MADSEN Alpha OAE+ Screener User Manual
7
1.9
Warnings – Alpha OAE+
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 Alpha OAE+ during testing.
•
If Alpha OAE+ is used during surgery, the probe and connectors must not touch conductive items including ground.
•
Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to
protective earth.
•
Do not use the instrument in the presence of flammable anesthetics (gases).
•
The instrument and any device to be connected which has its own power supply should be turned off before any connections are
established.
•
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.
•
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.
•
Alpha OAE+ 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 Alpha OAE+.
•
Make sure that the PC and the docking station are not within patient reach.
•
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.
•
Use only the power supplies specified in Technical Specifications, Power adapter.
•
Alpha OAE+ must not be used during the application of:
– HF surgical devices
– cardiac pacemakers
– defibrillators
– other electrical stimulators
•
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.
•
If you suspect your Alpha OAE+ handheld Screener might be defective, do not use it.
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.
•
Do not store or operate Alpha OAE+ at temperatures and humidity exceeding those stated in Technical Specifications, Operating
environment.
•
No parts may be eaten, burnt, or in any other way used for purposes other than audiometry.
•
Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent cross-infection.
•
This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.
•
Choking hazard! Do not leave eartips unsupervised within the reach of children.
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This device is intended for use by audiologists, ENTs, and other healthcare professionals.
•
To prevent injury to the ear canal when inserting the probe, use slight pressure, twisting the probe slightly as you insert it.
