Operator's Manual
Table Of Contents
- What is new in publication version 7.2?
- 1 Introduction
- 1.1 Before you start
- 1.2 Important safety instructions and additional information
- Important information regarding safety
- Disposal of the system
- Product safety
- General care
- Accessory box
- Meter
- Power off meter
- Automatic power-off
- Shut down meter
- Automatic shutdown
- Battery Pack
- Touchscreen
- Electromagnetic compatibility (EMC)
- Electrostatic discharge (ESD)
- Wireless connectivity
- Radiofrequency radiation exposure information
- Local Area Network: protection from unauthorized access
- Wired network connection
- 1.3 System components
- 1.4 Overview of the meter
- 1.5 Overview of the code key reader
- 1.6 Overview of the Accu-Chek Inform II Base Unit
- 1.7 Overview of the Accu-Chek Inform II Base Unit Hub
- 1.8 Overview of the accessory box
- 1.9 Reagents and consumables
- 1.10 Instructions for initial setup
- 2 Powering Up and Entering an Operator ID
- 3 Patient Glucose Testing
- 3.1 Information regarding blood glucose testing
- 3.2 Performing a patient glucose test
- Overview of test procedure
- Entering or selecting the patient ID
- Entering the patient ID manually
- Selecting the patient ID from a list
- Entering a patient ID with barcode scanner
- Confirming or selecting the test strip lot
- Patient identification information
- Inserting test strips
- Obtaining a blood sample
- Applying a blood sample
- Results screen
- Adding comments
- Add barcode content to a result
- Additional Patient Test
- 4 Glucose Control Testing
- 5 Review Results
- 6 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter
- 7 Linearity Testing
- 8 Proficiency Testing
- 9 Initial Startup
- 9.1 Connecting the base unit
- 9.2 Installing or replacing the battery pack
- 9.3 Docking the meter
- 9.4 Initial setup on the meter
- 9.5 Opening the Setup Menu
- 9.6 Date and time format
- 9.7 Display options and optional tests
- 9.8 Options for test strips
- 9.9 Options for glucose control tests
- 9.10 Value ranges (normal, critical, reportable)
- 9.11 Options for Operator ID Entry
- 9.12 Patient ID options
- 9.13 Creating a setup password
- 9.14 Setting the date and time
- 9.15 Beeper options
- 10 Maintenance and Care
- 11 Troubleshooting
- 12 General Product Information
- A Appendix
- B Appendix
- C Supplement for Other Test Entry
- D Supplement for Observed Test Sequence
- E Supplement for Enhanced Workflows
- F Appendix for Accu-Chek Inform II Base Unit (legacy version)
- G Limited Warranty
- Index
Linearity Testing • 7
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08424705001 (04) 2021-06 USA • Accu-Chek Inform II Operator’s Manual Version 7.2
7 Linearity Testing
7.1 Information regarding linearity tests
Observe the applicable regulations and directives of the
responsible regulatory agencies when performing linearity
tests. For information about sources for products required
during linearity testing or for technical assistance,
contact Roche Customer Support Center.
Linearity tests can help you to check the function and
accuracy of the entire system over the full range of
specified values. Linearity samples should be treated in
exactly the same manner as previously described for
control solutions used in glucose control testing.
The term “Linearity” describes the ability of the system to
maintain a constant accuracy over the full range of spec-
ified values. If test results were plotted against reference
values as a curve over the full range of these values, the
ideal (high linearity) would be a straight line. Linearity is
the range of values from the lowest to the highest for
which an instrument is proven capable of giving accurate
results.
When using a data management system for configura-
tion, it is possible to partially or fully disable the func-
tions described in this chapter. In this case, the
respective buttons in Main Menu 2 do not appear. See
also Appendix A.