Nidek Medical MC-500 User manual

Multicolor Laser Photocoagulator
Multicolor Laser Photocoagulator
MC-500
MC-500
OPERATOR’S MANUAL
OPERATOR’S MANUAL

NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
(Manufacturer) Telephone: [phone]
Facsimile: [phone]
NIDEK CO., LTD. : 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo,
(Tokyo Office) Bunkyo-Ku, Tokyo 113-0033, Japan
Telephone: [phone]
Facsimile: [phone]
NIDEK INCORPORATED : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A.
(United States Agent) Telephone: [phone]
Facsimile: [phone]
NIDEK S.A. : Europarc 13, rue Auguste Perret, 94042 Créteil, France
(EU Authorized Representative) Telephone: [phone]
Facsimile: [phone]
August 2011
17353-P902E
Printed in Japan
Original instructions

I
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Use this device properly and safely.
BE SURE TO READ THIS MANUAL BEFORE USING THE DEVICE.
THIS MANUAL CONTAINS ONLY INFORMATION TO UNDERSTAND THE MAIN BODY
OF THE PHOTOCOAGULATION SYSTEM. FOR THE OPERATION OF THE
PHOTOCOAGULATION SYSTEM, REFER TO THE OPERATOR’S MANUAL OF THE
APPLIED DELIVERY UNIT.
This Operator’s Manual contains information necessary for the operation of the NIDEK
Multicolor Laser Photocoagulator MC-500. This manual includes the operating
procedures, safety precautions, and specifications.
Especially, the cautions for safety and operating procedures must be thoroughly
understood before using the device. Keep this manual handy to verify use whenever
necessary.
Use of the photocoagulation system is limited to treatment of ocular diseases by
qualified physicians in accordance with the instructions in the operator’s manuals of the
main body and delivery unit. The physicians are responsible for the application of this
photocoagulation system and the treatment of various eye diseases.
Use of the photocoagulation system outside the scope of this manual may cause
unexpected troubles and adverse events.
There are no parts within the device that require servicing by the user other than fuses.
If you encounter any problems or have questions about the photocoagulation system,
please contact NIDEK or your authorized distributor.

II
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Table of Contents
III
1. BEFORE USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Device Outline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.3 Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.4 Classifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
1.5 Symbol Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.6 Precautions in Patient Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.7 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
1.8 Adverse Events and Adverse Device Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
2. SAFETY PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1 Storage, Transport, and Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
2.2 Handling Power Cord and cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2.3 Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.4 Patient environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
2.5 After Use, Maintenance, and Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
2.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
2.7 Safety Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
2.8 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
3. DEVICE CONFIGURATION . . . . . . . . . . . . . . . . . . . . . . . 21
3.1 Main Body - Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
3.2 Main Body - Rear View (with rear cover closed) . . . . . . . . . . . . . . . . . . . . . . . . .23
3.3 Main Body - Rear View (with rear cover open). . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.4 LCD Controller (Main Screen) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
3.4.1 For slit lamp or binocular indirect ophthalmoscope delivery unit . . . . . . . . . . . . . .27
3.4.2 For scan delivery unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
3.5 Control Box (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
3.6 Remote Control (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
3.7 CUSTOM Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
3.7.1 LCD Brightness screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
3.7.2 Sound Volume screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
3.7.3 Select Function screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
3.7.4 Other Setting screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
3.7.4.1 Select Summary Display screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

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3.7.4.2 Set Data Input/Output screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
{Printer setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
{LAN setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
3.7.4.3 Select Display Language screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
3.7.4.4 Select Voice Language screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
3.7.4.5 Adjust Clock screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
3.7.5 Memory List screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3.7.6 Modify Memory Data screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
3.8 Connecting Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.8.1 Network connection (LAN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3.8.2 Connecting barcode reader / magnetic card reader . . . . . . . . . . . . . . . . . . . . . . . . 57
3.9 Reading Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
3.10 Foot Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4. PHOTOCOAGULATION . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.1 Characteristics of Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.1.1 General characteristics of laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.1.2 Characteristics of wavelength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.2 Cautions in Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.2.1 Cautions in photocoagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4.2.2 Contraindications for photocoagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.3 Treatment Parameters in Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.4 Photocoagulation by Optional Delivery Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.4.1 Binocular indirect ophthalmoscope delivery unit . . . . . . . . . . . . . . . . . . . . . . . . . . 67
5. TRANSPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6. MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.1 List of Consumables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.2 Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.3 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.3.1 Cleaning the device exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.4 Calibrating Laser Power Output (Treatment and Aiming Beams) . . . . . . . . . 77
6.4.1 Measuring and calibrating laser power output (treatment beam) . . . . . . . . . . . . . . 77
6.4.2 Measuring and calibrating laser power output (aiming beam) . . . . . . . . . . . . . . . . 81
7. ADMINISTRATION AND CHECKS . . . . . . . . . . . . . . . . . 85
7.1 Administration and Controlled Area Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

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7.2 Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
7.3 Function Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
7.4 Check List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
7.5 Laser Beam Output Calibration List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
8. TROUBLESHOOTING GUIDE . . . . . . . . . . . . . . . . . . . . . 93
8.1 Interlock and Error Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
8.1.1 Interlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
8.1.2 Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
8.1.3 Error related to LAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
8.2 Indications of Misoperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
9. SPECIFICATIONS AND ACCESSORIES . . . . . . . . . . . . 99
9.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
9.2 Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
9.3 Delivery Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
9.4 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
10.EMC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
11.GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

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1
1
1. BEFORE USE
1.1 Device Outline
The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology
with the light source of wavelengths 647, 577, and 532 nm.
As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for
treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retin-
opathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treat-
ment of glaucoma.
Three wavelengths can be selected for the treatment beam: red (647 nm), yellow (577 nm), and green
(532 nm - same as the green laser photocoagulator). The most appropriate wavelength of the treat-
ment beam can be selected according to the diseases and other conditions. For example, red laser
beam (647 nm) has high transmittance and is suitable for photocoagulation of a part under bleeding
tissue. Yellow (577 nm) and green (532 nm) laser beams are highly absorbed by hemoglobin and
suited for photocoagulation of capillary aneurysm.
The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which
enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device,
various types of laser delivery units can be used as described in “9.3. Delivery Units” (page 101).
Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit
lamps and binocular indirect ophthalmoscope.
1.2 Intended Use
The NIDEK Multicolor Laser Photocoagulator MC-500 is intended to be used in ophthalmic surgical
procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

2
BEFORE USEPrinciples
1.3 Principles
The laser photocoagulation is thermal coagulation of tissue (protein) with heat generation by absorp-
tion of the laser energy that reaches through ocular media into the pigment of retina or choroid. Nor-
mally, protein coagulates and becomes white when its temperature rises to approximately 70ºC or
more. The degree of coagulation can be judged by observing the white spot with the ophthalmoscope
(such as slit lamp and binocular indirect ophthalmoscope). The generation of white spot varies slightly
within the same treatment beam emission range. The higher the laser power is and the longer the
laser emission time is, the greater the generated heat becomes. As the heat becomes greater, coagu-
lation effect spreads to surrounding tissues. Also take it into consideration that transmission of the
laser energy by the ocular media and the depth of area of heat generation differ according to the
wavelength.
The MC-500 splits the pumped laser beam into the aiming and treatment beams to control them sepa-
rately. Then the aiming and treatment beams are combined and lead to the fiber optic cable. The out-
put end of the fiber optic cable is connected to the delivery unit. The laser beam is formed into a spot
of a certain size in the optical system for the laser beam. Then the laser beam is emitted to the target
area. The delivery unit is equipped with a protective filter which protect the physician’s eyes from
exposure to the treatment laser beam reflected from the patient’s eye or contact lens.

3
BEFORE USEClassifications
1
1.4 Classifications
Classification under the provision of 93/42/EEC (MDD): Class IIb
The MC-500 is classified as a Class IIb device.
Laser classification: Class 4 laser product
The MC-500 is classified as a Class 4 laser product.
A Class 4 laser product is considered to be an acute hazard to the skin and eyes from direct
or scattered radiation.
Form of protection method against electric shock: Class I
The MC-500 is classified as a Class I device in which protection against electric shock and
does not rely on basic insulation only, but which includes additional safety grounding of
accessible conductive parts in the fixed wiring in such a way that accessible conductive
parts cannot become live in the event of a failure of the basic insulation.
For of protection against electrical shock (applied parts): Type B applied part
The MC-500 is provided with a Type B applied part.
A device with a Type-B applied part contains an internal electrical power source providing an
adequate degree of protection against electric shock in regards to allowable leakage cur-
rents and reliability of the protective ground connection (if present).
Conformity to electromagnetic compatibility standard
The MC-500 conforms to the EMC standard of IEC60601-1-2: 2001+A1: 2004.
Degree of protection against harmful ingress of water: IP20
The degree of protection by the enclosure of the MC-500 main body is classified as IP20,
and that of the foot switch is classified as IPX8.
An IP20 system is protected against an ingress of solid foreign objects, such as a finger hav-
ing a diameter of 12.5mm or greater, however, it is an ordinary system without protection
against an ingress of liquids. Be careful not to get water on the main body and control box.
An IPX8 system is a waterproof system provided with an enclosure preventing the effects
caused by immersion in water.
Degree of safety in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide
The MC-500 should not be used in the presence of a flammable anesthetic mixture with air,
or a flammable anesthetic mixture with oxygen or nitrous oxide caused by leakage or a dis-
charge.
Methods of disinfection recommended by manufacturer
The MC-500 does not include any parts that need sterilization or disinfection.
Mode of operation
The MC-500 is classified as a continuous operating device.
Classification by transference
The MC-500 is classified as a transportable device.

4
BEFORE USESymbol Information
1.5 Symbol Information
Indicates that the degree of protection against electric shock is of a Type B Applied Part.
Indicates that when the switch is pressed to this symbol side, power is not supplied to the
device.
Indicates that when the switch is pressed to this symbol side, power is supplied to the device.
Indicates the state of the key switch. When the switch is in this position, the system is not
operational.
Indicates the state of the key switch. When the switch is turned to this symbol position, it
automatically returns to the ON position and then the system becomes operational.
Indicates the fuse rating.
Indicates that the device must be supplied only with alternating current.
Indicates that important descriptions are contained in the operator’s manual and that the
operator must refer to the operator’s manual prior to operation or maintenance.
Indicates the switch to be pressed to stop laser beam emission in case of emergency.
The system is in normal condition while this indicator is on, and the system is in abnormal
condition when it is blinking.
Indicates that the treatment beam is in READY mode and laser emission is enabled.
Indicates that the treatment beam is in STANDBY mode and laser emission is disabled.
Indicates that the power output of the laser beam is shown in the display.
Indicates that the emission time of the laser beam is shown in the display.
Indicates that the spot size of the laser beam from the slit lamp is shown in the display.
Indicates that the interval time in the Repeat mode is shown in the display.
While this indicator that is on the left of the aiming level indicator is on, the aiming beam is
turned off.
Indicates the counter display.
Indicates the date of manufacture.
Indicates the manufacturer.
Alerts the operator to hazardous laser exposure.
Indicates the fiber optic cable connector.
Indicates that this product must be disposed of in a separate collection of electrical
and electronic equipment in EU.

5
BEFORE USEPrecautions in Patient Selection
1
1.6 Precautions in Patient Selection
Caution should be exercised when selecting patients with the following conditions to be treated with the
MC-500:
Patients with progressive eye disease
Patients who have difficulty in eye fixation due to nystagmus or condition that may induce nystagmus
Infant
Patients with aphakic eye or ocular disease
Patients with low intraocular transparency due to a disease that causes intraocular hemorrhage
Diabetic patients
Patients with myopic choroidal neovascularization
Patients with acute attack of primary angle closure (with corneal edema)
Patients with late glauocoma or extremely high intraocular pressure
1.7 Contraindications
Use of the MC-500 is contraindicated in patients with foveal choroidal neovascularization or myopic
choroidal neovascularization.

6
BEFORE USEAdverse Events and Adverse Device Effects
1.8 Adverse Events and Adverse Device Effects
Potential adverse events accompanying the use of the MC-500 may include, but are not limited to the
following:
[Adverse events]
• Increased intraocular pressure • Vitreous hemorrhage
• Narrowed visual field • Color vision deficiency
• Dark adaptation disturbance • Corectopia
• Hyphema • Corneal opacity
• Lenticular opacity • Retinal tear
• Hyphema • Corneal opacity
• Corneal damage • Retinal tear
• Epimacular membrane • Reduction in visual acuity
• Corneal burns • Scleral perforation
• Reduction in intraocular pressure • Dilated pupil
• Bullous keratitis • Postoperative iritis
• Choroidal detachment • Optic neuritis
• Localized cataract • Paracentral scotoma
• Posterior synechia • Myopia
• Closure of perforating wound • Retinal hemorrhage
• Choroidal hemorrhage • Phthisis bulbi
• Posterior vitreous membrane detachment • Reduction in contrast sensitivity
• Chorioretinal atrophy (or its spread) • Development of neovascularization
• Abscess dissemination in vitreous body • Peripheral anterior synechia (PAS)
• Effects of false photocoagulation on retina • Retinal detachment (Tractional retinal detachment)
• Macular edema (Cystoid macular edema) • Excessive photocoagulation
• Formation of subretinal connective tissue • Atrophic creep (Expansion of laser scar)
• Effects of false photocoagulation on fovea • Formation of retinochoroidal collateral veins
• Subretinal fibroplasia • Branch retinal artery occlusion
[Adverse device effects caused by failure of the photocoagulation system]
If any abnormality is found in the main body or delivery unit in the pre-operation function check, stop
using the main body and the delivery unit.
If use of the main body and delivery unit becomes impossible due to any abnormality in
them, interruption and reattempt of laser emission may be required.
With the failed main body or delivery unit, intended treatment result may not be obtained and
the health hazard or unexpected adverse events described in [Adverse events] below may
occur.

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2
2. SAFETY PRECAUTIONS
2.1 Storage, Transport, and Installation
In this manual, signal words are used to designate the degree or level of safety alerting. The defi-
nitions are as follows.
CAUTION
• Indicates a potentially hazardous situation which, if not avoided, may result in minor or
moderate injury or property damage accident.
WARNING • Indicates a potentially hazardous situation which, if not avoided, could result in death
or serious injury.
DANGER • Indicates a potentially hazardous situation which, if not avoided, may result in minor or
moderate injury or property damage accident.
Even situations indicated by “ CAUTION” may result in serious injury under certain conditions.
Safety precautions must be strictly followed at all times.
CAUTION
• The following are common conditions that need to be met during storage, transport,
and installation of the photocoagulation system:
- Not exposed to direct sunlight or ultraviolet rays.
- Not exposed to rain or water
- No chemicals or organic solvents are present.
- No poisonous gas, sulfur, salt or large amount of dust is contained in the air.
- Level and stable (10º or less) without vibration and shock.
- A place where the following environmental conditions for storage and transport (=
packed condition) and installation (=unpacked condition) are satisfied:
<Storage, transport>
.....Temperature: 0 to 50ºC (32 to 122ºF) / Humidity: 10 to 95%
(non-condensing)
<Installation>
............... Temperature: 15 to 30ºC (59 to 86ºF) / Humidity: 30 to 75%
(non-condensing)
• After transport or storage, or when the air-conditioning is turned off, the internal
structure of the photocoagulation system may be outside the specified
environmental conditions for use. In such a case, turn on the air-conditioning and
leave the system sit at least for an hour before turning on power to the system.
• Follow the instructions below to transport the photocoagulation system:
- Disconnect the delivery unit from the photocoagulation system main body and store
them in the shipping carton for each (keep the shipping carton) to transport the sys-
tem to other facilities.
- Avoid bumping the photocoagulation system when carrying or transporting it even if
it is stored in the shipping carton so that the alignment of optical components is not
affected.
- To avoid condensation, care should be taken so that the temperature varies as little
as possible during transport.

8
SAFETY PRECAUTIONSStorage, Transport, and Installation
CAUTION
• Follow the instructions below to install the photocoagulation system:
- Only properly trained people are allowed to install or adjust the photocoagulation
system.
- Install the photocoagulation system in a place level (10º or less) and stable without
vibration or shock.
- To avoid troubles from condensation, let the photocoagulation system sit until the
temperature of it becomes almost the same as that of the area for installation.
- Avoid installing the photocoagulation system where it is exposed to the direct flow
of air conditioning to prevent malfunction caused by temperature change and con-
densation.
- Do not install the photocoagulation system in a high-temperature, high-humidity, or
dusty place to avoid adverse effects on the lens and mirror.
- Install the photocoagulation system leaving 10 cm or more between the wall and
the ventilation hole on the side panel of the main body so that the system can radi-
ate heat properly.
• Follow the instructions below to move the position of the photocoagulation system:
- To avoid impact or shift of the optical axis caused by inertia force, fix movable parts
of the slit lamp in advance.
- Never pull the power cord or a connecting cable to transport the device.
- Never tilt the system more than 10º to avoid falling of them that may injure person-
nel and damage the system.
• Be sure to attach or remove the delivery unit to the main body with the key switch
turned OFF.
- If the delivery unit is attached or removed with the key switch turned ON, an error
may occur.
• This device has been tested and found to comply with the limits for medical
devices in IEC60601-1-2: 2001+A1: 2004. These limits are designed to provide
reasonable protection against harmful interference in a standard medical
installation. This device generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no
guarantee that interference will not occur in a particular installation. If this
device does cause harmful interference to other devices, which can be
determined by turning the device on and off, the operator is encouraged to try to
correct the interference by one of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation from other devices.
- Connect the device into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult the manufacturer or field service technician for help.
•The
International Electrotechnical Commission sets the essential requirements
for electrical and electronic equipment that may disturb, or be disturbed by, other
equipment. The MC-500 complies with these requirements as shown in the tables
in "10 EMC (Page 103)". Follow the guidance in the tables for use of the device
in an electromagnetic environment.

9
SAFETY PRECAUTIONSHandling Power Cord and cables
2
2.2 Handling Power Cord and cables
CAUTION
• Follow the instructions below to handle the power cord and cables of the
photocoagulation system:
- To avoid failure or malfunction, connect the cord and cable to the specified connec-
tors securely.
- To avoid break of cable that may cause short-circuit or fire, always pull the plug, not
the cord, when unplugging the power cord or do not coil the cord tightly or put it
under heavy objects.
- To avoid melting of the sheath, do not run the cord or cable near devices that pro-
duce heat.
- If the inside wires of the cord or cable are exposed, replace it with a new one imme-
diately to avoid short-circuit, electric shock, or fire.
- If any cord or cable are hot or touching them turns the power on or off, replace them
with new ones immediately to avoid fire or malfunction.
- To avoid injury or malfunction caused by break of wire or fall, never drag the system
by holding the cord or cable when transporting the system.
- To avoid malfunction or failure of the system, connect the cable plug to the specified
delivery unit connector on the front panel of the MC main body.
• Follow the instructions below to handle the power cord and cables of the
photocoagulation system:
- Use a grounded power outlet which meets the power requirements labeled on the
main body to prevent damage to the system and electric shock.
- To avoid electric shock, insert or disconnect the plug of the power cord with dry
hands.
- Do not overload the electrical output. Abnormal heat generation may occur and
result in fire.
• Follow the instructions below to handle the fiber optic cable:
- Loosely coil the fiber optic cable with a radius of 10 cm or more to prevent break or
deterioration.
- To avoid deterioration in laser delivery performance, be careful not to bump the fiber
optic cable (from dropping or hitting).
- To avoid deterioration in laser delivery performance, be careful not to soil or dam-
age the tip of the plug of the fiber optic cable plug, especially when inserting the
plug into the FIBER connector.
- To avoid laser emission from the delivery unit which is not being selected, connect
the plugs of the fiber optic and connecting cables from the delivery unit to the spec-
ified channels.

10
SAFETY PRECAUTIONSUse
2.3 Use
WARNING • Use of controls or adjustments, or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
• Follow the instructions below to handle the photocoagulation system:
- Before using the main body and the delivery unit of the system, read their opera-
tor’s manuals and thoroughly understand the safety precautions and operating
procedures.
[Use of the system with procedures specified herein may result in unexpected
system malfunction or adverse events.]
- Only service technicians properly trained by NIDEK is allowed to install and com-
posite the photocoagulation system. Only physicians are allowed to perform emis-
sion of treatment beam for surgery.
- Never modify or touch the internal structure of the photocoagulation system to
avoid electric shock or malfunction.
- Never soil or scratch the lens and mirror to maintain the performance of treatment
beam emission.
- Use the system with at least an assistant in the same room.
This is to prepare for the case such as electric shock. It is desirable that the
assistant is trained in resuscitation.
- Be sure to use accessories specified by NIDEK.
- Be sure to use delivery units specified for the MC-500.
- Be sure that the photocoagulation system is used under proper climate control
with appropriate temperature and humidity.
- If the temperature or humidity has changed substantially due to transport of the
photocoagulation system, leave the system sit for 30 minutes or more before using
it.
[Use of the system with procedures specified herein may result in unexpected
system malfunction or adverse events.]
- Prepare backup measures for the surgeries to be performed in case of failure of
the photocoagulation system.
- Be sure to properly explain to the patients about expected results and potential
adverse events preoperatively.
- Take care when using the system with other devices that are used in contact with
patients:
Interference of electromagnetic waves or other radiation may induce hazardous
conditions.
Contact coagulation by an electrosurgical knife may cause electric shock or
burning.
- The MC-500 main body is intended to be used in combination with the NIDEK SL-
1800, or Carl Zeiss Meditec 30SL/M or SL 130. Never use it singularly or in combi-
nation with other medical devices.
[Use of the system with procedures specified herein may result in unexpected
system malfunction or adverse events.]

11
SAFETY PRECAUTIONSUse
2
WARNING • Follow the instructions below before starting the photocoagulation system:
- Make sure that there is no flammable anesthetic gas in the operating room prior to
starting the photocoagulation system to prevent ignition or explosion caused by
treatment beam emission.
- All personnel in the operating room except the operator and patient must wear rec-
ommended (or equivalent to the recommended) safety goggles during operation of
the photocoagulation system to protect their eyes. In addition, instruct them never
to gaze directly at the laser beam even when wearing the safety goggles because
eyes may still become damaged.
<Recommended goggles>
For red - Yamamoto Kogaku Co., Ltd., YL300 He-Ne
For yellow and green - Yamamoto Kogaku Co., Ltd., YL-717 Nd-YAG SHG
- Prior to starting the photocoagulation system, perform operation checks and record
the results to prevent accidents. See "7 ADMINISTRATION AND CHECKS
(Page 85)".
- To prevent an interruption of laser emission which causes the necessity to perform
the surgery again due to any system abnormalities, stop using the
photocoagulation system if any abnormality is found in the checks before use and
function checks above.
• Follow the instructions below while the photocoagulation system is operational:
- Never gaze at the aiming beam that is emitted from the laser aperture directly or
direct it toward personnel to prevent accidental exposure to the laser beam. Always
pay attention to the direction of the aiming beam.
- Never leave the photocoagulation system unattended while it is operational to pre-
vent accident caused by unauthorized personnel. If the operator has to be away
from the system, turn the key switch to the off position, remove the key, and store it
in the customary place.
•During installation and operation of the photocoagulation system, observe the
following instructions about EMC (electromagnetic compatibility):
- Do not use the photocoagulation system simultaneously with other electronic
equipment to avoid electromagnetic interference with the operation of the
photocoagulation system.
- Do not use the photocoagulation system near, on, or under other electronic equip-
ment to avoid electromagnetic interference with the operation of the
photocoagulation system.
- Do not use the photocoagulation system in the same room as other electronic
equipment such as life-support equipment, equipment that has major effects on
the life of the patient and results of treatment, or any other measurement or treat-
ment equipment that involves small electric current.
- Do not use the photocoagulation system with portable and mobile radio frequency
communication systems because that may have an adverse effect on operation of
the photocoagulation system.
- Do not use cables or accessories that are not specified for the photocoagulation
system because that may increase the emission of electromagnetic waves from
the photocoagulation system and decrease the immunity of the system to electro-
magnetic disturbance.
• If any abnormal indication (other than treatment beam emission condition) is
displayed on the LCD controller or control box during operation of the
photocoagulation system, see "8 TROUBLESHOOTING GUIDE (Page 93)" and
perform the suggested actions.

12
SAFETY PRECAUTIONSUse
CAUTION
• Follow the instructions below to handle the LCD controller.
- Never press the LCD controller with a hard object such as a ball-point pen. Keep
magnetic objects away from the LCD controller.
Malfunction may result.
- Do not operate the LCD screen with wet hands.
Water intrusion may result in malfunction of the photocoagulation system.
- There may be a few constantly-lit, missing or dead pixels in your LCD screen which
are a characteristic of the LCD screens. This does not represent a failure of the
LCD screen. continuously use the monitor.
• When connecting to peripheral equipment like a PC with LAN connector via a
medical facility network, insert or connect an isolation transformer between
medical electrical equipment and the networked device (such as HUB), and the
networked device and any other electrical equipment.
Depending on the types or numbers of other electrical equipment connected to the
network, electric shock or malfunction/failure of the electrical equipment may occur.
For installation of the network isolation transformer, consult NIDEK or your autho-
rized distributor.
• Follow the instructions below to emit the laser beam:
- When the treatment beam (wavelength: 532, 577, and 647 nm) of the MC-500 is
emitted to tissue, the following symptoms may occur. Pay attention to the direction
of the aiming beam to avoid emission of the treatment beam onto eyes or skin inad-
vertently.
Eye symptoms: damage to parts such as the cornea or blindness
Skin symptoms: pain, burning.
- Make sure that there is no reflective object in the optical path of the laser prior to
laser beam emission to prevent exposure to the reflected laser beam.
- Set the treatment beam to a low power output initially, and then increase it until the
desired effect can be obtained to avoid emission of excessively intense treatment
beam. Always return the light intensity to the minimum level after every examina-
tion.
- It has been reported that the risk of vitreous hemorrhage is higher in Scan mode
than when Scan mode is not used. Therefore, start the treatment using the single
spot with the lowest power output, gradually increase the power output, then exe-
cute photocoagulation in Scan mode with the power output with which the intended
effects can be achieved. After the treatment, be sure to return the power output to
the lowest level.
- If an idirect lens is used for laser emission to protect the cornea and the vitreous
body from becoming damaged, do not set the spot size of the treatment beam
larger than about 200 μm.
- Place the photocoagulation system in the state in which treatment beam emission
is impossible (for example, when only observation of the eye is performed)
(STANDBY mode) except when laser beam emission in intended in order to pre-
vent inadvertent treatment beam emission.