App. 1.3
Docking station symbols
Symbol
Definition
Suitable for direct current only.
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE).
All electrical and electronic products, batteries, and accumulators must be taken to separate collection at the
end of their working life. This requirement applies in the European Union. Do not dispose of these products
as unsorted municipal waste.
You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also con-
tact your local authorities for advice on disposal.
App. 1.4
Warning notes - Alpha OAE+
Warning
•
The following conditions or practices might present possible injury or danger to the patient and/or the
user:
•
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.
•
The probe socket is intended to connect the ear probe or ear coupler to Alpha OAE+. No other device may be con-
nected to this socket.
•
Avoid accidental contact between connected but unused applied parts and other conductive parts including those con-
nected to protective earth.
•
Do not store or operate Alpha OAE+ at temperatures and humidity exceeding those stated in Technical Specifications,
Operating environment.
•
Do not use the instrument in the presence of flammable anesthetics (gases).
•
No parts may be eaten, burnt, or in any other way used for purposes other than audiometry.
•
We recommend that an annual calibration be performed on Alpha OAE+ and probe. Furthermore, we recommend
that calibration be performed if the equipment has suffered any potential damage.
•
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.
•
Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent cross-
infection.
68
Otometrics - MADSEN Alpha OAE+
App. 1 Standards and Safety
Follow instructions for use.
