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6
4. Safety
Device classification
CE Regulation 93/42 EEC: Class I
FDA: Class II
Ophthalmoscopes and retinoscopes are intended to illuminate
the interior of the eye. Otoscopes are intended to illuminate the
interior of the ear.
Carefully read this Instruction Section before using your Keeler
product. For your own safety and that of your customers
observe all cautionary information provided in this section. The
following information is intended to highlight potential safety
hazards that can be associated with misuse, or damage.
Warnings and cautions - General
Warning
• Check your Keeler product for signs of transport / storage
damage prior to use
• Do not use if the product is visibly damaged, and periodically
inspect for signs of damage
• Do not use in the presence of flammable gases / liquids, or in
an oxygen rich environment
• This product should not be immersed in fluids
• Do not position the device so access to the mains plug is
limited or obscured
Switch off the electrical supply and disconnect from the
mains electrical supply before cleaning and inspection.
• If the product emits a strange odour, heat or smoke, stop use
immediately. The continued use of a damaged product or part
may cause injuries
• Do not touch the terminal contacts of the charging dock or
hand unit, or the terminal contacts and the patient
simultaneously
Caution
• Use only genuine Keeler approved parts and accessories or
device safety and performance may be compromised
• Use only Keeler approved batteries, chargers and power
supplies as per the accessories listed in section 12
• Backwards compatibility of the
LED module has not
been tested
