NOVA BIOMEDICAL BIOPROFILE FLEX2 - Implementation; ESM Installation

3-1
3 Implementation
3. Implementation
3 Implementation
This section serves as a site preparation and implementation guide for the End User
when purchasing a BioProle FLEX2 + ESM system for integration with an ambr® 15 or
ambr® 250 microbioreactor system. It provides details concerning spatial requirements
and networking considerations. The End User is responsible for site preparation leading
up to the installation, which may involve: 1) Procuring a sterile hood or biosafety cabinet
(BSC) and preparing access holes on the left side of the hood (ambr® 15 only), and/or 2)
Verifying there is adequate bench space for the FLEX2 + ESM to the left of the ambr®.
It is the End User's responsibility to prepare this space by obtaining a bench or table
to hold the FLEX2 + ESM and ensuring accessibility of a power supply and corporate/
laboratory network port (if so desired). Note, electrical and environmental specications
for both pieces of Nova Biomedical equipment are outlined in Section 1.3. For specic
information about the ambr® 15 or ambr® 250 system, please contact Sartorius.
CAUTION: The FLEX2 + ESM should be installed on a stable, vibration-free surface.
The system should not be installed on the same bench top or within proximity
to any high-speed centrifuge system. Since these systems often create a
signicant amount of vibration, placement of the BioProle FLEX2 and/or
BioProle ESM near or on the same bench top may impact sample results.
Ensure the surface holding the FLEX2 + ESM does not contact the chiller or
ambr® system.
3.1 ESM Installation
The scheduling and implementation of events during ESM installation requires a coordinated
effort and will be dependent upon what equipment is available at a given time. Ideally,
the FLEX2, ESM, and ambr® would all be present, and both a Nova and Sartorius
representative would be on site together for a coordinated installation of all equipment.
When this is not the case, all parties will carry out their respective responsibilities. The
BioProle FLEX2 analyzer can be installed with the ESM Module included, or it can be
upgraded to ESM-Ready conguration later. The BioProle FLEX2 ESM should only be
installed by a trained and qualied Nova Field Support Specialist (FSS). During installation,
the FSS will unpack the ESM and place it in position, upgrade the FLEX2 hardware to
ESM-Ready conguration (if needed), ensure the FLEX2 software is V3.2 or newer,
install the required ESM consumables, and verify FLEX2 + ESM ow.
The ESM sample cup is included in the accessory pack provided by Nova Biomedical
at the time of installation. Although the cup is supplied by Nova, Sartorius is responsible
for sample cup installation as they must teach the cup's location to the ambr®'s liquid
handler arm and plumb uid lines from the cup to the FLEX2 + ESM once it is situated
on the ambr® uid deck. Lastly, Sartorius and Nova personnel will work together to verify
communication between the FLEX2 Bridge computer and ambr® control computer.