SGI-DNA BIOXP 3200 User manual

REV. 5.0 09.27.18
Part number 40010
BioXp™3200 System:
User's Guide

LEGAL NOTICES
Limited Use Label License Except as otherwise agreed in writing by our authorized representative, this product
is for INTERNAL RESEARCH USE ONLY AND NOT FOR HUMAN, ANIMAL, THERAPEUTIC
OR DIAGNOSTIC USE. For additional information about your rights under this research
license, please see our website at sgidna.com.
Limited Warranty a) SGI-DNA's entire liability and your exclusive remedy if the Product fails to conform
to the following warranty (a “Nonconforming Product”) shall be, at SGI-DNA's sole
option, either repair or replacement of such Nonconforming Product, or, if neither is
practicable, a refund of the fees paid for the Product. The warranty for the repaired
or replaced Product is limited to the scope and remaining duration of the original
warranty for the Nonconforming product or, if longer, for 30 days after the date of
shipment to you of the repaired or replaced Product. The warranty is contingent upon
proper use of the Product in accordance with the User's Guide and does not apply to
any Product that is subjected to unusual physical or electrical stress, misuse, neglect,
improper testing or storage, modication or unauthorized repair or upgrade.
b) SGI-DNA warrants that the product, as delivered, will be free from defects in
material and workmanship for a period of one year from the date it is delivered to you
(“the Warranty Period”).
c) This warranty gives you specic legal rights and you may have other legal rights
which vary from state to state. This warranty is non-transferable.
d) OTHER THAN AS EXPRESSLY SET FORTH ABOVE, SGI-DNA MAKES NO WARRANTIES,
EXPRESS, STATUTORY, IMPLIED, OR OTHERWISE. NO DISTRIBUTOR, AGENT OR
EMPLOYEE IS AUTHORIZED TO MAKE ANY MODIFICATIONS, EXTENSIONS OR
ADDITIONS TO THIS WARRANTY.
e) You shall indemnify, defend and hold harmless SGI-DNA from any costs, expenses,
damages, or other losses arising out of i) any warranty of greater scope or duration
than that set forth in this SGI-DNA Limited Warranty; and ii) failure to disclaim implied
warranties and limit remedies and liabilities, by and on behalf of SGI-DNA.
Trademark Information BioXp™ and Oligo Vault™ are trademarks of SGI-DNA.
Formula 409® is a registered trademark of the Clorox Company.
Fantastik® is a registered trademark of S. C. Johnson & Son, Inc.
TipOne® is a registered trademark of USA Scientic, Inc.
Regulatory Statement For Research Use Only
Statement of Proprietary
Information
Copyright in this work is vested in SGI-DNA and the document is issued in condence
for the purpose only for which it is supplied. It must not be reproduced in whole or
in part except under an agreement or with the consent in writing of SGI-DNA and
then only on the condition that this notice is included in any such reproduction.
No information as to the contents or subject matter of this document or any part
thereof arising directly or indirectly there from shall be given orally or in writing or
communicated in any manner whatsoever to any third party being an individual rm
or company or any employee thereof without the prior consent in writing of SGI-DNA.
2

Terms and Conditions IMPORTANT- This agreement (the“Agreement”) is a legal agreement between you and
SGI-DNA. By installing or otherwise using the BioXp™ 3200 System (referred in this
agreement as the“Product”), you agree to be bound by the terms of this Agreement. If
you do not wish to be bound by the terms of this Agreement, do not use the Product
and promptly return the unused, unopened Product to the place of purchase for a full
refund.
The user is prohibited from reverse engineering the software or output les generated
from the BioXp™ 3200 system.
Limitation of Liability SGI-DNA'S LIABILITY ARISING OUT OF OR RELATING TO A PRODUCT SHALL NOT
EXCEED THE AGGREGATE AMOUNTS YOU PAID TO SGI-DNA FOR THE PRODUCT. IN
NO EVENT WILL SGI-DNA BE LIABLE FOR LOST USE, PROFITS, REVENUE, COST OF
PROCUREMENT OF SUBSTITUTE GOODS, OR ANY OTHER SPECIAL, INDIRECT, RELIANCE,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED AND UNDER ANY
THEORY OF LIABILITY. THE FOREGOING LIMITATIONS SHALL APPLY REGARDLESS OF
WHETHER SGI-DNA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND
NOT WITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
Disclaimer The material in this manual is for informational purposes only and is subject to change
without prior notice at any time. SGI-DNA and/or its aliates assume no responsibility
for any errors that may appear in this document.
INDICATIONS FOR USE The BioXp™ 3200 System is a device which is intended for the processing of DNA
materials. The system is not approved for use other than that stated above.
Technical Services For technical assistance, please contact technical services at
[email protected] or 1-855-474-4362.
SGI-DNA
sgidna.com
© 2018 SGI-DNA. All rights reserved.
3

4
Table of Contents
Product Ordering Information 5
Safety Information 5
Manual Symbols 5
Precautions 5
Marking Symbols on the Equipment 5
Safety Warnings 6
Equipment Specications 8
System Components 8
Technical Specications 8
Installation Guide 8
System Location 8
Unpacking, Set up, and Power Up 10
Getting to Know the System 11
Ethernet Set Up 12
Load the Reagent and Recovery Plate Thermal Covers 12
Starting and Conguring the BioXp™ System 13
Start the BioXp™ System 13
Operational Features of the BioXp™ System 14
Delay Start 14
Tracking Progress During a Run 15
Cancel a Run 16
Shutting down the BioXp™ System 16
Instrument Troubleshooting 17
Power-Related Issues 17
General Instrument Troubleshooting 17
Error Messages 17
Cleaning and Maintenance 18
Cleaning Instructions 18
Calibration 18
Preventative Maintenance 18
Repair 18
Recommended Separation Distances 19
Equipment Disposal 19
WEEE Compliance 19
Regulatory Statements 20
FCC Compliance Statement 20
Guidance and Manufacturer’s Declaration: Emissions 20
Guidance and Manufacturer’s Declaration: Immunity 20

5
Product Ordering Information
Product Description Cat. No.
BioXp™ 3200 System, includes 1 year warranty Standard Ethernet conguration of
BioXp™ Instrument
BX 3200-01
BioXp™ 3200 System Service Contract, 1 year Covers parts and labor for instrument
failure for 1 year, renewable annually
BX 3200-05
Safety Information
Manual Symbols
This manual describes the use and maintenance of the SGI-DNA BioXp™ 3200 Instrument. Read this
manual completely before putting the instrument into service. The following icons are used in this
manual:
Electrical Safety Warning: Failure to follow these instructions can cause harm to
operators or subjects.
Important Note: Failure to follow these instructions can lead to damage of the system or
unexpected results.
Precautions
• The BioXp™ System conforms to the following standards: IEC 61010-1:2001 2nd Edition to include
EN61010-1:2001, IEC/EN 61010-2-010, IEC/EN 61010-2-081.
• The radiation exposure hazard is non-critical.
Covers and exterior components which the operator may come in contact with during
routine maintenance or calibration, shall operate at a voltage no greater than 25 V AC or
60 V DC.
Marking Symbols on the Equipment
Warning: Indicates a warning concerning operations that may
lead to personal injury or potential damage to the instrument if
not performed correctly.
Caution, Hot Surface, Do NOT Touch.
Conformité European: This mark is a declaration by the
manufacturer that the respective component complies with
the relevant directives and standards as issued by the European
Union.
Alternating Current.
Waste Electrical and Electronic Equipment (WEEE) Directive: Do
not dispose symbol. See "Equipment Disposal" on page 23 for
additional information.
Consult instructions for use.

6
Safety Warnings
Installation
The BioXp™ System is heavy. Do not attempt to lift or move the instrument without
the assistance and supervision of colleagues. Be certain to use appropriate moving
equipment and proper lifting techniques (including but not limited to making certain
that you have a secure grip on the instrument before lifting, keeping your spine in
a neutral position while lifting with your legs, and coordinating lifting and moving
movements with all appropriate personnel). Improper lifting can cause permanent back
injury.
Use this product only as specied. If the instrument is used in a manner not specied
by SGI-DNA, the protection provided by the instrument may be impaired, resulting in
personal injury or damage to the instrument.
Ground Circuit Protection
Check the mains electricity supply plug, voltage, and frequency to conrm that the
supply corresponds to the values shown on the instrument label.
Ensure that the supply of power to the instrument is via a socket tted with a protection
device, such as a circuit breaker of the correct rating, to provide automatic power cut-o
in the cause of an insulation fault.
Conrm that the mains wiring is grounded. SGI-DNA declines all responsibility for any
damages due to instrument non-grounding.
Main Power Switch
Do not position the instrument such that it is dicult to operate the main power switch.
Hazardous Chemical Warning
Chemicals used with the instrument may be hazardous.
Always wear protective gear including safety goggles, gloves, and a lab coat when
handling chemicals.
Exercise caution when handling ammable liquids.
Take precautions, including but not limited to installing proper ventilation systems, to
ensure that the BioXp™ System laboratory is safe and that operators of the instrument
will not be exposed to hazardous levels of harmful chemicals.
Follow all national, state, and local health and safety regulations and laws.
Use proper waste disposal in accordance with all relevant regulations.
Refer to applicable Material Safety Data Sheets (MSDSs).
Flammable Liquids: Instrument Warning
Exercise caution when using ammable liquids in the BioXp™ System to minimize the risk
of re.
Do not use any ammable liquids in the instrument except for the liquids required in the
included procedure.
Provide adequate ventilation for the instrument to prevent the accumulation of
ammable vapors.
All sources of ignition, such as open ame or electrical spark, are not permitted near the
instrument or in areas where ammable vapors may travel.
Ensure that the instrument, all neighboring equipment, and users of the instrument are
appropriately grounded to minimize the generation of static electricity.
Do not use the Ethanol Reservoir if it is cracked.

Flammable Liquids: Solution Handling Warning
Keep ammable liquids in covered containers when not in use.
Provide means to promptly and safely dispose of any ammable liquid leaks or spills.
Do not transfer liquids using air pressure.
Read applicable MSDSs.
Store ammable liquids in cool, well-ventilated areas away from corrosives, oxidizers, and
ignition sources.
Label containers and cabinets as "ammable materials" where applicable.
Use only approved safety vessels for ammable liquid storage.
Ground and bond ammable liquid containers to prevent static charge build-up.
Never pour ammable liquids down a drain or sink.
Dispose of empty ammable containers in an approved manner.
Electrical Safety Warnings
Do not attach the power cord to an extension cord or to a multiple portable socket.
Doing so may compromise shielding and/or grounding.
This equipment should not be used adjacent to or stacked with other equipment. If it
becomes necessary to use the BioXp™ System under these conditions, the unit should be
observed to verify normal operation in this condition.
Use only grounded mains outlets for instrument supply.
Use only grounded mains outlets to supply instrument.
Do not remove any panels. Panels should be removed only by trained service personnel.
The AC power cord is the primary disconnection device for the instrument. Ensure that
the point of connection is easily accessible and free of any obstructions.
Important Warning: Moving Parts
Do not override the door lock. When the door is locked, the moving parts of the
instrument are operational. Never attempt to physically restrict movement of instrument
components.
Interfering with moving parts may cause personal injury. Keep hands clear of moving
parts while operating the instrument.
Do not move or shift the instrument during operation.
If the instrument shows evidence of corrosion or wear, do not attempt to manipulate or
tamper with components of the instrument.
Important Warning: Disconnecting the Instrument
Disconnect power to the system before cleaning or performing maintenance.
DO NOT remove any panels; panels should be removed only by qualied service
personnel.
Do not disassemble unit.
7

8
Equipment Specications
System Components
Use of other parts or materials other than those supplied with the instrument can degrade
system performance and may cause safety hazards. Use only SGI-DNA approved or
supplied components.
Use only SGI-DNA supplied Power Supply Cord. Use of other power cords may compromise
electrical protection and could create a hazard.
Components of the BioXp™ System
BioXp™ 3200 Instrument
Power Cord
RJ45 Ethernet Cable
Reagent and Recovery Plate Thermal Covers
Ethanol Reservoir
Technical Specications
Product Name BioXp™ 3200 System
Power Input Voltage 100–240 V
Power Input Current 8.3 A Max
Operating Temperature Range 16°C to 40°C
Note: After cold storage, stabilize reagents for 1hour at
operating temperature prior to initiating processing.
Storage Temperature Range −18°C to 60°C
Operating and Storage Humidity Range 10% to 90% (non-condensing relative humidity)
Operating Altitude To 2000 m
Water Ingress Non-immersion, protection for damp wipe only
Weight 63.4 kg
Dimensions (W,H,D) 66 cm × 53 cm × 74 cm
Installation Guide
The following section is included for reference purposes only. As standard practice, SGI-DNA will install
the BioXp™ System.
CAUTION: Read the entire Installation Guide before unpacking the BioXp™ System. Be sure to read and
adhere to the "Safety Warnings" on pages 6–7. Contact SGI-DNA immediately if you have any
concerns or questions.
System Location
The BioXp™ 3200 System has a compact footprint and is designed to be used in the typical laboratory
environment. Install the instrument in a location that meets the following requirements:
• Lab bench space that is 87 cm (35 inches) wide and 74 cm (29.2 inches) deep to accommodate the
instrument and allow for 10 cm of clearance on the sides for proper ventilation.
• Clearance of 79 cm (31 inches) above the lab bench to allow the door to open upward properly
• An available AC power outlet present within 2 meters of the instrument
• Available internet connection through a wired Ethernet connection

9
Setup Precautions
Place the instrument on a clean, dry, at surface capable of holding the
weight of the system.
Allow 10 cm of clearance on both sides of the instrument for proper
ventilation.
Make certain that the power cord connection point is free and clear of
obstructions so that it is easily accessible.
The intended location must be stable so that the instrument will not move
or vibrate excessively when in use.
Avoid dusty areas.
Avoid areas where the instrument would sit in direct sunlight or near a
heat source.
Do not set the instrument up where liquids or chemicals are used. Ensure
that no liquids are spilled into the instrument.

10
Unpacking, Set up, and Power Up
WARNING! Using the BioXp™ System in a manner not specied by SGI-DNA may result in damage to the
equipment and/or personal injury.
1. Remove the crate from the BioXp™ System by positioning two people across from each other. Carefully
lift the box upward while leaving the instrument stationed on the foam cushions on the pallet as shown
in the following illustrations:
2. Remove the foam packaging materials from the top of the instrument.
3. Carefully coordinate lifting the BioXp™ System o of the pallet with at least two people using proper
lifting technique:
4. Making certain the path is clear, carry the instrument and place it on the site prepared according to the
stipulations outlined in "System Location" on page 8.
5. After removing the power cord from packaging, connect it to the power inlet located on the right rear
side panel of the instrument.
6. Check that the power switch located above the power cord inlet is in the “o” position (0).
7. Connect the instrument to a grounded power outlet.
Note: We recommend connecting the instrument to a 1500 VA/900 W uninterruptible power supply.

11
Getting to Know the System
Hardware Overview
Figure 1. Front and side view of the BioXp™ 3200
System.
Figure 2. The BioXp™ 3200 System Deck.
Figure 3. Labeled Deck Map.
Instrument Ports
Location Port/Inlet Used to
USB Ethernet Power Inlet
USB Do not use
Note: The USB port is for instrument
diagnostics and is for authorized service
personnel use only.
Ethernet Connect to sgidna.com for system operation
Power Inlet Power the instrument
Figure 4. Power On/O switch and communications ports.
User Interface Overview
The system touchscreen located on the front panel of the instrument will guide you through
conguration of the instrument, running a job, and will provide alerts if errors are detected. The
background color of the screen changes to indicate the following:
Touchscreen
Background Color Indication
Blue Normal operation: job set up or job in progress
Yellow System check or prompt requiring user attention
Red Error message
Green Job complete

Ethernet Set Up
The BioXp™ System requires an internet connection. Prior to connecting the instrument to the internet,
be sure to test the connection with the executable le provided with the BioXp™ System pre-installation
instructions: "Check User Instructions" (BX 3200-21). After testing and conrming the connection as
directed, connect the provided RJ45 Ethernet Cable to the Ethernet port located on the rear of the unit to
an available Ethernet wall jack located in your lab.
Load the Reagent and Recovery Plate Thermal Covers
1. Remove the Reagent and Recovery Plate Covers from the instrument packaging.
2. Place the covers on the Cover Stands as shown:
Cover 1
Cover 2
Thermocycler
Ethanol
Reservoir
Note: The Ethanol Reservoir is shown uncovered in the image above. Be certain to ll and cover the
Ethanol Reservoir prior to initiating a system run.
12

13
Starting and Conguring the BioXp™ System
Start the BioXp™ System
1. Turn the instrument on using the power switch located on
the side of the instrument.
2. If prompted, update the software.
The BioXp™ System will initiate a self-check process to verify the correct functionality of motion
control and other internal systems of the instrument. If the system is unable to perform a
successful self-check it will alert the user to the problem and will prevent the system from
operating until the problem has been addressed. The self-check process has been carefully
developed to ensure that the BioXp™ System is operating within optimal calibration ranges and
that all systems are functioning correctly before initiating a job run.
3. If reagents from previous jobs are on the instrument deck,
the system displays the Remove Materials Screen. Open
the door, remove the materials from previous jobs, and
then close the door.
If you are ready to load the instrument deck and begin a run, refer to the appropriate deck
loading instructions for your system run.

Operational Features of the BioXp™ System
Delay Start
The Delay Start function is a useful tool enabling you to schedule job runs at your convenience.
Immediately after a Delay Start is scheduled (before the delay time period elapses), the instrument
initiates reagent mixing from the Reagent Strips and the Reagent Plate. Therefore, ensure that the
Reagent Strips have thawed completely before initiating a Delay Start. If you decide to cancel a Delay
Start, consider that you may need to replace the Reagent Strips and Reagent Plate to run the job at a
later date since the master mixes created from combining the contents of the Reagent Strips and the
Reagent Plate are unstable.
To perform a Delay Start:
1. After pressing Delay Start on the Job Initiation Screen, the system will display a
DelayTimerScreen:
2. Use the arrows to set the delay start time and press OK.
Note: We recommend using the Delay Start feature for short periods of time, as necessary.
3. After the delay time has been scheduled, the system will display a Delay Start Screen with a timer
showing the length of time left until the run begins (in hours : minutes : seconds) and the expected
time of job completion (also in hours : minutes : seconds):
Note: If necessary, press Cancel Job to cancel the delay start and abort the job.
14

Tracking Progress During a Run
Time to Completion
During a run, the instrument will display the projected time to completion for the job
(in hours : minutes : seconds) and the estimated Time of Completion, as shown in the following
illustrations:
Step 1 Example Step 2 Example
Ways to Track Progress
You can track the progress of your reaction in a number of ways:
Parameter Denition
Time to Completion The system estimates the time at which the job will be completed.
Time Remaining The system estimates the time remaining for completion.
Visual Progress The system provides a progress bar through the various steps to completion.
Note: The scale of each step is not linear. (i.e. Step 1 requires much more time
than Step 4 but both steps are each depicted with a similar sized time lapse
bar).
Remote Progress
Tracking
The progress of your job can also be tracked by logging into your account at
sgidna.com.
Color Indicators
The internal colored lights change during the job process. The colors indicate what portion of the process
is taking place:
Color Indication
Blue Normal operation
Green Processing completed
Yellow Transition (e.g., inspection)
Red Malfunction
15

Cancel a Run
1. If you need to cancel a job during a run, slide your nger
to the right across the bar on the bottom of the Display
Screen During a Run.
Slide to cancel
IMPORTANT! You will not be able to reuse reagents if you cancel a job after the run has initiated
and the Reagent Plate Seal has been broken. Do not cancel a run unless absolutely necessary.
2. After sliding to cancel, the system will display a
Conrmation To Cancel screen. Press YES Cancel Job to
end the run or No to continue the run:
If you press YES Cancel Job, the instrument will display
a Countdown screen indicating the time remaining until
the job cancel is complete.
3. When prompted, remove all materials and used or
partially used consumables from the instrument deck:
Shutting down the BioXp™ System
Once processing is complete, power down the system by pressing the power button on the front panel.
16

Instrument Troubleshooting
Power-Related Issues
Issue Possible Solutions and Recommendations
The touch screen does not light up • Conrm that the power switch is in the "ON" position.
• Conrm that the instrument is plugged into a working
electrical outlet.
• Verify that the plug is securely connected to the side
of the instrument.
• Contact SGI-DNA Technical Services, 1-855-474-4362.
Power failure occurs during the instrument run • Contact SGI-DNA Technical Services, 1-855-474-4362.
General Instrument Troubleshooting
Issue Possible Solutions and Recommendations
Diculty operating the touchscreen • Contact SGI-DNA Technical Services, 1-855-474-4362.
Error Messages
If you observe a red-background error screen during operation, follow the screen instructions. If directed
or if the problem persists, make a note of the screen and Call SGI-DNA Customer Service at
1-855-474-4362. Additional information is included in the following table:
Error Message Issue Possible Solutions and Recommendations
Problem preventing the
system from running the
job
• May be caused by a barcode reading error. Open the door
and conrm that all plates are properly seated in their
respective retainers in the correct conguration, then press
Retry.
• Press Conguration and follow the on screen instructions.
17

Cleaning and Maintenance
Cleaning Instructions
Clean the exterior of the BioXp™ System with standard cleaners and a damp cloth.
Clean the internal surfaces periodically using a common household cleaner, such as Formula 409® or
Fantastik® cleaners. Spray the cleaner onto a cloth and then use the damp cloth to wipe instrument
surfaces. Do not spray cleaners directly into the instrument.
Do not use abrasive or caustic cleaners on internal or external instrument surfaces.
Spills
Take every precaution to ensure that no liquids are spilled into the instrument. Wipe up accidental spills in
and around the instrument immediately. If ethanol spills, dispose of ethanol-saturated towels according
to your institutional guidelines.
In the event of hazardous material spillage
• In the event of spillage of a hazardous material, the BioXp™ System user is responsible for
decontamination of the hazardous material on or inside the instrument.
• Before using a cleaning or decontamination method other than a recommended cleaner, contact
SGI-DNA to verify that the proposed decontamination method will not damage the equipment.
Calibration
Calibration of the motion control system is performed by the manufacturer; no periodic calibration is
required. The system will perform a self-check upon power up the rst time each day. A log of the self
check is stored on the system and may be used by SGI-DNA Service Technicians should any issue arise.
Preventative Maintenance
The BioXp™ System does not require any preventative maintenance of the system besides normal
cleaning.
Repair
Each BioXp™ System has been manufactured and calibrated to specications. There are no serviceable
or repairable components within the system. Do not attempt to disassemble any part of the system. Any
such action will void the product warranty. In the event you should experience a product failure, please
call SGI-DNA Technical Support at 855-474-4362.
Recommended Separation Distances
18

Equipment and Systems that are NOT Life-supporting
The BioXp™ System is intended for use in the electromagnetic environment specied below. The customer
or user of the BioXp™ System should ensure that it is used in such an environment. The BioXp™ System is
intended for use in the electromagnetic environment in which radiated disturbances are controlled. The
customer or user of the BioXp™ System can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF Communications Equipment and the BioXp™ System
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = [3.5]√P
V1
80 MHz to 800 MHz
d = [3.5]√P
E1
800 MHz to 2.5 GHz
d = [3.5]√P
E1
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the trans-
mitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects, and people.
Equipment Disposal
This product has parts that contain a small amount of mercury and lead in some components. Disposal of
these materials may be regulated in your community due to environmental considerations. Follow local
regulations for disposal of equipment or equipment accessories at the end of their life.
WEEE Compliance
The BioXp™ System complies with the European Union's Waste and Electrical and
Electronic Directive. For disposal or recycling information, please contact your local
authorities or the electronic industry alliance: www.eiae.org.
Regulatory Statements
19

20
FCC Compliance Statement
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a commercial or
medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to radio or television reception. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause interference to radio
and television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and the receiver
• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help.
The connection of a non-shielded equipment interface cable to this equipment will invalidate the FCC Certication of
this device and may cause interference levels which exceed the limits established by the FCC for this equipment. It is the
responsibility of the user to obtain and use a shielded equipment interface cable with this device. If this equipment has
more than one interface connector, do not leave cables connected to unused interfaces. Changes or modications not
expressly approved by the manufacturer could void the user’s authority to operate the equipment.
Portable and mobile RF communication devices such as cellular phones can adversely aect medical equipment.
Guidance and Manufacturer’s Declaration: Emissions
All equipment and systems
Emission tests Compliance Electromagnetic environment guidance
RF emissions CISPR11 Group 1 The BioXp™ System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.
RF emission CISPR11 Class A
The BioXp™ System is suitable for use in all commercial establishments.
Harmonic emission IEC
61000-3-2 Class A
Voltage uctuations IEC
61000-3-3 Complies
Guidance and Manufacturer’s Declaration: Immunity
All equipment and systems
The BioXp™ System is a class A device and is intended for use in the electromagnetic environment specied below.
The customer or user of the BioXp™ System should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete, or ceramic tile. If oors
are covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output lines
±2 kV for power
supply lines
±1 kV for input/output lines
Mains power quality should be that of a typical
commercial or laboratory environment.
Surge
IEC 61000-4-5
±1 kV dierential mode
±2 kV common mode
±1 kV dierential mode
±2 kV common mode
Mains power quality should be that of a typical
commercial or laboratory environment.
Voltage dips,
short interruptions,
and voltage variations on
power supply input lines
IEC 61000-4-11
<5% UT(>95% dip in UT)
for 0.5 Cycle
40% UT(60% dip in UT)
for 5 Cycles
70% UT(30% dip in UT)
for 25 Cycles
<5% UT(>95% dip in UT)
for 5 sec
<5% UT(>95% dip in UT)
for 0.5 Cycle
40% UT(60% dip in UT)
for 5 Cycles 70% UT
(30% dip in UT)
for 25 Cycles
<5% UT(>95% dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or laboratory environment. If the user of
the BioXp™ System requires continued operation during
power mains interruptions, it is recommended that the
instrument be powered from an uninterrupted power
supply or a battery.
Power frequency
(50/60 Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should be at levels
characteristic of a typical location in a typical commercial
or laboratory environment.
NOTE: UTis the AC mains voltage prior to application of the test level.
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