Roche ACCU-CHEK Inform II User Manual

3 • Patient Glucose Testing
52
■ The System Measurement Range refers to the
measurement range of the system itself (strips and
meter) and is the only range which cannot be con-
figured. With Accu-Chek Inform II test strips this
fixed range is 10 to 600 mg/dL (0.6 to 33.3 mmol/L).
If a result falls outside this range, the message HI or
LO appears, i.e., the result cannot be quantified
properly.
■ Glucose results above or below the Reportable
Range, as defined by the institution or local regula-
tory body, are above the highest or below the
lowest numerical results to be reported. Results
outside this range must not be used for intervention
decisions.
■ Glucose results above or below the Critical Range,
as defined by the institution, require immediate
action as defined by hospital policy.
■ Glucose results within the Normal Range, as
defined by the institution, are considered normal
and require no therapeutic action.
Patient Test
Out of Reportable Range
RR HI
Patient 123456789
Date 09/18/13 12:48 pm
12:48 pm
09/18/13
Patient Test
Out of Normal Range
12.2
Patient 123456789
Date 09/18/13 12:48 pm
mmol/L
09/18/13
12:48 pm
Patient Test
Out of Critical Range
16.9
Patient 123456789
Date 09/18/13 12:48 pm
mmol/L
09/18/13
12:48 pm
Patient Test
Out of Critical Range
1.9
Patient 123456789
Date 09/18/13 12:48 pm
mmol/L
12:48 pm
09/18/13
Patient Test
Out of Critical Range
CR LO
Patient 123456789
Date 09/18/13 12:48 pm
09/18/13
12:48 pm

Roche ACCU-CHEK Inform II Specifications

General

Brand	Roche
Model	ACCU-CHEK Inform II
Category	Blood Glucose Meter
Language	English

Summary

1 Introduction

1.1 Before you start

Information on intended use, important use information, and how to get help.

1.2 Important safety instructions and additional information

Safety instructions, disposal, product safety, and general care information.

1.3 System components

Details on the meter, code key reader, base unit, and accessory box.

2 Powering Up and Entering an Operator ID

2.1 Powering up the meter

Steps to power on the meter and check initial display information.

2.2 Entering the operator ID

Options for entering operator IDs, including manual or barcode scanning.

3 Patient Glucose Testing

3.1 Information regarding blood glucose testing

Requirements before performing a patient glucose test, including strip availability and operator ID.

3.2 Performing a patient glucose test

Overview of the patient glucose test procedure and steps.

4 Glucose Control Testing

4.1 Information regarding glucose control tests

Importance of control tests, regulatory requirements, and QC Lockout.

4.2 Performing glucose control tests

Steps to perform a glucose control test and criteria for success.

5 Review Results

5.1 Displaying test results from the memory

Information stored in data records for test results.

6 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter

6.1 Storing information about test strips

How code key information is stored and parameters can be modified.

6.2 Storing control solution information

Procedure to add glucose control lot numbers to the Control Lot list.

7 Linearity Testing

7.1 Information regarding linearity tests

Purpose of linearity tests, how they check system accuracy and are performed.

7.2 Performing a linearity test

Steps involved in performing a linearity test, including lot confirmation.

8 Proficiency Testing

8.1 Information regarding proficiency tests

Purpose of proficiency tests and regulatory requirements.

8.2 Performing a proficiency test

Steps involved in performing a proficiency test.

9 Initial Startup

9.1 Connecting the base unit

Instructions for connecting the base unit to power and network.

9.2 Installing or replacing the battery pack

Information on battery pack installation, charging, and date/time retention.

9.4 Initial setup on the meter

Overview of customizable settings available on the meter.

9.6 Date and time format

Options for selecting date/time format and editing permissions.

9.13 Creating a setup password

Process for creating and managing a setup password for security.

10 Maintenance and Care

10.1 Conditions for storage and shipping

General operating conditions and safety information for system handling.

10.2 Cleaning/disinfecting the Accu-Chek Inform II system

Procedures and agents for cleaning and disinfecting the system components.

10.4 Diagnostics view

Accessing system information, error logs, and testing components.

10.5 Unlocking a Download Lockout

Procedure to unlock the meter if data download is overdue.

11 Troubleshooting

Errors and unusual behavior without error messages

Common display symptoms and their possible solutions.

Meter reset

Procedure for resetting the meter when other remedies fail.

12 General Product Information

12.1 Technical data

Technical specifications for the meter, base unit, and power supply.

12.2 Further Information

Ordering information, manuals, and contact details for the system.

A Appendix

A.1 Table of configuration options

Overview of available settings and their accessibility on device/DMS.

B Appendix

B.1 Option: Wireless network (WLAN)

Principles of wireless communication and system deployment.

RF specific functionalities and effective performance claims

WLAN/Wi-Fi option, data transfer capabilities, and security protocols.

C Supplement for Other Test Entry

C.2 Overview of Other Test Entry (OTE)

Lists the types of tests and insulin information that can be entered.

C.3 Recording Other Patient Tests

Steps for recording patient test results using the OTE feature.

C.5 Reviewing Other Test Results

How to view stored OTE results (All, Patient, or QC).

D Supplement for Observed Test Sequence

Observed Test Sequence (OTS)

Function for observers to assess and record operator performance.

Using the OTS function

Steps for observers and operators to use the OTS function.