Bioneer Exiprep 96 Lite User manual

© Copyright 2021 BIONEER Corporation. All rights reserved.
REVISION 0 (2018-07-05)
ExiPrep  Lite
ExiPrep 
Automated Nucleic Acid Extraction System
A-5250
Version 7.0 (2021-06-18)
USER GUIDE
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ExiPrep  Lite
Contents
INTENDED USE ......................................................................................................... 1
Principle ................................................................................................................ 1
PRODUCT INFORMATION............................................................................................. 2
Product Description ..................................................................................................2
Product Advantages..................................................................................................2
Product Specifications...............................................................................................3
Product Components ................................................................................................ 5
Functional Description - Hardware................................................................................6
Functional Description –Software............................................................................... 14
Instrument Status Indicators...................................................................................... 21
WARNINGS AND PRECAUTIONS ........................................................................................................................ 22
General Precautions................................................................................................ 22
Installation Precautions ............................................................................................ 23
Usage Precautions ................................................................................................. 23
UV Lamp Precautions.............................................................................................. 24
Liquid Waste Precautions ......................................................................................... 24
Cleaning Precautions .............................................................................................. 24
Storage and Maintenance Precautions ......................................................................... 25
INSTALLATION........................................................................................................................................................ 26
Delivery Check ...................................................................................................... 26
Installation Requirements ......................................................................................... 26
Installation Precautions and Limitations ........................................................................ 26
Unpacking ........................................................................................................... 27
Removing the Transportation Lock .............................................................................. 28
Connecting the Power ............................................................................................. 29
Installation Check................................................................................................... 29
OPERATION ............................................................................................................30
Starting the Extraction Process .................................................................................. 34
Removing the Cartridges .......................................................................................... 36
Cleaning and Sterilizing the Instrument......................................................................... 38
Cleaning .............................................................................................................. 38
UV Sterilization ...................................................................................................... 43
Downloading the Operation Logs ................................................................................ 44
MAINTENANCE ........................................................................................................ 46
Changing the Magnetic Rods..................................................................................... 46
Updating the Software ............................................................................................. 47
Self-Test ............................................................................................................. 48
Fuse Replacement ................................................................................................. 50
Instrument Transport ............................................................................................... 51
Storage Requirements ............................................................................................. 51
Backup Power ....................................................................................................... 52
Instrument Disposal ................................................................................................ 52

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TROUBLESHOOTING ................................................................................................. 53
FREQUENTLY ASKED QUESTIONS................................................................................. 56
TECHNICAL SUPPORT ............................................................................................... 58
Requesting a Repair ............................................................................................... 58
Returning an Instrument for Service............................................................................. 58
ORDERING INFORMATION........................................................................................... 59
Instrument ........................................................................................................... 59
Instrument Components........................................................................................... 59
Kits .................................................................................................................... 59
LEGAL INFORMATION ................................................................................................ 60
Patent................................................................................................................. 60
Trademark ........................................................................................................... 60
Disclaimer............................................................................................................ 60
WARRANTY ............................................................................................................ 61
Responsibility........................................................................................................ 61
User Guide Amendments ......................................................................................... 61
KEY TO SYMBOLS .................................................................................................... 62
APPENDIX A: Certificate of Decontamination .................................................................... 65
APPENDIX B: Service Request Form ............................................................................... 67
APPENDIX C: ExiPrep ™96 Lite Maintenance Log ................................................................ 69

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ExiPrep  Lite
Tables
Table 1. ExiPrep ™96 Lite Components .............................................................................5
Table 2. Description of ExiPrep ™96 Lite External Components – Front and Rear View ...................6
Table 3. Description of ExiPrep ™96 Lite External Components – Sensors...................................7
Table 4. Description of ExiPrep ™96 Lite Internal Components – View A ....................................8
Table 5. Description of ExiPrep ™96 Lite Internal Components – View B .....................................9
Table 6. Description of ExiPrep ™96 Lite Internal Components – Plate 1................................... 10
Table 7. Description of ExiPrep ™96 Lite Internal Components - Plate 2 .................................. 11
Table 8. Description of ExiPrep ™96 Lite Internal Components – Plate 3................................... 12
Table 9. Description of ExiPrep ™96 Lite Internal Components – Elution Block ........................... 13
Table 10. Description of the Home Screen Components...................................................... 14
Table 11. Description of the Assign Sample Screen Components .......................................... 15
Table 12. Description of the Standard Protocol Screen Components....................................... 16
Table 13. Description of the UV Setup Screen Components.................................................. 17
Table 14. Description of the Setup Screen - General Tab Components ................................... 18
Table 15. Description of the Setup Screen - Log Tab Components ........................................ 19
Table 16. Description of the Setup Screen - Device Tab Components..................................... 20
Table 17. Instrument Status Indicator Color Definitions........................................................ 21
Table 18. Uninterruptable Power Supply Requirements ........................................................ 52
Figures
Figure 1. Nucleic acid extraction process .......................................................................... 1
Figure 2. ExiPrep ™96 Lite .............................................................................................2
Figure 3. ExiPrep ™96 Lite Components ............................................................................5
Figure 4. ExiPrep ™96 Lite External Components – Front and Rear View ..................................... 6
Figure 5. ExiPrep ™96 Lite External Components - Sensors ....................................................7
Figure 6. ExiPrep ™96 Lite Internal Components –View A....................................................... 8
Figure 7. ExiPrep ™96 Lite Internal Components – View B....................................................... 9
Figure 8. ExiPrep ™96 Lite Internal Components – Plate 1 .................................................... 10
Figure 9. ExiPrep ™96 Lite Internal Components –Plate 2 .................................................... 11
Figure 10. ExiPrep ™96 Lite Internal Components – Plate 3................................................... 12
Figure 11. ExiPrep ™96 Lite Internal Components – Elution Block ........................................... 13
Figure 12. Home Screen ............................................................................................. 14
Figure 13. Assign Sample Screen.................................................................................. 15
Figure 14. Standard Protocol Screen.............................................................................. 16
Figure 15. UV Setup Screen......................................................................................... 17
Figure 16. Setup Screen –General Tab ........................................................................... 18
Figure 17. Setup Screen –Log Tab................................................................................ 19
Figure 18. Setup Screen - Device Tab ............................................................................ 20

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ExiPrep  Lite
Read the entire contents of this User Guide before operating the instrument.
INTENDED USE
The ExiPrep ™96 Lite is the instrument capable of extracting nucleic acid needed in various samples as
blood, serum, sputum and tissues for the gene amplification test.
Principle
The ExiPrep ™96 Lite fully automates nucleic acid extraction using magnetic beads. All ExiPrep ™kits
contain buffers facilitating the binding of these magnetic beads and nucleic acids. Cartridges also are
present with cell lysis buffers. When the samples are dispensed into the cartridges, cells are lysed,
releasing their nucleic acids. During the binding step, the free nucleic acids stick to the silica surface of
the magnetic beads. A wash removes the impurities, and the final elution step isolates the nucleic acids
from the beads providing pure nucleic acids in the storage buffer.
Figure 1. Nucleic acid extraction process

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PRODUCT INFORMATION
Product Description
Figure 2. ExiPrep™96 Lite
The ExiPrep ™96 Lite runs automatically with preinstalled protocols optimized for all ExiPrep ™96
kits. The instrument is capable of extracting nucleic acids from up to 96 samples with
interchangeable magnetic rods. ExiPrep ™96 Lite can be used with 24- or 96-well plates depending
on the type of kit. Only ExiPrep ™96 kits manufactured by BIONEER are compatible with the
ExiPrep ™96 Lite instrument.
Product Advantages
•High throughput that extracts nucleic acids from up to 96 specimens at once.
•30 to 50-minute running time depending on the kit used.
•Wide range of compatible specimen types including blood, plasma, sputum, and tissue.
•Integrated 7-inch touchscreen.
•Contamination prevention system
•Efficient use of space with a layered structure and compact size

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ExiPrep  Lite
Product Specifications
Legal Specifications
Product category
Nucleic acid extraction system for in vitro
diagnostic use
Physical Specifications
Dimensions
•Instrument (W x D x H)
•Instrument with shipping container
•40 cm x 57.5 cm x 54.6 cm
(15.75 in x 22.64 in x 21.5 in)
•56.5 cm x 80.5 cm x 70.5 cm
(22.25 in x 31.7 in x 27.76 in)
Weight
46 kg (101.5 lbs)
Voltage
100 - 240 V~, 50/60 Hz
Power consumption
500 VA max (Fuse: 250 V, F6.3AL, 2 ea)
Environmental Specifications
Operation temperature range
15 –35°C (59 –95°F)
Transit humidity range
20 - 80%, no condensation
relative humidity 20 - 80%
Transit temperature range
0 - 40°C (32 –104°F), in shipping container
Storage temperature range
5 - 40°C (41 –104°F)
Storage humidity range
20 - 80%, no condensation
Software Specifications
Software version
Contact Customer Support for questions
relating to software version.

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Operating Specifications
Operating System
Built-in
Networking
TCP/IP
User Interface Display
7-inch Touch
Data Storage
USB 2.0 (2x)
Capacity
Maximum of 96 samples/run
Magnetic rods
8 or 32 in one block
Cartridge types
96 and 24 well
Heating block temperature
30 –90℃(86 - 194℉)
Cooling block temperature
4 - 90℃(39.2 - 19℉)
U.S. and Canadian Safety Standards
Standard for Electrical Equipment for Measurement, Control and Laboratory Use
Part 1: General Requirements,
UL 61010-1:2012, 3rd Ed. 5/11/12, CSA C22.2 No. 61010-1-12

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ExiPrep  Lite
Product Components
The components of the ExiPrep ™96 Lite package are shown below. The 8-well magnetic rods may
be purchased separately.
Figure 3. ExiPrep ™96 Lite Components
Table 1. ExiPrep ™96 Lite Components
Components
Cat. No.
Qty.
ExiPrep ™96 Lite
A-5250
1
32-well Magnetic Rod
A-5250-A2
3
Power Cord
-
1
User Guide
-
1
8-well Magnetic Rod (Optional)
A-5250-A4
3

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Functional Description - Hardware
Do not attempt to modify any component mentioned or use any component not mentioned in this
section. Any problem resulting from such action will be considered your responsibility.
Figure 4. ExiPrep ™96 Lite External Components –Front and Rear View
Table 2. Description of ExiPrep ™96 Lite External Components –Front and Rear View
No.
Component
Description
1
Touch Screen
Displays user interface
2
Power Button
On: Starts or resumes operation from standby mode
Off: Initiates the standby mode
Surrounding LCD indicates instrument status
3
Front USB Port
Connection for loading software and protocols into the
instrument and transferring operation logs from the
instrument.
4
Door
Provides access to interior of the instrument and
ensures that internal components are not accessible
when the instrument is in operation
5
Cooling Fan
Cools the elution block
6
LAN Port
Connection for transferring data via cable
7
Rear USB Port
Connection for loading software and protocols into the
instrument and transferring operation logs from the
instrument
8
Main Power Switch
On (|): Allows power to the instrument and places it in
Standby mode
Off (0): Turns off power to the instrument

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ExiPrep  Lite
Figure 5. ExiPrep ™96 Lite External Components - Sensors
Table 3. Description of ExiPrep ™96 Lite External Components –Sensors
No.
Component
Description
1
UV Lamp Safety Sensor
Deactivates the UV light if the instrument door is
opened during sterilization
2
Door Sensor
Stops the operation if the instrument door is opened
during processing

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Figure 6. ExiPrep ™96 Lite Internal Components –View A
Table 4. Description of ExiPrep ™96 Lite Internal Components –View A
No.
Component
Description
1
UV Lamp
Sterilizes the interior of the instrument
2
Magnetic Rod
Isolates nucleic acids using magnetic force
3
Dry Heating Block &
Contamination Shield 3
Binds the magnetic beads with nucleic acids
Prevents contamination of Plate 3
4
Contamination Shield 2
Prevents contamination of Plate 2
5
Contamination Shield 1
Prevents contamination of Plate 1
6
Incubation Heating Block
Facilitates the isolation of nucleic acids
7
Elution Block
Heats or cools cartridge 7 to stabilize the samples
during elution

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ExiPrep  Lite
Figure 7. ExiPrep ™96 Lite Internal Components –View B
Table 5. Description of ExiPrep ™96 Lite Internal Components –View B
No.
Component
Description
1
Magnetic Rod Cover Plate
Covers and protects the magnetic rods from the
buffers covers
2
Magnetic Rod
Isolates nucleic acids using magnetic force
3
Plate 3
Carries buffer cartridges 5 and 6 back and forth
4
Plate 2
Carries buffer cartridges 3 and 4 back and forth
5
Plate 1
Carries buffer cartridges 1 and 2 back and forth

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Figure 8. ExiPrep ™96 Lite Internal Components –Plate 1
Table 6. Description of ExiPrep ™96 Lite Internal Components –Plate 1
No.
Component
Description
1
Plate 1
Carries cartridges 1 and 2 back and forth
2
Cartridge Zone 1
Location for placement of cartridge 1 containing
samples
3
Cartridge Zone 2
Location for placement of cartridge 2

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ExiPrep  Lite
Figure 9. ExiPrep ™96 Lite Internal Components –Plate 2
Table 7. Description of ExiPrep ™96 Lite Internal Components - Plate 2
No.
Component
Description
1
Plate 2
Carries cartridges 3 and 4 back and forth
2
Cartridge Zone 3
Location for placement of cartridge 3
3
Cartridge Zone 4
Location for placement of cartridge 4

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Figure 10. ExiPrep ™96 Lite Internal Components –Plate 3
Table 8. Description of ExiPrep ™96 Lite Internal Components –Plate 3
No.
Component
Description
1
Plate 3
Carries buffer cartridges 5 and 6 back and forth
2
Cartridge Zone 5
Location for placement of cartridge 5
3
Cartridge Zone 6
Location for placement of cartridge 6

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ExiPrep  Lite
Figure 11. ExiPrep ™96 Lite Internal Components – Elution Block
Table 9. Description of ExiPrep ™96 Lite Internal Components –Elution Block
No.
Component
Description
1
Elution Block
Controls the temperature of buffer cartridge 7 to
stabilize the samples during the elution step
2
Buffer Cartridge Zone 7
Location for placement of cartridge Loads buffer
cartridge 7 in zone 7 where extracted nucleic acids are
deposited at the end of the process

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Functional Description –Software
This section describes the functions of each screen displayed by the ExiPrep ™96 Lite. For additional
details on usage, refer to the OPERATION and MAINTENANCE sections of this Guide.
Figure 12. Home Screen
Table 10. Description of the Home Screen Components
No.
Component
Description
1
Assign Sample
Opens the Assign Sample screen
2
Standard Protocol
Opens the Standard Protocol screen
3
Protocol
Displays the selected protocol
4
UV Lamp
Displays the UV sterilization screen
5
Plate
Moves cartridge plates and the magnetic rod cover
plate for loading and unloading consumables and for
cleaning
6
Setup
Opens Setup screen
7
Remaining Time
Each tap toggles the display to show Remaining Time,
Running Time, and Finish Time
8
Step
Displays the current step of the operation
9
Starts the operation
10
Pauses the operation
11
Stops the operation