Sensa Core Hemo Spark User manual

MEM
%
HCT
g/dL
n
WARRANTYWARRANTY
YEARSYEARS
33 3
YEARS
Blood Hemoglobin Measuring System
ISO
9001
ISO
13485
Obelis s.a., Bd General Wahis 53, 1030,
Brussels, Belgium. Tel:+(32) 2 732-59-54
Fax:+(32) 2 732-60-03 [email protected]

Table of Contents
Section 3
Section 4
Section 5
Section 6
Section 8
Section 9
Section 10
Section 11
Appendix 1
Appendix 2
Appendix 3
Section 1
Section 7
Section 2 Contents in Hemo Spark Kit............................................................ 6
Components...................................................................................... 7
Meter.............................................................................................7
Test Strips.....................................................................................10
Test Strips Storage and Handling.................................................12
Test Strips Precautions and Instructions for Use........................12
Initial Setup......................................................................................14
Power Supply...............................................................................14
Meter Setup and Options ...............................................................16
Test Number Setup .....................................................................17
Meter Setup ................................................................................18
Testing .............................................................................................20
Instructions for use of Lancing Device.......................................21
Instructions for use of Safety Lancets ...................................... 24
Data Transfer / Transmission.......................................................28
Deleting Data............................................................................... 28
Optical System Check..................................................................... 30
Maintenance ...................................................................................32
Cleaning.......................................................................................32
Recharging or Replacing the Batteries ......................................32
Precautions......................................................................................33
Troubleshooting...............................................................................34
Meter Specifications.......................................................................35
Index of Symbols.............................................................................36
Warranty..........................................................................................37
Introduction.......................................................................................4
Data/Communication .....................................................................28
Coding the Meter.........................................................................15
Code Chip Sample Count .............................................................15
Strip Testing ................................................................................ 26
Control Strips / Control Solutions................................................12
Strip Test Processing ................................................................. 25
Alternate Test Sites......................................................................5

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.

Upper arm
Forearm
Hand
Fingertips
Thigh
Calf
The human figure above shows the areas where you can test with the
. Avoid moles, veins, Hemo Spark Blood Hemoglobin(Hb) Measuring System
bones and tendons.
Suggested Test
Areas for the Hand
Alternate Test Sites
Warning:
We recommend that you test on your finger tips for better results.
Hemo Spark Blood Hemoglobin(Hb) Measuring System uses 10 µL sample.
So you can test on a variety of locations shown above.
Note :
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Carrying Case: Provides portability for testing wherever you go.
Control Strip or Control Solution: Verifies the proper operation of the meter by checking that
the meter can detect a pre-calibrated value / defined ranges respectively as mentioned in insert
Control Strip or Control Solution Package Insert: Provides detailed instructions on using
the Hb Hemoglobin Control Strip or Control Solution.
Hemo Spark Hemoglobin (Hb) Meter: Reads the Test Strips. Displays the hemoglobin (Hb)
concentration and the estimated hematocrit (Hct) value.
User's Manual: Provides detailed instructions on how to use the Blood Hemoglobin (Hb)
Measuring System.
Section 2 Contents in Hemo Spark Kit
Hemo Spark kit will have the items as per CONTENTS mentioned on the kit box
Before testing, read the instructions carefully and learn about all the components of the
Hemo Spark Blood Hemoglobin(Hb) Measuring System.
The following items are needed to perform a test:
Items in the Package
1. Hemo Spark Hemoglobin(Hb) Meter
2. Hemo Spark Blood Hemoglobin Measuring System User Manual
3. Hemo Spark Hemoglobin Control Strips*
4. Hemoglobin Control Strip Insert Sheet*
5. Hemoglobin Control Solutions*
6. Hemoglobin Control Solution Insert Sheet*
7. USB Cable*
8. (Lithium/NiMH /Zinc Carbon)3 AAA rechargeable batteries /ZnCl
9. Lancing Device
10. Warranty Card
11. Lancets
12. Power Adapter*
13. Carrying Case
sheet.
Note: Components with * are optional and are provided based on requirement.
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Section 3 Components
The Hemo Spark Hemoglobin (Hb) Meter reads the test strips and displays the hemoglobin
(Hb) concentration and hematocrit (Hct) value. Below diagram describes the parts of your
meter.
Meter
1. LCD (Liquid Crystal Display)
2. Left Arrow Button
4. Strip Channel
3. Setup Button
5. Right Arrow Button
◄
◄
6
1
7
8
5
2
4
9
3
10
7. Battery Cover
8. Serial Port
9. Printer Interface/USB
6. On/Off Button
10. Code Chip
7

Meter Display
During testing, the Hemo Spark Hemoglobin (Hb) Meter will display icons showing the status,
options available and prompts for testing:
Sound Icon: Appears when the sound is turned on.
Battery: Flashes when the battery should be recharged or replaced.
Test Number: Indicates assigned test number.
Test Result Area: Indicates test result or displays menu options.
Memory: Indicates a test result is being recalled from memory.
Measurement Units: Indicates the units for the test result.
Hct Value: Shows calculated Hct value.
Test Strip and Blood Drop Symbols:
Indicates when to insert test strip or apply sample/specimen.
MEM CHK C
%
Lev
HCT
mmol/L
CAL
g/dL
AM
PM
CODE
SET n
Link computer
Sound
Blood drop symbol
Test / Control strip symbol
Unit
Battery
Date and Time
SET mode
Memory
Test result area
HCT value
Test number
Bluetooth
Printer
8

Meter Use and Precautions
* Do not get water or other liquids on or inside the meter.
* Keep the test strip channel clean.
* Keep the meter dry. Avoid exposure to extreme temperatures or humidity.
* Do not drop the meter or get it wet. If either has occurred, ensure the meter is working
properly by running an Optical Check. Refer to Section 8 Optical System Check for details.
* Do not take the meter apart. This will void the warranty.
* Refer to Section 9 Maintenance for details on how to clean the meter.
* Keep the meter and all associated parts out of reach of children.
Note:
Follow proper precautions and all local regulations
when disposing of the meter and used batteries.
All Hb Systems Preventive Warnings with Regard to EMC
This instrument is tested for immunity to electrostatic discharge, as specified in IEC
61000-4-2. However, use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets, etc.) may cause damaging static
discharges that can cause erroneous results.
This instrument complies with the emission and immunity requirements described in
IEC 61000-4-8 and IEC 61000-4-3. Do not use this instrument in close proximity to
strong sources of electromagnetic radiation. These may interfere with proper
operation of the meter.
For professional use, the electromagnetic environment should be evaluated prior to
operation of the system.
1.
2.
3.
9

Front Back
1
2
3
Test Strips
The Hemo Spark Blood Hemoglobin (Hb) Measuring Test strips are made out of plastic.
A reagent layer within the test strip contains a chemical reagent system that works with the
Hemo Spark Hemoglobin (Hb) Meter to measure the hemoglobin (Hb) concentration in
capillary and venous whole blood or arterial whole blood.
1. Insert Arrows:
Located on the front of the test strip. These arrows indicate the direction in which the test
strip should be inserted.
2. Sample Application Area:
After the test strip is inserted into the strip Channel, apply 10 µL of blood to the center of
3. Handle:
Located on the end of the test strip. This handle is used to insert and remove the test strip
from the meter.
Test strip appears as shown below:
the test strip.
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