Braun Aesculap activ L Manual

Aesculap®activ L
Aesculap Spine
Instructions for use/Technical description
activ L revision instruments and distraction forceps
Instructions for use/Technical description
activ L revision instruments and distraction forceps
Note for U.S. users
This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use
for United States users can be obtained by visiting our website at www.aesculapImplantsystems.com and
clicking the "Products" menu. If you wish to obtain a paper copy of the Instructions for Use, you may
request one by contacting your local Aesculap representative or Aesculap's customer service at
1-866-229-3002. A paper copy will be provided to you upon request at no additional cost.
Gebrauchsanweisung/Technische Beschreibung
activ L-Revisionsinstrumente und -Spreizzangen
Mode d’emploi/Description technique
Instruments de révision et pinces d’écartement activ L
Instrucciones de manejo/Descripción técnica
Instrumentos y tenazas de revisión activ L
Istruzioni per l’uso/Descrizione tecnica
Strumenti di revisione e pinze divaricatrici activ L
Instruções de utilização/Descrição técnica
Instrumento de revisão e tenaz activ L
Gebruiksaanwijzing/Technische beschrijving
activ L-revisie-instrumenten en -spreidtangen
Bruksanvisning/Teknisk beskrivning
activ L-revisionsinstrument och -spridartänger
Инструкция по примению/Техническое описание
Инструменты для проведения ревизии и дистракционные щипцы activ L
Návod k použití/Technický popis
Revizní nástroje a distrakční kleště activ L
Instrukcja użytkowania/Opis techniczny
Przyrządy rewizyjne i kleszczyki rozszerzające activ L
Technical alterations reserved
Revízne nástroje a rozťahovacie kliešte activ L
Kullanım Kılavuzu/Teknik açiklama
activ L revizyon ekipmanları ve distraksiyon penseleri
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone [phone] | Fax [phone] | www.aesculap.com
Aesculap – a B. Braun company
TA-Nr. 011904 04/14 V6 Änd.-Nr. 49358
- DIR 93/42/EEC
Technical alterations reserved
A
FW960R
FW966R
FW967R
FW968R
FW998R
FW965R
C
D
EF
B
1
34
56
7
10
11
8
2
8
3
6
7
FW968R
FW965R
FW966R/
FW967R
FW998R FW579R
10/11
912
11109
14
10
12
13
6
15
8
9
12
4
1
23
5

Aesculap®activ L
activ L revision instruments and distraction forceps
Legend
Aactiv L angled distraction forceps FW960R
Bactiv L angled revision distraction forceps FW965R
Cactiv L revision instrument for endplates FW966R; size S/M
Dactiv L revision instrument for endplates FW967R; size L/XL
Eactiv L revision instrument for PE inlay FW968R
Factiv L handle for revision instrument FW998R
1Handle parts
2Lock
3Locking lever
4Working tip
5Pins
6Jaw piece
7Endplates
8Adjustment knob
9Anchoring rods
10 Hook
11 Recesses
12 Lock nut
13 Pins
14 Slots
15 Tubular shaft
Symbols on product and packages
Applicable to
►For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The activ L revision instruments and distraction forceps are used for the distraction/mobilization of two adjacent
lumbar vertebral bodies or prostheses plates, as well as for the repositioning and revision of activ L intervertebral
disk prostheses.
activ L angled distraction forceps FW960R
The activ L angled distraction forceps is used for the distraction/mobilization of two adjacent vertebral bodies.
activ L angled revision distraction forceps FW965R
The activ L angled revision distraction forceps is used for distracting the two activ L metal plates of an implanted
activ L prosthesis in order to remove the PE inlay in corrective surgery.
activ L revision instrument for endplates FW966R/FW967 and handle FW998R
The activ L revision instrument for endplates and the corresponding handle are used for the repositioning and revi-
sion of activ L intervertebral disk prostheses.
activ L revision instrument for PE inlay FW968R
The activ L revision instrument for PE inlay is used for the revision of the activ L PE inlay.
Safe handling and preparation
Use of the activ L revision instruments and distraction forceps requires precise knowledge about spine surgery and
the stabilization and biomechanical situation at the spine.
Surgical application of the activ L revision instruments and distraction forceps is described in detail in the associated
operating manual.
►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.
Safe operation
Distracting/mobilizing vertebral bodies with the activ L angled distraction
forceps FW960R
Note
Mobilization of the intervertebral disk space is a critical process and should be performed under X-ray control.
Note
The intervertebral space distraction is often wedge-shaped. Sufficient load relief in the posterior intervertebral disk
space is required so that parallel distraction can be performed over the entire intervertebral space.
►Insert the working end 4into the intervertebral space, see Fig. 2. When doing so, ensure that the instrument is
pushed as dorsally as possible into the intervertebral disk space.
►Distract/mobilize the distraction forceps FW960R by pressing the handle parts 1together as required.
Note
Lock 2engages automatically when handle parts 1are released.
Removing the activ L angled distraction forceps FW960R
►Gently press the handle parts 1together and actuate locking lever 3, see Fig. 1.
This releases the lock 2of the distraction forceps FW960R.
Applying the activ L angled revision distraction forceps FW965R
►Insert pins 5of the distraction forceps FW965R into the holes on the right-hand side of the implant, see Fig. 4.
►Distract the distraction forceps FW965R by pressing the handle parts 1together as required.
Note
Lock 2engages automatically when handle parts 1are released.
Removing the activ L angled revision distraction forceps FW965R
►Gently press the handle parts 1together and actuate locking lever 3, see Fig. 3.
This releases the lock 2of the distraction forceps FW965R.
Removing the PE inlay with activ L revision instrument for PE inlay FW968R from
the intervertebral disk prosthesis
►Insert the jaw part 6of the revision instrument FW968R between the two endplates 7of the intervertebral disk
prosthesis, see Fig. 5. Ensure the following:
– The orientation of the revision instrument FW968R in the caudal direction corresponds with the “caudal”
marking on the revision instrument.
– The edges of the jaw part 6are pointing in the direction of the inferior endplates.
►Push the revision instrument along the lower endplate, until the jaw part 6engages on the PE inlay.
►Turn the adjustment knob 8clockwise to fix the PE inlay in place on jaw part 6, see Fig. 6.
►Lift the revision instrument FW968R with fixated PE inlay over the edge of the inferior endplate and remove from
the endplate by pulling in the anterior direction.
►To remove the PE inlay from the revision instrument FW968R:
– Rotate the adjustment knob 8in a counterclockwise direction.
– Pull the PE inlay from the jaw part 6.
Reposition/remove endplates with activ L revision instrument for endplates
FW966R/FW967R
►Screw handle FW998R onto handpiece of revision instrument FW966R/FW967R, see Fig. 7.
Note
The pins 13 on the screw connection of the anchoring rods of the revision instrument will point in the same direction
as the corresponding hooks on the front part.
Note
In case of an incomplete revision of the implant, the endplates are removed one after another. The slotted hammer is
also used for the revision procedure.
Note
The endplates can grow into and adhere strongly to the vertebral bodies. This can considerably complicate the revision
procedure. If the revision is of a prosthesis implanted a number of years ago, the endplates may need to be removed
from the intervertebral body with a chisel or elevator prior to using the revision instrument.
►Turn the anchoring rods 9so that both hooks 10 are pointing outwards, see Fig. 8.
►Push the revision instrument FW966R/FW967R between the endplates. When doing so, ensure that the hooks
reach over the posterior edges of the plates.
►Turn both anchoring rods 990° in the direction of the plate to be removed.
►Pull back the anchoring rods 9. When doing so, ensure that the anchoring rods engage securely in the
recesses 11 on the posterior side of the plate, see Fig. 9.
►Fix the anchoring rods 9in place by turning the lock nut 12 counterclockwise. When doing so, hold the anchoring
rods so that they cannot turn anymore.
►Carefully reposition or withdraw the plate.
►To remove the endplate completely, hit it out with the slotted hammer FW579R.
Caution, general warning symbol
Caution, see documentation supplied with the product
WARNING
Risk of injury and/or malfunction!
►Always carry out a function check prior to using the product.
DANGER
Risk of fracture of the vertebral body endplates and/or injury to surrounding
structures due to overdistraction!
►Apply proper care when distracting.
►Avoid excessive distraction.
CAUTION
Damage to the product caused by actuation of the locking lever!
►To release lock 2, gently press the handle parts 1 together and actuate locking
lever 3.
DANGER
Injury to surrounding blood vessels and soft tissue!
Damage to the product or to the activ L disk prosthesis!
►To protect the blood vessels, always use a retractor in conjunction with this
product.
►Always insert the product into the two holes at the right-hand side of the
prosthesis.
CAUTION
Damage to the product caused by actuation of the locking lever!
►To release the lock, gently press the handle parts together and actuate locking
lever 3.
DANGER
Risk of injury to nerves and surrounding structures due to uncontrolled posterior
pressure of the hooks of the anchoring rods!
►Apply proper care when manipulating the anchoring rods.
►Do not apply excessive pressure.

►Undo the lock nut 12 by turning it clockwise.
►Turn the anchoring rods 990° in the anterior direction and remove the endplate.
►If applicable, remove other endplates in the same way.
Disassembly
activ L revision instrument for endplates FW966R/FW967R
►Unscrew handle FW998R of revision instrument FW966R/FW967R.
►Turn the anchoring rods 9so that the hooks 10 are positioned in the direction of the slots 14.
►Slide the anchoring rods 9behind the handpiece until the hooks 10 are positioned on the middle section of the
revision instrument FW966R/FW967R. When doing so, slide the hooks 10 through the slots 14, see Fig. 10.
►Turn the lock nuts 12 counterclockwise until they are fully undone.
►Slide the lock nuts 12 along the anchoring rods behind the handpiece.
activ L revision instrument for PE inlay FW968R
►Turn the adjustment knob 8counterclockwise and gently pull on the jaw part 6until the jaw part comes out, see
Fig. 11.
Assembly
activ L revision instrument for endplates FW966R/FW967R
►Slide the lock nuts 12 along the anchoring rods 9as far as the threaded rods, see Fig. 10.
►Turn the lock nuts 12 clockwise onto the threaded rods.
►Turn the anchoring rods 9so that the hooks 10 are positioned in the direction of the slots 14.
►Slide the hooks 10 through the slots 14.
activ L revision instrument for PE inlay FW968R
►Insert the jaw part 6into the tubular shaft 15 of the revision instrument FW968R until it engages, see Fig. 11.
When doing so, ensure that the “caudal” marking on the tubular shaft is aligned with the edge of the jaw part 6.
►Push the jaw part 6in the direction of the adjustment knob 8and turn the adjustment knob clockwise until the
jaw part is positioned just in front of the tubular shaft. When doing so, ensure that the jaw part is not compressed
by the tubular shaft.
Validated reprocessing procedure
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 oper-
ator/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 the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
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 temper-
atures >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. Fail-
ure 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 applica-
tion/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
►Open up instruments with hinges.
Preparations at the place of use
►If applicable, rinse non-visible surfaces preferably 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.
Preparations before cleaning
FW966R, FW967R, FW968R:
►Disassemble the product prior to cleaning, see Disassembly.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion 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/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/
disinfection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
►Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
Validated cleaning and disinfection procedure
Manual cleaning/disinfection
►Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►After manual cleaning/disinfection, check visible surfaces visually for residues.
►Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics,
and high-grade steel, according to the manufacturer’s instructions.
►Observe specifications regarding concentration, temperature and exposure
time.
►Do not exceed the maximum permitted cleaning temperature of 60 °C.
Validated procedure Specific requirements Reference
Manual cleaning with
immersion disinfection
■FW960R
■FW965R
■FW968R
■FW998R
■Cleaning brush: TA011944
■20 ml disposable syringe
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges,
ensure that these are in an open position and, if appli-
cable, move the hinge while cleaning.
■Drying phase: Use lint-free cloth or medical com-
pressed air
Chapter Manual clean-
ing/disinfection and
subchapter:
■Chapter Manual
cleaning with
immersion disinfec-
tion
Manual cleaning with
ultrasound and immer-
sion disinfection
■FW966R
■FW967R
■Cleaning brush: TA011944
■20 ml disposable syringe
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges,
ensure that these are in an open position and, if appli-
cable, move the joint while cleaning.
■Drying phase: Use a lint-free cloth or medical com-
pressed air
Chapter Manual clean-
ing/disinfection and
sub-chapter:
■Chapter Manual
cleaning with ultra-
sound and immer-
sion disinfection
Manual pre-cleaning
with brush and subse-
quent mechanical
alkaline cleaning and
thermal disinfection
■FW960R
■FW965R
■FW968R
■FW998R
■Cleaning brush: TA011944
■20 ml disposable syringe
■Place the instrument in a tray that is suitable for clean-
ing (avoiding rinsing blind spots).
■Keep working ends open for cleaning.
■Place instruments in the tray with their hinges open.
Chapter Mechanical
cleaning/disinfection
with manual pre-
cleaning and sub-
chapter:
■Chapter Manual
pre-cleaning with a
brush
■Chapter Mechani-
cal alkaline clean-
ing and thermal
disinfecting
Manual pre-cleaning
with ultrasound and
brush, and subsequent
mechanical alkaline
cleaning and thermal
disinfection
■FW966R
■FW967R
■Cleaning brush: TA011944
■20 ml disposable syringe
■Place the instrument in a tray that is suitable for clean-
ing (avoiding rinsing blind spots).
■Keep working ends open for cleaning.
■Place instruments in the tray with their hinges open.
Chapter Mechanical
cleaning/disinfection
with manual pre-
cleaning and subchap-
ter:
■Chapter Manual
pre-cleaning with
ultrasound and
brush
■Chapter Mechani-
cal alkaline clean-
ing and thermal
disinfecting
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 - - - -

►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►Fully immerse the product in the cleaning/disinfectant 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.
Phase III
►Fully immerse the product in the disinfectant solution.
►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
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection 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.
Phase III
►Fully immerse the product in the disinfectant solution.
►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.
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►Fully immerse the product in the cleaning/disinfectant 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.
Manual pre-cleaning with ultrasound and brush
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection 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.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►Check visible surfaces for residues after mechanical cleaning/disinfecting.
Inspection, maintenance and checks
►Allow the product to cool down to room temperature.
►After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured compo-
nents).
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 - - - -
Phase Step T
[°C/°F]
t
[min]
Conc.
[%] Water quality Chemical
I Disinfec-
tant
cleaning
RT (cold) >15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
II Rinsing RT (cold) 1 - D–W -
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 concen-
trate, pH ~ 9*
II Rinsing RT (cold) 1 - D–W -
Phase Step T
[°C/°F]
t
[min]
Water
quality Chemical
I Prerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD-W ■Concentrate, alkaline:
–pH=13
– <5 % anionic surfactant
■0.5 % working solution
– pH = 11*
III Intermediate
rinse >10/50 1 FD-W -
IV Thermal disin-
fecting 90/194 5 FD-W -
V Drying - - - According to the program for cleaning
and disinfection device
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).

►Dry the product if it is wet or damp.
►Repeat cleaning and disinfection of products that still show impurities or contamination.
►Check that the product functions correctly.
►Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►Check for compatibility with associated products.
Packaging
►Appropriately protect products with fine working tips.
►Store products with ratchet locks fully opened or locked no further than in the first notch.
►Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
►Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers).
►Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Steam sterilization
FW966R, FW967R, FW968R:
Note
The product may only be sterilized when dismantled.
Note
To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further
than on the first ratchet tooth.
►Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets).
►Validated sterilization process
– Disassemble the product (FW966, FW967, FW998)
– Steam sterilization using fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Storage
►Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Technical Service
►For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]e
Other service addresses can be obtained from the address indicated above.
Disposal
►Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
TA-Nr. 011904 04/14 V6 Änd.-Nr. 49358
WARNING
Risk of injury and/or malfunction!
►Do not modify the product.