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Arjo HUNTLEIGH Team3 Instructions For Use Manual
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Arjo HUNTLEIGH Team3 Instructions For Use Manual

Arjo HUNTLEIGH Team3 Instructions For Use Manual

Fetal monitor
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INSTRUCTIONS FOR USE
Team3
Fetal Monitor
777449EN-20
04/2022

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  • Page 1 INSTRUCTIONS FOR USE Team3 Fetal Monitor 777449EN-20 04/2022...

  • Page 2: Table Of Contents

    Table of Contents 1. Safety ....................6 Warnings ....................6 Infection Control ..................8 Patient Applied Parts ................8 Service Life ..................... 8 2. Introduction ..................9 Intended Use and Indications ............... 10 2.2 Clinical Benefit ..................10 Contraindications .................. 10 2.4 Confirming Fetal Life Before Use ............10 2.5 Unpacking / Preliminary Checks ............
  • Page 3 5.4.2 FHR Monitoring ...................... 43 5.4.3 TOCO /IUP ......................43 5.4.4 MSpO / MHR / MECG ................... 43 5.4.5 Maternal NIBP ......................44 5.4.6 Trace Format ......................44 5.5 Switching the Unit OFF ................. 45 5.6 Battery Charging ................... 45 6. Monitoring Fetal Parameters .............46 6.1 Preliminary .....................
  • Page 4 10. Sonicaid Trend ..................74 10.1 Introduction .................... 74 10.2 Sonicaid Trend ..................75 10.3 Sonicaid Trend results ................75 10.4 Viewing Sonicaid Trend data ..............76 11. D awes-Redman Antepartum Analysis ..........78 11.1 Intended Use ..................78 11.2 Overview ....................78 11.3 The Dawes-Redman Criteria ..............79 11.4 Dawes-Redman Analysis ..............
  • Page 5 16.7 Display ....................109 16.8 Default Settings ..................110 16.9 General Standards ................. 112 17. Accessories ..................113 18. Warranty and Service ................114 Appendix 1 Electromagnetic Compatibility ...........115 Appendix 2 Manufacturer's Performance Criteria Specification ..119 Appendix 3 Ultrasound Safety Considerations ........121 Appendix 4 End of Life Disposal .............123 Appendix 5 Maternal SpO2 Additional Nellcor Clinical Information ..124 Appendix 6 Sonicaid Wireless Telemetry ..........130 Connecting the Sonicaid Freedom telemetry unit ........

  • 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. Team3 provides just one indicator of fetal condition. This should be assessed as part of an holistic approach to obstetric care together with other factors. A complete assessment must be made before taking appropriate action. If there is any doubt concerning the accuracy of any measurement, an alternative method should be used. Symbols General Warning Refer to Instructions for Use Attention, consult accompanying documents / Instructions for Use Warnings Do not use in the presence of flammable gases or in oxygen rich environments. Do not sterilise the product or its accessories. The product will be damaged, and there is a risk of patient and user harm. Keep dry, do not immerse Team3 in liquid. Ultrasound and Toco transducers are IPX7 rated. Team3 with wired transducers is not intended for use in water birth situations. Always fit Protective cover to protect against fluid ingress when moving Team3 by hand or on a trolley. Do not use in the sterile field unless additional barrier precautions are taken. Use only recommended accessories listed in this manual. Do not dispose of batteries in fire as this can cause them to explode. The optional Lithium battery pack is a service replaceable item. Replacement by inadequately trained personnel could result in a hazard. Do not use with defibrillators. Ensure that all Team3 leads and applied parts are removed from the patient before applying Defibrillation.
  • Page 7 Team3 series monitors are not intended for use with patients fitted with cardiac pacemakers. Do not use with electrosurgical devices. Team3 can be isolated from the AC mains supply by removing the IEC mains inlet connector. Ensure that this is fully accessible at all times. Team3 is a Class 1 product that relies for safety on its protective earth. Ensure it is connected to a suitably earthed AC mains supply. Do not use in the home environment. Do not use the Team3 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 fields could possibly interfere with it. This may be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated. Do not expose to excessive heat, including prolonged exposure to sunlight. This equipment must not be modified. This equipment is for use only by suitably qualified healthcare practitioners. When configuring the system, consider and minimise the risk of persons tripping over cables. Do not use during magnetic resonance imaging (MRI) scanning. Do not use if there is any damage to the unit or its accessories. The use of the Team3 is restricted to one patient at a time. The risk of cyber attack on the fetal monitor is negligible. No special means are required to secure the device or its updates. Instructions For Use...

  • Page 8: Infection Control

    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 is not provided as a diagnostic ECG function and is therefore not designed to meet all of the requirements of IEC 60601-2-27. The emissions characteristics of this equipment make it suitable for use in individual areas and hospitals (CISPR 11 Class A). If it is used in a residential environment, (for which CISRR 11 Class B is normally required), this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as re-locating or re-orienting the equipment. When monitoring the fetal heart rate using an external ultrasound transducer, the fetal heart rate may sometimes be falsely reported. This is characteristic of ultrasound monitoring and can have a number of causes, including inadvertent monitoring of the maternal heartrate or signal artefact (see section 6.3). Infection Control Single use transducer belts are for single patient use only and must not be re-used. For other single use accessories refer to the user instructions supplied with them. Patient Applied Parts As defined in IEC60601-1:2005, the patient applied parts of the Team3 Fetal Monitor are the:...

  • Page 9: Introduction

    Introduction The Team3 series of fetal/maternal monitors are intended for antepartum (Team3A) and intrapartum use (Team3I). The following features are standard on all models (Team3A and Team3I): • Dual channel ultrasound fetal heart rate detection with audio. • External monitoring of maternal contractions •...

  • Page 10: Intended Use And Indications

    Intended Use and Indications The Team3 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. Monitoring using ultrasound is recommended from the 26th week of gestation for routine fetal monitoring.

  • Page 11: Unpacking / Preliminary Checks

    2.5 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. 2.5.1 Contents Standard - All models Item Item Item 1 x Team3 1 x Ultrasound Transducer 1 x Toco transducer...

  • Page 12: Product Identification

    Product Identification 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. 3.1 Front Panel Touchscreen FHR2 US/FECG socket On/Off Button TOCO Transducer socket Printer * FHR3 US/FECG socket * FHR1 US/FECG socket * Depending on model/options purchased. Instructions For Use...

  • Page 13: 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. Base Panel Label 777320-7 Instructions For Use...

  • Page 14: Side Panel

    Side Panel Nellcor MSpO Socket option BCI MSpO Socket options Maternal SpO Maternal NIBP * Maternal ECG * Transducer storage * Depending on model/options purchased. Product Labelling Note: Product labelling should be read from a distance no greater than 0.5m. Applied parts (Ultrasound Applied parts (Maternal NIBP/MSpO Probes /TOCO/ FECG/ fetal event marker) are type BF* MECG) are type CF* This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic...
  • Page 15 Huntleigh Healthcare Ltd. Manufactured 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden Attention, consult accompanying Warning documents / Instructions for Use Alternating current (AC)

  • Page 16: Setup

    Setup 4.1 System Connection WARNING: These requirements must be met when a Team3 is connected to any other electrical equipment, such as a PC. Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information Technology equipment, this standard is IEC950/ EN60950. Anyone who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC60601-1:2005;...

  • Page 17: Probe/Sensor/Cuff Connection

    4.2 Probe/Sensor/Cuff Connection Ensure all probe/sensor leads are fully inserted into the appropriate socket. Do not remove any cables by pulling on the lead. Loading Paper Refer to Section 9.6 - Loading Printer Paper. 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.
  • Page 18 Wall bracket If the unit is seldom moved, a purpose-designed bracket is available as an accessory to allow the Team3 to be wall mounted with maximum safety. Follow the instructions provided with the bracket regarding assembly and proper mounting of the Team3. Brackets must be installed by trained personnel using fixings appropriate for the wall construction and load. Carry out load tests before use.

  • Page 19: Operation

    Operation 5.1 Switching the Unit ON If the DVI option is installed and an external touchscreen is connected, the external screen must be powered on before either applying mains power to Team3, or turning it In this mode, all references to the touchscreen control of Team3 in this manual refer to the external touchscreen.

  • Page 20: Application Screen

    Application Screen The application screen will be displayed and automatically configured according to the options / modules fitted to the unit. The screen is arranged into a series of waveforms and numerical indicators. All functions are accessed via the touchscreen, either through the Control Bar Menus located across the bottom of the screen or by touching each application.

  • Page 21: Entering Patient Data

    When the database is ~85% full, a message will prompt the user to archive traces >1 year old. This message is repeated each time the unit is switched on until this is done. After 7 days, if still not done, the system will force archiving. Traces are archived to a USB memory stick via one of the 2x USB ports on the rear panel.
  • Page 22 Note To search for patient records stored in the fetal monitor, enter passcode 9 8 7 6 5 after touching Search. Touch the ‘Gestation’ box to enter the ‘Set Gestational Age’ screen. Touch to return to the Monitoring screen with the details on this form. Searching for Patient Names Touch to return to the Monitoring screen with the details of this patient in the Patient Data region.
  • Page 23 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. Touch any up or down arrow icon to change the values.

  • Page 24: 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 25: 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 confirm.

  • Page 26: Print / Record

    5.3.1 Print / Record See Section 9 - Printing for details. Touch to print or record.* Indicates printing or recording is active. Touch to cancel printing or recording. All printed data is also recorded. The recorded data can be reviewed when required. Annotation Icon appears in the control bar when printing or recording is active.
  • Page 27 Annotation Main Menu Touch each note category to access the sub menu options available. Note The Easinote sub-system is very flexible allowing up to 12 groups of 12 notes to be configured on Team3. Note The "Mark" button allows users to print a blank annotation field on the trace for adding a hand written note. Note Refer to Sections 16.5 and 16.6 for details on how to access the Settings Management feature to customise and translate notes. Note The "Custom" button allows users to type custom notes using an on-screen keyboard - click on the "Send" button to output the message. Annotation Sub Menu Touch any of the options to add the note to the recording/printing data. The selected note will appear on the printed / recorded data.

  • Page 28: Settings Menu

    5.3.7 Settings Menu Touch on the control bar to view the Settings menu. This menu allows users to configure the Team3 settings to be specific to the patient. The settings remain in effect until the monitor is powered off, unless they are saved as defaults. To save new settings as defaults, make the desired changes, then navigate to Settings Management and select Save Local Settings.
  • Page 29 Patient Data Trace & Printer Settings Trace Speed & Scale Printer Paper Lock Codes Secure Settings Code Unlock Code Service Code Patient Data Code Settings Management NIBP Protocol Touch to return to previous page. accepts data and does not. returns to Main Application screen. For all Menu and sub menu screens the options are selected/deselected by touching on the icons as follows: Option disabled...
  • Page 30 Note: The Trace Offsets sub menu is only available if not printing or recording. Note: Team3 will return all settings to Default levels when switched off. Default settings can be customised - refer to Section 16.5. Note: If the mains supply is interrupted for more than 30 seconds when no backup battery is provided, the Team3 shall revert to Default settings. Settings Sub Menus Clinical Settings Sub Menu Instructions For Use...
  • Page 31 Note Date & Time and Recording limits settings not available when printing/ recording. System Settings Sub Menu Note Does not set Alarm Volume or volume of heart sounds. Note The "Clinical Sounds" option buttons allow listening of just one sound channel or multiple sounds. Instructions For Use...
  • Page 32 If enabled, printing / recording stops after this time has elapsed. Instructions For Use...
  • Page 33 In this screen, the operator can change the background colour of the screen to suit their preference or ambient light levels. Note Print Twin Grids not accessible when printing or recording. WARNING Ensure that ALARM LIMITS are set to realistic values. Use of extreme values can render the ALARM SYSTEM useless. Instructions For Use...
  • Page 34 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. TPA - TOCO Persistence Alert Note Only available if MSpO option fitted. Instructions For Use...
  • Page 35 Note Only available in Team3I models or if MSpO2 option fitted in Team3A. Note Only available if NIBP option fitted. Note This sets the volume level for alarm sounds. This is independent of the user set volume level for normal audio sounds. Alarm volume cannot be set to zero. Instructions For Use...
  • Page 36 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 the secure area. Note Refer to Section 16.5 and also the Service manual.

  • Page 37: View Menu

    5.3.8 View Menu Touch the icon to access the View Menu settings. 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. Instructions For Use...
  • Page 38 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 39 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. Instructions For Use...
  • Page 40 The MECG/ FECG screens display a trace from any ECG probe (Fetal or maternal) that is plugged Touch to freeze the screen to view the trace. Touch restart the trace. Instructions For Use...

  • Page 41: Monitoring Parameters

    5.4 Monitoring Parameters You can configure 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 42: 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 configuration is dependent on whatever sensors/ probes are attached.

  • Page 43: 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 44: Maternal Nibp

    MSpO2 / MHR If the MECG lead is not in use, the MHR measured by MSpO 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 45: Switching The Unit Off

    5.5 Switching the Unit OFF Touch and hold to switch the unit Off. A confirmation screen will be displayed. Power Off Touch Power Off to turn off the Team3 or touch to return to the last screen. Alternatively, continued touch on the off button for ~15-20s will switch the unit off directly from any machine state.

  • Page 46: Monitoring Fetal Parameters

    Monitoring Fetal Parameters 6.1 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 Team3. 2. Check the printer (If fitted). Ensure there is sufficient paper. 3. Check the printer setup (FHR offsets, Twins grids). 4. Enter patient details, if required. 5.
  • Page 47 Note The printed trace, and the trace saved to the patient database, will only show trace data from the point when the printer is started. Any on-screen trace data prior to this will be discarded. 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 48: False Recording Of Fhr

    6.3 False recording of FHR When monitoring the fetal heart rate using an external ultrasound transducer, the fetal heart rate may sometimes be falsely reported. This is characteristic of ultrasound monitoring and can have a number of causes, including: • Inadvertent monitoring of the maternal heart rate; whereby the transducer picks up stronger signals from the pulsations of the maternal vessels, particularly in the second stage of labour (when the fetal head and heart is lower within the birth canal); • Signal artefact, such as double-counting or half-counting, whereby the recorded fetal heart rate suddenly appears suspiciously higher or suspiciously lower than the audio signal coming from the monitor’s loudspeaker. Note: If you have reason to doubt the reliability of the fetal heart rate and/or maternal heart rate, always confirm by independent means. How to minimise the chances of double rating, half rating or other types of artefact occurring 1. Palpate the maternal pulse for one minute simultaneously and record it on the printed output. Check that the maternal rate is different from the displayed fetal rate. 2.

  • Page 49: Print Twins Grids

    4. To hear the audio signal for each fetus, press the relevant area of screen. The Audio symbol shows which is the active audio channel. 5. Check that the two/three heart rates are different. f the heart rates appear similar check the positions of the transducers.

  • Page 50: Fetal Ecg (Team3I Models Only- Using A Fetal Ecg Electrode)

    6.5 Fetal ECG (Team3I models only- using a Fetal ECG electrode) Connection An FECG transducer can be connected via any of the green sockets on the front of the monitor (FHR1, FHR2, FHR3). Note: Only one FECG transducer can be connected at a time. If more than one FECG transducer is connected, the following screen will be displayed: It is possible to monitor FECG for a fetus independently of the ultrasound monitoring. The FECG channel can be used simultaneously with the two ultrasound channels for triplet monitoring.

  • Page 51: Monitoring Maternal Parameters

    Monitoring Maternal Parameters 7.1 Contractions (using TOCO transducer) Use only TOCO transducers supplied with the Team3, 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. 2. Connect the TOCO transducer to the pink socket on Team3. 3.

  • Page 52: Contractions (Using Iup Transducer)

    7.2 Contractions (using IUP transducer) Use only IUP transducer types supplied with the Team3, 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. Follow the manufacturers’ instructions for correct use. Do not connect IUP transducers to Team3 Antepartum models as they are not compatible. 1. Connect the IUP connecting lead to the pink socket on Team3. 2. Check IUP units of measurement (mmHg or kPa). Change, if required. (See Section 5.3 - Settings Menu). 3. Insert the catheter as described in the instructions supplied with it. 4.

  • Page 53: Manual Fetal Movement Event Marker

    Please be aware Automatic Fetal Movement Marker’s in the absence of fetal life may be a result of: • Movement of the deceased fetus during or following maternal movement. • Movement of the deceased fetus during or following maternal abdominal examination.

  • Page 54: Maternal Ecg (Mecg)

    Note: Team3 can record both Manual and Automatic Fetal Movements simultaneously. 7.4 Maternal ECG (MECG) 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 is not provided as a diagnostic ECG function and is therefore not designed to meet all of the requirements of IEC 60601-2-27.

  • Page 55: Fetal Cross Channel

    7.4.1 Fetal Cross Channel The monitor’s ‘Fetal Cross-channel’ detection technology can help by continuously monitoring the maternal pulse and fetal heart rate by detecting when the same heart rate is being recorded. Either MECG or SPO2 finger sensor can be used to derive the maternal pulse. If the maternal and/or fetal heart rates appear similar an alarm will sound and 'FETAL CROSS CHANNEL' will be printed.

  • Page 56: Maternal Blood Pressure

    Maternal Blood Pressure Team3 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 defined by the user). An alarm is triggered if the mother’s blood pressure goes above or below certain limits. The alarm can be switched off if preferred.

  • Page 57: Taking Bp Measurements

    Other considerations There are many other factors which can effect BP measurement and reflect best practice against national and international guidelines. Key issues that affect accuracy of BP measurements: • The patient should be relaxed and rested – minimum 3 minutes before commencing measurement •...
  • Page 58 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 59 Failed measurements (manual and automatic) When an NIBP measurement fails: • The NIBP display shows ---/--. Always use the correct size of cuff. Do not use any cuffs other than those licensed for use with the Team3. For maternal use only; do not use on neonates. Safety mechanisms are incorporated to prevent over-inflation, or extended period inflation. 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. Readings are also subject to the well documented "white coat effect" and patients should be rested for a minimum of 3 minutes before measurements are taken. It is recommended that BP readings are confirmed using a manual sphygmomanometer before diagnosing clinical hyper- / hypo- tensive conditions requiring treatment. Avoid taking measurements during contractions as this may affect the reading. Frequent measurements may cause blood flow interference and injure the patient. To prevent further injury, do not place the cuff on any wound. Do not place the blood pressure cuff on a limb under intravenous infusion, intravenous therapy or arteriovenous shunt, or the transient blood flow interference will injure the patient. Do not place the cuff on the arm at the same side as mastectomy. The increasing cuff pressure may cause transient function failure to other monitoring equipment used on the same limb. Ensure the inflation tube connecting the blood pressure cuff to the Monitor is not obstructed or tangled. Extremes of temperature, humidity and altitude outside limits specified for Team3 can affect results.
  • Page 60 Reviewing BP Results Touch and hold the NIBP region to access the NIBP menu. Touch to show the BP results screen. The NIBP results will de displayed. Touch to scroll through the results. Note: BP results can be printed in review mode - see section 5.3.8. Instructions For Use...

  • Page 61: Maternal Oximetry

    7.6 Maternal Oximetry Team3 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 Note If using the Freedom SF1, you will need to view the Version screen (See 16.5...
  • Page 62 Relocate the sensor periodically (at least every 4 hours) and monitor skin integrity. If the mother experiences discomfort due to the oximetry sensor, discontinue use immediately. A poor MSpO 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. Do not use the MSpO sensor on the same arm as the NIBP cuff. BCI (Round/Rectangular Socket) A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor. To check the function of the device, an optional Oximeter/ECG Patient Simulator is available as an accessory (Smiths Medical PM, Inc. Cat# 1606). The simulator attaches to the Oximeter in place of the sensor or patient cable. It provides a known %SpO and pulse rate signal to the Oximeter, allowing the Oximeters performance to be checked. Nellcor (Rectangular Socket) Some models of commercially available bench top functional testers and patient simulators can be used to verify the proper functionality of Covidien Nellcor™ monitoring systems, sensors, and cables. Reference the individual testing device's operator's manual for the procedures specific to the model of tester used. While such devices may be useful for verifying that the sensor, cabling, and monitoring system are functional, they are incapable of providing the data required to properly evaluate the accuracy of a system's measurements. Further information The following information and warnings are supplied in accordance with the requirements of ISO 9919:2005 clause 6.8.2 (aa): 1.
  • Page 63 3. The function or accuracy of the MSpO system may be affected by the following: • Incorrect sensor position. • Presence of an arterial catheter, blood pressure cuff, or intravascular line on the same limb. • Ambient light. • Excessive patient movement. •...
  • Page 64 BCI Clinical Eval. report: This study was a descriptive, cross-sectional investigation of healthy, human subjects comparing four Model 31400 Pulse Oximeter Modules (Board 31402B2) determined oxygen saturation (SpO ) values during motion (test condition) to CO-oximeter determined functional oxygen saturation (SaO ) values (reference condition). Two additional Model 31400 Pulse Oximeter Modules (Board 31402B2) which were not subjected to motion were used as a control and to determine stable plateaus in the oxygen saturation readings.

  • Page 65: Alarms

    Alarms 8.1 What is meant by an alarm The alarms in Team3 are intended to alert users to monitoring data which fall outside user set levels/timings for each type of alarm. They are not intended to alert users to clinical conditions or pathology. They must not be relied on for this, which remains the responsibility of the user.

  • Page 66: 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 Low O Saturation Alarm Maternal High O...

  • Page 67: Nellcor Spo2 Technical Alarms (Nellcor Spo2 Option Only)

    8.5 Nellcor SpO2 technical alarms (Nellcor SpO2 option only) The following technical alarms may be displayed: MSpO2 Extended updates Indicates maternal heart rate measurement has been static for 25+ seconds. If triggered, the displayed MHR is invalid. Re-position the sensor (try a different finger) . MSpO2 Pulse Timeout Indicates that the pulse signal has been lost. Re-position the sensor (try a different finger) .

  • Page 68: Printing

    Printing Introduction Team3 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 69: Print Speed And Duration

    Print speed and duration Print speed is selectable at 1, 2 or 3 cm/minute 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/minute 75 hours 2cm/minute 37.5 hours 3cm/minute...

  • Page 70: Loading Printer Paper

    Loading printer paper When the printer tray is opened, a help screen displaying the following diagram is shown. The screen may be closed by closing the paper tray or bypassed using the back button Note: Ensure the paper remains centrally aligned while closing the drawer. The screen automatically returns to normal operation when the tray is closed but this is not an indicator that the tray is FULLY closed. Always ensure it is fully closed by checking that the front face of the paper tray is flush with the front face of the surrounding case. 9.7 Using non-Sonicaid paper We strongly recommend the use of standard Huntleigh paper.

  • Page 71: 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. With plain paper, where the grid is printed at the same time as the trace data, any alignment error is eliminated, ensuring 100% print accuracy.

  • Page 72: Turning Off The Printer

    9.9 Turning off the printer 9.9.1 Normal recording Touch the Green printer button . The button will flash 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 73: Stopping The Printer While Print Timer Running

    following screen appears. Touch to stop the analysis or to cancel. 9.9.3 Stopping the printer while print timer running If the print timer is available this will show as an overlay on the print button When the printer is active this will show as follows If you attempt to stop the printer before the print timer expires, the following screen will be displayed.

  • Page 74: Sonicaid Trend

    10. Sonicaid Trend 10.1 Introduction Sonicaid Trend is a software option available with all Team3 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 75: Sonicaid Trend

    10.2 Sonicaid Trend Trend measurements are performed at 15 minutes, and every 15 minutes thereafter. It fits 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 76: 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. The graph views are particularly powerful in alerting clinicians to long term trends which are easily missed and can highlight significant clinical issues - an application note further detailing this function is available from your supplier.
  • Page 77 Instructions For Use...

  • Page 78: Dawes-Redman Antepartum Analysis

    11. Dawes-Redman Antepartum Analysis 11.1 Intended Use The intended use of Dawes-Redman analysis is to analyse clinically indicated antepartum CTGs in pregnancies from 26 weeks gestation onwards. It can be used on women who are experiencing Braxton-Hicks contractions but it is not intended for use in latent or established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents and epidural anaesthesia.

  • Page 79: The Dawes-Redman Criteria

    11.3 The Dawes-Redman Criteria The Dawes-Redman criteria have been developed by Dawes, Redman et al at Oxford University over many years based on a growing database - the largest of its type in the world. It is a unique evidence based approach to CTG interpretation designed to replace the traditional visual interpretation based on highly subjective opinion, which is subject to high inter- and intra-observer variation.

  • Page 80: Using Dawes-Redman Analysis

    The system then compares the calculated results with the Dawes-Redman criteria. • If the analysis is stopped prior to 10 minutes, 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 81 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. While printing or recording •...

  • Page 82: 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, Team3 will display the results from the last analysis calculation.
  • Page 83 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 fitting is uncertain Short-term variation is less than 3ms Possible error at the end of the record Deceleration at the end of the record...
  • Page 84 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 85: Using Team3 With A Crs System

    12. Using Team3 with a CRS System The Team3 can be connected to the following PC-based Central Record Systems: • Sonicaid FetalCare • Sonicaid Centrale The Team3 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. 12.1 Connecting Team3 to Sonicaid FetalCare and Sonicaid Centrale 1. Connect the Sonicaid FetalCare connecting lead to the RS232 connector on the rear of Team3. 2.

  • Page 86: Trouble Shooting

    13. 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 Team3 should be switched off, disconnected from mains power source and a qualified technician should be consulted.

  • Page 87: Fetal Event Marker

    13.3 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 last event marker. pressed. Team3 does not beep when Check event marker is connected the mother presses the event Check sound setting.

  • Page 88: Care And Cleaning

    14. Care and Cleaning 14.1 General Care All Huntleigh products have been designed to withstand normal clinical use, however they can contain delicate components, for example the ultrasound transducer, which should be handled and treated with care. 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.

  • Page 89: General Cleaning And Disinfecting

    14.2 General Cleaning and Disinfecting Always keep the external surfaces clean and free of dirt and fluids using a clean dry cloth. 1. Wipe any fluids from the surface of the product using a clean dry cloth. 2. Wipe with a cloth dampened in 70% Isopropyl Alcohol. 3.

  • Page 90: Nibp Cuff And Maternal Oximetry Sensor

    The use of disinfectant materials, other than those listed, is the responsibility of the user for their efficacy and compatibility with the device. Approved Products DO NOT USE LINGET ANIOS SURFA'SAVE WIP'ANIOS Excel Surfanios Premium Clinell Alcohol Wipes (Red) Clinell Alcohol Wipes Plus+ (Red) Clinell Universal Wipes (Green) Clinell Universal Spray (Green) WARNING After using chemicals ALWAYS rinse off / remove the chemical with absorbent material, dampened in clean water and dry with a clean cloth. 14.4 NIBP Cuff and Maternal Oximetry Sensor For cleaning and disinfection, refer to instructions supplied by the manufacturer. 14.5 Transducer Belts Re-useable belts can be hand-washed at 40°C maximum using a washing powder or...

  • Page 91: Maintenance

    15. Maintenance Warning It is very important that all instructions in the Maintenance section are followed carefully. 15.1 User maintenance The checks below can be performed by any user of the equipment. Mechanical inspection Every three months: 1. Inspect the AC supply cable, transducers, and all other assemblies and connectors for loose or broken parts, or any other damage. 2.

  • Page 92: Technical Maintenance

    15.2 Technical maintenance Refer to your Service department for details of technical maintenance and support. 15.3 Corrective maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd. The Sonicaid Team3 Service Manual (order part number 777490) is designed as an aid to engineers in maintenance and service of repairable parts.
  • Page 93 Service Sub Menu Service menu options are for use by trained biomedical staff only. Enter a 5 digit code via the touchscreen, (default code 5 5 5 5 5 ), to enter the Service Menu. For service use only. Allows additional features to be enabled with a valid license key.
  • Page 94 Recordings Manager allows trace records to be moved to the internal archive database. For service use only. Allows qualified biomedical engineers to perform tests related to NIBP measurement. Instructions For Use...
  • Page 95 Archive Manager allows trace records from the internal archive to be transferred back into the live database. Instructions For Use...
  • Page 96 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 an antepartum demo mode. Switch unit off/on to activate.
  • Page 97 * Mains Frequency Setting The default setting for the mains frequency on this product is 50Hz. Touch to select required frequency. Touch to confirm. Allows these functions to be enabled/disabled. This button is not available while printing is in progress. Instructions For Use...
  • Page 98 Trace and Printer Settings Sub Menu Non-Sonicaid papers require a non-standard paper tray to be fitted Instructions For Use...
  • Page 99 Lock Codes Sub Menu Instructions For Use...
  • Page 100 Save Local Settings = Fix all current settings as defaults. Apply Defaults = Overwrite all current settings with the stored defaults. Imports and Exports allow transfer to and from Team3 via USB Flash Drive.* Note: Do NOT transfer settings files from one monitor to another if the software versions are not the same. Note: Import/Export buttons are only displayed when a USB Flash Drive is installed. *A software tool is available from your supplier to support the Easinote function. See section 16.6. Instructions For Use...

  • Page 101: Customising Easinotes

    Allows NiBP protocol details to be customised. 15.6 Customising Easinotes WARNING The Secure Settings menus should be accessed by authorised personnel only. The Easinote sub-system is very flexible allowing up to 12 groups of 12 notes to be configured on Team3. Refer to Section 16.5 for details on how to change the Language and to access the Settings Management feature.
  • Page 102 Customising Easinotes 1. Contact Huntleigh Service and get a link to download the Easinotes Editing tool. 2. Install the tool and run it. (See image below). 3. Open the Easinotes.hcf file on the USB Flash Drive, exported from your Team3. 4. On the left of the tool is shown each of the Categories (See section 5.3.6.).

  • Page 103: Specifications

    16. Specifications 16.1 Equipment Classification Protection against Class 1 electric shock. Applied Parts Type CF - Ultrasound Probes /TOCO/ FECG/MECG Type BF - Maternal NIBP/MSpO2/fetal event marker Mode of operation. Continuous Degree of protection Main Unit : IP30 when Fixed or Stationary. against harmful IP32 with protective cover used ingress of particles...

  • Page 104: Transducers

    16.4 Transducers Ultrasound Range 30 to 240 bpm Accuracy ± 1 bpm over the range 100-180 bpm ± 2 bpm outside range Alarms High: 150-200 bpm Low: 50-120 bpm Signal Loss: % loss in last 5 minutes Mode Directional pulsed Doppler Repetition rate 3.0kHz Frequency 1.0MHz (green)
  • Page 105 Uterine activity (external TOCO) Range 0-100 relative units Sensitivity 80% (±5%) scale reading equivalent to 100g Offset range ±100g Auto zero Manual and auto zero facility Safety Type CF protection Ingress Protection IPX7 Uterine activity (internal IUP) Transducers Intran Plus 400 / Koala IPC5000C ® Or as detailed in the current Team3 Accessories and Consumables Brochure Pressure range 0-100 mmHg/0-13.3 kPa (user selectable)

  • Page 106: Alarm Characteristics

    Alarm characteristics Alarm Sound Pressure Minimum 53db(A) Levels at 1m Default 75db(A) Maximum 92db(A) Alarm tone 3 pulses Pulse frequency = 311Hz Pulse duration = 170ms Rise time = 17ms Fall time = 28ms Inter pulse gap = 160ms Pulse amplitudes within 10% of each other Inter burst interval between 2.5s and 30s Maternal oximetry Module...
  • Page 107 Maternal blood pressure Method Oscillometric Pressure Range 0-300mmHg Measurement ranges Systolic 25-280 mmHg Diastolic 10-220 mmHg Pulse 30-240 bpm Accuracy Measurement Measurement Required according during during inflation, to international deflation standards Pressure transducer ±1 mmHg ±1 mmHg max. ±3 mmHg accuracy Measurement <1.7 mmHg <1.19 mmHg max.

  • Page 108: Printer

    16.5 Printer Print head 128mm thick film Resolution 8 dots per mm Printer speeds 1, 2, or 3cm per minute (user selectable) 10 cm per minute fast forward Paper Plain thermal paper, z-fold, 45m length FHR scales 30–240 bpm or 50–210 bpm (user selectable) Annotation ●...

  • Page 109: Display

    Interfaces Telemetry Sonicaid Wireless Telemetry System Sonicaid Centrale Sonicaid Fetalcare * Depending on model ** Intrapartum Model only 16.7 Display Technology TFT Liquid Crystal Display (LCD) Size 8.4" diagonal Resolution SVGA, 800 x 600 Viewing Angle 170° Data display ULT1, ULT2 Fetal heart rate (30–240 bpm) Pulse rate and confidence indicator FECG...

  • Page 110: Default Settings

    16.8 Default Settings Alarms Loss of Signal Fetal Heart Rate High - 160bpm for 3 minutes ON Low - 110bpm for 3 minutes ON Toco Persistance Alert 50% for 5 minutes OFF Maternal Heart Rate High - 100bpm for 3 minutes OFF Low - 60bpm for 3 minutes OFF Maternal Systolic High -140mmHg OFF...
  • Page 111 Printer Vertical scale 20 bpm/cm Minor Vertical Scale 10 bpm Speed 1 cm/min Twins Print Grid FHR2 Offset FHR3 Offset Paper Type Sonicaid Timer Non Stress Test Timer Period 10 minutes OFF View Start Screen Numeric Background colour Black Uterine Activity Toco Zero Level Toco Auto Zero IUP Units mmHg Instructions For Use...

  • Page 112: General Standards

    Miscellaneous Screen Lock Code 00123 Screen Lock Enabled Mains Frequency 50Hz Alarm Icons Bell Date Format dd/MM/yyyy MSpO Alarm Timeout 1 minute NIBP Valid Period 10 minutes Show Mean Arterial Pressure Secure Settings Code 12345 Keyboard Language en-GB 16.9 General Standards IEC60601-1: 2005 + A1:2012 ISO15223-1:2012 ANSI/AAMI ES60601-1:2005 IEC60601-2-49:2011 CAN/CSA C22.2 No 601.1-M90 (R2005) IEC62304 JIS T 0601-1:2012 IEC60601-1-2: 2007 Instructions For Use...

  • Page 113: Accessories

    17. Accessories Use only recommended accessories listed in this manual or in the Accessories and Consumables catalogue. Please refer to the Accessories and Consumables catalogue included with the monitor for further details of products available for use with the Team3. The latest issue of this catalogue is available on request from local Huntleigh representatives. Available accessories, consumables and spares include: Accessories Item...

  • Page 114: Warranty And Service

    18. Warranty and Service Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns If for any reason the Team3 has to be returned, please: •...

  • Page 115: Appendix 1 Electromagnetic Compatibility

    Appendix 1 Electromagnetic Compatibility Make sure the environment in which Team3 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 116 Guidance and Manufacturer’s declaration - electromagnetic immunity The Team3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Team3 should assure that it is used in such an environment. Immunity Compliance IEC 60601 test level Electromagnetic Environment - guidance Test level Portable and mobile RF communications equipment should be used no closer to any part of the Team3, including cables, than the recommended separation distance calculated from the equation applicable to...
  • Page 117 Guidance and Manufacturer’s declaration - electromagnetic immunity The Team3 intended for use in the electromagnetic environment specified below. The customer or the user of the Team3 should assure that it is used in such an environment. IEC 60601 test Electromagnetic Environment - Immunity Test Compliance level level guidance Electrostatic ± 6 kV contact ±...
  • Page 118 Recommended separation distances between portable and mobile RF communications equipment and the Team3 The Team3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the customer or user of the Team3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Team3 as recommended below, according to the maximum output power of the communications equipment.

  • Page 119: Appendix 2 Manufacturer's Performance Criteria Specification

    Appendix 2 Manufacturer's Performance Criteria Specification The Essential performance is derived from the specific part 2 standards for Ultrasound, NIBP, SPO2 and ECG, viewed in the context of Fetal monitoring. Function Essential performance User expectation if EP is lost (EP) System System power on/off Blank screen with no audio - obvious to status maintained.
  • Page 120 Battery status clearly Worst case scenario is that the monitor indicated. shuts down which is obvious to the user. MECG/FECG HR range and accuracy. Unexpected or erratic pulse rate patterns would prompt the user seeking alternative confirmation. Settings maintained Worst case scenario is that the user is following mains loss.

  • Page 121: Appendix 3 Ultrasound Safety Considerations

    Appendix 3 Ultrasound Safety Considerations General Diagnostic ultrasound has been in use for over 35 years with no confirmed 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 identified in the future.
  • Page 122 Acoustic Output The ultrasound transducer used with the Sonicaid Team3 fetal monitors has a single mode of operation, with fixed acoustic output parameters that are not user adjustable. Acoustic Output Reporting Table for Track 1 – Non-Auto-scanning Mode Sonicaid Team3 Operating Mode: PWD Application(s): Fetal Monitoring Acoustic Output SPTA.3 SPPA.3 (mW/cm (mW/cm Global Maximum Value* 0.013 1.2 (Note 1) 5.8 (Note 1) Associated...

  • Page 123: Appendix 4 End Of Life Disposal

    Additional Information Parameter Value Uncertainty @ transducer face 0.30 mW/cm2 Note 1 ±24% SATA Note 1: ‘In-situ’ de-rating of 0.3dB/cm/MHz has been applied in order to derive de-rated values. Uncertainties The reported uncertainties are based on standard uncertainties multiplied by a coverage factor k = 2 providing a level of confidence of approximately 95%. Acoustic Parameter Uncertainty Power...

  • Page 124: Appendix 5 Maternal Spo2 Additional Nellcor Clinical Information

    Appendix 5 Maternal SpO2 Additional Nellcor Clinical Information Nellcor Theory of Operation Overview This chapter explains the theory behind operations of the Nellcor™ Portable SpO Patient Monitoring System. Theoretical Principles The monitoring system uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a Nellcor™ sensor to a pulsating arteriolar vascular bed, such as a finger or toe.

  • Page 125: Automatic Calibration

    Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies, a monitoring system must know the mean wavelength of the sensor's red LED to accurately measure SpO2. During monitoring, the monitoring system’s software selects coefficients that are appropriate for the wavelength of that individual sensor's red LED;...

  • Page 126: Measured Versus Calculated Saturation

    Unique Technologies Functional versus Fractional Saturation This monitoring system measures functional saturation where oxygenated hemoglobin is expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482, report fractional saturation where oxygenated hemoglobin is expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins.

  • Page 127: System Features

    Data Update Period, Data Averaging, and Signal Processing The advanced signal processing of the OxiMax™ algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. The OxiMax™ algorithm automatically extends the dynamic averaging time required beyond seven (7) seconds during degraded or difficult measurement conditions caused by low perfusion, signal artifact, ambient light, electrocautery, other interference, or a combination of these factors, which results in an increase in the dynamic averaging.

  • Page 128: Study Population

    Methods Data from 11 healthy volunteers were included in the analysis. Sensors were rotated on digits and brow to provide a balanced study design. SpO2 values were continuously recorded from each instrument while inspired oxygen was controlled to produce five steady state plateaus at target saturations of approximately 98, 90, 80, 70 and 60%.

  • Page 129: Adverse Events Or Deviations

    Figure A-1. Modified Bland-Altman Plot Test Sensor; Avg CO-oximeter value 70-100% SpO2 Avg CO-oximeter value 70-100% SpO2 Oximetry board with MAX-A sensor Trendline of MAX-A sensor Oximetry board with MAX-N sensor Trendline of MAX-N sensor Oximetry board with MAX-FAST sensor Trendline of MAX-FAST sensor Adverse Events or Deviations The study was conducted as expected with no adverse events and no deviations from the protocol.

  • Page 130: Appendix 6 Sonicaid Wireless Telemetry

    Appendix 6 Sonicaid Wireless Telemetry 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. Connecting the Sonicaid Freedom telemetry unit 1. If Sonicaid Freedom is mounted on the Team3 trolley, the aerial must be mounted on Team3 using the SF1 Freedom Antenna Fixing Kit. Full instructions are provided with the kit. Contact your local sales representative for details. If it is not mounted on the Team3 trolley, ensure the Sonicaid Freedom is securely located on a suitable flat surface and connect the aerial directly to the Sonicaid Freedom rear panel socket, ensuring it is kept vertical during use.

  • Page 131: Using The Telemetry Unit

    Using the telemetry unit 1. Switch on the telemetry unit. 2. Check that the transmitter is fully charged. 3. Examine the mother, and establish the best position for the transducers. 4. Attach the transducers securely to the mother. Note When the wireless transducers are undocked from the receiving station, a symbol will be shown on the ULT1/TOCO channel to indicate wireless monitoring. To disable wireless operation and return to wired transducer monitoring, dock the wireless transducer back into the receiver charging bays.

  • Page 132: Appendix 7 Sonicaid Wireless Transducer System

    Appendix 7 Sonicaid Wireless Transducer System Please refer to the IFU supplied with the Sonicaid Wireless Transducer System for detailed instructions on the use, care and maintenance before connecting and using the equipment. Connecting the Sonicaid Wireless Transducer System 1. FTS-3 should be placed on a flat surface. Alternatively, it can be installed on a Huntleigh approved trolley. 2. Connect the power cable from a suitable wall socket to the mains connector on the rear panel.

  • Page 133: Using The Sonicaid Wireless Transducer System

    Using the Sonicaid wireless transducer system 1. Switch on the Sonicaid wireless transducer system. 2. Check that the wireless transducers are fully charged. 3. Examine the mother, and establish the best position for the transducers. 4. Take out the transducer from the docking slot of the base station and it will power on automatically.

  • Page 134: Ending Monitoring

    Note: the TOCO-E transducer monitors DECG or MHR only when it is connected with the DECG or MECG cable. If the TOCO-E transducer is not connected with the DECG or MECG cable, it only monitors TOCO. Besides, the DECG cable and the MECG cable cannot be connected to the TOCO-E transducer at the same time. Note: when using the TOCO-E transducer to monitor DECG or MHR, it is recommended that the DECG cable or the MECG cable be kept straight to avoid damage to the TOCO-E transducer’s interface caused by twisted cable. Note: To disable wireless operation and return to wired transducer monitoring, dock the wireless transducers back into the docking slots in the base station. Ending Monitoring Once monitoring is complete and the wireless transducers and base station have been cleaned, dock the wireless transducers into the docking slots in the base station, so they are easily located when you want to use the system again, and so the transducer batteries can be charged.
  • Page 135 This section is only applicable to United Kingdom (UK) market when UK marking is applied to the Arjo medical device labelling. UK Symbol: UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approval Body supervision.
  • Page 136 ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2016 A Member of the Arjo Family www.huntleigh-healthcare.us/ As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.