Huntleigh Sonicaid Team 3 Series Instructions For Use Manual
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Huntleigh Sonicaid Team 3 Series Instructions For Use Manual

Fetal/maternal monitors
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Summary of Contents for Huntleigh Sonicaid Team 3 Series

  • Page 1 Team 3...

  • Page 2: Table Of Contents

    Table of Contents 1. Safety ................. 6 Warnings ....................6 Infection Control ..................7 Patient Applied Parts ................7 2. Introduction ................ 8 Intended Use and Indications ............... 9 Unpacking / Preliminary Checks ............10 2.2.1 Contents ........................ 10 Operator Positioning ................10 3.
  • Page 3 6. Monitoring Fetal Parameters ..........42 Preliminary ..................... 42 Ultrasound Monitoring ................42 False recording of FHR ................. 44 Twins / Triplets Ultrasound Monitoring ..........44 Fetal ECG (Team 3I models only- using a scalp electrode) ....45 7. Monitoring Maternal Parameters ........47 Contractions (using TOCO transducer) ..........
  • Page 4 11.Dawes-Redman Antepartum Analysis ....... 70 11.1 Intended Use ..................70 11.2 Overview ....................70 11.3 The Dawes-Redman Criteria ..............71 11.4 Dawes-Redman Analysis ..............71 11.5 Using Dawes-Redman analysis ............72 11.6 Dawes-Redman Analysis report ............74 12. Using Team 3 with a CRS System ........77 12.1 Using Team 3 with Sonicaid FetalCare and Sonicaid Centrale ..
  • Page 5 Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifi cations and materials without notice. Sonicaid and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2016. © Huntleigh Healthcare Ltd. 2016...

  • Page 6: Safety

    Safety We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA guidelines). This is considered to be good practice and should be observed at all times. Team 3 provides just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors.

  • Page 7: Infection Control

    Do not use in the home environment. Do not use the Team 3 in vehicles or in aircraft. If this product is connected to another item of electrical equipment, ensure that the system is fully compliant with IEC60601-1:2005. This product contains sensitive electronics, therefore, strong radio frequency fi...

  • Page 8: Introduction

    Introduction This Instructions for Use is compatible with monitors fi tted with Version 5 software. The Team 3 series of fetal/maternal monitors are intended for antepartum (Team 3A) and intrapartum use (Team 3I). The following features are standard on all models (Team 3A and Team 3I): •...

  • Page 9: Intended Use And Indications

    Intended Use and Indications The Team 3 fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities.

  • Page 10: Unpacking / Preliminary Checks

    Unpacking / Preliminary Checks We recommend that a thorough visual inspection is made immediately the unit is received. Should any damage be evident or any parts missing, ensure that Huntleigh Healthcare Ltd is informed at once. 2.2.1 Contents Standard - All models...

  • Page 11: Product Identifi Cation

    Safety and performance are only assured when used in conjunction with the correct types of transducer. Do not attempt to connect any devices via these sockets other than those supplied or recommended by Huntleigh. Front Panel Touchscreen FHR2 US/FECG socket...

  • Page 12: Rear Panel

    Rear Panel Mains Socket DVI Socket * Equipotential earth point Rating Label Fetal Event Marker Socket USB Port x 2 RS232/CRS Socket Ethernet Port ** Wireless Telemetry Socket * Depending on model/options purchased. ** Not enabled - future upgrade.

  • Page 13: Side Panel

    Side Panel Maternal MSpO Maternal NIBP * Maternal ECG * Transducer storage * Depending on model/options purchased. Product Labelling Applied parts (Ultrasound Applied parts (Maternal NIBP/SpO Probes / TOCO / MECG / fetal event marker) are type B* FECG) are type CF* This symbol signifi...
  • Page 14 Attention, consult accompanying Warning documents / Instructions for Use Alternating current (AC) On/Standby Device Identifi er Protective Earth Serial Number Reference Number Manufacturer Date of Manufacture Keep Dry Do not use hook Cardboard packaging can be Fragile recycled. 50°C Temperature Limitations Limits of Relative Humidity Max 90% RH -10°C...

  • Page 15: Setup

    IEC60601-1:2005; clause 16. If there is any doubt as to whether your system complies, consult the technical service department or your local Huntleigh representative. If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by IEC60601-1 is to be used in the patient environment (within 1.5m of the patient),...

  • Page 16: Handling And Mounting

    Handling and Mounting Trolley If the unit is moved regularly, for maximum safety it is recommended that it is mounted on the purpose-designed trolley, which is available as an accessory. Follow the instructions provided with the trolley regarding assembly and proper mounting of the Team 3.

  • Page 17: Operation

    Operation Switching the Unit ON Connect the monitor to the local mains supply. The unit will automatically power If the unit is in off/standby mode with power already applied, press and hold for approximately 2 seconds to switch on. A short tone will be heard. The unit will briefl...

  • Page 18: Patient Data

    5.2.1 Patient Data Touch and hold the Patient Data region in the top left corner of the screen to enter the Patient Data screen. This screen allows the operator to enter the patient’s name, ID number, navigate to the ‘Set Gestational Age’ screen and search for previous patients. Enter Patient Name and Patient ID using the on-screen keyboard.
  • Page 19 Searching for Patient Names Touch to return to the Monitoring screen with the details of this patient in the Patient Data region.
  • Page 20 Setting Gestational Age The Set Gestation dialogue allows the operator to change any one of: • Last menstrual period date • Gestational age • Estimated due date Based on the current date, changing any one of these will automatically update the other two.

  • Page 21: Lock / Unlock Screen

    5.2.2 Lock / Unlock Screen Touch to access the Lock Screen. Touch to lock screen or to exit with out locking. Touch to unlock the screen. The operator will need to enter a 5 digit code via the touchscreen, (default code 0 0 1 2 3 ), to unlock the screen.

  • Page 22: Date / Time

    5.2.3 Date / Time Touch and hold the Date/Time area of the screen to enter the Data and Time screen. (Note: This screen can also be accessed via the Settings Menu.) Use the arrows to set the current date and time. Press to confi...

  • Page 23: Record / Print

    5.3.1 Record / Print Touch to start recording or printing*. The icon will turn green and printing will start. The Annotation icon will appear in the command bar which allows the operator to add pre-defi ned notes to the printout. This will be explained in the Annotation section.
  • Page 24 Annotation Main Menu Touch each note category to access the sub menu options available. Note: The Easinote sub-system is very fl exible allowing up to 12 groups of 12 notes to be confi gured on Team 3. The default English notes consist of 8 groups of 7 or 8 notes. Refer to Sections 16.5 and 16.6 for details on how to access the Settings Management feature to customise and translate notes.

  • Page 25: Settings Menu

    5.3.7 Settings Menu This menu allows the operator to confi gure the Team 3. Touch to access the Settings menu. For all function screens, touch to return to the previous page or to return to the Main Application screen. For all Menu and sub menu screens the options are selected/deselected by touching on the icons as follows: Option disabled Option enabled...
  • Page 26 Settings Sub Menus Clinical Settings Sub Menu...
  • Page 27 Note : Date & Time and Recording limits settings not available when printing/recording. System Settings Sub Menu Note : Does not set Alarm Volume. Press confi rm.
  • Page 28 If enabled, printing / recording stops after this time has elapsed. In this screen, the operator can change the background colour of the screen to suit their preference or ambient light levels.
  • Page 29 Note : Print Twin Grids not accessible when printing or recording.
  • Page 30 Alarm Settings Sub Menu Touch each check box to enable / disable each alarm. If selected a will appear in the box. Touch to set each trigger threshold. UTA - Uterine Tetany Alarm Note : Only available if SpO option fi tted.
  • Page 31 Note : Only available if SpO or MECG option fi tted. Note : Only available if NIBP option fi tted.
  • Page 32 Note : Options in this screen depend on the licensed features. Intrapartum units will start up with Trend and Antepartum units will start up with Dawes Redman. The defaults can be changed in the Secure Settings area. The operator will need to enter a 5 digit code (default 1 2 3 4 5) to enter...

  • Page 33: View Menu

    5.3.8 View Menu Touch the icon to access the View Menu settings. Note : This icon is only available while printing if an FECG or MECG lead is connected. Main Menu Touch each category to access the sub menu options available. Note : FECG, MECG sub menu buttons will only be displayed in Intrapartum models and only if probes are attached.
  • Page 34 This screen allows the operator to select a previous CTG trace to review. The operator can choose to search for the CTG trace either by date or Patient Name / ID. Touch the CTG trace required and touch . The selected trace will now be displayed on the application screen.
  • Page 35 Navigates to the Select CTG trace screen. Starts a new monitoring session with a new patient. Starts a new monitoring session with the selected patient. Displays Blood Pressure results screen. Touch the "Print" button to print out the results.
  • Page 36 The MECG / FECG screens display a trace from any ECG probe (Fetal or maternal) that is plugged in. Touch freeze the screen to view the trace. Touch restart the trace.

  • Page 37: Monitoring Parameters

    Monitoring Parameters You can confi gure the screen to display a white or black background. (Refer to ‘Settings’). The application screen can be displayed in either Numeric or Trace format. Touch to toggle between displaying the data in numeric or trace format.

  • Page 38: Numeric Format

    5.4.1 Numeric Format The numeric data screen increases the size of the numeric data and removes the traces. This is useful when operators are not in direct attendance as the numbers can be seen from a distance. The display is split into regions, its confi guration is dependent on whatever sensors/probes are attached.

  • Page 39: Fhr Monitoring

    5.4.2 FHR Monitoring Singleton Monitoring In singleton monitoring, the FHR in displayed in large digits in the top centre region. Display shows FHR via wired ultrasound transducer with audio. Twins Monitoring In twins monitoring, the FHR display region is split to display the two separate Fetal Heart rates, both using wired ultrasound.

  • Page 40: Maternal Nibp

    / MHR If the MECG lead is not in use, the MHR measured by will be displayed. 5.4.5 Maternal NIBP The NIBP region shows a measurement having been made. Touch and hold the NIBP region to access the NIBP menu. Refer to 'Maternal Blood Pressure' Section 7.5 for instructions on performing maternal blood pressure.

  • Page 41: Switching The Unit Off

    Switching the Unit OFF Press and hold to switch the unit Off. A confi rmation screen will be displayed. Power Off Touch Power Off to turn off the Team 3 or touch to return to the last screen. Alternatively, continued holding of the off button for ~15s will switch the unit off directly from any machine state.

  • Page 42: Monitoring Fetal Parameters

    Monitoring Fetal Parameters Preliminary Ensure that the transducers and transducer belts are clean and ready for use. In particular, check the transducers for cracks or signs of damage. See also cleaning instructions in Section 15. 1. Switch on Team 3. 2.
  • Page 43 Hints on Monitoring TOCO Transducer Ultrasound Transducer Transducer positioning for Ultrasound monitoring • Make sure the transducer is placed in the optimum position. Avoid positions with strong placental sounds (swishing) or the fetal cord pulse at the same rate as the fetal heart. •...

  • Page 44: False Recording Of Fhr

    False recording of FHR When monitoring FHR, the heart rate may be falsely reported. This can have a number of causes including double-rating or half rating, and is characteristic of ultrasound fetal monitoring. Another cause may be detection of maternal signals, (particularly in the absence of fetal signals).

  • Page 45: Fetal Ecg (Team 3I Models Only- Using A Scalp Electrode)

    When interpreting a trace to which the +20bpm or -20bpm offsets have been applied, the interpreter must subtract or add these offsets (20 bpm) from the displayed baseline rate to determine true baseline rate – failure to do so may result in misinterpretation of the trace &...
  • Page 46 Monitoring procedure using Safelinc™ / Qwik Connect™ electrodes Follow the instructions for use supplied with the fetal ECG scalp electrode 1. Attach the FECG lead to the mother’s leg, using the adhesive pad. 2. Attach the FECG electrode to the fetal presenting part. 3.

  • Page 47: Monitoring Maternal Parameters

    Monitoring Maternal Parameters Contractions (using TOCO transducer) Use only TOCO transducers supplied with the Team 3, or listed in the Accessories. 1. Ensure that the TOCO transducer and belt are clean and ready for use. In particular, check the transducer for cracks or signs of damage. See also cleaning instructions in Section 15.

  • Page 48: Contractions (Using Iup Transducer)

    Contractions (using IUP transducer) Use only IUP transducer types supplied with the Team 3, or listed in the Accessories. Always check transducers and their packaging before use to ensure that there is no damage and that sterility has not been compromised.

  • Page 49: Manual Fetal Movement Event Marker

    7.3.2 Manual Fetal Movement Event Marker The Fetal Movement Event Marker is a pushbutton switch fi tted with a captive cable and connector which is supplied as standard. It is plugged into the socket on the rear of the unit. The switch allows maternally sensed fetal movements to be recorded.

  • Page 50: Maternal Ecg

    Maternal ECG Monitoring MECG allows a check to be made that the fetal heart rate being recorded does in fact belong to the fetus and not the mother. MECG monitoring procedure 1. Use self-adhesive disposable electrodes. Placement of the electrodes is not critical, though it is a good idea to have the lower electrode placed clear of the diaphragm, as the muscles here are very active in contraction.

  • Page 51: Maternal Blood Pressure

    Maternal Blood Pressure Team 3 can measure the mother’s systolic and diastolic blood pressure, mean arterial pressure, and the average pulse rate during the measurement. Measurements can be made manually or automatically (at an interval defi ned by the user). An alarm is triggered if the mother’s blood pressure goes above or below certain limits.

  • Page 52: Taking Bp Measurements

    Other considerations There are many other factors which can effect BP measurement & refl ect best practice against national & international guidelines. Key issues that affect accuracy of BP measurements: • The patient should be relaxed & rested – minimum 3 minutes before commencing measurement •...
  • Page 53 Manual NIBP Touch to start a manual NIBP reading. Once completed, the reading will be displayed in the NIBP region. Automatic NIBP To set an automatic measurement, touch to set the interval between measurements. Touch to start the measurement. Once completed, the reading will be displayed.
  • Page 54 Safety mechanisms are incorporated to prevent over-infl ation, or extended period infl ation. However, patients should be advised to summon assistance if any discomfort results from the use of the NIBP function, and its use discontinued. Note that, as with all auto-BP measurement systems, results may vary from one make to another, and from measurements based on using a manual sphygmomanometer.

  • Page 55: Maternal Oximetry

    Maternal Oximetry Team 3 can measure the mother’s blood oxygen saturation and pulse rate. An alarm sounds (if enabled), if the mother’s oxygen saturation drops below the set level, or if her pulse rate goes above or below certain limits. 7.6.1 Procedure 1.
  • Page 56 A poor MSpO2 signal may prevent the FHR cross-checking from functioning. If a good MHR indication cannot be obtained other methods must be used to prevent accidental interpretation of MHR as FHR. Inspect MSpO sensor for damage before use. Check MSpO signal quality regularly to ensure that no deterioration has occurred.
  • Page 57 8. Recommended maximum application time: 4 hours 9. Probe temperatures >41°C – Specifi c instructions: Not applicable 10. Probe temperatures >41°C – Operator sequence of actions: Not applicable 11. Probe temperatures >41°C – Maximum temperature: Not applicable 12. Probe temperatures >41°C – Age restriction: Not applicable 13.

  • Page 58: Alarms

    Alarms What is meant by an alarm During most monitoring sessions things occur which are to some extent unexpected or outside normal routine. These are referred to collectively as alarms, even though many of them are not in the least alarming. These alarms must not be relied on to detect pathological heart rate patterns.

  • Page 59: Responding To Alarms

    Printed Indicators • Fetal alarms • Maternal alarms FECG, ULT1, ULT2 and ULT3 Fetal High Heart Rate FECG, ULT1, ULT2 and ULT3 Fetal Low Heart Rate FECG, ULT1, ULT2 and ULT3 Fetal Signal Loss Maternal High Heart Rate Maternal Low Heart Rate Maternal O Saturation Alarm Maternal Systolic High Alarm...

  • Page 60: Printing

    Printing Introduction Team 3 incorporates a thermal printing system for use with continuous fan-fold thermal paper. It is virtually silent, rendering it unobtrusive in operation. Paper options The printing system is optimised for use with plain Sonicaid thermal print paper, although alternative paper trays are available as accessories to facilitate the use of Philips or GE/Corometrics paper.

  • Page 61: Print Speed And Duration

    Print speed and duration Print speed is selectable at 1, 2 or 3 cm/sec according to user preference or local clinical practice. Total running times with a standard 45m pack of Sonicaid paper are as follows: Speed Running Time 1cm/sec 75 hours 2cm/sec 37.5 hours...

  • Page 62: Loading Printer Paper

    Note: Ensure the paper remains centrally aligned while closing the drawer. Using non-Sonicaid paper We strongly recommend the use of standard Huntleigh paper. There are many advantages to our plain paper including: • 100% trace registration accuracy •...

  • Page 63: Sample Trace (Sonicaid Paper)

    IMPORTANT: As paper tracks through a printer mechanism it will move from side to side due to variations in paper and printer mechanism alignment. This is an unavoidable feature of all printers of this type, as used in all makes of fetal monitors.

  • Page 64: Turning Off The Printer

    Turning off the printer 9.9.1 Normal recording Touch the Green printer button . The button will fl ash while the printer’s buffers are cleared and become grey when the printing has stopped. Touch the Green printer unavailable button . If the paper has run out, the following screen will appear.
  • Page 65 If the paper has run out, touch the Green printer unavailable button . The following screen appears. Touch to stop the analysis or to cancel.

  • Page 66: Sonicaid Trend

    10. Sonicaid Trend 10.1 Introduction Sonicaid Trend is a software option available with all Team 3 series monitors. It measures fetal heart rate parameters at regular intervals, and describes the trace in a way that is quantitative and not qualitative. Trend is not intended as a replacement for skilled visual interpretation of the trace, but it does help long- term changes in the fetal heart rate pattern to be assessed.

  • Page 67: Sonicaid Trend

    10.2 Sonicaid Trend Trend measurements are performed at 15 minutes, and every 15 minutes thereafter. It fi ts a baseline using the last 60 minutes of fetal heart data collected, then calculates the following parameters: • Baseline heart rate (bpm) for the last 60 minutes •...

  • Page 68: Viewing Sonicaid Trend Data

    10.4 Viewing Sonicaid Trend data When Printing, Recording or Viewing a CTG If Trend results are available in any of these modes of operation, the Trend button in the Control Bar will appear Green. Touching this button will display Trend Results associated with the CTG. TREND data can be viewed either in numeric table form or in graph views.

  • Page 70: Dawes-Redman Antepartum Analysis

    The analysis integrated into Team 3 is a full implementation of the latest, most powerful, version of the world-renowned Dawes-Redman CTG analysis. Developed by Dawes, Redman et al., at Oxford University, it is based on the world's largest database of its type & is unique to Huntleigh's range of fetal monitors. IMPORTANT Interpretation and diagnosis of the CTG record remain the responsibility of the appropriately qualifi...

  • Page 71: The Dawes-Redman Criteria

    11.3 The Dawes-Redman Criteria • An episode of high variation, above the fi rst centile for gestational age. • No decelerations > 20 lost beats ( >100 lost beats on records longer than 30 minutes). • 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 is normal.

  • Page 72: Using Dawes-Redman Analysis

    The system then compares the calculated results with the Dawes / Redman criteria. • If the analysis is stopped prior to 10 minute, there are no analysis results. • If the analysis is stopped between 10 and 60 minutes and the Criteria are MET, the system prints and displays the message Dawes-Redman Criteria Met as well as all of the measurement parameters.
  • Page 73 Failure to follow all of these instructions will bring up a warning message when the Dawes-Redman button is pressed. Start the printer or recording to start analysis. The CTG will contain the message ‘Dawes-Redman Started’ and the Dawes-Redman button will turn Light Purple.

  • Page 74: Dawes-Redman Analysis Report

    While reviewing a CTG with analysis results • If the Criteria are Met, the Dawes-Redman button will be Green. • If the Criteria are Not Met, the Dawes-Redman button will be Cyan. • If the Green Dawes-Redman button is pressed, Team 3 will display the results from the last analysis calculation.
  • Page 75 Reasons for not meeting the criteria If the criteria were not met, the reasons are included in the printout. Possible reasons are: Reason Basal heart rate outside normal range Large decelerations No episodes of high variation No movements and fewer than 3 accelerations Baseline fi...
  • Page 76 A single asterisk indicates one of the following conditions: • Short term variation < 4ms, but ≥ 3 ms • Basal heart rate < 116 bpm or > 160 bpm on a record ≥ 30 minutes • Decelerations present, but not meeting the criteria for size of record length A single asterisk does not necessarily mean that the record cannot pass the criteria.

  • Page 77: Using Team 3 With A Crs System

    Sonicaid FetalCare • Sonicaid Centrale The Team 3 has been validated for use with the listed Huntleigh Software systems. Other manufacturers' systems using the industry standard HP50 / Philips communications protocol should also work but may not have been validated - contact Huntleigh for details.

  • Page 78: Telemetry - Sonicaid Freedom

    13. Telemetry – Sonicaid Freedom Please refer to the IFU supplied with the Sonicaid Freedom for detailed instructions on the use, care and maintenance before connecting and using the equipment. 13.1 Connecting the Sonicaid Freedom telemetry unit 1. Ensure the receiver aerial is fi tted and securely fastened to the connector on the rear panel.

  • Page 79: Trouble Shooting

    14. Trouble Shooting This section gives some of the more common problems encountered during use together with possible causes. If the problem cannot be located after consulting the table in this section, the Team 3 should be switched off, disconnected from mains power source and a qualifi...

  • Page 80: Fetal Event Marker

    14.3 Fetal event marker SYMPTOM POSSIBLE CAUSE / REMEDY No mark appears on the trace Check event marker is connected when the mother presses the Check enough time has elapsed since button event marker. last pressed. Team 3 does not beep when Check event marker is connected the mother presses the event Check sound setting.

  • Page 81: Care And Cleaning

    Periodically, and whenever the integrity of the system is in doubt, carry out a check of all functions as described in the relevant section of the IFU. If there are any defects to the housing contact Huntleigh or your distributor for repair or to order a replacement.

  • Page 82: General Cleaning And Disinfecting

    15.2 General Cleaning and Disinfecting Always keep the external surfaces clean and free of dirt and fl uids using a clean dry cloth. Wipe any fl uids from the surface of the product using a clean dry cloth. Wipe with a cloth dampened in 70% Isopropyl Alcohol. Completely dry with a clean, dry lint free cloth.

  • Page 83: Nibp Cuff & Maternal Oximetry Sensor

    Warning: Repeated and unnecessary use of concentrated solutions will result in damage to the product. Do not allow Sodium Hypochlorite solutions to come into contact with metal parts. The use of disinfectant materials, other than those listed, is the responsibility of the user for their effi...

  • Page 84: Maintenance

    3. Look carefully for cracks which may allow the ingress of liquids or gels. 4. Replace any broken or damaged transducers or cables. 5. If there is damage to the main Team 3 unit, contact your local Huntleigh Healthcare Ltd representative.

  • Page 85: Technical Maintenance

    16.4 Servicing Servicing should be performed only by Huntleigh Healthcare Ltd or their appointed service agent. If you have diffi culty obtaining service for Team 3, contact Huntleigh Healthcare Ltd.
  • Page 86 Secure Settings Sub Menus...
  • Page 87 Measures pressure applied to the NIBP port. Allows the entry of licence codes for features like Dawes- Redman and Trend analysis.
  • Page 88 Settings Sub Menu This button is not available while printing is in progress. Trace and Printer Settings Sub Menu Non-Sonicaid papers require a non- standard paper tray to be fi tted...
  • Page 89 Changing the timezone allows for daylight savings to be implemented. The unit will request a power down when “Save” is touched Save Local Settings = Fix all current settings as defaults. Apply Defaults = Overwrite all current settings with the stored defaults.

  • Page 91: Customising Easinotes

    Allows the system to be used in demonstration mode. Plays a previously recorded CTG in a continuous loop until this dialogue used to turn it off. Requires the power to be cycled off and on. Click on one of the demo traces - this will enable demo mode. Switch unit off/ on to activate.
  • Page 92 Easinotes fi le from the USB Flash Drive. 5. Exit the menu and remove the USB fl ash drive. 6. If possible, send the Easinotes.hcf fi le that you are now using to Huntleigh so that it can be included in later software releases.

  • Page 93: Specifi Cations

    17. Specifi cations 17.1 Equipment Classifi cation Class 1 Protection against electric shock. Type CF - Ultrasound Probes / TOCO / MECG / Applied Parts FECG Type B - Maternal NIBP/SpO2/fetal event marker Continuous Mode of operation. Main Unit : IP30 Degree of protection Ultrasound and Toco: IPX7 against harmful ingress...

  • Page 94: Transducers

    17.4 Transducers Ultrasound 30 to 240 bpm Range ± 1 bpm over the range 100-180 bpm Accuracy ± 2 bpm outside range High: 150 -200 bpm Alarms Low: 50 - 120 bpm Signal Loss: % loss in last 5 minutes Minimum: 53db(A) Alarm Sound...
  • Page 95 Uterine activity (external TOCO) 0–100 relative units Range 80% (±5%) scale reading equivalent to 100g Sensitivity ±100g Offset range Manual and auto zero facility Auto zero Type CF protection Safety IPX7 Ingress Protection Uterine activity (internal IUP) Intran Plus 400 Transducers Koala IPC5000C...
  • Page 96 Maternal blood pressure Oscillometric Method 0-300mmHg Pressure Range Systolic 25 - 280 mmHg Measurement Diastolic 10 - 220 mmHg ranges Pulse 30 – 220 bpm Measurement Measurement Required according Accuracy during during to international defl ation infl ation, IMT standards Pressure transducer ±1 mmHg ±1 mmHg...

  • Page 97: Printer

    Maternal oximetry BCI (Smiths Industries) 3444 Finger Sensor Sensor types NELLCOR DS100A Or as detailed in the current Team 3 Accessories & Consumables Brochure 0-99% SpO2 Saturation range ±1SD of normal distribution, within ranges: Saturation 70–99% ±2 digits accuracy 0–69% unspecifi ed 30-240 bpm Pulse rate range ±2 bpm or ±2%, whichever is greater...

  • Page 98: Connections

    17.6 Connections * Front Panel 1.0MHz ultrasound transducer / fetal ECG lead FHR1 1.0MHz ultrasound transducer / fetal ECG lead FHR2 1.0MHz ultrasound transducer / fetal ECG lead FHR3 Toco transducer/IUP lead ** TOCO Side Panel Maternal pulse oximetry MSpO2 Maternal non-invasive blood pressure NIBP Maternal ECG lead...

  • Page 99: Display

    17.7 Display TFT Liquid Crystal Display (LCD) Technology 8.4" diagonal Size SVGA, 800 x 600 Resolution 170° Viewing Angle Data display Fetal heart rate (30–240 bpm) ULT1, ULT2, ULT3 Pulse rate and confi dence indicator Fetal heart rate (30–240 bpm) FECG Pulse rate Maternal heart rate (30–240 bpm)
  • Page 100 Automatic Analysis Unlicenced OFF - a licence key can be purchased to activate this Dawes-Redman OFF - a licence key can be purchased to activate this TREND Audio 6 (out of 20) 6 (out of 20) Touch 10 (out of 20) Alarms 10 (out of 20) Fetal Movement...

  • Page 101: General Standards

    Uterine Activity Toco Zero Level Toco Auto Zero mmHg IUP Units Miscellaneous 00123 Screen Lock Code Screen Lock Enabled 50Hz Mains Frequency Bell Alarm Icons dd/MM/yyyy Date Format 1 minute SpO2 Alarm Timeout 10 minutes NIBP Valid Period Show Mean Arterial Pressure 12345 Secure Settings Code Keyboard...

  • Page 102: Accessories

    Please refer to the Accessories & Consumables catalogue included with the monitor for further details of products available for use with the Team 3. The latest issue of this catalogue is available on request from local Huntleigh representatives. Available accessories, consumables and spares include:...

  • Page 103: Electromagnetic Compatibility

    19. Electromagnetic Compatibility Make sure the environment in which Team 3 is installed is not subject to strong sources of electromagnetic interference (e.g. 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 104 Guidance and Manufacturer’s declaration - electromagnetic immunity The Team 3 is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Team 3 should assure that it is used in such an environment. Immunity Compliance IEC 60601 test level...
  • Page 105 Guidance and Manufacturer’s declaration - electromagnetic immunity The Team 3 intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Team 3 should assure that it is used in such an environment. IEC 60601 test Compliance Electromagnetic Environment - Immunity Test...
  • Page 106 Recommended separation distances between portable and mobile RF communications equipment and the Team 3 The Team 3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the customer or user of the Team 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Team 3 as recommended below, according to the maximum output power of the communications equipment.

  • Page 107: Ultrasound Safety Considerations

    20. Ultrasound Safety Considerations General Diagnostic ultrasound has been in use for over 35 years with no confi rmed adverse effects on patients or instrument operators at the intensities typical of present diagnostic instruments. However, available data are not wholly conclusive, and the possibility remains that biological effects may be identifi...
  • Page 108 Acoustic Output The ultrasound transducer used with the Sonicaid Team 3 fetal monitors has a single mode of operation, with fi xed acoustic output parameters that are not user adjustable. Acoustic Output Reporting Table for Track 1 – Non-Auto-scanning Mode Sonicaid Team 3 Operating Mode: PWD Application(s): Fetal Monitoring...
  • Page 109 Additional Information Parameter Value Uncertainty @ transducer face 0.30 mW/cm2 Note 1 ±24% SATA ‘In-situ’ de-rating of 0.3dB/cm/MHz has been applied in order to Note 1: derive de-rated values. Uncertainties The reported uncertainties are based on standard uncertainties multiplied by a coverage factor k = 2 providing a level of confi...

  • Page 110: End Of Life Disposal

    21. End of Life Disposal This symbol signifi es that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures.

  • Page 111: Warranty & Service

    • Mark the package ‘Service Department ‘ For further details, refer to NHS document HSG(93)26 (UK only). Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certifi cate. Service Department. Huntleigh Healthcare, Diagnostic Products Division, 35, Portmanmoor Rd.,...
  • Page 112 2016 777449EN-7 (ENGLISH)

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