SALIENT CHARACTERISTICS DIABETES TESTING SUPPLIES.pdf

SALIENT CHARACTERISTICS

Diabetes Testing Supplies

Date: March 28, 2023

· PERFORMANCE SPECIFICATIONS:

· Package quantity 1 care kit

· Storage requirements Store at temperatures between -13° F and 158° F

· Warranty 36 months from time of manufacture

· Package quantity of at least 50 test strips

· Expiration 18 months from time of manufacture

· Manufacturing location USA

· Spill-resistant SmartPack vial

· The strip vial design protects against spills and makes it easy to remove just one strip.

· The full-end application area allows a tiny drop to be placed anywhere along the yellow edge of the test strip and is the largest dosing area among leading brands.

· The test result appears in less than 4 seconds after dosing the strip.

· Automatic coding: No coding is needed, resulting in fewer steps in testing.

· Intuitive design and user-friendly navigation

· The three-button, user-friendly interface is designed for users who want a simple test.

· The meter's large, easy-to-read display makes it simple to see test results.

· The meter automatically stores up to or at least 720 blood glucose results in memory with the time and date of the test. Arrow buttons make it easy to access and review stored blood glucose results.

· The meter automatically stores up to or at least 30 control results in memory, which can be transferred to compatible software for viewing.

· The system calculates averages from results for the last 7, 14, 30, or 90 days.

· Before starting a test and during testing, the system performs extensive quality checks to ensure accurate results.

· Bluetooth connectivity can wirelessly transmit results to healthcare apps, displaying data in helpful trends and graphs that can be shared with a healthcare professional.

· If desired, data can be transferred by USB cable from the meter to diabetes management software on a PC or on the web.

· System Specificationsategory Specification

· Measurement principle FAD glucose dehydrogenase (GDH), electrochemical

· Range of measurement 20 to 600 mg/dL

· Measuring time Less than 4 seconds

· Operating temperature 43°F to 113°F (6°C to 45°C)

· Operating humidity 10% to 90%

· Sample volume 0.6 μL

· Hematocrit range 10% to 65%

· Altitude Up to 10,150 feet (3,094 meters) above sea level

· Sample types Capillary

· Test sites Fingertip, palm, upper arm

· Reference method Hexokinase with deproteinization, converted into plasma values according to IFCC recommendation

· Acceptance Criteria (ISO 15197:2013/EN ISO 15197:2015):

· ≥95% of the individual glucose measured values shall fall within ±15 mg/dL of the reference results at glucose concentrations <100 mg/dL or within ±15% at glucose concentrations ≥100 mg/dL.

· ≥99% of individual glucose measured values shall fall within zones A and B of the

· Consensus Error Grid (CEG) for Type 1 diabetes.

· Automatic off 90 seconds after performing a test, 15 seconds after a test strip is removed

· Power supply Two 3-volt lithium batteries (coin cell type CR2032)

· Display LCD

· Construction Hand-held

· Meter type Suitable for continuous operation

· Must have FDA approval for testing designed critically ill patients.

· Must have 24/7 365 available technical support.

· Must be able to easily send reports to your healthcare team. Customize reports. View simple reports or manage comprehensive health information for yourself or your whole family. To run with the current diabetes management system, CD-ROM drive; keyboard and mouse or compatible pointing device; available USB port The ACCU-CHEK 360 system is compatible with and any upgrades.

· Bluetooth connectivity can wireless transmit results to healthcare apps, displaying data in helpful trends and graphs that can be shared with a healthcare professional.

· If desired, data can be transferred by USB cable from the meter to diabetes management software on a PC or on the web approved by I.H.S. IT Team.