Operator’s Manual

LightLink - CXL
Corneal Cross-Linking System
Operator’s Manual
for the

LightLink - CXL
Corneal Cross-Linking System

Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : DCX001
Rev. No. : 03
 Operator’s Manual for the LightLink-CXL Corneal
Cross-Linking System
Clinicians or Doctors should ensure that they are adequately knowledge of operation
prior to using the LightLink-CXL Corneal Cross-Linking System.

This Operators 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 sell by or on the order of a physician

This Operators Manual contains confidential and proprietary information of the

Manufacturer.

Manufactured by: LightMed Corporation, No.1-1, Lane. 1, Pao-An St. Sec. 3,Shulin
District., New Taipei City 23861, Taiwan
USA Address: 1130 Calle Cordillera, 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 – Operator’s Manual Rev. No. : 03 Page 2 of 69

 Document Title: Operators Manual for the LightLink-CXL Corneal Cross-
Linking System
Document Number: DCX001
Document Revision History:
DRAFT Sep 2012 Draft prepared
Oct 2012 A1
01 April 2013 Issue
02 May 2013 Modify Section 5
03 Aug 2014 Revised the interface and changed the system picture with
grey color

LightLink-CXL – Operator’s Manual Rev. No. : 03 Page 3 of 69

 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
2.5 Safety Controls and Features ................................................................................12
2.6 Product Labeling ....................................................................................................15
Section 3 PRODUCT SPECIFICATIONS .................................................................................. 16
Section 4 PRINCIPLES OF OPERATION ................................................................................. 18
4.1 General Description............................................................................................... 18
4.2 LightLink-CXL Controls and Displays ................................................................... 19
4.2.1 Base wheel and Control Box...........................................................................20
4.2.2 LCD Control Panel Display Screen ........................................................................ 22
4.3 Basic Operation Overview...............................................................................34
Section 5 INSTALLATION........................................................................................................ 43
5.1 Introduction and Requirements ........................................................................... 43
5.2 Unpacking and Receiving Inspection ...................................................................44
5.3 Tools and Equipment ............................................................................................ 45
5.4 Setting Up the UV light System Parts ..................................................................46
5.5 Reassembling Process ........................................................................................... 47
5.6 Initialization the Equipment ................................................................................. 56
Section 6 CLINICAL USE..........................................................................................................58
6.1 Introduction ........................................................................................................... 58
6.2 Clinical Guidelines ................................................................................................ 60
Section 7 MAINTENANCE ...................................................................................................... 64
7.1 Operator / User Maintenance ...............................................................................64
7.2 Cleaning..................................................................................................................64
7.3 Repairs.................................................................................................................... 65
7.4 Periodic Maintenance ........................................................................................... 65
Section 8 TROUBLESHOOTING ............................................................................................ 66
8.1 Warning ................................................................................................................. 66
8.2 Error Codes ............................................................................................................ 67

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 LIST OF DRAWINGS / FIGURES
Figure Description Page
2.1 Safety Controls and Features 12
2.2 Product Safety Labeling 15
4.1 System breakdown diagram 19
4.2 Base wheel and Control Box 20
4.3 LCD Control Panel Display Screen 22
4.4 Screen Shot Panel and Controls 23
4.5 Configuration Screen and Run Control 25
4.6 UV Applying Process And Corneal Soaking (Stage II) Screen Shot 28
4.7 Pre Corneal Soaking Stage Configuration Menu 31
4.8 Corneal Soaking Procedure Finished Screen Shot 33
4.9 LCD Power Switch 34
4.10 Live Camera Engaged 35
4.11 Control Box Power Key Switch 35
4.12 System Engaged 36
4.13 Treatment Selection Icon 36
4.14 Ready Icon 37
4.15 Corneal Soaking Timer (Stage I) 37
4.16 Configuration screen 38
4.17 Timer Countdown 38
4.18 Initial timer 1 39
4.19 Initial timer 2 39
4.20 Initial UV & Riboflavin Stage II Process 40
4.21 Initial UV & Riboflavin Stage II Process set over 40
4.22 Procedures Summary Report 41
4.23 End of the procedures and record the data 42
5.1 Whole System Packaging Carton 44
5.2 Packaging Label 44
5.3 LightLink-CXL Corneal Cross-Linking System Breakdown 46
5.4 Wheel Stopper Location 47
5.5 LCD Ass’y latching releasing process 1 48
5.6 LCD Ass’y latching releasing process 2 48
5.7 LCD Ass’y latching process 49
5.8 LCD cable connecting process 49
5.9 Elevation Process 49
5.10 Laser Arm Assembling 50

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 5.11 Wiring Clearances Process 50
5.12 Tray Table Assembling 51
5.13 Four Screws Removing Process 52
5.14 UV Head Holding 52
5.15 UV Head Holder Securing Process 53
5.16 UV Head Connection 53
5.17 Upper Laser Cover Assembling 54
5.18 System is Ready 55
6.1 chemical properties 60

Record Sheet

Installation Record Sheet 57

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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 Operators
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

USA 21 CFR 1040.20 (1979)

LightLink-CXL – Operator’s Manual Rev. No. : 03 Page 8 of 69

  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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2.5 Safety Controls and Features
For the LightLink-CXL Corneal Cross-Linking System to comply the various requirements
of the standards (referred to previously), there are number of Controls and Features that
are provided (refer to Figure 2.1).

Figure 2.1
Safety Controls and Features
Legend
1. Emergency Stop Switch 2. Key Switch
3. Interlock Connector

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All safety features or controls must be engaged in order for the system to operate or
function properly except audit warning. A full detailed description of these safety
features is provided in following:

1. Emergency Stop Switch

This switch is functioned as a fast response shutdown of the UV light System in the
event of some serious problem occurring. It is a RED color push switch that locks
down when pushed and in this position, all power to the internal parts is removed.
The switch actuator (the red button) must be rotated outward in order for the
power to be restored.
2. Key Switch
The Key switch is the main power ON/OFF switch. The power can only be turned on
by inserting the key and rotating clockwise to the ON position. In the ON position,
the key cannot be removed. The key should be stored in a safe and controlled place.
3. Remote Door Interlock Connector
This remote door interlock connector is functioned as an engaged key to the system.
By default this Interlock connector is plugged in with dummy tangle for the normal
operation. It is located on the back of the console where two wires can be wired
out to a switch on the treatment room door for sudden door opening interruption
which may cause the system to pause or “hold” so that this will protect or prevent
the unwanted deflection UV light exposed to anyone. Once the door is closed the
system will go back to the STANDBY mode. On the other hand, if the operator
decides to continue the procedure, he/she may trigger activate the TREAT mode for
continuation.

When the LightLink-CXL Corneal Cross-Linking System is first turned on the

microprocessor performs various checks to ensure that the UV light is functioning
correctly. If the self-check test passes then the unit goes to the STANDBY mode.
In addition to these particular safety controls there are a number of features that have
been built-in to the LightLink-CXL Corneal Cross-Linking System:
 All the safety controls are in placed or engaged so as to prevent the operator
inadvertently firing the UV light.
 The UV light system has protective housings covering to prevent exposure to UV
light emissions. Special tools are required to remove the housings and only
authorized and trained agents are permitted to remove them.
 The UV light system has been designed to comply the electrical safety standards for
earth connections and earth leakages.

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 The UV light head gives an audible warning whenever the UV light is firing.
Note: With all these controls and features, the LightLink-CXL Corneal Cross-Linking
System is a very safe instrument when it is used correctly and as indicated in this
manual.

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2.6 Product Labeling
All the labels on the LightLink-CXL Corneal Cross-Linking System comply with the
requirements of the various regulatory standards referred to previously.

EMERGENCY EMERGENCY

EC REP EU Authorized Representative

(MDD 93/42/EEC)
Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany

MANUFACTURED:
ULTRAVIOLET
POWER RADIATION

POWER

ULTRAVIOLET EC REP EU Authorized Representative

RADIATION (MDD 93/42/EEC)
Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany

MANUFACTURED:

Lightmed Corporation
MODEL NO:
SERIAL NO:
PRESSURIZED BUTTON

DOOR
INTERLOCK
WARNING
INPUT: 100-230V ~ (Fuse:T3.15AH250V) Risk of fire
50/60Hz, 400VA Replace only with
fuse as marked above

DOOR
PRESSURIZED BUTTON INTERLOCK

WARNING
INPUT: 100-230V ~ (Fuse:T3.15AH250V) Risk of fire
50/60Hz, 200VA Replace only with
fuse as marked above

Figure 2.2
Product Safety Labeling

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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

IRRADIANCE Adjustable: 1mW/cm²‐ 45mW/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 120mm

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

Fuse rating T3.15AH250V @ 100-230Vac (Time Lag)

UPS (Optional) 220VAC or 110VAC

Temperature Range Transport: -10 to 70°C

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 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)

LightLink-CXL – Operator’s Manual Rev. No. : 03 Page 17 of 69

Section 4 PRINCIPLES OF OPERATION
4.1 General Description
LightLink-CXL Corneal Cross-Linking system has been engineered as a safe, and highly
sophisticated medical device, with all its modules individually attested and calibrated to
highest standards and optimum precision.
This equipment can only be operated by properly identified ophthalmic physicians or
under their supervision (identified as “user”).
It is the user’s responsibility to be aware and familiar the entire treatment protocol on
how to use the equipment, as well as ministering the dosage of photosensitive solution
(Riboflavin) applied to the patient.

General Operation
The system is consisted of four major parts:
- Base wheel & control box,
- LCD touch screen,
- UV light arm ass’y and
- UV light head ass’y
In the control box is where the power supply distributed. The system software and
touch controls are embedded in the LCD screen module. All the hard wiring and
connections are also embedded into the UV light arm. As for the UV light is generated
through the UV light head. Inside UV light head consists of all the electronics control and
CCD camera, illumination light and UV LEDs.
When the system is powered by turning the key-switch, emergency button released, and
interlock plug connected, the software will control and command the UV light head to
initial the UV light treatment according to the user’s preference. The software then will
communicate and validate if the system hardware are in place in order for system to pass
the self-testing process (more detailed refer to operation overview section 4.3).

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4.2 LightLink-CXL Controls and Displays

All the LightLink-CXL Corneal Cross-Linking System’s controls and displays are located
either on the UV light head or the touch screen panel (refer to fig. 4.1).

LCD Touch Screen Control Box

UV Light Head

Figure 4.1
System breakdown diagram

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4.2.1 Base wheel and Control Box
This is where all electronics component and controls unified. A detailed description is
explained on the next page.

3
4

Figure 4.2
Base wheel and Control Box

Legend
1. Emergency Stop Switch 2. Key Switch
3. Up / Down Control 4. Interlock Key Connector

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1. Emergency Stop Switch
This switch is provided a fast response shutdown of the UV light system in the event
of some serious problem occurring. It is a RED color push switch that locks down
when pushed and in this position, all internal power will be removed. In order for
system to restore the power, the switch must be rotated to reset to the on position.
2. Key Switch
This key switch is the main power ON/OFF switch. The power can only be turned on
by inserting the key and rotating clockwise to the ON position. In the ON position
the key cannot be removed. The key should be stored in a safe and controlled place.
3. Up / Down Control Button
This is control button to elevate and down the pressurized UV light arm.
4. Interlock Key Connector
This is connector where to activate the system. It is also safety feature control. You
may use in conjunction with remote door control switch.

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4.2.2 LCD Control Panel Display Screen

LightLink-CXL Corneal Cross-Linking System software features several types of screens,

as well as pop-up windows that display on the screen.
The screen is divided into two major portions. Left hand side of screen is called the
screen shot panel and control and the right hand side is the configuration screen and run
control (refer to fig. 4.3).

Configuration
Screen

Screen
Shot
Panel

Figure 4.3
Controls LCD Control Panel Display Screen Run Control

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Screen Shot Panel and Controls

This is the main program screen and all the control and configuration variable are set up
here. The screen divided into two major sections. The left screen is the shot panel and
controls. The right screen is the configuration set up and controls including the 'run' or
activating button. More detailed explaination of the controls are described on the next
page.

8 5 6

1 2 3 4 7 Figure 4.4
Screen Shot Panel and Controls

Legend
1. Shutdown Function Button 2. Saving Function Button
3. Customized Parameter Folder 4. Query or Help Function
5. Snapshot Mode 6. Record Mode
7. Snap shot Saving Function 8. Power Feedback Value Display

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1. Shutdown Function Button
This button will initial the shutdown process only for the LCD touch panel but not the
UV light head.

2. Save Function
This will save your file upon requested.

3. Customized Parameter Folder

This folder contains all the customized setting or parameter used in treatment or
indication. A pop out keyboard screen allows user to key in the user preference
name. It is very easy to access and retrieve any file per requested.

4. Query or Help Function

This function will assist in the event of clarification required and it is always link to the
manual for the cross reference.
5. Snap shot Mode
This function will activate the snap shot function.
6. Record Mode
This function will activate the record function.

7. Snap Shot Files Reallocate Interface Function

This functions as for snap shot file transferring to USB device only. This interface will
allow the pictures files to be reallocate directly to destination location.

8. Power Feedback Value Display

This display will show the actual power performing value.

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Configuration Screen and Run Control

This screen is where all the configuration variable are set up or adjust. This includes
Duration, Spot Size, Intensity, Aiming, Backlight, Density, Run Control, and Adjusters.
More detailed individual control is described on the next page.

1 2

3 4

5 6

7 8

9
11
10

Figure 4.5
Configuration Screen and Run Control

Legend
1. Density Indicator 2. Treatment Mode Selection Adjuster
3. Intensity Indicator 4. Intensity Adjuster
5. Duration Indicator 6. Duration Adjuster
7. Spot Sizes Indicator 8. Spot Size Adjuster
9. Aiming Indicator 10. Backlight Indicator
11. Ready Button

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1. Density Indicator
This display will show the density values. The density is formulated by intensity
times the duration in sec and divided by one thousand

2. Treatment Mode Selection Adjuster

This adjuster can be used to select preset treatment mode as Standard mode,
Intermediate mode, Accelerated Mode, and Custom mode. Its individual preset
configuration as follows:
a. STANDARD: 3.0mW/ cm²x 30min exposure @ Total 5.4J/cm²
b. INTERMIDIATE: 9.0mW/cm²x 10min exposure @ Total 5.4J/cm²
c. ACCELERATED: 18mW/ cm²x 5min exposure @ Total 5.4J/cm²
d. RAPID: 30mW/cm²x 3min exposure @ Total 5.4J/cm²
e. CUSTOMIZED: 45mW/cm²x 2min exposure@ Total 5.4J/cm²

3. Intensity Indicator
This indicator will show the light intensity values. It ranges from 0 to 30mW/cm2

4. Intensity Adjuster
The adjuster up / down key can be used to increase or decrease the UV light intensity.

5. Duration Indicator
This indicator will show the duration set up values according to the user 's preference.
It is in second unit and ranges from 10 to 1800S.

6. Duration Adjuster
The adjuster up / down key can be used to increase or decrease the duration times.

7. Spot Sizes Indicator

This indicator will show the spot sizes in mm unit. It ranges from 4 to 11mm.

8. Spot sizes Adjuster

The adjuster up / down key can be used to increase or decrease the spot sizes.

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9. Aiming Indicator
This indicator will display the aiming intensity level value. It ranges from 1 to 10
levels.

10. Backlight Button

This light will assist the user to enhance surrounding backlight. It ranges from 0 to 3
levels.

11. Ready Button

This key function is to confirm the configuration setting and will proceed to next
stage after being pressed it.

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UV Applying Process And Corneal Soaking (Stage II)
After the preload configuration is set up from the main screen and activate the process.
The pop up screen will appear and this where corneal soaking process takes place. This
screen divided into two major sections. The left part of the screen section contains the
configuration and countdown display. The right part of the screen contains the
scheduling, beeping, start and reset controls. More detailed explanation is listed on the
next page.

1
6 7
2

8 10
3

4 9 11

5 12 14

15
13

18 17 16

Figure 4.6
UV Applying Process And Corneal Soaking (Stage II) Screen Shot
Legend
1. Corneal Soaking Button (Stage I) 2. Duration indicator
3. Spot Size Indicator 4. Intensity Indicator
5. Density Indicator 6. UV Schedule Indicator
7. Schedule Adjuster 8. Audio Indicator
9. Audio Adjuster 10. Audio Type Indicator
11. Audio Type Selector 12. Pulse Duration
13. Pulse Duration Adjuster 14. Pulse Interval
15. Pulse Interval Adjuster 16. Exit Button
17. UV Start Button 18. UV Summary

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1. Corneal Soaking Button
This button is used to initial the pre corneal soaking countdown process (stage I)

2. Duration indicator
The indicator will show the Density remaining

3. Spot Size Indicator

The indicator will show the spot size

4. Intensity Indicator
The indicator will show the Intensity

5. Density Indicator
The indicator will show the Density Remaining

6. UV Schedule Indicator
This indicator will show the time remaining

7. Schedule Adjuster
This adjuster is used to increase or decrease the corneal soaking interval time
scheduling.

8. Audio Indicator
The Indicator will show the Audio level Intensity

9. Audio Selector
The adjuster up/down key can use to increase or decrease the audio level intensity

10. Audio Type Indicator

The indicator is to show the type of beeping sound is selected it. There are two types
of beep and continuous beeping

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11. Type Selector
This adjuster allows you to select the type of beeping

12. Pulse Duration

This will display the pulse duration or "ON" time frame and its time unit is in second

13. Pulse Duration Adjuster

This button will adjust the pulse duration time

14. Pulse Interval

This will display the pulse interval or "OFF" time frame and its time unit is in second

15. Pulse Interval Adjuster

This button will adjust the pulse interval time

16. Exit Button

This button will return to the main program screen and abort the treatment program

17. UV Start Button

This button will activate the UV light source for the treatment and return to main
program screen

18. UV Summary
This summary report will provide you the detailed and progress report on the
treatment session (refer to below figure)

Total Running or 'ON' Time

Total'OFF' Time

Total Processing Time (ON+OFF)

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Pre Corneal Soaking (Stage I)
This stage will allow you to use the countdown timer when pre corneal soaking process
begins. The scheduling, beeping type and start control may be set up as the user’s
preference or practice.

2
3

8
9

10

Figure 4.7
Pre Corneal Soaking Stage Configuration Menu
Legend
1. Soaking Duration Time 2. Soaking Duration Time Adjuster
3. Audio Indicator 4. Audio Type Indicator
5. Audio Type Adjuster 6. Audio Adjuster
7. Soaking Schedule Adjuster 8. Soaking Schedule Indicator
9. Start Button 10. Exit Button

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1. Soaking Duration Time
This is the scheduling time for soaking.

2. Soaking Duration Time Adjuster

This adjuster can increase or decrease of soaking during time frame and its timing
starts in minute basis

3. Audio Indicator
The indicator will show the audio level intensity

4. Audio Type Indicator

The indicator will display the audio type selected and two audio types are beeping
and continuous beeping

5. Audio Type Selector

The audio type selection can be adjusted through these adjusters

6. Audio Adjuster
This adjuster can increase or decrease the volume intensity

7. Soaking Schedule Adjuster

This adjuster is used to increase or decrease the total corneal soaking time
scheduling.

8. Soaking Schedule Indicator

The Indicator will show the total time frame of corneal soaking

9. Start Button
This button will start the time frame countdown or pause

10. Exit Button

This button will return to the previous screen and/or abort the program

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Procedure Finished Screen Shot
This screen shows the UV laser finished process and the total amount of time and density.

‘Confirm’ button allow you to confirm and return to main program.

Figure 4.8
Corneal Soaking Procedure Finished Screen Shot

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4.3 Basic Operation Overview
Initialization the system

- Turn on LCD panel power

LCD Power Switch

Figure.4.9 LCD Power Switch

- Wait for the system to be boot up correctly

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 - Ensure the live camera is functioning properly

Live Camera Engaged

Figure 4.10 Live Camera Engaged

- Power on the control box

Control Box Power Key Switch

Figure 4.11 Control Box Power Key Switch

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 - Ensure the system is establishing communication System Engaged

Figure 4.12 System Engaged

Treatment Mode Selection

- Select the “Treatment Selection”

Treatment
Selection Icon

Figure 4.13 Treatment Selection Icon

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 - Execute the “Ready” icon to proceed to soaking stage configuration

Ready
Icon

Figure 4.14 Ready Icon

Initial Corneal Soaking Timer (Stage I)

- Initial the “soaking stage” icon by pressing it

Soaking Stage I
Activated Icon

Figure 4.15 Corneal Soaking Timer (Stage I)

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 - Configure preference time frame and initial the countdown process

Configuration
screen

Figure 4.16 Configuration screen

- Countdown begins

Timer
Countdown

Figure 4.17 Timer Countdown

Timeout

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 - May initial any timeout as requested and restart again by pressing “Start” icon

Figure 4.18 Initial timer 1

- Re-initial timer if required or exit to proceed to Stage II process

Figure 4.19 Initial timer 2

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 Initial UV & Riboflavin Stage II Process
- Initialize the stage II and configure the during timing, pulse modulation function
and preference alarm sound type if required
Applying
Interval
Configuration Screen timing

Beeping
Sound
Type

Audio
Sound
Volume

Pulse
modulation
(duration &
Treatment Configuration Internal)

Command
Icon Keys
Figure 4.20 Initial UV & Riboflavin Stage II Process
- Setup the apply the Riboflavin solution time interval during the stage II or UV
processing and also the Pulse function (Interval / Duration) activation

Figure4.21 Initial UV & Riboflavin Stage II Process set over

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 - Time out to re-apply the Riboflavin solution time interval expired during the
stage II or UV processing and continue or review summary or exit

- Review procedures summary and continue the cycle until the whole process
completed

Figure 4.22 Procedures Summary Report

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 - End of the procedures and record the data if required

Figure 4.23 End of the procedures and record the data

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Section 5 INSTALLATION
5.1 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.

5.2 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 : [email protected]
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.

5.3 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. Set of metric Allen keys (M3 / M4 / M6)
3. 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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 5.4 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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5.5 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

Figure 5.5 LCD Ass’y latching releasing process 1

Figure 5.6 LCD Ass’y latching releasing process 2

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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

LCD Tilting Position Tighness Adjustment

by using the wretch enclosed in the
packaging
Figure 5.7 LCD Ass’y latching process
- 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

Figure 5.8 LCD cable connecting process

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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

Pressurized button

Figure 5.9 Elevation Process

- 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

Figure 5.10 Laser Arm Assembling

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- Gently glide in over the wheel base and ensure the no tangle or jam in the wiring
Note: Unevently slide in will result laser arm rocks possible causing the entire 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.

Cover the cap

Figure 5.11 Wiring Clearance Process

- Place the end cap after the wiring clearance process is completed it
- Take the tray table top and gently slide over the base and secure with the two M6
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

Table top

M6 size screws x 2 enclosed in

the packaging

Height will be fixed

once secured

Figure 5.12 Tray Table Assembling

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

Four Screws
Removing

Leave this side

hanging over the
laser arm

Figure 5.13 Four Screws Removing Process

- Gently place the UV laser head and use this side to hold UV head

Holder UV head

Figure 5.14 UV head Holding

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- 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

Stopper lock
(Always at lower
Securing screws position)

Figure 5.15 UV Head Holder Securing Process

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

Red dot to red dot

Figure 5.16 UV Head Connection

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- Gently assemble the top cover and secure with the four Phillips screws (Enclosed in
packing)

Fugure 5.17 Upper Laser Cover Assembling

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

Figure 5.18 System is Ready

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 5.6 Initialization the Equipment

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 to process
- 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 22.

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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 6 CLINICAL USE

6.1 Introduction
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.

Main Indications for Use:

The LightLink-CXL Corneal Cross-Linking System is being increasingly renowned as the
most innovative and revolutionary para-surgical procedure designated for treatment
numerous corneal disorders such as keratoconus, iatrogenic ectasia, post LASIK ectasia,
pellucid marginal degeneration.

Riboflavin Use in Cross-Linking:

Procedure involves irradiating the cornea by the UV-A light as generated by the cross
linking system, in conjunction with an independent Riboflavin (vitamin B2) solution, that
acts as a stimulant being photosynthesized by the UV-A on the corneal tissue, and
equally acting as a safety filer, creating a superficial barrier on the cornea preventing the
UV-A rays from reaching the inner retina.
Riboflavin is administered in form of droplets onto the cornel surface and is thus an
essential element of each corneal cross-linking procedure.
It is available and should be applied in two formulations as:

- Isotonic solution (Riboflavin 5-phosphate (0.1%) plus 20% Dextran T500)

- Hypotonic solution (Riboflavin 5-phosphate (0.1%))
Isotonic or Hypotonic solution is administered depending on the different levels of
corneal thickness, assuring the optimum treatment safety, in line with the recognized
corneal cross linking treatment protocols. The physician must measure and asses the
corneal thickness prior to each procedure using additional diagnostic equipment.

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Riboflavin Supply
Riboflavin must be manufactured under fully aseptic conditions by a Class II GMP
accredited manufacturer. It is commercially and readily available as generic solution,
available from numerous manufacturers, which are all suitable for use with the LightLink-
CXL device. LightMed Corporation does not limit the physician the choice of supplier for
the Riboflavin use in conjunction with the LightLink-CXL on the same commercial
industry merits such that
- In many markets globally Riboflavin is considered and registered as a device and
not a pharmaceutical agent, on merits that it acts as a filter protecting the retina
from UV-A light
- Subsequently some markets do not recognize Riboflavin as a CE device but a
Pharmaceutical agent, hence some element of pharmacological action is present
during the procedure
It is thus essential and commercially feasible for LightMed not to limit itself nor its
customers to a choice of Riboflavin supplier, nor to enforce a bundle model as none of
the global manufacturers of Riboflavin at present fulfills a requirement of either a CE
(Device) or Pharmaceutical approvals on the same solution.

Mechanism of Action
The combination of riboflavin and ultraviolet irradiation induces a photo polymerization
process that increases the corneal biomechanical resistance through formation of new
inter fibrillar covalent bonds of the corneal collagen.
The UV‐A activated riboflavin then stimulates production of singlet oxygen O²assisting in
a physical formation of new cross‐linked bonds across adjacent collagen strands in the
stroma.
The irradiation of the riboflavin molecules by UV‐A causes them to lose their internal
chemical balance, producing oxygen free radicals at which point, the riboflavin molecule
is unstable and becomes stable only when it is linked to two collagen fibrils. It creates a
crossed bridge between the collagen fibrils (cross‐linking), thus producing a general
strengthening of the cornea.
Once “crossed bridged” is created between collagen fibrils (therefore the term:
“cross‐linking”), it produces a rigidity increase of corneal layer.
Cross‐links change several physic‐chemical properties of collagen which is an indirect
evidence for cross‐linking.

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 Figure 6.1 chemical properties
Evidence from ongoing clinical research demonstrates a successful mechanical strength
recovery of the cornea by the cross‐linking process, leading to a successful arrest of
keratoconus progression, and increase of corneal rigidity up to 320%.

6.2 Clinical Guidelines

Disclaimer:
The following information has been based on the results of various clinical studies and are
provided with the intention of serving as general guidance only. Corneal Collagen Cross-
Linking with Riboflavin is considered as a revolutionary and still emerging technique under
clinical investigation, it is the ophthalmologist’s responsibility to familiarize themselves
with the latest recommended treatment techniques.

Eligibility and Exclusion Criteria:

Ongoing clinical studies and publications demonstrate the Corneal crosslinking with
Riboflavin as safe and effective treatment indicated for Grades I and II Keratoconus,
Post-Lasik Iatrogenic Ectasia, and Pellucid Marginal Degeneration.
Preoperative patient assessment is still necessary to determine whether a patient with
keratoconus or other corneal disorder is an appropriate candidate for Corneal collagen
Cross-Linking treatment.

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The primary contradiction for the corneal cross-linking procedure would be for patients
with:
-Patients with corneal thickness below 350μm (after removal of epithelium) in order
to prevent the retinal exposure to the UV light.
-Patients with severe corneal tissue scarring as uneven cornea (scarred corneal tissue)
may result in hot spots or penetration of the UV light to the retina.
-Patients with Keratometry measurement greater than 58 Diopters as the cornea may
not flatten enough to make the procedure worthwhile.
-Patients with history of severe corneal herpes simplex virus, as the exposure to the
UV-A light may reactivate the virus.
-Patients with pre-existing severe dry eye disease requires preoperative treatment,
because the condition may delay epithelial healing after corneal collagen cross
linking.

Pre Treatment Tools and Equipment:

- Cross Link System
- Pachymeter
- Surgical microscope / Slit Lamp producing blue light
- Topical anesthesia drops (e.g. novesine)
- Lid speculum
- Corneal marker 8.5 mm (large edge)
- Alcohol 20%
- Eye sponges
- 1ml or 3ml Riboflavin 1% with dextran 20%
- 1ml or 3ml Riboflavin 1% without dextran
- Eye pad
- Antibiotic eye drops
- Bandage contact lens

Treatment Steps (based on conventional protocol):

Step A: Corneal Abrasion
1. Apply a drop of topical anaesthesia.
2. Check the corneal thickness by the pachymeter at the thinnest location which is
slightly de-cantered inferiorly in keratoconus patients. Usually is greater (>)
450μm, if lower then expect a thin cornea after removing the epithelium.
3. Place the speculum onto the eye. While looking thru the microscope (optional),
place the corneal marker firmly and well cantered on the cornea and administer a
few drops of alcohol 20% for 30 second then soak the alcohol with the eye sponge.
4. Perform epithelium abrasion (usually 8-9mm).
5. Using a new corneal sponge carefully remove the fragile epithelium (Usually the
epithelium thickness is about 50μm).
6. Again, re-measure the corneal thickness NOTING if:

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 a. If the corneal thickness is greater (>) 400μm, proceed only with riboflavin
with dextran, as use of the ISOTONIC solution will help to maintain or slightly
swell (up to 2%) the cornea.
b. If corneal is below (<) 400μm than also prepare riboflavin without dextran, as
use of the HYPOTONIC solution swells the cornea, thereby broadening the
indications for Corneal Cross linking.

Step B: Corneal Soaking with Riboflavin

1. Proceed by administering one drop of Riboflavin every 5 minutes for a period of
30 minutes in total (6 drops).
2. At the end of the 30 minute period, recheck the Corneal Thickness with the
Pachymeter.
NOTE: If the corneal thickness is below < 400μm, start administering drops of the
Riboflavin without Dextran (Hypotonic) every 2, 3 minutes for about 10 minutes
until the cornea has swollen and become equal to or greater than (>) 400μm.
Ensure to confirming it by re-measuring the Corneal Thickness.
3. Check the Riboflavin diffusion in the anterior chamber with the Slit lamp (if
available).

Step C: Corneal Irradiance (UV-Application)

1. Confirm correct adjustments of the LightLink-CXL system (Aiming Beam positioning
X, Y and Z) and orientate the patient by instructing them to gaze at the fixation
target during the course of the procedure.
NOTE: The working distance of the LightLink-CXL is 120mm, whilst the distance can be
easily adjusted by focusing the two aiming beams to, a single beam produced at its
sharpest profile.
2. Select the correct aperture (treatment spot size to 6, 8 or 10mm), MAKE SURE TO
AVOID UV LIGHT CONTACT WITH THE LIMBUS.
NOTE: The size of the treatment beam should be the largest possible but smaller than
the limbus diameter to avoid destruction of corneal stem cells.
3. Set the desired treatment type noting the LightLink-CXL has inbuilt 4 different
treatment modes (protocols);
a. STANDARD: 3.0mW/ cm²x 30min exposure @ Total 5.4J/cm²
b. INTERMIDIATE: 9.0mW/cm²x 10min exposure @ Total 5.4J/cm²
c. ACCELERATED: 18mW/ cm²x 5min exposure @ Total 5.4J/cm²
d. RAPID: 30mW/cm²x 3min exposure @ Total 5.4J/cm²
NOTE: Each treatment option maintains the same overall Total Irradiance of 5.4J/cm²
delivered to the eye. Such is now considered to be the overriding safety factor UV-A
exposure during Corneal Cross-Linking treatment.
LightLink-CXL is also equipped with a closed loop power output circuit and built in power
meter, maintaining a safer and precise output energy

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 4. Continue administering 1 drop of Riboflavin every:
- 3 to 5 minutes until the end of the procedure (in STANDARD mode).
- 1.5 to 2 minutes until the end of the procedure (in INTERMIDIATE mode).
- 1 minute until the end of the procedure (in ACCELERATED mode).
- 0.5 to 1 minute until the end of the procedure (in RAPID mode).
5. Make sure that during the UV-A light is well centered and in focus during
treatment.
NOTE: The Riboflavin administration timer can be set on the LightLink-CXL system to
provide audible reminder and message prompting the user to administer it.
6. The LightLink-CXL will automatically turn off its UV-A light irradiance at the end
of the preset irradiation (3-30 minute) treatment period.

Post Treatment
- Immediate and follow on post treatment care requires;
- Administration of antibiotic eye drops (usually one drop per treated eye).
- Application of a bandage contact lens on the treated eye.
- Antibiotic eye drops and Topical Steroids QID for 4 days (QID = 4 times a day).
- Apply Analgesics as needed.
- Follow up daily, remove the contact lens on day 4.
- Fluorometholone eye drops QID for 1 month.

Side-Effects
Data from various studies on Corneal Cross-linking indicates the treatment as save,
effective and with no significant side effects recorded to date. The safety of crosslinking
to the intraocular structures has been also extensively evaluated indicating that the
Keratocytes are depleted to the 300μm level. These cells however regenerate by 6
months. The corneal endothelium, the crystalline lens, and the retina are preserved as
long as a minimum corneal thickness of 400μm is respected. The ultraviolet light dose is
designed to prevent damage to the corneal endothelium and other structures within the
eye. No cataracts have been attributed to this treatment in European trials.
Postoperatively, there is some light sensitivity and mild discomfort during the first week
but not unlike photorefractive keratectomy (PRK). Other consequences of the
procedure include an inability to wear contact lenses for several weeks after the
treatment. Also, corneal shape changes necessitate the refitting of contact lenses or
changes in spectacle correction. As with many treatments, there may also be long-term
risks that have not yet been identified. The increased corneal rigidity resulting from the
procedure may wear off over time and further periodic treatments may be required.
Data from clinical research indicates repeat corneal cross-linking procedure needs to be
performed every 7 years.

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Section 7 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.

7.1 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.

7.2 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.

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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.

7.3 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.

7.4 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.

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Section 8 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.

8.1 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

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8.2 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 -Call the authorized service or
Too High is exceeded by 20% of the manufacturer for further assistance
preset power value
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
manufacturer for further assistance
Err 08 - Calibration -The system is -Call the authorized service or
Error uncalibrated manufacturer for further assistance

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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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