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,
expected contact time shall be less than 1 min, and will not touch AVAS-402
so frequently once it is set up.
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 AVAS-402_User
Manual_Rev 1.0 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,
professional 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)
– Average degree of aging-related short term memory impairment
– impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz
Operating Principle:
The device provides input through I/O ports, and accessories through USB
ports or its LAN connections. The device computes the input data with its
processing unit and then output the generated data to accessories or other
devices through its I/O ports or through its LAN 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.
2 System Setup
2.1
A Quick Tour of the AVAS-402
Before you start to set up the AVAS-402, take a moment to become familiar
with the locations and purposes of the controls, drives, connections and
ports, which are illustrated in the figures below.
When you place the AVAS-402 upright on the desktop, its front panel
appears as shown in Figure 2.1.
