COOK Inc
Nathanson Liver Retractor Instructions for Use
16 Pages
Preview
Page 1
INSTRUCTIONS FOR USE
ENGLISH
The Nathanson Liver Retractor is held in place by the Murdoch Mechanical Retraction Arm. Reorder codes: MMA-1000 The Nathanson Liver Retractor can be held in place by any of the following commercially available mechanical arms: • The Murdoch Arm. Dedicated Locking Handle. • The BOOKWALTER® Retractor which attaches to the horizontal flex bar. • The Iron Intern® plus the Universal Gemma Connection Clamp.
NATHANSON LIVER RETRACTION SYSTEM
INTENDED USE
45mm 55mm
The Nathanson Liver Retraction System is intended to be used to retract the left lobe of the liver during surgery in the upper gastro-intestinal region.
95mm
75mm
DESCRIPTION • Available in four sizes. • Can be used with the Murdoch Mechanical Arm. • Stainless steel construction with matte metal finish to reduce light reflection. • Small NLR has a 45 mm distal tip distance. • Medium NLR has a 55 mm distal tip distance. • Large NLR has a 75 mm distal tip distance. • Extra large NLR has a 95 mm distal tip distance. • Supplied non-sterile. Reference: Dr. Les Nathanson, Department of Surgery, Royal Brisbane Hospital, Brisbane, Australia.
Front view
End view
Setting up Place the retractor holder on the opposite side of the table from the surgeon’s working side.
Steps for insertion NOTE: The insertion point for the Nathanson Liver Retractor depends upon the procedure being performed, size of the patient and personal preference of the surgeon. For example, when performing a Nissen Fundoplication, an optimal site may be the point inferior to the Xiphoid Process. Step 1 Commence insufflation of the peritoneal cavity in the normal manner. Step 2 Upon obtaining set maximum pressure insert a 5 mm trocar. Remove the trocar and enlarge the tract, if necessary with a pair of artery forceps. Step 3 Holding the Nathanson Liver Retractor by the handle and maintaining the curved radius in a vertical position, insert the retractor with a twisting motion. Do not connect the Nathanson Liver Retractor to the retractor arm. Step 4 Under direct laparoscopic vision, manoeuvre the curved edge of the Nathanson Liver Retractor in a superior direction under the left lobe of the liver. Step 5 Continue placement of the ports. When this is complete, attach the Nathanson Liver Retractor to the retractor arm and elevate the liver to the desired position.
Reorder codes NLRS-1100 Small retractor only. NLRS-1010 Medium retractor only. NLRS-1001 Large retractor only. NLRS-1002 Extra Large retractor only.
PRECAUTIONS • Ensure that NLR is operated and used only by the persons trained in the procedure. • Read, follow, and keep the instructions for use. • Use the device only in accordance with its intended use. • Remove the packaging and clean the NLR with the reprocessing instructions prior to its initial sterilization. • Do not use if NLR is damaged or defective.
3
Table 1: Process paremeters – Automated cleaning Temperature– Phase Time (Minutes) Treated water Pre-wash 2.2 Cold water Wash 4.5 Set point: 72°C (162°F) Rinse 15 Seconds Set point: 91°C (196°F) Thermal rinse 1 Set point: 82.2°C to 93°C (180°F to 199°F) Drying 7 Set point: 98.9°C (210°F) High
Periodic release of the retractor pressure may be necessary throughout the procedure to minimise the risk of hepatic ischaemia.
Cleaning and sterilizing instructions • Do not use acidic detergents in automated or manual cleaning as this will cause corrosion of NLR. • It is recommended that the NLR is reprocessed as soon as reasonably practicable, or within at least 30 minutes following use. Limitations on reprocessing Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use.
Cleaning (manual) Equipment: Sonicator, detergent (enzymatic detergent pH 7.0-10.0). 1. Sonicate NLR in prepared detergent solution (Detergent concentration: 4 mL/liter (0.5 oz per gallon))2 in ultrasonic unit at 45°C (113°F) for 10 minutes with ultrasonic frequency at 40 kHz. 2. Rinse the NLR using treated water1 for two minutes. 3. Dry NLR using non-linting cloth and compressed air. 1 Treated water as defined in AAMI TIR34 Water for Reprocessing of Medical Devices. 2 Detergent concentration: Validation was performed using Cidezyme Xtra Multienzyme Detergent. Detergent concentration used as recommended by manufacturer: Manual – 8 mL/liter (1 oz per gallon); Automated: 4 mL/liter (0.5 oz per gallon). Any equivalent detergent can be used for cleaning. Detergent concentration to be as per that manufacturer’s recommendation for cleaning processes.
Initial treatment at the point of use 1. Keep the NLR moist immediately after use, or as soon as practical. 2. Remove excess soil from NLR with water and wipe with non-linting cloth. Preparation before cleaning Equipment: non-abrasive brush, detergent (enzymatic detergent pH 7.0-10.0) 1. Rinse the NLR under ambient running tap water for 3 minutes. 2. Remove excess soil while rinsing using a non-abrasive brush or non-linting cloth. 3. Soak the device in prepared enzymatic detergent solution (Detergent concentration: 8 mL/liter (1 oz per gallon))2 for 20 minutes. 4. Use a non-abrasive brush to thoroughly clean, especially the difficult to reach, surfaces for 3 minutes while the Nathanson Liver Retractor is immersed. 5. Rinse the device under tap water for 3 minutes.
Drying Ensure the Nathanson Liver Retractor is dry before packaging.
Cleaning (automated) Equipment: Washer/disinfector, detergent (enzymatic detergent pH 7.0-10.0) 1. Load products into washer/disinfector. 2. Complete a cleaning cycle using prepared enzymatic detergent solution (Detergent concentration: 4 mL/ liter (0.5 oz per gallon))2. 3. Minimum cycle parameter set points are listed in Table 1 or alternately use a cleaning cycle validated for non-complex re-usable medical devices (RMD)s. 4. When unloading, check for complete removal of visible contaminants. If necessary, repeat cycles or use manual cleaning. 5. Dry NLR using non-linting cloth and compressed air.
Maintenance No maintenance required. Inspection and function testing Visually inspect for damage and wear.
4
Sterilization Moist heat sterilize as per ISO/TS 17665 Part 1 and Part 2. 1. Prepare NLR for sterilization. 2. Pack NLR in the sterilization pouch or place it in a tray and ensure that steam can penetrate through all surfaces. 3. Run sterilization cycles in pre-vacuum mode with either of the paremeters described in Table 2. Table 2: Moist heat sterilization parameters Process steps Parameters Method Moist heat sterilization Pre-vacuum phases 3 Temperature 132°C (270°F) 134°C (273°F) Exposure time 4 minutes 3 minutes Drying time 30 minutes Packaging – Post sterilization Carefully examine the sterile instrument packaging prior to use, ensuring package integrity is maintained. Do not use if package is opened or damaged. If so, repeat the reprocessing steps. The sterile barrier system should comply with ISO/TS 16775 and ISO 11607 Part 1 and 2. Storage Store in a dark, dry, cool place. Avoid extended exposure to light.
The instructions provided above have been identified by the manufacturer of the medical device as being CAPABLE of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually performed using equipment, materials and personnel in the reprocessing facility achieve the desired result. This normally requires validation and routine monitoring of the process. The Bookwalter is a Specialty Surgical Instrumentation Inc. product. The Iron Intern is an Automated Medical Products Corp. Product. The Cidezyme Xtra Multienzyme is an Advanced Sterilization Products product.
5
WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 Brandl Street, Eight Mile Plains QLD 4113 AUSTRALIA Phone: +61 7 3434 6777, 1800 777 222
COOK INCORPORATED 750 Daniels Way Bloomington, IN 47404 U.S.A.
cookmedical.com
© COOK 2020
IFU-NLRS-8