Hartmann Vivano Tec Pro - Incident Reporting; Manufacturer;Sales; Introduction; Notes on the Operating Instructions

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Allergies
Application of the Vivano negative pressure wound therapy is not recommended if the patient is allergic to any
component of the VivanoSystem�
Thermal risks
To reduce the risk of overheating, the power supply should not be covered and should be used in a location where air is
free to circulate�
Electromagnetic fields
The VivanoTecPro negative pressure unit must not be used in the presence of strong magnetic fields (such as an induction
stove) and must not be used near the application of HF surgical equipment�
Electromagnetic fields might essentially alter performance, pressure may be different to that set or the unit may behave
erratically or stop operating�
IMPORTANT: In case of unexpected operation or events, please contact the manufacturer�
Small parts
Do not inhale or swallow small parts�
Outer casing composition
VivanoTecPro casing parts contain PFBS salt (Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate)�
Auxiliary battery composition
The VivanoTec Pro auxiliary battery contains EGDME (1,2-dimethoxyethane, ethylene glycol dimethyl ether)�
Special notes
Keep out of the reach of children�
1.5 Incident reporting
For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation
(EU) 2017/745 on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and/or its authorised representative and to your national authority�
2. Manufacturer/Sales
Further information, accessories, consumables and spare parts are available from:
PAULHARTMANNAG
Paul-Hartmann-Straße 12
89522 Heidenheim, Germany
www�vivanosystem�info
3. Introduction
3.1 Notes on the operating instructions
These operating instructions contain important information on safe, correct and effective operation of the VivanoTecPro
negative pressure unit� The operating instructions must be completely read and followed� The instructions for use serve
the purpose of teaching the user about the operation and as a reference book� Reprinting, even of excerpts, is permitted
only with the written consent of PAULHARTMANNAG�
The operating instructions must always be kept in the vicinity of the device� Cleaning, care and inspection as well as
correct operation ensure the operational safety and capability of the VivanoTecPro negative pressure unit and are
indispensable� Repairs, recurrent tests and replacement of the rechargeable battery may only be carried out by specialist
personnel authorised by PAULHARTMANNAG�
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