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SL-D301
User Manual
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Topcon SL-D301 User Manual

USER MANUAL SLIT LAMP
SL-D301
INTRODUCTION
Thank you for purchasing the SLIT LAMP SL-D301.
INTENDED USE / INDICATIONS FOR USE
FEATURES
This instrument has the following features:
• Various accessories to extend the system
• Ergonomic cable layout
• Clear fluorescent cornea observation and photography of cornea
• Clear eyeground observation and photography by color conversion filter
PURPOSE OF THIS MANUAL
To get the best usage from the instrument, please read DISPLAYS FOR SAFE USE and GENERAL SAFETY INFORMATION. Keep this manual with the instrument for future reference.
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1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission.
2. The contents of this manual are subject to change without prior notice and without legal obligation.
3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc.
4. Original Instructions This manual was originally written in English.
©2016 TOPCON CORPORATION
ALL RIGHTS RESERVED
CONTENTS
INTRODUCTION ......................................................................................................................... 1
DISPLAYS AND SYMBOLS FOR SAFE USE .................................................................... 5
GENERAL SAFETY INFORMATION .................................................................................... 6
HOW TO USE THIS MANUAL ................................................................................................ 8
GENERAL MAINTENANCE INFORMATION ...................................................................... 8
DISCLAIMERS ............................................................................................................................ 8
POSITIONS OF WARNING AND CAUTION INDICATIONS .......................................... 9
SYSTEM DIAGRAM .......................................................................................................................... 10
COMPONENT NAMES .................................................................................................................. 10
COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT ........................... 10
STANDARD ACCESSORIES ......................................................................................................... 11
COMPONENTS .................................................................................................................................. 12
COMPONENTS .............................................................................................................................. 12
ASSEMBLY PROCEDURE ............................................................................................................. 13
SECURING THE POWER UNIT .................................................................................................... 13
SECURING THE TABLETOP SO-TABLE06 (OPTIONAL ACCESSORY) ................................... 13
SECURING THE TABLETOP SO-TABLE07 (OPTIONAL ACCESSORY) .................................... 13
SECURING THE CHINREST ......................................................................................................... 14
SECURING THE BASE UNIT AND RAIL COVER ......................................................................... 15
SECURING THE BINOCULAR TUBES ......................................................................................... 15
SECURING THE ILLUMINATION UNIT ......................................................................................... 15
REMOVING THE ILLUMINATION UNIT PAD ................................................................................ 16
CONNECTING THE CABLES ........................................................................................................ 17
FITTING THE CHINREST TISSUE ................................................................................................ 17
FITTING THE CAP ......................................................................................................................... 17
FITTING THE DIFFUSION LENS SO-DFL01 (OPTIONAL ACCESSORY) ................................... 18
SECURING THE TONOMETER MOUNT SO-TM1 (OPTIONAL ACCESSORY) .......................... 19
PREPARATIONS ............................................................................................................................... 20
POWERING ON ............................................................................................................................. 20
ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) ................................................. 20
OPERATION PROCEDURE ........................................................................................................... 22
FIXING THE PATIENT'S FACE AND FIXATION ........................................................................... 22
OPERATING THE MICROSCOPE UNIT ....................................................................................... 23
OPERATING THE BASE AND FOCUSING ................................................................................... 24
OPERATING THE ILLUMINATION UNIT ...................................................................................... 25
ENDING PROCEDURE ................................................................................................................. 29
MAINTENANCE AND CHECKUPS .............................................................................................. 30
PERIODIC MAINTENANCE ...........................................................................................................30
DAILY CARE .................................................................................................................................. 30
PLACING AN ORDER FOR CONSUMABLES .............................................................................. 30
USER MAINTENANCE ITEMS ...................................................................................................... 30
DEALER MAINTENANCE ITEMS .................................................................................................. 30
REPLACING ILLUMINATION LAMPS ........................................................................................... 31
REPLACING SOCKETS ................................................................................................................ 32
RESTOCKING CHINREST TISSUE .............................................................................................. 32
DAILY CARE .................................................................................................................................. 33
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CLEANING APPLIED PARTS ........................................................................................................ 33
CLEANING LENSES AND MIRRORS ........................................................................................... 33
TROUBLESHOOTING ................................................................................................................... 34
TROUBLESHOOTING GUIDE ....................................................................................................... 34
SPECIFICATIONS AND PERFORMANCE .................................................................................... 35
GENERAL INFORMATION ON USAGE AND MAINTENANCE ........................................... 36
INTENDED PATIENT POPULATION ............................................................................................. 36
INTENDED USER PROFILE ..........................................................................................................36
ENVIRONMENTAL CONDITIONS FOR USE ................................................................................ 36
STORAGE, USAGE PERIOD ........................................................................................................ 36
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ........................................... 37
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTAION ............................. 37
ELECTRIC RATING ....................................................................................................................... 37
DIMENSIONS AND WEIGHT ......................................................................................................... 37
SYSTEM CLASSIFICATION ..........................................................................................................38
OPERATION PRINCIPLES ............................................................................................................ 38
CHECKPOINTS FOR MAINTENANCE .......................................................................................... 38
DISPOSAL ..................................................................................................................................... 39
PATIENT’S ENVIRONMENT ......................................................................................................... 40
REQUIREMENTS FOR THE EXTERNAL DEVICE ....................................................................... 40
ELECTROMAGNETIC COMPATIBILITY ....................................................................................... 41
OPTICAL RADIATION HAZARD .................................................................................................... 45
RELATIVE SPECTRAL DISTRIBUTION OF ILLUMINATION LIGHT ............................................ 45
TYPE OF PLUG ............................................................................................................................. 46
OPTIONAL ACCESSORIES ........................................................................................................... 47
SYSTEM CONFIGURATION ......................................................................................................... 47
DIGITAL CAMERA UNIT DC-4 ...................................................................................................... 48
BACKGROUND ILLUMINATION BG-2GN ..................................................................................... 48
YELLOW FILTER UNIT .................................................................................................................. 48
IRIS DIAPHRAGM SO-DF01 .........................................................................................................48
12.5X EYEPIECE ........................................................................................................................... 48
20X EYEPIECE .............................................................................................................................. 48
TONOMETER MOUNT SO-TM1 .................................................................................................... 49
HRUBY LENS ................................................................................................................................ 49
PARALLEL BINOCULAR TUBE PB-2 ............................................................................................ 49
ADAPT COVER SO-AC7 ............................................................................................................... 49
DIFFUSION LENS SO-DFL01 ....................................................................................................... 49
TABLETOP SO-TABLE06, 07 ........................................................................................................50
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DISPLAYS AND SYMBOLS FOR SAFE USE
To encourage safe and proper use and to prevent injury to the operator and others or potential damage to property, important messages are put on the instrument body and inserted in this manual. We suggest that everyone understand the meaning of the following displays, icons and text before read­ing the GENERAL SAFETY INFORMATION and observe all listed instructions.
DISPLAY
Display Meaning
Situations in which the device should not be used because the
CONTRAINDICATION
WARNING
CAUTION
NOTE
risk of use clearly outweighs any possible benefit.
Incorrect handling by ignoring this display may lead to a risk of death or serious injury.
Incorrect handling by ignoring this display may lead to personal injury or physical damage.
Useful functions to know. Paying attention to these will prevent the noted problems.
SYMBOL
Symbol IEC/ISO Publication Description Description (French)
IEC 60417-5032 Alternating Current Courant alternatif
IEC 60878-02-02 Type B applied part Partie appliquée du Type B
ISO 7010-W001 General warning sign
ISO 7010-M002
ISO 7000-2497 Date of manufacture Date de fabrication
ISO 7000-2498 Serial number Numéro de série
ISO 7000-3082
ISO 15223-1
Refer to instruction manual/ booklet
Manufacturer Fabricant
Authorised Representative in the European Community
Symbole d'avertissement général
Voir le manuel/la brochure
Représentant autorité pour l’Union européenne
IEC 60417-5264
IEC 60417-5265
“On” (only for a part of EQUIP­MENT)
“Off” (only for a part of EQUIP­MENT)
Mise en service d'une partie d'appareil
Mise hors service d'une partie d'appareil
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GENERAL SAFETY INFORMATION
CONTRAINDICATION
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.
WARNING
Ensuring the Safety of Patients and Operators
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.
To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument body. (The patient may be injured.)
The Topcon SL-D301 is a medical device. The software and hardware has been designed in accor­dance with U.S., European and other international medical device design and manufacturing stan­dards. Unauthorized modification of the Topcon SL-D301 software or hardware, or any addition or deletion of any application in any way can jeopardize the safety of operators and patients, the perfor­mance of the instrument, and the integrity of patient data.
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. 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 direct or indirect ophthalmoscopes, 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 to 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.
Equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide.
The Topcon SL-D301 has no special protection against harmful ingress of water or other liquids (clas­sified IPX0). To avoid damage to the instrument and cause a safety hazard, the cleaning solutions, including water, should not be directly applied to the device. Using a dampened cloth (without drip­ping), is a good method to clean the exterior surface of the enclosure.
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.
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Preventing Electric Shock and Fire.
To avoid fire in the event of an instrument malfunction, immediately turn off the power switch and remove the power plug from the outlet if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to disconnect the power plug from the outlet. Ask your dealer for repairs.
CAUTION
Ensuring the Safety of Patients and Operators
Be careful not to let the patient touch this instrument. The patient's hand may be pinched by a movable part.
To avoid burns caused by heat, do not replace the lamp with a new one immediately after it goes off.
To avoid injury to the patient's head, incline the illumination unit slowly while holding the base unit.
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.
Preventing Electric Shock and Burn
To avoid injury or fire caused by electric shock, turn off the power switch and unplug the power cord when not in use.
To avoid injury caused by electric shock, turn off the power switch when replacing the lamp.
Electromagnetic Compatibility (EMC)
This instrument has been tested (with 100/120/230V) and found to 2007as class B(classified according to CISPR11). 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.
comply with IEC60601-1-2 Ed.3.0:
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HOW TO USE THIS MANUAL
• Read the instructions on pages 1 to 9 before using the machine.
• If you would like an overview of the system, begin by reading OPERATION PROCEDURE (page 22).
GENERAL MAINTENANCE INFORMATION
USER MAINTENANCE
To maintain the safety and performance of the instrument, unless done by an authorized service engi­neer, never attempt to do maintenance of items other than those specified here in. For details about maintenance, read the description of this manual.
Replacing the Illumination Lamp
The illumination lamp 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 user manual.
•The device does not provide a diagnose of any condition or lack thereof or any recommendation for appropriate treatment. The relevant healthcare provider is fully responsible for all diagnose and treatment decisions and recommendations.
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POSITIONS OF WARNING AND CAUTION INDICATIONS
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To ensure safety, warning labels are provided on the instrument body. Use the instrument following these warning instructions. If any of the following labels are missing, con­tact your dealer or TOPCON (see the back cover).Fabricant
No. Label Meaning Signification
CAUTION
・To prevent electric shocks, switch off
the power supply and remove the
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power cord before replacing the lamp.
・Do not replace the lamp immediately
after switching it off: the high temper­atures could cause burns.
• Afin d’éviter les chocs électriques, coupez l’alimentation électrique et débranchez le câble d’alimentation avant de remplacer la lampe.
• Ne pas remplacer la lampe immédiatement après l’avoir éteinte: la température élevée peut provoquer des brûlures.
CAUTION
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To avoid injury to the patient’s head, incline the illumination unit slowly while holding the base unit.
Afin d’éviter de blesser le patient à la tête, inclinez lentement l’élément lumineux tout en maintenant la base de l’appareil.
CAUTION
When operating the base unit, please
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note the following:
・Beware of catching fingers in the
　moving parts.
・Avoid hitting the patient’s eyes or
nose.
Degree of protection against electric shock : TYPE B APPLIED PART
AC adapter Model :BPM050S18F03 Manufacturer :Bridge Power Corporation
Lorsque vous maniez la base de l’appareil, veuillez noter les points suivants:
• Faites attention à ne pas vous coincer les doigts dans les parties en mouvement.
• Évitez de heurter les yeux ou le nez du patient.
Degré de protection contre les chocs électriques : TYPE B PARTIE D'APPLICATION
Adaptateur secteur Modèle :BPM050S18F03
Fabricant :Bridge Power Corporation
PRÉCAUTION
PRÉCAUTION
PRÉCAUTION
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SYSTEM DIAGRAM

Plug Lamp house cover
Aperture/slit length display window
Filter selector lever Aperture/slit-length
selector knob
Canthus marker
Mirror
Centering knob Inclination lever Slit width controls
Photography button Control lever
Base locking knob Base
Forehead rest
Chinrest
Objective lens
Magnification selector handle
Fixing knob
Diopter adjusting ring
12.5× eyepiece
Magnification index mark
Chinrest adjuster
Microscope arm
Illumination arm locking knob
Power switch
Microscope arm locking knob
Illumination Unit
Tabletop
Power Supply
Microscope Unit
Base Unit
Chinrest Unit
Bightness adjustment knob
Fixation target
Tabletop*
Illumination arm

COMPONENT NAMES

COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT

* Tabetop is opptional accessory.
Forehead rest: Polyamide resin Chinrest : Polyamide resin
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SYSTEM DIAGRAM

STANDARD ACCESSORIES

D301
Make sure that all the following standard accessories are included. Figures in parentheses are the quantities.
Chinrest tissue (1) Dust cover (1) Test rod (1)
Crosshead screwdriver (1) Screwdriver (1) AC adapter (1)
(model:BPM050S18F03)
Chinrest tissue pin (2) Square mirror (1)
Luminous fixation target (1) Cap (1) Cleaning brush (1)
Illumination lamp (1) Socket (1) User manual (1),
Accessory case (1)
Instruction manual (1)
Power cord (1) *
* More than one power cord can be included on certain occasions.
For optional accessories, see “Optional Accessories” on page 47.
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SYSTEM DIAGRAM

COMPONENTS

COMPONENTS

(1) Illumination unit (2) Binocular tubes (3) Base unit
(4) Power Supply (5) Rail cover (6) Chinrest unit
(7) Rail cover fixing screw
Article name Qty Article name Qty
(1) Illumination unit 1 (5)Rail cover 2
(2) Binocular tubes 1 (6)Chinrest unit 1
(3) Base unit 1 (7) Rail cover fixing screw 4
(4) Power Supply 1
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COMPONENTS

ASSEMBLY PROCEDURE

* The illustration depicts the SO-TABLE06.

SECURING THE POWER UNIT

• The tabletop SO-TABLE06 and SO-TABLE07 is optional accessory.
1 Affix the power supply to the back of the tabletop with 4 screws.

SECURING THE TABLETOP SO-TABLE06 (OPTIONAL ACCESSORY)

CAUTION
FITTING TO AUTOMATIC INSTRUMENT TABLE AIT-16
To prevent falling during use and movement, secure each unit.
1 Place the tabletop on the instrument table, and secure it with the 4 bolts attached to the instru-
ment table.

SECURING THE TABLETOP SO-TABLE07 (OPTIONAL ACCESSORY)

1 Peel off the tape which secures the plastic washer to the mounting bracket’s shaft.
ASSEMBLY PROCEDURE
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2 Insert the plastic washer, together with the shaft, into the cavity for the ophthalmic unit arm.
Washer
Shaft

SECURING THE CHINREST

1 Take out the chinrest from the upper section of the container box.
2 Attach the chinrest to the bottom face of the table, and affix it to the table using 4 screws.
3 Chinrest fitted to the tabletop.
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ASSEMBLY PROCEDURE

SECURING THE BASE UNIT AND RAIL COVER

Rail cover
Fixing knob
Microscope unit
30° - 60°
Indices
1 Align the wheel of the base unit with the rail of the tabletop. 2 Secure the rail covers with 4 screws (7): (2 screws each on the right and left sides).

SECURING THE BINOCULAR TUBES

1 Align the pin of the microscope unit with the groove on the binocular tubes, and fit the binocular
tubes with the fixing knob.
NOTE
Make sure you do not touch the lens surfaces.

SECURING THE ILLUMINATION UNIT

Loosen the microscope arm locking-knob of the base unit, manually turn the shaft and tilt the guide rod­shaft index 30-60°, then refasten the microscope-arm locking-knob.
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ASSEMBLY PROCEDURE
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