Country-specific information and labels
000000-1520-928_GA_EN_021013
7
Specified purpose
CAUTION - RISK OF OPERATING ERRORS
This device may only be installed, operated, used, and maintained by
persons who have been properly trained or who have the required
knowledge and experience to do so. Please adhere to the additional
national qualification guidelines applicable in your country.
The following user profiles must be considered.
User profile I: Measurement with the i.Profiler
® plus
The user should have experience in the following areas:
•
Procedures and handling of customers/patients in the healthcare sector
•
Standard anamnesis and screening procedures in ophthalmology and/or
optometry
•
Standard patient instructions during a measuring procedure on the
human eye for optimization of measurement quality
•
Standard acoustic and optical warning signals/displays on medical devices
during a measuring procedure on the human eye
•
Standard device interfaces (USB, Ethernet, VGA)
•
Familiarity with the Microsoft Windows operating system and
applications based on it
•
Standard maintenance, cleaning and calibration procedures on medical
devices
User profile IA: Assistant optician/optometrist
The user (e.g. trainee, salesperson) should have the experience described
under user profile I plus the following skills:
•
Handling of standard test records and measurement results in optics/
optometry such as refraction values (sphere, cylinder, axis), higher-order
aberrations (Zernike polynomials), ophthalmometer readings (corneal
radii) and corneal topography data (axial, local and height representation,
etc.)
•
Evaluation of the quality of readings with the aid of evaluation criteria for
measurement quality in the user manual
