Operating Principle; Intended User Profile - Advantech POC-S199 Series User Manual

1.4

Operating Principle

The device provides input through touch panel, hard keys located at the bottom of it,
accessories through USB ports or its LAN/WLAN connections. The device computes
the input data with its processing unit and then output the generated data to LCD
panel, accessories or other devices through its I/O ports or through its LAN/WLAN
connections. The device is able to store data in its storage, and when the device is
turned off, still maintain the data in the memory units of the storage.
1.5

Intended User Profile

Intend user profile:
 Age: 18 to 65
 Weight: not relevant
 Health: not relevant
 Nationality: Global
 Patient state: patient will not be the operator.
 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:
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 POC-S199_User
Manual_Rev1.0 for qualification method, when considered necessary by the
manufacturer, technician shall be called back for retraining and annual train-
ing 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: SOP_Writing_Guidelines-ed.3
 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-S199 Series User Manual 6