Registered medical product
The saccadic trainer has been a registered medical device since July 2020. Of the original 15 exercises, the six best exercises have been selected to specifically compensate for hemianopsia / visual neglects. If you want to try the other exercises, use the new app "Oculy":
www.oculy.app.
What does that mean?
Clinically evaluated
The product was clinically evaluated: It was found that it is a comparable product in the field of compensatory eye training and that it is not necessary to investigate the product with a separate study, as it is based on a well-studied principle.
Registered medical product
This product is approved as a certified medical device according to current legislation.
Compensation of visual field defects
The software is used to compensate for visual field loss. The focus is on training the healthy eyes to compensate for the limitation.
Interviews
The product was developed based on interviews with patients and health professionals (doctors, neuropsychologists, orthoptists and occupational therapists).
Checked for risks
The software has been tested for various risks: Every person can use the software without hesitation as long as they do not have acute eye diseases (e.g. inflammation) or suffer from photosensitive evoked epilepsy.
Tests
Risks and the entire product are regularly checked for errors according to a predefined test scenario.
Declaration of conformity
Nom et adresse de l’entreprise
Nome eindirizzo della ditta
Name andaddress of the firm
Dichiariamo sotto nostra responsabilità che / W e declare underour soleresponsibility that
le dispositif médical
the medical device
il dispositivo medico
Nom, type ou modèle, numéro de lot ou série, év. source et nombre d'exemplaires
Nome, tipoo modello, numero di lotto o di serie, ev. fonte e numerodi esemplari
Name, type or model, batch or serial number, possibly sources and number of items
class
/ remplit toutes les exigences de la directive sur les dispositifs médicaux 93/42/CEE (ou 90/385/CEE) qui le
concernent /soddisfa tutte le disposizioni della direttiva 93/42/CEE (opure 90/385/CEE) che lo riguardano /
meets all the provisions of the directive 93/42/EEC (or 90/385/EEC) which apply to it.
naleNormen oder andere normative Dok u-
mente
autres documents normatifs appliqués
altri documenti normativi applicati
standards or other normative documents
Procédure d’évaluation de la conformité
Procedimentodivalutazionedellaconformità
Conformity assessment procedure
Organeresp.
Notified Body (if consulted)
Nome e funzione / Name and function
