Tabla De Contenido - Ulthera Cellfina CM1 Instrucciones De Uso Del Sistema

Ulthera, Inc.
FIGURES ...................................................................................................................................................... 4
COMMON NAME .......................................................................................................................................... 6
DEVICE DESCRIPTION ............................................................................................................................... 6
INDICATIONS FOR USE .............................................................................................................................. 8
CONTRAINDICATIONS ................................................................................................................................ 8
WARNINGS .................................................................................................................................................. 8
ADDITIONAL WARNINGS ............................................................................................................................ 9
PRECAUTIONS ............................................................................................................................................ 9
RISKS............................................................................................................................................................ 9
CLINICAL STUDIES ..................................................................................................................................... 9
S ................................................................................................................................................... 10
AFETY
E ............................................................................................................................................ 10
FFECTIVENESS
S R P
UBJECT EPORTED AIN
C ................................................................................................................................................. 12
ONCLUSION
DESCRIPTION OF PROCEDURE ............................................................................................................. 12
P -P .......................................................................................................................................... 12
RE ROCEDURE
P M
ATIENT ARKING AND
A D .................................................................................................................................. 13
NESTHESIA ELIVERY
S T
UBCUTANEOUS ISSUE
P - C
OST TREATMENT ARE AND
S C
UPPLY AND ONDITIONS FOR
S C .................................................................................................................................. 14
TERILE OMPONENTS
M M P
OTOR ODULE AND OWER
C P T
ELLFINA ROCEDURE
S ................................................................................................................................................... 14
TORAGE
A N
DDITIONAL ECESSARY
A N
DDITIONAL ECESSARY
DIRECTIONS FOR USE ............................................................................................................................. 15
S D
EE THE ESCRIPTION OF
P T
REPARING THE REATMENT
S D P
TERILE EVICE REPARATION
P M
REPARING THE OTOR
V -A T
ACUUM SSISTED ISSUE
A I
NESTHESIA NTRODUCTION
S R
UBCUTANEOUS ELEASE
D D ......................................................................................................................................... 23
EVICE ISPOSAL
CLEANING, DISINFECTING AND MAINTENANCE .................................................................................. 23
M C P
ANUAL LEANING ROCEDURE
DEVICE MALFUNCTION OR FAILURE ..................................................................................................... 25
STORAGE, TRANSPORT AND HANDLING ENVIRONMENTAL CONDITIONS ...................................... 25
SPECIFICATIONS ...................................................................................................................................... 25
EMC INFORMATION .................................................................................................................................. 26
CITED REFERENCES ................................................................................................................................ 29
SYMBOLS ................................................................................................................................................... 30
INTELLECTUAL PROPERTY ..................................................................................................................... 31
1007270IFU Rev D
Cellfina
TABLE OF CONTENTS
............................................................................................................................. 12
P .......................................................................................................... 12
HOTOGRAPHY
R ................................................................................................................. 13
ELEASE
M
ANAGEMENT OF
U ................................................................................................................ 14
SE
S ........................................................................................................... 14
UPPLY
................................................................................................................... 14
RACKER
S ................................................................................................................ 14
UPPLIES
E ............................................................................................................. 15
QUIPMENT
P
ROCEDURE FOR PATIENT PREPARATION STEPS
A : ............................................................................................................... 15
REA
...................................................................................................................... 16
M (CM1) ....................................................................................................... 16
ODULE
C G
APTURE AND UIDANCE
.......................................................................................................................... 18
............................................................................................................................. 19
.................................................................................................................... 24
®
System
C ..................................................................... 13
OMPLICATIONS
..................................................................................... 18
...................................................... 15
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User Manual