Tomey H Series User manual

TSL-4000H
SLIT LAMP
OPERATOR MANUAL
H Series

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SLIT LAMP TSL-4000H by TOMEY
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
2. SAFETY................................................................................................................. 3
2.1 PHOTOTOXICITY ............................................................................................................................3
2.2 WARNINGS AND CAUTIONS..........................................................................................................4
2.3 CONTRAINDICATION.....................................................................................................................5
3. CLEANING AND DISINFECTION INSTRUCTIONS.................................................... 5
4. NAMES OF CONTROLS AND COMPONENTS ......................................................... 6
5. ASSEMBLY............................................................................................................ 8
5.1 ILLUMINATION TOWER ASSEMBLY PROCEDURE.............................................................................8
5.2 CABLE ATTACHMENT PROCEDURE ................................................................................................9
5.3 FITTING APPLANATION TONOMETERS, T TYPE AND Z TYPES.........................................................10
6. INSTRUCTIONS FOR USE .................................................................................... 11
6.1 SETTING THE BINOCULARS..........................................................................................................11
6.2 PREPARING THE PATIENT AND USING THE SLIT LAMP ..................................................................12
6.3 DESCRIPTION OF FILTERS, APERTURES AND MAGNIFICATIONS.....................................................13
7. ROUTINE MAINTENANCE ................................................................................... 14
7.1 LED SYSTEMS ..............................................................................................................................14
7.2 REGULARLY INSPECT THE DEVICE FOR DAMAGE OR DIRT............................................................14
7.3 CLEANING AND CHANGING THE MIRROR....................................................................................14
7.4 ELECTRICAL CONNECTIONS ........................................................................................................14
7.5 OPTICS........................................................................................................................................14
7.6 AXLE AND MECHANICAL PARTS ..................................................................................................15
8. WARRANTY ........................................................................................................ 15
9. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 15
9.1 ELECTROMAGNETIC EMISSIONS..................................................................................................15
9.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................16
9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................18
9.4 TECHNICAL SPECIFICATIONS .......................................................................................................18
10. ACCESSORIES AND SPARES................................................................................ 21
11. PACKAGING AND DISPOSAL INFORMATION....................................................... 22

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EN EN
SLIT LAMP TSL-4000H by TOMEY SLIT LAMP TSL-4000H 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.
Classification: 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 specifications 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

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SLIT LAMP TSL-4000H by TOMEY SLIT LAMP TSL-4000H by TOMEY
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 Tomey 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 magnified
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 filters allowing the user to control the characteristics of the
examination light.
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 after 171
seconds.
While no acute optical radiation hazards have been identified 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
flashbulb in advance.
Tomey GmbH shall on request, provide the user with a graph showing the
relative spectral output of the instrument.
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if both
the instruments and their accessories are exclusively from Tomey GmbH. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.
Observe the following precautions in order to ensure safe operation of the instrument.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Check your Tomey product for signs of transport / storage damage prior to use.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• This product should not be immersed in fluid.
• Repairs and modifications to the instrument must be made only by the specialized
technicians of the manufacturer’s Technical Service Centre or by personnel trained and
authorised by the manufacturer. The manufacturer declines any and all responsibility for
loss and / or damages resulting from unauthorised repairs; furthermore, any such actions
will invalidate the warranty.
• The power switch and mains plug are the means of isolating the device from the mains
supply - ensure both the power switch and mains plug are accessible at all times.
• Do not position the equipment so that is difficult to press the power switch or remove the
mains plug from the wall socket.
• Refraction stand variants or adaptors should only be used in combination with EN/IEC
60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices.
• Route power cords safely to eliminate risk of tripping or damage to user.
• Before any cleaning of the instrument or the base unit ensure the power lead is
disconnected.
• LEDs can reach high temperatures in use – allow to cool before handling.
• Do not exceed maximum recommended exposure time.
• Should the instrument suffer shocks (for example, should it accidentally fall), and the
optical system or the illumination system are damaged it may be necessary to return the
instrument to the manufacturer for repair.

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SLIT LAMP TSL-4000H by TOMEY SLIT LAMP TSL-4000H by TOMEY
• After removal of the LED, do not touch the Slit Lamp LED electrical contacts and patient
simultaneously.
• The owner of the instrument is responsible for training personnel in its correct use.
• Ensure the instrument or instrument table is placed on a level and stable surface.
• Use only genuine Tomey approved parts and accessories or device safety and performance
may be compromised.
• Shut down after every use. In case the dust cover is used: risk of overheating.
• For indoor use only (protect from moisture).
• Electrical equipment can be affected by electromagnetic interference. If this occurs whilst
using this equipment, switch the unit off and reposition.
• Do not touch accessible connectors and the patient simultaneously.
• Before use, the Slit Lamp should be allowed to adjust to the ambient room temperature for
several hours. This is especially important when the unit has been stored or transported in a
cold environment; this can cause severe condensation to develop on the optical elements.
Before use, the Slit Lamp should be allowed to adjust to the ambient
room temperature for several hours. This is especially important when the
unit has been stored or transported in a cold environment; this can cause
severe condensation to develop on the optical elements.
2.3 CONTRAINDICATION
There is no restriction to patient population this device can be used with other than those
outlined in the contra-indications stated below.
Slit lamps can produce discomfort in some photophobic patients due to the high illumination.
Additionally patients must be co-operative and capable of sitting upright for the duration of
the examination, therefore the technique may not be suitable for patients who are unable to sit
upright for long periods of time or those with limited neck and back mobility.
3. CLEANING AND DISINFECTION INSTRUCTIONS
Before any cleaning of the instrument or the base unit, ensure the power
lead is disconnected.
Only manual non-immersion cleaning as described should be used for this instrument. Do not
autoclave or immerse in cleaning fluids. Always disconnect power supply from source before
cleaning.
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl
alcohol solution (70% IPA by volume). Avoid optical surfaces.
2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
not saturated with solution.
3. Surfaces must be carefully hand-dried using a clean non-shedding cloth.
4. Safely dispose of used cleaning materials.
4. NAMES OF CONTROLS AND COMPONENTS
Headrest Assembly
1. Fixation light cable
2. Main lamp cable (4 pin socket)
3. Forehead rest band
4. Patient’s eye height marker
5. Fixation light
6. Chinrest
7. Chinrest height adjuster
8. Patient grab handles
9. Power lead, chinrest to lamp housing
KSL-H Series
10. Lamp cover
11. Lamp cover release screws
12. Lever for grey (ND), blue, diffuser and red free filters
13. Slit length, slit rotation and aperture control
14. Scale for slit rotation
15. Illumination mirror
16. Slit offset centering knob
17. Inclination latch 5° to 20°
18. Slit width controls
19. Test bar & tonometer plate mounting hole and cover
20. Illumination arm locking knob
21. Microscope arm locking knob
22. Eyepiece assembly securing knob
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Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
Surfaces must be carefully hand-dried using a clean non-shedding cloth.
NAMES OF CONTROLS AND COMPONENTS
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