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2.
INTENDED USE
USM-100H is intended to serve as a medical computer
integration with hospital systems. USM-100H is designed for
general purpose used in medical computer related application in
the hospital environment, for data collection and for dis-playing
information via connecting a display.
It should not be used as a life-support system.
The USM-100 system and its components have CE approval and
comply with IEC60601-1-2. Installers, system integrators, and OEMs
have to mitigate system and application specific risks.
For critical systems, installers and system integrators are advised to
consider arranging additional risk control measures, like external
back-up system(s).
Le système USM-100 et ses composants sont homologués CE et
conformes à la norme IEC60601-1-2. Les installateurs, les intégrateurs
de systèmes et les équipementiers doivent atténuer les risques propres
au système et aux applications.
Pour les systèmes critiques, les installateurs et les intégrateurs de
systèmes sont invités à envisager de prendre des mesures de contrôle
des risques supplémentaires, tels que des systèmes de sauvegarde
externes.
Intended User Profile
2.1
Intend user profile:
Age: 18 to 55
Weight: not relevant
Health: not relevant
Nationality: Global
Patient state: patient will not be the operator.
Occupation: medical IT engineer
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 USM-100H 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 USM-100H_User Manual 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
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USM-100H User Manual
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