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

USER GUIDE: Ionic® Purification System Purigen Biosystems
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
7
•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.
8
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.
9
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
FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.
10
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