Braun Aesculap S4 MIS Spyder Manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
S4® MIS Spyder Instrumentation
Gebrauchsanweisung/Technische Beschreibung
S4® MIS Spyder Instrumente
Mode d’emploi/Description technique
Instrumentation S4® MIS Spyder
Instrucciones de manejo/Descripción técnica
Instrumental S4® MIS Spyder
Istruzioni per l’uso/Descrizione tecnica
Strumentazione S4® MIS Spyder
Instruções de utilização/Descrição técnica
Instrumental S4® MIS Spyder
Gebruiksaanwijzing/Technische beschrijving
S4® MIS Spyder instrumentarium
Bruksanvisning/Teknisk beskrivning
S4® MIS Spyder Instrumentation
Инструкция по примению/Техническое опи-
сание
Инструменты S4® MIS Spyder
Návod k použití/Technický popis
Instrumentace S4® MIS Spyder
Instrukcja użytkowania/Opis techniczny
Instrumentarium S4® MIS Spyder
Návod na použivanie/Technický opis
Nástroj S4® MIS Spyder
Kullanım Kılavuzu/Teknik açiklama
S4® MIS Spyder Aleti

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910

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14 15 16
17 18 19

2
Aesculap®
S4® MIS Spyder Instrumentation
Aesculap® S4® MIS Spyder Instrumentati on
Legend
1Tissue Dilator 6, 10, 16.5, 20, 24 mm (ME389T–
ME393T)
2Tissue Dilator Handle (ME394T)
3Upper Right Frame Arm (ME300R)
4Upper Left Frame Arm (ME301R)
5Lower Right Frame Arm (ME302R)
6Lower Left Frame Arm (ME303R)
7Mini-Open Frame Rack (ME304R)
8Frame Arm Rotator (ME380R)
9Blade Handle (ME381R)
10 Table Arm Pivot Connection Block (ME382R)
11 C/C Blade 16.5x40 mm–16.5x110 mm (ME342T–
ME349T)
12 C/C Blade 20x40 mm–20x110 mm (ME365T–
ME372T)
13 C/C Blade 24x40 mm–24x110 mm (ME319T–
ME326T)
14 C/C Blade Light Rod Clip (ME387R)
15 M/L Blade Light Rod Clip (ME388R)
16 M/L Blade Cvd 7x40 mm–7x100 mm (ME278T–
ME293T)
17 M/L Blade Cvd 20x40 mm–20x100 mm (ME373T–
ME379T)
18 Delta Blade 7x17x40 mm–7x34x110 mm
(ME327T–ME334T)
19 Delta Blade 20x26x40 mm–20x43x110 mm
(ME357T–ME364T)
Symbols on product and packages
Applicable to Spyder Instrumenta-
tion Set
►For item-specific instructions for use and informa-
tion on material compatibility, see also the
Aesculap Extranet at www.extranet.bbraun.com
Intended use
The S4MIS Spyder Instrumentation set is intended for
use during posterior fusion of the lumbar spine with
the S4System to retract the soft tissue and provide
access to the operative region. The instrumentation
can be used for either the minimal invasive or the per-
cutaneous approach to the pedicle.
Caution, general warning symbol
Caution, see documentation supplied
with the product

3
Available sizes
Name Sizes
Tissue Dilator 6 mm
10 mm
16.5 mm
20 mm
24 mm
Spyder Retractor C/C
Blade
16.5x40 mm
16.5x50 mm
16.5x60 mm
16.5x70 mm
16.5x80 mm
16.5x90 mm
16.5x100 mm
16.5x110 mm
20x40 mm
20x50 mm
20x60 mm
20x70 mm
20x80 mm
20x90 mm
20x100 mm
20x110 mm
24x40 mm
24x50 mm
24x60 mm
24x70 mm
24x80 mm
24x90 mm
24x100 mm
24x110 mm
Spyder Retractor M/L
Blade Cvd
7x40 mm
7x50 mm
7x60 mm
7x70 mm
7x80 mm
7x90 mm
7x100 mm
20x40 mm
20x50 mm
20x60 mm
20x70 mm
20x80 mm
20x90 mm
20x100 mm
Delta Blade 7x17x40 mm
7x19x50 mm
7x22x60 mm
7x24x70 mm
7x27x80 mm
7x29x90 mm
7x31x100 mm
7x34x110 mm

4
Aesculap®
S4® MIS Spyder Instrumentation
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site 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 compo-
nents.
►Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
►Replace any damaged components immediately
with original spare parts.
Safe operation
Dilation
►Dilate the paraspinal muscles starting with the
smallest diameter (6 mm) Tissue Dilator (ME389T)
and work up to the diameter of the cranial-caudal
(C/C) retractor blades you intend to use (16.5 mm,
20 mm, or 24 mm diameters).
►The dilator handle may be attached to each dilator
if desired.
Lower Frame and Cranial Caudal (C/C) Blade Inser-
tion
►After inserting the final dilation diameter, select
the length of the cranial-caudal (C/C) retractor
blades based on the depth indicator on the dilator.
►Insert the C/C blades into the assembled “lower”
frame (ME302R, ME303R, ME304R) by loosening
the grub screw, engaging the blades into the frame
and then tightening the grub screw.
►Close the retractor, creating a tube from the
blades.
►Slide blades over the final dilator, and remove the
tissue dilator.
►Expand the lower arm of the retractor by rotating
the thumb ratchets of the retractor.
►The blades of the lower retractor may be flared
using the retractor rotator arms (ME380R). Insert
the rotator arms into the retractor and rotate the
arms inwards to flare blades.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
WARNING
Mini-open frame disassembles
or jams due to unsecured
blades!
►When placing blades into
the frame arms always fin-
ger-tighten the grub screw
to fix each blade in place
to ensure blades do not pop
out during use.
►Do not force blade into the
frame arm as this will
cause it to jam and make it
difficult to remove.
WARNING
Damage to the surrounding
muscle and soft tissues by
retractor blades!
►Do not over retract blades.

5
Upper Frame and Medial Lateral (M/L) Blade Inser-
tion
►The M/L blades of the upper retractor may be
inserted in a similar fashion using the upper frame
of the retractor. The upper retractor frame has gold
anodization on the collar for easy identification.
►Place the upper retractor arm over the lower
retractor arm and expand and flare the upper
retractor in a similar fashion if desired.
Blade Replacement
►Blade lengths and shapes may be changed in situ
through the use of the blade holding instrument
(ME381R).
►Before removing any blades, release the force of
the soft tissue on the retractor blades by returning
them to their parallel position.
►Insert the rotator arm into the retractor, pull back
on the collar and rotate the arm to the upright
position.
►Re-inserting the final dilator will hold the soft tis-
sue while the retractor blade is exchanged.
►To remove a blade, insert the retractor blade handle
into the blade notches and rotate the knob coun-
ter-clockwise. Loosen the grub screw and remove
the blade.
►To insert a new blade, place the new blade in the
retractor arm, tighten the grub screw and rotate
the blade removal knob clockwise to disengage the
tool.
WARNING
Frames may not nest correctly
if not assembled in right order!
►For the mini-open proce-
dure ensure that the lower
frame (silver collar) is
inserted first.
►If a second frame is to be
used, insert the upper
frame (gold collar) over
and perpendicular to the
lower frame, ensuring that
the frames nest together
correctly.
WARNING
Inability to remove retractor
blades due to pressure from
retracted tissues!
►Always set the retractor
blades back to their verti-
cal position prior to
removing them.
►Pressure exerted by the tis-
sues on the blades can
make retraction of the col-
lar difficult. Use the Blade
Arm Rotator to relax the
pressure on the teeth
under the collar while gen-
tly retracting the collar.
WARNING
Damage to Blade Holder
Instrument or C/C blades due
to over tightening knob!
►Over tightening the knob
on the Blade Holder Instru-
ment will put unnecessary
load on the threads and
jaws of the instrument and
may cause expansion of
the caudal cranial blades
that makes removal or
insertion of the blade in
the Spyder frame arm
impossible.

6
Aesculap®
S4® MIS Spyder Instrumentation
Lighting
►For additional visibility attach a light source to
either the C/C Blade Light Rod Clip (ME387R) or
the M/L Blade Light Rod Clip (ME388R).
For additional visibility, the medial blade and M/L
light clip will provide the best visibility.
Securing the Lower Frame
If desired, the lower arms of the retractor can be
attached to the table arm.
►Attach the table arm connection block (ME382R)
to the retractor arm (ME304R).
►Attach table arm connection block (ME382R) to
the table arm (FF280R) by sliding the (ME382R)
into the collar and tighten the knob.
The Spyder Retractor is now attached to the table
arm assembly.
Disassembling
Frame Arm (ME300R–ME303R):
►Remove any blades attached to the frame arm by
loosening the grub screw.
►Open ratchet lock and slide the Frame Arm off the
Mini-Open Frame Rack (ME304R).
►Remove the thumb ratchet from the Frame Arm.
►Unthread grub screw so that it remains in the hold-
ing arm but is completely disengaged from its
threading.
►Retract and rotate the collar 180° so that it is held
by the positive stop in the retracted position for
cleaning.
Blade Handle (ME381R):
►Hold the blade handle head upright.
►Unscrew the nut on the shaft proximally towards
the handle.
Nut disengages the threading on the shaft.
►Turn the knob on the bottom counter clockwise
until the head/shaft detaches from the handle.
►Remove the head/shaft from the handle.
►Remove the knob from the handle.
Table Arm Pivot Connection Block (ME381R):
►Unscrew nut from the threading on the shaft away
from the connector.
►Unscrew wheel from connection block.
Assembling
Frame Arm (ME300R–ME303R):
►Screw grub screws until they fully engage their
threads.
►Insert thumb screws into the Frame Arm block.
►Engage Frame Arm onto the Mini-Open Frame Rack
(ME304R):
– The Left and Right Upper Frame arms (gold col-
lar) should be paired with one another.
– The Right and Left Lower Frame arms (silver
collar) should be paired with one another.
– The arm of the Frame Arm should face away
from the teeth on the rack.
– The thumb screws should be on the distant
ends of the rack,
– The frame arms are facing inward.
►Retract the collar and rotate the arms until the
concave frame faces inward, and the grub screws
point out and upward.
WARNING
Damage to the light clip due to
overheating!
►Using a light source
greater than 300 watts
will lead to excessive heat-
ing of the light cable and
light clip.

7
Blade Handle (ME381R):
►Insert the knob into the slot on the bottom of the
handle.
►Insert the head/shaft until it engages the threads
inside the knob.
►Hold the blade handle head upright.
►Turn the knob clockwise until the head/shaft fully
engages with the handle.
►Orient the head so that the pegs on the head will
mesh with the slots on the handle.
►Ensure that the head is fully engaged with the han-
dle.
►Thread the nut on the handle distally towards the
head until it is fully threaded.
►Ensure the Blade Handle operates correctly by
turning the knob counter clockwise to spread open
the arms and clockwise to close the arms.
Table Arm Pivot Connection Block (ME381R):
►Thread the wheel onto the block until it is fully
engaged.
►Thread the nut on the shaft towards the connector
until it is fully engaged.
Validated reprocessing procedure
General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual 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 responsi-
ble for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disin-
fectant 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 temperatures >45 °C nor fixating disin-
fecting 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 fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
Additional drying, if necessary.

8
Aesculap®
S4® MIS Spyder Instrumentation
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’ recommen-
dations 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 discol-
oration 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, fractur-
ing, premature aging or swelling.
►Do not use metal cleaning brushes or other abra-
sives 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 carry-
ing out the reprocessing procedure
►Disassemble the product immediately after use, as
described in the respective instructions for use.
►Open up products 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 con-
tainer for cleaning and disinfection within 6 hours.
Preparation before cleaning
►Disassemble the product prior to cleaning, see Dis-
assembling.
Cleaning/disinfection
Product-specific safety notes on the repro-
cessing procedure
►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 man-
ual cleaning/disinfecting.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechan-
ical cleaning/disinfecting.
– as an integrated mechanical support measure
for mechanical cleaning/disinfecting.
– for additional cleaning of products with resi-
dues left after mechanical cleaning/disinfect-
ing.
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents and/or exces-
sive temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instruc-
tions which are approved
for (e.g. titanium, high-
grade steel).
►Observe specifications
regarding concentration,
temperature and exposure
time.

9
Validated cleaning and disinfection procedure
Validated procedure Specific requirements Reference
Manual cleaning with
immersion disinfection
ME389T–ME393T
ME394T
ME304R
ME380R
ME319T–ME326T
ME327T–ME334T
ME335T–ME341T
ME350T–ME356T
ME357T–ME364T
ME387R
ME388R
■Cleaning brush: e.g. TA011944
■Disposable syringe 20 ml
■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 immer-
sion disinfection
Manual cleaning with
ultrasound and immer-
sion disinfection
ME300R
ME301R
ME302R
ME303R
ME381R
ME382R
■Cleaning brush: TA011944,
TE654202, or GK469200
■Disposable syringe 20 ml
■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 ultra-
sound and immersion disinfection
Mechanical alkaline
cleaning and thermal
disinfection
ME304R
ME380R
ME319T–ME326T
ME387R
ME388R
■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

10
Aesculap®
S4® MIS Spyder Instrumentation
Manual pre-cleaning
with brush and subse-
quent mechanical alka-
line cleaning and ther-
mal disinfection
ME389T–ME394T**
ME327T–ME334T
ME335T–ME341T
ME350T–ME356T
ME357T–ME364T
■Cleaning brush: e.g. TA011944,
TE654202, or GK469200
■Disposable syringe 20 ml
■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.
■Keep working ends open for
cleaning.
■Place products in the tray with
their hinges open.
Chapter Mechanical cleaning/disinfection
with manual pre-cleaning and sub-chap-
ter:
■Chapter Manual pre-cleaning with a
brush
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Manual pre-cleaning
with ultrasound and
brush, and subsequent
mechanical alkaline
cleaning and thermal
disinfection
ME300R
ME301R
ME302R
ME303R
ME381R
ME382R
■Cleaning brush: e.g. TA011944,
TE654202, or GK469200
■Disposable syringe 20 ml
■Place the product in a tray that is
suitable for cleaning (avoiding
rinsing blind spots).
■Connect components with lumens
and channels directly to the rins-
ing port of the injector carriage.
■Keep working ends open for
cleaning.
■Place products in the tray with
their hinges open.
Chapter Mechanical cleaning/disinfection
with manual pre-cleaning and sub-chap-
ter:
■Chapter Manual pre-cleaning with
ultrasound and brush
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Validated procedure Specific requirements Reference

11
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 neces-
sary.
Manual cleaning and wipe disinfecting
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT: Room temperature
Phase I
►Clean the product under running faucet water,
using a suitable cleaning brush until all visible res-
idues have been removed from the surfaces.
►Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
Phase II
►Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.
Phase III
►Wipe all surfaces of the product with a single-use
disinfectant wipe.
Phase IV
►After the specified exposure time (at least 1 min),
rinse the disinfected surfaces under running FD
water.
►Drain any remaining water fully.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
--D–W -
II Drying RT - - - -
III Wipe disinfection - >1 - - Meliseptol HBV wipes 50 % Pro-
pan-1-ol
IV Final rinse RT
(cold)
0.5 - FD-W -
VDrying RT - - - -

12
Aesculap®
S4® MIS Spyder Instrumentation
Phase V
►Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.
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
►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
1min.
►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 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 -
VDrying RT - - - -

13
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 Vali-
dated 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 disinfection procedure.
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 -
VDrying RT - - - -

14
Aesculap®
S4® MIS Spyder Instrumentation
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
1min.
►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 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 Vali-
dated cleaning and disinfection procedure.

15
Mechanical cleaning/disinfecting
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 process-
ing must be serviced and checked at regular intervals.
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 mechani-
cal cleaning/disinfecting.
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
IPrerinse <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 disinfect-
ing
90/194 5 FD-W -
VDrying - - - According to the program for cleaning
and disinfection device

16
Aesculap®
S4® MIS Spyder Instrumentation
Mechanical neutral or mild 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 neutral
►Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
►Repeat the cleaning/disinfecting process if neces-
sary.
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemical
I Prerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD-W Neutral:
■Concentrate:
– pH neutral
– <5 % anionic surfactant
■0.5 %* working solution
Mildly alkaline:
■Concentrate:
– pH = 9.5
– <5 % anionic surfactant
■0.5 % solution
III Intermediate rinse >10/50 1 FD-W -
IV Thermal disinfecting 90/194 5 FD-W -
VDrying - - - According to the program for
cleaning and disinfection device

17
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 process-
ing 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 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
1min.
►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.
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 -

18
Aesculap®
S4® MIS Spyder Instrumentation
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 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
1min.
►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.
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 Rinsing RT (cold) 1 - D–W -