Maxwell® CSC Instrument Operating Manual
Instructions for Use of Product(s)
Literature # TM457
The Maxwell® CSC Instrument is available only in Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Korea, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom and United States.
The Maxwell® CSC Instrument is intended for use, in combination with Maxwell® CSC reagent kits, as an in vitro diagnostic (IVD) medical device to perform automated isolation of nucleic acids. The nucleic acid isolated using the Maxwell® CSC Instrument is suitable for direct downstream analysis by standard amplification methods. These methods include a variety of polymerase chain reaction (PCR) tests for human in vitro diagnostic purposes. The Maxwell® CSC Instrument is not intended for use as part of a specific in vitro diagnostic test. The Maxwell® CSC Instrument is intended for professional use only. Diagnostic results obtained using the nucleic acids purified with this system must be interpreted in conjunction with other clinical or laboratory data. The Maxwell® CSC Instrument is not intended for use with reagent kits other than Maxwell® CSC reagent kits or with samples other than those defined within the intended use and product limitations of the specific Maxwell® CSC reagent kit being used. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids purified using the Maxwell® CSC Instrument.
For Maxwell® CSC Instruments (AS4000) sold in the United States or Canada, please refer to TM424.
For Maxwell® CSC Instruments (AS4000) with serial numbers lower than 9800000201 using the 2.X software, please refer to this version of TM424 (English) or TM424 (français).
For Maxwell® CSC Instruments (AS4000) using the 1.X software, please refer to TM373.
Summary of Changes
The following changes were made to the 10/19 revision of this document:
1. Updated to include language specific to running the instrument in IVD Mode.
2. Added instructions to install Maxwell® CSC protocol methods in Section 5.C.