Chattanooga Intelect Focus Shockwave - Safety during treatment of the patient; Warning against damage to equipment and the device

13 610 02 1018
9
General Safety Information
1.1.2 Safety during treatment of the patient
General note:
Organs with gas inclusions, in particular parts of the lung, are NOT allowed to be
exposed to shock waves.
As it passes through tissue, the shock wave’s energy is slightly reduced; this reduction
is signicantly weakened by the bone structure.
Shock waves can give rise to undesirable heart reactions. The patient must be
continuously observed during the treatment.
• While applying focused shockwaves at maximum adjustment, do not use more
than 6.000 subsequent shocks and stick to a consecutive break of 5 minutes.
• Only perform treatments approved by the manufacturer!
The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.
Air bubbles reduce the effectiveness of shock waves. Therefore, air bubbles must
always be removed from the shock wave path.
1.2 Warning against damage to equipment and
the device
Any damage to the device resulting from incorrect operation is not covered by the
manufacturer’s warranty.
Electromagnetic compatibility
This device complies with the requirements of the applicable standard on
electromagnetic compatibility.
Nevertheless, portable and mobile HF communications equipment (e.g. mobile
phones) can interfere with medical electrical equipment.
This device is subjected to special precautions regarding EMC and needs to be
installed according the EMC guidelines in chapter 9.4 cOnfOrMity with standards.
The use of accessories or cables that are not authorised by the manufacturer can
result in increased interference emissions or reduced resistance to interference
emissions by the device.
The Chattanooga Intelect F-SW is not allowed to be positioned immediately next
to or jointly with other devices. If the operation near or jointly with other devices is
required, the Chattanooga Intelect F-SW must be tested in that particular environment
to ensure operation according to technical specication.
If the Chattanooga Intelect F-SW is connected to a 240 V mains supply with a mains
frequency of 60 Hz, the mains supply must be balanced
The system must only be connected to properly earthed and correctly installed
shockproof sockets!