SONOPET

Insufflator

PNEUMO SURE Model F114 High Flow Insufflator Instructions for Use Rev H Oct 2014

Instructions for Use

410 Pages

Table of contents 1  Important User Notes ... 3  2  Safety Information... 4 2.1 Hazards... 5  3  Device Purpose... 7 3.1 Laparoscopy Applications ... 7 3.1.1 Using High Flow Operating Mode ... 7 3.1.2 Using Pediatric Operating Mode... 7 3.1.3 Using Bariatric Operating Mode ... 8 3.1.4 Contraindications for Laparoscopy Applications... 8 3.2 Using Vessel Harvest Operating Mode... 8 3.3 General Device-Inherent Dangers ... 8 3.3.1 Device-Inherent Dangers - Laparoscopy ... 10 3.3.2 Device-Inherent Dangers - Vessel Harvesting... 12  4  Initial Device Startup ... 14 4.1 Gas connection ... 14 4.1.1 Connecting a Gas Bottle... 15 4.1.2 Connecting to Central Gas Supply... 15  5  Operating the Device - General ... 16 5.1 Front of the Device... 16 5.2 Rear of the Device ... 16 5.3 Touch screen display... 17 5.4 Switch on Device ... 18 5.5 Connecting Insufflation Tube Set ... 19 5.6 Using the Gas Heating... 20 5.6.1 Using the direct pressure measurement function (Real-Time Pressure Sensing RTP)... 21 5.6.2 Displaying/Selecting Insufflation Operating Mode ... 23 5.6.3 Setting the Nominal Pressure - General ... 23 5.6.4 Setting the Nominal Flow - General ... 23 5.6.5 Gas Consumption Display... 24 5.6.6 Starting/Stopping Insufflation... 24 5.6.7 Using the SIDNE Port (Optional) ... 25 5.6.8 Turning Device Off ... 25  6  Using and Controlling the PNEUMO SURE High Flow Insufflator in High Flow Mode ... 26 6.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in High Flow Operating Mode ... 26 6.2 Selecting High Flow Insufflation Mode... 28 6.3 Presetting Nominal Pressure in High Flow Operating Mode... 28 6.4 Presetting Nominal Flow in High Flow Operating Mode... 28 6.5 Performing the Function Test in High Flow Operating Mode... 29 6.5.1 Filling Tube System with CO2 ... 31 6.6 Using the Device during Surgery ... 31 6.6.1 Insufflating with Veress Cannula... 31 6.6.2 Insufflating with the Trocar... 32 6.6.3 "Real-Time Pressure Sensing" functionality (RTP) ... 32 6.6.4 Stop the Insufflation... 33  7  Using and Controlling the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode ... 34 7.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Pediatric Operating Mode ... 34 7.2 Selecting Pediatric Operating Mode ... 36 7.3 Presetting Nominal Pressure in Pediatric Operating Mode ... 36 7.4 Presetting Nominal Flow in Pediatric Operating Mode ... 37 7.5 Performing the Function Test in Pediatric Operating Mode before Using the Device during Surgery... 38 7.5.1 Filling Tube System with CO2 ... 40 7.6 Using the Device during Surgery ... 40 7.6.1 Insufflating with Veress Cannula... 40 7.6.2 Insufflating with the Trocar... 41 7.6.3 "Real-Time Pressure Sensing" functionality (RTP) ... 41 7.6.4 Stop the Insufflation... 42  8  Using and Controlling the PNEUMO SURE XL High Flow Insufflator in Bariatric Operating Mode... 43 8.1 Device-Specific Dangers when Using the PNEUMO SURE High Flow Insufflator in Bariatric Operating Mode ... 43 8.2 Selecting Bariatric Operating Mode... 45 8.3 Presetting Nominal Pressure in Bariatric Operating Mode... 46 8.4 Presetting Nominal Flow in Bariatric Operating Mode... 46 8.5 Performing the Function Test in Bariatric Operating Mode before Using the Device during Surgery ... 47 8.5.1 Filling Tube System with CO2 ... 48 8.6 Using the Device during Surgery ... 49 8.6.1 Insufflating with Veress Cannula... 49 8.6.2 Insufflating with the Trocar... 49  EN
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