Lightmed LightLink-CXL User manual

Service Manual
LightLink - CXL
Corneal Cross-Linking System

Service Manual
for the
LightLink - CXL
Corneal Cross-Linking System
Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : DCX002
Rev. No. : 01

LightLink-CXL –Service Manual Rev. No. : 01 Page 2of 98
Service Manual for the LightLink-CXL Corneal Cross-
Linking System
Technician or Engineer should ensure that they are adequately trained and understood in
the procedures that the LightLink-CXL Corneal Cross-Linking System prior to operating or
repairing the equipment.
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 Device 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 Service Manual contains confidential and proprietary information of the
Manufacturer.
Manufactured by: LightMed Corporation, No.1-1, Ln. 1, Pao-An St. Sec. 3,Shulin
District., New Taipei City 23861, Taiwan
USA Address: 1130 Calle Cordillera, Suite 101, San Clemente, CA 92673
Tel No.: 1-949-218-9555 Fax No.:1- 949-218-9556
Copyright ©LightMed Corporation
EC REP
EU Representative: Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany

LightLink-CXL –Service Manual Rev. No. : 01 Page 3of 98
Document Title:
Preliminary Service Manual for the LightLink-CXL Corneal
Cross-Linking System
Document Number:
DCX002
Document Revision History:
DRAFT
Sep 2012
Draft prepared
01
Aug 2014
New release

LightLink-CXL –Service Manual Rev. No. : 01 Page 4of 98
Contents of Manual
Section 1 INTRODUCTION ....................................................................................... 9
Section 2 SAFETY.....................................................................................................10
2.1 Product Classifications.......................................................................................... 10
2.2 Warnings and Precautions..................................................................................... 11
2.3 User Safety..............................................................................................................12
2.4 Patient Safety .........................................................................................................13
Section 3 PRODUCT SPECIFICATIONS................................................................... 14
Section 4 SYSTEM SETUP........................................................................................16
4.1 Introduction and Requirements........................................................................... 16
4.2 Unpacking and Receiving Inspection....................................................................17
4.3 Tools and Equipment ............................................................................................ 18
4.4 Setting Up the UV light System Parts .................................................................. 19
4.5 Reassembling Process...........................................................................................20
4.6 Final Verification / Checkout………………………………………...…………..30
Section 5 SYSTEM OVERVIEW............................................................................... 33
5.1 General Operating Theory .................................................................................... 33
5.2 Theory of Operation..............................................................................................34
5.3 System Subassemblies.......................................................................................... 37
1. Laser Head Ass'y...............................................................................................36
A. CPU PCB ……………………………...……………………………………36
B. Aiming Module ..........................................................................................39
C. CCD Camera................................................................................................40
D. Aperture Motor Ass'y…………………………………………………….41
E. Backlight LED ……………………………………..……………………42
F. Detector PCB………………………………...…………………………...43
2. Power control box…………………………………………………………....44
A. Power Supply……………………………………………………………..44
B. LCD Power Supply ………………………………………...……………..45
C. AC Filter PCB……………………………………………………………....45
3. LCD Interface Module………………………………………………………..45
Section 6 REPAIRING PROCEDURES .....................................................................46
6.1 Repair Procedures.................................................................................................46
A. Microprocessor PCB Replacment ............................................................47
B. Aiming Module Replacement ..................................................................49
C. Detector PCB Replacement ......................................................................51
D. Backlight PCB Replacement .....................................................................52
E. Aperture Motor Ass'y Replacement ........................................................53
F. CCD Camera Replacement .......................................................................54

LightLink-CXL –Service Manual Rev. No. : 01 Page 5of 98
Section 7 CALIBRATION / ALIGNMENT PROCEDURES ...................................... 566
7.1 Calibration Procedures .........................................................................................56
A. Motor Aperture Calibration ..................................................................... 57
B. Power Calibration......................................................................................62
C. Detector Calibration..................................................................................66
D. Spot Size Power Calibration.....................................................................69
7.2 Alignment Procedures ...........................................................................................71
1. Aiming Alignment....................................................................................... 72
A. Spot Size Overlapping Alignment....................................................... 72
B. Aiming Intensity Adjustment ............................................................76
2. CCD Camera Alignment ..............................................................................79
Section 8 MAINTENANCE .......................................................................................81
8.1 Operator / User Maintenance............................................................................. ..81
8.2 Periodic Maintenance ........................................................................................... 81
8.3 Repairs…...............................................................................................................82
8.4 Periodic Maintenance...........................................................................................82
Section 9 TROUBLESHOOTING............................................................................. 83
9.1 Warning..................................................................................................................83
9.2 Error Codes ............................................................................................................84
Section 10 SOFTWARE UPGRADING PROCEDURES ..............................................86
10.1 Introduction...........................................................................................................86
10.2 Preparation..........................................................................................................836
10.3 Driver Software Downloading and Installation................................................836
10.4 Software Installation Procedures ........................................................................88
A. Window 7.0 or Above...................................................................................88
B. Window XP...................................................................................................92
10.5 Configuration Procedures ....................................................................................94
10.6 Downloading Procedures .....................................................................................96
Section 11 WARRANTY TERMS...............................................................................98

LightLink-CXL –Service Manual Rev. No. : 01 Page 6of 98
LIST OF DRAWINGS / FIGURES
Figure
Description
Page
4.1
Whole System Packaging Carton
17
4.2
Packaging Label
17
4.3
LightLink-CXL Corneal Cross-Linking System Breakdown
19
4.4
Wheel Stopper Location
20
4.5
LCD Ass’y latching releasing process 1
21
4.6
LCD Ass’y latching releasing process 2
21
4.7
LCD Ass’y latching process 1
22
4.8
LCD Ass’y latching process 2
22
4.9
LCD cable connecting process
23
4.10
The pressurized button
23
4.11
Laser arm ass’y Assembling
24
4.12
Wiring Clearances and End Cap Assembling
24
4.13
Tray Table Assembling
25
4.14
Four Screws Removing Process
26
4.15
UV Head Holding
26
4.16
UV Head Holder Securing Porcess
27
4.17
UV Head Connection
28
4.18
The cabling twining laser arm ass’y
28
4.19
Upper laser cover ass’y 1
29
4.20
System is Ready
29
4.21
Treatment mode
31
5.1
System Block Diagram Overview
35
5.2
CPU PCB
36
5.3
Legends
36
5.4
Aiming modules(Right side)
39
5.5
Aiming modules(Left side)
39
5.6
CCD Camera
40
5.7
Aperture Motor Ass’y
41
5.8
Backlight LED Ass’y
42
5.9
Detector Ass’y
43
5.10
Power control box
44
5.11
AC filter PCB
45
6.1
UV head PCB
47
6.2
Nut is locking at the back of PCB
48

LightLink-CXL –Service Manual Rev. No. : 01 Page 7of 98
6.3
Aiming set screws
49
6.4
Aiming connectors
49
6.5
Detector PCB replacement
51
6.6
Backlight PCB replacement
52
6.7
Aperture Motor Ass'y Replacement
53
6.8
Camera Replacement
54
6.9
Power Holder Replacement
55
7.1
Pass code entering
57
7.2
The software position in Main Program
57
7.3
A hidden icon at the left top corner on screen
58
7.4
Main page of Calibration Mode
58
7.5
Motor Aperture Calibration (Motor Parameter) Mode
59
7.6
UV Light At Focal Length
60
7.7
Origin Spot Size Calibration
61
7.8
5mm Spot Size Calibration
61
7.9
Wavelength Setup
62
7.10
Power Parameter Menu
62
7.11
UV Light in the Detector Area
63
7.12
Power Parameter
64
7.13
Detector Parameter Setup
66
7.14
Detector Trim Pot (VR3) Adjustment Location
67
7.15
Detector Parameter
67
7.16
Power Spot Parameter
69
7.17
Aiming is not overlapping with UV Light
72
7.18
Aiming Alignment Screw
73
7.19
Aiming overlapping with UV Light
74
7.20
Separating Aiming
75
7.21
Aiming Energy
75
7.22
One aiming spot in detector
76
7.23
VR Location For Aiming Energy
77
7.24
CCD Camera with Aiming on the screen
78
7.25
CCD Camera alignment Screws
78
7.26
CCD Camera Alignment Completion
79

LightLink-CXL –Service Manual Rev. No. : 01 Page 8of 98
Record Sheet
Installation Record Sheet
33
Power Parameter Calibration Record Sheet
65
Detector Parameter Calibration Record Sheet
68
Spot Size Power Calibration Record Sheet
70
Aiming Power Calibration Record Sheet
78

LightLink-CXL –Service Manual Rev. No. : 01 Page 9of 98
Section 1 INTRODUCTION
This manual is intended to provide the operator with an overview of the operation and
safety requirements for the LightLink-CXL Corneal Cross-Linking System. 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 system.
All care has been taken in the preparation and checking of this manual however there is
no guarantee provided that all information is correct. The information provided in this
manual is subject to change without notice.
Only approved or authorized accessories may be used in the LightLink-CXL. 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.
All maintenance and service work must be carried out by authorized and trained service
agents and only those procedures outlined in the operator and service manual are
allowed. Any service work carried out by unauthorized persons will void all warranties.
No circuit diagrams or component part lists are to be supplied for the LightLink-CXL. 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 LightLink-CXL Corneal Cross-Linking System the operator should read
this manual carefully and pay particular attention to the sections of Safety, Operation
and Maintenance.

LightLink-CXL –Service Manual Rev. No. : 01 Page 10 of 98
Section 2 SAFETY
This Corneal Cross-Linking System has been designed and tested to function in a safe and
correct when used as indicated in this manual.
DO NOT use this system before reading and understanding completely this Service
Manual.
This manual presents the necessary information to properly operate the LightLink-CXL
Corneal Cross-Linking System. The manual purpose is to familiarize the user with all the
equipment functions and demonstrate how to attain the intended treatment as well as
ensuring patient safety.
Note that the chosen clinical protocols often depend on individual patient response, and
the available options in the equipment are based on clinical evidence found in the
literature. For any questions, request assistance and guidance from our technical
assistance.
This equipment can only be operated by properly identified doctors or under their
supervision (identified as “user”). It is the user responsibility to be aware of the entire
protocol on how to use the equipment, its prescription and application in a particular
patient, as well as ministering the dosage of photosensitive drugs applied to the patient.
The ultraviolet photosensitive drug is not an integral part of the LightLink-CXL Corneal
Cross-Linking System. Its acquisition, storage and handling are the user responsibility.
The ultraviolet photosensitive drug is not included in the registry of LightLink-CXL
Corneal Cross-Linking System in the regulatory bodies.
2.1 Product Classifications
The LightLink-CXL Corneal Cross-Linking System is a ultraviolet lamps
Ophthalmic device as specified in the standard USA 21 CFR’s 1040.20.
The LightLink-CXL Corneal Cross-Linking System is classified as Class I Type B
Electromedical equipment as specified in the IEC60601-1 standard.
The LightLink-CXL Corneal Cross-Linking System is classified as a Class II device according
to the FDA CFR21 regulations.
The LightLink-CXL Corneal Cross-Linking System is classified as a Class II Type B Medical
Device according to the MDD 93/42/EEC (as amended by 2007/47/EC).
The LightLink-CXL has been designed to comply with the following standards:
Ultraviolet lamps standards

LightLink-CXL –Service Manual Rev. No. : 01 Page 11 of 98
USA 21 CFR 1040.20 (1979)
Electrical standards
IEC60601-1 (2005)
IEC60601-1-2 (2007)
USA UL 60601-1
JIS T1001 (1992) and T1002 (1992)
Others
MDD 93/42/EEC (as amended by 2007/47/EC)
ISO14971 (2007)
IEC62471(2007)
2.2 Warnings and Precautions
The following warnings and precautions apply to the LightLink-CXL System and should
be observed by all users at all time:
DO NOT try to service or repair the system other than what is included in this
manual. Service should only be performed by an authorized and trained agent of
the manufacturer.
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.
All modifications or repairs must be performed by qualified professionals
approved by LightMed Corporation.
For safety reasons, unauthorized persons should never open the equipment,
therefore avoiding dangerous situations
Always use clinical protocols that are scientifically recognized nationally or
internationally.
The equipment’s correct functioning depends on the installation, in addition to a
suitable location selected for its operation. The use of a grounded outlet is
specifically recommended, or the coupling of the pin-earth grounding in the
physical location.
The use of non-specified controls, adjustments or procedures may result in
ultraviolet radiation exposure, dangerous to the user. Read these guidelines,
and always note the special particularities used in the markings of the
equipment.
DO NOT operate the equipment in the presence of flammable gases, special
attention should be given to avoid using the equipment in places where there
are flammable oxidizable gases or anesthetics

LightLink-CXL –Service Manual Rev. No. : 01 Page 12 of 98
Equipment not suitable to use near a flammable anesthetic mixture with air,
oxygen or nitrous oxide.
DO NOT point the light beam to flammable materials (cotton, etc.).
Turn off the equipment when it is not in continuous use, and make sure to keep
the place used protected so that it is not be handled or used by unqualified
persons.
DO NOT block the ventilation grid at the optical module.
Cleaning of the equipment should be done when it is turned off, using a slightly
moistened clean non-abrasive cloth. DO NOT use solvents or abrasive cleaning
products.
There may be a fire risk and/or explosion when the light output is near
flammable materials, solutions or gases.
Only use the Touch Screen PC provided by manufacturer which is IEC60601-1
approved.
Disposal of this product may be regulated in your community due to
environmental considerations. For disposal or recycling information, please
contact your local distributor and/or the manufacturer.
2.3 User Safety
The LightLink-CXL Corneal Cross-Linking System is electro medical equipment emitting
ultraviolet light, developed in accordance with the International Standards for Safety.
For the type of equipment that emits ultraviolet light, it is recommended to avoid
exposure of skin and eyes to the light beam if no therapy is being performed. The
operators must be aware that they cannot look directly to the light beam and cannot
point it to the skin.
Special attention should be given to avoid that some reflected light in mirrored surfaces
reaches the eyes accidentally. It is essential to use protective glasses to prevent the
spread of UV light. Check with the Technical Assistance of LightMed in case of doubts.
It must be dispensed special attention to avoid that the reflected light in
mirrored surfaces hit the eye accidentally. The utilization of protector glasses
that block the UVA light propagation is indispensable. Consult the LightMed
technical support team in case of doubt.
Only personnel authorized by LightMed can open and perform internal
maintenance of the equipment. There is a risk of electric shock if opened and
handled by unauthorized personnel.

LightLink-CXL –Service Manual Rev. No. : 01 Page 13 of 98
We do not recommend the equipment use in places with gases, anesthetics or
flammable liquids that could hit the equipment. Consult the LightMed technical
support team in case of doubt
LightMed Corporation does not take responsibility, directly or indirectly, for property
damage, personal injury or financial losses that may occur due to the inappropriate use
of this equipment, and the user is accountable for taking all the precautions listed.
2.4 Patient Safety
The LightLink-CXL Corneal Cross-Linking System should be operated by an
Ophthalmologist who has knowledge about the Corneal Crosslink treatment and the
methods for using this equipment.
The patient must be lying down on a stretcher or comfortable reclining bed in a calm
atmosphere that does not create abrupt distractions to the patient.
The dosage of the photosensitive drug, Riboflavin, and/or the UV light should be
administered with care and with the right quantities to prevent possible eye damage to
the patient.

LightLink-CXL –Service Manual Rev. No. : 01 Page 14 of 98
Section 3 PRODUCT SPECIFICATIONS
The following are the System Specifications for the The LightLink-CXL Corneal Cross-
Linking System.
UV LIGHT WAVELENGTH
365nm ± 5nm
UV LIGHT SOURCE
UV LED Cluster System
MAX. POWER RANGE
Factory Limited 30mW/cm2
IRRADIANCE
Adjustable: 1mW/cm² ‐ 30mW/cm²Continuously Variable
POWER MONITORING
Automatic: By integrated power monitor with feedback
loop.
OPERATING INTERFACE
11.6” Touch screen colour LCD with built in PC
PULSE DURATION
Adjustable: 10S - 30min
CALIBRATION
Automatic
INTEGRATED POWER METER
YES
MAX. POWER OUTPUT ERROR
<10%
SPOT SIZES
4 ‐ 11mm Continuously Variable
WORKING DISTANCE
120 mm
AIMING BEAM
Dual Red Diodes 635 - 650nm
AIMING BEAM POWER
< 1.0mW
VIDEO SYSTEM
Integrated Hi‐Res Auto‐Focusing Camera
FLOOR STAND
Integrated, height adjustable with pantographic arm
OPERATING VOLTAGE
90 ‐ 240VAC, 50/60Hz Auto‐ranging
DIMENSIONS (in centimetres cm)
130cm (H) x 128 (W) x 40cm (L) At full system span
WEIGHT
48kg
Electrical Input
100 to 230 Vac. 50/60 Hz Single phase
Power
200VA
UPS (Optional)
220 / 110VAC (500VA capacity)

LightLink-CXL –Service Manual Rev. No. : 01 Page 15 of 98
Fuse rating
T3.15AH250V @ 100-230Vac (Time Lag)
Temperature Range
Transport: -10 to 70°C
Operating: 15 to 30°C
Storage: -10 to 55°C
Relative Humidity Range
Operating: 30% - 85% non-condensing
Storage and Transport: up to 95% non-condensing
Atmospheric pressure
Operating: 800-1060 mbar
Storage and Transport: 500-1060 mbar
Cooling System
Air cooled
Optional Accessories
The following accessory can be purchased from the Distributor to use with LightLink-CXL
Corneal Cross-Linking System UV light Product. It is only available for customers outside
the EU Countries due to the requirements for CE Marking. The manufacturer does not
have controlled over the use of the attachments that are available and their indications
for use.
Item Description
Part Number
Suppliers
FDA (k) Number
Safety glasses
OD6@365nm
620003
NOIR
N/A(CE-Certified
EN207/EN208)

LightLink-CXL –Service Manual Rev. No. : 01 Page 16 of 98
Section 4 SYSTEM SETUP
4.1 Introduction and Requirements
It is strongly recommended that the manufacturer or its authorized agent install the
LightLink-CXL Corneal Cross-Linking System at the operator site to ensure that the
system is operating correctly, aligned and calibrated according to specification. After
this initial installation it is the operator’s responsibility to ensure the UV light system is
operating correctly whenever the UV light is moved or relocated.
The following procedures should be followed in order to successfully install the UV light
system. The checklist and report form should be completed and a copy sent to the
manufacturer. In the event that the report is not sent to the manufacturer then the
manufacturer reserves the right to decline any warranty claims that may be
forthcoming.
The installer should also retain a copy and the customer may keep a copy too.
All precautions care must be taken when installing the LightLink-CXL Corneal Cross-
Linking System to ensure that you or others are not exposed to any hazardous UV light
radiation. Always wear UV light safety glasses suitable for this particular wavelength
to protect your eyes.
The installation requirements are:
1. 100-230 Volts, 50 or 60Hz AC mains power supply with an earth connection. This is a
single-phase outlet capable of delivering up to 400 Watts.
2. A mains power cable is supplied but the connector may not suit the outlet available
so it is advisable to have a spare locally compatible cable available. The Cable
assembly must be CE approved for EU Countries.
3. A suitable room to place the UV light System in that provides for a safe working
environment is required. As with other ophthalmic equipment a dimly lit room is
preferred.
4. The UV light System has the facility to connect a remote door interlock to the UV
light treatment room. If this option is required then the customer must organize this
with an electrician and the manufacturer or authorized agent can provide
instructions on how to connect to the UV light System. The UV light System is
provided with a Bypass plug in the event that this option is not installed. This plug is
referred to as the “Interlock Key” and must be inserted into the control box in order
for the system to operate. Do not remove this Bypass connector unless you intend
to install the remote door interlock switches at the site. Removing the connector
will prevent the UV light from operating.
5. If the user needs to reallocate the system to a new location it is recommended to
unlock all the movement stoppers on the base wheel station and carefully transport

LightLink-CXL –Service Manual Rev. No. : 01 Page 17 of 98
to the new location. If the new location is at a different facility then the User should
consider repackaging the LightLink CXL system in its original packing prior to moving
to the new site. This will help to prevent any damage occurring to the System.
When the relocation is completed then the correct operation and functioning of the
UV light system should be performed according to the following steps in section 5.4
of this Operator Manual.
4.2 Unpacking and Receiving Inspection
When receiving the UV light system, usually there is only one cardboard box. Inside the
box, you will receive the wheel base & control box, LCD touch screen, UV light head and
UV light arm ass’y.
Figure 4.1
Whole System Packaging Carton
XL0000
LightLink-CXL
Serial Number :
Manufactured By :
LightMed Corporation, No.1-1, Lane 1,
Pao-An St. Sec. 3, Shulin City,
TEL : [phone]
E-mail : [e-mail]
FAX : [phone]
Taipei, TAIWAN, R.O.C. 238
Manufactured :
Model :
This device complies to the requirements of
21CFR . Chapter 1 . Sub-chapter J .
Ophthalmic Corneal Cross-Linking
Fragile Medical Device
LightLink-CXL
Figure 4.2
Packaging Label

LightLink-CXL –Service Manual Rev. No. : 01 Page 18 of 98
Upon receiving the system inspect the packing carton for any signs of mishandling,
which must be reported to the freight handler before the instrument is unpacked. If
there is damage, then the manufacturer reserves the right to decline any warranty claims
that may be forthcoming so it is essential that the freight company will take full
responsibility for any damages.
If the outer cardboard packaging looks OK then you can proceed to remove the internal
packed assemblies
The packing checklist is used to confirm the individual layer contents and notify the
manufacturer if any discrepancy. The motorized table is an optional and may be
purchased from the manufacturer.
4.3 Tools and Equipment
In order to be able to effectively carry out a full initial installation of the LightLink-CXL
Corneal Cross-Linking System the following tools and equipment are required and
available from the manufacturer:
1. UV light Power Meter (to measure from 0 to 2 watts CW)
2. Photographic thermal paper (Zap-it or equivalent)
3. Set of metric Allen keys
4. Screwdrivers (Philips / Roberson)
It is both essential and mandatory to have the all above listed tools and equipment in
order to assemble or disassemble LightLink-CXL Corneal Cross-Linking System in a
correct and safe way

LightLink-CXL –Service Manual Rev. No. : 01 Page 19 of 98
4.4 Setting Up the UV light System Parts
Preparation
All the items shall be unpacked from their appropriate cartons and carry cases and shall
inspect for any transportation damage and general condition. Extreme care do not to
touch the optic lens or parts and make sure all the items are available.
The System consist of four major parts as follows:
Base wheel & Control box
LCD Touch Screen
Swing UV Arm
UV light Head
Figure 4.3 LightLink-CXL Corneal Cross-Linking System Breakdown
UV light Head
UV light Arm
LCD Touch
Screen
Base Wheel & Control Box