Minimally Invasive Suturing Devices

Transcription

1 Instructions for Use Minimally Invasive Suturing Devices MODELS COVERED ECDL-01 Standard Laparoscopic Length 374 mm ECDS-01 Shorter Length for Urogynecology 222 mm and other natural orifice applications ECDX-01 Longer Length for Bariatric 449 mm and Single-Port applications Endo360 Minimally Invasive Suturing Devices are provided NON-STERILE and must be sterilized by compatible sterilization methods outlined in this document. Endo360 Minimally Invasive Suturing Devices MUST BE PERFORMANCE TESTED according to the Performance Testing protocol in this document (sections and 3.3.2) prior to each use.

2 IMPORTANT INFORMATION Re-Order Numbers: Working Length ECDL-01 Standard Laparoscopic Length 374 mm ECDS-01 Shorter Length for Urogynecology 222 mm and other natural orifice applications ECDX-01 Longer Length for Bariatric and 449 mm Single-Port applications. Working Length Endo360 Minimally Invasive Suturing Devices are provided NON-STERILE and must be sterilized by compatible sterilization methods outlined in this document. Endo360 Minimally Invasive Suturing Devices are RE-USABLE instruments and must be performance tested according to the test protocol in this document prior to each use. NOTE: Use of Endo360 Minimally Invasive Suturing Devices requires a compatible EndoEvolution Endo360 Suture. CAUTION: United States of America, Federal Law restricts the sale to and distribution and use of Endo360 Minimally Invasive Suturing Devices to or on the order of, a physician. Device Serial Number: SP50461 REV 04

3 Instructions for Use 1. GENERAL INfORmATION 1.1. Endo360 Minimally Invasive Suturing Devices must only be used with compatible Endo360 Sutures Endo360 Minimally Invasive Suturing Devices enable placement of single interrupted stitches or a series of running (continuous) stitches through soft tissue. 2. PRODUCT DESCRIPTION 2.1. Components REUSABLE SUTURING DEVICES Product Code Device Description Working Length Trocar Diameter ECDL-01 Standard Laparoscopic length 374 mm 12 mm ECDS-01 Shorter length for Urogynecology 222 mm 12 mm ECDX-01 Longer length for Bariatric and Single-Port 449 mm 12 mm DISPOSABLE SUTURE CARTRIDGES Ethicon Needle USP Suture Product Code Material Suture type Equivalents* Type Size Length ECN-A100T Polydioxanone (PDO) Absorbable Monofilament PDS II Taper 0 39 ECN-A120T Polydioxanone (PDO) Absorbable Monofilament PDS II Taper 2/0 39 ECN-A130T Polydioxanone (PDO) Absorbable Monofilament PDS II Taper 3/0 39 ECN-B100T Polypropylene Non-absorbable Monofilament Prolene Taper 0 39 ECN-B120T Polypropylene Non-absorbable Monofilament Prolene Taper 2/0 39 ECN-B130T Polypropylene Non-absorbable Monofilament Prolene Taper 3/0 39 ECN-C100T PGA Absorbable Braided Vicryl Taper 0 39 ECN-C120T PGA Absorbable Braided Vicryl Taper 2/0 39 ECN-C130T PGA Absorbable Braided Vicryl Taper 3/0 39 ECN-E100T Polyester Non-absorbable Braided Ethibond Taper 0 39 ECN-E120T Polyester Non-absorbable Braided Ethibond Taper 2/0 39 ECN-E130T Polyester Non-absorbable Braided Ethibond Taper 3/0 39 ECN-F100T Silk Non-absorbable Braided Perma-Hand Taper 0 39 ECN-F120T Silk Non-absorbable Braided Perma-Hand Taper 2/0 39 ECN-F130T Silk Non-absorbable Braided Perma-Hand Taper 3/0 39 ECN-M100T Monoswift Absorbable Monofilament Monocryl Taper 0 39 ECN-M120T Monoswift Absorbable Monofilament Monocryl Taper 2/0 39 ECN-M130T Monoswift Absorbable Monofilament Monocryl Taper 3/0 39 STAINLESS STEEL STERILIZATION TRAY Product Code Product Description ECDT-00 Securely holds one device of any length ECDT-01 Securely holds two devices of any length 1

4 Instructions for Use 2.2. Indications for Use: Endo360 Minimally Invasive Suturing Devices are intended for minimally invasive surgical applications for the approximation of soft tissue. The Endo360 Minimally Invasive Suturing Devices are designed to aid in the prevention of suture needlestick injuries Contraindications: None 2.4. DESCRIPTION Of OPERATION Endo360 Minimally Invasive Suturing Devices are manually-driven mechanical needle drivers. A single-use sterile plastic loading cartridge containing a single proprietary Endo360 needle (with suture attached) is used to load the Endo360 needle onto the distal end of the reusable Endo360 Instrument. The Endo360 needle is engaged by the compression of the handle and driven completely through the tissue to be sutured. 3. OPERATING INSTRUCTIONS 3.1. Preparation for use Endo360 Minimally Invasive Suturing Devices are reusable instruments the Instrument(s) and are provided NON-STERILE. Prior to use, the Instruments must be cleaned, lubricated and sterilized in accordance with the instructions listed below. 2 SP50461 REV 04

5 Endo360 Minimally Invasive Suturing Device CLEANING PROCEDURE (Validated in accordance with AAMI TIR 12) Caps: a) Tip Protector Cap; remove and discard. b) Flush Port Cap; unscrew the white tethered luer lock cap from the Flush Port, making sure the port remains open during cleaning and sterilization Run water through the flush port at least twice, using a 20cc syringe or using tap water from an appropriately configured faucet Submerge the Instrument in an enzymatic, neutral ph detergent safe for use with plastic and metal Instruments. Prepare the detergent according to the manufacturer s recommendations. Soak the Instrument for five (5) minutes in the protein solubilizing detergent Scrub the submerged Instrument with a soft bristled brush. Agitate the Instrument in the solution while scrubbing. Pay particular attention to the needle driving mechanism when brushing. Maneuver any movable parts by hand to loosen any trapped soil Rinse the Instrument with warm (38-49 C) tap water for one (1) minute Place the Instrument into a bath containing warm (38-49 C) tap water. Agitate the device by hand for at least one (1) minute. Repeat this process two (2) additional times Ultrasonically clean the Instrument for ten (10) minutes in an enzymatic, neutral ph detergent. Prepare the detergent according to the manufacturer s recommendations Rinse the Instrument with clean tap water for at least one (1) minute Dry the exterior of the Instrument with a clean, lint-free cloth. 3

6 Instructions for Use LUBRICATION After cleaning and drying, all moving parts of the Instrument should be lubricated with a Steam Sterilizable Instrument Lubricant ( instrument milk ). Be sure to thoroughly lubricate all moving parts of the front end and also the handle. Cycle the device trigger at least five (5) times after lubricating to disperse lubricant throughout the mechanism STERILIZATION PROCEDURE (VALIDATED IN ACCORDANCE with AAmI TIR 12) Clean the reusable Instrument in accordance with the cleaning procedure detailed above Lubricate the reusable Instrument as described above Caution! The Flush Port must be open (port cap off) during sterilization. Double wrap the Instrument with CSR in accordance with standard hospital practices Sterilize the Instrument in a Steam Autoclave using the following cycle: 132 C (270 F) Pre-vacuum 4 Minute Full Cycle Exposure LOADING ThE ENDO360 NEEDLE AND SUTURE with LOADING CARTRIDGE The Endo360 needle, suture, and suture loading cartridge are all contained within a sterile package. Endo360 suture loading cartridges are available with absorbable and nonabsorbable braided and monofilament sutures in sizes 0, 2/0, and 3/ The Endo360 needle is a standard taper point curved suture needle. The needle is curved to a proprietary Needle notches shape (270 ) and includes tiny atraumatic notch features that enable the device mechanism to repeatedly drive the needle in its complete, 360 circular path The non-sterile outer package and the sterile inner package are opened in the usual manner The sterile loading cartridge with needle and suture is contained within the sterile inner package. 4 SP50461 REV 04

7 Endo360 Minimally Invasive Suturing Device In order to load the Endo360 needle onto the Instrument, use the thumb to retract the sliding needle cover to expose the needle track Remove the loading cartridge from the sterile inner package and hold the loading cartridge firmly between thumb and forefinger. The needle side of the loading cartridge should be facing down. Secure the suture under the thumb on the back side of the loading cartridge. The back side of the loading cartridge should be facing up Lay the device on a table to ensure stability. Line up the loading cartridge parallel to the tip of the device and press the tip of the loading cartridge firmly into the needle track. The loading cartridge will fit snugly and securely. Pull back on the sliding needle cover Press cartridge and needle firmly into needle track Release the sliding needle cover and lift the loading cartridge away from the device. The needle is now loaded securely and correctly Performance test as per 3.3 below. The suture may now be cut to the surgeon s preferred length. There are inch-mark graduations along the shaft of the device to aid in measuring the length of the suture. z z z z 5

8 Instructions for Use 3.3 PERfORmANCE TESTING Once the needle is securely and correctly loaded onto the Instrument, gently hold the suture away from the tip of the Instrument (perpendicular to the distal tip) and deliberately not too fast and completely squeeze and release the handle several times to cycle the needle completely several times in order to ensure that the needle is properly loaded and that the device is properly functioning. Observe the needle completely cycling 360 several times. The needle should cycle freely and smoothly without any roughness, jamming, or other difficulty. If the needle cycles freely and smoothly several times, the Endo360 Minimally Invasive Suturing Device is now ready to use IF THE NEEDLE DOES NOT ROTATE FREELY AND SMOOTHLY SEVERAL TIMES, IMMEDIATELY REPLACE THE NEEDLE AND REPEAT THIS PERFORMANCE TESTING BEFORE PROCEEDING TO USE THE DEVICE IN SURGERY. Complete articulation and roticulation control 3.4 method Of USE Be sure the Instrument is sterilized, loaded, and performance tested prior to use. Be sure the suture has been cut to the surgeon s preferred length Before inserting the Endo360 MIS Suturing Device (Instrument) into the trocar, squeeze the handle ONCE so that the needle is driven completely across the aperture at the tip of the device. Then insert the device through the trocar and slide the Instrument into abdomen. Once the tip of the device is visible within the abdominal cavity, squeeze the handle one more time to bring the needle back to the ready position When tensioning a knot, ALWAYS withdraw the device toward the trocar. Do not push the device away from the trocar in order to tension the knot To place a stitch, position the distal tip of the Instrument at the desired location. 6 SP50461 REV 04

9 Endo360 Minimally Invasive Suturing Device The distal end of the device maybe articulated left or right by moving the Articulation Control. Always unlock the articulation control lock before attempting to articulate the tip of the Instrument. Always lock the articulation control lock once the tip of the Instrument has been articulated to the desired angle. The device can be roticulated by manipulating the roticulation control. Manipulating articulation control Completely squeeze the handle twice to drive the needle in a complete circular arc of 360 and place the stitch. Squeeze and release the handle completely and deliberately. Do not squeeze and release the handle too fast, as the suture may jam or the suture may be passed twice through the same spot Tie and cut the suture for interrupted suturing, or repeat the previous steps 1-3 for continuous suturing. Device nomenclature Flush port Roticulation control Articulation control Needle release control Articulation control lock Squeeze handle 7

10 Instructions for Use Device nomenclature (continued) Flush port Needle release control 4 POST OPERATION SET-UP, CLEANING, maintenance AND STERILIZATION 4.5 Discard used needle in a sharps container. 4.6 Clean device as described in section Lubricate the device as described in section Sterilize the device as described in section TRANSPORT AND STORAGE CONDITIONS 5.5 Device should only be shipped in an appropriately padded and secure shipping package. 5.6 Operating Temperature: 50 F to 95 F (10 C to 35 C). 5.7 Storage Temperature: 32 F to 113 F (0 C to 45 C). 8 SP50461 REV 04

11 SyMBOLS USED ON LABELINg: REF Catalog Number SN Serial Number Manufacturer Authorized Representative in the European Community Caution, consult accompanying documents Rx Only Federal (USA) Law restricts this device to sale, distribution and use by or on the order of a physician. 9

12 EndoEvolution, LLC 10 Commerce Way, Suite 5 Raynham, MA USA Customer Service Toll Free (US only): ENDO360 Fax: info@endoevolution.com EMERGO EUROPE Molenstraat BH, The Hague The Netherlands Rx Only 2013 EndoEvolution, LLC. * Ethicon, PDS II, Prolene, Vicryl, Ethibond, Perma-Hand, and Monocryl are Trademarks of Johnson & Johnson and are used here for the purpose of equivalent comparison only. The Endo360 Device and suture cartridges are covered by one or more of the following US Patents: Nos. 5,437,681; 5,540,705; 6,923,819; 7,862,572; 7,993,354; 8,066,737 and 8,123,764 and patents pending. Endo360 and the Endo360 logo are trademarks of EndoEvolution, LLC. SP50461 REV 04