ROCAMED MH01 - Laser Safety; General Safety; Classification; Training of the Medical Staff

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NOTE-MH01-EN rev05
2 LASER SAFETY
2.1 General Safety
· For safety use of this device, it’s necessary to know all the safety standards.
· This manual contains important information about safety use of the device
· All people who works with this device must know the operation and safety instructions in
this manual.
· Only trained personnel with appropriate safety guidelines can work with this device.
· The laser must be closed. Only authorized personnel can open the external cover.
· Only the service staff can work on the electrical section of the device.
· This User Guide should be available in the operation area of the laser device.
· All warning labels must always be in good condition.
CAUTION
- Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure
IMPORTANT!
For shipment and storage below +5°C, the cooling system must be emptied.
NOTE!
To prevent damage during transport or shipment of the products we recommend using the original
packaging material.
2.2 Classification
This device is a Medical Laser classified as Class 4 according to IEC 60825-1.
2.3 Training of the medical staff
The use of the laser device is restricted only to the specialist medical staff*: that, depending on
their experience and expertise, can make choices appropriate to achieve the desired
therapeutic effects.
It is recommended that all operators and support personnel are adequately trained on laser
safety standards.
*(This device must only be used by adequately qualified and trained medical personnel with experience in Urology,
Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy Pulmonary, Gynaecology, ENT, Dermatology, Plastic
Surgery and General Surgery)