Blood Glucose Monitoring System

FAST, ACCURATE, EASY TO USE

help@microdot.biz | www.microdot.biz0088

HELPLINE: 0800 088 3920ROI: 1850 211896

NO CODING

MEETS ISO 15197:2013

microdot+ is manufactured in state of the art facilities in the UK by teams who have many years experience in blood glucose. microdot+ is designed to meet the glucose testing requirements of both patients and healthcare professionals and meets the ISO 15197:2013 accuracy standards as confirmed in independent UK clinical trials.

For professionals we supply a Quality Assurance (QA) system, control solutions, External Quality Assurance System (EQAS) and full disinfection protocols together with training and support.

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BLOOD GLUCOSE MONITORING SYSTEMFAST, ACCURATE, EASY TO USE

www.microdot.biz

1. Insert strip into meter test port 2. Add blood to strip 4. Discard strip into safety bin3. Read results on meter display

INSTRUCTIONS FOR USE

METER FEATURES• No coding or calibration.• Large easy to read display• Automatic fill check (meter only runs if enough blood added)• Audible assist (meter bleeps when enough blood added)• Insulin and glucose reading memory (500 results)• 4 programmable alarms to remind when to test• Computer download (available separately)• 14 day averaging of results• Trend analysis and hypoglycaemia alarms if the glucose level is changing rapidly• Strip ejection feature (so no handling of contaminated strips)• Control solutions supplied within kit

CLINICALLY ACCURATE

STRIP FEATURES• 0.6uL sample.• Visual fill window• Edge and top fill• Advanced glucose dehydrogenase chemistry (NAD dependent), normally only available on large hospital analysers, means no interferences from oxygen, maltose, Icodextrin, Octagam, IV solutions and 20 other interfering substances. Can safely be used with patents on oxygen therapy and dialysis

Cambridge Sensors Ltd. Unit 9 Cardinal Park Godmanchester Huntingdon PE29 2XG UK

LBL-212-16D

ISO 9001, ISO 13485, FDA and MHRA registered

1) Yon Hin et al. J. of Diabetes Science and Technology Aug 20162) Freckmann et al. J. of Diabetes Science and Technology, Vol 6, Issue 5, 2012

The accuracy of microdot+ has been assessed in independent UK clinical studies that show microdot+ conforms to the new ISO 15197:2013 accuracy requirements. In this study in Cambridge, UK, 118 samples from over 100 patients with diabetes were tested in duplicate on three lots of microdot+ test strips from December 2015 to February 2016. This study confirmed smaller independent studies conducted earlier in Germany and the UK 1,2. On a graph of the Consensus Error Grid, all 708 results fell in Zone A and B of the Consensus Error Grid (the ISO 15197:2013 standard calls for 99%).

Another ISO 15197:2013 criterion is that 95% of measured glucose values shall fall within 0.83 mmol/L (15 mg/dl) of the reference value at glucose concentrations <5.55 mmol/L (100 mg/dl) or within 15% at glucose concentrations ≥ 5.55 mmol/L (100 mg/dl). The result from 3 microdot+ lots of test strips were 96.8%.

For Glucose concentration<5.55mmol/l (<100 mg/dl)

For Glucose concentration≥5.55mmol/l (≥100 mg/dl)

LOTS 1, 2, 3

Within ± 0.28 mmol/l(Within ± 5 mg/dl)

101/150 (67.3%)

Within ± 5% Within ± 10% Within ± 15%

273/558 (48.9%)

Within ± 0.83 mmol/l (Within ± 15 mg/dl) andWithin ± 15%

453/558 (81.2%) 535/558 (95.9%)

685/708 (96.8%)

140/150 (93.3%) 150/150 (100%)

Within ± 0.56 mmol/l(Within ± 10 mg/dl)

Within ± 0.83 mmol/l(Within ± 15 mg/dl)

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