Purigen Ionic User manual

Purigen Biosystems, Inc.
5700 Stoneridge Drive, Suite 100
Pleasanton, CA 94588
TEL: +1 877 787-4436 EMAIL: [email protected]
NUCLEIC ACID PURIFICATION – PURE AND SIMPLE™
Ionic™ Purification System
SITE PREP GUIDE
VERSION 3.0
PART NUMBER: PUR-DOC-1
© 2019 Purigen Biosystems, Inc. All rights reserved.
NUCLEIC ACID PURIFICATION – PURE AND SIMPLE™

TOC
Copyright 3
Support 4
Introduction 5
Additional Resources 5
Delivery and Installation 5
Box Dimensions and Contents 6
Laboratory Requirements 6
General Requirements 6
Instrument Dimensions 7
Placement Requirements 8
Lab Bench Guidelines 8
Vibration Guidelines 9
Electrical Requirements 9
Power Specifications 9
Recommendations 9
Power Cords 10
Fuses 10
Uninterruptible Power Supply 10
Product Certifications and Compliance 10
Environmental Considerations 11
Pre-Installation Checklist 12
Acknowledgment and Authorization 13
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IONIC™ PURIFICATION SYSTEM

Copyright
© 2019 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 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.
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IONIC™ PURIFICATION SYSTEM

Support
For technical information or advice, please contact PurigenBiosystems Support at any time.
Phone: 1-877-PURIGEN (787-4436)
Email: support@purigenbio.com
PurigenBiosystems, Inc.
5700 Stoneridge Drive, Suite 100
Pleasanton, CA 94588
DOCUMENT NUMBER:PUR-DOC-1
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IONIC™ PURIFICATION SYSTEM

Introduction
This guide contains specifications and guidelines for preparing your site for installation and operation of the Ionic™
Purification System. Prior to installation of your Ionic system, a PurigenBiosystems Field Service Engineer (FSE) will
contact you to schedule the install and confirm that your site meets the preparation requirements described in this
document. If your system installation has already been scheduled, and you believe your site may not be ready in
time, please contact your PurigenBiosystems Field Service Engineer (FSE) for assistance.
Laboratory space requirements
Electrical requirements
Environmental constraints
Computing requirements
User-supplied consumables and equipment
Additional Resources
The following documentation is available for download from the PurigenBiosystems website.
Guide Name Description
Ionic™ Purification System
User Guide
Provides an overview of instrument components and software, and procedures for proper instrument
maintenance and troubleshooting.
Ionic™ Cells to Pure DNA Kit Provides steps to use the Protocol and instructions for the Cells to Pure DNAKit.
Ionic™ FFPE to Pure DNAKit Provides steps to use the Protocol and instructions for FFPEto Pure DNA Kit.
Table 1: Additional Documentation Resources
Delivery and Installation
Following your purchase of an Ionic system, a PurigenBiosystems representative will contact you to confirm receipt
of your order and provide an early estimate of delivery. Prior to delivery, a PurigenBiosystems FSE will contact you
to schedule the installation.
The Ionic system will be shipped to you directly. In this case, you will receive shipment tracking information from
PurigenBiosystems. Inspect the packages containing your Ionic system and report any signs of damage or rough
handling to your PurigenBiosystems Support.
I M P O R T A N T Do not unpack the instrument prior to installation. The system must be
unpacked by a PurigenBiosystems FSE during installation.
C A U T I O N Only PurigenBiosystems personnel can unpack, install, or move the instrument.
Mishandling of the instrument can affect the alignment or damage instrument components.
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C A U T I O N After your PurigenBiosystems representative has installed and prepared the
instrument, do not relocate the instrument. Moving the instrument improperly can affect the
alignment and compromise data integrity. If you want to relocate the instrument, contact your
PurigenBiosystems representative.
Box Dimensions and Contents
The Ionic system is shipped in a double-wall corrugated fiberboard box with a designer tray with full overlap, poly
straps and hand holds. Use the following dimensions to determine the minimum door width required to
accommodate the shipping container.
Measurement Box Dimensions
Height 62.7 cm (24.7 in.)
Width 47.2 cm (18.6 in.)
Depth 55.1 cm ( 21.7 in.)
Weight 29.0 kg (64 lbs.)
Table 2: Box Dimensions
The box contains the instrument along with the following components:
1 Power Cable
1 Leveling Plate
Laboratory Requirements
This section provides requirements and guidelines to set up your lab space for the Ionic system properly. For more
information, see "Environmental Considerations" on page11.
General Requirements
Adequate floor space near the installation site to accommodate the unpacking and unboxing of system
components.
Adequate clearance around the instrument for operator and service access.
Access to receptacle for power.
Rigid table or benchtop with the appropriate footprint and construction required to minimize unwanted
vibration or instability.
Adequate ventilation to accommodate heat output for all devices in the laboratory where system will be used.
Adequate management of the laboratory environment to minimize fluctuations in temperature and humidity.
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Instrument Dimensions
Figure 1: Instrument Dimensions with Leveling Plate (Front)
Figure 2: Instrument Dimensions with Leveling Plate (Side)
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The Ionic system must be placed on a leveling platform which is provided by PurigenBiosystems. The leveling
platform minimally increases the overall dimensions and weight.
The Ionic system has the following dimensions upon installation:
Measurement (with leveling plate) Instrument Dimensions
Width 43 cm (16.9 in.)
Depth 52 cm (20.5 in.)
Height 45 cm (17.7 in.)
Weight 24.5 kg (54.0 lbs.)
Table 3: Measurement with Leveling Plate
Placement Requirements
Select the installation location for your Ionic system prior to scheduled installation. The Ionic system must be
positioned to allow access to the power switch and power outlet, for proper ventilation, and for servicing the
instrument.
Make sure that you can reach around the left-side of the instrument to turn on or turn off the power switch on
the back panel adjacent to the power cord.
Position the instrument so that personnel can quickly disconnect the power cord from the outlet.
The instrument must be accessible from all sides using the following minimum clearance dimensions:
Access Minimum Clearance
Sides Allow at least 35 cm (14 in.) empty bench space to the left-hand or right-hand side of the instrument for pipettes, pipette tips,
reservoir, and keyboard.
Rear Allow at least 10.16 cm (4.0 in.) behind the instrument.
Top Allow at least 2 cm (0.79 in.) above the instrument. If the instrument is positioned under a shelf, make sure that the minimum
clearance requirement is met.
Table 4: Instrument Clearance Requirements
C A U T I O N If you need to relocate the Ionic system, contact your PurigenBiosystems
representative. Moving the instrument improperly can impact the alignment and compromise
data integrity.
C A U T I O N Heat generated by the instrument is expelled as hot air from the rear of the
instrument, which must not be blocked by any object closer than 10 cm to avoid potentially
dangerous overheating.
Lab Bench Guidelines
PurigenBiosystems recommends placing the instrument on a fixed lab bench or table capable of supporting an
instrument weighing 24.5 kg (54.0 lbs.) and with enough surface area to encompass the instrument and provide
adequate workspace for operators. Use of mobile tables or benches with casters should be avoided.
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N O T E Lysate preparation can occur on empty bench space, a separate benchtop, or in a BSL
hood.
Vibration Guidelines
C A U T I O N The Ionic system is sensitive to vibrations.
Use the following guidelines to minimize vibrations during runs and ensure optimal performance:
Place the instrument on a sturdy ,immobilized, surface that is isolated from nearby equipment or designed to
suppress the transmission of vibration from nearby equipment.
Do not place other equipment on the bench that produces vibrations, such as a shaker, vortexer, centrifuge,
freezer, or instruments with heavy fans.
Do not install the instrument near frequently used doors. Opening and closing of doors might induce
vibrations.
Do not install a keyboard tray that hangs below the bench.
Do not touch the instrument or open the reagent compartment during operation.
Do not place objects on top of the instrument.
Electrical Requirements
This section lists power specifications and describes electrical requirements for your facility.
Power Specifications
Type Specification
Line Voltage 110 - 120 VAC, 60 Hz, 2.5 A
Power Consumption 300 Watts
Table 5: Instrument Power Specifications
Recommendations
The following practices are recommended to ensure safe operation of the PurigenBiosystems Ionic system:
The instrument should be plugged into a receptacle on a dedicated circuit with proper voltage, amperage and
grounding.
A power line regulator is required if the voltage fluctuates in excess of +/- 10% of the normal voltage.
A surge protector is recommended in areas with frequent electrical storms or near electrically “noisy” devices
such as refrigerators or centrifuges.
Instrument must be placed less than 2 meters from a power outlet.
The power outlet must be accessible at all times for safety.
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Power Cords
Hazardous voltages are removed from the instrument only when the power cord is disconnected from the AC power
source.
The table below lists the specifications for the power cord included with the instrument.
Specification North America
Current Rating 10 A
Voltage Rating 125 VAC
Input Connection 1 NEMA 5-15P
Input Connection 2 IEC 320-C13
Cord Length 6.56' (2.00m)
Cord Type SJT
Table 6: Instrument Power Cord Specifications
W A R N I NG Never use an extension cord to connect the instrument to a power supply.
Fuses
The Ionic system contains no user-replacable fuses.
Uninterruptible Power Supply
PurigenBiosystems recommends the use of a user-supplied uninterruptible power supply (UPS). PurigenBiosystems
is not responsible for runs affected by interrupted power regardless of whether the instrument is on a UPS. Standard
generator-backed power is often not uninterruptible and a brief power outage occurs before power resumes, which
interrupts a run.
PurigenBiosystems recommends the use of a UPS rated at least 1500VA/750W with a total capacity of 300Wh to
avoid loss of sample and materials during a power outage (APC BX1500M 1500VA Back-UPS Pro, or similar).
Product Certifications and Compliance
The Ionic Purification System is certified to the following standards:
UL 61010-1, 3rd Edition
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
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Environmental Considerations
The Ionic Purification System is designed to operate within the following environmental conditions:
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%.
Table 7: Operating Environment Specifications
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Pre-Installation Checklist
A specific installation site for the system has been selected, is available, and conforms with the requirements
specified above
A primary and secondary operator of the Ionic system has been identified, and contact information has been
provided to your PurigenBiosystems Field Service Engineer (FSE)
Primary Operator Secondary Operator
Primary Operator Secondary Operator
Name
Email
Phone
The primary and secondary operators will be available on the day of system installation to attend the
installation and system training
Customer-supplied materials listed above are available within arm’s length of the installation site
Lysate preparation can occur on a benchtop or in a BSL hood
If at the time of scheduled installation the FSE determines that one or more checklist items are incomplete, it may be
necessary to re-schedule the installation for another time, and you may be responsible for additional costs.
A PurigenBiosystems FSE will contact your responsible IT person prior to your scheduled installation to ensure that
your site is ready and that all checklist items have been completed. Your Field Application Specialist will contact the
operator trainees prior to your scheduled installation.
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Acknowledgment and Authorization
Please sign and return this form to support@purigenbio.com to confirm that site preparations are complete. Upon
receipt, we will return our confirmation of receipt and acknowledgment to arrange installation.
I, _____________________________ agree that I am authorized to approve installation of Ionic Purification System and I
agree to have fulfilled all the requirements stated above.
Name (Signature)
Name (Print)
Date
Position/Title
For internal PurigenBiosystems support team use only:
I, _______________________________ agree that I have received and approved installation of Ionic system.
Name (Signature)
Name (Print)
Date
Position/Title
Address PurigenBiosystems, Inc.
5700 Stoneridge Drive, Suite 100
Pleasanton, CA 94588
DOCUMENT NUMBER:PUR-DOC-1
FOR RESEARCH USE ONLY AND NOT FOR USE IN DIAGNOSTIC PROCEDURES.13
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