EyeTech CXL-365 vario User Manual Download

Page: 47 / 49

CXL-365 vario

corneal cross-linking

1025_IFU_507536 CXL-365 vario_EN_Rev 09

Page 47 of 49

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.

Date: _________________

Serial number of device: _____________________________

Occurrence; failure description, potential hazard:

__________________________________________________________________________________

Clinic: ______________________________________________________________________

Reported through name / signature: _____________________________________

Send to:

MLase AG

Industriestr. 17

82110 Germering

Germany

Tel.: +49 89 8941850 0

Fax.: +49 89 8941850 10

Please use a copy!

Summary of Contents for CXL-365 vario

Page 1: ...r 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 ...

Page 2: ... 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 Des...

Page 3: ...echanical 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 4...

Page 4: ... 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 49 89 8941850 0 Fax 49 89 8941850 10 email info mlase com homepage www mlase com ...

Page 5: ... cornea have a damage threshold of 0 36 mW cm 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...

Page 6: ...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 aluminiu...

Page 7: ...e 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 ...

Page 8: ...ct 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 ...

Page 9: ...vice 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 cont...

Page 10: ...y setting There are the following tolerances Adjustment of the Illumination Tolerance range of the Illumination 3 mW cm 2 7 mW cm2 3 3 mW cm2 9 mW cm 8 1 mW cm2 9 9 mW cm2 18 mW cm 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 ...

Page 11: ... 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 d...

Page 12: ...e 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 ...

Page 13: ... 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 decr...

Page 14: ...d 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 ...

Page 15: ...es 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 ...

Page 16: ...oss linking 1025_IFU_507536 CXL 365 vario_EN_Rev 09 Page 16 of 49 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 ...

Page 17: ...7536 CXL 365 vario_EN_Rev 09 Page 17 of 49 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: ...g 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 ...

Page 19: ...age 19 of 49 3 Description 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 ...

Page 20: ...y 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 ...

Page 21: ... Figure 20 UV Meter On off switch Measurement range change Freeze measurement in display Do not use this button as it might distort the measurement Record value Do not use this button as it might distort the measurement Horizontal bar length 400 mm Vertical bars 2 pieces length 250mm Table clamp Clamp Measurement adapter ...

Page 22: ... of 49 4 Instruction for use 4 1 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: ...ergy Make the Illumination Check Position the device above the eye of the patient Push the Start Stop button The device is in emission mode now the treatment time is running Fine adjustment of distance and beam diameter at the beginning of the treatment Execute the treatment the treatment time depends on adjusted energy The device stopped automatically after expired treatment time and shows the me...

Page 24: ...2 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 Figure 23 Fixation of the vertical bar ...

Page 25: ...d 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 Figure 25 Montage of device on the horizontal bar Fix screw ...

Page 26: ...d adapter cable Plug in the adapter cable on the upper side of the housing and on the other hand plug in the power supply in the wall socket Make sure that the cable is not in danger to change the positioning of the device Make also sure that the plug is not unplugged accidently Switch on the device with the on off button on the right side of the housing On the display the software version is show...

Page 27: ... Page 27 of 49 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 Figure 29 display after self test ...

Page 28: ...ocol 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 A correct positioning Figure 31 of the measurement head is important for the measurement Figure 30 Mounting of the measurement adapter on device Figure 31 Correct positioning of the measurement head on device No gap ...

Page 29: ...the POWER button and use the measurement range 20mW cm Figure 33 UV Meter Do not use the HOLD und REC button This might cause wrong measurement numbers In case you see the battery symbol on the display of the UV meter you have to exchange the battery see section 6 3 Do not use the UV meter with the battery sign on the display Switch on button Measurement range 20mW cm ...

Page 30: ...wed to perform a treatment with the device Please contact your distributor 4 5 2 Illumination check Put the aperture to the maximum position 11 mm Figure 34 For this purpose loosen the fixation screw of the aperture adjust it to its upper endpoint and fix it again Figure 34 aperture adjustment for illumination check The aperture must be fixed during the Illumination check and during the treatment ...

Page 31: ...ation Tolerance range of the Illumination 3 mW cm 2 7 mW cm2 3 3 mW cm2 9 mW cm 8 1 mW cm2 9 9 mW cm2 18 mW cm 16 2 mW cm2 19 8 mW cm2 Figure 36 Setpoint range of the Illumination In case the measurement is not in this interval it is not allowed to use the device for surgery Please contact your distributor 4 6 Positioning of the device while application Remove measurement adapter from the device F...

Page 32: ... 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 For the rough positioning of the device is a marking arrow beam aperture Figure 4 mounted on the housing side Figure 39 Positioning at patients eye Swivel mounted Orientation guide for beam exit Swivel mounted ...

Page 33: ...m is caused to the patient 4 7 1 Start of treatment Have a clock ready at the start of the treatment and control the timing of the treatment The treatment is started by pressing the Start Stop button The device displays during treatment in the display EMISSION and the emission light is on The remaining time of the treatment is in the 2nd display line Figure 41 Figure 41 Display while treatment Che...

Page 34: ... of the stand Distance too large Distance correct distance too small Figure 42 pictures for correct distance adjustment The fine positioning of the beam on the eye is done by rotating it on its axis After adjustment the clamp on the stand has to be tightened again 4 7 3 Adjustment of beam diameter The beam diameter of the device can be adjusted between min 7 and max 11mm on the patient s eye Becau...

Page 35: ...sing of the Start Stop Button the illumination will be continued Pay attention to the correct illumination time Figure 44 Display after interruption of the treatment 4 7 5 End of Treatment After 5 minutes the emission is switched off automatically with an acoustic beep The Display shows END OF TREATMENT Figure 45 Figure 45 Display after treatment The device now responds to no more keystrokes and c...

Page 36: ... 8 mW cm Treatment distance 50 5 mm Beam diameter in application area 7 11 3 mm continuously adjustable Power input Max 19 VA Operating conditions 18 28 C max 70 rel not condensing 2000 m Transport conditions 10 50 C Keep dry Min 3 hours acclimatization time before using Storage conditions 18 28 C Keep dry Power supply Model no XP Power VEP15US12 Input 100 240VAC 50 60Hz 0 5A Output 12VDC 1 25A Di...

Page 37: ... to be fulfilled when applyinig this paragraph The device connected to the interface must comply to the following specifications Specifiactions of device connected to interface stand Parameter Specification Fixation 4x M3 Maximum length of screw in 10 mm Expected service life min 5 years Regulatory requirements IEC 60601 1 In each case the latest edition by applying considering the period of trans...

Page 38: ... parts The following parts can be ordered individual as spare parts for the device Suitcase Stand parts Table clamp clamp and horizontal bars 5 3 Accessories There are no accessories for this product available 5 4 Expected service life The expected service life of the device is determined to 5 years ...

Page 39: ...ould be performed regularly Use abrasion resistant cloth moisten is with a disinfectant like Bacillol and wipe the surface gently 6 2 Calibration of the ME equipment To ensure that the equipment over its useful life always meets the basic safety and essential performances the equipment must be calibrated once a year The date of the next calibration is determined on the UV meter by the label depict...

Page 40: ...lock 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 Connect new battery of the same type 9V block and put it back into the compartment Figure 46 Close the UV meter Switch on the UV meter and check the display Figure 46 Exchange the battery of the UV Meter ...

Page 41: ...evice Repeat the illumination check at unchanged energy setting restart the Treatment by pressing the Start Stop button NOTE New Treatment duration must be defined and monitored by doctor because the treatment timer starts again Switch off the device after the end of the new treatment duration The total treatment time Section 2 1 6 must not be exceeded Battery symbol is shown in the display of the...

Page 42: ...or UV Meter display defect Please contact distributor for repair UV meter out of calibration see section 6 2 Please contact distributor for repair Illumination check is out of tolerances Loss of power of UV diode Please contact distributor for repair UV meter out of calibration Please contact distributor for recalibration Out of temperature range Adjust environmental temperature to 18 28 C Apertur...

Page 43: ...uropean Union Disposal Information This symbol means that according to local laws and regulations your product should be disposed of separately from household waste When this product reaches its end of life take it to a collection point designated by local authorities Collection points accept products for free The separate collection and recycling of your product at the time of disposal will help ...

Page 44: ...CXL 365 vario corneal cross linking 1025_IFU_507536 CXL 365 vario_EN_Rev 09 Page 44 of 49 6 7 Index Forms and templates Please do not use the following forms immediately first make a copy ...

Page 45: ...f 49 6 7 1 Training documentation Date ________________________ Device serial number ________________________ Trained by Company _______________________ Name signature ______________________________________________________________ List of trained persons NAME Signature Please use a copy ...

Page 46: ...cross linking 1025_IFU_507536 CXL 365 vario_EN_Rev 09 Page 46 of 49 6 7 2 Documentation of repair and maintenance Serial number device ________________________ date maintenance repair comment name signature Please use a copy ...

Page 47: ...__ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ __________________________________________________________________________________ _________________________________________________________________...

Page 48: ...n The illumination check has to be performed before of each treatment set point zero 0 0 0 1 mW cm emission depending on energy setting 3 0 0 3 mW cm 9 0 0 9 mW cm 18 0 1 8 mW cm date zero setpoint 0 0 0 1mW cm emission setpoint see above Test successful value within tolerance Name signature yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no yes no ye...

Page 49: ...CXL 365 vario corneal cross linking 1025_IFU_507536 CXL 365 vario_EN_Rev 09 Page 49 of 49 7 Index NA ...

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