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

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


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

:
IV
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

V
:
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

:
VI

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.