3M Emphaze AEX BV60R Sicherheitshinweise Seite 3

English Instructions Are the Original Instructions. All Other Languages Are Translations of
EN
the Original Instructions.
Failure to follow installation, operation, and maintenance instructions may result in system failure
and will void warranty.
Safety Information
Read, understand, and follow all safety information contained in these instructions prior
to installation and use of the 3M™ Emphaze™ AEX Hybrid Purifi er Scale-Up Capsules.
Retain these instructions for future reference.
Intended Use:
Single use processing of aqueous based biological pharmaceuticals (drugs) and vaccines strictly
following the product operating instructions and cGMP requirements, where applicable. Customers
must determine whether the 3M product is suitable for a specifi c application based on a risk
assessment that considers the product leachable characteristics and its impact on drug safety.
Prohibited Use:
Do not use as a component in a medical device that is regulated by any agency, and/or globally
exemplary agencies, including but not limited to: a) FDA, b) European Medical Device Directive
(MDD), c) Japan Pharmaceuticals and Medical Devices Agency (PMDA). Do not use in applications
involving permanent implantation into the body, life-sustaining medical applications, applications
requiring Food Contact compliance.
WARNING: Indicates a hazardous situation which, if not avoided, could result in serious
injury or death.
CAUTION: Indicates a hazardous situation which, if not avoided, could result in minor or
moderate injury and/or property damage.
NOTICE: Indicates a situation which, if not avoided, could result in property damage.
WARNING: Explosion hazard
Single use
Wear PPE
30°C
Storage conditions
0°C
Explanation of Signal Word Consequences
Explanation of Safety and Related Symbols
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