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.

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 10 of 114
ALWAYS try to let the laser has its own or dedicated power outlet. Additional
items may be plugged in a Multiple Portable Socket Outlet, which may be
plugged into an additional outlet.
DO NOT use the Laser Console if the ambient temperature is outside the range
of 20 to 35°C. This temperature range is the rated operating temperature limits
where the Laser system can be guaranteed to operate without any interruptions
to normal use. Outside this range of temperature it is possible that the Laser will
generate an error condition where the word “hold” is displayed and the system
goes to Standby until the internal temperature returns to within normal limits
then the Laser can be used again but the error condition may reoccur unless the
rated temperature comes within limits.
2.3 Optical Hazards
Guidance for the safe use of Lasers and Laser systems is found in the standard IEC60825-
1, the USA 21CFR 1040.10 and 1040.11, and ANSI Z136.1 - 1986.
During normal operation of the TruScan 532 Single-Wavelength the operator is protected
from Laser hazards by built in optical absorption Safety Filters. All other personnel in the
area should wear protective eyewear to eliminate the risk of eye injury occurring.
The optical density (OD) of eye protection must be greater than or equal to 4 and the
wavelength of 532nm range is also specified on it. It is shown in the following format:
OD4+ @ 532nm
Otherwise, the safety glasses are NOT suitable for this purpose of eye protection. Safety
Glasses are required to have the CE mark applied if used in the EU.
The TruScan 532 Single-Wavelength uses a Class II Laser Diode Aiming beam. Its
Wavelength range from 635 to 650 nanometers (nm) and the maximum power output is
set at the factory to be less than 1mW delivered to the patients cornea. However it is
always recommended to use the lowest aiming beam intensity during treatments.
The TruScan 532 Single-Wavelength Photocoagulator Laser has been classified as a Class
4 and its classification specified accordingly to the above quoted standards. This
classification is also based on the Accessible Emission Limits (AEL) as calculated
according to the standards.
2.3.1 Nominal Ocular Hazard Distance (NOHD)
The Nominal Ocular Hazard Distance (NOHD) is the distance between the equipment and
a person’s eye for which the optical power, from the equipment, entering the dilated
pupil of the person will be less than or equal to the Maximum Permissible Exposure (MPE)
as specified in the standards (i.e. less than a Class 1 Laser Output).

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 11 of 114
The calculated NOHD for the TruScan 532 / Single-Wavelength with different Laser
Delivery Units is:
5 meters at maximum power settings for the Endoprobes
18 meters at maximum power settings and 1000m spot size for Slit lamp Delivery
Units
20 meters at maximum power settings for LIO
Therefore when the laser is in operation, all persons that are closer than these distances
to the equipment should be wearing eye protection.
Patients, where possible, should have the untreated eye covered or protected from laser
reflections.
2.3.2 Avoid Exposure to Laser beams
Reassembly or maintenance of the laser system should only be performed by authorized
and trained personnel. The external housing of the laser system should never be
removed otherwise you or standby observers could be exposed to dangerous levels of
laser radiation and potentially lethal electrical voltages.
Eye safety filters are designed to protect physician’s eyes from back scattered laser
beams must always be used. They are integrated into the Slit lamp and LIO Delivery
Units. When using the endoprobes a separate filter that attaches to the operating
microscope must be used.
For other personnel that may be exposed to reflections or backscatter they must wear
safety glasses or goggles. In any case NEVER look directly at the treatment laser beam as
severe eye injury is likely. This means avoid looking into the aperture of any of the laser
delivery units or the console.

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 12 of 114
2.4 Electrical Hazards
The TruScan 532 Single-Wavelength Photocoagulator laser has been designed to apply
the International Standards for Medical Equipment. The laser system is designed to
operate with three terminal prongs AC voltage where the third prong pin is the earth-
grounded prong.
Warning: It is not safe to operate the TruScan 532 Single-Wavelength photocoagulator
laser without an earth-grounded receptacle. There is possible risk of electric shock.
No cover or housing need to be removed by the operator or user. Only the authorized
and trained service or agent can remove the cover or housing assembly since there is
possible of exposing laser radiation and high current or voltages.

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 13 of 114
2.5 Safety Controls and Features
The system is equipped with numerous safety controls and features that are complied
with standard regulation and more detailed are outlined below figure.
Figure 2.1 Safety Controls and Features

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 14 of 114
All safety features or controls must be engaged, in order for the system to operate or
function properly except audit warning. A full detailed description of these safety
features is provided in following:
1. Emergency Stop Switch
This switch is functioned as a fast response shutdown of the Laser System in the
event of some serious problem occurring. It is a RED color push switch that locks
down when pushed and in this position, all power to the internal parts is removed.
The switch actuator (the red button) must be rotated outward in order for the
power to be restored.
2. Key Switch
The Key switch is the main power ON/OFF switch. The power can only be turned on
by inserting the key and rotating clockwise to the ON position. In the ON position,
the key cannot be removed. The key should be stored in a safe and controlled place.
3. Port 1 & 2 (Shutter Modules / Fiber connector detecting switch)
Inside the Laser System there are two shutter modules that completely blocks the
beam path at all times except when the system is in the READY mode and
footswitch is activated. There are electronic sensors that check the position of the
shutter at all times for the microprocessor. Whenever the system boots up, it will
check for the shutter position to validate if the shutter is engaged and functioned.
Another safety check is the fiber holder detecting sensor feedback loop where the
system will display a warm message, if this fiber not properly connected or faulty
micro switch occurred.
4. Delivery Key Connector
This connector is used to constantly monitor the correct type of delivery key is being
inserted or not to ensure the system integrity performance. The system will give a
warning message until the delivery key is re-inserted back.
5. Standby Button Indicator
When this button is activated, it will turn yellow light on the screen therefore the
system is in the Standby mode, and both the aiming laser and treatment laser
CANNOT be delivered to the patient.
6. Ready Button Indicator
When this button is activated, it will turn to red light on the screen therefore the
system is in READY mode and both the aiming laser and treatment laser CAN be
delivered to the patient if footswitch is engaged. The System will go back into the
STANDBY mode, if it is unoperated for 10 mins or deactivated.
7. Remote Door Interlock Connector

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 15 of 114
This remote door interlock connector is functioned as an engaged key to the system.
By default this Interlock connector is plugged in with dummy tangle for the normal
operation. It is located on the back of the console where two wires can be wired out
to a switch on the treatment room door for sudden door opening interruption which
may cause the system to pause or “hold” so that this will protect or prevent the
unwanted deflection laser exposed to anyone. Once the door is closed the system
will go back to the STANDBY mode. On the other hand, if the operator decides to
continue the procedure, he/she may trigger activate the Ready mode for
continuation.
8. Footswitch Connector
The microprocessor constant monitors the signal from the footswitch in order to be
certain that the switch contact is good. It is not possible to go to the READY mode
or change any set up condition if the footswitch is already depressed.
9. Volume Control Bar
This control bar is the beeping warning control. It will give the operator a warning
sound in regarding if there is an error or warning occurred and cannot be turned off.
When the TruScan 532 Single-Wavelength is first turned on the microprocessor performs
various checks to ensure that the Laser is functioning correctly. If the self-check test
passes then the unit goes to the STANDBY mode.
In addition to these particular safety controls there are a number of features that have
been built-in to the TruScan 532 Single-Wavelength:
All the safety controls are in placed or engaged to prevent the operator
inadvertently firing the laser.
The laser system has protective housings covering to prevent exposure to laser
emissions. Special tools are required to remove the housings and only authorized
and trained agents are permitted to remove them.
There are optical safety filters built into the laser system to protect the operator’s
eyes from being exposed to the laser beam when using the equipment.
The laser system has been designed to comply the electrical safety standards for
earth connections and earth leakages.
If the laser system is not used or no controls are operated for 10 minutes the System
will go back to the STANDBY mode if it was set into the READY mode.
The Console gives an audible warning whenever the laser is firing.
Note: With all these controls and features, the TruScan 532 Single-Wavelength
is a very safe instrument when it is used correctly and as
indicated in this manual.

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 16 of 114
2.6 Product Labeling
All the labels on the TruScan 532 Single-Wavelength complies with the requirements of
the various regulatory standards refer to previously.
Console system
A full detailed of all the safety and control labels is shown in the figures 2.2 and 2.3.
Figure 2.2 Laser Console Safety and Control Labels

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 17 of 114
Console system continues...
Figure 2.3 Laser Console Safety Labels

TruScan 532 Single - Wavelength –Operators Manual Rev. No 02 Page 18 of 114
Integrated Slit lamp LDU
Figure 2.4(a)
Integrated Slit lamp LDU with labels (RH side)

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Integrated Slit lamp LDU continues...
Figure 2.4(b)
Integrated Slit lamp LDU with labels (LH side)