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Blood Glucose Meter
ACCU-CHEK Inform II
Roche ACCU-CHEK Inform II User Manual
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Accu-Chek
®
Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual
2
Table of Contents
Default Chapter
7
Table of Contents
7
1 Introduction
13
Before You Start
13
Intended Use
13
Important Information Regarding Use
13
If You Need Help
14
Note on the Use of "Base Unit" in this Manual
14
Note on Illustrations in this Manual
14
What Can the System Do for You
15
Important Safety Instructions and Additional Information
16
Important Information Regarding Safety
17
Disposal of the System
18
Product Safety
19
General Care
19
Accessory Box
19
Meter
19
Automatic Power-Off
19
Battery Pack
20
Touchscreen
21
Electrostatic Discharge (ESD)
21
Local Area Network: Protection from Unauthorized Access
22
Wired Network Connection
22
Wireless Connectivity
23
Radiofrequency Radiation Exposure Information
24
System Components
27
Overview of the Meter
28
Overview of the Code Key Reader
30
Overview of the Base Unit
31
Overview of the Accu-Chek Inform II Base Unit Hub
32
Overview of the Accessory Box
33
Reagents and Consumables
33
1.10 Instructions for Initial Setup
34
2 Powering up and Entering an Operator ID
35
Powering up the Meter
35
Adjusting the Display
36
Enabling/Disabling Wireless Connectivity
36
Closing Startup
37
Entering the Operator ID
38
Entering an Operator ID with Barcode Scanner
39
Entering the Operator ID Manually
40
Entering a Password
40
3 Patient Glucose Testing
41
Information Regarding Blood Glucose Testing
41
Preparing to Test
41
Performing a Patient Glucose Test
42
Overview of Test Procedure
42
Entering or Selecting the Patient ID
43
Entering the Patient ID Manually
45
Selecting the Patient ID from a List
45
Entering a Patient ID with Barcode Scanner
46
Confirming or Selecting the Test Strip Lot
47
Inserting Test Strips
48
Obtaining a Blood Sample
49
Applying a Blood Sample
50
Results Screen
51
Adding Comments
54
4 Glucose Control Testing
57
Information Regarding Glucose Control Tests
57
Glucose Control Testing Intervals
58
Information Stored During Glucose Control Testing
59
Control Solutions
60
Preparing to Run a Glucose Control Test
60
Performing Glucose Control Tests
61
Overview of Test Procedure
61
Starting a Glucose Control Test
62
Confirming or Selecting the Lot Number for Control Solutions
63
Confirming or Selecting the Test Strip Lot
64
Inserting Test Strips
65
Applying the Control Solution
66
Results Screen
67
Performing a STAT Test
68
5 Review Results
69
Displaying Test Results from the Memory
69
Information Stored in Data Records for Test Results
69
List of Results Stored in the Memory
70
6 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter
73
Storing Information about Test Strips
73
Transferring Code Key Information to the Meter
74
Editing Test Strip Data
77
Storing Control Solution Information
80
Entering the Lot Number of the Control Solution
80
Selecting a Stored Lot Number as the Current Lot Number
83
Storing Linearity Test Information
85
Entering the Lot Number of the Linearity Test
85
Selecting a Stored Lot Number as the Current Lot Number
87
7 Linearity Testing
89
Information Regarding Linearity Tests
89
Linearity Testing Intervals
90
Information Stored During Linearity Testing
90
Linearity Test Kit
91
Preparing to Run a Linearity Test
91
Performing a Linearity Test
92
Overview of Test Procedure
92
Starting a Linearity Test
92
Confirming or Selecting the Lot Number for Linearity Test Kits
93
Confirming or Selecting the Test Strip Lot
93
Inserting Test Strips
94
Applying a Linearity Test Sample
95
Results Screen
96
8 Proficiency Testing
97
Information Regarding Proficiency Tests
97
Information Stored During Proficiency Testing
98
Preparing a Proficiency Test
98
Performing a Proficiency Test
99
Overview of Test Procedure
99
Starting a Proficiency Test
99
Entering the Proficiency Sample ID
100
Confirming or Selecting the Test Strip Lot
100
Inserting Test Strips
101
Applying a Proficiency Sample
102
Results Screen
103
9 Initial Startup
105
Connecting the Base Unit
105
Installing or Replacing the Battery Pack
106
Removing the Battery Pack
107
Installing the Battery Pack
108
Docking the Meter
110
Initial Setup on the Meter
112
Menu Overview
113
Opening the Setup Menu
116
Date and Time Format
117
Display Options and Optional Tests
118
Options for Test Strips
119
Options for Glucose Control Tests
121
Value Ranges (Normal, Critical, Reportable)
123
9.11 Options for Operator ID Entry
124
9.12 Patient ID Options
125
9.13 Creating a Setup Password
126
9.14 Setting the Date and Time
127
9.15 Beeper Options
128
10 Maintenance and Care
129
10.1 Conditions for Storage and Shipping
129
General Operating Conditions
129
Storage
130
10.2 Cleaning/Disinfecting the Accu-Chek Inform II System
130
Acceptable Cleaning/Disinfecting Agents
131
Cleaning/Disinfecting the Meter
132
How to Clean/Disinfect
134
Cleaning the Barcode Scanner Window
136
Cleaning/Disinfecting the Base Unit
136
Cleaning/Disinfecting the Accessory Box
137
Cleaning the Code Key Reader
138
Cleaning the Accu-Chek Inform II Base Unit Hub
138
10.3 Logging Maintenance Activities
139
10.4 Diagnostics View
140
10.5 Unlocking a Download Lockout
142
10.6 Deleting Patient Data
144
11 Troubleshooting
145
Errors and Unusual Behavior Without Error Messages
145
Pop-Up Messages
149
Meter Reset
151
12 General Product Information
153
12.1 Technical Data
153
12.2 Further Information
156
Ordering
156
Accu-Chek Inform II Operator's Manual and Quick Reference Guide
157
Reagents and Solutions
157
Information about Software Licenses
158
Contact Roche
159
A Appendix
161
Table of Configuration Options
161
Example of Barcode Symbologies
173
B Appendix
175
Option: Wireless Network (WLAN)
175
Preliminary Note
175
Background
175
Technical Implementation
176
RF Specific Functionalities and Effective Performance Claims
178
C Supplement for Other Test Entry
181
Before You Start
181
Description
181
Overview of Other Test Entry (OTE)
182
Introduction
182
Recording Other Patient Tests
185
Recording Other Control Tests
192
Introduction
192
Other Control Testing Intervals
192
Stored Control Information
192
Warning Messages
198
Reviewing Other Test Results
199
Other Test Entry Configuration Options
202
D Supplement for Observed Test Sequence
203
Observed Test Sequence (OTS)
203
Using the OTS Function
204
Index
207
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Roche ACCU-CHEK Inform II Specifications
General
Brand
Roche
Model
ACCU-CHEK Inform II
Category
Blood Glucose Meter
Language
English
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