Bard QuickLink 70310QCA1 User manual

1
QUICKLINK
®
Delivery System
MANUAL RADIONUCLIDE APPLICATOR SYSTEM
Model #: 70310QCA1
Manufacturer
Bard Brachytherapy, Inc.
Carol Stream, IL 60188 USA
[phone]
www.bardmedical.com
[email protected]
PHYSICAL CHARACTERISTICS
The QUICKLINK®Delivery System is designed to assemble brachytherapy seeds,
SOURCELINK™synthetic spacers, and SOURCELINK™Connectors in cartridges into seed
trains of variable lengths and with variable seed-to-seed spacing as predetermined by
the physician. The QUICKLINK®Loader is composed of stainless steel, GE Ultem®1000
plastic, and shielding glass.
SOURCELINK™Connectors and SOURCELINK™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. SOURCELINK™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]
SOURCELINK™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 SOURCELINK™Connectors and
SOURCELINK™Spacers, they chemically react with the polymer to break the polymer
chains through hydrolysis. The material is then metabolized.1,2,3
INDICATIONS
The QUICKLINK®Delivery System is indicated for use with SOURCELINK™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.
SOURCELINK™Connectors are indicated for use in seed spacing and linking in
brachytherapy procedures. The SOURCELINK™ Connector spacer is used in seed
approximation in brachytherapy procedures.
CONTRAINDICATIONS
SOURCELINK™Connectors and SOURCELINK™Spacers, being absorbable, should not be
used where permanent spacing or linking is required.
ADVERSE REACTIONS
Adverse side effects associated with the use of SOURCELINK™Connectors and
SOURCELINK™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 QUICKLINK®Delivery System loaded cartridges and components are supplied sterile.
The cartridges are indicated for single use only. The QUICKLINK®Delivery System Loader
is supplied non-sterile and must be sterilized in an autoclave before use.
FEATURES
The QUICKLINK®Delivery System comes equipped with the following features [Figure 2]:
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[FIGURE 2]
QUICKLINK®Cartridges
The QUICKLINK®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 QUICKLINK®cartridges containing seeds, spacers,
and SOURCELINK™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 SOURCELINK™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 SOURCELINK™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 SOURCELINK™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
QUICKLINK®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 SOURCELINK™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
SOURCELINK™Connectors and SOURCELINK™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 QUICKLINK®Delivery System components may become biohazardous.
Handle per accepted medical practice and within applicable laws and regulations. The
QUICKLINK®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 QUICKLINK®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 QUICKLINK®Delivery System
components that contain radioactive materials. Initiate radiation surveys on the
QUICKLINK®Delivery System components at the completion of the brachytherapy
5.5 mm
0.5mm Seed-to-Seed SOURCELINK ™Connector
0.5 mm
5.0mm Extension SOURCELINK ™ Connector
5.0 mm
5.5mm Standard SOURCELINK™Connector
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procedure to ensure complete removal of radioactive materials. The shielding glass
contains lead, and must be disposed of according to local regulations.
Caution: Storage requirements are temperature dependent
Extra care should be taken to avoid exposing the QUICKLINK®cartridges containing
bioabsorbable SOURCELINK™components to excessive heat or moisture. Store
unopened packages at room temperature. Discard open, unused cartridges,
SOURCELINK™Connectors, and SOURCELINK™Spacers.
Do not store bioabsorbable components at temperatures that exceed 40°C.
Caution: Elevated temperatures following loader steam sterilization
After sterilization, allow the QUICKLINK®Delivery System loader components to cool to
room temperature prior to use.
Caution: Avoid damaging the system or using damaged materials
Never use visibly damaged, bent or broken QUICKLINK®Delivery System loaders,
cartridges or components. This may cause system damage or jamming.
Do not force cartridges into the carriage slots. The slots are keyed to accept the
appropriate cartridges, and minimal effort is required to properly seat the cartridges.
When handling this or any other synthetic absorbable material, care should be taken
to prevent any damage to the material. Avoid crushing or crimping damage to the cup
ends caused by the application of forceps or tweezers.
Ensure the needle adapter and stylet are finger-tight. Do not make any other
adjustments to the QUICKLINK®Delivery System.
Do not tamper with the mechanisms that reside beneath the carriage when removing
the carriage from the loader. These components are aligned to rigid specifications,
and must be handled carefully to maintain proper loader functionality.
In the event the QUICKLINK®Loader or cartridges become inoperable due to damage
or malfunction, any or all components may be removed from the cartridges and
implanted manually.
Do not adjust the indicator in the cartridge when the cartridge is loaded. The indicator
provides a spring bias to the components to allow for dispensing in the loader, and lifting
the indicator and allowing it to snap closed can damage the components and cartridge.
Do not re-sterilize SOURCELINK™Connectors or SOURCELINK™Spacers either loose or
in cartridges. The components are supplied sterile and indicated for single use. If
desired, radioactive seeds may be removed from a cartridge and re-sterilized. Do not
re-sterilize QUICKLINK®cartridges.
Caution: Limitations on use
The QUICKLINK®Delivery System is prescription use only. Users should be familiar with
procedures and techniques involving absorbable spacers and seed train products before
using the SOURCELINK™Connectors. SOURCELINK™Connectors are designed to provide
accurate spacing in increments of 0.5cm with typical 4.5mm brachytherapy sources.
Use of SOURCELINK™Connectors with brachytherapy sources of other lengths will result
in atypical spacing.
Caution: Key points for use of the QUICKLINK®Delivery System
Ensure that the compression handle is fully seated to the compression slide before
assembling a seed train.
The gate button must remain depressed until the seed train is completely dispensed
from the loader and the stylet is retracted.
Ensure the lead glass door is closed prior to assembling or dispensing seed trains.
DIRECTIONS FOR USE
1. Remove the protective tab from the bottom of the QUICKLINK®cartridge prior to
use by grasping the cartridge by the cartridge body and pulling the tab out of the
side of the cartridge. To prevent inadvertent dispensing of a component, do not
hold the cartridge body by the green plunger when removing the tab.
2. Insert the cartridges containing seeds, SOURCELINK™Connectors, and
SOURCELINK™Spacers into the carriage. Ensure that the cartridges are fully
seated in the carriage receptacle. The carriage and cartridges are marked as
follows to indicate the correct placement of cartridges as well as the current
selection:
Radioactive implant seed QUICKLINK®Cartridge
5.5mm Standard SOURCELINK™Cartridge
5.0mm Extension SOURCELINK™Cartridge
0.5mm Seed-to-Seed SOURCELINK™Cartridge
SOURCELINK™Spacer Cartridge
3. Retract the compression slide handle to the right until it contacts the rear plate to
seat the slide compression mechanism (if unseated).
4. Attach the implant needle to the QUICKLINK®Delivery System by pushing the
needle hub firmly onto the needle adapter.
5. Move the carriage to select which item to dispense by aligning the indicator with
the symbol indicating the desired item.
Note: The position of the Extension SOURCELINK™Connector in the cartridge is
accurately represented by the icon. Therefore, when spacing at either end
of a seed train is desired, an Extension SOURCELINK™Connector may
only be used at the leading end of the train. Spacing at the trailing end of
the train must be provided by one or more spacers.
6. Push the dispense button to dispense and move the selected item into the
assembly track.
Note: During normal operation, the dispense button will return to the “up” position
after a component is dispensed. If a cartridge is empty, the button will come
to a stop before it reaches the bottom of its range of motion. Further
pressing will cause the button to release from its internal mechanism to
prevent damage to the cartridge. The button may be lifted to the “up”
position to reseat it to the internal mechanism, and the empty cartridge may
be removed and replaced.
Note: The dispense mechanism is designed to completely dispense a single
component once depressed. The button must be pressed through its
complete range of motion – if the button is only pressed partially down, it
will remain in the midrange position and prevent carriage motion or further
dispensing. Complete the compression of the button to dispense the
selected component and release the carriage for further dispensing.
7. Repeat items 4-5 until all items necessary to build the predetermined seed train
have been dispensed.
8. Visually inspect the dispensed components, if desired, through the lead glass door
prior to assembly of the seed train. Incorrect components can be removed as
necessary by opening the lead glass door to access the assembly track.
Note: If desired, the carriage mechanism may be removed from the loader to
inspect the area beneath the carriage. To remove the carriage, depress the
carriage release button while lifting the carriage upward. To replace, align
the two latch prongs on the underside of the carriage with the
corresponding receptacles in the loader and snap the carriage into place.
9. Move the carriage to the arrow symbol indicating that the QUICKLINK®Delivery
System is ready to either compress or dispense a seed train.
10. Move the handle on the releasable slide left towards the carriage to compress the
seed train. Continue motion in this direction until the slide handle releases and
comes to a full stop.
11. Retract the slide to the right until it contacts the rear plate to seat the slide
compression mechanism.
12. The assembled seed train may be inspected through the lead glass door, and
proper seed spacing confirmed using the assembly base ruler.
13. Move the handle on the releasable slide left again towards the carriage while
holding the gate button down in order to dispense the seed train through the
needle adapter.
14. Retract the handle of the releasable slide fully to the right.
15. Remove the loaded implant needle by pulling the needle hub away from the needle
adapter.
TROUBLESHOOTING
Condition: SOURCELINK™Connectors not connected after compression

Ensure compression slide has been fully reset before compression;
Stylet bent – replace;
The seed train is incorrectly built consisting of either two female or two male
ends placed adjacent to each other;
Ensure the SOURCELINK™Connector material is not damaged preventing
compression.
Condition: SOURCELINK™Connectors are ejected from the loader during
compression

Ensure the lead glass cover is securely closed;
Do not press the gate button during compression, allowing ejection of unlinked
components through the needle adapter.
Condition: Pushing the dispense button does not eject any items or
produces a partial dispense

Ensure that the handle is not being pulled while the dispense button is being
depressed. Pulling on the handle during dispensing can cause the cartridge
to become misaligned with the dispense track, resulting in a lock out or a jam;
Ensure the selected cartridge is fully seated in the corresponding carriage
receptacle;
Remove cartridge from carriage and reinsert back into the carriage;
Ensure the dispense blade is not jammed - remove the carriage and inspect
dispense blade, verify there are no loose components;
The selected cartridge is empty - replace with a full cartridge;
The dispense button is not fully depressed - press button fully;
If cartridge does not dispense following troubleshooting, replace cartridge.
Condition: The assembled seed train cannot be loaded into the attached
implant needle

Ensure that you hold the gate button down while sliding the releasable slide.
Ensure the seed train has been properly built and does not include damaged
components
Condition: Implant needle does not stay attached to the needle adapter

Ensure needle adapter is appropriate for the implant needle used.
Condition: Completed seed train does not load smoothly into the attached
implant needle.

Ensure needle adapter is appropriate for the implant needle used.

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QUICKLINK®LOADER CLEANING, LUBRICATION AND STERILIZATION
Note: Limitations on processing – Repeated cleaning and steam sterilization
has minimal effect on the QUICKLINK®Loader. The QUICKLINK®Loader should
be inspected for damage prior to use and replaced or repaired as necessary.
Manual Cleaning:
1. Point of Use - No particular requirements.
2. Containment and Transportation - No particular requirements.
3. Instrument Preparation - Remove the stylet and carriage from the QUICKLINK®
loader. Open the lead glass door, and ensure that it remains open throughout
the cleaning procedure. Remove any QUICKLINK®cartridges, loose seeds,
spacers and SOURCELINK™components.
Note: If loose seeds are found, immediately contact Radiation Safety for
safe handling and disposal of the seeds.
4. Initial Rinse - Rinse the loader and accessories thoroughly with cool (25°C) tap
water. Remove any excess soil by brushing with a soft bristle brush. Ensure all
hard to reach areas are flushed.
5. Enzymatic Presoak - Prepare enough multi-tiered enzymatic cleaner solution
(Ruhof Endozime®AW Plus or equivalent), following the manufacturer’s
instructions, to completely wet the QUICKLINK®loader and accessories.
Thoroughly wet the loader and accessories with enzymatic cleaning solution
and allow them to soak for a minimum of 5 minutes. Actuate the loader while in
the cleaning solution to ensure the cleaning solution reaches the hard-to-reach
areas.
6. Cleaning - Using a soft bristle brush, brush all accessible areas of the loader
and accessories for a minimum of one minute to remove visible evidence of
debris or soil. Actuate the loader while brushing to ensure the solution reaches
the hard-to-reach areas.
7. Rinse - Rinse the loader and accessories thoroughly with cool (25°C) tap water
until there is no visible evidence of the cleaning solution. Actuate the loader
while rinsing to ensure the rinse water reaches the hard-to-reach areas.
8. Repeat - Repeat Steps 5-7 once, for a total of 2 Presoak/Cleaning/Rinse
cycles.
9. Visual Inspection - Inspect the instrument to ensure that all debris and soil has
been removed. If there is any evidence of debris or soil, repeat all of the
aforementioned steps until there is no evidence of debris or soil remaining. For
devices that fail visual inspection, contact Bard Brachytheraphy, Customer
Service at [phone].
10. Drying – Drying can be performed at temperatures below 135°C.
11. Maintenance and Inspection – Verify that the QUICKLINK®loader and carriage
are free from obvious defects or damage. Verify that the stylet is straight. Verify
that the lead glass door has adequate visibility. Verify that the slide
compression mechanism and release are working properly. Replace the loader
and/or components as necessary.
Automated Cleaning:
1. Point of Use - No particular requirements.
2. Containment and Transportation - No particular requirements.
3. Instrument Preparation - Remove the stylet and carriage from the QUICKLINK®
loader. Open the lead glass door, and ensure that it remains open throughout
the cleaning procedure. Remove any QUICKLINK®cartridges, loose seeds,
spacers and SOURCELINK™components.
Note: If loose seeds are found, immediately contact Radiation Safety for
safe handling and disposal of the seeds.
4. Initial Rinse - Rinse the loader and accessories thoroughly with cool (25°C) tap
water. Remove any excess soil by brushing with a soft bristle brush. Ensure all
hard to reach areas are flushed.
5. Enzymatic Presoak - Prepare enough multi-tiered enzymatic cleaner solution
(Ruhof Endozime®AW Plus or equivalent), following the manufacturer’s
instructions, to completely wet the QUICKLINK®loader and accessories.
Thoroughly wet the loader and accessories with enzymatic cleaning solution
and allow them to soak for a minimum of 5 minutes. Actuate the loader while in
the cleaning solution to ensure the cleaning solution reaches the hard-to-reach
areas.
6. Manual Clean - Using a soft bristle brush, brush all accessible areas of the
loader and accessories for a minimum of one minute to remove visible evidence
of debris or soil. Actuate the loader while brushing to ensure the rinse water
reaches the hard-to-reach areas.
7. Rinse - Rinse the loader and accessories thoroughly with cool (25°C) tap water
until there is no visible evidence of the cleaning solution. Actuate the loader
while rinsing to ensure the rinse water reaches the hard-to-reach areas.
8. Washer-Disinfector Cleaning - Place the open loader and accessories in the
washer-disinfector with the loader assembly plate facing the ceiling of the
washer-disinfector. Process the instruments according to the following cycle:
Phase Recirculation
Time(min) Water temperature Detergent Type (if applicable)
Pre-Wash 05:00 Cold tap water:
61°F (16°C)
Maximum
N/A
Wash 10:00 140°F (60°C)
Set point Multipurpose detergent (neodisher®MediClean
forte or equivalent)
Rinse 05:00 Hot tap water:
109°F (43°C)
Minimum
N/A
9. Visual Inspection - Inspect the instrument to ensure that all debris and soil has
been removed. If there is any evidence of debris or soil, repeat all of the
aforementioned steps until there is no evidence of debris or soil remaining. For
devices that fail visual inspection, contact Bard Brachytherapy Customer
Service at [phone].
10. Drying – Drying can be performed at temperatures below 135°C.
11. Maintenance and Inspection – Verify that the QUICKLINK®loader and carriage is
free from obvious defects or damage. Verify that the stylet is straight. Verify
that the lead glass door has adequate visibility. Verify that the slide
compression mechanism and release are working properly. Replace the loader
and/or components as necessary.
QUICKLINK®Loader Lubrication Procedure
BARD®recommends lubricating the QUICKLINK®loader before each case. Lubricant
should be applied prior to sterilization. The recommended lubricant is MiltexSpray
Lube (REF 3-700, available from Miltex Inc., York PA).
Instructions for applying lubricant to loader
1. Remove stylet if present and close the lead glass door if open. Always apply
lubricant with lead glass door closed to prevent lubricant from getting on the
dispense track.
2. Remove carriage from loader.
3. The holes on the underside of the loader indicated by 1(see figure below) are
points where a single spray should be applied in each hole.
4. Hold lubricant spray bottle 1”-2” from surfaces 2&3(see figure below) and apply
with a single spray pump at each location.
5. After applying lubricant to areas indicated, any excessive lubricant should be
wiped away with a lint free cloth.
6. Mount carriage back on loader and actuate back and forth.
7. Actuate compression slide handle forward and back.
Sterilization:
Caution: Key points for use of the QUICKLINK®Delivery System
DO NOT sterilize by irradiation
DO NOT process the QUICKLINK®loader and accessories at
temperatures above 135°C
DO USE appropriate personal protective equipment as dictated by
facility protocol
Prior to sterilization, the QUICKLINK®loader and accessories should be
properly cleaned and lubricated (loader only)
For sterilization, the QUICKLINK®loader must be sterilized with the lead
glass door open
Sterilization Preparation
Wrap loader and accessories individually with hospital sterilization wrap and secure
with autoclave tape prior to sterilization. Ensure the lead glass door of the loader is
in the open position prior to wrapping.
Sterilization conditions – The QUICKLINK®Loader and accessories should be
sterilized using one of the following sterilization cycles:
Gravity Displacement Autoclave
Full Cycle
Temperature Full Cycle Exposure
Time
Dry Time
(in chamber) Cool Down Time at Room/Ambient
Temperature
275°F (135°C) 10 minutes N/A 30 minutes
Pre-Vacuum Autoclave
Full Cycle
Temperature Full Cycle Exposure
Time
Dry Time
(in chamber) Cool Down Time at Room/Ambient
Temperature
275°F (135°C) 5 minutes N/A 30 minutes
273°F (134°C) 18 minutes N/A 30 minutes
270°F (132°C) 4 minutes N/A 30 minutes
273°F (134°C) 3 minutes N/A 30 minutes
1. Storage – Store at room temperature.
2. Additional information – When sterilizing multiple instruments in one autoclave
cycle, ensure the sterilizer’s maximum load is not exceeded. The instructions
above have been validated by BARD®as being capable of preparing the
QUICKLINK®loader for re-use. It remains the responsibility of the processor to
ensure that the processing as actually performed using equipment, materials
and personnel in the processing facility achieves the desired result. This
requires validation and routine monitoring of the process. Likewise, any
deviation from the instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
3. Instrument Reassembly – After sterilization, replace carriage, stylet, and
needle adapter accessories prior to use. Ensure carriage slides freely.

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QUICKLINK®LOADER SPARE PARTS
The QUICKLINK®Delivery System Spare Parts are intended for changing the
compatibility of the QUICKLINK®Delivery System with various commercially available
implant needles or for replacement of damaged parts. Available spare parts are
described below:
Stylets: [Part Number 70310QCC1]
The stylet is manufactured of stainless steel and designed to compress the seeds
and SOURCELINK™Connectors into a seed train. The stylet may become bent over
time and may require replacement. It is equipped with a Luer-lock fitting and can be
easily replaced if needed.
Lead Glass: [Part Number 70310QCA6]
The lead glass in the lead glass door is designed to protect the operator from
radiation exposure. The lead glass might become clouded over time due to the
sterilization process and may require replacement if visualization of the
compression channel is prevented.
Needle Adapters
Stainless steel adapters are provided for the attachment of implant needles to the
QUICKLINK®Delivery System. The needle adapters may be changed as necessary to
accommodate different styles of implant needles. The needle adapters available
are:
Primary Needle Adapter: [Part Number 70310QCA2]
Primary Needle Adapter – Locked: [Part Number 70310QCA5]
Compatible with the following needles:
BARD®BRACHYSTAR®Needles 71820X, 81820X, 171850
AVID Medical P/N AV1820PN
CP Medical P/N CPPS1820
CP Medical P/N PSPP-1820-PDO (Point Plug PDO™)
Manan Medical Products P/N 2330-18ME-20-P
Manan Medical Products P/N 2340-18BE-20-P
Manan Medical Products P/N 2360MUS-18BE-20
Medical Device Technologies (MD Tech) P/N 500518200X
Med-Tec P/N MT-BT-5001-25
NeedleTech Products P/N 40052-01E
NeedleTech Products P/N 40087-01E
Worldwide Medical Technologies P/N PSS1820
Luer Needle Adapter: [Part Number 70310QCA3]
Compatible with the following needles:
AVID Medical P/N AV1820ZN (Metal Hub Zebra™)
Mentor P/N 97-1030 (Metal Hub)
Mentor P/N 97-1040
Small Hub Needle Adapter: [Part Number 70310QCA4]
Compatible with the following needles:
Medical Device Technologies (MDTech) P/N 500618200X
Worldwide Medical Technologies P/N PSS1820EZ (EZ Load)
QUICKLINK®LOADER SPARE PART REPLACEMENT
Needle Adapter Replacement
1. Remove the needle adapter from the loader by rotating the knurled adapter
base counterclockwise.
2. Rethread the new needle adapter into the front plate and rotate clockwise
to tighten.
Stylet (Part Number 70310QCC1) Replacement
1. Fully retract the compression handle to the right.
2. Depress the carriage release button and remove the carriage.
Note: When removing the carriage from the loader, do not tamper with the
mechanisms that reside beneath the carriage. These components are
aligned to rigid specifications, and must be handled carefully to
maintain proper loader functionality.
3. Turn the loader over to expose the underside of the loader housing.
4. Manually separate the compression handle from the compression mechanism,
exposing the stylet hub.
5. Remove the stylet by rotating the knurled hub counterclockwise.
6. Feed the new stylet through the opening in the stylet support doors and into the
front plate to allow the stylet hub to mate with the stylet anchor. Rotate the
stylet base clockwise to tighten.
7. Return the loader to the upright position and replace the carriage.
Lead Glass (Part Number 70310QCA6) Replacement
1. Open the lead glass door by pushing down the door release button.
2. Use a .050” hex head wrench to remove the 8 screws from the lead glass
retaining frame.
3. Remove the retaining frame and damaged glass.
Note: The shielding glass contains lead, and must be disposed of according to
applicable laws and regulations.
4. Install the replacement glass and retaining frame and secure with the frame
screws.
Note: The needle adapters, stylets and lead glass are the only parts of the
QUICKLINK®Loader that are serviceable by the customer. For more
extensive repair or loader replacement, contact Bard Brachytherapy
Customer Service at [phone].
ORDERING
QUICKLINK®Delivery System components may be ordered from, and questions
should be directed to, Bard Brachytherapy Customer Service, [phone].
GRAPHICAL REPRESENTATION OF LINKED SEEDS
Refer to the graphical representation of linked seeds in Figure 3.
SYMBOLS USED ON LABELING (QUICKLINK®Loader)
only Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.
Serial Number Catalog Number
Caution Manufacturer
Consult Instructions for Use Non-Sterile
SYMBOLS USED ON LABELING (Cartridges, Sources and SOURCELINK™)
only Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Units Use By
Caution Consult Instructions for Use
Sterilized using gamma
irradiation. Catalog Number
Single Use Do not use if package is
damaged.
Do not resterilize Manufacturer
40°C
Upper Limit of Temperature Serial Number
Lot Number
Certain devices used with QUICKLINK®are single use devices. Do not resterilize any
portion of these devices. Reuse and/or repackaging may create a risk of patient or
user infection, compromise the structural integrity and/or essential material and
design characteristics of the device, which may lead to device failure, and/or lead to
injury, illness or death of the patient.
TRADEMARKS
Bard, BrachySource, BrachyStar, QuickLink and SourceLink are
trademarks and/or registered trademarks of C. R. Bard, Inc.
A
ll other trademarks are the property of their respective owners.
Endozime™is a trademark and/or registered trademark of The Ruhof Corporation
Year of Authorization to affix the CE Mark was 2007.
Copyright © 2018 C. R. Bard, Inc. All Rights Reserved.
REFERENCES
1. Domb, A.J., Kost, J., and Wiseman, D.M.; Handbook of Biodegradeable
Polymers; 1996, Harwood Academic Publishers; The Netherlands, pp. 3-27,
pp. 451-471.
2. Claes, L.E., Ignatius, A.A, Rehm, K.E. and Scholz, C., New Bioresorbable pin
for the reduction of small bony fragments: design, mechanical properties and
in vitro degradation, Biomaterials (1996) 17, 1621-1626.
3. Rehm, K.E., Helling, H.J. and Claes, L.E., Bericht der Arbeitsgruppe
Biodegradable Implantate, Aktulelle Traumatologie (1994) 24, 70-74.
PK0319939 12/2018

[FIGURE 3]
PK0319939 12/2018
GRAPHICAL REPRESENTATION OF LINKED SEEDS
Seeds linked with 5.5mm Standard SOURCELINK™Connector, providing 1cm center-to-center spacing.
Seeds linked with 5.5mm Standard SOURCELINK™Connector and 0.5mm Seed-to-Seed SOURCELINK™Connector providing both 0.5cm center-to-center spacing and 1cm center-to-center spacing.
Seeds linked with 5.5mm Standard SOURCELINK™Connector and 5.0mm Extension SOURCELINK™Connector, providing 2cm center-to-center spacing.