Introducing Contents Meter details & kit GlucoRx services, - - PDF document

Introducing

BLOOD GLUCOSE MONITORING SYSTEM

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Contents

• Meter details & kit
• GlucoRx services, compliance & approvals
• Softw are
• Studies
• Cost savings
• Product w ebsite
• Manufacturer
• Contact details

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New GlucoRx blood glucose meter is an affordable, quality product that facilitates simple management of diabetes. Use GlucoRx test strips only for stress-free and precise testing.

no coding 0.7µL blood volume; 7 seconds reaction time accurate & painless AST strip & lancet ejection 4 alarm reminders easy result indicators & ketone w arning result range: 1.1 - 33.3 mmol/L haematocrit range: 20 - 60% memory: 450 readings w ith day averages PC link facility size: 75L/45W/16Hmm, 40.8g w ithout CR2032 battery

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GlucoRx Kit includes...

• Blood glucose meter
• Test strips
• Control solution
• Lancing device w ith clear cap

for AST

• Sterile lancets
• Instructions
• Log book
• Warranty card
• Carry case

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GlucoRx Test strips

pack size 2 x 25s DT price £9.95, PIP code 349-1347

These strips utilise glucose oxidase (GOD) enzymes for blood glucose measurement - blood sample types: fresh capillary w hole blood; AST; also no interference for patients

• n dialysis containing

maltose.

GlucoRx Control solution

w arranty holders entitled to free solution every 6 months

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GlucoRx Lancing device

• lancet ejection - avoids needle stick

injuries!

• durable construction
• convenient pen shape
• adjustable tip allow s precise

customisation of lancet penetration

• easy operation
• clear cap for AST

GlucoRx blood Lancets (single use)

• very smooth, tri-bevel point
• gauge: 0.31mm
• sterile w ith x-ray irradiation
• easy to use and grip
• pack size 200s

DT price £5.50, PIP code 349-1354

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Services

All GlucoRx products are CE/MHRA/FDA/DT approved Full QA System; ISO 13485:2003 & ISO 9001:2008 requirements fulfilled

Compliance

– registered users entitled to a free battery and control solution every 6 months

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European registrations

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PC link

Use our Healthcare System to help manage your blood glucose: http://w w w.glucorx.co.uk/products-s.html ….. a personal computer application that enables upload, storage and analysis of test data from the GlucoRx meter through graphs and other softw are tools (request standard RS232 PC interface cable from DiME).

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Performance & Clinical studies

The accuracy of the GlucoRx (TD-4230) blood glucose monitoring system has been evaluated according to ISO 15197. The two bold lines represent the acceptance criteria from this guideline. ASSESSMENT: 100% of the individual difference w as w ithin ±15mg/dL w hen glucose concentration w as less than 75mg/dL. 98% of the individual difference w as w ithin ±20% w hen glucose concentration w as ≧75mg/dL.

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98% of the individual results fall w ithin Zone A w hich indicates clinically accuracy. Also the precision [intermediate (day-to-day precision) and repeatability (w ithin-day precision)] of TD- 4230 w as examined and show ed acceptable precision. THEREFORE THE REQUIREMENTS

FOR ISO 15197 HAVE BEEN MET WITH THE GLUCORX METER.

Measurements from TD-4230 correlate w ell and match those values given by YSI- 2300 over a w ide range of glucose values.

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German study

Investigation of the measuring accuracy of 12 different systems for blood glucose self measurement according to DIN EN ISO 15197

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Question: Due to the central meaning of blood glucose (BG) - self measurement for the monitoring and the adjustment of the intensified insulin therapy must exhibit the used blood glucose measuring systems a sufficiently high quality. The appropriate requirements on Blood glucose measuring systems for self-'s application w ith diabetes mellitus are stated in the European standard EN ISO

• 15197. Therefore the follow ing minimum accuracy must be fulfilled: 95% of the

individual glucose measured values must, regarding the results of the Reference procedure, w ith glucose concentrations. Methodology: Became in January 2009 as w ell as betw een July and October 2009 altogether 12 blood glucose measuring systems of different manufacturers w ith CE-indications tested. Kapilläre blood tests of 100 different test persons w ere measured w ith 2 measuring instruments each of a type. Directly before and after the measurements w ith the systems w hich can be tested samples w ere removed for measurement w ith tw o reference procedures (Hexokinase method (HK), Hitachi 917, Roche DIAGNOSTICs and Glukoseoxidase method (GOD), YSI 2300 STAT PLUS, YSI Inc.). Here full blood concentrations w ere measured. For blood glucose measuring systems, w hich are calibrated on plasma concentrations, w ere converted the reference measured values into plasma-equivalent concentrations. The normal function of the tested systems and that Reference devices became on each attempt day by the measurement suitable quality inspection samples examines.

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Table 1: Organization of the pairs of measured values into the glucose concentration ranges on the basis the reference method YSI Table 2: Results of the blood glucose measurements after ISO standard (* : The manufacturer data to the reference method w ere converted. Goods no data available, GOD w as used.) Illustration 1: Test devices (v.l.n.r.: Screening BZ, Hämatokrit, reference 1, test device 1, test device 2, reference 2) Illustration 2: Strew ing diagrams for each of the tw elve devices. Along the x axis the BGReferenzmessw erte is indicated in mg/dl. On the y axis the BG-differences are in mg/dl betw een Equipment measured value and reference measured value laid on. The broken lines indicate the maximum deviations from ±15, permissible after ISO standard, mg/dl and/or to ±20%. Conclusion: About 7 of 12 tested blood glucose measuring systems at least 95%

• f the measured values w ere w ithin the given borders and w ould fulfill thereby

the acceptance criteria for the system accuracy, defined by the standard EN ISO 15197, compared w ith the reference method used by the manufacturer.

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DRUG TARIFF February 2011

Savings

• f up to

34%!

BIOSENSOR STRIPS

• to be read only w ith appropriate meter

BASIC PRICE (P)

FOR 50

GlucoRx Test Strips 995 Advantage Plus 1517 Aviva 1489 Contour 1485 FreeStyle 1490 FreeStyle Lite 1490 GlucoMen LX Sensors 1465 OneTouch Ultra 1475 OneTouch Vita 1481 Optium Plus 1480

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Savings of up to 40%!

DRUG TARIFF February 2011

LANCETS - STERILE, SINGLE-USE GAUGE BASIC PRICE (P)

FOR 200

GlucoRx Lancets 0.31mm/30 gauge 550 BD-MicroFine + 0.20mm/33 gauge 632 FastClix 0.3mm/30 gauge 913 FreeStyle 0.5mm/25 gauge 702 Microlet 0.5mm/28 gauge 717 Multiclix 0.3mm/30 gauge 909 OneTouch Comfort 0.20mm/33 gauge 722 OneTouch FinePoint 0.5mm/25 gauge 708 Softclix 0.4mm/28 gauge 740 Softclix XL 0.8mm/21 gauge 740

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Website w w w.glucorx.co.uk

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For Professionals

GLOBAL MARKET COVERAGE:

America 54% Europe 25% Middle East 10% Asia 7% Taiw an 4%

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Manufacturer - TaiDoc Technology Corp.

• Taiw anese medical product

company established in 1998

• Became top blood glucose system

manufacturer in Taiw an in 2007

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Production capacity

• Based on 8 hours a day w ith 1 production line per month.
• Easily extendable: more production lines extension available, two-folds

in one month

Main contacts: Nilesh Nathw ani, Chris Chapman & Priya Thakur

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DiME – distributor of GlucoRx products and medical

disposable equipment for the pharmaceutical industry in the UK and throughout Europe 4 Wintonlea Monument Way West Woking Surrey GU21 5EN Customer services Phone: 01483 755133 Fax: 01483 770195 E-Mail: info@ glucorx.co.uk