Table of Contents
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Table of Contents
Related Manuals for Siemens HearCheck Screener
Summary of Contents for Siemens HearCheck Screener
- Page 1 HearCheck Screener User Guide...
- Page 2 Introduction This booklet is a guide to the use and maintenance of the HearCheck Screener, a hearing screening device. You can now screen quickly and easily, determining whether further assessment is indicated (e.g. by a local hearing care professional). Symbols...
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Page 3: Table Of Contents
Contents Your HearCheck Screener Important hints Insert the batteries Preparation before use How to use Reading the results Maintenance Applicable standards Environmental conditions for use Technical Data Guidance and Manufacturers Declaration... -
Page 4: Your Hearcheck Screener
Your HearCheck Screener Intended use: The device is a screening test device intended to be used with adult persons only and either operated by the person under test or by a third person applying test tones of particular frequency and level to the person under test. - Page 5 Light indicators Start button Battery compartment Ear cover Label Ear cup Included in delivery: - HearCheck Screener - Replacement ear cups (25 pcs.) - User Manual - 2x AAA batteries...
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Page 6: Important Hints
No modification of this equipment is allowed. WARNING Do not use noisy equipment (e.g. like 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. - Page 7 Make sure the battery door is closed before using the device. This device is not an audiometer and should not be used for the purpose of hearing disability diagnosis. For reliable results you are advised to use the device in environments where background noise does not exceed 50 dB (A).
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Page 8: Insert The Batteries
Insert the batteries Preparation before use Please insert a new ear cup into the ear 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. -
Page 9: How To Use
How to use STEP 1. Gently place the cup of the device over the ear. It's important that the edges of the cup are in contact with the patient's head. Move any hair out of the way, remove glasses, earrings and hair bands or anything that may prevent achieving adequate contact around the ear. - Page 10 6. How to use STEP 3. Count and record the number of times indicated for the first sequence. STEP 4. The start button must be pushed within 20 seconds of the end of the first sequence (after the third light has appeared) to start the second sequence.
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Page 11: Reading The Results
Reading the results Please note: these are screening results 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. -
Page 12: Maintenance
Use water or lukewarm, diluted solution of water and household detergent to wet the cloth. Do not use alcohol or other solvents, and never immerse the HearCheck Screener in water. The device has been factory calibrated and should be returned for recalibration three years after the... -
Page 13: Applicable Standards
Applicable standards EN 980: Symbols for use in the labelling of medical device EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety EN 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety. Collateral standard. Electromagnetic compatibility Environmental conditions for use Operation Temperature range... -
Page 14: Technical Data
Technical Data General Classifications Medical devices class: Protection class: Applied parts: Type BF IP protection class according to IEC 60529: IPX0 AP or APG classification: Not applicable Operating mode: Continuous operation Power: Internally powered equipment Sterilisation / disinfection: See manual chapter 9 Accuracy of measurement: 3 dB Test frequencies:... -
Page 15: Guidance And Manufacturers Declaration
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. - Page 16 Guidance and manufacturer's declaration - electromagnetic emissions The HearCheck Screener is intended for use in the electro magnetic environment specified below. The customer or the user of the HearCheck Screener should assure that it is used in such an environment.
- Page 17 Guidance and manufacturer's declaration - electromagnetic immunity The HearCheck Screener is intended for use in the electro magnetic environment specified below. The customer or the user of the HearCheck Screener should assure that it is used in such an environment.
- Page 18 5 cycles mains interruptions, it is recommended that the 70 % U HearCheck Screener is (30 % dip in U powered from an for 25 cycles uninterruptible power supply or a battery. < 5 % U (>...
- Page 19 - guidance Portable and mobile RF communications Equipment should be used no closer to any part of the HearCheck Screener, including cables, than the recommended separation distance calculated fom the equation applicable to the frequency of the transmitter.
- Page 20 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.
- Page 21 RF communications equipment and the HearCheck Screener The HearCheck Screener is intended for use in an electro magnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HearCheck Screener can help prevent electromagnetic interference by maintaining...
- Page 22 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 is affected by absorption and reflection from structures, objects and people.
- Page 24 Manufactured by Sivantos GmbH under Trademark License of Siemens AG. With the CE marking Sivantos confirms compliance with the European Directive 0123 93/42/EEC concering medical devices. Within the European Union, the marked equipment is covered by "Directive 2002/96/EC of the European Parliament...