Polymer Ligating Clips, Appliers and Removers Instruction for Use

Transcription

1 LAPAROSCOPIC REMOVERS LAPAROSCOPIC APPLIERS OPEN SURGERY APPLIERS PRODUCT DIMENSIONS DEVICE DESCRIPTION Polymer Ligating Clips, Appliers and Removers Instruction for Use Ankalaps polymer ligating clips are single use, non absorbable, non active devices designed for use in general surgical procedures that require vessel or tissue ligation. Ankalaps polymer ligating clips are implantable devices used to stop the flow of blood vessels, ducts and tissues in surgical operations made of material from the acetyl homopolymer. The clips are in the form of cartridges containing 6 clips. It is sterile. The cartridges are sold in boxes containing 14 or 25 cartridges. DIMENSION MEDIUM-LARGE(ML) LARGE (L) EKSTRA LARGE (XL) REFERANCE CODE AMLG6 ALP6 AXLY6 COLOUR CODE GREEN PURPLE GOLD Ankalaps Endoscopic Ligating Clip Appliers are designed for use as delivery devices for Ankalaps Polymer Ligating Clips. Clip appliers are reusable instruments that manually load and deliver one clip at a time. Ankalaps Endoscopic Clip Removers are used as a removal device for Ankalaps Polymer Ligating Clips. The removers are manufactured from stainless steel. Other ligating clips can not be used with these practitioners. REFERANCE DK CK BK AK REFERANCE D C B A

2 POLYMER LIGATING CLIPS APPLIERS WARNINGS AND MEASURES CONTRA INDICATI ONS INDICATIONS Ankalaps Polymer Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. They can be used in open and laparoscopic surgery. Surgeons should apply the appropriate size clip fort he size of vessel and tissue structure to be ligated such that the clip completely encompasses the vessel and tissue structure. Ankalaps Polimer Clips can be used in adult patients. The use of newborns, babies and pregnancies depends on the decision of the physician and the benefit-loss relationship should be considered. Medium 2-7mm in diameter vessels, Medium-Large 3-10mm in diameter vessels, Large 5-13mm in diameter vessels, Extra-Large 7-16mm in diameter vessels. Unusable for artery and arteries of the artery and vein system of the heart. (Arteriae pulmonalis, aorta ascendens, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebralis, truncus brachicephalicus, venae cordis, venae pulmonalis, vena cava superior ve vena cava inferior.) The most commonly used general surgery, urologicak surgery and gynecology; colectomy ve rectomy cholecystotomy (open/ laparoscopic), nephrectomy (open / laparoscopic), uterotomy (open / laparoscopic) and resection, sapheneus ve internal breast artery dissociation, appendicisit (open / laparoscopic), gastrectomy. Etc. Clips can be combined with laparoscopic partial nephrectomy, intracorporeal suture during the control of parenchymal hemorrhage ourside the control of vessel. In this way, cutting of the tissue during the strecthing of the suture can be avoided. Ankalaps Ligating clips are not intended for use as a fallopian contraceptive tubal occlusion device. Ankalaps Ligating clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies. Must be used as appropriate vessel diameter. M clips should be used with 2-7mm, ML clips should be used 3-10mm, L clips should be used 5-13mm, XL clips should be used 7-16mm vessel diameter. Failure to use appropriate clips in appropriate diameter tissues may lead to vessel injury and ligation failure. Clips should be used with Ankalaps branded Applicators and Removers. The use of different brand appliers and removers may cause deformation and ligation problems about clips. For safe application,the enviromental dissection of the vein must be completed before application. Since the clips has a locking mechanism,application of the clip without releasing may cause the clip to break,not close and open. For safe application, the curved tip of the clip around and outside the vein must first be visualized. After applying the clip, it is necessary to leave at least 1mm between the cutting point and the clip. The clip should be placed at a 90 degree angle to the tissue. They should not cross. Cross-mounting can cause the clip to tilt, undfold and slide. During the clip closure, there should be no tissue between the locking mechanism. It prevents the clip locking.clips can be opened. Clip applicator arms should not be over-tightened. The clip has audible and visual feedback with click sound. After this feedback, applicator s arms should not be further tightened. Overtightened may cause vascular injury and applicator damage. The applicator should be removed carefully following the application. Otherwise it may cause the vessels next to it to break down. After application of the clips, only partial splitting should be performed to control hemostasis prior to cutting the tissue. At least two clips should be placed on the patient side of the vein. Applications with a one clip may be risky. The product is not sterilized again. Repeated sterilization can lead to infections and deterioration of product performance. Repetaed use of only disposable products may result in exposure to viral, bacterial, fungal or prionic pathogens. Instruction for verified cleaning and sterilization methods and reprocessing to restore original specifications is not available for these products. This product is not designed to cleaned, disinfected or resterilized. Ankalaps clips are designe dfor permanent ligation of vessels or tissue structures. If you need to remove the clips, you can use Ankalaps Removers. If the clips broken during removal, the opeator must remove the broken clip parts from the site of operation. NOTE: Ankalaps ligation clips are provided as sterile. DO NOT STERILE AGAIN Always check applicator s mouth alignment before using. When closed, the ends of the mouths should be aligned and aligned with each other.it is very important to align the mouth for safe application of the clip. If this is not done, the patient may be harmed. Regular maintanence, care and cleaning are required to ensure proper functionally. This applier is NOT designed for use with an operative cannula fort he purposes of maintaning pneumoperitoneum. Proceed carefully when inserting the instrument through cannula. Do NOT apply lateral pressure on the applier as damage to the working tip may ocur. Before use, examine the instrument for bent,broken,cracked or worn parts. In order to avoid unnecessary gas loss, ensure the cleaning port cap fits tigthly on the Luer Lock flush port. A spare cap is provided for your convenience. Always confirm that the clips remains in the applier after insertion of the applier and clip through a cannula. Do not attempt to close the jaws on a vessel or anatomic strucuture without a clip properly loaded into the jaws.closure of empty jaws on a vessel or anatomic structure may result in patient injury. Rotation knob should only be avtivated with jaws in open position. Failure to do this may result in damage to the applier.

3 CARE,CLEANING AND STERILIZATION CLIP REMOVER INSTRUCTION FOR USE CLIP APPLICATION INSTRUCTION FOR USE Ankalaps clip is generally suitable for vessels and tissue structures. The choice of clips for specific applications should be determined by the decision of the operator. Loading Clips and Inserting the applier down the cannula 1. To load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge. Gently press the applier over the clip until there is an audible double click.do not force the applier into the cartridge or onto the clip. The applier should enter and withdraw from the cartridge easily. 2. Remove the applier from the cartridge ensuring the clip is held securely in the applier jaws. The clips bosses should seat in the notches of the applier jaws ( picture 1). It may be necessary to hold the cartridge to allow the clip to be removed. 3. Compress the applier handles and insert the applier jaws and shaft down the cannula. Maintain compression on the applier handles until the jaws clear the cannula. Clip positioning and closure 1). During application, Orient the single tooth of the clips as shown(picture1). This allows the user to visually confirm encapsulation of the structure being ligated. 2) Position the clip around the tissue to be ligated in a manner that provides clear visualization of the locking mechanism.(picture2). NOTE: Avoid excess tissue in the locking mechanism of the clip. Apply sufficient force to the applier handles so the jaws close and the clip locks shut(picture3). 3) Releasing pressure on the applier handles allows the applier to return to a fully open position. NOTE: Leave a distal cutt of tissue approxiamtely 2-3 mm from the ligating clip if the vessel is divided.(picture4). DO NOT USE THE SIDE OF THE CLIP AS A CUTTING GUIDE. Insert the Ankalaps Polymer Remover down an approxiamtely sized cannula. The clip must be approached from the hinge side, not the locking mechanism side. Approach the clip on the vessel and using the turn knob, rotate the jaws of the remover so the jaws are directly over and in line with the legs of the clip. Advance the remover until the user visualizes the hinge of the clip resting at the back of the remover jaws as shown. NOTE: The hinge of the clip MUST rest in this channel to ensure disengagement of the clip legs. (picture 1.1). Once the hinge is properly located in this channel, apply steady pressure to the remover ring-handles until a slight click is felt. This indicates the clip legs have disengaged.(picture2) Opening the remover ring-handles will allow the clip to open on the vessel. Visually confirm the clip has opened sufficiently to allow removal. Endoscopic forceps should be used to remove the clip from the ligation site. Ensure the clip remains open and withdraw the clip up the cannula, maintaning grasping force on the clip. Manual load applier/remover jaws are delicate and can easily become damaged, as can some other applier/remover compotents. Mishandling of appliers/removers may result in impreper load and/or closure of the jaws. Appropriate care, cleaning, lubrication and maintenance are important to ensure proper function. Please examine the applier/remover before each surgery for potential damage. Pay particular attention to the jaws. Damaged or misaligned applier jaws may not allow clips to close acceptable for occlusion of intended strcuture. Damaged remover jaws may not allow for clip removal. Preperation at Point of Use Directly after use, remove coarse contamination from the instruments and keep the instrument moist for transit to the processing site. Prior to cleaning and sterilization do not use any fixing agents or hot water (>104 F, >40 C) since this may lead to the fixation of residue and can interfere with the cleaning process. Ankalaps Polymer clip appliers and removers are provided with a cleaning port which permits access to the interior channels and cavities. Uncap the cleaning port, but do not remove the cap tether completely from the instrument. Flush the remover with warm distilled or filtered water for approximately two minutes or until the visible gross debris is removed from the device.

4 STERILIZATION CLEANING, DISINFECTION AND DRYING INSTRUCTIONS Automatic Processing Instructions For Use with Alkaline or Enzymatic Detergents Pre-cleaning Soak the instrument in tap water for a minimum time of 5 minutes. Brush under tap water until all residues are removed. Flush the distal pivot joint and proximal handle joint with a syringe until the rinse water is clear. Cleaning Place the opened instrument in a wire basket on the slide in tray and start the cleaning process. Pre-rinse 2 minutes with cold water. Wash for 5 minutes at 131 F (55 C) with a %0,5 alkaline detergent or at 131 F (55 C) with %0,8 enzymatic detergent. Neutralize for 3 minutes with cold water. Rinse for 2 minutes with cold water. Note: The preparation of concentration,temperature and application time of the cleaning agent must be according to the instructions for use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Manual Processing Instructions For Use with Enzymatic Detergents Pre-cleaning Soak the instrument in tap water for a minimum time of 5 minutes. Brush under tap water for approximately 40 seconds until no residues are visible. Flush the distal pivot joint and proximal handle joint with a syringe until teh rinse water is clear. Cleaning Place the instrument in an ultrasonic bath at 104 F (40 C) with a %0,8 enzymatic detergent. Sonicate for 10 minutes. Remove the instrument and flush with de-ionized water approximately 15 seconds. Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the instructions for use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Drying Dry the outside of the instruments using the drying cycle of the cleaning equipment. If necessary, instruments can be dried by hand with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens. Disinfection Anka Sağlık Gereçleri does not provide disinfection instructions due to the sterility instructions provided. Functional Check Inspect instruments after each sterilization cycle and prior to each use as they may be damaged during transit to the customer, during receiving at the customer s site, during use in a previous procedure or during the cleaning or sterilization process. All moving parts must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of the instrument handle and reinforcing screw. Inspect instruments for rüşt, pitting, cracking or burrs, staining or discoloration, and worn or broken parts. Repair or replace any instrument found not to be acceptable. Maintenance, Handling and Operation of Surgical Instruments The assembly and disassembly of the instrument must only be performed by personel trained to the institution s training requirements. The instrument must be cleaned, lubrcated, functionally checked,and sterilized prior to each use. Use a non-silicone, water-based lubricant prior to sterilization. Do not use mineral oil,petroleum or silicon-based lubrication products. Do not use an instrument with broken, cracked or worn parts. Only use the instrument for its intended use. Miuse or impoper handling may result in damage,potentially resulting in user or patient injury. If repair is required, returm clean and sterile instruments to Anka Sağlık Gereçleri. Where appropriate, instruments should be sterilized in the disassembled/open position. Attached latches can cause the instrument to malfunction. Seperate instruments made of different materials to prevent electrochemical reactions from occuring. It has been approved to sterilize the devices according to the following parameter: Sterilization Method Instrument Configuratio n Temperature Exposure Time (minimum) Drying Time (minimum) PreVac Wrapped 270 F (132 C) 4 minute 10 minute PreVac Wrapped 275 F (135 C) 3 minute 10 minute PreVac Wrapped 273 F F (134 C C) 3 minute 10 minute PreVac Wrapped 250 F (121 C) 30 minute 10 minute Gravity Wrapped 270 F F (132 C C) 10 minute 10 minute NOTE: Flash sterilization is not recommended for use with these instruments. NOT: The following methods of sterilization are NOT recommended as they could damage the instrument: Ethylene oxide sterilization, dry heat sterilization, liquid chemical sterilants,and chemical sterilant gases..

5 PRODUCT INFORMATION DISCLOSURE Anka Sağlık Gereçleri excludes all warranties, except Anka Sağlık s applicable standart warranty whether expressed or implied, including but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Anka Sağlık Gereçleri shall not be liable for any incidental or consequential loss, damage or expense, directly arising from use of this product expect for the intended use specified. Anka Sağlık Gereçleri does not assume nor authorizes any person to assume for them any other or additional liability or responsibility in connection with these products. ENEDOSCOPIC SURGICAL APPLIER WARRANTY Ankalaps manual load endoscopic appliers are covered by a two year warranty on defects in materials and workmanship and a two year repair service on tip alignment and refurbishment as long as the appliers are used as intended for application of Ankalaps clips and have not been repaired by unauthorized personel. LIFE EXPECTANCY Immediately following each complete sterilization cyce the instrument should be inspected prior to use. The instruments should be inspected for signs of rust, cracking, pitting, breaking,staining and/or discoloration, burrs, sharp edges or protrusion as well as any another signs of defect. Special attention should be paid to ensure the instrument shaft is perpendicular to the instrument cap. Instruments found with any signs of the aforementioned defects are not safe for use with patients and should be immediately discarded. LIGATION SYSTEM COMPATIBILITY There are number of ligating clips on the market today in addition to Ankalaps Ligating Clips from Anka Sağlık Gereçleri. Ankalaps Appliers and Removers have been designed for use exclusively with Ankalaps Ligating Clips. Applier colour coding matches the colour of the ligating clip cartridge with which it is be used. Anka Sağlık Gereçleri does not assume responsibility for unsatisfactory results caused by the use of any equipment or clips not specifically identified by Anka Sağlık Gereçleri as an integral part of this specific system. For additional information or guidance on Cleaning and Sterilization instructions, contact with your Anka Sağlık Sales Representative or Anka Sağlık Customer Service from this phone number : Manufacturer Document No: APC01 Issue Date: Revision No: Rev.05 Revision Date: BRAND NAME 2 PRODUCT NAME 3 CE MARK AND NOTIFY BODY 4 CATALOG NUMBER Indicates the manufacturer's catalog number, where the medical device can be identified.

6 5 LOT NUMBER Represent the part/lot code of manufacturer 6 PRODUCTION DATE Indicates the date of manufacture of the medical device. 7 DISPOSABLE Single Use 8 STERILIZED WITH E.O Indicates that a medical device is sterilized using ethylene oxide. 9 ONLY FOR EXPERT USERS 10 SEE INSTRUCTIONS FOR USE 11 DO NOT USE THE PACKAGE IF IT IS DAMAGED Indicates that the medical device should not be used if the packaging is damaged or opened. 12 DO NOT STERILE AGAIN Indicates that a medical device can not be re-sterilized. 13 EXPIRY DATE Indicates the expiration date of the medical device. 14 MANUFACTURER It specifies the manufacturer of the medical device as defined in the EU Directives 90/385 / EEC, 93/42 / EEC and 98/79 / EC.

7 15 TEMPERATURE It indicates the temperature limits that the medical device can be safely exposed to. 16 KEEP DRY Indicates that the medical device must be protected from moisture. 17 KEEP AWAY FROM THE SUN Indicates that the medical device should be kept away from light sources. 18 ATTENTION Indicates that the user must refer to the operating instructions for important stimuli such as warnings and precautions that can not be offered due to many reasons on the medical device. 19 OF PRODUCT 20 HUMIDITY RESTRICTION Indicates the moisture limits that the medical device can be safely exposed to Etc. PRODUCT EAN13 NUMBER