Land: Hviderusland
Sprog: russisk
Kilde: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
CooperSurgical Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
CooperSurgical Inc.
2020-11-11
SKW RETRACTOR SYSTEM INSTRUCTIONS FOR USE (ENGLISH) NOTICE D’UTILISATION (FRANÇAIS/FRENCH) GEBRAUCHSANWEISUNG (DEUTSCH/GERMAN) ISTRUZIONI PER L’USO (ITALIANO/ITALIAN) INSTRUCCIONES DE USO (ESPAÑOL/SPANISH) INSTRUÇÕES DE UTILIZAÇÃO (PORTUGUÊS/PORTUGUESE) ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ ( РУССКИЙ, RUSSIAN) WC 92515072 - Attachment 3 SKW DFU Page 1 of 24 2 SKW RETRACTOR SYSTEM • INSTRUCTIONS FOR USE • ENGLISH DEVICE DESCRIPTION/INTENDED USE The SKW Retractor System is a single-use, disposable device that is used to retract tissue from the surgical site. It is designed for use with an inflatable penile prosthesis (penoscrotal approach), or an artificial urinary sphincter (transverse scrotal approach). SKW RETRACTOR SYSTEM COMPONENTS • 1 Retractor Ring • 1 Penile Strap • 2 Baby Deavers • 1 Catheter Clip • Set of Hooks: - 7 Yellow, 12-mm Blunt Stay Hooks (3 Extra) - 1 Green, 5-mm Sharp Stay Hook - 2 Spira Three-Finger Hooks INDICATIONS FOR USE The SKW Retractor System is indicated for use to provide incision retraction and to aid in visualization during surgical procedures. CONTRAINDICATIONS There are no known contraindications associated with the use of this device. WARNINGS • Do not use if sterile barrier is damaged. • Do not use if the device has been opened or damaged. • For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or re-sterilization may create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. • Dispose of in accordance with all applicable Federal, State and local Medical Hazardous waste practices. R X ONLY WC 92490333 - Læs hele dokumentet