Normal use
Instructions for use • CALCUSPLIT handpiece with lithotripsy solid probes •
PQW255_EN_V1.0_03-2021_IFU_CE-MDR
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2 Normal use
2.1 Intended purpose
CALCUSPLIT probe
CALCUSPLIT probes are intended to guide pneumatic pulse energy for lithotripsy to the
calculus. Probes are surgically invasive and meant for short-term use.
Lithotripsy handpiece
Handpieces are intended to convert as well as transmit energy from the main system to the
probe in endoscopic lithotripsy applications. Handpieces do not have body contact.
Tubes
Hoses are used to supply or transport away gases/liquids/suction materials for lithotripsy
applied parts. Tubes are non-invasive and are meant for short-term use.
2.2 Indications
The use of the CALCUSON/CALCUSPLIT system with the corresponding applied parts is
indicated when invasive lithotripsy in urology is indicated in the opinion of the treating
physician.
2.3 Contraindications
The CALCUSON/CALCUSPLIT system with the corresponding applied parts must not be used
for interventions in direct contact with the CNS (central nervous system) and central circulatory
system. Furthermore, there are no contraindications for the use of the CALCUSON/
CALCUSPLIT system directly associated with the product.
2.4 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
2.5 Patient groups
There are no restrictions in terms of patient groups for this product.
