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EXCEL V OPERATOR MANUAL
D1025, REV H, 10/17
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, IEC 60601-1, IEC 60601-
1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1
• 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.
CAUTION
Always verify that the treatment parameters are correct before
activating the system.
CAUTION
The system should always be in STANDBY mode until the
handpiece is safely positioned at the area to be treated.
CAUTION
Before placing the system in READY mode, confirm that the laser
aperture on the handpiece is safely positioned to prevent
unintended treatment exposure.
NOTE
The recessed handpiece lens(es) and the CoolView sapphire
cooling window should be kept clean during and prior to each
treatment procedure. See the Maintenance section for
recommended cleaning and disinfecting procedures.
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