idrive Ultra Powered Stapling System Product Information Kit Stapling Made Smarter
Table of Contents Product Introduction 2 System Introduction 3 Features and Benefits 4 System Components 5 Tri-Staple Technology Overview Technical Data 6 510(k) Clearance 8 Indications for Use 9 Instructions for Use 14 Cleaning and Decontamination 15 Sterile Processing 15 Testing Highlights 16 Competitive Comparison 2. Product under development. Not available for sale in all regions.
The idrive Ultra powered stapling system provides surgeons with an unprecedented level of precision, enabling them to position and keep the stapler exactly where they intend completely one-handed and at a push of a button. 2
Features and Benefits Unprecedented Precision Unlimited points of articulation within 45-degree left and right range 61% reduction in reload tip motion during firing 1 Fine control of reload jaw opening and closure Microprocessor controlled firing speed; reduces variability in application Fully-Powered Design True one-handed operation Intuitive, finger-tip control Fully-powered articulation, rotation clamp, fire and open Universal and Reusable Endo GIA reloads with Tri-Staple technology Curved Tip, Black, and Radial reloads 30 mm, 45 mm, 60 mm reloads Waste stream and inventory space reductions 1. Average 61% reduction in reload tip travel during firing when compared to Ethicon Endo-Surgery Echelon Flex * in indicated media, n=10 surgeons, 172 total trials, p<.0005 (Report on file with Covidien) * Trademark of its respective owner. 3
System Components Reorder Code Description Photo IDRVULTRA1 idrive Ultra Powered Handle EGIAADAPT Endo GIA Adapter INTB100 idrive Battery Pack IDRVBIG idrive Battery Insertion Guide idrive Battery Charger and Power Supply INTBIC1 INTBIC1EU INTBIC1IT INTBIC1JA INTBIC1SW INTBIC1UK United States Continental Europe Italy Japan Switzerland United Kingdom IDRVTRAY 2 idrive Sterilization Tray IDRVRET 2 idrive Manual Adapter Tool 4 2. Product under development. Not available for sale in all regions.
Tri-Staple Technology Overview Preserving tissue integrity is the ultimate premise behind the advanced Tri-Staple TM technology design. Tri-Staple TM technology reloads are designed to work in harmony with the natural properties of tissue to optimize performance before, during and after stapling. Vascular/Medium Tissue Reload* 2.5 mm 2.0 mm Stepped cartridge face 3.5 mm 3.0 mm 4.0 mm Medium/Thick Tissue Reload* 3.0 mm Stepped cartridge face 5.0 mm Extra-Thick Tissue Reload* 4.5 mm 4.0 mm Stepped cartridge face Universal Platform idrive TM Ultra Stapling System One Handle Fits All Reloads Endo GIA Black Reload with Tri-Staple Technology Endo GIA Radial Reload with Tri-Staple Technology Endo GIA Curved Tip Reload with Tri-Staple Technology Endo GIA Purple Reload with Tri-Staple Technology Endo GIA Gray Reload Endo GIA Tan Reload with Tri-Staple Technology Suddenly Thick, Hard-To-Reach, High-Risk, and Low-Visibility Tissue Won't Seem Like Such a Challenge 5
510(k) Clearance 6
510(k) Clearance 7
Indications for Use 8
Instructions for Use 9
Instructions for Use 10
Instructions for Use 11
Instructions for Use 12
Instructions for Use 130 F 54 C 86 F 30 C Do not use if package is opened or damaged Caution, consult accompanying documents Upper temperature limit 2012 Covidien. Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA. Covidien Ireland Limited, IDA Business & Technology Park, Tullamore. www.covidien.com COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally registered trademarks of Covidien AG. 2012/07-3 59 F 15 C Store at room temperature 0123 13
Cleaning and Decontamination Manual 1. Wipe down the components with a lint-free cloth soaked in a ph-neutral detergent solution. 2. Scrub all exposed surfaces with a soft brush to remove surgical debris, as required. 3. Immerse the components in a warm enzymatic bath diluted per the manufacturer s specifications and soak for ten minutes. Automatic 1. Wipe down the components with a lint-free cloth soaked in a ph-neutral detergent solution. 2. Scrub all exposed surfaces with a soft brush to remove surgical debris, as required. 3. Rinse under warm running tap water for a minimum of one minute. 4. Inspect the components for cleanliness. 5. Manually agitate the devices in the enzymatic bath for a minimum of one minute. 6. Rinse under warm running tap water for a minimum of one minute. 7. Perform a final rinse under purified water for a minimum of one minute. 8. Dry with a clean, soft, lint-free cloth. The recommended automatic cleaning cycle is as follows: Treatment Time (MM:SS) Temperature Chemical Pre-Wash 00:45 Cold Tap Water N/A Enzyme Wash 04:00 Hot Tap Water Enzymatic Cleaner (Prolystica 2X concentrate enzymatic cleaner or equivalent) Rinse 00:15 Hot Tap Water N/A Wash 03:00 Hot Tap Water ph Neutral Detergent (Prolystica 2X concentrate neutral detergent or equivalent ph neutral detergent Rinse 00:15 Hot Tap Water N/A Thermal Rinse 01:00 Hot Purified Water heated N/A to 180 F (82 C) Dry 05:00 High Setting 203 F (95 C) N/A 1 Sterrad is a registered trademark of Advanced Sterilization Products, a Johnson & Johnson Company 2 Always refer to product instructions for use for complete indications, contraindications, warnings, precautions and operating instructions. 14
Sterile Processing Charging Battery 1. Insert the battery pack into the battery charger, aligning the connectors. 2. The charging cycle will start automatically when the battery pack is inserted correctly into the battery charger. 3. The charge status indicator light panel indicates the following: Green: battery pack is ready for use. Flashing Amber: battery pack is charging, and is not ready for use. Flashing Red: remove and reinsert battery; if flashing red persists replace battery pack. Do Not Sterilize the Battery Pack. Sterilizing 132 C Prevacuum (Hi Vac) Steam Cycle² Exposure temperature: 132 C - 135 C (270 F - 275 F) Exposure Time: 4 minutes Exhaust: Fast Vacuum Dry Time: 20 minutes 134 C Prevacuum (Hi Vac) Steam Cycle² Exposure Temperature: 133.5 C - 136.5 C (272-278 F) Exposure Time: 3 minutes Exhaust: Fast Vacuum Dry Time: 20 minutes Autoclave only. Do not flash sterilize. Do not use Hydrogen Peroxide Gas Plasma (STERRAD ¹ ). The idrive Ultra powered handle and Endo GIA adapter have been tested to allow exposure to temperatures up to 137 C for 5 minutes to allow for variations in local requirements. Storage 0% Humidity limitations 85% 86 F 30 C 59 F 15 C Store at room temperature 120 F 49 C 0 F -18 C Transport temperature limitations 279 F 137 C Upper temperature limit Store the components at room temperature, at a humidity between 0 and 85% 1 Sterrad is a registered trademark of Advanced Sterilization Products, a Johnson & Johnson Company 2 Always refer to product instructions for use for complete indications, contraindications, warnings, precautions and operating instructions. 15
Competitive Comparison Feature Covidien idrive Ultra 2 EES Echelon Flex * Powered Stapler EES Echelon Flex * Stapler Single, powered handle compatible with 30 mm, 45 mm, and 60 mm reloads 4 Compatible with Endo GIA reloads with Tri-Staple technology 4 Extra-thick reload with tissue indications up to 3 mm 4 New, sterile knife blade and anvil with every firing 4 Integrated feedback display 4 Power source Rechargeable, 16.8 V lithium battery, 300-procedure minimum 4 single-use batteries per handle. Single use, disposable Reusability Reusable Single use, disposable Single use, disposable Points of articulation with 45-degree maximum range Unlimited 3 on each side (left, right) 3 on each side (left, right) Articulation Powered, push-button operation Manual; second instrument or lateral pressure against body structure Manual; second instrument or lateral pressure against body structure Rotation Powered and manual Manual only Manual only Clamping Powered Manual only Manual only Firing Powered Powered Manual only Jaw opening Powered Manual only Manual only 2. Product under development. Not available for sale in all regions. 16
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COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. * Trademark of its respective owner. Other brands are trademarks of a Covidien company. 2012 Covidien 11.12 M121086 555 Long Wharf Drive New Haven 06511 Phone: 1-800-722-8772 Fax: 1-888-636-1002 www.covidien.com www.tristaple.com