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DGM001519.01 UM Sirius CE/ROTW
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General Safety
x For the safe use of this device, it is necessary to be aware of all the safety standards.
x This manual contains important information about safe use of the device.
x All people working with this device must know the operation and safety instructions in this manual.
x Only trained personnel with appropriate safety guidelines can work with this device.
x The laser console must be closed. Only authorized personnel can open the external cover.
x Only the service staff can work on the electrical section of the device.
x This User Guide should be available in the operation area of the laser device.
x All warning labels must always be in good condition.
Warning: Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Warning: To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
Classification
This device is a Medical Laser classified as Class 4 according to IEC 60825-1.
System Safety Features
The Sirius Laser system incorporates the following safety features:
x The laser will stop firing when the pressure is removed from the footswitch.
x An automatic circuit breaker shuts the system off in the event of an electrical overload.
x The laser device is provided with an operating room door interlock connection, which must be set up
by the hospital personnel.
x The key can only be removed when the key switch is in the OFF configuration.
x An on-board microprocessor continuously monitors the status of the system, and displays messages on
the video screen along with appropriate operator prompts.
x Laser energy cannot be emitted from the system unless a fiber optic has been connected.
x Laser will go into Ready (to fire) status when the READY button is touched.
x A continuous audible tone is heard when the surgical beam is activated (i.e. foot pedal is pressed).
x An Emergency Laser Stop switch is available to disable the system immediately, in the case of an
emergency situation.
Training of the medical staff
The use of the laser device is restricted only to the specialist medical staff*: these people, 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, Thoracic
and Pulmonary, ENT, Neurosurgery, Gastroenterology, Gynecology, Lithotripsy and General Surgery.
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