Chattanooga Intelect Focus Shockwave - Essential performance

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TechnicalSpecications
Essential performance:
Equipment safety (“essential performance“) according to IEC/EN 60601-1, 3rd edition:
– The ME Equipment shall be free from incorrect display of energy levels.
– The ME Equipment shall be free from unintended shock wave release.
NOTE
When the medical product is distributed to third parties, the following must
be observed:
– The complete device documentation must be delivered together with the
medical product.
– The medical product may only be exported to a foreign country when the
medical product and the corresponding indications are allowed there.