User Manual MUT_RD_009H_GB Page
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of 43
3.4.1
Signage plate of the EyeOP1 Control Unit
The signage plate of the EyeOP1 device is located on the rear side. It bears the following information:
1.
Address
and
telephone
number
of
manufacturer (EYE TECH CARE).
2.
Device model and item code (ETC_XXXX_YY).
3.
Date of manufacture (year and month) and
serial number of the unit.
4.
Type and characteristics of changeable fuses.
5.
Supply voltage (V), frequency (Hz), and
maximum absorbed power (VA).
6.
Nominal power (acoustic W) and nominal
output frequency (MHz) of the therapy
probe.
7.
Weight of the Control Unit.
a.
"Manufacturer" symbol accompanied by
manufacturer's address on label (1.)
b.
Warning
: Essential to refer to instructions for
use.
c.
Applied part of the type BF medical device
d.
Temperature of storage
e.
CE marking
f.
Storage in a dry place
g.
The control unit to be discarded is WEEE
(waste electrical and electronic equipment).
Return it to an appropriate collection point
for processing, recovery, and recycling of this
type of waste or to a distributor.
3.4.2
EYEOP-PACK labels
The EYEOP-PACK contains several labels affixed in various locations on the primary and secondary
packaging.
3.4.2.1
Tyvek covering and label of the PET primary packaging
The various elements of the EYEOP-PACK are packaged in a PETg (polyethylene
terephthalate glycol) blister, a recyclable plastic material closed with a Tyvek covering,
the content of which has been ethylene-oxide sterilized. This primary package is
contained in an individual carton box. The printed tyvek covering contains important
information. Moreover, an adhesive label is affixed to it.