Qualigen FastPack IP System - Storage Conditions; Statement of Compliance; Disposal; Principle of Operation

72 65000159 Rev. 008 (06/17)
Storage Conditions
FastPack
®
IP System Analyzer
Storage Temperature: 15 °C (59 °F) to 32 °C (90 °F)
Humidity: 10% to 80% relative humidity
Stacking Limits: Not to exceed four high
Statement of Compliance
FCC, Sec 15 Class A Radiated Conducted Emissions
EN 61326-1 Class A Radiated Conducted Emissions
IEC 1000-3-2 Powerline Harmonics Test
IEC 1000-3-3 Powerline Flicker Test
IEC 1000-4-2 ESD Immunity
IEC 1000-4-3 Radiated Susceptibility
IEC 1000-4-4* EFT Immunity
IEC 1000-4-5 Lightning Surge Immunity
IEC 1000-4-6* RF Common Mode Immunity
IEC 1000-4-11 Voltage Dips & Short Interruptions
Low Voltage Directive 72/23/EEC
EN 61010-1 Safety Requirements
EN 61010-2
UL 61010-1
CSA 22.2 NO. 61010-1
CSA 22.2 NO. 61010-2
*IEC 100-4-4 and IEC 1000-4-6 were passed under criterion C.
Disposal
This product contains recyclable materials. Do not dispose of this product as unsorted
waste. Please contact your local dealer or Qualigen, Inc. for disposal instructions.
Principle of Operation
Sample is added to the FastPack
®
via the injection port. The FastPack
®
contains all the premeasured
reagents, in sealed chambers, necessary to perform the desired test. The pack label contains a bar code
with all necessary information required by the analyzer to run the test.
The FastPack
®
IP System analyzer performs the test by automatically mixing and moving the sample and
reagents within the pack. The sample and reagents are moved from one chamber to another by applying
uniform pressure to the compartment by means of internal pressure pads extended from the analyzer. The
pressure pads are driven by compressed air supplied by a small air compressor in the analyzer.
The FastPack
®
IP System analyzer is capable of running both sandwich, and competitive formatted
immunoassays. For the sandwich type assays, the chemical principle is as follows: A sample of unknown
analyte concentration is mixed with an excess amount of known concentration of capture and labeled
antibody solution. This mixture is incubated for a preset time to allow the capture antibody and the labeled
antibody to bind to the analyte in a sandwich format. This mixture is then brought into contact with the
coated paramagnetic particles, which bind to the capture antibody (and thus the analyte). The amount of
labeled antibody bound to the paramagnetic particles is directly proportional to the analyte concentration
in the sample.