Sensa Core Hemo Spark, User Manual

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Section 1 Introduction
Intended Use
The Hemo Spark Blood Hemoglobin(Hb) Measuring System is intended for the quantitative
determination of hemoglobin (Hb) in capillary, venous & arterial human whole blood . The
testing system is designed for in vitro diagnostic use only (external use only).
The Hemo Spark Blood Hemoglobin Measuring System is for professional in vitro diagnostic
use only. Simply add a drop of blood to the test strip, and the result is displayed on the
screen in less than 30 seconds. This device has not been evaluated for pediatric subjects.
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* Read instructions carefully. Complete any necessary training before use.
* Only use Hemo Spark Hemoglobin (Hb) Test Strips with the Hemo Spark Hemoglobin (Hb) Meter.
* For Professional in vitro diagnostic use only.
* Test only whole blood specimens. Blood samples with EDTA or heparin anticoagulants can be used.
* This device has not been evaluated for pediatric subjects.
* Keep out of reach of children.
* For any queries, please contact Customer Support at 1800 212 2880
The Hemoglobin Test strip includes a mesh covered sample reaction zone. Sample is applied
to the center of the sample reaction zone. The mesh functions to separate the sample evenly
on the entire reaction layer. The reagents on the reagent layer function to hemolyze and
release the hemoglobin. The hemoglobin is converted to methemoglobin to cause a color
Principle of Operation for the Methodology
The meter reads the reflection of the strip at every second until the end point of the reaction
is detected. The reflection at the end point is directly proportional to the hemoglobin
concentration. The end point is defined as following:
To ensure accurate results:
change on the strip.
The reflection changes between ±1% in three continuous second. Then the reflection at the
last second will be read as the end point.
The Hemo Spark Blood Hemoglobin(Hb) Measuring System provides results in less than
30 seconds. The test only requires 10 μL drop of whole blood. The meter can store up to
1,000 results and can be powered by 3 AAA rechargeable batteries (Lithium/NiMH
/Zinc /ZnCl
Carbon) or an optional AC adapter.