Keeler KSL-H User manual

SLIT LAMP
INSTRUCTIONS FOR USE
Digital IFU supplement
&

KSL-H AND KSL-Z by KEELER www.keeler.co.uk
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 © Keeler Limited 2015. Published in the UK 2015.

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CONTENTS
Introduction 2
Symbols used in these Instructions for Use 3
including the Slit Lamp and packaging
Indications for use 4
Intended use/purpose of instrument
Brief description of the instrument
Safety 5
Cleaning and disinfection instructions 7
Transport, storage and working conditions
Installation and setup of digital unit 8
Controls 11
Electromagnetic emissions 12
Technical Specification 14
Contact, packaging and disposal Information 15
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2
1 INTRODUCTION
Thank you for choosing this Keeler product.
These Instructions for Use are aimed solely at hardware installation
on the slit lamp of the digital camera assembly (DCA), which to display
captured images needs to be used in conjunction with CE compliant or
FDA cleared imaging software installed on a medically approved PC. For
detailed instructions on use of the Keeler Desktop Slit Lamp please refer
to the Slit Lamp Manual EP59-70040.
Please read this manual carefully before using your Keeler Slit Lamp,
this will ensure the safety of the patient and ensure you get the best
performance from this precision optical device.
This manual should be read in conjunction with the Keeler Slit Lamp
H- series IFU (EP59-70040) or Keeler Slit Lamp Z-series IFU (EP59-
70043). Contact your distributor if do not have a copy of this IFU.
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2 SYMBOLS USED IN THESE INSTRUCTIONS FOR USE AND THE PACKAGING OF THE UNIT:
Manufacturer’s name and address
Mandatory action sign
Follow Instructions for Use
Optical radiation hazard
Trip Hazard
Hot surface
General warning sign
Type B Applied Part
Non-ionizing radiation
Keep dry
Reference Number
Serial Number
Date of manufacture
The CE mark on this product indicates it has been tested to and conforms
with the provisions noted within the 93/42/EEC Medical Device Directive
This way up
Material suitable for recycling
Fragile
The symbol on the Product or on it’s Packaging and instructions indicates
it was put on the market place after August 2005 and this product shall not
be treated as Household Waste
Operating Instructions
Exposure +
Exposure –
PC connection
Camera connection
REF
SN
+
-

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3 INDICATIONS FOR USE 5 BRIEF DESCRIPTION OF THE INSTRUMENT
4 INTENDED USE / PURPOSE OF INSTRUMENT
This Keeler 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.
This device is intended to be used only by suitably trained and authorised
healthcare professionals.
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 Digital Slit Lamp consists of multiple subassemblies; Illumination
Tower; Observation System; XYZ Translation Base; Chinrest Assembly, Digital
Camera Assembly and a Table Top with Power Supply and Accessory Drawer,
(not applicable to the refraction stand unit).
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. The digital module is fitted
between the magnification drum and viewing optics and is used to capture an
image of the patients pathology.
Many ophthalmic instruments illuminate the eye with intense light. The light
intensity on the Keeler Slit Lamp is continuously adjustable from maximum
to zero. In addition there is an infra-red filter incorporated in the illumination
system of the Keeler Slit Lamp H-series to reduce IR light levels.
The Keeler Slit Lamp is designed and built in conformity with EC Directive
93/42/EEC and the ISO 9000 and ISO 13485 series of quality standards.
The ‘CE’ (European Community) mark attests that the Keeler Slit
Lamp complies with the provisions of the EC Directive 93/42/EEC.
Classification: CE Regulation 93/42 EEC: Class I
FDA: Class II
IEC/EN Standard 60601-1: H-series - Safety Class II
Application part: Type B
Operation mode: continuous operation
Production processes, testing, start-up, maintenance, and repairs
are conducted in strict conformity with the applicable laws and
international reference standards.
The 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 magnified view of the eye structures in detail,
enabling anatomical diagnoses to be made for a variety of eye conditions.
The digital camera allows pictures to be captured of this pathology.
SLIT LAMP by KEELER www.keeler.co.uk
Caution: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.

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5 BRIEF DESCRIPTION OF THE INSTRUMENT 6 SAFETY
PHOTO TOXICITY
Because prolonged intense light exposure can damage
the retina, the use of the device for ocular examination
should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to
provide clear visualization of the target structures. This device should be used
with filters that eliminate UV radiation (< 400 nm) and, whenever possible,
filters that eliminate short-wavelength blue light (<420 nm).
The retinal exposure dose for a photochemical hazard is a product of the
radiance and the exposure time. If the value of radiance were reduced in half,
twice the time would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for slit lamps,
it is recommended that the intensity of light directed into the patient’s eye
be limited to the minimum level which is necessary for diagnosis. Infants,
aphakes and persons with diseased eyes will be at greater risk. The risk may
also be increased if the person being examined has had any exposure with
the same instrument or any other ophthalmic instrument using a visible light
source during the previous 24 hours. This will apply particularly if the eye has
been exposed to retinal photography.
It is well established that exposure of the eye to intense light sources for
extended periods of time poses a risk of retinal photic injury/ocular damage.
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 exeed the recommended maximum exposure (RME) of 2.2J/
cm², unless additional action is taken by the user to minimise exposure,
after 1.40 min (70 seconds for Z-series). The risk of retinal injury at an
exposure of 2.2J/cm² is not high, but becasue some patients may be more
susceptible that others, caution is advised if this radiant exposure value
is exceeded. However, because of significant risk of injury at exposures
exeeding 10 J/cm², the user should avoid exposures longer that 6.4 mins
(5.3 mins for Z-Series) when using the ancillary 90D lens.
The relative spectra output for Keeler Slit Lamp H-series and Z-series
is provided below
Figure 2. Relative
Spectral output Keeler
Slit Lamp Z-series
Figure 1. Relative
Spectral output Keeler
Slit Lamp H-series

6
WARNINGS AND CAUTIONS
Observe the following prescriptions in order to ensure safe operation of the
instrument For the safety warning regarding the Keeler Slit Lamp please
consult the Keeler Slit Lamp IFU.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for
signs of damage or misuse.
• Check your Keeler 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.
• 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.
• As the Digital Camera Assembly is medical equipment, special precautions
are needed regarding EMC (electromagnetic compatibility)
• It is important that the Digital Camera Assembly is configured and installed/put
into service, in accordance with the instructions/guidance provided herein and is
used only in the configuration as supplied.
• 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.
• Care should be taken when handling halogen bulbs. Halogen bulbs can shatter
if scratched or damaged.
• After removal of the bulb, do not touch the Slit Lamp bulb 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 Keeler 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, for
example videostream may freeze for one minute or more. If this occurs whilst
using this equipment, switch the unit off and reposition. Essential performance
is determined as continuous videostream which cannot be interrupted for
longer than one minute.
• Do not touch accessible connectors and the patient simultaneously.
• Despite the testing of the Digital Camera Assembly that has been undertaken,
normal operation of the Digital Camera Assembly can be affected by other
electrical/electronic equipment and portable and mobile RF communications
equipment.
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• Keeler digital KSL is not intended to be used with wireless technology.
Do not plug a wireless dongle into USB port. It is advisable to disable
wireless technology on the computer to prevent unauthorised access to
the camera.
• Keeler digital KSL cannot be used in the vicinity of sources known to cause
electromagnetic disturbance (magnetic resonance imaging, computed
tomography, radio-frequency identification, metal detectors, electronic
article surveillance and other electromagnetic security systems). Do not
bring the Keeler digital Slit lamp into magnetic resonance environment.
• The Digital Camera Assembly should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use with other equipment is
necessary, the Digital Camera Assembly and the other equipment should
be observed/monitored, to verify normal operation in the configuration in
which it will be used.
7 CLEANING AND DISINFECTION INSTRUCTIONS
Before any cleaning of the instrument or the base unit, ensure
the power leads and USB cables are 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.
a Wipe the external surface with a clean absorbent, non-shedding cloth
dampened with a water / detergent solution (2% detergent by volume)
or water / isopropyl alcohol solution (70% IPA by volume). Avoid optical
surfaces.
b Ensure that excess solution does not enter the instrument.
Use caution to ensure cloth is not saturated with solution.
c Surfaces must be carefully hand-dried using a clean non-
shedding cloth.
d Safely dispose of used cleaning materials.
8 TRANSPORT, STORAGE AND WORKING CONDITIONS
The following ambient condition limits are recommended for the Keeler
Slit Lamp, for transport and storage it is recommended that the Slit Lamp
is kept in its original manufacturers packaging.
WORKING ENVIRONMENT
+10°C to +35°C
30% to 75% relative humidity
TRANSPORT AND STORAGE CONDITIONS
Transport: -10°C to +60°C
Storage: -10°C to +55°C
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.

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9 INSTALLATION OF DIGITAL UNIT
For ‘Digital Ready’ variants of the Keeler Slit Lamp a Digital Camera
Assembly (DCA) must be purchased separately, contact Keeler or your
local distributor for details.
Set up the Slit Lamp as directed in the Instructions For Use (IFU)
EP59-70040, Contact your distributor if you are unable to locate a
copy of these Instructions.
1Install the Digital Camera Assembly (DCA) - carefully remove the
eyepiece assembly from the magnification block by unscrewing the
securing knob at the same time as supporting the eyepieces. The
eyepieces assembly is a dovetail type fit to the magnification block.
2Fit the digital camera assembly to the rear of the magnification
block and tighten the securing knob to hold it in place.
3Re-fit the eyepiece assembly to the rear of the DCA and secure
it by tightening the securing knob.
SLIT LAMP by KEELER www.keeler.co.uk
Care must be taken to avoid getting any dirt or dust on any of
the optical components.
securing knob