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IsoCord Needle Loading Station - SeeDos, UK

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<strong>IsoCord</strong> ®<br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

BEBIG Isotopen- und<br />

Medizintechnik GmbH<br />

Robert-Rössle-Straße 10<br />

D - 13125 Berlin<br />

Germany<br />

Tel.: +49 (0)30 94 10 84 - 130<br />

Fax: +49 (0)30 94 10 84 - 112<br />

0044<br />

70300-1601<br />

Revision 01, 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

Content<br />

1. Manufacturer ....................................................................................................... 3<br />

2. Introduction and Intended Use ............................................................................ 3<br />

3. Product Description ............................................................................................. 5<br />

4. Accessories ......................................................................................................... 6<br />

5. Use...................................................................................................................... 8<br />

5.1. Preparation................................................................................................... 8<br />

5.2. Insert the Magazine...................................................................................... 9<br />

5.3. Insertion of the Drive Knob and Checking of the Seed Chain .................... 10<br />

5.4. Mounting the <strong>Needle</strong> .................................................................................. 10<br />

5.5. Moving the Magazine Holder into the “<strong>IsoCord</strong> position”............................ 11<br />

5.6. Dispensing ................................................................................................. 11<br />

5.7. Cutting of the Seed Chain .......................................................................... 12<br />

5.8. Moving the Magazine into the “mandrel position”...................................... 13<br />

5.9. <strong>Loading</strong> the Trimmed Seed Chain Piece into the <strong>Needle</strong>........................... 14<br />

5.10. Removing the <strong>Needle</strong>................................................................................. 15<br />

5.11. <strong>Loading</strong> more <strong>Needle</strong>s ............................................................................... 15<br />

5.12. End of the Seed Chain ............................................................................... 15<br />

5.13. End of <strong>Loading</strong> ........................................................................................... 15<br />

5.14. Removing Magazine................................................................................... 16<br />

6. Directions for the Implantation............................................................................17<br />

6.1. Sealing the Implant <strong>Needle</strong>s ...................................................................... 17<br />

6.2. Seed Type.................................................................................................. 17<br />

6.3. Correction of the Implantation Depth.......................................................... 17<br />

7. Maintenance and Sterilization ............................................................................18<br />

8. Safety Instructions..............................................................................................22<br />

9 Trouble Shooting ....................................................................................................23<br />

9.1 The Seed Chain Does not Move out of the Magazine..................................... 23<br />

9.2 The Seed Chain Does not Thread into the Positioning System ...................... 25<br />

9.3 The Seed Chain Piece Gets Stuck in the Guiding System ......................... 26<br />

9.4 The Strand will not Completely load into the <strong>Needle</strong>.................................. 26<br />

9.5 Damage of a Seed ..................................................................................... 27<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 2 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

1. Manufacturer<br />

BEBIG Isotopen- und Medizintechnik GmbH<br />

Robert-Rössle-Str. 10, D-13125 Berlin<br />

Tel.: +49 (30) 94 10 84-130<br />

Fax: +49 (30) 94 10 84-112<br />

e-mail: info@bebig.de<br />

www.bebig.de<br />

2. Introduction and Intended Use<br />

Interstitial Brachytherapy is a treatment method for prostate cancer with little side<br />

effects which is becoming more and more popular. Small completely encapsulated<br />

radioactive implants, so-called seeds, are introduced into the prostate and remain<br />

there. The radiation emitted by the seeds destroys the tumor cells.<br />

The seed implantation can be done in different ways. The device described here is<br />

used for the so-called “pre-loaded needle“ technique. According to a treatment plan,<br />

implantation needles are loaded with a certain number of seeds and spacers. Each<br />

needle is inserted at a certain position, and the loaded number of seeds and spacers<br />

is implanted into the prostate at a certain track and depth.<br />

The loading can be done with loose seeds and spacers. The user sorts seeds and<br />

spacers alternately and slides them into the desired needle. Alternatively one can<br />

work with a ready-made seed chain, a so-called strand. Therefore, the seed chain<br />

has to be cut to the appropriate length, for example into a piece containing four<br />

seeds. This four seeds piece is then inserted into the needle.<br />

The <strong>IsoCord</strong> seed chain contains seeds and spacers in an alternating sequence, with<br />

10 mm distance between the middle of two consecutive seeds. The <strong>IsoCord</strong> seed<br />

chain is housed in a magazine due to radiation safety and ease of use requirements.<br />

A magazine can contain up to 75 seeds.<br />

Intended Use<br />

The <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> is used to move the <strong>IsoCord</strong> seed chain out of<br />

its magazine, cut the chain into the defined lengths and move these cut lengths or<br />

strands into the attached implantation needle. While performing the steps above, the<br />

user is very well shielded from the emitted radiation of the seeds.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 3 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

User<br />

The use of the <strong>IsoCord</strong> system is restricted to personnel specially trained in radiation<br />

safety and the proper use of the provided equipment.<br />

Bebig provides a certain training to dedicated users when the system is installed in<br />

the clinic. The successful training is documented by a certificate from Bebig. Only<br />

personnel holding this certificate is allowed to work with the <strong>IsoCord</strong> system.<br />

Further Information<br />

In the following, the use of the <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> with <strong>IsoCord</strong> seed<br />

chains is described.<br />

For further information about the <strong>IsoCord</strong> seed chain itself, especially about the<br />

physics of the seeds, please refer to the corresponding manual.<br />

In the following, the term seed chain is used to describe the whole length of the seed<br />

chain which is still in or connected to its magazine, while the term strand is used to<br />

describe a cut piece of the seed chain, which will be put into an implantation needle.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 4 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

3. Product Description<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

The <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>, BEBIG article NLS.101, is composed of six<br />

main components which are mounted to a common base plate.<br />

1: <strong>Needle</strong> Holder<br />

Here the implantation needle will be attached.<br />

2: Movable Magazine Holder<br />

When the <strong>IsoCord</strong> magazine is inserted into the magazine holder, the<br />

transportation lock is automatically disabled. The holder can be moved between<br />

two positions. In the so-called “<strong>IsoCord</strong> position”, the outlet of the magazine is<br />

aligned with the adjacent guiding system so that the seed chain can be moved<br />

out. In the other position, the so-called “mandrel position”, the built-in mandrel is<br />

aligned in such a way that the cut strand can be moved with the mandrel into the<br />

attached needle.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 5 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

3: Drive Knob<br />

The knob is inserted into the magazine. By turning the knob counterclockwise the<br />

contents of the magazine are propelled forward and the seed chain moves out of<br />

the magazine.<br />

4: Positioning Unit with Lighting<br />

The front of this unit is covered with a sheet of stainless steel which provides<br />

optimal radiation protection for the user. The seed chain is illuminated to allow a<br />

safe distinction between seeds and spacers while it is watched in the mirror. The<br />

power for the light is provided by an external power supply unit.<br />

5: Cutting System<br />

The cutting system facilitates an exact cut of the correctly positioned seed chain<br />

in the middle of a spacer.<br />

6: Built-in Mandrel<br />

It is used to move the cut strand into the attached needle. A return spring pulls the<br />

mandrel back into its starting position.<br />

4. Accessories<br />

To load implantation needles with seed chain pieces, the user needs the needles and<br />

the seed chain itself. More accessories for handling failures are provided.<br />

<strong>IsoCord</strong> Chain in Magazine<br />

The <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> can and may only be used with an <strong>IsoCord</strong><br />

seed chain in its magazine.<br />

Implantation <strong>Needle</strong>s<br />

In principle, any 18 Gauge (ETW, BETW or UTW) prostate implantation needles can<br />

be used with the <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>. The only requirements for their<br />

use with the <strong>IsoCord</strong> system are that they have a minimum inner diameter of 1.04<br />

mm and that their connection fits the needle holder.<br />

This is certainly the case for the needles provided by BEBIG; therefore, we<br />

recommend to use only these needles, BEBIG article number 000.430.<br />

<strong>IsoCord</strong> Sterilisation Tray (NLZ.100)<br />

This tray has defined positions for the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> and its accessories<br />

find a dedicated place in the in sterilisation tray. This tray can also be used for storing<br />

the parts.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 6 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

<strong>IsoCord</strong> Screw Driver (NLZ.101)<br />

If the drive knob is turned too far into the “Magazine” direction, the seed chain might<br />

disappear completely into the magazine or even slip out of the drive mechanism. In<br />

this case the magazine inspection flap has to be opened to re-thread the seed chain.<br />

A sterilizable hexagonal screw driver is provided for this purpose.<br />

<strong>IsoCord</strong> Waste Container (NLZ.102)<br />

The stainless steel waste container is used to store remaining pieces of the seed<br />

chain. Since it is sterilizable, it can be used on the sterile workplace. Its wall<br />

thickness is sufficient shield the radiation from the iodine seeds.<br />

<strong>IsoCord</strong> Tweezers (NLZ.103)<br />

The tweezers have a rounded tip but slightly rough jaws to hold the seed chain<br />

without damaging it. They can be sterilized, but may not be used for surgical<br />

procedures.<br />

<strong>IsoCord</strong> Scissors (NLZ.104)<br />

The scissors are used to cut the seed chain precisely at a spacer position when<br />

required e.g. to divide a strand that has already been cut. They are sterilizable.<br />

<strong>IsoCord</strong> Power Supply<br />

The light inside the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> is powered by an external power supply<br />

unit. This unit (NLZ.105) and the corresponding power cord (NLZ.106) are available<br />

as replacement parts. They cannot be sterilized.<br />

<strong>IsoCord</strong> <strong>Needle</strong> Rack (NLZ.107)<br />

Optionally, a shielded needle rack is available to hold the preloaded needles until<br />

they are implanted. The needle rack can be sterilized.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 7 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5. Use<br />

The following describes the preparation and the use of the <strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong><br />

<strong>Station</strong>.<br />

5.1. Preparation<br />

The <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> and its accessories must be sterilized prior to their use<br />

according to the instructions given in chapter 7, Maintenance and Sterilization. Also,<br />

a sufficient number of needles has to be available.<br />

The sterile workplace is set up according to the local procedures. A sterile area, 70<br />

cm wide and 50 cm deep, is sufficient. There should be a power outlet close to the<br />

sterile area and a safe place for the power supply of the positioning unit.<br />

Place the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> in the lower right part of the workplace facing the<br />

user. This ensures that the attached needle is completely inside the sterile area. The<br />

space behind the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> can be used as sterile storage area for the<br />

prepared needles, the magazine(s) and the needle rack. The sterilized accessories<br />

including scissors, tweezers, waste container and the hexagonal screw driver, can be<br />

positioned below the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>.<br />

Before you start, check that you have all of the equipment required.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 8 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

Connect the sterile cable of the <strong>Needle</strong><br />

<strong>Loading</strong> <strong>Station</strong> with the nonsterile one of the<br />

power supply unit, but do it outside the sterile<br />

area. Pay attention to the orientation of the<br />

connectors: the tongue of one connector has<br />

to fit to the groove of the other. Now you can<br />

connect the power supply unit to an electrical<br />

outlet.<br />

Change the sterile gloves afterwards or let someone else handle the unsterile part.<br />

There might be residue from the steam sterilization on the mirror surface of the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> which can disturb the view of the seeds. This residue should<br />

be wiped using a sterile swap.<br />

Prepare the needles. Seal the needle tips using common techniques. Take a<br />

magazine out of its sterile packaging.<br />

5.2. Insert the Magazine<br />

After preparing the workplace and equipment as described<br />

above, the needles can be loaded. Take a magazine and<br />

unscrew the radiation protection cap.<br />

Insert the magazine into the corresponding<br />

holder of the <strong>Needle</strong> <strong>Loading</strong><br />

<strong>Station</strong>. Put the left side down first so<br />

that the connector piece fits into the<br />

bush of the holder.<br />

Then press down the right side. If necessary,<br />

jiggle it a little bit up and down<br />

until it fits in. The transportation lock of<br />

the magazine is automatically released<br />

by the little pin located in the right lower<br />

corner of the holder. It might seem a little<br />

tight, but with some practice it is easy to<br />

do. An accurate fit is necessary for precise<br />

cutting of the seed chain.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 9 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5.3. Insertion of the Drive Knob and Checking of the Seed Chain<br />

Insert the drive knob into the magazine.<br />

Make sure that the orientations of the two<br />

hexagons coincide.<br />

Check if the seed chain can be moved<br />

out now. The magazine holder has to be<br />

in the so-called “mandrel position” (see<br />

paragraph 5 and 8 in this chapter). In this<br />

position the bushing of the holder, where<br />

the seed chain moves out, is visible.<br />

Turn the knob counterclockwise by a few<br />

degrees (identified by the notches at the<br />

periphery of the drive knob), i.e., in the<br />

direction indicated by the inscription<br />

“<strong>Needle</strong>” on the knob. The knob should<br />

be easily turned, without much<br />

resistance, and the seed chain should<br />

come out of the bushing. If this is not the<br />

case, do not try to turn the knob forcibly,<br />

but proceed as recommended in chapter<br />

9, Trouble Shooting.<br />

Now turn the drive knob clockwise, i.e., into the direction<br />

indicated by the inscription “Magazine” on the knob, until<br />

the tip of the seed chain is flush with the bushing.<br />

5.4. Mounting the <strong>Needle</strong><br />

Move the hub of the needle over the<br />

tip of the needle holder until the jaws<br />

clamp the needle as shown in the<br />

picture. It is just a little push and<br />

click. If necessary, turn the needle<br />

slightly.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 10 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5.5. Moving the Magazine Holder into the “<strong>IsoCord</strong> position”<br />

Now move the magazine holder forward into the “<strong>IsoCord</strong> position”. In this position<br />

the opening of the magazine in aligned with the guiding system of the positioning unit<br />

and the needle.<br />

Both end positions are fixed by a ball catch which initially resists the movement.<br />

Push, as shown in the picture, with your thumbs against the magazine holder while<br />

you hold the mounting plate in place with your middle fingers. This will prevent the<br />

station from sliding on a slippery surface, e.g., a sterile sheet.<br />

The magazine holder moves between these two positions in a diagonal direction (in<br />

the picture from the right lower to the left upper corner). The end position is reached<br />

when the holder fits close to the cutting system and the ball catch is engaged.<br />

5.6. Dispensing<br />

To move the seed chain out of the<br />

magazine, turn the drive knob slowly<br />

counterclockwise. This direction is<br />

indicated on the knob by the big arrow<br />

and the inscription “<strong>Needle</strong>”. Use the<br />

mirror to watch the seed chain move into<br />

the positioning unit while turning the<br />

drive knob.<br />

If the seed chain does not appear, do not turn the drive knob any further. Instead,<br />

follow the directions in chapter 9, Trouble Shooting.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 11 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

The non-translucent seeds (dark) are clearly distinguishable from the translucent<br />

spacers (light). In this window you can see up to six seeds at once.<br />

If you want to load a needle with a strand<br />

of, for example, three seeds, turn the drive<br />

knob only so far, that the first seed is<br />

located at position “3”.<br />

Position the seed chain so that the seeds are coincident with the black marks above<br />

the numbers. Pay special attention to the seed at position “1”, the one right to the<br />

viewer. Ensure accurate positioning in order to cut the end spacer exactly in the<br />

middle. Ensure that you view the chain at position “1” at a right angle, as oblique<br />

perspectives might result in misalignment.<br />

Even without the internal lighting all<br />

elements can be distinguished from each<br />

other very well. You will, however, get a<br />

different picture, as shown on the right:<br />

Now the seeds appear brighter than the<br />

spacers. The spacers are also<br />

distinguishable from the seeds by their<br />

slight “indentation”.<br />

5.7. Cutting of the Seed Chain<br />

After positioning the seed chain as<br />

described above, remove your hand<br />

from the drive knob to avoid<br />

unintentional change of the position.<br />

Now you can cut the chain by pushing<br />

the knife of the cutting system down and<br />

releasing it.<br />

Attention: Before cutting, please re-check the position of the chain!<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 12 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5.8. Moving the Magazine into the “mandrel position”<br />

To load the cut strand into the needle you must move the needle holder into the<br />

“mandrel position”. In this position the built-in mandrel is aligned with the guiding<br />

system. Pull the magazine holder back with your index fingers while supporting the<br />

base plate with your thumbs.<br />

When the lower ball catch is engaged, the end position is reached.<br />

A short piece of seed chain is visible at the outlet hole of<br />

the magazine holder. Correctly cut, this piece is half a<br />

spacer, so there is minimal radiation coming from the<br />

next seed still inside the connector piece.<br />

Turn the drive knob back a bit, into the direction<br />

“Magazine”, so that the seed chain is just visible at the<br />

outlet hole. Do not turn any further. This ensures optimal<br />

radiation protection and trouble-free re-threading of the<br />

seed chain into the positioning unit the next time you<br />

confection.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 13 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5.9. <strong>Loading</strong> the Trimmed Seed Chain Piece into the <strong>Needle</strong><br />

The trimmed strand can now be loaded into the needle. Move the built-in mandrel<br />

into the direction of the needle by pushing the handle accordingly.<br />

Move the mandrel only as far as the point where you can see the end of the cut<br />

strand in the window. Examine the location of the cut to control your positioning.<br />

In the right picture the spacer was not cut<br />

excactly in the middle but still acceptably.<br />

If you have a larger deviation, you have to<br />

correct your alignment of seeds and<br />

marks during the positioning procedure.<br />

Attention: If a seed is damaged accidentally, proceed as recommended in<br />

chapter 9, Trouble Shooting. Never implant a damaged seed!<br />

Move the mandrel slowly and carefully to<br />

the end position. The end of the strand is<br />

approx. 3.5 cm away from the claws of<br />

the needle holder. On BEBIG supplied<br />

needles this position is marked „IIII“ as<br />

you see in the picture in the next<br />

paragraph. Carefully return the mandrel<br />

to its start position.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 14 Rev. 01 / 2004-06-15


<strong>IsoCord</strong><br />

Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

5.10. Removing the <strong>Needle</strong><br />

The loaded needle is removed in the<br />

following way: Hold the needle at its<br />

hub, as close to the needle holder as<br />

possible to avoid unnecessary radiation<br />

exposure from the strand within the<br />

needle sheath. Activate the release pin<br />

at the station and remove the needle,<br />

turning the needle slightly if necessary.<br />

Store it in a suitable place (ideally the<br />

<strong>Needle</strong> Rack NLZ.107) or hand it over<br />

directly to the surgeon.<br />

5.11. <strong>Loading</strong> more <strong>Needle</strong>s<br />

To load more needles, repeat all steps from attaching the needle to removing the<br />

loaded needle. Document precisely so that you always know exactly how many<br />

seeds you have already loaded and how many are still in the magazine.<br />

5.12. End of the Seed Chain<br />

For technical reasons, there are a few<br />

additional spacers in line at the end of the<br />

seed chain. Of course, these cannot be<br />

used as active implants.<br />

The picture on the right shows the end of<br />

the seed chain, the last seed in position<br />

“2”. If you cut the seed chain now, you<br />

would get an incorrect needle loading.<br />

Therefore, position the seed chain so that the last seed is at position “1” and<br />

separate this last strand from the residual seed chain.<br />

When you have reached the final seed, turn the drive knob even further in the<br />

“<strong>Needle</strong>” direction. The remaining seed chain will be cut inside the magazine. By<br />

checking the remainder with an appropriate detector or by a visual inspection, you<br />

can verify that no seed is left.<br />

5.13. End of <strong>Loading</strong><br />

If possible, you should empty the magazine completely. If you still have seeds in the<br />

magazine, you can check the number of seeds remaining by counting them to verify<br />

your documentation. You can count a chain with up to twelve seeds in the <strong>Needle</strong><br />

<strong>Loading</strong> <strong>Station</strong> without any additional accessories. A seed chain with more<br />

remaining seeds would protrude from the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>.<br />

If you have more than twelve seeds left, attach a needle to the station and use an<br />

appropriate shield or keep a sufficient distance from the needle while counting the<br />

seeds thirteen and more.<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 15 Rev. 01 / 2004-06-15


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Manual for the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

Move the seed chain out of the magazine the same way that you load the needles.<br />

Count every seed that passes position “1” until the end of the seed chain is reached.<br />

Afterwards turn the drive knob in the other direction and re-wind the seed chain.<br />

Ensure that you take the seed chain back so far, so that it just disappears from the<br />

window.<br />

5.14. Removing Magazine<br />

When you have finished the loading remove the magazine from the magazine holder.<br />

This should be done in the “mandrel position”.<br />

Firstly, the remaining seed chain should be turned back into the magazine.<br />

Turn the driving knob clockwise, as indicated by the inscription “Magazine” on the<br />

knob, so that the end of the seed chain remainder is flush with the bushing. Now turn<br />

about 3–4 notches on the knob further. This ensures the complete return of the seed<br />

chain into the magazine, with the possibility of moving the seed chain out of the<br />

magazine again, if necessary.<br />

Take the drive knob out of the magazine. Remove the magazine using the “last in -<br />

first out” priciple: First lift up the right lower corner (at the locking pin) a bit and then<br />

the right upper corner. After the right side is out, take the magazine completely out of<br />

the holder. Screw on the radiation protection cap.<br />

If there are seeds left in the magazine, document their number on the label with date<br />

and signature. The magazine has to be treated according to the radiation protection<br />

laws, so store it in a suitable safe until you return it to BEBIG. Please return also<br />

empty magazines.<br />

For the BEBIG return service; please contact our customer support.<br />

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6. Directions for the Implantation<br />

6.1. Sealing the Implant <strong>Needle</strong>s<br />

There is no need for a special sealing material when using <strong>IsoCord</strong>. The spacers<br />

within the <strong>IsoCord</strong> strands provide sufficient rigidity to easily penetrate a bone wax<br />

seal.<br />

6.2. Seed Type<br />

The <strong>IsoCord</strong> seed chains utilize BEBIG IsoSeeds of the type I25.S06. Choose this<br />

type in your planning software.<br />

6.3. Correction of the Implantation Depth<br />

The Configuration of the <strong>IsoCord</strong> strand loaded needle differs from a needle loaded<br />

with loose seeds because of the construction of the <strong>IsoCord</strong> seed chain and the<br />

operation mode of the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>.<br />

While a loose seed configuration starts with a seed, an <strong>IsoCord</strong> configuration always<br />

starts with half a spacer.<br />

Please bear that in mind when you implant an <strong>IsoCord</strong> strand loaded needle.<br />

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7. Maintenance and Sterilization<br />

Cleaning<br />

After use the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> needs to be cleaned from residue of the cut<br />

seed chain using a damp swap. Please ensure that no material gets into the guiding<br />

system. A commercially available cleaning agent for surgical instruments can be<br />

used for heavier dirt. Please ensure that you carefully follow its instructions for use<br />

and avoid all cleaning agents containing acid or alkalines.<br />

Maintenance<br />

Check that all moveable parts are still<br />

functional, in particular the built-in mandrel. It<br />

should be moved completely forward and<br />

slowly backward to recoil its return spring.<br />

Lubricate this spring with a biocompatible<br />

instrument spray.<br />

The ball catch which holds the magazine holder in place has to be treated the same<br />

way. It is positioned under the magazine holder.<br />

The magazine holder should be in the<br />

“mandrel position”. Hold the station<br />

upright and spray the lubricant onto the<br />

ball as shown in the picture.<br />

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Similarly, the guide of the release pin of<br />

the needle holding mechanism should be<br />

lubricated. This is especially important<br />

because this mechanism has no bearing.<br />

Push the pin forward, spray the axis and<br />

move backwards and forwards a couple<br />

of times so that the oil is well distributed.<br />

Repeat if necessary until the pin can be<br />

moved easily.<br />

Also, the axes and the release mechanism of the needle holder need to be<br />

maintained with instrument spray.<br />

Water spots from the steam sterilization should be wiped with a damp cloth.<br />

Also check and maintain the accessories. The tip of the screw driver should be<br />

lubricated from time to time to avoid corrosion.<br />

Service<br />

The <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> should be sent back to the manufacturer once a year.<br />

Please Co-ordinate with BEBIG’s customer support and you will receive an exchange<br />

unit in advance. You can then use the transport case of the exchange unit to return<br />

your station.<br />

Exchange of the Lighting Unit<br />

The durability of the lighting unit is limited by the number of sterilization cycles. It will<br />

be exchanged at the annual service by the manufacturer. Should your lightening unit<br />

fail before the annual service, you can easily exchange the unit yourself.<br />

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If you do not already have an exchange lighting unit, request one from BEBIG. The<br />

exchange itself is very easy, all you need is a 2 mm hexagonal wrench. Place the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> face down onto the table using some form of cushion or<br />

supporting objects to avoid any damage to its moving parts.<br />

Unscrew the two outer screws of the lighting unit. Then you can remove the unit.<br />

Replace it with the new unit and tighten the screws again.<br />

Sterilization<br />

The whole of <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> with the exception of the external power supply<br />

unit and its power cables can be steam sterilized. The external power supply unit and<br />

its power cables must not and need not be sterilized at all. All accessories and the<br />

<strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> can be inserted into the special sterilization tray and fixed to<br />

it.<br />

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Place all accessories – drive knob,<br />

scissors, tweezers, screw driver and<br />

waste container (container and lid<br />

separated) – into the corresponding<br />

supports, as shown in the picture.<br />

Now place the <strong>Needle</strong> <strong>Loading</strong><br />

<strong>Station</strong>, in the “<strong>IsoCord</strong> position”, on<br />

top of it. Position the base plate at<br />

the side of the needle holder into the<br />

notch of the support and the station<br />

in such a way that the opening in the<br />

base plate is exactly matching the<br />

support with the threaded hole.<br />

Now, with the plastic screw provided,<br />

screw the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong><br />

onto the support. The connection<br />

cable should be coiled around the<br />

designated supports.<br />

Secured this way, the whole tray can be sealed into a sterilization bag or wrapped in<br />

sterilization paper.<br />

The steam sterilization has been validated in a device according to DIN EN 285 using<br />

the following set of parameters:<br />

Temperature<br />

Pressure<br />

Time<br />

134° C<br />

3 bar<br />

5 min<br />

The use of these parameters does not automatically guarantee sterility. The user<br />

must ensure that sterility is obtained by using approved methods, e.g., bio indicators.<br />

If you have further questions, contact the manufacturer of your sterilization device.<br />

Other Sterilization methods are not approved by BEBIG.<br />

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8. Safety Instructions<br />

• Before you start loading needles, familiarize yourself again with the procedure.<br />

• Do not turn the magazine drive outside the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>. The transport<br />

lock will prevent this anyway, but using too much force could damage the<br />

magazine drive.<br />

• Make sure you turn the knob in the right direction, e.g., counterclockwise, in the<br />

„<strong>Needle</strong>” direction, to move the seed chain out of the magazine.<br />

• Move the magazine holder only in the described way. Please do not touch the<br />

drive knob while shifting the magazine, otherwise unintentional movement of the<br />

knob and therefore movement of the seed chain can cause damage of the latter.<br />

• Before you cut the seed chain, please re-check and ensure that it is in the correct<br />

position. Pay special attention to the seed at mark “1”.<br />

• Do not touch the driving knob while you finally check the position of the seed<br />

chain nor while you cut it. It is advisable to press the cutter with the hand used to<br />

turn the knob.<br />

• Check the position of the cut by moving the built-in mandrel forward a little so that<br />

you can see the end of the cut strand. If the cut is not in the middle of the spacer,<br />

adjust your positioning accordingly before the next cut.<br />

• Always finalize the loading of a needle before you take a break! Leave the <strong>Needle</strong><br />

<strong>Loading</strong> <strong>Station</strong> in the “mandrel position”. In this way you can be sure to start<br />

again from a defined point, and you do not have to remember what you did last.<br />

• Do not use too much force if problems occur (adhering, jamming) while trying to<br />

move the seed chain out of the magazine into the guiding system. Instead,<br />

analyze the underlying failure and follow the instructions in chapter 9, Trouble<br />

Shooting.<br />

• Never implant a damaged seed!<br />

• If you cut the seed chain using the <strong>IsoCord</strong> scissors, make sure that both ends of<br />

the seed chain are held securely, so that no piece can spring away. For example,<br />

you can grab one end with the <strong>IsoCord</strong> tweezers while the other end is still<br />

inserted in a needle.<br />

• The external power supply and its power cable must not be sterilized.<br />

• The traceability of the <strong>IsoCord</strong> seed chain is guaranteed by its serial number. This<br />

serial number is written on the label of the magazine and the corresponding<br />

packages. Include the serial number of the magazines<br />

you used for implantation in your documentation of the<br />

patient data.<br />

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9 Trouble Shooting<br />

9.1 The Seed Chain Does not Move out of the Magazine<br />

You insert a magazine into the holder of the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> and turn the<br />

knob to move out the seed chain, but the seed chain does not appear at the bushing.<br />

This may have one of the following reasons:<br />

• Make sure you did not insert an empty magazine by mistake.<br />

• Make sure you really turned the knob into the “<strong>Needle</strong>” direction.<br />

After you excluded these failures, there are still the following possibilities:<br />

The connection piece of the magazine and the bushing of the magazine holder are<br />

not aligned properly.<br />

To correct this, take the magazine out of the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> and examine it<br />

to see if the seed chain has been damaged while trying to move it out. If this is not<br />

the case, insert the magazine again and try it once more. If this is unsuccessfull, you<br />

will have to thread the seed chain by hand into the bushing:<br />

Take the magazine out of the <strong>Needle</strong> Loding <strong>Station</strong><br />

and release the transportation lock with the help of the<br />

<strong>IsoCord</strong> screw driver. This is achieved by pulling the<br />

lock in the direction of the right lower corner, away<br />

from the middle of the magazine.<br />

With the help of the drive knob, move the seed chain<br />

approx. 2 cm out of the magazine. Put the screw<br />

driver you just used for releasing the lock aside.<br />

Now guide the piece of the seed chain you just moved<br />

out through the bushing and insert the magazine as<br />

normal.<br />

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If the seed chain is already damaged, you have to cut off the damaged part. Release<br />

the magazine lock by hand as described above and turn the seed chain out so far<br />

that the first undamaged spacer is completely visible. Put the magazine down, grip<br />

the end of the seed chain with the tweezers and cut the first undamaged spacer with<br />

the <strong>IsoCord</strong> scissors right in the middle. Retry to insert the magazine or try to thread<br />

the seed chain by hand through the bushing as described above. Be aware of the<br />

additional exposure to radiation from seeds already outside the magazine.<br />

There is also a possibility that the seed chain is no longer being propelled forward.<br />

This failure can be caused by turning the seed chain too far back into magazine<br />

(about a 60° turn of the drive knob, calculated from that position where the end of the<br />

seed chain levels with the bushing).<br />

Re-threading of the seed chain<br />

Keep the magazine inserted in the <strong>Needle</strong> <strong>Loading</strong><br />

<strong>Station</strong>. Open the inspection flap by removing the two<br />

upper screws with the <strong>IsoCord</strong> screw driver.<br />

To take off the flap, turn the third screw on the left side<br />

counterclockwise to lift the flap.<br />

Grip the flap with the tweezers and take it off.<br />

Identify the end of the seed chain in the<br />

window. If necessary, turn the knob clockwise<br />

until the end of the chain appears. Grip it with<br />

the tweezers and pull it taut.<br />

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Feed the chain through the tube towards the<br />

friction wheel by turning the knob slowly in the<br />

“<strong>Needle</strong>” direction. While doing so, guide the<br />

seed chain with the tweezers at the upper<br />

wall of the casing until the seed chain comes<br />

out of the bushing.<br />

Now grip the end coming out of the bushing at the spacer behind the first seed and<br />

turn the knob back until the chain clings tight to the wheel. Make sure the coils do not<br />

cross each other and correct, if necessary.<br />

Keeping hold of the end of the seed chain without pulling, take off the knob and<br />

reposition the lid of the magazine. After you verified that everything is in the correct<br />

position and the seed chain can be easily moved, screw on the lid.<br />

Altogether, this procedure involves a slightly increased radiation exposure. Hence,<br />

you should work accurately and efficiently, but without hurry. If possible, use a<br />

shielding screen made out of lead perspex.<br />

9.2 The Seed Chain Does not Thread into the Positioning System<br />

The seed chain can be moved out of the bushing of the magazine holder but does<br />

not thread into the guiding system of the positioning unit. This failure occurs when the<br />

seed chain has been moved too far out of the bushing before the magazine holder<br />

has been brought into the “<strong>IsoCord</strong> position”. Therefore, the seed chain hits the<br />

positioning unit at the side of the inlet hole and is bent. This bent end piece has to be<br />

cut off .<br />

Put the magazine holder into the “mandrel position” and move the seed chain further<br />

out of the magazine by turning the knob until the first undamaged spacer is<br />

completely visible.<br />

Grip the damaged end of the seed chain with the<br />

tweezers, hold the drive knob with your hand and<br />

pull the chain slightly until it is taut. Now grip the<br />

damaged end with the tweezers and cut it in the<br />

middle of this first undamaged spacer. Make sure<br />

that no seed is damaged and dispose the cut<br />

piece properly using the waste container.<br />

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9.3 The Seed Chain Piece Gets Stuck in the Guiding System<br />

Do not use force at all to push a seed chain piece or strand further if it cannot be<br />

moved forward and is stuck in the guiding system of the positioning unit. Instead, try<br />

to push it backwards. In order to do this move the magazine holder back into the<br />

“mandrel position” and remove the attached needle. Now feed the stylet of one of the<br />

needles into the tip of the needle holder of the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>. Push the<br />

strand back carefully until it appears at the other end of the positioning unit, the<br />

cutting knife. Now grip it with the tweezers and take it out completely. Check if a seed<br />

is damaged. You can still use this piece for implantation if no seed is damaged and<br />

the seed chain is sufficiently intact. Just load it with the tweezers into a needle<br />

manually. If the strand is damaged at both ends in a way that it cannot be loaded into<br />

a needle, you have to cut off the affected parts. Use the <strong>IsoCord</strong> scissors and secure<br />

both ends while cutting. Only cut at the spacer positions with enough clearance to the<br />

seeds. Do not damage a seed.<br />

9.4 The Strand will not Completely load into the <strong>Needle</strong><br />

If the BEBIG provided implant needles are not used then there is a possibility that the<br />

strand will not load completely into the needle. This is because the design of the<br />

needle holder of the station is optimized for the BEBIG provided needles. With other<br />

needles (e.g., MDTECH REF 500618200X) the strand is not guided all the way down<br />

the needle. The built-in mandrel does not sit directly behind the strand, but slightly off<br />

and blocks further movement of the strand into the needle. In this case you must<br />

remove the needle and fully load the strand using the stylet of the needle.<br />

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9.5 Damage of a Seed<br />

If you incorrectly position the seed chain and accidentally cut through a seed instead<br />

of a spacer then you have a contamination incident from a damaged seed. In this<br />

case you are no longer handling a sealed radiation source, but open radioactivity.<br />

This is an incident which requires notification of the authorities if your license does<br />

not include the handling of open radioactivity.<br />

How you proceed, depends on the requirements of your license and the local<br />

regulations. In particular, the question if the already started implantation of a patient<br />

can be finished has to be answered. This is the responsibility of the persons in<br />

charge in the clinic, possibly in consultation with the responsible authorities.<br />

The following discusses the risks which arise for the patient and the user if the<br />

treatment is continued and how these risks can be minimized.<br />

Avoiding the distribution of the contamination<br />

By cutting a seed the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> is contaminated, particularly, close to<br />

the cutting system. First of all it is important to avoid any distribution of the<br />

contamination.<br />

The radioactive iodine in the <strong>IsoCord</strong> seeds is bound to a ceramic body which will<br />

crumble into several small pieces and some dust. Most of these pieces and dust will<br />

be located around the cutting system on the base plate. This dust must not be<br />

distributed in the room (e.g., a strong air draft). Hence, pull the magazine holder back<br />

into the “mandrel position” very carefully and pick up the pieces and dust with a damp<br />

sterile swap. Deposit them with the swap in a suitable container, e.g., the <strong>IsoCord</strong><br />

waste container.<br />

Next, cut the damaged seed from the seed chain<br />

which is still in the magazine. Turn the knob into the<br />

direction “<strong>Needle</strong>” only so far that the next but one<br />

spacer comes out. Now hold the first spacer following<br />

the damaged seed with the tweezers and cut the<br />

second spacer with the scissors. This seed chain<br />

piece with the damaged seed has also to be deposited<br />

into the container. Make sure you do not produce any<br />

further contamination by handling the open seed. Turn<br />

the seed chain back into the magazine far enough so that the end of the chain just<br />

disappears in the bushing. Wipe the surface of the bushing with a sterile damp swap<br />

to minimise possible contamination.<br />

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Now the seed chain piece with the other part of the cut seed will be disposed. The<br />

accidental cutting of a seed is already noticeable through its distinct higher cutting<br />

resistance and a slightly metallic cutting sound. At the latest it should be detected<br />

during the control of the position of the cut, certainly before the strand is loaded into<br />

the needle. It can therefore be assumed that the seed chain is still in the glass tube<br />

of the positioning system. Remove the needle and feed the stylet of an implant<br />

needle, starting at the needle holder, into the guiding system of the <strong>Needle</strong> <strong>Loading</strong><br />

<strong>Station</strong>. Now carefully push the seed chain piece with the damaged seed back until it<br />

comes out of the opening of the cutting system. Do not grip it with the tweezers on<br />

the open seed but at the next spacer and deposit it into the container.<br />

Warning:<br />

Under no circumstances implant a strand with a damaged seed!<br />

Assessment of the remaining contamination and the risk for the patient<br />

According to our tests, a maximum of 4% of seed activity is released when cutting a<br />

seed. The main part is in small pieces and dust, which should have been removed<br />

already. The remaining contamination is located on the knife of the cutting system, at<br />

the bushing and in the guide tube of the positioning unit. If you continue with the<br />

needle loading in a normal manner, you will pick up some of this contamination with<br />

every following seed chain piece. It is evident that the first piece is contaminated by<br />

far the most. It is recommended that you dispense and cut a first strand of 3 seeds,<br />

remove it backwards, as described above, and discard it. In this way the<br />

contamination is reduced even further.<br />

Following these measures a maximum contamination of only 0.2% of the original<br />

seed activity remains, i.e., for an apparent activity of a seed of 0.7 mCi the remaining<br />

contamination is approx. 67 kBq. For further risk evaluation one assumes that this<br />

contamination is transmitted completely to the patient, which is actually not the case.<br />

In fact, the following strands definitely pick up and transmit less contamination to the<br />

patient.<br />

If the remaining contamination is passed completely to the patient and in the<br />

assumption that it passes completely into the blood stream, the patient will have an<br />

additional radiation exposure of about 1mSv effective, respectively 18mSv thyroid<br />

dose.<br />

This anticipated maximum value of the effective dose exposure is just within the<br />

limits of the allowed radiation exposure for the population according to German law.<br />

Thus, continuing the implantation of the patient is not an unjustifiable risk for the<br />

health of the patient. In the end, the responsible physician has to make the decision if<br />

this is tolerable for the patient.<br />

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Decontamination<br />

It is highly unlikely to completely decontaminate the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> at the<br />

clinic. It is therefore necessary to securely package all contaminated components.<br />

The easiest way is to carefully wrap the <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong>, including the<br />

magazine and all accessories, in the sterile sheet you placed under the <strong>Needle</strong><br />

<strong>Loading</strong> <strong>Station</strong>, put everything into a sterilization bag and seal it thoroughly.<br />

Package the bag in a way so it cannot be damaged accidentally, e.g., in a stable<br />

cardboard box cushioned with shock absorbing fillers.<br />

Finally, check your complete work place with a contamination monitor.<br />

Please contact the BEBIG customer support (contact see below) to arrange the<br />

return shipment and to get further information.<br />

For the return shipment you need packaging according to the dangerous goods<br />

transportation laws.<br />

Please notify your local authority about this incidence according to the<br />

requirements of your license.<br />

Please give also notice to BEBIG:<br />

BEBIG Isotopen- und Medizintechnik GmbH<br />

Robert-Rössle-Str. 10, D-13125 Berlin<br />

Tel.: +49 (30) 94 10 84-130<br />

Fax: +49 (30) 94 10 84-112<br />

e-mail: info@bebig.de<br />

<strong>IsoCord</strong> <strong>Needle</strong> <strong>Loading</strong> <strong>Station</strong> Manual 29 Rev. 01 / 2004-06-15

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