Purigen Ionic Purification System User manual

2021 PURIGEN BIOSYSTEMS, INC.All rights reserved. PUR-DOC-20
USER GUIDE
Ionic® Purification System
Purigen Biosystems, Inc.
5700 Stoneridge Drive, Suite 100
Pleasanton, CA 94588
TEL:
[phone]
EMAIL:
[email protected]
REV 3.0
PART #: 44001

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
2
Table of Content
Copyright .................................................................................................................................................................................................4
Support ....................................................................................................................................................................................................5
EU WEEE Directive Compliance.................................................................................................................................................................................................5
Safety Information ................................................................................................................................................................................6
Regulatory ......................................................................................................................................................................................................................................6
Instrument Safety.........................................................................................................................................................................................................................6
Proper Use......................................................................................................................................................................................................................................6
Electrical Safety ............................................................................................................................................................................................................................ 7
Environment................................................................................................................................................................................................................................... 7
Biological Safety ...........................................................................................................................................................................................................................7
Chemicals .......................................................................................................................................................................................................................................8
Waste Disposal..............................................................................................................................................................................................................................8
Mechanical Hazards.....................................................................................................................................................................................................................8
Labels on the Ionic Purification System ...............................................................................................................................................................8
Introduction ............................................................................................................................................................................................9
Product Use....................................................................................................................................................................................................................................9
Product Use Limitations..............................................................................................................................................................................................................9
Instrument Features ....................................................................................................................................................................................................................9
Instrument Specifications........................................................................................................................................................................................................10
Fluidic Chip Specifications .......................................................................................................................................................................................................10
Fluidic Chip Dimensions..........................................................................................................................................................................................10
Fluidic Chip Volumes................................................................................................................................................................................................ 10
Fluidic Chip Storage and Handling .......................................................................................................................................................................10
Product Components.................................................................................................................................................................................................................. 11
Terms and Definitions................................................................................................................................................................................................................. 11
General Description............................................................................................................................................................................. 12
System Overview........................................................................................................................................................................................................................ 12
Installation Procedures...................................................................................................................................................................... 14
Operating Procedures......................................................................................................................................................................... 15
Ionic Purification System Software........................................................................................................................................................................................ 15
Using the Instrument ................................................................................................................................................................................................................. 16
Create or Select User Profile ...................................................................................................................................................................................................16
Select an Ionic Purification Kit Protocol................................................................................................................................................................................ 18
Defining Samples for a Purification Kit Run .........................................................................................................................................................................18
USB Upload ................................................................................................................................................................................................................ 19
User Defaults ............................................................................................................................................................................................................ 22
Manual Input ............................................................................................................................................................................................................. 23
Review Results ......................................................................................................................................................................................................... 24

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
3
Settings ........................................................................................................................................................................................................................................25
About Instrument..................................................................................................................................................................................................... 26
Manage Users .......................................................................................................................................................................................................... 27
Add User..................................................................................................................................................................................................................... 28
Deactivate User........................................................................................................................................................................................................ 29
Reactivate User......................................................................................................................................................................................................... 31
Maintenance & Service .......................................................................................................................................................................................... 32
Shutdown.....................................................................................................................................................................................................................................33
Maintenance Procedures.................................................................................................................................................................. 34
Regular Maintenance................................................................................................................................................................................................................34
Periodic Maintenance Procedures ........................................................................................................................................................................................ 34
Cleaning the Ionic Purification System ..............................................................................................................................................................35
Procedure ..................................................................................................................................................................................................................36
Decontaminating the Ionic Purification System..............................................................................................................................................40
Interior ........................................................................................................................................................................................................................40
Exterior ........................................................................................................................................................................................................................ 41
Other Maintenance Procedures .............................................................................................................................................................................................. 41
Self Test ..................................................................................................................................................................................................................... 42
Open/Close Cover ................................................................................................................................................................................................... 43
Save System Logs................................................................................................................................................................................................... 44
System Time Settings ............................................................................................................................................................................................46
System Update......................................................................................................................................................................................................... 48
Instrument Statistics..............................................................................................................................................................................................48
Save Diagnostics ..................................................................................................................................................................................................... 49
Shipping the Instrument ......................................................................................................................................................................................... 51
Troubleshooting .......................................................................................................................................................................................................................... 51

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
4
Copyright
© 2021 Purigen Biosystems, Inc. All rights reserved. Duplication and/or reproduction of all or any portion of this document without the express
written consent of Purigen Biosystems, Inc. is strictly forbidden. Nothing contained herein shall constitute any warranty, express or implied, as to
the performance of any products described herein. Any and all warranties applicable to any products are set forth in the applicable terms and
conditions of sale accompanying the purchase of such product. Purigen Biosystems provides no warranty and hereby disclaims any and all
warranties as to the use of any third-party products or protocols described herein. The use of products described herein is subject to certain
restrictions as set forth in the applicable terms and conditions of sale accompanying the purchase of such product. “Ionic®” is a registered
trademark of Purigen Biosystems, Inc. All other trademarks are the property of their respective owners. All products and services described herein
are intended FOR RESEARCH USE ONLY and NOT FOR USE IN DIAGNOSTIC PROCEDURES.
All product names, brands, and trademarks are properties of their respective owners.

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
5
Support
For technical information or advice, please contact Purigen Biosystems Support at any time.
Phone: 1-877-PURIGEN (787-4436)
Email: [email protected]
Purigen Biosystems, Inc.
5700 Stoneridge Drive, Suite 100
Pleasanton, CA 94588
USA
EU WEEE Directive Compliance
The EU Waste Electrical and Electronic Equipment Directive implemented the EU WEEE Directive 2012/19/EU requiring Producers of electronic
and electrical equipment (EEE) to manage and finance the collection, reuse, recycling and to appropriately treat WEEE products currently on the
EU market. The goal of this directive is to minimize the volume of electrical and electronic waste disposal and to encourage re-use and recycling
at the end of life.
If you have purchased Purigen Biosytems-branded electrical or electronic products in the EU and are intending to discard these products at the
end of their useful life, please do not dispose of them at your municipal waste center. All electronic products bearing the WEEE Symbol shall alert
our customers that Purigen Biosystems is making a return and collection system available to you, free of transportation and recycling costs, for
proper disposal arrangements for these products.
Please contact Purigen Support (info above) to make arrangements for verification and the proper return of the equipment.

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
6
Safety Information
Regulatory
The Ionic Purification System is certified to the following standards:
•UL 61010-1, 3rd Edition (UL evaluation done only to 120V/60Hz)
•CAN/CSA C22.2 No. 61010-1-12, 3rd Edition
•Subpart B of Part 15 of FCC Rules for Class A digital devices
•ICES-003, Issue 6
•EN61326-1:2013
•EN61010-1:2010
•WEEE Directive 76/769/EC
Instrument Safety
Prior to using this instrument, all operators must complete the following:
•Thorough review of this manual with careful attention to all safety information
•Training on all safety guidelines established for the laboratory where the instrument will be used
•Training for the proper use and operation of an Ionic system
•Review of all safety materials including applicable Material Safety Data Sheet (MSDS) and SDS documents
Precautions are illustrated in the following way:
WARNING
Indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to
alert against unsafe practices.
CAUTION
Indicates a potentially hazardous situation, which, if not avoided, could result in death or serious injury.
Proper Use
Inappropriate use of the Ionic Purification System may cause personal injury or irreparable damage to the instrument.
•Only trained personnel should operate the Ionic system following Purigen Biosystems published methods.
•Only Ionic system qualified service engineers should service the Ionic system.
•Routine maintenance should be performed in accordance with "Maintenance Procedures" on page 34 of this guide.
Damage to the Ionic system caused by inappropriate use, neglect to perform required maintenance, or performing inappropriate
maintenance may void warranty or require services not covered by standard service contract terms.
At all times, the following warnings apply:
•Do not move the instrument after it has been installed
•Do not unplug the instrument while it is in operation

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•Do not spill liquids on any area of the instrument
•Do not use with flammable materials or in the presence of toxic fumes
•Do not attempt to manually move the system cover
•Use only with Purigen Biosystems Fluidic Chips and associated kits and protocols
Laboratory supervisors and/or facility managers must take the necessary precautions to ensure a safe workplace and appropriate
training of personnel. All laboratory activities should be in accordance with all national, state, and local health and safety regulations.
Care should be taken to ensure that instrument operators and laboratory personnel are not exposed to hazardous or infectious
materials as defined by SDS (or MSDS), and other laboratory safety and regulatory documentation.
Electrical Safety
This instrument contains electrical components within its covers. Removal of any covers or panels while the instrument is connected to
live power (plugged in) can expose live electrical current and create a danger to laboratory personnel.
Always observe the following recommendations:
•Only use the power cord provided to connect the instrument to a properly grounded power receptacle.
•Do not remove any covers, panels or attempt to access, adjust, or replace any internal components of the instrument.
•Avoid spilling any liquids on any component of the instrument.
Regularly monitor the instrument for unsafe electrical states and contact Purigen Biosystems Support immediately if an unsafe state is
observed. Unsafe states can include any of the following:
•Power cord or power receptacle is visibly damaged
•Instrument covers are visibly damaged
•Large amounts of liquid cover any component of the instrument
•Instrument has been mishandled, dropped, or has been impacted by another object
•Instrument surfaces or covers appear to have been corroded or display chemical residue
Environment
The Ionic Purification System is designed to operate within the following environmental conditions:
TABLE 1:Operating environment specifications
Operating Environment
Specification
Temperature
Maintain a lab temperature of 15⁰C – 25⁰C; This temperature is the operating temperature of the instrument.
Humidity
Maintain a non-condensing relative humidity between 30–70%
Biological Safety
Specimens, samples, or reagents containing materials from humans should considered potentially infectious. Use, storage, and
disposal of such materials should be in accordance with all national, state, and local safety regulations. Always wear appropriate
personal protective equipment as determined by the safety guidelines established for the laboratory where the instrument is being
used.

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
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Chemicals
Chemicals used in or in association with use of this instrument may be considered hazardous. Use, storage, and disposal of such
materials should be in accordance with all national, state, and local safety regulations. Always wear appropriate personal protective
equipment as determined by the safety guidelines established for the laboratory where the instrument is being used.
The Ionic system is not intended for use with flammable liquids or liquids that produce a toxic fume. Such liquids should not be used
within any component of the instrument and the instrument should not be operated in the presence of such liquids without proper
ventilation.
Waste Disposal
Used labware, Ionic system fluidic chips, and personal protective equipment that may have come in contact with hazardous or
infectious materials should be collected and disposed of properly in accordance any safety guidelines established for the laboratory
where the instrument is used and with national, state, and local health and safety regulations.
All reagents, including Ionic system kit reagents, should be disposed of in accordance with SDS (or MSDS) recommendations.
Mechanical Hazards
The cover of the Ionic system will extend and retract during normal operation. Contact with the cover while it is moving should be
avoided.
Labels on the Ionic Purification System
Product Label
Warning Symbol
Definition
Use Caution During Use
Operation of this instrument should be performed by trained
users following the guidance provided in documentation from
Purigen Biosystems.
Warning: Electrical Shock Hazard
Disconnect power before servicing.
No User Serviceable Parts Inside
Maintenance requiring removal of the outer cover must be
performed by an authorized Purigen Biosystems
representative.

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
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Introduction
The Ionic system is designed for use in research laboratories for the extraction and purification of nucleic acids from biological samples.
The instrument uses a proprietary technology, isotachophoresis, to separate and aggregate nucleic acids without surface binding; to
preserve the native state of the nucleic acid for high purity and quantity.
Please read this user guide in its entirety before using the Ionic system.
Carefully review all safety information, operation, and maintenance instructions. Proper use and maintenance of the instrument as well
as observance of applicable safety guidelines is necessary to prevent damage to the instrument or harm to its users.
Product Use
The Ionic system is exclusively designed to be used with Purigen Biosystems Ionic Purification kits to perform fully automated
extraction and purification of nucleic acids for scientific research applications. This system is intended to be used by trained
professionals following all applicable safety guidelines in accordance with all applicable safety regulations. The Ionic system is for
research use only.
Product Use Limitations
The Ionic system is not intended for use with reagent kits or methods other than Purigen Biosystems purification kits. The system is
recommended for use only with samples defined within the product limitations of the Purigen Biosystems purification kit and method
being used.
Purigen Fluidic chips are designed for laboratory use only and must be stored and handled properly to achieve the expected
performance. Each chip should remain sealed inside a static dissipative bag and only opened prior to immediate use. Chips should be
handled only while wearing gloves and gripped by the side skirts. Contact of any kind with the chip surface and features (wells,
connection points) should be avoided except for the loading or removal of samples and reagents by pipette. Failure to follow this
guidance can result in poor performance or run errors.
Instrument Features
•Easy-to-use and easy-to-maintain system operation
•Standardized sample preparation workflow
•Comprehensive technical support
•Touchscreen-guided operation
•Auto-generated reports and logs
•USB support for data transfer

USER GUIDE: Ionic® Purification System Purigen Biosystems
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Instrument Specifications
TABLE 2:Instrument specifications
Specification
Value
Weight
24.5 kg (54.0 lbs.)
Dimensions (W x D x H)
41.9 x 48.9 x 42.4 cm (16.5 x 19.3 x 16.7 inches)
Power requirements
North America:
120 VAC, 50/60Hz, 2.5 A with a NEMA 5-15 receptacle
Europe:
230 V∿50 Hz, 1.0 A (connectors vary by country)
Ventilation requirements
Minimum 5.09 cm (2 inches) around all sides
Usable temperature range
15 - 25°C (59-77°F), Indoor use only
Humidity
30-70% (non-condensing)
Fluidic Chip Specifications
Fluidic Chip Dimensions
TABLE 3: Fluidic chip dimensions
Description
Value
Height
14.53 mm
Width
85.48 mm
Length
127.76 mm
Fluidic Chip Volumes
TABLE 4: Fluidic chip volumes
Description
Value
Number of samples
Up to 8 samples per fluidic chip
Sample well volume
200 µL (typical)
Buffer well volume
Varies by protocol
Extraction well volume
> 50 µL
Fluidic Chip Storage and Handling
TABLE 5: Storage and handling specifications
Description
Value
Temperature
15 to 32 °C
Packaging
In sealed, static dissipative bag
Handling
With disposable gloves, avoiding contact with surface

USER GUIDE: Ionic® Purification System Purigen Biosystems
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Product Components
Ionic Purification System Instrument (Part Number: 44001)
Includes:
•1 instrument (with leveling system)
•1 power cable
Terms and Definitions
TABLE 6:Terms and Definitions
Term
Definition
Ionic Purification Kits
Kit containing the fluidic chip and reagents
Fluidic chip(s)
Ionic® Purification Chip(s)
Ionic Purification System instrument chip holder
Location where the chip rests in the instrument
Ionic Purification System instrument screen
Refers to the touchscreen on the instrument
Ionic Purification System
Umbrella term to cover instrument, technology, and consumables
Ionic system
Short name to specifically call out the instrument
Extraction well
Wells on the chip where the nucleic acid is collected
Sample well
Wells on chip where the sample is dispensed
“XYZ” buffer well
Wells on chip where buffers are dispensed
Dispense
Act of depositing a material into a well of the chip “Dispense lysate from previous step into…”
Aspirate
Act of removing any material that is not extract from the chip “Aspirate and dispose of any remaining….”
Collect
Act of removing extraction from the chip “Collect extracted sample from…”
Channel
Physical connection between a series of wells on the chip where isotachophoresis occurs for an
individual sample

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1
2
3
4
General Description
The revolutionary Ionic® Purification System from Purigen Biosystems uses isotachophoresis (ITP) to extract, purify, and concentrate
nucleic acid from biological samples. Samples prepared by the system are pure, abundant, and ready in just 60 minutes.
System Overview
FIGURE 1:Instrument (front)
TABLE 7:Instrument parts (front)
Call Out
Instrument Component
Definition
1
Touchscreen
Operation of the Purigen Biosystems Ionic system is conducted entirely through the integrated touchscreen.
Operators can select and initiate protocols as well as import sample information and export run data from the
touchscreen. All error messages, help messages, and prompting will occur on the touchscreen during normal
operation. The system software also includes integrated user management to track protocols and information by
user.
2
Cover
The Ionic system utilizes an actuated cover during normal operation to control the environment and processing of
samples on a Purigen Biosystems fluidic chip. The cover will automatically extend and retract in response to
interaction with the instrument's touchscreen while progressing through a protocol or performing maintenance
operations.
3
Chip holder
The chip holder within the instrument provides a location for the placement of a Purigen Biosystems fluidic chip. The
holder is designed to prevent placement of a fluidic chip in an incorrect orientation.
4
USB port
Operators can insert a USB flash drive into the USB port at the front of the system to export data files for off-line
analysis.
5
Leveling knobs
(left, right)
The integrated leveling system is adjusted at the time of system install. Adjustment may be necessary to re-level the
instrument after moving the instrument or if the position of the instrument has somehow changed after installation.
5

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
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FIGURE 2:Instrument (back)
TABLE 8:Instrument parts (back)
Call Out
Instrument Component
Definition
1
Product label
See
"Labels on the Ionic Purification System"
on page 8 for a close-up image of the product label.
2
Exhaust fans
The exhaust fans located at the rear of the Purigen Biosystems Ionic Purification System maintain a safe operating
temperature within the instrument. Refer to the Purigen Biosystems Ionic Purification System Site Preparation
Guide or Specifications for recommendations on appropriate clearance to prevent obstructing the airflow from the
fans.
3
Power receptacle
Used to connect the power cord included with the instrument to the power outlet.
4
RJ-45 port
Used for instrument service only.
5
Power switch
The power switch located at the rear of the system is used to power on and power off the instrument. Do not power
off the instrument while the system software is running. To shut down the system software, see
"Shutdown"
on
page 32.
TABLE 9:Ionic system LED display
LED Color
LED State
System State
Cyan
Slow flash Idle
Green
Solid Active
Red
Fast flash Error
Green
Slow flash Run complete
1
2
4
3
5

USER GUIDE: Ionic® Purification System Purigen Biosystems
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Installation Procedures
IMPORTANT
Do not unpack the instrument prior to installation. The system must be unpacked by or under the supervision of a Purigen
Biosystems representative.
Purigen Biosystems offers both a traditional installation, performed at your site by a Purigen Biosystems representative, and a Virtual
Installation and Training where a Purigen Biosystems representative will guide you through the installation and training over a series of
remote web-based teleconferences.
To learn more about our Virtual Installation and Training program visit: https://purigen.co/ionic-virtual-install.
CAUTION
After your Purigen Biosystems representative has installed and prepared the instrument, do not relocate the instrument. Moving the instrument
improperly can damage the instrument and compromise data integrity. If you want to relocate the instrument, contact your Purigen Biosystems
representative.

USER GUIDE: Ionic® Purification System Purigen Biosystems
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Operating Procedures
Ionic Purification System Software
The system software is comprised of many screens. The main functions that a user would need are explained in the sections below.
•"Using the Instrument" on the next page
•"Create or Select User Profile" on the next page
•"Defining Samples for a Purification Kit Run" on page 18
−"USB Upload" on page 19
−"User defaults"on page 21
−"Manual Input" on page 23
−"Review Results" on page 25
•"Settings" on page 26
−"About Instrument" on page 27
−"Manage Users" on page 28
−"Maintenance & Service" on page 35
The table below lists functions that are available in many of the system software screens.
TABLE 10:System software screen icons and buttons
Icon/Button
Name
Definition
Cog icon
Loads the Setting screen
Help icon
Loads the Help screen
Shutdown icon
Used to shut down the system software
Add User icon
Loads the Add User screen
Clear icon
Clear the text in the User Name text box in the Create New User screen
USB download icon
Initiates the USB download function
Cancel button
Cancels the current operation, if applicable
Back button
Returns the to the previous screen
Next button
Moves to the next screen

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Using the Instrument
1. Ensure the instrument cover is free of any obstructions.
2. Turn on the system using the power switch at the rear of the instrument.
3. Press Start on the Start screen.
FIGURE 3:Start screen
Create or Select User Profile
1. If you have not already created a User Profile, create a profile by pressing the button at the bottom of the touchscreen.

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2. Use the touchscreen keyboard to enter the desired User Name and press Save.
FIGURE 5:Create New User screen
TABLE 11:Create a User screen
Call Out
Screen Component
Definition
1
User Name textbox
Use the touchscreen keyboard to type in a new user name
2
Cancel button
Click Cancel button to return to the Choose a User Screen without adding the user
3
Save button
Click Save button to add the new user
4
Help icon
Loads the Help screen
TIP
If you select the. icon in the input area, the existing text is cleared.
NOTE
Once a
User Profile
is created, it is saved in the system software and can be selected from the menu in the future.

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FIGURE 6: Choose a User screen
3. Select the user profile you just created or a previously created profile to go on to the next step.
Select an Ionic Purification Kit Protocol
After a user profile has been selected, a list of available purification kit protocols will be displayed.
Select the protocol you wish to run and follow the guidance on the touchscreen.
For detailed protocols available for each Ionic purification kit, please visit: https://www.purigenbio.com/support/documentation..
Defining Samples for a Purification Kit Run
1. In the Select a channel naming option screen, press USB Upload, Manual Input, or User defaults.
NOTE
If available, a barcode scanner can be used to scan the samples.
2. For additional details on USB Upload, see "USB Upload" below.
3. For additional details on User defaults, see "User Defaults" on page 22.
4. For additional details on Manual Input, see "Manual Input" on page 23.

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USB Upload
1. In the Select a channel naming option screen, press USB Upload.
NOTE
If available, a barcode scanner can be used to scan the samples.
2. Insert a USB drive in the USB port located on the front bottom-right of the instrument.
FIGURE 7: Sample screen – Step 2
3. If there are valid sample CSV files on the USB drive and no errors loading the USB drive were encountered, a screen listing the
sample files on the USB drive is shown. Select the sample file you would like to use.
FIGURE 6:Sample screen – Step 3

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FIGURE 9: Sample-names.csv file contents
NOTE
The CSV input file should have two columns.
Column A:
Should contain a lowercase or uppercase letter (a-h) to identify the channel.
Any other characters will cause an error.
Column B:
Should contain the sample name which can be made up of numbers, letters, dashes, and underscores.
Any other characters will cause an error.
4. The first Review screen is displayed. Verify sample names and then press the arrow button on the right side of the screen to
continue.
NOTE
Deselect the checkbox next to a
Channe
l if you will not be adding a sample to that
Channel
to disable it.