Lightmed LightLas 532/670 User manual

Operator Manual
Multi-Wavelength Pattern
Scanning System –LightLas
532 / 670

Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –Operators Manual Rev. No 01
Page 1 of 126
Operator Manual
for the
Multi-Wavelength Pattern
Scanning System - LightLas
532 / 670
Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : DC1800
Rev. No. : 01

Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –Operators Manual Rev. No 01
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Operator Manual for the Multi-Wavelength Pattern Scanning
System –LightLas 532 / 670
Clinicians and Doctors should ensure that they are adequately trained in the
procedures that the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670
Photocoagulator Laser will be used for prior to operating the equipment.
This Service Manual should be studied and understood before proceeding to operate
the equipment on patients.
!
CAUTIONS - Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure.
CAUTIONS - Any modification to the Ophthalmic Laser will result in the necessity for
it to be reclassified
CAUTIONS - U.S. law restricts this device to sale by or on the order of a physician
This Service Manual contains confidential and proprietary information of the
Manufacturer.
Manufactured by: LightMed Corporation, No.1-1, Ln. 1, Pao-An St. Sec. 3,Shulin
Dist., New Taipei City 23861, Taiwan
USA Address: 1030 Calle Cordillera, Suite 101, San Clemente, CA 92673
Tel No.: 949-218-9555 Fax No.: 949-218-9556
Copyright ©LightMed Corporation
REPEC
EU Representative: Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Document Title:
Operator Manual for the Multi-Wavelength Pattern Scanning
System - LightLas 532 / 670
Document Number:
DC1800
Document Revision History:
DRAFT
October 2012
Draft prepared

Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –Operators Manual Rev. No 01
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Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –Operators Manual Rev. No 01
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Table of Contents
Section 1 INTRODUCTION ……………………………………………………………..8
Section 2 SAFETY.………………………………………………………………………9
2.1 Product Classifications ….…………………………………………………………... 9
2.2 Warnings and Precautions …………………………………………………………. 10
2.3 Optical Hazards ……………………………………………………………………..12
2.3.1 Nominal Ocular Hazard Distance (NOHD)....................................................12
2.4 Electrical Hazards ……………………………………………………………………13
2.5 Safety Controls and Features ……………………………………………………….14
2.6 Product Labeling …………………………………………………………………….18
2.61 Console system............................................................................................... 18
2.62 Integrated Slit lamp LDU ..............................................................................20
2.63 Laser Indirect Ophthalmoscope LDU ........................................................... 22
Section 3 PRODUCT SPECIFICATIONS ……………………………...………………..23
3.1 Introduction ………………………………………………………………………… 23
3.1.1 Console Laser System ……………………………………………………...24
3.2.1 Laser Delivery Unit (LDU) ………………………………………………….25
3.3.1 Accessories …………………………………………………………………26
3.2 CSO SL980 Slit lamp Specifications …………………………………...…………...26
Section 4 PRINCIPLES OF OPERATION ….………………………………………..27
4.1 General Description ………………………………………………………………..27
4.2 Laser Console ……………………......……………………………………………..35
4.3 LCD Control Panel Display Screen……………………………………….................41
4.3.1 Console Control Screen…………………………………………………39
4.3.2 Pattern Control Screen ..............................................................................39
4.4. Remote Control Panel ............................................................................................. 53
4.5 Truscan Integrated into CSO model SL980………………………………57
A. Integrated CSO SL980 Controls Breakdown ……………………………59
4.6 Laser Indirect Ophthalmoscope (LIO).…………………………………...……60
Section 5 Installation………….…………………………………………………...63
5.1 Introduction ………………………………………………………………………...63
5.2 Unpacking and Receiving Inspection ……………………………………………...65
5.3 Tools and Equipment ………………………………………………………………66
5.4 Preparation …………………………………………………………...…………….67
5.4.1 System components …..…………..…………………………………… 67
A. System table top and motorized stand ………………………. ....……… 69
B. LDU system / LCD System / Footswitch / Accessories…..…… ... ………. 74
5.5 Final Verification / Checkout ……………………………………………………… 82
A. Slit lamp Integrity Rechecks ………………………………………………82

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B. Laser Indirect Ophthalmoscope (Optional) …………………………83
C. Endoprobe (Optional) ………………………………………………86
5.6 Integrated System Initialization and Validation …………….……………………..82
A. LCD / Console Validation ……………………………………………..87
B. Console Control Panel and Aiming Intensity Validation ……………87
C . P a t t e r n S c a n C o n t r o l V a l i d a t i o n ……………89
D . M i c r o J o y s t i c k M o v e m e n t V a l i d a t i o n ……89
E . R e m o t e C o n t r o l V a l i d a t i o n ( O p t i o n a l ) ……89
Section 6 CLINICAL USE…………………………………………………………93
6.1 Different types of LDUs Indication / Contraindication Use ……………………….94
6.1.1 Slit lamp Delivery Unit …………………………………………………...94
6.1.2 Laser Indirect Ophthalmoscope (LIO) …………………………………….94
6.1.3 Endoprobe devices ………………………………………………………...95
6.2 General Warnings …………………………………………………………………...97
6.3 Possible side-effect or adverse reactions …………………………………………..99
Section 7 MAINTENANCE…………………………………………………………100
7.1 Operator / User Maintenance ……………………………………………………...100
7.2 Laser Beam Alignment Check ……………………………………………………...101
7.3 System Output Power Checking Procedure ……………………………………...102
Section 8 TROUBLESHOOTING………………………………………………………104
8.1 Symptom .................………………………………………………………………..104
8.2 Warning …………………………………………………………………………….106
A. LCD Control Warning Only …………………………………………………..105
B. Remote Control Warning Only ……………………………………………...112
8.3 Error Codes …………………………………………………………………………113
Section 9 European Community Issues……………………………………..117
Section 10 EMC Test Tables…………………………………………………….119

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LIST OF DRAWINGS / FIGURES
Figure
Description
Page
2.1
Safety Controls
14
2.2(a)
Laser Console Labels
18
2.2(b)
Laser Console Labels
19
2.4(a)
Integrated Slit lamp LDU with Labels (RH side)
20
2.4(b)
Integrated Slit lamp LDU with Labels (LH side)
21
2.5
LIO LDU with Labels
22
4.1
System software start up screen shot
31
4.2
System software boot up ok and system is "Standby" mode
31
4.3
System software is ready to shutdown
34
4.4
Laser Console Connection / Controls
35
4.5
Screen shot display
38
4.6
Console Control Screen
39
4.7
Pattern Scan Control Screen Shot
43
4.8
Remote Control Panel Breakdown
52
4.9
Integrated Slit lamp LDU Controls
56
4.10(a)
SL980 Slit lamp Parts List and Controls
58
4.10(b)
SL980 Slit lamp Parts List and Controls
59
4.11(a)
Front View of LIO LDU Controls
60
4.11(b)
Top View of LIO LDU Controls
60
5.1
Integrated Slit lamp LDU Packing
65
5.2
Portable Carry Cases for Console and LDU’s
65
5.3
Inter-power Connection (Left hand side)
69
5.4
Slit lamp with Power Plugs Facing Each Other
69
5.5(a)
Rear View Box Connection
70
5.5(b)
Removal Fuse Socket
70
5.5(c)
Removal Fuse
71
5.5(d)
Voltage Setting Verification and Reinsert Back Process
71
5.6
Final Assembled Product and Verification Recheck
72
5.7
Slit lamp Packaging Ass'y
74
5.8
Assembled Upper and Lower Housings Screw
75
5.9
Completed Assembling Upper and Lower Housing Ass'y
75
5.10
Cabling Stuffed Underneath of Table Top's Cabling Gutter
76
5.11(a)
Slit lamp Arm Ready for Delivering Housing
76
5.11(b)
Fitting Delivering Housing to the Slit lamp and Securing it
77
5.12
Mounting Chinrest Ass'y and Fitting Delivery Fiber to Truscan Aperture
77

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Figure
Description
Page
5.13(a)
Hang console and plug in all the front panel connections
78
5.13(b)
Console Rear End Connections
78
5.14
Arm rest installed
79
5.15(a)
Clamp down the LCD Panel Holder in the middle of the gutter
79
5.15(b)
Organize the two control panel cablings and ready to fit the LCD
80
5.15(c)
Complete securing four holding screws behind the LCD panel and
two cablings connected
80
5.16(a)
Software System boot up
81
5.16(b)
System Ready to operate
81
5.17(a)
Fiber and Delivery Key fitted to Console Front Panel
83
5.17(b)
Fiber tips cleaning
83
5.17(c)
LCD LIO Intensity Control Knob
84
5.17(d)
LIO Intensity Control Knob
84
5.18
Endoprobe plug installation
85
5.19(a)
Front End Connection
89
5.19(b)
Rear End Connection
89
5.20(a)
System boot up sequential display 1
90
5.20(b)
System boot up sequential display 2
90
5.20(c)
System boot up sequential display 3
90
5.21
Initial Aiming Intensity Verification
90
8.1(a)
Sample of Error code display
112
8.1(b)
Sample of Remote Control Error code display
115
Record Sheet
Installation Record Sheet
91-92
Power Meter Calibration Record Sheet
102
Appendix
Appendix I (Accessories / Parts Listing Detailed)
124- 125

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Section 1 INTRODUCTION
This manual is intended to provide the operator with an overview of the operation
and safety requirements for the Multi-Wavelength Pattern Scanning System -
LightLas 532 / 670 Ophthalmic Laser. This manual is not intended to provide
instructions on actual treatment procedures and it is expected that users will have
undertaken training prior to using the equipment.
The Manufacturer and Distribution organization assume no liability through the use
of this Laser system.
All care has been taken in the preparation and checking of this manual however there
is no guarantee provided that all information is correct. The information provided in
this manual is subject to change without notice.
Only approved or authorized accessories may be used in the Multi-Wavelength
Pattern Scanning System - LightLas 532 / 670. The Manufacturer and Distribution
organization shall not be held liable or responsible for damages or injury caused as a
result of using non-approved accessories. This includes all Optical Fiber systems,
Laser Delivery Units, Safety Filters, Safety Glasses and Table units.
All maintenance and service work must be carried out by authorized and trained
service agents and only those procedures outlined in the operator and service
manual are allowed. Any service work carried out by unauthorized persons will void
all warranties.
No circuit diagrams or component part lists are to be supplied for the Multi-
Wavelength Pattern Scanning System - LightLas 532 / 670. If you require technical
documentation that is not provided in this manual then please contact the
manufacturer or your local distributor in writing with your reasons for wanting them
and then a copy of the service manual may be provided.
Before using the Multi-Wavelength Pattern Scanning System - LightLas 532 / 670
Photocoagulator the operator should read this manual carefully and pay particular
attention to the sections of Safety, Operation and Maintenance.

Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 –Operators Manual Rev. No 01
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Section 2 SAFETY
This Laser system has been designed and tested to function in a safe and correct
when used as indicated in this manual.
Do not use this laser before reading and understanding completely this Operators
Manual.
It is important to remember that this laser emits high levels of visible laser radiation
which can cause permanent and irreparable eye and tissue damage. Always observe
precautions for laser safety including using warning signs, safety glasses and only
operating the laser in a treatment room that provides protection to casual observers.
2.1 Product Classifications
The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator
Laser is a Class IV laser product as specified in the standard IEC60825-1 (2007) and the
USA 21 CFR’s 1040.10, 1040.11.
The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator
Laser is classified as Class I Type B Electromedical equipment as specified in the
IEC60601-1 standard.
The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator
Laser is classified as a Class II device according to the FDA CFR21 regulations.
The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 Photocoagulator
Laser is classified as a Class II Type B Medical Device according to the MDD 93/42/EEC
(as amended by 2007/47/EC).
The Multi-Wavelength Pattern Scanning System - LightLas 532 / 670 has been designed to
comply with the following standards:
Laser standards
IEC 60825-1 (2007)
USA 21 CFR 1040.10, 1040.11 (1997)
IEC60601-2-22 (1995)
Electrical standards
IEC60601-1 (1988) + A1(1991) and A2(1995)
IEC60601-1-1 (2000)
IEC60601-1-2 (2007)
USA UL 2601
JIS T1001 (1992) and T1002 (1992)