titanium ring & tandem set al13017000 2011-04-06 en

BRACHYTHERAPY

INSTRUCTIONS FOR USETitanium Ring & Tandem Applicator Combination SetAL13017000

Component List

Qty. Product # Material Reu

sab

le

Au

tocl

ave

Pla

sma

CT

MR

I

Description

Ring applicator, 30°, 32 mm diameter 1 AL07362000 Titanium -



Intrauterine tandem, set of 3, 30°, length 20, 40, and 60 mm 1 AL07365000 Titanium -



Rectal retractor (white Acetal) 1 AL07368000 Titanium/ acetal -

Build-up cap for ring, 5 mm (black Acetal) 1 AL07325000 Black acetal -

Build-up cap for ring, 7.5 mm (white Acetal) 1 AL07326000 White acetal -

Sterilization plugs (pack of 25) 4 GM11009960 PEEK - -

Table 1

Varian BrachyTherapy Offices

Manufacturer: Varian Medical Systems, Inc. AL13017000_7 En of 8 3100 Hansen Way Date: 2011-04-06 Palo Alto, CA 94304 USA 0086

EU Authorized RepresentativeVarian BrachyTherapy Varian Medical Systems Varian Medical Systems UK Ltd.700 Harris Street Haan GmbH Gatwick Road, CrawleySuite 109 Bergische Strasse 16 West Sussex, RH10 9RGCharlottesville, VA 22903 USA 42781 Haan, Germany United Kingdom


BRACHYTHERAPY

Precautions, Warnings & Complications

CAUTION: Each physician is responsible for using the appropriate technique and deciding on the indi-cation for use of this applicator set based on his own experience, training and medical judgment. The physician must be trained in the proper use of the Varian afterloader.

CAUTION: There is no limitation to patient popula-tion. Limitations are on the maximal radiation dose applicable to the individual organs.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

CAUTION: The leak stop button is a single use device that must be disposed of after use. A reused button might not securely protect the connector of the transfer or source guide tube, so moisture could enter which could lead to malfunction of or damage to the Varian afterloader.

WARNING: Under no circumstances should any component from the Titanium Ring & Tandem Applicator Combination Set (AL13017000) be replaced with components from the standard Ring and Tandem Applicator Set (AL13015000, AL13016000, AL13016001, or AL13016002).

WARNING: The Titanium Ring & Tandem Appli-cator Combination Set (AL13017000) has been vali-dated for use in field strengths of 1.5 and 3.0 Tesla.

WARNING: Remove all metal parts like obturators /mandrins, channel marker clips, marker wires, length gauges, etc. prior to entering the MR room.

WARNING: The titanium connector must be covered by a cotton cloth to avoid direct body contact while performing MR scanning. The tita-nium connector could be affected by RF heating which could result in skin irritation if not protected.

WARNING: Failure to use the sterilization plugs and leak stop buttons may lead to contamination, as the inside of the applicator is not sterile. The sterilization plug must remain in place until just prior to insertion of the applicator, and a new one must be put in place after treatment.

WARNING: The Titanium Ring & Tandem Appli-cator Combination Set (AL13017000) was designed solely for use with Varian afterloaders. The manu-facturer does not accept responsibility if an after-loader device from another manufacturer is used.

WARNING: Inaccuracies in dwell positions within the ring can lead to unintended dose delivery if the individual applicator is not characterized. Users must characterize the Titanium Ring & Tandem Applicator Combination Set through autoradiog-raphy to ensure an accurate dwell position delivery when used with the Varian GammaMed and VariSource afterloaders. Refer to the documents entitled Guidelines for Commissioning Ring & Tandem Applicators for GammaMed After-loaders and Guidelines for Commissioning Ring & Tandem Applicators for VariSource After-loaders for detailed recommendations.

.

Titanium Ring & Tandem Applicator Combination Setconfiguration with and without 1.65 mm Titanium Interstitial Needles

Magnetically induced displacement force and torque:

Safe for static magnetic fields of 3 T withStatic magnetic field gradient | ∇B | < 170 T/m (extrapolated)

Static magnetic field gradient product | B |·| ∇B | < 370 T2/m (extrapolated)

RF heating: Titanium Ring & Tandem Applicator Combination Set,configuration with 1.65 mm Titanium Interstitial Needles (17 cm penetration*)

and without 1.65 mm Titanium Interstitial Needles (15.5 cm penetration*)positions have been tested by scanning with a 3 Tesla Magnetom Trio

Siemens MR system - laser indicator at torso center.

Recommendation: Local body SAR< 1.98 W/kg (3 T, Titanium Ring & Tandem Applicator Combination Set,

configuration with 1.65 mm Titanium Interstitial Needles (17 cm penetration*)or without 1.65 mm Titanium Interstitial Needles (15.5 cm penetration*)

(theoretically estimated WBA SAR < 0.5 W/kg)with maximum continuous scan duration of 15 minutes for MR scan with body coil

(recommended local SAR is based on theoretical extrapolation to maintainlocalized temperature increase ≤ 2°C based on in vitro test results,

valid for test configuration only).Note: the whole body averaged (WBA) software displayed SAR is

inappropriate to scale exact local temperature increases.Local SAR can deviate and result in much higher values than the WBA-SARsoftware displayed. Measurement inaccuracies and additional safety margins

should be taken into account.No other RF heating testing than 3 Tesla only was performed.

Gradient magnetic fields: stimulation level of ≈ 75% (3 T Magnetom Trio,Siemens) was used during RF heating test. No tests have been performed

regarding possible nerve or other tissue stimulation.

The Titanium Ring & Tandem Applicator Combination Setwith and without 1.65 mm Titanium Interstitial Needles has not been tested in

combination with other devices.

MR image artifacts: MR image quality may be compromised if the area ofinterest is in the same area or relatively close to the position of the device.Therefore, it may be necessary to optimize MR imaging parameters for the

presence of this instrument.

MR Conditional

*Note: Deviation from the penetration depth may result in local SAR and temperature increase.



BRACHYTHERAPY

Indications for Use

The Titanium Ring & Tandem Applicator Combination Set is indicated for high dose rate irradiation of the uterus and cervix. This set offers a versatile means of treating uterine and cervical disease. Based on a standard ring applicator design, this version is manufactured from Titanium and is fully compatible with both CT and MR imaging systems (1.5 and 3.0 Tesla MRI). This system features a 32 mm diameter ring, which can be used in conjunction with interlocking tandems of 20, 40, and 60 mm lengths. The applicator includes tandem angles of 30, 45, and 60 degrees. Also included with the set are two ring build-up caps (5 mm and 7.5 mm) and a rectal retractor. The set is presented in a sterilization tray.

The Titanium Ring & Tandem Applicator Combination Set is intended for continuous use of up to 24 hours of contact with patients.

General Information

Carefully follow these instructions for use. The Titanium Ring & Tandem Applicator Combination Set contains the compo-nents listed in Table 1.

The applicator set should only be used by a physician who has received full training in the appropriate Varian afterloader system. Use only Varian transfer or source guide tubes to connect the applicator to the afterloader.

This applicator set is compatible with the following Varian afterloaders: GammaMedplus and 3/24, VariSource 200 and iX and VariSource ID. Please refer to the Instructions for Use for VariSource ClickFit™ Transfer Guide Tube Set (GM19001010-1040) when using this applicator set with the VariSource afterloader. Use the appropriate Varian X-ray markers for taking radiographs.

Tables 2.1 – 2.3 contain the accessories required to use the applicator set with the GammaMedplus series, VariSource 200 and iX, and VariSource ID afterloaders and to take radiographs (if required). Optional components and accessories available for this set are listed in Table 3.

Required for GammaMedplus Series

Req

uir

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ty

Product #Description

Source guide tube with locking mechanism for 320 mm appli-cators, GammaMedplus 1 GM11000340

Length gauge, GammaMedplus 1 GM11000330

Table 2.1



BRACHYTHERAPY

Required for VariSource 200 and iX

Req

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ed

qu

anti

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ClickFit™ transfer guide tube, set of 4 for VariSource 200 1 GM19001000

Measurement ruler 1 AL13169000

Measurement marker wire 1 AL13154000

Measurement marker clip 1 AL13119000

Table 2.2

Required for VariSource ID

Req

uir

ed

qu

anti

ty


ClickFit™ transfer guide tube, set of 4 for VariSource ID 1 AL13303000

Measurement ruler 1 AL13169000

Measurement marker wire 1 AL13154000

Measurement marker clip 1 AL13119000

Table 2.3

Optional Components & Accessories

Req

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ed

qu

an

tity


Universal applicator clamping device 1 GM11008700

Source guide tube support (GammaMed units only)

1 GM11001390

X-ray marker BV for 320 mm applicators, ø 0.9 mm, uncoded

2 GM11009600

Table 3



BRACHYTHERAPY

Cervical sleeve 30 mm, reusable 1 GM11001160






Cervical sleeve 20 mm, single use 1 AL13142000




Leak stop button, non-sterile, pack of 50 1 GM11003810

Flexible fixation mechanism for gynecological applicators 1 GM11001960

Bracket for ring applicator for flexible fixation device 1 GM11006100

Spare tandem set, 30°-45°-60°, 80 mm long, Titanium 1 AL07372000

Titanium needle 113 mm, 16 gauge (1.65 mm), sharp trocar point

1 GM11010210


1 GM11010220


1 GM11010230


1 GM11010240

Titanium needle 113 mm, 16 gauge (1.65 mm), blunt trocar point

1 GM11010410


1 GM11010420


Req

uir

ed

qu

anti

ty


Table 3



BRACHYTHERAPY

Delivery Condition and Testing

Each Titanium Ring & Tandem Applicator Combination Set is carefully packaged. It is in a clean but non-sterile condition. The packaging should be unopened and undamaged upon receipt. Remove the components from the packaging in a clean environment. These reusable applicators must be handled care-fully to avoid damage. As the manufacturer cannot control the final use of these applicators, the manufacturer cannot be held responsible for damage resulting from mishandling. Prior to each treatment, the user must ensure that the applicator is undamaged and still meets specifications.

After connecting the source guide tube, use the length gauge (GM11000330) for the GammaMedplus to check the correct source guide tube/applicator probe combination length. For the VariSource afterloader, this test should be performed using the measurement ruler, marker wire and marker clip (AL13169000, AL13154000, AL13119000).

Assembly and Use

CAUTION: Ensure the sterilization plugs are fitted to the ring and tandem at all times, except when the transfer or source guide tube is attached. This prevents solutions or foreign materials from entering the ring or tandem. Liquids or other kinds of contaminants entering the tubes can lead to malfunction of or damage to the Varian afterloader and may obstruct the passage of the source wire.

WARNING: Incorrect length measurement can lead to patient misadministration.

WARNING: Using a damaged applicator can lead to incorrect treatment of the patient and may cause radiation hazards to patients and medical staff.


1 GM11010430


1 GM11010440

Vienna-style build-up cap, 5 mm (black) for 1.65 mm (16 gauge) needles

1 AL07528000

Vienna-style build-up cap, 7.5 mm (white) for 1.65 mm (16 gauge) needles

1 AL07529000

Plastic needle with mandrin, ø 2.0 mm diameter, 113 mm length (GammaMed units only)

1 GM11007560


1 GM11007570


1 GM11007580

Vienna-style build-up cap, 5 mm (black) for 2.0 mm plastic needles (GammaMed units only)

1 AL07530000

Vienna-style build-up cap, 7.5 mm (white) for 2.0 mm plastic needles (GammaMed units only)

1 AL07531000


Req

uir

ed

qu

anti

ty


Table 3



BRACHYTHERAPY

Prior to each use (including the first use), clean, disinfect and sterilize the applicator carefully according to the supplied instructions.

Select the tandem of the appropriate length and angle based on the patient anatomy. The tandem length may be deter-mined by sounding the uterus.

Note: Take care not to bend the ring and tandems when removing them from the sterilization cassette.

Select the ring that corresponds to the selected tandem.

Misaligned

Misaligned

Perfect Perfect

Note: Ensure that the ring angle chosen matches that of the tandem being used. In the case where incompat-ible components are used, the applicator will be misaligned as indicated in the figure below, and the correct treatment will not be delivered.

Note: The rings are angled to match the angle of the tandems. Each angle is clearly indicated on the prox-imal end of the tube.

Select the desired ring build-up cap and fit this to the end of the ring, ensuring that it sits correctly on the end of the ring and that the build-up has the correct orientation (facing the cervix).

Insert the tandem through the cervix into position in the uterus.

Slide the ring over the proximal end of the tandem into position against the cervix. Ensure that the thumbscrew is fully loosened prior to assembly.

As the ring slides over the tandem, interlock the locating shoulders at the distal end of the tube and the locking mech-anism at the proximal end.

Tighten the locking thumbscrew to hold the tandem and ring together.

If the applicator is to be used with the rectal retractor, it may be fitted at this point. Adjust the thumbscrew on the rectal retractor such that the retractor is in the position of minimum retraction. Slide the fixation bracket of the rectal retractor over the ends of the tubes while positioning the retractor into the vagina. Once the retractor has been fixed to the ring and tandem, adjust the retractor to the desired position by means of the thumbscrew.

Immobilize the applicator with the universal applicator clamping device or use set (GM11001960) for attachment to the patient’s body.

To take radiographs, remove the sterilization plugs from the ring and tandem and insert the X-ray marker fully into each channel.

Take X-ray films as required for dosimetry. When the films are completed, remove the X-ray markers and replace the sterilization plugs until ready to attach the transfer or source guide tubes.

Remove the sterilization plugs and attach the transfer or source guide tubes according to the treatment plan. Take care to correctly match the indexer/turret channels with the tandem (Channel 1) and the ring (Channel 2). For more information, refer to the transfer or source guide tube instructions for use.

WARNING: Interchanging transfer or source guide tube connections will lead to incorrect treatment of the patient.

Ensure that there is no tension in the transfer or source guide tube. For support, use the source guide tube support (GM11001390 for GammaMed units only).

Before starting the treatment, as necessary, inform the patient about appropriate behavior during the treatment.

The patient can now be treated according to the user manual for the Varian afterloader.

CAUTION: Blood or moisture entering the transfer or source guide tube connector can cause the connector to malfunction. Use the leak stop button (GM11003810) or sufficient pads to protect the connector.

At periodic intervals, it may be necessary to check the length of the applicator with the transfer or source guide tube attached as indicated by the transfer or source guide tube instructions for use.

When the treatment is completed, disconnect the transfer or source guide tubes and replace the sterilization plugs on the ring and tandem.



BRACHYTHERAPY

Note: For VariSource only - The turn radius of the ring portion of this applicator is 16 mm. However, despite this, the minimum turn radius specification of the VariSource afterloader and source wire remains 17 mm. Consequently, with the exception of this device, no other applicators should be used with a turn radius of less than 17 mm.

Removal and Disassembly

Remove the applicator attachment (if used).

Remove the rectal retractor (if used).

CAUTION: Do not disassemble the rectal retractor completely, as the adjustment screw will be damaged if completely removed.

Loosen the locking thumbscrew at the proximal end of the ring.

Disengage the locking shoulders at the distal end of the tandem and remove the ring by sliding it off of the tandem.

WARNING: During the removal of the ring from patients with narrow vaginal anatomy, the thumb-screw might need to be covered with a finger to avoid damage to the vaginal wall mucosa by the edges of this screw.

Withdraw the tandem.

Dismantle the ring build-up cap.

Note: Be sure to dismantle the ring build-up cap before cleaning.

Place the sterilization plugs on the ring and tandem.

Cleaning, Disinfecting and Sterilization

All parts of the Titanium Ring & Tandem Applicator Combina-tion Set are reusable. Before the first use, and after each use, clean, disinfect and sterilize all parts of the Titanium Ring & Tandem Applicator Combination Set according to the sepa-rately enclosed instructions (GM11010200). For sterilization instructions for the accessories, refer to the corresponding instructions for use.

CAUTION: The sterilization plug is a single use device that must be disposed of after use. A reused plug might not securely close the tandem, so mois-ture could enter which could lead to malfunction of or damage to the Varian afterloader.

Storage and Repeated Use

Store the applicator so it will not be damaged. We suggest storing all parts in a suitable sterilization box. Close the ring and tandems with a sterilization plug to avoid contamination while stored without being packed in a sterilization box or bag. Store at a temperature between 0° and 30° C.

The applicator was designed for repeated use. Except for the rectal retractor and the build-up caps, the Titanium Ring & Tandem Applicator Combination Set can be steam sterilized up to 500 times. The rectal retractor and the build-up caps can be steam sterilized up to 100 times. After this period of reuse, dispose of the applicator parts according to local rules.

Prior to each use, it is the sole responsibility of the user to thor-oughly check all applicator parts and accessories for any damage and to ensure that the applicator and/or accessory meets factory specifications according to these instructions for use. For storage instructions for the accessories, refer to the corresponding instructions for use.

If the proper condition of a part is in question, that part must not be used. The part should be returned immediately for inspection by the manufacturer. If damage to a part is obvious, please contact the manufacturer for a replacement part.

The manufacturer is not responsible for the use of damaged parts or the use of parts that do not meet factory specification.

Varian BrachyTherapy Technical Support

For technical questions relating to this applicator and its use or for reporting any incidents involving the applicator, contact Varian BrachyTherapy Technical Support. Refer to the Varian BrachyTherapy Technical Support Contacts reference sheet for contact information.


titanium ring & tandem set al13017000 2011-04-06 en

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