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3.1 Safety instructions for the CliniMACS
Formulation Unit
In the event of unexpected process abortion or messages on the screen of the
CliniMACS Prodigy that advises the operator to contact technical support,
immediately contact the Miltenyi Biotec Technical Support. If secure operation is
no longer possible, immediately switch off the CliniMACS Prodigy and
disconnect the power cord of the CliniMACS Prodigy and contact Miltenyi Biotec
Technical Support or an authorized local Miltenyi Biotec Service Provider.
3.1.1 Usage and installation
Risk of improper operation due to increased electromagnetic emissions
or decreased electromagnetic immunity. The use of consumables,
accessories, transducers, and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation. Electrical equipment
requires special precautions regarding electromagnetic compatibility
(EMC) and must be installed and placed in service according to the EMC
information (see "Appendix"). Portable and mobile RF communications
equipment can affect medical electrical equipment. Only use the
instrument with accessories, transducers, and/or cables approved by
Miltenyi Biotec.
Risk of process failure. If alarm signals are not recognized and the required
actions are not executed or confirmed there is the risk of process failure.
Confirm that optical and acoustical alarm signals can be recognized by the
operator at any time during the process.
Risk of injury. If installed improperly without consulting this user manual, the
CliniMACS Formulation Unit may lead to injury. The installation of the
CliniMACS Formulation Unit must be performed as described in section 4.4
of this user manual. The Formulation Unit must be installed on a CliniMACS
Prodigy which is placed evenly on a flat and stable surface, which is capable
of supporting at least 120 kg and free of vibrational or other mechanical
forces.
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