7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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TLR Instruction For Use
itan Spine
T
013/05
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Summary
1. User manual ................................................................................................................ 3
1.1. Presentation .......................................................................................................... 3
1.1.1. Destination .................................................................................................... 3
1.1.2. Surgical contex t .............................................................................................. 3
1.1.3. Description ..................................................................................................... 4
1.2. Convenience kit content ......................................................................................... 4
1.3. Handling instructions .............................................................................................. 4
1.3.1. General ......................................................................................................... 4
1.3.2. K-wire and K-wire handle ................................................................................. 6
1.3.3. Dilators, dilator holder and probe ...................................................................... 6
1.3.4. Retractor, blades and wr ench ........................................................................... 8
1.3.5. Table clamp (use for mobile and static pos ition) ................................................ 11
1.3.6. Disposable light m ats and extension c ords ........................................................ 13
1.3.7. Light cable and light holder ............................................................................. 14
1.3.8. Shim, broach and shim/broach holder .............................................................. 16
1.3.9. Optional blade extension ................................................................................. 17
1.3.10. Optional 4
1.3.11. Container .................................................................................................. 20
2. Instructions for cleaning, sterilization and maintenance .................................................... 22
2.1. Handling prior to cleaning ...................................................................................... 22
2.1.1. Disassembling of the retractor ......................................................................... 22
2.1.2. Shim/broach holder disassembling ................................................................... 24
2.1.3. 4
2.1.4. Dilators holder special handling ca r e................................................................. 25
2.1.5. Table clamp base special handling care ............................................................. 25
2.2. Cleaning – decontamination ................................................................................... 26
2.2.1. Preparation f or cleaning .................................................................................. 26
2.
2.2. Manual Cleaning ............................................................................................ 26
2.2.3. Automatic Cleaning ........................................................................................ 27
2.3. Sterilization.......................................................................................................... 28
2.4. Storage ............................................................................................................... 28
2.5. Maintenance......................................................................................................... 29
2.5.1. Retractor ...................................................................................................... 29
2.5.2. Table clamp connector .................................................................................... 29
2.5.3. 4
2.5.4. Shim holder .................................................................................................. 30
2.6. Complaints........................................................................................................... 31
2.7. Contact ............................................................................................................... 31
3. Chart of medical device symbols used ............................................................................ 31
th
blade support special ha ndling care ............................................................. 24
th
blade support ........................................................................................... 30
th
blade and its support ................................................................. 19
7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
Classification
directive
SINGLE-USE
SINGLE-USE
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USER MANUAL
1. User Manual
1.1.
Presentation
1.1.1. Destination
This kit is composed of several instruments which will be used by a trained orthopedic
surgeon or neuro-surgeon to create a lateral or posterior access to the spine.
This kit is used to p rovide a spin al access channel through the tissue. The ret ractor will
move apart the flesh to allow the surgeon access to the disk or at the wound bottom.
1.1.2. Surgical context
Probes and light mats are sterile single-use products. Other instruments of the kit are
reusable.
K-wire Non-sterile Reusable NA I
K-wire handle Non-sterile Reusable NA I
K-wire cap Non-sterile Reusable NA I
Dilator Non-sterile Reusable NA I
Dilator holder Non-sterile Reusable NA I
Sterile/Non-
sterile
Single-use/
Reusable
510(k)
according to the
annex IX of 93/42CE
Extension cords for light mats Non-sterile Reusable K091035 I
Probe STERILE
Blade Non-sterile Reusable NA IIa
4th blade support Non-sterile Reusable NA I
Retractor body Non-sterile Reusable NA I
Wrench Non-sterile Reusable NA I
Table clamp Non-sterile Reusable NA I
Dual cable light Non-sterile Reusable K901035 I
Light mats STERILE
Shim Non-sterile Reusable NA IIa
Broach Non-sterile Reusable NA IIa
Larger extension Non-sterile Reusable NA IIa
K063729 IIa
exempt Is
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: Read the following handl i ng instruct ions before use. Failure to
warranty.
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USER MANUAL
Shim holder Non-sterile Reusable NA I
Tray Non-sterile Reusable NA Not Applicable
1.1.3. Description
This instrumentation is designed for spinal surgery.
Its main purpose is to keep away the flesh of the wound from the working area where the
surgeon will perform a surg ical procedure on t he disk in a lateral, ant erior or posterior
approach.
The retract or comes with a set of blades of vari ous lengths, a set o f dilators and som e
additional instruments like a dilator holder, a nerve monitoring probe, light mats etc.
follow these instructions coul d render the device unusable and void a ny
1.2. Convenience kit content
Refer to the Retractor Kit Cue Card included in the packaging.
1.3. Handling instructions
1.3.1. General
Before the surgery:
- Check that every instrument - including single use ones - mentioned in the cue card is
present.
- Check that no instrument is used or deficient.
If anything is missing or doesn't seem right, call your local agent as soon as possi bl e and
discard the kit.
Be aware that any failure in cleaning, maintenance or usage can lead to an unusable,
corroded, broken instrument that could be dangerous to the patient and the medical staff.
Take required precautions to handle that instrumentation. Small parts can be lost. Some
instruments are sterile (probe and light mat): check the packaging is unharmed. Check the
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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USER MANUAL
expiry dat e on th e ste ril e produ cts. Som e part s ar e sha rp and requ ire t o b e handled with
care in order not to harm the patient and the medical staff.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: Read the own Instruction For Use of the probe before a ny use of
Figure 1
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USER MANUAL
1.3.2. K-wire and K-wire handle
The K-wire and the K-wire handle are reusable products. Be careful, K-wire is very
sharp. Wearing gloves is recommended.
Using the K-wire handle is rec ommended to insert the K-wire. Insert the K-wire in the
handle: (see figure 1). Beware the insertion direction: sharp tip should stay outside
of the K-wire handle. Screw and unscrew the chuck to secure and release the K-wire. K-
wire is used to locate the center of the channel and to guide the dilators (see next c hapter).
1.3.3. Dilators, dilator holder and probe
Dilators and di l ators h ol der a re r eusa bl e. Th e dispo sable p robe is a sterile si ngl e u se
product. Check the expiry date and the packaging before use. Dispose after use.
the product. Titan Spine c an't be re sponsible for any misuse of the
disposable probe. This Instruction for Use is included inside the packaging.
Step 1: Plug the probe to a suitable electrical source via DIN 42802 touch proof connectors.
Insert car efully th e probe i n the sm allest di lator tu be groov e. The d etection ball (l ocated
at the end of th e p rob e) wil l b e exp osed at th e en d o f th e d il at or (se e f i gu re 2). The ball
probe should never stick out from the distal end of the dilator probe. Do not
overstrain nor press too hard while inserting the probe.
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USER MANUAL
Figure 2
Step 2: Use the dilator holder to handle the dilators (see figure 3). Dilator h older can b e
connected to the table clamp to avoid surgeon hand exposure during X-rays.
Figure 3
Step 3: Slide down carefully the smallest dilator containing the probe into the wound.
Step 4: Rem ov e the p r obe from th e di l ator on c e ne rv e m oni tori n g is compl et ed an d sl i de
carefully the largest dilator on top of the smallest dilator. Nerve monitoring can be
performed at this stage using the groove located in the dilator.
Step 5: Once the largest dilator is in position, it will provide the surgeon with the desired
diameter where the retractor blades will fit tightly around it for the inse rtion of the de vice.
Removing advice: First remove the probe, then the dilator. Dispose the probe after use.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
L R C
L
R
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USER MANUAL
1.3.4. Retractor, blades and wrench
The retractor, blades and wrench are reusable devices.
- Choose the blades size using the graduation on the dilators (blades length depending on
the thickness of the patient, on the selected access fo r the surgery or on the surgeon's
needs).
- Fix t he 3 sel ected b lad es on t he ret racto r bo dy: t hey sl ide vert ica lly ei th er from th e top
or from beneath, until a click can be heard:
• Place a right blade (R marked) on the right arm (R marked) (see figure 4)
• Place a left blade (L marked) o n the left arm (L marked)
• Place a central blade (C marked) on the middle arm
- Before inserting the retractor in the wound, check that the retractor is well closed: blades
shall make a closed circle (see fi gure 4). If necessa ry, use the right a nd left screws to
reduce the an gle of the bla des (refer to figure 6 for more deta ils). Then sli de down the
retractor body with its blades in the wound around the largest dilator (see figure 5).
Figure 4
Figure 5
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
c) Knob for central bl a de:
selected blades
b) Knob for tilting the l ateral blades
a) Knob for spreadi ng the lateral blades
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USER MANUAL
- Spreading is obtained via 3 different movements (see figure 6):
• a) Spreading of the lateral blades: Squeezing the handle and screw the knob
to maintain spreading as needed (see figure 7).
• b) Tilting movement of the lateral blades: to enlarge the well on the bottom,
use the screws on the left and right arms: screwing opens angularly the
blades, unscrewing closes the blades (see figure 8).
• c) Lateral movement of the selected blades: Screwing the big black knob will
enlarge the opening, either the central blade will slide posterior or the 2
lateral bl ades will slid e ant erior, dep endi ng on wher e th e ret ractor cla mp i s
fixed to the table (see figure 9).
Lateral movement of the
Figure 6
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
L R C L R
Push buttons to
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USER MANUAL
Figure 7
Figure 8
Figure 9
Tip: The wrench can be used to screw and unscrew every knob of the retracto r.
Removing advice: To remove the blades from the retractor, use the push button on each
arm of the retractor and pull the corresponding blade (see figure 10).
release the blades
Figure 10
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: Read the Instruction For Use of the table clamp before any use of
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USER MANUAL
1.3.5. Table clamp (use for mobile and static position)
The table clamp is a reusable device. It's a flexible arm which is used to fasten the retractor
to the surgery table.
the product. Titan Spine can't be responsible for any misuse of the table clamp.
This Instruction for Use is included inside the packaging.
- To fix the flexible arm to the surgery table, refer to the specific Instruction For Use of the
table clamp.
Use knob 1 to fasten the table clamp base to the surgical table rail (See figure 11).
Use knob 2 to set the height of the arm.
Use knob 3 to lock the three articulations.
Use knob 4 to fasten the retractor with the arm.
Figure 11
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
Figure 12
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USER MANUAL
- Use the black connector to fix the table clamp to the retractor (see figure 12). To fix the
retractor on the table clamp, depending on the surgeon choice, there are 2 different
options:
• Central blade is mobile & lateral blades are fixed: Use th e steel lock to
lock the retractor body and lateral blades. Only the central blade will slide
forwards and backwards when screwing and unscrewing the black knob.
• Central blade is fixed and lateral blades are mobile: Use the black lock to
immobili ze the central arm. Screw ing an d unscrewin g the black knob will sl ide
the lateral blades (and the retractor body) forwards or backwards.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: R ead the Instruct ion For Use of the l ight mats and the e xtension
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USER MANUAL
1.3.6. Disposable light mats and extension cords
The light mats are sterile single use products. Check the expiry date and the
packaging before use. Dispose after use. The extension cords are reusable.
The light mat and its optic fiber cable are employed to light up the bottom of the wound.
cords before any use of the pro duct. Titan Spine can't be responsible for any
misuse of the light mats or the extension cords. Those Instructions for Use are
included inside the packaging.
- Plug the extension cord to the light mat.
- Plug the ex tens ion cord to a suitable light so urce , following t he instruct ions fo r use of the
light mats.
- Sli de carefu lly t he mat through the dedicated slot inside the blade until the appropriate
depth (see figure 13).
Removing advice: To remove the disposable light mat, slide carefully the light mat out
of the blade. Dispose after use.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: Read the Instruction For Use of the dual light cable before any us e
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USER MANUAL
Figure 13
1.3.7. Light cable and light holder
The light cable and the light holder are reusable.
The light cable helps to light up the wound.
of the product. Titan Spine can't be responsible for any misuse of the dual light
cable. This Instruction for Use is included inside the packaging.
- These lights are inserted into the light holder.
- The light holders are placed in their corresponding holes:
• Spot 1: on the retractor body (see figure 14)
• Spot 2: on the optional 4th blade support (see figure 15) (In that case, the 4th
blade support uses the same holes as the light cables (spot 1): both plastic
connectors of the 4th blade support are inserted i n t he ret ract or bod y as sh ow n i n
the chapter 1.3.9 Optional 4th blade and its support
)
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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USER MANUAL
Figure 14
- Adjust the position of the lightning system by orienting the light support to the suitable
direction.
- After sev e ra l uses, the l ight holder ca n lose its fitti n g. U se a co mm on f lat screwdriver to
give back to the light holder its appropriate f itting .
Figure 15
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1.3.8. Shim, broach and shim/broach holder
Shim, broach and shim/broach holder are reusable products.
- Clip the shim (or broach) lug in the shim/broach holder dedicated claw on the top end of
the holder (see picture 16). The laser marking on the shim (or broa ch) provides you with
the correct orientation.
- Make sure t h e lug is well tightened by t h e h old er c law (see fig u re 1 7 ) before locking the
shim (or broach) by pushing the firing pin (with the thumb) (see picture 18).
Figure 16
Figure 17
Figure 18
- Insert the shim (or broach) i nto the blade dedicated slot until the suitable depth (see
figures 19 & 20).
- Release the shim (or broach) by pushing the trigger (with the forefinger).
Figure 19
Figure 20
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1.3.9. Optional blade extension
The blade extension is reusable.
- Handling of the blade extension (see fi gure 2 4) is si mila r as the sh im/ broach pro cedure
(see precedent chapter 1.3.8 Shim, broach and shim/broach holder
extension lug in the shim/broach holder dedicated claw on the top end of the holder (see
picture 16).
- Make sure t h e lug is well tightened by t h e h old er c law (see fig u re 1 7 ) before locki n g t h e
blade extension by pushing the firing pin (with the thumb) (see picture 18).
Figure 21
). Clip the blade
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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- Insert the blade extension into the blade dedicated slot until the suitable depth (see figure
25).
Figure 22
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1.3.10. Optional 4th blade and its support
The 4th blade and its support are reusable.
- Clip of the 4
the same spots used to plug the light cables in chapter 1.3. 7 L ig h t c a b le a n d light hold e r
th
blade support connectors t o the retract or spot s (see figu re 21) (they are
).
Figure 23
- Select the suitable 4th blade (de pending on the required length and width). I nsert the 4th
blade in the dedicated groove inside the support. At this point the 4th blade is still mob ile:
it can be moved up and down (through the groove support) or laterally (support is
sliding), even angularly (see figure 22).
- Lock the height and the latera l position of the 4
(see figure 23).
Figure 24
th
blade screwing the knob with the wrench
Figure 25
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
Cover
Retractor Tray
Blade Tray
Base
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USER MANUAL
1.3.11. Container
The container is composed of 1 base, 2 trays and 1 cover. It is reusable.
- Each component has its own place: use the silk-screening image to store correctly the
instruments inside the container.
- The first tray to be inserted is the blade tray. The last one is the retractor tray. They are
not swappable (see figure 18).
- The handles of the retractor tray are retractable.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Figure 26
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Instructions for Cleaning, Sterilization and Maintenance
2. Instructions for Cleaning, Sterilization and Maintenance
2.1.
Recommendations for the handling of these surgical instruments are as follows:
- Do not let blood or tissue dry on the instrument.
- Rinse the instrument immediately after use and before decontamination.
- As much as possible, manipulate instruments made from different metals
- Check the functionality and cleanliness of each instrument before use.
- Time dwell between use and cleaning of the devices should be minimal.
- Devices should be carried into wet wraps from the surgery room to the cleaning
- Some de vices s hould be disass embled prior to cleaning , some should b e handle d
2.1.1. Disassembling of the retractor
- Hold the tips away from eac h o ther screwing the later al nut and turn the black k nob unt il
Handling prior to cleaning
separately.
room.
specifically prior to cleaning, as described below.
the central arm is totally out.
- Both handles hav e to be removed from the retrac tor body. Push the left and right butto ns
to release both handles (see figure 27).
Figure 27
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Instructions for Cleaning, Sterilization and Maintenance
- With the retractor body in its opened position (see figure 28), remove the screws on the
bottom side of the retractor body: the central screw will release the central arm (see figure
29), left and right screws release left and right arms (see figure 30).
BEWARE NOT TO LOSE ANY PART (SCREWS, SPRINGS, ETC)
THIS DISASSEMBLING IS NOT RECOMMENDED
FOR MEDICAL HEALTHCARE FACILITIES
Figure 28
Figure 30
Figure 29
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Instructions for Cleaning, Sterilization and Maintenance
2.1.2. Shim/broach holder disassembling
Disassemble the shim/broach holder for cleaning: take off the pin (see figure 31), then
pull the firing pin and hold up the rod (see figure 32).
Figure 31
Figure 32
2.1.3. 4th blade support special handling care
The support must be completely opened (maximum wingspan) to maximize the access
for cleaning. Screw must be totally loosened.
Figure 33
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Instructions for Cleaning, Sterilization and Maintenance
2.1.4. Dilators holder special handling care
Open the holder to its maximum to let appear the cog (see figure 34).
Figure 34
2.1.5. Table clamp base special handling care
The thumb screw, which fastens the tube to the base (see figure 35), has to be loosened
to free up the washer to allow for a more efficient cleaning and sterilization.
Figure 35
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
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Instructions for Cleaning, Sterilization and Maintenance
2.2. Cleaning – decontamination
Regarding the extension cords, the light cables and the table clamp, refer to the
corresponding Instruction For Use (IFU).
2.2.1. Preparation for cleaning
Disassemble any device that can be disassembled before cleaning. Open devices when
possible. See instructions provided to that intend in the precedent chapter.
Cleaning agents must be prepared as recommended by manufa cturer.
Do not use fixation agents or hot water (>40°C).
2.2.2. Manual Cleaning
Completel y sub merg e t he d evi ce in an enzyme solution (Aniosyme DD1, 0.5%) and allow
to soak for 10 minutes at room temperature (20-25°C) with ultrasonic vibrations.
Use a soft bristled, nylon brush to gently scrub the device for 5 minutes at room
temperature (20-25°C) and until all visible soil has been removed. Do not use metallic
brush.
Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas.
Thoroughly flush lumens, holes and other hard-to-clean areas wi th the enzyme sol ution
(Aniosyme DD1, 0.5%), at room temperature (20-25°C).
Rinse devi ce in running wa ter for at least 1 minute. Thoroughly flush lumens, holes and
other hard-to-clean areas.
Repeat the ri nse step twice (to ach ieve 3 rinsing). The 3
water.
Visually inspect the device for remaining soil and repeat the steps above if necessary.
Remove exce ss moisture f rom the i nstrument wi th a clean, absorbent a nd non-shedding
wipe or using compressed air.
rd
rinsing should be in purified
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
HAMO ECOLINE LM-25
Pre-cleaning
<45°C 2 minutes
Cleaning
55°C 5 minutes
Neutralization
2 minutes
Rinsing
Tap water
Thermal
90°C 5 minutes
Drying
22 minutes
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Instructions for Cleaning, Sterilization and Maintenance
2.2.3. Automatic Cleaning
Completel y sub merg e t he d evi ce in an enzyme solution (Aniosyme DD1, 0.5%) and allow
to soak for 5 minutes at room temperature (20-25°C) with ultras onic vibrations.
Use a soft bristled, nylon brush to gently scrub the device for 2 minutes at room
temperature (20-25°C) and until all visible soil has been removed. Do not use metallic
brush.
Particular attention must be given to crevices, lumens, mated surfaces,
connectors and other hard-to-clean areas.
Thoroughly flush lumens, holes and other hard-to-clean areas wi th the enzyme sol ution
(Aniosyme DD1, 0.5%).
Rinse devi ce in purifi ed water for at least 1 min ute. Thoroughly flush lumens, holes and
other hard-to-clean areas.
Place the devices in a suitable washer/disinfector basket and process through a standard
washer/disinfector cleaning cycle.
Visually inspect the device for remaining soil and repeat the steps above if necessary.
Example of Vario TD cleaning cycle:
Cycle Vario TD liq ui d e
NEODISHER FLA
Disinfection
2 minutes cold water
Demineralized water
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
Pre-Vacuum Steam Sterilization
Gravity Steam Sterilization
Sterilization Temperature: 132° C
Sterilization Temperature: 135° C
Dry Time: 30 minutes
Dry Time: 30 minutes
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Instructions for Cleaning, Sterilization and Maintenance
DO NOT CLEAN THE SINGLE-USE PRODUCTS.
2.3. Sterilization
Please refer to chapter 2.1.5.Table clamp base special handling c are to free up
the washer of the table clamp base before sterilization.
Regarding the extension cords, the light cables and the table clamp, refer to the
corresponding Instruction For Use (IFU).
Surgical Instruments are supplied non-sterile. Prior t o use, ru n foll owing val idat ed steam
sterilization cycle:
Full cycle:
Sterilization Exposure Time: 4 minutes
DO NOT STERILIZE THE SINGLE-USE PRODUCTS.
Sterilization Exposure Time: 10 minutes
Full Cycle:
2.4. Storage
The devices have to b e stor ed i n dry conditions: area shall be v entilated, safe from dust,
humidity, insects and others pests, any other potentials contamination sources. No
extreme temperature and humidity rate are allowed.
The user have to prevent any mix up, damage, deterioration, contamination, or another
adverse effects to the products during the handling and the storage.
Regarding the probe, the light mats, the extension cords, the light cables and the table
clamp, refer t o the correspondin g Instruction For Use (IFU) . Be aware that the storage
dwell time of sterile products is limited by the sterilization expiry date.
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7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
WARNING: DO NOT lubricate any part which will be in contact with the
2 threads
3 guillotines
1 slide
Joint
Figure 37
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Instructions for Cleaning, Sterilization and Maintenance
2.5. Maintenance
- Use surgery lubricant before each use. Apply only where it is recommended in the
following pic tures (red circles).
patient.
2.5.1. Retractor
Figure 36
2.5.2. Table clamp connector
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Figure 38
Thread
Trigger
Figure 39
Firing pin
2 pins
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Instructions for Cleaning, Sterilization and Maintenance
2.5.3. 4th blade support
2.5.4. Shim holder
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Instructions for Cleaning, Sterilization and Maintenance
2.6. Complaints
Any Health Care Professional who has any complaint or who has experienced any
dissatisfaction in the quality, identity, reliability, safety, effectiveness and/or performance
of surgical instruments should notify Titan Spine.
Titan Spine must be notified immediatel y by te lephon e, fax o r wri tten corr espond ence of
any serious acci dent or if there has been a ri sk of a serious accident wh ich may or has
caused the death or serious det erioration in health of a pati ent or user. When filling a
complaint, please provide the name(s), serial numbers(s), number(s) of the lot of the
component(s) in question, the name and address of the perso n making the complaint, the
nature of the complaint with as many details as possible and notification of whether an
answer is requested.
2.7. Contact
Titan Spine
6140 W. Executive Drive, Suite A
Mequon, WI 53092
USA
: 866.822.7800
: 262.242.7802
www.titanspine.com
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CONTROLLED
Instructions for Cleaning, Sterilization and Maintenance
3. Chart of medical device symbols used
Manufacturer
Date of manufacture (YYYYMM or YYYY)
Caution, consult accompanying documents
Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner
Keep product dry
Batch code / lot number
Consult Instructions for Use
CE mark
Non sterile
32
7100-0005 ENDOSKELETON TL Retractor (TLR) – Instructions for Use Rev: 02
CONTROLLED
Instructions for Cleaning, Sterilization and Maintenance
Catalog, reorder or reference number
Do not use if package is damaged
Sterile EO
Single use only
Expiry date
Latex free
33
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