RIGHTEST™ ELSA Blood Glucose Meter Getting Started Guide

Meter Overview

This guide provides instructions for the RIGHTEST™ ELSA Blood Glucose Meter.

Front View of Meter

• Test Strip Port: Insert test strips here.
• Display Window: Shows your test result, messages, and other information.
• Main Button: Used to operate the meter.
• Meter Label
• Battery Cover: Slide off to change the battery.

Back View of Meter

• Sample Entry
• Viewing Window
• Depth adjustable cap
• Release button
• Lancet carrier
• Safety tab
• Lancing Device
• Hub
• Plunger
• Protective cover

Consumables

• Test Strip Vial: Contains test strips. Note: Discard 3 months after opened. Record first opening date.
• Control Solution: Used for quality control checks.
• Lancet: Disposable needle for obtaining blood samples.

1. Battery Installation

Follow these steps to install or replace the battery:

1. Turn the meter over. Press and slide down the battery cover to open it.
2. Install the battery, ensuring it is inserted the correct way up.
3. Slide the battery cover back on until it snaps into place.

[Diagram shows sliding battery cover, inserting battery, and closing cover.]

2. Setting Up Your Meter - Setting the Date, Time, and Test Unit

Configure your meter's settings:

1. Press and release the [main button] to turn on the meter.
2. Press and hold the [main button] for 7 seconds to enter Settings mode. The meter may turn off briefly before entering this mode. Continue holding until Settings mode appears.
3. With the year blinking, tap the [main button] to scroll to the next number for the year.
4. Press and hold the [main button] to confirm the year and move to the next setting (month).
5. Repeat steps 3 and 4 to set the month, day, time format (12-hour or 24-hour), hour, minute, volume, and test unit (mg/dL or mmol/L). Note: The unit may be fixed based on regional regulations and might not be changeable.

[Diagrams show example displays for setting year, month, day, time (12h/24h), volume, and unit (mg/dL/mmol/L).]

Note: Do not use this meter near sources of strong electromagnetic radiation to prevent interference. Keep the meter free of dust, water, and other liquids.

3. Preparing the Lancing Device

Prepare the lancing device for blood sampling:

1. Hold the depth adjustable cap with one hand and the hub with the other. Bend the device at the join until it gently pops open.
2. Pull apart both ends to separate the cap from the hub.
3. Push a new disposable lancet into the lancet carrier, ensuring it is held securely.
4. Twist off and set aside the protective cover of the disposable lancet.
5. Reattach the depth adjustable cap.
6. Rotate the clear top part of the cap to adjust the depth. More lines visible in the viewing window indicate a greater depth. Options typically include settings for soft/thin skin, average skin, or thick/calloused skin.
7. Pull back the plunger until you hear a click. The device is now primed. Release the plunger; it will return to its original position.

[Diagrams show steps for opening the lancing device, inserting a lancet, removing the lancet cover, reattaching the cap, adjusting depth, and priming the plunger.]

4. Performing a Test

Follow these steps to perform a blood glucose test:

1. Wash and dry your hands thoroughly. Take one test strip from the vial and close the vial cap immediately.
2. Insert the test strip into the test strip port on the meter with the Viewing Window facing up. Push the test strip in until you hear a click. The meter will automatically calibrate.
3. When the flashing blood drop icon appears on the display, hold the lancing device to your fingertip and press the release button.
4. Use a minimum blood sample volume of 0.75 µL. Samples larger than 3.0 µL may contaminate the meter. [Diagram shows sample sizes: 0.75 µL, 1.0 µL, 1.5 µL, 2.0 µL, 3.0 µL.]
5. Touch and hold the blood droplet to the test strip sample entry port until you hear a beep and the Viewing Window is filled with blood. If the window is not filled or the test does not start, discard the strip and repeat with a new one.
6. A countdown will appear on the screen. After 5 seconds, the test result will be displayed.
7. Remove the test strip from the meter and discard it properly according to local regulations.
8. Remove the used lancet from the lancing device. Do not touch the used lancet. Press the lancet tip into the protective cover.
9. Hold down the release button and pull back the plunger to eject the lancet.
10. Discard the lancet into a suitable sharps biohazard container.
11. Reattach the depth adjustable cap after finishing the test.

[Diagrams illustrate inserting the test strip, applying blood to the strip, and the countdown.]

Alternative Site Testing: Palm or Forearm Blood Sampling

For testing on the palm or forearm:

1. Install the clear cap on the lancing device and follow steps 1 and 2 of "Performing a Test".
2. Massage the target area on the palm or forearm for a few seconds to increase blood flow.
3. Immediately after massaging, press and hold the lancing device against the target area.
4. Press the release button.
5. After pressing the button, continue holding the lancing device against the skin. Gradually push the device against your skin with increasing pressure until a sufficient blood droplet is formed.
6. Discard the lancet into a suitable sharps biohazard container.

Note: Do not test from the palm or forearm if you are testing for hypoglycemia (low blood glucose).

[Diagrams show palm and forearm testing, indicating pressing for a few seconds and pushing the release button.]

Note: The RIGHTEST Lancing Device is intended for single-person use only. For more information, please see the User's Manual.

Manufacturer Information

BIONIME CORPORATION

No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan

Tel: +886 4 2369 2388

Fax: +886 4 2261 7586

Email: info@bionime.com

Website: http://www.bionime.com

EC REP:

Emergo Europe

Prinsessegracht 20

2514 AP The Hague

The Netherlands

Email: EmergoVigilance@ul.com

Model Number: 101-3GM111-0C0

Revision Date: 2021-06

CE