K - 2 Operator’s Manual
K Indications For Use
System: Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
General(Track 1
Only)
Specific (Track 1 &
3)
BMPWDCWD
Color
Doppler
Amplitude
Doppler
Combined
(specify)
Other (Spe
cify)
Ophthalmic Ophthalmic
Fetal Imaging &
Other
Fetal NNN NNN
Note
1,2,3,4,6
Abdominal NNNNN N N
Note 1,
2,3,4,6,8,9,
11
Intra-operative
(Specify*)
NNN NNNNote 1, 2,4
Intra-operative
(Neuro)
Laparoscopic
Pediatric NNNNN N N
Note 1,
2,4,6
Small Organ
(Specify**)
NNN NNN
Note 1,
2,4,6,7,8,9
Neonatal Cephalic N N N N N N N
Note 1,
2,4,6
Adult Cephalic NNNNN N N
Note 1,
2,4,6
Trans-rectal N N N N N N
Note 1,
2,3,4,6,7
Trans-vaginal N N N N N N
Note 1,
2,3,4,6,7
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skeletal
(Conventional)
NNN NNN
Note 1,
2,4,6,7,8,9
Musculo-skeletal
(Superficial)
NNN NNN
Note 1,
2,4,7,8,9
Intravascular
Thoracic/Pleural
(Specify****)
NN NNN
Note 1,
2,4,6
Cardiac
Cardiac Adult N N N N N N N
Note 1,
2,4,5,6,10
Cardiac Pediatric N N N N N N N
Note 1,
2,4,5,6
Intravascular
(Cardiac)
Trans-esoph.
(Cardiac)
NNNNNNNNote 1,5,6
Intra-cardiac
Peripheral vessel
Peripheral vessel N N N N N N N
Note 1,
2,4,6,7,8,9
Other (Specify***) N N N N N N
Note 1,
2,3,4,6,7