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SLIT LAMP RSL 4300/4500 by RODENSTOCK
SLIT LAMP RSL 4300/4500 by RODENSTOCK
Consult instructions for use
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Medical device
The Rodenstock Slit Lamp is designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745
and ISO 13485 Medical Devices Quality Management Systems.
Classifi cation: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifi cations and other information contained in this document without prior notice.
This IFU is also available on the Rodenstock website.
Copyright © Rodenstock Instruments 2021. Published in the UK 2021.
1. INDICATIONS FOR USE
This device is intended to be used only by suitably trained and authorised healthcare
professionals.
CAUTION: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
Intended use / purpose of instrument
The Rodenstock Slit Lamp facilitates an examination of the anterior segment, or frontal
structures and posterior segment, of the human eye, which includes the eyelid, sclera,
conjunctiva, iris, natural crystalline lens and cornea. The binocular slit-lamp provides
stereoscopic magnifi ed view of the eye structures in detail, enabling anatomical diagnoses to
be made for a variety of eye conditions.
Brief description of the instrument
This Rodenstock Slit Lamp can either be mounted onto a custom table top supplied by Rodenstock
or can be mounted on a third party’s table top (refraction unit) by suitably trained technicians.
The Rodenstock Slit Lamp consists of 5 assemblies; Illumination Tower; Observation System; XYZ
Translation Base; Chinrest Assembly and a Table Top with Power Supply and Accessory Drawer.
The light intensity is controlled by a variable rheostat located on the XYZ Translation Base.
There are a number of selectable fi lters allowing the user to control the characteristics of the
examination light. Many ophthalmic instruments illuminate the eye with intense light. The light
intensity on the Rodenstock Slit Lamp is continuously adjustable from maximum to zero.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular
damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 81 seconds.
While no acute optical radiation hazards have been identifi ed for slit
lamps, we recommend keeping the intensity of the light reaching the
patient’s retina to the minimum possible for the respective diagnosis.
Children, people with aphakia and people suffering from eye conditions
are most at risk. An increased risk may also occur if the retina is exposed
to the same or a similar device with a visible light source within 24 hours.
This applies, in particular, if the retina has been photographed with a
fl ashbulb in advance.
Rodenstock Instruments shall on request, provide the user with a graph
showing the relative spectral output of the instrument.