PLUSOPTIX A12C User Manual page 5

Use according to purpose
Mobile Pediatric Autorefractor "plusoptiX A12C" and "plusoptiX A12R" measure the sphere,
cylinder, axis, gaze and pupil diameter in both eyes simultaneously (binocular) in a non-dilated
pupil (miosis). These measurement values are used to calculate gaze asymmetry and inter
pupillary distance.
Anisometropia can only be detected in miosis reliably by means of a binocular refraction
measurement. In this regard, it is irrelevant whether the child accommodates during
measurement, as the refraction differential of both eyes remains constant, despite
accommodation.
The spherical measurement values take into account +1.00 dpt to compensate for the
accommodation on the camera at a distance of one meter. Manual correction is not required.
Note:
The interpretation of the measurement values for recommending therapy is
reserved exclusively for the eye care professional.
Note:
The measurement values may not be used directly for the prescription of glasses
or contact lenses.
Responsibility of the operator
- The operator must ensure that only trained users operate the device.
- At a minimum, the training must consist of reading this user manual and instruction in the
use of the device. A user already trained can perform instruction in the use of the device. In
addition, training is offered by Plusoptix and authorized Plusoptix distributors.
- The operator is responsible for ensuring that external devices connected to Mobile Pediatric
Autorefractor "plusoptiX A12C", "plusoptiX A12R" respectively, complies with the EN
60601-1 and EN 60601-1-1 norms together with the device.
- The operator is responsible for ensuring that in the case of servicing or a warranty claim,
Mobile Pediatric Autorefractor "plusoptiX A12C", "plusoptiX A12R" respectively, is only
opened by Plusoptix or an authorized Plusoptix distributor. Opening the device exposes you
to a risk of an invisible electric shock. In addition, the device warranty becomes null and
void, as does the approval as a medical device.
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