80191-03 SeedVac Sequential
Contents
1. sale distri bution or use of this device to by or on the order of a licensed medical practitioner The use of this device should be restricted to the supervision of a qualified medical physicist Handling of radioactive sources is potentially hazardous and should be performed by qualified personnel Should repair or replacement of this device become necessary after the war ranty period the customer should seek advice from Standard Imaging Inc prior to such repair or replacement If this device is in need of repair it should not be used until all repairs have been made and the product is functioning properly and ready for use The owner of this device has sole responsibility for any malfunction re sulting from abuse improper use or maintenance or repair by anyone other than Standard Imaging Inc The information in this manual is subject to change without notice No part of this manual may be copied or reproduced in any form or by any means without prior written consent of Standard Imaging Inc Page 2 Overview The SeedVac is a vacuum driven device designed to pull prostate implant seeds and spacers into a special needle fitted with a glass or plastic tip These seeds and spacers are then placed into an implant needle The prescribed sequence of seeds and spacers is visually verified in the glass tip before being placed into the needle The SeedVac is composed of the following parts A vacuum pump Fig 1 an aluminum hand pie2. SeeDOS Product User Manual Seed Vac Subject Table of Contents General Precautions ooocccccnnonononennconncnnnnonenaninococinonononananinos Customer Overview RESPONSES ns he ecient Needle LO ACN corais A ai Sect de hale ih cl e DCC OQUE sadias ani is ia a cue SE Magazine A On eens Aeon nee Tae neon A a a a a e ana DEIVICO noa ea IAS PvE TE EI AE Parts and Warranty ACCESSOTIES nean aa a a a a e adaa Page 1 General Precautions Failure to observe these precautions may result in injury to personnel or damage to device CAUTION Proper use of this device depends on careful reading of all instructions and labels CAUTION Steam Sterilize autoclave or ETO sterilize only Do not gamma ray sterilize CAUTION Do not sterilize pump or power supply rere WARNING After steam sterilization unit will be hot Allow adequate cooling time before handling Do not drop or mishandle unit Customer Responsibility This product and its components will perform properly and reliably only when operated and maintained in accordance with the instructions contained in this manual and accompanying labels A defective device should not be used Parts which may be broken or missing or are clearly worn distorted or contaminated should be replaced immediately with genuine replacement parts manufactured by or made available from Standard Imaging Inc A CAUTION Federal law in the U S A and Canada restricts the
3. Y ANY DEFECT FAILURE OR MALFUNCTION OF THE PRODUCT WHETHER A CLAIM OF SUCH DAMAGE IS BASED UPON THE WARRANTY CONTRACT NEGLIGENCE OR OTHERWISE Distributed by SeeDOS Ltd For further information or a quotation please contact Colin Walters at cwalters seedos com Page 9
4. ce Fig 2 which includes autoclaveable tubing to connect to the vacuum pump a special needle fitted with a glass or plastic tip to collect the seeds and spacers Fig 3 and an optional cartridge loading needle used when inserting seeds into the cartridge of a Mick TP Magazine REF 7609 7609 D Fig 4 A brass shield near the end of the hand piece provides radiation protection during the loading procedure In addition a fine screen embedded inside the hand piece prevents seeds from being sucked into the flexible tubing or vacuum pump If a seed is accidentally sucked into the hand piece simply turn off the vacuum pump and point the tip of the hand piece downward The needles attach to the hand piece via a standard Luer lock For the collec tion needles a crimp at the junction of the glass tube and the stainless steel tube prevents any material from being sucked into the hand piece Replacement tips should be sterilized and held in reserve in case one becomes non sterile during loading For the cartridge loading needle a single seed is picked up at one time and manipulated as needed The tubing and aluminum hand piece must be sterilized between each use All materials have been carefully selected to accommodate repeated sterilizations A UL listed wall transformer non sterilizable supplies the vacuum pump with power Page 3 Needle Loading To ease needle loading the Seed Vac needles can be rotated to point them in a dir
5. e glass To load the needle place the glass tip into the inner lumen of the implant needle being certain to seat the tip near the bottom of the lumenal funnel to insure a smooth flow of seeds into the needle Lift your finger from the hole to break the vacuum and release the seeds into the needle A WARNING Tilting the glass tip with respect to the lumen of the implant needle during this needle loading procedure could result in breakage of the glass tip Use every precaution to prevent this and be certain that no glass shards fall into the needle under any circumstances Glass needle tip breakage is an extremely unlikely event but users should be aware of this possibility and avoid it Seed Counting The SeedVac can also be useful for counting seeds as they are received from the manufacturer Simply verify the number of seeds that will fit into the glass tip at one time and then count the number of full tips that can be filled plus any remainder This greatly reduces manual counting time and radiation exposure time Page 4 Magazine Loading Insert the optional Cartridge Loading Needle onto the Luer lock tip of the SeedVac Prepare the seeds and magazines to be loaded as usual utilizing a stabilizing device for the cartridge such as the Mick V Block REF 7509 En able the vacuum and pick up a single seed as close to its center as possible Fig 6 If the seed is accidentally sucked into the needle tip it will be able to p
6. ection suitable for collecting seeds To do so attach a needle loosen the set screw holding the luer fitting rotate the needle to the desired positon tighten the set screw This should be done prior to sterilization Sterilize the hand piece and several needles prior to use following the sterilization equipment manufacturer s or healthcare facility s recommendations Users should validate the chosen steril ization procedures Do not sterilize the vacuum pump or its wall transformer Connect the tubing of the hand piece to the vacuum pump and one of the collection needles to the hand piece following the accepted sterility procedures set up by your institution Turn on the pump The seeds and spacers should already be available and in sight near the loading area To create a vacuum place your finger over the hole near the front of the hand piece applying firm pressure to make a seal As long as your finger remains over the hole there will be a continuous vacuum Touch the glass tip to the seed or spacer to be picked up Positioning the tip at a 30 40 degree angle will work well for sucking the seeds or spacers into the glass tube Fig 5 In addition by working behind a Needle Loading Shield such as SI Model No 90070 one can reduce finger dose by angling the tip around the side of the Shield Draw the desired sequence of seeds and spacers into the glass tip The se quence can be verified by visualizing the seeds and spacers through th
7. eld Finger hole to enable release vacuum Embedded screen Luer lock tip Hand Piece Figure 2 Crimp to prevent seed uptake Stainless steel Flexible joint Glass or plastic tube Standard luer fitting Special Needle for Seed Spacer Collection Figure 3 Page 6 Stainless steel Notch for seed pickup Standard luer fitting Optional Cartridge Loading Needle Figure 4 Typical Seed Loading Method Figure 5 Page 7 Parts and Accessories List 90091 72009 Replacement Glass Tip Set oes 10 glass tips without needles 72010 Replacement Needle Assembly Set pa 3 needle assemblies and 6 spare glass tips Optional Cartridge Needle 035 Hex Wrench Notice We welcome your evaluation of this manual Your comments and suggestions help us improve our publications Doc No 80191 03 8 00 9 pgs Page 8 Warranty This product is sold by Standard Imaging Inc under the warranty herein set forth The warranty is extended only to the buyer purchasing the product directly from Standard Imaging Inc or as a new product from an authorized dealer or distributor of Standard Imaging Inc For a period of twelve 12 months from the date of original delivery to the purchaser or a distributor this product is warranted against func tional defects in materials and workmanship glass components excluded provided it is prope
8. rly operated under conditions of normal use and that repairs and replacements are made in accordance herewith The forego ing warranty shall not apply if the product has been disassembled al tered or repaired other than by Standard Imaging Inc or if the product has been subject to abuse misuse negligence or accident Standard Imaging s sole and exclusive obligation and the purchaser s sole and exclusive remedy under the above warranties are limited to re pairing or replacing free of charge at Standard Imaging s option a prod uct 1 which contains a defect covered by the above warranties 2 which are reported to Standard Imaging not later than seven 7 days after the expiration date of the 12 month warranty period 3 which are returned to Standard Imaging promptly after discovery of the defect and 4 which are found to be defective upon Standard Imaging s examination Trans portation charges are the buyer s responsibility STANDARD IMAGING INC SHALL NOT BE OTHERWISE LIABLE FOR ANY DAMAGES IN CLUDING BUT NOT LIMITED TO INCIDENTAL DAMAGES CONSE QUENTIAL DAMAGES OR SPECIAL DAMAGES THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EX PRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE IN CLUDING ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICU LAR PURPOSE IN NO EVENT SHALL STANDARD IMAGING INC BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RE SULTING FROM THE USE MISUSE OR ABUSE OF THE PRODUCT OR CAUSED B
9. roceed only a short distance less than the seed length before being stopped by a perma nent block inside the needle tip Simply lift your finger to disable the vacuum and drop the seed Carefully insert the seed into the cartridge and slide downward Maintain the vacuum during this entire time to ensure maximum seed hold ing power Release the vacuum only after the seed is in place Repeat as needed to fill the cartridge Note The tip is centered on the seed before in sertion Maintain the vacuum until the seed is fully in position within the cartridge Figure 6 Inserting the seed into the magazine cartridge Maintenance Exterior cleaning of the vacuum pump can be done with a soft brush and a cloth Gently brush all surfaces to remove dirt and dust Remove any remaining dirt with a cloth slightly dampened with a solution of mild detergent and water or a liquid disinfecting agent Be especially careful that this is an external cleaning only and do not permit any liquid to seep into the vacuum pump in any manner during cleaning Check each glass tip before sterilization and use to make certain that no cracks or chips are visible Discard any damaged tips Replacement needle sets are avail able from Standard Imaging REF 72009 or 72010 Service There are no serviceable parts on the SeedVac Page 5 Vacuum port ST LJ On Off Vacuum Pump Figure 1 Radiation shi
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