Lightmed TruScan 532 User manual

Operator's Manual
TruScan 532 Single-
Wavelength

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 1 of 114
Operator's Manual
for the
TruScan 532 Single-
Wavelength
Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : DC1801
Rev. No. : 02

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 2 of 114
Operator's Manual for the TruScan 532 Single-Wavelength
Clinicians or/and Doctors should ensure that they are adequately knowledge of the
operation or training prior to using the TruScan 532 Single-Wavelength Photocoagulator
Laser equipment.
This Operator's 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 sell by or on the order of a physician
This Operator's Manual contains confidential and proprietary information of the
Manufacturer.
Manufactured by: LightMed Corporation, No. 1-1,Lane 1, Sec. 3 Pao An St.,Shulin
District., New Taipei City 23861 , Taiwan
USA Address: 1130 Calle Cordillera, San Clemente, CA 92673
Tel No.: 949-218-9555 Fax No.: 949-218-9556
Copyright ©LightMed Corporation
EU Representative: Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Document Title:
Operator Manual for the TruScan 532 Single-Wavelength
Document Number:
DC1801
Document Revision History:
DRAFT
October 2012
Draft prepared
01
Sept. 2014
New issue
02
April 2015
Revised Figure 2.1 2.2 2.3 4.4 5.7 5.13 (b) 5.16(a) 5.18(b)
Remove 2.1 standards year

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 3 of 114
Table of Contents
Section 1 INTRODUCTION .................................................................................................. 7
Section 2 SAFETY................................................................................................................ 8
2.1 Product Classifications.......................................................................................8
2.2 Warnings and Precautions ................................................................................9
2.3 Optical Hazards................................................................................................ 10
2.3.1 Nominal Ocular Hazard Distance (NOHD) ........................................... 10
2.3.2 Avoid Exposure to Laser beams............................................................ 11
2.4 Electrical Hazards.............................................................................................12
2.5 Safety Controls and Features ..........................................................................13
2.6 Product Labeling............................................................................................. 16
Section 3 PRODUCT SPECIFICATIONS ..............................................................................21
3.1 TruScan 532 Single-Wavelength System Specification...................................21
3.2 CSO SL980 and SL990 Slit lamp Specifications ............................................. 24
Section 4 PRINCIPLES OF OPERATION ............................................................................. 26
4.1 General Description......................................................................................... 25
4.2 Laser Controls and Displays............................................................................34
A. Laser Console ............................................................................................34
B. LCD Control Panel Display Screen............................................................ 37
- Console Control Screen..................................................................38
- Pattern Scan Control Screen..........................................................42
4.3 Remote Control Panel......................................................................................51
4.4TruScan Integrated into CSO model SL980................................................... 55
4.5Laser Indirect Ophthalmoscope (LIO) ........................................................... 57
4.6 Integrated CSO SL980 Controls Breakdown.................................................59
Section 5 INSTALLATION ..................................................................................................61
5.1 Introduction and Requirements ....................................................................60
5.2 Unpacking and Receiving Inspection............................................................63
5.3 Tools and Equipment .....................................................................................64
5.4Preparation..................................................................................................... 65
5.4.1 System Components........................................................................... 65
A.Table Top and Motorized Stands........................................................66
B. LDU Systems/LCD/Footswitch/Accessories ........................................71
5.5Final Verification / Checkout.......................................................................... 79
A. Slit Lamp ............................................................................................. 79
B. LIO........................................................................................................81
C. Endoprobe .......................................................................................... 83

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 4 of 114
5.6Initialization Equipment ...............................................................................84
A.LCD/Console Validation ......................................................................84
B. Console Control Panel and Aiming Integrity Validation....................84
C. Pattern Scan Control Validation.........................................................88
D. Microjoystick Movement Validation..................................................88
E. Remote Control Verification ..............................................................88
Section 6 CLINICAL USE ................................................................................................... 93
6.1 Different types of LDUs Indication / Contraindication Use..........................95
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 ............................................................................................96
6.3 Possible side-effect or adverse reactions ......................................................98
Section 7 MAINTENANCE .................................................................................................99
7.1 Operator / User Maintenance..................................................................................99
7.2 Laser Beam Alignment Check ....................................................................... 100
7.3 System Output Power Checking Procedure ................................................ 101
Section 8 TROUBLESHOOTING .......................................................................................103
8.1 Symptom / Warning .......................................................................................103
8.2 Warning ..........................................................................................................105
8.3 Error Codes.....................................................................................................107
Section 9 Warranty Term ...............................................................................................110

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 5 of 114
LIST OF DRAWINGS / FIGURES
Figure
Description
Page
2.1
Safety Controls and Features
13
2.2
Laser Console Safety and Controls Labels
16
2.3
Laser Console Safety Labels
17
2.4(a)
Integrated Slit lamp LDU with Labels (RH side)
18
2.4(b)
Integrated Slit lamp LDU with Labels (LH side)
19
2.5
LIO LDU with Labels
20
4.1
System software start up screen shot
29
4.2
System software boot up ok and system is "Standby" mode
29
4.3
System software is ready to shutdown
32
4.4
Laser Console Connection / Controls
33
4.5
Screen shot display
36
4.6
Console Control Screen
37
4.7
Pattern Scan Control Screen Shot
41
4.8
Remote Control Panel Breakdown
50
4.9
Integrated Slit lamp LDU Controls
54
4.10(a)
Front View of LIO LDU Controls
56
4.10(b)
Top View of LIO LDU Controls
56
4.11
SL980 Slit lamp Parts List and Controls
58/59
5.1
Packing Carton for integrated LDU and slit lamp
62
5.2
Portable Carry Cases for Console
62
5.3
Inter-power connection(Right hand side)
66
5.4
Stands with power plugs facing each other
66
5.5(a)
Rear view box connection
67
5.5(b)
Removal fuse socket
67
5.5(c)
Removal fuses
68
5.5(d)
Voltage Setting Verification and Reinsert Back Process
68
5.6
Final assembled product and verification recheck
69
5.7
Slit lamp Packaging Ass’y
71
5.8
Housing Screw Location
72
5.9
Assembled Upper and Lower Housing and organized Cabling
72
5.10
Cabling Stuffed Underneath of Table Top Cabling Gutter
73
5.11(a)
Slit Lamp Arm Ready for Delivery Housing
73
5.11(b)
Delivery Housing Fitting Process
74
5.12
Delivery Fiber Holder Process
74

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 6 of 114
5.13(a)
Hang Console and Plug In All the Front Panel Connections
75
5.13(b)
Plug In All the Rear Panel Connections
75
5.14
Clamp Down the LCD Panel Holder in the Middle of the Gutter
76
5.15(a)
Software System Boot Up
76
5.15(b)
System Ready to Operate
77
5.16(a)
Fiber and Delivery Key Fitted to Console Front Panel
80
5.16(b)
Fiber Tips Cleaning
80
5.16(c)
LCD LIO Intensity Control
81
5.16(d)
LIO Control Knob
81
5.17
Endoprobe Coupling Plug Assembling Process
82
5.18(a)
Front End Connection
88
5.18(b)
Rear End Connection
88
5.19(a)
System Boot Up Sequential Display 1
89
5.19(b)
System Boot Up Sequential Display 2
89
5.19(c)
System Boot Up Sequential Display 3
89
5.20
Initial Aiming Intensity Verification
89
8.1
Sample of Error Code Display
106
Record Sheet
Installation Record Sheet
90/91
System Throughput Power Record Sheet
101
Appendix
Appendix I (Optional Accessories)
110

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 7 of 114
Section 1 INTRODUCTION
This manual is intended to provide the operator with an overview of the operation and
safety requirements for the TruScan 532 Single-Wavelength 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 this particular laser system. 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 provided for this particular laser
system. 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 TruScan 532 Single-Wavelength Photocoagulator Laser system the
operator should read this manual carefully and pay particular attention to the sections of
Safety, Operation and Maintenance.

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 8 of 114
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 TruScan 532 Single-Wavelength Photocoagulator Laser is a Class IV laser product as
specified in the standard IEC60825-1 (2007) and USA 21 CFR’s 1040.10 and 1040.11.
The TruScan 532 Single-Wavelength Photocoagulator Laser is classified as Class I Type B
Electromedical equipment as specified in the IEC60601-1 standard.
The TruScan 532 Single-Wavelength Photocoagulator Laser is classified as a Class II
device according to the FDA CFR21 regulations.
The TruScan 532 Single-Wavelength 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 TruScan 532 Single-Wavelength has been designed to comply with the following
standards:
Laser standards
IEC 60825-1
USA 21 CFR 1040.10 and 1040.11
IEC60601-2-22
EN60601-2-22
Electrical standards
IEC 60601-1
EN 60601-1
EN/IEC 60601-1-2
USA UL 2601
JIS T1001 and T1002
Others

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 9 of 114
MDD 93/42/EEC (as amended by 2007/47/EC)
EN 62304
EN 62366
EN ISO14971
2.2 Warnings and Precautions
The following warnings and precautions apply to the TruScan 532 Single-Wavelength
Laser System and should be observed by all users at all time:
DO NOT look directly into or at the laser beam or at specular laser reflections
since direct and reflected laser light from the laser aperture can cause
permanent eye injury.
DO NOT operate the laser unless observers are using the correct protective
eyewear. The protective eyewear must have an optical density of OD4 or more
and for this particular wavelength system. This information must be present on
the eyewear.
DO NOT use objects that can readily reflect light in the vicinity of the laser beam
to avoid reflecting the beam in a hazardous manner.
DO NOT fire the Laser directly onto flammable agents or gasses as the focused
laser beam may cause ignition. There is no AP/ APG protection.
DO NOT try to service or repair the laser other than what is included in this
manual. Service should only be performed by an authorized and trained agent of
the manufacturer.
DO NOT fire the laser on a patient without first checking the operation of the
laser and verifying the optical alignment of the treatment Laser beam.
ALWAYS use the lowest power settings possible when treating a patient with
the laser and start the treatment with minimum level of power.
ALWAYS set the correct spot size and/or use the most appropriate one for the
power setting and type of procedure that is to be performed.
DO NOT put the laser into ‘TREAT’mode until ready to operate on the patient.
DO NOT inhale any laser plume generated by the Laser during surgery.
Personnel should take an extreme measured precaution, such as wearing
surgical masks or use plume evacuation systems when a treatment is
undergoing. Caution - Laser plume may contain viable tissue particulates.
ALWAYS take particular care of the optical fibers that connect the Laser Delivery
Units to the Console to make sure they do not get damaged. Additional clinical
warnings may be found in Section 6.1.4 of this Manual.