System Safety; Electrical And Fire Safety - Ulthera DeepSEE DS 4 - 4.5 Instructions For Use Manual

4. System Safety

The following precautions and warnings must be reviewed and observed:

4.1. Electrical and Fire Safety

W arning: To avoid risk of electric shock, always inspect the Ulthera
transducer, handpiece and cable before use. Do not use a damaged
cable or a transducer that has been damaged or is leaking fluid.
The Ulthera System is intended for indoor, dry location use. Avoid liquid spills
and splashes. Keep coupling gel away from the handpiece-transducer
connections.
The Ulthera System comes with a three-conductor AC power cord and plug.
Use a properly grounded outlet and always plug the Ulthera System directly
into the outlet. Never remove the ground conductor or compromise the
ground conductor via any AC adapter plugs or extension cords.
Disconnect the power cord from the outlet by pulling on the plug not the
cord.
AC powered USB printers or storage devices may pose a shock hazard. Do
not touch the USB connectors and the patient at the same time.
Turn off the AC power switch and disconnect the AC power supply before
cleaning the control unit.
Do not remove the covers on the control unit or handpiece; the control unit
contains hazardous voltages. The Ulthera System contains no user-
serviceable components. If the system requires service, contact Ulthera, Inc.
No modification of this equipment is allowed.
The Ulthera System should not be used near flammable gases or anesthetics.
Fire or explosion can result. The Ulthera System is not AP or APG rated.
Avoid restricting ventilation under and behind the Ulthera control unit.
Maintain an open space of at least 4 inches/ 10 cm around the control unit. If
ventilation holes are obstructed, the system could overheat.
The Ulthera transducers are rated as a Type B patient applied part. It may
provide a connection between the patient and protective earth. This may
present a hazard if the patient becomes connected to other equipment with
excessive electrical current leakage.
Do not touch the handpiece electrical contacts and patient simultaneously.
Ulthera, Inc.
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