Miltenyi Biotec CliniMACS Formulation Unit User Manual page 14

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Hazards to users, instrument damage, and/or malfunction, unpredictable
results, premature wear and tear, and/or reduced life time of the
instrument if the following safety information, warnings, precautions,
and instructions are not observed at all times when using the instrument.
Observe the following safety information, warnings, precautions, and
instructions at all times when using the instrument.
• Always operate, handle, use, and maintain the CliniMACS Formulation Unit in
accordance with the safety information, warnings, precautions, instructions
and recommended procedures provided in the CliniMACS Formulation Unit
User Manuals and other written instructions issued by Miltenyi Biotec. Do
not deviate from these operating instructions and procedures.
• Always ensure that the CliniMACS Formulation Unit is operated, handled,
used, and maintained only by appropriately skilled and professional
personnel familiar with the construction, operation, and hazards involved
with the instrument. The instrument is intended for the use in the
professional facility healthcare environment. The instrument is not intended
to be used near active HF surgical equipment. The customer or user should
assure that it is used in such an environment.
• Always operate, handle, use, and maintain the CliniMACS Formulation Unit in
compliance with all applicable laws, rules, regulations and administrative
provisions, including, without limitation, all regulations regarding health and
safety at work and, as appropriate, the safety of devices, as applicable at the
location where the CliniMACS Formulation Unit is operated.
• Always use the CliniMACS Formulation Unit for its intended purpose only (in
accordance with the product documentation and within its performance
limits), and not in any other manner or for any other purpose.
• Never use the CliniMACS Formulation Unit with consumables, parts, or
accessories other than those approved by Miltenyi Biotec, to ensure safe and
proper operation of the instrument. Note: The use of consumables, parts, or
accessories not expressly approved by Miltenyi Biotec could void your
warranty and/or invalidate your authority to operate this instrument under
applicable regulations.