País: Bielorrusia
Idioma: ruso
Fuente: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Avanos Medical, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Avanos Medical
2022-05-26
INTRODUCER KIT FOR FOR JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE FOR USE WITH: MIC * JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE AND MIC-KEY * LOW-PROFILE JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE Instructions for Use 2 FIG 1 FIG 2 FIG 3 FIG 4 FIG 9 FIG 10 FIG 11 FIG 12 FIG 13 FIG 14 FIG 15 FIG 16 FIG 17 FIG 18 FIG 19 FIG 20A MIC-KEY* J/GJ FIG 20B MIC* J/GJ FIG 21A MIC-KEY* J/GJ FIG 21B MIC* J/GJ FIG 5 FIG 6 FIG 7 FIG 8 SINGLE USE ONLY DO NOT USE IF PACKAGE IS DAMAGED CAUTION RX ONLY DO NOT RESTERILIZE CONSULT INSTRUCTIONS FOR USE STERILIZED USING ETHYLENE OXIDE NOT MADE WITH NATURAL RUBBER LATEX MR CONDITIONAL 3 AVANOS* INTRODUCER KIT FOR JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE FOR USE WITH: MIC * JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE AND MIC-KEY * LOW-PROFILE JEJUNAL/GASTRIC-JEJUNAL FEEDING TUBE INSTRUCTIONS FOR USE Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician. KIT CONTENTS: GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY* T-FASTENERS SCALPEL HEMOSTAT DILATOR INTRODUCER STOMA MEASURING DEVICE SEEKING CATHETER SYRINGE TABLE A MIC*/MIC-KEY* TUBE OUTER DIAMETER RECOMMENDED DILATION 14 Fr 18 FR 16 Fr 20 FR 18 Fr 22 FR INTENDED USE: The AVANOS* Introducer Kit for Jejunal and Gastric-Jejunal Feeding Tube is intended to facilitate primary placement of the AVANOS* MIC* Jejunal and Gastric-Jejunal Feeding Tube and MIC-KEY* Low-Profile Jejunal and Gastric-Jejunal Feeding Tube. CONTRAINDICATIONS: Contraindications include, but are not limited to ascites, colonic interposition, portal hypertension, gastric varices, peritonitis, aspiration pneumonia and morbid obesity (stoma lengths longer than 10 cm). WARNING: VERIFY PACKAGE INTEGRITY PRIOR TO OPENING. DO NOT USE IF PACKAGE IS DAMAGED OR STERILE BARRIER COMPROMISED. DO NOT REUSE, REPROCESS, OR RESTERILIZE THIS MEDICAL DEVICE. REUSE, REPROCESSING, OR RESTERILIZATION MAY 1) ADVERSELY AFFECT THE KNOWN BIOCOMPATIBILITY CHARACTERISTICS OF THE DEVICE, 2) COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE, 3) LEAD TO THE DEVICE NOT PERFORMING AS INTENDED, OR 4 Leer el documento completo