Keeler H Series User manual

SLIT LAMP
INSTRUCTIONS FOR USE
H Series
A world without vision loss

1 EN
KSL-H by KEELER
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 TABLE TOP AND BASE ASSEMBLY PROCEDURE...............................................................................8
5.2 ILLUMINATION TOWER ASSEMBLY PROCEDURE.............................................................................9
5.3 CABLE ATTACHMENT PROCEDURE ..............................................................................................10
5.4 FITTING APPLANATION TONOMETERS, T TYPE AND R 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............................................................15
7.3 CLEANING AND CHANGING THE MIRROR....................................................................................15
7.4 ELECTRICAL CONNECTIONS ........................................................................................................15
7.5 OPTICS........................................................................................................................................15
7.6 AXLE AND MECHANICAL PARTS ..................................................................................................15
8. WARRANTY ........................................................................................................ 15
9. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 16
9.1 ELECTROMAGNETIC EMISSIONS..................................................................................................16
9.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................17
9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................18
9.4 TECHNICAL SPECIFICATIONS.......................................................................................................19
10. ACCESSORIES AND SPARES................................................................................ 22
11. PACKAGING AND DISPOSAL INFORMATION....................................................... 22

2
EN
KSL-H by KEELER
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
Use-by date Serial number
Catalogue number Medical device
Translation
The Keeler 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.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.

3 EN
KSL-H by KEELER
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 Keeler 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 Keeler Slit Lamp can either be mounted onto a custom table top supplied by Keeler or can
be mounted on a third parties table top (refraction unit) by suitably trained technicians.
The Keeler 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 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.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.