D-0128226-A – 2020/12
Air Fx Caloric Irrigator – Instructions for Use - US
Page
5
2.3 Marking
The following marking can be found on the instrument:
[Esc]
Name in brackets of the keyboard key to press
An applied part that includes a patient connection that is intended to deliver electrical energy
or an electrophysiological signal to or from the patient shall be a Type BF part. An EOG
amplifier is considered a Type BF part.
An applied part that includes a patient connection which can be disconnected from the patient
immediately is a Type B part. The
[Subject]
is a Type B part.
Refer to the Instructions for Use
Observe precautions for handling electrostatic sensitive devices
It is against the law to dispose of electronic devices in the trash. The crossed-out wheelie bin
symbol shows that the components cannot simply be tossed into the trash but must be
recycled or disposed in accordance to local environmental regulations.
Chinese RoHS compliance standard where the product contains less than the maximum
concentration value of lead, mercury, cadmium, hexavalent chromium, polybrominated
biphenyls, and polybrominated diphenyl ethers.
Electrical ground
ETL 5003648 - This device has met Electronic Testing Laboratories standards
0123
The CE-mark indicates that the manufacturer meets the requirements of Annex II of the
Medical Device Directive 93/42/EEC for the quality system.
Medical Device
