Cutera Excel V+, Operator'S Manual, Page: 89 / 112

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EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
Regulatory Compliance
excel V+ is designed to comply with the following:
• 21 CFR Chapter I, Subchapter J, as administered by the Center for Device and Radiological
Health of the US Food and Drug Administration (FDA)
• US Federal Performing Standards 21 CFR 1040.10 and 1040.11 (2015), IEC 60601-1
(Edition 3.1, 2012), IEC 60601-1-2 (Edition 4.0, 2014), IEC 60601-1-6 (Edition 3.1, 2013),
IEC 62366 (Edition 1.1, 2014), IEC 60601-2-22 (Edition 3.1, 2012), and IEC 60825-1
(Edition 3.0, 2014)
• European Medical Device Directive (MDD) 93/42/EEC
Location of Controls
Operation and adjustment controls are located so that the user need not be exposed to laser radiation
during operation or adjustment.
Key Lock Switch
To prevent unauthorized use, the system can only be turned on with the proper key. The key cannot be
removed while in the ON (or START) position and the system will only operate with the key in place.
When treatments are complete or the system is not is use, always remove and store the key.
Emergency Off Push-Button
The system can be immediately shut down, terminating laser or light energy emission by pushing the red,
mushroom-shaped emergency off button that is located in the upper right hand corner of the control
panel. Following emergency shutoff, the keyswitch must be used to restart the system.
Laser Emission Indicator
The treatment beam can only be delivered when the system is in READY mode and the READY icon is
highlighted on the touchscreen display. When the footswitch is pressed and the treatment beam is being
delivered, the system will emit an audible tone and the yellow laser emission icon will illuminate on the
Treatment Screen.
Remote Interlock
A remote interlock connector on the back panel, when used in conjunction with an external switch
connected to the treatment room door, will shut down the system if the treatment room door is opened.