BBraun
activO frame system
320 Pages
Preview
Page 1
A B
G
C
H
J
D
E
F
K
I
B J A E
F
C B D
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1 D 15°
90°
1
3
1 3 1 K 2 click
4
5 2-3
1
1
click
6
2-3
click
G
4
G
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Aesculap® activO frame system activO frame Aesculap system®
Legend A B C D E F G H I J K
Connecting piece with quick-release coupling Coupling bar Coupling piece short Radiolucent valve Fixation screws Screwdriver for fixation screws Fastening clamp T-wrench OP field illumination bar UNITRAC universal holder Forceps for changing the blades
Symbols on product and packages Sterilization using irradiation Not for reuse in intended applications as defined by the manufacturer Use by
Caution, general warning symbol Caution, see documentation supplied with the product
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Applicable to ► For item-specific instructions for use and informa-
tion on material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com
Intended use The Aesculap activO frame system is used to keep free a ventral or ventrolateral approach to the spine. With this system, valves can be placed at any position on the ring and fastened on the spine, using fixation screws. Illumination and optics elements can be adapted, too. The frame can be fastened to the operating table (see instructions for use TA011611 or TA009150 respectively). In the latter configuration, fixation with fixation screws on the spine is not required.
Available sizes
Safe handling and preparation
Art. no.
Designation
BV399R
Forceps for changing the blades
CAUTION Federal law restricts this device to sale by, or on order of a physician!
BV858R
Connecting piece with quick-release coupling
BV859R
Coupling piece short
BV860R
Coupling bar 150 mm
BV861R
Coupling bar 200 mm
BV862P
Radiolucent valve: Size S-green
BV863P
Radiolucent valve: Size S-yellow
BV864P
Radiolucent valve: Size L-blue
BV865SU
Fixation screw: Size S-green
BV866SU
Fixation screw: Size M-yellow
BV867SU
Fixation screw: Size L-blue
BV868R
Screwdriver for fixation screws
BV869R
Fastening clamp
BV899R
T-wrench
OP803
OP field illumination bar 100 mm
Note Use of the activO frame system requires precise knowledge about the biomechanical situation at the spine. ► Ensure that the product and its accessories are
operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► Do not use products that are in open or damaged sterile packaging. ► Do not use the product after its use-by date. The products BV865SU, BV866SU and BV867SU are sterilized by radiation and are supplied in sterile packaging. The product must not be reused. ► Do not re-sterilize the product.
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Aesculap® activO frame system Safe operation Mounting the radiolucent valves
WARNING
WARNING
CAUTION
Injuries to nerve roots and spinal cord due to mismatch between fixation screw and valve sizes! ► Use the color-coded fixation screws matching the color of the valve. ► Screw in the fixation screw under X-ray monitoring. Injury to soft tissue parts or vessels, caused by fixation screws! ► Position the valve without a fixation screw. Only when the valve is correctly positioned, insert and tighten the fixation screw.
CAUTION
Breakage, deformation or loosening of the fixation screw due to manipulating the valve after insertion of the fixation screw, resulting in complication or prevention of fixation screw removal from the valve! ► Place the valve in the correct position before inserting the fixation screw. ► When using a valve with a fixation screw: Affix the valve to the associated frame using the coupling bar. Valve breakage! ► Avoid knocks on the valve or on components connected to the valve. ► Do not impel the fixation screws with a mallet under any circumstances.
► Select a valve D of appropriate length (S, M or L) for
the patients. ► Valve D can be fixed to the vertebral body with a
fitting fixation screw E. Be careful to use a valve and screw of the same size (see color code). ► Apply screwdriver F on the hexagon head of fixation screw E.
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► Insert and tighten fixation screw E in valve D, see
Adapting the coupling bars
Fig. 1.
WARNING
E
F
Damage to soft tissue parts! Loss of approach due to incorrect tightening or mounting of the coupling bars! ► Tighten the nut of the coupling bar, then verify that the angular position cannot be moved anymore. ► Always engage the valve coupling until it clicks.
► Depending on application, mount coupling piece C
or coupling bar B on radiolucent valve D. Note Optionally, coupling bars B can be mounted at an offset angle of 90°.
D ► If necessary mount universal holder J on the
respective coupling. ► To extent the construct, install connecting piece
with quick-release coupling A on the respective coupling, see Fig. 2.
B
J Fig. 1
A C
Loosening the fixation screw
B D
► Apply screwdriver F on fixation screw E and
unscrew counterclockwise. ► Remove screwdriver F with fixation screw E from the operating field. Note The fixation screw E is fixed on the screwdriver F.
Fig. 2
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Aesculap® activO frame system Adjusting the inclination angle of the coupling bars Note Coupling bars B can be adjusted to an inclination of between 15° upwards and 90° downwards.
Releasing the quick-release coupling ► Grip the quick-release coupling 1 of the connect-
ing piece A or the UNITRAC universal holder J on the handle part and pull backwards, see Fig. 4.
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► To loosen the coupling lock, apply T-wrench H on
hexagon 1 and untighten counterclockwise. ► Move T-wrench H to the required angle and
tighten hexagon 1 turning the tool clockwise, see Fig. 3. Coupling bar B is locked again.
click
1 Fig. 4 Note Optionally, optics holder RT081R can be fixed to UNITRAC universal holder J and connecting piece with quick-release coupling A.
15°
► Fasten connecting piece with quick-release cou-
90°
Fig. 3
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pling A on the frame, using fastening clamp G, and install optics holder RT081R (see instructions for use TA009907).
Uncoupling the radiolucent valve Note Radiolucent valve D can be uncoupled in two different ways. ► Grasp the coupling and press with the thumb on
pin 1 of valve D. - or ► Push forceps K with the jaw side 2 under the coupling and use the forceps bolt 3 to push them onto the pins 1 of the valve D, see Fig. 5.
Mounting the fastening clamp on the frame
WARNING
3 CAUTION
1 K 2
Loss of approach due to incorrect mounting and closing of the fastening clamp! ► Firmly tighten the fastening nut. ► Always engage the coupling bars and the frame until they click. Loss of the fastening nut and the upper clamping element caused by complete removal of the fastening nut! ► Only loosen the fastening nut by 2–3 turns.
► Loosen fastening nut 1 by 2–3 counterclockwise
turns. ► Click the fasting clip G into the desired position
Fig. 5
onto the frame 4 (BV814R/BV815R), see Fig. 6. Fastening clamp G is fixed on frame 4.
2-3 1
click
G
4
Fig. 6
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Aesculap® activO frame system ► Click the coupling bar B or connecting piece with
the quick-release coupling A into the jaw piece of the fasting clamp G and place it in the desired position, see Fig. 7.
Dismounting the fastening clamp from the frame ► Loosen fastening nut 1 by 2–3 counterclockwise
turns, using T-wrench H if necessary. ► Unclick coupling bar B or connecting piece with
2-3 1
quick-release coupling A from the jaw part of fastening clamp G. ► Slide off fastening clamp G from the frame by applying lateral pressure on the clamp, see Fig. 9.
click
G
Fig. 7 ► Tighten fastening nut1 until the clamp is fully
G
closed. If necessary tighten further with T-wrench H, see Fig. 8.
Fig. 9
H
Fig. 8 8
Mounting the OP field illumination bar
WARNING
Burns from the hot end of optical fiber! ► When using the product with a light source, make certain that the end of the optical cable does not touch human tissue or highly inflammable materials. Keep a distance of at least 10 mm. ► Only use light sources of a power rating of up to 180 W.
► Affix the surgical lighting rod I directly with the
fastening clip G or, using the bracket BV020R and the bracket for OP surgical lighting FG410R affix onto the coupling bars A, B or C. The OP field illumination bar has three different light cable connectors, see Fig. 10. ► Unscrew connectors that are not required.
ACMI
Disassembling/Assembling the fastening clamp Disassembling ► Remove fastening nut1 from threaded pin 3 by
turning it counterclockwise. ► Remove jaw part 2, see Fig. 11.
1
2
3
Wolf
Aesculap Olympus Storz
Fig. 11
Assembling ► Put jaw part 2 with its hole over threaded pin 3.
Fig. 10
► Screw on fastening nut1 clockwise, with the hexa-
gon facing upwards.
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Aesculap® activO frame system Validated reprocessing procedure
Single-use products
General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com. The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
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WARNING
Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!
Note Products for single use are BV865SU, BV866SU and BV867SU.
General information Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as
described in the instructions for use (BV869R).
Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably
Cleaning/disinfection Product-specific safety notes on the reprocessing procedure
DANGER
CAUTION
Risk to patients! ► FG410R and BV020R should only be cleaned mechanically! Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for use, for example, on aluminum, plastic materials, and high-grade steel, ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 55 °C.
with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning ► Disassemble the product prior to cleaning.
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Aesculap® activO frame system ► Use suitable cleaning/disinfecting agents if the
product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
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Validated cleaning and disinfection procedure Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection ■ BV399R, BV842R, BV859R, BV862P– BV864P, BV868R, BV869R, BV899R, BV901R–BV904R, FK166R, OP803, RT069R, RT092R
■ Suitable cleaning brush:,
Chapter Manual cleaning/disinfection and sub-chapter: ■ Chapter Manual cleaning with immersion disinfection
e.g. TA011944
■ 20 ml disposable syringe ■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection ■ BV814R, BV815R, BV843R, BV858R, BV860R, BV861R, RT073R, RT081R
■ Suitable cleaning brush:, e.g. TA011944
■ 20 ml disposable syringe ■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
Chapter Manual cleaning/disinfection and sub-chapter: ■ Chapter Manual cleaning with ultrasound and immersion disinfection
■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection ■ BV399R, BV859R, BV901R–BV904R, FK166R, OP803
■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Place products in the tray with their hinges open.
Chapter Mechanical cleaning/disinfecting and sub-chapter: ■ Chapter Mechanical alkaline cleaning and thermal disinfecting
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Aesculap® activO frame system
Validated procedure
Specific requirements
Reference
Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ■ BV842R, BV862P–BV864P, BV868R, BV869R, BV899R, RT069R
■ Suitable cleaning brush:,
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter: ■ Chapter Manual pre-cleaning with a brush
e.g. TA011944
■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
■ Place products in the tray with their hinges open. Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection ■ RT092R
■ Suitable cleaning brush:, e.g. TA011944
■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter: ■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting
■ Place products in the tray with their hinges open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection ■ BV020R, BV814R, BV815R, BV843R, BV858R, BV860R, BV861R, FG410R, RT073R, RT081R
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■ Suitable cleaning brush:, e.g. TA011944
■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Place products in the tray with their hinges open.
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter: ■ Chapter Manual pre-cleaning with ultrasound and brush
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfecting cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed
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Aesculap® activO frame system ► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfec-
tant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.
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Phase III ► Fully immerse the product in the disinfectant solu-
tion. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of
the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible
surfaces). ► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable
syringe at least five times. ► Drain any remaining water fully.
Phase V ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
Manual cleaning with ultrasound and immersion disinfection Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed
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Aesculap® activO frame system ► Note the information on appropriate cleaning
brushes and disposable syringes, see Validated cleaning and disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath
(frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Drain any remaining water fully.
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Phase III ► Fully immerse the product in the disinfectant solu-
tion. ► Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of
the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible
surfaces) under running water. ► Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable
syringe at least five times. ► Drain any remaining water fully.
Phase V ► Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.