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1. Important safety instructions
The VivanoTecPro negative pressure unit is designed in accordance with IEC 60601-1 / EN 60601-1� The negative pressure
unit and the supplied power supply constitute a medical electrical system with Class II protection�
Please note the environmental conditions as stated in the technical data (see chapter Technical data)�
Transportation
The packaging material must be stored in case the unit needs to be transported again� Please observe the applicable
national regulations�
Before usage
Before use, check that the exudate canister and the connection tubing are not damaged�
Before using the unit, the user (physician or a qualified person) must check that the displays and acoustic signals function
correctly�
The user (physician or a qualified person) must have an unimpeded view of, and easy access to the touchscreen�
Positioning of the device
The negative pressure unit must always remain in an upright position during operation�
The negative pressure unit must not be placed on a patient’s bed�
Monitoring
IMPORTANT: The monitoring frequency must be adapted according to the overall health status of the patient and the
treated wound condition, evaluated by the supervising physician�
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 user (physician or a qualified person) must check the functionality of the negative pressure unit regularly� In the
unlikely event of failure of the negative pressure unit, the user (physician or a qualified person) must make provisions to
continue the patient’s therapy by other suitable methods�
Avoid the risk of the tube becoming blocked by regularly checking the tubing system and its connections for leaks and
kinks�
IMPORTANT: No liquid must be allowed to enter the negative pressure unit� If liquid has nevertheless entered the
negative pressure unit, the unit must be checked by customer service�
IMPORTANT: If there are any signs of infection, the attending physician must be notified immediately�
Exudate canister/ Dressing Change
The exudate canister may only be changed by the user (physician or a qualified person) during the therapy�
When changing the dressing, please observe the corresponding instructions for the materials that you use�
Disclaimer
The manufacturer assumes no liability for personal injury or material damage if
• the manufacturer’s original parts have not been used,
• the information contained in these operating instructions has not been observed,
• assembly, resetting, modifications, expansions or repairs have not been carried out by manufacturer-authorised
persons
CAUTION!
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