Normal use
Instructions for use • VITOMEAGLE • TVA900_EN_V1.0_05-2023_IFU_CE-MDR 7
2 Normal use
2.1 Intended use
3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function
The 3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function is intended for white light and
fluorophore visualization of the surgical field in the visible and near-infrared spectral range during
diagnostic and surgical interventions. The 3D Exoscope with NIR/ICG, 5-ALA and Fluorescein function
does not have body contact.
2.2 Indications
Exoscopes are suitable for visualization during diagnostic and surgical interventions.
2.3 Contraindications
The medical devices are not used in body contact with the patient but generate images which can be
used for visualization during diagnostic and surgical interventions.
Furthermore, the medical devices must not be used for ophthalmologic interventions because
KARLSTORZ light sources are contraindicated in this specialty.
2.4 Clinical benefits
Exoscopes (2D exoscopes and 3D exoscopes) and the support components assist surgical
interventions by providing “heads up” display and ergonomic features to the surgeon, providing high
quality imaging which improve the work efficiency and patient safety. They are non-inferior to the
standard treatments with regards to outcomes and safety for the chosen medical indications.
2.5 Residual risks
No residual risks directly related to the product were identified.
2.6 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant specialist
qualification.
2.7 Patient population
There are no restrictions in terms of patient groups for this product.
2.8 Intended conditions of use
The product may only be used in hospitals and doctors’ offices in suitable ambient conditions, see
chapter Ambient conditions [p.14] and see chapter Electromagnetic compatibility [p.32].
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