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TOPCON

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INSTRUCTION MANUAL
SLIT LAMP
SL-1E
INTRODUCTION
Thank you for purchasing the TOPCON SL-1E Slit Lamp.
This instrument is used for the magnified observation of the anterior segment of the
eye and its parts.
This SL-1E has the following features:
• Smooth mechanical movements
• Bright and clear observation of the eye with natural color rendition
• Apochromatic optical system to enhance natural color and resolution
• Robust construction for performance and durability
This Instruction Manual covers an overview of the basic operation, troubleshooting,
checking, maintenance and cleaning of the SL-1E Slit Lamp.
To get the best results from this instrument, read "Displays for Safe Use" and "Safety
Cautions".
Keep this Instruction Manual close at hand for future reference.
PRECAUTIONS
The patient who undergoes an examination by this instrument must maintain concentration for a few minutes and keep to the following instructions:
To fix the face to the chinrest, forehead rest, etc.
To keep the eye open.
To understand and follow instructions when undergoing an examination.
WARNING
To avoid injury to the patient’s eye and nose, pay particular attention
while operating the instrument body.
(The patient may be injured.)
CAUTION
This instrument must not be used for the following patients:
• Patients who are hypersensitive to light
• Patients who recently underwent photodynamic therapy (PDT)
• Patients taking medication that causes photosensitivity.
This symbol is applicable for EU member countries only.
To avoid potential negative consequences for the environment and possibly human
health, this instrument should be disposed of (i) for EU member countries - in
accordance with WEEE (Directive on Waste Electrical and Electronic Equipment),
or (ii) for all other countries, in accordance with local disposal and recycling laws.
CAUTION : Federal laws restricts this device to the sale by or on the order of a physician.
WARNING : Handling the cord on this product or cords associated with
accessories sold with this product, will expose you to lead, a chemical known
to the State of California to cause birth detects or other reproductive harm.
Wash hands after handling.
1
INTRODUCTION
CAUTIONS FOR USE
Use this instrument carefully on the following patients:
• Patients who have epidemic corneitis, conjunctivitis or any other infectious disease
• Patients who are taking medications that cause light hypersensitivity.
Be careful not to let the patient touch this instrument. The patient's hand may be pinched by the
movable part.
To avoid injury or fire caused by electric shock, turn off the power switch and unplug the power
cord. Then, replace the fuse with the rated one.
To avoid injury caused by electric shock, turn off the power switch when replacing the lamp.
To avoid burns caused by heat, do not replace the lamp with a new one immediately after it
goes off.
When operating the base unit, please note the following:
• Beware of catching fingers in the moving parts.
• Avoid hitting the patient's eyes or nose.
To avoid injury to the patient's head, incline the illumination unit slowly while holding the base
unit.
Disposal
When disposing the instrument and/or parts, follow the local regulations for disposal and recycling.
STORAGE PLACE, USAGE PERIOD
1. When storing the instrument, ensure that the following conditions are met:
(1) The instrument should not be splashed with water.
(2) Store the instrument where environmental conditions are appropriate.
(3) Do not store or transport the instrument on a slope or uneven surface or in an area
where it is subject to vibrations or instability.
(4) Do not store the instrument where chemicals are stored or gas is generated.
2. Usage period
8 years from delivery providing regular maintenance is performed (according to the self-certification [TOPCON data])
USER MAINTENANCE
1. Regularly maintain and check the instrument and its parts.
2. When using the instrument after a prolonged period of inactivity, confirm normal and safe
operation beforehand.
3. Keep the objective lens free from finger prints and dust.
4.When not in use, protect the instrument with the dust cover.
5.If the objective lens is stained, clean it following the "Cleaning" instructions listed in this
Instruction Manual.
2
INTRODUCTION
DISPLAYS FOR SAFE USE
In order to ensure the safe use of the product and to prevent harm to the operator and others, or
damage to property, a number of important warnings are placed on the product and inserted in the
instruction manual.
It is recommended that all users understand the meaning of the following displays and icons
before reading the "Safety Cautions" text.
DISPLAYS
DISPLAY
MEANING
WARNING
Ignoring or disregarding this display may lead to death or serious injury.
CAUTION
Ignoring or disregarding this display may lead to personal injury
or physical damage.
 Injury refers to cuts, bruises, sprains, fractures, burns, electric shocks, etc.
 Physical damage refers to damage to buildings, equipment or furniture.
ICONS
ICON
MEANING
This indicates Prohibition.
Specific content is expressed with words or an icon either inserted
in the icon itself or located next to the icon.
This indicates Mandatory Action.
Specific content is expressed with words or an icon either inserted
in the icon itself or located next to the icon.
This icon indicates Hazard Alerting (Warning).
Specific content is expressed with words or an icon either inserted
in the icon itself or located next to the icon.
3
DISPLAYS FOR SAFE USE
SAFETY CAUTIONS
WARNING
Icon
Prevention item
Page
To avoid fire and electric shock in case of leakage, be sure to use
a grounded outlet. Do not connect to outlets that are not grounded.
15
To avoid electric shock, unplug the power cord from the grounded
outlet before removing the fuse cover. Do not connect the power
cord to the grounded outlet with the fuse cover not correctly
attached.
30
To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch ( ) and disconnect the power
cord from the instrument if you see smoke coming from the instrument, etc.
Don't install the instrument where it is difficult to disconnect the
power cord from the instrument. Ask your dealer for service.
-----
CAUTION
Icon
4
SAFETY CAUTIONS
Prevention item
Page
To avoid electric shock, do not touch the external connection terminal and the patient at the same time.
31,34
This instrument has been tested (with 100/120/230V) and found
to comply with IEC60601-1-2: Ed.3.0 : 2007 as class A (classified
according to CISPR11).
According to IEC60601-1-2, this instrument is more suitable to
connect with exclusive power supply system in establishment
such as hospital, etc than it connects with the domestic electricity
power supplies.
This instrument radiates radio frequency energy within standard
and may affect other devices in the vicinity.
If you have discovered that turning on / off the instrument affects
other devices, we recommend you change its position, keep a
proper distance from other devices, or plug it into a different outlet. Please consult your authorized dealer if you have any additional questions.
-----
MAINTENANCE
USER MAINTENANCE
To maintain the safety and performance of the instrument, never attempt to do maintenance of items other than those specified here unless done by an authorized service engineer. For details about maintenance, read the chapter entitled "Maintenance" in this
manual.
REPLACING THE ILLUMINATION LAMP
The illumination lamp can be replaced if necessary. For specific instructions, see page 31.
REPLACING THE FUSES
Fuses on the primary side can be replaced if necessary. For specific instructions, see
page 30.
DISCLAIMERS
 TOPCON is not responsible for damage due to fire, earthquakes, actions or inactions
of third persons or other accidents, or damage due to negligence and misuse by the
user and any use under unusual conditions.
 TOPCON is not responsible for damage derived from inability to properly use this
equipment, such as loss of business profits and suspension of business.
 TOPCON is not responsible for damage caused by operations other than those
described in this Instruction Manual.
 The device does not provide a diagnose of any condition or lack thereof or any recommendations for appropriate treatment. The relevant healthcare provider is fully responsible for all diagnose and treatment decisions and recommendations.
5
MAINTENANCE
WARNING INDICATIONS AND POSITIONS
To ensure safety, warning labels are placed on the instrument body.
Use the instrument according to these warning instructions. If any of the following labels are missing, contact your dealer or TOPCON (see the back cover for contact information).
CAUTION
 To prevent electric shock, switch off the power supply and remove
the power cable before replacing the lamp.
Afin d'éviter tout choc électrique, coupez le contact et débranchez
le câble d'alimentation avant de remplacer l'ampoule.
 To avoid burns, do not touch the lamp immediately after switching
the instrument off.
Afin d'éviter toute brûlure, prenez garde à la température élevée de
l'ampoule lorsque le remplacement de celle-ci se fait immédiatement après avoir coupé l'alimentation électrique.
[Refer to instruction manual]
CAUTION
When operating the base unit, note
the following:
Pendant la manipulation de la base
de l'instrument, veillez prendre les
précautions suivantes;
 To prevent fingers from being
caught in between, be aware of
moving parts.
Prenez garde aux pièces mobiles
afin d'éviter be coincer les doigts.
 Keep a safe distance from the
patient's face to prevent injuries to
the nose and eyes.
Gardez une distance de travail
appropriée afin d'éviter le contact
avec les yeux et le nez du patient.
[Refer to instruction manual]
Degree of protection
against electric shock:
TYPE B APPLIED PART
6
WARNING INDICATIONS AND POSITIONS
CONTENTS
INTRODUCTION ...............................................................................................................1
DISPLAYS FOR SAFE USE ..............................................................................................3
SAFETY CAUTIONS .........................................................................................................4
MAINTENANCE .................................................................................................................5
DISCLAIMERS ...................................................................................................................5
WARNING INDICATIONS AND POSITIONS ....................................................................6
CONFIGURATION .................................................................................................................9
NAMES OF MAIN BODY COMPONENTS ........................................................................9
CONFIGURATION OF PARTS IN CONTACT WITH PATIENT ........................................9
STANDARD ACCESSORIES ..........................................................................................10
COMPONENTS .................................................................................................................... 11
COMPONENTS ...............................................................................................................11
ASSEMBLY PROCEDURE ...............................................................................................12
ASSEMBLY PROCEDURE ..............................................................................................12
CHECKING PROCEDURE ..............................................................................................15
OPERATION PROCEDURES ..........................................................................................16
PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY
DISTANCE ADJUSTMENT ..............................................................................................16
PATIENT POSITION ........................................................................................................17
BASE OPERATION .........................................................................................................17
OPERATION OF THE ILLUMINATION UNIT ..................................................................18
TROUBLESHOOTING ........................................................................................................19
TROUBLESHOOTING GUIDE ........................................................................................19
SPECIFICATIONS ...............................................................................................................20
ENVIRONMENTAL CONDITIONS ..................................................................................22
ELECTROMAGNETIC COMPATIBILITY .........................................................................23
OPTICAL RADIATION HAZARD .....................................................................................27
SYSTEM CLASSIFICATION ............................................................................................28
PURPOSE OF USE .........................................................................................................28
OPERATION PRINCIPLE ................................................................................................28
SHAPE OF PLUG ............................................................................................................29
SYMBOL ..........................................................................................................................29
MAINTENANCE .................................................................................................................... 30
DAILY CARE ....................................................................................................................30
REPLACING THE FUSE ................................................................................................. 30
REPLACING THE CHINREST PAPER ...........................................................................30
REPLACING THE ILLUMINATION LAMP ....................................................................... 31
CLEANING .......................................................................................................................32
ORDERING SUPPLIES ...................................................................................................33
USER MAINTENANCE ITEMS ........................................................................................33
OPTIONAL ACCESSORIES .............................................................................................34
FIXATION TARGET .........................................................................................................34
7
CONTENTS
HRUBY LENS ..................................................................................................................35
10×MEASURING EYEPIECE ..........................................................................................36
16×EYEPIECE ................................................................................................................. 36
ACCESSORY DRAWER ................................................................................................. 37
APPLANATION TONOMETER ........................................................................................37
AUTOMATIC INSTRUMENT TABLE AIT-15 ...................................................................37
8
CONTENTS
CONFIGURATION
NAMES OF MAIN BODY COMPONENTS
Chinrest jack
10
Fixation target
mounting holes
Eyepiece
Forehead rest *1
Canthus marker
Magnification changer lever
Slit rotation control ring
Slit width control knob
Chinrest *1
Aperture and slit length
control wheel
Chinrest adjuster
Filter selection lever
Cap
Lamphouse cover
Illumination arm
locking screw
Lamphouse cover
clamping screw
Click stop
Microscope arm
locking screw
Joystick
Base locking knob
Rail cover
Pilot lamp
Base
Power switch
Brightness control switch
Table
*1 : Contacting part (class B)
CONFIGURATION OF PARTS IN CONTACT WITH PATIENT
Forehead rest : Polyamide resin
Chinrest
: Polyamide resin
9
CONFIGURATION
STANDARD ACCESSORIES
Make sure that all the following standard accessories are included.
Figures in parentheses are the quantities.
Some accessories are not included as standard depends on the model.
Chinrest paper (1)
Focusing test rod (1)
Spare illumination lamp (1)
Spare chinrest paper pin (2)
Spare fuse (1)
Brush (1)
Dust cover (1)
Instruction manual (1)
Accessory box (1)
Phillips screwdriver (1)
Wrench (not supplied with unit model slit lamp) (1)
10
CONFIGURATION
COMPONENTS
COMPONENTS
(1) Main unit
(2) Instrument type table (w/power supply)
(2)’ Unit type table (w/power supply)
(3) Rail cover
(4) Chinrest unit
(5) Power cable
Article name
Q'ty
(1) Main unit
1
(2) Instrument type table (w/power supply)
1
(2)' Unit type table (w/power supply)
1
(3) Rail cover
2
(4) Chinrest unit
1
(5) Power cable
1
11
COMPONENTS
ASSEMBLY PROCEDURE
ASSEMBLY PROCEDURE
(1) Selecting Voltage and Fuse
Display window
Voltage selector
Fuse holder
[except for U.S.A. and Canada]
Voltage selector
Fuse holder
[for U.S.A. and Canada]
* Check the setting on the voltage selector, which is located on the bottom of the power supply.
* If the selector does not match the outlet voltage, turn the selector to the proper setting with a
screwdriver.
* Turn the center of the fuse holder with the Phillips screwdriver, remove the fuse and check it's
rating. Insure that the fuse is the correct rating for the supplied voltage:
(except for U.S.A. and Canada)
(for U.S.A. and Canada)
F1, F2: T1AL 250V(100, 120V)
F1, F2: T1AL 250V(120V)
T500mAL 250V(220, 240V)
T500mAL 250V(220V)
F3:
F4AL 125V
F3:
F4AL 125V
(2) Mounting the Table
(a) To attach the table on the instrument table AIT-15, use the four 8×24mm bolts with locking
washers.
Bolt
* Raise the table to allow the bolts to pass through the mounting flange.
* Place the table on the mounting flange of the table and screw the bolts into the mounting
bracket. The controls of the power supply should face the practitioner. Tighten the bolts
securely with the included wrench.
12
ASSEMBLY PROCEDURE
(b) To secure the unit model table to the ophthalmic unit.
Washer
* Peel off the tape which secures the plastic washer to the mounting bracket's shaft.
* Insert the shaft of the mounting bracket into the hole of the arm on the ophthalmic unit. The
plastic washer should be between the mounting bracket and the arm.
Note: The power supply is attached to the left side of the unit top (practitioner's view). If the
ophthalmic stand is located to the left of the ophthalmic chair, the power supply must
be relocated to the right side of the unit top to prevent interference with the arm. In this
instance, remove the four wood screws which attach the power supply to the unit top,
re-position the power supply in a similar position to the right side of the unit top, and reattach the power supply with the four screws.
(3) Mounting the Chinrest
Chinrest cord
Chinrest mounting plate
* Remove the four screws which are attached to the chinrest mounting plate with the Phillips
screwdriver.
Screw
* Place the chinrest cord in the gap between the chinrest mounting plate and the chinrest
assembly. While making sure that the cord is not being pinched by the mounting plate, retighten the previously removed screws.
13
ASSEMBLY PROCEDURE
(4) Mounting the Main Unit
Tape
Wheel
Rail
* Place the wheels of the base assembly evenly on the table rails.
* After checking to see that the main unit moves smoothly on the rails, insert the rail covers in
the space between the rail and table.
* Remove the protective tape from the illumination unit and the hole cap while being careful to
avoid touching the lens surface.
(5) Connecting Cables
Cable clip
* Connect the chinrest cable, main body cable and power cable to the power supply.
* Remove the cable clips from the bottom of the table top, slip them over the chinrest and
power cables and re-attach them to the table.
14
ASSEMBLY PROCEDURE
(6) Installing the Chinrest Paper
Pin
* Remove the two pins from the chinrest.
* Place the pins through the holes in the chinrest paper. Remove the wrapping from the chinrest paper.
* Align the pins with the holes in the chinrest and secure the paper to the assembly.
(7) Accessory Box
* An accessory box is supplied to store the accessories.
CHECKING PROCEDURE
WARNING
To avoid fire and electric shock in case of leakage, be sure to use a
grounded outlet. Do not connect to outlets that are not grounded.
(1) Power Plug
* Make sure that the instrument is always properly grounded.
(2) Illumination and Instrument Functions
* Turn the power supply on and observe that the illumination is passing through the opened slit
controls.
* Check to see that the slit width and length controls, filter lever and magnification changer
lever operate smoothly and properly.
(3) After the installation is completed, turn the power supply off and cover the instrument
with the dust cover.
15
ASSEMBLY PROCEDURE
OPERATION PROCEDURES
PREPARATION-DIOPTER COMPENSATION AND INTERPUPILLARY DISTANCE ADJUSTMENT
Before using the instrument, always carry out the diopter compensation and interpupillary distance adjustments.
(1) Use of the focusing test rod
The focusing test rod which is a standard accessory, is used to establish the proper microscope settings for each use.
Insert test rod in the hole in chinrest with the flat surface at the top of test rod facing the microscope.
Test rod
Chinrest
(2) Preparation of illumination unit
* Turn the power switch ON. Set the brightness control switch at the '0.1' position.
* Turn aperture and slit length control wheel until slit diameter becomes 14mm, then turn slit
width control knob to set slit width to maximum.
* Use joystick gross control to move base so that illumination is provided on the test rod.
* Then use joystick fine control to move base so that a 1 to 2mm width slit image focuses
sharply on test rod when seen naturally by eye.
(3) Diopter compensation
Independently set the diopter setting for each eyepiece as follows.
* First, turn the eyepiece ring in a counterclockwise direction until it stops.
* Now, turn the ring clockwise until a sharp image is seen through the microscope on the
focusing test rod.
Ring
16
OPERATION PROCEDURES
Prism box
(4) Interpupillary distance adjustment
While looking through the eyepieces at the image on the focusing test rod, adjust the converging binocular's prism box, so that the image is fused and a stereo-scopic image results. For
operator comfort, since each eyepiece can be moved independently, insure that both eyepieces are at the same height.
Prism box
At the same height
PATIENT POSITION
Positioning patient's head
Have the patient place his chin on the chinrest and forehead against the forehead rest. Adjust the
chinrest adjuster so that the patient's outer canthus is at the approximate height of the canthus
marker.
Canthus marker
Chinrest adjuster
BASE OPERATION
(1) Horizontal gross adjustment
To adjust the microscope's position horizontally, move the base while keeping the joystick in
the vertical position.
(2) Horizontal fine adjustment
For fine adjustment, such as alignment or focusing, tilt the joystick to the left or the right.
(3) Vertical fine adjustment
For fine vertical adjustment, turn the joystick clockwise to raise the microscope and counterclockwise to lower it.
17
OPERATION PROCEDURES
(4) Locking the base
To lock the base, tighten the base locking knob.
(5) Focusing
* Gross adjustment for alignment or focusing is done by the operation described in (1)
* Fine adjustment for alignment or focusing should be done by the operations described in (2)
and (3) above while looking through the microscope.
OPERATION OF THE ILLUMINATION UNIT
(1) Change of slit size
By operating the slit width control knob or turning the aperture and slit length control wheel,
ideal slit width, slit length and spot size can be achieved.
(2) Change of slit position
By turning the illumination unit or operating slit rotation control ring, the desired positioning of
the slit image can be obtained.
(3) Change of filter
A cobalt-blue filter or red-free filter can be set in the light path.
White mark -- No filter
Blue mark -- Blue filter
Green mark -- Red-free filter
18
OPERATION PROCEDURES
TROUBLESHOOTING
TROUBLESHOOTING GUIDE
If any problem should occur, first consult the following trouble shooting table, and follow the
suggested instructions. Then, if the trouble is not corrected, contact your nearest TOPCON
dealer.
Trouble
No illumination
Possible Cause
Refer to
Power cable is not properly con- Connect cable to the outlet.
nected to the power outlet.
Power switch is still OFF.
Turn power switch ON.
P. 14
----
The lamp socket is damaged from Replace the socket.
the heat.
P. 31
The lamp has burned out.
Replace the lamp.
P. 31
Fuse has blown.
Replace the fuse.
P. 30
Insert lamp correctly.
P. 31
Slit light is too dim The lamp is not correctly inserted.
Fuse has blown
Remedy
Voltage selector setting is incorrect. Check voltage selector and
(except for USA and Canada)
set it to the correct position.
P. 12
Voltage selector setting is incorrect. Check voltage selector and
(except for USA and Canada)
set it to the correct position.
P. 12
Type of fuse used is incorrect.
Replace with the correct
type as specified.
P. 30
19
TROUBLESHOOTING
SPECIFICATIONS
MICROSCOPE
Type
Binocular stereoscopic microscope with erect image.
Magnification changer
Revolver type objective changing system provides two magnification changes.
Objective
1× and 1.6×
Eyepieces
10× and (16× option)
Objectives × Eyepieces = Magnification Field of view
Magnification & field of view
1×
10×
10×
18mm diameter
1.6×
10×
16×
11.25mm diameter
1×
16×
16×
14.25mm diameter
1.6×
16×
25.6×
9mm diameter
Pupillary adjustments
55mm to 75mm
Diopter adjustments
-5D to +3D
SLIT ILLUMINATION
Slit projection
1.23×
Slit width
Continuously variable from 0 to 14mm
Slit length
14mm, 10mm, 8mm, 5mm, 3mm, 2mm, 1mm
Aperture diameters
14mm, 10mm, 8mm, 5mm, 3mm, 2mm, 1mm
Slit angle
Continuously rotatable from vertical to horizontal
Filters
Blue, Red-free
Lamp
6V 20W halogen
BASE
Longitudinal movement
80mm
Lateral movement
100mm
Fine cross-slide adjustments
12mm
Vertical movement
30mm
CHINREST
Vertical movement
80mm
POWER
Source voltage
120V/220V AC (USA and Canada)
100/120/220/240V AC (except for USA and Canada)
Frequency
50-60Hz
Power input
30VA
DIMENSION & WEIGHTS
Dimensions
W/Table
W/Unit Table
W/O Table
W/O Table and Chinrest
20
SPECIFICATIONS
550mm(W) × 398mm(D) × 552mm(H)
440mm(W) × 378mm(D) × 552mm(H)
329mm(W) × 276mm(D) × 405~435mm(H)
329mm(W) × 276mm(D) × 405~435mm(H)
Weight
W/Table
W/Unit Table
W/O Table
W/O Table and Chinrest
19kg
18kg
12kg
10kg
Table size
550mm × 370mm
Unit Table size
440mm × 350mm
Subject to change in design and/or specifications without advance notice.
Agency Compliance
The SL-1E is designed to comply with the following agency standards:
• IEC60601-1:2005 Ed3.0
• EN60601-1:2006/AC:2010
• IEC60601-1-2 Ed3.0:2007/EN60601-1-2:2007/AC:2010
• UL 60601-1: 2003
• ISO 10939: 1998
• ISO 15004-1: 2006
• ISO 15004-2: 2007
• EC Medical Device Directive 93/42/EEC
The following statement is the "Essential performance" provided for by IEC60601-1.
1) The halogen lamp isn't to be turned off.
2) There are no component failures.
21
SPECIFICATIONS
ENVIRONMENTAL CONDITIONS
ENVIRONMENTAL CONDITIONS FOR USE
Temperature
Humidity
Air pressure
: 10°C - 40°C
: 30% - 90% (without dew condensation)
: 700hPa - 1060hPa
STORAGE CONDITIONS
Environmental conditions (without package)
 Temperature : 10°C - 40°C
Humidity
: 10% - 95% (without dew condensation)
Air pressure
: 700hPa - 1060hPa
 THIS INSTRUMENT DOES NOT MEET THE TEMPERATURE REQUIREMENTS OF ISO
15004-1 FOR STORAGE. DO NOT STORE THIS INSTRUMENT IN CONDITIONS WHERE
THE TEMPERATURE MAY RISE ABOVE 40°C OR FALL BELOW 10°C.
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE
Temperature
Humidity
: -20°C - 50°C
: 10% - 95%
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION
Temperature
Humidity
22
SPECIFICATIONS
: -40°C - 70°C
: 10% - 95%
ELECTROMAGNETIC COMPATIBILITY
This product conforms to the EMC Standard (IEC60601-1-2 Ed.3.0: 2007).
a) MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS.
b) Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
c) The use of ACCESSORIES, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the EQUIPMENT or SYSTEM.
d) The EQUIPMENT or SYSTEM should not be used adjacent to or stacked with other equipment. IF adjacent or stacked use is necessary, the EQUIPMENT or SYSTEM should be
observed to verify normal operation in the configuration in which it will be used.
Guidance and manufacturer's declaration - electromagnetic emissions
The SL-1E is intended for use in the electromagnetic environment specified below.
The customer or the user of the SL-1E should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC61000-3-3
Complies
The SL-1E uses RF energy only for its internal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
The SL-1E is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
23
SPECIFICATIONS
Guidance and manufacturer's declaration - electromagnetic immunity
The SL-1E is intended for use in the electromagnetic environment specified below.
The customer or the user of the SL-1E should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
Voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
Compliance
level
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
± 2 kV for power
supply lines
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 1 kV for
input/output
lines
± 1 kV
line(s) to line(s)
± 1 kV
line(s) to line(s)
± 2 kV
line(s) to earth
± 2 kV
line(s) to earth
<5% Ut
(>95% dip in Ut)
for 0.5 cycle
40% Ut
(60% dip in Ut)
for 5 cycles
70% Ut
(30% dip in Ut)
for 25 cycles
<5% Ut
(>95% dip in Ut)
for 5 sec
<5% Ut
(>95% dip in Ut)
for 0.5 cycle
40% Ut
(60% dip in Ut)
for 5 cycles
70% Ut
(30% dip in Ut)
for 25 cycles
<5% Ut
(>95% dip in Ut)
for 5 sec
3 A/m
3 A/m
Electromagnetic environment
- guidance
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
or the SL-1E requires continued
operation during power mains
interruptions, it is recommended
that the SL-1E be powered from
an uninterruptible power supply
or battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE Ut is the a.c. mains voltage prior to application of the test level.
24
SPECIFICATIONS
Guidance and manufacturer's declaration - electromagnetic immunity
The SL-1E is intended for use in the electromagnetic environment specified below.
The customer or the user of the SL-1E should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the SL-1E, including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80MHz
3V
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 2.5GHz
3 V/m
d = 1.2
P
d = 1.2
d = 2.3
P
P
80MHz to 800MHz
800MHz to 2.5GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than
the compliance level in each frequency
range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1
NOTE 2
a
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SL-1E is used exceeds
the applicable RF compliance level above, the SL-1E should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the SL-1E.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
25
SPECIFICATIONS
Recommended separation distance between
portable and mobile RF communications equipment and the SL-1E
The SL-1E is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SL-1E can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SL-1E as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output
power of transmitter
W
m
150kHz to 80MHz
d = 1.2 P
80MHz to 800MHz
d = 1.2 P
800MHz to 2.5GHz
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1
NOTE 2
At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
26
SPECIFICATIONS
OPTICAL RADIATION HAZARD
THE RELATIVE SPECTRAL OUTPUT
SL-1E:Illumination spectral distribution
1
0.9
Rerative intensity
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
300
400
500
600
700
800
Wavelength (nm)
900
1000
1100
PHOTOCHEMICAL LIGHT SOURCE RADIANCES OF THIS INSTRUMENT
LA (without crystalline lens) : 352 mW/ (cm2·sr)
LB (with crystalline lens)
: 338 mW/ (cm2·sr)
MEANING OF LB AND LA
Spectrally-weighted photochemical radiance LB and LA give a measure of the potential hazard that
exists for a beam of light to cause photochemical damage to the retina. LB gives the measure for
eyes in which the crystalline lens is in place. LA gives this measure for aphakes in which the lens
has not been replaced by a UV blocking intraocular lens or for the eyes of very young children.
The value stated for an SL-1E gives a measure of hazard potential when the instrument is operated at maximum intensity and maximum aperture. Values of LB or LA over 80 mW/(cm2·sr) are
considered high for beams which wholly fill a dilated pupil.
The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. For instance, at a radiance level of 80 mW/ (cm2·sr), 3 min irradiation of the dilated (8
mm diameter) pupil would cause the retinal exposure dose level to attain the recommended exposure limit. If the value of radiance were reduced to 40 mW/ (cm2·sr), twice that time (i.e. 6 min)
would be needed to reach the recommended limit. The recommended exposure is based on calculations arising from the American Conference of Governmental Industrial Hygienists (ACGIH)
Threshold Limit Values for Chemical Substances and Physical Agents (1995-1996 edition).
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.
While no acute optical radiation hazards have been identified for SL- 1E 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 a greater risk. The
risk may also be increased if the person being examined has had an exposure with the same
instrument or any other ophthalmic instrument using a visible light source during the previous 24
h. this will apply particularly if the eye has been exposed to retinal photography.
27
SPECIFICATIONS
SYSTEM CLASSIFICATION
 Degree of protection against electric shocks: Type B applied part
Type B applied part is the applied part complying with the specified requirements of the
Standard IEC 60601-1 to provide protection against electric shock, particularly regarding
allowable LEAKAGE CURRENT.
 Type of protection against electric shocks: Class I equipment
Class I equipment does not depend on basic insulation only for protection against electric
shocks. It can also be earthed; therefore, the metal parts with which one comes into contact
do not become conductive if the basic insulation fails.
 The mode of operation: continuous operation equipment
 Degree of protection against ingress of water: IP×0
SL-1E is the ordinary instrument (enclosed instrument without protection against ingress
of water)
 Methods of sterilization or disinfection recommended by the manufacture: SL-1E do not have
any part to be sterilized or disinfected.
 Not AP or APG equipment
PURPOSE OF USE
This instrument is used for the enlargement observation of eyeballs and the parts.
OPERATION PRINCIPLE
Illuminates the observed part by the illumination light emitted from the illumination optical system and allows enlargement observation by binocular stereoscopic microscope.
28
SPECIFICATIONS
SHAPE OF PLUG
Country
Voltage/frequency
Shape of plug
Mexico
110V/50Hz
Type C&E
Argentina
220V/60Hz
Type A
Peru
220V/60Hz
Type A
Venezuela
110V/50Hz
Type C&E
Bolivia & Paraguay
220V/60Hz
Type A (Most common)
Type H (Infrequently)
Chile
220V/60Hz
Type A
Colombia
110V/50Hz
Type C
Brazil
220V/60Hz
127V/60Hz
Type A
Type C
Ecuador
110V/50Hz
Type C&E
USA
120V/60Hz
Type A (Hospital Grade)
Canada
120V/60Hz
Type A (Hospital Grade)
SYMBOL
Symbol
IEC/ISO Publication
Description
Description (French)
IEC 60417-5032
Alternating Current
Courant alternatif
IEC 60417-5008
Off (power: disconnection Éteint (courant:
from the main power supply) avec le secteur)
IEC 60417-5007
On (power: connection to Allumé (courant: raccordethe main power supply)
ment sur le secteur)
IEC 60878-02-02
Type B applied part
Partie appliquée du Type B
ISO 7010-W001
General warning sign
Symbole
général
ISO 7010-M002
Refer to instruction manual/
Voir le manuel/la brochure
booklet
coupure
d'avertissement
29
SPECIFICATIONS
MAINTENANCE
DAILY CARE
* Remove dust from the instrument except the lenses and prisms, using a dry soft cloth at regular intervals.
* This instrument may be adversely affected by dust. Use the dust cover when not in use.
REPLACING THE FUSE
WARNING
To avoid electric shock, unplug the power cord from the grounded outlet before removing the fuse cover. Do not connect the power cord to
the grounded outlet with the fuse cover not correctly attached.
* First, turn the power switch OFF, and remove the power cable from the outlet.
* With a Phillips screwdriver, turn the center of the fuse holder at the back of the power unit.
The fuse will come out.
* Replace it with a new fuse and then tighten the center of the fuse holder.
* Always use the same type of fuse as indicated in the holder:
F1, F2: T1AL 250V (100,120V)
T500mAL 250V (220,240V)
F3:
F4AL 125V
REPLACING THE CHINREST PAPER
If the chinrest paper supply is depleted, remove the pins on the chinrest, place the new package of paper over the chinrest and replace the two locating pins.
Pin
30
MAINTENANCE
REPLACING THE ILLUMINATION LAMP
CAUTION
To avoid electric shock, do not touch the external connection terminal
and the patient at the same time.
When replacing the lamp, use care as the metal components inside the housing can become
extremely hot. The suggested procedure is as follows:
* After turning the power switch OFF, loosen the lamphouse cover clamping screw to remove
the lamphouse cover.
* Hold the connector as illustrated below, turn the clamping lever in the direction of the arrow,
and remove the socket and lamp assembly.
* Insert the new lamp into the socket.
* Place the assembly into the housing by aligning the guide with the groove in the lamp flange.
Connector
Socket
Illumination lamp
Clamping lever
Guide
Note:
If the lamp and/or socket is incorrectly attached, uneven or partially obscured illumination may
occur. (i.e., edge of the 14mm circle may be partially occluded)
* Re-assemble the illumination housing following in the reverse order of the above procedures.
* Turn the power switch ON and check to see that the new lamp is properly illuminated.
31
MAINTENANCE
CLEANING
(1) Cleaning the lens and mirror
If any dust settles on the lens or mirror, remove it as follows:
Use the cleaning brush, which is included in the standard accessories, to remove the dust. In
case any dust still remains, wipe it off using a soft cotton cloth moistened with a little alcohol.
Never use your finger or any hard object for cleaning.
(2) Cleaning the gliding plate, base rail and shaft
If the gliding plate or cross-slide rail and shaft are dirty, an unsmooth vertical or horizontal
movement of the cross-slide results. Clean them by using a dry cloth.
(3) Cleaning the plastic parts
To clean the plastic parts, such as chinrest and forehead rest, use only a cloth moistened with
a solution of neutral detergent and water to wipe off the accumulated dust. Avoid using other
types of cleansers.
Shaft
Rail
Gliding plate
(4) Cleaning applied parts
Wipe the forehead rest and chinrest with a cloth moistened with a tepid solution of neutral
detergent for kitchenware
32
MAINTENANCE
ORDERING SUPPLIES
To order the following replacement parts, be sure to specify the product name, part number
and quantity required.
Product name
Part number
Illumination lamp
40340 20700
Socket
44615 20100
Chinrest paper
40310 40820
Fuse
F1, F2: T1AL 250V (100, 120V)
T500mAL 250V (220, 240V)
F3:
F4AL 125V
44635 60030
44635 60040
44620 67710
Appearance
USER MAINTENANCE ITEMS
Item
Inspection
Cleaning
Adjustment
Replacement
Supply
Inspection time
Contentss
Before using
• Adjusting the diopter and pupillary distance
• Focus of slit image
• The base unit must move smoothly.
• The components must be fitted in place correctly.
• The chinrest unit must be fitted to the table unit correctly.
• The cables and plugs must be connected correctly.
• The objective lens, eyepiece and mirror must not be
stained or damaged.
When the part • Objective lens
is stained
• Eyepiece
• Mirror
• Sliding plate, rail and wheel shaft unit
• Forehead rest and chinrest unit
As required
• Slit width control knob torque
As required
• Illumination lamp
• Fixation target lamp
• Socket
• Fuse
As required
Chinrest tissue
33
MAINTENANCE
OPTIONAL ACCESSORIES
To avoid electric shock, do not touch the external connection terminal
and the patient at the same time.
CAUTION
FIXATION TARGET
Target for the fixation of patient's eyes.
* The fixation device can be installed on either side of the chinrest.
* Insert the fixation target into either of the two mounting holes and then remove the cap to
insert the fixation target plug into the chinrest jack.
Specifications
Annular Fixation Target
Red-LED
DC 2V
Fixation target
Hole
Plug
34
OPTIONAL ACCESSORIES
HRUBY LENS
Used for observation of the fundus and posterior segment of the vitreous body.
In routine applications, only the anterior segment of the vitreous body can be examined
because of the refraction effects of the cornea and crystalline lens. However, with the Hruby
Lens, examination of the fundus and the posterior segment of the vitreous body is possible.
Operation procedure
(1) The pupil should be well dilated by administering a mydriatic approximately 20 minutes
before the examination.
(2) Remove the hole cap to insert Hruby lens guide plate in the hole of carrier arm so that the
groove of guide plate fits with guide pin on the microscope arm.
(3) Insert the lower end of the Hruby Lens shaft in the groove on the guide plate.
(4) Center the illumination and microscope arms so that they face the patient's eye.
(5) Align lever, shown in the illustration below, with the center of the microscope's field of view.
Then move the lever backward and forward to position close to the patient's eye.
(6) Use the joystick to focus on the fundus.
The slit width and length will have to be adjusted to reduce the undesirable reflections
seen in the field of view.
(7) To view a different segment, either turn the microscope and illumination arms or have the
patient alter fixation by manipulating the fixation target.
Specifications
Hruby Lens: -58.7 diopters
Hruby lens
Lever
Guide plate
35
OPTIONAL ACCESSORIES
10×MEASURING EYEPIECE
Use this accessory eyepiece in place of the normal eyepiece for measurements of both the
size and angle. The measuring eyepiece is extremely helpful when fitting toric contact lenses:
Specifications
Scales
Linear Scale:
16mm; minimum 0.5mm, increments to be used at 10×magnification
Angle Scale:
360°; minimum 5°readings
Diopter compensation: -5D to +3D
16×EYEPIECE
Increases the total magnification of the slit lamp.
Specifications
Total magnification:
16×, 25.6×
Field of view:
11.25mm dia, 9mm dia
Diopter compensation: -5D to +3D
36
OPTIONAL ACCESSORIES
ACCESSORY DRAWER
For storing the focusing test rod and other accessories.
APPLANATION TONOMETER
Haag-Streit AG Model R900 can be used.
AUTOMATIC INSTRUMENT TABLE AIT-15
Specifications
• Dimensions ......................510(W)×450(D)mm
• Table height......................600~820mm
• Table size .........................490×500mm
• Weight ..............................approx. 23kg
• Power consumption..........270VA
• Source voltage .................120V AC, 50/60Hz (USA and Canada)
100-120V, 220-240V AC, 50/60Hz (except for USA and Canada)
37
OPTIONAL ACCESSORIES
When contacting us, please have the following information at hand re
your unit:
 Machine type: SL-1E
 Manufacturing No. (Displayed on the rating plate on the left of the
base.)
 Period of Usage (i. e. the purchase date).
 Description of Problem (as detailed as possible).
SLIT LAMP SL-1E
INSTRUCTION MANUAL
The 2011 version (2011.06-100TH 7 )
Date of issue: 3, June 2011
Published by TOPCON CORPORATION
75-1 Hasunuma-cho, Itabashi-ku, Tokyo, 174-8580 Japan.
©2011 TOPCON CORPORATION
ALL RIGHTS RESERVED
SLIT LAMP
SL-1E
44615 95997
Printed in Japan 1106-100TH 7
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