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Safety and Maintenance DO NOT use an expired probe sheath. Before using probe sheaths, verify whether the term of validity has expired. Probes must be cleaned and disinfected before they are replaced or disposed. 2.5 Biopsy Safety and Maintenance 2.5.1 Biopsy Special Concerns Biopsy needles and biopsy guides are not delivered sterile unless it is clearly labeled! If biopsy-equipment is not sterile it is MANDATORY to clean and disinfect biopsy needles and biopsy guides before the first usage to avoid infections or disease transmissions! If available, please also consult accompanying documents delivered with the biopsyequipment. There may be restrictions on performing IVF, CVS or PUBS. Please consider the local laws and regulations! Caution All biopsy equipment depicted and described in this Basic User Manual has been validated for use with the system and software. Biopsy brackets provided by Civco are only validated with needle guides Ultra Pro II. If biopsy equipment which is not listed in this Basic User Manual is used, the user has the possibility to configure and store the predicted biopsy line. In this case the user has to be aware that the biopsy equipment/probe/system/software combination may not be validated and therefore responsibility for correct configuration and usage lies with the user. Caution When performing a freehand biopsy, i.e. not using a biopsy guide, it is the user's responsibility to use appropriate equipment. Ensure that the needle (especially the needle tip) is always visible in the ultrasound image during the whole biopsy procedure. 2.5.1.1 Preparing the Patient • • Prepare the patient according to the usual procedures for the purpose. An ultrasound examination with this system must be performed either under supervision, or by adequately trained and qualified medical staff. A biopsy must only be performed by physicians with adequate experience. Under all circumstances the necessary safety precautions and sterility measures have to be respected. It is absolutely necessary to ensure that before performing a biopsy, the selected and displayed biopsy line corresponds to the biopsy needle guide mounted to the transducer (left/ right). 2-22 Voluson™ E8/E8 Expert Basic User Manual H48691CF Revision 2
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