Operating Principle; Intended User Profile - Advantech POC-624-02 Series User Manual

1.5

Operating Principle

The device provides input through the touch panel, hard keys located at the bottom of
it, accessories through USB ports, or its LAN/WLAN connections. The device com-
putes the input data with its processing unit and then outputs the generated data to
the 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, it maintains the data in the memory units of the storage.
1.6

Intended User Profile

Intend user profile:
Age: 18 to 65

Weight: not relevant

Health: not relevant

Nationality: Global

Patient state: the patient shall 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 of intensive reading experience (school)

Knowledge:

Minimum – read and understand "westernized Arabic" numerals when written in
Arial font
– can distinguish: every part of the body as described in the user manual
– trained and authorized by the manufacturer only.
To be considered as trained and authorized, a person must complete the train-

ing course of the manufacturer; see document number xxxxx for the qualifica-
tion method. When considered necessary by the manufacturer, a technician
shall be called back for retraining and annual training is also considered neces-
sary.
Language understanding: English, whenever other languages are required, a

professional translation company shall translate and have the translation
reviewed by the manufacturer. See SOP document number: XXXXX
Experience: Mentally and physically competent, with specific medical training to

understand basic information and 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 the device
– Average degree of aging-related short-term memory impairment
– Hearing impaired by 40%, resulting in 60% of normal hearing at 500 Hz to 2
kHz
POC-624-02 Series User Manual 8