Lightmed LightLink CXL User manual

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

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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)