Braun Aesculap Acculan 4 Manual

Aesculap®Acculan 4
Aesculap Power Systems
en Instructions for use/Technical description
Dermatome GA340 / Dermatome 0.1 mm GA341
de Gebrauchsanweisung/Technische Beschreibung
Dermatom GA340 / Dermatom 0,1 mm GA341
fr Mode d’emploi/Description technique
Dermatome GA340 / Dermatome 0,1 mm GA341
es Instrucciones de manejo/Descripción técnica
Dermátomo GA340 / Dermátomo 0,1 mm GA341
it Istruzioni per l’uso/Descrizione tecnica
Dermatomo GA340 / Dermatomo 0,1 mm GA341
pt Instruções de utilização/Descrição técnica
Dermátomo GA340 / Dermátomo 0,1 mm GA341
nl Gebruiksaanwijzing/Technische beschrijving
Dermatoom GA340 / dermatoom 0,1 mm GA341
sv Bruksanvisning/Teknisk beskrivning
Dermatom GA340 / Dermatom 0,1 mm GA341
fi Käyttöohje/Tekninen kuvaus
Dermatom GA340 / Dermatom 0,1 mm GA341
et Kasutusjuhend/Tehniline kirjeldus
Dermatoom GA340 / dermatoom 0,1 mm GA341
ru Инструкция по примению/Техническое описание
Дерматом GA340/дерматом 0,1 мм GA341
cs Návod k použití/Technický popis
Dermatom GA340 / Dermatom 0,1 mm GA341
pl Instrukcja użytkowania/Opis techniczny
Dermatom GA340 / dermatom 0,1 mm GA341
sk Návod na použitie/Technický opis
Dermatóm GA340/Dermatóm 0,1 mm GA341
tr Kullanım Kılavuzu/Teknik açiklama
Dermatom GA340 / Dermatom 0,1 mm GA341

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25
24 21 18 19
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17 16 15
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Aesculap®Acculan 4
Dermatome GA340 / Dermatome 0.1 mm GA341
Legend
1Product (Dermatome)
2Trigger (for oscillation frequency control)
3Safety catch
4Battery bay
5Locking pin
6Sterile funnel
7Battery
8Lid
9Lid release element
10 Battery removal device
11 Dermatome blade
12 Sliding surfaces
13 Blade cover
14 Roll pin
15 Clamping lever
16 Blade guide peg
17 Pusher dog
18 Setting lever
19 Lock (of setting lever)
20 Dial wheel
21 Surface
22 Guide slots
23 Flap rod
24 Flaps
25 Flap tab
26 Nut
27 Symbol for alignment of flaps (on the flap rod)
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
Rotational direction for loosening the nut
Direction of rotation to tighten the nut
Alignment of flaps on the flap rod
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

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.4 Absolute contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
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 . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.4 Removing the rechargeable battery . . . . . . . . . . . . . . . . . . . . . . 5
6.1.5 Protection against inadvertent activation. . . . . . . . . . . . . . . . . 6
6.1.6 To mount the flap rod and flaps. . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1.7 Inserting the dermatome blade . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1.8 Removing the dermatome blade. . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1.9 Intraoperative storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.1 Adjusting the cutting thickness . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.2 Adjusting the cutting width . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.3 Operating the product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.4 Taking skin grafts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.3 Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . . 7
7.4 Disassembling the product before carrying out the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.4.1 Removing the flap rod of the dermatome . . . . . . . . . . . . . . . . . 8
7.5 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.6 Single-use products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.7 Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.7.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.8 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . . 9
7.9 Automatic cleaning/disinfection with manual pre-cleaning . . 10
7.9.1 Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . . 10
7.9.2 Mechanical alkaline cleaning and thermal disinfection. . . . . . 11
7.10 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 11
7.11 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.12 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.13 Sterilization for the US market. . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.14 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
9. Troubleshooting list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
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 Dermatome GA340 / Dermatome 0.1 mm GA341, combined with der-
matome blade, is used for split skin removal in adjustable depth.
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.
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 central
circulatory system.
Oscillation frequency min. 0 min-1 to max. 6 500 min-1
Operating mode Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
■60 second application, 60 second pause
■10 repetitions
■30 min cooling time
■Max. temperature 48 °C

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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 information
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 tech-
niques.
►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 TA022450 "Notes on electromagnetic compatibility (EMC) for
Acculan components", see Aesculap Extranet at
https://extranet.bbraun.com
►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
■Li-Ion battery short GA346 (charged)
■Sterile funnel GA678
■Lid GA675
■Dermatome blade GB228R
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 8so that it is sterile.
The product moves the dermatome blade 11 in oscillation. The oscillation
frequency is controlled electronically and can be continuously regulated
with the trigger 2.
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 dam-
age.
►Use the products and their accessories only if they are in perfect tech-
nical condition.
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
GA340
GA341
Dermatome
– or –
Dermatome 0.1 mm
GA678 Sterile funnel
TA014549 Instructions for use of Dermatome GA340/GA341
(flyer)

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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.
►Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact 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, see Fig. A.
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.
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.
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 tech-
nical condition, see Function check
WARNING
Risk of injury and/or malfunction due to unrecog-
nized change to cutting setting!
The basic adjustment of the cutting setting can
change if the product falls on the floor, for exam-
ple.
►Do not use product.
►Have the manufacturer inspect the product.
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).
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.

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►Turn the product 1with the battery shaft 4upwards.
►Press both safety catches 9on 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 blade change, for
example, the trigger can be locked.
To lock trigger:
►Twist the safety catch 3to position OFF.
The trigger 2is blocked and the product 1cannot be operated.
To unlock trigger:
►Twist the safety catch 3to position ON.
The trigger 2is unlocked and the product 1can be operated.
6.1.6 To mount the flap rod and flaps
►Install the flaps 24 on flap rod23 to the edge of the rear surface.
Observe the symbol 27 on the face of the thread, see Fig. C.
►Screw the nut 26 counterclockwise onto the thread of flap rod 23
(left-handed thread).
►Turn the nut 26 up to the edge of the visible surface.
►Insert and twist the complete flap rod 23 in its guide slots 22 on the
side surfaces.
►Push the flap rod 23 laterally all the way so that the cross pin of the
flap rod 23 comes to rest in the guide slot 22.
►Tighten nut 26 by turning it counterclockwise.
6.1.7 Inserting the dermatome blade
►Engage safety catch 3.
►Push both clamping levers 15 in the direction of the arrows, see Fig. C.
Blade cover 13 is now unlocked.
►Open blade cover 13 in the direction of the arrow.
►Safely insert dermatome blade 11 in pusher dog 17 and blade guide
peg 16, see Fig. D.
►Close blade cover 13.
►Tighten both clamping levers 15 so that roll pin 14 engages in the
recess of clamping lever 15.
6.1.8 Removing the dermatome blade
►Release both clamping levers 15.
►Open blade cover 13.
►Remove the dermatome blade 11 from pusher dog 17 and blade guide
peg 16.
6.1.9 Intraoperative storage
Note
The ECCOS fixation can be used for intraoperative storage. The dermatome
can not be processed in this position, however. For the correct processing
position, see Validated reprocessing procedure.
►Engage safety catch 3.
►Fold back the clamp of the ECCOS fixation.
►Insert product 1in the ECCOS fixation, see Fig. E
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.
►Ensure that the dermatome blades are not mechanically damaged.
►Ensure that a dermatome blade is correctly seated in the dermatome.
►Check that the dermatome blade is securely seated.
►Check that the roll pin is securely seated.
►Release product for use (ON position).
►Briefly operate product at maximum oscillation frequency.
►Make certain that the rotational direction is correct in each case.
►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).
Note
The slight whistling noise when the product is starting up is due to the con-
struction.
6.3.1 Adjusting the cutting thickness
Note
The skin condition (e.g. due to age) of the patient must be considered when
adjusting the cutting depth (graft thickness).
►Set the cutting depth with setting lever 18. The lock 19 of the setting
lever 18 prevents any unintentional change to the setting of the cut-
ting depth, see Fig. C.
►Read the cutting depth on dial wheel 20 (1/10 mm gradation).
►Follow the troubleshooting information, see Troubleshooting list.
DANGER
Risk of infection and contamination due to torn or
cut surgical gloves!
►Avoid contact with the cutting edge when
inserting the dermatome blade.
DANGER
Risk of injury and material damage due to inadver-
tent activation of the dermatome while inserting
the dermatome blade!
►Prior to inserting the dermatome blade, engage
the safety catch, see Protection against inadver-
tent activation.
WARNING
Risk of infection or injury due to aerosol formation
or particles!
►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.

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6.3.2 Adjusting the cutting width
Note
The width of the skin graft will be approx. 2mm less than the cutting width
set by the flaps.
►Set the required cutting width by opening the appropriate number of
flaps 24.
►Safely lift flaps 24 by pressing flap tabs 25, see Fig. F.
6.3.3 Operating the product
Note
The slight whistling noise when the product is starting up is due to the con-
struction.
►Activate trigger 2.
The saw runs at the continuously controlled oscillation frequency.
6.3.4 Taking skin grafts
Note
To familiarize with the operation of the Dermatome prior to itsfirst surgical
application, the user should carry out some test cuts on a specimen.
►Stretch flabby skin.
►With the sliding surface in level contact with the skin, push product 1
forward in a smooth movement, applying gentle pressure. Be careful
not to cant the product 1.
►For very thin grafts, use a forceps, from time to time, to lay up the
resected portion of the graft on surface 21, see Fig. C.
►Turn off the motor and pull the freshly cut skin graft out of the device
- or -
►Lower the handle and cut off the skin graft with the product 1.
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 overmanual 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.
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 applica-
tion 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 rins-
ing 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 (dermatome blade,
battery, accessories).
►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 Disassembling the product before carrying out the
reprocessing procedure
►Remove battery 7from the product 1, see Removing the rechargeable
battery.
►Open the clamping levers 15 to remove the dermatome blade 11, see
Removing the dermatome blade.
►Disassemble the product 1immediately after use, according to instruc-
tions.
WARNING
Risk of injury/cuts by the dermatome blade if the
flaps are opened incorrectly!
►Always use the flap tabs for lifting the flaps.

8
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7.4.1 Removing the flap rod of the dermatome
►Loosen nut 26 by turning it clockwise (left-handed thread).
►Screw the nut 26 back to the end of the visible surface.
►Press on nut 26 and push flap rod 23 approx. 4 mm to one side.
►Twist flap rod 23 until it can be removed.
►Remove flap rod 23.
►Slide off the flaps 24 from flap rod 23.
The flap rod 23 has been dismantled.
7.5 Preparation before cleaning
►Prior to the first mechanical cleaning/disinfection process, mount the
ECCOS fixations in a suitable tray (e.g. JC254R) or use the ECCOS tray
GB256R with fixations equipped.
►Insert the products in the correct position into the ECCOS fixations, see
Fig. G.
7.6 Single-use products
Dermatome blade GB228R
7.7 Cleaning/disinfection
7.7.1 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.
WARNING
Risk of infection for patients and/or users and
impairment of product functionality due to reuse.
Risk of injury, illness or death due to contamination
and/or impaired functionality of the product!
►Do not reprocess the dermatome blade GB228R.
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.

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7.8 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 com-
ponents 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 - D–W Until visually clean
II Cleaning with enzyme solution RT (cold) ≥2 0.8 D–W pH-neutral*
III Intermediate rinse RT ≥5- D–W –
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 - - - -

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7.9 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 serviced
and checked at regular intervals.
7.9.1 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
►Dismantle the flap rod for cleaning. Store flap rods, flaps and nut sep-
arately in tray.
►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 qual- ity Chemistry/Note
IRinsing RT (cold) - - D–W Until visually clean
II Brushes RT (cold) - - D–W Until visually clean

11
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7.9.2 Mechanical alkaline cleaning and thermal disinfection
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
►Insert the product in its proper position in the ECCOS fixation. Insert
the battery compartment over the clamp and swivel device into the
ECCOS fixation so that the trigger 2points upwards.
►Ensure that the blade cover 13 is kept open through the entire process-
ing procedure.
►Dismantle the flap rod 23 for cleaning. Store flap rod 23, flaps 24 and
nut 26 separately in tray.
►After automatic cleaning/disinfection, check visible surfaces for resi-
dues and repeat the cleaning/disinfection process as needed.
7.10 Inspection, maintenance and checks
Note
Aesculap recommends lubricating the flap rod, flaps, sliding surfaces and
other moving parts, (e.g. trigger, cover lids) with STERILIT-Power-Systems
oil spray GB600 or the STERILIT-Power Systems drip lubricator GA059 prior
to every sterilization. Remove excess oil with a lint-free wipe.
►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.
►Set aside the product if it is damaged.
7.11 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. G.
►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.
Phase Step T
[°C/°F] t [min] Water qual- ity Chemistry/Note
I Pre-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

12
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7.12 Steam sterilization
Note
The product may only be sterilized with the blade, battery and lid as well as
opened blade cover all demounted.
Note
The product can be sterilized with a mounted flap tab and flaps in the open
position.
►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.
7.13 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.
7.14 Storage
►Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
►Store sterile single-use GB228R product in germ-proof packaging in a
dry, dark and temperature-controlled room.
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.
CAUTION
Damage or destruction of the batteries due to pro-
cessing!
►Do not sterilize the rechargeable battery.
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

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9. Troubleshooting list
►Have defective products repaired by Aesculap Technical Service, see Technical Service.
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
sterilization.
Fall damage, product defective Product heating Have the manufacturer repair the product.
Blunt tool Heating of tool and product Change tool.
Insufficient power Product defective Insufficient product performance Follow operating instructions (preparation,
care).
Preventative: lubricate product before every
sterilization.
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
Blunt tool Tool blades worn out Change tool.
Loud running noise Defective product drive/ball
bearings
Loud, perceptible noise during operation Follow operating instructions (preparation,
care).
Preventative: lubricate product before every
sterilization.
Have the manufacturer repair the product
Lid cannot be
attached/removed
Lid not compatible Lid does not click into place Use the compatible lid for GA340/GA341.
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 GA340/GA341.
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 battery
removal device not
attachable
Sterile funnel or battery
removal device not compatible
Sterile funnel or battery removal device
not attachable to the battery shaft
Use compatible sterile funnel or battery removal
device for GA340/GA341.
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.

14
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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
Dermatome blade not
moving
Defective gearings Product runs loudly Have the manufacturer repair the product
Insufficient cutting per-
formance of dermatome
blade
Dermatome blade blunted Worn cutting edge of dermatome blade Replace dermatome blade
Adjusted dermatome Product has insufficient power Have the manufacturer repair the product
Cutting depth
uneven/deviating from
setting
Skin grafts uneven / too thick /
too thin
Mechanical influence (e.g. fall on floor) Have the manufacturer repair the product
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
GA059 STERILIT-Power-Systems drip lubricator (50 ml)
GA346 Li-Ion battery short
GA340345 Nut
GA643817 Flap rod
GA670210 Flap
GA675 Lid
GA678 Sterile funnel
GA679 Battery removal device
GB228R Dermatome blade
GB256R ECCOS set for dermatome
GB487R ECCOS fixation for lid
GB488R ECCOS fixation for sterile funnel
GB489R ECCOS fixation for battery removal device
GB498R ECCOS fixation for straight machine
GB600 STERILIT Power Systems oil spray
TA014548 Instructions for use of Dermatome GA340/GA341
(A4 for ring binder)
TA014549 Instructions for use of Dermatome GA340/GA341
(flyer)

15
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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 Canada
for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Art. no. Designation Class
GA340 Dermatome IIa
GA341 0.1 mm Dermatome IIa
Max. power approx. 250 W
Max. oscillation frequency 6500min
-1
Blade travel approx. 3.1 mm
Cutting depth setting 0.2 mm to 1.2 mm (with GA340)
0.1 mm to 1.1 mm (with GA341)
Scale gradations of 1/10 mm
Cutting width max. approx. 78 mm, set by
10 flaps of width 8 mm
Weight (operational) 1.65 kg ±10 %
Dimensions (L x W x H, ready for
operation)
277 mm x 113 mm x 83 mm ±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)
■60 second application, 60 second
pause
■10 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.

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Aesculap®Acculan 4
Dermatom GA340 / Dermatom 0,1 mm GA341
Legende
1Produkt (Dermatom)
2Drücker (zur Regulierung der Oszillationsfrequenz)
3Drückersicherung
4Akkuschacht
5Verriegelungsbolzen
6Steriltrichter
7Akku
8Verschlussdeckel
9Verschlussentriegelung
10 Akku Entnahmehilfe
11 Dermatomklinge
12 Gleitflächen
13 Klingen-Abdeckung
14 Spannbolzen
15 Spannhebel
16 Klingenführungszapfen
17 Mitnehmerzapfen
18 Stellhebel
19 Arretierung (des Stellhebels)
20 Skalenscheibe
21 Fläche
22 Führungsschlitze
23 Klappenstange
24 Klappen
25 Klappennase
26 Mutter
27 Symbol zur Ausrichtung der Klappen (auf der Klappenstange)
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
Drehrichtung zum Lösen der Mutter
Drehrichtung zum Festziehen der Mutter
Ausrichtung der Klappen auf Klappenstange
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
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Inhaltsverzeichnis
1. Geltungsbereich. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2. Allgemeine Informationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.1 Zweckbestimmung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.2 Wesentliche Leistungsmerkmale . . . . . . . . . . . . . . . . . . . . . . . . 17
2.3 Indikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.4 Absolute Kontraindikationen . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1.4 Akku entnehmen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
6.1.5 Sicherung gegen unbeabsichtigtes Betätigen . . . . . . . . . . . . . . 20
6.1.6 Klappenstange und Klappen montieren . . . . . . . . . . . . . . . . . . . 20
6.1.7 Dermatomklinge einlegen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.1.8 Dermatomklinge entnehmen . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.1.9 Intraoperatives Ablegen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.2 Funktionsprüfung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.3 Bedienung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.3.1 Schnittstärke einstellen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.2 Schnittbreite einstellen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.3 Produkt betreiben . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.3.4 Hauttransplantate entnehmen . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7. Validiertes Aufbereitungsverfahren . . . . . . . . . . . . . . . . . . . . . . 21
7.1 Allgemeine Sicherheitshinweise . . . . . . . . . . . . . . . . . . . . . . . . . 21
7.2 Allgemeine Hinweise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
7.3 Vorbereitung am Gebrauchsort. . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.4 Demontage vor der Durchführung des Aufbereitungsverfahrens 22
7.4.1 Klappenstange des Dermatoms demontieren . . . . . . . . . . . . . . 22
7.5 Vorbereitung vor der Reinigung . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.6 Produkte für den einmaligen Gebrauch . . . . . . . . . . . . . . . . . . . 22
7.7 Reinigung/Desinfektion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.7.1 Produktspezifische Sicherheitshinweise zum
Aufbereitungsverfahren. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
7.8 Manuelle Reinigung mit Wischdesinfektion . . . . . . . . . . . . . . . 23
7.9 Maschinelle Reinigung/Desinfektion mit manueller
Voreinigung . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
7.9.1 Manuelle Vorreinigung mit Bürste . . . . . . . . . . . . . . . . . . . . . . . 24
7.9.2 Maschinelle alkalische Reinigung und thermische Desinfektion 25
7.10 Kontrolle, Wartung und Prüfung . . . . . . . . . . . . . . . . . . . . . . . . 25
7.11 Verpackung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
7.12 Dampfsterilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
7.13 Lagerung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
8. Instandhaltung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
9. Fehler erkennen und beheben. . . . . . . . . . . . . . . . . . . . . . . . . . . 27
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
Das Dermatom GA340 / Dermatom 0,1 mm GA341, kombiniert mit Derma-
tomklinge, wird zur Gewinnung von Spalthaut in einstellbarer Dicke ver-
wendet.
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.
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.
Oszillationsfrequenz min. 0 min-1 bis max. 6 500 min-1
Nennbetriebsart Betrieb mit nicht periodischen Last- und
Drehzahländerungen (Typ S9 gemäß IEC EN
60034-1)
■60 s Anwendung, 60 s Pause
■10 Wiederholungen
■30 min Abkühlzeit
■Max. Temperatur 48 °C

18
de
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.
►"Hinweise zur elektromagnetischen Verträglichkeit (EMV) für Acculan
Komponenten" TA022450 beachten, siehe Aesculap Extranet unter
https://extranet.bbraun.com
►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
■Li-Ionen Akku kurz GA346 (geladen)
■Steriltrichter GA678
■Verschlussdeckel GA675
■Dermatomklinge GB228R
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 8steril ver-
schlossen.
Das Produkt versetzt die Dermatomklinge 11 in Oszillation. Die Oszillati-
onsfrequenz wird elektronisch geregelt und kann stufenlos mit dem
Drücker 2reguliert werden.
5. Vorbereiten
Wenn die folgenden Vorschriften nicht beachtet werden, übernimmt
Aesculap insoweit keinerlei Verantwortung:
►Kein Produkt aus offenen oder beschädigten Sterilverpackungen ver-
wenden.
►Vor der Verwendung Produkt und dessen Zubehör auf sichtbare Schä-
den prüfen.
►Nur technisch einwandfreie Produkte und Zubehörteile verwenden.
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
GA340
GA341
Dermatom
– oder –
Dermatom 0,1 mm
GA678 Steriltrichter
TA014549 Gebrauchsanweisung für Dermatom GA340/GA341
(Faltblatt)