Normal use
Instructions for use • KARL STORZ OR1 FUSION
®
, Rel. 1.4.2 • JEB924_EN_V1.0_02-2021_IFU_CE-MDR
6
2 Normal use
2.1 Intended use
The OR1 FUSION CONTROL® is designed for use in operation rooms by qualified personnel.
The OR1 FUSION CONTROL® is an appliance (comprising hardware and software) for the
documentation of audiovisual data and patient data during diagnostic and therapeutic
procedures. It allows the operation to be recorded and described for documentation purposes.
The audiovisual data that is recorded and forwarded using the OR1 FUSION CONTROL® is for
examination and information purposes, and not primarily for making diagnoses. The recorded
audiovisual data is not intended to be shown intraoperatively on the operation monitor.
2.2 Indications
Routing of audio, video, and control signals from signal sources to signal destinations in the
case of medical procedures.
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.
2.4 Patient groups
There are no restrictions in terms of patient groups for this product.
The product does not come into direct contact with the patient.
2.5 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
