MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 31 OF 38
4.2 GENERAL SAFETY PRECAUTIONS
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Before turning on the device for the first time, read this manual carefully.
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The device may only be used under the supervision of the physician prescribed the treatment.
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All personnel must be properly trained before using the device. This training should include the servicing technique,
maintenance, verification of proper functioning and safety precautions associated with using the device.
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Shockwave therapy requires direct bodily contact, therefore do not use it on damaged skin!
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Do not apply shockwave therapy: To areas of the body with gas-containing organs, close to large nerve bundles
or blood vessels, on the spinal cord or on the head!
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We do not recommend applying shockwave to the body parts under local anaesthesia.
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The device does not use any drugs, creams, gels or other substances which are an integral part or which are applied by
its use.
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The device is equipped with a protection system that prevents the connection of accessories other than those supplied by
the manufacturer. Consequently it will not operate with equipment from other manufacturers.
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Only the power supply adapter approved and supplied by the manufacturer, complying with the specifications listed in
Chapter Technical Parameters, may be connected to the device.
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The product complies with Class A emissions according to CISPR11, IEC 60601-1-2.
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Portable and mobile high-frequency communication devices (such as mobile phones) may affect the function of the device.
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The electrical cables which are to be connected to the device must be installed and tested according to the existing valid
standards (IEC 364). If it is not known whether cables are safe and/or correct, then they should be checked and/or
upgrade by an inspection engineer.
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Check whether the parameters of the main power supply correspond to the requirements of the device according to
Technical Parameters section
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The device requires the environmental conditions that are stated in the Technical Parameters section. It must not be used
in an environment where there is a danger of explosion or of water penetrating the device. The device cannot be in
connection with flammable anaesthetics or oxidizing gasses (O2, N2O, etc.).
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Do not place the device in direct sunlight or near strong electromagnetic fields to prevent mutual functionality influence. If
this happens, move the device further away from the source of interference or contact an authorized BTL service
department.
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Inspect the device thoroughly before each use. Look for loose cables, cracked cable insulation, cracks in the shockwave
applicator’s housing and functional behavioural differences in the display or the operating elements. If any anomalies or
inconsistencies are found, stop using the device and contact an authorized BTL service department. If the behaviour of
the device shows any divergences from the functionality procedures described in this user’s manual, stop using the device
and contact an authorized BTL service department.
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If the device shows any defects or if there are any doubts concerning its correct and safe functioning, terminate therapy
immediately. If the source of the concern can be determine after a thorough study of the user's manual, then contact an
authorized BTL service department immediately. If the device is not used in accordance with this manual or if it is used
when the device exhibits functional differences from those stated in this manual, then BTL is not responsible for any
damage to or caused by the device.
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Do not try to open, remove protective covers, or dismantle the device for any reason. There is a danger of electrical shock
and/or serious injury. Even the replacement of the lithium battery and the air micro-filter must be done an authorized BTL
service department only!
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All material and parts which come into direct contact with the client's body (such as cleaning agents, the applicators,
electrodes) must respectively comply with the standards related to irritants, allergens, toxins, geotaxis and carcinogens
(ISO 10993-1, ISO 10993-3, ISO 10993 5). The user is responsible for all these materials and parts if they were not
supplied by an authorized BTL equipment supplier.
