Device Description
The z.one pro Ultrasound Platform and products derived there from (for example, but not
limited to, the ZS3 and the z.one pro with and without the SP UI option) is used for
ultrasound evaluation of the following applications: Laparoscopic, Fetal, Abdominal, Intra-
operative, Pediatric, Ophthalmic, Small Organ/Parts (breast/testes, thyroid, etc.),
Transvaginal, Transrectal, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic,
Vascular, Tissue Elasticity, Contrast Imaging, Musculoskeletal, Superficial Musculoskeletal
and Peripheral Vascular applications. Users include ultrasound imaging technicians
(sonographers) and physicians. This ultrasound system may be used in a hospital (e.g.
imaging laboratory, emergency room, patient bedside, and operating room), medical clinic,
physician's office or a mobile imaging center.
The z.one pro Ultrasound Platform consists of two major components: 1) Cart; and, 2)
Transducer(s). The Cart contains the software driven imaging electronics and user
interfaces (keyboard, monitor, handles, etc.). It houses the microprocessor, memory,
amplifiers and power supplies for the microprocessor. It sends electrical currents to and
receives electrical pulses from the compatible transducers. The Cart performs the
calculations involved in processing the data to produce the displayed ultrasound images.
Standard Configuration
Main unit
Storage bins
System software
Accessories:
Power cables
Operator's manual
Operator's manual in multi-language (disk)
Options
No.
1.
CW Enable
2.
ECG Enable
3.
Strain Elastography
4.
ARFI
5.
Small Parts CEUS
6.
GYN CEUS
7.
Abdominal CEUS
8.
Cardiac CEUS
9.
CEUS Sequence
10.
HD Scope
11.
Advanced Cardiac
z.one pro Instructions
Item
Remarks
/
Not applicable for the FDA
region.
Only applicable for liver in the
FDA region
Only applicable for LVO in
the FDA region
Only applicable for liver and
LVO in the FDA region
/
Including AutoEF and
Expanded Echo Calcs.
2 |
P a g e
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