Storz 11301D4 - 2 Normal Use; Intended Use; Indications; Contraindications

Normal use
Instructions for use • LED battery light source with fast screw thread • KCC914_EN_V1.0_11-2020_IFU_CE-
MDR
5
2 Normal use
2.1 Intended use
Battery light sources are mobile light sources and are used for generating and transmitting light
to KARL STORZ endoscopes in ENT medicine. Battery light sources are non-invasive and are
designed for transient use in invasive procedures through a body orifice
2.2 Indications
The use of the instrument set is indicated if it is indicated in the opinion of the attending
physician.
This includes, amongst other things:
– Rhinology, rhinoplasty
– Sinus surgery and transnasal access for skull base surgery
– Ear diagnostics and ear surgery
– Adenotomy, tonsillectomy, tracheotomy
– Laryngoscopy, endolaryngeal microlarynx and transoral microsurgery
– Esophagoscopy, diverticuloscopy
2.3 Contraindications
The use of the basic instrument set 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. The basic instrument set must not be used
for procedures in direct contact with the central nervous system (CNS) and 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.