Arjo Huntleigh Sonicaid Team3 USA Instructions For Use Manual Download

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Instructions For Use

1.2 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.

1.3 Patient Applied Parts

As defined in IEC60601-1:2005, the patient applied parts of the Team3 Fetal Monitor are the:

•  TOCO Transducer
•  Ultrasound Transducer
•  Patient Event Marker
•

NIBP Cuff

Summary of Contents for Huntleigh Sonicaid Team3 USA

Page 1: ...Fetal Monitor INSTRUCTIONS FOR USE Team3 USA 777732 1 10 2021 ...

Page 2: ... 2 3 Lock Unlock Screen 18 5 2 4 Date Time 19 5 3 Control Bar 19 5 3 1 Record Print 20 5 3 2 Paper Feed 20 5 3 3 Numeric Trace View 20 5 3 4 Volume Up Down 20 5 3 5 Annotation EasiNotes 20 5 3 6 PDF 20 5 3 7 Settings Menu 22 5 3 8 View Menu 29 5 4 Monitoring Parameters 32 5 4 1 Numeric Format 33 5 4 2 FHR Monitoring 34 5 4 3 TOCO 34 5 4 4 Maternal NIBP 34 5 4 5 Trace Format 35 5 5 Switching the Un...

Page 3: ...11 5 Printing 54 12 Care and Cleaning 55 12 1 General Care 55 12 2 General Cleaning and Disinfecting 55 12 3 Cleaning and Disinfecting Patient Applied Parts 55 12 4 NIBP Cuff 56 12 5 Transducer Belts 56 13 Maintenance 57 13 1 User maintenance 57 13 2 Technical maintenance 57 13 3 Corrective maintenance 57 13 4 Servicing 57 13 5 Secure Settings 58 13 6 Customising Easinotes 66 14 Specifications 68 ...

Page 4: ...for Use 1 1 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 Prot...

Page 5: ...he 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 us...

Page 6: ...use only and must not be re used For other single use accessories refer to the user instructions supplied with them 1 3 Patient Applied Parts As defined in IEC60601 1 2005 the patient applied parts of the Team3 Fetal Monitor are the TOCO Transducer Ultrasound Transducer Patient Event Marker NIBP Cuff ...

Page 7: ...ntended Use and Indications The Sonicaid Team3 Antepartum fetal monitor Team3 fetal monitor is indicated for use by trained healthcare professionals in non invasive monitoring of physiological parameters in pregnant women and fetuses during the antepartum period of pregnancy The Team3 fetal monitor is intended for pregnant women from the 28th week of gestation through to term The devices are inten...

Page 8: ...ducer 1 x Toco transducer 1 x Event marker 1 x Pack of standard paper 1 x 250ml Ultrasound Gel Quick Start Guide 1 x Instructions for Use 2 x Transducer belt 1 x Power Cord Blood Pressure Option Item Item Item 1 x Medium Cuff 1 x Large Cuff 1 x Connecting Hose Note All Team3 models are twins capable as standard but are supplied with 1x US transducer For twins an extra US transducer is required to ...

Page 9: ...ion 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 1 2 4 6 5 3 1 Touchscreen 4 FHR1 US socket 2 On Off Button 5 FHR2 US socket 3 Printer 6 TOCO Transducer socket Depending on model options purchased ...

Page 10: ...Socket 6 DVI Socket 2 Equipotential earth point 7 Rating Label 3 Fetal Event Marker Socket 8 USB Port x 2 4 RS232 CRS Socket 9 Ethernet Port 5 Wireless Telemetry Socket Depending on model options purchased Not enabled future upgrade 3 3 Base Panel Label DI 777776 1 25EA ...

Page 11: ... in accordance with local procedures 25EA MEDICAL PATIENT MONITORING EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 A1 2012 CAN CSA C22 2 No 60601 1 14 IEC 60601 1 6 2010 ed 3 A1 2013 IEC 60601 1 8 2006 ed 2 Am 1 2012 IEC 80601 2 30 2009 ed 1 A1 2013 IEC 60601 2 37 ed 2 Am1 IEC 60601 2 49 ed 2 2011 ISO 80601 2 61 2011 ed 1 This symbol ...

Page 12: ...of Manufacture Keep Dry Do not use hook Fragile Cardboard packaging can be recycled 40 C 10 C Temperature Limitations 93 Limits of Relative Humidity PVC Does not contain PVC LATEX Not made with natural rubber latex YYYY MM Use By Do Not Reuse Fetal Event Marker Equipotential Earth Limits of Atmospheric Pressure IP30 Protected against ingress of solid foreign objects 2 5mm diameter Not protected ag...

Page 13: ...C60601 1 This may be achieved by using a medical grade isolating transformer Suitable types are available via Huntleigh sales agents 4 An Equipotential earth point is provided on the rear of the monitor for connection to a recommended earth point at the installation The earth wire should be run separately from any mains or current carrying cables and should be kept as short as possible Connection ...

Page 14: ...heels while the cart is in motion Do not attempt to free trapped cables without stopping the cart and applying the brakes When moving Team3 either by hand or when cart mounted the protective cover with a minimum of IPX2 should be fitted to prevent ingress of fluids which may be encountered during transit A suitable cover is available as an accessory Wall bracket If the unit is seldom moved a purpo...

Page 15: ...ication Screen 5 2 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 Note that...

Page 16: ...o move selected traces to the Archive memory the Archive Manager to restore traces to the live database Note that this does not increase the overall database capacity but in large databases this does speed up access to traces in the live database for review Refer to section 13 5 5 2 2 Entering Patient Data Touch and hold the Patient Data region in the top left corner of the screen to enter the Pat...

Page 17: ...in the Patient Data region Setting Gestational Age The Set Gestation dialogue allows the operator to change any one of Last menstrual period date2 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 The maximum value of gestation age is set at 44 weeks Touch to return to ...

Page 18: ... Data screen with a cleared value of gestational age 5 2 3 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 19: ...ed via the Settings Menu Use the arrows to set the current date and time Press to confirm 5 3 Control Bar Displayed along the bottom of the screen is the control bar Functions depend on the options modules installed and the operating mode of the unit Record Numeric View Trace View Volume Up Menu Annotation EasiNotes Paper Feed Volume Down Settings Print Record ...

Page 20: ...r through printer If option s installed 5 3 3 Numeric Trace View Touch to toggle between displaying the data in numeric or trace format 5 3 4 Volume Up Down Touch to decrease or increase the volume 5 3 5 Annotation EasiNotes Annotation Icon appears in the control bar when printing or recording is active This feature allows the operator to add a pre stored note to the printout or recorded file Touc...

Page 21: ... annotation field on the trace for adding a hand written note Note Refer to Sections 13 5 and 13 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 recordi...

Page 22: ... from the Settings menu Touch any button to view the sub menu options available for it Each sub menu is described on the following pages The images show the default settings for each option Settings Clinical Fetal TOCO System Sound Recording Limits Background Colour Date Time Printer Illumination CRS Trace Offsets Alarm FHR TOCO NIBP Alarm Volume Secure Settings Service Licensing passcode 12345 pa...

Page 23: ... Decreases selection Settings Main Menu Touch each category to access the sub menu options available Note The Trace Offsets sub menu is only available if not printing or recording Note The Trace Offsets sub menu is only visible when ultrasound transducers are plugged into the FHR1 and FHR2 sockets on the frontof the unit Note Team3 will return all settings to Default levels when switched off Defau...

Page 24: ...24 Instructions For Use EN Settings Sub Menus Clinical Settings Sub Menu ...

Page 25: ... 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 ...

Page 26: ...tructions For Use EN 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 27: ...al Records Systems CRS as well as Sonicaid Centrale Select Huntleigh for use with Sonicaid Reporter 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 ...

Page 28: ...Use EN 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 NIBP option fitted ...

Page 29: ... for normal audio sounds Alarm volume cannot be set to zero 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 13 5 and also the Service manual 5 3 8 View Menu Touch the icon to access the View Menu settings Main Menu Touch to access the sub menu options available ...

Page 30: ...e or Patient Name ID Touch the trace required and touch The selected trace will now be displayed on the application screen You can scroll through the trace by touching and moving the thick grey scroll bar on the screen The trace view updates when you release the scroll bar If a printer is fitted press to print the trace Review Mode Sub Menu When the monitor is in review mode touching this button o...

Page 31: ... to print out the results USB to Store Trace PDF to USB Drive 8GB max 1 Select View Menu 2 Review Trace 3 Enter PIN code to enable access to stored traces PIN code 98765 4 Select trace from list by using the arrow to scroll through the traces 5 Insert USB into USB drive in the rear panel of the fetal monitor 6 Select View Menu and then select Discharge Patient 8 Remove USB from the fetal monitor t...

Page 32: ... 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 or to toggle between displaying the data in numeric or trace format Numeric format Trace format ...

Page 33: ...ly be enabled on one channel at a time Touch and hold on any FHR or MHR region of the screen to select audio for that channel A speaker symbol will appear on the channel if audio is enabled To turn the audio off touch the region displaying the speaker symbol Fetal Heart Rate Signal Confidence The heart rate is depicted by a flashing heart symbol on the bottom right corner of each region The color ...

Page 34: ...egion is split to display the two separate Fetal Heart rates both using wired ultrasound Audio is enabled for channel 1 only 5 4 3 TOCO TOCO The TOCO region shows TOCO measurements in progress Touch and hold on the TOCO region to Zero the TOCO 5 4 4 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 Pres...

Page 35: ...cal trace screen emphasizes the display of data in graphical form with numeric data shown on the right hand side Numerical Data Trace Data Fetal HR TOCO Annotation Annotations and Clinical Events are printed vertically in the TOCO region of the trace screen ...

Page 36: ...ate 5 6 Battery Charging If the following conditions are all true The unit is switched OFF The unit is connected to the mains supply The battery option is installed The battery is not fully charged then the On Off button will illuminate green and flash indicating that the battery is charging Otherwise the indicator will be OFF Note Typical charge time to 90 capacity from discharged is 3 hours Note...

Page 37: ...bdomen and secure over transducer button Transducer and belt attachment 4 Apply Aquasonic coupling gel liberally to the face of the transducer Position the transducer on the abdomen over the fetal site Move it slowly until the characteristic hoof beat sound of the fetal heart is heard 5 When a good signal is being obtained Team3 displays the FHR Check that the fetal heart pulse lamp flashes with e...

Page 38: ...se at the same rate as the fetal heart If the fetus is in the Occiput Anterior presentation and the mother is supine the clearest heart sound will normally be found on the midline below the umbilicus It is not possible to monitor the fetal heart rate unless an audible fetal heart signal is present It is important to distinguish the fetal pulse from the maternal pulse To do this feel the mother s p...

Page 39: ...he green transducers to the green sockets marked FHR1 FHR2 on Team3 On the main screen the ULT1 2 regions become active 2 Palpate the abdomen and ascertain the lie of each fetus 3 Place the ultrasound transducers on the patient s abdomen in the optimum positions Use the ULT1 transducer to monitor the first presenting fetus Make the transducers secure with belts 4 To hear the audio signal for each ...

Page 40: ... region of the screen to zero the contractions to the set level 0 10 20 see settings If enabled an auto zero function will activate if the trace has been flat for 3 minutes Check the baseline periodically and re zero the TOCO if necessary 7 2 Fetal Movement Event Marker Fetal movement events can be captured in 2 ways automatic and manual 7 2 1 Automatic Fetal Movement Event Marker This function is...

Page 41: ...of equipment to the Fetal Event Marker socket Before use inspect the Fetal Event Marker switch and connecting cable assembly ensuring that it is clean and undamaged See Section 15 for cleaning procedures The Fetal Event Marker must be kept dry Do not immerse or use in the presence of liquids 1 Connect the event marker to the jack socket on the rear of Team3 2 Give the event marker to the mother Te...

Page 42: ...rors in the BP measurement Cuff positioning To ensure accurate measurement the cuff must be positioned correctly It is positioned on the upper arm and can be applied over light clothing Any tight thick or constrictive clothing should be removed The cuff must be applied with the hose coming out at the bottom of the cuff not the top and should be level with the heart When fitting the cuff note the p...

Page 43: ...NIBP menu You can select either manual mode or automatic mode 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 A clock symbol will be shown in the NIBP region An NIBP...

Page 44: ...e 1 to 5 minutes 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 as...

Page 45: ...t 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 Reviewing BP Results Touch and hold the NIBP region to access the NIBP menu Touch to show the BP results screen The NIBP res...

Page 46: ...s seen and heard When the Team3 enters an alarm condition an alarm sounds will appear at the top of the screen and the associated alarm regions will flash An alarm indicator will be printed on the trace screen identifying the time of the alarm An alarm condition will be printed on the TOCO region of the screen The alarm will continue to sound until the operator acknowledges the alarm Touch to ackn...

Page 47: ...oss of signal Acknowledge alarm if appropriate For FHR reposition the transducer For other parameters check transducer attachment and connections Fetal Cross Channel Re position transducers if required 8 4 Controlling alarms There are four ways of controlling alarms Acknowledge i e silence it when it occurs Switch it off so that it is never triggered Alter thresholds so that it occurs more frequen...

Page 48: ...ecommended This has a 25 year rated lifetime Alternatively consider the use of Central Monitoring Software which allow traces to be stored and archived electronically 9 3 Paper care and handling To preserve the life of the paper both before and after printing it should be stored indoors at a temperature of 18 25 C and with a relative humidity of 40 60 Do not expose to UV light sources such as dire...

Page 49: ...0 minutes notice of paper end Use this time to unwrap and prepare a new pack ready for printing When the paper end is reached the printer will stop The printer icon on the control bar will change to Print information will be stored in memory for up to 100 hours to allow the paper pack to be changed Follow the procedure described below for changing the paper pack Once a new pack of paper has been i...

Page 50: ... 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 With pre printed paper this error cannot be eliminated and will result in alignment errors between the trace and the grid 9 8 Sample Trace Sonicaid paper The illustrati...

Page 51: ...paper has run out the following screen will appear Touch to stop the recording or to cancel If cancelling replenish the paper to continue 9 9 2 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 follo...

Page 52: ...stems Other manufacturers systems using the industry standard HP50 Philips communications protocol should also work but may not have been validated contact Huntleigh for details 10 1 Connecting Team3 to Sonicaid Reporter software 1 Connect the Sonicaid Reporter connecting lead to the RS232 connector on the rear of Team3 2 Refer to the connection instructions supplied with your Sonicaid Reporter so...

Page 53: ...k transducer placement Check the transducer is not damaged Consider switching from Ultrasound to FECG No FHR trace printed Check Print button has been pressed Check there is paper in the paper tray Check paper tray is fully pushed in Only one trace twins OR Traces superimposed twins Check Printer Offsets in Printer setup See Section 5 3 7 No beep when button pressed Check sound setting See section...

Page 54: ...rint information will be stored in memory for up to 100 hours to allow the paper pack to be changed Poor print quality 1 Make sure the correct paper is loaded 2 Make sure the paper is loaded correctly 3 Make sure the paper tray is fully pushed in 4 Try printing again 5 If there is no improvement clean the print head See Section 13 Printer stops working Check paper supply and feed If not successful...

Page 55: ...es Do not use phenolic detergent based disinfectants solutions containing cationic surfactants ammonia based compounds perfumes or antiseptic solutions such as Sterisol or Hibiscrub If detergent or disinfectant wipes are used ensure that excess solution is squeezed from the wipe prior to use Do not allow any fluid to enter the products and do not immerse in any solution Always wipe off disinfectan...

Page 56: ...nd then dry with a clean lint free cloth 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 efficacy and compatibility with the device Approved Products DO NOT USE LING...

Page 57: ... paper pack 3 Using a lint free cloth and pure alcohol wipe along the full width of the print head which is beneath the plastic edge of the paper compartment 4 Replace the paper tray and paper pack Check NIBP cuffs and hose Once a month 1 Check the NIBP hose Straighten out any kinks and distortions 2 Check the cuff s for wear and damage 13 2 Technical maintenance Refer to your Service department f...

Page 58: ... Touch to access the Settings menu The operator will need to enter a 5 digit code via the touchscreen default code 1 2 3 4 5 to enter the Secure Settings Menu 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 ...

Page 59: ...lows additional features to be enabled with a valid license key For service use only Allows qualified biomedical engineers to calibrate the fetal monitor s NIBP system Recordings Manager allows trace records to be moved to the internal archive database ...

Page 60: ...iomedical engineers to perform tests related to NIBP measurement 12625 Wetmore Road Suite 308 San Antonio TX 78247 1 800 343 0974 Option 2 Arjo Service Center Archive Manager allows trace records from the internal archive to be transferred back into the live database ...

Page 61: ... 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 Alternatively selecting the tick box will run an intrapartum demo mode To disable demo mode switch the unit off on ...

Page 62: ... implemented The unit will request a power down when Save is touched Mains Frequency Setting The default setting for the mains frequency on this product is 60Hz Touch to select required frequency Touch to confirm Note The Mains Frequency for the US is 60 Hz Do not change this setting ...

Page 63: ...63 Instructions For Use EN Allows these functions to be enabled disabled This button is not available while printing is in progress Trace and Printer Settings Sub Menu ...

Page 64: ...64 Instructions For Use EN Non Sonicaid papers require a non standard paper tray to be fitted Lock Codes Sub Menu ...

Page 65: ...65 Instructions For Use EN ...

Page 66: ...l details to be customised 13 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 13 5 for details on how to change the Language and to access the Settings Management feature Exporting Easinotes 1 With Team3 switched on plug ...

Page 67: ...tes to be deleted and their relative positions changed in the list 6 At the bottom of the tool the 2 text boxes allow the selected Category or Note to be edited These text boxes allow text in any Windows language to be used so for instance a full set of French notes could be assembled 7 When editing is complete save your work overwriting the original file Importing Easinotes 1 With Team3 switched ...

Page 68: ...duct Ultrasound and Toco IPX7 Other transducers Not protected Suitability for use in an oxygen rich environment Not suitable 14 2 General Rated Supply Voltage 100 230V AC Fuse Type 2 x T3 15AH 250V Power Input 50 60Hz 8 133VA Battery optional 14 4V Lithium Ion Battery Pack Real time clock battery Panasonic CR2032 BN 3V lithium Size Width 318mm Height 230mm Depth 237mm Weight 5 7Kg with Printer Ser...

Page 69: ...C60601 2 37 2007 Thermal Indices TI and Mechanical Index MI are 1 0 for all device settings 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 Alarm characteristics Alarm Sound Pressure Levels at 1m Minimum 53db A Default 75db A Maximu...

Page 70: ... Measurement accuracy standard deviation 5 6 mmHg 3 48 mmHg max 8 mmHg Modes Manual or automatic User selectable interval in Auto Mode 1 2 3 5 10 15 20 30 45 60 90 or 120 minutes Record display On screen display and printed record of Systolic blood pressure Diastolic blood pressure Pulse rate Mean arterial pressure Alarms Systolic High 100 180mmHg Systolic Low 50 150mmHg Diastolic High 70 130mmHg ...

Page 71: ...er fetal ECG lead FHR2 1 0MHz ultrasound transducer fetal ECG lead TOCO Toco transducer IUP lead Rear Panel IEC 320 C14 chassis plug Mains power Fetal Event Marker socket inch jack plug connection Equipotential Earth Point Provides common earthing point for connected equipment RS232 Central Record System CRS Auxiliary Wireless telemetry system DVI Socket External display USB Ports External Keyboar...

Page 72: ... Persistance Alert 50 for 5 minutes OFF Maternal Heart Rate High 100bpm for 3 minutes OFF Low 60bpm for 3 minutes OFF Maternal Systolic Pressure High 140mmHg OFF Low 90mmHg OFF Maternal Diastolic Pressure High 90mmHg OFF Low 60mmHg OFF Audio FHR 6 out of 20 Touch 6 out of 20 Alarms 10 out of 20 Fetal Movement 10 out of 20 Communications protocol HP50 over RS232 Automatic Movement Detect 40 OFF NIB...

Page 73: ...o Zero ON Miscellaneous Screen Lock Code 00123 Screen Lock Enabled ON Mains Frequency 50Hz Alarm Icons Bell Date Format dd MM yyyy NIBP Valid Period 10 minutes Show Mean Arterial Pressure ON Secure Settings Code 12345 Keyboard ON Language en US 14 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 ...

Page 74: ... is available on request from local Huntleigh representatives Available accessories consumables and spares include Accessories Item Part No Cart ACC OBS 072 Wall mounting Bracket ACC OBS 076 NIBP Cuff Various Sizes Patient Event Marker SP 7775 6901 Ultrasound and TOCO Transducers Service Manual 777490 Team3 Protective cover ACC OBS 088 Consumables Item Part No Aquasonic Gel various Sizes Sonicaid ...

Page 75: ... Disposal This symbol signifies 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 76: ...y reason the Team3 has to be returned please Clean the product following the instructions in this manual Pack it in suitable packing Attach a decontamination certificate or other statement declaring that the product has been cleaned to the outside of the package Mark the package Service Department Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination ...

Page 77: ...onents may result in increased emissions or decreased immunity of the Team3 WARNING The Team3 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the Team3 should be observed to verify normal operation in the configuration in which it will be used WARNING Portable RF communications equipment including peripherals such as antenna cables an...

Page 78: ... than the compliance level in each frequency range c Interference may occur in the vicinity of the equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people b Field strengths from fixed transmi...

Page 79: ...o earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ur 95 dip in Ur for 0 5 cycles 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles 5 Ur 95 dip in Ur for 5 s 5 Ur 95 dip in Ur for 0 5 cycles 40 Ur 60 d...

Page 80: ... display free from noise Waveform distortion is obvious to the user and generally accompanied by audio disturbance Ultrasound intensity controlled The user would experience loss of function or temperature increase Transducer temperature not excessive In extreme fault situation warming of the transducer would be the worst case outcome NIBP Pulse rate accuracy maintained Unexpected or erratic pulse ...

Page 81: ...th the Sonicaid Team3 fetal monitors is summarized in the following tables The values given are based on measurements in water using a calibrated hydrophone and are stated as the estimated de rated intensities The de rated intensity constitutes the most biologically relevant parameter available since true determinations of the actual absorbed dose in tissue would require invasive measurement techn...

Page 82: ...4 2 4 Beam Dimensions x 6 cm 0 066 0 066 y 6 cm 0 067 0 067 PD µS 70 70 PRF Hz 3000 3000 Overall EBD cm2 all eight crystals 7 95 Definition of Terms ISPTA 3 The de rated spatial peak temporal average intensity ISPPA 3 The de rated spatial peak pulse average intensity ISATA The spatial average temporal average intensity MI The mechanical index Pr 3 The de rated peak negative pressure Wo The ultraso...

Page 83: ...nties 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 28 Pressure 10 Intensity 20 Centre Frequency 10 Thermal and mechanical indices are below 1 under all circumstances Measurements were made by the National Physical Laboratory Teddington Middlesex UK in accor...

Page 84: ... the serious incident to the medical device manufacturer or the distributor In the European Union the user should also report the serious incident to the Competent Authority in the member state where they are located Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff CF24 5HN United Kingdom T 44 0 29 20485885 sales huntleigh diagnos...

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