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This document is valid only on the date printed. If unsure of
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00860902-90-128 Rev. A
en
EXPEDIUM® VERSE Spine SystemIMPORTANT NOTE TO OPERATING
SURGEONEXPEDIUM® VERSE spinal implants, like any other temporary
internal fixation devices, have a finite useful life. The patient’s
activity level has a significant impact on this useful life. Your
patient must be informed that any activity increases the risk of
loosening, bending, or breaking of the implant components. It is
essential to instruct patients about restrictions to their
activities in the postoperative period and to examine patients
postoperatively to evaluate the development of the fusion mass and
the status of the implant components. Even if solid bone fusion
occurs, implant components may nevertheless bend, break, or loosen.
Therefore, the patient must be made aware that implant components
may bend, break, or loosen even though restrictions in activity are
followed.
Because of the limitations imposed by anatomic considerations
and modern surgical materials, metallic implants cannot be made to
last indefinitely. Their purpose is to provide temporary internal
support while the fusion mass is consolidating. These types of
implants are more likely to fail if no bone graft is used, if a
pseudarthrosis develops, or if patients have severe or multiple
preoperative curves.
The surgeon may remove these implants after bone fusion occurs.
The possibility of a second surgical procedure must be discussed
with the patient, and the risks associated with a second surgical
procedure must also be discussed. If the implants do break, the
decision to remove them must be made by the physician who must
consider the condition of the patient and the risks associated with
the presence of the broken implant.
DESCRIPTIONDePuy Spine implants are NOT compatible with implants
from other manufacturers unless otherwise specified.
Implants from each of the DePuy Spine systems are NOT
interchangeable with implants from other DePuy Spine systems unless
otherwise specified. Implants designed to interface with a specific
rod diameter are NOT compatible with other rod diameters unless
otherwise specified. Implants designed to interface with a
specific rod diameter are compatible with rods from other
systems having the same diameter and same material per the table
below.
Dual diameter rod components can have a combination of rod
diameters corresponding to the existing straight rod diameters from
each of the Spine Systems listed in the table below. These dual
diameter rods can be used to connect rod constructs formed from the
Original System to rod constructs from the Secondary System per the
table below.
ORIGINAL SYSTEM SECONDARY SYSTEM(S)
EXPEDIUM VERSE Connects ToEXPEDIUM/VIPER/VIPER2, ISOLA/TIMX,
MONARCH, MOSS MIAMI
Implants made of different materials are NOT compatible unless
otherwise specified. The table below specifies implant material
compatibility.
MATERIAL COMPATIBLE WITHStainless Steel alloys Stainless Steel
alloys
Titanium alloys
Titanium alloys, Cobalt-Chromium-Molybdenum,
Cobalt-Nickel-Chromium-Molybdenum, PEEK, Commercially Pure
Titanium
Cobalt-Chromium-Molybdenum
Titanium alloys, Cobalt-Nickel-Chromium-Molybdenum
Cobalt-Nickel-Chromium-Molybdenum
Titanium alloys, Cobalt-Chromium-Molybdenum
Commercially Pure Titanium Titanium alloys
A subset of EXPEDIUM VERSE components may be used for posterior
pedicle screw fixation in pediatric cases. These constructs may be
comprised of a variety of shapes and sizes of rods (ranging from
4.5 to 6.35), hooks, screws, bolts, and connecting components.
Similarly to the EXPEDIUM VERSE implants used in adult cases, these
components can be rigidly locked into a variety of configurations,
with each construct being tailor-made for the individual case.
-
2 of 14This document is valid only on the date printed. If
unsure of the print date, please re-print to ensure use of the
latest revision of the IFU (available at www.e-ifu.com). The onus
resides with the user to ensure that the most up-to-date IFU is
used.
DePuy Spine prepares Surgical Technique Manuals showing the use
of the implants and instruments for each Spine System. Contact your
DePuy Spine sales representative to obtain copies of these Surgical
Technique Manuals.
EXPEDIUM VERSE Spine SystemThe EXPEDIUM VERSE Spine System
consists of longitudinal rods, monoaxial screws, polyaxial screws,
uni-planar screws, reduction screws, cable/wire screws, bolts,
slotted connectors, wires, hooks, reduction hooks, transverse
connectors, SFX Cross Connector System, dual rod connectors, sacral
extenders, lateral connectors, and washers.
The EXPEDIUM VERSE Spine System is compatible with other systems
through the use of single or dual rod connectors, lateral
connectors, sacral extenders and dual diameter rods as follows:
• ISOLA Spine System rods • VIPER/VIPER2 System rods • MONARCH
Spine System rods • MOSS MIAMI Spine System rods • TIMX Low Back
System rods • Synthes SYNAPSE System rods
The cable/wire screw is intended to be used with stainless steel
ISOLA Beaded Sublaminar Wire, manufactured by DePuy Spine, Inc., or
with the stainless steel Single Cable with Crimp and Bar and the
Single ISOLA Cable with Eyelet Leader components of the Songer
Spinal Cable System, manufactured by Pioneer Surgical Technologies
and distributed by DePuy Spine, Inc.
The EXPEDIUM VERSE Spine System components are available in
commercially pure titanium or titanium alloy conforming to ASTM
F-67, ASTM F-136 or ASTM F-1472 specifications, stainless steel
conforming to ASTM F-138, ASTM F-1314, or F-2229 specifications,
cobalt-nickel-chromium-molybdenum alloy wire conforming to ASTM
F-562 specifications, as well as longitudinal rods in
cobalt-chromium-molybdenum alloy conforming to ASTM F-1537
specifications.
Cobalt-chromium-molybdenum alloy rods and
cobalt-nickel-chromium-molybdenum alloy wires are intended for use
with titanium components only.
Ring nut and set screw assemblies are only intended for use with
polyaxial, uni-planar, and monoaxial single innie (SI) pedicle
screws and pedicle hooks within the EXPEDIUM 4.5mm and 5.5mm
stainless steel and titanium Systems.
The extension tabs on the reduction screw and hook components
are intended to be removed intraoperatively.
INDICATIONSThe EXPEDIUM VERSE Spine Systems are intended to
provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment
of acute and chronic instabilities or deformities of the thoracic,
lumbar and sacral spine.
The EXPEDIUM VERSE Spine System is intended for noncervical
pedicle fixation and nonpedicle fixation for the following
indications: degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by
history and radiographic studies); spondylolisthesis; trauma (i.e.,
fracture or dislocation); spinal stenosis; curvatures (i.e.,
scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and
failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS
instrumentation, the EXPEDIUM VERSE System is intended for
noncervical pedicle fixation and nonpedicle fixation for the
following indications: degenerative disc disease (defined as back
pain of discogenic origin with degeneration of the disc confirmed
by history and radiographic studies); spondylolisthesis; trauma
(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e.,
scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and
failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in
pediatric patients, the EXPEDIUM VERSE System metallic implants are
indicated as an adjunct to fusion to treat adolescent idiopathic
scoliosis. The EXPEDIUM VERSE systems are intended to be used with
autograft and/or allograft. Pediatric pedicle screw fixation is
limited to a posterior approach.
CLEANING AND STERILIZATIONImplants and instruments of the
EXPEDIUM VERSE Spine Systems may be provided either sterile or
non-sterile and this will be clearly identified on the product
labels.
Sterile ImplantsFor the implants supplied sterile, the contents
are sterile unless the package is damaged, opened, or the
expiration date on the device label has passed. The integrity of
the packaging should be checked to ensure that the sterility of the
contents is not compromised. Remove implants from packaging, using
aseptic technique, only after the correct size has been
determined.
PRECAUTION: Do not use implants if the condition of the package
and/or labeling indicates a chance that the devices may not be
sterile.
Implants supplied sterilized from the manufacturer must not be
resterilized.
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Non-Sterile ImplantsFor the implants supplied non-sterile, they
will be supplied clean. ISO 8828 or AORN recommended practices for
in-hospital sterilization should be followed for all
components.
Cleaning InstructionsFor EXPEDIUM Spine System:
ScopeDePuy Synthes EXPEDIUM VERSE Spine System
WARNINGS • Follow the instructions and warnings issued by the
suppliers of any cleaning and equipment used.
• Do not exceed 140°C (284°F) during reprocessing steps. • Avoid
exposure to hypochlorite solutions, as these will promote
corrosion.
• Highly alkaline conditions (pH > 11) can damage products
with aluminum parts
• Manual Cleaning must be performed prior to Automated Cleaning
for all devices with lumens.
Limitations on Reprocessing • Repeated processing has minimal
effects on instrument life and function.
• End of useful life is generally determined by wear or damage
in surgical use.
• Carefully inspect instruments between uses to verify proper
functioning.
• Send damaged instruments to a supplier of authorized repair or
refurbishment services.
Decontamination Considerations – Creutzfeldt-Jakob Disease
(CJD)
• Under certain classifications of risk, the World Health
Organization (WHO), or local regulatory authorities recommend
special CJD inactivation processing procedures. Consult WHO and
local regulations for further information.
Care at the Point of Use • Clean instruments as soon as possible
after use. If cleaning must be delayed, immerse instruments in a
compatible detergent solution, spray with an instrument pre-soak
solution, or cover instruments with a towel moistened with purified
water to prevent drying and encrustation of surgical soil.
• Avoid prolonged exposure to saline to minimize the chance of
corrosion.
• Remove excessive soil with a disposable wipe.
Containment and Transportation • Reprocess instruments as soon
as is reasonably possible after use.
• Place the device in its respective position within the
instrument tray.
• The image of the device is marked in its intended position
within the tray
Preparation for CleaningFor multi-piece or complex instruments,
please reference their disassembly instructions. Disassembly
instructions are available per request by contacting DePuy Spine
Customer Service (800-227-6633).
In the event that the instructions below cannot be completed as
directed, please contact Customer Service to have the instruments
returned for processing.
Manual CleaningAll Instruments and Implants:
• Prepare an enzymatic cleaning solution in accordance to the
manufacturer’s instructions.
• Soak soiled devices for a minimum recommended time specified
by the enzymatic cleaning solution manufacturer or 5 minutes,
whichever is longer.
• Use a soft bristle scrub brush (plastic bristles, like nylon)
to remove all traces of blood and debris from the device
surfaces.
EXPEDIUM Cannulated Taps: • EXPEDIUM Cannulated Taps have a 2 mm
diameter cannulation. • Use a minimum 12 inch (305mm) long, 3 mm
brush diameter, soft lumen brush (plastic bristles, like nylon) to
scrub the lumen or cannula of each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
EXPEDIUM Alignment Guides: • EXPEDIUM Alignment Guides have an
11–12 mm diameter lumen.
• Use a minimum 12 inch (305 mm) long, 13 mm brush diameter,
soft lumen brush (plastic bristles, like nylon) to scrub the lumen
or cannula of each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
-
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the print date, please re-print to ensure use of the latest
revision of the IFU (available at www.e-ifu.com). The onus resides
with the user to ensure that the most up-to-date IFU is used.
4 of 14
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
EXPEDIUM Modular Handles: • EXPEDIUM Modular Handles have a
4–6.35 mm diameter hole. • Use a minimum 7 mm brush diameter, soft
lumen brush (plastic bristles, like nylon) to scrub the hole of
each device.
Ratcheting Adapter (286710490): • The Ratcheting Adapter has a
2.4 mm diameter lumen. • Use a minimum 3 mm brush diameter, soft
lumen brush (plastic bristles, like nylon) to scrub the lumen of
each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
• Scrub the exterior surface of the device while actuating the
ratchet mechanism.
EXPEDIUM Quick Connect Screwdriver: • Actuate the driver while
scrubbing the surface of the device by pulling the inner shaft and
turning the outer sleeve at least three full rotations.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the handle cavity.
• Repeat the flushing of the handle cavity through two different
openings.
EXPEDIUM Devices with Lumens: • Use a minimum 12 inch (305 mm)
long, tight fitting, soft lumen brush (plastic bristles, like
nylon) to scrub the lumen or cannula of each device. Minimum brush
diameters are specified in the table below for each lumen size. A
toothbrush style brush, or equivalent, can be used for large lumen
(>15 mm) devices:
Device Description
Product Code
Lumen Size
Brush Diameter
SAI COUNTER TORQUE 279704055 12 14MMSI DRIVER SLEEVE 279712200
10 14DRIVER SLEEVE FOR SI SCREWS 279712250 9 12
SI REDUCTION TUBE 279712460 9 –14 15MMSI ROD STABILIZER
279712500 12 13APPROXIMATOR FC SLEEVE 279712580 9 10APPX FC
ROTATION TUBE 279712599 11 12LATERAL APPROXIMATOR 279712660 11
12FACILITATOR 279712888 11 12EXP 5.5 ANTITORQUE 279712920 12 13
Device Description
Product Code
Lumen Size
Brush Diameter
DI DRIVER SLEEVE 279722250 11 12XPDM DI REDUCTION TUBE 279722460
10 11DI ROD STABILIZER 279722500 12 13EXP DI FAR SCREWDRIVER SLEEVE
279722850 11 12
EXP DI FACILITATOR 279722888 12 13MIS ALIGNMENT DEVICE 279726400
2 7OPEN ALIGNMENT DEVICE 279726401 2 7IEXP CLOSED BOLT DRIVER
279729440 8 10EXP CLOSED BLT DRIVER COLLET 279729445 5 6
IEXP NUT INSERTER 279729450 5 10IEXP 8MM TIGHTENER L-HANDLE
279729470 8 9
IEXP SLOTTED CONN STABLIZER 279729610 7 8
IEXP CANN PLACEMENT WRENCH 279729640 7 8
EXP 635 MINI QUICK STICK 279734210 11 16DRIVER SLEEVE 279763250
11 12ROD STABILIZER 279763500 12 13APPROXIMATOR FLEX CLIP 279763570
11 15APPROXIMATOR FC SLEEVE 279763580 9 10APPROXIMATOR FC ROTATION
TUBE 279763599 11 12
SI APPROXIMATOR SLEEVE 279763660 11 12DI APPROXIMATOR SLEEVE
279763670 11 12FACILITATOR 279763888 12 14EXP 6.35 ANTITORQUE
279763920 12 13VBD QUICK STICK 279788835 11 16VBD QUICK STICK OUTER
SLEEVE 279788840 11 16
EXPEDIUM DEROTATION REDUCTION 279788870 16 17
EXP DEROT FLEX-CLIP INSERT 279788872 11 12
EXP DEROT FLEXCLIP INSERT 6.35 279788874 11 12
EXP DEROT QUICK STICK-SHORT 279788878 11 16
EXP5.5 DEROTATION QUICK STICK 279788935 11 16
EXP 5.5 DEROTATION QCK STICK F 279788955 11 16
-
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the print date, please re-print to ensure use of the latest
revision of the IFU (available at www.e-ifu.com). The onus resides
with the user to ensure that the most up-to-date IFU is used.
5 of 14
Device Description
Product Code
Lumen Size
Brush Diameter
CABLE/WIRE SCREWDRIVER 286210040 5 6ROD STABILIZER, SI 286210140
11 12ROD STABILIZER, SLOTTED CONN 286210230 11 12
FACILITATOR 286240085 9 10IN-LINE APPROXIMATOR PLUG 286240095 9
10
EXP 4.5 IN-LINE APPROX INSERTE 286240096 11 12
TUBE BENDERS 286260060 8 9SFX STABILIZER 289410400 7 9SFX CENTER
ALIGN GUIDE 289410450 7 9EXP 4.5 SFX STABILIZER 289420400 8 9EXP
ANT MONOAXIAL SCRW DRVR SLEEVE 287720105 9 10
EXP ANT CROSS CONN APPLICATOR 287730140 11 12
EXPEDIUM devices with holes or cavities: • Use a minimum 7 inch
(175 mm) long, tight fitting, soft lumen brush (plastic bristles,
like nylon) to scrub the holes of each device. Minimum brush
diameters are specified in the table below for each hole size:
Device Description
Product Code
Hole Size
Brush Diameter
EXP OFFSET BOLT TUBE/PUSHER 279729480 6 & 3 mm 7 & 4
mm
IEXP BOLT CUTTER 279729910 7 8IEXP ROD CUTTER 279729930 5 8BOLT
ALIGNMENT GUIDE 286210240 5 & 3 mm 6 & 4 mm
EXPEDIUM One Handed Rod Approximators: • Use a minimum 12 inch
(305 mm) long, tight fitting, soft lumen brush (plastic bristles,
like nylon) to scrub the lumen of each device. Minimum brush
diameters are specified in the table below for each lumen size. A
toothbrush style brush, or equivalent, can be used for large lumen
(>15 mm) devices:
Device Description
Product Code
Lumen Size
Brush Diameter
ONE HANDED ROD APPROXIMATOR 279712510 11 12
ROD APPROX W/DOVETAIL 279712525 N/A N/A 6.35 ONE HANDED ROD
APPROX 279712610 12 18
LATERAL APPROXIMATOR 279712650 10 15
Device Description
Product Code
Lumen Size
Brush Diameter
KERRISON STYLE REDUCT DEVICE 279763425 10 11
LATERAL APPROXIMATOR 279763650 10 15SQUEEZE HANDLE ROD APPROX
286240080 N/A N/A
IN-LINE APPROXIMATOR 286240090 11 15
• Actuate the Approximator while scrubbing the surface of the
device by squeezing the handle at least three times.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the spring and the mated surfaces between the
inner and outer shafts.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
All Instruments (cont.): • Rinse the instrument with warm, 85°F
– 104°F (30°C - 40°C), tap water for a minimum of one minute and
until visual evidence of debris, soil, and cleaning solution are
gone.
• Pay particular attention to flush the lumen of the dilators,
ports, and suction tubes with warm, 85°F – 104°F (30°C - 40°C), tap
water.
• Ultrasonically clean the device components for 10 minutes in
neutral pH detergent, prepared in accordance with the
manufacturer’s instructions.
• Rinse the device components with warm, 85°F – 104°F (30°C -
40°C), tap water for a minimum of one minute and until visual
evidence of debris, soil, and cleaning solution are gone.
• Dry the device components immediately after final rinse with a
clean towel or compressed air until visibly dry.
— OR —
Automated CleaningImplants
• Prepare an enzymatic cleaning solution in accordance to the
manufacturer’s instructions.
• Soak implants for a minimum recommended time specified by the
enzymatic cleaning solution manufacturer or 5 minutes, whichever is
longer. • Rinse the implants with warm, 85°F – 104°F (30°C - 40°C),
tap water for a minimum of one minute (with agitation if contained
within the caddy) and until visual evidence of cleaning solution is
gone.
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• Ultrasonically clean the implants for 10 minutes in neutral pH
detergent, prepared in accordance with the manufacturer’s
instructions.
• Continue processing with the All Instruments section.
All Instruments: • Prepare an enzymatic cleaning solution in
accordance to the manufacturer’s instructions.
• Soak soiled instruments for a minimum recommended time
specified by the enzymatic cleaning solution manufacturer or 5
minutes, whichever is longer.
• Use a soft bristle scrub brush (plastic bristles, like nylon)
to remove all traces of blood and debris from the device
surfaces.
EXPEDIUM Cannulated Taps: • EXPEDIUM Cannulated Taps have a 2 mm
diameter cannulation. • Use a minimum 12 inch (305 mm) long, 3 mm
brush diameter, soft lumen brush (plastic bristles, like nylon) to
scrub the lumen or cannula of each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
EXPEDIUM Alignment Guides: • EXPEDIUM Alignment Guides have an
11– 12 mm diameter lumen.
• Use a minimum 12 inch (305mm) long, 13 mm brush diameter, soft
lumen brush (plastic bristles, like nylon) to scrub the lumen or
cannula of each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
EXPEDIUM Modular Handles: • EXPEDIUM Modular Handles have a 4 –
6.35 mm diameter hole.
• Use a minimum 7 mm brush diameter, soft lumen brush (plastic
bristles, like nylon) to scrub the hole of each device.
Ratcheting Adapter (286710490): • The Ratcheting Adapter has a
2.4 mm diameter lumen. • Use a minimum 3 mm brush diameter, soft
lumen brush (plastic bristles, like nylon) to scrub the lumen of
each device.
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
• Scrub the exterior surface of the device while actuating the
ratchet mechanism.
EXPEDIUM Quick Connect Screwdriver: • Actuate the driver while
scrubbing the surface of the device by pulling the inner shaft and
turning the outer sleeve at least three full rotations.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the handle cavity.
• Repeat the flushing of the handle cavity through two different
openings.
EXPEDIUM Devices with Lumens: • Use a minimum 12 inch (305 mm)
long, tight fitting, soft lumen brush (plastic bristles, like
nylon) to scrub the lumen or cannula of each device. Minimum brush
diameters are specified in the table below for each lumen size. A
toothbrush style brush, or equivalent, can be used for large lumen
(>15 mm) devices:
Device Description
Product Code
Lumen Size
Brush Diameter
SAI COUNTER TORQUE 279704055 12 14MMSI DRIVER SLEEVE 279712200
10 14DRIVER SLEEVE FOR SI SCREWS 279712250 9 12
SI REDUCTION TUBE 279712460 9 –14 15MMSI ROD STABILIZER
279712500 12 13APPROXIMATOR FC SLEEVE 279712580 9 10APPX FC
ROTATION TUBE 279712599 11 12LATERAL APPROXIMATOR 279712660 11
12FACILITATOR 279712888 11 12EXP 5.5 ANTITORQUE 279712920 12 13DI
DRIVER SLEEVE 279722250 11 12XPDM DI REDUCTION TUBE 279722460 10
11DI ROD STABILIZER 279722500 12 13EXP DI FAR SCREWDRIVER SLEEVE
279722850 11 12
EXP DI FACILITATOR 279722888 12 13MIS ALIGNMENT DEVICE 279726400
2 7OPEN ALIGNMENT DEVICE 279726401 2 7IEXP CLOSED BOLT DRIVER
279729440 8 10EXP CLOSED BLT DRIVER COLLET 279729445 5 6
IEXP NUT INSERTER 279729450 5 10IEXP 8MM TIGHTENER L-HANDLE
279729470 8 9
-
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the print date, please re-print to ensure use of the latest
revision of the IFU (available at www.e-ifu.com). The onus resides
with the user to ensure that the most up-to-date IFU is used.
7 of 14
Device Description
Product Code
Lumen Size
Brush Diameter
IEXP SLOTTED CONN STABLIZER 279729610 7 8
IEXP CANN PLACEMENT WRENCH 279729640 7 8
EXP 635 MINI QUICK STICK 279734210 11 16DRIVER SLEEVE 279763250
11 12ROD STABILIZER 279763500 12 13APPROXIMATOR FLEX CLIP 279763570
11 15APPROXIMATOR FC SLEEVE 279763580 9 10APPROXIMATOR FC ROTATION
TUBE 279763599 11 12
SI APPROXIMATOR SLEEVE 279763660 11 12DI APPROXIMATOR SLEEVE
279763670 11 12FACILITATOR 279763888 12 14EXP 6.35 ANTITORQUE
279763920 12 13VBD QUICK STICK 279788835 11 16VBD QUICK STICK OUTER
SLEEVE 279788840 11 16
EXPEDIUM DEROTATION REDUCTION 279788870 16 17
EXP DEROT FLEX-CLIP INSERT 279788872 11 12
EXP DEROT FLEXCLIP INSERT 6.35 279788874 11 12
EXP DEROT QUICK STICK-SHORT 279788878 11 16
EXP5.5 DEROTATION QUICK STICK 279788935 11 16
EXP 5.5 DEROTATION QCK STICK F 279788955 11 16
CABLE/WIRE SCREWDRIVER 286210040 5 6ROD STABILIZER, SI 286210140
11 12ROD STABILIZER, SLOTTED CONN 286210230 11 12
FACILITATOR 286240085 9 10IN-LINE APPROXIMATOR PLUG 286240095 9
10
EXP 4.5 IN-LINE APPROX INSERTER 286240096 11 12
TUBE BENDERS 286260060 8 9SFX STABILIZER 289410400 7 9SFX CENTER
ALIGN GUIDE 289410450 7 9EXP 4.5 SFX STABILIZER 289420400 8 9
Device Description
Product Code
Lumen Size
Brush Diameter
EXP ANT MONOAXIAL SCRW DRVR SLEEVE 287720105 9 10
EXP ANT CROSS CONN APPLICATOR 287730140 11 12
• Push the brush through the entire length of the lumen using a
twisting motion to remove debris at least five times from both
ends.
• Use a 50 ml syringe filled to capacity with enzymatic cleaning
solution to flush the lumen of each device.
EXPEDIUM devices with holes or cavities: • Use a minimum 7 inch
(175 mm) long, tight fitting, soft lumen brush (plastic bristles,
like nylon) to scrub the holes of each device. Minimum brush
diameters are specified in the table below for each hole size:
Device Description
Product Code
Hole Size
Brush Diameter
EXP OFFSET BOLT TUBE/PUSHER 279729480 6 & 3 mm 7 & 4
mm
IEXP BOLT CUTTER 279729910 7 8IEXP ROD CUTTER 279729930 5 8BOLT
ALIGNMENT GUIDE 286210240 5 & 3 mm 6 & 4 mm
EXPEDIUM One Handed Rod Approximators: • Use a minimum 12 inch
(305 mm) long, tight fitting, soft lumen brush (plastic bristles,
like nylon) to scrub the lumen of each device. Minimum brush
diameters are specified in the table below for each lumen size. A
toothbrush style brush, or equivalent, can be used for large lumen
(>15 mm) devices:
Device Description
Product Code
Lumen Size
Brush Diameter
ONE HANDED ROD APPROXIMATOR 279712510 11 12
ROD APPROX W/DOVETAIL 279712525 N/A N/A6.35 ONE HANDED ROD
APPROX 279712610 12 18
LATERAL APPROXIMATOR 279712650 10 15KERRISON STYLE REDUCT DEVICE
279763425 10 11
LATERAL APPROXIMATOR 279763650 10 15SQUEEZE HANDLE ROD APPROX
286240080 N/A N/A
IN-LINE APPROXIMATOR 286240090 11 15
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All Instruments (cont.): • Rinse the instrument with warm, 85°F
– 104°F (30°C - 40°C), tap water for a minimum of one minute and
until visual evidence of debris, soil, and cleaning solution are
gone.
• Pay particular attention to flush the lumen of the dilators,
ports, and suction tubes with warm, 85°F – 104°F (30°C - 40°C), tap
water.
• Ultrasonically clean the device components for 10 minutes in
neutral pH detergent, prepared in accordance with the
manufacturer’s instructions.
• Rinse the device components with warm, 85°F – 104°F (30°C -
40°C), tap water for a minimum of one minute and until visual
evidence of debris, soil, and cleaning solution are gone.
• Load the device components so that the lumens of the ports,
dilators, and suction tubes can drain.
• Clean, using the “INSTRUMENTS” cycle in a validated washer
disinfector and a pH neutral cleaning agent intended for use in
automated cleaning using the minimum cycle parameters below:
Phase
Recirculation Time
Water Temp
Detergent Type
Pre-Wash 2:00 Cold Tap Water N/A
Enzyme Wash 1:00 Hot Tap Water Enzymatic Cleaner
Wash 2:00 65.5°C Neutral pH DetergentRinse 0:15 Hot Tap Water
N/ADry 15:00 66°C N/A
Cleaning Inspection • Inspect all devices before sterilization
or storage to ensure the complete removal of soil from surfaces,
lumens, holes, and moveable parts.
• If areas are difficult to inspect visually, check for blood by
immersing or flushing the instrument in a 3% hydrogen peroxide
solution. If bubbling is observed, blood is present. Rinse
instru-ments for a minimum of 1 minute with warm, 85°F – 104°F
(30°C - 40°C), tap water after using hydrogen peroxide
solution.
• If soil is still present, re-clean the instrument.
DisinfectionDevices must be terminally sterilized prior to
surgical use. See Sterilization instructions.
MaintenanceCarefully inspect instruments between uses to verify
proper functioning. Send damaged instruments to a supplier of
authorized repair or refurbishment services.
Inspection and Functional Testing • Visually inspect the
instruments for damage and wear. • The shafts should be free of
bending and distortion. • Cutting edges of the Drills should be
free of nicks and have a continuous edge.
• Moveable parts should have smooth movement without excessive
play.
• Locking mechanisms should fasten securely and close
easily.
Packaging • If desired, use instrument trays to contain
instruments that are provided in sets.
• Double wrap instruments in accordance with local procedures,
using standard wrapping techniques such as those described in the
current revision of ANSI/AAMI ST79.
Sterilization • Use a validated, properly maintained and
calibrated steam sterilizer.
• Effective steam sterilization can be achieved using the
following cycle:
Cycle Type
Temperature
Exposure Time
Dry Time
Pre-Vacuum 270°F (132°C) 4 minutes 60 minutesPre-Vacuum 273°F
(134°C) 3 minutes 60 minutes
• Post-sterilization drying of the sterilization load within the
sterilization vessel is standard practice in hospitals. ANSI/AAMI
ST79:2006, “Comprehensive guide to steam sterilization and
sterility assurance in health care facilities” provides guidance to
hospitals for selecting appropriate drying parameters based on the
sterilization cycle that is being conducted. Sterilizer
manufacturers also typically provide recommendations for drying
parameters for their specific equipment.
• Only legally marketed, FDA cleared sterilization wrap,
pouches, or DePuy Synthes Reusable Sterilization Containers should
be used by the end-user for packaging terminally sterilized
devices. The manufacturer’s instructions for use for the
steril-ization wrap, pouches, or DePuy Synthes Reusable
Sterilization Containers are to be followed. The use of DePuy
Synthes Reusable Sterilization Containers are limited to use in the
United States only, and are not approved for use outside of the
United States.
StorageStore sterile packaged devices in a manner that provides
protection from dust, moisture, insects, vermin, and extremes of
temperature and humidity.
8 of 14This document is valid only on the date printed. If
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latest revision of the IFU (available at www.e-ifu.com). The onus
resides with the user to ensure that the most up-to-date IFU is
used.
-
MAGNETIC RESONANCE (MR) COMPATIBILITYThe EXPEDIUM VERSE Spine
System has not been evaluated for safety and compatibility in the
MR environment. They have not been tested for heating or migration
in the MR environment.
USAGEWARNING: The safety and effectiveness of pedicle screw
spinal systems have been established only for spinal conditions
with significant mechanical instability or deformity requiring
fusion with instrumentation. These conditions are significant
mechanical instability or deformity of the thoracic, lumbar, and
sacral spine secondary to severe spondylolisthesis (grades 3 and 4)
of the L5-S1 vertebra, degenerative spondylolisthesis with
objective evidence of neurologic impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and effectiveness of these devices for
any other conditions are unknown.
CoCr tapered rods are not intended to connect the EXPEDIUM Spine
System to the Synthes SYNAPSE System.
PRECAUTION: The implantation of pedicle screw spinal systems
should be performed only by experienced spinal surgeons with
specific training in the use of this pedicle screw spinal system
because this is a technically demanding procedure presenting a risk
of serious injury to the patient. The surgeon must be thoroughly
knowledgeable not only in the medical and surgical aspects of the
implant, but must also be aware of the mechanical and metallurgical
limitations of metallic surgical implants. Postoperative care is
extremely important. The patient must be instructed in the
limitations of the metallic implant and be warned regarding weight
bearing and body stresses on the appliance prior to firm bone
healing. The patient should be warned that noncompliance with
postoperative instructions could lead to failure of the implant and
possible need thereafter for additional surgery to remove the
device.
Refer to the individual system surgical technique manuals for
additional important information.
DePuy Spine Spinal System components should not be used with
components from other manufacturers unless otherwise specified.
Stainless steel components may interfere with the quality of
imaging obtained using MRI.
During the surgical procedure, the rods may be cut to size and
shaped to provide correction and maintain proper anatomic lordotic
and kyphotic alignment.
When using anterior thoracic/lumbar screw fixation systems,
staples, staple washers and washers are available to optimize
proper staple/screw/rod alignment and stability.
Screw diameters of 11 mm and 12 mm are indicated for use only in
the sacrum or ilium. Pre-operative use of CT imaging to determine
the appropriate screw diameter, length, insertion trajectory, and
clearance is strongly recommended when large diameter screws are
indicated.
After solid fusion occurs, these devices serve no functional
pur-pose and may be removed. In some cases, removal is indicated
because the implants are not intended to transfer or to support
forces developed during normal activities. Any decision to remove
the device must be made by the physician and the patient taking
into consideration the patient’s general medical condition and the
potential risk to the patient of a second surgical procedure.
These devices are not intended or expected to be the only
mechanism for support of the spine. Regardless of the etiology of
the spinal pathology, for which implantation of these devices was
chosen, it is the expectation and requirement that a spinal fusion
or arthrodesis be planned and obtained. Without solid biological
support provided by spinal fusion, the devices cannot be expected
to support the spine indefinitely and will fail in any of several
modes. These modes may include bone-metal interface failure,
implant fracture, or bone failure.
POSTOPERATIVE MOBILIZATIONUntil X-rays confirm the maturation of
the fusion mass, external immobilization (such as bracing or
casting) is recommended.
Instructions to the patient to reduce stress on the implants are
an equally important part of the attempt to avoid the occurrence of
clinical problems that may accompany fixation failure.
CONTRAINDICATIONSDisease conditions that have been shown to be
safely and predictably managed without the use of internal fixation
devices are relative contraindications to the use of these
devices.
Active systemic infection or infection localized to the site of
the proposed implantation are contraindications to
implantation.
Severe osteoporosis is a relative contraindication because it
may prevent adequate fixation of spinal anchors and thus preclude
the use of this or any other spinal instrumentation system.
Any entity or condition that totally precludes the possibility
of fusion, i.e., cancer, kidney dialysis, or osteopenia is a
relative contraindication. Other relative contraindications include
obesity, certain degenerative diseases, and foreign body
sensitivity. In addition, the patient’s occupation or activity
level or mental capacity may be relative contraindications to this
surgery. Specifically, patients who because of their occupation or
lifestyle, or because of conditions such as mental illness,
alcoholism, or drug abuse, may place undue stresses on the implant
during bony
9 of 14This document is valid only on the date printed. If
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-
healing and may be at higher risk for implant failure. See also
the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING
TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this
insert.
WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING
TEMPORARY METALLIC INTERNAL FIXATION DEVICESFollowing are specific
warnings, precautions, and possible adverse effects that should be
understood by the surgeon and explained to the patient. These
warnings do not include all adverse effects that can occur with
surgery in general, but are important considerations particular to
metallic internal fixation devices. General surgical risks should
be explained to the patient prior to surgery.
WARNINGS1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY
IMPORTANT. The potential for satisfactory fixation is increased
by the selection of the proper size, shape, and design of the
implant. While proper selection can help minimize risks, the size
and shape of human bones present limitations on the size, shape and
strength of implants. Metallic internal fixation devices cannot
withstand activity levels equal to those placed on normal healthy
bone. No implant can be expected to with-stand indefinitely the
unsupported stress of full weight bearing.
2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING
ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation
appliances are load-sharing devices which are used to obtain
alignment until normal healing occurs. If healing is delayed, or
does not occur, the implant may eventually break due to metal
fatigue. The degree or success of union, loads produced by weight
bearing, and activity levels will, among other conditions, dictate
the longevity of the implant. Notches, scratches or bending of the
implant during the course of surgery may also contribute to early
failure. Patients should be fully informed of the risks of implant
failure.
3. MIXING METALS CAN CAUSE CORROSION. There are many forms of
corrosion damage and several of these occur on metals surgically
implanted in humans. General or uniform corrosion is present on all
implanted metals and alloys. The rate of corrosive attack on metal
implant devices is usually very low due to the presence of passive
surface films. Dissimilar metals in contact, such as titanium and
stainless steel, accelerate the corrosion process of stainless
steel and more rapid attack occurs. The presence of corrosion often
accelerates fatigue fracture of implants. The amount of metal
compounds released into the body system will also increase.
Internal fixation devices, such as rods, hooks, etc., which come
into contact with other metal objects, must be made from like or
compatible metals.
4. PATIENT SELECTION. In selecting patients for internal
fixation devices, the following factors can be of extreme
importance to the eventual success of the procedure:
A. The patient’s weight. An overweight or obese patient can
produce loads on the device that can lead to failure of the
appliance and the operation.
B. The patient’s occupation or activity. If the patient is
involved in an occupation or activity that includes heavy lifting,
muscle strain, twisting, repetitive bending, stooping, running,
substantial walking, or manual labor, he /she should not return to
these activities until the bone is fully healed. Even with full
healing, the patient may not be able to return to these activities
successfully.
C. A condition of senility, mental illness, alcoholism, or drug
abuse. These conditions, among others, may cause the patient to
ignore certain necessary limitations and precautions in the use of
the appliance, leading to implant failure or other
complications.
D. Certain degenerative diseases. In some cases, the progression
of degenerative disease may be so advanced at the time of
implantation that it may substantially decrease the expected useful
life of the appliance. For such cases, orthopaedic devices can only
be considered a delaying technique or temporary remedy.
E. Foreign body sensitivity. The surgeon is advised that no
preoperative test can completely exclude the possibility of
sensitivity or allergic reaction. Patients can develop sensitivity
or allergy after implants have been in the body for a period of
time.
F. Smoking. Patients who smoke have been observed to experience
higher rates of pseudarthrosis following surgical procedures where
bone graft is used. Additionally, smoking has been shown to cause
diffuse degeneration of intervertebral discs. Progressive
degeneration of adjacent segments caused by smoking can lead to
late clinical failure (recurring pain) even after successful fusion
and initial clinical improvement.
G. The safety and effectiveness of these devices has not been
established for use as part of a pediatric growing rod construct.
These devices are only intended to be used when definitive fusion
is being performed at all instrumented levels
10 of 14This document is valid only on the date printed. If
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resides with the user to ensure that the most up-to-date IFU is
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-
H. The use of pedicle screw fixation in the pediatric population
may present additional risks when patients are of smaller stature
and skeletally immature. Pediatric patients may have smaller spinal
structures (pedicle diameter or length) that may preclude the use
of pedicle screws or increase the risk of pedicle screw
malpositioning and neurological or vascular injury. Patients not
skeletally mature that undergo spinal fusion procedures may have
longitudinal spinal growth, or may be at risk for rotational spinal
deformities (the “crankshaft phenomenon”) due to continued
differential growth of the anterior spine.
Other adverse events related to pedicle screw fixation, such as
screw or rod bending, breakage, or loosening, may also occur in
pediatric patients. Pediatric patients may be at increased risk for
device related injury because of their smaller stature.
PRECAUTIONS1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An
explanted metal implant should never be reimplanted. Even though
the device appears undamaged, it may have small defects and
internal stress patterns which may lead to early breakage. Reuse
can compromise device performance and patient safety. Reuse of
single use devices can also cause cross-contamination leading to
patient infection.
2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT.
Contouring of metal implants should only be done with proper
equipment. The operating surgeon should avoid any notching,
scratching or reverse bending of the devices when contouring.
Alterations will produce defects in surface finish and internal
stresses which may become the focal point for eventual breakage of
the implant. Bending of screws will significantly decrease the
fatigue life and may cause failure.
3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If
the device is not removed after the completion of its intended use,
any of the following complications may occur: (1) Corrosion, with
localized tissue reaction or pain; (2) Migration of implant
position resulting in injury; (3) Risk of additional injury from
postoperative trauma; (4) Bending, loosening, and/or breakage,
which could make removal imprac-tical or difficult; (5) Pain,
discomfort, or abnormal sensations due to the presence of the
device; (6) Possible increased risk of infection; and (7) Bone loss
due to stress shielding. The surgeon should carefully weigh the
risks versus benefits when deciding whether to remove the implant.
Implant removal should be followed by adequate postoperative
management to avoid refracture. If the patient is older and has a
low activity level, the surgeon may choose not to remove the
implant thus eliminating the risks involved with a second
surgery.
4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the
patient’s ability and willingness to follow instructions are among
the most important aspects of successful bone healing. The patient
must be made aware of the limitations of the implant, and
instructed to limit and restrict physical activities, especially
lifting and twisting motions and any type of sports participation.
The patient should understand that a metallic implant is not as
strong as normal healthy bone and could loosen, bend and/or break
if excessive demands are placed on it, especially in the absence of
complete bone healing. Implants displaced or damaged by improper
activities may migrate and damage the nerves or blood vessels. An
active, debilitated, or demented patient who cannot properly use
weight-supporting devices may be particularly at risk during
postoperative rehabilitation.
5. CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the
proximity of vascular and neurologic structures to the implantation
site, there are risks of serious or fatal hemorrhage and risks of
neurologic damage with the use of this product. Serious or fatal
hemorrhage may occur if the great vessels are eroded or punctured
during implantation or are subsequently damaged due to breakage of
implants, migration of implants or if pulsatile erosion of the
vessels occurs because of close apposition of the implants.
The implantation of pedicle screw spinal systems in pediatric
patients should be performed only by experienced spinal surgeons
with specific training in the use of this pedicle screw spinal
system in pediatric patients because this is a technically
demanding procedure presenting a risk of serious injury to the
patient.
Preoperative and operating procedures, including knowledge of
surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the
successful utilization of the system in pediatric patients.
PHYSICIAN NOTE: Although the physician is the learned
intermediary between the company and the patient, the important
medical information given in this document should be conveyed to
the patient.
POSSIBLE ADVERSE EFFECTS1. Bending or fracture of implant.
2. Loosening of the implant.
3. Metal sensitivity or allergic reaction to a foreign body.
4. Infection, early or late.
5. Nonunion, delayed union.
6. Decrease in bone density due to stress shielding.
11 of 14This document is valid only on the date printed. If
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resides with the user to ensure that the most up-to-date IFU is
used.
-
7. Pain, discomfort, or abnormal sensations due to the presence
of the device.
8. Nerve damage due to surgical trauma or presence of the
device. Neurological difficulties including bowel and/or bladder
dysfunction, impotence, retrograde ejaculation, and
paraesthesia.
9. Bursitis.
10. Paralysis.
11. Dural tears experienced during surgery could result in the
need for further surgery for dural repair, a chronic CSF leak or
fistula, and possible meningitis.
12. Death.
13. Vascular damage due to surgical trauma or presence of the
device. Vascular damage could result in catastrophic or fatal
bleeding. Malpositioned implants adjacent to large arteries or
veins could erode these vessels and cause catastrophic bleeding in
the late postoperative period.
14. Screw back out, possibly leading to implant loosening,
and/or reoperation for device removal.
15. Damage to lymphatic vessels and/or lymphatic fluid
exudation.
16. Spinal cord impingement or damage.
17. Fracture of bony structures.
18. Degenerative changes or instability in segments adjacent to
fused vertebral levels.
Additional Adverse Events for Pediatric Patients1. Inability to
use pedicle screw fixation due to anatomic
limitations (pedicle dimensions, distorted anatomy).2. Pedicle
screw malpositioning, with our without neurological or
vascular injury.3. Proximal or distal junctional kyphosis.4.
Pancreatitis.
LIMITED WARRANTY AND DISCLAIMERPRODUCTS FROM DEPUY SYNTHES
PRODUCTS, LLC ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL
PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER
EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED.IF MORE THAN TWO
YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS
INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE
FOR CURRENT INFORMATION AT +1-800-365-6633 OR AT
+1-508-880-8100.
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resides with the user to ensure that the most up-to-date IFU is
used.
-
MATERIAL MATL
SYMBOL TRANSLATION
A/T ACROFLEX®/Ti ACROFLEX®/Titanium
A AI Aluminum
A/P A l /PLAluminum/Plastic
B/R Ba/RADEL®Barium/RADEL®
Ba/PEEKBarium Sulfate (BaSO4)/
PEEK Polymer
CaP CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMoCobalt Chromium
Molybdenum
CMTC CoCrMo/Ti /CALCIUM
PHOSPHATECobalt Chromium
Molybdenum/Titanium/Calcium Phosphate
CoNiCrMoCobalt Nickel
Chromium Molybdenum
F FOAMFoam
HA Hydroxyapatite
NiTi Ni /TiNickel /Titanium
PL Plastic
SRSI SS/RADEL®/SILICONE
Stainless Steel /RADEL®/Silicone
SRSN SS/RADEL®/
SILICONE/Ti Al NitrideStainless Steel /RADEL®/
Silicone/Titanium Aluminum Nitride
SS/RADEL®/SILICONE/Ti Nitride
Stainless Steel/RADEL®/Silicone/Titanium Nitride
SRTA SS/RADEL®/Ti Al NitrideStainless Steel /RADEL®/
Titanium Aluminum Nitride
STA SS/Ti Al NitrideStainless Steel /
Titanium Aluminum Nitride
S/U SS/ULTEMStainless Steel /Ultem
T TiTitanium and its alloys
S/R SS/RADEL®Stainless Steel /RADEL®
R/T POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/A Ti /AlTitanium/Aluminum
Ti /CoCrMoTitanium/Cobalt
Chromium Molybdenum
P/F PL/FOAMPlastic /Foam
PY Polyester
PEEK/C PEEK/CARBON
FIBER COMPOSITEPolyether Ether Ketone/Carbon Fiber Composite
PEEK OPTIMA®Polyether Ether Ketone
P POLYMERPolymer
P/CM PE/CoCrMoPolyethylene/Cobalt
Chromium Molybdenum
P/C POLYMER/CARBON FIBER COMPOSITE
Polymer/Carbon Fiber Composite
Si /NITINOLSilicone/Nitinol
S SSStainless Steel
S/A SS/AlStainless Steel /Aluminum
SBR SS/Ba/RADEL®Stainless Steel /Barium/
RADEL®
S/P SS/PHENOLICStainless Steel /Phenolic
S/PL SS/PLStainless Steel /Plastic
LOT LOT NUMBER
REF REFCATALOG NUMBER
QTY QUANTITY
SZ SIZE
MADE IN MADE IN
NTINEURAL TISSUE
INSTRUMENT
IOMNEUROMONITORING
INSTRUMENTS
Federal (USA) law restricts this device to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of temperature = T1
Upper Limit of temperature = T2
25°C
STORE AT ROOM TEMPERATURE
KEEP AWAY FROM SUNLIGHT
SINGLE USE
ATTENTION. SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS FLAMMABLE LIQUID
DO NOT USE IF PACKAGE IS
DAMAGED
MSRMEASURING DEVICE
STERILESTERILE
STERILE ASterile medical device
processed using aseptic technique
STERILE RSTERILIZATION BY
IRRADIATION
STERILE EOSTERILIZATION BY ETHYLENE OXIDE
LATEX FREELATEX FREE
NONSTERILE
NONSTERILENONSTERILE
MANUFACTURER
DATE OF MANUFACTURE
US REPUS REPRESENTATIVE
EC REPAUTHORIZED EUROPEAN
REPRESENTATIVE
DISTDISTRIBUTED BY
XXXX-XX
USE BY
Ti /HA Titanium/Hydroxyapatite
Ti /UHMWPE/HATitanium/Ultra-High
Molecular Weight Polyethylene/Hydroxyapatite
SS/TiStainless Steel /Titanium
SS/Al /SILICONEStainless Steel /
Aluminum/Silicone
SS/SILICA GLASSStainless Steel /Silica Glass
SS/SILICA GLASS/PL/SILICONE
Stainless Steel /Silica Glass/Plastic /Silicone
SS/SILICA GLASS/RADEL®/SILICONE
Stainless Steel /Silica Glass/RADEL®/Silicone
SS/SILICA GLASS/SILICONE
Stainless Steel /Silica Glass/Silicone
S/SI SS/SILICONEStainless Steel /Silicone
SS/WC/SILICONEStainless Steel /Tungsten
Carbide/Silicone
W/C Tungsten Carbide
Ti/CoCrMoTitanium / Cobalt Chromium Molybdenum
13 of 14This document is valid only on the date printed. If
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latest revision of the IFU (available at www.e-ifu.com). The onus
resides with the user to ensure that the most up-to-date IFU is
used.
-
*
DePuy Spine, Inc. 325 Paramount Drive
Raynham, MA 02767-0350 USA
*
Medos International SÀRL Chemin-Blanc 38
2400 Le Locle, Switzerland
*For recognized manufacturer, refer to product label.
US REP
DePuy Spine, Inc. 325 Paramount Drive
Raynham, MA 02767-0350 USA Phone: +1 (800) 451 2006 FAX: +1
(508) 828 3700
EC REP
DePuy International, Ltd. St. Anthony’s Road
Leeds LS11 8DT England Phone: +44 113 270 0461 FAX: +44 113 272
4101
Issued November 2014 © DePuy Synthes Spine, a division of DOI
2013-2014.
All rights reserved.
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resides with the user to ensure that the most up-to-date IFU is
used.
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00860902-90-128 Rev. A
bg
Спинална система EXPEDIUM® VERSEВАЖНА ЗАБЕЛЕЖКА ЗА ОПЕРИРАЩИЯ
ХИРУРГСпиналните импланти EXPEDIUM® VERSE, подобно на всички други
изделия за временна вътрешна фиксация, имат ограничен полезен
живот. Нивото на активност на пациента има значи телно влияние
върху този полезен живот. Вашият пациент трябва да бъде информиран,
че всяка активност повишава риска от разхлабване, огъване или
счупване на компонентите на импланта. От съществено значение е
пациентите да се инструктират за ограниченията на тяхната активност
в постоперативния период и да се изследват посто-перативно за
оценяване на развитието на фузионната маса и на състоянието на
компонентите на импланта. Дори ако настъпи солидна костна фузия,
компонентите на импланта могат все пак да се огънат, счупят или да
се разхлабят. Затова пациентът трябва да бъде уведомен, че
компонентите на импланта могат да се огънат, счупят или да се
разхлабят, дори ако се спазват ограниченията в активността.Поради
ограниченията, наложени от анатомични съображения и от модерните
хирургични материали, металните импланти не могат да бъдат
направени така, че да траят неопределено дълго. Тяхното
предназначение е да осигуряват временна вътрешна опора, докато
фузионната маса се консолидира. По-вероятно е тези видове импланти
да не функционират добре, ако не се използва костен графт, ако се
развие псевдоартроза или ако пациентите имат тежки или множествени
изкривявания преди операцията.Хирургът може да отстрани тези
импланти след настъпване на костна фузия. Възможността за втора
хирургична процедура трябва да се обсъди с пациента, също трябва да
се обсъдят рисковете, свързани с втора хирургична процедура. Ако
имплантите се счупят, решението за отстраняването им трябва да се
вземе от лекаря, който трябва да прецени състоянието на пациента и
рисковете, свързани с присъствието на счупения имплант.
ОПИСАНИЕИмплантите на DePuy Spine НЕ са съвместими с импланти от
други производители, освен ако не е указано друго. Имплантите от
всяка от системите на DePuy Spine НЕ са взаимно заменяеми с
импланти от други системи на DePuy Spine, освен ако не е указано
друго. Имплантите, предвидени за интерфейс с пръчки с конкретен
диаметър НЕ са съвмес-тими с пръчки с друг диаметър, освен ако не е
указано друго. Импланти, предвидени за интерфейс с пръчки с
конкретен диаметър са съвместими с пръчки от други системи, които
имат същия диаметър и са от същия материал в съответствие с
таблицата по-долу.Пръчките с два диаметъра могат да имат комбинация
от диа-метри на пръчките, съответстващи на наличните диаметри на
прави пръчки от всяка от спиналните системи, изброени в таблицата
по-долу. Тези пръчки с два диаметъра могат да се използват за
свързване на конструкции от пръчки, образувани от оригиналната
система, към конструкции от пръчки от вторичната система в
съответствие с таблицата по-долу.
ОРИГИНАЛНА СИСТЕМА ВТОРИЧНА СИСТЕМА(И)
EXPEDIUM VERSEСвързва се към
EXPEDIUM/VIPER/VIPER2, ISOLA/TIMX, MONARCH, MOSS MIAMI
Имплантите, произведени от различни материали, НЕ са съвместими,
освен ако не е указано друго. В таблицата по-долу е посочена
съвместимостта на материалите на имплантите.МАТЕРИАЛ СЪВМЕСТИМ
ССплави с неръждаема стомана Сплави с неръждаема стомана
Титаниеви сплавиТитаниеви сплави, кобалт-хром-молибден,
кобалт-никел-хром-молибден, PEEK, търговски чист титан
Кобалт-хром-молибден
Титаниеви сплави, кобалт-никел-хром-молибден
1 of 16Този документ е валиден само към отпечатаната дата. Ако
не сте сигурни каква е тази дата, моля, отпечатайте отново, за да
сте сигурни, че използвате последното издание на инструкциите за
употреба. (Наличен на www.e-ifu.com). Задължението за използване на
най-актуалните инструкции за употреба е на потребителя.
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2 of 16
МАТЕРИАЛ СЪВМЕСТИМ СКобалт-никел-хром-молибден
Титаниеви сплави, кобалт-хром-молибден
Търговски чист титан Титаниеви сплави
Подгрупа от компоненти на EXPEDIUM VERSE може да се използва за
задна педикуларна винтова фиксация при педиатрични случаи. Тези
конструкции могат да се състоят от разнообразни по форма и размер
пръчки (от 4,5 до 6,35), куки, винтове, болтове и свързващи
компоненти. Подобно на използваните при възрастни импланти EXPEDIUM
VERSE, тези компоненти могат да се заключват ригидно в разнообразни
конфигурации, като всяка конструкция се създава персонализирано за
конкретния случай.DePuy Spine подготвя ръководства за хирургична
техника, показващи употребата на имплантите и инструментите за
всяка спинална система. Свържете се с Вашия търговски представител
на DePuy Spine, за да получите копия на тези ръководства за
хирургична техника.
Спинална система EXPEDIUM VERSEСпиналната система EXPEDIUM VERSE
се състои от лонгитудинални пръчки, моноаксиални винтове,
полиаксиални винтове, монопланарни винтове, редукционни винтове,
винтове за кабели/телове, болтове, конектори със слотове, телове,
куки, редукционни куки, трансверзални конектори, система с
кръстосани конектори SFX, конектори от двойни пръчки, сакрални
удължители, латерални конектори и шайби. Спиналната система
EXPEDIUM VERSE е съвместима с други системи посредством
използването на конектори с една или с две пръчки, латерални
конектори, сакрални удължители и пръчки с два диаметъра, както
следва:
• Пръчки на спиналната система ISOLA • Пръчки на системата
VIPER/VIPER2 • Пръчки на спиналната система MONARCH • Пръчки на
спиналната система MOSS MIAMI • Пръчки на системата за долна част
на гръбнака TIMX • Пръчки на системата Synthes SYNAPSE
Винтът за кабели/телове е предназначен за употреба със
субламинарната зърнеста тел от неръждаема стомана ISOLA,
произведена от DePuy Spine, Inc., или с единичния кабел от
неръждаема стомана с гънка и пръчка и с единичния кабел с водач с
отвор ISOLA на спиналната кабелна система Songer, произведена от
Pioneer Surgical Technologies и разпространявана от DePuy Spine,
Inc.Компонентите на спиналната система EXPEDIUM VERSE се предлагат
във варианти от търговски чист титан или
титаниева сплав, отговаряща на спецификациите на ASTM F-67, ASTM
F-136 или ASTM F-1472, неръждаема стомана, отговаряща на
спецификациите на ASTM F-138, ASTM F-1314 или F-2229, тел от
кобалт-никел-хром-молибденова сплав, отговаряща на спецификациите
на ASTM F-562, както и лонгитудинални пръчки от
кобалт-хром-молибденова сплав, отговаряща на спецификациите на ASTM
F-1537. Пръчките от кобалт-хром-молибденова сплав и пръчките от
кобалт-никел-хром-молибденова сплав са предвидени за употреба само
с титаниеви компоненти. Комплектите от пръстеновидни гайки и
заключващи винтове са предвидени за употреба само с полиаксиални,
монопланарни и моноаксиални с една вътрешна част (SI) педикуларни
винтове и педикуларни куки в рамките на 4,5 mm и 5,5 mm системи
EXPEDIUM от неръждаема стомана и титан. Удължаващите крила на
редукционните винтове и куки са предвидени да се отстраняват
интраоперативно.
ПОКАЗАНИЯСпиналните системи EXPEDIUM VERSE са предназначени за
осигуряване на имобилизация и стабилизация на гръбначните сегменти
при пациенти със завършен костен растеж като спомагателно средство
към фузията при лечение на остра и хронична нестабилност или
деформитети на торакалния, лумбалния и сакралния сегмент на
гръбнака.Спиналната система EXPEDIUM VERSE е предназначена за
педикуларна фиксация извън цервикалния сегмент на гръбнака и
непедикуларна фиксация при следните показания: дегенеративно
заболяване на дисковете (дефинирано като болка в гърба от
дискогенен произход с дегенерация на диска, потвърдена от
анамнезата и рентгенографски изследвания); спондилолистеза; травма
(т.е. фрактура или дислокация); спинална стеноза, изкривявания
(т.е. сколиоза, кифоза и/или лордоза); тумор, псевдоартроза; и
неуспешна предходна фузия при пациенти със завършен костен
растеж.Когато се използва със заден перкутанен достъп с
инстру-менти за MIS, системата EXPEDIUM VERSE е предназначена за
педикуларна фиксация извън цервикалния сегмент на гръбнака и
непедикуларна фиксация при следните показа-ния: дегенеративно
заболяване на дисковете (дефинирано като болка в гърба от
дискогенен произход с дегенерация на диска, потвърдена от
анамнезата и рентгенографски изследвания); спондилолистеза; травма
(т.е. фрактура или дислокация); спинална стеноза, изкривявания
(т.е. сколиоза, кифоза и/или лордоза); тумор, псевдоартроза; и
неуспешна предходна фузия при пациенти със завършен костен
растеж.
Този документ е валиден само към отпечатаната дата. Ако не сте
сигурни каква е тази дата, моля, отпечатайте отново, за да сте
сигурни, че използвате последното издание на инструкциите за
употреба. (Наличен на www.e-ifu.com). Задължението за използване на
най-актуалните инструкции за употреба е на потребителя.
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3 of 16
Когато се използват за задна педикуларна винтова фиксация извън
цервикалния сегмент на гръбнака при педиатрични пациенти, металните
импланти на системата EXPEDIUM VERSE са показани като спомагателно
средство за фузия при лечение на идиопатична сколиоза при
подрастващи. Системите EXPEDIUM VERSE са предназначени за употреба
с автографт и/или алографт. Педикуларната винтова фиксация е
ограничена за заден достъп.
ПОЧИСТВАНЕ И СТЕРИЛИЗИРАНЕИмплантите и инструментите на
спиналните системи EXPEDIUM VERSE могат да се предоставят стерилни
или нестерилни и това ще бъде ясно обозначено на етикетите на
продуктите.
Стерилни имплантиЗа имплантите, които се предоставят стерилни,
съдържанието е стерилно, ако опаковката не е повредена, отворена
или срокът на годност на етикета на изделието не е изтекъл.
Целостта на опаковката трябва да се провери, за да се гарантира, че
стерилността на съдържанието не е нарушена. Извадете имплантите от
опаковката, като използвате асептична техника, едва след определяне
на правилния размер. ПРЕДПАЗНИ МЕРКИ: Не използвайте импланти, ако
състоянието на опаковката и/или етикета показва, че има вероятност
изделията да не са стерилни.Имплантите, които се предоставят
стерилизирани от производителя, не трябва да се стерилизират
повторно.
Нестерилни имплантиИмплантите, които се предоставят нестерилни,
ще се предоставят чисти. За всички компоненти трябва да се следват
препоръчваните от ISO 8828 или AORN процедури за стерилизация в
болницата.
ИНСТРУКЦИИ ЗА ПОЧИСТВАНЕЗа спинална система EXPEDIUM:
ОбсегСпинална система EXPEDIUM VERSE на DePuy Synthes
ПРЕДУПРЕЖДЕНИЯ • Следвайте указанията и предупрежденията,
издадени от производителите на използваните почистващи средства и
оборудване. • Не превишавайте 140°C (284°F) по време на стъпките на
повторна обработка.
• Избягвайте излагане на разтвори на хипохлорит, тъй като те
могат да причинят корозия. • Силно алкални условия (pH > 11)
могат да повредят продуктите с алуминиеви части. • Преди
автоматизирано почистване трябва да се извърши ръчно почистване за
всички изделия с лумени.
Ограничения за повторна обработка • Повторната обработка има
минимален ефект върху живота и функцията на инструмента. • Краят на
полезния живот по принцип се определя от износването или
повреждането при хирургична употреба. • Оглеждайте внимателно
инструментите преди отделните им използвания, за да се уверите в
правилното им функциониране. • Изпращайте повредените инструменти
на доставчик за оторизирана поправка или сервизен ремонт.
Съображения във връзка с обеззаразяване – Болест на
Creutzfeldt-Jakob (Cjd)
• При определени класификации на риска Световната здравна
организация (СЗО) или местните регулаторни власти препоръчват
специални процедури за обработка за инактивиране на CJD. За
допълнителна информация направете справка с разпоредбите на СЗО и
местните разпоредби.
Грижа на мястото на употреба • Почиствайте инструментите колкото
е възможно по-скоро след употребата им. Ако почистването трябва да
се отложи, потопете инструментите в разтвор на съвместим детергент,
напръскайте ги с разтвор за предварително накисване на инструменти,
или покрийте инструментите с кърпа, навлажнена с пречистена вода,
за да предотвратите засъхването и образуването на люспи от
хирургични замърсявания. • Избягвайте продължителното излагане на
физиологичен разтвор, за да намалите възможността за корозия. •
Отстранете излишните замърсявания с кърпа за еднократна
употреба.
Съхранение и транспортиране • Обработвайте повторно
инструментите колкото е разумно възможно по-скоро след употреба. •
Поставете изделието в съответното му положение в таблата за
инструменти. • Изображението на изделието е обозначено на
предвиденото място в таблата.
Този документ е валиден само към отпечатаната дата. Ако не сте
сигурни каква е тази дата, моля, отпечатайте отново, за да сте
сигурни, че използвате последното издание на инструкциите за
употреба. (Наличен на www.e-ifu.com). Задължението за използване на
най-актуалните инструкции за употреба е на потребителя.
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4 of 16
Подготовка за почистванеЗа многокомпонентни или сложни
инструменти, моля, направете справка с указанията им за
разглобяване. Указания за разглобяване могат да бъдат получени при
поискване от отдела за обслужване на клиенти на DePuy Spine на (800
227-6633).В случай, че указанията по-долу не могат да се изпълнят
според посоченото, моля, свържете се с отдела за обслужване на
клиенти за връщане на инструментите за обработка.
Ръчно почистванеВсички инструменти и импланти:
• Пригответе ензимен почистващ разтвор в съответствие с
инструкциите на производителя. • Накиснете замърсените изделия
най-малко за препоръчителното време, посочено от производителя на
ензимния почистващ разтвор или за 5 минути, което е по-дълго. •
Използвайте четка за изтъркване с меки влакна (с пластмасови
влакна, например найлон), за да отстраните всички следи от кръв и
остатъци от повърхностите на изделието.
Канюлирани винторези EXPEDIUM: • Канюлираните винторези EXPEDIUM
имат канюлация с диаметър 2 mm. • Използвайте мека четка за лумен с
дължина най-малко 305 mm (12 инча) и диаметър 3 mm (с пластмасови
влакна, например найлон) за изтъркване на лумена или канюлата на
всяко изделие. • Прокарайте четката по цялата дължина на лумена с
въртеливо движение за отстраняване на остатъците, най-малко пет
пъти от двата края. • Използвайте спринцовка от 50 ml, напълнена до
крайния обем с ензимен почистващ разтвор, за да промиете лумена на
всяко изделие.
Водачи за подравняване EXPEDIUM: • Водачите за подравняване
EXPEDIUM имат лумен с диаметър 11–12 mm. • Използвайте мека четка
за лумен с дължина най-малко 305 mm (12 инча) и диаметър 13 mm (с
пластмасови влакна, например найлон) за изтъркване на лумена или
канюлата на всяко изделие. • Прокарайте четката по цялата дължина
на лумена с въртеливо движение за отстраняване на остатъците,
най-малко пет пъти от двата края.
• Използвайте спринцовка от 50 ml, напълнена до крайния обем с
ензимен почистващ разтвор, за да промиете лумена на всяко
изделие.
Модулни дръжки EXPEDIUM: • Модулните дръжки EXPEDIUM имат отвор
с диаметър 4 – 6,35 mm. • Използвайте мека четка за лумен с
диаметър най-малко 7 mm (с пластмасови влакна, например найлон) за
изтъркване на отвора на всяко изделие.
Адаптор със зъбен механизъм (286710490): • Адапторът със зъбен
механизъм има лумен с диаметър 2,4 mm. • Използвайте мека четка за
лумен с диаметър най-малко 3 mm (с пластмасови влакна, например
найлон) за изтъркване на лумена на всяко изделие. • Прокарайте
четката по цялата дължина на лумена с въртеливо движение за
отстраняване на остатъците, най-малко пет пъти от двата края. •
Използвайте спринцовка от 50 ml, напълнена до крайния обем с
ензимен почистващ разтвор, за да промиете лумена на всяко изделие.
• Изтрийте външната повърхност на изделието, докато задвижвате
зъбния механизъм.
Винтоверт за бързо свързване EXPEDIUM: • Задействайте
винтоверта, докато изтривате повърхността на изделието, като
издърпате вътрешната ос и завъртите външния ръкав най-малко на три
пълни оборота. • Използвайте спринцовка от 50 ml, напълнена до
крайния обем с ензимен почистващ разтвор, за да промиете кухината
на дръжката. • Повторете промиването на кухината на дръжката през
два различни отвора.
Изделия с лумени EXPEDIUM: • Използвайте мека четка за лумен с
дължина най-малко 305 mm (12 инча) и плътно прилягане (с
пластмасови влакна, например найлон) за изтъркване на лумена или
канюлата на всяко изделие. Минималните диаметри на четката са
посочени в таблицата по-долу за всеки размер на лумен. Четка тип
„четка за зъби“ или подобна на нея може да се използва за изделия с
широк лумен (> 15 mm):
Описание на изделието
Код на издели-
ето
Раз-мер на лумена
Диаме-тър на четката
SAI ИЗДЕЛИЕ ЗА ОБРАТНО УСУКВАНЕ 279704055 12 14
MMSI РЪКАВ НА ВИНТОВЕРТ 279712200 10 14
Този документ е валиден само към отпечатаната дата. Ако не сте
сигурни каква е тази дата, моля, отпечатайте отново, за да сте
сигурни, че използвате последното издание на инструкциите за
употреба. (Наличен на www.e-ifu.com). Задължението за използване на
най-актуалните инструкции за употреба е на потребителя.
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Описание на изделието
Код на издели-
ето
Раз-мер на лумена
Диаме-тър на четката
РЪКАВ НА ВИНТОВЕРТ ЗА SI ВИНТОВЕ 279712250 9 12
SI РЕДУКЦИОННА ТРЪБА 279712460 9 -14 15MMSI СТАБИЛИЗАТОР ЗА
ПРЪЧКИ 279712500 12 13
FC РЪКАВ ЗА АПРОКСИМАТОР 279712580 9 10APPX FC РОТАЦИОННА ТРЪБА
279712599 11 12
ЛАТЕРАЛЕН АПРОКСИМАТОР 279712660 11 12ФАСИЛИТАТОР 279712888 11
12EXP 5.5 ИЗДЕЛИЕ ЗА АНТИ-УСУКВАНЕ 279712920 12 13
DI РЪКАВ НА ВИНТОВЕРТ 279722250 11 12XPDM DI РЕДУКЦИОННА ТРЪБА
279722460 10 11
DI СТАБИЛИЗАТОР ЗА ПРЪЧКИ 279722500 12 13
EXP DI ДАЛЕЧЕН РЪКАВ НА ВИНТОВЕРТ 279722850 11 12
EXP DI ФАСИЛИТАТОР 279722888 12 13MIS ИЗДЕЛИЕ ЗА ПОДРАВНЯВАНЕ
279726400 2 7
ИЗДЕЛИЕ ЗА ОТКРИТО ПОДРАВНЯВАНЕ 279726401 2 7
IEXP ЗАТВОРЕН ВИНТОВЕРТ ЗА БОЛТОВЕ 279729440 8 10
EXP ПАТРОННИК ЗА ЗАТВОРЕН ВИНТОВЕРТ ЗА БОЛТОВЕ
279729445 5 6
IEXP ПРИСПОСОБЛЕНИЕ ЗА ВЪВЕЖДАНЕ НА ГАЙКИ 279729450 5 10
IEXP 8 MM L-ОБРАЗНА ДРЪЖКА НА ИЗДЕЛИЕ ЗА ЗАТЯГАНЕ
279729470 8 9
IEXP СТАБИЛИЗАТОР ЗА КОНЕКТОРИ СЪС СЛОТОВЕ 279729610 7 8
IEXP ГАЕЧЕН КЛЮЧ ЗА ПОСТАВЯНЕ НА КАНЮЛИ 279729640 7 8
EXP 635 МИНИ ИЗДЕЛИЕ ЗА БЪРЗО ЗАЛЕПВАНЕ 279734210 11 16
РЪКАВ НА ВИНТОВЕРТ 279763250 11 12СТАБИЛИЗАТОР ЗА ПРЪЧКИ
279763500 12 13ГЪВКАВ КЛИПС ЗА АПРОКСИМАТОР 279763570 11 15
Описание на изделието
Код на издели-
ето
Раз-мер на лумена
Диам