Blood Glucose Monitoring System

Specifications Basic Information Measurement method Electrochemical Biosensor Technology Enzyme type GDH-FAD Intended Use Home testing or professional use to monitor the blood glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip and venous whole blood. Venous blood tests can only be measured by professionals. Measuring Principle Using the latest biosensor technology. It measures the glucose levels of the blood specimen by using a disposable dry reagent strip which can produce an electrical current. And the current will transfer to the meter for measurement. The amount of the current is proportional to the amount of glucose present in the blood sample. Test results are “plasma equivalent”. Display mode Reflective TN LCD Key quantities & functions 3 keys (Mode, forward, backward) Battery 2*CR2032 Operating environment Temperature: 10℃～40℃ (50℉~104℉); Control solution: 20℃～30℃ Humidity:  80% R.H. Storage/ Transport environment Meter: Temperature: -40℃～55℃ / Humidity: 90% R.H. Strip: Temperature: 4℃～30℃ / Humidity:  90% R.H. Control: Temperature: 2℃～30℃ / Humidity:  90% R.H. Product Life Meter: 5 years Strip: Shelf life: 24 months; Shelf life after opening: 180 days (Below 30℃) Control: Shelf life: 24 months; Shelf life after opening: 90 days  (Below 30℃) Measurement range of glucose 10～600 mg/dl ( 0.5～33.3 mmol/l) Control solution concentration range Medium level: 120~164 mg/dl (6.6~9.2 mmol/l) High level: 362~492 mg/dl (20.1~27.4 mmol/l) Accuracy range of measurement If glucose concentration < 100 mg/dl, Bias % (95% CI)  ±15 mg/dl else Bias % (95% CI)  ±15%   Ref. YSI 2300 System accuracy (ISO 15197) Criterion A 95% of measured value fall within either ±15 (<100mg/dl) mg/dl or 15% (100 mg/dl) of reference Criterion B 99% of measured value within CEG zones A and B Hematocrit Range 0%~70% Measuring time 5 seconds Sample volume 1.0 µl Control solution volume 4 ml Function Unit Display mg/dl and mmol/l Time display 12h Memory mode (Sets) 1000 Average display Last 7 / 14 / 30 / 60 / 90 Days averaging   Talking function No Ketone warning / Voice indicator (Beep) No Insufficient sample volume  detection Yes Meal Comment Yes, Pre/Post Meal Marker Before / After meals Average of blood glucose No Data-Link AM100 PD-B: Yes (Including wired transmission and wireless transmission) AM100 PD: Yes (Including wired transmission) Package Test Strip vial 25 pcs/vial 50 pcs/vial box 1 vial/ box, including instruction 2 vials/box, including instruction Meter box Including 1 meter, 1 user’s guide, 1 Logbook, 1 Lancing device, 50 Lancets Control Solution Pouch Including 1 control solution medium level, 1 control solution high level, control solution instruction (Packed in the blood glucose meter pouch)