B. Braun Aesculap Acculan 3Ti User manual

Aesculap®Acculan 3Ti
Aesculap Power Systems
Instructions for use
Acculan 3Ti small drill GA671
Gebrauchsanweisung
Acculan 3Ti Kleine Bohrmaschine GA671
Mode d'emploi
Acculan 3Ti petite perceuse GA671
Instrucciones de manejo
Acculan 3Ti Taladro pequeño GA671
Istruzioni per l'uso
Acculan 3Ti Perforatrice piccola GA671
Instruções de utilização
Acculan 3Ti máquina de furar pequena GA671
Gebruiksaanwijzing
Acculan 3Ti Kleine boormachine GA671
Bruksanvisning
Acculan 3Ti liten borrmaskin GA671
Инструкция по применению
Acculan 3Ti Малая дрель GA671
Návod k použití
Acculan 3Ti Malá vrtačka GA671
Instrukcja użytkowania
Acculan 3Ti Mała wiertarka GA671
Návod na používanie
Acculan 3Ti-Malá vŕtačka GA671
Kullanım Kılavuzu
Acculan 3Ti Küçük matkap GA671
사용방법 및사용시 주의사항
의료용핸드피스 (ACCULAN 3Ti DRILL, GA671/ 형명
개별기재 )

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
Aesculap®Acculan 3 TiAcculan 3Ti small drill G A671
Note
Store the instructions for use for Acculan 3Ti in a folder!
Legend
1Drill attachment with quick-action chuck adapter
2Drill attachment with Jacobs chuck
3Reamer attachment with quick-action chuck
adapter
4Kirschner wire attachment
5Rotating sleeve
6Small drill
7Button for counterclockwise rotation
8Rotational speed control button
9Safety catch
10 Locking pin
11 Cover
12 Cover release button
13 Battery
14 Sterile funnel
15 Kirschner wire protection sleeve
16 Coding
17 Adaptor (for Kirschner wire protection sleeve and
rinsing adapter)
18 Battery removal device
19 Drill attachment (for radiolucent angle transmis-
sion)
20 Adapter (AO large to DHS/DCS)
21 Sagittal saw attachment
Symbols on product and packages
Caution, general warning sym-
bol
Caution, see documentation
supplied with the product
Follow the instructions for use
Marking of electric and elec-
tronic devices according to
directive 2002/96/EC (WEEE).
see Disposal
Classification Type BF
Reverse button clockwise/
counterclockwise rotation +
oscillation mode switch
Motor speed control
Keep this product dry!

3
Contents
1. Safe handling 4
2. Product description 4
2.1 Scope of supply 4
2.2 Components required for operation 4
2.3 Intended use 5
2.4 Operating principle 5
3. Preparation 5
4. Working with the Acculan 3Ti small drill 5
4.1 System set-up 5
4.2 Function checks 11
4.3 Safe operation 11
5. Validated reprocessing procedure 13
5.1 General safety instructions 13
5.2 General information 14
5.3 Dismantling prior to carrying out the
reprocessing procedure 14
5.4 Preparations at the place of use 14
5.5 Preparation before cleaning 14
5.6 Cleaning/disinfection 15
5.7 Manual cleaning/disinfecting 18
5.8 Mechanical cleaning/disinfecting 20
5.9 Inspection, maintenance and checks 21
5.10 Packaging 21
5.11 Steam sterilization 21
5.12 Sterilization for the US market 22
5.13 Storage 22
6. Maintenance 22
7. Troubleshooting list 23
8. Technical Service 23
9. Accessories/Spare parts 24
10. Technical data 24
10.1 Ambient conditions 25
11. Disposal 25
12. Distributor in the US/Contact in Canada
for product information and complaints 25
The battery requires no main-
tenance. Since battery cells
are subject to wear and age-
ing, Aesculap recommends
replacing the battery cells
every 12 months.
See also stamp/label for the
next recommended battery
cell replacement date at the
international B. Braun/
Aesculap agency, see Techni-
cal Service
Service sticker on small drill.
Reference to the next due
maintenance appointment
(date) with the international
B. Braun/Aesculap agency, see
Technical Service
Remove adhesive label before
charging the battery for the
first time
Date of manufacture

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
1. Safe handling
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
►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.
►To prevent damage caused by improper setup or
operation, and in order not to compromise war-
ranty and manufacturer liability:
– Use the product only according to these
instructions for use.
– Follow the safety and maintenance instruc-
tions.
– Only combine Aesculap products with each
other.
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site training, knowledge, or experience.
►Use product and accessories in surgery and/or in
the framework of emergency medical treatment.
►Keep the instructions for use accessible for the
user.
►Always adhere to applicable standards.
►Follow the instructions for use for the Acculan 3Ti
charger TA022160.
2. Product description
2.1 Scope of supply
2.2 Components required for opera-
tion
Designation Art. no.
Small drill GA671
Kirschner wire protection sleeve GA672207
Rinsing adapter GA672211
Cover GA675
Battery GA666
Sterile funnel GA678
STERILIT Power Systems adapter GB600840
Instructions for use for GA666 TA011867
Instructions for use for Acculan 3Ti
attachments
TA011936
Instructions for use for GA671 TA012033
Cleaning brush TA011944
Designation Art. no.
Small drill GA671
Battery (rechargeable, charged) GA666
Charger GA677
Drill and reamer attachments see TA011936
Cover GA675
Sterile funnel GA678

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2.3 Intended use
Note
To power acetabulum reamers, use the Acculan 3Ti drill
and reamer motor.
Depending on the type and extent of the work to be per-
formed during the implantation of a hip endoprosthe-
sis, an intraoperative battery change may be necessary.
The small drill 6is used for drilling, reaming, tapping,
screwing in and unscrewing of screws, and applying of
Kirschner wires in bone surgery.
The attachments (accessories) allow simple and quick
coupling of the respective tools. Each attachment is
compatible with the respective tool set.
2.4 Operating principle
The small drill 6contains an electric motor, a
rechargeable battery for power supply of the motor,
and electronic circuitry for controlling its rotational
speed. The motor speed can be adjusted continuously
by pressing rotational speed control button 8.
The direction of rotation can be changed especially for
tapping and for loosening of bone screws. To change
the direction of rotation, fully press down button for
counterclockwise rotation 7.
The small drill 6is fitted with a spindle cannulation to
insert guide skewers or similar devices with a diameter
of up to 4.0 mm. Some attachments are fitted with a
cannulation of a smaller diameter.
3. Preparation
Non-compliance with the following instructions will
preclude all responsibility and liability in this respect
on the part of Aesculap.
4. Working with the
Acculan 3Ti small drill
4.1 System set-up
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.
►Please address your B. Braun/Aesculap partner or
Aesculap Technical Service with any inquiries in
this respect; for a contact address, see Technical
Service.
DANGER
Risk of injury due to unap-
proved configuration using
additional components!
►For all applied components,
ensure that their classifi-
cation matches that of the
application component
(e.g. Type BF or Type CF) of
the respective device.

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
Inserting the battery
►Hold small drill 6with the battery compartment
upwards and attach funnel 14 (sterile), see Fig. 1.
Fig. 1
►Have a second person guide battery 13 (unsterile)
into the battery compartment, see Fig. 2. Observe
coding 16 when doing this.
Fig. 2
Note
The coding on the floor of the battery compartment of
the unit must match the coding at the bottom of the
battery.
Note
After insertion of the battery, a series of acoustic blips
will indicate that the small drill is ready for operation.
CAUTION
Damage to, or destruction of
the batteries due to process-
ing!
►Do not sterilize batteries.
14
6
14
13
16

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►Once the battery has been inserted, have a helper
remove sterile funnel 14 (unsterile), see Fig. 3.
Fig. 3
►Mount cover 11 (sterile) in such a way that it
engages at both cover release buttons 12,
see Fig. 4.
Fig. 4
Note
Sterility of the unit is ensured only if the cover is
mounted correctly.
14
11
12

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
Removing the battery
The battery must be removed after the operation and
prior to processing of the unit.
Note
If necessary, the battery removal device can be used to
facilitate removal of the battery, see Fig. 7!
►Hold small drill 6with the battery compartment
pointing upward.
►Press both cover release buttons 12 on the
cover 11 simultaneously and remove cover 11.
►With one hand, completely envelope the battery
compartment at its lower end, see Fig. 5.
Fig. 5
►Remove battery 13 from the battery compartment
by knocking the unit against the palm of the hand,
see Fig. 6.
Fig. 6
CAUTION
Damage to the battery caused
by knocking it against hard
objects!
►To remove the battery, only
ever knock the motor unit
against the palm of the
hand.

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Intraoperative battery change
The battery removal device is used for intraoperative
battery changes ensuring that sterile conditions are
safely maintained.
►Hold small drill 6with the battery compartment
pointing upward and remove cover 11.
►Mount sterile battery removal device 18, see Fig. 7.
Fig. 7
►Mildly shake small drill 6with battery removal
device 18 attached and the battery compartment
pointing downward.
The battery slides smoothly into battery removal
device 18.
►Hand over battery removal device 18 containing
the discharged battery to an unsterile person.
►Insert a charged battery, see Inserting the battery.
Coupling and uncoupling of attachments of
small drill
►Secure small drill 6against inadvertent activation
by engaging safety catch 9.
Note
For further information on the small drill attachments,
see TA011936.
To apply drilling wires we recommend using the special
Kirschner wire chuck. This quick-action chuck adapter
allows quick and easy tensioning of drilling wires.
To protect against injuries when using long drilling
wires, screw in the Kirschner wire protection sleeve
supplied with the product.
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8
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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
►Screw Kirschner wire protection sleeve 15 into
adapter 17, see Fig. 8.
Fig. 8
Coupling
►Push the attachment onto the small drill 6 , until it
you hear it engage, see Fig. 9.
Fig. 9
Uncoupling
►Turn rotating sleeve 5in the direction of the arrow
(clockwise when viewed from the rear end of small
drill 6), see Fig. 10.
Fig. 10
►Remove the attachment from small drill 6.
Protection against inadvertent activation
The rotational speed control button can be locked to
prevent inadvertent activation of the small drill during
a tool change.
►To lock rotational speed control button 8: Turn
safety catch 9to its OFF position, see Fig. 11.
Rotational speed control button 8is locked and
small drill 6can not be operated.
1517
6
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5

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►To unlock rotational speed control button 8: Turn
safety catch 9to its ON position, see Fig. 11.
Rotational speed control button 8is unlocked and
small drill 6can be operated.
Fig. 11
Coupling tools in the tool chuck adapter
Note
The coupling of tools is described in instructions for use
TA011936.
4.2 Function checks
Note
The function checks must be carried out prior to each
surgical application of the unit and after each intraop-
erative battery change!
Note
Only use the device if it is in perfect condition.
►Make certain that a battery has been installed.
►Make certain that the attachment is securely
seated.
►Check that the tool is seated properly.
►Briefly run the small drill at maximum speed in
clockwise and counterclockwise mode.
►Make certain that the rotational direction is cor-
rect in each case.
4.3 Safe operation
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8
9
6
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
WARNING
Risk of injury due to inadver-
tent activation of the motor
during coupling of an attach-
ment/tool!
►Secure motors that are not
actually used against inad-
vertent activation.
WARNING
Risk of injury caused by aero-
sol formation or particles dur-
ing reaming, cutting or drill-
ing!
►Always wear eye protection
when using the small drill.

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
Note
The motor found within this Acculan 3Ti hand piece is
powered by a magnetic system. To ensure that the
motor of this powered instrument does not inadver-
tently activate, do not allow the hand piece to come in
contact with any magnetic sources (i.e. magnetic
instrument pads). Please note that having the safety
switch in the locked position does not assure that the
motor will not run inadvertently.
Note
The low whistling noise at startup of small drill 6is nor-
mal for this product!
To run small drill 6 in clockwise rotation mode:
►Press rotational speed control button 8, see Fig. 12.
Small drill 6 is controlled continuously to run at a
speed appropriate for the present attachment.
To run small drill 6 in counterclockwise rotation mode:
►Fully press/actuate first the button for counter-
clockwise rotation 7and press speed control but-
ton 8, see Fig. 12.
Small drill 6 is controlled continuously to run at a
speed appropriate for the present attachment.
Oscillating or tapping mode
►To activate the oscillating or tapping mode: Press
counterclockwise rotation button 7for 3 s,
see Fig. 12.
The drill issues a short acoustic signal.
►To activate left rotation: Press the rotational speed
control button 8in addition to the counterclock-
wise rotation button 7, see Fig. 12.
Small drill 6 runs counterclockwise.
►To activate tapping mode: Press trigger 8within
the first half of its total travel range, see Fig. 12.
Small drill 6alternately runs counterclockwise and
clockwise, with the clockwise angle of rotation
always larger than the counterclockwise angle of
rotation.
►To activate oscillating mode: Press trigger 8within
the second half of its total travel range, see Fig. 12.
Small drill 6 alternately runs counterclockwise and
clockwise.

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►To deactivate the oscillating or tapping mode:
Press counterclockwise rotation button 7for 3 s,
see Fig. 12.
The drill issues an acoustic signal.
Fig. 12
5. Validated reprocessing pro-
cedure
5.1 General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only
be ensured if the processing method is first validated.
The operator/sterile processing technician is responsi-
ble for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disin-
fectant must be used.
Note
For the latest information on reprocessing and material
compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
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6

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
5.2 General information
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore the time interval between application and
processing should not exceed 6 h; also, neither fixating
pre-cleaning temperatures >45 °C nor fixating disin-
fecting agents (active ingredient: aldehydes/alcohols)
should be used.
Excessive measures of neutralizing agents or basic
cleaners may result in a chemical attack and/or to fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
Additional drying, if necessary.
Only process chemicals that have been tested and
approved (e.g. VAH or FDA approval or CE mark) and
which are compatible with the product’s materials
according to the chemical manufacturers’ recommen-
dations may be used for processing the product. All the
chemical manufacturer's application specifications
must be strictly observed. Failure to do so can result in
the following problems:
■Optical changes of materials, e.g. fading or discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fractur-
ing, premature aging or swelling.
►Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
►Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, link to Publications, Red
Brochure – Proper maintenance of instruments.
5.3 Dismantling prior to carrying out
the reprocessing procedure
►Disassemble the product immediately after use, as
described in the respective instructions for use.
►Dismount all mounted components, e.g. tools
(drills, saw blades, etc.), accessories (adapters, pro-
tective sleeves, etc.), tubes, cables and batteries.
5.4 Preparations at the place of use
►Remove any visible surgical residues to the extent
possible with a damp, lint-free cloth.
►Transport the dry product in a sealed waste con-
tainer for cleaning and disinfection within 6 hours.
5.5 Preparation before cleaning
►Carry out non-fixating/NaCl-free pre-cleaning
immediately after use.

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5.6 Cleaning/disinfection
Product-specific safety instructions for the
reprocessing procedure
►Do not clean motors/handpieces by ultrasonic
treatment and do not immerse them in any liquids.
To avoid the risk of corrosion/malfunctioning,
allow any fluid that has entered the product to
drain out immediately.
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents!
►Only use cleaning/disin-
fecting agents approved
for surface cleaning. Fol-
low the manufacturer’s
instructions for the respec-
tive cleaning/disinfecting
agent.
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents and/or exces-
sive temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instruc-
tions which
–be approved for plastic
material and high-
grade steel,
–do not attack softeners
(e.g. in silicone).
►Observe specifications
regarding concentration,
temperature and exposure
time.
►Do not exceed the maxi-
mum permitted cleaning
temperature of 60 °C.

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
Validated cleaning and disinfection procedure
Validated procedure Special features Reference
Manual cleaning and
wipe disinfection
■When cleaning instruments with
movable hinges, ensure that these
are in an open position and, if
applicable, move the joint while
cleaning.
■Dryingphase: 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.
(Immediately remove any fluid
that entered the product inadver-
tently.)
■For cleaning the cannulation, use
special cleaning brush
(TA011944).
■Clean difficult-to-access areas
with soft round plastic brushes of
fitting diameter.
Chapter Manual cleaning/disinfecting and
subsection:
■Chapter Manual cleaning and wipe dis-
infecting

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Mechanical alkaline
cleaning and thermal
disinfecting
■Use Eccos tray GB243R fitted
with Acculan 3Ti holders, or
mount appropriate holders in a
suitable tray (instructions for use
TA009721 for Aesculap Eccos
holder system).
■Insert the product in its proper
position in the Eccos holder.
■Connect the internal rinsing sys-
tem to the product/the Eccos
holder and the rinsing port of the
rinsing trolley.
■If the washer/disinfector is not
equipped for internal rinsing, pre-
clean the cannulation manually,
Chapter Manual cleaning/disin-
fecting, phase I.
■Otherwise, connect rinsing
adapter to the washer/disinfector
or rinsing cart.
■Connect rinsing adapter to the
product: Screw rinsing adapter
into attachment 17.
Chapter Mechanical cleaning/disinfecting
and subsection:
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Validated procedure Special features Reference

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Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
5.7 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
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT: Room temperature
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
--D–W -
II Drying RT - - - -
III Wipe disinfection - >1 - - Meliseptol HBV wipes 50 % Pro-
pan-1-ol
IV Final rinse RT
(cold)
0.5 - FD-W -
VDrying RT - - - -