User's Manual

User Manual
Manual No. AMSL/DMR/UM/FD 009
Rev. 00 Effective Date 12.07.2022 Page | 11
2.6 Product Intended Part of the body or type of tissue applied to or interacted with
- Measurement site: Full Body parts
- Condition: Intact or wound skin
2.7 Product Intended user profile
Considerations
Requirement Description
Education
Minimum
- Graduate of radiology college
Maximum
- No maximum
Knowledge
Minimum
- 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 at least one year
experience
Maximum
- No maximum
Note
Patient should not operate the device by its own, in case result in malfunction of the
equipment.
2.8 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°