our vision is to improve health · blood glucose and -ketone monitoring system checks ketone too...
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www.i-sens.com
i-SENS (Jiangsu) Co., Ltd. Huatai Road, Gangkou Street Fenghuang Town, Zhangjiagang City, Jiangsu Province, ChinaTel : +86-25-6668-6681
iSENS BIOSENSORS INDIA Pvt.Ltd. Unit No.1116-17, JMD Megapolis, Sohna Road, Gurgaon, Haryana 122001, IndiaTel : +91-0124-651-6606
i-SENS, Inc. Germany Ludwig-Erhard Strasse 30-34, 65760 Eschborn, GermanyTel : +49-6196-9675635
i-SENS CHILE SpA. Manzano 343, Oficina 412. Recoleta. Santiago. ChileTel : +59-228-409-536
i-SENS USA, Inc. 10050 Medlock Bridge Road, Suite 100, Duluth, GA 30097, USATel : +1-678-417-5990
i-SENS, Inc. Headquarters43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, KoreaTel : +82-2-910-0696 Fax : +82-2-941-0868
PG
A1E9500 R
EV1 2015/09
02 / 03Introduction of i-SEN
S
2000 - 2003 2003 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.
2004 - 2006 2006 Manufactured 1,000,000 glucose strips per day
2005 ODM glucose strips FDA cleared
2004 EM Mark, Europe CE, ISO 13485 certification
2007 - 2008 2008 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
2009 - 2010 2010 Established i-SENS, USA.
2010 CareSens N certified by China CFDA
2009 Frost & Sullivan award for Self-Monitoring Product of the year
2009 Launched electrolyte analyzer ‘i-Smart 30’
2011 - 2012 2012 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
2013 - 2014 2014 Established i-SENS(Jiangsu) Co., Ltd.
2014 Launched CareSens N NFC
2014 Launched VetMate
2013 Listed on KOSDAQ
2013 “World Class 300” by The Ministry of Knowledge Economy of Korea
20152015 Launched A1Care & i-Smart 300
2015 Established i-SENS CHILE SpA. & iSENS BIOSENSORS INDIA Pvt.Ltd.
2015 Launched GDH-FAD BGMS
Our vision is to improve health with high quality products
based on cutting edge biosensor technology.
CEO, i-SENS, Inc.
Geun Sig Cha
History of i-SENS
World-class Production Facilities
• Clean area facility • High-tech monitoring & control stations • Electronic visual inspection system
Songdo (IFEZ) Plant
Capacity : 0.8 billion strips
Overseas Branch and Subsidiary Companies
Headquartersi-SENS, Inc. Germany
i-SENS (Jiangsu) Co., Ltd. i-SENS, Inc. Shanghai Daibiaochu
04 / 05Introduction of i-SEN
S
i-SENS USA, Inc.
i-SENS, Inc. Headquarters
iSENS BIOSENSORS INDIA Pvt.Ltd.
i-SENS CHILE SpA.
Wonju Plant
Capacity : 2 billion strips
Simple and Reliable Code Detection System
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.
Advanced Electrochemical Signal Processing Technology
• 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.
06 / 07Technology of i-SEN
S
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.
Figure 1. System Accuracy of CareSens BGMS (2,400 test results).
Car
eSen
s, m
g/dL
CareSens
, mm
ol/L
Reference YSI 2300 STAT PLUS, mg/dL
Figure 2. Hematocrit Dependent Bias of CareSens BGMS.
Hematocrit, %
Mean D
ifference in Bias from
C
ontrol, %(Interval 2, 3)
Mea
n D
iffer
ence
in B
ias
from
C
ontr
ol, m
g/dL
(Inte
rval
1)
Diabetes Management Software
08 / 09
Available Operating Systems Integrated Management System
For Mobile (Android, iOS)
( Push Setting )( Logbook )( Daily Graph )( Statistics )( Summary )
For PC (Windows, MAC, Web)
SmartLog™
SmartLog™’s Extensive Networking SmartLog™ provides mobile healthcare services through 3G, Bluetooth and NFC.
Family Doctor
10 / 11
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)
Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• PP2* alarm *2 hours after meal• Data port
Slim & Smart
Talking Function
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 500 test result memory• 5-50 °C(41-122 °F)
Features• No coding required • Talking function • Hypoglycemia indicator • Strip ejection button• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port
Millions of Customers' Choice
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory • 5-50 °C(41-122 °F)
Features• No coding required• 1, 7, 14, 30, 90-day test averages (total, pre-meal and post-meal) • Post-meal flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port
Convenient with NFC
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 500 test result memory• 5-50 °C(41-122 °F)
Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages (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)• Data port
Blood G
lucose Monitoring System
12 / 13B
lood Glucose M
onitoring System
Specifications• 0.4 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65%• 5-45 °C(41-113 °F)• Fresh capillary/venous whole blood
Features• Enzyme : GDH-FAD• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Strip ejection button• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port
No Oxygen Interference
Convenient with Bluetooth SMART
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)
Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• Strip ejection button• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages • Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Bluetooth SMART• Data port
Specifications• 0.4 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory• 5-45 °C(41-113 °F)• Fresh capillary/venous whole blood
For blood β-Ketone testing• 0.5 μL / 8 seconds• 0.1-8.0 mmol/L• Hematocrit : 30-60%• 15-30 °C(59-86 °F)
Feature• Enzyme : GDH-FAD• No coding required• Hypoglycemia / Hyperglycemia indicator• Strip expiration date indicator• Strip ejection button• Auto back-lighted LCD• 1, 7, 14, 30, 90-day test averages• 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• Data port
Blood Glucose and -Ketone Monitoring System
Checks Ketone Too
NEW
NEW
14 / 15B
lood Glucose M
onitoring System
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 15-65%• 1,000 test result memory• 5-50 °C(41-122 °F)
Features• Coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• PP2* alarm *2 hours after meal• Data port
Proven Accuracy
Simple & Easy
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L) • Hematocrit : 20-60 %• 10 test result memory• 10-40 °C(50-104 °F)
Features• No coding required • Ring for strap
Large Display, Easy to Read
Specifications• 0.5 μL / 5 seconds• 20-600 mg/dL(1.1-33.3 mmol/L)• Hematocrit : 15-65 %• 1,000 test result memory• 5-50 °C(41-122 °F)
Features• No coding required• Hypoglycemia indicator• Strip expiration date indicator• 1, 7, 14, 30, 90-day test averages• Pre-meal, Post-meal, Fasting and No-mark flagging• 4 alarms(PP2* and 3-time set alarms) *2 hours after meal• Data port
For Your Pet
Specifications• 0.4 μL / 5 seconds• 10-600 mg/dL(0.6-33.3 mmol/L) • Hematocrit : 20-60 % • 500 test result memory• 5-50 °C(41-122 °F)
Features• Enzyme : GDH-FAD • No coding required• Hypoglycemia indicator• Strip ejection button• 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• Data port
Hospital Blood Glucose Monitoring System
16 / 17P
OC
T
Compact & Smart, Fits in your hand
Specifications• 0.4 μL / 5 seconds• 10-600 mg/dL(0.6-33.3 mmol/L)• Hematocrit : 15-65%• 1,500 test result memory• Measurement temperature : 5-45 °C(41-113 °F)• 3.7V Li-ion polymer rechargeable battery
Features• Enzyme : GDH-FAD• Strip ejection button• No coding required• 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 SolutionConnect 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.
Car
eSen
s E
XPER
T, m
g/dL
Reference YSI 2300 STAT PLUS, mg/dL Hematocrit, %
Mean D
ifference in Bias from
Control, %
(Interval 2, 3)Mea
n D
iffer
ence
in B
ias
from
Con
trol
, mg/
dL(In
terv
al 1
)
• System Accuracy Test Results • Hematocrit Effect Test Results
Web-based CareSens Data Manager
Accuracy Criteria
Percent (n/n)within criteria 580/864 (67.1 %) 812/864 (94.0 %) 853/864 (98.7 %)
Within ± 5 mg/dLor ± 5 %
Within ±10 mg/dLor ± 10 %
Within ±15 mg/dLor ± 15 %
Specifications• Cartridge
• Analyzer
Sample & volume Measurement time Accuracy Precision Dimension & weight Operating temperature Humidity DisplayMemoryInterfaceOS
Whole Blood(Venous, Capillary); 2.5 μL4 minutes 20 seconds±6 % of target value(95 % CI)C.V. 3 %290 X 250 X 130mm; 3.8 kg15-32 °C(59-90 °F)10-90 %7〃touch screen, color LCD5,000 Sample dataUSB; Serial(RS232), LAN(R145 Ethernet)Android
18 / 19P
OC
T
STEP-1
HbAo + HbA1c+ Hbx etc.
Glycated peptidesIncluding
Fructosyl-Val-HisHydrogen Peroxide
HbA1cRBC Lysis
Lysingbuffer
Fructosyl-Val-His Hydrogen Peroxide
STEP-2 STEP-3 STEP-4
ProteaseFPOX POD
Color change
Assay Principle
IFCC IssueDeviation
from IFCC target (mmol/mol)
Reproducibility (%)
Excellent 0.0 – 1.9 < 2 > 0.9950
0.8 (at 30)1.2 (at 60)1.6 (at 90)
1.85 0.9987
Good 2.0 - 3.9 2.00 – 3.49 0.9901 – 0.9950
Acceptable 4.0 - 6.9 3.50 – 4.99 0.9851 – 0.9900
Poor 7.0 - 9.9 5.00 – 6.99 0.9801 – 0.9850
Unacceptable > 9.9 > 6.99 < 0.9801
A1CareTM
Linearity
POCT HbA1c Analyzer
» Simple & Easy Preparation» Fast & Reliable Result» High Usability
Advantages of A1CareTM
• Easy & simple installation• All-in-one, self-contained reagent cartridge• Small blood sample size (2.5 μL)• No sample pretreatment and pipetting required
Simple & Easy Preparation• 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
High Usability
• HbA1c test results within 4 minutes 20 seconds • All-in-one cartridge to minimize user error• Internal temperature control system
Fast & Reliable Result
PerformanceA1CareTM 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).
A1CareTM 40 of 40 results within ± 6%
NGSP Criteria 37 of 40 results within ± 6%
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