SeedVac TM REF 90091

Transcription

1 SeedVac TM REF STANDARD IMAGING INC Murphy Drive Middleton, WI Feb / Standard Imaging Inc. DOC # TEL TEL FAX R

2 General Precautions 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. WARNING: After steam sterilization, unit will be hot. Allow adequate cooling time before handling. Do not drop or mishandle unit. Warnings and Cautions alert users to dangerous conditions that can occur if instructions in the manual are not obeyed. Warnings are conditions that can cause injury to the operator, while Cautions can cause damage to the equipment. Typical Sterilization Procedures This section of the manual only refers to the hand piece and tube parts of the SeedVac TM. CAUTION: Do not use dry heat or chemical sterilization or damage to the parts may result. WARNING: These items are not sterile when shipped to the customer. Before use they must be sterilized using steam or ethylene oxide (EtO). All parts are fabricated from the highest quality aluminum, stainless steel and plastic, and are designed to withstand high temperatures: Steam sterilization (autoclave): Use the normal cycle (250 degrees F or 121 degrees centigrade at 15 psi for 15 to 30 minutes) or the flash cycle (270 degrees F or 132 degrees centigrade at 30 psi for 3 to 12 minutes). Ethylene oxide (EtO) sterilization: Use cycle and aeration times recommended by the manufacturer of the Sterilizer or use those determined at the hospital. Exterior cleaning should be done with a soft brush and a cloth. Gently brush all surfaces to remove dirt and dust. To remove any remaining dirt, use a cloth slightly dampened with a solution of mild detergent and water or a liquid disinfecting agent. 2

3 Table of Contents PAGE 2 General Precautions 3 Overview 4 General Operation 6 Maintenance 6 Parts and Accessories 7 Service Policy 7 Customer Responsibility 8 Warranty Overview 7601 MURPHY DRIVE MIDDLETON, WI USA The SeedVac TM 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 TM is composed of the following parts: A vacuum pump, Figure 1, an aluminum hand piece, Figure 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, Figure 3, and an optional cartridge loading needle, used when inserting seeds into the cartridge of a Mick TP Magazine (REF 7609, 7609-D), Figure 4. The needles attach to the hand piece via a standard Luer lock. For the collection 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. 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. 3

4 General Operation Crimp to prevent seed uptake Plastic tip Vacuum port On/Off switch (Flexible joint occurs at crimp) Glass tube Stainless steel Standard luer fitting Figure 1: Vacuum Pump Figure 3: Special needle for seed/spacer collection Radiation shield Finger hole to enable/release vacuum Stainless steel Notch for seed pickup Embedded screen Luer lock tip Standard luer fitting Figure 2: Hand Piece Figure 4: Optional cartridge loading needle Needle Loading To ease needle loading, the SeedVac needles can be rotated to point them in a direction suitable for collecting seeds. To do so, attach a needle, loosen the set screw holding the luer fitting, rotate the needle to the desired position, 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 health care facility s recommendations. Users should validate the chosen sterilization 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 degree angle will work well for sucking the seeds or spacers into the glass tube, Figure 5. In addition, by working behind a Needle Loading Shield, such as SI Model No , 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 sequence can be verified by visualizing the seeds and spacers through the 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. 4

5 General Operation Continued 30 o - 40 o Figure 5: Typical seed loading method 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. 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 holding 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 insertion. Maintain the vacuum until the seed is fully in position within the cartridge. Figure 6: Inserting the seed into the magazine cartridge 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. 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). Enable the vacuum, and pick up a single seed as close to its center as possible Figure 6. If the seed is accidentally sucked into the needle tip, it will be able to proceed only a short distance (less than the seed length) before being stopped by a permanent block inside the needle tip. Simply 5

6 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 available from Standard Imaging, REF or There are no serviceable parts on the SeedVac. If assistance is desired in the proper disposal of this product (including accessories and components), after its useful life, please return to Standard Imaging. Parts and Accessories REF Description SeedVac Instruction Manual Replacement Glass Tip Set (10 glass tips without needles) Replacement Needle Assembly Set (3 needle assemblies and 6 spare glass tips) Wall Mount Power Supply Optional Cartridge Needle.035 Hex Wrench Product Standards: IEC Externally Certified 6

7 Service Policy Customer Responsibility If service, including recalibration, is required, please contact Standard Imaging s Customer Service department by phone or prior to shipping the product. Standard Imaging s Customer Service and Technical Service staff will attempt to address the product issue via phone or . If unable to address the issue, a return material authorization (RMA) number will be issued. With the RMA number, the product can be returned to Standard Imaging. It is the responsibility of the customer to properly package, insure and ship the product, with the RMA number clearly identified on the outside of the package. The customer must immediately file a claim with their carrier for any shipping damage or lost shipments. Return shipping and insurance is to be pre-paid or billed to the customer, and the customer may request a specific shipper. Items found to be out of warranty are subject to a minimum service fee of 1 hour labor (excluding recalibrations) for diagnostic efforts and require a purchase order (PO) before service is performed. With concurrence from customer, the product may be replaced if it is unserviceable or if the required service is cost prohibitive. Products incurring service charges may be held for payment. Standard Imaging does not provide loaner products. See the Standard Imaging Warranty and Customer Responsibility for additional information. 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. CAUTION: Federal law in the U.S.A. and Canadian law restrict the sale, distribution, or use of this product to, by, or on the order of a licensed medical practitioner. The use of this product should be restricted to the supervision of a qualified medical physicist. Measurement of high activity radioactive sources is potentially hazardous and should be performed by qualified personnel. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from Standard Imaging Inc. prior to such repair or replacement. If this product 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. After repair, the product may need to be calibrated. The owner of this product has sole responsibility for any malfunction resulting 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. 7

8 Warranty Standard Imaging, Inc. sells this product 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 provided in the table below from the date of original delivery to the purchaser or a distributor, this Standard Imaging, Inc. product, provided in the table is warranted against functional defects in design, materials and workmanship, provided it is properly operated under conditions of normal use, and that repairs and replacements are made in accordance herewith. The foregoing warranty shall not apply if the product has been altered, disassembled or repaired other than by Standard Imaging, Inc. or if the product has been subject to abuse, misuse, negligence or accident. Product Standard Imaging Ionization Chambers Standard Imaging Well Chambers Standard Imaging Electrometers Standard Imaging Software Products All Other Standard Imaging Products Standard Imaging Custom Product Consumables Serviced Product Resale Products ADCL Product Calibration (Standard Imaging uses the UW-ADCL for recalibrations required under warranty) Warranty Period 2 years 2 years 2 years 1 year 1 year 90 days 90 days 90 days As defined by the Original Equipment Manufacturer 0-90 days = 100% of ADCL Calibration Costs days = 75% of ADCL Calibration Costs days = 50% of ADCL Calibration Costs days = 25% of ADCL Calibration Costs (days from date of shipment to customer) Standard Imaging s sole and exclusive obligation and the purchaser s sole and exclusive remedy under the above warranties are, at Standard Imaging s option, limited to repairing, replacing free of charge or revising labeling and manual content on, a product: (1) which contains a defect covered by the above warranties; (2) which are reported to Standard Imaging, Inc. not later than seven (7) days after the expiration date of the warranty period in the table; (3) which are returned to Standard Imaging, Inc. promptly after discovery of the defect; and (4) which are found to be defective upon examination by Standard Imaging Inc. Transportation related charges, (including, but not limited to shipping, customs, tariffs, taxes, and brokerage fees) to Standard Imaging are the buyer s responsibility. This warranty extends to every part of the product except consumables (fuses, batteries, or glass breakage). Standard Imaging, Inc. shall not be otherwise liable for any damages, including but not limited to, incidental damages, consequential damages, or special damages. Repaired or replaced products are warranted for the balance of the original warranty period, or at least 90 days. This warranty is in lieu of all other warranties, express or implied, whether statutory or otherwise, including any implied warranty of fitness for a particular purpose. In no event shall Standard Imaging, Inc. be liable for any incidental or consequential damages resulting from the use, misuse or abuse of the product or caused by any defect, failure or malfunction of the product, whether a claim of such damages is based upon the warranty, contract, negligence, or otherwise. This warranty represents the current standard warranty of Standard Imaging, Inc. Please refer to the labeling or instruction manual of your Standard Imaging, Inc. product or the Standard Imaging, Inc. web page for any warranty conditions unique to the product. 8