2
3
EN
EN
SLIT LAMP TSL-7000Z by TOMEY
SLIT LAMP TSL-7000Z by TOMEY
Consult instructions for use
General warning sign
Date of manufacture
Warning: Electricity
Manufacturer’s name and
address
Warning: Floor level obstacle
Country of manufacture
Warning: Non-ionizing
radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling
Warning: Optical radiation
This way up
Warning: Hot surface
Keep dry
Conformité Européene
Fragile
Type B applied part
Do not use if package is
damaged
Class II equipment
Temperature limit
Atmospheric pressure
limitation
Authorised representative in
the European Community
Humidity limitation
Catalogue number
Serial number
Translation
Medical device
The Tomey 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.
Copyright © Tomey GmbH 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 Tomey 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.
The Tomey Slit Lamp is an instrument consisting of a light source that can be focused to shine
a thin sheet (slit) of light into the eye. It is used in conjunction with a biomicroscope. The 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 examination 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 Tomey Slit Lamp can either be mounted onto a custom table top supplied by Tomey or can
be mounted on a third parties table top (refraction unit) by suitably trained technicians.
The Tomey 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 Tomey 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
