Keeler PSL Classic User manual

Instructions for use
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Contents
1. Introduction
2. Symbols
3. Indications for use
4. Intended use / purpose of instrument
5. Brief description of the instrument
6. Safety
7. Cleaning and disinfection instructions
8. Transport, storage and working conditions
9. Warnings and cautions
10. Names of controls and components
11. Instructions for use
Preparing the power supply and the base unit
Preparing the Portable Slit Lamp prior to use
Preparing the patient
12. Problem solving
13. Changing the bulb
14. Routine instrument maintenance
15. Specifications and electrical ratings
16. Technical specifications
17. Accessories
18. Contact, packaging and disposal information
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1. Introduction
Thank you for choosing this Keeler product.
Please read this manual carefully before using your rechargeable Keeler
Portable Slit Lamp, this will ensure the safety of the patient and ensu you
get the best performance from this precision optical device.
Your Keeler Portable Slit Lamp includes:
•Portable Slit Lamp illumination body and magnification optics
•Base charger unit
•Power supply –switch mode all voltages/frequencies (Part 1941-P-7778)
•User instructions and quick guide
•Lens cloth
The information contained within this manual must not be reproduc in
whole or part without the manufacturer's prior written approval. The
manufacturer reserves the right to make changes to specifications and other
information contained in this document without prior notice.
Copyright © Keeler Limited 2009. Published in the UK 2009.
Please read and follow these instructions carefully. Home Back Next3

2. Symbols
Read user instructions for Warnings, Cautions
Keep dry
and additional information
Double insulated
Power input port
Fragile
Type B protections against shock
This way up
Consult instructions for use
Material suitable for recycling
Manufacturers name and address
This Symbol on the Product or on its Packaging
and instructions indicates that it was put on the
market place after August 2005 and that this
product shall not be treated as Household Waste.
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3. Indications for use
The Keeler Portable Slit Lamp (PSL) is an AC-powered Slit
Lamp biomicroscope 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.
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4. Intended use / purpose of instrument
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.
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5. Brief description of the instrument
The Keeler Portable Slit Lamp comprises a rechargeable hand
held portable illuminated biomicroscope system and a desk
mounted base charger unit that is powered from a low voltage
(12V) power supply.
The hand held unit incorporates a lithium ion rechargeable battery
powering the illumination system. The illumination system and
fixation targets are activated using a double click trigger located
on the front of the grip/handle. To increase or reduce the light
intensity there is a rheostat located below the eyepieces on the
rear of the grip /handle.
PSL Classic
The 10x and 16x magnification optical system is controlled using a
flip lever located under the adjustable eyepieces.
PSL One
The PSL One is a fixed 10x magnification system.
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6. Safety
The Keeler Portable Slit Lamp is designed and built in conformity
with EC Directive 93/42/EEC and the ISO 9000 and EN 46000 series
quality standards.
The (European Community) mark attests that the Slit Lamp
complies with the provisions of Annexes I, VI, and VII of EC
Directive 93/42/EEC.
Classification: CE Regulation 93/42 EEC: Class I
FDA: Class II
Production processes, testing, start-up, maintenance, and repairs
are conducted in strict conformity with the applicable laws and
international reference standards.
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6. Safety
When using the instrument, scrupulously observe all the relevant
accident prevention measures established by law to ensure the
safety of the patient.
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. Many
ophthalmic instruments illuminate the eye with intense light. The light
levels 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 to reduce IR light levels.
No visible retinal lesions have been identified as a result of using
Keeler Slit Lamps, however young children and persons with diseased
eyes may be at a higher risk. The risk may also be slightly increased if
the person being examined has had any exposure with the same
instrument or an other ophthalmic instrument using an intense visible
light source during the previous 24 hours. This will apply particularly if
the eye has been subjected to retinal photography.
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
44 minutes.
Figure 1: Relative spectral output of PSL
Quantity
Measured
Group 2
Pass/Fail
Comments
Value
limit
Group 2
E
ir-cl
54.82 mW cm
-2
100 mW cm
-2
Pass
-
L
38.0 mW sr
-1
cm
-2
10 J cm
-2
Pass with
Exposure
A-r
exposure
limit 44
limit
minutes
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6. Safety
The following statement is provided for US customers and references FDA Slit
Lamp Guidance.
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.
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7. Cleaning and disinfection instructions
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.
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8. Transport, storage and working conditions
The following ambient condition limits are recommended for
the Keeler Portable Slit Lamp, for transport and storage it is
recommended that the Slit Lamp is kept in its original
manufacturers packaging.
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 be stored or
transported in a cold environment; this can cause severe
condensation on the optical elements.
Working environment
+10°C to +35°C
30% to 75% relative humidity
Transport and storage conditions
Transport: -40°C to +70°C
Storage: -10°C to +55°C
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9. Warnings and cautions
Observe the following prescriptions in order to
ensure safe operation of the instrument
Warning
•Never use the instrument if visibly damaged and periodically
inspect it for signs of damage or misuse.
•Never use the instrument if the ambient temperature, atmospheric
pressure, and/or relative humidity are outside the limits given
above.
•Before any cleaning of the instrument or the base unit ensure the
power lead is disconnected.
•Clean only the exterior surfaces of the instrument following the
instructions contained in this manual.
•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.
•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.
•Always carefully observe the safety rules and other
precautions published herein.
•This device is intended to be used only by suitably trained and
authorised healthcare professionals.
•Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
•The owner of the instrument is responsible for training
personnel in its correct use.
•Route power cords safely to eliminate risk of tripping or
damage to user.
•Ensure the instrument is placed on a level and stable surface.
•Do not use in the presence of flammable gas/liquid.
•The bulb may be hot if the Slit Lamp has been in continuous
use, take care when removing the bulb.
•After removal of the bulb, do not touch bulb contacts and
patient simultaneously.
• Only use approved Keeler power supply
1941-P-7778 or instrument may
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malfunction.
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10. Names of controls and components
Portable Slit Lamp illumination body and
magnification optics
1. Trigger
Click and hold the trigger to turn the lamp illumination on. Double click (similarly to a
computer mouse button) to turn both the illumination lamp and fixation targets on.
2. Prism optical body
Projects a thin sheet (slit) of light perpendicular to the prism face.
3. Eyepieces –dioptrical adjustment
Rotate clockwise to achieve a + (plus) setting and anti-clockwise for a –(minus) setting.
4. Eyepieces –PD adjustment
Rotate the left eyepiece anti-clockwise and the right eyepiece clockwise to increase the
PD value. Rotate the left eyepiece clockwise and the right eyepiece anti-clockwise to
decrease the PD value.
5. Latex free protective sleeves
These sleeves can be folded forwards to better suit spectacle wearers.
6. Fixation targets
Provides a light source for the patient to focus upon. Double click (similarly to a
computer mouse button) to turn both the illumination lamp and fixation targets on.
7. Objective lenses
These lenses are flush with the external surface at a magnification of 10x and protrude
from the device at a magnification of 16x.
8. Slit wheel
Rotate the slit wheel to select either a slit of 0.15mm (0.15), 0.5mm (0.5), 0.8mm (0.8),
1.6mm (1.6), a circle of 12mm (O), or a square of 1mm ( ) for a/c flare assessment. (The
text in the brackets corresponds to the icons on the slit wheel.)
9. Filter wheel
Rotate the filter wheel to select either a red free (R.F), blue (B.F), neutral density (N.D) or
clear filter (O). (The text in the brackets corresponds to the icons on the filter wheel.)
5
4
6
7
3
2 1
8
9
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10. Names of controls and componen
Portable Slit Lamp illumination body and magnification opti
10.
Magnification change lever (PSL Classic only)
Push this lever to the right to set the magnification at 10x and to the left to set the magnifi
at 16x.
11.
Alternative power socket
In addition to charging through the base charger unit, the device can also be charged throu
this socket.
12.
Charging LED
The yellow charging LED is on continuously during normal charging and blinks when trickle charging.
Trickle charging can occur at the start of charging a completely discharged battery or when attempting
to charge a completely charged battery.
13.
Battery state LED
The yellow battery state LED blinks when the battery is almost empty.
14.
Brightness adjustment wheel
Rotating this wheel clockwise increases the brightness of the illumination lamp. Rotating
this wheel anti-clockwise decreases the brightness of the illumination lamp.
Portable Slit Lamp base charger unit
17
15.
Power socket for Keeler 12V Power Supply
Connect the power supply cable to this socket and the place the slit lamp body in the
charger unit to charge the device.
16.
Recharging connection pins
Connects the slit lamp body to the charger unit to charge the device.
17.
Recess for slit lamp body
Place the slit lamp body in the charger unit when not in use.
18.
Grooves for power cable
15
Place the power supply cable in the most suitable groove to keep the unit tidy.
19.
Protective rubber feet
Ensures the surface onto which the charger unit is placed does not become scratched.
20.
Charging safety feature
Note: No electrical power is conducted through the pins (16) until the slit lamp body is
placed into the recess of the charger unit.
10
14
13
16 11 12
18
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11. Instructions for use
Preparing the power supply and the base unit
1.Attach the appropriate mains plug adapter to the transformer after
removing the blanking plate or if required use an IEC 60320 type
7 connector (not supplied).
2.Connect the output power supply cable to the socket on the
underside of the recharging base unit.
3. Place the Portable Slit Lamp on the base charger unit, the
yellow LED will illuminate to indicate the unit is being
charged. From fully discharged to fully charged usually takes
2.5 hours.
Illumination ‘on time’ 50 minutes
(when used at full intensity from fully charged)
IEC 60320 TYPE 7 connector
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11. Instructions for use
Preparing the Portable Slit Lamp prior to use
1.Set the Pupillary distance of the eyepieces by firmly grasping
them and adjusting the distance by gently rotating the prism
bodies inwards or outwards until a full circular image is seen
binocularly.
5. To set the slit at an angle rotate the illumination tower about
its pivot axis.
6. Holding the slit lamp firmly click and hold the trigger to turn
on the illumination lamp. Double click and hold the trigger to
turn on both the illumination lamp and fixation targets. The
lamp does not run continuously, after a duration of 2 minutes
2.Adjust the dioptric power of each of
the eyepieces, one at a time. Adjust
the eyepiece to it’s highest + (plus)
setting and looking through the optics
at the peripheral focus marker, slowly
adjust the eyepiece towards the –
(minus) setting until the focus marker
is sharply in focus. Repeat this for the
other eyepiece.
Peripheral
focus marker
it automatically switches off.
Note –for very small or young patients,
babies in arms and some animals,
sometimes it may be preferable to use
the Portable Slit Lamp inverted –
see illustration.
Note –it can be beneficial to
stabilize the Slit Lamp using the
Note –Spectacle wearers may prefer to fold the rubber eye cup
forwards.
3.Set the magnification to either x10 or x16 using the
magnification change lever (PSL Classic only).
4.Select your preferred slit width and filter by rotating the slit and
the filter wheels.
technique shown in the
illustration below.
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11. Instructions for use
Preparing the patient
The patient should be as comfortable as possible and positioned to
allow easy access to the eye to be examined.
The Keeler portable Slit Lamp is designed to be ambidextrous,
hold the Slit Lamp in your preferred hand simultaneously
squeezing the trigger on/off switch.
To improve stability, especially at higher magnifications you may like
to use your other hand as a ‘bridge’ between the Slit Lamp body and
the patient.
As with other Slit Lamp examination procedures it may be
necessary to elevate the patient’s lid.
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12. Problem solving
Problem
Solution
Check the unit is fully charged
No illumination,
Check the position of the filters and
or low
slits to ensure they are set correctly
illumination
Check and if necessary change
the bulb
Slit slanted at an
Check the position of the slit disc, it
may not be located correctly at a slit
angle
position
Circle incomplete
Check the position of the slit and
filter discs, it may not be located
or offset
correctly at a slit position
Poor focus
Check the dioptric settings of the
eyepieces
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13. Changing the bulb
Warning the bulb may be hot if the Slit Lamp has been
in continuous use, take care when removing the bulb.
Make sure the power is disconnected before changing the bulb.
1
To change the bulb, first allow 5 minutes for it to cool down if
the Slit Lamp has been in use.
This is how you change a bulb
1. Unscrew the black plastic bulb cover by turning
anti-clockwise.
2. Remove the old bulb, allow 5 minutes for it to cool
down if the Slit Lamp has been in use. 2
3
3.Insert the new bulb, ensuring the
notch is facing upwards as shown.
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