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.