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EXCEL HR OPERATOR MANUAL
D1796, REV. D, 12/16
Regulatory Compliance
All Cutera aesthetic platforms are designed to comply with the following:
• US Federal Performing Standards 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC 60601-
1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22 and IEC 60825-1
• 21 CFR Chapter I, Subchapter J, as administered by the Center for Device and
Radiological Health of the US Food and Drug
Administration (FDA)
• European Communities Medical Device Directive 93/42/EEC
Location of Controls
Operation and adjustment controls are located so that the user need not be exposed to the treatment
beam 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 l (on) or (start) position, and the system will only operate with the key in place.
When the system is not in use, always remove and store the key.
Emergency Off Button
The system can be immediately shut down, terminating laser emission, by pushing the red emergency off
button that is located next to the keyswitch. 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 emits an audible tone, and a yellow indicator next to the READY button illuminates
to indicate treatment beam emission.
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 the system down if the treatment room door is opened.
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