Sensa Core Hemo Spark User Manual
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Sensa Core Hemo Spark User Manual

Hemoglobin measuring system
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Y E A R S
Y E A R S
Y E A R S
n
MEM
g/dL
%
HCT
SCHS-0120A

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Summary of Contents for Sensa Core Hemo Spark

  • Page 1 Y E A R S Y E A R S Y E A R S g/dL SCHS-0120A...

  • Page 3: Table Of Contents

    Table of Contents Section 1 Introduction..................4 Contents in Hemo Spark Kit ............5 Section 2 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...

  • Page 4: Introduction

    * 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.

  • Page 5: Contents In Hemo Spark Kit

    4. Hemoglobin Control Strips Insert Sheet 5. Carrying Case 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.

  • Page 6: Components

    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 6. Battery Cover 1. LCD (Liquid Crystal Display) 7.
  • Page 7 Meter Display During testing, the Hemo Spark (Hb) Hemoglobin Meter will display icons showing the status, options available and prompts for testing: Test number Code chip CODE Link computer SET mode Sound Memory Blood drop symbol Test result area Test strip symbol...
  • Page 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.

  • Page 9: Test Strips

    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.
  • Page 10 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.

  • Page 11: Special Instructions For Test Strip In The Vial

    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.

  • Page 12: Precautions

    Precautions * 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.

  • Page 13: Initial Setup

    Section 4 Initial Setup Before testing, ensure the following procedures are followed. Turn on Meter 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.

  • Page 14: Coding The Meter

    Coding the Meter 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.

  • Page 15: Meter Setup And Options

    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 ◄ ◄ to select and press button to enter following setup sub-modes: Test number setup.

  • Page 16: Test Number Setup

    Test Number Setup From the No. SEt screen, press button to enter Test Number Setup mode. The test number can be set to any number from 1 - 999. Press ◄ ◄ until the correct test number is displayed. To quickly cycle to the desired test number, press and hold ◄...

  • Page 17: Meter Setup

    Meter Setup From the SEt screen, press to enter Meter Setup mode Hour Setup The first option sets the clock to either 12 or 24 hour mode. Press ◄ or ► to switch between the two settings. Press to save and advance to setting the year. Year Setup The year, month &...
  • Page 18 Time Setup 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.

  • Page 19: Testing

    (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.

  • Page 23: Strip Processing And Testing

    Strip Test Processing Ensure the meter is set up properly as described in previous sections. 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. The meter will briefly show a blank display.
  • Page 24 Strip Testing Insert a test strip into the Strip/Device Channel in the same direction as the arrows indicate on the strip. Ensure that the test strip is inserted all the way to the end of the Strip/Device Channel, until the white edge of the test strip above the black line is no longer visible. The blood drop symbol will flash when the meter is ready for the sample to be applied.
  • Page 25 The meter will begin testing automatically with three dashes in a line flashing on the display indicating the test is in progress. Hb results will be displayed within 15 seconds, with Hct value displayed at the bottom of the screen g/dL If the insufficient sample, meter display LO.

  • Page 26: Data/Communication

    Section 7 Data/Communication Data Transfer/Transmission Plug the USB cable into the USB port located on the top of the meter and connect the other end of the USB cable to a suitable PC. Note: The PC must have suitable software installed to receive and process the data being transmitted from the meter.
  • Page 27 Press button to enable data deletion, MEM will be displayed. Press and hold button until the meter returns to the Setup Menu. Memory/Database From the Initial Screen (refer to Section 5 Meter Setup), press ◄ or ► to show the first record. g/dL Press ◄...

  • Page 28: Optical System Check

    Section 8 Optical System Check Press Set up button and ► to find Check Control Solution mode. Note: * The control strip or control device is intended for checking the optical system. Refer to Section 9 Quality Control Test for using control solutions. * Allow the control strips or control devices and the meter to reach room temperature 2-40°C (36 - 104ºF) prior to testing.
  • Page 29 Press button to start the optical check. If the meter displays YES, the meter is normal. If the meter displays no, the meter is not functioning properly. If the meter displays no, check the control strip for contamination or if it is bent or damaged. If there are any visible signs of damage or contamination, discard the control strip or control device and retest using a new strip or device.

  • Page 30: Quality Control

    Section 9 Quality Control Each lab should use its own standards and procedures for performance. Test known specimens/controls at each of the following events in accordance with local, state, and/or federal regulations or accreditation requirements. * Each new day of testing. * A new strip of test strips or test devices is opened * A new operator uses the meter * Test results seem inaccurate...

  • Page 31: Maintenance

    Section 10 Maintenance Proper maintenance is recommended for best results. Cleaning For best results, the meter should be cleaned after each day of testing. Meter Surface A cotton cloth can be used to clean the surface of the meter. Use a damp cotton cloth if necessary.

  • Page 32: Precautions

    Section 11 Precautions Observe the precautions listed below to ensure accurate results and proper operation of the meter. * The protection provided by the equipment may be impaired if used in a manner not defined in this instruction manual. * Wear gloves to avoid contact with potentially hazardous biological specimens during testing.

  • Page 33: Troubleshooting

    Section 12 Troubleshooting Causes Display Solution Ensure the sensor area is clean and The sensor area is damaged, that there are no objects covering dirty, or blocked at turn-on, the sensor area. Refer to Section 10 such as a used test Cleaning.
  • Page 34 Repeat test and apply enough sample. Use around 10μL of Insufficient sample whole blood. If the sample was taken from a The test result is higher than sample container, ensure the 25.6 g/dL (256 g/L or 15.9 sample is mixed well and repeat mmol/L) test Inser t the code chip that...

  • Page 35: Appendix 1 Meter Specifications

    Appendix 1 Meter Specifications Feature Specifications Reflectance Photometry Methodology Less Than 15 seconds Test Time 0-25.6 g/dL, 0 -256 g/L, 0-15.9 mmol/L Measurement Range Whole blood (Capillary, Venous, Arterial) Sample 10 μL Sample Volume 3 AAA batteries (1.5V) Power Source AC Adapter (Mini USB, 5V DC) 100 hours or 1000 tests Battery Life...

  • Page 36: Index Of Symbols

    Appendix 2 Index of Symbols Attention, see Use by instructions for use Manufacturer Code Number For In vitro diagnostic Keep Dry use only 50 C Meter Lot Number Store between 0-50 ⁰C Tests per Kit Serial Number Do not discard along USB Port with household waste Keep away from...

  • Page 37: Appendix 3 Warranty

    Sensa Core shall replace the meter under warranty with a reconditioned meter or, at its option, repair at no charge a meter that is found to be defective. Sensa Core shall not be responsible for shipping charges incurred in the repair of a meter.
  • Page 40 Manufactured by: Sensa Core Medical Instrumentation Pvt. Ltd. Plot No: 3, Export Promotion Industrial Park, Pashamylaram, Sangareddy (Dist) - 502307. Hyderabad, Telangana, INDIA. Tel: +08455 - 223400 web: www.sensacore.com...

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