Nucletron

Advanced Gynecological Applicator Instructions for Use

64 Pages

Table of Contents Table of Contents Chapter Title Page 1 Introduction... 4 2 Preparations before use... 7 3 Inspection of the parts before use... 9 4 Insertion... 10 5 Imaging... 30 6 Source dwell positions... 33 7 Treatment... 35 8 Removal, disassembly, disposal... 37 9 Reprocessing... 38 10 Appendices... 50 Advanced Gynecological Applicator Instructions for Use ©2016 Elekta. All rights reserved. Document ID: 777.00493MAN-04 Page 3

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Advanced Gynecological Applicator

Instructions for Use for: 3905TH

Document ID: 777.00493MAN-04 Publication date: 2017-02 Language: English

Copyright © 2016 Elekta. All rights reserved. No part of this documents may be reproduced in any form without written permission from the copyright holder. Trademarks All trademarks of Elekta products are the property of Elekta. Acknowledgment of other trademarks Elekta acknowledges the trademarks and registered trademarks of other manufacturers that we use in this document. Referenced documents Elekta does not supply all the documents that we refer to in this document with the equipment. Elekta reserves the right to make the decision on which of the documents we supply with the equipment. Contact information MANUFACTURER Nucletron B.V. Subsidiary of Elekta AB Waardgelder 1 3905 TH VEENENDAAL The Netherlands Tel.: +31 318 557 133

TECHNICAL SUPPORT Contact your local Elekta representative for technical support or visit www.elekta.com

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Table of Contents

Table of Contents Chapter Title

Page

Introduction... 4

Preparations before use... 7

Inspection of the parts before use... 9

Insertion... 10

Imaging... 30

Source dwell positions... 33

Treatment... 35

Removal, disassembly, disposal... 37

Reprocessing... 38

Appendices... 50

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Introduction

1.1

Intended use The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

WARNING 1.1 The Advanced Gynecological Applicator can only be used by qualified physicians, trained in brachytherapy techniques. The physician is responsible for its proper clinical use and the prescribed radiation dose.

CAUTION 1.1 Federal (U.S.) and State laws restrict the sale of this product to a physician or on a physician's order.

1.2

Contraindications There are no known general contraindications for using this device.

1.3

Adverse reactions There are no known adverse reactions.

1.4

Device description The Advanced Gynecological Applicator is a gynecological applicator for intracavitary and interstitial brachytherapy treatment. You can use it for treatment of the vagina, cervix and uterus. The applicator consists of tubes, caps and templates to place needles. You can combine components to reach a wide range of target areas. The tubes and the needles, if used, guide the radioactive source of the afterloader to the target volume.

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Introduction

Figure 1.1 Overview of the Advanced Gynecological Applicator

(1)

Interstitial Lunar Ovoid Tube (7)

Bracelet for Guiding Tube

(2)

Intrauterine Tube

(8)

Number Tag for Guiding Tube

(3)

Vaginal Cap

(9)

Perineal Template Dorsal

(4)

Guiding Tube

(10) Perineal Template Ventral

(5)

Fixation Element

(11) Perineal Bar

(6)

Fixation Clip

The minimum configuration contains two Interstitial Lunar Ovoid Tubes (1), which you assemble in the vagina onto an Intrauterine Tube (2). The Interstitial Lunar Ovoid Tubes (1) and Intrauterine Tube (2) have a channel to guide a radioactive source through the tube to a certain position. You can fix the applicator tubes with the Fixation Element (5) and the Fixation cCip on top (6). On each of the Interstitial Lunar Ovoid Tubes (1), you can assemble a Vaginal Cap (3). The tubes and caps are available in different sizes and shapes to fit in the patient's body. After you have inserted the applicator in the patient, you can use dedicated guiding tubes (4) to insert, guide and lock the needles. To Advanced Gynecological Applicator Instructions for Use ©2016 Elekta. All rights reserved.

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Introduction

identify the needle/channel numbers, you can attach number tags (8) to the guiding tubes. To have an overview of all needles, you can sort them with a bracelet (7). With the Perineal Templates Dorsal (9) and Ventral (10), you can insert needles in parallel from the perineum into the parametrium. The Perineal Bar (11) is a tool to fixate the applicator to the patient.

1.5

Life expectancy • Guiding tubes, number tags and bracelet: Single use products. • Other parts: Reusable, delivered non-sterile. Typical life expectancy of 3 years or 100 uses, whichever comes first.

1.6

Compatible devices The Advanced Gynecological Applicator is compatible with the following Elekta devices: • Brachytherapy Systems: Flexitron HDR, Flexitron Cobalt-60, microSelectron Digital V3, microSelectron V2 • Radiotherapy Planning System: Oncentra Brachy (Oncentra Masterplan) • ProGuide needles, interstitial titanium needles, catheters, markers, transfer tubes For full details on Compatible Devices, see the Compatible devices appendix.

1.7

MRI safety information The Advanced Gynecological Applicator is MR Safe. Compatible devices and accessories may not be MR Safe, e.g. X-ray catheters, transfer tubes and other items with metal parts. Consult the applicable instructions for use.

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Preparations before use

Preparations before use Read the following warnings, cautions and notes to prepare for the insertion, imaging and treatment procedure.

WARNING 2.1 Carefully read all instructions prior to use. Observe all cautions and warnings throughout these instructions. Failure to do so may result in complications.

WARNING 2.2 Make sure that all components are clean, sterile and undamaged before use. Incorrect cleaning and sterilization can result in clinical complications. Remove damaged components from clinical use.

WARNING 2.3 Ensure proper placement of the intrauterine tube to avoid perforation of the uterine wall.

WARNING 2.4 Fixation of the applicator must be performed properly to avoid unintended movement of the applicator during treatment preparation, planning and execution.

WARNING 2.5 Excessive patient movements and other excessive external forces can cause disconnected, kinked or damaged transfer tubes and applicators.

WARNING 2.6 Do not put too much force on the applicator to avoid damage or too much bending of the applicator tubes. A damaged applicator can cause patient injury.

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Preparations before use

WARNING 2.7 The physical position and properties of applicators might change due to patient movement, changes in temperature and humidity. Before every treatment, check there is a clear passage for the source and that the treatment plan is valid for the applicator position relative to the patient.

WARNING 2.8 Verify the applicator length where treatment is to be applied.

WARNING 2.9 To accurately plan the treatment and to activate the appropriate dwell positions for clinical treatment, the X-ray catheters for use during the imaging procedure must be calibrated to the appropriate source positions.

WARNING 2.10 Take care not to damage or kink the X-ray catheters. This may lead to inaccurate indication of source positions.

WARNING 2.11 Regularly check the length of each transfer tube to ensure the accuracy of source positioning.

WARNING 2.12 Do not mix up channel numbers during imaging, treatment planning, treatment verification and treatment execution.

CAUTION 2.1 Only remove sterilization caps from the open end of applicator tubes for assembly of the applicator, the insertion of markers or to connect transfer tubes, to prevent foreign materials and/or bodily fluids entering the applicator.

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Inspection of the parts before use

Inspection of the parts before use Before use, inspect all the applicator parts and accessories that will be used for the procedure. • All parts to be used must be clean and sterile. • Inspect the packaging and shelf life of the product. For sterile delivered products, inspect the sterile package for seal integrity and damage to the package before opening and using the product. • Visually inspect all parts for indication of unacceptable weakening, bending, cracks, corrosion, general deterioration or damage. • Inspect joints and connections on play, strength or other forms of degradation. • Remove unacceptable parts from clinical use. • Perform appropriate QA and commissioning tests before you use the applicator clinically.

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Insertion

4.1

Insert applicator

Note:

If you want to use interstitial needles, assemble the applicator as described in the Insert Needles via Vagina section.

Note:

If you use the Intrauterine Tube 30mm 15° combined with needles, the needles will not run parallel to the Intrauterine Tube. Elekta recommends to only use the Intrauterine Tube 30mm 15° when you cannot use the Intrauterine Tube 30mm 30°.

Figure 4.1 Intrauterine Tube

1 Add the Sterilization Caps to the Intrauterine Tube (1) and the Interstitial Lunar Ovoid Tubes. Sterilization Caps are used to protect the inner lumen from contamination. 2 Insert the Intrauterine Tube (1) into the vagina until it is in position using standard gynecological techniques.

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Insertion

Figure 4.2 Lock the Interstitial Lunar Ovoid Tube on the Intrauterine Tube

3 Guide one of the Interstitial Lunar Ovoid Tubes (in the image shown: Right) along the Intrauterine Tube. 4 Fit the locking element on the Intrauterine Tube into the notch of the Interstitial Lunar Ovoid Tubes (A).

Figure 4.3 Click mechanism on the Intrauterine Tube

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Insertion

5 Lock the Interstitial Lunar Ovoid Tube to the Intrauterine Tube with the click mechanism (1). 6 Do the same with the Interstitial Lunar Ovoid Tube (Left).

Figure 4.4 Interstitial Lunar Ovoid Tubes connected to the Intrauterine Tube

Note:

Make sure that the Interstitial Lunar Ovoid Tubes are correctly attached to the Intrauterine Tube. If the two ovoid tubes are aligned, you can click the ovoid tubes to the Intrauterine Tube without effort.

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Insertion

Figure 4.5 Lock the Fixation Element

7 Optionally, attach the Fixation Element (1) onto the applicator. 8 To lock the Fixation Element, horizontally move the Fixation Clip (2) into the Fixation Element (A). 9 Turn the Fixation Clip towards the applicator (B). It is also possible to connect the Fixation Element in combination with the Perineal Bar or the Perineal Template Ventral. For information on how to attach the Perineal Bar, see the Perineal Bar section. For information on how to attach the Perineal Template Ventral, see the Insert Needles via Perineal Wall section.

4.2

Insert needles via vagina You can insert ProGuide Needles as well as titanium needles into the cervix and parametrium via the vagina. To guide the needles through the applicator and lock them, you can use Guiding Tubes. There are two types:

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Insertion

• Guiding Tubes for Interstitial Lunar Ovoid Tubes (long) • Guiding Tubes for Vaginal Caps (short) The length of the two guiding tubes differs as well as the dimensions of the connector. As a result, the two guiding tubes are not interchangeable. For more information on the guiding tubes, see the Sterile Accessories for the Advanced Gynecological Applicator instructions for use. 4.2.1

Needle configuration sheet information With a Needle Configuration Sheet you can record the needle configuration. Please see the Elekta SalesForce portal where it is available for download, document ID 77700528.

4.2.2

Insert ProGuide Needles

Note:

Elekta recommends that you only use needles of plastic with a round tip.

Note:

Insert the ProGuide Needles before you insert the applicator into the patient. The maximum number of ProGuide Needles that you can use in the combined Right and Left Interstitial Lunar Ovoid Tubes is: • 22mm: 12 ProGuide Needles • 26mm: 16 ProGuide Needles • 30mm: 16 ProGuide Needles

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Insertion

Figure 4.6 Channels for 22mm ovoid

Figure 4.7 Channels for 26mm, 30mm ovoid

Per 22mm ovoid, a maximum of 6 needles can be inserted, of which 3 oblique and 3 straight needles. • Channels for oblique needles: A, C and E • Channels for straight needles: B, D and F Per 26mm and 30mm ovoid, a maximum of 8 needles can be inserted, of which 4 oblique and 4 straight needles. • Channels for oblique needles: A, C, E and G • Channels for straight needles: B, D, F and H To insert, guide and lock the 294mm needles when the applicator is inserted in the patient, use the Guiding Tubes for Interstitial Lunar Ovoid Tubes. This is the longer one of the two types of guiding tubes.

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Insertion

tooltip

Figure 4.8 Fit the Guiding Tube in the Interstitial Lunar Ovoid Tube

1 Fit the Guiding Tube (1) into one of the slots (2). View A shows the Guiding Tube fitted in a parallel slot of the ovoid. B shows the Guiding Tube fitted in an oblique slot of the ovoid tube.

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Insertion

Figure 4.9 ProGuide Needle with obturator in the Guiding Tube

2 Insert a ProGuide Needle (5) with obturator (4) in the Guiding Tube (2). 3 Push the ProGuide Needle through the guiding tube, until the needle tip is just below the surface of the Interstitial Lunar Ovoid Tube (1). 4 Turn the nut (3) at the proximal end of the Guiding Tube to lock the ProGuide Needle.

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Insertion

tooltip

Figure 4.10 Set the depth of the needle

5 Use the Insertion Tool (A) to insert the needles into the patient with precision and at a preferred depth. 4.2.3

Attach Vaginal Caps With Vaginal Caps, you can treat tumor tissue in the upper two thirds of the vagina.

Note:

When you use the Vaginal Cap, use plastic needles.

Note:

When you use the Vaginal Cap, use the parallel slots in the Interstitial Lunar Ovoid Tubes.

Note:

The Guiding Tubes for the Vaginal Cap are shorter than the Guiding Tubes for the Interstitial Lunar Ovoid Tubes.

Note:

When you use the Vaginal Cap, use the flexible obturator. To identify which obturator you can use, see the Compatible Devices appendix. To treat the upper two thirds of the vagina, you can attach a Vaginal Cap to one or both Interstitial Lunar Ovoid Tubes (Right, Left).

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Insertion

Pre-assemble the Vaginal Cap onto the Interstitial Lunar Ovoid Tube before you insert the applicator.

tooltip Figure 4.11 Attach the Vaginal Cap

1 Select the Vaginal Cap (1) that matches the size of the Interstitial Lunar Ovoid Tubes (22mm, 26mm, 30mm). 2 Insert the alignment pin of the Vaginal Cap (1) into the alignment hole of the Interstitial Lunar Ovoid Tube (2).

Figure 4.12 Turn the Vaginal Cap onto the Interstitial Lunar Ovoid Tube

3 Turn the Vaginal Cap towards the tube. The click mechanism on the anterior part of the Vaginal Cap clicks onto the Interstitial Lunar Ovoid Tube. Advanced Gynecological Applicator Instructions for Use ©2016 Elekta. All rights reserved.

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Insertion

Figure 4.13 Put the Guiding Tube in the Vaginal Cap

4 Put the connector of the Guiding Tube for Vaginal Caps into the slot of the Vaginal Cap. 5 Insert a ProGuide Needle with a flexible obturator (see the Compatible Devices appendix) in the Guiding Tube and Vaginal Cap. 6 Push the ProGuide Needle through the Vaginal Cap and into the Interstitial Lunar Ovoid Tube. 7 Put the needle tip just below the surface of the Interstitial Lunar Ovoid Tube. 8 To lock the needle, turn the nut at the proximal end of the Guiding Tube. 9 Insert the applicator into the patient. 10 If needed, push the needles through the Guiding Tubes into the cervical tissue or the parametrium with the Insertion Tool.

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