App. 1
Standards and Safety
This manual contains information and warnings that must be followed to ensure safe performance of Alpha OAE+. Local
government rules and regulations, if applicable, should be followed at all times.
App. 1.1
Alpha OAE+ symbols
Symbol
Definition
Follow instructions for use.
Complies with Type BF requirements of IEC60601-1.
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accord-
ance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.
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. 1.2
Accessory symbols
Symbol
Definition
Non sterile product.
Do not reuse.
Otometrics - MADSEN Alpha OAE+
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App. 1 Standards and Safety
