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© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09
2.1.1 Intended users
Users are qualified medical professionals such as ophthalmologists, optometrists,
opticians, nurses and researchers or other qualified specialists as permitted by local
legislation. The interpretation of biometry data is restricted to professionals with the
appropriate educational background as permitted by local legislation.
2.2 Medical purpose
This device has the following medical purpose:
• Investigation of the anatomy of the eye.
2.2.1 Indications
The use of this device is indicated for the following medical conditions:
• Cataracts
• Corneal irregularities
• Refractive errors
2.2.2 Part of the body
This device is intended for the examination of the human eye.
2.2.3 Patient population
This device is intended for use on human patients with the physical ability to sit in
front of a biometer with their head resting against the headrest in a steady position
and the mental ability to follow instructions. Patients must be at least 6 years old.
2.2.4 Contraindications
There are no known contraindications.
2.3 Principles of operation
• The device uses contact-less measurement technologies: OLCR interferometry
to measure biometry data along the visual axis (A-scan) and an integrated cam-
era with dedicated illumination for keratometry, iris and pupil measurements.
• The optional T-cone illuminates the patient’s eye with placido rings to measure
anterior corneal topography. It is designed as a non-electrical part and uses the
camera illumination source.
2.3.1 Operating environment
This device is intended to be used in professional health care facilities such as hos-
pitals, physician's, optometrist's and optician's practices. For optimal use of the
device, the ambient lighting should be attenuated.
2.4 Clinical benefit
Anatomical measurements of the eyes serve as basis of information for any medical
condition related to the divergence of these measurements from known standards.
Such measurements are well known to be paramount for intra-ocular lens (IOL)
power calculations to achieve optimal postoperative outcomes. Both cataract and re-
fractive surgery patients benefit from the refined IOL calculations.
The clinical benefits of the product outweigh the remaining residual risks to the pa-
tient.
