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2. Introduction to Ottai CGM System
2.1 Name and Model
^¼ġã˜īģŔąģřīřŌ<ěřÙīŌã\īģąŔīňąģùŸŌŔãġ
\īßãě˜\ɪ
ň¼ßãģ¼ġã˜dŔŔ¼ą
ɤ˚ɤªīňėąģù~ňąģÙąŅěã
āãīģŔąģřīřŌ<ěřÙīŌã\īģąŔīňąģùŸŌŔãġřŌãŌ
electrochemical sensor to monitor glucose levels in
ąģŔãňŌŔąŔą¼ěƏřąß˚¼ŌãßīģŔāããěãÙŔňīÙāãġąÙ¼ěňã¼ÙŔąīģ
ŅňąģÙąŅěã˛ŔāãùěřÙīŌãąģŌřØÙřŔ¼ģãīřŌąģŔãňŌŔąŔą¼ěƏřąß
is oxidated by glucose oxidase on the sensor and the
ãěãÙŔňīģŌ¼ňãŔň¼ģŌøãňňãßŔīŔāãġãŔ¼ěãěãÙŔňīßã˛ŔāãňãØŸ
ùãģãň¼ŔąģùÙřňňãģŔ˚āãÙřňňãģŔąģŔãģŌąŔŸąŌŅňīŅīƑąīģ¼ě
ŔīŔāãùěřÙīŌãÙīģŔãģŔąģŔāãąģŔãňŌŔąŔą¼ěƏřąß˚āãŌãģŌīň
ąŌąģŔīřÙāŲąŔāŔāãŌřØÙřŔ¼ģãīřŌąģŔãňŌŔąŔą¼ěƏřąß˛ÙīěěãÙŔŌ
the electrochemical signal and outputs the analog signal.
āãŔň¼ģŌġąŔŔãňňãÙãąűãŌŔāã¼ģ¼ěīùŌąùģ¼ěīøŔāãŌãģŌīň˛
ÙīģűãƑŌąŔąģŔī¼ßąùąŔ¼ěŌąùģ¼ěŔāňīřùāŔāã¼ģ¼ěīùøňīģŔ
ãģ߲¼ģßŔň¼ģŌġąŔŌąŔŔīŔāãġīØąěã~~Ŕāňīřùāň¼ßąī
øňãŇřãģÙŸ˚āã~~ňãÙãąűãŌŔāãŌąùģ¼ě¼ģßŅňīűąßãŌ
ňã¼ßąģùŌīøŔāãùěřÙīŌãěãűãěīģġīØąěã~~ąģŔãƐ¼Ùã
øīňřŌãňŌŔīňã¼ß˚¼ŌãßīģŔāãġīģąŔīňąģùùň¼Ņā˛Ŕāã
patient’s daily maximum and minimum glucose values
¼ģßŔāãҼŔŔãňģīøùěřÙīŌãƏřÙŔř¼ŔąīģŌÙ¼ģØã¼ģ¼ěŸƀãß˚
āãňã¼ěŔąġãßąŌŅě¼ŸīøùěřÙīŌãű¼ěřãŌ¼ěŌīŅňīűąßãŌŔāã
ҼŔąãģŔŲąŔā¼āąùā¼ģßěīŲùěřÙīŌã¼ěãƑøřģÙŔąī잼ŌŲãěě
as information on the orientation and rate of change of
glucose trend.
2.3 Scope of Application and Function
Continuous Glucose Monitoring System is intended for
adults (aged 18 and above) with diabetes mellitus who
ģããßŔīġīģąŔīňŔāãąňùěřÙīŌãěãűãěŌ˚āãÙňąŔąÙ¼ěøřģÙŔąīģ
īø<\ŌąŌňã¼ěŔąġãùěřÙīŌãġīģąŔīňąģù˚āãŌŸŌŔãġąŌ