Sensa Core Hemo Spark Manuale utente
MEM
%
HCT
g/dL
n
WARRANTYWARRANTY
YEARSYEARS
55
5
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.
4
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
5
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
◄
◄
2
1
6
8
6
3
4
5
7 9
10
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.
7
MEM CHK C
%
Lev
HCT
mmol/L
CAL
g/dL
AM
PM
CODE
SET n
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.
8
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:
9
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
10
Altri manuali per Hemo Spark
1
Indice
Altri manuali Sensa Core Strumento di misura
