Lightmed LightLink CXL User manual

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

1

Operator’s Manual
for the
LightLink - CXL
Corneal Cross-Linking System
Directive 93/42/EEC
Doc. No. : DCX001
Rev. No. : 01

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Operator’s 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 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 sale 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, 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: Operators Manual for the LightLink-CXL Corneal Cross-
Linking System
Document Number: DCX001-01
Document Revision History:
DRAFT Sep. 2012 Draft prepared
A1
01
Oct. 2012
April 2013
A1
Issue

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Contents of Manual
Section 1 INTRODUCTION .................................................................................... 8
Section 2 SAFETY ................................................................................................. 9
2.1 Product Classifications ........................................................................ 9
2.2 Warnings and Precautions ................................................................. 10
2.3 User Safety .......................................................................................... 11
2.4 Patient Safety ..................................................................................... 12
2.5 Safety Controls and Features ............................................................. 13
2.6 Product Labeling ................................................................................ 16
Section 3 PRODUCT SPECIFICATIONS ................................................................ 18
Section 4 PRINCIPLES OF OPERATION ...............................................................20
4.1 General Description ............................................................................ 20
4.2 LightLink-CXL Controls and Displays .................................................. 21
4.2.1 Base wheel and Control Box............................................................... 22
4.2.2 LCD Control Panel Display Screen ......................................................24
Section 5 INSTALLATION .................................................................................... 35
5.1 Introduction and Requirements ......................................................... 35
5.2 Unpacking and Receiving Inspection ................................................ 36
5.3 Tools and Equipment .......................................................................... 37
5.4 Setting Up the UV light System Parts ............................................... 38
5.5 Reassembling Process ........................................................................39
5.6 Initialization the Equipment ............................................................... 42
Section 6 CLINICAL USE ..................................................................................... 44
6.1 Introduction ....................................................................................... 44
6.2 Clinical Guidelines .............................................................................. 46
Section 7 MAINTENANCE ................................................................................... 50
7.1 Operator / User Maintenance ............................................................ 50
7.2 Cleaning ............................................................................................. 50
7.3 Repairs ................................................................................................ 51
7.4 Periodic Maintenance ......................................................................... 51
Section 8 TROUBLESHOOTING .......................................................................... 52
8.1 Warning .............................................................................................. 52
8.2 Error Codes ......................................................................................... 53

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LIST OF DRAWINGS / FIGURES
Figure Description Page
2.1 Safety Controls and Features 13
2.2 Product Safety Labeling 16
2.3 Product Safety Labeling 17
4.1 System breakdown diagram 20
4.2 Base wheel and Control Box 22
4.3 LCD Control Panel Display Screen 24
4.4 Screen Shot Panel and Controls 25
4.5 Configuration Screen and Run Control 27
4.6 Corneal Soaking Stage Screen Shot 30
4.7 Pre Corneal Soaking Stage Countdown Screen Shot 33
4.8 Corneal Soaking Procedure Finished Screen Shot 34
5.1 Whole System Packaging Carton 36
5.2 Packaging Label 36
5.3 LightLink-CXL Corneal Cross-Linking System Breakdown 38
5.4 Wheel Stopper Location 39
5.5 LCD Touch Screen Reassembling 40
5.6 UV light Arm Reassembling 40
5.7 UV light Head Reassembling 41
Record Sheet
Installation Record Sheet 43

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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)

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 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.
 We do not recommend the equipment use in places with gases, anesthetics or

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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

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earth connections and earth leakages.
 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.
Figure 2.2
Product Safety Labeling

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DOOR
INTERLOCK
POWER
100-230V ~ (Fuse:T3.15AH250V)INPUT:
50/60Hz, 400VA fuse as marked above
WARNING
Risk of fire
Replace only with
EMERGENCY
PRESSURIZED BUTTON
ULTRAVIOLET
RAD IATION
EMERGENCY
PRESSURIZED BUTTON
POWER
DOOR
INTERLOCK
100-230V ~ (Fuse:T3.15AH250V)INPUT:
50/60Hz, 200VA fuse as marked above
WARNING
Risk of fire
Replace only with
ULTRAVIOLET
RADIATION
Lightmed Corporation
MODEL NO:
SERIAL NO:
Schiffgraben 41, 30175 Hannover, Germany
Medical Device Safety Service GmbH
(MDD 93/42/EEC)
EU Authori zed Representative
Shulin City, Taipei 238, TAIWAN
No1-1, Lane 1, Pao-An Street, Section 3
Manufactured by LightMed Corporation
MANUFACTURED:
EC REP
Schiffgraben 41, 30175 Hannover, Germany
Medical Device Safety Service GmbH
(MDD 93/42/EEC)
EU Authorized Representative
Shulin City, Taipei 238, TAIWAN
No1-1, Lane 1, Pao-An Street, Section 3
Manufactured by LightMed Corporation
MANUFACTURED:
EC REP
Figure 2.3
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
MAX. POWER RANGE
Factory Limited
30
mW/cm
2
IRRADIANCE Adjustable:
1
mW/cm² - 30mW/cm² Continuously 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: 1
0
S
-
3
0
min
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
Inte
grated, 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
P
ower
200VA
Fuse rating T3.15AH250V @ 100-230Vac (Time Lag)

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Temperature Range Transport: -10 to 70°C
Operating: 15 to 30°C
Storage:
-
10 to 55°C
Relative Humidity Range
Operating: 30%
-
85% non
-
condensing
Storage and Transport: up to 95% non
-
condensing
Atmospheric pressure
Operating: 800
-
1060 mbar
Storage and Transport: 500-1060 mbar
Cooling System Air cooled
Optional Accessories
The following accessory can be purchased from the Distributor to use with LightLink-CXL
Corneal Cross-Linking System UV light Product. It is only available for customers outside
the EU Countries due to the requirements for CE Marking. The manufacturer does not
have controlled over the use of the attachments that are available and their indications
for use.
Item Description Part Number Suppliers FDA (k) Number
Safety glasses
OD6@365nm
620003 NOIR N/A(CE-Certified
EN207/EN208)