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• Page 1
  SonicaidTeam Operator’s Manual Huntleigh HEALTHCARE Ltd 2006 All rights reserved 738311-A February 2006…
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  Sonicaid Team Operator’s Manual 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 Directive.

• Page 3: Table Of Contents

  Sonicaid Team Operator’s Manual Contents Contents……………………..3 Standards compliance………………….6 Indications for use………………….7 System Installation ………………….8 Calibration …………………….. 8 Multiple Portable Socket Outlets………………9 Electromagnetic compatibility ………………10 Copyright…………………….. 11 Trademarks ……………………11 Note on terminology ………………….. 12 Sensors ……………………..

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  Sonicaid Team Operator’s Manual Contents Monitoring …………………… 40 Ultrasound transducers ……………… 40 External Toco (contractions) transducer …………43 Fetal ECG scalp electrode (TeamIP only) …………44 Twin heart rate monitoring …………….46 Intrauterine pressure catheter (contractions)……….47 Maternal Heart Rate monitoring (not available in the USA and Canada) . 47 Team connected to FetalCare or System8002……….
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  Sonicaid Team Operator’s Manual Contents Team DM (Distance Monitoring) …………….83 Description …………………. 83 Manual mode setup ………………83 Home mode setup ………………84 Modem setup………………..85 Team DM connections………………86 Procedures………………….. 87 Troubleshooting ………………….. 88 General questions………………. 88 Problems when you first switch on …………… 89 Problems replaying or printing traces…………

• Page 6: Standards Compliance

  Sonicaid Team Operator’s Manual Standards compliance Sonicaid Team complies with: EN60601-1: 1990 Medical Electrical Equipment Part 1 General Requirements for Safety EN60601-1-1: 1993 Safety Requirements for Medical Electrical Systems [collateral standard] EN60601-1-2: 1993 Medical Electrical Equipment Part 1. General require- ments for safety Section 1.2 Collateral standard: Electro- magnetic compatibility –…

• Page 7: Indications For Use

  Sonicaid Team Operator’s Manual Indications for use Sonicaid Team fetal monitors are indicated for use during labour and delivery (Intrapartum) and to monitor fetal and maternal vital signs during the antepartum period. Sonicaid Team Standard monitors one channel of fetal heart rate with an ultrasound transducer, and uterine activity with an external toco transducer.

• Page 8: System Installation

  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 IEC950/EN60950.

• Page 9: Multiple Portable Socket Outlets

  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 IEC601-1-1/EN60601-1-1 Amendment 1.

• Page 10: Electromagnetic Compatibility

  Sonicaid Team Operator’s Manual Electromagnetic compatibility 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.

• Page 11: Copyright

  Huntleigh Healthcare Ltd disclaims all liabilities for loss or damage arising out of the possession, sale or use of this document. Sonicaid is a registered trademark of Huntleigh Healthcare Ltd in the UK and other countries.

• Page 12: Note On Terminology

  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.

• Page 13: Addresses

  Sonicaid Team Operator’s Manual Addresses Sonicaid Products Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN, UK. Telephone +44 (0)2920 485885 +44 (0)2920 492520 E-mail sales@huntleigh-diagnostics.co.uk Web page www.huntleigh-healthcare.com…

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  Sonicaid Team Operator’s Manual Addresses…

• Page 15: Introduction

  Sonicaid Team Operator’s Manual 1 Introduction 1.1 Team fetal monitors Sonicaid Team fetal monitors provide accurate and reliable monitoring throughout the antepartum and intrapartum periods. The fetal monitor consists of a base unit which collects the monitored information and a printer unit. Four base unit models are available: Team Standard Monitoring of single fetal heart rate with an ultrasound trans-…

• Page 16: Main Unit: Front Panel

  Sonicaid Team Operator’s Manual 1.2 Main unit: front panel CARDIO input, blue connector: 2 MHz ultrasound transducer, OR MECG input: maternal ECG lead (optional)*, OR FECG input for fetal ECG lead Model identification: Team Standard, Team Duo, Team DM or Team IP CARDIO input, yellow connector: 1.5 MHz ultrasound transducer Power-on indicator light EXT input, pink connector: external contractions (Toco) transducer, OR…

• Page 17: Main Unit: Rear Panel

  Sonicaid Team Operator’s Manual 1.3 Main unit: rear panel AC mains on/off switch: O = off, 1 = on. When you switch on, the power on indicator on the front panel shows green. Input socket for the AC mains supply RS485 Interface for Axis.(1.5kV DC isolation).

• Page 18: Contrast Control

  Sonicaid Team Operator’s Manual Rear panel label The label on the rear of the Team unit shows the manufacturing serial number, the Team frequency and the date of manufacture: Serial number Team frequency 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 control is for the use of service engineers only.

• Page 19: Team Printer: Front Panel

  Sonicaid Team Operator’s Manual 1.5 Team printer: front panel 1 Printer control button. Press once for on-off. Press and hold down for fast forward. 2 Printer on indicator.

• Page 20: Team Printer: Rear Panel

  Sonicaid Team Operator’s Manual 1.6 Team printer: rear panel Printer setting switches. See below. Connector to main unit (7-pin DIN). Connect 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…

• Page 21: Team Printer Wedge Assembly (Option)

  Sonicaid Team Operator’s Manual 1.7 Team printer wedge assembly (option) For Team fetal monitors there is a wedge which can be fitted between the Team base unit and the Team printer unit, to improve the visibility of the trace. To assemble 1 Remove the centre blanking-plug (if fitted) from the Team base unit top.

• Page 22: Team Printer To Team Base Unit Assembly

  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 1 Press the release button beneath the left edge of the printer platen. 2 Lift the platen to the left and off the top of the printer. 3 Remove the paper pack.

• Page 23: Team Base Unit To Team Trolley Assembly

  Sonicaid Team Operator’s Manual 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.

• Page 24: Transducers And Cables

  Sonicaid Team Operator’s Manual 1.10 Transducers and cables Ultrasound transducer Used for non-invasive monitoring of the fetal heart rate. Two transducers are available: Primary, yellow, 1.5MHz Secondary, blue, 2.0MHz The 2.0MHz transducer can only be used on a Team Duo or Team IP base unit.

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  Sonicaid Team Operator’s Manual Safelinc fetal ECG lead Attached to the mother’s leg, it is used for interconnection between Team and a fetal ECG scalp electrode. Colour-coded blue, can only be used on a TeamIP base unit. Fetal movement event marker The patient uses this hand-held push- button lead to record fetal movement events.

• Page 26: Team Display Panel

  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 CTG). Alphanumeric display mode Key to alphanumeric display 1 Heart rate, in beats per minute.

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  Sonicaid Team Operator’s Manual FHR Trace Display mode (CTG mode) 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).

• Page 28: The Team Keypad

  Sonicaid Team Operator’s Manual 1.12 The Team Keypad There are eight buttons on the Team display 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 page…

• Page 29: Getting Started

  Sonicaid Team Operator’s Manual 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. 2 Check paper.

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  Sonicaid Team Operator’s Manual Using the printer 1 To switch the printer on, press the button on the printer front panel. 2 To fast forward the paper, press and hold down the printer button. 3 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.

• Page 31: The Team Printer

  Sonicaid Team Operator’s Manual 2.2 The Team printer There are three Team printers available: Standard Thermal printer for a continuous paper record of monitored data. Care * With analysis for use during the antepartum period. The analysis measures fetal heart rate parameters, performs a test against criteria that define a normal record, and highlights any abnormalities.

• Page 32: Trace Annotation

  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) Europe and the rest of the world To change the vertical scale, see section 2.3.

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  Sonicaid Team Operator’s Manual Twin fetal heart rates Set switch 3 down to print twin fetal heart rate traces superimposed on a full-width fetal heart rate scale, or up to print side-by-side on two separate fetal heart rate scales. In side-by-side printing, the primary channel (ULT-Y) is printed on the top scale, the secondary channel (ULT-B or FECG or MECG*) below.

• Page 34: Loading Printer Paper

  Sonicaid Team Operator’s Manual 2.4 Loading printer paper 1 Press the release-button beneath the left edge of the printer platen. 2 Lift the platen to the left and off the top of the printer. 3 Place the pack of paper in the compartment beneath.

• Page 35: Printer Operation

  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.

• Page 36: Team Menu System

  Sonicaid Team Operator’s Manual 2.6 Team menu system To see the menu, press [MENU] (top right on the Team keypad). <<<T IME/DAT E NEX T >>> <<<ALARM <<<ANNO T AT E ELAPSED T IME>>> EX IT >>> Using the Team Menu Each menu item has arrows (>>>) pointing at the the buttons on the Team keypad.

• Page 37: User Name

  Sonicaid Team Operator’s Manual 2.7 User name You can enter a hospital or clinic name (maximum 13 characters) to be printed on the header of the trace. Entering a User Name 1 Press [MENU] three times. 2 Press [USER NAME]. 3 Enter the hospital or clinic name.

• Page 38: Version

  Sonicaid Team Operator’s Manual 2.9 Version Provides information about the software version and facilities installed in your Team. 1 Press [MENU] three times. 2 Press [VERSION]. At the top of the display Team shows the version of software fitted, and the amount of data storage available (in minutes). For an explanation of [RECONFIGURE], see ‘Changing language’, below.

• Page 39: Entering Patient Details

  Sonicaid Team Operator’s Manual 2.11 Entering Patient Details You can enter the Gestation Period, Patient Name and Patient Reference Number into the Team. These details are then printed on the header of the trace. The details are not saved when the Team unit is switched off. To add patient details 1 Press [MENU] once.

• Page 40: Monitoring

  Sonicaid Team Operator’s Manual 3 Monitoring 3.1 Ultrasound transducers 1 Connect the yellow transducer to the yellow socket on Team. 2 Place the belt around the abdomen, and secure it with the buckle. 3 Apply Aquasonic coupling gel liberally to the face of the transducer. Palpate the fetus and position the transducer on the abdomen over the fetal site.

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  Sonicaid Team Operator’s Manual False recording of low baseline FHR When monitoring a low baseline FHR using Doppler ultrasound, the heart rate may be falsely reported. This effect 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.
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  Sonicaid Team Operator’s Manual Transducer buckle and belt attachment Toco transducer Ultrasound transducer Transducer positioning…

• Page 43: External Toco (Contractions) Transducer

  Sonicaid Team Operator’s Manual 3.2 External Toco (contractions) transducer 1 Check that the plastic membrane on the front face of the Toco transducer is present and undamaged. 2 Connect the Toco transducer to the pink socket on Team. 3 Place the belt round the abdomen, and secure it with the buckle. 4 DO NOT use coupling gel.

• Page 44: Fetal Ecg Scalp Electrode (Teamip Only)

  Sonicaid Team Operator’s Manual 3.3 Fetal ECG scalp electrode (TeamIP only) Fetal scalp electrodes Sonicaid Products supplies two types of fetal scalp electrode: Safelinc electrodes (FDA-compliant), and Sonicaid electrodes (not FDA-compliant). In the USA and Canada, the use of FDA-compliant electrodes is required by law. In the rest of the world, the choice of lectrodes may depend on local legislation.

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  Sonicaid Team Operator’s Manual Connection diagram for Sonicaid electrodes FECG socket: pin 1 M REF pin 2 FECG REF pin 3 FECG electrode Key: 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…

• Page 46: Twin Heart Rate Monitoring

  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 2.0 MHz transducer 1.5 MHz transducer Team IP…

• Page 47: Intrauterine Pressure Catheter (Contractions)

  Sonicaid Team Operator’s Manual 3.5 Intrauterine pressure catheter (contractions) Available only on the Team IP base unit. The interconnecting lead between the base unit and the intrauterine catheter is not included, but is available as an option. Team is designed for use with an Intran disposable catheter. 1 Connect the intrauterine pressure (IUP) connecting lead to the pink socket on Team.

• Page 48: Team Connected To Fetalcare Or System8002

  Sonicaid Team Operator’s Manual A recommended arrangement of the lectrodes 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).

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  Sonicaid Team Operator’s Manual 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.

• Page 50: Events And Alarms

  Sonicaid Team Operator’s Manual 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.

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  Sonicaid Team Operator’s Manual In a study of 14 near-term normal fetuses with the threshold set at 40%, the sensi- tivity and specificity of the Actogram function (compared with scanner-identified breathing, limb movement and trunk movement) were 96% and 68% respectively. This data is published with the kind permission of Professor David James of the Department of Obstetrics and Gynaecology, Queens Medical Centre, Nottingham.
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  Sonicaid Team Operator’s Manual Data storage Team stores Actogram event marks when it stores an FHR record. It does not store the Actogram activity graph and threshold value. Twins Actogram works from information collected only from the 1.5 MHz transducer, but it may also sometimes detect fetal movements from the other twin.

• Page 53: Recording Clinical Events

  Sonicaid Team Operator’s Manual 4.3 Recording clinical events Clinical events can be recorded either as a solid square event mark printed at the bottom of the fetal heart rate trace, or as a clinical event note printed at the top of the fetal heart rate trace.

• Page 54: Alarms

  Sonicaid Team Operator’s Manual 4.4 Alarms Alarm setup menu 1 Press [MENU] once. 2 Select [ALARM]. <<<SIG NAL LO SS <<<LO W FHR FET AL MO VEMENT >>> <<<HIG H F HR EX IT >>> 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.

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  Sonicaid Team Operator’s Manual To set an FHR alarm: 1 From the Alarm setup menu press either [LOW FHR] or [HIGH FHR]. 2 Select [ALARM ON SILENT] or [ALARM ON AUDIBLE]. If you set a silent alarm, and the alarm is triggered, a notification appears on the display message bar, but the Team does not beep.

• Page 56: Storing Records

  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 contrac- tions information and fetal event marks.

• Page 57
  Sonicaid Team Operator’s Manual Auto Store details A record can be stored without entering patient details. Team labels the record with the number ASNN, where NN 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.

• Page 58: Selecting A Stored Record For Review

  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.

• Page 59: Transferring A Stored Record To Sonicaid Fetalcare Or System8002

  Sonicaid Team Operator’s Manual 5.5 Transferring a stored record to Sonicaid FetalCare or System8002 You can transfer a selected record to a Sonicaid FetalCare or Sonicaid System8002 for analysis either by direct cable connection or (using Team DM) by modem. This section describes direct cable connection.

• Page 60: Deleting A Stored Record

  Sonicaid Team Operator’s Manual 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].

• Page 61: Care Printer (Option)

  Sonicaid Team Operator’s Manual 6 Care Printer (option) 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.

• Page 62: The Dawes/Redman Criteria

  Sonicaid Team Operator’s Manual 6.3 The Dawes/Redman criteria The Dawes/Redman criteria are criteria for normality. If a record meets the criteria, this means that as far as the analysis can tell by measuring the features of the trace, the fetus is normal. It is not a guarantee that the baby is healthy, but it does mean there is nothing in the trace which gives cause for concern.

• Page 63
  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.

• Page 64: Using The Analysis

  Sonicaid Team Operator’s Manual Actogram Event marks recorded by the Actogram facility are not used by the Team Care analysis. Alarms During analysis the Signal Loss alarm is fixed at 30%. In addition, there 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.

• Page 65
  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>>>] in the display message bar. The Team shows the last calculated values for short term variation, number of minutes of high variation and basal heart rate.

• Page 66: The Analysis Report

  Sonicaid Team Operator’s Manual 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: Values for the calculated parameters When the Dawes/Redman criteria (criteria for normality) were first met Whether the Dawes/Redman criteria were met at the time the analysis was stopped Abnormalities…

• Page 67
  Sonicaid Team Operator’s Manual Abnormalities Double asterisks indicate one of the following conditions: Fetal heart rate < 116 bpm or > 160 bpm on a record of less than 30 minutes Decelerations > 100 lost beats (> 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 <…
• Page 68
  Sonicaid Team Operator’s Manual Example printout of TeamCare trace and analysis report…
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  Sonicaid Team Operator’s Manual Example printout of TeamCare twins analysis results…

• Page 70: Plotting Trend Data

  Sonicaid Team Operator’s Manual 6.7 Plotting trend data Pre-printed Trend Graph forms are available in packs of 50, part number 8902-8002. These enable you to produce a plot manually of the key values given in the analysis report. With other clinical information, these graphs may allow a trend of fetal health to be discerned.

• Page 71
  Sonicaid Team Operator’s Manual A basal heart rate less than 105 bpm requires further investigation at once. A few normal fetuses at 38–42 weeks gestation have a basal heart rate of 110–115 bpm. The threshold of 115 bpm at which a warning is given is chosen conservatively, to give warning of a compromised fetus in which the fetal heart rate may be falling progressively.
• Page 72
  Sonicaid Team Operator’s Manual 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: % likelihood of metabolic (ms) acidaemia or intrauterine death >…
• Page 73
  Sonicaid Team Operator’s Manual Calculating peak-to-peak variation The fetal heart rate record is analysed in one-minute intervals. Intervals containing a deceleration or part of a deceleration are discarded, as are intervals with high signal loss or artefact. For each remaining interval the maximum to minimum variation in the fetal heart rate within that minute is calculated.

• Page 74: References

  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 IJM, 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’…

• Page 75: Trend Printer (Option)

  Sonicaid Team Operator’s Manual 7 Trend Printer (option) The Trend printer is the printer supplied if you purchase TeamIP Trend. Note: Sonicaid Trend analysis is not approved for sale in the USA and Canada. 7.1 Introduction The Team Trend printer incorporates an analysis system for use during the intra- partum period.

• Page 76: Team Trend Analysis

  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: 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…

• Page 77: Using The Analysis

  Sonicaid Team Operator’s Manual 7.3 Using the analysis Starting the analysis 1 Set up Team as you would to record a normal trace. 2 Press the printer button once to start the printer. This starts the analysis as well. Stopping the analysis To stop the printer, press [PRINTER], then [HALT].

• Page 78: Analysis Results

  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.

• Page 79
  Sonicaid Team Operator’s Manual Printout showing Team Trend analysis results…

• Page 80: Viewing Trend Data

  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 returns to the fetal heart rate display after two minutes, or when you press [EXIT].

• Page 81
  Sonicaid Team Operator’s Manual One point is allocated: For every 5 minutes the heart rate is away from the baseline. If the commonest heart rate is < 1% of the total number of heart rates. If the current 60-minute baseline value differs from the previous 60-minute value by more than 20 bpm.
• Page 82
  Sonicaid Team Operator’s Manual 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 to calculate the parameter values.

• Page 83: Team Dm (Distance Monitoring)

  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.

• Page 84: Home Mode Setup

  Sonicaid Team Operator’s Manual 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. 2 Select [START-UP MODE]. 3 The start-up mode is shown as ‘MANUAL’.

• Page 85: Modem Setup

  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.

• Page 86: Team Dm Connections

  Sonicaid Team Operator’s Manual 8.5 Team DM connections 1 Remove the telephone handset connector from the telephone socket. 2 Plug the dual adaptor into the telephone socket. 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.

• Page 87: Procedures

  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.

• Page 88: Troubleshooting

  Sonicaid Team Operator’s Manual 9 Troubleshooting 9.1 General questions Question Answer Why when Team is turned Team has a software version of Automatic Gain on do you initially get a Control (AGC). This enables it to detect a wider range rate with the transducers of input signals and extract the best FHR.

• Page 89: Problems When You First Switch On

  Sonicaid Team Operator’s Manual 9.2 Problems when you first switch on Problem Remedy The Team Menu does not 1 Switch the Team unit off. appear when you switch 2 Switch on again, holding down the [MENU] key. 3 Wait for the Team unit to beep, then release the [MENU] key.

• Page 90: Problems Replaying Or Printing Traces

  Sonicaid Team Operator’s Manual 9.3 Problems replaying or printing traces Problem Remedy On Team Duo I can’t hear the Use the loudspeaker enable button on the 1.5MHz transducer. MENU (left-hand side of the display). Problem Remedy When I try and reprint a stored On Team Duo and Team IP you must select trace, the CTG trace is blank.

• Page 91: User Maintenance

  Sonicaid Team Operator’s Manual 10 User Maintenance WARNING: ALWAYS SWITCH OFF THE TEAM AND DISCONNECT THE AC SUPPLY CABLE AND TRANSDUCERS BEFORE ATTEMPTING TO CARRY OUT ANY CLEANING OR MAINTENANCE. 10.1 Cleaning and sterilisation Cleaning, general Wipe the instrument case, transducers, event marker, fetal ECG electrode leg plate and IUP extension cable with a cloth dampened in soap or detergent solution to remove aquasonic gel, blood, saline etc.

• Page 92: Printer Paper

  Sonicaid Team Operator’s Manual 10.2 Printer paper Use only Sonicaid paper. Use of non-approved paper may result in poor quality printing or damage to the printer, and could invalidate the printer warranty. 10.3 Technical maintenance The checks below should be carried out at intervals of three months to a year, dependent on equipment use and environmental conditions.

• Page 93: Corrective Maintenance

  10.4 Corrective maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd, Sonicaid Products. The Sonicaid Team Service Manual (order part number 8909-8540) is designed as an aid to engineers in maintenance and service of repairable parts.

• Page 94: Accessories, Consumables And Spares

  Sonicaid Team Operator’s Manual 10.5 Accessories, consumables and spares Accessories Team trolley 8900-6990 Carrying bag for base unit 8900-8003 Carrying bag for base unit and printer 8900-8006 Intran IUP catheter interconnection lead (Team IP) 8400-6937 Maternal ECG lead (Team IP) 8402-6969 Team-to-System8002 lead 8400-6952…

• Page 95: Servicing And Guarantee

  Sonicaid Team Operator’s Manual 10.6 Servicing and guarantee Servicing Servicing should be performed only by Sonicaid Products or their appointed service agent. If you have difficulty obtaining service for Team, contact Sonicaid Products. Guarantee Team is guaranteed against defects in materials or workmanship for 12 months from the date of purchase.

• Page 96: Specifications

  Sonicaid Team Operator’s Manual 11 Specifications 11.1 Physical and environmental Physical Dimensions (base unit) W275 x H83 x D275mm Weight (base unit) 3kg approx. Dimensions (printer) W275 x H83 x D236mm Weight (printer) 2.5kg approx. Recommended operating and storage conditions Operating temperature 10°C to 35°C (50°F to 96°F) Storage temperature…

• Page 97: Printer

  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…

• Page 98
  Sonicaid Team Operator’s Manual Fetal ECG input Direct FECG protection category Scalp: minimum signal threshold 30 µV Patient leakage current 100 µA max (240V) Sampling rate ± 1 ms Heart rate Calculated to ± 0.25 bpm Maternal ECG input Direct FECG protection category Scalp: minimum signal threshold 30 µV Patient leakage current…

• Page 99: Safety

  Sonicaid Team Operator’s Manual 11.5 Safety Team is designed to comply with: IEC601 Part 1 (1988) BS5724 Part 1 (1989) Team is Class 1 equipment, with protective earth via the AC mains input. Team must be connected to an earth supply complying with local safety standards. The installation engineer must check the correctness of the supply voltage label and the fuse ratings for the local supply.

• Page 100
  Sonicaid Team Operator’s Manual vii) Installation is the responsibility of the vendor via a competent person, approved by Sonicaid Products. viii) This equipment is not protected against: a) the effects of defibrillator shocks or discharge. b) the effects of high-frequency currents. c) the effects of ‘bistoury’, either TENS (transcutaneous electrical nerve stimulation) or electro-surgery.

• Page 101: Ultrasound Safety Considerations

  Sonicaid Team Operator’s Manual 11.6 Ultrasound safety considerations General Diagnostic ultrasound has been in use for over 25 years with no confirmed adverse effects on 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.

• Page 102
  Sonicaid Team Operator’s Manual Acoustic output Sonicaid FM800 is exempt from the declaration of acoustic output information in accordance with clause 4 of IEC 1157 (EN 61157). This is because the maximum probable levels of the following three parameters are below the limits specified in clause 6, namely: peak negative pressure <…

• Page 103: Appendix 1: External Connections

  Sonicaid Team Operator’s Manual Appendix 1: External Connections Input/output levels and pin numbers All input and output voltages are system earth referred and not isolated. Only signal voltage up to 1V maximum should be used. Logic levels up to +5V are permitted on data lines.

• Page 104
  Sonicaid Team Operator’s Manual RS485 interface Pluggable cord connector (PCC), isolated to 1.5kV DC. Interface for Sonicaid Axis. Signal Input/Output 0V reference Output Not connected Bed resistor Input Input Bed resistor Input RS232 interface 9-way D-type socket, isolated to 500V DC. Isolated interface to a PC running Sonicaid System8002;…
• Page 105
  Sonicaid Team Operator’s Manual Fetal event marker connector 1/4″ jack socket. Signal 1 Tip Switch 2 Ring Signal ground (via switch) 3 Sleeve Chassis ground Team Printer connector 8-pin D-type connection to the Team printer module. Signal 30V nominal +8V nominal Not connected Ground Ground…

• Page 106: Appendix 2: Transducer Problems

  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 Service Department of Sonicaid Products, or their appointed service agent. Preliminary 1 Connect the ultrasound transducer to the Team.

• Page 107
  Sonicaid Team Operator’s Manual 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.

• Page 108: Appendix 3: Procedures For Distance Monitoring

  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 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…

• Page 109
  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].
• Page 110
  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].
• Page 111
  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.
• Page 112
  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.
• Page 113
  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:…

Service Manual

94 Pages

File Type: PDF

File Size: 1.63 MB

File Name: Soniciad Team Service Manual April 1996.pdf