DRTECH EVS3643W - Intended Use and Conditions

DRT-MAN-093
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2.3 Intended Use
 Intended Patient Population
Considerations
Requirement Description
Age
Paediatric to Geriatric
Health
Not relevant
Nationality
Multiple
Sex
Not relevant
Patient state
Patient is user
Patient is not user
Patient is not user
Not relevant, unless patient is agitated
 Intended Part of the Body or Type of Tissue Applied to or Interacted with
Measuring site: body
Condition: Intact or wound skin
 Intended User Profile (Operator Profile)
Considerations
Requirement Description
Education
Minimum
 At least a bachelor's degree in radiology
Knowledge
Minimum
 Read and understand Western "Arabic
numerals" written in Arial font
 Can distinguish human body
 Understands hygiene
Language
understanding
Minimum
 Understand the manual in English
Experience
Minimum
 Licensed physician or other qualified medical
professional`
Permissible
impairments
Minimum
 Mild reading vision impairment or corrected
vision to log MAR 0.2
 Average degree of age-related short term
memory impairment
 Impaired by 40 % resulting in 60 % of normal
hearing at 500 Hz to 2 kHz
CAUTION
MISE EN GARDE
U.S. Federal Law restricts this device to the sale by or on the
order of a licensed physician or other qualified medical
professional