nRichDX Revolution User manual

nRichDx RevolutionTM User Manual
For Catalog# 10081
nRichDX, Inc.
15339 Barranca Pkwy
Irvine, CA 92618 USA
[phone]
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Contents
Preface
About this User Manual
Safety and Special Notices
Symbols Glossary
Contacting Us
Chapter 1 Introduction to the Revolution System
Intended Use
Use Statement
Chapter 2 Instrument Overview
Revolution System-Set up
User Interface
Chapter 3 Operating Instructions
Starting a Run
Stopping a Run
Opening the door during a run
Useful Suggestions
Display Messages
Error Messages
Chapter 4 Cleaning
Chapter 5 User Replaceable Parts and Supplies

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Replacing Fuses
Replacing Cartridge Clips
Chapter 6 Specifications

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Preface
nRichDX provides this document to its customers with a product purchase to use in the
product operation. This document is copyright protected and any reproduction of the
whole or any part of this document is strictly prohibited, except with the written
authorization of nRichDX.
The contents of this document are subject to change without notice. All technical
information in this document is for reference purposes only. The system
configurations and specifications in this document supersede all previous information
received by the purchaser.
nRichDX makes no representations that this document is complete, accurate or error- free
and assumes no responsibility and will not be liable for any errors, omissions, damage or
loss that might result from any use of this document, even if the information in the
document is followed properly.
This document is not part of any sales contract between nRichDX and a purchaser. This
document shall in no way govern or modify any Terms and Conditions of Sale, which
Terms and Conditions of Sale shall govern all conflicting information between the two
documents.
About This User Manual
This user manual is written for the operator, for example, laboratory technician. This
manual provides information on the nRichDX Revolution™ System, including the
installation and operating instructions.
This document aims to provide information for:
• Reviewing safety precautions
• Installing the Revolution System
• Using the Revolution System in routine jobs – the processing step
• Performing basic cleaning and maintenance procedures
• Troubleshooting the instrument performance
This user manual also describes the features and specifications of the Revolution System
instrument as well as ordering information.
Read the manual in its entirety before operating the instrument.
Print and keep the user manual for future reference. The user manual is an important
part of the instrument and should be readily available during the use of the instrument.

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Safety and Special Notices
Make sure you follow the precautionary statements presented in this guide. The
safety and other special notices appear in boxes.
Safety and special notices include the following:
WARNING Incorrect grounding can cause electric shock and damage the system.
Never operate the system until the power cord is connected correctly to an
electrical ground. Use a three-pronged (grounded)power cord to connect the
system to a matching three-wire grounded outlet. Do not use an adapter to
connect the power plug to a two-pronged outlet.
WARNING Use the safety features of the instrument. Do not compromise the
integrity of safety interlocks and sensors.
Under normal operating conditions, the instrument protects the user from
exposure to moving parts. The front door is monitored by an interlock switch which
will not allow operation while the door is open.
Never attempt to defeat this interlock. Intentionally defeating this safety measure
may cause a risk of injury from moving parts.
WARNING Risk of personal injury from electrical shock. Electronic components can
cause shock or injury. To prevent possible injury or shock, do not modify the
instrument and do not remove any components (such as covers, doors or panels)
unless otherwise instructed in this document. No user-serviceable components are
inside the instrument. Contact nRichDX, Inc. if servicing is required.
WARNING Risk of personal injury if electronic equipment is used near fumes or
flammable gases. Avoid this risk by never operating electronic equipment close to
fumes or flammable gases.
WARNING Always operate the system with the door closed to avoid injury.

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WARNING
Normal operation might involve the use of solutions and test samples that are
pathogenic or toxic. Such materials require that you take all necessary safety
precautions.
• Handle body fluids with care because they can transmit disease. No known
test offers complete assurance that they are free of micro-organisms.
• Handle all infectious samples according to good laboratory procedures and
methods to prevent spread of disease.
• Some of the most virulent infectious agents – Hepatitis (B and C) and HIV (I-
V) viruses, atypical mycobacteria, and certain systemic fungi – require extra
safety precautions.
• Risk Group II materials (as identified in the World Health Organization
Laboratory Biosafety Manual) require biosafe containment. Materials of a
higher group require more than one level of protection.
• Dispose of all waste solutions according to correct environmental and safety
guidelines
WARNING California Proposition 65 Warning Statement. This product can expose
you to chemicals known to the State of California to cause Cancer and Reproductive
Harm.
WARNING Failure to use the provided power cords can cause risk of electric shock
or fire.
CAUTION Wear Personal Protective Equipment (PPE) such as gloves, eye shields,
and lab coats when performing any procedure. To avoid injury, observe and follow
all the warnings and cautions throughout this manual. Wash hands thoroughly
after contact with sample media and all maintenance activities. Observe all
laboratory policies and procedures related to the handling of biohazardous
materials. Refer to the applicable sources (such as Material Safety Data Sheets) for
specific hazard information.

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Symbols Glossary
Symbol
Description
Title of Symbol: Caution
Meaning of symbol: Indicates the need for the user to
consult the instructions for use for important
cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be
presented on the medical device itself.
Standard Number, Title of Standard, and Symbol
Reference Number: ISO 15223-1. Medical devices –
Symbols to be used with medical device labels,
labelling and information to be supplied 1: General
Requirements. #5 4.4
Title of Symbol: Warning; Biological hazard
Meaning of Symbol: To warn of biological hazard.
CAUTION The system generates and can radiate radio frequency energy. If the
system is not installed and operated correctly, this energy can cause interference
with other equipment. In addition, other equipment can radiate radio frequency
energy to which the system is sensitive. If you suspect interference between the
system and other equipment, nRichDx recommends the following actions to correct
the interference.
• This equipment complies with the emission and immunity requirements
described in this part of the EN/IEC 61326 series.
• As to emission, this system has been designed and tested to CISPR 11 Class
A, so in a domestic environment, it ma cause radio interference, in which
case, you may need to take measure to mitigate interference.
• It is recommended to evaluate the electromagnetic environment prior to
operations of the system.
• Do not use this system in close proximity to sources electromagnetic
radiation (for example, unshielded intentional RF sources), as they can
interfere with the proper operations.
• Do not use medical equipment that can be susceptible to malfunctions
caused by Electric Magnetic Field (EMF) close to the system.

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Standard Number, Title of Standard, and Symbol
Reference Number: IEC 60878. Graphical Symbols for
electrical equipment medical practices. #7010-w009
Supplemental Product-Specific Manufacturer
Information
This label indicates a caution to operate only with all
covers in position to decrease risk of personal injury or
biohazard.
Wear Personal Protective Equipment (PPE) such as
gloves, shields, and lab coats. Handle and dispose of
biohazardous materials according to your laboratory
procedures.
Title of Symbol: Manufacturer
Meaning of Symbol: Indicates the medical device
manufacturer as defined in EU 90/385/EEC,
93/42/79/EC.
Standard Number, Title of Standard, and Symbol
Reference Number: ISO 15223-1. Medical devices –
Symbols to e used with medical device labels, labelling
and information to be supplied -Part 1: General
Requirements. #5.1.1.
Title of Symbol: In vitro diagnostic medical device
Meaning of Symbol: Indicates a medical device that is
intended to be used as an in vitro diagnostic medical
device.
Standard Number, Title of Standard, and Symbol
Reference Number: ISO 15223-1: Medical devices.
Symbols to be used with medical device labels,
labelling and information to be supplied. General
requirements, clause 5.5.1

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Title of Symbol: Graphical symbols to be used with
medical device labels, labelling, and information to
be supplied.
Indicates the manufacturer's catalogue number so
that the medical device can be identified.
Title of Symbol: Warning; Crushing of hands
Meaning of Symbol: To warn of a closing motion of
mechanical parts of equipment
Standard Number, Title of Standard, and Symbol
Reference Number: ISO 7010. Graphical Symbols for
electrical equipment in medical practices. #W024
Use caution to avoid injury to hands when close to
equipment with moving mechanical parts.
Title of Symbol: cNRTLus Certification Mark
Meaning of Symbol: This symbol indicates recognition
by a Nationally Recognized Testing Laboratory (NRTL)
that the system has met the relevant product safety
standards for the United States.
OSHA, CEC
Title of Symbol: Fuse Location
Meaning of Symbol: Indicates the location of a fuse.
Title of Symbol: Protective earth; protective ground
Meaning of Symbol: to identify any terminal which is
intended for connection to an external conductor for
protection against electric shock in case of a fault, or
the terminal of a protective earth (ground) electrode.

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Standard Number, Title of Standard, and Symbol
Reference Number: IEC 60417: Graphical symbols for
use on equipment – Overview and application, #5019
Title of Symbol: Serial number
Meaning of Symbol: Indicates the manufacturer’s
serial number so that a specific medical device can be
identified.
Standard Number, Title of Standard, and Symbol
Reference Number: ISO 15223-1. Medical devices –
Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1:
General Requirements. #5.1.7
Contacting Us
For the latest information on products and services, visit our website at:
www.nrichdx.com.
For Customer Support contact us at: [email protected]
Chapter 1 – Introduction to the Revolution System
Intended Use
The Revolution™ Processor is designed to perform semi-automated extraction and
purification of nucleic acids from biological liquid specimens intended for molecular
biological applications. The processor is intended for use by professional users, such as
technicians trained in molecular biological techniques and the operation of the
Revolution ™ Processor.
The Processor is designed exclusively for use with nRichDX Revolution isolation reagents
for the extraction of nucleic acids from human samples for in vitro diagnostic testing.
The instrument is driven by an integrated microprocessor that controls the system
rotator (measured in revolutions per minute; RPM) and the system timer. The Processor
features an easy-to-use interface that allows the user to easily adjust the run time and
speed.
Use Statement
This device is intended for indoor use only. Safety Protection may be impaired if used in
a manner not specified by nRichDX.

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If you use the system in a manner not specified by nRichDX, the protection provided by
the system can be impaired and incorrect results or system failure can occur.
This manual is designed to familiarize users with the Revolution Processor, including its
functions, specifications, operation, and routine care and maintenance. nRichDX, Inc.
recommends that users read this entire manual, including all safety-related information,
before operating the instrument.
Chapter 2 - Instrument Overview
In addition to these instructions, the contents of the Revolution Processor packaging
include the instrument, a power cord, and a drip tray.
Revolution System Set-Up
1. Remove the instrument from its shipping container and ensure all packing materials
have been removed from the instrument.
2. Two people should lift the instrument onto its desired location by grasping underneath
the base at the sides of the instrument and then placing the rear base of the unit down
first followed by the front being careful to remove fingers from underneath as the front
of the unit is lowered. After setting the rear of the instrument down and at the point of
lowering the front of the instrument you can grasp the metal frame adjacent to the door
and lower the front onto the support feet.
3. Plug the female end of the power cord into the back of the instrument and the male end
into a 100 - 240V, 50-60 Hz grounded receptacle.
4. Remove the packing materials from the drip tray.
5. Slide the drip tray through one of the openings, located on either the right or left side
panels, of the mixing chamber so that the tray is resting on the bottom of the mixing
chamber. The drip tray should be oriented so any liquid will be captured inside the tray.
6. The instrument is now ready for use.
User Interface
The Revolution Processor has an intuitive user interface that is comprised of the following
elements:

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• Digital display
• Power indicator light
• Stop/Start button and indicator light
• Time adjustment keys
• Speed adjustment keys
Chapter 3 - Operating Instructions
1. Turn on the power switch located in the back of the instrument. The POWER light on the
user interface will illuminate.
2. Ensure that the instrument is in the home position. If the instrument is not in the home
position, the display will read “press start to home”. Press the start key to home the
instrument.
3. Open the mixing chamber door.
4. Place the Revolution Cartridge Rack containing up to 8 Revolution nRicher Cartridges
into the instrument.
5. Load the Revolution Cartridge Rack onto the rack mounting pins by inserting top of
cartridge rack (single hole) onto the top pin and lining up the bottom pins with the
bottom slots in the rack. Slide the rack under the flange feature of the pins. Ensure that
the rack is captured by all 3 pins.
6. Close the mixing chamber door. The door must be fully closed to operate the
instrument.
7. Use the arrow keys to adjust the speed and time according to the appropriate
Revolution Isolation Kit program located in the Revolution Isolation kit Instructions for
Use. The timer range is between 1 min and 999 minutes and the speed range is between
10 RPM and 30 RPM.

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Notice: The Speed and Time CANNOT be adjusted while the instrument is running.
Starting a Run
To start the run, depress the START/STOP. The START/STOP led will illuminate when the
instrument is running. Once run is complete, clear the completed run by depressing any arrow
key.
Stopping a Run
To stop a run at any point, depress the START/STOP key. The device will slow to a stop and the
instrument will return to the home position. The run parameters will be saved at the stopping
point. These parameters can be adjusted if needed.
When ready to restart a run, depress the START/STOP key.
Opening the Door During a Run
Opening the door during a run will immediately turn off the motor and stop the run. If the door
is opened mid-run, follow the instructions on the screen to restart the run from the stopping
point:
• Depress any arrow key
• Depress the START/STOP key to home the instrument
The run parameters will be saved at the stopping point. These parameters can be adjusted if
needed.
When ready to restart the run, depress the START/STOP key.
Useful Suggestions
Loading and Unloading the Rack:
Always use two hands (one on each handle) to load/unload the rack onto the rack mount pins.
Ensure the rack is fully engaged with all three rack mount pins before starting a run.
Loading and Unloading the Sample Cartridges:
Insert the cartridges straight down into their respective cartridge slots to load. Remove by
pulling straight up out of the cartridge slot. Do not manually manipulate the spring clips while
doing this as aggressive manipulation of the spring clip may damage it. The spring clip will be
moved aside without additional manipulation as you push or pull the cartridge in and out of the
slot.
Always use two hands to load/unload the cartridges into the rack. One hand should hold on to
the rack while loading/unloading the cartridges.
Confirm that the cartridges are completely set in the recessed area of the cartridge slot to
ensure that the rack clips are fully engaged.

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Turn Off the Instrument when not in Use:
Turn off the instrument utilizing the switch at the rear of the instrument when not in use to
minimize wear on the motor and the electronics.
Display Messages:
Device State
Screen Display
Start Up
nRichDX Mixer
VER: 0.18.6
followed by
nRichDX Mixer
PRESS ANY ARROW KEY TO CONTINUE
Un-homed
PRESS START
TO HOME
Homing
HOMING
or
HOMING
COMPLETE
Homed, Prior to Programming a
Run
SPEED: 30 RPM
TIME: 0:00
Note: The speed and time displayed are the set points
and can be adjusted.
Running
RUNNING XX RPM
Note: While running, display RPM indicates actual speed.
TIME: XXX:XX
Note: Display time indicates time remaining.
Stopping
STOPPING
Run Completion
RUN COMPLETE
PRESS ANY ARROW KEY
Error
ERROR: message
See error messages section below.
Error Messages:
If an error occurs, follow the instructions on the screen to clear the error and restart or resume
the run.
Error Message
Sequence to Clear Error
ERROR: STALL DETECTED. CLEAR OBSTRUCTION.
PRESS ANY ARROW KEY.
Clear the obstruction.
Depress any arrow key.
Depress START/STOP to home.
ERROR: DOOR OPEN. CLOSE DOOR TO CONTINUE.
PRESS ANY ARROW KEY.
If door is opened during a run:
Depress any arrow key.

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If the device loses power during a run and the device resets, the screen will display the start-up
screen. In this case the run information will not be saved.
Chapter 4 - Cleaning
Remove the drip tray and wash with 70% ethanol in water solution. Clean all internal
instrument surfaces by wiping down with a 70% ethanol in water solution and/or a 10% bleach
in water solution. Internal surfaces include the drive shaft, rack mounts, rack pins and drip
shield. Also wipe down the front panel and door handle during periodic cleaning.
Chapter 5 - User Replaceable Parts and Supplies
The following supplies can be ordered by contacting nRichDX at www.nRichDX.com
Cartridges are purchased as a component of the various extraction kits. Other instrument
components and supplies that can be purchased individually include:
Name
Description
Part #
Revolution Cartridge Rack
Rack supporting 8 cartridges
100305
Drip Tray
Tray placed at base of mixer in case of
spills
100291
Revolution Mag Capsule
Magnetic capsule used to collect beads
during enrichment
100083
Fuse
T3.0A H, 250V 5x20mm
100244
Cartridge Rack Clip
Replacement spring clips for Revolution
Cartridge Rack
100203
Replacing Fuses
If the instrument does not seem to get power after you press the Power button, confirm that
the power cord is securely connected to a functioning power outlet and to the power port on
the rear of the instrument.
If the power failed while the instrument was running, verify that the power cord is not loose
nor disconnected and that power to the power outlet is functioning properly.
If these checks fail to remedy the loss of power, replace the fuse. There is one spare fuse in the
spare fuse compartment of the fuse carrier which is part of the power outlet on the rear of the
instrument. If necessary, you can obtain replacement fuses from nRichDX. See the User
Depress START/STOP to home. Depress
START/STOP to restart the run.
If door is opened prior to a run:
Close door. Depress START/STOP to run.
ERROR: HOME SWITCH NOT FOUND.
PRESS ANY ARROW KEY.
Inspect device and remove any obstruction.
Depress any arrow key to continue.
Depress START/STOP to home.

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Replaceable Parts and Supplies section above for details on fuse specifications and part
numbers.
Replacing Cartridge Rack Clip
If a cartridge rack clip becomes damaged so that it does not function properly, it can be
replaced by using a Philips screwdriver to unscrew the screw and washer holding it at the base
and replacing it with a new clip and screwing it back into place with the washer between the
screw-head and the base of the clip. The clip should be oriented so that the bend at the base is
facing the hole for the cartridge.
Chapter 6 - Specifications
Item
Description
Operating Environment
Indoor use only
System Power
100-240V, 50/60Hz, 2A
Installation Category II
Fuse Replacement
5x20mm cartridge type, T3.0A H, 250V
Dimensions
Width: 35.6 cm (14 in.)
Height 62.0 cm (25 in.)
Depth: 62.0 cm (24.25 in.)
Spacing
Allow 2” of clearance around the unit. One side of unit will
need 12” of clearance to safely insert and remove the drip tray.
Either side can be used for this. This 12” is not necessary during
normal operation but must be available for maintenance.
Weight
20.55 kg (45.3lbs)
Ambient Operating
Conditions
Temperature: 18°C to 28°C (64°F to 82°F)
Relative humidity: 15% RH to 80% RH (non-condensing)
Pollution Degree 2
Ambient Storage
Conditions
Temperature: 0°C to 60°C (32°F to 140°F)
Relative humidity: 15% RH to 80% RH (non-condensing)
Altitude
Up to 2000m (6562 ft.)
Mains Disconnect
The mains disconnect is the Appliance Coupler. Ensure
accessibility to the rear of the unit after installation.