Basic Safety Instructions - Attention - Asskea proVisio M28 Gebrauchsanweisung

2.6 Basic safety instructions – ATTENTION!
Risk of damage due to improper power supply
Improper operation causes overvoltage in the device that may be transmitted to the operator.
• Ensure prior to startup that the mains supply for connecting the ASSKEA proVisio
secretion aspirator is suitable at 100 V to 240 V AC and a mains frequency of 50-60 Hz.
• Ensure prior to startup in UL listed markets such as the USA and Canada that the mains
supply is designed for a supply voltage of 120 V AC.
• Use only the supplied power supply unit with the ASSKEA proVisio
aspirator (see section 8).
Risk of application under non-approved conditions
• The device is intended for mobile, temporary outdoor use (according to IP protection class
22), but not for permanent outdoor use and operation outdoors.
Health risks due to handling of infectious or pathogenic germs
Infectious and pathogenic germs in the aspirate pose health risks.
• Never operate the device without a bacterial filter.
• While carrying out cleaning / disinfection, make sure that the bacteria filter does not get
wet.
• Always perform the aspiration using a sterile disposable catheter.
• The suction tube must never come into direct contact with the aspiration site.
• Follow the hygiene, cleaning and decontamination instructions (section 5 Maintenance).
Risk of strangulation
• People may strangle themselves on the tubing or the mains cable, especially if tubes or
cables are unduly long.
• Ensure that no unauthorized / uninvolved persons are near the device during aspiration.
• Store the device incl. accessories in the shipping carton until the next use.
Risk of damage due to electromagnetic phenomena
Medical electrical devices are subject to special precautionary measures regarding
electromagnetic compatibility (see section 9).
Hazard to persons due to improper handling
• Use the device only for its intended purpose.
• Never use the device for aspiration in the low vacuum range (e.g., thoracic drainage).
• If aspiration procedures are carried out too often, slight bleeding and pain may occur.
• When using the power supply unit, ensure that it is first connected to the aspirator and then
to the mains supply (100 V to 240 V AC).
• Disconnect the power supply unit from the mains supply in exactly the opposite sequence
(first remove the power supply unit from the mains supply (100 V to 240 V AC) and then
remove it from the aspirator).
• Never touch parts of other devices than ME devices in the patient environment and the
patient simultaneously.
Safety defects due to improper accessories and spare parts
The use of accessories and spare parts, detachable parts, or materials that are not
recommended by ASSKEA GmbH and specified in the instructions for use may compromise the
safety and function of the device. Any warranty is excluded for damage caused by using
accessories and spare parts not recommended or by improper use.
• Use only original accessories and spare parts. (see section 10)
Warning of safety defects due to improper connections to the ME system
The connection of the ME system with other devices, fixtures, or pieces of equipment not
recommended by ASSKEA GmbH and not specified in the instructions for use may compromise
the safety and function of the ME system. Any warranty is excluded for damage caused by
connecting devices, fixtures, or pieces of equipment not recommended with the ASSKEA
proVisio ® M28 secretion aspirator or by improper use.
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