1
Q
UICK
L
INK
®
Delivery System
MANUAL RADIONUCLIDE APPLICATOR SYSTEM
Model #: 70310QCA1
Manufacturer
Bard Brachytherapy, Inc.
Carol Stream, IL 60188 USA
(800) 977-6733
www.bardmedical.com
[email protected]
PHYSICAL CHARACTERISTICS
The Q
UICK
L
INK
®
Delivery System is designed to assemble brachytherapy seeds,
S
OURCE
L
INK
™
synthetic spacers, and S
OURCE
L
INK
™
Connectors in cartridges into seed
trains of variable lengths and with variable seed-to-seed spacing as predetermined by
the physician. The Q
UICK
L
INK
®
Loader is composed of stainless steel, GE Ultem
®
1000
plastic, and shielding glass.
S
OURCE
L
INK
™
Connectors and S
OURCE
L
INK
™
Spacers are synthetic absorbable
monofilament seeding spacers that are designed to be assembled with brachytherapy
seeds into seed trains of variable lengths and with seed-to-seed spacing as
predetermined by the physician [Figure 1]. They are composed of a 70% L-lactide and
30% D,L-lactide copolymer. S
OURCE
L
INK
™
Connectors are approximately 0.9mm in
diameter and come in various sizes to provide accurate spacing of seeds in 0.5cm
center-to-center increments.
[FIGURE 1]
S
OURCE
L
INK
™
Connector spacers are approximately 0.8mm in diameter and are
available in lengths of 5.0 and 5.5mm.
Information regarding the specific brachytherapy seed used may be found in the
accompanying seed Instructions for Use.
IN-VIVO CHARACTERISTICS
As body fluids initially come into contact with the S
OURCE
L
INK
™
Connectors and
S
OURCE
L
INK
™
Spacers, they chemically react with the polymer to break the polymer
chains through hydrolysis. The material is then metabolized.
1,2,3
INDICATIONS
The Q
UICK
L
INK
®
Delivery System is indicated for use with S
OURCE
L
INK
™
Connectors,
spacers and brachytherapy seeds in the assembly of seed trains of variable lengths and
predetermined spacing between the seeds for use in brachytherapy procedures.
S
OURCE
L
INK
™
Connectors are indicated for use in seed spacing and linking in
brachytherapy procedures. The S
OURCE
L
INK
™
Connector spacer is used in seed
approximation in brachytherapy procedures.
CONTRAINDICATIONS
S
OURCE
L
INK
™
Connectors and S
OURCE
L
INK
™
Spacers, being absorbable, should not be
used where permanent spacing or linking is required.
ADVERSE REACTIONS
Adverse side effects associated with the use of S
OURCE
L
INK
™
Connectors and
S
OURCE
L
INK
™
Spacers include: minimal acute inflammatory tissue reaction, calculus
formation in urinary and biliary tracts in the event of prolonged contact with salt solutions
such as urine and bile, and transitory local irritation.
HOW SUPPLIED
The Q
UICK
L
INK
®
Delivery System loaded cartridges and components are supplied sterile.
The cartridges are indicated for single use only. The Q
UICK
L
INK
®
Delivery System Loader
is supplied non-sterile and must be sterilized in an autoclave before use.
FEATURES
The Q
UICK
L
INK
®
Delivery System comes equipped with the following features [Figure 2]:
6
8
1
2
9
10
5
4
3
7
[FIGURE 2]
Q
UICK
L
INK
®
Cartridges
The
Q
UICK
L
INK
®
cartridges are constructed of radiation-resistant polycarbonate, and
hold a maximum of 20 components. The cartridges are marked with a descriptive icon
and scale to indicate the identity and approximate quantity of the contained
component, as well as provide a visual key for insertion into the loader carriage.
Carriage
The carriage is designed to hold the Q
UICK
L
INK
®
cartridges containing seeds, spacers,
and S
OURCE
L
INK
™
Connectors. Each slot in the carriage is keyed to a specific cartridge
to prevent mix-ups. The carriage may be moved front to back to align the desired
component cartridge with the dispensing indicator, or to allow compression and
ejection of a seed train. The carriage is also equipped with a quick-release
button to allow for carriage removal and inspection.
Assembly Base and Ruler
The assembly base is designed to provide a track for the compression of the seeds
and S
OURCE
L
INK
™
Connectors. The ruler provides a means for verifying that the
desired train configuration is obtained prior to delivery into the needle.
Dispense Button
The dispense button transfers one component from the indicated cartridge to the
assembly track when pressed.
Lead Glass Door
This shielding door is designed to provide radiation protection for the user while
allowing for visual inspection of the seed train in the assembly track. The door is
automatically latched closed, and may be opened by pressing the door release button
on the rear of the assembly base.
Compression Slide Handle
The compression slide is designed to deliver the necessary stylet force for
compression of the seeds and the S
OURCE
L
INK
™
Connectors into a seed train. The
compression slide is factory adjusted to ensure that the proper compressive force is
delivered every time. The compression slide is fitted with two support doors to minimize
buckling of the stylet during compression.
Gate Button
The gate button is designed to control the gate at the end of the assembly track which
is the base for compression of S
OURCE
L
INK
™
Connectors and seeds. The gate will be
closed in normal (up) position to allow for compression. When depressed, the gate will
open and allow the seed train to be dispensed through the needle adapter.
Needle Adapter
Stainless steel adapters are provided for the attachment of implant needles to the
Q
UICK
L
INK
®
Delivery System. They are designed in 4 different styles to fit all
commercially available implant needles.
Removable Stylet
The stylet is designed to compress the seeds and S
OURCE
L
INK
™
Connectors into a
seed train and has been equipped with a luer-lock fitting for quick and easy
replacement.
WARNINGS AND PRECAUTIONS
Warning:
Potential calculus formation with absorbable materials
As with any foreign body, prolonged contact of synthetic absorbable material, including
S
OURCE
L
INK
™
Connectors and S
OURCE
L
INK
™
Spacers, with salt solutions, such as
those found in the biliary or urinary tracts, may result in calculus formation.
Warning: Potential biohazard
After use, the Q
UICK
L
INK
®
Delivery System components may become biohazardous.
Handle per accepted medical practice and within applicable laws and regulations. The
Q
UICK
L
INK
®
Delivery System loader is reusable, and the loader components must be
thoroughly cleaned and sterilized prior to use and between uses.
Warning: Radioactive materials / Lead components
The Q
UICK
L
INK
®
Delivery System components and the contained brachytherapy
seeds should be used only by physicians who are qualified by training and
experience in the safe use and handling of radionuclide brachytherapy sources and
whose training and experience have been approved by the appropriate authorities
authorized to license the use of radioactive materials. Use appropriate radiation
safety protection practices when working with the
Q
UICK
L
INK
®
Delivery System
components that contain radioactive materials. Initiate radiation surveys on the
Q
UICK
L
INK
®
Delivery System components at the completion of the brachytherapy
5.5 mm
0.5mm Seed-to-Seed S
OURCE
L
INK
™
Connector
0.5 mm
5.0mm Extension S
OURCE
L
INK
™ Connector
5.0 mm
5.5mm Standard S
OURCE
L
INK
™
Connector
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2
4
5
9
8
6
10
7
3
