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AirCal

User Guide

Doc. No. 7-50-1240-EN/06

Part No. 7-50-12400-EN

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Summary of Contents for ICS AirCal

Page 1: ...AirCal User Guide Doc No 7 50 1240 EN 06 Part No 7 50 12400 EN ...

Page 2: ...metrics the Otometrics Icon AURICAL MADSEN HI PRO 2 Otoscan ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U S A and or other countries Version release date 2019 12 04 215491 Technical support Please contact your supplier Otometrics ICS AirCal 2 ...

Page 3: ...elivery Head Foot Switch 18 5 Performing a Caloric Irrigation 20 6 ICS AirCal System Safety 21 7 Service cleaning and maintenance 24 8 Other references 25 9 Technical Specifications 25 10 Notes on EMC Electromagnetic Compatibility 27 11 Troubleshooting 34 12 Firmware procedures 35 Otometrics ICS AirCal 3 ...

Page 4: ...ior knowledge of the medical and scientific facts underlying the procedure Use An air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of airflow and tem perature and that is intended for vestibular function testing of a patient s body balance system The vestibular stimulation of the semicircular canals produces involuntary eye movements that are me...

Page 5: ...etting started 2 1 Room Setup A Sink B VNG ENG Equipment C Counter D Cabinets over counter E Examiner s stool F Light bar G Footstool H Examining table I Telephone Otometrics ICS AirCal 5 2 Getting started ...

Page 6: ...air pump housing is secured with transportation screws These screws must be removed to allow the housing to move and thereby reduce the amount of noise the air pump produces It is important to keep the transportation screws to secure the housing in the event the device needs to be shipped 1 Remove transportation screws A and B 2 Store them with your Syringe Kit Funnel and Allen Key 2 2 2 Installin...

Page 7: ...e ICS AirCal on its side 3 Locate the bracket mounting holes 4 Attach the bracket to the unit using the Allen key to tighten the screws 5 Hold the cradle with the end that holds the bottom of the delivery head facing the front of the unit Slide the cradle onto the bracket in the horizontal position 6 For units placed at the edge of the table tilt the bracket forward until it stops 7 Ensure the mou...

Page 8: ...the irrigator on in order to use the foot switch 2 2 3 2 Connecting to an ICS VNG ENG system The ICS AirCal can be connected to an ICS VNG ENG system Connect the irrigator cable to the back of the irrigator and to the ICS VNG ENG system Connecting the 2 devices together gives additional functionality See Activation Trigger Operation 19 for more inform ation 2 2 3 3 Connecting the Mains power cable...

Page 9: ...To prevent electrical shock the ICS AirCal irrigator must be turned off and disconnected from the electrical wall outlet when filling or refilling the water reservoir Caution Use this procedure if 1 the ICS AirCal was just received from shipping dry It needs to be filled and primed 2 If the water level in the display has gone to zero because user never refilled it when orange bar was present 3 If ...

Page 10: ...ont panel locate the small cover at the back right side Using the Allen key supplied with the cradle unscrew the reservoir cover and remove A Reservoir cover 4 Using the Allen key unscrew the internal cover and remove 10 Otometrics ICS AirCal 2 Getting started ...

Page 11: ...A Internal cover 5 Expand the funnel supplied with the ICS AirCal irrigator and place in the refill hole of the reservoir Otometrics ICS AirCal 11 2 Getting started ...

Page 12: ...ing 1 Plug in the irrigator into the electrical wall outlet and turn on 2 Turn off the airflow 3 Locate the priming switch on the back panel 4 Press the priming switch to turn on and hold 5 seconds 5 Release the priming switch to turn off and wait 5 seconds 6 Repeat steps 4 and 5 for a total of 10 times on and 10 times off 7 Press the cool button Decrease the temperature to 12 C 8 If the temperatu...

Page 13: ...the electrical wall outlet and turn on Note The default airflow rate for caloric irrigation is 8 liters per minute Shipping may cause the airflow knob to move You may have to reset the airflow Priming with bent tube 1 Take the syringe with bent tube and remove enough water from the reservoir to fill the syringe 2 Put the end of the bent tube into the pump inlet hole The tube will be facing toward ...

Page 14: ...external cover and tighten screws to secure 15 Plug in the irrigator into the electrical wall outlet and turn on Caution Due to the possibility of freezing during shipment water must be drained from the reservoir before shipping the ICS AirCal See Troubleshooting 34 for draining instructions 3 ICS AirCal Front Panel This section describes all operational controls located on the front panel of the ...

Page 15: ...the Stored Default Values 16 3 3 3 Switching between cool and warm temperature The warm or cool temperature buttons allow the operator to select the stimulus desired If the ICS AirCal is connected to an ICS VNG ENG system selecting the caloric protocol e g Left Warm will automatically select the tem perature on the irrigator Therefore no manual selection is needed However the default startup tempe...

Page 16: ...e airflow and clockwise to decrease the airflow The range for the airflow rate is 4 to 10 liters per minute The airflow rate is set based on the knob position The flow rate selection actual only will be indicated on the display panel If the ICS AirCal is in operation mode the digital display shows the actual flow rate If the ICS AirCal is in standby mode the display will be off 3 6 Beep Volume A b...

Page 17: ...aution Only use distilled water Using common water from the tap will result in mineral deposits and will harm the ICS AirCal 1 Turn off ICS AirCal and disconnect from the electrical wall outlet 2 Wipe off any dust on the top of the ICS AirCal prior to opening the case to refill the reservoir 3 Face the ICS AirCal front panel On the back right side is a small cover Using the Allen key supplied with...

Page 18: ...pe light can be turned on and off using the button located on the back of the handle below the lens Note Turn light off when not in use Note Caution symbol indicates that the inner speculum should never be placed in the ear without an Outer Dis posable Speculum attached to it A Inner Speculum B Flow Time Activation Trigger C Full View Otoscope Lens D Light On Off Button 18 Otometrics ICS AirCal 4 ...

Page 19: ...r and for light to flash If the ICS AirCal is connected to an ICS VNG ENG system In VNG first depression also starts the tracing and successive depressions start the video recorder or center tracing depend ing on software configuration In ENG first depression also starts the tracing and successive depressions centers the tracing If the computer is turned on but the Otometrics VNG ENG software is n...

Page 20: ...re is reached 0 4 C the actual tem perature display will stop flashing Using a regular otoscope or the delivery head with airflow turned off examine the ear canal for the presence of cerumen and also to determine how best to direct the airstream The ear canal should be essentially free of cerumen If it is not this must be removed prior to stimulating Do not use water to remove cerumen as this will...

Page 21: ...safe performance of the ICS AirCal system Local government rules and regulations if applicable should be followed at all times When the ICS AirCal device is used in conjunction with a test device make sure that all information cautions and warn ings in the User Manual for the test device are followed For safety specifics concerning test modules and test devices see the specific manuals 6 1 Symbols...

Page 22: ...t for Computer used for firmware upgrades and future development Located on Back Panel Priming Switch for Water Reservoir ISO 15223 1 Symbol 5 4 2 Do not reuse Indicates a medical device that is intended for one use or for use on a single patient during a single procedure Related to specific accessories EN 50419 Electronic equipment covered by the Directive 2012 19 EU on waste electrical and elect...

Page 23: ...p prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment 10 Immediately discontinue use of the equipment if skin irritation or discomfort occurs 11 Only distilled water should be used when filling or refilling the water reservoir Using common water from the tap will result in mineral deposits and will harm the ICS AirCal 12 Th...

Page 24: ...rties 7 Service cleaning and maintenance Warning Under no circumstances disassemble ICS AirCal Contact your supplier Parts inside ICS AirCal must only be checked or serviced by authorized personnel 7 1 Service For the sake of safety and in order not to void the warranty service and repair of electro medical equipment should be car ried out only by the equipment manufacturer or by service personnel...

Page 25: ...ing as expected a re calibration may be needed 8 Other references For more detailed information see the Reference Manual available on CD part 8 49 91500 9 Technical Specifications ICS AirCal is type 1079 from Natus Medical Denmark ApS Operating environment Temperature 15 C to 35 C 59 F to 95 F Operations at temperatures below 20 C 4 F or above 60 C 140 F may cause permanent damage Rel Humidity 90 ...

Page 26: ...emperature 60 seconds Temperature accuracy 0 4 C Time range 0 4 C 1 to 99 seconds Recommended setting 60 seconds Flow rate range 4 10 liters per minute Recommended setting 8 liters per minute Flow rate accuracy 0 4 liters per minute Dimensions Width 34 3 cm 13 5 inches Depth 30 5 cm 12 inches Height 10 2 cm 4 inches Weight With empty reservoir 7 9 kg 17 5 lbs With full reservoir 8 2 kg 18 lbs Powe...

Page 27: ...his reason the installation and operating instructions provided in this document should be followed closely Portable and mobile high frequency communication devices such as mobile phones may interfere with the func tioning of ICS AirCal IEC 60601 1 2 2014 and EN 60601 1 2 2015 Guidance and manufacturer sdeclaration electromagnetic emissionsfor all equipment and systems ICS AirCal is intended for u...

Page 28: ... or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 2 kV I O line s to earth 1 kV line s to line s 2 kV line s to earth 2 kV I O line s to earth Mains power quality should be that of a typical com mercial or hospital environment Voltage dips short inter ruptions and voltage vari ations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 ...

Page 29: ... transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which ICS AirCal is used...

Page 30: ...st Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 ICS AirCal uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class A ICS AirCal is suitable for use in all environments including domestic environments and those dir ectly connected to th...

Page 31: ...cles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the ICS AirCal requires con tinued operation during power mains interruptions it is recommended that the ICS AirCal be powered from an unin terrupti...

Page 32: ...ntended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges c Field strengths from fixed transmitters such as base stations for radio cellular cordless telep...

Page 33: ...on distance d in meters m can be estimated using the equa tion applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation...

Page 34: ...at it is working properly Whether the units works or not contact Natus Medical Denmark ApS technical support and report that the ICS AirCal is not performing as expected Water Removal Procedure Caution If shipping the device make sure to 1 Drain the water from the reservoir to prevent the possibility of damage caused by freezing and 2 Secure the air pump housing with the transportation screws supp...

Page 35: ...firmware mode button accessed through hole A and the ICS AirCal USB port B A Access to firmware button B USB Port 3 Connect the USB cable to the ICS AirCal USB port and to the USB port on the computer 4 Turn on the computer and insert the ICS AirCal firmware upgrade CD 5 Using a ballpoint pen press and hold the firmware mode button while turning on the ICS AirCal Hold for 3 seconds the display wil...

Page 36: ...driver This procedure installs the device driver on the computer that will be used to update the ICS AirCal firmware 1 Turn on the computer 2 Insert the ICS AirCal firmware upgrade CD 3 On the CD inside AirCal Driver folder locate the AirCalInstaller exe file 4 Double click on the file to run the installer program 36 Otometrics ICS AirCal 12 Firmware procedures ...

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