9
NOTE: For more information related to bleeding in the context of negative pressure wound therapy, please refer to the
Bleeding section of this document�
Disconnection from the VivanoTecPro unit
The decision on how long the patient can be disconnected from the VivanoTecPro unit is a clinical assessment that has to
be made by the attending physician�
The time interval for safe interruption of the therapy is strongly depended on the overall patient and wound status,
as well as the exudate composition and amount of exudate extracted per time unit�
Long interruption might lead to exudate retention and local maceration effects, as well as to a blocked wound dressing
due to coagulation effects within the foam matrix� Lack of the effective barrier between the wound and the non-sterile
environment increases the risk of infection�
IMPORTANT: Do not leave the dressing with the VivanoTecPro unit being switched off for prolonged time periods� In case
of leaving the dressing for a longer time period, it is recommended for a physician to perform an evaluation of the wound
condition along with the overall health status of the patient� According to the physician’s evaluation, either rinsing of the
wound along with a dressing change or switching to an alternative therapy is recommended�
Intermittent pressure mode
Intermittent pressure, as compared to continuous pressure, may be used for enhancing local perfusion and granulation
formation, if tolerable for the patient, the patients’ health and wound condition� However, the continuous therapy is
generally recommended for the treatment of patients with an increased risk of bleeding, acute enteric fistulas, highly
exudating wounds, or when wound bed stabilization is required�
Pressure settings
PRECAUTION: Pressure settings below 50mmHg may potentially lead to exudate retention and decreased therapeutic
efficiency�
PRECAUTION: High pressure settings may increase the risk for micro-trauma, hematoma and bleeding, local hyperfusion,
tissue damage or fistula formation�
Correct pressure setting for the Vivano negative pressure wound therapy must be decided by the supervising physician
and should be based upon the exudate output, overall patient status as well as recommendations from therapeutic
guidelines�
Dressing of the intact skin
Dressing of the intact skin should cover about 5cm around the wound� Prolonged or repeated dressing of bigger areas
might result in tissue irritation�
IMPORTANT: In case of tissue irritation, discontinue the Vivano negative pressure wound therapy� Application of the
wound dressing on intact skin may create wrinkles on the dressing surface� Formation of wrinkles significantly increases
the risk of dressing leakage, and as a consequence occurrence of infection�
IMPORTANT: Special care should be taken when applying the wound dressing to the peri-wound area’s fragile skin�
Dressing of wounds susceptible to irritation
For wounds susceptible to constant irritation (close proximity to limbs), continuous (rather than intermittent) therapy is
indicated�
Circumferential dressings
Circumferential dressings should be used under medical supervision� Lack of adequate protective measures might cause
local hypoperfusion�
Dressings in the vicinity of the vagus nerve
Dressings in the vicinity of the vagus nerve should be used under medical supervision as its stimulation might cause
bradycardia�
IFU_4095080_0302884_190824_EN.indd 9IFU_4095080_0302884_190824_EN.indd 9 19.08.24 12:3119.08.24 12:31
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