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• The VivanoTec / VivanoTec Pro unit has not been
evaluated for use in paediatrics. Before prescribing
its use on a child, the weight and height of the
patient must first be checked.
• The VivanoTec / VivanoTec Pro unit is not
compatible with magnetic resonance imaging
(MRI). The VivanoTec / VivanoTec Pro unit should
therefore not be operated in the vicinity of an
MRI unit.
• The VivanoTec / VivanoTec Pro unit must be
removed from the wound dressing and from the
patient during any hyperbaric oxygen therapy or
defibrillation procedure.
• Circumferential dressings should be performed
under medical supervision. Lack of adequate
protective measures might cause local
hypoperfusion.
• Dressing application in the vicinity of the vagus
nerve should be performed under medical
supervision, as its stimulation might cause
bradycardia.
Intended use
VivanoTec Exudate Canister serves the collection
and safe storage of secretion and serves the
protection from contamination of patient, user
and environment. The filter system of the Exudate
Canister protects the unit from contamination and
filters the air for the flushing.
_IFU_VivanoTec_Exudate_Canister_260718.indd 10
Indications for use
The Vivano System is used in wounds with injured
tissue to support healing by secondary intention.
The Vivano System may be used on intact skin and
wounds healing by primary intention when direct
contact with the underlying structure is prevented by
a suitable wound contact layer.
Treatment with VivanoTec Exudate Canister in
conjunction with the Vivano system is appropriate in
the following types of wounds:
• Chronic wounds
• Acute wounds
• Traumatic wounds
• Dehiscent wounds
• Infected wounds
• Ulcers (e.g. pressure or diabetic ulcers)
• Grafts
• Partial thickness burns
• Surgical incisions (only with a suitable wound
contact layer e.g. Atrauman Silicone)
The VivanoTec Exudate Canister is meant only for use
in humans.
The VivanoTec Exudate Canister may be used in
hospitals, as well as in the homecare environment.
Users
Users are specialist medical personnel. The exudate
canister in combination with the negative pressure
unit may only be used by a physician or by qualified
and authorised personnel acting on the instructions
of a physician. Users must have knowledge and
understanding of the special medical application of
the negative pressure unit.
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26.07.18 15:22
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