Marking - Interacoustics Aqua Stim Instructions For Use Manual

The external water tank should be placed at the same level as the irrigator. Do not place the external water
tank higher than the irrigator.
Do not place the water tank at a position above the irrigator as this may affect water fill and
overflow functions.
Water is drawn from the external water tank into the irrigator for heating to 30°C or 44°C prior to each
irrigation. Water will remain in the irrigator until it has been emptied by following the draining instructions.
Prior to transport, follow the water draining instructions in this manual. Do not ship the irrigator
without draining it as the internal water may damage components due to freezing and this will
void the warranty.

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
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
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.
0123
Medical Device
D-0128227-A – 2020/12
Aqua Stim Water Irrigator – Instructions for Use - US
[Subject] is a Type B part.
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