Limitation Of Procedure; Warranty (For U.s. Only); Support / Services / Supplies - Qualigen FastPack IP System Manuel

For the competitive type assays, an immuno-reactive form of the analyte is bound to the paramagnetic
particles. Initially, the sample is mixed with a labeled antibody, and this mixture is added to the analyte-
bound paramagnetic particles. The analyte in the sample competes with the particle-bound analyte for the
labeled antibody. The amount of labeled antibody which binds to the paramagnetic particles is inversely
proportional to the analyte concentration in the sample.
For both assay formats, the antibody-bound paramagnetic particles are processed the same in the analyzer.
The analyzer uses a magnet to hold the paramagnetic particles with their attached labeled antibody
complex while they are washed repeatedly. The wash removes any unbound antibody. Finally, a substrate
solution is added which reacts with the labeled antibody to emit light.
During the entire run of the FastPack IP, temperature control of 37 to 45 °C ± 0.5°C for the FastPack IP
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is achieved by heating metal plates that adjoin the FastPack IP. The light produced is read by a
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photomultiplier tube. The analyzer provides a light-tight seal around the pack during the test process.
The FastPack IP System analyzer performs a comprehensive self-diagnostic test each night at 12:00 am.
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The same test is performed when "Run Diagnostic" is selected in the set-up menu. Throughout testing, the
analyzer monitors temperature, air pressure, background light, system power, and force profiles of seal
ruptures and clamps.

Limitation of Procedure

Please read the information packaged in the FastPack IP Reagent Kit regarding up-to-date product
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specifications and limitations.

Warranty (For U.S. Only)

Qualigen FastPack IP System Limited (1 year) Warranty
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Qualigen warrants, to the original purchaser, that the FastPack IP System will be free from defects in
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materials and workmanship for a period of one year from the date of purchase.
Qualigen's liability for all matters arising under this warranty shall be limited solely to the repair or (in
Qualigen's sole discretion) replacement of the product. If Qualigen reasonably determines that a repair or
replacement is covered by this warranty, Qualigen shall bear the cost of shipping the repaired or
replacement product to the customer. Risk of loss or damage during shipments under this warranty shall
be the responsibility of the party shipping the product. If product shipped to Qualigen under this warranty
is not suitably packaged for shipment, any physical damage present to the product on receipt by Qualigen
(and not previously reported) shall be presumed to have occurred in transit and will be the responsibility
of the customer. The customer must obtain a Return Authorization from Qualigen prior to shipping the
product back to Qualigen.
Qualigen shall not be obligated under this warranty if the need for repairs or replacements directly or
indirectly results from customer's: (i) failure to use or store the product as specified by Qualigen; (ii)
failure to properly perform the services or maintenance required in the Operator's Manual for a product;
(iii) repairs to a product by persons other than Qualigen service personnel; (iv) replacement of parts with
other than Qualigen genuine parts; (v) negligence or negligent operation of any product; or (vi) alterations
or modifications of any product without authorization from Qualigen.
THIS WARRANTY, TOGETHER WITH ANY OTHER WRITTEN WARRANTY THAT MAY BE ISSUED BY
QUALIGEN, IS THE SOLE AND EXCLUSIVE WARRANTY AS TO QUALIGEN PRODUCTS, EXTENDS
ONLY TO THE CUSTOMER AND IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY AGAINST INFRINGEMENT.
Note: Qualigen does not warranty the StatSpin centrifuge. Please check with StatSpin for warranty
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information.

Support / Services / Supplies

For questions concerning the FastPack IP System or if supplies or services are needed, contact your local
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FastPack IP System dealer or Qualigen, Inc.
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