Hartmann Vivano Tec Pro - Electrical Safety; General Precautions

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potential contact of intestinal content with the wound, enteric fistula needs to be surgically separated, following local
guidelines or established surgical practices�
Spinal cord injuries with the development of autonomic hyperreflexia
Discontinue the negative pressure wound therapy if the patient has spinal cord injuries with the development of
autonomic hyperreflexia�
Magnetic Resonance Imaging
This device is not considered as MRI safe and must not be used in close proximity to an MRI unit�
Defibrillation
The VivanoTecPro unit must be disconnected if resuscitation of the patient using a defibrillator is necessary�
Hyperbaric oxygen therapy (HBO)
The VivanoTecPro unit must be disconnected for patients undergoing hyperbaric oxygen therapy, as its use is considered
a potential fire hazard�
External heat sources
Keep the negative pressure unit away from sources of heat and flames�
Electrical safety
Before connecting the device, check that the mains voltage and mains frequency indicated on the device correspond to
the values for the supply network� The connecting cable and the accessories must be checked for damage before use of
the negative pressure unit�
IMPORTANT: Damaged cables must be replaced immediately�
NOTE: Only medical and undamaged mains connections must be used� Multiple socket outlets or extension cables may
not be used�
IMPORTANT: The patient must not take a bath or shower while the VivanoTecPro negative pressure unit is in place�
The therapy should be interrupted for this purpose only after consultation with the attending physician�
IMPORTANT: Never touch the mains plug or the power supply with wet hands and never touch the power supply cable or
the DC input and the patient at the same time�
IMPORTANT: No alterations may be made to the unit or the supplied power supply�
Flammable or explosive gases and/or liquids
The negative pressure unit must not be used in the presence of readily flammable or explosive gases and/or liquids�
IMPORTANT: The negative pressure unit is not designed for use within areas at risk of explosion and oxygen-enriched
areas� Areas at risk of explosion can occur through the use of flammable anaesthetic agents, (or mixtures with air, oxygen
or nitrous oxide), skin cleansers and skin disinfectants�
1.4 General precautions
Please pay attention to the following precautions:
Damaged, expired or contaminated product
Do not use any component of the VivanoSystem in case of damage, expiration or any suspicion of contamination� It may
cause overall decline in the therapeutic efficiency, wound contamination and/or infection�
Single use only
All disposable components of the VivanoSystem are meant for single use only� Reusing a single-use medical device is
dangerous� Reprocessing devices, in order to reuse them, may seriously damage their integrity and their performance�
Information available on request�
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