Kraj: Białoruś
Język: rosyjski
Źródło: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Greatbatch Medical, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Greatbatch Medical
2020-10-22
PTFE PEELABLE INTRODUCER KIT Instructions For Use (en) Mode d’emploi (fr) Gebrauchsanleitung (de) Gebruiksaanwijzing (nl) Instrucciones de uso (es) Istruzioni per l’uso (it) Instruções de Utilização (pt EU) Brugsvejledning (da) Bruksanvisning (sv) Οδηγίες χρήσης (el) Návod k použití (cs) Instruções de uso (pt BR) 使用方法 (ja) Kullanım Talimatları (tr) Инструкции по применению (ru) 使用说明 (zh CN) 사용 지침 (ko) วิ ธี ใช้ (th) 使用說明 (zh TW) Bruksinstruksjoner (no) Használati utasítás (hu) Instrukcja użytkowania (pl) Návod na použitie (sk) 1 2 3 4 5 6 7 8 9 10 1 1 12 13 14 15 16 17 18 19 20 2 1 22 23 1 WARNINGS AND PRECAUTIONS • Product is sterile in unopened, undamaged package. • For single use only. DO NOT REUSE. DO NOT REPROCESS. • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. • Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure. • Federal (USA) law restricts this device to sale by or on the order of a physician. • The introducer shall be used only with components contained in this kit and is intended for use with leads or catheters with the same or smaller diameter than the inner diameter stated on the label. • Do not attempt to re-insert a partially or completely withdrawn needle. • Discard of Medical Device: Safely discard the medical device in accordance with local laws and regulations. INDICATIONS FOR USE Peelable introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system. CONTRAINDICATIONS Use of this introducer is contraindicated if the patient has a known or suspected obstruction in the subclavian vein. There is increased risk of pneumothorax for a patient who has severe chronic lung disease. Poor healing may result in a patient who has had irradiation to Przeczytaj cały dokument