Cryoablation Needles 17G MRI - Instructions for Use
Contents
1. 6 ss oon ob hed cbs oboe Rb aka tb hen TS 6 2 Handling and Sterilization TI 7 Potential Adverse Events 8 Directions for 8 1 Removal from 8 2 Needle Handling Insertion and Removal 9 DISCLAIMER OF WARRANT Y cs cc Gescceedecnt ees 17G MRI Cryoablation Needles 1 Product Description 1 1 Intended Use The Galil Medical patented 17G MRI Cryoablation Needles are components used in conjunction with a Galil Medical Cryoablation System when performing cryogenic destruction of tissue and are intended to convert high pressure gas to either a very cold Freezing application or to a warm Thawing application 1 2 Technical Description Each 17 gauge disposable MRI cryoablation needle straight or angled 90 has a sharp cutting tip a shaft a color coded handle a gas tube and a connector All components are illustrated in Fig 1 needle markings are shown in Fig 2 H me ih A a Cutting Tip Needle Shaft length 175 mm diameter 1 5 mm 3 Needle Handle color coded La Gas Tube length 2 5m s Fig 1 17G MRI Cryoablation Needle Components 17G MRI Cryoablation Needles 1 Needle markings begin 20 mm from the needle tip and include a thin mark every 5 m2. The 17G disposable MRI cryoablation needles are packaged in a sealed film Tyvek pouch Each pouch is labeled Sterile for SINGLE USE only NoTE The Galil Medical 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 3 Indications for Use The Galil Medical Cryoablation Systems are intended for cryogenic destruction of tissue during surgical procedures various Galil Medical ancillary products are required to perform these procedures Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery dermatology neurology including cryoanalgesia thoracic surgery ENT gynecology oncology proctology and urology These Systems are designed to destroy tissue including prostate and kidney tissue liver metastases tumors skin lesions and warts by the application of extremely cold temperatures A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manuals 17G MRI Cryoablation Needles 3 4 Contraindications There are no known contraindications specific to use of the Galil Medical 17G MRI Cryoablation Needles 5 Warnings Do not use this device for any purpose other than the stated
3. MRI conditional needles MRI text on the needle handle packaging is labeled MR conditional Do not use standard cryoablation needles labeled MR unsafe near magnetic resonance imaging MRI equipment 6 2 Handling and Sterilization Observe the expiration date of this product Do not use past the listed expiration date Before opening a needle pack check the sterilization indicator in the external packaging Each cryoablation needle is provided for one time use only 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 Open the outer pouch carefully aseptically remove each inner pouch 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 attempt to bend a straight 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 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
4. e GALILMEDICAL 17G MRI CRYOABLATION NEEDLES INSTRUCTIONS FOR USE C 0473 CAUTION Federal USA law restricts this device to sale by or on R only the order of a physician CE D CE Mark of Conformity Do not reuse Use by Batch code H 1 STERILE Date of manufacture Sterilization using ethylene oxide E Catalog number Consult instructions for use Authorized representative in the European Community Manufacturer Do not use if package is damaged MR conditional QTY Quantity This document provides instructions for use and recommended guidelines exclusively for the Galil Medical 17G MRI Cryoablation Needles This document is provided as an addendum to the User Manual supplied with each Galil Medical Cryoablation System The system User Manual should be relied on for detailed information regarding the operation of Galil Medical s Cryoablation Systems and Cryoablation Needles 17G MRI Cryoablation Needles 1 Product Description 1 1 Intended Use 1 2 Technical Description ble of Contents 1 3 Galil Medical 17G MRI Cryoablation Needles 1 4 Needle Performance 1 5 Product 5 lt 2 How Supplied 3 Indications for Use Seite Fe i a E 5
5. 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 Galil Medical Cryoablation System The Galil Medical 17G MRI 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 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 BEFORE THE PATIENT IS ANESTHETIZED Integrity and Functionality Tests on the Cryoablation Needles and Thermal Sensors 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 In the rare event that a needle breaks while inserted in the tissue act immediately to remove needle parts from the patient s body and report such event to Galil Me
6. pathogens 17G MRI Cryoablation Needles 5 6 3 During Use Use imaging guidance to monitor needle insertion positioning and removal Always ensure use of needles in a strictly sterile environment 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 from other 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 which may affect performance 6 4 After Use After disconnecting needles from the cryoablation system use strong scissors to cut each needle at the point where the plastic 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 pathogens 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 a
7. 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 8 Directions for Use 8 1 Removal from Package 1 Remove the cryoablation needle from the package and place in a sterile work area 2 Place the needle in its appropriate position in the 17G Cryoablation Needle Holder according to the planned needle configuration refer to Needle Testing Device Instructions for Use Remove the connector cap then connect the needle to the corresponding port on the cryoablation system manifold needle connection panel The needle is now ready for the Integrity and Functionality Test NoTE For detailed instructions on connecting needles to the system manifold and performing the Needle Integrity and Functionality Test refer to the appropriate Cryoablation System User Manual 8 2 Needle Handling Insertion and Removal Correct insertion of cryoablation needles into the target tissue is the responsibility of the physician Note Needles have a sharp tip usually no additional incision is required 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 han
8. dical If a needle inadvertently strikes bone do not start or continue the Freezing process 6 Precautions 6 1 General The physician is solely responsible 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 Galil Medical Cryoablation System is required prior to conducting cryoablation with a Galil Medical System Instructions for Use Continuously monitor the cryoablation procedure using imaging guidance such as direct visualization ultrasound Computer Tomography CT or Magnetic Resonance Imaging MRI Use Galil Medical s 17G MRI Single Point Thermal Sensors TS to monitor attainment of the 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 As an example the skin surface can be protected by warm saline irrigation or other means as determined by the physician 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 When performing MRI guided cryoablation procedures ensure selection of Galil Medical s
9. dle with one hand only Insertion depth may be estimated using the needle marking on the shaft Use imaging guidance as necessary to guide needle insertion and placement Use imaging guidance to verify that the cryoablation needle is placed at the desired location prior to activating the needle Thaw as necessary before removing needle NoTE Galil Medical s ultra thin MRI needles are specially designed with a cone shaped tip to minimize bleeding However some bleeding may occur In the event of bleeding apply treatment in accordance with good clinical practice and hospital s treatment protocol For example following removal of needle hold compression until hemostasis is achieved and if necessary place appropriate dressing on needle insertion site 17G MRI Cryoablation Needles 7 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 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 8 Instructions for Use For assistance contact www galilmedical com USA Galil Medical Inc 4364 Round Lake R
10. dverse 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 DVT ecchymosis edema swelling ejaculatory dysfunction erectile dysfunction organic impotence fever fistula glomerular filtration rate elevation hematoma hematuria hypertension hypotension hypothermia idiosyncratic reaction ileus impotence infection injection site reaction myocardial infarction nausea neuropathy obstruction pain pelvic pain pelvic vein thrombosis penile tingling numbness perforation GU perirenal fluid collection pleural effusion pneumothorax probe site paresthesia prolonged chest tube drainage prolonged intubation pulmonary embolism pulmonary failure rectal pain renal artery renal vein injury renal capsule fracture 6 Instructions for Use 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
11. m a thicker mark every 10 mm a single heavy mark at 50 mm a double heavy mark at 100 mm and a triple heavy mark at 150 mm 175 mm 150 mm 100 mm 50 mm 20 mm dl Fig 2 17G MRI Cryoablation Needle Shaft Markings 1 3 Galil Medical 17G MRI Cryoablation Needles Cryoablation Needle Type Handle Color IceSeed MRI IceSeed MRI IceRod MRI IceRod MRI NOTE Galil Medical s standard Cryoablation Needles are described the Galil Medical 17G Cryoablation Needles nstructions for Use 1 4 Needle Performance The needle type determines the iceball dimensions Iceball dimension measurements were made after two cycles of 10 min 100 Freezing separated by 5 min Thawing in gel at room temperature Accuracy is 2 mm width 3 mm length IceSeed IceRod 1 47 mm 17 gauge 1 47 mm 17 gauge 31mm 36mm 40mm x 58mm 19mm x 26 5mm 27mm x 50mm 10 5mm x 19mm 16mm 41mm 2 2 I 2 Instructions for Use NoTE For information regarding software control of needle performance refer to the appropriate cryoablation system User Manual 1 5 Product Specifications Materials Needle Shaft Stainless steel MRI Needle shaft Nickel Chromium superalloy Needle Handle Brass coated with heat shrink tubing Gas Tube Polyurethane Connector Polyoxymethylene gt naa naja Sterilization Method Ethylene Oxide EO 2 How Supplied
12. oad Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 Europe Galil Medical UK Ltd The Office Building Suite 21 Gatwick Road Manor Royal Crawley West Sussex RH10 9RZ United Kingdom Telephone 44 0 1 293 459848 Fax 44 0 1 293 459840 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 E mail mail obelis net 0473 Copyright 2010 Galil Medical LGC10 NDM10en 01 July 2010 17G MRI Cryoablation Needles 9
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