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Preliminary Service

Manual

LightLink - CXL
Corneal Cross-Linking System
Preliminary Service Manual
for the

LightLink - CXL
Corneal Cross-Linking System

Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : XLxxxx-xxx
Rev. No. : A1
Service Manual for the LightLink-CXL Corneal Cross-
Linking System
Clinicians and Doctors should ensure that they are adequately trained in the procedures
that the LightLink-CXL Corneal Cross-Linking System will be used for prior to operating
the equipment.

This Service 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 Device will result in the necessity for it
to be reclassified

CAUTIONS - U.S. law restricts this device to sale 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
Dist., New Taipei City 23861, Taiwan
USA Address: 1030 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

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Document Title: Preliminary Service Manual for the LightLink-CXL Corneal
Cross-Linking System
Document Number: XLxxxx-xxx
Document Revision History:
DRAFT Sep. 2012 Draft prepared
Oct. 2012 A1

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Contents of Manual
Section 1 INTRODUCTION ....................................................................................... 7
Section 2 SAFETY...................................................................................................... 8
2.1 Product Classifications ............................................................................................ 8
2.2 Warnings and Precautions ...................................................................................... 9
2.3 User Safety ............................................................................................................. 10
2.4 Patient Safety ......................................................................................................... 11
Section 3 PRODUCT SPECIFICATIONS................................................................... 12
Section 4 SYSTEM SETUP........................................................................................14
4.1 Introduction and Requirements ........................................................................... 14
4.2 Unpacking and Receiving Inspection .................................................................... 15
4.3 Tools and Equipment ............................................................................................ 16
4.4 Setting Up the UV light System Parts ................................................................... 17
4.5 Reassembling Process ........................................................................................... 18
Section 5 SYSTEM OVERVIEW ................................................................................ 14
5.1 General Operating Theory .................................................................................... 14
5.2 Theory of Operation............................................................................................... 15
5.3 System Subassemblies .......................................................................................... 16
A. Laser Head Ass'y.......................................................................................... 17
B. Power Control Box ..................................................................................... 18
C. LCD Interface Module ................................................................................ 27
Section 6 REPAIRING PROCEDURES ..................................................................... 30
6.1 Repair Procedures .................................................................................................48
A. Microprocessor PCB Replacment ............................................................. 49
B. Aiming Module Replacement ..................................................................50
C. Detector PCB Replacement.......................................................................51
D. Backlight PCB Replacement.....................................................................52
E. Aperture Motor Ass'y Replacement........................................................53
F. CCD Camera Replacement .......................................................................54
Section 7 CALIBRATION / ALIGNMENT PROCEDURES ........................................ 50
7.1 Calibration Procedures .........................................................................................68
A. Motor Aperture Calibration .....................................................................68
B. Power Calibration...................................................................................... 69
C. Detector Calibration .................................................................................. 69
D. Spot Size Power Calibration.....................................................................79
7.2 Alignment Procedures ..........................................................................................68
1. Aiming Alignment .......................................................................................68
A. Spot Size Rounded Alignment............................................................ 69
B. Spot Size Overlapping Alignment ...................................................... 69

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C. Aiming Intensity Adjustment ............................................................79
2. CCD Camera Alignment ..............................................................................68
Section 8 MAINTENANCE ...................................................................................... 30
8.1 Operator / User Maintenance ............................................................................. ..45
8.2 Periodic Maintenance ........................................................................................... 56
Section 9 TROUBLESHOOTING............................................................................. 70
9.1 Warning .................................................................................................................. 70
9.2 Error Codes ............................................................................................................. 71
Section 10 SOFTWARE UPGRADING PROCEDURES .............................................. 70
10.1 Introduction ........................................................................................................... 70
10.2 Preparation ............................................................................................................. 71
10.3 Driver Software Downloading and Installation ................................................... 71
10.4 Software Installation Procedures ......................................................................... 71
A. Window 7.0 or Above....................................................................................71
B. Window XP...................................................................................................72
10.5 Configuration Procedures ..................................................................................... 71
10.6 Downloading Procedures ...................................................................................... 71
Section 11 WARRANTY TERMS ............................................................................... 70

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LIST OF DRAWINGS / FIGURES
Figure Description Page
2.1 Safety Controls and Features 11
2.2 Product Safety Labeling 14
4.1 System breakdown diagram 18
4.2 Base wheel and Control Box 19
4.3 LCD Control Panel Display Screen 21
4.4 Screen Shot Panel and Controls 22
4.5 Configuration Screen and Run Control 24
4.6 Corneal Soaking Stage Screen Shot 27
4.7 Pre Corneal Soaking Stage Countdown Screen Shot 30
4.8 Corneal Soaking Procedure Finished Screen Shot 31
5.1 Whole System Packaging Carton 33
5.2 Packaging Label 33
5.3 LightLink-CXL Corneal Cross-Linking System Breakdown 35
5.4 Wheel Stopper Location 36

Record Sheet

Installation Record Sheet 44

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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.

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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

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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

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 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.

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 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.

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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 55mm

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)

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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 620003 NOIR N/A(CE-Certified
OD6@365nm EN207/EN208)

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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

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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 5.1
Whole System Packaging Carton
LightLink-CXL
Ophthalmic Corneal Cross-Linking
Fragile Medical Device
Model : LightLink-CXL
Serial Number :
Manufactured :
Manufactured By :
LightMed Corporation, No.1-1, Lane 1, XL0000
Pao-An St. Sec. 3, Shulin City,
Taipei, TAIWAN, R.O.C. 238
TEL : 886-2-2688-1726
FAX : 886-2-2688-5875
E-mail : sales@lightmed.com
This device complies to the requirements of
21CFR . Chapter 1 . Sub-chapter J .

Figure 5.2
Packaging Label

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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

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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

UV light Arm

UV light Head LCD Touch Base Wheel & Control Box


Screen

Figure 5.3
LightLink-CXL Corneal Cross-Linking System Breakdown

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4.5 Reassembling Process
Prior to begin the reassembling process, appropriate tools, installation site selection and
environment precaution are prepared. Please follows the below procedures:

- Roll out the base wheel & control box and station it over well level ground
- Lock up the wheel station two stoppers (refer to fig. 5.4)

Wheel stopper

Figure 5.4
Wheel Stopper Location

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- Take the LCD display ass’y with the bracket mounted and gently release or pull the
releasing latch outward or backward refer to figure below

Latch head pulling backward

LCD Ass’y latching releasing process

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- Take released latch LCD and gently slide against the mounting bracket and lock the
latch when it is through

Mounting Bracket

- Connect the all the LCD cabling

Note: LCD power cable needs to be push up before securing the screw and 9 pins
connector needs to be connected at COM 1 only

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- Release the pressurized button to lift up height

Note: By doing this process will allow the arm ass’y and base wheel ass’y are closer
and easily to slide in the arm ass’y

- Take the laser arm ass’y and use the shoulder to hold and connect the connector

Note: Ensure the wheel base is locked all the time before the arm ass’y is mounting

Red dot to red dot connection

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- Gently glide in over the wheel base and ensure the no tangle or jam in the wiring

Note: Unevenly slide in will result laser arm rocks possible causing the entire laser
arm ass’y to fall off. The wiring clearance is critical in this procedure since it may
result in broken or loosen wiring during the arm swinging process.

- Take the tray table top and gently slide over the base and secure with the two screws

Note: The height can be determine on the user preference but once secured the
tray top will remain the adjusted height and can’t longer adjustable until it reset it
again

Height will be fixed


once secured

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- Unrelease the four holding screws and leave one side over the laser arm

Leave this side hanging


over the laser arm

- Take the laser head ass’y and gently hold it and secure it over the laser with four
screws

Note: Be extreme careful about securing the laser head if you are installing alone
due to improper installation will result laser head dropping.
Ensure the stopper is always locked prior for any swing integrity test

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Stopper lock
Securing screws (Always at lower position)

OR

- Gently place over the laser head ass’y over a flat and secure table top and adjust the
Cross-link height to the laser head

Table top

- Ensure the cabling is CW winding only and connect the connector

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- Take the two upper laser cover ass’y and gently assemble over the laser arm with
four screws

- Now the system is fully installed and ready to initial the testing

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4.6 Final Verification / Checkout
Prior to power on the system, ensure all the connectors and connections are in place
and the electrical standard is met the system specification. The initialization
procedures are outlined as:

- Disengage the emergency button and interlock plug-in


- Plug in the key into keyhole and turn the key-switch for power on
- Boot up system software and allow self-testing process kick in
- Check for any abnormality or error code process (refer to troubleshooting section 8.0)

If the system rechecking process is valid, then the system is ready to go. More detailed
screen operation and description refer to section 4.2 page 21.

Now the system is fully setup, the final verification is required to conduct before demo
or handle over to user end. These performance procedures can be divided as follows:

 UPS Main power rechecks (Optional)


 LCD Software and camera rechecks
 Power control and laser head rechecks

UPS Main Power (Optional)

- Power on the main switch and allow it to boot and distribute the power source
- Validate if there is abnormally beeping sound

LCD Software and camera integrity

- Power on the LCD and await for the boot up process to be complete
- Validate if there is software program is properly boot up (refer to below figure)
- Validate if the camera integrity is ok

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Power Control and Laser Head

- Power on by turning the key-switch and validate if the green LED is able to lit
- Recheck if the aiming are visible or in place displaying the two dots
- Validate if the LCD and laser head module established connection

System Initialization and Validation

Once everything validated then proceed to system initialization process

A. Control Panel Integrity


- Randomly select the treat mode
- Validate if there is communication protocol establish
- Validate all the controls are functioning accordingly such as, aiming intensity,
Backlight…etc.
- Execute the UV process
-
B. Aiming Integrity Validation
- Engage the aiming intensity to see if the aiming spots are evenly distributed
- Proceed to calibration process if not valid (refer to section x on page xx)

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Installation Record Sheet
Product Name: Corneal Cross-Linking System

Model: LightLink- CXL Serial Number: _____________

1. System Setup ( Tick for OK )


1.1 All parts received and checked OK. 
1.2 No damage to instrument packaging. 
1.3 Adjust cables then attach cable clamps etc. 
1.4 Attach mains power cable. 
1.5 Finish System assembly. 

2. UV light System Checks


2.1 UV light Power ON is indicated by Display LEDs being ON. 
2.2 UV light System does self-checks at Start up. 
2.3 Confirm that no Error messages are displayed. 
2.4 All Display Panel controls and displays are functioning. 
2.5 The Aiming beam is visible and intensity is adjustable. 

Installers Name : _____________________ Date: __________________

Distributor Name: ______________________ Date: __________________

Customer Name : ______________________ Date: __________________

(Send this Installation Report to the Manufacturer immediately.)

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Section 5 System Overview

5.1 General Operating Theory

LightLink-CXL Corneal Cross-linking System is a specialized Ophthalmic Medical Device


controlled by sophisticated PC embedded software integrated with the system. The
system emits a low level UV-A light of 365nm, produced by the UV LED (Light Emitting
Diode) Cluster, through a specialized Optical Module producing a homogeneous spot
size and power controllable beam, intended for delivery on Corneal Surface.
The intention of the device is to allow a non-invasive treatment of Corneal disorders
utilizing a controllable ultraviolet light in a procedure clinically referred to as Corneal
Cross-linking.

The system consists of three major parts: Laser Head, Control Box, and LCD touch
control panel integrated with computer platform

A coil power cord is uncoiled and connected to appropriate source power plug in order
for system to function properly first. Secondly, power switch on the LCD control panel
display is then turn on and wait for the system to boot up properly without any error.

Once the software is properly boot up, then the key-switch is inserted and turned to the
ON position (with the Emergency switch in the out or OFF position). And then the laser
head microprocessor controller will perform some internal checks to verify that the
machine is functioning as it should be.

Camera and aiming are engaged when the system is boot up properly and system is
ready to perform the treatment.

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5.2 Theory of Operation

There are three major elements of modules linked together to formulate the entire laser
system such as, Laser Head ass’y, Power Control Box Ass’y, and LCD Touch Screen
integrated with software system.

Laser Head Ass’y


This is where all the laser beams are generated and distributed. It includes MCU PCB,
laser rod, two aiming modules, CCD camera, aperture motor, and backlight LED. More
detailed descriptions are explained in the System Component section.

Control Box Ass’y


It consists of AC filter PCB, Power supply, LCD power source, and UPS (optional). For
more detailed individual component are explained in the system component section.

LCD Control Panel Ass’y


It provides the interface between the laser system and user. This is where all the controls
are located. It is done through the embedded system software.

LightLink-CXL – Service Manual Rev. No. : A1 Page 31 of 87


5.3 System Subassemblies / Components

The following system block diagram provides an overview of basic details for the design
of the Crosslink system. These blocks diagram includes PC UI controller, Power supply,
and CPU Module. For details individual subassemblies or components explanation are
listed below.

Webcam

LED Lamp

Micro
PC Aiming Diode
Controller
Controller
Interlock

365 UV LED

Motor
Controller

Power Power
UV LED
Supply Supply
Detector

AC
Mains

System Block Diagram Overview

LightLink-CXL – Service Manual Rev. No. : A1 Page 32 of 87


1. Laser Head Ass’y

A. CPU PCB

2
3

15 14 13 12 11 10 9 8 7

Legends
1. Main Power Connector (CN1) 2. Power Photosensor Connector (CN2)
3. CCD Camera and Backlight Connector (CN8) 4. Aiming Module Signal Connector (CN4)
5. Aiming Module Signal Connector (CN5) 6. Interlock Key Connector (CN6)
7. Aiming Intensity (VR1) 8. Aiming Intensity (VR2)
9. Aperture Motor VR Connector (CN7) 10. RS232 Communication Connector (CN3)
11. Aperture Motor Connector (CN9) 12. Power Energy Gain Adjuster (VR3)
13. Software Download Connector (JP1) 14. CPU Chips (U1)
15. Buzzer (BZ1)

LightLink-CXL – Service Manual Rev. No. : A1 Page 33 of 87


This is PCB is the main PCB or the only PCB is the laser system and it is located in the
center of the laser head. It is where the all the electronics and laser are generated
and controlled. It is controlled and interfaced with two modules, UVLEDs laser
module, laser aperture motor, backlight LED, buzzer, interlock, and LCD RS232
transceiver (refer to below diagram)

White LED Aiming Laser


RS232 transceiver
light module Module

MCU msp430f169 support white LED light for the Aiming Laser
external camera video capture, two aiming module, Module
UVLED laser system, Aperture motion control,
buzzer, interlock signal, RS232 communication port,
etc UVLED Laser
DC to DC power supply on board had +12V +5V - Module (including
12V…etc photo sensor
feedback)

AC to DC power Interlock Buzzer


Laser Aperture Spot
module +24V interface
rate motion
controller

The input voltage applies to the CPU then it converts to +12, +5, and -12VDc.

The laser voltage is gradually increased to 24 VDC and maintains it if the laser system
is activated it. When the laser is ‘ON’, the voltage must greater than 20 VDC then
the condition ‘ON’ criteria is met (refer to figure xx).

Once the voltage drops till below 16 VDC then the laser is in ‘OFF’ condition. This is
triggering system is accomplished by Schmitt trigger concept.

The CPU then will translate if the voltage is at +5VDC for ‘ON or 20VDC’ state and 0
VDC for ‘OFF or <=16VDC’ state and it can measure across the TP17 (POR signal).

If the laser is unable to function properly or has no output, then confirm if there is 24
VDC across the ZD1 or CN1 connector or TP11 and TP17 for the digital output signal of
5VDC.

LightLink-CXL – Service Manual Rev. No. : A1 Page 34 of 87


24V

20V

16V

0V
Laser OFF Laser ON Laser OFF Laser ON

Power startup
In UVLED circuitry driver, the voltage falls within 0 to 2.5V and can be measured
across TP12. This voltage value represents the output power. The voltage is
proportional to output power (1mW to 40mW). For example, if the voltage is at
2.5VDC, then the output power is close to 40mW.
UVLED voltage should fall within 14.5V to 18.5V measures across CN8 pin 3 & 5 when
the laser is ‘ON’ stage. UVLED photo sensor is connected to CN2 and feedback to
MCU for the UVLED power intensity. The adjustment could be adjusted through the
VR3 pot.

Aiming circuitry is controlled by a set of DAC IC and current limited circuitry loop.
Two aiming intensity can be adjusted through VR1 and VR2 pot. CN4 connector is
corresponding to VR1 and CN5 is VR2. Aiming control voltage range is from 0 to
2.5VDC and can measure across TP9.

Laser aperture controlled circuit is controlled by VR via CN7 connection. The VR


value determines the aperture size where then translate the motor position through
LM628 motor controlled IC. The motor encoder will predetermine the aperture size.
CN9 is the motor connection.

The user and system interface communication establishment is via through the RS232
protocol and CN3 is the connection.

The buzzer is also built in the CPU PCB located in lower left quadrant.

CN6 is used to connect the 'Interlock key'.

CN8 is the connection for CCD camera and backlight LED.

LightLink-CXL – Service Manual Rev. No. : A1 Page 35 of 87


B. Aiming Module

Aiming No.1 Aiming No.2

Two aiming modules are used to aim the target. The intensity can be recalibrated in
the CPU PCB through two VRs (VR1 and VR2). The intensity is range from 0 to 300
mW. The voltage is proportional to intensity. The intensity is divided into 10
segment bar graph. So when the max intensity is turned, voltage is at xx VDC.

LightLink-CXL – Service Manual Rev. No. : A1 Page 36 of 87


C. CCD Camera

CCD Camera

This CCD camera is assisting the doctor to view the treatment area closely and
accurately. The resolution of the camera is 1200 million pixels.

CCD camera is USB plug-in device and the applied voltage is +5VDC and the current
consumption is 0.5A

The CCD camera position can be realigned through the four set screws. More
detailed you may refer to the realignment process on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 37 of 87


D. Aperture Motor Ass’y

Aperture Motor Ass'y

This motor ass'y is used to control the laser aperture spot size. The VR pot is
reflected back the DAC position for CPU to control.

The motor applied voltage is +/- 12VDC. The motor ass'y has current limited
protection of 60mA so if there is any over current incident, the system will shut it
down.

LightLink-CXL – Service Manual Rev. No. : A1 Page 38 of 87


E. Backlight LEDs

White LED Backlight

This white backlight LED is used to assist the doctor to see the treatment area much
more clearly. The applied voltage is +12VDC. The LED intensity is driven by current.
The max current limitation is 40mA. TP20 is the rechecking point in the CPU PCB and
the voltage is ranged from 0-2.5VDC.

LightLink-CXL – Service Manual Rev. No. : A1 Page 39 of 87


F. Detector PCB

Detector PCB

This detector is used to feedback the laser output power to MCU so it will
recalculate if the power gain is correctly. The applied voltage is +5VDC.

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2. Power Control Box

Power Supply

AC Filtering PCB

LCD Power Supply

A. Power Supply

This power supply converts the AC to DC voltage and provides the corrected voltage
to operate system. It is an auto-ranging power supply module. The input main
voltage can be ranged from 90 to 240 AC volts. The output voltage is +12 VDC.

LightLink-CXL – Service Manual Rev. No. : A1 Page 41 of 87


B. LCD Power Supply

This power supply converts the AC to DC voltage and provides the corrected voltage
to the LCD display module. It is an auto-ranging power supply module. The input
main voltage can be ranged from 90 to 240 AC volts. The output voltage is +24 VDC.

C. AC Filter PCB

The Input mains voltage is connected to this PCB. This PCB provides electrical
filtering so that the Laser system can pass the EMC requirements of the relevant
standards. It is auto-switching range voltage.

3. LCD Interface Module

This software platform provides an interface between the user and console system.
More screen operation control are detailed or explained in the operator manual
section 4 on page 27.

LightLink-CXL – Service Manual Rev. No. : A1 Page 42 of 87


Section 6 Repairing Procedures

6.1 Repair Procedures


This section contains common field repair procedures for replacing various defective
components of console system. Before performing any of these repair procedures, be
sure you have used the troubleshooting procedures in Section 9 of this manual to
properly isolate the instrument’s problems.

Repair Notes

 Before removing any module part ensure the power is always turned off and
power cord disconnected.
 Ensure the statics wrist band is always worn prior to removing any laser diodes
since they are static sensitive components.

LightLink-CXL – Service Manual Rev. No. : A1 Page 43 of 87


A. Microprocessor PCB Replacement

Removal

1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws by using 2.0mm and 2.5mm Allen keys
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors

First screw

Other two screws

Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 44 of 87


B. Aiming Module Replacement

Removal

1. Remove the laser head cover off (only the front cover)
2. Disconnect the aiming connector (Depending on the which one)
3. Loosen the screw by using 1.5mm Allen key
4. Gently and slowly remove the laser diode up
Note: Do remember to tag all the connectors

Two aiming connectors

Set screw

Installation
1. Place back the new laser diode and retighten the set screw
2. Reconnect the connectors and verify it carefully prior to power on
Note: Do remember to reconnect the connector before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance and recalibrate it if required
refer to section xx on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 45 of 87


C. Detector PCB Replacement

Removal

1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5. Remove the cable connection and the two screws by using 1.5mm
6. Gently and slowly remove the PCB down

Two 1.5mm screws

Detector Connector

Installation
1. Reseat the PCB back and screw back the two screws
2. Reconnect back the connector
3. Reseat the CPU PCB back to the screw pole and screws back the three screws
4. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
5. Ensure there is no loosen connections and close up the cover top
6. Power on and validate the system performance refer to section xx on page xx.
7. Recalibrate the Power and Detector parameter (refer to recalibration
procedures)

LightLink-CXL – Service Manual Rev. No. : A1 Page 46 of 87


D. Backlight PCB Replacement

Removal

1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5.

Connector

two screws

Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 47 of 87


E. Aperture Motor Ass'y Replacement

Removal

1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5. Loosen all the screws and gently remove the motor ass'y from the gear contact

2.5mm Allen screws * 3

Installation
1. Reseat the motor ass'y back to the gear and screws back the screws
2. Reseat the CPU PCB ass'y back
3. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
4. Ensure there is no loosen connections and close up the cover top
5. Power on and validate the system performance refer to section xx on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 48 of 87


F. CCD Camera Replacement

Removal

1. Remove the laser head front cover off and open the rear cover partially
2. Disconnect and tag the cablings or connectors
3. Remove the three screws
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors

Two screws and wirings

Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.

LightLink-CXL – Service Manual Rev. No. : A1 Page 49 of 87


Section 7 Calibration / Alignment Procedures
7.1 Calibration Procedures

Purpose
The purpose of this procedure is to calibrate or restore the laser system after any
module replacement or during any routine checkout process. Prior to commencing the
procedure, only the qualified or trained personnel is permitted to conduct this process.
Performing these procedures will reset the all the factors of the laser system.

The procedures can be defined into four parts:


- Motor Aperture Calibration (Motor Parameter)
- Power Calibration (Power Parameter)
- Detector Calibration (Detector Parameter)
- Spot Size Power Calibration (Power Spot Parameter)

Equipments / Tools required:


 Interlock Connector
 Calibrated Laser Power Meter
 Safety Goggle (for this specified system)
 VR pot adjuster or small flat screw driver

Note: Do remember to remove the front cover before any realignment process
takes place

LightLink-CXL – Service Manual Rev. No. : A1 Page 50 of 87


A. Motor Aperture Calibration (Motor Parameter)

This procedure will calibrate the motor aperture position which allows the system to
have the corrected spot size during the any treatment procedure. Improper spot size
will affect the treatment quality.

- Enter to calibration mode


- Double clicks the hidden icon at the left top corner screen (refer to fig. xx)

Hidden Icon

Pass code: '0000'

- Enter the pass code "0000"


- Restart the main program again by click the “Truscan” program in startup menu

Double clicks to initial


the software

LightLink-CXL – Service Manual Rev. No. : A1 Page 51 of 87


- Double clicks the top left corner of the screen display before entering the main
program
Note: If not striking the hidden icon correctly, the all process will need to
restart again
Double clicks Hidden
Icon

Motor
Parameter Icon
- Press the "Motor Parameter" icon to initial the calibration process
- Set the spot size to 4mm and power to 1mW

LightLink-CXL – Service Manual Rev. No. : A1 Page 52 of 87


Power and Spot
Configuration

UV Light Run Button

- Start up the UV light execution run icon


- Lower the laser head to focus the spot size and well homogeneous or spot
intensity well distributed on the standard spot sizes calibration sheet
- Stop the UV light

- Initial the "Origin Spot Calibration" icon button

LightLink-CXL – Service Manual Rev. No. : A1 Page 53 of 87


Saving Icon
Origin Calibration
Icon

Motor Position
Direction (CW
or CCW)

- Fire the laser again and realign the spot size to fit the reference spot size 4mm by
rotating CW or + and CCW or - direction
- Repeat the process until it fits into the reference spot circle and save the
calibration value and cycle power and validate the origin position or 4mm
- Repeat the same process from 5mm to 11mm and save every interval position
value
Note: The position alignment from 5mm or above spot size is only in CW
direction

Initial Origin Position

Saving icon

CW direction
alignment

LightLink-CXL – Service Manual Rev. No. : A1 Page 54 of 87


B. Power Calibration (Power Parameter)

This procedure will calibrate the power performance which allows the system to have
the corrected power throughput during the treatment procedure. Improper power will
affect the treatment quality.

- Enter to calibration mode


- Double clicks the hidden icon at the left top corner screen (refer to fig. xx)
- Press the "Power Parameter" icon to initial the calibration process
- Set the power meter wavelength at 365nm and set the spot size to 11mm in main
calibration menu (refer to motor parameter) and power to 30mW
- Initial ‘Ready’ button for spot size reinitialization or reconfiguration process
before entering the Power Parameter menu

Wavelength at

Set 'Power'
at 30mW

LightLink-CXL – Service Manual Rev. No. : A1 Page 55 of 87


- Place the Power meter underneath of laser head
Note: Ensure the spot size is centered of the detector area

- Start up the UV light execution run icon

Execution
Run Key

- Measure the power against the calibration data sheet (refer to below figure) and
adjust the factor value until it is consisted with the data sheet specification
- Repeat the same process until every scale is performed and calibrated
- Save the values before exiting from the power parameter screen

LightLink-CXL – Service Manual Rev. No. : A1 Page 56 of 87


C. Detector Calibration (Detector Parameter)

This procedure will calibrate the system detector value which allows the consisted value
during the any treatment procedure. Improper detected will result in treatment quality
or endanger patience.

- Enter to calibration mode


- Double clicks the hidden icon at the left top corner screen (refer to fig. xx)
- Press the "Detector Parameter" icon to initial the calibration process
- Set the power meter wavelength at 365nm and set the spot size to 11mm in main
calibration menu (refer to motor parameter) and power to 30mW

Set 'Power'
at 30mW

Set this factor


ratio to "1.o"

- Place the Power meter underneath of laser head

LightLink-CXL – Service Manual Rev. No. : A1 Page 57 of 87


Note: Ensure the spot size is centered of the detector area

- Set the factor to 1.0 ratio at power 30mW interval


Note: Ensure this value needs to be set up as "1.0" ratio because of true linear
ratio
- Start up the UV light execution run icon
- Measure the detected value should fall within 28.5 +/- 20% for the 30mW interval

Detected value

LightLink-CXL – Service Manual Rev. No. : A1 Page 58 of 87


- Calibrate the VR if the range does meet the specification and repeat the same
process once the value is within criteria

- Proceed to next interval and adjust the interval ratio value so it will fall within the
calibration data sheet
- Save the value when the process is completed

LightLink-CXL – Service Manual Rev. No. : A1 Page 59 of 87


D. Spot Size Power Calibration (Power Spot Parameter)

This procedure is intended to calibrate the individual spot sizes power for the system
spot power consistency and accuracy during the treatment procedure.

-Enter to calibration mode


- Double clicks the hidden icon at the left top corner screen (refer to fig. xx)
- Press the "Power Spot Parameter" icon to initial the calibration process
- Set the power meter wavelength at 365nm and set the spot size to 4mm in main
calibration menu (refer to motor parameter) and power to 30mW
- Start UV light run icon and measure if the value falls within the calibration
specification guideline

LightLink-CXL – Service Manual Rev. No. : A1 Page 60 of 87


7.2 Alignment Procedures

Purpose
The purpose of this procedure is to align or restore the laser system after any module
replacement or during any routine checkout process. Prior to the commencing the
procedure, only the qualified personnel is permitted to conduct this process.

There are two alignments required when replacing:

1. Aiming Alignment
- Spot size
- Intensity
- Overlapping
2. CCD Camera Alignment

Equipments / Tools required:


 Interlock Connector
 Calibrated Laser Power Meter
 Safety Goggle (365nm wavelength)
 VR pot adjuster or small flat screw driver
 Allen key 2.5mm

LightLink-CXL – Service Manual Rev. No. : A1 Page 61 of 87


1. Aiming Alignment

A. Spot Size Rounded Alignment


- Remove the laser cover partially (only the front cover)
- Loosen the reflected mirror holding screws (refer to below figure)

Left Side Reflector Mirror Right Side Reflector Mirror


Right Side Reflector Mirror

- Adjust the reflected mirror until the uniform and rounded spot is formed

LightLink-CXL – Service Manual Rev. No. : A1 Page 62 of 87


B. Spot Size Overlapping Alignment
- Enter to calibration mode
- Set spot size at 4mm and power at 1mW
- Place the reference spot size calibration sheet beneath the laser aperture or
head
- Fire the UV and focus the spot size into homogeneously or well uniform
- Repeat the process until it is uniform and then off the UV light
- Use 3.0mm allen key and move the one spot toward to the reference spot size
of 4mm

LightLink-CXL – Service Manual Rev. No. : A1 Page 63 of 87


LightLink-CXL – Service Manual Rev. No. : A1 Page 64 of 87
- Repeat the same process until the it is properly unifying at 4mm spot size and
then increase the spot to 8mm to validate if the spot size is centered of
reference spot of 8mm

LightLink-CXL – Service Manual Rev. No. : A1 Page 65 of 87


C. Spot Size Intensity Adjustment
- Open up the front laser cover ass'y
- Enter calibration mode
- Initial the UV light and disengaged it
- Raise the laser head for the aiming spots separation
- Place the detector at one of the aiming spot
- Identify which aiming spot position correspondence for VR
- Use VR pot adjuster to adjust the value to greater than 250 for both two aiming
- Repeat the same process until the value is reached

LightLink-CXL – Service Manual Rev. No. : A1 Page 66 of 87


2. CCD Camera Alignment
- Open up the front first and remove it down
- Gently pull back the rear laser cover ass'y until you see the camera ass'y
- Remove the screws and de-soldered all points
- Enter calibration mode
- Initial the UV light and disengaged it
- Raise the laser head for the aiming spots separation
- Place the detector at one of the aiming spot
- Identify which aiming spot position correspondence for VR
- Use VR pot adjuster to adjust the value to greater than 250 for both aimings
- Repeat the same process until the value is reached

LightLink-CXL – Service Manual Rev. No. : A1 Page 67 of 87


Section 8 MAINTENANCE
The LightLink-CXL Corneal Cross-Linking System has been designed to require minimal
maintenance. There are several simple routine procedures that are to be carried out by
the operator, but aside of these there are no operator maintenance requirements.
The manufacturer however does recommend that the LightLink-CXL be serviced by an
authorized service agent every 12 months. During this Preventative Maintenance (PM)
service visit the UV light System will be Calibrated and Aligned and the general operating
function confirmed.
It is a requirement that on an annual basis (every 12 months) the LightLink-CXL has the
Power meter calibrated to a known calibrated meter and have its earth leakage current
and earth resistance measured according to EN60601-1. These procedures can only be
performed by an authorized service agent of the manufacturer.
If at any time you have concerns about any aspect of the Operation / Calibration or
Alignment of the LightLink-CXL, you are urged to contact the authorized representative
or the manufacturer in order to decide on a suitable course of action.
Refer to Section 9 of this Manual for particular National requirements of EU Countries.

8.1 Operator / User Maintenance


It is recommended that the LightLink-CXL Corneal Cross-Linking System equipment is
annually checked by LightMed Authorized Representative. Please contact the Authorized
Service to check the technical and commercial conditions.
 LightMed Corp. cannot be held liable for the equipment if it is opened and/or
modified by unauthorized persons.
 If the equipment is used in a manner other than that specified by the Engineering,
the warrantee will automatically be cancelled. Read carefully the operation
conditions. If in doubt, see our Technical Assistance Service.

8.2 Cleaning
The cleaning should be done with a lint-free cloth moistened with a non-abrasive
cleaning solution. For example, water and a mild detergent are more appropriate. Do not
use organic solvents as gasoline, alcohol, kerosene, etc. for cleaning the outside of the
LightLink-CXL.
When cleaning the inside of the dome of the stimulator it is advisable to use a special
soft cleaning cloth to reduce the possibility of scratching the LCD display.

LightLink-CXL – Service Manual Rev. No. : A1 Page 68 of 87


Do not tip over the LightLink-CXL during cleaning, as this may increase the risk of the
cleaning solution going into the device, resulting in damage and a safety electrical risk.
The LightLink-CXL cannot be placed in autoclave.
When a liquid is spilled on the LightLink-CXL the device should be cleaned immediately
with an appropriate lint-free absorbent cloth. After cleaning, check that there is no liquid
in the electrical socket. The liquid may cause short circuits in the contacts. Clean the
electrical socket with a wad of cotton and wait one hour before connecting the
LightLink-CXL to the electrical outlet.
 The LightLink-CXL must be turned off and unplugged from the electrical outlet when
it is cleaned. After cleaning the device wait at least 1 minute before plugging the
LightLink-CXL to the electrical outlet.
 The LightLink-CXL is a high-precision equipment and so it is absolutely necessary that
all possible care is taken during cleaning.

8.3 Repairs
To ensure a long and useful life to your medical equipment, LightMed recommends that
the LightMed Authorized Service distributor or your Technical Assistance own
periodically check the condition of the device and replace parts as needed.
In the case of any defect in the LightLink-CXL immediately consult the LightMed
Authorized Distributor. The right to repair the LightLink-CXL or perform regular
maintenance or replacement of spare parts is reserved for the LightMed Authorized
distributor or the manufacturer.

8.4 Periodic Maintenance


LightMed Corp. recommends periodic INSPECTIONS every year, which should include
verifying the software and adjustments and calibrations of the systems of mechanical
and electronics.

LightLink-CXL – Service Manual Rev. No. : A1 Page 69 of 87


Section 9 TROUBLESHOOTING
The LightLink-CXL is designed to have a service free part as possible. It is divided into
three major sections such as, Symptom, Warning, and Error code.

9.1 Warning
A completed listing of LightLink-CXL warnings and the suggested corrective action are
detailed as following:

Warning Cause(s) Remedy Action(s)


Warning - Interlock -Interlock plug not -Check the Interlock connection
connected -If the problem persists, call the
authorized service or manufacturer
for further assistance
Warning – Motor -Motor is moving - Wait for Motor to be ready.
Move -If the problem persists, call the
authorized service or manufacturer
for further assistance
Warning – - Laser head power not -Power on the laser head again
Communication engaged or -If the problem persists, call the
failure miscommunication authorized service or manufacturer
failure for further assistance

LightLink-CXL – Service Manual Rev. No. : A1 Page 70 of 87


9.2 Error Codes
If during normal operation of the LightLink-CXL Corneal Cross-Linking System or during
the Start up or Special Modes, if a fault, error, or warning condition is found by the
microprocessor then the System will go to the Standby and an error or warning message
will be shown on the Display. The System cannot be used when an error message is
displayed.

If an error message is regularly shown on the system display then a service person must
check the UV light system and make adjustments where possible.
Under no circumstances should unauthorized or untrained personnel attempt repairs.
Refer to the warranty conditions for further details.
A complete listing of the LightLink-CXL error codes along with the suggested corrective
actions are shown below:
Error code Cause(s) / Description Remedy Action(s)
Err 01 - Motor -Motor failed to operate -Reboot the system
Failure -If the problem persisted, call the
authorized service or manufacturer
for further assistance
Err 02 – UV Diode -UV Diode current is out -Call the authorized service or
Current Too High of range or over the limits manufacturer for further assistance
Err 03 - Aiming UV -Aiming UV light beam -Call the authorized service or
light Failure failure manufacturer for further assistance
Err 04- Aiming UV -Aiming UV light beam -Call the authorized service or
light Failure failure manufacturer for further assistance
Err 05 – UV Power -The measured o/p power -Recalibrate the power and detector
Too High is exceeded by 20% of the parameter
preset power value -Validate the power detector sensor
integrity
-Call the authorized service or
manufacturer for further assistance
Err 06 – UV Power -The measured o/p UV -Call the authorized service or
Too Low light power is under by manufacturer for further assistance
30% of the preset power
value
Err 07 - System Time -The system stop running -Reboot the system
Error for 100ms -Call the authorized service or

LightLink-CXL – Service Manual Rev. No. : A1 Page 71 of 87


manufacturer for further assistance
Err 08 - Calibration -The system is -Call the authorized service or
Error uncalibrated manufacturer for further assistance
Err 09 – ROM Error -System failed to pass the -Reboot the system
software integrity test -If the problem persisted, call the
authorized service or manufacturer
for further assistance
Err 10 – Watchdog -System watchdog flag -Reboot the system
Error -Call the authorized service or
manufacturer for further assistance
Err 11 - -No communication -Reboot the system
Communication between optical driver -If the problem persisted, call the
Error and the console within authorized service or manufacturer
the time of frame of for further assistance
300ms during UV firing
Err 12 - Power Error -The system power is -Call the authorized service or
failure manufacturer for further assistance

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Section 10 Software Upgrading Procedures

10.1 Introduction
The purpose of this procedure is to upgrade or rewrite the software V 1.X for Truscan
system. Performing this procedure will erase the original program and install the new
version into the CPUs for the whole system.

10.2 Preparations
Equipment Requirement

-MSP-FET430UIF kit (including MSP430 CD-ROM, MSP-FET430UIF USB-to-JTAG


Emulation Interface, USB cable type A/B, 14-conductor cable)

-PC or Laptop

System Requirement

Window XP or above

10.3 Driver Software Downloading Procedures


- Access the website http://www.elprotronic.com/download.html and download the
CSO14x01 or “Flash Programmers for TI's MSP430 MCU uses TI's FET Adapter” (refer to
below figure)
Note: This is freeware software therefore the version could be different from time to
time

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- Execute the downloading process

- Wait till the process finished it

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-Unzip the file

10.4 Software Installation Procedures


A. Window 7 version or above
- Execute the 'Setup' file and Click the 'I agree' term

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- Step through all below procedures until the installation completed it

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B. Window XP Version
- Execute the 'Setup' file and Click the 'I agree' term

- Step through all below figures

- Configure the path to be: C:\Program Files\IAR Systems\Embedded Workbench


4.0\430\drivers\TIUSBFET\WinXP

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10.5 Configuration Procedures

- Plug in the MSP-FET430UIF including the cable and execute the program icon

- Click the 'Setup' menu and open up the 'Memory Option'


- Ensure below configuration are set up

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- Open up the 'Setup' menu and then 'Connection / Device Reset'

- Validate if the below configuration are set up correctly

- End of configuration and exit the program

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10.6 Downloading Procedures
A. Console (MCU1)
- Execute the FET-430 program again and ensure the MSP-FET430UIF is plug in
- Open up the console and locate the MCU1 socket and then plug in

- Power on the console and configure the download file by 'Open Code File' icon

File retrieving Programming initialization

Specific type selection Group Selection

- Retrieve the file 'MCU1' from your destination or stored area


- Choose the microcontroller group to be MSP430F1xx and MSP430F169
- Execute 'AUTO PROG' icon for the downloading process begins

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B. Console (MCU2)
- Repeat the same process for MCU2 programming and ensure choose the
correct microcontroller group: MSP430F2xx and MSP430F2619 and file name
MCU2
C. Remote Control Downloading
- Power down the console and open up the remote control rear cover
- Connect the MSP-FET430UIF to the back of remote control

- Retrieve the file 'REMOTE_Vxx' from your destination or stored area


- Ensure the microcontroller group is set at MSP430F1xx and MSP430F169
- Power up the console and remote control plug in
- Execute 'AUTO PROG' icon for the downloading process begins
- Cycle the power when it is finished and close the remote rear end cover ass'y

Figure 1. WinXP Hardware Recognition

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Section 11 Warranty Terms

The manufacturer provides a Limited Warranty on the Crosslink Laser for a fixed period
of time from the date of initial installation. The warranty period is for a minimum of 12
months however some Distributors may offer extended warranty periods. Please
contact your Distributor for this information if you are unsure of the details. The
manufacturer warrants that the Crosslink will be free of defects in materials and
workmanship for this period provided an authorized agent of the manufacturer carries
out the installation. The warranty applies only to the original purchaser of the
equipment in the country of original shipment.

This warranty will become void and the manufacturer and distributor organization will
not hold any responsibility for the correct operation or safety of the warranted
equipment if it:

 has been altered, modified, serviced or repaired by anyone other than authorized
agents of the manufacturer.
 is not operated according to the instructions contained in this manual.
 is not serviced according to the instructions and procedures contained in the
manual.
 is subjected to misuse, negligence or accidents.
 is not installed according to the manufacturer instructions.
 is connected to, or used with accessories or spare parts that are not and have not,
been tested and approved by the Manufacturer.

The obligation of this warranty shall be limited to the repair or replacement, at the
manufacturer’s recommendation and expense, of any materials or products that are
shown to be defective from faulty material and / or poor workmanship during the stated
warranty period. The manufacturer reserves the right to examine and make the
necessary repairs at its own premises, at an authorized repair center, or the site of
installation. The customer will pay for all freight and handling charges.

The manufacturer shall not be liable for any incidental or special damages or any other
loss, damage or expense that arises directly or indirectly from a warranty claim, the use
of the warranted product, the inability to use the warranted product while being
repaired or replaced, or otherwise.

Except as expressed above the manufacturer makes no other warranty of any kind,
express or implied, including warranties of merchantability of fitness for any particular
purpose or use.

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