caresens data manager solution - medcase · 2016. 3. 29. · caresens. expert hospital blood...

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Hospital Blood Glucose Monitoring System 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 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. CareSens EXPERT, mg/dL Reference YSI 2300 STAT PLUS, mg/dL Hematocrit, % Mean Difference in Bias from Control, %(Interval 2, 3) Mean Difference in Bias from Control, mg/dL(Interval 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/dL or ± 5 % Within ±10 mg/dL or ± 10 % Within ±15 mg/dL or ± 15 %

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Page 1: CareSens Data Manager Solution - Medcase · 2016. 3. 29. · CareSens. EXPERT Hospital blood glucose monitoring system fulfills not only the accuracy requirements of ISO 15197:2013,

Hospital Blood Glucose Monitoring System

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 %