Intended User Profile - Advantech POC-615-12 Series User Manual

1.6

Intended User Profile

Intend User Profile:
Age: 18 to 65

Weight: not relevant
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Health: not relevant
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Nationality: Global

Patient state: patient will not be the operator.
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Part of the body or type of tissue applied to or interacted with: hands and fin-

gers, expected contact time shall be less than 1 min.
Education level: at least 8 years intensive reading experience (school)

Knowledge:
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Minimum – read and understand "westernized Arabic" numerals when written in
Arial font
– Can distinguish: every parts of body as described in user manual
– Trained and authorized by manufacturer only.
To be considered as trained and authorized, they must complete the training

course of the manufacturer; see document number xxxxx for qualification
method, when considered necessary by the manufacturer, technician shall be
called back for retraining and annual training is also considered necessary.
Language understanding: English, whenever other languages are required, pro-

fessional translation company shall translate and review by the manufacturer,
see SOP document number: XXXXX
Experience: Mentally and physical competent, specific medical training to

understand basic knowledge for symbols.
Permissible impairments:

– Mild reading vision impairment or vision corrected to log MAR 0,2 (6/10 or 20/
32)
– One arm / hand system capable of guiding and holding device
– Average degree of aging-related short term memory impairment
– impaired by 40% resulting in 60% of normal hearing at 500 Hz to 2 kHz
POC-615-12 Series User Manual 8