Lightmed TruScan Pro User manual

Operator'sManual
TruScan Pro

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 2of 109
Operator’s Manual
For The
TruScan Pro
2460
Directive 93/42/EEC
Doc. No.: DC1841
Rev. No.: 01

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 3of 109
Operator’s Manual for the TruScan Pro
Clinicians and/or Doctors should ensure that they are adequately knowledgeable of the
operation or training prior to using the TruScan Pro laser equipment.
This Operator's Manual should be studied and understood before proceeding to operate the
equipment on patients.
CAUTION!
The use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure!
Any modifications to the Laser will result in it needing a reclassification!
United States Federal Law restricts this device to be sold by or on the order of a physician!
This Operator's Manual contains confidential and proprietary information of the Manufacturer.
Copyright © LIGHTMED Corporation
Manufactured by: LIGHTMED Corporation, No.1-1, Lane 1, Sec. 3, Pao An St., Shulin
District, New Taipei City 23861, Taiwan
____________________________________________________________________________
USAAddress: 1130 Calle Cordillera, San Clemente, CA 92673
USA Telephone No.: [phone] Fax No.: [phone]
Email: [e-mail]
____________________________________________________________________________
EU Representative: Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover,
Germany
____________________________________________________________________________
Document Title: Operator’s Manual for the LIGHTMED TruScan Pro
(Integrated Delivery System)
Document Number: DC1841
Document Revision History:
A1 Nov 2019 New issue
A2 Jan 2020 Content format revision
01 Aug 2020 add Keeler Vantage

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 4of 109
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.....................................................................................................................10
2.3.1 Nominal Ocular Hazard Distance (NOHD)..................................................................11
2.3.2 Avoid Exposure to Laser Beams..................................................................................11
2.4 Electrical Hazards.................................................................................................................12
2.5 Safety Controls and Features............................................................................................12
2.6 Product Labeling ..................................................................................................................15
2.6.1 Console System................................................................................................................15
2.6.2 Slit Lamp Laser Delivery Unit (LDU)............................................................................18
2.6.3 Laser Indirect Ophthalmoscope (LIO) LDU...............................................................19
2.6.4 Symbols Identification....................................................................................................20
Section 3 Product Specifications................................................................................................21
3.1 Console Laser System Specifications............................................................................21
3.1.1 General Specifications....................................................................................................21
3.1.2 Treatment Laser Specifications....................................................................................21
3.1.3 Aiming Laser Specifications.........................................................................................22
3.2 LDU Specifications...............................................................................................................23
3.2.1 Slit Lamp Specifications.................................................................................................23
3.2.2 LIO Specifications............................................................................................................24
3.2.3 Endo-ocular Probes Specifications.............................................................................24
3.2.4 Safety Filter Specifications............................................................................................25
3.2.5 Head-up Display (HUD) Specifications.......................................................................25
Section 4 Principles of Operation...............................................................................................26
4.1 General Description.............................................................................................................26
4.2 Laser System Operation.....................................................................................................27
4.3 Liquid Crystal Display (LCD) Screen Controls.............................................................31
4.3.1 Menu Bar.............................................................................................................................32
4.3.2 Console Control Panel....................................................................................................39
4.3.3 Pattern Scanner Panel ....................................................................................................42
4.4 3D Mouse Controls...............................................................................................................71
4.5 TruScan Integrated into CSO Model SL950...................................................................73

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 5of 109
Section 5 Installation......................................................................................................................75
5.1 Introduction and Requirements........................................................................................75
5.1.1 Requirements Prior to Installation...............................................................................75
5.2 Unpacking and Receiving Inspection .............................................................................76
5.3 Tools and Equipment...........................................................................................................77
5.4 Installation Process .............................................................................................................77
5.5 HUD Installation Process....................................................................................................86
5.6 LDU Optical Alignment........................................................................................................87
5.6.1 LIO (Optional) Alignment................................................................................................87
5.6.2 Endoprobe (Optional) Alignment.................................................................................88
5.7 System Verification..............................................................................................................89
5.7.1 LCD / Console Verification.............................................................................................89
5.7.2 Pattern Scanner Controls Verification........................................................................89
5.7.3 Micro Joystick Movement Verification .......................................................................89
5.7.4 Output Power Verification..............................................................................................89
Output Power Record Sheet ...............................................................................................................91
Installation Report .................................................................................................................................92
Section 6 Clinical Use....................................................................................................................95
6.1 LDUs in Clinical Use............................................................................................................95
6.2 Clinical Use General Warnings.........................................................................................96
6.3 Possible Side Effects or Adverse Reactions.................................................................97
Section 7 Troubleshooting...........................................................................................................99
7.1 Error Symptoms....................................................................................................................99
7.2 Warning Messages...............................................................................................................99
7.3 Error Codes..........................................................................................................................101
7.4 3D Mouse Error Symptoms..............................................................................................102
Section 8 User Maintenance.......................................................................................................105
Section 9 Warranty Details and Conditions...........................................................................106
Appendix I Optional Accessories................................................................................................107
Appendix II Glossary........................................................................................................................108

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 6of 109
List of Drawings / Figures
Figure
Item
Page
1
Safety Controls and Features
12
2
Laser Console Safety Labels (Bottom Panel)
15
3
Laser Console Safety Labels (Back Panel)
16
4
Slit Lamp LDU With Labels
18
5
LIO LDU With Labels
19
6
System Software Start-Up Screen
29
7
System Software Display When In “STANDBY” Mode
30
8
Shut Down Screen Display
30
9
User Mode Login Display
31
10
User Mode Screen Display Divided into Three Panes
31
11
Function Option Menu
32
12
Console Control Screen
39
13
Pattern Scanner Panel Controls
42
14
Slit Lamp LDU Controls
73
15
Packing Carton for the Table Assembly
76
16
Portable Carrying Case for TruScan Console
76
17
Remove the foam packaging
77
18
Loosening Two Spring-Loaded Screws on the Left Console Holder Cover
78
19
Removing the Cover from the Table
78
20
Removing the Cable Cover underneath the Tabletop
78
21
Feeding Remote Cable from the Console Cavity to the Tabletop
79
22
Routing the Cable and Fiber from the Slit Lamp
79
23
Screwing the Metal Cable Cover Plate Back onto the Tabletop
80
24
Attaching the Chinrest to the Tabletop
80
25
Slit Lamp and Chinrest Cable Management
81
26
Connecting the Slip Lamp Ground and Fixation Lamp Cables
81
27
Cable Management Ties
81
28
Cable Management Spine
82
29
Mounting the LCD Screen onto the Tabletop
82
30
Mounting the LCD Screen onto the Arm
83
31
Connecting LCD Screen Cables
83
32
Mounting the Laser Console to the Console Hanger
83
33
Connecting the Cables to the Laser Console
84
34
Releasing Console Hanger from the Stopper
84
35
Pushing the Console Hanger Back into the Console Cavity
84
36
Inserting the Fiber Assembly into Port 1 of the Laser Console
85
37
Turning the System ON
85
38
Final Assembly of the TruScan Pro System
85
39
LIO Assembly
86
40
Fiber Tip Cleaning
86
41
LIO Control Knobs
87
42
Endoprobe Coupling Plug Assembly
87
43
Warning Message Example
98
44
Error Code Example
100

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 7of 109
Record Sheet
No.
Item
Page
1
Output Power Record Sheet
90
2
Installation Report
91
Appendix
No.
Item
Page
1
Optional Accessories
106
2
Glossary
107

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 8of 109
Section 1 Introduction
This manual is intended to provide the Operator with an overview of the operation and safety
requirements for the TruScan Pro 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.
Caution has been taken into consideration in the preparation and revision of this Manual.
However, there is no guarantee that all information written here will be accurate. The information
provided in this Manual is subject to change without notice.
Only approved or authorized accessories may be used with this laser system. The Manufacturer
and Distributor organization shall not be held liable or responsible for damages or injury caused
as a result of using unapproved accessories. This includes all optical fiber systems, laser delivery
units (LDU), safety filters, safety glasses, and table units.
All maintenance and service work must be carried out by authorized and trained Service
Technicians and only those procedures outlined in the Operator’s 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 laser system. If you require
any technical documentation that is not provided in this manual, please contact the Manufacturer
or your local distributor, in writing, with your reasons for requesting them and only then a copy of
the Service Manual may be provided.
Before using the TruScanPro Ophthalmic Laser system, the operator should read this manual
carefully and pay attention to the sections of safety, operation, and maintenance.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 9of 109
Section 2 Safety
This laser system has been designed and tested to function in a safe and correct operation when
used as indicated in this manual. Do not use this laser without reading and completely
understanding this Operator’s Manual. It is important to remember that this laser emits high levels
of visible and invisible laser radiation, which can cause permanent and irreparable eye and tissue
damages. 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 Pro Ophthalmic Laser is classified as:
•Class IV laser product as specified in the standards IEC60825-1 (2007) as well as USA
21 CFR 1040.10 and 1040.11.
•Class I type B electromedical equipment as specified in the IEC60601-1 standard.
•Class II device according to the FDA CFR21 regulations.
•Class II type B medical device according to the MDD 93/42/EEC (as amended by
2007/47/EC).
The TruScan Pro Ophthalmic Laser has been designed to comply with the following standards:
Standards
Description
Laser
•IEC 60825-1:2014
•EN 60825-1:2014
•EN 60601-2-22:2013
•IEC 60601-2-22:2007+A1:2012
Electrical
•IEC 60601-1 3.1 Edition
•EN 60601-1 3.1 Edition
•IEC 60601-1-2 4th Edition
•EN 60601-1-2 4th Edition
•ANSI/AAMI 60601-1
Others
•MDD 93/42/EEC (as amended by 2007/47/EC)
•IEC 60601-1-6 Edition 3.1
•EN 60601-1-6 Edition 3.1
•IEC62366 Edition 3.1
•EN62366 Edition 3.1
•ISO 15223 :2016
•EN ISO14971:2012

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 10 of 109
2.2 Warnings and Precautions
The following warnings and precautions apply to the TruScan Pro Ophthalmic Laser system and
should be observed by all users at all time:
•DO NOT look directly into or at the laser beam orat 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 that has
an optical density of OD4 or higherthat accommodates this laser system. The OD information
must be visible 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 authorized and trained technicians.
•DO NOT fire the laser on patients without checking the operation of the laser and verifying the
optical alignment of the laser treatment beam.
•ALWAYS use the lowest power settings possible when treating patients and start the
treatment with minimum power setting.
•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 ‘READY’mode until ready to operate on the patient.
•DO NOT inhale any laser plume generated bythe laser during surgery. Personnel should take
precautions, such as wearing surgical masks or use plume evacuation systems, when a
treatment is undergoing.
oCaution! Laser plume may contain viable tissue particulates.
•ALWAYS take extra care of the optical fibers that connect the LDUs to the console to make
sure they do not get damaged. Additional clinical warnings may be found in Section 6 Clinical
Use in this Manual.
•ALWAYS make sure the Laser has its own 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°C-35°C,
which is the rated operating temperature limits where the Laser system can be guaranteed to
operate withoutany interruptions. Outside this range of temperature, it is possible for the Laser
to generate an error condition where a message is displayed, and the system goes into
STANDBY mode until the internal temperature returns to normal limits. Only then the Laser
can be used again but the error condition may reoccur unless the rated temperature comes
within limits.
2.3 Optical Hazards
The guidance for the safe use of Lasers and Laser systems can be found in StandardsIEC60825-
1, USA 21CFR 1040.10 and 1040.11, as well as ANSI Z136.1-1986. During normal operations of
the TruScan Pro Laser, 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.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 11 of 109
The optical density (OD) of eye protection must be greater than or equal to 4 (≥ 4) and the range
that includes the wavelengths of 532 nanometers (nm), 561 nm, 577 nm, 670 nm, or 810 nm is
also specified on it. The safety glasses specifications are typically shown in this format:
OD4+ @ 577 / 670 nm, or 532 / 810 nm, or 561 nm
Otherwise, the safety glasses are NOT suitable for eye protection purposes that meet the
standard requirements of this laser. Safety glasses are required to have the CE mark if used in
the European Union.
The TruScan Pro laser uses a Class II Laser Diode Aiming beam. Its wavelengths range from 635
to 650 nm and the maximum power output (to be delivered to the patient’s cornea) is set at the
factory to be less than 1 milliwatts (mW) (< 1 mW). It is recommended to use the lowest aiming
beam intensity during treatment. This laser’s classification as Class IV is also based on the
Accessible Emission Limits (AEL), as mentioned in the standards above.
2.3.1 Nominal Ocular Hazard Distance (NOHD)
The Nominal Ocular Hazard Distance (NOHD) specifies that the distance between the equipment
and a patient’s eye, where the optical power from the equipment enters the dilated pupil of the
patient, should be less than or equal to the maximum permissible exposure (MPE) (≤ MPE), as
specified in the standards (i.e. less than a Class I laser output).
The calculated NOHD for the TruScan Pro Laser with different LDUs is as follows:
LDU
NOHD (m)
Power
Settings
Spot Size
(µm)
Endoprobe
5
Maximum
-
Slit lamp
18
1,000
Laser Indirect Ophthalmoscope (LIO)
20
-
Therefore, when the laser is being used, all persons who are closer to the laser than the distances
mentioned above should be wearing eye protection. Patients 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 ofthe laser system should never be removed. Otherwise,
the user and/or observers could be exposed to dangerous levels of laser radiation and potentially
lethal electrical voltages.
The eye safety filters are equipped on the LDUs as follows:
LDU
Eye Safety Filter
Endoprobe
A separate filter must be attached to the operating microscope.
Slit lamp
Eye safety filters are integrated into the device.
LIO

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 12 of 109
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 to occur. Avoid looking into the LDU or console aperture.
2.4 Electrical Hazards
The TruScan Pro laser is designed to apply the International Standards for Medical Equipment.
This laser system is designed to operate with three terminal prongs for AC voltage where the third
pin serves as the earth-grounding prong.
WARNING! It is not safe to operate the TruScan Pro laser without an earth-grounding receptacle
as there will be a possible risk of electrical shock!
No cover or housing will need to be removed by the operator or user. Only authorized and trained
Service Technicians will be allowed to remove the cover or housing assembly to minimize the
possibility of laser radiation exposure and high current or voltage.
2.5 Safety Controls and Features
The system is equipped with numerous safety controls and features that are compliant with the
standard regulations. More details are shown below:
Figure 1: Safety Controls and Features.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 13 of 109
No.
Item
Description
1
Emergency stop button
Provides a manual immediate shutdown of the entire
laser system in the event of an emergency or irregular
behavior of the laser system. It has a bright red button that
locks down when pressed, where all power is cut off from
the internal components. To restore power to the system,
rotate the red button in the direction stated on the button
label.
2
Power button
This momentary power button is the main ON/OFF
switch. When the switch is in the ON position, both the
laser console and monitor control systems power up
together, and vice versa when the switch in in the OFF
position. This safety feature prevents the operator from
leaving the system partially ON when not in use. The
power can only be turned ON by pressing the power
button once and a light ring will light up, indicating that the
system is powered up.
3
Laser aperture (Port 1 / 2)
The LDU fiber is connected here. The fiber connector
must be fully screwed into the port inlet to ensure proper
laser beam alignment. A sensor switch is integrated into
the port, which verifies the position of the fiber and
enables the delivery function of the console. Laser beam
will only be delivered through this aperture if the fiber is
securely and correctly attached.
4
Delivery key connector
Each LDU has its own unique delivery key that must be
fitted into this socket to allow the microprocessor to
recognize which LDU is being used. Always make sure
that the delivery key inserted corresponds to the LDU that
is being used.
5
AC outlet
Provides power to thecontrol module. The AC outlet is on
the same circuit as the emergency stop button, which
means when the emergency stop button is activated, the
power to the AC outlet will automatically be cut off.
6
Footswitch connector
Connects to the footswitch module, which acts as the
trigger for laser firing mechanism. The footswitch
connection can be established by using a wired or
wireless footswitch.
7
Remote interlock connector
This is a regulatory requirement for the system to have a
safety feature available. Two wires can be connected
from the interlock switch to the treatment door’s switch.
Once the door opens, the circuit will open as well, thus
disabling the system which then prompts an error
message. Once the door closes, the circuit is complete,
and the system will go into the default STANDBY mode.
In the regions that do not utilize this function, a dummy
interlock connector must be equipped for the system to
operate.
8
Monitor port
This is used to accept communication from remote control
modules.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 14 of 109
9
Joystick connector
This is used to supply feedback or monitor joystick
movement during operation.
10
Service port
Provides access to the micro controller unit (MCU) board
for system diagnostic and system upgrades.
11
Main power inlet
This socket is used to connect the laser console to the
main power. The input voltage is 100 –250 VAC. Two 8-
Ampere (8 A) fuses are used to protect against power
surge and overcurrent.
12
Scan delivery
This connector receives signals from the LDUs for spot
size position and provides power to galvomotors.
13
Touch screen monitor
The touch screen monitor port is a USB 3.0 type
connection that is reserved to be used with the system’s
control module which receives signals from the user
interface.
14
Display port
Sends signals to the monitor to display the system’s user
interface.
15
USB 3.0 port
This is a standard USB 3.0 type connection available to
use with accessories such as 3D mouse and other
upgrades.
When the TruScan Pro laser is first turned on, the microprocessor performs various checks to
ensure that the laser is functioning properly. If the self-check test passes, then the unit goes into
STANDBY mode. In addition to these safety features, there are also several features that have
been built-in to the TruScan Pro laser system:
•All the safety controls are in place to prevent the operator from unintentionally firing the laser.
•This laser system is equipped with protective housing covers to prevent exposure to laser
emissions. Special tools are required to remove the housing covers and only authorized and
trained Service Technicians 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.
•This laser system is designed to comply with the electrical safety standards for ground
connections and ground leakages.
•If the laser system is not used or no controls are operated for 10 minutes, the system will go
into STANDBY mode.
•The console produces an audible warning whenever the laser fires.
NOTE: With these controls and safety features, the TruScan Pro laser system is a very safe
instrument when used correctly and as indicated in this manual.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 15 of 109
2.6 Product Labeling
All the labels on the TruScan Pro laser system comply with the requirements of various regulatory
standards that were previously mentioned.
2.6.1 Console System
All the safety and control labels on the console system are shown below:
Without 561um version
With 561um version
Figure 2: Laser console safety labels (bottom panel).
Without 561um version
With 561um version
Figure 3: Laser console safety labels (back panel).

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 16 of 109
Item
Label Description
1
2
Indicates the medical device’s manufactured
date as per ISO 15223-1, 5.1.3.
Indicates the authorized representative in the
European Community as per ISO 15223-1.
3
Caution. Indicates the need for the user to
review the instructions for use for important
cautionary information such as warnings and
precautions that cannot, for a variety of
reasons, be presented on the medical device
itself as per ISO 15223-1, 5.4.4.
Indicates the optical fiber applicator as per IEC
60601-2-22-113.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 17 of 109
Indicates the optical radiation hazard of laser
products according to their degree as per IEC
60825-1:2007, 411/07.
Indicates the emergency laser stop button as
per IEC 60601-2-22-101.
Do not dispose with domestic household
waste. This equipment must not be disposed
of as unsorted municipal waste. Disposing of
WEEE together with normal waste may pose
a risk to the environment and to human health,
due to certain substances used in that
equipment as per EN 50419.
Type B applied part. One of the six ways of
applied part, which indicates that the medical
device does not need to touch the patient
when it is in use, or that it can be removed
immediately as per IEC 60417-2497.
For indoor use only. Indicates that this medical
device is an electrical equipment designed
primarily for indoor use as per IEC 60417-
5957.
Conformité Européene or European
Conformity. Indicates Manufacturer
declaration that the product complies with the
essential requirements of the relevant
European health, safety, and environmental
protection legislation as per 93/42/EEC,
Article 17.
Refer to instruction manual/booklet. Indicates
that the instruction manual/booklet must be
read prior to use as per ISO 7010-M002.
Class II equipment. Indicates that this
equipment meets the safety requirements
specified for Class II equipment as per IEC
60417-5172.
Electrical output information. Indicates that the
maximum output current is 5 amps and the
output voltage is 12 volts. Solid and dashed
lines signify DC output.
Indicates the remote interlock connector as
per IEC 60825-1-3-74 and IEC 60601-2-22-
112.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 18 of 109
2.6.2 Slit Lamp Laser Delivery Unit (LDU)
All the safety and control labels on the slit lamp LDU are shown below:
Figure 4: Slit lamp LDU with labels.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 19 of 109
2.6.3 Laser Indirect Ophthalmoscope (LIO) LDU
All the safety and control labels on the LIO LDU are shown below:
Figure 5: LIO LDU with labels.

LIGHTMED TruScan Pro –Operator’s Manual Rev. No. 01 Page 20 of 109
2.6.4 Symbols Identification
All the symbols and markings on the TruScan Pro laser system are shown below:
Symbol
Description
This product requires a 100-volt current.
Laser radiation.
Laser radiation warning.
Power ON.
Power OFF.
Electronic copy of information on symbols for medical device.
Applied Part: Type B.
Protective ground.
Caution.
Electrical shock.
Waste electrical and electronic equipment (WEEE). Product
must be disposed of properly.
Serial number
Optical fiber applicator