Storz 26003AA - Normal Use; Indications; Contraindications; Target User Populations

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Normal use

Instructions for use • Telescopes in laparoscopy • 513BNP_EN_V2.0_09-2023_IFU_FDA 7

2 Normal use

2.1 Indications

For telescopes with diameter ranging from 3 mm-5 mm (26004BA, 26009BA, 26007AA, 26007BA,

26011AA, 26011BA, 26046AA, 26046BA, 26046FA)

The KARLSTORZ HOPKINS Telescopes are intended to provide visualization during laparoscopy,

thoracoscopy, and general surgery in adults and pediatrics.

For telescopes with diameter ranging from 5.5 mm-11 mm (26031BA, 26038AA, 26048FSA,

26003AEA, 26075AA, 26003BEA, 26003FEA, 26034AA, 26048BSA, 26003FA, 26048ASA, 26003BA,

26003AA)

The KARLSTORZ HOPKINS Telescopes are intended to provide visualization during laparoscopy,

thoracoscopy, and general surgery in adults.

2.2 Contraindications

The use of telescopes 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. Telescopes must not be used for procedures in direct contact with the central

nervous system (CNS) and central cardiovascular system.

2.3 Target user populations

The medical device may only be used by doctors and medical assistants with a relevant specialist

qualification.

2.4 Patient groups

For telescopes with diameter ranging from 3 mm-5 mm (26004BA, 26009BA, 26007AA, 26007BA,

26011AA, 26011BA, 26046AA, 26046BA, 26046FA)

These products are intended for the following patient groups:

Patient group Description

Neonates From birth to 1 month of age

Infants >1 month to less than 2 years

Children 2 years to less than 12 years

Adolescents 12 years through 21 (up to but not including the 22nd birthday)