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Idiomas disponibles
Ulthera, Inc.
Sterile Device Preparation
1)
The components of the Cellfina
all components are single use and provided sterile. The provided sterile cover is required for the Motor
Module.
2)
Using sterile technique, open the Cellfina
prep area or area for use.
3)
Remove the inner tray cover and set aside. Remove the Vacuum Handpiece with attached anesthesia
needle Guidance Platform and lid. Connect the lid with the 6 mm side facing up. Connect to the accessory
sterile vacuum tube and isolation canister of a commercially available suction pump (with footswitch
attachment) to the barbed connector on the Vacuum Handpiece. Return to sterile prep area.
Preparing the Motor Module (CM1)
Do not immerse the Motor Module or Power Supply in any liquid. There are three states for the Blue LED on top
of the Motor Module: 1) OFF; 2) ON (solid); and 3) MOTOR FAULT (flashing). Flashing indicates a motor
current fault condition. When this condition occurs remove the Motor Module from the patient. Power should be
cycled off and then back on to reset the Motor Module. Verify the operation of the Motor Module by the following
steps prior to use with the Micro-Blade Assembly. Clean and Disinfect the Motor Module by following the manual
cleaning procedure.
Note: The Duty Cycle is the cycle of operation of a device that operates intermittently rather than continuously.
The Duty Cycle for the Motor Module is a maximum on-time of 30 seconds, followed by a minimum off-time of 10
seconds. Exceeding this Duty Cycle can lead device overheating and potential patient injury.
1)
Connect the Power Supply (on the Motor Module) to the Power Supply cable and plug the Power Supply into
MAINS power. Use the appropriate Power Supply adaptor provided according to the international regions
pictured below ensuring the tab on the adaptor fits into the slot of the power supply and clicks into place (see
detailed instructions below). Avoid patient contact while handling Power Supply. Based on region not all
adaptors may be provided.
North America Region
1007270IFU Rev D
®
Cellfina
System
®
System are illustrated in Figure 1. With the exception of the Motor Module,
®
sealed tray and remove the inner tray and place on the sterile
UK Region
EU Region
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