Ulthera DeepSEE DS 4 - 4.5, Инструкция по эксплуатации

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resolves within 2 hours and 2 day. Tenderness to the touch is also possible
and typically resolves within 2 days to 2 weeks of treatment.
•
Welting: The treated area may exhibit a localized area of linear visible
edema following treatment. This typically resolves within 1 day to 3 weeks
of treatment.
•
Raised area of edema: The treated area may exhibit a localized area of
linear visible edema following treatment. This typically resolves within 1
day to 3 weeks of treatment.
•
Bruising: Mild bruising, which is caused by damage to soft tissue blood
vessels, may occur occasionally and typically resolves within 3 days and 3
weeks of treatment.
•
Transient Sensory Nerve Effects (as a result of inflammation of the nerve):
o
Paresthesia and/or numbness may be experienced and typically
resolves within 4 days to 5 weeks of treatment.
o Tingling may result after treatment and typically resolves within 3 to
5 days of treatment.
o Itching may result after treatment and typically resolves within 1 to
3 weeks of treatment.
No permanent nerve injuries were reported during clinical trials.
•
Burns/Scarring: The possibility for burns, which may or may not result in
permanent scar formation, may occur if incorrect treatment technique is
used (e.g. tilting transducer, incorrect line spacing, gel pockets, etc. see
section 7.3.4 & 7.3.5). Some scars may respond to medical treatment and
resolve fully.
2.6. Complaints and Adverse Events
No serious adverse events were observed during the clinical study evaluation
of the Ulthera System.
Ulthera follows MDR (Medical Device Reporting) rules for handling complaints
and adverse events. Should an adverse event be suspected or reported,
contact Ulthera, Inc. at the number on the back page of this document; for
those outside the U.S., contact your local Ulthera representative.