البلد: روسيا البيضاء
اللغة: الروسية
المصدر: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Avanos Medical, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Avanos Medical
2022-05-26
LOW-PROFILE G-TUBE Instructions for Use MIC-KEY * SF GASTROSTOMY FEEDING TUBE _2_ I 1 2 3 G A E B C D H F J _3_ Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician. KIT CONTENTS: 1 – MIC-KEY* SF Gastrostomy Feeding Tube (Low-Profile G-Tube) (FIG. 2) 1 – MIC-KEY* SF Continuous Feed Extension Set, 2 in. (FIG. 1-J) 1 – MIC-KEY* SF Bolus Feed Extension Set, 2 in. (FIG. 1-F) 1 – 6 ml Luer Slip Syringe 1 – Package Water Soluble Lubricant 4 – 4 in. x 4 in. Gauzes NOT INCLUDED: Stoma Measuring Device (FIG. 3) DESCRIPTION The MIC-KEY* SF G-Tube allows for delivery of enteral nutrition and medication directly into the stomach and/or gastric decompression. INDICATIONS FOR USE The MIC-KEY* SF G-Tube is indicated for use in patients who require long-term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. CONTRAINDICATIONS Contraindications for placement of a low-profile gastrostomy feeding tube include, but are not limited to: • Colonic interposition • Ascites • Portal hypertension • Peritonitis • Uncorrected coagulopathy • Infection around stoma site • Uncertainty as to gastrostomy tract direction and length (abdominal wall thickness) • Lack of adherence of the stomach to the abdominal wall (replacement only) • Lack of established gastrostomy tract (replacement only) • Evidence of infection around stoma site (replacement only) • Presence of multiple stoma fistulous tracts (replacement only) e WARNING 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) CREATE A RISK OF CONTAMINATION AND CAUSE THE TRANSMISSION OF INFECTIOUS DISEASES RESUL اقرأ الوثيقة كاملة