Intended Users; Prescription Device; Operator Profile - GE Vscan Extend User Manual

Introduction

Intended users

Prescription Device

Operator profile

CAUTION
1-6
Vscan Extend is intended to be used by qualified and trained
healthcare professionals that are legally authorized by law in the
country, state or other local municipality in which he practices to
use the device. The list of the potential users includes but is not
limited to (based on title/geographical location): primary care
physicians, point-of-care users, sonographers, medical
healthcare technicians, nurses, midwives, paramedics, nurse
practitioner, physician assistants, medical students.
The users may or may not be working under supervision or
authority of a physician.
For USA only:
CAUTION: Federal law restricts this device to sale by or on the
order of a physician.
Qualified and trained healthcare professionals with at least a
basic level of general ultrasound training that includes limited
image acquisition techniques and interpretation (i.e. position the
probe correctly on the patient and determine at least normal vs.
abnormal anatomy views during scanning).
The operator must read and understand the user manual.
Contact GE sales representative for product training assistance
and visit the Vscan web portal for reference materials.
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Vscan Extend User Manual
5721203-100 Rev. D