EyeTech CXL-365 vario User Manual
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EyeTech CXL-365 vario User Manual

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CXL-365 vario
corneal cross-linking
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.
1025_IFU_507536 CXL-365 vario_EN_Rev 09
Page 1 of 49

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Summary of Contents for EyeTech CXL-365 vario

  • Page 1 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).

  • Page 2: Table Of Contents

    CXL-365 vario corneal cross-linking Table of contents Introduction ............................. 5 Intended use and indication ....................5 Contraindication ........................5 Known side effects ........................5 Functional description ......................6 Safety ............................... 7 General safety notes ....................... 7 2.1.1 General symbols used in manual..................7 2.1.2...
  • Page 3 CXL-365 vario corneal cross-linking 4.5.2 Illumination check ......................30 Positioning of the device while application................31 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...
  • Page 4 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.

  • Page 5: Introduction

    CXL-365 vario corneal cross-linking Introduction 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...

  • Page 6: Functional Description

    CXL-365 vario corneal cross-linking 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.

  • Page 7: Safety

    CXL-365 vario corneal cross-linking Safety 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).
  • Page 8 CXL-365 vario corneal cross-linking 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...

  • Page 9: General Safety Remarks

    CXL-365 vario corneal cross-linking 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...

  • Page 10: Safety Remarks For User

    CXL-365 vario corneal cross-linking 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“.

  • Page 11: Limitation Of Use

    CXL-365 vario corneal cross-linking 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.

  • Page 12: 2.1.11 Danger Of Electricity

    CXL-365 vario corneal cross-linking 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.

  • Page 13: 2.1.14 Electromagnetic Compatibility

    CXL-365 vario corneal cross-linking 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.

  • Page 14: 2.1.15 Guidance And Manufacturer's Declaration For Electromagnetic Compatibility

    CXL-365 vario corneal cross-linking 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.
  • Page 15 CXL-365 vario corneal cross-linking 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.

  • Page 16: Product Labels

    CXL-365 vario corneal cross-linking 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)
  • Page 17 CXL-365 vario corneal cross-linking 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)
  • Page 18 CXL-365 vario corneal cross-linking 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)

  • Page 19: Description

    CXL-365 vario corneal cross-linking Description Components of the device UV-Lamp CXL-365 vario Start / Stop Button Emission-LED Illumination adjustment Button for illumination check Aperture adjustment Figure 14: front view Beam exit Figure 15: bottom view Power In On / Off Switch...
  • Page 20 CXL-365 vario corneal cross-linking Power supply Lock for country specific power plug interface country specific power plug interfaces Figure 17: Power supply XP Power VEP15US12 and country specific power plug interfaces SMB clip male – connect to CXL power in Low-voltage connection –...
  • Page 21 CXL-365 vario corneal cross-linking Stand Horizontal bar (length: 400 mm) Vertical bars (2 pieces, length: 250mm) Table clamp Clamp Figure 19: Stand UV-Meter Freeze measurement in display Do not use this button as it might distort the measurement! Measurement adapter...

  • Page 22: Instruction For Use

    CXL-365 vario corneal cross-linking Instruction for use Planned fundamental operation procedure The fundamental sequence of the usage of the device is shown in Figure 21. The individual steps are explained in the following sections. The correct positioning and treatment is in the responsibility of the surgeon.
  • Page 23 CXL-365 vario corneal cross-linking 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! Adjust Illumination Switching on the device positioned above the Measuring adapter The device will make a self-test.

  • Page 24: Installation Of The Device

    CXL-365 vario corneal cross-linking Installation of the device Adjust screw according to the thickness of the table and tighten accordingly (Figure 22). Figure 22: fixation of the clamp Connect the two bars (250 mm) using the two 10mm supplied wrenches and fix it into the table clamp (Figure 23).
  • Page 25 CXL-365 vario corneal cross-linking Mount clamp on vertical bar and bring it into the right position and fix it with the screw. Adapt the horizontal bar into the clamp and fix it. (Figure 24) Figure 24: Montage horizontal bar Mount the device on horizontal bar and bring it into the right position and fix it with the screw (Figure 25).

  • Page 26: Adjust Illumination

    CXL-365 vario corneal cross-linking Adjust Illumination With the rotary switch on the front panel, the Illumination of the device can be set. There are three selection levels: 3, 9 and 18 mW / cm ². The treatment time is set with the energy.
  • Page 27 CXL-365 vario corneal cross-linking The illumination must not be changed after switching on the device. If the position of the rotary switch be changed, the device must be turned off and the illumination check must execute again. Figure 28: display after switching on...

  • Page 28: Illumination Check

    CXL-365 vario corneal cross-linking Illumination check Please document the measurement results in the test protocol in section 6.7.4 (please make a copy of this page!). For the illumination check the measurement adapter must be slid all the way onto the device (Figure 30).
  • Page 29 CXL-365 vario corneal cross-linking Figure 32: Please note the plug orientation! Switch on the UV – meter by pressing the POWER button and use the measurement range 20mW/cm². Switch on button Measurement range 20mW/cm² Figure 33: UV-Meter Do not use the „HOLD“- und „REC“-button. This might cause wrong measurement numbers.

  • Page 30: Check Zero Position Of The Uv - Meter

    CXL-365 vario corneal cross-linking 4.5.1 Check zero position of the UV - meter Before the illumination check the zero position of the UV – meter has to be checked. For this purpose the illumination of the device is not yet activated! Check the emission LED (no light!). In case the LED is on switch the lamp off and switch the UV –...

  • Page 31: Positioning Of The Device While Application

    CXL-365 vario corneal cross-linking All key pressings are confirmed by an acoustic signal, to see the proper reaction of the device. Document the measured number in the protocol and compare it with the setpoint. The setpoint range is dependent on the energy setting. There are the following tolerances:...
  • Page 32 CXL-365 vario corneal cross-linking Figure 38: Fixation of device The device has to be positioned accurately above the eye of the patient, in order to make sure that applied dose and beam parameters are correct. The distance from device to the eye has to be within 50 +/- 5 mm (Figure 40).

  • Page 33: Treatment

    CXL-365 vario corneal cross-linking Distance between bottom of the unit and the eye = 50 ± 5 mm Figure 40: Rough positioning of the device to the patient The fine positioning will performed during initiation of treatment. Please follow section 4.7.2.

  • Page 34: Correct Alignment And Positioning At The Eye

    CXL-365 vario corneal cross-linking 4.7.2 Correct alignment and positioning at the eye The distance setting has to be checked immediately after the start of treatment. Because the setting usually takes only a few seconds, the treatment can be continued. Hold the device firmly with one hand for distance correction and solve the terminal screw on the cross piece of the stand for height adjustment with the other hand.

  • Page 35: Interruption And Continuation Of Treatment

    CXL-365 vario corneal cross-linking 4.7.4 Interruption and continuation of treatment The emission of the device can be interrupted by pressing the Start / Stop button while the treatment. The display will show “STOPPED” and the remaining time (Figure 44). By a second pressing of the Start / Stop-Button the illumination will be continued.

  • Page 36: Technical Data, Accessory

    CXL-365 vario corneal cross-linking Technical Data, Accessory Technical specifications and mechanical characteristics 5.1.1 General Parameter Specification Wavelength 365 ± 5 nm Width of spectrum (fwhm) 9 nm Power density depending on energy setting: 3,0 ± 0,3 mW/cm², 9,0 ± 0,9 mW/cm², 18,0 ±...

  • Page 37: Interfaces

    CXL-365 vario corneal cross-linking 5.1.2 Interfaces This chapter is only applicable when using the device with a stand, other than the ones included. Chapter 2.1.4 has to be fulfilled when applyinig this paragraph. The device connected to the interface must comply to the following specifications.

  • Page 38: Spare Parts

    CXL-365 vario corneal cross-linking Spare parts The following parts can be ordered individual as spare parts for the device: • Suitcase • Stand parts: Table clamp, clamp and horizontal bars Accessories There are no accessories for this product available. Expected service life The expected service life of the device is determined to 5 years.

  • Page 39: Installation, Maintenance, Trouble Shooting, Disposal

    CXL-365 vario corneal cross-linking Installation, Maintenance, Trouble shooting, Disposal Cleaning and maintenance Avoid direct contact with the beam exit optics. Keep measurement adapter attached while cleaning, storage etc. The adapter protects the optics. Do not flush the device with cleaning liquids to avoid damage from penetration of the liquid into the device Do not use aggressive cleaning agents like acetone.

  • Page 40: Exchange Of Battery At Uv - Meter

    CXL-365 vario corneal cross-linking Exchange of battery at UV – meter Only use the following 9V block batteries: ANSI 1604, JIS 006P, IEC 6F22 or IEC 6LR61 Open the battery compartment on the backside of the UV – meter. Loosen cable and take battery out.

  • Page 41: Faq-List

    CXL-365 vario corneal cross-linking FAQ-List Do not try to open or to repair the device. If you cannot solve a problem with the following remedial actions please contact your distributor for help. Problem Description Possible cause Recommended action Display stays dark after Connection to power supply is Check connection.
  • Page 42 CXL-365 vario corneal cross-linking Problem Description Possible cause Recommended action Extraneous light hits the sensor Position measurement adapter of the UV - meter correct on UV-Lampe Sensor of UV-Meters or UV- Please contact distributor for Meter display defect repair UV – meter out of calibration Please contact distributor for (see section 6.2)

  • Page 43: Sending Back Of Device

    CXL-365 vario corneal cross-linking Sending back of device Please clarify details with your distributor the reason of sending the device back. Your distributor will help you to organize shipment. Always use the original packaging. Always send the device complete (UV-meter, UV lamp CXL-365 vario, complete case).

  • Page 44: Index

    CXL-365 vario corneal cross-linking Index Forms and templates Please do not use the following forms immediately, first make a copy. 1025_IFU_507536 CXL-365 vario_EN_Rev 09 Page 44 of 49...

  • Page 45: Training Documentation

    CXL-365 vario corneal cross-linking 6.7.1 Training documentation Date: ________________________ Device serial number: ________________________ Trained by: Company: _______________________ Name, signature: ______________________________________________________________ List of trained persons: NAME Signature Please use a copy! 1025_IFU_507536 CXL-365 vario_EN_Rev 09 Page 45 of 49...

  • Page 46: Documentation Of Repair And Maintenance

    CXL-365 vario corneal cross-linking 6.7.2 Documentation of repair and maintenance Serial number device: ________________________ date maintenance repair comment name/signature                     ...

  • Page 47: Information On Incidents Occurring After Marketing

    CXL-365 vario corneal cross-linking 6.7.3 Information on incidents occurring after marketing According to 93/42/EWG article 10 all incidents with medical devices have to be reported. Any occurrence, problem or change in performance or output, which causes death or injury at the patient hast to be reported.

  • Page 48: Test Protocol Of Illumination

    CXL-365 vario corneal cross-linking 6.7.4 Test protocol of illumination Serial number of device:_____________________________ Please make a copy of this form and use the copy for the documentation. The illumination check has to be performed before of each treatment! set point: zero: 0.0 ± 0.1 mW/cm²;...

  • Page 49: Index

    CXL-365 vario corneal cross-linking Index 1025_IFU_507536 CXL-365 vario_EN_Rev 09 Page 49 of 49...

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