Sensa Core Hemo Spark User manual

MEM
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HCT
g/dL
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WARRANTYWARRANTY
YEARSYEARS
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YEARS
SCHS-0120A

Table of Contents
Contents in Hemo Spark Kit ........................................................ ...5
Section 3 Components..................................................................................... 6
Meter.............................................................................................6
Test Strips......................................................................................9
Special Instructions for Test Strip in the Vial ..............................11
Precautions...................................................................................12
Section 4 Initial Setup.....................................................................................13
Power Supply...............................................................................13
Coding the Meter.........................................................................14
Section 5 Meter Setup and Options ..............................................................15
Test Number Setup .....................................................................16
Meter Setup ................................................................................17
Section 6 Testing ............................................................................................19
Getting a Drop of Blood..............................................................20
Strip Processing and Testing ..................................................... 23
Data Transfer...............................................................................26
Deleting Data...............................................................................26
Section 8 Optical System Check.................................................................... 28
Optical Check.............................................................................. 28
Section 9 Quality Control...............................................................................30
Section 10 Maintenance ..................................................................................31
Cleaning.......................................................................................31
Replacing the Batteries ..............................................................31
Section 11 Precautions......................................................................................32
Section 12 Troubleshooting.............................................................................33
Appendix 1 Meter Specifications...................................................................35
Appendix 2 Index of Symbols.........................................................................36
Appendix 3 Warranty......................................................................................37
Section 1 Introduction......................................................................................4
Section 7 Data/Communication ....................................................................26
Section 2

* Read instructions carefully. Complete any necessary training before use.
* Use the Code Chip included in each box of test strips.
* Only use Hemo Spark Hemoglobin (Hb) Test Strips with the Hemo Spark Hemoglobin (Hb) Meter.
* For in vitro diagnostic use only.
* For professional 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 help with any additional questions or issues, please contact Customer Support at 1800 212 2880
Section 1 Introduction
Intended Use
The Hemo Spark Hemoglobin (Hb) Testing System is for the quantitative determination of
hemoglobin in capillary whole blood or arterial or venous whole blood. The testing system is
designed for in vitro diagnostic use only (external use only), and is suitable for self-testing.
The system is for health care professionals and persons with anemia to measure hemoglobin.
Simply add a drop of blood to the test strip, and the result is displayed on the screen in
15 seconds. This device has not been evaluated for pediatric subjects.
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 cartridge/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 Hemoglobin (Hb) Testing System provides results in less than 15 seconds.
The test only requires a single 10 μL drop of whole blood. The meter can store up to 1,000
results and can be powered by 3 AAA (1.5V) batteries or an optional AC adapter.
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Carrying Case: Provides portability for testing wherever you go.
Control Strip or Control Device: Verifies the proper operation of the meter by checking that
the meter can detect a pre-calibrated value.
Control Strip Package Insert: Provides detailed instructions on using the Hb Hemoglobin
Control Strips or Control Devices.
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 Hemoglobin (Hb) Testing
System.
Section 2 Contents in Hemo Spark Kit
Inspect the kit box, meter, and accessories for any visible damage, contact Customer Support
at 1800 212 2880.
Before testing, read the instructions carefully and learn about all the components of the
Hemo Spark Hemoglobin (Hb) Testing System.
The following items are needed to perform a test:
Items in the Package
1. Hemo Spark Hb Meter
2. Hemo Spark Hemoglobin User Manual
3. Hemo Spark Hemoglobin Control Strips
4. Hemoglobin Control Strips Insert Sheet
5. Carrying Case
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Section 3 Components
The Hemo Spark (Hb) Hemoglobin 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. On/Off Button
3. Right Arrow Button
4. Left Arrow Button
5. Strip Channel
6. Battery Cover
7. Code Chip Slot
8. Printer Interface
9. USB interface
10. Setup Button
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8
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4
5
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Meter Display
During testing, the Hemo Spark (Hb) Hemoglobin Meter will display icons showing the status,
options available and prompts for testing:
Sound Icon: Appears when the sound is turned on.
Battery: Appears when the battery should be 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.
Code: Indicates the code number of the test strip or devices.
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/device or apply sample/specimen.
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MEM CHK C
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HCT
mmol/L
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g/dL
AM
PM
CODE
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Link computer
Sound
Blood drop symbol
Test strip symbol
Unit
Battery
Date and Time
Code chip
SET mode
Memory
Test result area
HCT value
Test number

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 10 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.
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Front Back
1
2
3
Test Strips
The Hemo Spark Hemoglobin (Hb) 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 hole in the
center of the test strip.
3. Handle:
Located on the end of the test strip. This handle is used to insert and remove the test strip
from the meter.
Each Test strip appears as shown:
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Sample Application
For best results, fill the sample application area with approximately 10 µL of blood. Incorrect
results may occur if the sample is not applied correctly or if the sample application area is
not filled.
After applying the sample, ensure the sample application area is completely covered as
shown in the above picture. This area should remain covered throughout the entire test. If it
is not covered, or if there is too much specimen covering the area, repeat the test with a new
test strip.
Note:
Do not add more blood to the test strip if the sample applied to the sample application
area. When a “Lo” or “E-5” appears on the display, check the back side of the sample
application area to confirm whether or not enough blood has been applied as in the
above picture. Discard the used strip and retest with a new strip.
Each package of test strips is printed with a code number (Code), lot number (Lot),
unopened expiration date (Exp), and test quantity (Quantity) in a vial. Whenever a new vial
is opened, mark the date on the label. Calculate the opened expiration date by adding three
months. Record this date on the label.
Code Number
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Front Back
Reference Pad
Test Strips Storage and Handling
* Store test strips in a cool, dry place. Store away from heat and direct sunlight.
* Store as packaged in the closed vial at room temperature (2-40°C)
* Do not freeze or refrigerate.
* Replace the cap on the test strip vial immediately after removing it from container.
* Do not use your test strips past the unopened expiration date printed on the label. Using
the test strips past the unopened expiration date may produce incorrect test results.
Test Strips Precautions and Instructions for Use
* Test strips must be stored in the original vial with the cap tightly closed.
* Replace the cap on the test strip vial immediately after removing a test strip.
* A new vial of test strips may be used for 3 months after first being opened. The opened
expiration date is 3 months after the date the vial was first opened. Write this date on the
vial label after opening. Discard the vial 3 months after it was first opened. Usage after this
period may result in inaccurate readings.
* For in vitro diagnostic use. Test vials are only to be used outside the body for testing purposes.
* Do not use test strips that are damaged in any way. Do not reuse test strips.
* Before testing, make sure that the code number on the meter display matches the number
shown on the test strip vial label and the ink-jet printing on the code chip. Refer to the test strip
package insert for more details.
Control Strips
The Hemo Spark (Hb) Hemoglobin Control Strips are plastic strips containing a brown
reference pad which works with the Hemo Spark (Hb) Hemoglobin Meter to ensure the
optical system is working properly. After the control strip is inserted into the meter, the
optical system of meter detects the color intensity of the control strip or device. The meter
displays YES or no to show whether the meter is functioning properly. Refer to Section
8 Optical Check for details. The control strip/device appears as shown below:
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* Store in the closed vial at room temperature within 2-40°C (36 - 104ºF) and avoid exposing
it to direct sunlight, extreme temperature or humidity. Control strips or control devices
should be stored tightly capped in their protective vial to keep them in good working
condition.
* Do not freeze or refrigerate.
* Keep the control strips or control devices clean and do not bend. Do not touch the test
area of the strip or device.
* Remove the control strip or control device for immediate use. Put the control strip or
control device back and close the vial tightly immediately after use. Do not use contaminated,
discolored, bent or damaged control strips or control devices.
* Do not use after the expiration date.
* For in vitro diagnostic use only.
Precautions
* Store control strips in a cool, dry place. Store away from heat and direct sunlight.
* Transport and store in its closed vial within 2-40°C (36 - 104ºF), less than 95% humidity.
* Do not freeze or refrigerate.
* Replace the cap on the control strips vial immediately after removing it from container.
* A new vial of control strips may be used for 2 years after first being opened. The opened
expiration date is 2 years after the date the vial was first opened. Write the opened
expiration date on the vial label after opening. Discard the vial 2 years after it is first opened.
Usage after this period may result in inaccurate readings.
Storage and Handling
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Turn on Meter
Section 4 Initial Setup
Press button to turn the meter on. The screen will briefly display all of the LCD symbols.
Observe the LCD at startup to ensure all segments and display elements are turned on, and
there are no missing icons or elements. After startup, observe there are no permanently
To use the meter with the power adapter, connect the Mini USB port of the power adaptor
to the USB port located on the top of the meter with a USB cable, and plug the adaptor into
a 100-240V ac, 50-60 Hz primary power outlet. The meter can also be powered from the USB
port of a personal computer, connected by a USB cable. OR The meter will turn on
automatically after the batteries are inserted. The meter will display the date and time setup
screen. Refer to Section 5 Meter Setup for details. After the date and time have been set,
the meter will automatically turn off.
The meter can be operated using the certified AC Adapter or 3 AAA batteries (1.5V). To use
the meter with batteries, insert 3 AAA batteries (1.5V) into the battery compartment located
on the back of the meter.
Before testing, ensure the following procedures are followed.
The meter will turn off automatically after 5 minutes of inactivity.
turned on segments or icons.
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Each time a new box of test strips are used, the code chip packaged with the new box of
test strips must be inserted into the meter. Take the code chip from the test strips or test
devices box. Compare the code number on the code chip with the code number printed on
the vial label. Results may be inaccurate if the two numbers are not identical. If the code
number on the code chip does not match the number on the vial label with which it was
packaged contact customer support or local distributor immediately.
Insert the new code chip into the code chip slot of the meter. It should easily snap into place.
The code chip should remain in the meter. Do not take it out until a new box of test strips or
test devices is needed. The code number will appear on the Initial Screen after startup.
Coding the Meter
Please contact your local distributor immediately.
If the code number on the code chip does not match
the number that is displayed on the screen.
If the code chip is not properly inserted into the code
chip slot, or if it is missing, the meter will display three
dashes.
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CODE

Section 5 Meter Setup and Options
With the meter turned on, press setup button and hold for 4 seconds to enter Meter Setup
mode shown below.
Press button to display several setup sub-modes. Press or to select and press
button to enter following setup sub-modes:
◄ ◄
No. SEt
Test number setup. The test number can be from 1 to 999.
Refer to P15
CHE
Optical Check mode. Refer to Section 8
SYS
System Setup mode. Refer to P16
PC
Data transfer mode. Refer to Section 7
dEL
Deleting Data mode. Refer to Section 7
Exit setup mode. Confirm exit by button
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From the No. SEt screen, press button to enter Test Number Setup mode.
Test Number Setup
The test number can be set to any number from 1 - 999.
Press or until the correct test number is displayed. To quickly cycle to the desired test
number, press and hold or
Press to save and return to No. SEt screen.
◄ ◄
◄ ◄
Note: Once the meter reaches test number 999, the next test number will be 1.
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Press ◄ or ►until the correct month is displayed.
Press button to save.
The day will flash with d displayed on the screen. Press ◄ or ► until the correct day is displayed.
Month and Date Setup
Next, with m displayed on test result area with month flashing at the bottom of the screen.
Press ◄ or ► until the correct year is displayed
single dash(-) with year flashing and y displayed on test result area.
Then press button to save and proceed to setup time.
From the SEt screen, press to enter Meter Setup mode
Meter Setup
The first option sets the clock to either 12 or 24 hour mode. Press ◄ or ► to switch between
the two settings.
Hour Setup
OR
Press to save and advance to setting the year.
Year Setup
The year, month & date will appear at the bottom of the display. They will be separated by a
Press button to save and start setting month and date.
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The hour and minutes will appear at the top of the display. They will be separated by a colon,
with flashing hour.
Press ◄ or ► until the correct hour is displayed. Press to save and proceed to setup minute.
Note: The meter will display AM or PM if the 12H time setting is chosen.
Minutes will flash. Press ◄ or ► until the correct Minutes are displayed. Press button
to save and proceed to Test Number Reset Setup.
Time Setup
Test Number Reset Setup
Press ◄ or ► to turn the test number reset ON or OFF. The test number will reset to 1 for
each new day of testing when the test number reset is turned on. Press to save and proceed
to setup unit.
“OFF” means test number will continue the last number when meter turns off at last time.
“On” means test number will start from No. 1 and do not continue the last number.
Press button to save.
Units Setup
Press ◄ or ► to select either g/dL, g/L, or mmol/L.
OR OR
Press button to save.
Sound Set Up
Press ◄ or ► to turn the sound ON or OFF. The Sound Symbol will appear on the display
when the sound is turned on. Press button to save and return to the setup screen.
Press ◄ or ► until Elt is displayed and press button to exit setup. The screen will briefly
go blank and display the initial screen.
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mmol/Lg/dL

Section 6 Testing
Before performing any test, review the Hemo Spark Hemoglobin (Hb) meter User’s manual.
Review Section 9 Quality Control for detailed instructions on running quality control tests to
ensure that results are within range prior to reporting test results. The following steps show
how to use each component to measure the hemoglobin (Hb) concentration.
Sample Collection
The Hemo Spark Hemoglobin (Hb) Meter requires a very small specimen. This may be
obtained from fresh capillary whole blood. EDTA venous whole blood may be used as well.
Before testing, choose a clean, dry work surface. Review the procedure. Make sure all of
the items needed to obtain a drop of blood are available.
Venous Blood & Arterial Blood Testing
For fresh whole venous blood specimens, collect the venous blood in a closed container with
EDTA-K2, EDTA-K3, and EDTA-Na2 anticoagulants. Mix the specimen well. Then collect
approximately 10 μL into a capillary transfer tube. Apply it to the center hole of the sample
application area of the strip. Do not touch the test strip with the tube.
• Whole Blood must be tested within 8 hours of collection.
• Mix the sample well before testing. This is to ensure the cellular components are evenly
distributed.
• Allow the sample to reach a temperature between 2-40°C (36 - 104ºF), approximately
15 minutes if the sample has been refrigerated.
• Anticoagulants other than EDTA-K2, EDTA-K3, EDTA-Na2 are not recommended for use.
Note:
Refer to the Clinical and Laboratory Standards Institute (CLSI) Documents H3-A6, Collection
of Diagnostic Blood Specimens by Venipuncture
Fingertip Blood Testing
Here is an example of how to use a Lancing device with sterile Lancets for fingertip blood
sampling. If you use a different single-use auto-disabling safety lancet, please follow the
manufacturer’s instructions.
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