i-sens CHILE SpA. Manzano 343, Oficina 412. Recoleta. Santiago. Chile Tel :
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1 i-sens, Inc. Headquarters 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea Tel : Fax : i-sens USA, Inc Medlock Bridge Road, Suite 100, Duluth, GA 30097, USA Tel : i-sens CHILE SpA. Manzano 343, Oficina 412. Recoleta. Santiago. Chile Tel : isens BIOSENSORS INDIA Pvt.Ltd. Unit No , JMD Megapolis, Sohna Road, Gurgaon, Haryana , India Tel : i-sens, Inc. Germany Ludwig-Erhard Strasse 30-34, Eschborn, Germany Tel : i-sens (Jiangsu) Co., Ltd. Huatai Road, Gangkou Street Fenghuang Town, Zhangjiagang City, Jiangsu Province, China Tel : PGA1E9500 REV1 2015/09
2 CEO, i-sens, Inc. Geun Sig Cha Our vision is to improve health with high quality products based on cutting edge biosensor technology. 02 / 03 Introduction of i-sens History of i-sens Launched blood glucose monitoring system CareSens 2003 Successfully developed CareSens glucose strips 2002 Completion of Seoul factory and R&D center 2000 Founded i-sens, Inc Manufactured 1,000,000 glucose strips per day 2005 ODM glucose strips FDA cleared 2004 EM Mark, Europe CE, ISO certification Established branch office in China 2008 Launched CareSens N 2008 CareSens II, CareSens POP cleared by FDA 2007 ODM glucose monitoring system certified by Japan s MHLW 2007 Completed Wonju factory Established i-sens, USA CareSens N certified by China CFDA 2009 Frost & Sullivan award for Self-Monitoring Product of the year 2009 Launched electrolyte analyzer i-smart New Zealand sole suppliership 2012 Launched CareSens N POP, CareSens N Voice 2012 Completed Songdo factory 2011 Established branch office in Europe 2011 Japan OEM launched Established i-sens(jiangsu) Co., Ltd Launched CareSens N NFC 2014 Launched VetMate 2013 Listed on KOSDAQ 2013 World Class 300 by The Ministry of Knowledge Economy of Korea Launched A1Care & i-smart Established i-sens CHILE SpA. & isens BIOSENSORS INDIA Pvt.Ltd Launched GDH-FAD BGMS
3 Songdo (IFEZ) Plant Capacity : 0.8 billion strips Overseas Branch and Subsidiary Companies i-sens USA, Inc. i-sens, Inc. Headquarters i-sens, Inc. Headquarters Germany 04 / 05 Introduction of i-sens World-class Production Facilities Clean area facility High-tech monitoring & control stations Electronic visual inspection system Wonju Plant Capacity : 2 billion strips isens BIOSENSORS INDIA Pvt.Ltd. i-sens CHILE SpA. i-sens (Jiangsu) Co., Ltd. i-sens, Inc. Shanghai Daibiaochu
4 Advanced Electrochemical Signal Processing Technology Simple and Reliable Code Detection System 06 / 07 Technology of i-sens Uses a set of glucose-specific signals extracted from sophisticated signals. Provides highly accurate and precise glucose value. Provides users with the most accurate results and convenience. Eliminates the anxiety of inaccurate results from miscoding. i-sens CoreSignal Technology is an electrochemical signal processing technology developed for very accurate and far more precise monitoring of blood glucose level than the conventional glucose self monitoring products. Electrochemical signals generated from a tiny glucose strip filled with human blood is not as simple as it may sound; the physical, chemical and biological properties of blood are so diverse from person to person that the signal pattern is complicated. CodeSens is our patented no-coding technology. Superior No Coding Technology. CodeSens allows glucose meter to automatically recognize the code number of each glucose strip so that users can get the most reliable and accurate results. No code chip, code strip, nor barcode reader required. It automatically detects the code number when a glucose test strip is inserted into the meter. CareSens BGMS with CoreSignal Technology and CodeSens Technology fulfills not only the accuracy requirements of ISO 15197:2013, but also all other requirements such as the hematocrit bias and interference effects presented in the ISO 15197:2013 guidance. CareSens, mg/dl CareSens, mmol/l Mean Difference in Bias from Control, mg/dl(interval 1) Mean Difference in Bias from Control, %(Interval 2, 3) Reference YSI 2300 STAT PLUS, mg/dl Figure 1. System Accuracy of CareSens BGMS (2,400 test results). Hematocrit, % Figure 2. Hematocrit Dependent Bias of CareSens BGMS.
5 Diabetes Management Software SmartLog s Extensive Networking SmartLog provides mobile healthcare services through 3G, Bluetooth and NFC. 08 / 09 Family Doctor Available Operating Systems For Mobile (Android, ios) Integrated Management System SmartLog For PC (Windows, MAC, Web) ( Summary ) ( Statistics ) ( Daily Graph ) ( Logbook ) ( Push Setting )
6 Talking Function Millions of Customers' Choice 10 / test result memory Talking function (total, pre-meal and post-meal) Post-meal flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal (total, pre-meal and post-meal) Post-meal flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal Slim & Smart Auto back-lighted LCD (total, pre-meal and post-meal) Post-meal flagging PP2* alarm *2 hours after meal Convenient with NFC 500 test result memory (total, pre-meal and post-meal) Post-meal flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal NFC(Near Field Communication) Blood Glucose Monitoring System
7 NEW Convenient with Bluetooth SMART Auto back-lighted LCD Pre-meal, Post-meal, Fasting and No-mark flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal Bluetooth SMART No Oxygen Interference 0.4 μl / 5 seconds Hematocrit : 15-65% 5-45 C( F) Fresh capillary/venous whole blood Enzyme : GDH-FAD Pre-meal, Post-meal, Fasting and No-mark flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal Blood Glucose and -Ketone Monitoring System 0.4 μl / 5 seconds 5-45 C( F) Fresh capillary/venous whole blood For blood -Ketone testing 0.5 μl / 8 seconds mmol/l Hematocrit : 30-60% C(59-86 F) Checks Ketone Too Feature NEW Enzyme : GDH-FAD Hypoglycemia / Hyperglycemia indicator Auto back-lighted LCD Pre-meal, Post-meal, Fasting and No-mark flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal Ketone test alarm Bluetooth SMART 12 / 13 Blood Glucose Monitoring System
8 Simple & Easy Hematocrit : % 10 test result memory C( F) Ring for strap Proven Accuracy Hematocrit : 15-65% Coding required Pre-meal, Post-meal, Fasting and No-mark flagging PP2* alarm *2 hours after meal Large Display, Easy to Read Pre-meal, Post-meal, Fasting and No-mark flagging 4 alarms(pp2* and 3-time set alarms) *2 hours after meal For Your Pet 0.4 μl / 5 seconds mg/dl( mmol/l) Hematocrit : % 500 test result memory Enzyme : GDH-FAD Auto back-lighted LCD 14-day test averages(each animal type and ID) Maximum number of ID entries : 4 dogs & 4 cats Calibrated for dogs & cats 5-time set alarms Compatible with VetLog animal diabetes management software 14 / 15 Blood Glucose Monitoring System
9 Hospital Blood Glucose Monitoring System Compact & Smart, Fits in your hand 0.4 μl / 5 seconds mg/dl( mmol/l) Hematocrit : 15-65% 1,500 test result memory Measurement temperature : 5-45 C( F) 3.7V Li-ion polymer rechargeable battery Enzyme : GDH-FAD 3.5 color LCD(touch screen) Barcode scanner(1d or 2D) Data transfer : WiFi, USB Standard : POCT1-A, IHE DEC(ASTM&HL7) Efficient QC management CareSens Data Manager Solution Connect easily to your hospital network with our system over WiFi or wired. Web-based system enables users to access CareSens Data Manager from any location at any time. CareSens EXPERT & CareSens Data Manager system supports multiple security protocols (POCT1- A and IHE DEC(incl. ASTM&HL7)) to ensure the integrity of patient data. Performance of CareSens Expert CareSens EXPERT Hospital blood glucose monitoring system fulfills not only the accuracy requirements of ISO 15197:2013, but also all other requirements such as the hematocrit bias and interference effects presented in the ISO 15197:2013 guidance. System Accuracy Test Results Hematocrit Effect Test Results CareSens EXPERT, mg/dl Accuracy Criteria Percent (n/n) within criteria Reference YSI 2300 STAT PLUS, mg/dl Hematocrit, % Within ± 5 mg/dl or ± 5 % Web-based CareSens Data Manager Within ±10 mg/dl or ± 10 % Within ±15 mg/dl or ± 15 % 580/864 (67.1 %) 812/864 (94.0 %) 853/864 (98.7 %) Mean Difference in Bias from Control, mg/dl(interval 1) Mean Difference in Bias from Control, %(Interval 2, 3) 16 / 17 POCT
10 » Simple & Easy Preparation» Fast & Reliable Result» High Usability POCT HbA1c Analyzer Assay Principle RBC Lysis STEP-1 Lysing buffer HbA o + HbA1c + Hbx etc. STEP-2 STEP-3 STEP-4 HbA1c Protease Glycated peptides Including Fructosyl-Val-His Advantages of A1Care TM Simple & Easy Preparation Easy & simple installation All-in-one, self-contained reagent cartridge Small blood sample size (2.5 μl) No sample pretreatment and pipetting required Fast & Reliable Result HbA1c test results within 4 minutes 20 seconds All-in-one cartridge to minimize user error Internal temperature control system IFCC Issue Fructosyl-Val-His FPOX Hydrogen Peroxide High Usability Performance A1Care TM has acquired the NGSP and IFCC certifications with its performance beyond the standards required by the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry (IFCC). NGSP Criteria 37 of 40 results within ± 6% A1Care TM 40 of 40 results within ± 6% Deviation from IFCC target (mmol/mol) Reproducibility (%) Hydrogen Peroxide POD Color change On-screen step-by-step guide Android OS-Useful and easy to use Intuitive color touch screen External barcode scanner for safer and faster patient ID entry No complicated maintenance required due to all-in-one cartridge Linearity Unacceptable / 19 POCT Poor Acceptable Cartridge Analyzer Sample & volume Measurement time Accuracy Precision Dimension & weight Operating temperature Humidity Display Memory Interface OS Whole Blood(Venous, Capillary); 2.5 μl 4 minutes 20 seconds ±6 % of target value(95 % CI) C.V. 3 % 290 X 250 X 130mm; 3.8 kg C(59-90 F) % 7 touch screen, color LCD 5,000 Sample data USB; Serial(RS232), LAN(R145 Ethernet) Android Good Excellent A1Care TM 0.8 (at 30) 1.2 (at 60) 1.6 (at 90)
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