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The Accu-Chek® Inform II system is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial, and neonatal whole blood samples for monitoring blood glucose.

The system is also intended for quantitative measurement of glucose (sugar) in venous whole blood, arterial whole blood, and neonate arterial and heel stick whole blood samples throughout all hospital and all professional healthcare settings including patients receiving intensive medical intervention/therapy.

This product is for monitoring hypoglycemia in neonates diagnosed with laboratory glucose methods. The system is indicated for use by healthcare professionals. For healthcare professionals, the system is a bedside unit that can help you provide quality patient care by measuring blood glucose and by automating the record keeping associated with blood glucose and glucose control tests.

Intended use #2 US
The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control.

The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.

The Accu-Chek Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings.

This system should only be used with single-use, auto-disabling lancing devices.

The multiple-patient use Accu-Chek Inform II Blood Glucose Monitoring System will consist of:
  • Meter: Accu-Chek Inform II Meter
  • Test Strip: Accu-Chek Inform II Test Strip
  • Controls: Accu-Chek Inform II Control Solutions
  • Linearity: Accu-Chek Linearity Kit

Intended use #3 ROW
The Accu-Chek® Inform II is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial and neonatal whole blood samples for monitoring blood glucose. The Accu-Chek Inform II is intended for near-patient testing.
Not for self-testing", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" } ] } } ] }

Accu-Chek® Inform II system

Safe for patients. Simple for professionals. Efficient for hospitals.

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Confidence at the Point of Care

The Accu-Chek® Inform II solution brings ISO15197:2013 safety standards to bedside glucose testing and ­helps ensure safety for patients and users

  • Infection control with an integrated product design of the meter, the test strips and the lancets
  • Improved clinical decision making with reports of actionable data per user needs
  • Patented technology in a six-electrode test strip to perform extensive quality checks

 

Premium quality of results

 

Enabling POC testing to meet the ISO 15197:2013 standards when non-laboratory experts conduct glucose testing

  • With lot-by-lot calibration and traceability to NIST
  • High accuracy with proven repeatability and reproducibility1, 190+ interferences tested2

 

Improved workflow and regulatory compliance

 

Automated re-certification of device users and many other ­automated job tasks centralize the decentralized Point of Care traffic efficiently

  • POC workflow automation with automated user re-certification and notifications
  • Access and action of test results, operator performance, and system issues on the go

 

By your side support

 

By your side support is a given for continued success with your hospital blood glucose solution – provided by the market leader* in hospital glucose testing

  • More than 20 years of experience in service and support, with over 200,000 meter placements in the world and a broad expertise in ­system installation, analysis, consultancy and user training

 

*Market Data 2019;BBC IVD Solutions (IQVIA)

Accu-Chek Inform II system
  • With a wireless-enabled measuring device
  • Data entry via touch screen and/or 2D barcode reader:
    • User-ID and Patient ID/case number
    • Password
    • Lot numbers for test strips and controls
  • Watertight design for easy cleaning and better infection control
  • Extended data management capabilities:
    • Designed to connect with the cobas POC IT 1000 solution and cobas® infinity POC
    • Complete documentation of results including patient and operator identification

 

Accu-Chek Inform II test strips

 

  • Fast measuring time: only 5 seconds
  • Small sample volume: 0.6 μL
  • Approved for use with capillary, venous, arterial and neonatal blood
  • Not dependent on partial pressure of oxygen

 

Accu-Chek Safe-T-Pro Plus

 

  • Single-use sterilized lancet, safely contained in the housing – no direct needle contact possible
  • 3 adjustable depth settings (1.3/1.8/2.3 mm) for flexibility and patient comfort
  • Safety mechanism designed to ensure lancet can only be used once
  • Complete lancing device disposed of after use – minimizes the risk of injury

References

  1. Roche Accu-Chek® Inform II Test Strip Package Insert, 2021.
  2. Evaluation Report: Accu-Chek® Inform II Test Strips, 2020. (ISO 15197:2013).

Overview

Ordering Information

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