The JBAIDS Instrument is controlled for export under the International Traffi c in Arms
Regulations (ITAR), administered by the U.S. Department of State, Directorate of
Defense Trade Controls (DDTC), and may not be exported or transferred to any foreign
national without prior approval of the DDTC.
This document is used solely for the purpose of JBAIDS
Instrument Operation. This document shall not be disclosed outside of the U.S. Government and shall not be
duplicated, used, or disclosed in whole or in part for any
purpose.
The information contained in this document is subject to change without notice.
Idaho Technology makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability
and fitness for a particular purpose. Idaho Technology shall not be liable for errors contained herein or for incidental consequential damages in
connection with the furnishing, performance or use of this material.
The JBAIDS System, JBAIDS Software, and reagent kits are covered by US Patent Nos. 6,787,338; 6,387,621; 6,245,514; 6,174,670; 6,197,520;
6,303,305; 6,503,720; 6,569,627; and 6,730,501 and their foreign counterparts and other pending patents.
Idaho Technology logo is a trademark of Idaho Technology Inc.
Names of products and brands appearing in this manual are trademarks or registered trademarks of their respective owners.
The purchase of this product allows the purchaser to use it for amplifi cation and detection of nucleic acid sequences for providing human in vitro
diagnostics. No general patent or other license of any kind other than this specifi c right of use from purchase is granted hereby.
.
CUSTOMER AND TECHNICAL SUPPORT
Reach Us On the Web
Idaho Technology’s Web site is – http://www.idahotech.com
For JBAIDS information – https://jbaids.idahotech.com
We strongly encourage users to visit our Web site for answers to frequently
asked questions, updated information and additional insights into operating
the JBAIDS System.
Reach Us By E-mail
Contact Idaho Technology by e-mail in the following areas:
support@idahotech.com - Technical Support
it@idahotech.com - General Support
Reach Us By Phone
Technical support is available during the following times:
8 a.m. to 5 p.m. - Mountain Standard Time
For general and technical support call:
1-800-735-6544 - United States and Canada
(801) 736-6354 - Utah
+1-801-736-6354 - International*
*Note: The “+” represents the U.S. international prefix number needed to place a call from the
user’s country to the United States. This is followed by the country code (“1”).
Reach Us By Fax
To contact Idaho Technology by fax, use the following numbers:
1-801-588-0507 - United States and Canada
+1-801-588-0507 - International
Quick Guides for setting up the instrument
can be found in Appendix C.
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CONTENTS
Customer and Technical Support .........................................................III
Abbreviation of Terms ...........................................................................IX
Tm ................................melting temperature
USB .............................universal serial bus
UV ................................ultraviolet
V ..................................volt
W .................................watt
< X >JBAIDS Instrument < > System Manual < > REV 3
INSTRUMENT MANUAL SYMBOLS
The following symbols can be found throughout this manual. Use the definitions below as a guideline
to their interpretation.
This symbol defines a potentially hot surface. Use caution when working near these
areas to avoid bodily injury. Keep flammables and combustibles at a safe distance.
This symbol warns the user to operate the instrument according to the instructions
provided in this manual. If used otherwise, a potentially hazardous situation could
result.
This symbol highlights user tips to operate the instrument more efficiently.
BIOHAZARD
This symbol defines a Biohazard danger. Use standard laboratory technique when
handling pathogenic material.
This symbol indicates a protected ground terminal. Connect this terminal to ground
before making any electrical connections.
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CHAPTER 1: Technical Components of the JBAIDS Instrument
CHAPTER 1:
TECHNICAL COMPONENTS
OF THE JBAIDS INSTRUMENT
Description of the JBAIDS Program
The Joint Biological Agent Identification and Diagnostic
System (JBAIDS) program was created to provide rapid
positive identification and diagnostic confirmation of biological warfare agents and other pathogens of operational
concern for the four branches of the U.S. Military: U.S.
Army, U.S. Navy, U.S. Air Force, and U.S. Marine Corps.
The JBAIDS instrument was created as a reusable, portable, and modifiable system capable of simultaneous,
reliable identification of multiple biological warfare agents
and pathogens of operational concern and clinical significance. This instrument is configured to support reliable,
quick, and specific identification of biological agents from
various clinical specimens and environmental samples. It
also enhances force protection by providing medical personnel and commanders an expedient means to reliably
and quickly identify naturally occurring or intentional biological threats.
The JBAIDS instrument is a man-portable modified commercial-off-the-shelf system. The instrument
operates in various environmental conditions and passes a 1-meter drop test.
System Description
The JBAIDS instrument detects and identifies various microbes associated with infectious disease
and biological warfare agents. Specific test reagents and DNA sample purification kits that are produced by Idaho Technology are used in conjunction with this instrument for detection of organisms.
The JBAIDS instrument is a field-hardened air thermocycler capable of automatically analyzing samples for the presence of targeted DNA sequences. The instrument combines rapid
thermocycling technology and a real-time fluorimeter to identify test samples. Thermocycling amplifies DNA while the fluorimeter enables real-time detection. It is a rapid, robust, sensitive, and specific method of pathogen detection. The JBAIDS instrument is capable of analyzing 32 samples
(including controls) in less than 40 minutes.
CHAPTER 1: Technical Components of the JBAIDS Instrument
The JBAIDS instrument and laptop.
The instrument’s basic features in transportation position.
CHAPTER 1: Technical Components of the JBAIDS Instrument
The case easily fits inside a reinforced backpack making transport more convenient and safe.
LIFTING HAZARD: Improper lifting of the instrument could result in a strain injury. Lifts over
3 feet in height require two people.
Padded Shoulder Straps
Adjustable
Chest Strap
Adjustable
Waist Belt
Each instrument comes with a rugged laptop, pre-loaded with software for run and analysis of the
JBAIDS. It has a sealed magnesium alloy case, shock-mounted hard drive, and is moisture and dust
resistant.
CHAPTER 1: Technical Components of the JBAIDS Instrument
A 1 GB USB flash drive is provided with the laptop for record storage.
Temperature Control of the Instrument
Temperature control of the cycle chamber is modulated by a temperature sensor in the cycling chamber. Ambient temperature air is driven into the instrument by the intake fan, causing positive pressure to force the air through the heating duct and into the carousel chamber. The air is heated at the
end of the heating duct by a heat coil and dispersed into the chamber by the secondary vortex fan.
Cooling is done in a similar manner by forcing unheated ambient temperature air into the chamber to
cool the samples.
The over temperature sensor in the chamber prevents overheating if the temperature control sensor
fails.
The Fluorimeter Component
A three-channel fluorimeter block is used for the real-time detection of the dyes/probes in each
amplification reaction. The fluorimeter reads and stores data for each sample simultaneously in all
three channels with every fluorescence acquisition. Excitation of each sample is from a light emitting
diode (LED) that is filter tuned and passed through a dichroic mirror at 470 nanometers (nm). The
three detection channels are filter tuned and correspond to 530 nm, 640 nm, and 705 nm respectively.
For fluorescence excitation, the instrument is equipped with an LED light source. This LED, which is
an integral part of the fluorimeter, requires no maintenance and has an extremely long life span.
The fluorimeter provides three channels, which detect emitted light with varying wavelengths.
Because of the high quality optics, the measurement is both extremely fast and sensitive. In a normal amplification run, measurement of a sample takes about 20 milliseconds.
CHAPTER 2: Safety Precautions When Working with the JBAIDS Instrument
CHAPTER 2:
SAFETY PRECAUTIONS WHEN WORKING
WITH THE JBAIDS INSTRUMENT
This symbol defines a potentially hot surface. Use caution when working near these
areas to avoid bodily injury. Keep flammables and combustibles at a safe distance.
BIOHAZARD
This symbol warns the user to operate the instrument according to the instructions
provided in this manual. If used otherwise, a potentially hazardous situation could
result.
This symbol highlights user tips to operate the instrument more efficiently.
This symbol defines a Biohazard danger. Use standard laboratory technique when
handling pathogenic material.
This symbol indicates a protected ground terminal. Connect this terminal to ground
before making any electrical connections.
CHAPTER 2: Safety Precautions When Working with the JBAIDS Instrument
LABORATORY USE
General Precautions
One of the most important rules of working in a laboratory environment is to avoid contamination.
Some important rules to follow are:
Do not return to a previous area without first ensuring proper decontamination procedures (i.e.,
•
washing and changing protective clothing and gloves).
Use filter tips on pipettes when working with any liquid solution.
•
Use different pipettes for setting up the reactions and for handling the samples.
•
Follow the diagram when establishing a clean, contamination-free working environment.
•
Outside Sample Collection of
Raw Sample
StartFinish
Lab Room
Area 1 Sample Prep
Lab Room
Area 2 Reaction Prep
Lab Room
Area 3 Run Reaction
Safety Precautions
Laboratory Procedures
• Avoid routine exposure to biohazards or potentially infectious material. Exposure can occur by
inhalation, ingestion, or skin absorption.
• Potentially infectious material must be manipulated inside a biosafety laboratory.
• A biosafety cabinet must be used when potentially infectious material is used in procedures that
may create aerosols or splashes. These activities include shaking, blending, and bead-beating.
• The centrifuge cap must be securely in place before starting the centrifuge.
Inhalation
• Minimize exposure by preventing splashes, sprays, or aerosols. Use a biosafety cabinet or other
ventilation devices when possible.
Ingestion
• Never use mouth suction for pipetting or starting a siphon.
• Wash hands often.
Skin Absorption
• Wear personal protective equipment (PPE) when handling potentially infectious material.
CHAPTER 2: Safety Precautions When Working with the JBAIDS Instrument
Handling of Biohazard Wastes
• Use universal precautions whenever handling human-source bodily fluids or any sample/specimen that could possibly contain pathogens.
• Place all contaminated waste in a red or orange plastic bag labeled with the biohazard pictogram.
• Kill (i.e., autoclave or treat with 10% bleach [1 part bleach to 9 parts water]) all cultures, stocks,
or live microorganisms before disposal.
• Place materials to be autoclaved in a proper autoclavable container in order to avoid spills and
leaks inside the autoclave and the surrounding area.
Decontamination and Cleaning Procedures
The decontamination and cleaning procedures listed are intended to limit spread of DNA and/
or polymerase chain reaction (PCR) amplicon or biohazards as a result of a broken capillary.
Decontamination is necessary to prevent false-positive readings in subsequent assays. Only decontaminate areas of potential contamination. For instance, if a capillary breaks while in the JBAIDS
reaction chamber, decontaminate the JBAIDS instrument, sample chamber, sample carousel, and
bench top (or other area) surrounding the JBAIDS. If a capillary breaks while loading or unloading
from the sample carousel, decontaminate only the sample carousel and any other potentially contaminated areas.
After a capillary breakage, change gloves and other potentially contaminated PPE. Change gloves
often during decontamination process, especially during the first steps of decontamination and
before touching any clean surface. All personal protective equipment should be disposed of after
decontamination.
Materials
This list provides items that are necessary in a laboratory to keep contamination to a minimum.
• 10% bleach solution in a squeeze or spray bottle (1 part bleach to 9 parts water)
CHAPTER 2: Safety Precautions When Working with the JBAIDS Instrument
Assessment of Risk Related to Capillary Breakage
Warning: It is EXTREMELY IMPORTANT that contamination from broken capillaries be
contained and cleaned IMMEDIATELY. Capillaries that break after PCR can contain large
quantities of target amplicon. This material, although noninfectious, is easily disseminated
by normal human activity. Consequently, very small (molecular) quantities can be amplified
by PCR in future runs, which will then be identified as positive by the JBAIDS instrument.
Treat all broken capillaries as capable of contaminating your area.
If a capillary tube breaks in the sample carousel, take the following precautions to avoid contamination.
• Put on PPE such as gloves and safety shield.
• Stop the run and unplug the instrument before beginning cleanup.
• Ensure no one else uses any potentially contaminated areas or instruments.
• Decontaminate and dispose of the broken capillary using the following steps:
- Dispose of potentially contaminated gloves and put on clean gloves.
- Dispose of the potentially contaminated lab coat and put on a clean lab coat..
- Clean up broken capillary, discard in capillary containment bin or biohazard sharps waste,
and completely remove capillaries from carousel, if necessary.
- Change gloves.
- Follow decontamination procedures for cleaning affected areas.
WARNING: If the broken capillary contained human source material and/
BIOHAZARD
or sample from a suspected pathogenic source, the risk of biohazard
contamination exists in addition to the DNA amplicon contamination.
Sample Carousel Decontamination
Instrument carousels are interchangeable and disposable. Contact Idaho Technology to obtain
replacement carousels. Idaho Technology recommends replacement of contaminated carousels
to minimize the possible spread of contamination. Also, the decontamination process can
make insertion and removal of capillaries in the carousel more difficult, leading to capillary
breakage and future contamination of the instrument. Therefore, to allow continued use of the
instrument after a broken capillary incident, always maintain at least one spare carousel with the
instrument.
If a spare carousel is not available, the following procedure can be used to decontaminate the carrousel. Obtain a replacement carousel if the decontamination processes fail to eliminate all contamination or if the carousel is damaged.
Place carousel on bench top.
1.
Spray 10% bleach (1 part bleach to 9 parts water) solution on both sides (top and bottom)
2.
of carousel and bench area. Let sit for 10 minutes.
Wipe carousel and bench area with paper towel.
3.
Repeat step 2 and 3 twice, for a total of three wipes.
4.
Spray distilled water on both sides of carousel. In particular, squirt distilled water into the
5.
capillary holes to remove any excess bleach.
Wipe carousel and bench area; dry with a new paper towel.
6.
Spray both sides of carousel with DNAZap, or equivalent product. See product for proper
CHAPTER 2: Safety Precautions When Working with the JBAIDS Instrument
Rinse by spraying distilled water on both sides of carousel.
8.
Wipe carousel and bench area dry with a new paper towel. Tap the carousel on your hand
9.
or clean bench top to remove excess distilled water.
10.
Use a new nylon brush to dry out all holes in the carousel. Make sure carousel is dry, as
residual bleach could alter fluorescence readings. If desired, check all carousel holes by
inserting a clean, empty capillary. If insertion and removal of a capillary is difficult for any
hole, repeat rinsing and drying steps.
11.
Discard nylon brush.
Sample Chamber Decontamination
Warning: Be careful not to touch or bump the temperature sensors located
in the sample chamber. Do not wipe bleach on the optics.
1. Remove carousel from instrument and decontaminate carousel by following the procedures
above.
2. Remove the chamber fan by lifting it straight up to remove glass underneath the fan blades.
Decontaminate chamber fan following procedures in "Sample Carousel Decontamination."
3. Remove glass from instrument (including the sample chamber) with a paper towel lightly
moistened with distilled water. You may carefully remove glass from the optics with a moistened paper towel by touching the wet towel to the glass and then disposing of glass and
towel. Be careful not to scratch the optics.
4. Wet a paper towel with 10% bleach (1 part bleach to 9 parts water) and wipe sample chamber and the inside of the heat duct assembly.
5. Repeat bleach step 4 twice with fresh paper towels for a total of three bleach wipes.
6. Wet a paper towel with distilled water and wipe carousel chamber and the inside of the heat
duct assembly. Do not wipe the optics.
7. Repeat distilled water step 6 with a fresh paper towel.
8. Clean the optics of the instrument, if necessary, with lens cleaner and lens paper. Use light
pressure when cleaning the optics.
9. Repeat optics cleaning step 8 with fresh lens paper.
10. Visually check the temperature control sensor to make sure it is straight and not bent to the
side.
JBAIDS Instrument Decontamination
Note: If the sample carousel or chamber has been contaminated, follow the appropriate
decontamination procedures listed before decontaminating the outside of the JBAIDS
instrument.
1. Wet a paper towel with 10% bleach (1 part bleach to 9 parts water) solution and wipe entire
instrument, including the bottom and bench top where the instrument had contact.
2. Repeat step 1 twice with fresh paper towels, for a total of three bleach wipes.
3. Change gloves, then wet a new paper towel with distilled water and wipe entire instrument,
including the bottom and any place the instrument touched the bench top.
This section describes how to set up and run the JBAIDS instrument. For replacement parts, see
Appendix E for a list of items and their ITI national stock number (NSN) and part number (if available). Save the boxes and shipping material that accompany these items to ensure that they are
packaged properly when being shipped to different locations.
Installation Requirements
Space and Power Requirements
• 32" x 16" space is needed for setup.
• Standard 110/220 volts AC grounded power source with surge protection is required for operation
Support Equipment Maximum Size and Power Requirements
A set of support equipment that is shipped on a pallet weighs approximately 1,700 lb and is 191 ft3
and requires 22 amps of grounded power. When the entire JBAIDS instrument is set up with all of the
accompanying support equipment, the footprint requires approximately 100 ft2, or five 48" x 30" tables,
plus walking room around the testing area.
Set-up Conditions
For operation, select a clean, well-ventilated area of sufficient size for both the instrument and the
computer. This location should allow unrestricted airflow into the instrument’s air intake.
Since the instrument releases hot air during operation, it is advisable to keep heat sensitive
Caution Hot
or highly flammable items at a safe distance from the instrument.
Installation of the JBAIDS Instrument
To unpack the instrument, set the backpack flat on its harness side.
1. Unsnap the four lock-straps and completely unzip the backpack. Open the backpack and
remove the instrument.
2. Set the instrument on a sturdy flat surface and press the red pressure release button to equalize the pressure inside the instrument case.
3. Open the case by flipping up and turning the case latches counter-clockwise. Remove the top
half of the case. The power and serial cables for the instrument are stored in a pouch in the
top of the instrument case and should be removed for use.
Laptop
Centrifuge
Capillary
Tubes
4. Rotate the heating duct assembly to the operating position.