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JPI CUBE X Series - Intended Use

JPI CUBE X Series
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DOC. NO.: JDP-013-CUBEX
Issued Date: 2017.07.21
Revision: 2017.07.21(Rev.0)
18/54 Page
1.6 Intended Use
The system is intended to be used for human in hospital environment under supervision of
recommended medical practitioner. The purpose of the system is to acquire X-ray digital
images of a patient and show the images to a doctor for diagnosis.
1.6.1 Intended patient profile
a) Weight : under 150kg
b) Height : under 2m
c) Age : all ages
d) Sex : male or female
1.6.2 Intended part of the body
a) head
b) chest
c) spine
d) abdomen
e) pelvis
f) arm and leg
g) hand and foot
1.6.3 Intended user profile
a) Age : Over 20 years old
b) Education : Radiology
c) Knowledge : Human anatomy and operation of X-ray machine
d) Permissible impairments : not allowed
e) Sex : male or female
f) No mental illness