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© INNOLUX Corporaon │ X-Ray Products
1.7 Product Intended user profile
Considerations
Requirement Description
Education
Minimum
-
Graduate of radiology college
Maximum
-
No maximum
Knowledge
Minimum
-
Read and understand 'westernized
Arabic' numerals when written in Arial
font
-
Can distinguish of human body
-
Understands hygiene
Maximum
-
No maximum
Language
Understanding
Minimum
-
Local language
Maximum
-
Understand the operation manual that
is writing in English
Experience
Minimum
-
Physician or legally certified operator
Maximum
-
No maximum
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Note
Patient should not operate the device by its own, in case result in malfunction
of the equipment.
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1.8 Product Intended conditions of use
Considerations
Condition
Environment including
hygienic requirements
-
Non-sterile
-
Multiple patient use
-
Less than ten minute contact
-
Indoor use only
-
Ambient luminance range: 100 to 1500 lx
-
Viewing angle: normal to the display ±20°
Frequency of use
-
Reusable
-
1day: 200 shot
Location
-
In hospital environment
Mobility
-
Portable ME equipment to be used on a
patient