5
AURICAL OTOcam 300 video otoscope standards and
safety
This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.
When the Video Otoscopy module is used in conjunction with a device (including devices other than those produced by
Otometrics), make sure that all information and warnings in the documentation of the device are followed.
Complies with Type BF requirements of IEC60601-1.
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
Consult user manual for cautions.
Follow instructions for use.
Complies with Class II requirements of the safety standard IEC 60601-1.
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.
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.
5.1
Warning notes
Warning
•
Do not stare into the light beam, or point the light beam in the direction of other people’s eyes. It can
damage the eyes.
Warning
•
For continued protection against fire hazard, replace fuses with the same type and rating only.
•
Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
•
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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Otometrics - AURICAL OTOcam 300
5 AURICAL OTOcam 300 video otoscope standards and safety