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WARNING!
Sterile media and accessories
Always work exclusively with sterile substances and media, sterile fluids, and
sterile accessories if so indicated.
WARNING!
Reprocessing of sterile disposable products
Reuse of inflow or outflow tube can cause an infection hazard for patients and/or
users as well as impair of product functionality. Contamination and/or impaired
functionality of the system can cause risk of injury, illness, or death. Do not re-pro-
cess or reuse single-use inflow or outflow tube sets.
WARNING!
Contamination
Do not use device and/or accessories if signs of contamination are detected. Make
sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.
WARNING!
Replacement device and accessories
In case the system or any of the accessories fail during a procedure, an alternative
system and replacement accessories should be kept within easy reach to be able to
finish the operation with the replacement components.
WARNING!
Parameters and tolerances exceeded
If the specified parameters and tolerances are exceeded, the system must be re-
turned to Hologic for evaluation.
WARNING!
This product contains phthalates!
The vacuum tube sets for this device contain diethylhexylphthalate (DEHP), which
is classified as toxic to reproduction according to the EU Directive 1272/2008/EEC
on Classification, Labeling and Packaging of Dangerous Substances. DEHP may im-
pair fertility and may cause harm to the unborn child. Therefore, this product must
not be used for unauthorized applications. When applied within the intended use,
the potential risk to pregnant or breastfeeding women as well as to children result-
ing from the DEHP contained in this product is not critical.
WARNING!
Condensation / Water penetration
Protect system from moisture. Do not use if moisture has penetrated the system.
WARNING!
Replace the fuse
Replace the fuse only with a fuse of the same type and rating (see Chapter Tech-
nical Data [} 52]).
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