Madsen AccuScreen OAE & ABR Screener User Manual
7
1.9
Safety Information
Warning: The following conditions or practices might present possible injury or danger to the patient and/or the user:
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Do not connect any external device (e.g., printer) to AccuScreen during testing.
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If AccuScreen is used during surgery, the probe and connectors must not touch conductive items including ground.
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AccuScreen must not be used during the application of:
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HF surgical devices
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cardiac pacemakers
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defibrillators
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other electrical stimulators
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AccuScreen must not be used during the application of HF surgical devices as this may result in burns at the site of the
electrical stimulator of the biopotential input part electrodes and possible damage to the electrical stimulator
or biological amplifiers.
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Conductive parts of electrodes and their connectors including the neutral electrode are not to contact
other con ductive parts and earth.
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Avoid accidental contact between connected but unused applied parts and other conductive parts including
those connected to protective earth.
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Do not use the instrument in the presence of flammable anesthetics (gases).
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For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
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We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as
this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.
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AccuScreen’s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment,
but negative effect or loss of functionality of other local devices may occur if they are placed in close vicinity of
AccuScreen.
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Make sure that the PC and the docking station are not within patient reach.
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When assembling an electro-medical system, the person carrying out the assembly must take into account that other
connected equipment which does not comply with the same safety requirements as this product may lead to a reduction
in the overall safety level of the system.
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If you suspect your AccuScreen OAE & ABR Screener might be defective, do not use it.
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Any PC connected to the device or used in the proximity of the patient must comply with IEC 60950-1:2005 and IEC
62368-1:2020.
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The AccuScreen OAE & ABR Screener and any device to be connected that has its own power supply should be turned
off before any connections are established.
Caution: The following conditions or practices might present possible injury to the user or patient. Or there may be risk of
damage to the data or the device.
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Do not store or operate AccuScreen at temperatures and humidity exceeding those stated in Technical Specifications,
Operating environment.
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No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended
Use section of this manual.
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Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent
cross-infection.
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This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care
professional.
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Choking hazard! Do not leave eartips unsupervised within the reach of children.
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This device is intended for use by audiologists, ENT's, and other healthcare professionals.
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To prevent injury to the ear canal when inserting the probe, use slight pressure, twisting the probe slightly as you
insert it.