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Lightmed LightLink CXL, Operator'S Manual

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Lightmed LightLink CXL Operator'S Manual Download Page 5

 

 

4

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 

Summary of Contents for LightLink CXL

Page 1: ...Operator s Manual LightLink CXL Corneal Cross Linking System ...

Page 2: ...1 ...

Page 3: ...Operator s Manual for the LightLink CXL Corneal Cross Linking System Directive 93 42 EEC Doc No DCX001 Rev No 01 ...

Page 4: ...3 ...

Page 5: ...ein 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 Di...

Page 6: ...5 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 ...

Page 7: ... 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 ...

Page 8: ...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...

Page 9: ...Link 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 ...

Page 10: ...e 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 ...

Page 11: ...pproved 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 spe...

Page 12: ...nking 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 ...

Page 13: ...recautions 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 photosen...

Page 14: ...inking 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 ...

Page 15: ...he 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 ...

Page 16: ... 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: ...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: ...ATION Lightmed Corporation MODEL NO SERIAL NO Schiffgraben 41 30175Hannover Germany Medical Device SafetyS ervice GmbH MDD93 42 EEC EU Authorized Representative Shulin City Taipei 238 TAIWAN No1 1 Lane 1 Pao An Street S ection 3 Manufactured byLightMed Corporation MANUFACTURED EC RE P Schiffgraben 41 30175 Hannover Germany Medical Device Safety Service GmbH MDD 93 42 EEC EU Authorized Representati...

Page 19: ...our LCD with built in PC PULSE DURATION Adjustable 10S 30min CALIBRATION Automatic INTEGRATED POWER METER YES MAX POWER OUTPUT ERROR 10 SPOT SIZES 4 11mm Continuously Variable WORKING DISTANCE 55mm AIMING BEAM Dual Red Diodes 635 650nm AIMING BEAM POWER 1 0mW VIDEO SYSTEM Integrated Hi Res Auto Focusing Camera FLOOR STAND Integrated height adjustable with pantographic arm OPERATING VOLTAGE 90 240V...

Page 20: ...ptional 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 Nu...

Page 21: ...mination 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 Gen...

Page 22: ...splays 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 Figure 4 1 System breakdown diagram UV Head LCD Touch Screen Control Box ...

Page 23: ...his 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 Interlock Key Connector ...

Page 24: ...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 T...

Page 25: ... 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 Figure 4 3 LCD Control Panel Display Screen Screen Shot Panel Configura tion Screen Controls Run Control ...

Page 26: ...rols 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 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 Shot or Record Function 6 Snapshot Mode 7 Snap shot Saving Functio...

Page 27: ...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 Shoot or Record Function This function will execute the picture shooting or video recording process 6 Snap Shoot Mode This function will activate the snap shot mode 7 Snap Shot Files Reallo...

Page 28: ... Adjusters More detailed individual control is described on the next page 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 1 2 3 4 5 6 7 8 9 10 11 ...

Page 29: ...l 5 4J cm d RAPID 30mW cm x 3min exposure Total 5 4J cm 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 ran...

Page 30: ...ntensity 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: ...tion 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 Figure 4 6 Corneal Soaking Stage Screen Shot Legend 1 Corneal Soaking Button 2 Duration indicator 3 Spot Size Indicator 4 Intensity Indicator 5 Density Indicator 6 Schedule Indicator 7 Schedule Adjuster 8 Audio Indicator 9 Audio Adjus...

Page 32: ...he indicator will show the Density Remaining 6 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 Adjuster The Adjuster up down key can be used to increase or decrease the Audio level intensity 10 Type...

Page 33: ...juster 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: ...his 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: ... 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: ...nts 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 ligh...

Page 37: ...acking 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 XL0000 LightLink CXL Serial Number Manufactured By LightMed Corporation No 1 1 Lane 1 Pao An St Sec 3 Shulin City TEL 886 2 2688 1726 E mai...

Page 38: ...dual 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...

Page 39: ...ion 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 boxLCD Touch Screen Swing UV Arm UV light Head Figure 5 3 LightLink CXL Corneal Cross Linking System Breakdown UV light Head UV light Arm LCD Touch Screen Base Wheel Control Box ...

Page 40: ...ls 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 Figure 5 4 Wheel Stopper Location Wheel stopper ...

Page 41: ...ecure 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 Figure 5 6 UV light Arm Reassembling UV light Arm ...

Page 42: ...acket and four screws refer to fig 5 7 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 UV light Head ...

Page 43: ...ed as Disengage the emergency button and interlock plug in Plug in the key into keyhole and turn the key switch for power on Boot up system software and allow self testing process kick in Check for any abnormality or error code process refer to troubleshooting section 8 0 If the system rechecking process is valid then the system is ready to go More detailed screen operation and description refer t...

Page 44: ...ystem 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 ___...

Page 45: ...K 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 cor...

Page 46: ... 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 a...

Page 47: ...in 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...

Page 48: ...ink 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 t...

Page 49: ...ilable 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 55mm whilst the distance can be easily adjusted by focusing the two aiming beams to a single beam ...

Page 50: ...rops 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 endothe...

Page 51: ...ink 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 conta...

Page 52: ...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 Tec...

Page 53: ... Warning Interlock Interlock plug not connected Check the Interlock connection If the problem persists call the authorized service or manufacturer for further assistance Warning Motor Move Motor is moving Wait for Motor to be ready If the problem persists call the authorized service or manufacturer for further assistance Warning Communication failure Laser head power not engaged or miscommunicatio...

Page 54: ...rate Reboot the system If the problem persisted call the authorized service or manufacturer for further assistance Err 02 UV Diode Current Too High UV Diode current is out of range or over the limits Call the authorized service or manufacturer for further assistance Err 03 Aiming UV light Failure Aiming UV light beam failure Call the authorized service or manufacturer for further assistance Err 04...

Page 55: ...stem watchdog flag Reboot the system Call the authorized service or manufacturer for further assistance Err 11 Communication Error No communication between optical driver and the console within the time of frame of 300ms during UV firing Reboot the system If the problem persisted call the authorized service or manufacturer for further assistance Err 12 Power Error The system power is failure Call ...

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