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Guidance and Manufacturers Declaration

The device complies to EN 60601-1-2 and requires  
special precautions regarding Electromagnetic 
Compatibility (EMC). It must be installed and put into 
service according to EMC information provided in this 
document. Please take into account, that portable and 
mobile RF communications equipment can affect  
medical electrical equipment.

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Summary of Contents for HearCheck Screener

Page 1: ...HearCheck Screener User Guide ...

Page 2: ...tion marked with the warning symbol WARNING WARNING points out a situation that could lead to serious injuries Advice and tips on how to handle your device better Instruction Indicates that something has to be done This symbol is placed on the bag containing the ear cups and it indicates that the ear cups should not be re used This symbol is placed inside the ear cover and indicates that the instr...

Page 3: ...ts 6 Insert the batteries 8 Preparation before use 8 How to use 9 Reading the results 11 Maintenance 12 Applicable standards 13 Environmental conditions for use 13 Technical Data 14 Guidance and Manufacturers Declaration 15 3 4 5 6 7 8 9 10 11 12 13 3 ...

Page 4: ...equency and level to the person under test The device is intended to be used as a handheld device only Therefore all parts of the device are intended to be touched by the operator or the person under test with the hand The opening of the Ear Cover is intended to be applied to the area of the ear of the person under test only when covered with an Ear Cup Each Ear Cup is only intended for single use...

Page 5: ...Light indicators Start button Battery compartment Ear cover Label Ear cup 1 2 3 4 5 6 Included in delivery HearCheck Screener Replacement ear cups 25 pcs User Manual 2x AAA batteries 1 2 3 4 5 6 3 5 ...

Page 6: ...radio wave transmitting devices or cellular phones in the vicinity of the HearCheck Screener to avoid malfunction The device should not be used adjacent or stacked with other equipment WARNING To avoid improper function of the device use only accessories specified by the manufacturer WARNING Replace ear cup cover for each patient Do not reuse covers 4 Important hints 6 ...

Page 7: ...ronments where background noise does not exceed 50 dB A For battery replacement please use only Alcaline Type AAA batteries or NiMH or NiCd rechargeable batteries type AAA Do not connect directly to any other power source Remove the batteries if equipment is unlikely to be used for some time Do not throw used batteries into household waste Use locally provided battery recycling systems for environ...

Page 8: ... cover of the device before use Use a new cup for each patient or each ear if there is any sign of infection Used ear cups can be disposed of in normal waste Replacement ear cups are available from the customer service Part number 101 74 191 Insert the batteries 1 2 8 ...

Page 9: ... the start button once to initiate the functional test sequence If it is working correctly you will see all 3 lights flash in sequence 3 times This indicates that the device is ready to use The test sequence will begin in 3 seconds with three signals at 1000 Hz 55dBHL 35dBHL 20dBHL A light will appear when a tone is being played first left then middle then right The subject should indicate when a ...

Page 10: ...start the second sequence STEP 5 You will see all 3 lights flash in sequence 3x3 times The test sequence will begin in 3 seconds with three signals at 3000 Hz 75dBHL 55dBHL 35dBHL STEP 6 Count and record the number of times the subject has indicated that a tone was heard STEP 7 Repeat steps 2 through 6 on the other ear Button should be pressed within 20 seconds after the first test or the screener...

Page 11: ...sults and should not be used as audiometric assessment The lower the score the more likely the patient will benefit from a hearing aid Please see below an example of how the results should be recorded Score the right ear in exactly the same way 2 1 3 8 11 ...

Page 12: ... and should be returned for recalibration three years after the manufacturing date labelled inside the ear cover or three years after first use whatever is more appropriate If you need to return the device please contact the customer service To determine proper functionality and adequate calibration an operator with normal hearing or a person who can hear all 6 signals should perform a hearing tes...

Page 13: ...rical equipment Part 1 General requirements for safety Collateral standard Electromagnetic compatibility Operation Temperature range 10 C to 40 C Relative humidity 30 to 75 non condensing Air pressure 70 kPa to 106 kPa During transportation Temperature range 20 C to 60 C Relative humidity 10 to 90 non condensing Air pressure 70 kPa to 106 kPa Environmental conditions for use 11 10 13 ...

Page 14: ...tinuous operation Power Internally powered equipment Sterilisation disinfection See manual chapter 9 Accuracy of measurement 3 dB Test frequencies 1000 Hz 3000 Hz Tolerance of frequencies 5 Total Harmonic Distortion THD 10 Test levels 20 35 55 75 dBHL Power save function Automatic power off after 20 sec Battery Size AAA 1 5 V Number of batteries 2 Battery Lifetime 1000 measurements Technical Data ...

Page 15: ...es special precautions regarding Electromagnetic Compatibility EMC It must be installed and put into service according to EMC information provided in this document Please take into account that portable and mobile RF communications equipment can affect medical electrical equipment 13 15 ...

Page 16: ...1 The HearCheck Screener 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 CISPR 11 Class B The HearCheck Screener is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that sup...

Page 17: ...scharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Mains power quality should be that of a typical commercial or hospital envir...

Page 18: ...d be that of a typical commercial or hospital environment If the user of the HearCheck Screener requires continued operation during power mains interruptions it is recommended that the HearCheck Screener is powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of...

Page 19: ...4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Not applicable 3 V m Recommended separation distance Not applicable d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed R...

Page 20: ...roadcast 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 the HearCheck Screener is used exceeds the applicable RF compliance level above the HearCheck Screener should be observed to verify normal operation If abnormal per...

Page 21: ...ng to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 Not applicable 0 12 0 23 0 1 Not applicable 0 37 0 74 1 Not applicable 1 2 2 3 10 Not applicable 3 7 7 4 100 Not applicable 12 23 For transmitters ra...

Page 22: ...nd 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 22 ...

Page 23: ...23 ...

Page 24: ...January 2003 on waste electrical and electronics equipment Amended by Directive 2003 108 EC WEEE u Recycle devices batteries and accessories according to national regulations Siemens AG 05 2012 MS Document No A91SAT 00102 99T3 7600 Order Item No 101 75 178 Printed in Germany www bestsound technology com Sivantos GmbH Henri Dunant Strasse 100 91058 Erlangen Germany Phone 49 9131 308 0 Manufactured ...

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