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RSL 4500digital and RSL 5000digital by RODENSTOCK
RSL 4500digital and RSL 5000digital by RODENSTOCK
Consult instructions for use
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Medical device
The Rodenstock Slit Lamp Digital IFU 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
This Rodenstock Slit Lamp is an AC-powered slit lamp biomicroscope and is intended for use
in eye examination of the anterior eye segment, from the cornea epithelium to the posterior
capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural
properties of the anterior eye segment.
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 parties table top (refraction unit) by suitably trained
technicians.
The Rodenstock Digital Slit Lamp consists of multiple subassemblies; Illumination Tower;
Observation System; XYZ Translation Base; Chinrest Assembly and Digital Camera Assembly.
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. The digital module is fi tted between the magnifi cation drum and viewing
optics and is used to capture an image of the patients pathology
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 171 seconds for
H Type and 81 seconds for Z Type respectively.
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 shall on request, provide the user with a graph showing the
relative spectral output of the instrument.