INSTRUCTIONS FOR USE Part number S551077 Rev. G Effective June 2012

IsoCArtrIdge®

Part Number S551077 Rev. F Effective February 2009

INStRuctIoNS FoR uSE

Caution: Federal law restricts this device to sale by or on the order of a physician.

notE: Refer to the seed manufacturer’s Instructions For Use for information, cautions, and warnings on I-125 or Pd-103 seeds contained within the IsoCartridge.

Note: Refer to the spacer manufacturer’s Instructions For Use for information, cautions, and warnings on the synthetic bio-absorbable spacers contained within the IsoCartridge.

DEsCriptionThe IsoCartridge is a shielded cartridge that is intended for use only in the Theragenics Isoloader Automated Needle Loading System and Physics Workstation for Brachytherapy. The Isoloader is indicated for use as a dose calibrator intended to assay I-125 and Pd-103 radionuclide seeds prior to their administration to patients, and as an accessory to a manual/remote radionuclide applicator system that provides an automatic needle loading feature for loading sterile I-125 or Pd-103 radionuclide seeds and synthetic bio-absorbable spacers into sterile brachytherapy needles prior to their administration to patients.

The following inventory may be contained within the IsoCartridge:

• seeds (I-125 or Pd-103)

Sterile Radioactive

• mm PG 910 synthetic absorbable Sterile 5.5 spacers

• cm PG 910 synthetic absorbable spacersSterile 1.0 (Spacers are 90% glycolide and 10% L-Lactide copolymer)

Radioactive seeds are contained within a 5 mm-wall stainless steel housing, providing radiation shielding. notE: see enclosed warning for exposure limits to isoCartridges containing pd-103.

Patient data and material inventory information is stored on a computer chip within the IsoCartridge. This data is used in a safety check performed when the IsoCartridge is initialized and compared to a dose plan.

The IsoCartridge is compatible with the following needles:

tg2979 Core 18ga. Preload style Square plastic hub, prewaxed tg2981 Core 18ga. Preload style, Round plastic hub, prewaxed

When a needle is properly attached to the IsoCartridge by its luer-lock hub, a green light will illuminate next to needle in position.

®

IsoCArtrIdge®

Part Number S551077 Rev. F Effective February 2009

INStRuctIoNS FoR uSE

Caution: Federal law restricts this device to sale by or on the order of a physician.

notE: Refer to the seed manufacturer’s Instructions For Use for information, cautions, and warnings on I-125 or Pd-103 seeds contained within the IsoCartridge.

Note: Refer to the spacer manufacturer’s Instructions For Use for information, cautions, and warnings on the synthetic bio-absorbable spacers contained within the IsoCartridge.

DEsCriptionThe IsoCartridge is a shielded cartridge that is intended for use only in the Theragenics Isoloader Automated Needle Loading System and Physics Workstation for Brachytherapy. The Isoloader is indicated for use as a dose calibrator intended to assay I-125 and Pd-103 radionuclide seeds prior to their administration to patients, and as an accessory to a manual/remote radionuclide applicator system that provides an automatic needle loading feature for loading sterile I-125 or Pd-103 radionuclide seeds and synthetic bio-absorbable spacers into sterile brachytherapy needles prior to their administration to patients.

The following inventory may be contained within the IsoCartridge:

• seeds (I-125 or Pd-103)

Sterile Radioactive

• mm PG 910 synthetic absorbable Sterile 5.5 spacers

• cm PG 910 synthetic absorbable spacersSterile 1.0 (Spacers are 90% glycolide and 10% L-Lactide copolymer)

Radioactive seeds are contained within a 5 mm-wall stainless steel housing, providing radiation shielding. notE: see enclosed warning for exposure limits to isoCartridges containing pd-103.

Patient data and material inventory information is stored on a computer chip within the IsoCartridge. This data is used in a safety check performed when the IsoCartridge is initialized and compared to a dose plan.

The IsoCartridge is compatible with the following needles:

tg2979 Core 18ga. Preload style Square plastic hub, prewaxed tg2981 Core 18ga. Preload style, Round plastic hub, prewaxed

When a needle is properly attached to the IsoCartridge by its luer-lock hub, a green light will illuminate next to needle in position.

®

IsoCArtrIdge®

Part Number S551077 Rev. F Effective February 2009

INStRuctIoNS FoR uSE

Caution: Federal law restricts this device to sale by or on the order of a physician.

notE: Refer to the seed manufacturer’s Instructions For Use for information, cautions, and warnings on I-125 or Pd-103 seeds contained within the IsoCartridge.

Note: Refer to the spacer manufacturer’s Instructions For Use for information, cautions, and warnings on the synthetic bio-absorbable spacers contained within the IsoCartridge.

DEsCriptionThe IsoCartridge is a shielded cartridge that is intended for use only in the Theragenics Isoloader Automated Needle Loading System and Physics Workstation for Brachytherapy. The Isoloader is indicated for use as a dose calibrator intended to assay I-125 and Pd-103 radionuclide seeds prior to their administration to patients, and as an accessory to a manual/remote radionuclide applicator system that provides an automatic needle loading feature for loading sterile I-125 or Pd-103 radionuclide seeds and synthetic bio-absorbable spacers into sterile brachytherapy needles prior to their administration to patients.

The following inventory may be contained within the IsoCartridge:

• seeds (I-125 or Pd-103)

Sterile Radioactive

• mm PG 910 synthetic absorbable Sterile 5.5 spacers

• cm PG 910 synthetic absorbable spacersSterile 1.0 (Spacers are 90% glycolide and 10% L-Lactide copolymer)

Radioactive seeds are contained within a 5 mm-wall stainless steel housing, providing radiation shielding. notE: see enclosed warning for exposure limits to isoCartridges containing pd-103.

Patient data and material inventory information is stored on a computer chip within the IsoCartridge. This data is used in a safety check performed when the IsoCartridge is initialized and compared to a dose plan.

The IsoCartridge is compatible with the following needles:

tg2979 Core 18ga. Preload style Square plastic hub, prewaxed tg2981 Core 18ga. Preload style, Round plastic hub, prewaxed

When a needle is properly attached to the IsoCartridge by its luer-lock hub, a green light will illuminate next to needle in position.

®

TG2979 18ga. Preloaded style Square plastic hub, prewaxedTG2981 18ga. Preloaded style Round plastic hub, prewaxed

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WArNINgs ANd PreCAUtIoNs

A loaded IsoCartridge contains radioactive seeds. Use caution and follow established procedures for handling radioactive materials.

Upon receipt of an IsoCartridge, carefully inspect outer packaging for damage. Damaged packaging may compromise product sterility.

Carefully inspect IsoCartridge for visible damage prior to inserting into the Isoloader.

Inspect IsoCartridge needle mount for damage prior to use. A damaged needle mount may prevent proper needle attachment and/or loading.

Be careful when handling needles, as sharp point may cause injury.

Material that has been ejected from the IsoCartridge may contain radioactive seeds. Use extreme caution when handling ejected contents.

IsoCartridge sterility will be compromised by insertion of non-sterile seeds or spacers.

Seeds and spacers must be sterile prior to manual loading into an IsoCartridge.

IsoCartridges containing up to 159 Pd-103 seeds at 2.5 U may each emit up to 1 mR / hour at the IsoCartridge surface. Use appropriate exposure precautions.

in the event of Emergency seed recovery from the isoCartridge, heed these additional Warnings:

User should ensure that the container used is large enough to easily capture all material ejected out of IsoCartridge.

Ensure that the IsoCartridge is oriented upward while the cover is being removed to prevent seeds from falling out.

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physical CharacteristicsThe IsoCartridge consists of an aluminum body that houses electrical, mechanical and sensory components. An integral stainless steel housing contains the sterile radioactive seeds and spacer materials. The IsoCartridge is provided in a tray with a Tyvek® peel top.

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WArNINgs ANd PreCAUtIoNs

A loaded IsoCartridge contains radioactive seeds. Use caution and follow established procedures for handling radioactive materials.

Upon receipt of an IsoCartridge, carefully inspect outer packaging for damage. Damaged packaging may compromise product sterility.

Carefully inspect IsoCartridge for visible damage prior to inserting into the Isoloader.

Inspect IsoCartridge needle mount for damage prior to use. A damaged needle mount may prevent proper needle attachment and/or loading.

Be careful when handling needles, as sharp point may cause injury.

Material that has been ejected from the IsoCartridge may contain radioactive seeds. Use extreme caution when handling ejected contents.

IsoCartridge sterility will be compromised by insertion of non-sterile seeds or spacers.

Seeds and spacers must be sterile prior to manual loading into an IsoCartridge.

IsoCartridges containing up to 159 Pd-103 seeds at 2.5 U may each emit up to 1 mR / hour at the IsoCartridge surface. Use appropriate exposure precautions.

in the event of Emergency seed recovery from the isoCartridge, heed these additional Warnings:

User should ensure that the container used is large enough to easily capture all material ejected out of IsoCartridge.

Ensure that the IsoCartridge is oriented upward while the cover is being removed to prevent seeds from falling out.

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physical CharacteristicsThe IsoCartridge consists of an aluminum body that houses electrical, mechanical and sensory components. An integral stainless steel housing contains the sterile radioactive seeds and spacer materials. The IsoCartridge is provided in a tray with a Tyvek® peel top.

– 2 – – 3 –

WArNINgs ANd PreCAUtIoNs

A loaded IsoCartridge contains radioactive seeds. Use caution and follow established procedures for handling radioactive materials.

Upon receipt of an IsoCartridge, carefully inspect outer packaging for damage. Damaged packaging may compromise product sterility.

Carefully inspect IsoCartridge for visible damage prior to inserting into the Isoloader.

Inspect IsoCartridge needle mount for damage prior to use. A damaged needle mount may prevent proper needle attachment and/or loading.

Be careful when handling needles, as sharp point may cause injury.

Material that has been ejected from the IsoCartridge may contain radioactive seeds. Use extreme caution when handling ejected contents.

IsoCartridge sterility will be compromised by insertion of non-sterile seeds or spacers.

Seeds and spacers must be sterile prior to manual loading into an IsoCartridge.

IsoCartridges containing up to 159 Pd-103 seeds at 2.5 U may each emit up to 1 mR / hour at the IsoCartridge surface. Use appropriate exposure precautions.

in the event of Emergency seed recovery from the isoCartridge, heed these additional Warnings:

User should ensure that the container used is large enough to easily capture all material ejected out of IsoCartridge.

Ensure that the IsoCartridge is oriented upward while the cover is being removed to prevent seeds from falling out.

!

!

!

!

!

!

!

!

!

!

!

physical CharacteristicsThe IsoCartridge consists of an aluminum body that houses electrical, mechanical and sensory components. An integral stainless steel housing contains the sterile radioactive seeds and spacer materials. The IsoCartridge is provided in a tray with a Tyvek® peel top.

– 2 – – 3 –

WArNINgs ANd PreCAUtIoNs

A loaded IsoCartridge contains radioactive seeds. Use caution and follow established procedures for handling radioactive materials.

Upon receipt of an IsoCartridge, carefully inspect outer packaging for damage. Damaged packaging may compromise product sterility.

Carefully inspect IsoCartridge for visible damage prior to inserting into the Isoloader.

Inspect IsoCartridge needle mount for damage prior to use. A damaged needle mount may prevent proper needle attachment and/or loading.

Be careful when handling needles, as sharp point may cause injury.

Material that has been ejected from the IsoCartridge may contain radioactive seeds. Use extreme caution when handling ejected contents.

IsoCartridge sterility will be compromised by insertion of non-sterile seeds or spacers.

Seeds and spacers must be sterile prior to manual loading into an IsoCartridge.

IsoCartridges containing up to 159 Pd-103 seeds at 2.5 U may each emit up to 1 mR / hour at the IsoCartridge surface. Use appropriate exposure precautions.

in the event of Emergency seed recovery from the isoCartridge, heed these additional Warnings:

User should ensure that the container used is large enough to easily capture all material ejected out of IsoCartridge.

Ensure that the IsoCartridge is oriented upward while the cover is being removed to prevent seeds from falling out.

!

!

!

!

!

!

!

!

!

!

!

physical CharacteristicsThe IsoCartridge consists of an aluminum body that houses electrical, mechanical and sensory components. An integral stainless steel housing contains the sterile radioactive seeds and spacer materials. The IsoCartridge is provided in a tray with a Tyvek® peel top.

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INstrUCtIoNs For Use

unpaCking thE isoCartriDgE

iMportant: Retain the following packaging materials for RETURN SHIPMENT of used IsoCartridge:

• Returnshippingkitenvelope• Cardboardshippingcartonwithfoamand

cardboard inserts• Plasticpackagingtray• Leadpig/looseseedvial

Carefully open the shipping carton. Remove the following to be used during Isoloader operation:

• IsoCheckkit• IsoloaderSterileDrape

Remove the tray containing the IsoCartridge and place on a level surface, preferably in a location next to the Isoloader®. Drape the Isoloader using sterile drape providedperSection3.9ofthe isoLoaDEr usEr ManuaL. Carefully open the tray by grasping the pEEL tab and remove the lid.

Using sterile technique, remove the IsoCartridge from the trayandinsertintotheIsoloaderreceiver.GentlyseattheIsoCartridge in the Isoloader using a gentle push. See Section 3.10.1 of the isoLoaDEr usEr ManuaL for additional information.

The workstation will automatically lock the IsoCartridge and an isoCartridge Detected window will pop up. The status of the IsoCartridge can be viewed in the system status information window.

isoCartridge initializationTo initialize the IsoCartridge, touch Yes. The initialization routine performs Data Transfer, Initialization, Self-Test and Calibration procedures. The initialization procedure for the IsoCartridge will take approximately a minute.

note: The IsoCartridge is automatically locked into position and unlocked via software control. The status of the IsoCartridge® can be viewed in the System Status information window. If the Isoloader application is closed or the computer is turned off, the IsoCartridge is automatically unlocked.

A safety check is performed when the IsoCartridge is initialized and compared to a dose plan and differences that exist in patient name, ID, seed type and seed strength are shown.

(SeeSection3.10.4intheIsoloaderUserManual)

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isoCartridge Data Comparison With Dose plan

When the IsoCartridge is inserted into the Isoloader, patient and seed data are compared with the dose plan.

If the IsoCartridge data does not match the current Patient Dose Plan, a warning window will appear. This window provides the User with a helpful check to ensure that the proper seeds are used with the corresponding plan. The IsoCartridge data information should match the Patient Dose Plan in order to proceed with needle loading. A rED field indicates data mismatch.

Options:

Cancel – Discontinues IsoCartridge initialization procedure.

ignore – Allows the User to override and continue with the Data Transfer from the IsoCartridge.

If ignore is selected, final confirmation is required before going forward. This check will be performed again before the first needle is loaded.

assaying seedsPlease refer to Section 4.10 and Section 4.11.2 of the isoloader usEr ManuaL for instructions on how to assay seeds with the Isoloader workstation.

Loading needlesPlease refer to Section 4.4 of the isoloader usEr ManuaL for instructions on how to load needles using the Isoloader workstation.

isoCartridge removalTo remove the IsoCartridge, select the unLoCk isoCartriDgE button from the main button panel. A window will indicate the time left for removal of the cartridge. If it is not removed within 15 seconds, the IsoCartridge will be re-locked into the workstation. This operation may be cancelled any time during the countdown.

note: The IsoCartridge is automatically locked into position and unlocked via software control. The status of the IsoCartridge can be viewed in the System Status information window. If the Isoloader application is closed or the computer is turned off, the IsoCartridge is automatically unlocked.

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aBnorMaL shutDoWn oF thE isoLoaDErIf the Isoloader application program should terminate due to a Non-Responding application fault, DO NOT REMOVE THE ISOCARTRIDGE FROM THE ISOLOADER, because the pushrod contained in the IsoCartridge may have stopped in an improper position.

First, attach a sterile Loading Tray to catch any material that may be ejected during the recovery. Then, restart the Isoloader application and reinitialize the IsoCartridge. This should return the IsoCartridge to normal operation. If not, restart and try to reinitialize again.

If this is not successful, then it is recommended that the pushrod be manually parked into the IsoCartridge drum prior to further handling. This is to prevent material from being accidentally dispensed from the IsoCartridge.

to manually park the pushrod into the isoCartridge drum, perform the following three steps:

1. With the IsoCartridge still installed in the Isoloader and the sterile Loading tray attached, insert the sterile Loading pushrod into the small hole in the tube on the left side of the IsoCartridge. (See Fig. 1)

2. Push the Loading pushrod all the way in and remove. Resistance will be felt as the internal pushrod is moved. This is normal. (See Fig. 2)

3. The Isoloader application can now be re-started and the procedure continued. Reinitialize the IsoCartridge. Leave the Loading tray attached to catch any loose material that may be ejected. Run the IsoCheck procedure to verify the contents of all chambers.

Warning: In the event of an abnormal shutdown of the Isoloader, radioactive material may be ejected during the re-initialization process.

If the fault is unrecoverable then proceed to page 6 – EMErgEnCy sEED rECovEry FroM isoCartriDgE.

Fig. 1

Fig. 2

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EMErgEnCy sEED rECovEry FroM isoCartriDgEIf an unrecoverable Isoloader malfunction occurs, seeds may be quickly recovered from the IsoCartridge using the following procedure.

If the Isoloader does not respond, you may need to shut down the computer using Ctrl-Alt-Delete and select Shut Down. Remove power only as an emergency measure.

removal and disassembly of isoCartridge First obtain a suitable container into which the seeds and spacers will be ejected. Make sure that the container is large enough so that it can easily catch the loose seeds and spacers.

Warning: User should ensure that the container used is large enough to easily capture all material ejected from the IsoCartridge.

Begin by retracting the pushrod inside the IsoCartridge. Do this by inserting the Loading Pushrod into the needle luer tip of the IsoCartridge. Push the Loading Pushrod all the way in and remove. Resistance will be felt as the internal pushrod is moved. This is normal. (See Figs. 1 and 2)

Remove the IsoCartridge by pressing the UNLOCK ISOCARTRIDGE button (Section 3.10.3 of the Isoloader User Manual). If this does not work, exit from the Isoloader software application per Section 4.13 of the Isoloader User Manual. If this is unsuccessful, exit Windows® and power down the Isoloader.

Remove the Shield from the IsoCartridge by unscrewing the Luer-lock needle mount from the IsoCartridge and sliding the Shield off of the rear of the IsoCartridge. (See Fig. 3)

Hold the IsoCartridge with the left hand as indicated per the illustration in Figure 4. Ensure that the left pointer finger applies pressure onto the area labeled NEEDLE IN POSITION.

Cut the Quality Seal on the IsoCartridge and, using the 2mm hex key provided with the Isoloader accessories, unscrew the four (4) screws using a counter-clockwise motion. (See Fig. 5)

While securely holding the IsoCartridge with the left hand, use the right hand to gently slide the IsoCartridge faceplate out approximately one half inch. Use caution to ensure that the IsoCartridge body is oriented with the needle mount end tilted upward to prevent the contents from inadvertently dropping out. (See Fig. 6)

Remove the faceplate while holding the IsoCartridge body upright. Use extreme caution when conducting this step as loose radioactive seeds will now be exposed. (See Fig. 7)

Fig. 1 Fig. 2

Fig. 3 Fig. 4

Fig. 5 Fig. 6

Fig. 7 Fig. 8

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Warning: Ensure that the IsoCartridge is oriented upward while the cover is being removed to prevent seeds from falling out.

Warning: Radioactive Seeds. Use all appropriate precautions to minimize exposure. Hold the open IsoCartridge away from body.

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Empty the contents of the IsoCartridge into the container using a single, continuous motion. Visually verify that all chambers in the IsoCartridge are empty. A Geiger counter or similar device may be used to verify that all radioactive material has been removed. (See Fig. 8)

Separate seeds from spacers, discard the spacers and re-sterilize the seeds prior to manual loading. Use fresh, pre-sterilized spacers to complete the loading.

The brachytherapy sources may be sterilized by steam autoclaving or ethylene oxide. Refer to seed manufacturer’s Instructions For Use for additional guidance for sterilization.

Reassemble the IsoCartridge in the reverse order in which it was disassembled prior to returning in IsoCartridge shipping box.

unusED sEEDs / rEturns For DisposaLIf unused seeds remain in the IsoCartridge after the surgical case, leave seeds contained in the IsoCartridge, and refer to the return guidance listed below. Clean any loose seeds of biohazard material and place in the glass vial and then in the lead pig.

CLEaning proCEDurE For thE isoCartriDgEThe IsoCartridge is provided sterile, ready for one-time use and is not re-usable without factory reprocessing. After use, unscrew the metal needle mount from the IsoCartridge and slide the plastic shield off the pushrod tube and discard the shield. Wipe the IsoCartridge with a clean cloth slightly dampened with 70% alcohol or other approved disinfectant to remove any contaminants from the external surfaces of the IsoCartridge, being careful not to allow any fluid to seep into the IsoCartridge. The IsoCartridge must be returned free of any biohazard.

DO NOT AUTOCLAVE. DO NOT IMMERSE THE ISOCARTRIDGE IN ANY LIQUID.

proDuCt inForMation DisCLosurECore Oncology expressly disclaims all warranties, whether written or oral, statutory, expressly or implied, by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability, fitness or design. Core Oncology shall not be liable for any direct, incidental, or consequential loss, damage or expense, directly or indirectly arising from the use of this product. No representation or other affirmation of fact, including, but not limited to, statements regarding suitability for use, or performance of the product, shall be or be deemed to be a warranty by Core Oncology for any purpose. Core Oncology neither assumes nor authorizes any other or additional liability or responsibility in connection with this product.

rEturnED gooDs poLiCyFor information, please contact the Core Oncology Customer Care Department at:

Core oncology 3916 State Street, Suite 110 Santa Barbara, CA 93105 Phone (800) 371-5120 Fax (805) 297-8364

CUSTOMER SERVICEFor product information or to place an order, contact Theragenics® Customer Service at (877) 444-7333, Monday through Friday, 8:00 AM to 6:00 PM ET. Orders may also be submitted via facsimile at (800) 458-4303.

Defective, damaged, or out of specification product may be returned for credit with prior return authorization. Please do not return product without first obtaining a return authorization.

paCkaging DiagraM

© February 2009 core oncology

For technical support, call: 800-896-1865Manufacturing site:

M Core Oncology120 N.E. 26th StreetOklahoma City, OK 73105

3916 State Street, Suite 110Santa Barbara, CA 93105Customer Service: 800-371-5120Fax: (800) 297-8364

Upper cardboard support

Foam Sheet

Needle mount

Zip Lock bag

IsoCartridge

Plastic packaging tray

Lead pig & glass vial(for return of loose seeds)

Foam insert

Lower cardboard support

Isoloader®/IsoStrand®/Isocartridge®/Isocheck® protected by u.S.

Patent numbers 6,537,192; 6,599,231; 6,616,593; 6,869,390; 7,229,400; 7,351,192.

Theragenics Corporation®

5203 Bristol Industrial WayBuford, GA 30518USA