IceRod CX Cryoablation Needles - Instructions for
Contents
1. renal artery renal vein injury renal capsule fracture renal failure renal hemorrhage renal infarct renal obstruction renal vein thrombosis rectourethral fistula scrotal edema sepsis skin burn frostbite stricture of the collection system or ureters stroke thrombosis thrombus embolism transient ischemic attack tumor seeding UPJ obstruction injury urethral sloughing urethral stricture urinary fistula urinary frequency urgency urinary incontinence urinary leak urinary renal leakage urinary retention oliguria urinary tract infection vagal reaction voiding complication including irritative voiding symptoms vomiting wound complication and wound infection IceRod CX Cryoablation Needles 9 8 Directions for Use NoTE The CX Cryoablation Needle is designed for use only with the Visual ICE Cryoablation System For information regarding software control of needle performance refer to the Visual ICE Cryoablation System User Manual 8 1 Needle Preparation 1 Using aseptic technique carefully remove the cryoablation needle from the package and place in a sterile work area 2 Needle testing is conducted by placing the needles in a large basin at least 30 cm in diameter containing sterile water or saline CAUTION Take care to maintain sterility of each needle during testing Secure the needle tubing to the sterile table prior to beginning the needle testing process Fill the basin halfway with sterile wat2. 1 6 Product Specifications 24245640444 a a k ax ieai 4 2 How Supplied 1 4 IGS erort edo aica la bal SH 2 kla SS b a W k a 5 4 Contraindications 5 n ae ETENEE elo Woh E E QAD Arb T ah eee 09 3 5 OPECUN cau 356 xa sal bab ee b bi di a a gi oe 6 hd ae eed wee on Be ae Re RS 6 6 2 Handling and Sterilization 7 Da CU bk ee nee a a ae Ak ed a ew 8 CAFM Dm ppoppDoDBDBoBDBBByB H 9 7 Potential Adverse Events 9 Dir Se j l Kuna ke 10 8 1 Needle Preparation 10 POCO US b a l 24S ark eee 10 8 3 Needle 12 9 DISCLAIMER OF 12 IceRod CX Cryoablation Needles ii 1 Product Description 1 1 Intended Use The Galil Medical patented 17G IceRod CX Cryoablation Needles are components used in conjunction with the Galil Medical Visual ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures The Needles are intended to convert high pressure gas to either a very cold Freez
3. Indicator is not positioned outside the patient s skin Pay attention to needle position to avoid thermal injury to adjacent tissue organs 11 Instructions for Use 8 3 Needle Removal If Track Ablation is performed lt Do not remove the needle until needle cooling is complete CAUTION Removing the needle while it is still hot presents a risk of injury to adjacent tissue and or organs If needle sticking is experienced use a slight gentle twist of the needle followed by slow withdrawal If Track Ablation is not performed Thaw thoroughly and stop all needle operation prior to removing needles to minimize the risk of tissue injury NOTE Galil Medical s ultra thin needles are specially designed with a three facet trocar like tip to minimize bleeding However some bleeding may occur In the event of bleeding apply treatment in accordance with good clinical practice and the hospital s treatment protocol For example following needle removal hold compression until hemostasis is achieved if necessary place an appropriate dressing on the needle insertion site 9 DISCLAIMER OF WARRANTY Although reasonable care has been used in the design and manufacture of this product Galil Medical has no control over conditions under which this product is used GALIL MEDICAL THEREFORE DISCLAIMS ALL WARRANTIES WHETHER EXPRESSED OR IMPLIED WRITTEN OR ORAL INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OF FITNESS FOR
4. The needle has not been tested for multiple use Do not resterilize a cryoablation needle Inspect the packaging for damage Do not use a cryoablation needle if packaging appears opened or damaged or the device is damaged in the event of such occurrence contact a Galil Medical representative to arrange return of the complete package with the product IceRod CX Cryoablation Needles T Open the outer pouch carefully aseptically remove inner pouches and transfer to the sterile area Before use always inspect needles for damage bending or kinking A bent or damaged cryoablation needle must never be used Do not bend a cryoablation needle Before use always perform the Needle Integrity and Functionality Test Do not use a cryoablation needle that has failed to pass the Needle Integrity and Functionality Test Following insertion of each needle into a needle connection panel port lock each needle channel by engaging the locking bar Cryoablation Needles have sharp tips Care should always be taken to ensure safe handling of needles to eliminate the risk of injury or possible exposure to blood borne pathogens 6 3 During Use Always ensure use of needles in a strictly sterile environment Select and insert sufficient needles to ablate the target site Use image guidance to monitor needle insertion iceball formation needle positioning and removal Use image guidance to monitor adequate coverage of target tissue and to care
5. e GALILMEDICAL ICEROD CX CRYOABLATION NEEDLES INSTRUCTIONS FOR USE R only CE CE Mark of Conformity D Do not reuse Use by LOT Batch code E Date of manufacture STERILE EO Sterilization using ethylene oxide Catalog number E Consult instructions for use Manufacturer Authorized representative in the European Community Do not use if package is damaged lt A c 5 9 D GTY Quantity This document provides instructions for use and recommended guidelines exclusively for the Galil Medical CX Cryoablation Needles This document is provided as an addendum to the User Manual supplied with each Galil Medical Visual ICE Cryoablation System The Visual ICE System User Manual should be relied on for detailed information regarding the operation of Galil Medical s Visual ICE Cryoablation Systems and IceRod CX Cryoablation Needles IceRod CX Cryoablation Needles Table of Contents 6x4 Akad k kul al a dl d kk eee W4 1 1 1 Intended 1 1 2 Technical Descriptio i al 1 1 3 Needle Performance Cryoablation 2 1 4 Needle Performance Active 3 1 5 Needle Performance Track 4
6. A PARTICULAR PURPOSE GALIL MEDICAL SHALL NOT BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE ARISING FROM OR RELATED TO THE USE OF THIS DEVICE IceRod CX Cryoablation Needles 12 For assistance contact www galilmedical com USA Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Telephone 1 651 287 5000 1 877 639 2796 Fax 1 651 287 5199 1 877 510 7757 Galil Medical Israel Ltd Industrial Park Tavor Building 1 Yokneam 20692 Israel Telephone 972 4 9093200 Fax 972 4 9591077 Obelis s a Boulevard G n ral Wahis 53 1030 Brussels Belgium Telephone 32 2 732 59 54 Fax 32 2 732 60 03 Copyright 2012 Galil Medical LGC11 IRX29en 02 Sept 2012 13 Instructions for Use
7. ablation In vivo iceball dimensions and resulting ablation zone are determined by the cryoablation needle type number of needles placed tissue and tumor characteristics thermal heat sink from surrounding vasculature and treatment duration Monitoring iceball formation provides direct control throughout the procedure and is key to cryotherapy success NOTE Using ultrasound or CT visualization monitor iceball formation throughout the cryoablation procedure 2 Instructions for Use 1 3 1 Laboratory Testing The following laboratory model of iceball dimensions is provided to assist users in selecting the cryoablation needle s and needle placement to appropriately ablate the target area Typically in vivo dimensions are smaller than the dimensions generated in the laboratory Laboratory testing was performed in room temperature 21 C gel measurements were made after two 10 minute Freeze cycles separated by a 5 minute passive Thaw cycle Accuracy is 3 mm width 4 mm length ISOTHERM IceRod CX DATA 0 C 43 mm x 60 mm 20 C 28 mm x 47 mm 40 E 17 mm x 41 mm Height in millimeters Fig IceRod CX Isotherm Data 1 4 Needle Performance Active Thaw The IceRod CX Cryoablation Needle supports active thawing using helium or active thawing without helium using an i Thaw internal heater In addition the i Thaw heater can be activated to conduct the optional FastThaw The FastThaw function generate
8. er or saline e Place the needles individually in groups in the basin such that the full length of the needle is submerged in the sterile water or saline 3 Remove the connector cap then connect the needle to the corresponding port on the cryoablation system needle connection panel The needle is now ready for the Needle Integrity and Functionality Test NOTE For detailed instructions on connecting needles to the system s Needle Connection Panel and performing the Needle Integrity and Functionality Test refer to the Visual ICE Cryoablation System User Manual 8 2 Needle Use 8 2 1 Needle Handling and Insertion Correct insertion of cryoablation needles into the target tissue is the responsibility of the physician NOTE Although the needle has a sharp tip a small skin incision may be made at the point of needle insertion Always use two hands and support the needle mid shaft with two fingers to eliminate the risk of bending Do not insert the needle into tissue while holding the handle with one hand only Insertion depth may be estimated using the needle marks on the shaft Use image guidance as necessary to guide needle insertion and placement Use image guidance to verify that a cryoablation needle is placed at the desired location prior to activating the needle IceRod CX Cryoablation Needles 10 8 22 Notes for Conducting Freezing Select Freeze intensity and initiate Freezing Continue Freeze cycle fo
9. fully monitor margins between ablation zone and critical adjacent structures Ensure all connections between the cryoablation system and the cryoablation needle are tight Do not kink pinch cut or pull excessively on needle tubing Damage to needle handle or tubing may cause the needle to become inoperable During use avoid damage to the needle or needle coating from handling or inappropriate contact with surgical instruments Avoid bending the needle shaft Do not grasp needles with auxiliary instruments as this may cause damage to the needle shaft Do not expose a cryoablation needle to organic solvents such as alcohol which may damage the needle Do not immerse the proximal handle or cable connectors in fluids these may affect performance Active thawing produces heat along the distal needle shaft Use care to avoid thermal injury to non targeted tissues Ensure adequate thawing before attempting to remove needles When conducting Track Ablation be alert for the Active Zone Indicator as the needle is withdrawn to prevent unintended tissue damage from a hot needle Instructions for Use 6 4 After Use After disconnecting needles from the Cryoablation System use strong scissors to cut each needle at the point where the gas tubing meets the handle Cryoablation Needles have sharp tips Care should always be taken to ensure safe disposal of needles To eliminate the risk of injury or possible exposure to blood borne pa
10. h needle must be locked into a needle channel before initiating a cryoablation procedure BEFORE THE PATIENT IS ANESTHETIZED Needle Integrity and Functionality Tests on each Cryoablation Needle and Thermal Sensor must be completed successfully A defective cryoablation needle with a gas leak can cause a gas embolism in the patient Such needle must never be used and should be returned to Galil Medical for inspection and replacement IceRod CX Cryoablation Needles 5 IceRod CX needles are designed and indicated for freezing and thawing applications These needles are not designed indicated or tested for thermal protection Serious injury to patient tissue may result if used for thermal protection In the rare event that a needle breaks while inserted in the tissue act immediately to remove needle parts from the patients body and report such event to Galil Medical If a needle inadvertently strikes bone do not start or continue the Freezing process When using an IceRod CX Needle for Active Thaw FastThaw or Track Ablation the needle is extremely hot and requires careful use Discontinue all needle operation prior to needle removal to minimize risk of tissue injury Once a needle is activated for Track Ablation the needle will no longer support a Freeze operation Remove needles from the patient prior to disconnecting needles from the Visual ICE Cryoablation System 6 Precautions 6 1 General The physician is solely res
11. he freeze thaw temperatures for the intended treatment protocol Cryoablation causes freezing of tissue To limit this effect to only the target ablation area the physician should determine the means to protect adjacent organs and structures If the Visual ICE Cryoablation System contains pressurized helium Track Ablation and FastThaw cannot be activated Always ensure selection of desired needle type at the physician s discretion To identify needle type refer to the color coding and printed text on the handle The CX needle operates only with the Visual ICE Cryoablation System Availability of a back up needle is recommended should a replacement or additional needle be required during a procedure Do not use IceRod CX needles labeled MR unsafe near magnetic resonance imaging MRI equipment Ensure appropriate stability of needle tubing to avoid inadvertent snagging of tubing and or needle shifting during a procedure Use special care if placing a cryoablation needle near an implanted device No data on cryoablation in combination with other therapies is available from Galil Medical Use care in handling needle packages during transport and storage 6 2 Handling and Sterilization Observe the expiration date of this product Do not use past the listed expiration date Before opening a needle pouch check the sterilization indicator within the pouch Each cryoablation needle is provided for one time use only
12. ing application or to a warm Thawing application 1 2 Technical Description Each disposable 17 gauge CX needle angled 90 has a sharp cutting tip a shaft with distal coating a color coded handle gas tubing and a connector All components are illustrated in Fig 1 needle marks and coating are shown in Fig 2 HA Cutting Tip 2 Low friction non stick Coating 1 Active Zone Indicator 17 Needle Shaft length 175 mm diameter 1 5 Needle Handle red 7 Electrical Connector EH E 5 Gas Tubing eng 25 E En EJ Fig 1 17G IceRod CX Cryoablation Needle Components IceRod CX Cryoablation Needles Tet Shaft Properties Description 1 Heating Portion Located within the distal needle shaft below the coated area 2 Low friction Coating Starts 4 5 mm from tip ends 50 mm from tip 3 Thin Marks Starts 55 mm from tip in 5 mm intervals 4 Thick Marks Starts 60 mm from tip in 10 mm intervals 5 Active Zone Indicator Starts 70 mm from tip 10 mm band 6 Double Thick Marks Located 100 mm from tip 7 Triple Thick Marks Located 150 mm from tip Fig 2 CX Cryoablation Needle Shaft Marks The Active Zone Indicator is a marked band along the needle shaft distal to the heating portion of the needle The location of the Active Zone Indicator guides needle withdrawal following Track Ablation 1 3 Needle Performance Cryo
13. ponsible for all clinical use of the cryoablation needle and for any results obtained by use of the system All clinical decisions prior to and throughout the cryoablation procedure shall be made by the physician based upon his her professional opinion Training on appropriate use of a Visual ICE Cryoablation System is required prior to conducting cryoablation with this system Confirm availability of sufficient gas argon helium to conduct the planned procedure number of needles needle operations activated gas cylinder size pressure and gas flow affect required gas volume The following table is provided to assist in estimation of argon requirements for a procedure Cryoablation Procedure Example Needles 421 US and Asia 6000 psi 9 50 L Europe 4350 psi 300 bar 4 IceRod CX needle operated for two 10 min Freeze cycles 100 intensity and two 30 sec Track Ablation cycles Instructions for Use Use of multiple needles is recommended to fully cover a target site and provide a suitable margin Multiple needles placed in an adjacent configuration will typically create a large coalesced iceball Iceball formation must be monitored using image guidance to optimize a successful ablation procedure Continuously monitor the cryoablation procedure using image guidance such as direct visualization ultrasound or Computer Tomography CT Use Galil Medical s 17G Multi Point Thermal Sensors MTS to monitor attainment of t
14. r duration and intensity necessary to optimize cryoablation of the target site CAUTION Continuously monitor iceball formation using image guidance such as direct visualization ultrasound or Computed Tomography CT to ensure adequate tissue coverage and to avoid damage to adjacent structures See the Visual ICE Cryoablation System User Manual for instructions on system controls available to manage each Freeze cycle 8 2 3 Notes for Conducting Thawing e Only argon gas must be connected to operate Thaw or FastThaw If helium is connected i Thaw FastThaw operations are disabled helium is then used for active Thawing See the Visual ICE Cryoablation System User Manual for instructions on system controls available for i Thaw and FastThaw options 8 2 4 Notes for Performing Track Ablation Track Ablation can be activated immediately following the final Freeze process OR following final Thaw Hold the needle in a stationary position during Track Ablation NOTE The CX needle must be used to Freeze prior to activation of Track Ablation Following Track Ablation the same CX needle may not be used again for Freezing Track Ablation may be repeated as required Prior to each reactivation slowly withdraw the needle 30 mm For detailed instructions on using and controlling the Track Ablation option refer to the Visual ICE Cryoablation System User Manual CAUTION Ensure the Active Zone
15. s a temperature that is higher than that required for i Thaw resulting in a faster thaw time 1 4 1 Laboratory Testing Laboratory testing was performed 37 C gel to evaluate IceRod CX thawing performance and provide users with comparative thawing characteristics A single 10 minute Freeze cycle was conducted to create an iceball on each test needle Activation of CX Needle FastThaw results in iceball thawing approximately 30 faster than IceRod PLUS Needle helium thawing NOTE n vivo thawing performance will be determined by numerous factors including number and type of cryoablation needles used needle location tissue characteristics duration of Thaw activation IceRod CX Cryoablation Needles 3 1 5 Needle Performance Track Ablation When an IceRod CX Cryoablation Needle is connected to a Visual ICE Cryoablation System activation of Track Ablation is an option During Track Ablation the needle heats to an internal temperature of over 220 C transferring heat along 30 mm of the distal needle shaft 1 5 1 Porcine Testing An in vivo study was conducted in porcine liver tissue to evaluate the Track Ablation performance of the CX Cryoablation Needle and to measure the depth of tissue necrosis Cryoablation followed by Track Ablation was performed in the porcine tissue Histological assessment demonstrated a fairly uniform zone of tissue necrosis surrounding the path of Track Ablation The average
16. tems are designed to destroy tissue including prostate and kidney tissue liver metastases tumors and skin lesions by the application of extremely cold temperatures Contact Galil Medical for information on other specific indications for use 4 Contraindications There are no known contraindications specific to use of the CX Cryoablation Needles 5 Warnings Do not use this device for any purpose other than the stated intended use A thorough understanding of the technical principles clinical applications and risk associated with cryoablation procedures is necessary before using this product Use of this device should be restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Visual ICE Cryoablation System An IceRod CX Cryoablation Needle is a disposable product and is designed as a single use product This device has not been validated for resterilization or reprocessing Potential anticipated risks associated with reprocessing of this product include but are not limited to inadequate sterilization thereby creating an increased risk of patient infections and increased risk of blood borne pathogen disease transmission degradation of the shaft insulation with subsequent change in thermal properties degradation of performance due to material fatigue and pressure gas leakage thereby creating an increased risk of patient embolism and risk of under or over patient treatment Eac
17. thogens used needles should be disposed of in a biohazard container in accordance with hospital and safety regulations 7 Potential Adverse Events There are no known adverse events related to the specific use of the Cryoablation Needles There are however potential adverse events associated with any surgical procedure Potential adverse events which may be associated with the use of cryotherapy may be organ specific or general and may include but are not limited to abscess adjacent organ injury allergic anaphylactoid reaction angina coronary ischemia arrhythmia atelectasis bladder neck contracture bladder spasms bleeding hemorrhage creation of false urethral passage creatinine elevation cystitis diarrhea death delayed non healing disseminated intravascular coagulation DIC DVT deep vein thrombosis ecchymosis edema swelling ejaculatory dysfunction erectile dysfunction organic impotence fever fistula genitourinary perforation glomerular filtration rate elevation hematoma hematuria hypertension hypotension hypothermia idiosyncratic reaction ileus impotence infection injection site reaction myocardial infarction nausea neuropathy obstruction organ failure pain pelvic pain pelvic vein thrombosis penile tingling numbness perirenal fluid collection pleural effusion pneumothorax probe site paresthesia prolonged chest tube drainage prolonged intubation pulmonary embolism pulmonary failure rectal pain
18. width of the zone of histologically confirmed tissue damage was 2 28 mm 0 68 mm 1 6 Product Specifications Materials Needle Shaft Stainless steel Low friction Shafi Haya g Teflon type fluoropolymer Needle Handle Brass coated with heat shrink tubing Gas Tubing Polyurethane Connector Polyoxymethylene a a i i i ee Pe DED as Sterilization Method Ethylene Oxide EO 2 How Supplied The disposable 17G CX Cryoablation Needles are packaged in a sealed film Tyvek pouch Each pouch is labeled Sterile for SINGLE USE only NoTE The Galil Medical Visual ICE Cryoablation System is supplied separately Needle connectors are protected by a rubber cap This cap should be removed before connecting a needle to a cryoablation system Storage Store in the original package in a cool dry place Use By Refer to expiration date marked on the external packaging 4 Instructions for Use 3 Indications for Use The Galil Medical CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures The CX Cryoablation Needle used with the Visual ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery dermatology neurology including cryoanalgesia thoracic surgery with the exception of cardiac tissue ENT gynecology oncology proctology and urology The Visual ICE Cryoablation Sys
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