It is not permitted to use the remOVE DC Impulse outside of its intended use as
specified above. Using the remOVE DC Impulse for fragmentation of objects other
than the products specified above may lead to defects and damages to the remOVE
DC Impulse, destruction of the remOVE DC Cutter and permanent bonding of
remOVE DC Cutter to the object.
6 Contraindications
The remOVE DC Impulse must not be used if flexible endoscopic procedures
and/or the fragmentation and removal of an OTSC or FTRD clip manufactured by
Ovesco are contraindicated. Fragmentation and removal of a clip are also contra-
indicated as long as the clinical effect of the clip is still required.
7 Complications
The complications listed below are possible when using the product for its intended
purpose.
Damage to the tissue in the digestive tract, particularly:
- Thermal damage to the wall of the respective digestive organ
- Haemorrhages resulting from damage
- Perforations; these may also become apparent after medical intervention
- According to the official definition in the current standard, the following pas-
sage can generally be applied to all medical electrical equipment: “Even the
lowest current presents the risk of triggering ventricular fibrillation” (IEC
60601-1, section 8.7.3, A.14).
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