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Huntleigh Sonicaid Fetal Monitor

1. 22 8 Nouserconnection Z O 9 user connection CC 10 user connection 11 Audio fortest 12 user connection 13 Nouserconmecin 14 Nouserconnection 15 user connection 16 Nouserconnection 17 user connection 18 user connection Z O Z 19 user connection 20 DTR not used 00004 21 user connection 00000 22 user connection CC 23 No user connection 24 No user connection 25 on cometi 96 Sonicaid Team Operator s Manual RS232 interface 9 way D type socket isolated to 500V DC Isolated interface to a PC running Sonicaid System8002 etc Pim signal input output 1 2 Rx Input 3 TX Output 5 1 4 Isolated OV Reference 7 g G 8 9 97 Sonicaid Team Operator s Manual 98 Fetal event marker connector 1 4 jack socket 1 Switch 2 Ring Signal ground via switch 3 Sleeve Chassis ground Team Printer connector 8 pin D type connection to the Team printer module Rx Tx 30V nominal 5V 8V nominal Not connected Ground Ground 1 2 3 4 5 6 7 8 Sonicaid Team Operator s Manual Appendix 2 Transducer Problems The following tests will show whether there is a problem with an Ultrasound transducer If there is a problem contact the Huntlei
2. te ondar d 1 2 1 Printer setting switches See below 2 Connector to main unit 7 pin DIN Connect to the printer IN connector on the Team main unit 1 5MHz DUO Printer switch settings Paper speed Switch 5 1 cm min Down 2 min Up 3 cm min Up Scale Switch 4 20 bpm cm Down 30 bpm cm Up Dual monitoring Switch 3 Side by side Up Full width Down Graticule Switch 2 5 bpm Up 10 bpm Down Note switch 1 should always be Up Switch 6 Down Down Up 10 bpm m 1 PHR 2 FHR 20 bpm cm 30 bpm cm 1 cm min 2 cm min 3 cm min Diagram on printer 17 Sonicaid Team Operator s Manual 18 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 the screw head beneath Position the printer unit on top of the printer wedge with the feet of the printer in the depressio
3. guidance RF emissions Group 1 The Sonicaid Team uses RF energy only CISPR 11 for its internal function Its RF emissions are therefore very low and are not likely to cause any inteference in nearby electronic equipment RF emissions Class B The Sonicaid Team is suitable for use in CISPR 11 all establishments including domestic Harmonic emissions Class A establishments and those directly EC 61000 3 2 connected to the public low voltage Voltage fluctuations Complies power supply network that supplies flicker emissions IEC 61000 3 3 buildings used for domestic purposes Caution the Sonicaid Team should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary then the Sonicaid Team should be observed to verify normal operation in the configuration in which it will be used Electromagnetic immunity guidance to user 1 Guidance and manufacturer s declaration electromagnetic immunity The Sonicaid Team is intended for use in the electromagnetic environment specified below The customer or user of the Sonicaid Team should make sure it is used in such an environment Immunity test Electrostatic discharge IEC 61000 4 2 60601 test level 6kV contact 8kV air Compliance level 6kV contact 8kV air Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the
4. NOTE is the a c mains voltage prior to application of the test level Electromagnetic immunity guidance to user 2 Guidance and manufacturer s declaration electromagnetic immunity The Sonicaid Team is intended for use in the electromagnetic environment specified below The customer or user of the Sonicaid Team should make sure it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile communications equipment should be used no closer to any part of the Sonicaid Team including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms Vi V dz Hg IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands Radiated RF 3 V m E1 V m d E 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 1 2 5 GHz d m 800 MHz to 2 5 GHz 1 where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with this symbol NOTE1 At 80 MHz and 800 MHz the higher frequ
5. End of life disposal Definition this symbol indicates that this product comes under the provisions of EU Directive 2002 96 EC on waste electrical and electronic equipment WEEE and that this unit was placed on the market after 12 August 2005 This directive covers EOL end of life disposal Rules for the User within the EU at end of life this product may be disposed of only through a government approved collection scheme or a treatment facility If in doubt contact your local Huntleigh Healthcare Ltd representative 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 standard is 950 60950 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 or printer with enclosure leakage currents greater than those allowed by IEC601 1 EN60601 1 is to be used in the patient environment within 1 5m of the patient you must bring the enclosure leakage currents within the limits laid down by IEC601 1 EN60601 1 This may be done by using an isolating transformer such as the one supplied by Huntleigh
6. 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 access to the screw head beneath Using a screwdriver push down and secure the screw with approximately 4 turns Re fit the paper pack and platen 1 Printer platen shown removed 2 Centre fixing screw 3 Release button 19 Sonicaid Team Operator s Manual 20 1 9 Team base unit to Team trolley assembly A purpose designed trolley is an option on Team To attach Team to the trolley 1 Position the Team unit on the trolley top so that the securing screw is in 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 AR Trolley top Securing screw 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 for twins monitoring only do not use for single channel monitoring External Toco transducer Gives a subjective indication of contractions pressure Used for non invasive monitoring of the timing duration and co ordination of contractions Colour coded pink
7. Press USER NAME Enter the hospital or clinic name When done press SAVE Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER amp WN 2 8 Date and time Time and date are printed on the trace and shown on the Team display message bar Warning It is essential to check that the date amp time are correct prior to performing a CTG trace Failure to do so may result in incorrect date time stamping on the trace on the trace print out Caution Avoid rapid cycling 10 seconds of the mains on off switch on the unit or of the mains power supply to the unit Under certain circumstances this may result in stored data being lost In particular stored fields such as User name date amp time may be reset if the unit is switched off on rapidly Do not rely on the memory features in this product to store permanent information such as an equipment id number To reset the date and time 1 Press MENU once 2 Press TIME DATE 3 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 4 Enter the required time 5 When done press NEXT until Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER 6 Enter the date in the same way The date format European or USA depends on the language selected See Section 2 10 Changing Language Sonicaid Team Operator s Manual 2 9 Versi
8. 75801 WHOIS HJJH A JATIA GADI LYTI x 1 UH rat z9 i POF 5507 w311IV 380233 489 Siyaga HIH JISH HOM 1501 FHIL 1500 05 lt SHONIGHTT3O34 4 Ndi 9 1 1 x q Ln SISOH OVI v 108 SI 3odw ONT OETA LON SISATUNU bE iw 13H JON VIJIIDJO NULOiSHS3AVO CD SNIH BL AU 230 ION YIHAAIHO NUNGSH SIO CA SH NDRLVINUA WHEL IDHOHS CHIN 23008143 AGT MOIIVIHVA 537 IWH 335 1033 10 SHA bE IU 68 HIM 53005199 T 1507 UF SNOLIGHTT32O3U F 48 SE Y UJT SE 4 915 SE Udg OF lt 5 1 Sayad ROLL Wala JIYE 19504 x F M H did TELITI x NLP 18507 2165 An Example printout of TeamCare twins analysis results 65 Sonicaid Team Operator s Manual 66 6 7 Plotting trend data Team fetal monitor can be connected to the Sonicaid FetalCare or Sonicaid Centrale software system to allow analysis results to be plotted and presented in graph form for longitudinal trend analysis This is particular important for STV trending as a powerful predictive management tool in high risk pregnancies Contact your supplier or Huntleigh Healthcare or visit our website for further information on this see under addresses for details 6 8 Analysis parameters and calculations The baseline The analysis uses pulse interv
9. T am menu Systemic oec pee re Yr Eine en e ade cd a 33 2 7 USer rnae RTL 34 2 8 Dat and timers ur ug a aa e dedere te terius 34 2 9 Versieren ea aE ote se NAA As uM PE Me iei eeu 35 Sonicaid Team Operator s Manual 2 10 Changing 35 2 11 Entering Patient Details esses memes 36 3 Monitori co rre TTD AO Ot Evan PLE VR oq 37 3 1 Ultrasound 000 37 3 22 External Toco contractions transducer 40 3 3 Fetal ECG scalp electrode TeamlP only 41 3 4 Twin heart rate memes 43 3 5 Intrauterine pressure catheter contractions 44 3 6 Maternal Heart Rate monitoring not available in the USA and Canada 44 3 7 Team connected FetalCare or 8002 45 4 Events and Alarms det eR E ER NE e te M eR PARE 47 4 1 Recording fetal movement 2 2 20 47 4 2 ActOgt alti UR 47 4 3 Recording clinical events sss mmn 50 44 er actos duit vate Seat dette Lotti des 51 5 Storing Records iecit eet te s
10. Team shows the current channel selected Select the required channel When done press EXIT amp 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 Sonicaid Team Operator s Manual 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 1 Press MENU twice 2 Select REVIEW 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 Y 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 details for the selected record appear on the Rev
11. press MENU top right on the Team keypad TIME DATE NEXT gt gt gt lt lt lt ALARM lt lt lt ANNOTATE ELAPSED TIME gt gt gt gt gt gt Using the Team Menu Each menu item has arrows gt gt gt pointing at 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 123456 OPQRSTU 7890 VWXYZ gt gt gt lt lt lt ABCDEFG EXIT gt gt gt lt lt lt 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 shows this group with one character against each keypad button 3 Select the required character 33 Sonicaid Team Operator s Manual 34 2 7 User name You can enter a hospital or clinic name maximum 13 characters to be printed on the header of the trace Caution Avoid rapid cycling 10 seconds of the mains on off switch on the unit or of the mains power supply to the unit Under certain circumstances this may result in stored data being lost In particular stored fields such as User name date amp time may be reset if the unit is switched off on rapidly Do not rely on the memory features in this product to store permanent information such as an equipment id number Entering a User Name 1 Press MENU three times
12. the minimum amplitude or value of the ECG signal is 304V Operation of the Sonicaid Team below this amplitude or value may cause inaccurate results Cables Cables with which Sonicaid Team is compliant in terms of emissions and immunity 1 5MHz ultrasound transducer 2 0MHz ultrasound transducer Fetal ECG lead FECG scalp electrodes Toco transducer Fetal movement event marker Mains lead Maternal ECG lead Modem with telephone cable connection lead catheter Transducers and accessories Transducers and accessories with which Sonicaid Team is compliant in terms of emissions and immunity 1 5MHz ultrasound transducer Toco transducer Fetal movement event marker Mains lead 2 0MHz ultrasound transducer Fetal ECG lead FECG scalp electrodes connection lead catheter kit connection lead and 10 x IUP catheters Maternal ECG lead Maternal ECG skin electrodes Caution the use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment or system Electromagnetic emissions guidance to user Guidance and manufacturer s declaration electromagnetic emissions The Sonicaid Team is intended for use in the electromagnetic environment specified below The customer or user of the Sonicaid Team should make sure it is used in such an environment Emissions test Compliance Electromagnetic environment
13. 1 CARDIO input blue connector 2 MHz ultrasound transducer OR MECG input maternal ECG lead optional OR FECG input for fetal ECG lead 2 Model identification Team Team Duo Team DM or Team IP 3 CARDIO input yellow connector 1 5 MHz ultrasound transducer 4 Power on indicator light 5 EXT input pink connector external contractions Toco transducer OR INT input precalibrated IUP catheter transducer Keypad with eight control buttons Display panel MECG is not available in the USA or Canada Explanation of symbols 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 is not available in the USA or Canada 13 Sonicaid Team Operator s Manual 1 3 Main unit rear panel LOT Y TEAM FREQUENCY g i 85232 lt 6 ZW A C 0 5 A 7 1 2 3 4 5 6 Key 1 AC mains on off switch off 1 on When you switch 1 on the power on indicator on the front panel shows green 2 Input socket for the
14. 10 Trademarks urine etae ah ae ed ore EU 10 Note on terminology e ap Ee E ES ERE DER RE 11 S Sis cese det t t e t ne fec ub ele ut 11 1 ERN NN MU 12 1 1 Teamifetal moriitors Sea Ae TE os 12 1 22 Main unit front panel eec en rdi vpn ade o en 13 1 3 Main unit rear 0 0 mene eene 14 1 4 Contrast control e d e ete 15 15 Team printer front panel sss mmm 16 1 6 Team printer rear memes 17 1 7 Team printer wedge assembly option 18 1 8 Team printer to Team base unit assembly 19 1 9 Team base unit to Team trolley assembly sss 20 1 10 Transducers and cables a a mnm 21 1 11 Team display eee 23 1 12 The Team Keypad ed eere eene EA etd Dex me 25 2 Getting Started eorr ETHER TR RR HEY M Y Ex ev xw YER Va 26 2 1 Summary of recording procedure sssssssssssmmeens 26 2 2 The Team printer en tds 28 2 3 jIrace annotation J aN EAL An vata ea a e a 29 2 4 Loading printer 000 31 2 5 Printer operatione ERES oe eR RE een 32 2 6
15. 3kg approx Dimensions printer W275 x H83 x D236mm Weight printer 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 1096 to 10096 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 90 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 7 Contractions external toco Smythe guard ring tocody
16. AC mains supply ih 3 5232 interface to a PC running Sonicaid FetalCare RS232 Sonicaid System8002 or a central review system lt 6 500V DC isolation 9 way D type connector 4 Modem connection for distance monitoring 25 way D type Was Connect only modems which comply with EN60950 Same connector used for the Rimkus Telemetry system lt 6 5 Team printer connector 8 way DIN type 6 Fetal event marker socket 1 4 stereo jack socket Date of manufacture symbol for details of pin connections see Appendix 1 not available on Teams sold in the USA or Canada 14 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 sd Team frequency TEAM FREQUENCY MHz 1 4 Contrast control In the base of the Team main unit is a display contrast control marked with this symbol lt H This control is for the use of service engineers only 15 Sonicaid Team Operator s Manual 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 2 Printer on indicator 9 16 1 6 Team printer rear panel Sonicaid Team Operator s Manual WAPENS ust In the presence of Pleni de
17. 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 Sonicaid Team Operator s Manual 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 FetalCare 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 contractions information and fetal event marks You can select which channel to store Caution Avoid rapid cycling 10 seconds of the mains on off switch on the unit or of the mains power supply to the unit Under certain circumstances this may result in stored data being lost In particular stored fields such as User name date amp time may be reset if the unit is switched off on rapidly Do not rely on the memory features in this product to store permanent information such as an equipment id number 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 maxim
18. Healthcare Anybody who connects additional equipment to signal input or signal output parts of the system is configuring a medical system and is therefore responsible for ensuring that the system complies with IEC601 1 1 EN60601 1 1 If you are in any doubt whether your system does comply consult the technical service department of your local Huntleigh healthcare 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 is no special procedure for calibrating Sonicaid Team Sonicaid Team Operator s Manual Multiple Portable Socket Outlets including isolation transformers It is not recommended to power a medical system from a multiple portable socket outlet which is not supplied from an isolation transformer IEC601 1 1 EN60601 1 1 Amendment 1 If such an outlet is in use it should comply with the requirements of Annexe EEE 2 of 601 1 1 60601 1 1 Amendment 1 Note an isolation transformer is a 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 f
19. Manual 48 In a study of 14 near term normal fetuses with the threshold set at 4096 the sensitivity and specificity of the Actogram function compared with scanner identified breathing limb movement and trunk movement were 9696 and 6896 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 decrease 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 40 SENSITIVITY EXIT gt gt gt 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 Enter a new value The required threshold may depend on whether the trace is showing a high incidence of artefact It is recommended to set the threshold between 40 and 60 3 Observe the Actogram trace for a short period to see if the setting is satisfactory Sonicaid Team Operator s Manual Data storage Team stores Actogram event marks when it stores an FHR record It does not store the Ac
20. 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 101 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 MENU 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 1 Press MENU then NEXT then NEXT then START UP MODE 2 Press CHANGE Start up mode changes to HOME 3 Press SET STORE TI ME 4 Enter the store time required This must be between 12 and 65 minutes 5 Team asks IS THIS CORRECT If it is correct press ACCEPT If it is not correct press RE ENTER 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 is turned 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 Menu button on the keypad 2 Turn on the Team while c
21. a few minutes for the signal to stabilize and a clear 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 41 Sonicaid Team Operator s Manual Connection diagram for Sonicaid electrodes 7481 6101 42 FECG socket pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key 1 FECG socket on Team Red Green M REF Red Black FECG electrode ECG REF c FECG socket pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key 1 FECG socket on Team 2 MREF 3 FECG REF 4 FECG electrode Sonicaid Team Operator s Manual 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 0 MHz transducer 1 5 MHz transducer Team IP 2 0 MHz 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 TRACE FOR SAME HEART RATE e The printer prints this 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
22. and counted as signal loss Sonicaid Team Operator s Manual 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 ten Hof J Mulder EJH Nijhuis JG 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 J ournal of Obstetrics and Gynecology 2002 186 1095 1103 Brown R Patrick J The nonstress test how long is enough American J ournal 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 J ournal of Obstetrics and Gynecology 1992 166 415 69 Sonicaid Team Operator s Manual 70 7 Trend Printer option The Trend printer is the printer supplied if you purchase TeamlP Trend Note Sonicaid Trend analysis is not approved for sale in th
23. but not meeting the criteria for size or record length A single asterisk does not necessarily mean that the record cannot pass the criteria If all other parameters are normal at the 30 minute point the abnormality could be considered to be within acceptable limits to meet the analysis criteria Basal heart rate warnings A basal heart rate of 115 bpm or lower triggers a printed warning on the analysis report WARNING LOW BASAL FHR CHECK THAT FHR DOES NOT CONTINUE TO FALL FETAL MOVEMENTS PRESENT SINUSOIDAL RHYTHM 63 Sonicaid Team Operator s Manual V LON SI unogwi oum CITA SYSATUNV SHNIH IV 91931189 HVLEISH SJHV ASH NOIIMIHUA INONS 53405191 01 NOTLVISUA SSTT IWH 5150035 10 5266 SAA be i B f NIM 52009147 BOTH 2 SIVI 1501 OZ lt 501194313970 F 7998 ST Hall St 4 T 998 si Hdd OT lt SHOIIUHTT322 I NOMOVNIROO HdE JIVE 1599 19840 09 AROE N3d 8179 19134 9807 198015 98710 60 HIIS ALIA BEST HLIWS VE 801191539 24419655655 3 2 wr 96 70 80 Alva IVAOM Example printout of TeamCare trace and analysis report 64 d Team Operator s Manual icai Son TeITGSDEHIS 218393904 S18383A0H 19113 05 OL 3INIINOO LON 330 33H29 D HJ T SVI 07 DNINSUA 6 5801 THHOIS HJH 310H x d
24. by the Team Care analysis Alarms During analysis the Signal Loss alarm is fixed at 3096 In addition there is a fixed Toco alarm that alerts the user to a constant Toco value for 10 minutes Once this alarm has been acknowledged it will not re alarm during the same analysis Fetal ECG 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 Setup 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 Press the 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 BW Stopping the analysis 1 Press the printer button once to stop the printer 2 The trace 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 RESULTS gt gt gt in the display message bar The Tea
25. continuous operation The equipment must be serviced only by authorised and qualified personnel Huntleigh Healthcare 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 N gt 1 Fetal ECG electrode lead BF IUP catheter interconnection lead Maternal ECG lead 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 parts touching conductive parts w Ultrasound transducers External Toco transducer N Type B protection means these patient connections comply with permitted leakage currents dielectric strengths and protective earthing limits of 55724 1 601 1 93 Sonicaid Team Operator s Manual 94 vii Installation is the responsibility of the vendor via a competent person approved by Huntleigh Healthcare viii This equipment is not protected against xi a the effects of defibr
26. 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 From the Home Mode Setup Menu press VOI CE PHONE NO 2 Enter the 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 From the Modem Setup Menu press NEW PHONE NUMBER 2 Enter the telephone number required 3 Team asks IS THIS CORRECT If it is correct 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 From the 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 79 Sonicaid Team Operator s Manual 80 8 5 Team DM connections OU 5B Remove the telephone handset connector from the telephone socket Plug the dual adaptor into the telephone socket Reconnect the telephone handset to the dual adaptor Connect
27. law In the rest of the world the choice of electrodes may depend on local legislation FDA compliant non FDA electrodes compliant 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 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 connections is not important Make sure a good signal is maintained Allow a few minutes for the signal to stabilize and a clear 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 scalp or presenting part following the manufacturer s instructions Connect the FECG electrode to the FECG lead Allow
28. 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 amp WN 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 Appendix 4 Electromagnetic compatibility IEC EN60601 1 2 2001 Explanation of symbols This symbol indicates that the Sonicaid Team includes RF transmitter or that it applies RF electromagnetic energy for diagnosis or treatment Medical electrical equipment needs special precautions regarding EMC It must be installed and put into service according to the EMC information provided in the accompanying documents Portable and mobile RF communications equipment can affect medical electrical equipment Statement of essential performance The following are deemed to be essential performance e The displayed results for heart rate Toco IUP FECG should be consistent with the inputs e The printed results for heart rate Toco IUP FECG should be consistent with the inputs e The ultrasound audio output should be consistent with the input heart rate Fetal movements should be reported on the screen and printout e No spurious maternally sensed events should occur Minimum amplitude or value Caution
29. 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 MECG as a 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 annotates the 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 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 2 4 Loading printer paper 1 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 Place the 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
30. on the back of the transducer into the rack on the right hand side of the Team base unit Sonicaid Team Operator s Manual 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 Alphanumeric display mode 1 1 2 3 Key to alphanumeric display 1 Heart rate in beats per minute 2 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 Intra uterine pressure catheter 3 Contractions measurement Percentage full scale deflection when using an external Toco transducer Pressure mmHg kPa when using an intrauterine pressure catheter 4 Display Message Bar includes date time and patient name if entered Also used for display of interactive messages 5 Heart rate lamp a heart shaped flashing indicator 6 The active audio channel indicated by highlight on channel mode 7 Signal quality indicator No bars no signal Two bars average One bar poor Three bars good 8 gt press this key to change to Trace Display mode Note this facility is not available on any Team running the Care or Trend analysis or with Team IP when monitoring two heart rates using either ULT Y and FECG
31. relative humidity should be at least 3096 Electrical fast 2kV for power 2kV for power Mains power quality should be that transient burst supply lines supply lines of a typical commercial or hospital IEC 61000 4 4 1kV for input 1kV for environment output lines input output lines Surge 1kV differential 1kV differential Mains power quality should be that IEC 61000 4 5 mode mode of a typical commercial or hospital X2kV common 2kV common environment mode mode Voltage dips 596 Ur 29596 dip lt 5 Ur 29596 dip Mains power quality should be that short interrup tions voltage variations on power supply input lines IEC 61000 4 11 Power frequen cy 50 60Hz magnetic field 61000 4 8 in for 0 5 cycle 4096 6096 dip in for 5 cycles 70 Ur 30 dip in for 25 cycles 596 29596 dip in for 5 seconds 3 A m in for 0 5 cycle 4096 6096 dip in for 5 cycles 70 30 dip in for 25 cycles 596 29596 dip in for 5 seconds 3 A m of a typical commercial or hospital environment If the user of the Sonicaid Team requires continued operation during power mains interruptions it is recommended that the Sonicaid Team be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital location
32. 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 gt 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 3ms e Basal heart rate 116 bpm or gt 160 bpm on a record gt 30 minutes e Decelerations present
33. 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 On 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
34. 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 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 is titled 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 81 Sonicaid Team Operator s Manual 82 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 Trend analysis are also measured over a 15 minute period Answer Team has 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
35. the pack with the blue marks on the compartment Pull two folds clear of the chart printer to the right Then fold them back to the left across the top of the platen as it is fitted at a downwards angle to the right If necessary adjust the paper positioning between the sides of the paper channel and press down on the left edge of the platen to latch it If after a period of use the print quality is poor check that the platen is closed If still poor clean the print head as detailed in the Technical Maintenance section Sonicaid Team Operator s Manual 31 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 The trace header is fast printed 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 cm min Up Up Turning the printer off 1 Press the printer button once 2 The printer fast forwards a little way to allow the paper to be torn 3 The indicator 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 32 Sonicaid Team Operator s Manual 2 6 Team menu system To see the menu
36. 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 top scale the secondary channel ULT B or FECG below In full width printing the primary channel ULT Y is printed as a solid line the secondary channel ULT B or FECG as a dotted line 43 Sonicaid Team Operator s Manual 44 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 ch
37. you see the message TO BEGIN RECORDING PRESS 41 Remedy 1 2 3 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 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 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 Switch the Team unit off 2 Switch on again holding down the key 3 Wait for the Team unit to beep then release the key 4 The Telemetry menu option will now appear Remedy 1 Switch the Team unit off 2 Switch on again holding down the MENU key 3 Wait for the Team unit to beep then release the MENU key 4 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 83 Sonicaid Team Operator s Manual 84 9 3 Problems replaying or printing traces Problem On Team Duo 1 can t hear the 1 5MHz transducer Problem When I try and reprint a stored trace the trace is blank Problem The Toco channel of the graph is scratchy and distorted h
38. 1000 0270 1000 0240 Sonicaid Team Operator s Manual 10 6 Servicing and guarantee Servicing Servicing should be performed only by Huntleigh Healthcare s service department or their appointed service agent If you have difficulty obtaining service for Team contact Huntleigh Healthcare or your supplier Guarantee Team is guaranteed against defects in materials or workmanship for 24 months for the main unit 12 months for transducers and cables and 90 days for consumables applicable from the date of purchase Any system which is proven to be defective within this period shall at the discretion of Huntleigh Healthcare 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 goods are returned to Huntleigh Healthcare 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 Huntleigh Healthcare 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 Huntleigh Healthcare have any liability for loss or indirect damage or consequential damages 89 Sonicaid Team Operator s Manual 11 Specifications 11 1 Physical and environmental Physical Dimensions base unit W275 x H83 x D275mm Weight base unit
39. 2 1 4 Analysis results erem At IIb Rea RS 73 7 5 Viewing trend data ei a ot D RERUM EN 75 7 6 Analysis parameters and 75 8 Team DM Distance 77 8 1 Descriptiol xax E a la 77 8 2 Manualmode setup E XR 77 8 3 Home mode setup EORUM E ERI OERTES 78 Sonicaid Team Operator s Manual 8 4 Modem setup duet Peor epe gh drin P UE 79 8 5 x ERR RETE RR 80 98 6 gt Procedures ciis SEE RE t AL 81 9 Troubleshooting n dre eere 82 9 1 General d estloris cote eR ce Re ae Xe et eg 82 9 2 Problems when you first switch memes 83 9 3 Problems replaying or printing 84 9 4 Team cycling from Logo screen to 84 10 User Maintenance Tias eene pean dnce duode npe ec pee per ee 85 10 1 Cleaning and sterilisation csse Hmm 85 10 2 Printer Paper soie Eee o oe tet iet EO De P eel aha 86 10 3 Technical eee 86 10 4 Co
40. E 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 0088 Directive 93 42 EEC concerning medical devices THI S FETAL MONITORI NG SYSTEM IS A PRESCRIPTI ON DEVICE IN THE USA Sonicaid Team Operator s Manual Indications for use Sonicaid Team fetal monitors are indicated for use during the antepartum period and to monitor fetal and maternal vital signs during labour and delivery intrapartum 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 ultrasound transducers and uterine activity with an external toco transducer Sonicaid Team IP monitors twin fetal heart rates 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 catheter pressure transducer Team IP can also measure the maternal heart rate this feature 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
41. ER HR PERRA laced 53 Bed eo t edet as odori ere eet 53 5 2 Selecting a stored record for meme 55 5 3 Displaying a stored 55 5 4 Printing a stored 55 5 5 Transferring a stored record to Sonicaid FetalCare or System8002 56 5 6 Deleting a stored record sess emen 56 6 Care Printers osten naa eta ve Aap EU edet Perte eer 57 OL rete Pete cut end vr paite d a a s 57 6 2 Intended S6 o oreet egest enr DIU TEN Nd 57 6 3 The Dawes Redman criteria sss memes 58 6 4 Care analysis oe te 58 6 5 Using the analysis etm ede ER IET 60 6 6 The arialysis TepOrt coo eec ex eee 62 6 7 Plotting trend dataz ree er eret 66 6 8 Analysis parameters and 66 6 9 References ue eode eed ena vetet eene 69 7 Trend Printer option 70 Z3b JrtroductioDi saecu oer re t reete cr erint oratio merece Suae e Fn Nel er itas 70 42 Team Trend analysis oie D Dx or eee dei bee 71 7 3 Using tlie analysis ere Rer eren p eder tuy c een 7
42. NG PRESS gt gt gt Team starts storing data and a timer the display message bar shows the 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 is turned 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 MENU button on the keypad 2 Switch on Team while continuing to hold down the MENU button 3 Release the button when the logo clears from the display 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 the Team base unit 2 Switch on the Team base unit 3 The Team automatically tries to re dial and transfer the data Manual mode Auto Dial 1 Put Team into Manual mode With Team switched off press and hold down the MENU button on the keypad Switch
43. The following table shows the default print speed in different countries 1 cm min 3 cm min North America USA and Canada Y Europe and the rest of the world Y To change the print speed see section 2 5 Sonicaid Team Operator s Manual 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 graticule The header includes user name date and time and patient details if entered Graticule The graticule is printed at the same time as the trace data with a 5 bpm or 10 bpm grid Set printer switch 2 up for 5 bpm 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 29 Sonicaid Team Operator s Manual 30 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
44. 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 can connect Team directly to FetalCare or System8002 for real time analysis of monitored data Note Sonicaid Team can also be connected to the Sonicaid Centrale antenatal and labour management system for CTG viewing amp archiving This includes a CTG analysis option For further information on this and for advice on connection to other CRS systems contact your supplier or Huntleigh Healthcare s technical support department 45 Sonicaid Team Operator s Manual 46 Note analysing twins Team can send real time FHR data for twins to 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 COMI 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 Sonicaid Team Operator s Manua
45. als averaged over 1 16 minute to fit a baseline to the fetal heart rate trace Accelerations and decelerations are measured from this baseline The baseline follows slow but not rapid changes in 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 suggests the possibility of fetal infection 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 clinical 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 use the first of these definitions A count of a
46. am while continuing to press MENU Release the MENU button when the logo clears from the display Press MENU three times Select START UP MODE The start up mode is shown as HOME Press CHANGE The start up mode now shows MANUAL OU AUNE 77 Sonicaid Team Operator s Manual 78 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 1 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 Team is now ready for use at the remote site The next time it is turned 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 MENU on the keypad Turn on the Team while continuing to press MENU Release the MENU button when the logo clears from the display Press MENU three times Select START UP MODE The start up mode is shown as Press CHANGE The start up mode now shows MANUAL Setting up the store time In Home mode Team stores a record of preset length 12 65 minutes 1 From the Home Mode Setup Menu press SET STORE TIME 2 Enter the time required 3 Team asks IS THIS CORRECT If it
47. ave 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 extension cable with a cloth dampened in soap or detergent solution to remove aquasonic gel blood saline etc Wipe dry 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 296 Glutaraldehyde solut
48. 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 Sonicaid Team Operator s Manual 21 Sonicaid Team Operator s Manual 22 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 option Used for interconnection between Team and an intrauterine pressure catheter Colour coded pink can only be used on a Team IP base unit It is not 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 belongs to 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 external toco transducer can be stored by clipping the stud
49. ccelerations meeting both definitions is made on the analysis report Sonicaid Team Operator s Manual Decelerations The analysis defines a deceleration as being a trough gt 10 bpm below the baseline for more than 1 minute or gt 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 beats is 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 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 9o likelihood of metabolic ms acidaemia or intrauterine dea
50. clearest heart sound will normally be found on the midline below the umbilicus 38 Sonicaid Team Operator s Manual e itis not possible to monitor the fetal heart rate unless an audible fetal heart signal is present though it is possible to detect signals other than those of the fetal heart under some circumstances These may be falsely reported see section below To distinguish the fetal pulse from the maternal pulse palpate the mother s pulse during the examination and compare the value with that of the recorded signals or use the Maternal ECG facility e Auscultate the fetal heart with a Pinard stethoscope or a handheld Doppler to verify the fetal heart prior to placement of the ultrasound transducers Not available in the USA and Canada False recording of low baseline FHR When monitoring a low baseline FHR using Doppler ultrasound the heart rate may be falsely reported This effect is known as double counting and is characteristic of ultrasound fetal monitoring In normal circumstances the atrium and ventricle beat almost simultaneously The ultrasound reflected from these two chambers is used by fetal monitors to calculate the FHR When the FHR is low at 70 80bpm there is a longer time interval between the atrial and ventricular contractions A fetal monitor may take the reflection from each chamber as a separate beat and therefore falsely calculate the FHR It can also happen though very rarely that the monitor double
51. counts signals which are maternal in origin The Sonicaid Team s heart rate detection system separates movements of the heart away from the transducer from those towards the transducer This helps to correct some instances of double counting but does not entirely prevent it How to minimise the chances of double counting occurring 1 Always palpate the abdomen and listen to the fetal heart with a Pinard stethoscope or hand held Doppler unit before applying the ultrasound transducers This helps to verify the fetal heart and to locate the area where best signal quality can be expected 2 Palpate the maternal pulse for one minute simultaneously and record it on the printed trace 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 Team Audio signal The sound should be like a galloping horse not a swishing sound from maternal vessels 39 Sonicaid Team Operator s Manual Questionable FHR due to high signal loss When monitoring where high signal loss gaps in trace is experienced due to fetal movement reposition the ultrasound transducer for optimal signal strength i e where the loudest fetal heart sounds are obtained Secure with belt and buckle Extra gel may be required for optimal pick up During labour where questionable FHR is being recorded and cannot be improved by repositioning the ultrasound transducer consider m
52. d to provide reasonable protection against such interference Whether the equipment causes interference may be determined by turning the equipment off and on If it does cause or is affected by interference one or more of the following measures may correct the interference e Reorienting the equipment e Relocating the equipment with respect to the source of interference e Moving the equipment away from the device with which it is interfering e Plugging the equipment into a different outlet so that the devices are on different branch circuits Adding 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
53. 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 is to 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 fetus into 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 59 Sonicaid Team Operator s Manual 60 Actogram Event marks recorded by the Actogram facility are not used
54. e 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 60 MIN BASELINE 15 MIN BASELINE 60 MIN STV 60 MIN DECEL 15 MIN DECEL CONFIDENCE TREND 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 73 Sonicaid Team Operator s Manual 666 50 H 06T 1 IONIQILINOO ST 16 129 NIN 08 T3030 UH 07 T NIN 09 FALS 81 52531 15 0 86 10 51 NIW WO T 9934 02 97 ___4007 2911 TS 0 86 10 47 NIW WO 1 9914 01 41 NIW 09 2 1135 48 3400 021 ObT 097 DBT 087 002 002 m Printout showing Team Trend analysis results 74 Sonicaid Team Operator s Manual 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
55. e USA and Canada 7 1 Introduction The Team Trend printer incorporates an analysis system for use during the intrapartum period The analysis which provides measurement of fetal heart rate parameters 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 quantify 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 provides training support for trace interpretation and readily available data for clinical research projects The analysis is an 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 WARNING the analysis is valid on
56. e 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 Menu press DIRECT DATA 3 Data transfer 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 5 6 Deleting a stored record Once a record has been printed or transferred to Sonicaid FetalCare 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 Sonicaid Team Operator s Manual 6 Care Printer The Care printer is the 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 performs a test against criteria that define a normal record Abnormalities are highlighted The analysis is based on mor
57. e second analysis at 30 minutes Baseline heart rate The baseline heart rate is calculated as the 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 gt 10 bpm below the baseline for more than 1 minute or gt 20 bpm below the baseline for more than 30 seconds Signal loss The system monitors the loss of fetal heart rate signal Where there is a gap in the trace due to signal loss the analysis interpolates a straight line through the missing section when fitting the baseline If signal loss is greater than 50 the analysis will not be able
58. e 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 Radcliffe Hospital Oxford England See 6 8 References 6 2 Intended use The intended use of Sonicaid TeamCare is for the analysis of antepartum cardiotocograms in pregnancies from 26 weeks gestation onwards 32 weeks in the USA It can be used on women who are experiencing Braxton Hicks contractions but is not intended for use in established labour as the fetus is then exposed to additional factors such as labour contractions pharmacological agents and epidural anaesthesia The analysis provided Sonicaid TeamCare is intended as an adjunct to not a replacement for the physician s visual assessment of a cardiotocogram As such Sonicaid TeamCare is an aid to clinical management but not a diagnosis which remains the responsibility of an appropriately qualified physician Indeed both the physician s visual assessment of a cardiotocogram and the analysis provided by Sonicaid TeamCare should be considered within the context of a full clinical assessment before decisions are made regarding management Such an assessment may include further tests such as umbilical blood flow velocity waveforms or biophysical profiling Caution A variant of the Dawes Redman analysis is also available as an option in two PC based sof
59. eck that the heart rate being recorded belongs to the fetus and not the mother Available only on the Team IP The maternal ECG MECG lead and disposable electrodes are not included but are available as options 1 Apply self adhesive disposable electrodes to the mother As it is only necessary to pick up the maternal pulse and not the ECG complex placement of the electrodes is not critical but it is a good idea to have the third lower electrode placed clear of the diaphragm as the muscles here are very active in contraction Sonicaid Team Operator s Manual A recommended arrangement of the electrodes might be 2 Connect the MECG lead plug blue to the blue socket on Team 3 Clip the three flying leads of the MECG lead to the electrodes They are colour coded white black and red W B and R in the diagram above 4 Allow a few minutes for stabilisation and a clear 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 Team bleeps The display shows ICHECK 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 is the replacement for Sonicaid System8002 The analysis measures fetal heart rate parameters and performs a test
60. ency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Sonicaid Team is used exceeds the applicable F compliance level above the Sonicaid Team should be observed to verify normal operation If abnormal operation is observed additional measures may be necessary such as reorienting or relocating the Sonicaid Team gt Over the frequency range 150 kHz to 80 MHz the field strengths should be less than Vi V m EMC environment Make sure the environment in which Sonicaid Team is installed is not subject to strong sources of electromagnetic interference eg radio transmitters mobile phones This equipment generates and uses radio frequency energy If not installed and used properly in strict accordance with the manufacturer s instructions it may cause or be subject to interference Type tested in a fully configured system it has been found to comply with 601 1 2 60601 1 2 the standard intende
61. gh Healthcare Service Department or their appointed service agent Preliminary 1 Connect the ultrasound transducer to the Team 2 Turn on 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 99 Sonicaid Team Operator s Manual 100 Ultrasound transducer test The crystal elements in a transducer can be damaged if the transducer is dropped If one or more crystals have been damaged this can leave non receptive areas on the transducer face reducing the beam coverage The positions of the crystals behind the transducer face are shown below 1 Squeeze a small amount of Aquasonic gel on to the transducer face over each crystal 2 Move the gel tube rapidly up and down over each crystal keeping the tip of the gel tube in contact with the transducer Check that you get an audio signal synchronised with the tube movement Sonicaid Team Operator s Manual Appendix 3 Procedures for Distance Monitoring In the hospital The procedure required by the operator of the System8002 is titled Home
62. he Clinical Event button v 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 Sonicaid Team Operator s Manual 4 4 Alarms Alarm setup menu 1 Press MENU once 2 Select ALARM SIGNAL LOSS LOW FHR FETAL gt gt gt HIGH FHR Signal loss alarm You can set a signal loss threshold above which an alarm will occur This threshold 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 From the Alarm setup menu press SIGNAL LOSS 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 signal loss required 4 Team asks IS THIS CORRECT If it is correct press ACCEPT If it is not correct press RE ENTER To turn the signal loss alarm off 1 From the 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
63. he fetal heart is heard Check that the signal quality indicator shows at least two bars and preferably three Check that the fetal heart pulse lamp flashes with each fetal heartbeat 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 Adjust the sound level with the volume control buttons at the left side of the display Procedure for twins Team 1 2 Palpate the abdomen and ascertain the lie of each fetus Place the yellow transducer on twin two ensuring a good fetal heart rate signal Secure the transducer with a belt Place the blue transducer over twin one again ensuring a good fetal heart rate signal Secure the transducer with a belt 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 After use remove the blue transducer see warning in section 2 1 37 Sonicaid Team Operator s Manual Toco transducer Ultrasound transducer Transducer positioning Hints on use e Make sure the transducer is placed in the optimum position To determine this palpate the abdomen to determine fetal position Avoid placing the transducer where strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate occur e If the fetus is in the cephalic presentation and the mother is supine the
64. iew 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 From the Review Options Menu press DISPLAY 2 To scroll through the display press To change the displayed range press 4 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 real time printing at a speed of 10cm per minute 1 From the 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 55 Sonicaid Team Operator s Manual 56 5 5 Transferring a stored record to Sonicaid FetalCare 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 COMI interface on th
65. illator shocks or discharge b the effects of high frequency currents C the effects of bistoury either 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 601 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 parts in 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 consideratio
66. ion 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 7096 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 85 Sonicaid Team Operator s Manual 86 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 product 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 Raisethe small latch and remove the fuse 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 supp
67. is document Trademarks Sonicaid is a registered trademark of Huntleigh Healthcare in the UK and other countries Safelinc is a registered trademark of Tyco Sonicaid Team Operator s Manual 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 Sonicaid 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 11 Sonicaid Team Operator s Manual 12 1 Introduction 1 1 Team fetal monitors Sonicaid Team fetal monitors provide accurate and reliable monitoring throughout the antepartum and intrapartum periods The feta
68. l 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 felt 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 movement The Actogram value can be printed as a line graph on the contractions trace or as fetal event marks above the trace or both An event mark is printed every time the amplitude goes above a set threshold The default threshold is 4096 of full scale deflection but it can be set to any value in the range 0 9996 47 Sonicaid Team Operator s
69. l 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 transducer 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 fetal 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 clinic or the patient s home Team DM provides the same facilities as Team Standard but includes a modem for transmitting stored data This is an optional feature not currently available in the USA or Canada There are two Team printers available Care Thermal printer for a continuous paper record of monitored data incorporating 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 Sonicaid Team Operator s Manual 1 2 Main unit front panel Sonicaid
70. ly 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 1 Setall 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 AUN 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 still 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 beneath 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 Sonicaid enginee
71. ly during the first stage of labour Sonicaid Team Operator s Manual 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 in lost beats for the last 60 minutes Deceleration size in lost 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 as Mor 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 is thought that they are a sensible reflection of the visually assessed pattern Analysing twins When monitoring twins both channels are analysed simultaneously 71 Sonicaid Team Operator s Manual 72 7 3 Using the analysis Starting the analysis 1 Setup Team as you would to record a normal trace 2 Press the printer butt
72. m 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 MENU once 2 Select TURN ANALYSIS OFF 3 Press the printer button to start recording By default the analysis is 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 include the gestational age 61 Sonicaid Team Operator s Manual 62 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 Dawes Redman criteria were met at the time the analysis was
73. m 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 1696 from the baseline for 30 seconds or more A count of contractions meeting this definition is made on the analysis report Signal loss The system monitors the loss of fetal heart rate signal Where there is a 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 is fixed at 3096 The signal loss as a percentage of the whole record is given on the analysis report The analysis is not able to interpret the data if there is signal loss gt 8096 If there is signal loss gt 5096 during either an acceleration or a deceleration of greater than 20 lost beats the acceleration or deceleration is not counted Errors Signal artefacts are detected by the analysis
74. namometer with clip for attaching patient belt Auto zero and Manual zero Protection Category B Nominal Sensitivity 150g full scale 91 Sonicaid Team Operator s Manual 92 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 rms to ground 5 mV V mmHg x 596 nominal transducer Sonicaid Team Operator s Manual 11 5 Safety i iii iv i V Team is designed to comply with 601 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
75. ns General Diagnostic ultrasound has been in use for over 25 years with no confirmed adverse effects on 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 is therefore deemed desirable by medical and other scientific authorities that exposure to ultrasound should be limited to a duration and intensity appropriate to the clinical 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 clinical effects and observations b Ziskin M C in World Policies on the Use of Diagnostic Ultrasound in Obstetrics The American Institute of Ultrasound Policy and Statement on Safety Ultrasound in Medicine and Biology 12 711 714 1986 Fetal use Team is designed for continuous fetal heart rate monitoring during pregnancy and labour Interpretation of fetal heart rate pa
76. ns 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 Press the 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 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 5 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 fit the paper pack and platen To reassemble 1 2 Remove the centre blanking plug if fitted from the Team base unit top
77. on 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 CAUTI ON if you reconfigure Team any records held in the store are deleted and all defaults are reset to factory set defaults Team menus are available in different languages To change the choice of language 1 From the VERSION Menu select RECONFIGURE 2 Team displays a message EXIT THEN TURN UNIT OFF TO RECONFIGURE 3 Select EXIT Switch off Team then switch on again 5 Team now shows the available languages Select the language you want Use the button 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 35 Sonicaid Team Operator s Manual 36 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 as the number of weeks followed by the number of days If
78. on 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 CONTI NUE to resume Turning the analysis off To record a trace without the analysis 1 Press MENU once 2 Select TURN ANALYSIS OFF 3 When done press EXIT 4 Press the 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 is for 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 Sonicaid Team Operator s Manual 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 colour ULT Y Yellow ULT B or FECG Blu
79. onitoring by an alternative means e g fetal scalp electrode 3 2 External Toco contractions transducer 1 Check that the plastic membrane 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 6 Contractions activity is measured as a percentage of full scale deflection The contractions measurement automatically zeroes to 1096 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 AUN Replacing the membrane on the transducer 1 Remove damaged membrane 2 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 40 Sonicaid Team Operator s Manual 3 3 Fetal ECG scalp electrode TeamIP only Fetal scalp electrodes Sonicaid supply 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
80. ontinuing to press the Menu button 3 Release the key when the logo clears from the display 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 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 Connect the telephone and modem to the dual telephone adaptor Selecting and sending the stored record 1 Press MENU then NEXT then REVI EW A list of records appears 2 Press the key marked V until the selection arrow on the left of the displa
81. or ULT Y and MECG 23 Sonicaid Team Operator s Manual FHR Trace Display mode CTG mode 1 2 1 Go Gn n e 6 02 11 95 CTG I gt _ 3 4 1 Heart rate range beats per minute indicates the range currently displayed 2 Heart rate lamp heart shaped flashing indicator 3 Channel mode indicates heart rate channel on display 4 Display message bar used for display of interactive messages 5 Heart rate trace Displays the 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 Press the Enter button next to the menu pointer The display will show the trace over the range 80 120bpm The menu pointer will then read gt 2 Press the 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 3 Press the Enter button next to the menu pointer The display will return to Alphanumeric display mode 24 Sonicaid Team Operat
82. or 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 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 The copyright and the foregoing restrictions on the copyright use extend to all media in which this information may be preserved This copy of the Operator s Manual shall be used only in accordance with the conditions of sale of Huntleigh Healthcare or its distributors Huntleigh Healthcare makes no representations or warranties of any kind whatsoever with respect to this document Huntleigh Healthcare disclaims all liabilities for loss or damage arising out of the possession sale or use of th
83. or s Manual 1 12 The Team Keypad LA 60 N Ul OOOO There are eight buttons on the Team display panel Their primary functions are Toco zero zeroes the external Toco contractions transducer or UP catheter Volume control up Volume control down Channel select Menu access Not used Clinical event marker Enter confirms an entry or switches display modes ON AU P UN 25 Sonicaid Team Operator s Manual 26 2 Getting Started 2 1 Summary of recording procedure Setup 1 Place transducer belts across the bed or chair 2 Make the patient comfortable in a semi recumbent or sitting position Preparing the Team 1 Switch on The on off switch is on the rear of the base unit Caution Avoid rapid cycling 10 seconds of the mains on off switch on the unit or of the mains power supply to the unit Under certain circumstances this may result in stored data being lost In particular stored fields such as User name date amp time may be reset if the unit is switched off on rapidly Do not rely on the memory features in this product to store permanent information such as an equipment id number 2 Check paper Is there sufficient paper for the monitoring session Make sure the printer platen is securely closed 3 Connect transducers The plugs and sockets are colour coded the display confirms transducer connection Warning The blue 2 0MHz transducer must only be used f
84. or twins monitoring in conjunction with the Yellow 1 5MHz transducer If this is used for single channel monitoring certain monitor functions including the Care analysis will not operate correctly and may give misleading results After using the blue transducer for twins monitoring disconnect it do not leave this transducer plugged in Transducer placement 1 Palpate the abdomen to determine fetal lie and position 2 Position the Toco transducer pink centrally halfway between fundus and umbilicus Do not use gel Secure with belt and buckle 3 Zero the Toco Make sure the uterus is relaxed then press the zero button The 10 baseline is displayed 4 Gelthe yellow ultrasound transducer do not use the blue transducer see warning above Place it on the abdomen so as to obtain a clear heart sound Secure with belt and buckle 5 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 6 Adjust the volume using the volume up and down keys 7 Sonicaid Team Operator s Manual Connect the fetal event marker to the socket on the rear panel Show the patient how to use it Using the printer 1 2 3 To switch the printer on press the button on the printer front panel To fast forward the paper pres
85. r value 2 6 107 Gables E 108 Transducers and accessories 108 Electromagnetic emissions guidance to 109 Electromagnetic immunity guidance to user 1 110 Electromagnetic immunity guidance to user 2 111 environment ER MERI 112 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 requirements for safety Section 1 2 Collateral standard Electromagnetic compatibility Requirements and tests EN61157 1995 Requirements for the declaration of the acoustic output 1EC61157 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 Sonicaid Trend analysis addition for FECG the use of FDA compliant fetal scalp electrodes is required in the USA and Canada Patient safety WARNING DO NOT TOUCH LIV
86. resenting 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 27 Sonicaid Team Operator s Manual 28 2 2 The Team printer There are two Team printers available Care Thermal printer for a continuous paper record of monitored data 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 trace annotation loading printer paper and printer operation apply to both 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 standard 5 year paper 8400 8003 ArchiTrace 25 year archival paper 321414 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 product warranty Horizontal scale print speed The printer has three speeds 1 cm min 2 cm min and 3 cm min
87. returns to the fetal heart rate display after two minutes or when you press EXIT TIME 21 06 22 06 00 06 60 MIN BASELINE 139 141 138 60 MIN STV 7 8 8 6 8 0 60 MIN DECEL 280 290 350 CONFIDENCE M H H gt gt gt 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 is fitted in such a way as to follow slow but not rapid changes in the fetal heart rate The baseline is re fitted at every analysis as further information becomes available Confidence indicator The confidence measure for baseline fit is based on points for possible errors Points Confidence 1 High 20r3 Medium 4 Low Note the confidence indicator defaults to Low for the first analysis at 15 minutes 75 Sonicaid Team Operator s Manual 76 One point is allocated e For every 5 minutes the heart rate is away from the baseline e If the commonest heart rate is lt 1 of the total number of heart rates e If the current 60 minute baseline value differs from the previous 60 minute value by more than 20 bpm For every 2096 of hourly signal loss e Forthe third analysis at 45 minutes Two points are allocated e Forth
88. rrective maintenance 87 10 5 Accessories consumables and spares 88 10 6 Servicing and guarantee 0 89 11 Specifications ei t e eer ic e OR 90 11 1 Physical and menn 90 11 2 AC supply voltage and fuse 90 11 3 SPRINGS d o e ee PE UL dre ETE I MEER 91 11 4 Transducers e urre Ae ea Ae peter tide c Eee e erre ees 91 11 5 iSafeby sc E E dr eu d acu Eus 93 11 6 Ultrasound safety 5 lt eee eee eee eee eee 95 Appendix 1 External 96 Input output levels and pin 96 RS 232 INCOM ACE d c Sat et a eed 97 Fetal event marker 2 2 4 2 n 98 TEeany Printer connector pe tU nb iier c b 98 Appendix 2 Transducer lt 99 Appendix 3 Procedures for Distance Monitoring sess 101 Appendix 4 Electromagnetic compatibility IEC EN60601 1 2 2001 107 Explanation of symbols rte pete obe ue e aide ee e 107 Statement of essential performance 107 Minimum amplitude o
89. rs approved by Huntleigh Healthcare The Sonicaid Team Service Manual order part number 8909 8540 is designed as an aid to engineers in maintenance and service of repairable parts 87 Sonicaid Team Operator s Manual 88 10 5 Accessories consumables and spares Accessories Team trolley Carrying bag for base unit Carrying bag for base unit and printer Intran IUP catheter interconnection lead Team IP Maternal ECG lead Team IP Team to System8002 lead Service Manual Consumables Aquasonic gel 20gm sterile sachet 60gm tube 0 25 litre bottle 5 litre container Membrane for Toco transducer 50 Transducer belts 1 5 m pack of 2 Transucer belt buckle Fetal ECG scalp electrode spiral Belt for fetal ECG electrode leg plate Intran disposable IUP catheter transducer Printer paper standard 5 year grade 45m Printer paper ArchiTrace 25 year grade 45m Adult ECG electrodes pack of 25 Trend graph pad Spares 1 5 MHz ultrasound transducer 2 0 MHz ultrasound transducer External Toco transducer Fetal ECG electrode leg plate Event marker lead Team to printer lead Fuse T315mA 100 120V supply Fuse T160mA 200 240V supply 8900 6990 8900 8003 8900 8006 8400 6937 8402 6969 8400 6952 8909 6914 1300 0145 1300 0152 1300 0153 1300 0154 1300 0216 8400 8026 8400 6208 1400 0160 7481 6101 8400 8011 8400 8003 321414 ED 25 8902 8002 8400 6919 8400 6920 8400 6921 8400 6922 7775 6901 8900 6955
90. s 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 After use remove the blue transducer see warning above 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 patient 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 p
91. sonicaidTEAM Operator s Manual O Huntleigh Healthcare 2005 All rights reserved 738393 1 sonicaid Sonicaid Team Operator s Manual The Sonicaid Team range of fetal monitors has been designed and manufactured by Huntleigh Healthcare an international company that has always had an enviable reputation for innovation and quality of its products Sonicaid Team is in conformity with the Medical Device Directive 93 42 EEC and has been subject to the conformity assurance 0088 procedures laid down in the European Council Directive Huntleigh Healthcare is certified by LRQA as an approved medical device manufacturer Address Huntleigh Healthcare 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 diagnostics com Sonicaid Team Operator s Manual Contents TE 3 Standards compliance naod e ERA rH Pe Ar 6 Patient safety spritsen nannaa RARI a EEEE EEA EEA SE 6 Or e a E a 6 indications for secu e beneath eet ere Yun 7 End of life disposal otio E aa EE Ru 7 System linstallation c ERR oboe 8 Calibration ra e be a etn ae 8 Multiple Portable Socket Outlets sess Ime emen enne 9 EE
92. th 4 0 3 5 4 0 8 3 0 3 5 29 2 5 3 0 33 lt 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 as a 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 consecutive 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 is independent of the basal heart rate 67 Sonicaid Team Operator s Manual 68 High variation occurs when the fetus is in an active sleep phase and low variation when it is in quiet sleep As the 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 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 artefact For each remaining interval the maximu
93. 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 51 Sonicaid Team Operator s Manual 52 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 Enter the heart rate threshold required Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER Enter the delay time required Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER BU Ul 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 restarts if you reset the alarm while storing or printing When the set time has elapsed an alarm occurs To set the timer 1 Press MENU once 2 Select ELAPSED TIME 3 Select ALARM ON SILENT or ALARM ON AUDIBLE 4 Enter the period required 5 Team asks IS THIS CORRECT If it is correct press ACCEPT If not press RE ENTER To turn the timer off 1 Press MENU once 2 Select ELAPSED TIME 3 Select
94. tion or variability in high episodes gt the tenth centile and fetal movements gt 20 e No errors or decelerations at the end of the record 6 4 Care analysis 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 is shown 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 Section 6 6 Note if the criteria are met but for some reason you
95. to calculate the parameter values The signal loss also affects the reliability of the baseline fit Sonicaid Team Operator s Manual 8 Team DM Distance Monitoring 8 1 Description The Team DM base unit has a 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 remains in 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 Team in Manual start up mode If it is in Home mode With the Team unit turned off hold down the MENU button on the keypad Switch on Te
96. togram 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 Sonicaid mu 9 ULT Y 1 CM MIN 14 10 ULT Y 1 CM MIN 14 20 ULT Y 1 18 93 26 08 33 O SL 26 08 93 0 51 ttt tH ttt 6 tt ay ben tt 1 Actogram event marks 2 Actogram graph 49 Sonicaid Team Operator s Manual 50 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 as a clinical event note printed at the top of the fetal heart rate trace Event notes are selected from topic related menus on the Team display They can only be entered when the printer is active To enter a clinical event note 1 Press the Clinical Event button v on the Team keypad 2 Select a note topic from the note main menu DRUGS OTHER POSITION ANTENATAL MEMBRANES REASON gt gt gt lt lt lt PROCEDURES EXIT gt gt gt 3 Select a note from the topic sub menu To enter a clinical event mark 1 Press t
97. tterns can diagnose fetal and maternal problems and complications Minimising patient exposure The acoustic output of Team is internally controlled and cannot be varied by the operator The duration of exposure however is fully under his or her control The examination techniques we have recommended will help the user to get the maximum amount of diagnostic information with the minimum amount of exposure Acoustic output Sonicaid Team 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 1MPa output beam intensity 20mW cm spatial peak temporal average intensity 100mW cm Power measurements were made by the National Physical Laboratory Teddington Middlesex UK in accordance with NEMA UD 2 1998 95 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 5 are permitted on data lines Modem socket 25 way Canon type Connection from Team DM to modem for distance monitoring ein Signal insere 1 Nouserconnection Input 4 ye 0 y 5 Nouserconnection CC 6 Nouserconnection
98. tware products Fetalcare and Centrale Where either Fetalcare or Centrale is used to run an analysis at the same time as the Care analysis in the Team fetal monitor the results obtained may differ In all circumstances the Fetalcare or Centrale analysis should be taken as the definitive result in preference to the Care analysis result in the Team fetal monitor 57 Sonicaid Team Operator s Manual 58 6 3 The Dawes Redman criteria The Dawes Redman criteria are criteria for normality If a record meets the criteria then this indicates a normal reactive trace This must be interpreted in the context of the complete clinical picture with fetal condition based on a complete assessment of all aspects of the pregnancy not just on this analysis These are the criteria e An episode of high variation above the first centile for gestational age e No decelerations gt 20 lost beats gt 100 lost beats on records longer than 30 minutes e Basal heart rate between 116 and 160 bpm though a slightly lower or higher rate may be acceptable after 30 minutes if all other parameters are normal This is indicated by one asterisk on the analysis results to 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 term variation should be 3 ms or greater Either an accelera
99. um 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 is not 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 available 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 this number 53 Sonicaid Team Operator s Manual 54 Auto Store details A record can be stored without entering patient details Team labels the record with the number ASNN where NN is a 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 1 Press MENU twice Select SELECT STORE
100. y highlights the record you want to send Press SELECT Press SEND Make sure the Auto Dial number is correct If it is not press SETUP and correct it If it is correct press AUTO DIAL OU UW 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 fails to get a reply In this case repeat the procedure to send the record 2 If problems persist contact the hospital for assistance 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 Connect the telephone and modem to the dual telephone adaptor If it is 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 Set up the Team on the patient 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 Press TO BEGIN RECORDI
101. 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 is not 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 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 Sonicaid Team Operator s Manual 3 Monitoring 3 1 Ultrasound transducers 1 2 w Connect the yellow transducer to the yellow socket Team Do NOT use the blue transducer see warning in section 2 1 Place the belt around the abdomen and secure it with the buckle Transducer buckle and belt attachment Apply Aquasonic coupling gel liberally to the face of the transducer Palpate the fetus and position the transducer on the abdomen over the fetal site Move it slowly until the characteristic hoof beat sound of t

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