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Manual
LightLink - CXL
Corneal Cross-Linking System
Preliminary Service Manual
for the
LightLink - CXL
Corneal Cross-Linking System
Directive 93/42/EEC
as amended by 2007/47/EC
Doc. No. : XLxxxx-xxx
Rev. No. : A1
Service 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 Service Manual should be studied and understood before proceeding to operate the
equipment on patients.
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
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
EC REP
EU Representative: Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Record Sheet
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.
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.
The LightLink-CXL has been designed to comply with the following standards:
The following are the System Specifications for the The LightLink-CXL Corneal Cross-
Linking System.
CALIBRATION Automatic
DIMENSIONS (in centimetres cm) 130cm (H) x 128 (W) x 40cm (L) At full system span
WEIGHT 48kg
Power 200VA
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.
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 : sales@lightmed.com
This device complies to the requirements of
21CFR . Chapter 1 . Sub-chapter J .
Figure 5.2
Packaging Label
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.
UV light Arm
Figure 5.3
LightLink-CXL Corneal Cross-Linking System Breakdown
- 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
Mounting Bracket
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
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
- 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
Note: Unevenly slide in will result laser arm rocks possible causing the entire laser
arm 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.
- Take the tray table top and gently slide over the base and secure with the two 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
- 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
OR
- Gently place over the laser head ass’y over a flat and secure table top and adjust the
Cross-link height to the laser head
Table top
- Now the system is fully installed and ready to initial the testing
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 21.
Now the system is fully setup, the final verification is required to conduct before demo
or handle over to user end. These performance procedures can be divided as follows:
- Power on the main switch and allow it to boot and distribute the power source
- Validate if there is abnormally beeping sound
- Power on the LCD and await for the boot up process to be complete
- Validate if there is software program is properly boot up (refer to below figure)
- Validate if the camera integrity is ok
- Power on by turning the key-switch and validate if the green LED is able to lit
- Recheck if the aiming are visible or in place displaying the two dots
- Validate if the LCD and laser head module established connection
The system consists of three major parts: Laser Head, Control Box, and LCD touch
control panel integrated with computer platform
A coil power cord is uncoiled and connected to appropriate source power plug in order
for system to function properly first. Secondly, power switch on the LCD control panel
display is then turn on and wait for the system to boot up properly without any error.
Once the software is properly boot up, then the key-switch is inserted and turned to the
ON position (with the Emergency switch in the out or OFF position). And then the laser
head microprocessor controller will perform some internal checks to verify that the
machine is functioning as it should be.
Camera and aiming are engaged when the system is boot up properly and system is
ready to perform the treatment.
There are three major elements of modules linked together to formulate the entire laser
system such as, Laser Head ass’y, Power Control Box Ass’y, and LCD Touch Screen
integrated with software system.
The following system block diagram provides an overview of basic details for the design
of the Crosslink system. These blocks diagram includes PC UI controller, Power supply,
and CPU Module. For details individual subassemblies or components explanation are
listed below.
Webcam
LED Lamp
Micro
PC Aiming Diode
Controller
Controller
Interlock
365 UV LED
Motor
Controller
Power Power
UV LED
Supply Supply
Detector
AC
Mains
A. CPU PCB
2
3
15 14 13 12 11 10 9 8 7
Legends
1. Main Power Connector (CN1) 2. Power Photosensor Connector (CN2)
3. CCD Camera and Backlight Connector (CN8) 4. Aiming Module Signal Connector (CN4)
5. Aiming Module Signal Connector (CN5) 6. Interlock Key Connector (CN6)
7. Aiming Intensity (VR1) 8. Aiming Intensity (VR2)
9. Aperture Motor VR Connector (CN7) 10. RS232 Communication Connector (CN3)
11. Aperture Motor Connector (CN9) 12. Power Energy Gain Adjuster (VR3)
13. Software Download Connector (JP1) 14. CPU Chips (U1)
15. Buzzer (BZ1)
MCU msp430f169 support white LED light for the Aiming Laser
external camera video capture, two aiming module, Module
UVLED laser system, Aperture motion control,
buzzer, interlock signal, RS232 communication port,
etc UVLED Laser
DC to DC power supply on board had +12V +5V - Module (including
12V…etc photo sensor
feedback)
The input voltage applies to the CPU then it converts to +12, +5, and -12VDc.
The laser voltage is gradually increased to 24 VDC and maintains it if the laser system
is activated it. When the laser is ‘ON’, the voltage must greater than 20 VDC then
the condition ‘ON’ criteria is met (refer to figure xx).
Once the voltage drops till below 16 VDC then the laser is in ‘OFF’ condition. This is
triggering system is accomplished by Schmitt trigger concept.
The CPU then will translate if the voltage is at +5VDC for ‘ON or 20VDC’ state and 0
VDC for ‘OFF or <=16VDC’ state and it can measure across the TP17 (POR signal).
If the laser is unable to function properly or has no output, then confirm if there is 24
VDC across the ZD1 or CN1 connector or TP11 and TP17 for the digital output signal of
5VDC.
20V
16V
0V
Laser OFF Laser ON Laser OFF Laser ON
Power startup
In UVLED circuitry driver, the voltage falls within 0 to 2.5V and can be measured
across TP12. This voltage value represents the output power. The voltage is
proportional to output power (1mW to 40mW). For example, if the voltage is at
2.5VDC, then the output power is close to 40mW.
UVLED voltage should fall within 14.5V to 18.5V measures across CN8 pin 3 & 5 when
the laser is ‘ON’ stage. UVLED photo sensor is connected to CN2 and feedback to
MCU for the UVLED power intensity. The adjustment could be adjusted through the
VR3 pot.
Aiming circuitry is controlled by a set of DAC IC and current limited circuitry loop.
Two aiming intensity can be adjusted through VR1 and VR2 pot. CN4 connector is
corresponding to VR1 and CN5 is VR2. Aiming control voltage range is from 0 to
2.5VDC and can measure across TP9.
The user and system interface communication establishment is via through the RS232
protocol and CN3 is the connection.
The buzzer is also built in the CPU PCB located in lower left quadrant.
Two aiming modules are used to aim the target. The intensity can be recalibrated in
the CPU PCB through two VRs (VR1 and VR2). The intensity is range from 0 to 300
mW. The voltage is proportional to intensity. The intensity is divided into 10
segment bar graph. So when the max intensity is turned, voltage is at xx VDC.
CCD Camera
This CCD camera is assisting the doctor to view the treatment area closely and
accurately. The resolution of the camera is 1200 million pixels.
CCD camera is USB plug-in device and the applied voltage is +5VDC and the current
consumption is 0.5A
The CCD camera position can be realigned through the four set screws. More
detailed you may refer to the realignment process on page xx.
This motor ass'y is used to control the laser aperture spot size. The VR pot is
reflected back the DAC position for CPU to control.
The motor applied voltage is +/- 12VDC. The motor ass'y has current limited
protection of 60mA so if there is any over current incident, the system will shut it
down.
This white backlight LED is used to assist the doctor to see the treatment area much
more clearly. The applied voltage is +12VDC. The LED intensity is driven by current.
The max current limitation is 40mA. TP20 is the rechecking point in the CPU PCB and
the voltage is ranged from 0-2.5VDC.
Detector PCB
This detector is used to feedback the laser output power to MCU so it will
recalculate if the power gain is correctly. The applied voltage is +5VDC.
Power Supply
AC Filtering PCB
A. Power Supply
This power supply converts the AC to DC voltage and provides the corrected voltage
to operate system. It is an auto-ranging power supply module. The input main
voltage can be ranged from 90 to 240 AC volts. The output voltage is +12 VDC.
This power supply converts the AC to DC voltage and provides the corrected voltage
to the LCD display module. It is an auto-ranging power supply module. The input
main voltage can be ranged from 90 to 240 AC volts. The output voltage is +24 VDC.
C. AC Filter PCB
The Input mains voltage is connected to this PCB. This PCB provides electrical
filtering so that the Laser system can pass the EMC requirements of the relevant
standards. It is auto-switching range voltage.
This software platform provides an interface between the user and console system.
More screen operation control are detailed or explained in the operator manual
section 4 on page 27.
Repair Notes
Before removing any module part ensure the power is always turned off and
power cord disconnected.
Ensure the statics wrist band is always worn prior to removing any laser diodes
since they are static sensitive components.
Removal
1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws by using 2.0mm and 2.5mm Allen keys
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
First screw
Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.
Removal
1. Remove the laser head cover off (only the front cover)
2. Disconnect the aiming connector (Depending on the which one)
3. Loosen the screw by using 1.5mm Allen key
4. Gently and slowly remove the laser diode up
Note: Do remember to tag all the connectors
Set screw
Installation
1. Place back the new laser diode and retighten the set screw
2. Reconnect the connectors and verify it carefully prior to power on
Note: Do remember to reconnect the connector before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance and recalibrate it if required
refer to section xx on page xx.
Removal
1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5. Remove the cable connection and the two screws by using 1.5mm
6. Gently and slowly remove the PCB down
Detector Connector
Installation
1. Reseat the PCB back and screw back the two screws
2. Reconnect back the connector
3. Reseat the CPU PCB back to the screw pole and screws back the three screws
4. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
5. Ensure there is no loosen connections and close up the cover top
6. Power on and validate the system performance refer to section xx on page xx.
7. Recalibrate the Power and Detector parameter (refer to recalibration
procedures)
Removal
1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5.
Connector
two screws
Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.
Removal
1. Remove the laser head cover off (only the front cover)
2. Disconnect and tag the cablings or connectors
3. Remove the three screws (refer to CPU replacement procedures)
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
5. Loosen all the screws and gently remove the motor ass'y from the gear contact
Installation
1. Reseat the motor ass'y back to the gear and screws back the screws
2. Reseat the CPU PCB ass'y back
3. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
4. Ensure there is no loosen connections and close up the cover top
5. Power on and validate the system performance refer to section xx on page xx.
Removal
1. Remove the laser head front cover off and open the rear cover partially
2. Disconnect and tag the cablings or connectors
3. Remove the three screws
4. Gently and slowly remove the PCB down
Note: Do remember to tag all the connectors
Installation
1. Reseat the PCB back to the screw pole and screws back the three screws
2. Reconnect all the connectors and verify them carefully prior to power on
Note: Do remember to reconnect all connectors before turning on the power
3. Ensure there is no loosen connections and close up the cover top
4. Power on and validate the system performance refer to section xx on page xx.
Purpose
The purpose of this procedure is to calibrate or restore the laser system after any
module replacement or during any routine checkout process. Prior to commencing the
procedure, only the qualified or trained personnel is permitted to conduct this process.
Performing these procedures will reset the all the factors of the laser system.
Note: Do remember to remove the front cover before any realignment process
takes place
This procedure will calibrate the motor aperture position which allows the system to
have the corrected spot size during the any treatment procedure. Improper spot size
will affect the treatment quality.
Hidden Icon
Motor
Parameter Icon
- Press the "Motor Parameter" icon to initial the calibration process
- Set the spot size to 4mm and power to 1mW
Motor Position
Direction (CW
or CCW)
- Fire the laser again and realign the spot size to fit the reference spot size 4mm by
rotating CW or + and CCW or - direction
- Repeat the process until it fits into the reference spot circle and save the
calibration value and cycle power and validate the origin position or 4mm
- Repeat the same process from 5mm to 11mm and save every interval position
value
Note: The position alignment from 5mm or above spot size is only in CW
direction
Saving icon
CW direction
alignment
This procedure will calibrate the power performance which allows the system to have
the corrected power throughput during the treatment procedure. Improper power will
affect the treatment quality.
Wavelength at
Set 'Power'
at 30mW
Execution
Run Key
- Measure the power against the calibration data sheet (refer to below figure) and
adjust the factor value until it is consisted with the data sheet specification
- Repeat the same process until every scale is performed and calibrated
- Save the values before exiting from the power parameter screen
This procedure will calibrate the system detector value which allows the consisted value
during the any treatment procedure. Improper detected will result in treatment quality
or endanger patience.
Set 'Power'
at 30mW
Detected value
- Proceed to next interval and adjust the interval ratio value so it will fall within the
calibration data sheet
- Save the value when the process is completed
This procedure is intended to calibrate the individual spot sizes power for the system
spot power consistency and accuracy during the treatment procedure.
Purpose
The purpose of this procedure is to align or restore the laser system after any module
replacement or during any routine checkout process. Prior to the commencing the
procedure, only the qualified personnel is permitted to conduct this process.
1. Aiming Alignment
- Spot size
- Intensity
- Overlapping
2. CCD Camera Alignment
- Adjust the reflected mirror until the uniform and rounded spot is formed
8.2 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.
8.3 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.
9.1 Warning
A completed listing of LightLink-CXL warnings and the suggested corrective action are
detailed as following:
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 -Recalibrate the power and detector
Too High is exceeded by 20% of the parameter
preset power value -Validate the power detector sensor
integrity
-Call the authorized service or
manufacturer for further assistance
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
10.1 Introduction
The purpose of this procedure is to upgrade or rewrite the software V 1.X for Truscan
system. Performing this procedure will erase the original program and install the new
version into the CPUs for the whole system.
10.2 Preparations
Equipment Requirement
-PC or Laptop
System Requirement
Window XP or above
- Plug in the MSP-FET430UIF including the cable and execute the program icon
- Power on the console and configure the download file by 'Open Code File' icon
The manufacturer provides a Limited Warranty on the Crosslink Laser for a fixed period
of time from the date of initial installation. The warranty period is for a minimum of 12
months however some Distributors may offer extended warranty periods. Please
contact your Distributor for this information if you are unsure of the details. The
manufacturer warrants that the Crosslink will be free of defects in materials and
workmanship for this period provided an authorized agent of the manufacturer carries
out the installation. The warranty applies only to the original purchaser of the
equipment in the country of original shipment.
This warranty will become void and the manufacturer and distributor organization will
not hold any responsibility for the correct operation or safety of the warranted
equipment if it:
has been altered, modified, serviced or repaired by anyone other than authorized
agents of the manufacturer.
is not operated according to the instructions contained in this manual.
is not serviced according to the instructions and procedures contained in the
manual.
is subjected to misuse, negligence or accidents.
is not installed according to the manufacturer instructions.
is connected to, or used with accessories or spare parts that are not and have not,
been tested and approved by the Manufacturer.
The obligation of this warranty shall be limited to the repair or replacement, at the
manufacturer’s recommendation and expense, of any materials or products that are
shown to be defective from faulty material and / or poor workmanship during the stated
warranty period. The manufacturer reserves the right to examine and make the
necessary repairs at its own premises, at an authorized repair center, or the site of
installation. The customer will pay for all freight and handling charges.
The manufacturer shall not be liable for any incidental or special damages or any other
loss, damage or expense that arises directly or indirectly from a warranty claim, the use
of the warranted product, the inability to use the warranted product while being
repaired or replaced, or otherwise.
Except as expressed above the manufacturer makes no other warranty of any kind,
express or implied, including warranties of merchantability of fitness for any particular
purpose or use.