LC and Dario USB C Blood Glucose Monitoring Systems User Guide

June 13, 2024
DARIO

USB C Blood Glucose Monitoring Systems

LC and Dario USB C Blood Glucose Monitoring SystemsQuick Guide for Dario® LC and Dario® USB-C Blood
Glucose Monitoring Systems
Welcome to a healthier you!
Please read these instructions before operating the system.
LC and DarioPlease refer to Dario® USB-C Blood
Glucose monitoring systerms user guide for complete instructions. http://usa.mydario.com/support/getting-started/

Dario ® LC/Dario ® USB-C is an all-in-one glucose monitoring system that includes a lancing device, a strip cartridge and a miniature glucose meter in a durable shell. The miniature glucose meter connects to a compatible smart mobile device for managing your diabetes using the Dario ® App.

Indication for Use

The Dario ® LC/Dario ® USB-C Blood Glucose Monitoring System consists of the Dario ® LC/Dario ® USB-C Blood Glucose Meter, Dario ® Glucose Test Strips, Dario ® Glucose Control Solutions and the Dario ® App as the display component of the Dario ® LC/ Dario ® USB-C Blood Glucose Monitoring System. The Dario ® LC/ Dario ® USB-C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario ® LC/Dario ® USB-C Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Dario ® LC/Dario ® USB-C Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario ® LC/Dario ® USB-C Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Dario ® LC/Dario ® USB-C Blood Glucose Test Strips are for use with the Dario ® LC/Dario ® USB-C Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
The Dario ® LC/Dario ® USB-C Glucose Control Solutions are for use with the Dario ® LC/Dario ® USB-C Blood Glucose Meter and the Dario ® Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Upon receiving the Dario ® LC/Dario ® USB-C Welcome Kit, verify that it includes:

  • Dario ® LC/Dario ® USB-C System which includes the Lancing Device and Built-In Blood Glucose Meter with Lightning connector.
  • Dario ® 30 Sterile Lancets
  • Quick Guide for Dario ® LC and Dario ® USB-C Blood Glucose Monitoring Systems
  • 10 Disposable Covers (4.37”X8.19”)
  • User Guide for Dario ® LC and Dario ® USB-C Blood Glucose Monitoring Systems
  • Dario ® Test Strips (sold separately
  • Dario ® Control Solution Level 1 and 2 (sold separately)

If anything is missing or damaged do not use the product.
Contact customer service at 1-800-895-5921, a toll-free number in the U.S., 9:00 AM – 9:00 PM EST Monday through Friday or: https://mydario.com/support/getting-started/
Please contact your healthcare professional for questions outside of the customer support hours.
Your Dario® LC/ Dario® USB-C Blood Glucose Meter must be used with Dario® Test Strips.
The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients.
All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
For cleaning and disinfection please refer to Dario® LC and Dario® USB-C BGMS user guid.

Assemble Dario® LC/Dario ® USB-C

Dario® LC/Dario®
USB-C is comprised of three parts contained in one housing: a Test Strip Cartridge, a Lancing Device, and a Glucose Meter.LC and Dario USB C Blood
Glucose Monitoring Systems - assembly 1 Meet the Dario® systemLC and Dario USB C Blood Glucose
Monitoring Systems - assembly 2 Pictures in this quick guide are of Dario® LC Dario® USB-C is used in the same exact manner
For full list of compatible devices please refer to www.mydario.com/support /getting-started

  1. Open test strip package (provided as a separate package from the Welcome Kit).LC and Dario USB C Blood Glucose Monitoring Systems - assembly 3

  2. Remove Cartridge cover (white). Then insert the test strip cartridge until it snaps into place.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 4

  3. Close white cover.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 5

  4. Remove orange cover.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 6

  5. Insert a new lancet.
    The Welcome Kit contains a bag of 30 sterile lancets.LC and Dario USB C
Blood Glucose Monitoring Systems - assembly 7

  6. Twist off lancet cap.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 8You may adjust the lancet depth to one of four settings. 1 is the shallowest and 4 is the deepest setting.

  7. Close the orange cover. Your Dario® LC/Dario® USB-C is ready to go!

Measure with Dario® LC/Dario® USB-C

  1. Insert the phone into the disposable cover included in the Welcome Kit. Place the Dario® LC/Dario® USB-C meter port to fit the opening at the bottom of the disposable cover.
    To avoid the risk of transmitting blood borne pathogens, it is advised to use a disposable sleeve to cover your smart mobile device while taking the blood glucose test.LC and Dario USB C Blood Glucose Monitoring Systems - assembly
10

  2. Open the Dario® application.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 11

  3. Slide your thumb back on the ridged orange panel to release the Dario® LC/Dario® USB-C meter.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 12

  4. Grasp the meter with two fingers and remove it from the housing.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 13

  5. Plug the Dario® LC/Dario® USB-C meter into the connector port. The Dario ® logo should be facing up.   Note the Dario ®LC/Dario®  USB-C meter direction (logo facing up)LC and Dario USB C Blood Glucose Monitoring Systems - assembly 15

  6. Once connecting, the app will tell you to insert a new test strip.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 16

  7. Remove white cover.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 17

  8. Open the cartridge lidLC and Dario USB C Blood Glucose Monitoring Systems - assembly 18

  9. Remove a test strip.
    Now close the cartridge lid to protect the remaining test strips and put the white cover back on.LC and Dario USB C Blood Glucose Monitoring Systems -
assembly 19

  10. Insert a test strip into the test strip port.
    Verify the test strip direction as shown below.
    The app will let you know when a test strip has been successfully inserted.LC and Dario USB C Blood Glucose Monitoring Systems - assembly
20 Test strips should not be exposed in the open air for more than three minutes.

  11. Load the lancing device by sliding down as shown below.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 21

  12. Place the lancing device on to the side of your fingertip and press the lancet release button to prick your finger.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 22

  13. Apply a drop of blood to the tip of the test strip. Verify that enough blood is applied to fill the test strip window and turn it red. LC and Dario USB C Blood Glucose Monitoring Systems - assembly 24  Wait six seconds for test results.

  14. You successfully completed a blood glucose measurement. LC and Dario USB C Blood Glucose Monitoring Systems - assembly 25

  15. Dispose of used lancet and test strips in accordance with the instructions provided by your health care provider for biohazardous waste.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 26

  16. Place the Dario® LC/Dario® USB-C  meter back into the housing by pushing it in until it is locked into place.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 27

  17. Dispose of used lancet.LC and Dario USB C Blood Glucose Monitoring Systems - assembly 28

Words in: Description
Bold Names of menus, buttons, and screens.
Italics System response that occurs as a result of pressing a button or

performing a task.
Bold Italics| Emphasize important information.
Symbol| Description| Manufacturer
---|---|---
| Sterile Lancets Under Directive MDD 93/42/EEC| Beijing  Ruicheng Medical Supplies Co., Ltd.

SMART MOBILE DEVICE COMPATIBILITY:
Dario® LC/Dario® USB-C are compatible for use on iOS and Android smart mobile devices. For full list of compatible devices please refer to www.mydario.com/support/getting-started

STORAGE & SPECIFICATION:

Dario’ LC/ Dario’ USB-C Blood Glucose Monitoring System Specifications:

Result Range| 20-600 mg/dL (1.1-33.3 mmol/L)
Blood Source| Fresh capillary whole blood
Calibration| Plasma equivalent
Sample Size| 0.3 microliter
Test Time| 6 seconds
Assay Method| Glucose Oxidase Biosensor
Power Supply| Meter receives power from the smart mobile device
Glucose Units| mg/dL (mmol/L)
Display| Dario” application on a smart mobile device screen

System Environmental Information

Operating Conditions 50°F-95°F (10°C-35°C) 15-85% Relative Humidity
Test Strips Storage Conditions 36°F-90°F (2°C-32°C)10-90% Relative Humidity
Welcome kit Storage Temperature 34°F-95°F (1°C-35°C)
Operational Altitude _ Up to 10.000 feet (3,048 meters)

EXPLANATION OF SYMBOLS: The following symbols may appear on the device, instructions for use, accessories or shipping materials:

| Dario®logo
---|---
| LabStyle Innovation logo
| Consult instructions for use
| In Vitro Diagnostic
| Batch Code
| Expiry date
| Do not reuse
| CE Marking
| Temperature limitation
| Catalogue number
| Manufacturer: LabStyle Innovation Ltd. 8 Hatokhen St. North Industrial Park Caesarea 3088900 Israel
| content <30> Lancets
| Keep away from sunlight
| Sterilized using – Gamma Irradiation
| Intended for self-testing
| Do not use if seal is broken or missing.
| Caution Sign
| Warning Sign
| Note Sign

Welcome to a healthier you!
Customer support: 1-800-895-5921
toll-free number in the U.S.
9:00 AM – 9:00 PM EST
Monday through Friday
or: https://mydario.com/support/getting-started/

References

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