deceleration or part of a deceleration are discarded as are intervals with high signal loss or artefact Each remaining interval is divided into sixteen epochs of 3 75 seconds The mean fetal heart rate for each epoch is determined and expressed as a pulse interval in msecs The difference between adjacent epochs is calculated The short term variation is calculated as the mean of these adjacent epoch pulse intervals over the record during all valid minutes 71 Sonicaid Team Operator s Manual 72 The measurement of short term variation in the absence of episodes of high variation is independent of basal fetal heart rate and correlates with the development of metabolic acidaemia and intrauterine death as follows STV li
84. shold required 4 Team asks IS THIS CORRECT If it iscorrect press ACCEPT If not press RE ENTER 5 Enter the delay time required 6 Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER To turn an FHR alarm off 1 From the Alarm setup menu press either LOW FHR or HIGH FHR 2 Select ALARM OFF Timer alarms You can set a timer to tell you when a given period of time from 1 to 99 minutes has elapsed The timer starts when you start storing or printing and restartsif you reset the alarm while storing or printing When the set time has elapsed an alarm occurs To set the timer Press MENU once Select ELAPSED TIME Select ALARM ON SILENT or ALARM ON AUDIBLE Enter the period required Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER U AUNE To turn the timer off 1 Press MENU once 2 Select ELAPSED TIM E 3 Select ALARM OFF Acknowledging an alarm When an alarm occurs a notification appears on the display message bar The Team also beeps if you set ALARM ON AUDIBLE but not if you set ALARM oN SILENT To cancel the alarm press the ENTER key at the bottom right of the Team keypad 55 Sonicaid Team Operator s Manual 56 5 Storing Records 5 1 Storing You can store data electronically in the Team base unit Stored records can later be reviewed on the Team display printed or transferred to Sonicaid Fetal
85. sibility 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 dinical 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 61 Sonicaid Team Operator s Manual 62 6 3 The Dawes Redman criteria The Dawes Redman criteria are criteria for normality If a record meets the criteria this means that as far as the analysis can tell by measuring the features of the trace the fetusis normal It isnot a guarantee that the baby is healthy but it does mean there is nothing in the trace which gives cause for concern somebody please check that paragraph These are the criteria e An episode of high variation above the first centile for gestational age e No decelerations gt 20 lost beats 7 100 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 This is indicated by one asterisk on the analysis resultsto show that the fetal heart rate is low or high but that in the context of the rest of the record it is acceptable At least one fetal movement or three accelerations No evidence of a sinusoidal fetal heart rate rhythm Short t
86. tal heart rate monitoring either by two ultrasound transducers or invasively by a fetal ECG scalp electrode and an ultrasound transducer Uterine activity can be measured either with an external toco transducer or an intra uterine pressure catheter Team IP can also measure the maternal heart rate Team DM For use in a remote dinicor the patient s home Team DM provides the same facilities as Team Standard but includes a modem for transmitting stored data Thisis an optional feature not currently available in the USA or Canada There are three Team printers available Standard Thermal printer for a continuous paper record of monitored data Care Incorporates analysis for use during the antepartum period Trend Incorporates analysis for use during the intrapartum period This user manual covers the whole Team range and may describe some facilities not available in your Team unit 15 Sonicaid Team Operator s M anual 16 1 2 Main unit front panel 1 2 Sonicaid TeamIP Q A e J Nu 6 7 Key 1 CARDIO input blue connecor 2 MHz ultrasound transducer OR un BB W N Oo 7 MECG input maternal ECG lead optional OR FECG input for fetal ECG lead Model identification Team Standard Team Duo Team DM or Team IP CARDIO input yellow connector 1 5 MHz ultrasound transducer Power on indica
87. the stored record 1 Press MENU then NEXT then REVIEW A list of records appears 2 Pressthe key marked V until the selection arrow on the left of the display highlights the record you want to send Press SELECT Press SEND Make sure the Auto Dial number is correct If it isnot press SETUP and corred it If it is correct press AUTO DIAL om Uu At the hospital FetalCare or System8002 automatically receives the data you are sending At the end of the transfer The Team display shows TRANSFER HAS ENDED To continue using Team press RETURN Possible problems 1 System8002 may be busy at the hospital The Team display shows if the modem failsto get a reply In this case repeat the procedure to send the record 2 If problems persist contact the hospital for assistance Team Operator s manual issue number 738311 A Appendix 3 Sonicaid Team distance monitoring Home Mode storing and sending a record Set up the Team and modem 1 Plug the modem into the back of the Team base unit 2 Plug the dual telephone adaptor into the telephone wall socket 3 Conned the telephone and modem to the dual telephone adaptor If itis not convenient to connect the Team to the telephone socket whilst monitoring the patient continue with the procedure below The Team will attempt to send the record and fail At this point set up the Team as above follow the Home Mode Retry procedure under Home Mode problems sending a record
88. ther TENS transcutaneous electrical nerve stimulation or electro surgery External connections external connections are all referred to earth They are not intended for patient connected equipment The maximum voltages applied should not exceed the values in Appendix 1 Note A PC connected to the RS232 interface should meet the requirements of IEC601 1 or equivalent regarding earth leakage current dielectric strength tests protective earthing grounding and creepage and clearance requirements See Appendix 1 External Connections input output levels and pin numbers Protective earth testing only the miniature D socket shells on Team are pro tectively earthed The DIN connector shells and printer platen guide plates are functionally earthed via the internal screen DO NOT bond test these at high currents as damage may result The safety isolation from AC mains is by the transformer earthed screen The nature of the partsin direct or indirect contact with the patient is Ultrasound transducers ABS plastic External Toco transducer Anodised aluminium alloy polyester membrane Sonicaid FECG electrode Stainless steel Sonicaid FECG electrode lead Stainless steel rubber Safelinc FECG electrode Stainless steel Intran IUP catheter Polyurethane plastic Sonicaid Team Operator s Manual 11 6 Ultrasound safety considerations General Diagnostic ultrasound has been in use for over 25 years with no confirmed adverse effects on
89. tor light EXT input pink connector external contractions Toco transducer OR INT input precalibrated IUP catheter transducer Keypad with eight control buttons Display panel MECGisnot available in the USA or Canada Explanation of symbols o S Be This symbol beside the CARDIO and EXT input sockets indicates that these connections are classed as Type B This symbol beside the MECG FECG and INT TOCO input sockets indicates that these connections are classed as Type BF This symbol by the power on indicator light denotes AC input MECG isnot available in the USA or Canada Sonicaid Team Operator s Manual 1 3 Main unit rear panel HEN ioi u O TEAM FREQUENCY MHz foal A J RS485 RS232 lt 6 9 A Q cj i Sh a PII i amp J 1 2 3 4 5 6 7 Key 1 ACmainson off switch O off 1 on When you switch on the power on indicator on the front panel shows green S9 2 Input socket for the AC mains supply A Ua I oo Ul 3 RS485 Interface for Axis 1 5kV DC isolation Pluggable cord connector PCC type
90. trace annotation loading printer paper and printer operation apply to all three types of printer See Chapter 6 Care Printer and Chapter 7 Trend Printer for specific information on these two types Paper The printer uses a plain thermal paper pack part number 8400 8003 Use only Sonicaid paper The use of non approved paper may result in poor quality printing or damage to the printer and could invalidate the printer warranty Horizontal scale print speed The printer has three speeds 1 cm min 2 cm min and 3 cm min The following table shows the default print speed in different countries 1 cm min 3 am min North America USA and Canada Y Europe and the rest of the world Y To change the print speed see section 2 5 31 Sonicaid Team Operator s Manual 32 Vertical scale The printer s vertical scale can be 20 bpm cm or 30 bpm cm The following table shows the default scale in different countries 20 bpm cm 30 bpm cm North America USA and Canada Y Europe and the rest of the world Y To change the vertical scale see section 2 3 2 3 Trace annotation Trace header When the printer is switched on a header is printed before the trace data and grati cule The header includes user name date and time and patient details if entered Graticule The graticule is printed at the same time asthe trace data with a 5 bpm or 10 bpm grid Set printer switch 2 up for 5 bpm
91. tton v 27 Sonicaid Team Operator s Manual 28 1 12 The Team Keypad OOOO BR WN e There are eight buttons on the Team display panel Their primary functions are ON OU BWN FE Toco zero zeroes the external Toco contractions transducer or IUP catheter Volume control up Volume control down Channel select Menu access Display Help page Clinical event marker Enter confirms an entry or switches display modes Sonicaid Team Operator s Manual 2 Getting Started 2 1 Summary of recording procedure Setup 1 2 Place transducer belts across the bed or chair Make the patient comfortable in a semi recumbent or sitting position Preparing the Team 1 2 Switch on The on off switch ison the rear of the base unit Check paper Is there sufficient paper for the monitoring session Make sure the printer platen is securely closed Connect transducers The plugs and sockets are colour coded the display confirms transducer connection Transducer placement 1 2 Palpate the abdomen to determine fetal lie and position Position the Toco transducer pink centrally halfway between fundus and umbilicus Do not use gel Secure with belt and buckle Zero the Toco Make sure the uterus is relaxed then press the Toco zero button The 10 baseline is displayed Gel the ultrasound transducer yellow Place it on the abdomen so as to obtain a clear heart sound Secure with belt an
92. u button on the keypad 2 Turnon the Team while continuing to press the Menu button 3 Release the key when the logo clears from the display Team Operator s manual issue number 738311 A Appendix 3 Sonicaid Team distance monitoring Manual Mode storing a record Set up the Team 1 Turn the Team base unit on 2 Connect the transducers and event marker to the Team base unit 3 Attach the transducers to the patient Start recording 1 Press MENU then NEXT then STORE 2 Press ANNOTATE 3 Enter patient details Note Team can have a 13 character patient reference number FetalCare and System8002 store only the first 8 characters of this number 4 When done press STORE The Team is now storing trace data Stop recording 1 Press MENU then NEXT then STOP STORING 2 Disconnect the transducers from the patient Note the minimum length of recording you can send via a modem is 12 minutes Team Operator s manual issue number 738311 A Appendix 3 Sonicaid Team distance monitoring Manual Mode sending a record At the hospital System8002 must be set up in Auto Answer mode to send a record using Auto Dial FetalCare is set up to receive data automatically at any time Set up the Team and modem 1 Plug the modem into the back of the Team base unit 2 Plug the dual telephone adaptor into the telephone wall socket 3 Conned the telephone and modem to the dual telephone adaptor Selecting and sending

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