Ottai M8 - Page 43

43
āããģŌīňŔ¼ØąěąŔŸ
ãŅã¼Ŕ¼ØąěąŔŸīøŔāããģŌīňSecurity evaluation
indicators
Product Ease of Use
Sensor Life
Adverse Events
Device Defects
āãɤɢ˫ɤɢ͹ÙīģÙřňňãģÙãň¼ŔãŲ¼Ō
higher
than 90% for all time staging
except for the late stage (day 14)
where the 20/20%
concordance rate was 86.8%.
āãġã¼ģ\%ű¼ěřãŌøīň
Ŕāã¼ģŔãňąīň˺ß¼Ÿɣ˻˛¼ģŔãňąīň
ąģŔãňġãßą¼Ŕã˺ß¼ŸŌɤɧ˻˛
ąģŔãňġãßą¼Ŕã˺ß¼ŸŌɨɫ˻˛ġąßßěã
ě¼Ŕã˺ß¼ŸŌɣɢɣɥ˻˛¼ģßě¼Ŕã˺ß¼Ÿ
ɣɦ˻Ņā¼ŌãŌŲãňãɪ˚ɧɫɣ͹ɦ˚ɣɫɣ͹˛
ɨ˚ɩɣɨ͹ɤ˚ɪɧɤ͹˛ɪ˚ɧɤɧ͹ɥ˚ɦɧɢ͹˛
ɪ˚ɣɨɨ͹ɥ˚ɫɥɢ͹˛¼ģßɣɢ˚ɧɢɨ͹
ɨ˚ɧɨɦ͹˛ňãŌŅãÙŔąűãěŸ˚
āãġã¼ģű¼ěřãīøŔāãġã¼ģ
¼ØŌīěřŔãßąƆãňãģÙã˺~%˻øīň
Ņňąġ¼Ɣ˫ŌãÙīģß¼ƔŌãģŌīňŅ¼ąňŌ
was 0.065 ± 0.085.
āãŔīŔ¼ěŌÙīňãīøŔāã
ŇřãŌŔąīģģ¼ąňãŔīŔ¼ěãßɫɢŅīąģŔŌ˛
and the average of the total score
Ų¼Ōɪɨ˚ɢɩ˚ɤɩ˛ŌřùùãŌŔąģùŔā¼ŔŔāã
ease of use of the product is good.
āãŅňąġ¼Ɣ˫ŌãÙīģß¼ƔŌãģŌīňŌ
Ōřƒąűãß¼ġãßą¼ģīøɣɦß¼ŸŌīø
Ųã¼ň˛ŲąŔā¼Ùřġřě¼Ŕąűãīűãň¼ěě
failure rate of 11.6%.
ŔīŔ¼ěīøɧ˺ɨ˚ɫ͹˻Ņ¼ƑąÙąŅ¼ģŔŌ
experienced 6 adverse events. All
adverse events were positively
unrelated to the device.
^īßãűąÙãßãøãÙŔŌŲãňãøīřģßßřňąģù
the test.
ěąģąÙ¼ěŅãƐīňġ¼ģÙãßãŌÙňąŅŔąīģīøāąùā¼ģßěīŲùěřÙīŌã
¼ěãƑøřģÙŔąīģ
āąŌŅňīßřÙŔā¼Ō¼āąùā¼ģßěīŲùěřÙīŌã¼ěãƑøřģÙŔąīģ˚
Users can customize the upper and lower limits of the
target glucose range according to their own conditions.
ªāãģŔāãùěřÙīŌãąŌāąùāãňŔā¼ģŔāãřŅŅãňěąġąŔīøŔāã
Ŕ¼ňùãŔň¼ģùã˛īňěīŲãňŔā¼ģŔāãěīŲãňěąġąŔīøŔāãŔ¼ňùãŔ
ň¼ģùã˛Ŕāã~~ŲąěěŌãģß¼ģ¼ěãƑŔīŔāãřŌãň˚
āãŅãƐīňġ¼ģÙãīøŔāãāąùā¼ģßěīŲùěřÙīŌã¼ěãƑ
øřģÙŔąīģā¼ŌØããģãű¼ěř¼ŔãßŔāňīřùāÙěąģąÙ¼ěŔňą¼ěŌ˚DģŔāã
ÙěąģąÙ¼ěŔňą¼ě˛Ŕāãň¼ģùãøīňŔāãěīŲùěřÙīŌã¼ěãƑŲ¼ŌŌãŔ