7
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220590‑04090 – 2021 – 08
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.
2.2 Medical purpose
This device has the following medical purpose:
• Diagnosis and monitoring of diseases of the anterior segment of the eye
• Diagnosis and monitoring of injuries of the anterior segment of the eye
• Investigation of the anatomy and physiological or pathological state of the
anterior segment of the eye
2.2.1 Indications
The use of the slit lamp is indicated for the following medical conditions:
• Local and systemic diseases affecting the eye
• Lesions and defects of the anterior segment
• Acute infections and inflammations
• Presence of intraocular foreign bodies
• Other traumata of the eye
2.2.2 Part of the body
The slit lamp is intended for the examination of the human eye, specifically the
anterior segment of the eye (i.e., lids, lashes, conjunctiva, cornea, anterior chamber,
iris, and lens).
2.2.3 Patient population
This device is intended for use on human patients with the physical ability to sit in
front of a slit lamp with their head resting against the headrest in a steady position
and the mental ability to follow instructions.
2.2.4 Contraindications
There are no known contraindications.
2.3 Principles of operation
• The slit lamp implements the principle of focal illumination: The focal point of the
microscope and the illumination coincide.
• The microscope arm and the illumination arm are mounted on an instrument
base: Both can be swivelled independently around the same vertical axis.
• The instrument base can be moved in all three axes.
• When illuminating transparent media with a narrow, sharp slit, an 'optical
section' can be magnified and viewed through the microscope.
• The patient's head is fixed to a height-adjustable headrest holder so that the
examination can be carried out quickly and as comfortably as possible for both
doctor and patient.
2.3.1 Operating environment
The slit lamp is intended to be used in professional health care facilities such as
hospitals, physician's, optometrist's and optician's practices. For optimal use of the
slit lamp, the ambient lighting should be attenuated to improve image contrast. In
case of transillumination of the iris or for viewing details at great magnification at a
narrow slit, it may be necessary to completely darken the room.
2.4 Clinical benefit
The use of the slit lamp allows for the systematic examination of the eye under
magnification, thus permitting the diagnoses of pathologies that may have otherwise
remained unidentified and could have lead to blindness if left untreated.
The clinical benefits of the product outweigh the remaining residual risks to the
patient.
