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Sonicaid Team Operator’s Manual

6

Standards compliance

Sonicaid

Team

complies with:

EN60601-1: 1990

Medical Electrical Equipment Part 1
General Requirements for Safety

EN60601-1-1: 1993

Safety Requirements for Medical Electrical Systems

[collateral standard]

EN60601-1-2: 1993

Medical Electrical Equipment Part 1. General require-
ments for safety Section 1.2 Collateral standard: Electro-
magnetic compatibility – Requirements and tests.

EN61157: 1995

Requirements for the declaration of the acoustic output

[IEC61157:1992]

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:

z

Maternal ECG

z

Rimkus Telemetry

z

Use of Team with GMT Argus central review

z

Sonicaid Trend analysis

In addition, for FECG the use of FDA-compliant fetal scalp electrodes is required in
the USA and Canada.

Patient safety

WARNING: DO NOT TOUCH LIVE PARTS OF ANY EQUIPMENT (eg COM PORT
CONNECTOR PINS ON A PC) AND THE PATIENT AT THE SAME TIME.

CE Mark

Denotes conformity with the European Council
Directive 93/42/EEC concerning medical devices.

THIS FETAL MONITORING SYSTEM IS A PRESCRIPTION DEVICE IN THE USA.

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Содержание SonicaidTeam

Страница 1: ...SonicaidTeam Operator s Manual Huntleigh HEALTHCARE Ltd 2006 All rights reserved 738311 A February 2006...

Страница 2: ...id Team Operator s Manual 2 Sonicaid Team is in conformity with the Medical Device Directive 93 42 EEC and has been subject to the conformity assurance procedures laid down in the European Council Dir...

Страница 3: ...t control 18 1 5 Team printer front panel 19 1 6 Team printer rear panel 20 1 7 Team printer wedge assembly option 21 1 8 Team printer to Team base unit assembly 22 1 9 Team base unit to Team trolley...

Страница 4: ...54 5 Storing Records 56 5 1 Storing 56 5 2 Selecting a stored record for review 58 5 3 Displaying a stored record 58 5 4 Printing a stored record 58 5 5 Transferring a stored record to Sonicaid FetalC...

Страница 5: ...from Logo screen to off 90 10 User Maintenance 91 10 1 Cleaning and sterilisation 91 10 2 Printer paper 92 10 3 Technical maintenance 92 10 4 Corrective maintenance 93 10 5 Accessories consumables an...

Страница 6: ...iagnostic 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...

Страница 7: ...ivity with an external toco transducer Sonicaid Team IP monitors twin fetal heart rates either by two ultrasound trans ducers or invasively by a fetal ECG scalp electrode and an ultrasound transducer...

Страница 8: ...tient 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...

Страница 9: ...against mechanical damage and the ingress of liquids 3 Multiple portable socket outlets supplied with the system must not be used for powering equipment which does not form part of the system This is...

Страница 10: ...o 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 interferenc...

Страница 11: ...Huntleigh Healthcare Ltd or its distributors Huntleigh Healthcare Ltd makes no representations or warranties of any kind whatsoever with respect to this document Huntleigh Healthcare Ltd disclaims all...

Страница 12: ...etal 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 electroni...

Страница 13: ...s UK Sonicaid Products Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN UK Telephone 44 0 2920 485885 Fax 44 0 2920 492520 E mail sales huntleigh diagnostics...

Страница 14: ...Sonicaid Team Operator s Manual 14 Addresses...

Страница 15: ...d 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 T...

Страница 16: ...t 5 EXT input pink connector external contractions Toco transducer OR INT input precalibrated IUP catheter transducer 6 Keypad with eight control buttons 7 Display panel MECG is not available in the U...

Страница 17: ...4 RS232 interface to a PC running Sonicaid FetalCare Sonicaid System8002 or a central review system 500V DC isolation 9 way D type connector 5 Modem connection for distance monitoring 25 way D type C...

Страница 18: ...ws the manufacturing serial number the Team frequency and the date of manufacture 1 4 Contrast control In the base of the Team main unit is a display contrast control marked with this symbol This cont...

Страница 19: ...Sonicaid Team Operator s Manual 19 1 5 Team printer front panel Key 1 Printer control button Press once for on off Press and hold down for fast forward 2 Printer on indicator...

Страница 20: ...ct to the printer connector on the Team main unit Printer switch settings Paper speed Switch 5 Switch 6 1 cm min Down Down 2 cm min Up Down 3 cm min Up Up Scale Switch 4 20 bpm cm Down 30 bpm cm Up Du...

Страница 21: ...the printer wedge with the feet of the printer in the depressions on the printer wedge top 6 Using a screwdriver push down and secure the screw with approximately 4 turns 7 Re fit the paper pack and p...

Страница 22: ...ximately 4 turns 5 Remove the printer unit from the main unit 6 Re fit the paper pack and platen To reassemble 1 Remove the centre blanking plug if fitted from the Team base unit top 2 Position the pr...

Страница 23: ...o 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 l...

Страница 24: ...nit 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 can be u...

Страница 25: ...terine 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 mater...

Страница 26: ...USA or Canada TOCO External Toco transducer IUP Intra uterine pressure catheter 3 Contractions measurement Percentage full scale deflection when using an external Toco transducer Pressure mmHg kPa wh...

Страница 27: ...ow 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 11...

Страница 28: ...y panel Their primary functions are 1 Toco zero zeroes the external Toco contractions transducer or IUP catheter 2 Volume control up 3 Volume control down 4 Channel select 5 Menu access 6 Display Help...

Страница 29: ...n 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 Toco zero...

Страница 30: ...keypad The active audio channel is highlighted on the display Monitoring fetal ECG Using a Sonicaid scalp electrode 1 Put electrode gel on the base of the leg plate then strap the leg plate to the pat...

Страница 31: ...for sale in the USA and Canada The procedures described here on trace annotation loading printer paper and printer operation apply to all three types of printer See Chapter 6 Care Printer and Chapter...

Страница 32: ...scale see section 2 3 2 3 Trace annotation Trace header When the printer is switched on a header is printed before the trace data and grati cule The header includes user name date and time and patient...

Страница 33: ...in the USA and Canada Contractions scales When using an external Toco transducer the contractions scale is 0 100 relative units When using an intrauterine pressure catheter the contractions scale is 0...

Страница 34: ...rtly used pack align the blue marks on the pack with the blue marks on the compartment 4 Pull two folds clear of the chart printer to the right 5 Then fold them back to the left across the top of the...

Страница 35: ...er 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 of...

Страница 36: ...am 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 _ VW XYZ ABCDEFG EXIT HIJKLMN...

Страница 37: ...8 Date and time Time and date are printed on the trace and shown on the Team display message bar To reset the date and time 1 Press MENU once 2 Press TIME DATE 3 Press NEXT to move the cursor to the r...

Страница 38: ...language CAUTION 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 choi...

Страница 39: ...cursor back to the left 4 When done press NEXT until Team asks IS THIS CORRECT If it is correct press ACCEPT If it is not correct press RE ENTER 5 Enter the Patient Name maximum 13 characters When do...

Страница 40: ...te the abdomen and ascertain the lie of each fetus 2 Place the yellow transducer on twin two ensuring a good fetal heart rate signal Secure the transducer with a belt 3 Place the blue transducer over...

Страница 41: ...s which are maternal in origin The Sonicaid FM800 s heart rate detection system separates movements of the heart away from the transducer from those towards the transducer This helps to correct some i...

Страница 42: ...Sonicaid Team Operator s Manual 42 Transducer buckle and belt attachment Transducer positioning Toco transducer Ultrasound transducer...

Страница 43: ...g 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 con...

Страница 44: ...anes are ruptured attach the fetal scalp electrode 1400 0160 to the fetal scalp or the presenting part as described in the electrode instructions 4 Connect the electrode leads to the leg plate The pol...

Страница 45: ...REF pin 2 FECG REF pin 3 FECG electrode Key 1 FECG socket on FM800 2 Red 3 Green 4 M REF 5 Red 6 Black 7 FECG electrode 8 ECG REF Connection diagram for Safelinc electrodes FECG socket pin 1 M REF pi...

Страница 46: ...is highlighted on the Team display If the two heart rates appear similar z Team bleeps z The display shows CHECK TRACE FOR SAME HEART RATE z The printer prints this symbol on the trace Confirm the sou...

Страница 47: ...ressing 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 u...

Страница 48: ...l and fetal heart rates appear similar z Team bleeps z The display shows CHECK TRACE FOR SAME HEART RATE Confirm the source of the fetal heart rate you are monitoring 3 7 Team connected to FetalCare o...

Страница 49: ...ater 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 Co...

Страница 50: ...OVEMENT 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 ultr...

Страница 51: ...gram 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 Changing the Actogram displa...

Страница 52: ...nly 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 a...

Страница 53: ...nical event note 1 Press the Clinical Event button 9 on the Team keypad 2 Select a note topic from the note main menu DRUGS OTHER POSITION ANTENATAL MEMBRANES REASON PROCEDURES EXIT 3 Select a note fr...

Страница 54: ...larm 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...

Страница 55: ...LARM 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 ala...

Страница 56: ...maximum length of a record is 65 minutes this means there may be space for fewer than 14 records if there are several long records If there is not enough space for a record Team deletes the oldest rec...

Страница 57: ...2 Selecting which channel to store 1 Press MENU twice 2 Select SELECT STORE 3 Team shows the current channel selected 4 Select the required channel 5 When done press EXIT Start storing 1 Press MENU tw...

Страница 58: ...he selection arrow then press SELECT 5 The patient details for the selected record appear on the Review Options menu From here choose to display print or transfer the record to Sonicaid FetalCare or S...

Страница 59: ...n the rear of the PC running the FetalCare or System8002 software For full details of PC connections see the Sonicaid FetalCare User Guide or the Sonicaid System8002 User Guide Transferring a stored r...

Страница 60: ...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...

Страница 61: ...epartum CTGs NSTs in pregnancies from 26 weeks gestation onwards It can be used on women who are experiencing Braxton Hicks contractions but is not intended for use in established labour as the fetus...

Страница 62: ...is acceptable z At least one fetal movement or three accelerations z No evidence of a sinusoidal fetal heart rate rhythm z Short term variation should be 3 ms or greater z Either an acceleration or v...

Страница 63: ...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...

Страница 64: ...6 5 Using the analysis Starting the analysis 1 Set up Team as you would to record a normal trace 2 Press MENU once Check that the display says ANALYSIS IS ON If it says ANALYSIS IS OFF then select TU...

Страница 65: ...is 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...

Страница 66: ...ting 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...

Страница 67: ...variation below the first centile A single asterisk indicates one of the following conditions z Short term variation 4 ms but 3ms z Basal heart rate 116 bpm or 160 bpm on a record 30 minutes z Decele...

Страница 68: ...Sonicaid Team Operator s Manual 68 Example printout of TeamCare trace and analysis report...

Страница 69: ...Sonicaid Team Operator s Manual 69 Example printout of TeamCare twins analysis results...

Страница 70: ...analysis uses pulse intervals averaged over 1 16 minute to fit a baseline to the fetal heart rate trace Accelerations and decelerations are measured from this base line The baseline follows slow but...

Страница 71: ...a deceleration as being a trough 10 bpm below the baseline for more than 1 minute or 20 bpm below the baseline for more than 30 seconds The area of each deceleration is calculated and expressed in los...

Страница 72: ...ecutive minutes An episode of low variation is defined as a section of the trace where the one minute peak to peak variation is below a given threshold for 5 out of 6 consec utive minutes The threshol...

Страница 73: ...ed for twins traces but not divided between twin 1 and twin 2 Contractions The analysis defines a contraction as a rise in relative uterine pressure measurement to greater than 16 from the baseline fo...

Страница 74: ...natal 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 1...

Страница 75: ...on or limits of normality are provided Instead the clinician can use the numeric values to identify and quant ify the relative changes in fetal heart rate parameters over a period of time A numerical...

Страница 76: ...5 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...

Страница 77: ...UE 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 t...

Страница 78: ...ins 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 Blue Displayed results After each analysis the...

Страница 79: ...Sonicaid Team Operator s Manual 79 Printout showing Team Trend analysis results...

Страница 80: ...udio 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 t...

Страница 81: ...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 h...

Страница 82: ...e 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...

Страница 83: ...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 t...

Страница 84: ...Team while continuing to press MENU 3 Release the MENU button when the logo clears from the display 4 Press MENU three times 5 Select START UP MODE The start up mode is shown as HOME 6 Press CHANGE Th...

Страница 85: ...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...

Страница 86: ...ocket 3 Reconnect the telephone handset to the dual adaptor 4 Connect the modem into the modem connector on the rear of the Team base unit 5 Connect the modem lead between the modem and the dual adapt...

Страница 87: ...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 u...

Страница 88: ...likely to be detected Question Answer Why is STV measured only over a 60 minute period when the other parameters on the Team IP Trend analysis are also measured over a 15 minute period STV is measured...

Страница 89: ...CONFIGURE you will not lose any stored traces Problem Remedy On a Team Telemetry unit the Telemetry menu option does not appear in the Team Menu when you switch on 1 Switch the Team unit off 2 Switch...

Страница 90: ...ucer but have selected the blue transducer for storage Problem Remedy The Toco channel of the CTG graph is scratchy and distorted I have tried using a different Toco transducer but it displays the sam...

Страница 91: ...stronger than 1 10 mixture or in a 2 Glutaraldehyde solution such as Cidex 2 Wipe the lead with a clean damp cloth then a clean dry cloth Caution do not use isopropyl alcohol Do not expose metal compo...

Страница 92: ...e the 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 I...

Страница 93: ...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 Secti...

Страница 94: ...ainer 1300 0154 Membrane for Toco transducer 50 1300 0216 Transducer belts 1 5 m pack of 2 8400 8026 Transucer belt buckle 8400 6208 Fetal ECG scalp electrode spiral 1400 0160 Belt for fetal ECG elect...

Страница 95: ...id Products be either repaired or replaced free of charge provided that 1 The system has not been damaged by misuse mishandling or attempted repair by unapproved personnel AND 2 The goods are returned...

Страница 96: ...x 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 humid...

Страница 97: ...0 240 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 direction...

Страница 98: ...Maternal ECG input Direct FECG protection category BF Scalp minimum signal threshold 30 V Patient leakage current 100 A max 240V Sampling rate 1 ms Heart rate Calculated to 0 25 bpm Contractions inte...

Страница 99: ...fications or repairs are carried out by unauthorised personnel Identical replacement parts must be used v If there is doubt whether Team is operating correctly when being used on a patient fetal condi...

Страница 100: ...ng 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 x Prote...

Страница 101: ...t 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 N...

Страница 102: ...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 cm2 spat...

Страница 103: ...for distance monitoring Pin Signal Input output 1 No user connection 2 Tx Data Output 3 Rx Data Input 4 Vcc 5V 5 No user connection 6 No user connection 7 0V 8 No user connection 9 No user connection...

Страница 104: ...Axis Pin Signal Input Output 6 5 4 3 2 1 0V reference Tx Not connected Bed resistor Rx Bed resistor Output Input Input Input RS232 interface 9 way D type socket isolated to 500V DC Isolated interface...

Страница 105: ...tor 1 4 jack socket Pin Signal 1 Tip 2 Ring 3 Sleeve Switch Signal ground via switch Chassis ground Team Printer connector 8 pin D type connection to the Team printer module Pin Signal 1 2 3 4 5 6 7 8...

Страница 106: ...cer 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 again...

Страница 107: ...ive 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...

Страница 108: ...required by the operator of the System8002 is titled Home Mode preliminary set up At the remote location The procedures required at the remote location are titled Manual Mode storing a record Manual M...

Страница 109: ...then START UP MODE 2 Press CHANGE Start up mode changes to HOME 3 Press SET STORE TIME 4 Enter the store time required This must be between 12 and 65 minutes 5 Team asks IS THIS CORRECT If it is corre...

Страница 110: ...ent 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...

Страница 111: ...ENU then NEXT then REVIEW A list of records appears 2 Press the key marked until the selection arrow on the left of the display highlights the record you want to send 3 Press SELECT 4 Press SEND 5 Mak...

Страница 112: ...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 RECORDING PRESS Team start...

Страница 113: ...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 mod...

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