Hartmann Vivano Tec Pro - Contraindications; Warnings

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IMPORTANT: The VivanoTecPro negative pressure unit may only be used together with components of VivanoSystem by
PAULHARTMANNAG�
1.1 Contraindications
Contraindications for the use of the VivanoSystem:
• Malignant tumour wounds
• Non-enteric/unexplored fistulas
• Untreated osteomyelitis
• Necrotic tissue
NOTE: For more information on a particular contraindication, please refer to the Warnings and Precautions sections of
this document�
1.2 Warnings
Please pay attention to the following warnings related to the use of the VivanoTecPro unit:
Bleeding
NOTE: The VivanoSystem was not developed for the prevention or stopping of bleeding�
IMPORTANT: In the case of blood occurring suddenly or more frequently on the dressing, in the tubes or in the exudate
container switch the negative pressure wound therapy unit off immediately, undertake haemostatic measures and inform
the attending physician�
NOTE: Regardless of using the negative pressure wound therapy, certain medical conditions favor occurrence of bleeding
complications�
The following circumstances increase the risk of possibly fatal bleeding, if not controlled with appropriate care:
• Surgical sutures and/or anastomoses
• Non-sutured haemostatic agents, e�g� spray wound sealant or bone wax
• Trauma
• Irradiation
• Inadequate haemostasis
• Wound infection
• Treatment with anticoagulants or coagulation inhibitors
• Protruding bone fragments or sharp edges
Patients with increased risk of bleeding complications should be monitored with additional level of care, under the
responsibility of the supervising physician�
IMPORTANT: In patients with diagnosed acute bleeding, coagulation disorders or being treated with anticoagulants,
the 800 ml canister should not be used for the exudate collection� Instead, a 300 ml canister should be utilized�
Such practice enables more frequent monitoring of the patient by the health professionals, thereby reducing the
potential risk of excessive blood loss�
IMPORTANT: When using non-sutured haemostatic agents, additional protective measures should be implemented,
to prevent them from accidental displacement� Suitability for negative pressure wound therapy should be assessed by
a supervising physician on an individual basis�
Malignant tumour wounds
Negative pressure wound therapy for malignant tumour wounds is contraindicated, as it is linked to the risk of enhanced
tumour formation by proliferation support effect� However, it is considered as legitimate in a palliative context� For
patients in the end-of-life stage in whom a complete cure is no longer the aim, the improvement of their quality of life
by controlling the three most disabling elements: the odour, exudate, and pain associated with changing the dressings,
outweighs the risk of accelerating the spread of tumours�
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