Braun Aesculap Acculan 4 Manual

Aesculap®Acculan 4
Aesculap Power Systems
Instructions for use/Technical description
Oscillating saw GA331
Gebrauchsanweisung/Technische Beschreibung
Oszillierende Säge GA331
Mode d’emploi/Description technique
Scie oscillante GA331
Instrucciones de manejo/Descripción técnica
Sierra oscilante GA331
Istruzioni per l’uso/Descrizione tecnica
Sega oscillante GA331
Instruções de utilização/Descrição técnica
Serra oscilatória GA331
Gebruiksaanwijzing/Technische beschrijving
Oscillerende zaag GA331
Bruksanvisning/Teknisk beskrivning
Oscillerande såg GA331
Инструкция по примению/Техническое описание
Осциллирующая пила GA331
Návod k použití/Technický popis
Oscilační pila GA331
Instrukcja użytkowania/Opis techniczny
Piła oscylacyjna GA331
Návod na použitie/Technický opis
Oscilačná píla GA331
Kullanım Kılavuzu/Teknik açiklama
Titreşimli testere GA331
사용 설명서 /기술 설명
진동 톱GA331

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7

A
B
CC
D
E
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4
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10
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11
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12 3
7

2
Aesculap®Acculan 4
Oscillating saw GA331
Aesculap®Acculan 4Oscillating saw GA331
Legend
1Product (oscillating saw)
2Trigger (for oscillation frequency control)
3Safety catch
4Battery bay
5Locking pin
6Sterile funnel
7Battery
8Lid
9Cover release element
10 Battery removal device
11 Saw blade
12 Saw head
13 Button for saw blade release/
14 Saw blade coupling
The depictions are schematic only.
Symbols on product and packages
Caution
Observe important safety information such as warn-
ings and precautions in the instructions for use.
YYYY-MM
Maintenance label
Indication of the next maintenance appointment
(Date: Year-Month)
Machine-readable, two-dimensional code
The code contains a unique serial number which can be
used for electronic tracking of the individual instru-
ment. The serial number is based on the global stan-
dard sGTIN (GS1).
Date of manufacture
Follow the instructions for use
Labeling of electrical and electronic devices pursuant
to directive 2002/96/EG (WEEE)
Classification Type BF
Motor speed control
Manufacturer’s batch designation
Manufacturer’s serial number
Manufacturer’s article number
Temperature limits during transport and storage
Air humidity limits during transport and storage
Atmospheric pressure limits during transport and stor-
age
Operating mode
LOT
SN
REF
S9

3
Contents
1. Applicable to. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. General information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Main functions and design characteristics . . . . . . . . . . . . . . . . 3
2.3 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Absolute contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.5 Relative contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Scope of supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.2 Components required for operation . . . . . . . . . . . . . . . . . . . . . . 4
4.3 Operating principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6. Working with the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1 System set-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.1 Connecting the accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.2 Inserting the rechargeable battery . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.3 Intraoperative battery change. . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1.4 Removing the rechargeable battery . . . . . . . . . . . . . . . . . . . . . . 6
6.1.5 Protection against inadvertent activation . . . . . . . . . . . . . . . . . 6
6.1.6 Attaching and detaching the saw blade. . . . . . . . . . . . . . . . . . . 6
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.1 Operating the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 General information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.3 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.4 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.6 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . . 9
7.7 Automatic cleaning/disinfection with manual pre-cleaning . . 10
7.7.1 Manual pre-cleaning with a brush . . . . . . . . . . . . . . . . . . . . . . . 10
7.7.2 Mechanical alkaline cleaning and thermal disinfection . . . . . . 11
7.8 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 11
7.9 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.10 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.11 Sterilization for the US market . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.12 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8. Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
11. Accessories/Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
12. Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.1 Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 15
12.2 Performance data, information about standards . . . . . . . . . . . 15
12.3 Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
12.4 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
14. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1. Applicable to
►For item-specific instructions for use and information on material
compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
2. General information
2.1 Intended use
Task/Function
The oscillating saw GA331, combined with the relevant tool, is used for
processing hard tissue, cartilage and the like, as well as for bone replace-
ment materials.
Application Environment
The product fulfills the requirements for type BF pursuant to
IEC/DIN EN 60601-1 and is used in operating rooms in sterile environ-
ments of explosion risk areas (such as areas with pure oxygen or anesthe-
sia gases).
2.2 Main functions and design characteristics
Electrical systems generally heat up during continual operation. It is
advised to give the system a break after use to cool down, as listed in the
table on operating mode.
Oscillation frequency min. 0 min-1 to max. 13 000 min-1
Operating mode Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
■30 second application, 30 second pause
■7 repetitions
■30 min cooling time
■Max. Temperature 48 °C

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Aesculap®Acculan 4
Oscillating saw GA331
Heating depends on the tool used and the load. After a certain number of
repetitions, the system should cool down. This procedure prevents the sys-
tem overheating as well as possible injury to the patient or user.
The user is responsible for the use and adherence to the pause sequence
described.
2.3 Indications
The type and area of application depend on the tool selected.
2.4 Absolute contraindications
The product is not licensed for use on the central nervous system or cen-
tral circulatory system.
2.5 Relative contraindications
The safe and effective use of the product greatly depends on influences
which can only be controlled by the user. Therefore the specifications pro-
vided represent framework conditions only.
Clinically successful use of the product is dependent on the knowledge
and experience of the surgeon. The surgeon must decide which structures
it is sensible to treat and take into account the safety and warning infor-
mation contained in these instructions for use.
3. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
■General risk factors associated with surgical procedures are not
described in this documentation.
■It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■The operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
►Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►Prior to use, check that the product is in good working order.
►Follow TA022130 "Information on electromagnetic tolerance (EMT)".
►To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►Keep the instructions for use accessible for the user.
►Always adhere to applicable standards.
►Ensure that the electrical installation of the room is consistent with
the requirements of IEC/DIN EN.
►Do not operate the product in explosion-hazard areas.
►Sterilize product before use.
►When using the ECCOS fixation system, adhere to the appropriate
instructions for use for TA009721, see Aesculap Extranet at
https://extranet.bbraun.com
4. Product description
4.1 Scope of supply
4.2 Components required for operation
■NiMH battery long GA676 (charged)
■Sterile funnel GA678
■Cap GA675
■Saw blade (according to indication)
4.3 Operating principle
The product 1contains an electric motor, which is powered by a replace-
able battery 7.
The charged non-sterile battery 7is inserted into the product 1via the
sterile funnel 6and sealed with the lid 9so that it is sterile.
The oscillation frequency is controlled electronically and can be continu-
ously regulated with the trigger for oscillation frequency control 2.
The product 1has a coupling, which allows for the attachment of various
saw blades 11. These saw blades 11 lock automatically when attached to
the product.
The saw blade 11 can be removed by activating a push button 13.
WARNING
Risk of injury and material damage if this product
is not used as intended!
►Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to
improper handling of the product!
►Follow the instructions for use of all products
used.
Art. no. Designation
GA331 Oscillating saw
GA678 Sterile funnel
TA014543 Instructions for use for oscillating saw GA331 (flyer)

5
5. Preparation
Aesculap assumes no liability if the following rules are not followed:
►Do not use products from open or damaged sterile packaging.
►Prior to use, inspect the product and its accessories for any visible
damage.
►Use the products and their accessories only if they are in perfect tech-
nical condition.
6. Working with the device
6.1 System set-up
6.1.1 Connecting the accessories
Combinations of accessories that are not mentioned in the present
instructions for use may only be employed if they are specifically intended
for the respective application, and if they do not compromise the perfor-
mance and safety characteristics of the products.
All configurations must fulfill the fundamental standard
IEC/DIN EN 60601-1. The person connecting the devices with each other
is responsible for the configuration and must ensure that the fundamental
standard IEC/DIN EN 60601-1 or relevant national standards.
►Follow the instructions for use of individual accessories.
►In case of questions, contact your B. Braun/Aesculap partner or
Aesculap Technical Service, address see Technical Service.
6.1.2 Inserting the rechargeable battery
►Product 1with the battery shaft 4must be turned upwards and the
sterile funnel 6(sterile) attached, see Fig. A.
►Battery 7(non-sterile) is inserted into the battery shaft 4by a second
(non-sterile) person.
Note
After the battery has been inserted, multiple signals will sound, which indi-
cate that the product is ready to use.
►After insertion of the battery, have the sterile funnel 6(non-sterile)
removed by a second person.
►Attach the lid 8(sterile) in such a manner that it clicks into place with
both release catches 9.
Note
The sterility of the product is only guaranteed with a correctly placed lid.
WARNING
Risk of infection and contamination!
Product is delivered unsterilized!
►Sterilize the product before use pursuant to the
operating instructions.
WARNING
Risk of injury and material damage due to acciden-
tal activation of the product!
►Products which are not being actively used must
be secured against accidental activation (posi-
tion OFF).
WARNING
Risk of injury and material damage due to inappro-
priate use of tools!
►Always follow the safety advice and information
given in the instructions for use.
►When coupling/uncoupling, handle tools with
cutting edges with care.
WARNING
Damage to the product if dropped!
►Use the products only if they are in perfect
technical condition, see Function check
WARNING
Risk of burns to skin and tissue through blunt tools
or if product has not been maintained properly!
►Use tools only if they are in perfect condition.
►Replace blunt tools.
►Maintain the product properly, see maintenance
guide.
DANGER
Risk of injury due to unapproved configuration
using additional components!
►Ensure that the classification of all components
used is consistent with the classification of the
product (such as type BF or type CF).
CAUTION
The product does not function when using the
wrong battery!
►Do not use battery GA666 (with red base) or
GA346.

6
Aesculap®Acculan 4
Oscillating saw GA331
6.1.3 Intraoperative battery change
The battery removal device is used for intraoperative battery changes
ensuring that sterile conditions are safely maintained.
►Turn the product 1with the battery shaft 4upwards.
►Press both safety catches 9on the lid 8at the same time and remove
the lid 8.
►Attach the sterile battery removal device 10, see Fig. B.
►Shake the product 1with the attached battery removal device 10 with
battery shaft 4slightly downwards.
The battery 7will slide easily into the battery removal device 10.
►Give the battery removal device 10 including dead battery 7to the
non-sterile person.
►Insert a charged battery 7, see Inserting the rechargeable battery.
6.1.4 Removing the rechargeable battery
Rechargeable battery must be removed after each surgical procedure and
prior to processing of the device.
Note
The battery removal device can be used for easier battery removal, see
Fig. B.
►Turn the product 1with the battery shaft 4upwards.
►Press both safety catches 9 on the lid 8at the same time and remove
the lid 8.
►Tightly grasp the battery shaft 4at the lower end.
►Tap the battery shaft 4on the palm of the hand until the battery 7
slides out of the battery shaft 4and can be removed.
6.1.5 Protection against inadvertent activation
To prevent inadvertent activation of the product during tool change/align-
ment of the saw head 12, the trigger 2can be locked.
To lock trigger 2:
►Twist the safety catch 3to position OFF.
The trigger 2is blocked and the product 1cannot be operated.
To unlock trigger 2:
►Twist the safety catch 3to position ON.
The trigger 2is unlocked and the product 1can be operated.
6.1.6 Attaching and detaching the saw blade
Coupling the saw blade
►Secure product 1from inadvertent activation with the safety catch 3,
see Protection against inadvertent activation.
►Insert the saw blade 11 with its coupling end in the slot of saw blade
coupling 14 as far as it will go. Ensure that the locking pin engages in
the saw blade fenestration, and that the lateral stops of the saw blade
rest on the coupling, see Fig. C.
►If necessary press button for saw blade release/fixation 13.
Uncoupling the saw blade
►Secure product 1against inadvertent activation with the safety
catch 3. see Protection against inadvertent activation
►Fully press button for saw blade release/fixation 13.
►Pull out saw blade 11 from the saw blade coupling 14, see Fig. C.
Aligning the saw head
Saw head 12 can be turned to eight different positions, in steps of 45°.
►Secure product 1from inadvertent activation with the safety catch 3,
see Protection against inadvertent activation.
►Slightly pull out saw head 12 and turn it to the required position (in
steps of 45°).
Saw head 12 noticeably engages at each step, see Fig. D.
6.2 Function checks
The function checks must be carried out prior to each use and after each
intraoperative battery change.
►Make certain there is a battery in the battery compartment.
►Ensure that the lid has completely clicked into place.
►Pull on the saw blade to check that it is securely coupled.
►Check that the cutting edges of the saw blade do not exhibit any
mechanical damage.
WARNING
Risk of injury from hot battery!
Battery may be hot after use in the machine.
►Remove the battery with the battery removal
device and let it cool.
WARNING
Risk of injury from hot battery!
Battery may be hot after use in the machine.
►Let the battery cool in the machine and then
remove.
–or –
►Remove the battery with the battery removal
device and let it cool.
CAUTION
Damage to the battery caused by knocking it
against hard objects!
►Only remove battery by tapping the product on
the palm of the hand.
CAUTION
Damage to, or destruction of the batteries due to
processing!
►Do not sterilize batteries.
WARNING
Risk of injury when attaching/removing sawblades
in the ON position through inadvertent activation
of the product!
►Only attach/remove saw blades in the OFF posi-
tion.

7
►Check secure seating of the saw head: turn without pulling out.
►Release product for use (ON position).
►Briefly operate product at maximum oscillation frequency.
►Do not use the product if it is damaged or defective.
►Set aside the product if it is damaged.
6.3 Safe operation
Note
The product drive motor is operated using a magnetic sensor system. In
order to prevent inadvertent activation of the motor, the product may not
be exposed to any magnetic fields (such as magnetic instrument pads).
6.3.1 Operating the product
Note
The slight whistling noise when the product is starting up is due to the con-
struction.
►Activate trigger 2.
The oscillation frequency of the product 1is continuously variable.
7. Validated reprocessing procedure
7.1 General safety notes
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble 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
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing 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.
WARNING
Coagulation of patient tissue or risk of burns for
patients and user through hot product!
►Cool the tool during operation.
►Keep product/tool out of the reach of patients.
►Let the product/tool cool down.
►Use a cloth to protect against burns when
changing the tool.
WARNING
Risk of infection or injury through aerosol forma-
tion or particles ejected from the tool!
►Use suitable protection (such as waterproof pro-
tective clothing, face mask, safety gases, suc-
tion).
WARNING
Risk of injury and/or malfunction!
►Always carry out a function check prior to using
the product.
WARNING
Risk of injury when using the product beyond the
field of view!
►Apply the product only under visual control.
WARNING
Risk of injury and damage to the tool/system!
The tool may get caught in drapes (such as tex-
tiles).
►Do not let the tool come into contact with
drapes (such as textiles) during operation.
WARNING
Risk of burns to skin and tissue due to blunt saw
blades/lack of product maintenance!
►Only use perfectly sharp saw blades.
►Replace blunt saw blades.
►Maintain products properly, see maintenance
guide.

8
Aesculap®Acculan 4
Oscillating saw GA331
7.2 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation 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 neutralizing agents or basic cleaners may result in a chemical
attack and/or fading and the laser marking becoming unreadable either
visually or by machine.
On stainless steel, residues containing chlorine or chloride (such as surgi-
cal residues, drugs, saline solutions in water for cleaning, disinfection and
sterilization) may lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. These must be removed by
rinsing thoroughly with demineralized water and then drying.
Perform 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:
■Visual material changes (such as fading or color changes in titanium or
aluminum). For aluminum, the application/process solution only needs
to be pH >8 to cause visible surface changes.
■Material damage (such as corrosion, cracks, breaks, premature aging or
swelling).
►Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion
►For further detailed information on hygienically safe and material-pre-
serving/value-preserving reprocessing, see www.a-k-i.org, link to Pub-
lications, Red Brochure – Proper maintenance of instruments.
7.3 Preparations at the place of use
►Remove all attached components from the product (tool an accesso-
ries).
►Remove any visible surgical residues as much as possible with a damp,
lint-free cloth.
►Place the dry product in a sealed waste container and forward it on for
cleaning and disinfection within 6 hours.
7.4 Preparation before cleaning
►Prior to the first mechanical cleaning/disinfection process, mount the
ECCOS fixations in a suitable tray (e.g. GB243800).
►Insert the products in the correct position into the ECCOS fixations, see
Fig. E.
7.5 Cleaning/disinfection
7.5.1 Product-specific safety instructions for the reprocessing pro-
cedure
Note
The indicated drying time is a guide time only. It must be checked taking
into account the specific conditions (e.g. load) and if applicable adjusted.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents and/or excessive tempera-
tures!
►Use cleaning and disinfecting agents according
to the manufacturer’s instructions which
–are approved for plastic material and high-
grade steel,
–do not attack softeners (e.g. in silicone).
►Do not use cleaning agents that contain ace-
tone.
►Observe specifications regarding concentration,
temperature and exposure time.
►Do not exceed the maximum temperature of
60 °C during chemical cleaning and/or disinfec-
tion.
►Do not exceed the maximum temperature of
96 °C during thermal disinfection with FD
water.
►Dry the product for at least 10 minutes at a
maximum of 120 °C.
CAUTION
Damage or destruction of the batteries due to pro-
cessing!
►Protect battery from moisture.

9
7.6 Manual cleaning with wipe disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
RT: Room temperature
* Validated with enzyme cleaner “Cidezyme Johnson & Johnson”
►Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids. Let any fluid incursions drain out immediately,
otherwise there is a danger of corrosion and loss of function.
Phase I
►Mobilize non-rigid components during cleaning.
►Clean the product under running water, using a suitable cleaning brush
until all visible residues have been removed from the surfaces.
►Brush difficult to access surfaces with a suitable plastic cleaning brush
for at least 1 min.
Note
For details on difficult to access surfaces, see Acculan pre-cleaning and
care information TA016000 (available in Aesculap Extranet at
https://extranet.bbraun.com).
Phase II
►Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►Spray products with a pH neutral enzyme solution, let soak in for at
least 2 minutes and then wipe off.
Phase III
►Mobilize non-rigid components during cleaning.
►Rinse product under running tap water for at least 5 minutes.
►Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►Contamination should be removed with a lint-free cloth or soft brush
moistened with enzyme cleaner.
►Flexible components should be rinsed for 20 seconds with the water
pistol (cold water, at least 2.5 bar).
►After manual cleaning, check visible surfaces and areas of flexible
components for residues.
►If necessary, repeat the cleaning process (phase 1 to 3).
Phase IV
►Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
Phase V
►Wipe all surfaces of the product with a single-use disinfecting wipe.
Phase VI
►Rinse disinfected surfaces after the prescribed reaction time for at
least 1 minute under running demineralized water.
►Drain any remaining water fully.
Stage VII
►Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
Phase Step T
[°C/°F] t [min] Conc. [%] Water qual- ity Chemicals
I Pre-cleaning RT (cold) ≥2 - DW Until visually clean
II Cleaning with enzyme solution RT (cold) ≥20.8D–W pH-neutral*
III Intermediate rinse RT ≥5- DW –
IV Drying RT - - - -
V Wipe disinfection - >1 - - Meliseptol HBV wipes 50 % Propan-1-ol
VI Final rinse RT (cold) 0.5 - FD–W -
VII Drying RT - - - -

10
Aesculap®Acculan 4
Oscillating saw GA331
7.7 Automatic cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must fundamentally have a tested
efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883).
Note
The cleaning and disinfection machine used for processing must be ser-
viced and checked at regular intervals.
7.7.1 Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
►Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids. Let any fluid incursions drain out immediately,
otherwise there is a danger of corrosion and loss of function.
Phase I
►Mobilize non-rigid components during cleaning.
►Thoroughly clean the product under running water.
Phase II
►Mobilize non-rigid components during cleaning.
►Brush difficult to access surfaces with a suitable plastic cleaning brush
for at least 1 min.
►After manual preparation, check visible surfaces for residue and repeat
the pre-cleaning process as needed.
Note
For details on difficult to access surfaces, see Acculan pre-cleaning and
care information TA016000 (available in Aesculap Extranet at
https://extranet.bbraun.com).
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemistry/Note
IRinsing RT (cold) - - D–W Until visually clean
II Brushes RT (cold) - - D–W Until visually clean

11
7.7.2 Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
DW: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►Insert the product in its proper position in the ECCOS fixation.
►Set the saw head 12 between two locking positions for cleaning.
►After automatic cleaning/disinfection, check visible surfaces for resi-
dues and repeat the cleaning/disinfection process as needed.
7.8 Inspection, maintenance and checks
Note
Aesculap recommends occasional spraying of moving parts (such as knobs,
couplings, cover lids) with the Aesculap STERILIT-Power-Systems oil spray.
►Allow the product to cool down to room temperature.
►Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
►Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►Inspect the saw blades for broken, damaged or blunt cutting edges.
►Set aside the product if it is damaged.
7.9 Packaging
►Always follow the instructions for use of the respective packaging and
storage devices (e.g. instructions for use TA009721 for Aesculap-
ECCOS holder system).
►Insert the products in the correct position into the ECCOS fixations,
see Fig. E.
►Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►Ensure that the packaging will prevent a recontamination of the prod-
uct.
7.10 Steam sterilization
Note
Remove all attached components from the product (tools, accessories)
before sterilization.
►Check to ensure that the sterilizing agent will come into contact with
all external and internal surfaces (e.g. by opening any valves and fau-
cets).
►Use a validated sterilization method:
– Steam sterilization using fractional vacuum process
– Steam sterilizer DIN EN 285 and validated pursuant to
DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
When sterilizing multiple products in one steam sterilizer:
►Ensure that the maximum permitted load specified by the manufac-
turer for the steam sterilizer is not exceeded.
Phase Step T
[°C/°F] t [min] Water qual- ity Chemistry/Note
IPre-rinse <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 disinfection 90/194 5 FD–W -
VDrying - - - mind. 10 min at max. 120 °C
CAUTION
Damage or destruction of the batteries due to pro-
cessing!
►Do not sterilize the rechargeable battery.

12
Aesculap®Acculan 4
Oscillating saw GA331
7.11 Sterilization for the US market
■Aesculap advises against sterilizing the device by flash sterilization or
chemical sterilization.
■Sterilization may be accomplished by a standard prevacuum cycle in a
steam autoclave.
To achieve a sterility assurance level of 10-6, Aesculap recommends the
following parameters:
*Aesculap has validated the above sterilization cycle and has the data on
file. The validation was accomplished in an Aesculap sterile container
cleared by FDA for the sterilization and storage of these products. Other
sterilization cycles may also be suitable, however individuals or hospitals
not using the recommended method are advised to validate any alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
7.12 Storage
►Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
8. Maintenance
To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance labeling or at least once a year.
YYYY-MM
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
9. Troubleshooting list
►Have defective products repaired by Aesculap Technical Service, see
Technical Service.
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization
method Temp. Time Minimum drying time
Prevacuum 270 °F/275 °F 4 min 20 min
Issue Cause Detection Remedy
Product not running No battery No battery in the battery shaft Insert battery.
Battery not charged No signal tone when inserting the bat-
tery
Charge battery in charger.
Battery defective No signal tone when inserting the bat-
tery
Have the manufacturer repair the battery.
Product in locked OFF position Safety catch is in OFF position Turn the safety catch into the ON position.
Product defective Product not running Have the manufacturer repair the product.
Product becomes too
hot
Excessive use Product heating Follow operating instructions (operating mode).
Reprocessing/maintenance
carried out incorrectly
Product heating Follow operating instructions (preparation, care).
Preventative: lubricate product before every ster-
ilization.
Fall damage, product defec-
tive
Product heating Have the manufacturer repair the product.
Use of a defective attachment Product heating Have the manufacturer repair the attachment.
Blunt tool Heating of tool and product Change tool.

13
Insufficient power Product defective Insufficient product performance Follow operating instructions (preparation, care).
Preventative: lubricate product before every ster-
ilization.
Have the manufacturer repair the product.
Large amount of heat generated after a
short time
Follow operating instructions (operating mode).
Have the manufacturer repair the product
Product is operating in left
rotation mode
Serrated tool run in counterclockwise
mode
Operate serrated tool in right rotation.
Use of a defective attachment Attachment very hot Have the manufacturer repair the attachment.
Blunt tool Tool blades worn out Change tool.
Loud running noise Defective product drive/ball
bearings
Loud, perceptible noise during opera-
tion
Follow operating instructions (preparation, care).
Preventative: lubricate product before every ster-
ilization.
Have the manufacturer repair the product
Defective attachment
drive/ball bearings
Loud, perceptible noise during opera-
tion
Follow operating instructions (preparation, care).
Preventative: lubricate attachment before every
sterilization.
Have the attachment repaired by the manufac-
turer
Lid cannot be
attached/removed
Lid not compatible Lid does not click into place Use the compatible lid for GA331.
Lid deformed/defective Lid is difficult or cannot be
mounted/removed
Have the manufacturer repair the lid.
Connection to product
deformed/defective
Lid is difficult or cannot be
mounted/removed
Have the manufacturer repair the product.
Battery cannot be
inserted/removed
Battery not compatible Battery cannot be completely inserted
into the battery shaft
Use the compatible battery for GA331.
Battery deformed/defective Battery is difficult or cannot be
mounted/removed
Have the manufacturer repair the battery.
Battery shaft to product
deformed/defective
Battery is difficult or cannot be
mounted/removed
Have the manufacturer repair the product
Sterile funnel or bat-
tery removal device
not attachable
Sterile funnel or battery
removal device not compati-
ble
Sterile funnel or battery removal device
not attachable to the battery shaft
Use compatible sterile funnel or battery removal
device for GA331.
Sterile funnel or battery
removal device
deformed/defective
Sterile funnel or battery removal device
difficult or not attachable
Change sterile funnel or battery device.
Battery shaft to product
deformed/defective
Sterile funnel or battery removal device
difficult or not attachable
Have the manufacturer repair the product.
Speed control knob not
working
Product in locked OFF position Safety catch is in OFF position Turn the safety catch into the ON position.
Speed control knob sticks/is
defective
Speed control knob not working Have the manufacturer repair the product.
Saw blade not moving Loud running noise from
motor
Defective gearings Have repaired by manufacturer
Issue Cause Detection Remedy

14
Aesculap®Acculan 4
Oscillating saw GA331
10. Technical Service
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
►For service and repairs, please contact your national
B. Braun/Aesculapagency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
11. Accessories/Spare parts
Insufficient cutting
performance of the
saw blade
Saw blade teeth worn Blunt saw blade Replace saw blade
Battery too weak Insufficient motor power/speed Charge battery
Battery worn/defective Replace battery
Saw blade overheated Inadequate chip removal Move the saw back and forth during sawing and
ensure sufficient irrigation of the saw blade
The saw blade cannot
be coupled
Coupling components or saw
blades deformed
Deformation Have repaired by manufacturer
- Incompatible saw blade Insert a compatible Aesculap saw blade, see
Accessories/Spare parts
Saw blade cannot be
uncoupled
Locking pin not fully releasing
the saw blade
Button for saw blade release not
pressed completely
Fully press the saw blade release button, see
Attaching and detaching the saw blade
Issue Cause Detection Remedy
WARNING
Danger to life of patients and users if the product
malfunctions and/or protective measures fail or are
not used!
►Do not perform any servicing or maintenance
work under any circumstances while the product
is being used on a patient.
►Do not modify the product.
Art. no. Designation
GA675 Lid
GA676 NiMH battery long
GA678 Sterile funnel
GA679 Battery removal device
GB243R
GB244R
ECCOS sieve basket with fixation for Acculan 4
GB600 STERILIT Power Systems oil spray
GB495R ECCOS fixation for machine
GB487R ECCOS fixation for lid
GB488R ECCOS fixation for sterile funnel
GB489R ECCOS fixation for battery removal device
TA014542 Instructions for use for oscillating saw GA331 (A4
for ring binder)
TA014543 Instructions for use for oscillating saw GA331
(flyer)

15
12. Technical data
12.1 Classification acc. to Directive 93/42/EEC
12.2 Performance data, information about standards
The product was subject to 500 preparation cycles as a test by the manu-
facturer and has passed.
12.3 Operating mode
12.4 Environmental conditions
13. Disposal
Note
The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.
►Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Technical
Service.
14. Distributor in the US/Contact in Can-
ada for product information and com-
plaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Art. no. Designation Class
GA331 Oscillating saw IIa
Max. power approx. 250 W
Max. oscillation frequency 13 000 min-1
Weight (operational) 1,6 kg ±10 %
Dimensions (L x W x H, ready for
operation)
221mmx177mmx55mm±5%
Applied part Type BF
EMC IEC/DIN EN 60601-1-2
Conforming to standard IEC/DIN EN 60601-1
Operating mode Operation with non-periodic load and
speed changes (type S9 pursuant to
IEC EN 60034-1)
■30 second application, 30 second
pause
■7 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Operation Storage and transport
Temperature 10 °C to 27 °C -10 °C to 50 °C
Relative
humidity
30 % to 75 % 10 % to 90 %
Atmospheric
pressure
700 hPa to 1 060 hPa 500 hPa to 1 060 hPa
Adhere to national regulations when disposing of or recy-
cling the product, its components and its packaging!
The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
(The recycling pass includes disassembling instructions for
the product, as well as information for proper disposal of
components harmful to the environment.)
Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufac-
turer as a free-of-charge service.

16
Aesculap®Acculan 4
Oszillierende Säge GA331
Aesculap®Acculan 4Oszillierende Säge GA331
Legende
1Produkt (oszillierende Säge)
2Drücker (zur Regulierung der Oszillationsfrequenz)
3Drückersicherung
4Akkuschacht
5Verriegelungsbolzen
6Steriltrichter
7Akku
8Verschlussdeckel
9Verschlussentriegelung
10 Akku Entnahmehilfe
11 Sägeblatt
12 Sägekopf
13 Druckknopf zur Sägeblattentriegelung/
14 Sägeblattkupplung
Die Darstellungen sind nur schematisch.
Symbole an Produkt und Verpackung
Vorsicht
Wichtige sicherheitsbezogene Angaben wie Warnhin-
weise und Vorsichtsmaßnahmen in Gebrauchsanwei-
sung beachten.
YYYY-MM
Instandhaltungskennzeichen
Hinweis auf den nächsten Instandhaltungstermin
(Datum: Jahr-Monat)
Maschinenlesbarer zweidimensionaler Code
Der Code enthält eine eindeutige Seriennummer, die
zum elektronischen Einzelinstrumententracking ver-
wendet werden kann. Die Seriennummer basiert auf
dem weltweiten Standard sGTIN (GS1).
Herstelldatum
Gebrauchsanweisung befolgen
Kennzeichnung von Elektro- und Elektronikgeräten
entsprechend Richtlinie 2002/96/EG (WEEE)
Klassifikation Typ BF
Drehzahlsteuerung
Chargenbezeichnung des Herstellers
Seriennummer des Herstellers
Bestellnummer des Herstellers
Temperaturgrenzwerte bei Transport und Lagerung
Luftfeuchtigkeits-Grenzwerte bei Transport und Lage-
rung
Atmosphärendruck-Grenzwerte bei Transport und
Lagerung
Nennbetriebsart
LOT
SN
REF
S9

17
Inhaltsverzeichnis
1. Geltungsbereich . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2. Allgemeine Informationen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.1 Zweckbestimmung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.2 Wesentliche Leistungsmerkmale. . . . . . . . . . . . . . . . . . . . . . . . . 17
2.3 Indikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.4 Absolute Kontraindikationen. . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5 Relative Kontraindikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3. Sichere Handhabung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4. Gerätebeschreibung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.1 Lieferumfang. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.2 Zum Betrieb erforderliche Komponenten . . . . . . . . . . . . . . . . . . 18
4.3 Funktionsweise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5. Vorbereiten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6. Arbeiten mit dem Produkt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1 Bereitstellen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1.1 Zubehör anschließen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1.2 Akku einführen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1.3 Intraoperativer Akkuwechsel. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.1.4 Akku entnehmen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.1.5 Sicherung gegen unbeabsichtigtes Betätigen . . . . . . . . . . . . . . 20
6.1.6 Sägeblatt kuppeln und entkuppeln. . . . . . . . . . . . . . . . . . . . . . . 20
6.2 Funktionsprüfung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.3 Bedienung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.1 Produkt betreiben. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7. Validiertes Aufbereitungsverfahren . . . . . . . . . . . . . . . . . . . . . . 21
7.1 Allgemeine Sicherheitshinweise . . . . . . . . . . . . . . . . . . . . . . . . . 21
7.2 Allgemeine Hinweise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.3 Vorbereitung am Gebrauchsort . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.4 Vorbereitung vor der Reinigung . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.5 Reinigung/Desinfektion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.5.1 Produktspezifische Sicherheitshinweise zum
Aufbereitungsverfahren . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.6 Manuelle Reinigung mit Wischdesinfektion . . . . . . . . . . . . . . . 23
7.7 Maschinelle Reinigung/Desinfektion mit manueller
Voreinigung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.7.1 Manuelle Vorreinigung mit Bürste . . . . . . . . . . . . . . . . . . . . . . . 24
7.7.2 Maschinelle alkalische Reinigung und thermische Desinfektion 25
7.8 Kontrolle, Wartung und Prüfung. . . . . . . . . . . . . . . . . . . . . . . . . 25
7.9 Verpackung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.10 Dampfsterilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.11 Lagerung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
8. Instandhaltung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
9. Fehler erkennen und beheben . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
10. Technischer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
11. Zubehör/Ersatzteile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
12. Technische Daten . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
12.1 Klassifizierung gemäß Richtlinie 93/42/EWG . . . . . . . . . . . . . . 29
12.2 Leistungsdaten, Informationen über Normen . . . . . . . . . . . . . . 29
12.3 Nennbetriebsart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
12.4 Umgebungebedingungen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
13. Entsorgung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
1. Geltungsbereich
►Für artikelspezifische Gebrauchsanweisungen und Informationen zur
Materialverträglichkeit siehe auch Aesculap Extranet unter
https://extranet.bbraun.com
2. Allgemeine Informationen
2.1 Zweckbestimmung
Aufgabe/Funktion
Die oszillierende Säge GA331, kombiniert mit entsprechendem Werkzeug,
wird zum Bearbeiten von Hartgewebe, Knorpel und Artverwandtem, sowie
Knochenersatzmaterialien verwendet.
Anwendungsumgebung
Das Produkt erfüllt die Anforderungen des Typs BF gemäß
IEC/DIN EN 60601-1 und wird in OP-Räumen im sterilen Bereich außer-
halb des explosionsgefährdeten Bereichs (z. B. Bereiche mit hochreinem
Sauerstoff oder Anästhesiegasen) eingesetzt.
2.2 Wesentliche Leistungsmerkmale
Allgemein erwärmen sich elektrische Systeme bei Dauerbetrieb. Es ist
sinnvoll, dem System nach der Anwendung Pausen zur Abkühlung zu
gewähren, wie sie in der Tabelle zur Nennbetriebsart zu finden sind.
Die Erwärmung hängt vom verwendeten Werkzeug und der Last ab. Nach
einer bestimmten Anzahl von Wiederholungen sollte das System abkühlen.
Dieses Vorgehen verhindert ein Überhitzen des Systems sowie mögliche
Verletzungen von Patient oder Anwender.
Der Anwender ist verantwortlich für Anwendung und Einhaltung der
beschriebenen Pausen.
Oszillationsfrequenz min. 0 min-1 bis max. 13 000 min-1
Nennbetriebsart Betrieb mit nicht periodischen Last- und
Drehzahländerungen (Typ S9 gemäß IEC
EN 60034-1)
■30 s Anwendung, 30 s Pause
■7 Wiederholungen
■30 min Abkühlzeit
■Max. Temperatur 48 °C

18
Aesculap®Acculan 4
Oszillierende Säge GA331
2.3 Indikationen
Anwendungsart und Anwendungsbereich hängen von dem gewählten
Werkzeug ab.
2.4 Absolute Kontraindikationen
Das Produkt ist nicht zur Anwendung im zentralen Nervensystem bzw.
zentralen Kreislaufsystem zugelassen.
2.5 Relative Kontraindikationen
Der sichere und effektive Gebrauch des Produktes hängt stark von Einflüs-
sen ab, die nur der Anwender selbst kontrollieren kann. Deshalb stellen die
genannten Angaben nur Rahmenbedingungen dar.
Die klinisch erfolgreiche Verwendung des Produkts ist vom Wissen und der
Erfahrung des Chirurgen abhängig. Er muss entscheiden, welche Struktu-
ren sinnvoll behandelt werden können und dabei die in der Gebrauchsan-
weisung genannten Sicherheits- und Warnhinweise berücksichtigen.
3. Sichere Handhabung
■Allgemeine Risiken eines chirurgischen Eingriffs sind in dieser
Gebrauchsanweisung nicht beschrieben.
■Der Operateur trägt die Verantwortung für die sachgemäße Durchfüh-
rung des operativen Eingriffs.
■Der Operateur muss sowohl theoretisch als auch praktisch die aner-
kannten Operationstechniken beherrschen.
►Fabrikneues Produkt nach Entfernung der Transportverpackung und vor
der ersten Sterilisation reinigen (manuell oder maschinell).
►Vor der Anwendung des Produkts Funktionsfähigkeit und ordnungsge-
mäßen Zustand prüfen.
►TA022130 “Hinweise zur elektromagnetischen Verträglichkeit (EMV)”
beachten.
►Um Schäden durch unsachgemäßen Aufbau oder Betrieb zu vermeiden
und die Gewährleistung und Haftung nicht zu gefährden:
– Produkt nur gemäß dieser Gebrauchsanweisung verwenden.
– Sicherheitsinformationen und Instandhaltungshinweise einhalten.
– Nur Aesculap-Produkte miteinander kombinieren.
►Produkt und Zubehör nur von Personen betreiben und anwenden las-
sen, die die erforderliche Ausbildung, Kenntnis oder Erfahrung haben.
►Gebrauchsanweisung für den Anwender zugänglich aufbewahren.
►Gültige Normen einhalten.
►Sicherstellen, dass die elektrische Installation des Raums den Anforde-
rungen nach IEC/DIN EN entspricht.
►Produkt nicht in explosionsgefährdeten Bereichen einsetzen.
►Produkt vor dem Einsatz steril aufbereiten.
►Bei Verwendung der ECCOS-Halterungssysteme relevante Gebrauchs-
anweisung TA009721 einhalten, siehe Aesculap Extranet unter
https://extranet.bbraun.com
4. Gerätebeschreibung
4.1 Lieferumfang
4.2 Zum Betrieb erforderliche Komponenten
■NiMH Akku lang GA676 (geladen)
■Steriltrichter GA678
■Verschlussdeckel GA675
■Sägeblatt (je nach Indikation)
4.3 Funktionsweise
Das Produkt 1besitzt einen elektrischen Motor, der durch einen wechsel-
baren Akku 7mit Spannung versorgt wird.
Der geladene, unsterile Akku 7wird mittels Steriltrichter 6in das
Produkt 1eingeführt und dieses mit dem Verschlussdeckel 9steril ver-
schlossen.
Die Oszillationsfrequenz wird elektronisch geregelt und kann stufenlos mit
dem Drücker zur Regulierung der Oszillationsfrequenz 2reguliert werden.
Das Produkt 1hat eine Kupplung, die es ermöglicht diverse Sägeblätter 11
zu kuppeln. Diese Sägeblätter 11 verriegeln beim Aufstecken auf das Pro-
dukt selbstständig.
Durch Betätigen des Druckknopfs 13 kann das Sägeblatt 11 wieder gelöst
werden.
WARNUNG
Verletzungsgefahr und Sachschaden bei Benutzung
des Produkts entgegen seiner Zweckbestimmung!
►Produkt nur gemäß Zweckbestimmung verwen-
den.
WARNUNG
Verletzungsgefahr und Sachschäden durch falsche
Handhabung des Produkts!
►Gebrauchsanweisungen aller verwendeten Pro-
dukte einhalten.
Art.-Nr. Bezeichnung
GA331 Oszillierende Säge
GA678 Steriltrichter
TA014543 Gebrauchsanweisung für oszillierende Säge
GA331(Faltblatt)