Contraindications For Use; Intended Users - GE Vscan Air Manual

Introduction

Contraindications for use

WARNING
Clinical application not cleared for use in Japan
NOTE:
Clinical application not cleared for use in China
NOTE:

Intended users

User
Primary care physicians (PCPs)
Pre-hospital emergency care users
1-8
The Vscan Air diagnostic ultrasound system is not intended for
use with contrast agents.
Vscan Air diagnostic ultrasound system does not hold regulatory
clearance in Japan for Ophthalmic use.
Vscan Air diagnostic ultrasound system is not intended for
ophthalmic use or any use causing the acoustic beam to pass
through the eye in China.
The list of the potential users includes but is not limited to
(based on title/geographical location): physicians,
sonographers, medical healthcare technicians, paramedics,
nurses, nurse practitioner, midwives, midwife practitioner,
physiotherapists, physician assistants, medical students. The
users may or may not be working under supervision or authority
of a physician. Each user is expected to have a basic level of
general ultrasound training that includes limited image
acquisition techniques and interpretation (i.e. position the Vscan
Air CL correctly on the patient and determine at least normal vs.
abnormal anatomy views during scanning).
Table 1-4: User profile
General practitioners and family physicians (generally in clinic,
potentially during selected nursing home/retirement facility/
patient home visits or spending part time in pre-hospital
emergency care) as well as physicians who serve patients at
their home (part or full time) or non-physician healthcare
professionals working under their supervision (e.g. residents).
Physicians and supervised paramedics in providing medical
ambulance or air-ambulance services.
Description
Vscan Air
Direction GP092020-1EN Rev 18
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User Manual