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User and safety instructions
Congratulations on purchasing the PlenOptika QuickSee Free Pro Keratometry or the QuickSee Free! This
booklet will help you make the most of your experience with your QuickSee Free medical device.
Intended use
QuickSee Free medical devices are intended to measure the refractive power of the eye by measuring light
reflected from the eye using the optical techniques of wavefront aberrometry and keratometry (optional,
only in QuickSee Free Pro Keratometry model).
Indications for use
The QuickSee Free medical devices are indicated for use by healthcare professionals or under the direction of
a healthcare professional to screen for or measure an individual's refractive errors associated with poor vision.
Contraindications
The refractive error estimate is contraindicated in the following cases:
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Ocular drugs interfering with the visual system may affect the results.
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A history of eye surgery or the presence of mature cataracts may also affect the results.
Clinical benefits
1. Improved management of refractive errors (more than 2 billion people suffer from uncorrected refractive
error according to WHO data). The portability, usability and features of the technology allow the eyecare
professionals to be more efficient and enable minimally trained personnel to participate in the refraction
process.
2. QuickSee Free medical devices support the intended use of the device and derived model, which is to
produce an estimate of the refractive status of an eye.
3. QuickSee Free medical devices enable the intended use of the device and derived model, which is to
provide estimates of sphere, cylinder, and axis to assist and aid the eye-care professional in evaluating
refractive errors and prescribing vision correction for selected subjects. In addition, QuickSee Free Pro
Keratometry also provides keratometry readings.
Incident reporting
Incidents with medical devices should be reported to the competent authority of the country in which the user and/
or patient is established. If you have any doubt about the process, contact your local distributor or PlenOptika.
By default, PlenOptika will report incidents to The Spanish Agency of Medicines and Medical Devices
(AEMPS). Incident reporting is an essential element through which AEMPS records reported incidents in
order to identify any problems or defects related to medical devices. This registry enables the association
of cases and the generation of indications of product failures, as well as the assessment of the impact of the
events and, if necessary, the rapid adoption of the relevant corrective measures.
If you suspect an incident involving a medical device, you can report it using the electronic form found at the
link below. To do so, choose one of the two available forms: healthcare professional or patient. More informa-
tion on what, how, who, and why to report can be found in the link below:
https://notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do
Device description
QuickSee Free Pro Keratometry is a hand-held wavefront aberrometer/keratometer with a monocular form
factor. Operation involves asking the subject look at a distant object through the device and aligning their
eye with the red dot and pupil camera displayed on the screen. The device provides a measurement of a
subject's refractive error as well as keratometry values.
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