EyeTech CXL-365 vario User manual

CXL-365 vario corneal cross-linking
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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.

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The treatment timer on the device is used only to support the user. The proper
treatment sequence is in the responsibility of the user. Control the treatment time
with a clock and make a note of potential treatment interruptions in order to ensure
the correct dosage of UV radiation.
2.1.7 Limitation of use
The device must only be used with the included and suitably labeled components,
except requirements made in chapter 2.1.4 and 5.1.2. All components were tested for
the operation of the device and are admitted. Any usage of other components can
result in an undue hazard to the user and the patient. The UV lamp, UV meter and
measurement adapter are carrying serial numbers of each other. This ensures
identification of the matching equipment set.
The device must be used only within the specified conditions.
The device must be used only in designated areas for medical procedures that
conform to national guidelines and standards.
2.1.8 Operating conditions
Temperature
18 –28 °C
Humidity
max. 70% rel. (not-condensing)
Max. height above SL
2000 m
2.1.9 Storage conditions
Temperature
18 –28 °C
Additional
Keep dry
2.1.10 Transport conditions
Temperature
-10 –50 °C
Additional
Keep dry

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2.1.11 Danger of electricity
The device fulfills protection class 2 (protective isolation without protective earth conductor).
Use only the included power adapter (see the information on the nameplates of the
device and plug the AC adapter). The power supply unit is approved for medical
applications and is matched on the connected load of the device. Using a different
power supply may result in injury to the patient or the user!
In case of obvious damage of the power supply (housing or cable) do not use it! In
case of any damage please contact your distributor.
Do not use the unit in case of excessive moisture in the environment. Otherwise,
there is a risk of electric shock.
To avoid short-circuiting caused by condensing water we recommend acclimatizing
the product after transportation for approximately 3 hours.
2.1.12 Fire danger
Do not use the device in the vicinity of flammable liquids, gases etc…
2.1.13 Essential performances
The essential performances of the ME equpiment are wavelength, illumination intensity, illumination
time and beam profile. To maintain basic safety and essential performances of the equipment, a
regular calibration is mandatory. See chapter 6.2 for detailed information.

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2.1.14 Electromagnetic compatibility
The device corresponds to the EMC Class B according to EN 60601-1-2:2015 and
should be operated only in the appropriate environmental conditions.
Portable and mobile RF communications equipment can influence other medical
equipment. Make sure that there is enough distance (especially to other medical
devices, mobile phones etc.) to avoid mutual interference between the devices.
People with active implanted medical devices (e.g. pacemakers) should make sure
that they have sufficient distance to the device while operation.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should beobserved to verify that they are
operating normally.
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the ME equipment, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Guidance and manufacturer's declaration for electromagnetic compatibility see in chapter 2.1.15.

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2.1.15 Guidance and manufacturer's declaration for electromagnetic compatibility
Guidance and manufacturer's declaration –electromagnetic emissions
The EUT is intended for use in the electromagnetic environment specified below. The customer or
the user of the EUT should assure that it is used in such environment.
Emission test
Compliance
Electromagnetic environment - Guidelines
RF emissions
CISPR 11:2009 + A1:2010
Group 1
Class B
The ME equipment is designed for use in home
healthcare environment
Harmonic emissions
IEC 61000-3-2:2005 + A1:2008
+ A2:2009
Class A
Voltage fluctuations / flicker
emissions
IEC 61000-3-3:2013
Passed

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Guidance and manufacturer's declaration –electromagnetic immunity
The EUT is intended for use in the electromagnetic environment specified below. The customer or
the user of the EUT should assure that it is used in such environment.
Immunity test
Immunity test levels
Electromagnetic
environment -Guidelines
Electrostatic discharge
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
The ME equipment is
designed for use in home
healthcare environment
Electrical fast
transient/bursts
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Surges Line-to-line
IEC 61000-4-5:2005
± 0,5 kV, ± 1 kV
Voltage dips
IEC 61000-4-11:2004
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and
315°
0 % UT; 1 cycle
and
70 % UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions
IEC 61000-4-11:2004
0 % UT; 250/300 cycle
Rated power frequency
magnetic fields
IEC 61000-4-8:2009
30 A/m
50 Hz or 60 Hz
Conducted disturbances
induced by RF fields
IEC 61000-4-6:2013
3 V
0,15 MHz –80 MHz
6 V in ISM and amateur radio bands
between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
Radiated RF EM fields
IEC 61000-4-3:2006 +
A1:2007 + A2:2010
10 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
Proximity fields from RF
wireless
communications equipment
IEC 61000-4-3:2006 +
A1:2007 + A2:2010
27 V/m at 385 MHz
28 V/m at 450 MHz
9 V/m at 710/745/780 MHz
28 V/m at 810/870/930 MHz
28 V/m at 1720/1845/1970 MHz
28 V/m at 2450 MHz
9 V/m at 5240/5500/5785 MHz

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2.2 Product labels
Figure 1: name plate (45 mm x 90 mm)
Figure 2: user interface (120 mm x 54 mm)
Figure 3: ON/OFF (9.35 mm x 31.75mm)
Figure 4: beam exit (12.5 mm x 25 mm)

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Figure 5: nameplate power supply XP Power VEP15US12
Figure 6: labeling power supply (25 mm x 50 mm)
Figure 7: labeling power supply –power specifications XP Power VEP15US12
Figure 8: labeling UV-Meter (5 mm x 50 mm)

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Figure 9: labeling on the sensor plug of the UV-meter (12.5 mm x 25 mm)
Figure 10: labeling on the connector of the UV-meter (12.5 mm x 25 mm)
Figure 11: labeling storage conditions on case
(Größe 12,5 x 25 mm)
Figure 12: labeling transport conditions on case
(Größe 12,5 x 25 mm)
Figure 13: labeling storage and transport conditions on repackaging cardboard
(Größe 25 x 50 mm)

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3Description
3.1 Components of the device
UV-Lamp CXL-365 vario
Figure 14: front view
Figure 15: bottom view
Figure 16: left side
Aperture adjustment
Button for illumination check
Illumination adjustment
Start / Stop Button
Emission-LED
Beam exit
On / Off Switch
Power In

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Power supply
Figure 17: Power supply XP Power VEP15US12 and country specific power plug interfaces
Figure 18: Power supply adapter cable
Lock for country specific
power plug interface
UK
EU
US
country specific power plug
interfaces
SMB clip male –connect to
CXL power in
Low-voltage connection –
connect to power supply