Hartmann Vivano Tec Pro - Intended Use

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3.2 Intended use
The negative pressure unit is used to create and control a sub-atmospheric (negative) pressure at the site of an acute or
chronic wound in a human patient during negative pressure wound therapy (NPWT)�
Specification of the main function
The controlled negative pressure established by the system drains wound exudate and skin fragments away from the
surroundings of the wound and into a wound dressing and an associated tube system for collection in a designated
exudate canister
1
� In addition, the negative pressure stimulates cell growth
2
and blood circulation in the wound
3, 4
�
VivanoTecPro is only intended for use in conjunction with the VivanoSystem by PAULHARTMANNAG�
NOTE: To establish a functional negative pressure wound therapy dressing, at least the following further components are
required:
• VivanoMedFoam
• Hydrofilm transparent film dressing
• VivanoTecPort
• VivanoTecExudateCanister
IMPORTANT: The negative pressure unit must not be used for non-medical applications�
The VivanoSystem is meant only for use in humans� No general restrictions for the usage of the VivanoSystem in different
patient populations (e�g� adults and/or children) are given� However, the VivanoSystem has not been evaluated for use in
paediatrics�
VivanoTecPro may be used in hospital, residential care and home-care settings�
IMPORTANT: Please observe the environmental conditions as stated in the technical data (see chapter Technical data)�
The system has not been evaluated for use for emergency medicine in rescue operations (rescue vehicles, sites of
accidents)�
IMPORTANT: VivanoTecPro is not suitable for use in certain special environments (e�g�, presence of strong
electromagnetic fields, high frequency surgical equipment or flammable liquids or gases, hyperbaric oxygen chambers,
military areas,���)� (See chapter Special precautions)�
IMPORTANT: The VivanoSystem may only be used by a physician or a qualified person, as per law of your country,
in accordance with physician’s instructions�
Some activities can be transferred to the patient at the discretion of the attending physician by training� Activities which
may only be carried out by a physician or a qualified person are specifically marked in these operating instructions�
All other activities can be safely performed by the patient if trained by the attending physician�
NOTE: For patients, there is some important information regarding events that can occur during the therapy and which
should be observed (see chapter Additional information for patients)�
1
Lalezari S, Lee CJ, Borovikova AA, Banyard DA, Paydar KZ, Wirth GA, Widgerow AD� (2016) Deconstructing negative pressure wound therapy�
Int Wound J� doi:10�1111/iwj�12658
2
McNulty AK, Schmidt M, Feeley T, Kieswetter K� (2007) Effects of negative pressure wound therapy on fibroblast viability, chemotactic signaling, and proliferation in a provisional
wound (fibrin) matrix� Wound Repair Regen� 15:838-46�
3
Chen SZ, Li J, Li XY, Xu LS� (2005) Effects of vacuum-assisted closure on wound microcirculation: an experimental study� Asian J Surg� 28:211-7�
4
Wackenfors A, Sjögren J, Gustafsson R, Algotsson L, Ingemansson R, Malmsjö M� (2004) Effects of vacuum-assisted closure therapy on inguinal wound edge microvascular blood
flow� Wound Repair Regen� 12:600-6�
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