GeneXpert
®
Infinity
1. Kiosk Barcode Scanner - Scans the patient ID (optional) the specimen’s sample ID barcode, and the cartridge barcode, which enters the cartridge
type (e.g., Xpert® MRSA NxG) and settings into the
system.
At a glance
2. Keyboard (not shown, located in kiosk drawr) - The keyboard is used for data entry, and to make selections in the software.
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3. Conveyor - Place a sample-prepared cartridge on the conveyor belt and it is moved into the
GeneXpert® Infinity System.
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4. Lobby - This is the transition location between the Conveyor and the Gantry.
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5. Accumulator - This is a waiting area in which: • A cartridge waits to be loaded into a module
when no module is available to run the cartridge.
• A cartridge to be retained is placed after the test is completed (e.g., Re-test for Xpert C. Diff/Epi).
• A cartridge is temporarily held because it cannot be processed due to an unreadable barcode or unrecognized cartridge S/N when there is no room in the Shuttle.
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6. GeneXpert® Modules Area - Each panel contains eight modules. A cartridge is inserted into a mod-ule where the sample is processed for detection of of a specific genetic sequence or organism. Each module is part of an 8-module array labeled A1-A8, B2-B8, etc.
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7. Shuttle - This is the area where the system can place a used or rejected cartridge for access by the operator. A sensor is present in this Shuttle to detect and indicate if any cartridges are present. Capacity is 4 cartridges.
• Processing STAT samples
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10. Robotic Gantry System - Provides cartridge load and unload handling. The robotic Gantry picks up sample prepared cartridges from the lobby and places the cartridges into the appropriate modules for processing.
After test completion, the robotic arm moves tested cartridges from the GeneXert Module to be off-loaded to the Shuttle, the Waste Disposal Shelf, or the Accumulator. If instructed, the Gantry will move cartridge(s) in the Accumulator to the Shuttle for retrieval.
8. Waste Disposal Shelf - A cartridge is moved into this area after the test is completed. When this shelf is full, the next used cartridge pushes the old-est used cartridge into the Waste Container.
9. Waste Container (not shown) - A cartridge is dropped into this area when the Waste Disposal Shelf is full. A sensor detects the presence or ab-sence of the Waste Container. The waste container door is locked when the system is ON.
11. Gripper - Grips, holds and releases the cartridge. It is located on the Gantry.
12. Gantry Barcode Scanner - Scans the cartridge barcode when the cartridge is inside the GeneXpert Infinity System.
13. Emergency STOP Button - When a hardware emergency stop button is pressed, the transport system is stopped immediately.
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Desktop Icons
Xpertise software shortcut icon
GeneXpert folder icon
Shutdown Infinity shortcut icon
Cepheid Remote Service Access shortcut icon
Norton AntiVirus shortcut icon
GeneXpert Support Data-base Backup icon
Adobe Reader Software shortcut icon
ELO Touchscreen Calibra-tion Software shortcut icon
Infinity Operator Manual shortcut icon
Xpertise Icons
user name Current user name Login Change password Logout Exit software Message log Information message Error present
Touch Screen
TIP: For best results, use the pads of your finger on the touchscreen.
Go to Home screen
Host Status
Host
Lost Host communication
No outstanding orders
Outstanding order present
Outstanding order needs attention
View Another Test
Load or Retrieve Cartridges
Glass door is unlatched
Glass door is open
Common Xpertise
TM
and
Desktop Icons
See the Operator Manual for the complete list
Windows Key M Key
Shuttle is open
Database Status
Non-STAT Module Status
Utilization
Reserved STAT Module Status
STAT Module utilization
Replace Waste Container/ Close Waste Door
Waste Container is missing
Waste Container is full
Silence Alarm button
Pause button
Analysis mode operation
Manual mode operation
About
Archive test
Assay Statistics Report
Change operation mode
Control trend report
GX Maintenance Find Order Installation Qualification Maintenance Manage Assay Module Report Order Test Orders Patient Report Perform Self-test Plunger Maintenance Results Retrieved Test Setup Specimen Report Stop Test System Configuration System Log User Administration
User Type Configuration
View Outstanding Orders
Basic operations
Starting the system
1. Turn the power switch to the ON position (|). 2. Wait 2 minutes for the system to boot. 3. Close the shuttle door.
4. Enter your Windows password: cphd 5. Double click the Xpertise shortcut
on the desktop.
6. Log in with your user name and password, if required. 7. (Optional) Perform database management activities. The Infinity is now ready to process samples.
Shutting down the system
Important: Make sure the system is not running a
sample.
Important: Do not shut down from the Windows
start > shutdown menu.
1. Select Exit.
2. Select OK to confirm exiting the software.
3. (Optional) Perform database management activities. 4. Wait for the software to completely exit.
5. Double-click the System Shutdown shortcut on the
desktop.
6. Select OK to confirm system shutdown.
7. Turn the power switch to the OFF position (O). 8. Wait a minimum of 2 minutes before restarting the system.
Automation Mode workflow
1. Follow the package insert to prepare the cartridge. Note: Refer to Xpert Cartridge Labeling Guide for proper patient label placement (if applicable). 2. Select Orders
or select Manage Host Orders.
3. Select Order Test.
4. (Optional feature) Scan or enter the Patient ID and select Continue.
5. Scan or enter the Sample ID, select the STAT check box if applicable, and then select Continue.
6. Scan or enter the cartridge barcode. 7. Enter notes.
Note: You cannot enter notes if auto submit is
enabled.
8. Select Submit.
9. If required, enter your password.
10. Put the cartridge in the conveyor loading zone.
Checking a test in progress
To check test progress: • View Another Test • Module Status
• Home screen showing the tests since launch table
Viewing the System Log
To view the system log: 1. Select Maintenance.
2. Select System Log.
3. Enter the report criteria:
• Date range: All or select a range.
Note: Entries older than 1 year do not appear.
• Modules:
» Currently Connected Modules (default) » All Logged Modules
» Select the module(s) to include in the log • Show: Errors Only or All Entries
4. Select Preview PDF.
Basic operations
Removing cartridges
Note: These steps apply only to
Automation Mode.
1. Select Load or Retrieve Cartridges.
2. Select the check box next to the cartridge(s) that you want to remove. 3. Select Move to Shuttle or Fill Shuttle.
4. Select Open Shuttle.
5. The shuttle door opens slightly.
6. Pull the shuttle door open and remove the cartridge(s).
7. Close the shuttle door and select OK.
Viewing test results and
printing reports
Select View Results or View Another Test.
Pausing the system
You can safely open the glass doors to adjust or remove a cartridge or to clean a spill inside the cabinet.
Caution: Pausing the system for a long
time can cause tests to expire. Plan to resume from a “pause” within a short time.
To pause the system: 1. Select Pause.
2. Select Confirm Pause.
3. Open the glass door.
4. Adjust or remove the cartridge. 5. If you remove a cartridge, select
Remove Cartridge.
6. Scan the cartridge barcode. 7. Close the glass doors. 8. Select Resume.
Emergency Stop
Push the Emergency Stop button at anytime to prevent user injury or instrument damage.
Caution: Stopping the system for a long
time can cause tests to expire.
To stop all automation:
1. Press the Emergency Stop button.
2. Select Unlatch Glass Doors.
3. Open the glass doors.
4. Remove all cartridges from the conveyor.
Note: Retain these cartridges to be
reordered and run upon Resume.
5. If any cartridges fell, remove them and clean up any spills.
6. Close the glass doors.
7. Twist the emergency stop button clockwise until it resets.
8. Select Latch Glass Doors.
Automation to Manual Mode
1. Select Setup.
2. Select Change Operation Mode.
3. Select Edit.
4. Select Manual Mode.
5. Select Save and then OK.
6. Open the glass doors.
7. Remove all cartridges from the conveyor, accumulator shelves and shuttle.
8. Check each idle module for a cartridge and leave each door open.
9. Select Cartridge(s) Removed and then OK.
10. Select Close and confirm that the Manual
mode icon is present on the dashboard.
Basic operations
Manual Mode Workflow
1. Follow the package insert to prepare the cartridge.
2. Select Orders.
3. Select Order Test.
4. Scan the Patient ID (optional), Sample ID, and cartridge barcode.
5. (Optional) Enter information, such as priority, sample type, and notes. 6. Select Submit.
7. If required, enter your password. 8. Select Continue and follow screen
prompts.
9. Put the cartridge into the module with the flashing green light.
10. Close the module door.
11. When the test finishes, open the module door and leave it open.
Excluding (disabling) modules
1. Select Maintenance.
2. Select GX Maintenance.
3. Select Exclude Modules From Test.
4. Select Edit.
5. Select the check box(es) next to the modules you do not want to use. 6. Select Save.
7. Select Close.
Manual to Automation Mode
1. Remove all cartridges from the
conveyor, accumulator shelves, shuttle, and modules before changing to
automation mode. 2. Select Setup.
3. Select Change Operation Mode.
4. Select Edit.
5. Select Automation Mode.
6. Select Save and then OK.
Good practices
• Select the Home icon to return to the home screen.
• When the instrument is in Pause Mode, always scan the cartridge barcode after you remove it from the instrument. • Keep manually removed cartridges until the instrument returns to normal activity and you clear all warnings, reminders, and errors.
• Do not exit the software while a test is in progress. •
K1 K2 K3 K4 E1 E2 E3 E4 F1 F2 F3 F4 G1 G2 G3 G4 H1 H2 H3 H4 M1 M2 M3 M4 N1 N2 N3 N4 S1 S2 S3 S4 T1 T2 T3 T4 L1 L2 L3 L4 Q1 Q2 Q3 Q4 R1 R2 R3 R4 I1 I2 I3 I4 J1 J2 J3 J4 O1 O2 O3 O4 P1 P2 P3 P4 A1 A2 A3 A4 B1 B2 B3 B4 C1 C2 C3 C4 D1 D2 D3 D4
The molecular revolution is here.
www.Cepheid.com SYSTEM
Infinity-48s
Automated, multi-module molecular diagnostics analyzer for on-demand access processing of real-time PCR-based clinical diagnostics
Number of Modules 16, 24, 32, 40, and 48 Reagents
Cepheid test-specific, ready-to-use, barcoded cartridge
SAMPLE
Walk-Away Cartridge Capacity 119 samples per Infinity-48s
(48 loaded in modules, 48 queued, 19 on conveyor, and 4 in shuttle) QC Method
GeneXpert® test includes internal controls to monitor sample, processing, and performance.
Sample Barcode Types
Code 128, Code 39, Codabar, Interleaved 2 of 5
ELECTRICAL REQUIREMENTS
Power Line Requirements Line voltage: 200-240 VAC Frequency: 50 Hz to 60 Hz +/- 0.5 % Line Circuit Breaker: 20A
Power Consumption
Maximum current 16 Amps @ 200 VAC
ENVIRONMENTAL REQUIREMENTS Operating temperature 15 to 30°C (60 to 85 °F) Ambient humidity 20% to 80%, non-condensing Noise output <85 dB PHYSICAL Dimensions
217 cm (85 in) l , 89 cm (35 in) w, 200 cm (78.5 in) h Weight
~725 kg (~1600 lb)
CORPORATE HEADQUARTERS
904 Caribbean Drive Sunnyvale, CA 94089 USA
TECHNICAL SERVICES 1-888-838-3222 Option 2 TECH SERVICES FAX 1-408-542-8575 EMAIL [email protected]
EUROPEAN HEADQUARTERS
Vira Solelh
81470 Maurens-Scopont France
TECHNICAL SERVICES PHONE 33.563.82.53.19 TECH SERVICES FAX 33.563.82.53.01 EMAIL [email protected]
GeneXpert
®Infinity-48s
GeneXpert
®Infinity-80
SYSTEM
Infinity-80
Automated, multi-module molecular diagnostics analyzer for on-demand access processing of real-time PCR-based clinical diagnostics
Number of Modules
16, 24, 32, 40, 48, 56, 64, 72, and 80 Reagents
Cepheid test-specific, ready-to-use, barcoded cartridge
SAMPLE
Walk-Away Cartridge Capacity 183 samples per Infinity-80
(80 loaded in modules, 80 queued, 19 on conveyor, and 4 in shuttle) QC Method
GeneXpert® test includes internal controls to monitor sample, processing, and performance.
Sample Barcode Types
Code 128, Code 39, Codabar, Interleaved 2 of 5
ELECTRICAL REQUIREMENTS
Power Line Requirements Line voltage: 200-240 VAC Frequency: 50 Hz to 60 Hz +/- 0.5 % Line Circuit Breaker: 20A Power Consumption
Maximum current 16 Amps @ 200 VAC
ENVIRONMENTAL REQUIREMENTS Operating temperature 15 to 30°C (60 to 85 °F) Ambient humidity 20% to 80%, non-condensing Noise output <85 dB PHYSICAL Dimensions
274 cm (108 in) l , 89 cm (35 in) w, 200 cm (78.5 in) h Weight
