Instructions for Use Prostate
Contents
1. however they occur in lt 1 of patients e Nausea or sickness e Allergic reaction to antibiotic prophylaxis e Perineal swelling e Sepsis e Epididymitis e Temporary fecal incontinence e Urethral perforation e Deep venous thrombosis e Vascular embolization of the implant e g pulmonary embolism e Vasovagal episode e Cardiac arrhythmia SYMBOLS AND DESCRIPTIONS The following symbols are used in association with the Calypso System and Beacon transponders MR conditional Sterile using irradiation Symbol Do not re sterilize Do not use if package is damaged STERILE R Temperature Do not reuse ae limitation 55C 131F 18C 0F Humidity limitation Consult operating instructions Caution consult accompanying documents REFERENCES Raaijmakers R Roobol MJ Schroder FH Complication rates and risk factors of 5802 transrectal ultrasound TRUS guided sextant biopsies of the prostate within a population based screening program J Urol 2002 167 4 suppl 103 Kitamura K Shirato H Shimizu S et al Registration accuracy and possible migration of internal fiducial gold marker implanted in prostate and liver treated with real time tumortracking radiation therapy RTRT Radiother Oncol 2002 62 3 275 281 Nag S Vivekanandam S Martinez Monge R Pulmonary embolization of permanently implanted radioactive palladium 103 seeds for carcinoma of the prostate Int J Radiat Oncol Biol Phys 1997 39 3 667 672. 0 Pouliot J Aubin M Langen KM et al Non migration of radiopaque markers used for online localization of the prostate with an electronic portal imaging device Int J Radiat Oncol Biol Phys 2003 56 3 862 866 Shinohara K Roach M Ill Technique for implantation of fiducial markers in the prostate Urology 2008 71 2 196 200 Litzenberg DW Willoughby TR Balter JM Sandler HM Wei J Kupelian PA Cunningham AA Bock A Aubin M Roach M 3rd Shinohara K Pouliot J Positional stability of electromagnetic transponders used for prostate localization and continuous real time tracking Int J Radiat Oncol Biol Phys 2007 68 4 1199 206 Beacon and Calypso are registered trademarks of Varian Medical Systems Inc Varian Medical Systems Worldwide Headquarters 3100 Hansen Way Palo Alto CA 94304 USA Technical Assistance 888 488 7225 www calypsomedical com Patents pending Varian Medical Systems Seattle 2101 Ath Ave Suite 100 onal Seattle WA 98121 USA VMS UK Ltd Gatwick Road Crawley West Sussex RH10 9YRG United Kingdom 9
3. CALYPSO Beacon Care Package for Prostate Instructions for Use Varian Medical Systems LBLOO9O 002 Rev A 2012 2 10 Caution Federal law restricts this device to sale by or on the order of a physician INTRODUCTION Before implanting the Beacon transponders contained in this Beacon Care Package complete the Calypso training program and carefully read all sections in this document This document describes the Beacon Care Package components implantation procedure instructions and transponder placement in the prostate Each patient should be evaluated to determine if the patient is a candidate for implantation including whether their size limits them to setup for treatment or setup and tracking during treatment This must be evaluated prior to Beacon transponder implant following the guidelines outlined in the Calypso System User s Manual PRODUCT DESCRIPTION Beacon transponders are small passive electrical components encapsulated in biocompatible glass which are permanently implanted in or near the treatment target for use during radiation therapy Beacon transponders were developed specifically for use with the Calypso System in order to provide a reliable and accurate method for target localization and continuous real time tracking during radiation therapy treatments The Calypso System temporarily excites the implanted Beacon transponders each Beacon transponder then briefly emits a unique response signal which is dete
4. cted measured and used to determine the location of the patient s treatment target The Calypso System works in tandem with implanted Beacon transponders to continuously report the current position of the target relative to the treatment isocenter This Beacon Care Package contains three single use 14 gauge introducer needles introducers and Beacon transponders for implantation into a single patient Each transponder is manually loaded into the introducer for implantation INDICATIONS FOR USE The Calypso System is intended for use as an adjunct in treatment planning and radiation therapy to align and or monitor the patient s position relative to the isocenter of a radiation therapy system The Calypso System provides accurate precise and continuous localization of a treatment isocenter by using two or more Beacon transponders Implanted Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures Permanent Beacon transponders are indicated for implantation in the prostate and the peri prostatic tissue i e prostatic bed to align and monitor the treatment isocenter in real time during radiation therapy CONTRAINDICATIONS e Prosthetic implants in the pelvic region that contain metal or conductive materials e g an artificial hip e Use of anti coagulants or anti platelet drug therapy not including aspirin WARNINGS e The effect of the Calypso Sys
5. dard room temperature greater than 18 degrees C and less than 55 degrees C and kept dry e Beacon Care Packages contain introducer needles Handle introducers according to departmental sharps protocols COMPONENT DESCRIPTION Beacon Transponders Each Beacon transponder consists of a sealed biocompatible glass capsule containing a miniature passive electrical circuit Figure 1 The Beacon transponders are visible on kilovoltage radiographs CTs and ultrasound images Each Beacon transponder is packaged in a transfer capsule Figure 2 The transfer capsule is color coded and labeled A L or R to indicate the implant site for the Beacon transponder Apex Left mid gland or base Right mid gland or base The transfer capsule is used to load the Beacon transponder into the introducer Glass Capsule Electrical Components Figure Figure 2 Introducers e A separate introducer is used to implant each Beacon transponder into a region in or near the treatment target Each introducer consists of a customized 14 gauge needle assembly and an internal removable stylet A color mark on the hub indicates where the distal tip of the needle bevel is located e Each pouch contains one introducer and one Beacon transponder The Beacon transponder must be loaded into the introducer prior to implant see the section titled Preparing the Introducers for Implantation for complete instructions e A clip secures the extended stylet to
6. introducer is positioned within the prostate to prevent premature deployment of the Beacon transponder Insert the introducer into the needle guide 18 While holding the ultrasound transducer still position the introducer needle within the prostate so that the tip of the needle is positioned at the first target implant site and the entire beveled tip of the needle is within the prostate In the ultrasound image the needle bevel may be seen at the end of two bright parallel lines refer to Figure 9 If two bright lines are not visible the needle bevel may be seen as two bright points representing the proximal and distal tips of the bevel 19 When attempting to insert the needle into the prostate the prostate tissue may resist and become indented around the needle tip a phenomenon called tenting see Figure 10B To relieve the tenting and ensure the needle tip is completely within the prostate push the needle tip slightly farther into the prostate toward the anterior prostate border when viewed on the ultrasound image Figure 10C and then withdraw the needle slightly until the prostate returns to its original shape to view the actual insertion depth of the needle tip Return the distal point of the needle tip to the target site location FigurelOD LOC EE Figure 10 B Ae gt Pm pee 2 Es ONG el p Bi ees The entire beveled tip of the introducer needle must be completely inside the prostate gland
7. n or biopsy of the prostate e Instruct the patient on post operative care and potential complications e Wait 4 to 14 days after the implantation procedure to allow the prostate volume and Beacon transponders to stabilize e Acquire treatment planning CT images using either 1 0 mm or 1 5 mm slice spacing throughout the prostate e Perform treatment planning for external beam radiation therapy per standard institutional protocol e Perform external beam radiation therapy per standard institutional protocol e The implanted Beacon transponders can either be used as radiographic markers with kV x ray imaging or be used with the Calypso System to facilitate and optimize target localization and tracking during radiation therapy Refer to the Calypso System User s Manual ADVERSE REACTIONS Beacon transponders are implanted in the prostatic bed using standard introduction techniques for gold marker implantation and biopsy of the prostate e g transrectal The most frequent adverse events include e Bleeding e g hematuria hematospermia hematochezia e Pain e g procedural anal perineal bowel movements unspecified e Dysuria e Infection e g urinary tract infection e Fever Other observed adverse events include e Urinary retention e Urinary obstructive symptoms e g urinary frequency weak stream etc e Implant migration The following adverse events also have been documented in the literature following transrectal biopsy
8. nt and a sterile field have been prepared for placement of the introducers as is normally done for a gold marker fiducial implantation or prostate biopsy procedure e If necessary attach a sterile needle guide that will accommodate the 14 gauge introducers to the transrectal ultrasound probe Identify Target Implant Sites 11 Insert the transrectal ultrasound probe 12 Per institutional guidelines administer local anesthetics early in the procedure to provide time to take effect 13 Perform the TRUS study of prostate Using both sagittal and transverse TRUS planes survey the prostate and obtain a pre implant prostate volume to ensure adequate size for implantation 10 cc minimum volume recommended 14 Determine the optimal three target implant sites well within the prostate in the Apex Left mid gland or base and Right mid gland or base regions of the prostate refer to Figure 8 15 Select target implant sites to ensure best use with the Calypso System see Figure 8 Prepare and Insert First Introducer 16 Select the appropriate introducer device for the first target implant site e g Apex Left mid gland or base Right mid gland or base as indicated by the label and color of the introducer s clip and stylet Color Implantation Position in Prostate White Apex Blue Left mid gland or base Green Right mid gland or base 17 Remove the protective plastic sheath from the introducer but leave the clip in place until the
9. prior to deployment of the Beacon transponder If either the proximal end Figure 11A or the distal end Figure 11B of the needle tip bevel is positioned outside the prostate when the Beacon transponder is deployed it is possible that the transponder could be implanted outside the prostate Figure 11 B Incorrect Transponder Placement Deploy the Beacon Transponder 20 Remove the clip from the introducer Once the clip has been removed hold the introducer hub until the needle tip is positioned at the target site to prevent premature deployment of the Beacon transponder 21 While continuously holding the introducer in a stable position so that the tip remains stationary at the target site gently but steadily push the stylet forward while slightly retracting the cannula Figure 12 until the Beacon transponder is completely released from the introducer and seen on the ultrasound image Figure 12 Dispose of Used Introducer Needle 22 Withdraw the introducer needle Dispose of the used introducer needle in an appropriate sharps biohazard waste container Implant Remaining Beacon Transponders Repeat steps 16 through 22 to implant the second and third Beacon transponders using the appropriate introducer for each implant region of the prostate After Implantation Procedure e Survey the prostate with TRUS and locate the Beacon transponders e Follow standard practice for subsequent patient care following fiducial implantatio
10. ransfer capsule upright and screw the hub of the introducer needle onto the transfer capsule see Figure 6 This should be a snug not tight fit 6 Turn the introducer tip downward so that the Beacon transponder drops into the end of the introducer If the transponder does not drop on its own gently tapping the center of the capsule with your finger will cause the transponder to drop into the introducer see Figure 7 A slight crimp in the end of the introducer prevents the Beacon transponder from falling out Figure 7 Figure 6 Figure 5 7 Holding the introducer tip pointed downward unscrew the transfer capsule from the introducer hub 8 Ensure the clip is attached to the stylet before reinserting the stylet into the introducer 9 Continue to hold the introducer pointed downward and slowly insert the stylet into the introducer until the clip securely anchors the stylet being careful not to accidentally advance the Beacon transponder out of the needle 10 Place the loaded introducer on the sterile drape and repeat this procedure for the remaining introducers IMPLANT SITE RECOMMENDATIONS Using transrectal ultrasound imaging determine the optimal target implant sites for each of the 3 Beacon transponders before beginning the implantation procedure It is important to consider the following criteria when selecting target implant sites for the Beacon transponders to ensure optimal localization accuracy e Each Beacon tran
11. sponder has unique characteristics and the individual Beacon transponders are to be placed in the regions of the prostate indicated by the label and color coding of the introducer e Implant the Beacon transponders so that the transponders will be equidistant to the midpoint of the prostate e Implant the transponders such that they are well within the prostate e Avoid implanting the transponders near the urethra e The recommended distance between the transponders is 1 cm If the prostate is too small to accommodate this spacing select target implant sites within the prostate so that the Beacon transponders will be as far apart from each other as possible refer to Figure 8 C Transverse View Figure 8 Optimal Transponder Implantation Locations TRANSPONDER IMPLANTATION INSTRUCTIONS Patient Preparation Prior to Day of Implantation Per institutional guidelines consider antibiotic prophylaxis for fiducial implantation of the prostatic bed and use of local anesthesia Preparation on Day of Implantation e Have the patient perform routine bowel preparation to enable transrectal ultrasound TRUS imaging prior to the procedure e Load the Beacon transponders into the introducers and place them on a sterile drape prior to patient arrival as described in the Preparing the Introducers for Implantation section of this document e Prepare the patient for transrectal ultrasound TRUS examination e Ensure that the patie
12. tem operation on active implanted devices such as pacemakers and defibrillators in patients is unknown Be aware that the operation of the Calypso System may impact the normal functioning of such active implanted devices e Beacon Care Packages are gamma sterilized and are supplied sterile and non pyrogenic Use standard operating procedures to maintain the sterility of the devices during unpacking and use Do not use if package has previously been opened or appears to be damaged e Beacon transponders and introducers are for single use only Do not re sterilize or reuse e Each Beacon transponder has unique characteristics and should be implanted in the recommended region of the prostate The introducers are uniquely labeled and color coded to indicate the implant region e Beacon transponders must be implanted using transrectal ultrasound imaging for guidance e In the event that a Beacon transponder should drop onto the sterile drape during handling use only a gloved hand to pick up the transponder and place it in the hub end of the introducer do not use metal tweezers to pick up the transponder as it may damage the transponder surface If you must use metal tweezers to pick up the transponder discard the transponder If the transponder drops on a non sterile surface do not use the transponder e In the event that an introducer is damaged prior to use do not use the introducer for implant and dispose of it properly e Implantation
13. the needle hub see Figure 3 The clip should be reattached after the Beacon transponder is loaded in the introducer and should be left in place until the time of implant to prevent accidental premature deployment of the Beacon transponder Area of detail Figure 3 e Each Beacon transponder has a unique frequency associated with a specific region of the treatment target A L and R The introducer stylets and hubs are color coded blue white and green to distinguish them see Figure 4 Figure 4 Color Implantation Position in Prostate White Apex Blue Left mid gland or base Green Right mid gland or base PREPARING THE INTRODUCERS FOR IMPLANTATION Each Beacon Care Package consists of three pouches Each pouch contains one introducer and one Beacon transponder packaged in a Beacon transponder transfer capsule Open one pouch at a time to ensure the correct Beacon transponder is loaded in the corresponding introducer To load the Beacon transponder into the introducer 1 Place a sterile drape on a flat surface 2 Remove the transfer capsule and introducer from the pouch 3 Remove the stylet from the introducer leaving the clip attached to the stylet and place both the stylet and the introducer on the sterile drape 4 Hold the transfer capsule upright and unscrew the cap from the transfer capsule making sure that the Beacon transponder does not fall out of the capsule see Figure 5 5 Continue to hold the t
14. through a transperineal approach has not been evaluated PRECAUTIONS e Always follow the ultrasound transducer manufacturer s instructions when preparing the transducer to be used in an implant procedure e Non clinical testing has demonstrated that Beacon transponders are MR conditional A patient implanted with Beacon transponders can be safely scanned under the following conditions e Static magnetic field of 1 5T or 3T e Static magnetic field gradient of 2 51 m e Maximum whole body averaged specific absorption rate of 2 0 W kg for 20 minutes in the normal operating mode of MR scanning MR artifacts may extend up to and in some cases more than 2 cm from the transponder for a spin echo sequence e Use caution when the following additional therapies are required in the prostate brachytherapy treatment permanent seeds or HDR electrosurgical procedures e g harmonic scalpel transurethral needle ablation radio frequency RF ablation cryoablation lithotripsy and laser vaporization Avoid direct contact with the transponders when administering these therapies Beacon transponder functionality and encapsulation after administration of these therapies has not been assessed e Beacon transponders should be implanted only by physicians who have received Calypso implant training e Beacon Care Packages should be implanted before the sterilization expiration date on the package e Beacon Care Packages should be stored at stan
Download Pdf Manuals
Related Search