Brachytherapy Plastic Interstitial Needles Instructions for Use

BRACHYTHERAPY

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

Cautions and Warnings MRI Safety Information

CAUTION: Each physician is responsible for using the appropriate technique and deciding on the indication for use of the Plastic Interstitial Needles 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 population. 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.

Non-clinical testing and MRI simulations were performed to evaluate the Plastic Interstitial Needles. Non-clinical testing demonstrated that the Plastic Interstitial Needles are MR conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:

• Static magnetic field of 1.5 Tesla and 3 Tesla only. • Maximum spatial gradient magnetic field of 10,000 Gauss/cm (100T/m) or less.

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operation Mode of the MR system. All stainless steel parts (such as obturators/mandrins, marker wires, length gauges, etc.) must be removed prior to entering the MR environment.

•

MRI Related Heating

CAUTION: If a ClickFit™ connector becomes contaminated during a treatment, clean the connector surfaces by wiping with hospital wipes soaked in detergent solution until contamination is removed, followed by wiping with a hospital wipe soaked in purified water. Allow the connector to dry and place a cleaning cap on it before manual or machine cleaning. CAUTION: Cleaning caps, leak stop buttons and leak stop channel markers are single use devices that must be disposed of after use. A reused cleaning cap, leak stop button or leak stop channel marker might not securely protect the connector of the source or transfer guide tube, so liquid could enter and this could lead to malfunction of or damage to the Varian afterloader. WARNING: Failure to use leak stop buttons or leak stop channel markers may lead to contamination of the needles or source/ transfer guide tubes, which could lead to patient infection. Cleaning caps must be used when instruments are immersed for manual and machine cleaning or disinfection. Cleaning caps must be removed before sterilization so that the inside of the needles can be sterilized.

WARNING: The Plastic Interstitial Needles (GM11007560-7580, GM11010750) were designed solely for use with Varian afterloaders. The manufacturer does not accept responsibility if an afterloader device from another manufacturer is used.

Under the scan conditions defined above, the Plastic Interstitial Needles are expected to produce a maximum temperature rise of less than 1.4º C after 15 minutes of continuous scanning.

Artifact Information In non-clinical testing, the image artifact caused by the Plastic Interstitial Needles extends approximately 5 mm from this device when imaged using a gradient echo pulse sequence and a 3 Tesla MR system.

Indications for Use The interstitial plastic needles with 2 mm diameter, are indicated for use for interstitial brachytherapy treatment in areas such as the head and neck, gynecological, breast and prostate.

General Information Carefully follow these instructions for use. The Plastic Interstitial Needles should only be used by a physician who has received full training in the appropriate Varian afterloader system. The Plastic Interstitial Needles are designed for use within a CT and MRI environment. Each needle is supplied with a stainless steel mandrin, which can also be ordered individually. The needles and their associated mandrins are available in lengths of 113 mm, 200 mm, and 320 mm. The mandrins are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The needles can also be used with interstitial ovoids and ring caps. Note: The hub of the needle that connects to a source

or transfer guide tube is 2.5 mm in diameter.

EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom

Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA

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Page 2 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10

The Plastic Interstitial Needles are compatible with all Varian afterloaders (GammaMed and VariSource). Use only Varian source or transfer guide tubes to connect the needles to the Varian afterloader.

1

GM11000340

Source guide tube with locking mechanism for 200 mm needles, GammaMedplus (1 per channel)

1

GM11000320

Source guide tube with locking mechanism for 113 mm needles, GammaMedplus (1 per channel)

1

GM11000520

Source guide tube light with locking mechanism for 320 mm needles, GammaMedplus

1

GM11010760

Source guide tube light with locking mechanism for 200 mm needles, GammaMedplus

1

GM11007270

Source guide tube light with locking mechanism for 113 mm needles, GammaMedplus

1

GM11007280

X-ray marker BV set I, up to 320 mm applicators, coded 01-06

1

GM11009620

X-ray marker BV set I, up to 200 mm needles, coded 01-06

1

GM11009640

Length gauge, GammaMedplus

1

GM11000330

Cleaning caps, dark blue (pack of 25)

1

GM11010770

Silicone

-

1

1

 

Leak stop button (pack of 50)

1

GM11003810

Silicone

-

25

25

 

Material

CT

Product #

Source guide tube with locking mechanism for 320 mm applicators, GammaMedplus (1 per channel)

Description

Manual Cleaning Machine Cleaning

Required quantity

Required for GammaMedplus Series

MRI

The maximum implantation time for these needles is less than 30 days.

The Plastic Interstitial Needles are available in different lengths as listed in Table 1. Tables 2.1 – 2.2 contain the accessories required to use the Plastic Interstitial Needles with the GammaMedplus series and VariSource 200 and iX afterloaders and to take radiographs. Use the appropriate Varian X-ray markers for taking radiographs. Optional components and accessories available for this set are listed in Table 3.

Autoclave

The optionally available leak stop channel markers perform the same function as leak stop buttons (GM11003810) with the added benefit of designating the channel number.

Reusable

BRACHYTHERAPY

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

Data available in individual Instructions for Use.

Table 2.1

EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom

Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA

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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany

Page 3 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10

GM19002000

X-ray marker BV set I, up to 200 mm needles, coded 01-06

1

GM11009640

X-ray marker BV set I, up to 320 mm applicators, coded 01-06

1

GM11009620

Measurement ruler

1

AL13169000

Measurement marker wire

1

AL13154000

Measurement marker clip

1

AL13119000

Cleaning caps, dark blue (pack of 25)

1

GM11010770

Silicone

-

1

1

 

Leak stop button (pack of 50)

1

GM11003810

Silicone

-

25

25

 

Material

MRI

1

Material

CT

Product #

ClickFit™ needle transfer guide tube, set of 10, for VariSource 200, (Ch 01-10)

Description

Manual Cleaning Machine Cleaning

Required quantity

Reusable

Required for VariSource 200 and iX

Autoclave

BRACHYTHERAPY

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

Data available in individual Instructions for Use.

Product #

Reusable

Manual Cleaning Machine Cleaning

Autoclave

Leak stop channel markers (pack of 25), coded 1-12

1

GM11010510

Silicone

-

25

25

 

Leak stop channel markers (pack of 25), coded 13-24

1

GM11010520

Silicone

-

25

25

 

Stainless steel button for needle ø 1.6 - 2.0 mm, including M4 nut

1

GM11003830

Stainless steel

X-ray marker BV set II, up to 320 mm applicators, coded 7-12

1

GM11009630

X-ray marker BV set II, up to 200 mm needles, coded 7-12

1

GM11009650

Source guide tube support (GammaMed units only)

1

GM11001390

Description

 100 100 

CT

Required quantity

Optional Components & Accessories

MRI

Table 2.2

-

Data available in individual Instructions for Use

Refer to the manufacturer’s instructions on the label.

Table 3

EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom

Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA

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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany

Page 4 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10

BRACHYTHERAPY

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

Delivery Condition and Testing

Assembly and Use

Each Plastic Interstitial Needles 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.

CAUTION: Liquid or other kinds of contamination entering the needles can lead to malfunction of or damage to the Varian afterloader. WARNING: Using a damaged needle can lead to incorrect treatment of the patient and may cause radiation hazards to patients and medical staff.

These needles must be handled carefully to avoid damage. Prior to each treatment, the user must ensure that the needles are undamaged and still meet specifications. Check the needles thoroughly for kinks or damage and for sufficient sharpness of the tip and firm seating of the connector. The needle tip must be undamaged and must not be frayed. Check the mandrins thoroughly for straightness and damage. Needles with a kink should be considered damaged and must not be used, as they can cause serious problems during source movement. Please dispose of them according to local rules and replace them. Bending of a needle is considered normal wear and tear. Slight bending of a needle is generally acceptable, as long as the severity of the bending is not too much as to significantly alter the insertion trajectory. If the bending is severe enough to alter the insertion trajectory, the needle should be disposed of according to local rules and replaced. Before treatment, use the length gauge (GM11000330) for the GammaMedplus to check the correct source guide tube/needle combination length. For the VariSource afterloader, this test should be performed using the measurement ruler, marker wire and marker clip (AL13119000, AL13154000, AL13169000) to check the correct transfer guide tube/ needle combination length.

WARNING: A broken or kinked needle is irreparable and must not be used. It can lead to contamination and incorrect treatment of the patient through underexposure or overexposure and may cause radiation hazards to medical staff.

WARNING: Do not re-sharpen the needles, because this might result in losing the needle tip.

Prior to each use (including the first use), clean, disinfect and sterilize the needles and accessories carefully according to the supplied instructions. During the procedure, use cleaning caps when components are immersed in cleaning, disinfection, and rinse solutions. 

Note: In combination with the Titanium Fletcher-style

Applicator Set (GM11006200) or the Vienna Style Build-up Cap (AL07530000 or AL07531000), the 200 mm mandrin may be used to stabilize the connector end of the needle during insertion.

Note: When used with the VariSource afterloader and

connected with a ClickFit™ Transfer Guide Tube (GM19002xxx), the measured length should be 101.4 cm plus the needle length, and the BrachyVision planning length should be 100.0 cm. For example, when connected to a 200 mm needle, the measured length should be 121.4 cm and the BrachyVision planning length should be 120.0 cm. WARNING: An incorrect source or transfer guide tube/needle combination length can lead to incorrect treatment of the patient through underexposure or overexposure. Verify the correct source or transfer guide tube/needle combination length.

EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom

Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA

Open the packaging and take out the necessary amount of needles and mandrins. Place all components in a sterile environment.



Slide a leak stop button (or leak stop channel marker) over the needle to prevent any liquid from entering the needle connector. CAUTION: Blood or liquid entering the source or transfer guide tube connector can cause the connector to malfunction. Use the leak stop button (GM11003810), leak stop channel marker (GM11010510 or GM11010520) or sufficient pads to protect the connector.



If necessary, place a stainless steel button on the needles.



Insert a suitable mandrin to stiffen the needle. Ensure that the needle does not become bent during implantation.



Following implantation, remove the mandrin and place a sterile cleaning cap over the needle to prevent any liquid from entering the needle.

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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany

Page 5 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

BRACHYTHERAPY



Repeat the steps above until all needles are in place.



To take radiographs, remove the cleaning cap or mandrin and insert the corresponding X-ray marker. Ensure that the X-ray marker reaches the distal position of the needle. For more details refer to the X-ray marker instructions for use (GM11009600-09680).

WARNING: The patient must be advised about avoiding any movements that might change the position of the applicator or source/transfer guide tubes. If necessary, the patient must contact the treatment staff immediately by intercom or viewing equipment. A shift in position of the applicator or guide tube could lead to misadministration of the treatment.

Note: The dead space of the blunt needle tip is

3.9 + 0.4 mm / -0.2 mm. The dead space of the sharp/standard needle tip is 4.6 ± 0.4 mm.



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

Removal and Disassembly

B

A 



Connect each source or transfer guide tube to the corresponding channel of the indexer/turret according to the treatment plan. For GammaMed units, use only channels 01-19. For more information, refer to the source guide tube or transfer guide tube instructions for use. Remove the X-ray marker (if used) and connect the source or transfer guide tubes to the needles. WARNING: Interchanging source or transfer guide tube connections will lead to incorrect treatment of the patient.



Verify the correct source or transfer guide tube/ needle combination length as detailed in the “Delivery Condition and Testing” section above.



Ensure that there is no tension or tight curve in the source or transfer 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.

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Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA



Remove the source/ transfer guide tubes from the needles.



Inspect ClickFit™ connectors for contamination.



If contaminated, wipe the ClickFit™ connector surfaces with a hospital wipe soaked in enzymatic cleaner followed by wiping with a hospital wipe soaked in purified water.



Remove the leak stop buttons (or leak stop channel markers) from the needles.



Install a cleaning cap on the ClickFit™ connector before fully cleaning the component.



Disinfect the protruding end of the needles with a topical skin disinfectant (to prevent infection) and withdraw the needles carefully and individually.



Remove the stainless steel button from the needle (if in place). Push this down in the direction of the needle tip.

Cleaning, Disinfecting and Sterilization Before the first use, and after each use, clean, disinfect and sterilize all reusable parts of the Plastic Interstitial Needles according to the Applicators and Accessories Reprocessing Instructions (GM11011300) included on the Varian BrachyTherapy Applicators and Accessories Instructions for Use DVD (GM11010400). WARNING: The Plastic Interstitial Needles are single use devices when used in combination with the Titanium Fletcher-style Applicator Set (GM11006200) or the Vienna Style Build-up Cap (AL07530000 or AL07531000) and must be disposed of after use. A reused needle can lead to contamination and incorrect treatment of the patient through underexposure or overexposure and may cause radiation hazards to medical staff.

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Manufacturing Site: Varian Medical Systems Haan GmbH Bergische Strasse 16 42781 Haan, Germany

Page 6 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10

BRACHYTHERAPY

INSTRUCTIONS FOR USE Plastic Interstitial Needles GM11007560-7580, GM11010750

Note: Leak stop buttons (GM11003810) and leak stop

channel markers (GM11010510 and GM11010520) are intended for single use; however, unused leak stop buttons and leak stop channel markers can be reprocessed up to 25 times. Note: Remove the protection caps from the needle tip

before cleaning, disinfection and sterilization.

Storage and Repeated Use Store the Plastic Interstitial Needles so they will not be damaged. During storage in a non-sterile condition, the cleaning cap must be in place to avoid contamination. The Plastic Interstitial Needles were designed for repeated use. (see Note below). Use cycles for individual components are indicated in Tables 1 - 3. After this period of reuse, dispose of the needles or mandrins according to local rules. Every needle and mandrin is marked with a batch identification number. Note: When used in combination with the Titanium

Fletcher-style Applicator Set (GM11006200) or the Vienna Style Build-up Cap (AL07530000 or AL07531000), the Plastic Interstitial Needles are single use.

EU Authorized Representative: Varian Medical Systems UK Ltd. Gatwick Road, Crawley West Sussex, RH10 9RG United Kingdom

Legal Manufacturer: Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 USA

Please observe the expiration date (e.g. 2015-12) on the plastic needles. If the expiration date or the number of sterilization cycles has been exceeded, the needles may not be used and should be disposed of according to local rules. Needles with worn out tips may not be used any longer and must be disposed of according to local rules. Prior to each use, it is the sole responsibility of the user to thoroughly check all applicator parts and accessories for any damage and to ensure that the needles and/or accessory meets factory specifications according to these 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

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Page 7 of 7 PGM11007560-7580, GM11010750_9 EN Date: 2015-11-10