Important Safety Instructions; Contraindications; Special Precautions - Hartmann Vivano Tec Mode D'emploi

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Caution!

Important safety instructions

• Before use, check that the exudate canister and
the connection tubing are not damaged.
• The exudate canister is sterile and can be used in
the sterile operating environment.
• The exudate canister may only be changed by
specialist medical personnel during the therapy.
• Components marked with
In the event of reuse, these components lose their
function resulting in a high risk of infection.
• In order to guarantee undisrupted operation of
the negative pressure unit, the filling level of the
exudate canister should be regularly checked.
Once the maximum filling level has been reached,
it should be replaced with a fresh exudate canister.
• Avoid the risk of the tube becoming displaced or
blocked by regularly checking the tubing system
and its connections for leaks and kinks.
• The VivanoTec Exudate Canisters are only intended
for use in conjunction with the Vivano System by
PAUL HARTMANN AG or the ATMOS S042 NPWT
negative pressure wound therapy system.
• Regularly monitor the patient, the unit and the
wound dressing. Watch out for wound exudate,
maceration, infection and loss of vacuum. In order
to ensure a safe therapy, it is necessary to check
the wound dressing frequently. In doing so, be sure
to check the wound dressing for imperviousness,
and also for negative pressure, check the wound
edges for maceration and check the wound edges
and the exudate for signs of infection. In the event
of signs of an infection, the attending physician
must be informed immediately.
• The exudate canister has to be changed after each
patient, but after one week at the latest.
• The negative pressure unit incl. exudate canister
must always remain in an upright position during
operation.
• The negative pressure unit incl. exudate canister
must not be placed on a patient's bed.
_IFU_VivanoTec_Exudate_Canister_260718.indd 9

Contraindications

Contraindications for the use of the Vivano System:
• Malignant tumor wounds
• Non-enteric / unexplored fistulas
• Untreated osteomyelitis
• Necrotic tissue
IMPORTANT: The Vivano System must not be applied
directly over exposed nerves, anastomosis points,
blood vessels or organs.
must not be reused.

Special precautions

• Special precautionary measures are indicated in
• Blood vessels and organs must be adequately
• Bone fragments or sharp edges can damage
• Wounds with intestinal fistulas may only be treated
• In the case of movable parts of the body, which
• If the patient has spinal cord injuries, with the
• The VivanoTec / VivanoTec Pro unit must not be
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patients with acute bleeding, coagulation disorders
and patients being treated with anticoagulants.
The 800 ml exudate canister should not be used in
these cases. In the event of sudden or intensified
bleeding, the therapy must be discontinued
immediately. In such cases, the attending physician
must be informed and appropriate haemostatic
measures taken.
protected by means of overlying fascias, tissues
or other types of protective layers placed above
them. Special precautionary measures must be
undertaken in the case of infected, weakened,
irradiated or sutured blood vessels or organs.
vessels or organs and must therefore be covered
or removed before the application of negative
pressure therapy.
with the Vivano System in the presence of special
precautionary measures.
cannot be kept still, continuous (rather than
intermittent) therapy is indicated in order to
minimise irritations.
development of autonomic hyperreflexia, the
therapy must be discontinued.
used in the presence of strong magnetic fields
(such as an induction stove) and not used near
application of HF surgical equipment.
EN
26.07.18 15:22

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