HDR Prostate Contour Templates

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1 INSTRUCTIONS FOR USE HDR Prostate Contour Templates Large Matrix, Cat. # 0406 / Small Matrix, Cat. # 0404 Illustrated above is the HDR Contour Template (Small Matrix) configured for B&K with inserted 15.5 Gauge FlexiGuide Needles. Available Accessories through : Large and Small Matrix Prostate Contour Templates, Protective Cone & Leg Rest.

2 TABLE OF CONTENTS PARTS LIST / OPTIONAL ACCESSORIES. 3 ILLUSTRATION & LABELING OF SMALL TEMPLATE. 4 ILLUSTRATION & LABELING OF LARGE TEMPLATE.. 5 I. DESCRIPTION.. 6 II. FEATURES 6 III. MATERIALS.. 7 IV. INDICATIONS FOR USE 7 V. CONTRAINDICATIONS.. 7 VI. CAUTIONS/PRECAUTIONS.. 7 VII. COMPLICATIONS 8 VIII. RECOMMENDED INSTRUCTIONS FOR USE.. 8 IX. RECOMMENDED CLEANING PROCEDURE 10 X. STERILIZATION PROCEDURE

3 HDR Prostate Contour Templates Large Matrix, Cat. # 0406 / Small Matrix, Cat. # 0404 For use with FlexiGuide Needles NOTE: WHEN ORDERING THE HDR CONTOUR TEMPLATE, IT IS IMPERATIVE TO SPECIFY THE NEEDLE GAUGE TO BE USED AND THE MODEL OF THE ULTRASOUND TO ASCERTAIN COMPATIBILITY. THE TEMPLATES ARE AVAILABLE FOR MOST OF TODAY S EXISTING ULTRASOUND STEPPING DEVICES AND FOR A VARIETY OF FLEXIBLE NEEDLES. PARTS LIST SMALL MATRIX TEMPLATE INCLUDES 1. 1 ea. HDR Contour Template Body Cat. # ea. Locking Plate (matched to Template) Cat. # ea. Needle Lock Knob Cat. # ea. Protective Cone Lock Knobs Cat. # ea. Mounting Pins Cat. # ea Sterilization Tray Cat. # A 7. 1 ea Instructions for Use Manual Form. # LARGE MATRIX TEMPLATE INCLUDES: 1. 1 ea. HDR Contour Template Body Cat. # ea. Locking Plate (matched to Template) Cat. # ea. Needle Lock Knob Cat. # ea. Protective Cone Lock Knobs Cat. # ea. Mounting Pins Cat. # ea Sterilization Tray Cat.# A 7. 1 ea Instructions for Use Manual Form. # OPTIONAL ACCESSORIES (Can be ordered separately) 1. Sterile Disposable FlexiGuide Needle (25 per box each needle is provided with a Stylet) 15.5 Gauge x 20 cm & 15.5 x 25 cm Cat. # / Pathfinder Needle (sold individually) Cat. # 9807-PFO 3. Protective Cone Cat. # 807-PC 4. Leg Rest Cat.# 9807-LS 5. 6F MICK Sterile Stylets (36 ea. per box) Cat. # 1108 For one-time use only! 6. 6F MICK Reusable Stylets (provided individually) Cat. #

Small Matrix Template, Illustration of Parts & Labeling Small Matrix Prostate HDR Template Reduced

Matrix: 9 Rows a - f (1-5 ) 1 Row 5½ B - 5½ F / 1 Row 6b - 6e Spacing; 5.

a to small f to denote horizontal rows and with numbers 1 to 6 to denote the vertical rows.

for easy identification and traceability.

The Locking Plate is engraved with the needle gauge size as well as the matching serial number to

4 Small Matrix Template, Illustration of Parts & Labeling Small Matrix Prostate HDR Template Reduced in size & shape to conform more optimally to the perineum. Matrix: 9 Rows a - f (1-5 ) 1 Row 5½ B - 5½ F / 1 Row 6b - 6e Spacing; 5.0 mm Total of 115 holes Shown: B&K Compatible Labeling All templates are engraved with letters small a to small f to denote horizontal rows and with numbers 1 to 6 to denote the vertical rows. The Catalog number, needle gauge size and type are clearly inscribed on the top bar of the template for easy identification and traceability. The Serial Number is engraved on the underside of the top bar of the template for traceability. The Locking Plate is engraved with the needle gauge size as well as the matching serial number to the template body. Suture holes are incorporated peripherally on 4 corners of the template. FRONT & SIDE VIEW FRONT & TOP VIEW Catalog # Gauge Type Protective Cone Lock Knobs Needle Lock Knob Locking Plate Lift out to remove! Serial #- Backside 4

Large Matrix Template, Illustration of Parts & Labeling. Large Matrix Prostate HDR Template Matrix: A G / 1 7 13 Rows and 13 Columns / Hole Spacing; 5.

The Catalog number, needle gauge size and type are clearly inscribed on the top bar of the template for easy identification and traceability.

5 Large Matrix Template, Illustration of Parts & Labeling. Large Matrix Prostate HDR Template Matrix: A G / Rows and 13 Columns / Hole Spacing; 5.0 mm Total of 169 Holes Shown: B&K Compatible Labeling All templates are engraved with letters large A to large G to denote horizontal rows and with numbers 1 to 7 to denote the vertical rows. The Catalog number, needle gauge size and type are clearly inscribed on the top bar of the template for easy identification and traceability. The Serial Number is engraved on the underside of the top bar of the template for traceability. The Locking Plate is engraved with the needle gauge size as well as the matching serial number to the template body. Suture holes are incorporated peripherally on 4 corners of the template. FRONT & SIDE VIEW FRONT & TOP VIEW Protective Cone Lock Knob Needle Lock Knob Lock Plate Lift out to remove Catalog # Gauge Size Serial # - Backside Type 5

6 HDR Prostate Contour Templates I. DESCRIPTION For FlexiGuide Needles Catalog # s 0404(Small) & 0406 (Large) The HDR Contour Template is designed as a needle guidance system used for brachytherapy treatment of the prostate. The Template is offered in two sizes, small and large and contain an array of labeled needle channels to facilitate accurate placement of FlexiGuide needles into the prostate. The large template is square in shape and the small template has been downsized and shaped more optimally to conform to the perineum to provide a more comfortable fit and to ensure better needle placement. Both large and small templates feature a single Locking Plate actuated by a single Needle Lock Knob to simultaneously lock the array of implanted FlexiGuide Needles in place. There is a specially designed collar on the Needle Lock Knob that ensures a secure but safe holding of the respective needles in the template. This safety feature enables unobstructed passage of the HDR source through the implanted needles and prevents deformation of the FlexiGuide Needles while secured in locked position. FlexiGuide Needles are to be ordered separately. The HDR Contour TP Template Body and Locking Plate are entirely made of Aluminum and hard-coated. Three Titanium locking knobs are provided. The centrally located Needle Lock Knob serves to lock all FlexiGuide Needles simultaneously. The two lateral lock- knobs are used to dock the Protective Cone (provided separately) to the Template. The Template consists of two important components; the Contour Template Body and the Locking Plate. The Locking Plate moves bi-directionally to lock or unlock needles. Templates are fabricated for various gauge FlexiGuide Needles. IMPORTANT NOTE: HDR Contour Templates are design for Use with FlexiGuide Needles For Use with Rigid Needles, a different model template can be used The HDR Contour TP Template was designed for use with transrectal ultrasound (TRUS) imaging guidance. This is accomplished by mounting the template on a TRUS stepper / stabilizer system. The HDR Template is provided with two vertically mounted pins located at the base for compatibility with the B&K platform. II. FEATURES The following features are notable for the HDR Contour TP Template: Contoured to fit the sloping Perineum. One-lock mechanism for FlexiGuide Needles. Reusable and Autoclaveable. Provided with four suture holes allowing the template to be directly sutured to the perineum. Resistance-free Bore Holes for smooth Needle entry. It is used in conjunction with Ultrasound for enhanced needle guidance. Compatible with B & K, Siemens, Aloka and other Ultrasound Stabilizing Devices. Durable construction. 6

HDR Contour Template (Small Matrix) with inserted 15.5 Gauge FlexiGuide Needles and attached Protective Cone.

MATERIALS The following materials are used in the HDR Contour Template: HDR Contour Template and Locking Plate.

INDICATIONS FOR USE The HDR Contour TP Template is indicated for high-dose rate irradiation of the prostate. V.

Each physician is responsible for using the appropriate technique and determining the indication for use of th e HDR Contour TP Template,

7 HDR Contour Template (Small Matrix) with inserted 15.5 Gauge FlexiGuide Needles and attached Protective Cone. Needle Lock Knob Protective Cone Lock Knobs (2) Stylets Protective Cone 15.5 Gauge FlexiGuide Needles Contour Template Body III. MATERIALS The following materials are used in the HDR Contour Template: HDR Contour Template and Locking Plate.. Aluminum (Hard-coated) Lock Knobs. Titanium (Labeled with a T.) IV. INDICATIONS FOR USE The HDR Contour TP Template is indicated for high-dose rate irradiation of the prostate. V. CONTRAINDICATIONS As per acceptable clinical practice. VI. CAUTIONS / PRECAUTIONS 1. Each physician is responsible for using the appropriate technique and determining the indication for use of th e HDR Contour TP Template, based on his own experience, training and medical judgment. 2. The HDR Contour TP Template should only be used with the appropriate and matching FlexiGuide Needles. The Template is labeled according to Needle Size ordered. USING FLEXIGUIDE NEEDLES OF SIZES OTHER THAN THOSE MATCHING THE TEMPLATE CAN LEAD TO SERIOUS MALFUCTIONS AND MISADMINISTRATIONS. 7

8 3. All components of the HDR Contour TP Template must be properly cleaned and sterilized prior to every use. See Page 11 for Cleaning and Sterilization protocols. 4. FlexiGuide Needles made of Plastic materials cannot be provided with as sharp a point as a rigid needle and penetrating the skin may therefore be more difficult. Tenting may occur. It is strongly recommended using a Pathfinder Needle for the penetrati on of the ski n and to make a path for the FlexiGuide Needles to follow. This technique has proven to be beneficial. Pathfinders are available through SeeDOS Ltd (See page 3 for Optional Accessories) 5. Prior to use, verify that FlexiGuide Needles and Pathfinders are correct in size to match the template s gauge size. Special attention and care must be given to the FlexiGuide Needle tips. When used incorrectly and with inappropriate stylets, the tip of the FlexiGuide Needle may break off. HANDLE FLEXIGUIDE NEEDLES WITH UTMOST CARE! (Refer to separate Instructions for Use for the FlexiGuide Needle.) 6. Prior to use, the physical condition of all HDR Prostate Template components should be free of corrosion and in optimal working condition. Check for the integrity of the device after use. If corrosion or damage has occurred, the component has reached the end of its useful life and must be replaced. VII. COMPLICATIONS Contact SeeDOS Ltd for replacement. Possible complications associated with the HDR G YN Contour Template are related to in sertion and usage techniques and may include perforation, bleeding, mucosal irritation and infection. VIII. RECOMMENDED INSTRUCTIONS FOR USE NOTE: This Instruction for Use Manual re flects the use of th e Re-usable HDR Contour TP Template (#0404 & #0406)), with flexiguide needles. Rigid needles should not be used in these HDR Contour Templates. If the use of Rigid Needles is desired, a different type of re-usable HDR Contour Template is required. Contact SeeDOS Ltd for the appropriate re-usable HDR Contour TP Template. 1. Insertion of FlexiGuide Needles 1. Ascertain that the Needle Lock Knob is loosened. If needed, turn counterclockwise. 2. Ensuring the Stainless Steel stylet is inserted in the FlexiGuide Needle, insert the required number of needles through the needle ports in the Template to the required depth of treatment. (NOTE: FlexiGuide Needles provided separately). USEFUL TIP: For ease of penetration through the skin it is advantageous to use Pathfinder Needles, (# 9807-PFO). Insert Pathfinder Needles in the targeted holes of the Template to create a pathway for the flexible needles prior to insertion of the FlexiGuide Needle. NOTE: Pathfinders are provided separately. 8

3. Lock implanted FlexiGuide Needles in place by turning the Needle Lock Knob (#0404-38) clockwise by hand tightening. CAUTION!

Occasionally, the tip of a FlexiGuide Needle may be slightly larger in diameter and / or slightly bulbous preventing the FlexiGuide Needle from freely entering the needle channel in the template.

Caution: After needles are implanted use the Needle stylets to occlude the lumen of the needle to prevent foreign substances from entering the needle.

9 3. Lock implanted FlexiGuide Needles in place by turning the Needle Lock Knob (# ) clockwise by hand tightening. CAUTION! CAUTION! CAUTION! Occasionally, the tip of a FlexiGuide Needle may be slightly larger in diameter and / or slightly bulbous preventing the FlexiGuide Needle from freely entering the needle channel in the template. In this case Do Not use the FlexiGuide Needle and Do Not force it through the template as this could damage the FlexiGuide Needle. SHOULD THIS EVENT OCCUR - USE ANOTHER NEEDLE! Caution: After needles are implanted use the Needle stylets to occlude the lumen of the needle to prevent foreign substances from entering the needle. Recommendation: Prior to commencing HDR treatment, ascertain that all implanted FlexiGuide Needles are held in place securely. CONDUCT A MANUAL PULL TEST! Further tightening may be required. Conduct another pull test and continue tightening until the n eedle is tightened securely. If a particular needle remains loose, replace it with a new needle. IMPORTANT NOTE: The FlexiGuide Needles cannot be over tightened! Too much clamping pressure on the FlexiGuide Needles could result in shearing the plastic needle in half. To prevent shearing, a collar is incorporated in the Needle Lock Knob which limits the pressure on the FlexiGuide Needle while simultaneously allowing unobstructed HDR source movement through the needles. Additionally, Stylets can be reinserted to prevent the entry of unwanted fluids or matter. 4. Protecting Implanted Needles The protruding parts of the implanted needles may be subject to inadvertent or accidental displacement especially during the time span between fractions. Care must be taken to ensure that implanted FlexiGuide Needles remain in their original and planned treatment positions. PREVENTIVE MEASURES Protect the protruding FlexiGuide Needles by means of the Protective Cone (# 9807-PC). The following is strongly recommended: Upon completion of the treatment, carefully re-insert the Stylets into each of the implanted FlexiGuide Needles to prevent entry of foreign matter. Loosen the two Lock Knobs located on top of the template. Bundle the needles together and slide the Protective Cone over the implanted Needles. Dock the Protective Cone with the Template (see page 7) and turn the two Lock Knobs clockwise until the Cone is secured in place. Reverse the procedure at the start of a new treatment. 9

10 2. HDR Treatment CAUTION: Prior to the delivery of an HDR treatment, visually verify needle positions again to ascertain that all needles are still in their original positions as planned. ADJUST AS NEEDED. 1. Remove the Protective Cone from the Template by turning the Protective Cone Lock Knobs counterclockwise. 2. Carefully pull all Stylets out of the FlexiGuide Needles making sure to hold onto the plastic needle with one hand while pulling the Stylet out with the other. CAUTION: The process of connecting the Source Guide Tubes to the FlexiGuide Needles is delicate and utmost care and caution must be exercised during the coupling procedure of the remote afterloader to the FlexiGuide Needles. 3. POST HDR TREATMENT 1. Carefully disconnect all HDR Source Guide / Transfer Tubes from all implanted needles. Hold onto the FlexiGuide Needle with one hand while disconnecting the Source Guide / Transfer Tube with the other. 2. As needles are disconnected from Source Guide / Transfer Tubes, re-insert the Stylets into the implanted needles taking care not to displace the needle. Stylets should slide smoothly into the needles without strong resistance. NOTE: Please note that when re-inserting a stylet into a FlexiGuide Needle, some stylets may be a snug fit. Be advised that due to manufacturing tolerances of the needles, an Ir-192 HDR source has sufficient clearance on the inside of the needle for a smooth passing into the needle. IX. RECOMMENDED CLEANING PROCEDURE: 1. Upon completion of treatment, disassemble all components from the Template Body. 2. Insert all removed components into the Sterilization Cassette for cleaning and sterilization. 3. Soak all components in disinfectants as recommended by the hospital. 4. Immediately and thoroughly rinse all components with warm water. Caution: Prolonged exposure to some cleaning and disinfecting agents may affect the colour of the Aluminium based structure. Caution: Do not use Ultrasonic Cleaners or abrasive detergents. 10

11 X. STERILIZATION PROCEDURE After disassembling components from the Re usable HDR Contour TP Template and cleaning, insert all components in the Sterilization Cassette. All parts contained in the set can be AUTOCLAVED via Gravity Displacement method by using either Sterilization Parameter below. Temperature: 121 C or (250 F) Temperature 132 C or (270 F) Pressure 15 psig Pressure 15 psig Sterilization Time 30 Minutes Sterilization Time 3 minutes NOTE: The storage container doubles as a Sterilization Cassette. Warning: The cleaning and sterilization processes above will provide a sterile product. Any deviation from these reprocessing instructions must be properly qualified before patient use. DATA PROVIDED HEREIN IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED FOR CLINICAL USE OF ANY NATURE. USE OF THIS DATA IN SUCH A MANNER IS THE SOLE RESPONSIBILITY OF THE USER, AND THE AUTHOR OR SUPPLIER OF THIS INFORMATION MAKES NO CLAIM OR INFERENCE AS TO ITS CLINICAL SUITABILITY AND / OR ACCURACY. THE AUTHOR AND/OR DISTRIBUTOR OF THIS DOCUME NT ACCEPTS NO RESPONSIBILITY FOR THE USE OF THE DATA AND INFORMATION CONTAINED HEREIN. SeeDOS Ltd ASSUMES NO WARRANY OR LIABILITY FOR USE OF THIS INFORMATION OR PRODUCT. 11

STERILIZATION The following are GUIDELINES for product sterilization.

STERILIZATION The following are GUIDELINES for product sterilization. The following are GUIDELINES for product sterilization. Rultract retractor assemblies are reusable instruments. They are supplied non-sterile and must be cleaned and sterilized prior to initial use and