CXL-365 vario
corneal cross-linking
1025_IFU_507536 CXL-365 vario_EN_Rev 09
Page 9 of 49
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.
