Aesculap Acculan 3Ti
Aesculap Power Systems
CID lnstructions for use
Acculan 3Ti Dermatome GA670
CD Gebrauchsanweisung
Acculan 3Ti Oermatom GA670
CD Mode d'emploi
Acculan 3Ti Oermatome GA670
CD Instrucciones de manejo
Acculan 3Ti Dermtomo GA670
CD lstruzioni per l'uso
Acculan 3Ti Oermatomo GA670
CD lnstru oes de utiliza ao
Acculan 3Ti Dermtomo GA670
( E h ) Gebruiksaanwijzing
Acculan 3Ti Oermatoom GA670
BIBRAUN
CD Bruksanvisning
Acculan 3TI Oermatom GA670
@ ) IIIHCTPYK1.1"1A no np"1MeHeH"110
Acculan 3Ti ,QepMaTOM GA670
@) Nvod k pouf
Acculan 3TI Oermatom GA670
@) lnstrukcja uzytkowania
Acculan 3TI Oermatom GA670
@) Nvod na pouzvanie
Acculan 3TI Oermatm GA670
@ ) Kullanim Kllavuzu
Acculan 3TI Oermatom GA670
SHARING EXPERTISE
 9
1o i i i m l"1i...1111!!!"
9-..--,

12

18
 25

22 22
@
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

Note Symbols on product and packages

Sto re the instructions far use far Acculan 3Ti in a folder!
Caution, general warning sym-
bol
Legend Caution, see documentation
1 Dermatome supplied with the product
2 Nut
Follow the instructions for use
3 Sliding surfaces
4 Trigger (for controlling the oscillation frequency)
5 Safety catch
6 Blade cover Marking of electric and elec-
7 Clamping lever tronic devices according to
8 Sliding surfaces directive 2002/96/EC (WEEE}.
9 Blade guide peg see Disposal
1O Pusher dog
11 Flap tabs
12 Flaps Classification Type BF
13 Surface
14 Setting lever

T
15 Lock (of setting lever)
16 Dial wheel '' Keep this product dry!
17 Roll pin
18 Flap rod
19 Guide slots
20 Sterile funnel
21 Cover Adjusting the oscillation fre-
22 Cover release button quency
23 Battery
24 Dermatome blade
25 Battery removal device
26 Coding
 The battery requires no mainte- Contents
nance. Since battery cells are 1. Safe handling 4
subject to wear and ageing, 2. Product description 4
Aesculap recommends replac-
2.1 Scope of supply 4
ing the battery cells every
2.2 Components required for operation 4
12 months.
2.3 lntended use 4
See also stamp/label for the
next recommended battery cell 2.4 Operating principie 5
replacement date at the inter- 3. Prepa ration 5
national B. Braun/Aesculap 4. Working with the
agency, see Technical Service Acculan 3Ti Dermatome 5
4.1 System set-up 5
Remove adhesive label before
4.2 Function checks 11
charging the battery for the
4.3 Safe operation 12
first time
5. Validated reprocessing procedure 14
5.1 General safety instructions 14
5.2 Single-use products 14
Rotational direction for loosen- 5.3 General information 14
ing the nut

a
5.4 Dismantling prior to carrying out the
reprocessing procedure 15
Direction of rotation to tighten
5.5 Preparations at the place of use 16
the nut
5.6 Preparation before cleani ng 16
Service sticker on Acculan 3Ti 5.7 Clea ni ng/disi nfection 16
Dermatome 5.8 Manual cleaning/disinfecting 19
Reference to the next due 5.9 Mechan ical cleaning/disinfecting 21
maintenance appointment
5.10 lnspection, maintenance and checks 22
(date) with the international
5.11 Packaging 22
B. Braun/Aesculap agency, see
5.12 Steam sterilization 22
Technical Service
5.13 Sterilization for the US market 23
5.14 Storage 23
6. Maintenance 23
7. Troubleshooting list 24
Date of manufacture 8. Technical Service 24
9. Accessories/Spare parts 25
10. Technical data 25
10.1 Ambient conditions 26
11. Disposal 27
12. Distributor in the US/Contact in Canada
for product information and complaints 27
@@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

1. Safe handling 2. Product description

CAUTION
Federal law restricts this device to sale by, or on 2.1 Scope of supply
order o f a physician !
.,. Remove the transport packaging and clean the new Designation Art. no.
product, either manually or mechanically, prior to
Acculan 3Ti Dermatome GA670
its initial sterilization .
.,. Prior to use, check that the product is in good Cover GA675
working order.
Sterile funnel GA678
.,. To prevent damage caused by improper setup or
operation, and in arder not to compromise war- Battery GA666
ranty and manufacturer liability:
- Use the product only according to these lnstructions for use TA013000
instructions for use. lnstructions for use for TAOl 1867
- Follow the safety and maintenance instruc- battery GA666
tions.
- Only combine Aesculap products with each
other. 2.2 Components required for opera-
.,. Ensure that the product and its accessories are tion
operated and used only by persons with the requi-
site training, knowledge, or experience . Designation Art. no.
.,. Use product and accessories in su rgery and/or in
STERILIT Power Systems GA059
the framework of emergency medical treatment.
dripping oils (50 mi)
.,. Keep the instructions for use accessible for the
user . Acculan 3Ti Dermatome GA670
.,. Always adhere to applicable standards.
Cover GA675
.,. Follow the instructions for use for the Acculan 3Ti
charger TA022160. Sterile funnel GA678

Battery GA666

Charger GA677

Dermatome blade GB228R

STERILIT Power Systems GB600

ol spray (300 mi)

2.3 lntended use

The Acculan 3Ti Dermatome is used in dermatology/
traumatology for obtaining skin grafts.
2.4 Operating principie
In the Acculan 3Ti, the rotational speed o f the motor is
converted, through reduction gearing and an eccentric
drive unit, directly and with mnimum loss into oscil-
lating movement o f the dermatome blade.
lnstalling the flap rod o f the Acculan 3Ti der-
matome
3. Preparation
Non-compliance with the following instructions will
preclude ali responsibility and liability in this respect
on the part o f Aesculap.
Check the Acculan 3Ti dermatome and its accesso-
ries far visible damage befare use.
Use Acculan 3Ti dermatomes and accessories on ly
i f they are in perfect condition.
4. Working with the
Acculan 3Ti Dermatome
Please address your B. Braun/Aesculap partner or
Aesculap Technical Service with any inquiries in
this respect; far a contact address, see Technical
Service.
Attach flaps 12 on flap rod 18 down to the onset
o f the rear surface. Observe the symbol on the face
o f the thread.
Screw the nut 2 counterclockwise onto the thread
o f flap rod 18 (left-handed thread).
Turn the nut 2 up to the edge o f t h e visible surface.
lnsert and twist the complete flap rod 18 in its
guide slots 19 on the side surfaces.
Push the flap rod 18 laterally all the way so that
the cross pin o f t h e flap rod 18 comes to rest in the
guide slot 19.
Tighten nut 2 by turning i t counterclockwise.

4.1 System set-up

Connecting the accessories

A
DANGER
Risk of injury due to unap-
proved configuration using
additional components!
For ali applied components,
ensure that their classifi-
cation matches that of the 18 19
application component
(e.g. Type BF or Type CF) of Fig. 1 Mounting the flap rod
the respective device.

Combinations o f accessories that are not mentioned in

the present instructions far use may only be employed
i f they are specifically intended far the respective
application, and i f they do not compromise the perfor-
mance and safety characteristics o f the products.
@@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

lnserting the dermatome blade Removing the dermatome blade

.., Release both clamp levers 7.
Risk o f infection and contam-
.., Open blade cover 6.
ination due to torn or cut sur-
.., Remove the dermatome blade 2 4 from the pusher
gical gloves!
DANGER dog 1O and blade guide peg 9, see Fig. 2.
.., Avoid contact with the
cutting edge when insert-
ing the dermatome blade.

Risk o f injury and material

damage due to inadvertent
activation o f the dermatome
DANGER
while inserting the dermatome
blade!
.., Prior to inserting the blade,
engage the safety catch .

.., Engage safety catch 5 .

.., Push both da mp levers 7 in the direction of the
arrows.
Blade cover 6 is now unlocked. Fig. 2 Safe insertion and removal of the dermatome
blade
.., Open blade cover 6 in the direction of the arrow .
.., Safely insert the dermatome blade 2 4 into the
pusher dog 1O and blade guide peg 9, see Fig. 2 .
.., Close blade cover 6 .
.., Cock both clamp levers 7 so that the roll pin 17
grips into the recess of the clamp lever 7.
lnserting the battery .,. Get a helper to insert a battery 23 (unsterile)

&
through the sterile funnel 20 into the battery com-
Damage to, or destruction of partment (observe coding 26), see Fig. 4.
the batteries due to process-
ing !
CAUTION
.,. Do not sterilize batteries .

..,. Hold dermatome 1 so that the battery compart-

ment is facing upwards .
.,. Set the sterile funnel 20 in place, see Fig. 3.

Fig. 4 lnstalling the sterile funnel in the battery

compartment

Note
Once the battery is in the battery compartment, a series
o f acoustic blips wi/1 signa/ that the dermatome is ready
Fig. 3 lnstalling the sterile funnel for operation.

Note
The color code on the floor o f the battery compartment
must match the colorcode at the bottom ofthe battery.
@(@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

""' Once the battery has been inserted, have a helper ""' Mount cover 21 (sterile) in such a way that it
remove sterile funnel 20 (unsterile), see Fig. 5. engages at both cover release buttons 22, see Fig.
6.

Fig. 5 Removing the sterile funnel

Fig. 6 Mounting the cover

Note
Sterility of the unit is ensured on/y i f the cover is
mounted correctly.
Removing the battery 111- Hold dermatome 1 with the battery compartment

A
pointing upward.
Damage to the dermatome 111- Press both cover release buttons 22 on the
and/or battery caused by cover 21 simultaneously and remove cover 21.
knocking the unit against hard 111- With one hand, completely envelope the battery
CAUTION
objects! compartment at its lower end, see Fig. 7.
111- Only tap the dermatome
against the palm o f the
hand.
111-To remove the battery, only
ever knock the motor unit
against the palm o f the
hand.

Note
The battery must be removed after the surgical opera-
tion and prior to processing.

Note
Jf necessary, the battery removal device can be used to
facilitate removal o f the battery, see Fig. 9!

Fig. 7 Tapping the dermatome

@(@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

... Remove battery 23 from the battery compartment ... Hold dermatome 1 with the battery compartment
by knocking the unit against the palm of the hand, upward and remove cover 21.
see Fig. 8. ... Mount sterile battery removal device 25, see Fig. 9.

25

Fig. 8 Removing the battery

lntraoperative battery change

Note
The function checks must be corried out prior to eoch
surgica/ applicatian a f the unit and after each intraap-
erative battery change!
The battery removal device is used for intraoperative
battery changes ensuring that sterile conditions are
safely maintained.
Fig. 9 Using the battery removal device
... Slightly shake dermatome 1 with battery removal
device 25 mounted and the battery compartment
facing downward.
Rechargeable battery 23 will slip smoothly into
battery removal aid 25.
... Hand battery removal device 25 containing the
discharged battery 23 to an unsterile helper.
... lnsert charged battery 23, see lnserting the bat-
tery.
Protection against inadvertent activation
To prevent inadvertent activation of dermatome 1
while replacing the dermatome blade, trigger 4 must
be locked.
To lock trigger 4: Move safety catch 5 to its OFF
111>-
position, see Fig. 10.
Trigger 4 is locked. Dermatome 1 cannot be acti-
vated.
To unlock trigger 4: Move safety catch 5 to its ON
111>-
position, see Fig. 1O.
Trigger 4 is unlocked. Dermatome 1 can be acti-
vated.
Fig. 1O Engaging the safety catch
lntraoperative storage
Note
Eccos holder can be used for intraoperative storage o f
the dermatome. The dermatome can not be processed
in this position. For the correct processing position, see
Validated cleaning and disinfection procedure!
111>- Engage safety catch 5 against inadvertent activa-
tion, see Protection against inadvertent activation.
111>- Fold back the clamp of the Eccos holder.
111>- Place dermatome 1 in the Eccos holder, see Fig. 11.
Fig. 11 Storing the dermatome ready for operation in
its Eccos holder
4.2 Function checks
Note
The function checks must be carried out prior to each
surgical appfication ofthe unit and aftereach intraop-
erotive battery change!
.,.. Follow the advisories/procedure for inspection,
maintenance and checks, see lnspection, mainte-
nance and checks.
111>-Ensure that a dermatome blade is correctly seated
in the dermatome.
111>-Make certain that a battery has been installed.
.,.. Check that the roll pin is securely seated.
111>-Check that the dermatome blade is securely seated.
111>-Briefly actvate the dermatome at maximum oscil-
lation frequency.
@@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

4.3 Safe operation Adjust the cutting depth of the Acculan 3Ti

A
dermatome
Risk of injury caused by inad- Note
vertent activation of the The skin condition (e.g. due to age] o f the patient must
motor!
WARNING be considered when adjusting the cutting depth (graft
.,. Secure dermatomes that thickness) !
are not actually used
against inadvertent activa- .,. Adjust the cutting thickness with the setting
tion. lever 14.

A
Risk of injury dueto aerosol
formation and particles!
WARNING .,. Always wear eye protection
gear when using the der-
matome.
Lock 15 of setting lever 14 prevents inadvertent
changes of the cutting depth setting.
.,_ Read the cutting depth (graft thickness) on dial
wheel 16 (1 /10 mm gradation) .
.,. Follow the troubleshooting advisories/procedure,
see Troubleshooting list.

A Risk of injury and/or malfunc-

tion!
Adjust the cutting width of the Acculan 3Ti
dermatome

A
WARNING .,_ Always carry out a func-
tion check prior to using Risk of injury/cuts by the der-
the product. matome blade if the flaps are
opened incorrectly!
WARNING
Note .,_ Always use the flap tabs
The motor found within this Acculan 3Ti hand piece is for lifting the flaps.
powered by a magnetic system. To ensure that the
motor o f this powered instrument does not inadver- Note
tently actvate, do not al/ow the hand piece to come in The width o f the skin graft wi/1 be approx. 2mm /ess
contact with any magnetic sources {i.e. magnetic than the cutting width set by the flaps!
instrument pads). Please note that having the safety
switch in the locked position does not assure that the
motor wi/1 not run inadvertently.
.,. Set the required cutting width by opening the
appropriate number of flaps 12.
.,. Safely lift flaps 12 by pressing flap tabs 11, see Fig.
12.
Fig. 12 Safely lifting the flaps
.,. Completely open flaps 12 until they engage in their
end positions (flap width = 8 mm).
Operate Acculan 3Ti dermatome
Note
The low howling noise heard during startup of the
Acculan 3Ti Dermatome is normal far this product!
.,. Press trigger 4.
The saw runs at the continuously controlled oscil-
lation frequency.
Taking skin grafts
To familiarize with the operation of the Acculan 3Ti
Dermatome prior to its first surgical application, the
user should carry out sorne test cuts on a specimen .
.,. Stretch flabby skin .
.,. With the cutting surface in contact with the skin to
be cut, smoothly push forward the dermatome 1,
applying gentle pressure. Be careful not to cant
dermatome 1.
.,. For very thin grafts, use a forceps, from time to
time, to lay up the resected portien of the graft on
surface 13 .
.,. 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
dermatome 1.
@@
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

5. Validated reprocessing pro- 5.2 Single-use products

cedure
5.1 General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and laca/, clini-
cal hygiene instructions for sterile processing.
Note
Far patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJO or possible variants of CJO, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing shou/d be favored over man-
ual c/eaning as it gives better and more re fiable results.
Note
Successful processing of this medica/ device can only
be ensured i f the processing method is first validated.
The operator/sterile processing technician is responsi-
ble far this.
The recommended chemistry was used far va/idation.
Note
l f there is no final sterilization, then a virucidal disin-
fectant must be used.
Note
Far the latest information on reprocessing and material
compatibility see a/so the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
lnfection hazard for patients
and/or users and impairment
of product functionality due
WARNING
to reuse. Risk of injury, illness
or death dueto contamination
and/or impaired functionality
of the product!
._ Do not reprocess the prod-
uct !
Designation Art. no.
Dermatome blade GB228R
5.3 General information
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore the time interval between application and
processing should not exceed 6 h; also, neither fixating
pre-cleaning temperatures >45 e nor fixating disin-
fecting agents (active ingredient: aldehydes/alcohols)
should be used.
Excessive me asures of neutralizi ng agents or basic
cleaners may result in a chemical attack and/or to fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
Additional drying, if necessary.
Only process chemicals that have been tested and
approved (e.g. VAH or FDA approval or CE mark) and
which are compatible with the product's materials
according to the chemical manufacturers' recommen-
dations may be used for processing the product. AII the
chemical manufacturer's application specifications
must be strictly observed. Fa ilure to do so can result in
the following problems:
Optical changes of materials, e.g. fading or discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes.
Material damage such as corrosion, cracks, fractur-
ing, premature aging or swelling.
.,. Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
.,. Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, link to Publications, Red
Brochure - Proper maintenance of instruments.
5.4 Dismantling prior to carrying out
the reprocessing procedure
.,. Remove the batteries from the Acculan 3Ti Derma-
tome see Removing the battery.
.,. Open the clamping levers and remove the derma-
tome blade.
.,. Disassemble the product immediately after use, as
described in the respective instructions for use.
Removing the flap rod of the Acculan 3Ti der-
matome
.,. Loosen nut 2 by turning it clockwise (left-handed
thread).
.,. Screw the nut 2 back to the end of the visible sur-
face.
.,. Press on nut 2 and push flap rod 18 approx. 4 mm
to one side .
.,. Twist flap rod 18 until it can be removed.
.,. Remove flap rod 18.
.,. Slide o f f the flaps 12 from flap rod 18.
The flap rod 18 has been dismantled, see Fig. 13.
18 19
Fig. 13 Flap rod dismantled
@e@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

&
5.5 Preparations at the place of use Damage to the product d u e t o
11>- Remove any visible surgical residues to the extent inappropriate cleaning/disin-
possible with a damp, lint-free cloth. fecting agents and/or exces-
CAUTION
11>- Transport the dry product in a sealed waste con- sive temperatures!
tainer for cleaning and disinfection within 6 hours. 11>- Use cleaning and disinfect-
ing agents according to the
5.6 Preparation before cleaning manufacturer's instruc-
tions which
11>- Carry out non-fixating/NaCl-free pre-cleaning
- be approved for plastic
immediately after use.
material and high-
grade steel,
5.7 Cleaning/disinfection - do not attack softeners
(e.g. in silicone).
Product-specific safety instructions for the
11>- Observe specifications
reprocessing procedure

&
regarding concentration,
Risk o f damage to the product temperature and exposure
due to inappropriate cleaning/ time.
disinfecting agents !? 11>- Do not exceed the maxi-
CAUTION
11>- Only use cleaning/disin- mum permitted cleaning
fecting agents approved temperature o f 60 C.
for surface cleaning. Fol-
11>- Do not clean motors/handpieces by ultrasonic
low the manufacturer's
treatment and do not immerse them in any liquids.
instructions for the respec-
To avoid the risk of corrosion/malfunctioning,
tive cleaning/disinfecting
allow any fluid that has entered the product to
agent.
drain out immediately.
Validated cleaning and disinfection procedure

Validated procedure Special features Reference

Manual cleaning and Dismantle the flap rod for clean- Chapter Manual cleaning/disinfecting and
wipe disinfection ing. su bsection:
When cleaning instruments with Chapter Manual cleaning and wipe dis-
movable hinges, ensure that these infecting
are in an open position and, if
applicable, move the joint while
cleaning.
Drying phase: Use a lint-free cloth
or compressed air for medical
purposes
Ensure that the product is posi-
tioned in such a way that water
will not enter the product e.g.
through coupling interfaces.
(lmmediately remove any fluid
that ente red the product inadver-
tently.)
@(@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670
Validated procedure Special features
Mechanical alkaline
cleaning and thermal
disinfecting
Fig. 14 Tray with product in Eccos holder
Reference
Dismantle the flap rod for clean- Chapter Mechanical cleaning/disinfecting
ing. Store flap rods, flaps and nut and subsection:
separately. Chapter Mechanical alkaline cleaning
Ensure that the blade cover is and thermal disinfecting
kept open through the entire pro-
cessing procedure.
Use Eccos tray GB256R fitted
Acculan 3Ti holders; or mount
appropriate holders (e.g. Eccos
holder GB498R) in a suitable tray
(instructions for use TA009721
for Aescu lap Eecos storage sys-
tem).
lnsert the product into the Eccos
holder GB498R in the correct
position with the trigger facing
upwards. lnsert the battery com-
partment over the clamp and
swivel device into the Eccos
holder so that the trigger points
upwards, see Fig. 14.
5.8 Manual cleaning/disinfecting
.,. Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution .
.,. After manual cleaning/disinfection, check visible
surfaces visually for residues .
.,. Repeat the cleaning/disinfection process if neces-
sary.

Manual cleaning and wipe disinfecting

Phase Step T t Conc. Water Chemical

[ C/ F] [min] [O/o] quality

Cleaning RT D-W
(cold)
11 Drying RT
111 Wipe disinfection >1 Meliseptol HBV wipes 50 10 Pro-
pan-1-ol
IV Final rinse RT 0.5 FD-W
(cold)
V Drying RT

D-W: Drinking water

FD-W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT: Room temperature
@()
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

Phase 1
.,. Clean the product under running faucet water,
using a suitable cleaning brush until all visible res-
idues have been removed from the surfaces .
.,. Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
Phase 11
.,. Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.
Phase 111
.,. Wipe all surfaces of the product with a single-use
disinfectant wipe.
Phase IV
.,. After the specified exposure time (at least 1 min).
rinse the disinfected surfaces under running FD
water .
.,. Drain any remaining water fully.
Phase V
.,. Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.
5.9 Mechanical cleaning/disinfecting
Note
The cleaning and disinfection device must be o f tested
and approved effectiveness (e.g. FDA approval ar CE
mark according to DIN EN ISO 15883}.

Note
The c/eaning and disinfection device used far process-
ing must be serviced and checked at regular intervals.

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfection device without ultrasound

Phase Step T t Water Chemical/Note

[ C/ " F] [min] quality

Prerinse <25/77 3 D-W

11 Cleaning 55/131 10 FD-W Concentrate, alkaline:

- pH = 13
- <5 10 anionic surfactant
0.5 O/oworking solution
- pH = 11*
111 lntermediate rinse > 1 O/SO FD-W
IV Thermal disinfect- 90/194 5 FD-W
ing

V Drying According to the program for cleaning

and disinfection device

D-W: Drinking water

FD-W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
*Recommended: BBraun Helimatic Cleaner alkaline

Check visible surfaces for residues after mechani-

cal cleaning/disinfecting.
@(@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

5.1 O lnspection, maintenance and 5.12 Steam sterilization

checks
Damage to, or destruction of
Note
the batteries due to process-
Aesculap recommends lubrcating the flap rods, flaps, ing !
s/iding surfaces and other moving parts, e.g. trigger, CAUTION
... Do not sterilize batteries.
cover /ids etc., with STERILIT Power Systems oi/ spray
G8600/STERIL/T Power Systems drip lubricator GA059
prior to sterilization! Remove excess ol with a lint-free Note
wipe. The product may only be sterilized when dismantled.

.,. Allow the product to cool down to room tempera- Note

ture. The Accu/an 3Ti Dermatome can be sterilized with a
... lnspect the product after each cleaning and disin- mounted flap tab.
fecting cycle to be sure it is: clean, functional, and
... Check to ensure that the sterilizing agent will come
undamaged.
into contact with all externa! and interna! surfaces
... Check the product for any damage, abnormal run- (e.g. by opening any valves and faucets).
ning noise, overheating ar excessive vibration.
... Validated sterilization process
... Set aside the product if it is damaged.
- Disassemble the instrument
... After cleaning/disinfecting, inspect all surfaces and - Steam sterilization through fractionated vac-
difficult to access spots on the product for visible
uum process
dirt ar debris.
- Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
5.11 Packaging - Sterilization using fractionated vacuum pro-
.,. Always follow the instructions for use of the cess at 134 C/holding time 5 min
respective packaging and storage devices (e.g.
... When sterilizing several instruments at the same
instructions for use TA009721 for the Aesculap time in a steam sterilizer, ensure that the maxi-
Eccos storage system). mum load capacity of the steam sterilizer specified
... lnsert the product in its proper position in the by the manufacturer is not exceeded.
Eccos holder, or put it on a tray in such a way that
the product is protected against damage. Ensure
that all cutting edges are protected .
... Pack trays appropriately for the sterilization pro-
cess {e.g. in Aesculap sterile containers) .
... Ensure that the packaging will prevent a recon-
tamination of the product.
5.13 Sterilization for the US market 6. Maintenance
Aesculap advises against sterilizing the device by To ensure reliable operation, the product must be
flash sterilization or chemical sterilization. maintained once per year as indicated on the mainte-
Sterilization may be accomplished by a standard nance label, see Fig. 15, e.g. February 2012.
prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10- 6, Aesculap
recommends the following parameters:

Aesculap Orga Tray/Sterile container (perforated

bottom)
Minimum cycle parameters

Steriliza- Temp. Time Minimum

tion method drying
time
Fig. 15 Acculan 3Ti Dermatome maintenance label
Prevacuum 270 F/ 4 min 20 min
275 F For technical service, please contact your national
B. Braun/Aesculap agency, see Technical Service.

*Aesculap has validated the above sterilization cycle

and has the data on file. The validation was accom-
plished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.

5.14 Storage
.,.. Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area .
.,.. Store sterile packed single-use products dust-pro-
tected in a dry, dark and temperature-controlled
room.
@
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

7. Troubleshooting list

Malfunction Detection Cause Remedy

Dermatome blade not Loud running noise from Defective gearings Have repaired by manu-
moving. motor facturer
lnsufficient cutting per- Worn cutting edge of Dermatome blade Replace dermatome
formance of dermatome dermatome blade blunted blade
blade
lnsufficient motor power/ Battery too weak Charge battery
speed
Battery worn/defective Replace battery
Adjusted dermatome Have repaired by manu-
facturer

8. Technical Service Or in the US:

Attn. Aesculap Technical Services
Risk of injury and/or malfunc- 615 Lambert Pointe Drive
tion! Hazelwood
WARNING Do not modify the product. MO, 63042 USA
Aesculap Repair Hotline
Far service and repairs, please contact your Phone: +1 (800) 214-3392
national B. Braun/Aesculapp agency. Fax: +1 (314) 895-4420
Modifications carried out on medical technical equip- Other service addresses can be obtained from the
ment may result in loss of guarantee/warranty rights address indicated above.
and forfeiture of applicable licenses.
Service add resses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 (7461) 95 -1601
Fax: +49 (7461) 14 -939
E-Mail: ats@aesculap.de
9. Accessories/Spare parts 1O. Technical data
Art. no. Designation
Classification acc. to Directive 93/42/EEC

GA059 STERILIT Power Systems dripping Art. no. Designation Class

oils (50 mi)
GA666 Battery
GA643345 Nut
GA670 Acculan 3Ti Dermatome lla
GA643417 Flap rod

GA666 Battery
GA670 Acculan 3Ti Derma-
GA670

GA670210
Acculan 3Ti Dermatome

Flap DC voltage
-- -- tome

9.6 V
GA675 Cover Rated current approx. 2 A
GA677 Charger Max. power 250W
GA678 Sterile funnel Oscillation frequency O 1/min to a pprox.
GA679 Battery removal device 6 500 1/min

GB228R Dermatome blade Blade travel 3.1 mm

GB256R Eccos set for Acculan 3Ti Derma- Cutting depth 0.2 mm to 1.2 mm,
tome Gradation in
1/10 mm
GB498R Eccos holder for Acculan 3Ti Der-
matome Cutting width max. 78 mm, set by
10 flaps of width 8 mm
GB600 STERILIT Power Systems oil spray
(300 mi) Weight (operational) approx. 1.7 kg

Dimensions (L x W x H) approx. 290 mm x

Note 11 O mm x 90 mm
Far further information about the Aesculap Eccos Applied part Type BF
holder system, see TA009721.
EMC IEC/DIN EN 60601-1-2

Conforming to standard IEC/DIN EN 60601-1

@)@)
Aesculap Acculan 3Ti
Acculan 3Ti Dermatome GA670

10.1 Ambient conditions

GA666 Battery

Cell type NiMH Operation Storage and

transport
DC voltage 9.6 V
Tempera tu re 40"C 40 e
Nominal capacity 1.0SAh
,o e -10 e
Weight approx. 0.304 kg
Without con- Recommended
Dimensions (L x W x H) approx. 120 mm x densation maximum dura-
43 mm x 50 mm tion of storage is
3 months,
EMC IEC/DIN EN 60601-1-2 no direct sun-
Conforming to standard IEC/DIN EN 60601-1 light
Relative 9 0 1\'o

! } 5 7. 5 %
humidity
30% 1 0 % ! } 5

Atmospheric
pressure 1 0 6 0 h P a 1 0 6 0 h P a
700 hPa 500 hPa
11. Disposal
Note
The user institution is obliged to process the product
befare its disposa/, see Va/idated reprocessing proce-
dure.

Adhere to national regulations when

disposing of or recycling the prod-
uct, its components and its packag-
ing !
The recycling pass can be down-
loaded from the Extranet as a PDF
document under the respective arti-
cle number. (The recycling pass
includes disassembling instructions
for the product, as well as informa-
tion for proper disposal of compo-
nents harmful to the environment.)
Products carrying this symbol are
subject to separate collection of
electrical and electronic devices.
Within the European Un ion, disposal
is taken care of by the manufacturer
as a free-of-charge service.

ll- Detailed information concerning the disposal of

the product is available through your national
B. Braun/Aesculap agency, see Technical Service.

12. Distributor in the US/Con-

tact in Canada for product
information and complaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
(E 0123 - DIR 93/42/EEC Technical alterations reserved

Aesculap AG IAm Aesculap-Platz 178532 Tuttlingen IGermany

Phone +49 (O) 7461 95-01 Fax +49 (O) 746195-26001 www.aesculap.com

Aesculap - a B. Braun company TA-Nr. 013000 05/12 VG

And.-Nr. 44052