Zeiss opmi lumera 700, Инструкция по эксплуатации

Страница: 16 / 236

2 Safety notes Instructions for Use
OPMI LUMERA 700 2.3 Responsibilities and duties of the operator
16 / 236 G-30-1673-en - 14.0 - 2018-07-12
When finished, the surgeon swivels the microscope out of the
surgical field and into the park position. Pressing the reset button
on the XY coupling, or positioning the device in the park position,
resets the device to its initial values and makes it ready for the next
operation. The drape or the resterilizable caps are removed by the
surgeon or by a nurse. The drape is to be disposed of in accordance
with the hospital regulations of the respective country. The resteril-
izable caps can be sterilized again. The device can be cleaned and
disinfected.
The product must be regularly checked for full functionality by a
hospital technician.
At the end of the electronic device's service life, it must be disposed
of in accordance with the regulations of the respective country.
2.3 Responsibilities and duties of the operator
Operating personnel
The device may be operated only by properly instructed and trained
persons.
u
Make sure that the operating personnel are appropriately
trained and instructed.
u
Make sure that the operating personnel have read and under-
stood the Instructions for Use.
u
Keep the Instructions for Use available at all times for the
operating personnel.
u
To facilitate access for all operating personnel: Request
additional copies of the Instructions for Use as required from
ZEISS.
u
Specify the competencies for handling the device and state
who is authorized to perform what tasks.
u
Determine the reporting obligations for malfunction and
damage and make them known. Notification of the manufac-
turer and authorities. [
}
17]
u
Provide the necessary protective clothing.
u
Regularly check that the legal regulations applicable in your
country with regard to accident prevention and work safety are
being complied with.
Safety inspections
u
To prevent a decrease in device safety due to aging and wear:
Implement regular safety inspections as specified for this device
by the applicable national regulations.
The safety inspections may only be performed by the manufacturer
or qualified personnel.
u
Comply with the specified time limits.