StrykeFlow™ Suction/Irrigator Tips - Select your …

1 strykeflow Suction/Irrigator tips Regular tips Non-Conductive tips Pool suction tips Contents EN-3. Fran Deutsch.. DE-25. IT-37. Portugu s.. PT-49. Espa ES-61. NL-73. DA-85. FI-97. NO-107. SV-117. Polski.. PL-127.. EL-139. T rk e.. TR-151.. CHS-161.. JA-169.. KO-179. Table of Contents Product Description/Intended 4. 5. 5. Cautions.. 6. Instructions for 6. 6. Product Description/Intended Use The strykeflow Suction/Irrigator tip is an accessory to the strykeflow and AHTO. suction /irrigation systems. The tips are intended for evacuation and aspiration of fluids during general laparoscopic procedures. Regular tips 250-070-402 5 mm 28 cm Regular Tip, Vented, Metal Finish 250-070-403 5 mm 32 cm Regular Tip, Vented, Metal Finish 250-070-404 10 mm 32 cm Regular Tip, Vented, Metal Finish 250-070-407 5 mm 32 cm Hydrodissection Tip, Metal Finish 250-070-408 5 mm 45 cm Regular Tip, Vented, Metal Finish 250-070-409 5 mm 32 cm Hydrodissection Tip, Metal Finish 250-070-411 5 mm 24 cm Regular Tip, Vented, Metal Finish 250-070-437 5 mm 32 cm Aspiration Needle Tip 250-070-471 2 mm 32 cm Regular Tip with 1 Hole, Metal Finish 250-070-472 2 mm 32 cm Regular Tip with 2 Holes, Metal Finish 250-070-473 2 mm 34 cm Regular Tip with No holes, Metal Finish 250-070-482 5 mm 28 cm Regular Tip, Vented.

2 Non-Reflective Finish 250-070-483 5 mm 32 cm Regular Tip, Vented, Non-Reflective Finish 250-070-484 10 mm 32 cm Regular Tip, Vented, Non-Reflective Finish 250-070-487 5 mm 32 cm Hydrodissection Tip, Non-Reflective Finish 250-070-488 5 mm 45 cm Regular Tip, Vented, Non-Reflective Finish 250-070-489 5 mm 32 cm Regular Tip, No Holes, Non-Reflective Finish 250-070-490 3 mm 32 cm Regular Tip, Vented, Metal Finish 250-070-491 3 mm 32 cm Regular Tip, Non-Vented, Metal Finish Non-Conductive tips 250-070-420 5 mm 32 cm Non-Conductive Tip 250-070-421 5 mm 32 cm Non-Conductive Tip with 4 Holes Pool suction tips 250-070-405 10 mm 32 cm Pool suction Tip, Metal Finish 250-070-406 5 mm 32 cm Pool suction Tip, Metal Finish 250-070-485 10 mm 32 cm Pool suction Tip, Non-Reflective Finish 250-070-486 5 mm 32 cm Pool suction Tip, Non-Reflective Finish 250-070-492 10 mm 32 cm Stone Scooper EN-4.

3 Indications These devices are indicated for general purpose use as suction and/or irrigation devices in laparoscopic general surgery, general surgery, laparoscopic gynecologic surgery, gynecologic surgery, thoracic surgery, laparoscopic thoracic surgery, otolaryncologic surgery, plastic surgery, and urology. In laparoscopic applications, the tip may serve as a cannula to accommodate laparoscopic accessories, such as manual instruments or various accessory probes. Warnings 1 These devices are shipped non-sterile. Clean the tip thoroughly and sterilize before first use and after each use (see cleaning and sterilization procedures below). 2 Inspect the device prior to each use for cracks or breaks. Discard the product if there is any damage.

4 For Non-Conductive tips , cracks or breaks may lead to inadvertent flow of electricity, shocks, or saline leakage. 3 Do not use the tips or other laparoscopic instruments as laser backstops. Absorbed radiation may cause excessive heating of laparoscopic instruments. Reflected radiation may cause inadvertent burns. 4 For Non-Conductive tips : Laparoscopic electrosurgical procedures should only be performed by physicians having adequate training and familiarity with techniques, complications, and hazards of electrosurgical procedures. Verify compatibility of instrumentation, and make sure grounding and insulation are not compromised. When a Non-Conductive Tip is used in conjunction with an electrosurgical probe, the following conditions may result in an electrical shock hazard, unintentional cutting/coagulation, and/or unintentional flow of electricity: The electrosurgical probe is not in contact with tissue.

5 The electrosurgical probe is activated while irrigating or aspirating fluid. The electrosurgical probe is activated while there is irrigation fluid in the cannula. The electrosurgical probe is improperly assembled to the Suction/Irrigator . The post on the electrode is incompletely covered by the monopolar cord. Excessive buildup of debris on the tip of the electrosurgical probe. EN-5. Cautions 1 Federal (USA) law restricts this device to sale by or on the order of a physician. 2 For Non-Conductive tips : Do not exceed 7,000 V peak-to-peak or 120 Watts in coagulation mode. Do not apply excessive lateral force on the distal end. This may cause the tube to crack, break, or bend. Instructions for Use 1 After sterilization, in a sterile environment, aseptically assemble the tip onto the suction irrigator .

6 Hold the hub of the tip and screw it onto the front of the handpiece until the two components are fully assembled. 2 Make sure the O-ring is fully covered. Reprocessing Instructions apply to the devices only (without a tray). For instructions on how to reprocess the devices in a tray, consult the respective instructions for use. Warnings These devices are shipped non-sterile. Clean and sterilize the tips thoroughly before first use and after each use. Cautions Blood and debris left on the device will affect the operation of the device. The tip must be cleaned after each use prior to sterilization. Limitations on Proper processing has a minimal effect on the Reprocessing tip. End of life is normally determined by wear and damage due to use.

7 Do not leave the tip in solutions longer than necessary. This may accelerate normal product aging. Damage incurred by improper processing will not be covered by the warranty. EN-6. Preparation for Wipe excess soil from the tip using disposable Point of Use Prior paper towels. to Processing If an automated cleaning method will be used, rinse the tip in distilled water immediately after use. Containment and No particular requirements. Transportation Reprocess the tip as soon as reasonably practical following use. Preparation for 1 Disassemble the tip into its individual Manual or Automated components, if applicable. Cleaning 2 Prepare an enzymatic detergent1 according to the manufacturer's recommendations. 3 Wipe the entire tip with a clean cloth dipped in detergent.

8 4 Immerse the tip in the detergent. 1 Cleaning was validated using Enzol at 1 oz/gal. at 35-40 C. 5 Soak the tip in the detergent for 15 minutes. Manual Cleaning 1 Brush Prepare a fresh solution of enzymatic detergent1 according to the manufacturer's recommendations at 35 C. Thoroughly brush the exterior of the device and the lumen with a soft-bristled brush, focusing on any mated or rough surfaces. Inject any mated surfaces and crevices a minimum of five times. 2 Rinse Rinse the device with deionized water at ambient temperature to remove all detergent residue. Flush the lumen and any mated surfaces and crevices a minimum of five times After all detergent residues have been removed, continue to rinse for 30 seconds. Drain excess water from the device and dry it using a clean cloth or filtered pressurized air.

9 Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soils remains, repeat steps 1 and 2. EN-7. 3 Soak Prepare a non-enzymatic detergent2, according to the manufacturer's recommendations at 35 C. Fully immerse the device and inject the lumen and any mated surfaces and crevices with at least 50 mL of the detergent. Soak the device for 15 minutes. 4 Brush Thoroughly brush the exterior of the tip using a soft-bristled brush. Inject the prepared detergent into any mated surfaces five times. Brush any movable parts in their extreme open and closed positions. 5 Rinse Thoroughly rinse the device with deionized water until all detergent residue is removed. After all detergent residues have been removed, continue to rinse for 30 seconds.

10 2 Cleaning was validated using Prolystica 2x Neutral Detergent Drain the excess water from the device and at 35-40 C. dry it with a clean cloth or pressurized air. Automated Cleaning 1 Brush Prepare a fresh solution of enzymatic detergent1 according to the manufacturer's recommendations at 35 C. Thoroughly brush the exterior of the device and the lumen with a soft-bristled brush, focusing on any mated or rough surfaces. 2 Rinse Rinse the device with deionized water at ambient temperature to remove all detergent residue. After all detergent residues have been removed, continue to rinse for 30 seconds. EN-8. 3 Automated wash Place the device in the washer on an incline to facilitate drainage. Program the washer using the settings below.