Topcon SL-D701 User Manual
USER MANUAL
SLIT LAMP
SL-D701
INTRODUCTION
CAUTION : Federal law restricts this device to sale by or on the order of a Physician or
Practitioner(CFR 801.109(b)(1)).
Thank you for purchasing the SLIT LAMP SL-D701.
INTENDED USE / INDICATIONS FOR USE
The Slit Lamp SL-D701 is an AC-powered slitlamp 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 affect the structural properties of the anterior eye
segment.
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 instruction manual was originally written in English.
©2014 TOPCON CORPORATION
ALL RIGHTS RESERVED
CONTENTS
INTRODUCTION ......................................................................................................................... 1
GENERAL SAFETY INFORMATION .................................................................................... 5
HOW TO USE THIS MANUAL ................................................................................................ 7
GENERAL MAINTENANCE INFORMATION ...................................................................... 7
DISCLAIMERS ............................................................................................................................ 7
DISPLAYS AND SYMBOLS FOR SAFE USE .................................................................... 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 ............................................................................................................. 14
SECURING THE INSTRUMENT TYPE TABLE TOP .................................................................... 14
SECURING THE UNIT TYPE TABLE TOP .................................................................................... 14
SECURING THE PATIENT GRIP PG-1(OPTIONAL ACCESSORY) ............................................. 15
SECURING THE CHINREST BASE PLATE .................................................................................. 15
SECURING THE BASE UNIT AND RAIL COVER ......................................................................... 15
SECURING THE BINOCULAR TUBES ......................................................................................... 16
SECURING THE ILLUMINATION UNIT ......................................................................................... 16
REMOVING THE ILLUMINATION UNIT PAD ................................................................................ 17
CONNECTING AND SECURING OF CABLES ............................................................................. 17
FITTING THE CHINREST TISSUE ................................................................................................ 18
FITTING THE CAP ......................................................................................................................... 18
SECURING THE TONOMETER MOUNT SO-TM1 (OPTIONAL ACCESSORY) .......................... 19
COUNTER BALANCING THE VERTICAL MOVEMENT ............................................................... 20
PREPARATIONS ............................................................................................................................... 22
POWERING ON ............................................................................................................................. 22
HOW TO RECOVER FROM THE POWER SAVING STATE ........................................................ 22
ADJUSTING THE DIOPTER AND PUPILLARY DISTANCE (PD) ................................................. 22
OPERATION PROCEDURE ........................................................................................................... 24
FIXING THE PATIENT'S FACE AND FIXATION ........................................................................... 24
OPERATING THE MICROSCOPE UNIT ....................................................................................... 25
OPERATING THE BASE AND FOCUSING ................................................................................... 26
OPERATING THE ILLUMINATION UNIT ...................................................................................... 27
ENDING PROCEDURE ................................................................................................................. 32
MAINTENANCE AND CHECKUPS .............................................................................................. 33
MAINTAINING THE PRECISION ................................................................................................... 33
PERIODIC MAINTENANCE ...........................................................................................................33
DAILY CARE .................................................................................................................................. 34
PLACING AN ORDER FOR CONSUMABLES .............................................................................. 34
USER MAINTENANCE ITEMS ...................................................................................................... 34
RESTOCKING CHINREST TISSUE .............................................................................................. 34
CLEANING ..................................................................................................................................... 35
CLEANING/DISINFECTING PATIENT-CONTACTING PARTS .................................................... 35
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CLEANING LENSES AND MIRRORS ........................................................................................... 35
CLEANING THE SLIDING PLATE, RAIL AND WHEEL SHAFT .................................................... 35
TROUBLESHOOTING ................................................................................................................... 36
TROUBLESHOOTING GUIDE ....................................................................................................... 36
SPECIFICATIONS AND PERFORMANCE .................................................................................... 37
GENERAL INFORMATION ON USAGE AND MAINTENANCE ........................................... 39
INTENDED PATIENT POPULATION ............................................................................................. 39
INTENDED USER PROFILE ..........................................................................................................39
ENVIRONMENTAL CONDITIONS FOR USE ................................................................................ 39
STORAGE, USAGE PERIOD ........................................................................................................ 39
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ........................................... 40
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTAION ............................. 40
ELECTRIC RATING ....................................................................................................................... 40
DIMENSIONS AND WEIGHT ......................................................................................................... 40
SYSTEM CLASSIFICATION ..........................................................................................................41
OPERATION PRINCIPLES ............................................................................................................ 41
CHECKPOINTS FOR MAINTENANCE .......................................................................................... 41
DISPOSAL ..................................................................................................................................... 42
PATIENT’S ENVIRONMENT ......................................................................................................... 43
REQUIREMENTS FOR THE EXTERNAL DEVICE ....................................................................... 43
ELECTROMAGNETIC COMPATIBILITY ....................................................................................... 44
OPTICAL RADIATION HAZARD .................................................................................................... 48
TYPE OF PLUG ............................................................................................................................. 49
OPTIONAL ACCESSORIES ........................................................................................................... 50
SYSTEM CONFIGURATION ......................................................................................................... 50
DIGITAL CAMERA UNIT DC-4 ...................................................................................................... 51
BEAM SPLITTER ........................................................................................................................... 51
TV RELAY LENS ............................................................................................................................ 51
TV RELAY LENS TL-54/55 ............................................................................................................ 52
TV ATTACHMENT TL-56 ............................................................................................................... 52
TV ATTACHMENT TL-57 ............................................................................................................... 52
BACKGROUND ILLUMINATION BG-5 .......................................................................................... 53
OBSERVATION TUBE ................................................................................................................... 53
YELLOW FILTER UNIT .................................................................................................................. 53
IRIS DIAPHRAGM SO-DF01 .........................................................................................................53
12.5X EYEPIECE ........................................................................................................................... 53
20X EYEPIECE .............................................................................................................................. 53
TONOMETER MOUNT SO-TM1 .................................................................................................... 54
HRUBY LENS ................................................................................................................................ 54
PARALLEL BINOCULAR TUBE PB-2 ............................................................................................ 54
AUXILIARY SPRING SO-AS 1,2,3 ................................................................................................. 54
PATIENT HANDLE PG-1 ............................................................................................................... 54
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GENERAL SAFETY INFORMATION
CONTRAINDICATIONS
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.
WARNINGS
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-D701 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-D701 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-D701 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
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.
CAUTIONS
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
24).
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.
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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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 the instruction 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.
DISPLAYS
Display Meaning
Situations in which the device should not be used because the
CONTRAINDICATIONS
WARNINGS
CAUTIONS
NOTES
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.
SYMBOLS
Symbol IEC/ISO Publication Description Description (French)
IEC 60417-5032 Alternating Current Courant alternatif
IEC 60417-5008
IEC 60417-5007
IEC 60878-02-02 Type B applied part Partie appliquée du Type B
ISO 7010-W001 General warning sign
ISO 7010-M002
Off (power: disconnection from
the main power supply)
On (power: connection to the
main power supply)
Refer to instruction manual/
booklet
Éteint (courant: coupure avec le
secteur)
Allumé (courant: raccordement
sur le secteur)
Symbole d'avertissement
général
Voir le manuel/la brochure
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POSITIONS OF WARNING AND CAUTION INDICATIONS
2
1
3
4
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).
No. Label Meaning Signification
CAUTION
・To prevent electric shocks, switch off
the power supply and remove the
1
power cable 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
2
3
4
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.
Degree of protection against electric
shock
: TYPE B APPLIED PART
Afin d’éviter de blesser le patient à la tête,
inclinez lentement l’élément lumineux tout
en maintenant la base de l’appareil.
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
PRÉCAUTION
PRÉCAUTION
PRÉCAUTION
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SYSTEM DIAGRAM
Plug
Lamp house cover
Aperture/slit length
display window
Color conversion filter
selector lever
Filter selector lever
Aperture/slit-length
selector knob
Canthus marker
Mirror
Centering knob
Inclination lever
Slit adjustment knob
Photo switch
Control lever
Base locking knob
Brightness adjustment
knob
Base
Forehead rest *4
Chinrest *4
Objective lens
Magnification selector
handle
Barrier filter selector lever *2
Diopter adjusting ring
12.5× eyepiece
Magnification index mark
Chinrest adjuster
Microscope arm
Power switch
Illumination Unit
Table *3
Power Supply
Microscope Unit
Base Unit
Chinrest Unit
Exciter filter *1
Illumination arm locking
knob
Microscope arm
locking knob
Illumination arm
Base relay cable
COMPONENT NAMES
*1,2 A model without exciter filter for slit lamp/barrier filter for slit lamp is also available.
*3 A model without table unit is also available.
*4 Contacting part (class B)
COMPOSITION OF PARTS THAT COME IN CONTACT WITH THE PATIENT
Forehead rest: Polyamide resin
Chinrest : Polyamide resin
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SYSTEM DIAGRAM
STANDARD ACCESSORIES
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)
(This is not always included with
the standard specifications.)
Crosshead screwdriver (1) Screwdriver (1) Spanner (1)
Spare chinrest tissue pin (2) Square mirror (1) Hexagon wrench (2)
Cap (1) Cleaning brush (1) User manual (1)
For optional accessories, see “Optional Accessories” on page 50.
D701
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SYSTEM DIAGRAM
COMPONENTS
COMPONENTS
(1) Illumination unit (2) Binocular tubes (3) Base unit
(4) Instrument type table top
(w/power supply)
(6) Chinrest unit (7) Power cable (8) Auxiliary spring
(9) Chinrest fixing screw (10) Cable cover
(4)’ Unit type table top (5) Rail cover
(11) Cable cover fixing screw
* This component is unavailable
in some regions.
(12) Rail cover fixing screw (13) Cable clip (14) Tonometer maunt SO-TM1
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COMPONENTS
Article name Qty Article name Qty
(1) Illumination unit 1 (8) Auxiliary spring 2
(2) Binocular tubes 1 (9) Chinrest fixing screw 2
(3) Base unit 1 (10) Cable cover 1
(4) Instrument type table top
(w/power supply)*
or (4)’ Unit type table top* 1 (12) Rail cover fixing screw 4
(5) Rail cover 2 (13) Cable clip 3
(6) Chinrest unit* 1 (14) Tonometer maunt SO-TM1* 1
(7) Power cable 1
* (4) or (4)’ table top is not included, depending on the specifications.
* (6) Depending on chinrest and (14) Tonometer mount might not be included.
1 (11) Cable cover fixing screw 2
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COMPONENTS
ASSEMBLY PROCEDURE
Washer
SECURING THE INSTRUMENT TYPE TABLE TOP
CAUTION
FITTING TO AUTOMATIC INSTRUMENT TABLE AIT-15/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. To reverse the direction of the instrument table, remove the power supply from the
bottom of the table top and secure it on the opposite side.
NOTE
Connect the power cable to the table outlet and power supply of the instrument table.
Place the excess cable inside the cover, and attach the cover.
SECURING THE UNIT TYPE TABLE TOP
1 Remove the plastic washer from the unit type table top, which is taped to the shaft assembly.
2 Insert the plastic washer, together with the shaft, into the cavity for the ophthalmic unit arm.
In the unit type table top, the power supply is fitted to attach the ophthalmic unit on the
NOTE
right hand side. When attaching the ophthalmic unit on the left-hand side, remove the
power supply and reattach it to the right hand side (with 4 screws).
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ASSEMBLY PROCEDURE
SECURING THE PATIENT GRIP PG-1(OPTIONAL ACCESSORY)
Patient grip
Chinrest base
Chinrest base plate
Rail cover
1 Align the patient grip with a groove on the rear of the chinrest base.
2 Fix the patient grip with screws.
SECURING the Chinrest Base Plate
1 Secure the chinrest base plate to the unit type table top with 2 screws (9).
SECURING THE BASE UNIT AND RAIL COVER
1 Align the wheel of the base unit with the rail of the chinrest base plate.
2 Insert the connection cable into the LAN output terminal of the instrument.
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ASSEMBLY PROCEDURE
SECURING THE BINOCULAR TUBES
Screw
Microscope unit
30° - 60°
Indices
Indices
1 Align the pin of the microscope unit with the groove on the binocular tubes, and fit the screw with
a hexagon wrench.
In the model without excitor/barrier filter, fit binocular tube with the fixing screw.
NOTES
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.
2 Loosen the fixing screw on the outside of the fitting cavity of the illumination unit with a screw-
driver. Align indices and slowly lower the illumination unit onto the shaft of the base unit.
NOTES
While assembling the illumination unit, take care not to get your fingers caught.
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ASSEMBLY PROCEDURE
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