Zeiss AT 030, Product Documentation Set

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Instruction for use 2 Safety notes
AT 030 2.1 Intended user profile
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2 Safety notes
2.1 Intended user profile
The device may only be installed, operated, used and maintained by
persons who have the necessary training, knowledge and
experience to do so. Please also adhere to the national qualification
guidelines applicable in your country.
Persons who operate the device must have knowledge of basic
ophthalmic examination and diagnosis methods as well as of
ophthalmic optics. This includes, among others, persons belonging
to the following occupational groups or their national equivalents:
• Ophthalmologist
• Optometrist
2.2 Area of use
2.2.1 Indication for use
The AT 030 applanation tonometer is for measuring the intraocular
pressure of a seated patient.
2.3 Responsibilities and duties of the operator
Operating personnel
The device may only be operated by instructed and trained
personnel.
u
Ensure that the operating personnel have been trained and
instructed.
u
Ensure that the operating personnel have read and understood
the instructions for use.
u
The instructions for use should be readily accessible to the
operating personnel at all times.
u
To facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
u
Define the required skills for handling the device and provide
information on who is authorized for which activities.
u
Define rules for reporting errors and damage, and provide
information on these. Notification to manufacturers and
authorities [
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8]
u
Regularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.