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GeneXpert CE-5
Cepheid GeneXpert CE-5 - User Manual
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In Vi
tro Diagnostic Medical Device
302-6125, Rev
. C 2024-04
XPERT
CHECK
-
CE-5
Xpert
Check
Instructions
for
Use
2
Table of Contents
Main Page
Revision History
2
About this Document
3
Safety Information
3
Related Documents
3
Technical Assistance
4
Contact Information
4
Table of Contents
7
List of Figures
9
Introduction
11
Proprietary Name
11
Common or Usual Name
11
Intended Purpose
11
Intended Use
11
Intended User/Environment
11
Summary and Explanation
11
Reagents and Instruments
12
Materials Provided
12
Storage and Handling
12
Materials Required but Not Provided
13
Limitations
13
Warnings and Precautions
13
Chemical Hazards
15
Assistance and Contact Information
15
Software Buttons, Icons and Symbols
15
Procedure
21
System Preparation
21
Genexpert DX Preparation
21
Genexpert Xpress Preparation
21
Genexpert Infinity-48S or Genexpert Infinity-80 Preparation
21
Genexpert DX, Genexpert Xpress and Genexpert Infinity Optics Cleaning
22
I-CORE ® Lens Cleaning Procedure
22
Figure 2-1 I-CORE Lens Cleaning Brush
22
Figure 2-2 Inserting the Cleaning Brush into the I-CORE Slit
23
Data Collection Procedure: Genexpert DX, Genexpert Xpress and Genexpert Infinity
24
Figure 2-3 Terms of Service Screen
26
Figure 2-4 Xpert Check Login Screen
27
Figure 2-5 Login Error Screen
27
Figure 2-6 Home Screen
28
Figure 2-7 Contact Information Screen
29
Figure 2-8 Contact Information Screen
29
Figure 2-9 Open Module Doors Screen
30
Figure 2-10 Module Preparation Screen
31
Figure 2-11 Select Modules for Data Collection Screen
32
Figure 2-12 Confirm Module Selection Screen
33
Figure 2-13 Error Screen Examples
33
Figure 2-14 Scanning the Cartridge Barcode Screen
34
Figure 2-15 Confirm Skip Screen
35
Figure 2-16 Venting the Cartridge by Opening and Closing the Cartridge Lid - Animated Screen
36
Figure 2-17 Loading the Cartridge into the Module
37
Figure 2-18 Data Collection Screen
38
Figure 2-19 Test Completion Screen - Successful
39
Figure 2-20 Test Completion Screen - Unsuccessful Module Checking Example
39
Figure 2-21 Confirm Continue Screen Overlay
40
Figure 2-22 Uploading Xpert Check Data Screen
41
Figure 2-23 Upload Incomplete Error Screen
41
Figure 2-24 Downloading Xpert Check Code Screen
42
Figure 2-25 Applying Xpert Check Code Screen
43
Figure 2-26 Xpert Check Complete Screen
43
Figure 2-27 Exit the Program
44
Figure 2-28 Confirm Exit Screen
44
Xpert Check Completion for Non-Internet Connected Users
45
Users
45
Figure 2-29 Data Collection in Progress Screen
45
Figure 2-30 Test Completion Screen - Successful
45
Figure 2-32 Write Xpert Check Data to CD Screen - Step 2
47
Figure 2-33 CD Writing Program - Opening Screen
48
Figure 2-34 CD Writing Program - Insert a Writable Disk to Continue Screen - Example
49
Figure 2-35 CD Writing/Burning Progress Screen
50
Figure 2-36 CD Writing Completion Screen
51
Figure 2-37 Final Screen from Windows 7 after CD Writing Has Completed
51
Figure 2-39 Error Writing Xpert Check Data CD Screens - Two Examples
52
Figure 2-40 Exiting Screen
53
Figure 2-41 Data CD Labeling Example
53
Connected Users
54
Figure 2-42 Home Screen, Showing Enter Xpert Check Code Button
55
Figure 2-43 Enter Xpert Check Code Screen
55
Figure 2-44 Xpert Check Code File - Example
57
Figure 2-45 Applying Xpert Check Code Screen Example
58
Figure 2-46 Xpert Check Complete Screen
58
Figure 2-47 Xpert Check Status Screen
59
Figure 2-48 Xpert Check Summary Report Example
60
Figure 2-49 Xpert Check Summary Report Example
61
Return System to Normal Operation
62
Genexpert DX
62
Genexpert Xpress
62
Genexpert Infinity-48S or Genexpert Infinity-80
62
Information Key Screen
63
Reasons to Repeat Xpert Check with a New Cartridge
63
Reasons to Repeat Xpert Check with the same Cartridge
63
Application of Xpert Check Code
63
Figure 2-50 Information Key Screen
63
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Cepheid GeneXpert CE-5 Specifications
General
Brand
Cepheid
Model
GeneXpert CE-5
Category
Laboratory Equipment
Language
English
Need help?
General
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