EyeTech CXL-365 vario User manual

CXL-365 vario corneal cross-linking
1025_IFU_507536 CXL-365 vario_EN_Rev 09 Page 1 of 49
User Manual
CXL-365 vario
Revision: 09
Issue date: 04/2021
The instruction manual is valid for UV-Lamp CXL-365 vario, item number 507536
(Compare with nameplate on the device)
Copyright by MLase AG
All rights reserved. The operating instructions or parts thereof may not be without the written
permission of MLase AG copied or distributed of the device (Except for the attached forms in section
6.7 in relation to the use). Changes to the content of the instructions are not allowed.

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Table of contents
1 Introduction..................................................................................................................................... 5
1.1 Intended use and indication.................................................................................................... 5
1.2 Contraindication...................................................................................................................... 5
1.3 Known side effects .................................................................................................................. 5
1.4 Functional description............................................................................................................. 6
2 Safety............................................................................................................................................... 7
2.1 General safety notes ............................................................................................................... 7
2.1.1 General symbols used in manual..................................................................................... 7
2.1.2 General symbols and safety signs on the product .......................................................... 7
2.1.3 General safety remarks ................................................................................................... 9
2.1.4 Safety remarks for system integrators............................................................................ 9
2.1.5 Safety remarks for user ................................................................................................. 10
2.1.6 Safety remarks for application at patient...................................................................... 10
2.1.7 Limitation of use............................................................................................................ 11
2.1.8 Operating conditions..................................................................................................... 11
2.1.9 Storage conditions......................................................................................................... 11
2.1.10 Transport conditions ..................................................................................................... 11
2.1.11 Danger of electricity ...................................................................................................... 12
2.1.12 Fire danger..................................................................................................................... 12
2.1.13 Essential performances ................................................................................................. 12
2.1.14 Electromagnetic compatibility....................................................................................... 13
2.1.15 Guidance and manufacturer's declaration for electromagnetic compatibility............. 14
2.2 Product labels........................................................................................................................ 16
3 Description .................................................................................................................................... 19
3.1 Components of the device .................................................................................................... 19
4 Instruction for use ......................................................................................................................... 22
4.1 Planned fundamental operation procedure ......................................................................... 22
4.2 Installation of the device....................................................................................................... 24
4.3 Adjust Illumination ................................................................................................................ 26
4.4 Switching on and Commissioning.......................................................................................... 26
4.5 Illumination check ................................................................................................................. 28
4.5.1 Check zero position of the UV - meter .......................................................................... 30

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4.5.2 Illumination check ......................................................................................................... 30
4.6 Positioning of the device while application........................................................................... 31
4.7 Treatment.............................................................................................................................. 33
4.7.1 Start of treatment ......................................................................................................... 33
4.7.2 Correct alignment and positioning at the eye............................................................... 34
4.7.3 Adjustment of beam diameter...................................................................................... 34
4.7.4 Interruption and continuation of treatment................................................................. 35
4.7.5 End of Treatment........................................................................................................... 35
5 Technical Data, Accessory ............................................................................................................. 36
5.1 Technical specifications and mechanical characteristics ...................................................... 36
5.1.1 General .......................................................................................................................... 36
5.1.2 Interfaces....................................................................................................................... 37
Specifiactions of device connected to interface stand ................................................................. 37
5.2 Spare parts............................................................................................................................. 38
5.3 Accessories ............................................................................................................................ 38
5.4 Expected service life.............................................................................................................. 38
6 Installation, Maintenance, Trouble shooting, Disposal................................................................. 39
6.1 Cleaning and maintenance.................................................................................................... 39
6.2 Calibration of the ME equipment.......................................................................................... 39
6.3 Exchange of battery at UV –meter....................................................................................... 40
6.4 FAQ-List ................................................................................................................................. 41
6.5 Sending back of device.......................................................................................................... 43
6.6 European Union –Disposal Information............................................................................... 43
6.7 Index...................................................................................................................................... 44
6.7.1 Training documentation................................................................................................ 45
6.7.2 Documentation of repair and maintenance.................................................................. 46
6.7.3 Information on incidents occurring after marketing..................................................... 47
6.7.4 Test protocol of illumination......................................................................................... 48
7 Index.............................................................................................................................................. 49

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Product identification
Model/Type name:
CXL-365 vario
Item no.:
507536
Copyright by MLase AG
This operation manual is in possession of MLase AG based in Germany (Germering). The usage of this
document is restricted for operating issues at the CXL-365 vario. It is strictly forbidden to propagate it
to third parties. CXL-365 vario™ is a trademark of MLase AG.
Manufacturer
MLase AG
Industriestr. 17
82110 Germering
GERMANY
Phone: [phone]
Fax: [phone]
email: [email protected]om
homepage: www.mlase.com

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1Introduction
1.1 Intended use and indication
The product is a portable medical device to emit UV light of wavelength 365 nm using a light emitting
diode (LED). The device is used for the treatment of keratoconus (cone-shaped cornea). The
irradiation of the cornea with the UV light in combination with a photo sensitizer (riboflavin solution -
mix ratio: 0.1% riboflavin (vitamin B2), 20% dextran T500 in isotonic NaCl solution (pH 7.0)) leads to a
corneal cross-linking and thus to a stabilization of corneal shape.
The drug vitamin B2 (riboflavin photo sensitizer lotion) is not part of the product. The
drug vitamin B2 is excluded from the declaration of conformity to this device.
1.2 Contraindication
The UV radiation may cause a cell damage of the eye. 95% of UV radiation is absorbed in conjunction
with the photo sensitizer (riboflavin solution) in the cornea. Corneal endothelial cells, located on the
back of cornea, have a damage threshold of 0.36 mW / cm². This value is not reached during the
irradiation with riboflavin at a depth of the cornea of more than 300 microns. Minimum thickness of
the cornea is specified as a criterion for the feasibility of treatment with UV irradiation + Riboflavin
lotion. The thickness has to be at least 400 µm or more [1]. In corneal thickness of less than 400
microns no treatment may be carried out.
[1] Eberhard Spörl, Christine Wittig; Universitäts-Augenklinik Dresden; CLL Kongress 2005
Furthermore patients with the following characteristics must not be treated:
•Patients with active medical implants
•Patients with aphake- / pseudoaphake eyes
•Patients with prior herpectic infection (It may result in viral reactivation)
•Patients with concurrent infection
•Patients with severe corneal scarring or opacification
•Patients with history of poor epithelial wound healing
•Patients with severe ocular surface disease (ex. Dry eye)
•Patients with autoimmune disorders
1.3 Known side effects
Based on current information no side effects are known to crosslinking with described UV light
sources.
Nevertheless there are side effects like inflammation related to the surgical procedure.

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1.4 Functional description
The device emits UV light at a wavelength of 365nm by a light emitting diode (LED). The LED operates
in continious mode. The light gets homogenized and shaped by a Köhler beam path to a flat top
intensity at treatment position. The user operates the device by buttons and an LC display. The
device contains interfaces for attaching the power supply, UV meter for measuring the illumination
intensity and stand parts for mechanical attachment.
The device is no sterile product and has no sterile components. It doesn’t emit radioactivity.
The user and third parties will come in contact with the device and its materials like aluminium,
stainless steel, thermoelastic plastic.
For further information about technical specifications and mechanical characteristics see chapter 5.1.

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2Safety
2.1 General safety notes
2.1.1 General symbols used in manual
General warning symbol
Additional information
Empty battery indicator of UV meter
This product comes under the directive 2012/19/EU of the european parliament and
of the council of 4 July 2012 on waste electrical and electronic equipment (WEEE II).
Therefore according to local laws and regulations the product should be disposed of
separately from household waste.
Electromagnetic interference may occur in the vicinity of equipment marked with this
symbol (See chapter 2.1.15 for more information)
2.1.2 General symbols and safety signs on the product
General warning symbol
User manual
Instruction that the user has to read the user manual before using this medical device
Device with protection class II
(Protective insulation without protective earth conductor)
IP 30
Protection class against hazardous entry substances
(3 = protected against entry of substances ≥2,5mm Ø; 0 = no protection against
water)
This product comes under the directive 2012/19/EU of the european parliament and
of the council of 4 July 2012 on waste electrical and electronic equipment (WEEE II).
Therefore according to local laws and regulations the product should be disposed of
separately from household waste.

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Using only inside of buildings
Shows the manufacturer of the medicine product
Shows the date of production of the medicine product
Shows the order code of the medicine product
Shows the serial number of the medicine product
Declaration of conformity with applicable european guidlines
User manual
Instruction that the user has to read the user manual before using this medical device
Keep dry
Temperature limitation with minimum and maximum

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2.1.3 General safety remarks
Before using the device please read instruction manual!
The device may only be used by trained physicians who have expertise on the medical
effects and the potential hazards of this application.
The device may be used only in conjunction with a photo sensitizer vitamin B2
(riboflavin solution)! Do not perform a treatment without the photo sensitizer
Ratio of ingredients for Photo sensitizer: 0,1 % Riboflavin (Vitamin B2)
20 % Dextran T500
in isotonic NaCl-solution (ph 7,0)
A treatment with no or an incorrect photo sensitizer can cause severe damage to the
patient's eye!
Take proper care of the device. Avoid strong shocks or falls. In consequence of this
there may be damage to internal electronics or optical components! Store the device
always in the carrying case and store it to dry when it is not in use. For the return use
always the transport case and the original or adequate packaging carton.
Do not open the device and do not repair the device on your own. It is prohibited to
modify the device. Unauthorized modification will result in loss of warranty and
refusing liability by MLase AG. In case of technical problems please contact your
distributor.
Check the device and components before use for physical damage (e.g. housing or
cable damage, loose parts, rattling noise, optics damage…). In case of a damage don`t
switch the device on. Please contact your distributor.
Make records to all damages, incidents or other occurrences, please use the form in
section 6.7.3 for information transfer. Make a copy of this template.
If the device is not likely to be used for some time, check battery of the UV-meter in
terms of leakage and exchange it if necessary (See chapter 6.3).
2.1.4 Safety remarks for system integrators
When using the device with other devices, the combination must be treated as ME
system. The ME system must comply with IEC 60601-1. The specifications of all
devices must be free of conflicts (See chapter 5.1 for specifications of device).
Specifications of other devices or of the system must comply with chapter 5.1.2. The
specifications made in chapter 5.1.2 must be strictly adhered when applying this
paragraph. Country specific regulatory requirements have to be fulfilled from system
integrator.

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2.1.5 Safety remarks for user
Avoid touching the optics.
Do not look into the lamp while activated UV-emission. Although the device is
classified as “free group” according to EN62471, UV illumination can cause damage to
the eye! The activated UV–emission is shown at the display and by the LED
„EMISSION“.
2.1.6 Safety remarks for application at patient
Make sure that the device is firmly and securely attached to the stand and on the
couch or table. An insufficient attachment can lead to injury to the patient! Mount
the cable in a way that you do not stumble during the treatment.
Perform an illumination check prior to each treatment. For this purpose use the
attached measurement adapter and the included UV –meter. The check makes sure
that the irradiation intensity is in its defined limits and no harm is caused to the
patient. The tolerance range is dependent on the energy setting. There are the
following tolerances:
Adjustment of the Illumination
Tolerance range of the Illumination
3 mW/cm²
2,7 mW/cm2–3,3 mW/cm2
9 mW/cm²
8,1 mW/cm2–9,9 mW/cm2
18 mW/cm²
16,2 mW/cm2–19,8 mW/cm2
Please document the illumination check in the template in section 6.7.4 (please make
a copy of this page!). In case the shown value is outside of this range do not use the
lamp (A readjustment of the Performance is local not provided for security reasons!).
In this case please contact your distributor.
A radiation dose of 90 (mW∙min/cm²) in the treatment with the device must not be
exceeded! This results in following treatment times:
Adjustment of the Illumination
Treatment time
3 mW/cm²
30 minutes
9 mW/cm²
10 minutes
18 mW/cm²
5 minutes
Exceeding the treatment time may lead to patient harm!
The overall dose of illumination for each treatment time is the same!
Do not operate the device unattended! Monitor the device during the treatment;
monitor the proper functioning of the device and the positioning and spacing of the
device to the patient eye!
The aperture must be fixed during the "Illumination check" and during the treatment
by turning right the control lever.