Normal use
Instructions for use • S-PILOT
®
• PYB194_EN_V1.0_02-2021_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
Valves
Valves are used to regulate the volume flow during diagnostic or therapeutic interventions.
Cable
The connecting cable is used for electrical signal transmission.
2.2 Indications
Valves
Valves with corresponding accessories are suitable for all diagnostic and therapeutic
procedures that require controlled fluid removal in order to be performed successfully.
Cable
The connecting cable is used for electrical signal transmission. It does not depend on special
indications.
2.3 Contraindications
Use is contraindicated if, in the opinion of the responsible physician, the device is not
compatible with successful completion of the planned procedure due to its technical design.
The accessories must only be used with the intended devices. In general, medical devices
must not be used on patients who are not part of the defined patient group, or if the operation
itself is contraindicated. The use of pump systems is contraindicated if, in the opinion of the
responsible physician, the surgical method is contraindicated or the patient is not able to
undergo surgery or anesthesia due to his or her general condition. Pump systems (pump +
associated tube set) must not come into direct contact with the central nervous system (CNS)
or the central cardiovascular system.
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.
2.6 Intended conditions of use
The product may only be used in hospitals and doctors’ offices in suitable ambient conditions.
Condition Application
Frequency of use One or more times a day
Length of use Several minutes to several hours a day
Place of installation Positioning on a level, vibration-free surface
Mobility Can be moved if placed on a cart.
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