SPECIFICATIONS FOR BAX SYSTEM Q7 INSTRUMENT.docx

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Bax System Q7 Startup w/ Thermal Block
Solicitation number
55AGR-S153
Issued by
Nevada

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This document contains the specifications for the Hygiena BAX System Q7 instrument, which is an automated PCR-based method for detecting microorganisms in food and environmental samples. The BAX System includes hardware, software, reagent kits, and selected enrichment media. The method uses BAX System reagents on enriched samples for bacteria or yeast and mold testing. The document outlines the reagents, media, hardware, software, and facility requirements for the BAX System Q7 instrument. It also covers the service and training provided with the system purchase.

The related state and local contract opportunity is for the Bax System Q7 Startup with Thermal Block, and involves the jurisdictions of Washoe County and Sparks City in the state of Nevada. The document does not provide details on the quantities, response dates, award dates, or contract term for this opportunity.

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SPECIFICATIONS FOR

BID

BAX SYSTEM Q7 INSTRUMENT

METHOD:

1. The Hygiena™ BAX® System is an automated PCR-based method for detecting microorganisms in food and environmental samples.

2. The BAX® System consists of hardware (cycler/detector and computer workstation), software, reagent kits (assays) and selected enrichment media for detecting specific microorganisms.

3. The method uses BAX® System reagents on enriched samples for bacteria or yeast and mold testing. Samples are amplified in the BAX® System cycler/detector. Proprietary BAX® System software analyzes the raw data and displays results on screen.

4. The BAX® System is intended for use by qualified laboratory personnel who follow standard microbiology lab practice, including the safe handling and disposal of potentially pathogenic materials1. Advanced knowledge of molecular biology is not required.

REAGENTS:

1. BAX® System assays are sold as kits that contain common lysis reagents and target-specific PCR tablets:

Standard Assays
Real-Time Assays
E. coli O157:H7 MP
Campylobacter jejuni/coli/Mari
Enterobacter sakazakii (Cronobacter spp.)
E. coli O157:H7
Genus Listeria
Genus Listeria
Genus Listeria 24E
Shiga toxin-producing E. coli (STEC)
Listeria monocytogenes
Salmonella
Listeria monocytogenes 24E
Shigella
Salmonella
Staphylococcus aureau
Yeast and Mold
Vibrio cholerae/parahaemolyticus/volnificus

2. BAX® System assays are sold as kits containing PCR reagents in tableted form packaged in strips of PCR tubes to minimize handling and operator error. Lysis reagents in solution are also included in the kits. For yeast and mold testing, a Supplement kit of disrupter tubes and DNA stabilizer is also required.

3. Most BAX® System assays provide same-day or next-day results, depending on the protocol used. If a two-step enrichment is used, results are available on the third (3rd) day.

4. All targets have demonstrated excellent inclusivity/exclusivity with the BAX® System

5. Most BAX® System assays detect the target organism at concentrations of 104 or 105 cfu/mL after enrichment. Sensitivity for the yeast and mold assay is ˂ 50 cfu/g after enrichment.

MEDIA:

1. BAX® System media for Listeria – single-step enrichment – 24 hours for swabs, 28 hours for sponges.

2. BAX® System MP media – single-step enrichment – 8-24 hours.

HARDWARE:

1. The BAX® System consists of the following hardware:

a. Automated thermal cycler/detector with 96 wells

b. Computer workstation

i. Pentium 4 or better workstation with at least 2.8 GHz CPU

ii. Minimum 512 MB RAM

iii. Minimum 40 GB Hard Drive

iv. Flat screen monitor

v. Keyboard, mouse and cables

vi. CD read/write

2. A start-up package of other equipment and supplies is included in the purchase price:

a. Heating blocks with inserts

b. Cooling blocks with inserts

c. Capping/de-capping tools

d. Tube holders

e. Pipettes and tips

3. Yeast and mold testing requires a cell disruptor device, which is not included.

4. An uninterruptible power source (UPS) and/or a line noise filter is not supplied, but are recommended.

SOFTWARE:

1. The computer provided with the BAX® uses Microsoft Windows® operating system.

2. The proprietary BAX® System application contrsols the thermal cycler/detector (including set-up, process monitoring, and diagnostics), analyzes the data and provides results on screen.

FACILITY REQUIREMENTS:

1. The BAX® System Q7 instrument requires a power supply of 95-264 VAC, 47-63 Hz, with a 15 amp circuit.

2. Bench space must accommodate instrument dimensions of 34(l) x 45(D) x 49cm (H) (14 x 18 x 20 inches) and support at least 34.1 kg (75 pounds).

3. The instrument requires an unobstructed airflow of 10-35°C and 20-80% humidity.

4. Refrigeration is needed for the reagent kits and cooling blocks.

5. Complete facility requirements are available in the BAX® System Site Prep Checklist.

SERVICE:

1. The purchase of a BAX® System includes a one-year warranty on hardware. Service Agreements beyond the first (1st) are available for purchase.

2. The BAX® System purchase includes a User Guide for operation of the cycler/detector, and appropriate manuals from the manufacturer of the other components.

3. Should problems arise, a service representative is available by phone within 24-48 hours of call.

TRAINING:

Two (2) days of on-site training are included with the BAX® System purchase.

BAX ® SYSTEM Q7 INSTRUMENT SPEC SHEET

SYSTEM COMPONENTS:

· BAX® System Q7 cycler/detector

· Computer workstation and printer

· BAX® System application and MS Windows® OS

· Installation and training

DELIVERED WITH SYSTEM:

· License to perform PCR

· Heating block assemblies

· Cooling block assemblies

· Capping/de-capping tools

· Pipettes

· Start-up supplies

· Documentation

CUSTOMER-SUPPLIED REQUIREMENTS:

· BAX® System PCR assays

· Enrichment media

· Hypochlorite bleach and other standard solutions

· Refrigeration (2-8°C) for kits and cooling blocks

· Stomachers, incubators for enrichment

· Cell disrupter device for yeast and mold samples

CUSTOMER-SUPPLIED RECOMMENDED OPTIONS:

· Uninterruptible power source – 2.2 kVa

· Line noise filter – 2.2 kVa

· Surge protector – 10 kVa

Q7 INSTRUMENT SPECIFICATIONS:

· 14” wide x 18” deep x 20” high (34 x 45 x 49 cm)

· Approximately 75 pounds (34.1 kg)

· Power usage: 950 watts

· 100-240- VAC ± 10%, 50/60 Hz ± 1%, 15

· Two 12.5 A, 250 V, 5x 10 mm fuses

· 5 excitation and 5 emission filters

· Halogen bulb: 12 V, 75 W

· Thermal range: 4-100°V

· Thermal homogeneity ±0.5°C well-to-well within 30 seconds of reaching 60°C

· Ramp speed: ±1,6-3,5°C per second

· Warm up time: 5 minutes or less from 25°C start

· 65 decibels maximum

ENVIRONMENT:

· Altitude at or below 2000 m (6500 ft) above sea level

· Temperature 10-35°C (50-95°F)

· Relative humidity 20-80% (noncondensing)

· Locate away from heaters, cooling ducts and out of direct sunlight; protected from accidental spills

· Non-conductive pollutants only

THROUGHPUT:

· 1-96 tests per batch, time dependent on assay

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