Lightmed LightLink CXL Operator's Manual
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Lightmed LightLink CXL Operator's Manual

Corneal cross-linking system
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Operator's Manual
LightLink - CXL
Corneal Cross-Linking System

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Summary of Contents for Lightmed LightLink CXL

  • Page 1 Operator’s Manual LightLink - CXL Corneal Cross-Linking System...
  • Page 3 Operator’s Manual for the LightLink - CXL Corneal Cross-Linking System Directive 93/42/EEC Doc. No. : DCX001 Rev. No. : 01...
  • Page 5 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...
  • Page 6 Document Title: Operators Manual for the LightLink-CXL Corneal Cross- Linking System Document Number: DCX001-01 Document Revision History: DRAFT Sep. 2012 Draft prepared Oct. 2012 April 2013 Issue...

  • Page 7: Table Of Contents

    Contents of Manual Section 1 INTRODUCTION ..................8 Section 2 SAFETY ....................9 Product Classifications ................ 9 Warnings and Precautions ..............10 User Safety ..................11 Patient Safety ..................12 Safety Controls and Features ............. 13 Product Labeling ................16 Section 3 PRODUCT SPECIFICATIONS ..............
  • Page 8 LIST OF DRAWINGS / FIGURES Figure Description Page Safety Controls and Features Product Safety Labeling Product Safety Labeling System breakdown diagram Base wheel and Control Box LCD Control Panel Display Screen Screen Shot Panel and Controls Configuration Screen and Run Control Corneal Soaking Stage Screen Shot Pre Corneal Soaking Stage Countdown Screen Shot Corneal Soaking Procedure Finished Screen Shot...

  • Page 9: Introduction

    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.

  • Page 10: Safety

    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.

  • Page 11: Warnings And Precautions

     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 ...

  • Page 12: User Safety

    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.

  • Page 13: Patient Safety

    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.

  • Page 14: Safety Controls And Features

    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.
  • Page 15 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: 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.
  • Page 16 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.

  • Page 17: Product Labeling

    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...
  • Page 18 EMERGENCY EMERGENCY Manufactured by LightMed Corporation No1-1, Lane 1, Pao-An Street, Section 3 Shulin City, Taipei 238, TAIWAN EC REP EU Authorized Representative (MDD 93/42/EEC) Medical Device Safety Service GmbH Schiffgraben 41, 30175 Hannover, Germany MANUFACTURED: ULTRAVIOLET RADIATION POWER POWER...

  • Page 19: Product Specifications

    Section 3 PRODUCT SPECIFICATIONS The following are the System Specifications for the The LightLink-CXL Corneal Cross-Linking System . UV LIGHT WAVELENGTH 365nm ± 5nm UV LIGHT SOURCE UV LED Cluster System MAX. POWER RANGE Factory Limited 30mW/cm IRRADIANCE Adjustable: mW/cm² - 30mW/cm² Continuously Variable POWER MONITORING Automatic: By integrated power monitor with feedback loop.
  • Page 20 Temperature Range Transport: -10 to 70°C Operating: 15 to 30°C Storage: -10 to 55°C Operating: 30% - 85% non-condensing Relative Humidity Range Storage and Transport: up to 95% non-condensing Operating: 800-1060 mbar Atmospheric pressure Storage and Transport: 500-1060 mbar Air cooled Cooling System Optional Accessories The following accessory can be purchased from the Distributor to use with LightLink-CXL...

  • Page 21: Principles Of Operation

    Section 4 PRINCIPLES OF OPERATION 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”).

  • Page 22: Lightlink-Cxl Controls And Displays

    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). UV Head LCD Touch Screen Control Box Figure 4.1 System breakdown diagram...

  • Page 23: Base Wheel And Control Box

    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. Figure 4.2 Base wheel and Control Box Legend 1. Emergency Stop Switch 2. Key Switch 3. Up / Down Control 4.
  • Page 24 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.

  • Page 25: Lcd Control Panel Display Screen

    LCD Control Panel Display Screen 4.2.2 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.
  • Page 26 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.
  • Page 27 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.
  • Page 28 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, Audio, Density, Run Control, and Adjusters. More detailed individual control is described on the next page. Figure 4.5 Configuration Screen and Run Control Legend...
  • Page 29 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 Treatment Mode Selection Adjuster This adjuster can be used to select preset treatment mode as Standard mode, Intermediate mode, Accelerated Mode, and Custom mode.
  • Page 30 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. 11. Ready Button This key function is to confirm the configuration setting and will proceed to next stage after being pressed it.
  • Page 31 Corneal Soaking Screen Shot 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.
  • Page 32 Corneal Soaking Button This button is used to initial the pre corneal soaking countdown process Duration indicator The indicator will show the Density remaining Spot Size Indicator The indicator will show the spot size 4. Intensity Indicator The indicator will show the Intensity 5.
  • Page 33 11. Type Adjuster This adjuster allows you select the type of beeping 12. UV Start Button This button will activate the UV light source for the treatment and return to main program screen. 13. Reset Button This button will return to the main program screen.
  • Page 34 Pre Corneal Soaking Countdown Screen Shot 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. Figure 4.7 Pre Corneal Soaking Stage Countdown Screen Shot...
  • Page 35 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...

  • Page 36: Installation

    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.

  • Page 37: Unpacking And Receiving Inspection

    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.

  • Page 38: Tools And Equipment

    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.

  • Page 39: Setting Up The Uv Light System Parts

    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: ...

  • Page 40: Reassembling Process

    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...
  • Page 41 - Take the LCD display and secure the four screws at its rear end (refer to fig. 5.5) Figure 5.5 LCD Touch Screen Reassembling - Take the UV light arm ass’y and gently mount it over the base wheel (refer to fig. 5.6) UV light Arm Figure 5.6 UV light Arm Reassembling...
  • Page 42 - Mount the UV light head gently over the UV light arm and secure it with bracket and four screws (refer to fig. 5.7) UV light Head Figure 5.7 UV light Head Reasembling - Ensure the UV light head is well secured to the arm and swing around for the stability test Note: Ensure the stopper is always locked and well ground prior any integrity or stability testing.

  • Page 43: Initialization The Equipment

    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 process kick in - Check for any abnormality or error code process (refer to troubleshooting section 8.0)
  • Page 44 Installation Record Sheet Product Name: Corneal Cross-Linking System Model: LightLink- CXL Serial Number: _____________ 1. System Setup ( Tick for OK )  All parts received and checked OK.  No damage to instrument packaging.  Adjust cables then attach cable clamps etc. ...

  • Page 45: Clinical Use

    Section 6 CLINICAL USE 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.
  • Page 46 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.

  • Page 47: Clinical Guidelines

    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%. 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.
  • Page 48 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.
  • Page 49 6. Again, re-measure the corneal thickness NOTING if: 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.
  • Page 50 LightLink-CXL is also equipped with a closed loop power output circuit and built in power meter, maintaining a safer and precise output energy 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).

  • Page 51: Maintenance

    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.

  • Page 52: Repairs

    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.

  • Page 53: Troubleshooting

    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. Warning A completed listing of LightLink-CXL warnings and the suggested corrective action are detailed as following: Warning Cause(s)

  • Page 54: Error Codes

    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.
  • Page 55 Error uncalibrated manufacturer for further assistance Err 09 – ROM Error -System failed to pass the -Reboot the system software integrity test -If the problem persisted, call the authorized service or manufacturer for further assistance Err 10 – Watchdog -System watchdog flag -Reboot the system Error -Call the authorized service or...

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