Normal use
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR
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2 Normal use
2.1 Intended use
Exoscopes are used to visualize the surgical field during microsurgical, open and endoscopic
procedures. Exoscopes do not come into contact with the body.
2.2 Indications
Extracorporeal visualization of the operating field during microsurgical, open, and endoscopic
procedures. The VITOM / VITOM 3D system is only used for visualization; it does not change
the surgical method. Use of the VITOM / VITOM 3D system is indicated if visualization or
documentation of the surgical procedure makes sense in the opinion of the responsible
physician.
2.3 Contraindications
VITOM / VITOM 3D systems are not used in contact with the patient's body, they are intended
solely for imaging. Beyond that, there are no contraindications for the use of the VITOM /
VITOM 3D systems directly associated with the product. As KARL STORZ light sources are not
intended for use in ophthalmology, the use of the VITOM / VITOM 3D system is also
contraindicated in this field.
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 population
There are no restrictions in terms of patient groups for this product.
