Braun Acculan 3Ti Instructions For Use Manual
Aesculap Power Systems
Acculan® 3Ti
Instructions for use/Technical description
Acculan® 3Ti attachments
Gebrauchsanweisung/Technische Beschreibung
Acculan® 3Ti Aufsätze
Mode d’emploi/Description technique
Acculan® 3Ti embouts
Instrucciones de manejo/Descripción técnica
Acculan® 3Ti cabezales
Istruzioni per l’uso/Descrizione tecnica
Acculan® 3Ti terminali
Instruções de utilização/Descrição técnica
Acculan® 3Ti cabeçotes
Gebruiksaanwijzing/Technische beschrijving
Acculan® 3Ti opzetstukken
Brugsanvisning/Teknisk beskrivelse
Acculan® 3Ti tilbehør
Bruksanvisning/Teknisk beskrivning
Acculan® 3Ti tillsatserna
Инструкция по примению/Техническое
описание
Acculan® 3Ti соединительные насадки
1
5.1
5
44.1
2.1
3
2
66.1
4.2
4.3
7.1
77.2
Aesculap Power Systems
Acculan® 3Ti attachments
Legend
1 Drill attachment (black unlocking sleeve)
2 Reamer attachment (blue unlocking sleeve)
2.1 Unlocking sleeve
3 Drill attachment with Jacobs chuck
4 Kirschner wire attachment
4.1 Scale
4.2 Adjustment sleeve
4.3 Clamping lever
5 Drill attachment (for radiolucent angle
transmission)
5.1 Adapter for radiolucent angle transmission
6 Adapter (AO large to DHS/DCS)
6.1 Unlocking sleeve
7 Sagittal saw attachment
7.1 Saw blade coupling
7.2 Button for saw blade release/fixation
Symbols on product and packages
Adhere to instructions for use
Notice indicating the next scheduled service (date) by an international B. Braun/Aesculap agency,
see Maintenance
Date of manufacture
Contents
1. Safe handling ...........................................................3
2. Product description ................................................ 3
2.1 System components ............................................... 3
2.2 Components necessary for use ........................... 3
3. Drill and reamer attachments ............................. 4
3.1 Intended use .............................................................4
3.2 Operating principle ................................................. 4
3.3 Safe operation ......................................................... 4
Coupling a tool........................................................ 4
Uncoupling a tool................................................... 4
3.4 Technical specifications ........................................ 5
4. Kirschner wire attachment GB643R .................. 6
4.1 Intended use ............................................................. 6
4.2 Operating principle ................................................. 6
4.3 Safe operation ......................................................... 6
Inserting the Kirschner wire ................................ 7
Clamping the Kirschner wire............................... 7
4.4 Technical specifications ........................................ 7
5. Drill attachment GB645R (for radiolucent
angle transmission) ................................................8
5.1 Intended use ............................................................. 8
5.2 Operating principle ................................................. 8
5.3 Safe operation ......................................................... 8
Coupling the radiolucent transmission unit.... 8
Uncoupling the radiolucent transmission unit. 8
Coupling a tool........................................................ 9
Uncoupling a tool................................................... 9
5.4 Technical specifications ........................................ 9
6. Adapter GB628R (AO large to DHS/DCS) .......10
6.1 Intended use ...........................................................10
6.2 Operating principle ...............................................10
6.3 Safe operation .......................................................10
Coupling the adapter........................................... 10
Uncoupling the adapter...................................... 10
Coupling a tool...................................................... 10
Uncoupling a tool................................................. 10
6.4 Accessories .............................................................10
6.5 Technical specifications ......................................10
7. Sagittal saw attachment GB660R ...................11
7.1 Intended use ...........................................................11
7.2 Operating principle ...............................................11
7.3 Safe operation .......................................................11
Coupling the saw blade....................................... 11
Uncoupling the saw blade.................................. 11
7.4 Technical specifications ......................................11
8. Working with the attachments ........................12
8.1 System set-up ........................................................12
Connecting the accessories................................ 12
Coupling and uncoupling of attachments on
the drill and reamer motor unit........................ 12
2
8.2 Function checks .....................................................13
8.3 General operation .................................................14
9. Validated processing procedure ........................14
9.1 General notes .........................................................15
9.2 Preparations at the place of use ......................15
9.3 Preparation prior to cleaning ............................15
9.4 Cleaning/Disinfecting ..........................................16
9.5 Manual cleaning/disinfecting ............................17
9.5 Manual cleaning and wipe disinfection ......... 17
9.6 Mechanical cleaning/disinfecting ....................18
Mechanical alkaline cleaning and thermal
disinfecting............................................................. 19
9.7 Inspection, maintenance and checks ..............20
9.8 Packaging ................................................................20
9.9 Sterilization method and parameters .............21
9.10 Sterilization for the US market .........................21
9.11 Storage .....................................................................21
10. Troubleshooting list ..............................................22
10.1 General malfunctions ..........................................22
10.2 Malfunctions of the Kirschner wire
attachment .............................................................23
10.3 Malfunctions of the sagittal saw
attachment .............................................................23
11. Maintenance ..........................................................24
12. Technical Service ...................................................24
13. Accessories/Spare parts .......................................25
14. Technical specifications ......................................26
14.1 Ambient conditions ..............................................26
15. Disposal ....................................................................26
16. Distributor in the US/Contact in Canada
for product information and complaints .......27
1. Safe handling
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾ To prevent damage caused by improper setup or
operation and to avoid forfeiture of liability rights:
– Use the product only according to these
instructions for use.
– Observe all safety information and maintenance
advisories.
– Only combine Aesculap products with each other.
¾ Ensure that the product and its accessories are
operated and used only by persons with the
requisite training, knowledge or experience.
¾ Keep the instructions for use accessible for all O.R.
personnel.
¾ Always adhere to applicable standards.
2. Product description
2.1 System components
Designation Art. no. Enclosed
Cleaning
brush
Key for
Jacobs chuck
2.2 Components necessary for use
Designation Art. no.
Acculan® 3Ti small power
drill
Acculan® 3Ti drill and
reamer motor
Attachment Vary with indication
Adapter Vary with indication
Suitable tools and
Kirschner wires
Note
For possible combinations of attachments with the
Acculan® 3Ti small power drill GA671, follow the
information in Instructions for Use TA012033!
TA011944 All drill and reamer
attachments/Kirschner
wire attachment
GB643R
GA031201 For drill attachment
GA638R
GA671
GA672
Vary with indication
3
Aesculap Power Systems
Acculan® 3Ti attachments
3. Drill and reamer attachments
Abb. 1
3.1 Intended use
Drill and reamer attachments are used to adapt
rotating tools applied in bone surgery for work on
bones and cartilage.
3.2 Operating principle
The drill and reamer attachments are powered by a
motor coupled through an Aesculap Acculan® 3Ti
coupling.
The drill and reamer attachments convert the motor
rotation to rotation of the tool adapted in the
respective attachment.
The drill and reamer attachments can be coupled to
the drive unit in three different angular positions at
steps of 120°.
Drill attachments are identified by their black
unlocking sleeves, whereas reamer attachments come
with blue unlocking sleeves.
3.3 Safe operation
Risk of injury due to heat necrosis!
¾ Do not use drill attachments to
operate reamer tools such as the
DANGER
Recommended application
Use GB630R, GB634R, GB635R, GB636R, GB637R and
GB638R only for drilling and tapping.
Use GB654R, GB655R and GB656R only for acetabular
reaming and medullary reaming.
¾ For information on how to connect the drill and
reamer attachments, siehe Coupling and uncoupling of attachments on the drill and reamer motor
unit.
Coupling a tool
¾ Slide back unlocking sleeve 2.1.
¾ Push the tool shaft in its proper position down to
the stop in the tool adapter of the attachment.
¾ Release unlocking sleeve 2.1.
The tool is now coupled.
Uncoupling a tool
¾ Slide back unlocking sleeve 2.1.
¾ Remove the tool.
acetabulum reamer and the
medullary reamer.
¾ Operate any reamer tool only
with a reamer attachment.
4
3.4 Technical specifications
Drill attachments (black unlocking sleeve)
GB630R GB634R GB635R GB636R GB637R GB638R
Connection Hudson/
Zimmer
Dimensions
Length x ∅ in mm
Weight, in grams approx. 263 approx. 430 approx. 246 approx. 253 approx. 250 approx. 333
Gear
ratio
Drive speed, in
1/min
Torque
in Nm
Cannulation
∅ in mm
Reamer attachments (blue unlocking sleeve)
Connection Harris AO large Hudson/Zimmer
Dimensions
Length x ∅ in mm
Weight, in grams approx. 323 approx. 334 approx. 344
Gear ratio 100:1 100:1 100:1
Drive speed, in 1/min max. 250 max. 250 max. 250
Torque, in Nm max. 19 max. 19 max. 19
Cannulation ∅ in mm 444
approx.
100 x 39
25:1 25:1 25:1 25:1 25:1 25:1
max. 1 000 max. 1 000 max. 1 000 max. 1 000 max. 1 000 max. 1 000
max. 5 max. 5 max. 5 max. 5 max. 5 max. 5
4 4 4444
Jacobs chuck
keyless
∅ 0.6–7.4 mm
approx.
125 x 39
GB654R GB655R GB656R
approx. 106 x 39 approx. 107 x 39 approx. 118 x 39
AO small Aesculap
hexagon
approx.
90 x 39
approx.
86 x 39
Trinkle Jacobs chuck
with key
∅ 0–6.5 mm
approx.
93 x 39
approx.
110 x 39
5
Aesculap Power Systems
Acculan® 3Ti attachments
4. Kirschner wire attachment
GB643R
Abb. 2
4.1 Intended use
Kirschner wire (K-wire) attachments are used in
orthopedics and traumatology to insert Kirschner wires
into bones.
4.3 Safe operation
To protect against injuries when using long drilling
wires, screw in the Kirschner wire protection sleeve
supplied with the product.
17 15
Abb. 3
¾ Screw protection sleeve 15 into adapter 17.
¾ Connect the Kirschner wire attachment, siehe Cou-
pling and uncoupling of attachments on the drill
and reamer motor unit.
¾ Align clamping lever 4.3 over the trigger buttons of
the drill and reamer motor.
4.2 Operating principle
Kirschner wire attachments are powered by a motor
with an Aesculap Acculan® 3Ti coupling.
The Kirschner wire attachment is a quick-action chuck
that clamps and drives Kirschner wires.
6
Inserting the Kirschner wire
The following diameter ranges can be set for the
adjustment sleeve:
∅ 0.6-1.8 mm
∅ 1.8-3.0 mm
∅ 3.0–4.0 mm
¾ Leave clamping lever 4.3 in forward position (away
from the drive unit).
¾ Set adjustment sleeve 4.2 to the correct diameter
range for the diameter of the Kirschner wire: Push
back and turn adjustment sleeve 4.2 until the
intended diameter range setting is reached.
¾ Release adjustment sleeve 4.2, making certain that
adjustment sleeve 4.2 clicks into position.
¾ Insert the Kirschner wire into the Kirschner wire
attachment until the required extension length is
reached.
The Kirschner wire is held in the intended position
in the attachment by an automatic clamping
mechanism.
Clamping the Kirschner wire
¾ Pull clamping lever 4.3 towards the motor unit (the
stronger the clamping lever is pulled, the stronger
the clamping force on the Kirschner wire).
The Kirschner wire is clamped in now.
Note
The Kirschner wire remains clamped only as long as the
clamping lever is pulled towards the motor unit. The
clamping lever automatically returns to its rest position
away from the motor unit, and the Kirschner wire can
be moved freely again as soon as the clamping lever is
released.
4.4 Technical specifications
GB643R
Kirschner wire ∅ in mm 0.6–4.0
Dimensions L x W x H, inmm93 x 36 x 137
Weight, in grams approx. 300
Gear ratio 25:1
Drive speed, in 1/min max. 1,000
7
Aesculap Power Systems
Acculan® 3Ti attachments
5. Drill attachment GB645R
(for radiolucent angle
transmission)
Abb. 4
Note
The drill attachment can be used only with Synthes
Radiolucent Drive 511.300!
Note
Always observe the instructions for use of Synthes
Radiolucent Drive 511.300!
5.1 Intended use
The drill attachment allows connecting a radiolucent
angle transmission for applying drill holes in the bone
under radiographic control.
5.2 Operating principle
The drill attachment is powered by a motor fitted with
an Aesculap Acculan® 3Ti coupling.
The drill attachment transfers the rotational speed of
the motor to the adapted radiolucent angle
transmission.
The drill attachment can be coupled to the motor unit
in three different positions, separated by 120°.
5.3 Safe operation
¾ Couple the drill attachment, siehe Coupling and
uncoupling of attachments on the drill and reamer
motor unit.
Coupling the radiolucent transmission unit
¾ Fully engage the radiolucent angle transmission in
adapter 5.1 of the drill attachment.
¾ If necessary, slightly move the radiolucent unit.
Uncoupling the radiolucent transmission unit
¾ Forcefully pull out the radiolucent angle
transmission from the drill attachment.
8
Coupling a tool
Note
Always observe the instructions for use of Synthes
Radiolucent Drive 511.300!
Uncoupling a tool
Note
Always observe the instructions for use of Synthes
Radiolucent Drive 511.300!
5.4 Technical specifications
GB645R
Dimensions L x W x H, inmm110 x 35 x 35
Weight, in grams approx. 225
Gear ratio 30:1
Drive speed, in 1/min max. 900
9
Aesculap Power Systems
Acculan® 3Ti attachments
6. Adapter GB628R (AO large to
DHS/DCS)
Abb. 5
6.1 Intended use
The adapter is used for connecting tools with DHS/DCS
coupling to drill or reamer attachments with AOProtek coupling.
6.2 Operating principle
The adapter is driven by a drill or reamer attachment
powered by a motor fitted with an Aesculap Acculan®
3Ti coupling. The drill or reamer attachment transfers
the rotational speed of the motor to adapter GB628R
and thus to the coupled tool.
6.3 Safe operation
Note
Use the adapter only with Synthes tools with DHS/DCS
tool coupling or tools of a comparable geometry!
¾ For information on how to connect the drill and
reamer attachments, siehe Coupling and uncoupling of attachments on the drill and reamer motor
unit.
Uncoupling the adapter
¾ For uncoupling the adapter, siehe Uncoupling a
tool.
Coupling a tool
¾ Slide back unlocking sleeve 6.1.
¾ Insert the tool shaft in its correct position down to
the stop in the tool coupling of the adapter.
¾ Release unlocking sleeve 6.1.
The tool is now coupled.
Uncoupling a tool
¾ Slide back unlocking sleeve 6.1.
¾ Remove the tool.
6.4 Accessories
Designation Synthes art. no.
DHS Tripple Reamer 338.130, 338.430
DHS Reamer 357.044, 357.045
DHS Drill Bit 357.047, 351.270,
359.081, 359.079
6.5 Technical specifications
GB628R
Dimensions L x W x H, inmm61 x 22 x 22
Weight, in grams approx. 70
Drive speed, in 1/min max. 250
Coupling the adapter
¾ For coupling the adapter, siehe Coupling a tool.
10
7. Sagittal saw attachment
GB660R
Abb. 6
7.1 Intended use
The sagittal saw attachment is used for intraoperative
dissection of bone and cartilage tissue.
7.2 Operating principle
The sagittal saw attachment is powered by a motor
fitted with the Aesculap Acculan® 3Ti coupling.
The sagittal saw attachment converts the motor
rotation into oscillation of the saw blade. The bone is
dissected by the oscillating movement of the saw
blade.
No key or wrench is required for inserting the saw
blades. The sagittal saw attachment can be coupled to
the drive unit in three different positions separated by
steps of 120°.
7.3 Safe operation
¾ Connect the sagittal saw attachment, siehe Cou-
pling and uncoupling of attachments on the drill
and reamer motor unit.
Coupling the saw blade
¾ Insert the saw blade with its coupling end in the
slot of saw blade coupling 7.1 as far as it will go.
Ensure that the locking pin engages in the saw
blade fenestration, and that the lateral stops of the
saw blade rest on the coupling.
¾ If necessary press button for saw blade release/fix-
ation 7.2.
¾ Check that the tool is seated properly: Pull at the
saw blade.
Uncoupling the saw blade
¾ Fully press button for saw blade release/
fixation 7.2.
¾ Extract the saw blade from saw blade coupling 7.1.
7.4 Technical specifications
GB660R
Dimensions L x W x H, inmm89 x 36 x 44
Weight, in grams approx. 270
Gear ratio 1.5:1
Stroke frequency in 1/min max. 17 000
WARNING
Risk of injury caused by inadvertent
loosening of the saw blade during
operation!
¾ Do not press the button for saw
blade release/fixation during
operation.
¾ Check for secure fixation of the
tool after any tool change.
11
Aesculap Power Systems
Acculan® 3Ti attachments
8. Working with the
attachments
8.1 System set-up
Note
The attachments are supplied in unsterile condition.
Risk of infection and
contamination!
¾ Sterilize the attachments prior
DANGER
WARNING
CAUTION
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
performance and safety characteristics of the
products.
¾ Please address any questions in this respect to your
B. Braun/Aesculap partner or to Aesculap Customer
Service.
to operation.
Risk of injury due to inadvertent
activation of the motor during
coupling of an attachment/tool!
¾ Secure motors that are not
actually used against
inadvertent activation.
Damage to the attachment caused
by inappropriate tool!
¾ Use an appropriate tool for
changing the attachment tool.
Avoid contact with cutting
edges.
Coupling and uncoupling of attachments on
the drill and reamer motor unit
Protection against inadvertent activation
Abb. 7
The rotational speed control button can be locked to
prevent inadvertent activation of the drill and reamer
motor unit during a tool change.
Note
For further information on the drill and reamer motor
unit, see TA011869.
12
Coupling
A
Abb. 8
¾ Push the attachment onto drill and reamer motor
A until it clicks into position.
Uncoupling
B
A
Abb. 9
¾ Turn rotating sleeve B in the direction of the arrow
(clockwise when viewed from the rear end of drill
and reamer motor unit A).
¾ Remove the attachment from drill and reamer
motor unit A.
8.2 Function checks
Note
Function checks must be performed prior to each
operation with the unit and after each intraoperative
attachment or tool change!
¾ Make certain that the attachment is securely
seated.
¾ Make certain that the tool/Kirschner wire is seated
properly.
¾ Briefly run the drill and reamer motor unit, with the
attachment coupled and a tool inserted, at
maximum speed in clockwise and
counterclockwise mode.
¾ Watch out for damage, irregular running noises,
excessive vibrations and excessive heat developed
by the handpieces.
¾ Only use the unit if it is in perfect condition.
13
Aesculap Power Systems
Acculan® 3Ti attachments
8.3 General operation
Risk of injury caused by
aerosol formation or particles
during reaming, cutting or
WARNING
WARNING
¾ Start the motor powering the attachment at
moderate speed.
¾ To avoid slipping, apply only moderate pressure.
¾ To avoid tool breakage, do not bend the tool.
¾ Cool the tool during operation. This will improve
chip removal and reduce the risk of necrosis.
drilling!
¾ Always wear eye
protection when using the
drill and reamer motor
unit.
Risk of burns to skin and
tissue caused by hot, blunt
tools!
¾ Do not use damaged or
defective tools.
9. Validated processing procedure
Note
Adhere to national statutory regulations, international
standards and guidelines, and local, clinical hygiene
instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD),
suspected CJD or possible variants of CJD, observe the
relevant national regulations concerning the
reprocessing of the products.
Note
Mechanical processing should be preferred over
manual cleaning, as mechanical processing produces
better and more reliable cleaning results.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
Note
Successful processing of this medical product can only
be ensured if processing is performed through a
validated processing procedure. The user/processor is
responsible for the validation.
Due to process tolerances, the manufacturer’s
specifications can only serve as an approximate guide
for assessing the processing procedures applied by the
individual operator/processors.
14
9.1 General notes
Encrusted or fixated residues from surgery can make
the cleaning process more difficult or ineffective, and
can cause corrosion of stainless steels. To avoid this,
the time interval between application and processing
should not exceed 6 h, and neither fixating precleaning temperatures >45 °C nor any fixating
disinfecting agents (active ingredient: aldehyde,
alcohol) be used.
Excessive doses of neutralizers or basic detergents can
cause chemical degradation and/or fading and
obliteration of laser inscriptions on stainless steel
surfaces, regarding visual reading and machinereadability of the inscriptions.
Residues containing chlorine or chlorides e.g. in
surgical residues, medicines, saline solutions and in the
service water used for cleaning, disinfection and
sterilization will cause corrosion damage (pitting,
stress corrosion) and result in the destruction of
stainless steel products. To remove such residues, the
products must be rinsed sufficiently with fully
desalinated water and dried thoroughly.
Only process chemicals that have been tested and
approved (e.g. VAH/DGHM 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 process parameters specified by the
chemical’s manufacturer, such as temperatures,
concentrations and exposure times, must be strictly
observed. Failure to do so can result in the following
problems:
• optical changes to the material, e.g. fading or
discoloration of titanium or aluminum. For
aluminum, pH >8 in the application/process can
already cause visible surface changes.
• material damage such as corrosion, cracks,
fracturing, premature aging or swelling.
¾ Do not use process chemicals that cause stress
cracking or brittleness of plastic materials.
¾ Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, Publications Red Brochure
– Proper maintenance of instruments.
9.2 Preparations at the place of use
¾ Disassemble the product immediately after use, as
described in the respective instructions for use.
¾ Dismount all coupled components, e.g. tools (drills,
saw blades, etc.), accessories (adapters, protection
sleeves, etc.), tubes, cables, batteries, etc.
¾ Remove visible surgical residues as completely as
possible, using a lint-free wet wipe.
9.3 Preparation prior to cleaning
¾ Have the product dry in a disposal container and
ready for immediate cleaning and disinfecting
within 30 min after use.
15
Aesculap Power Systems
Acculan® 3Ti attachments
9.4 Cleaning/Disinfecting
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive
CAUTION
temperatures!
¾ Use cleaning and disinfecting
agents according to the
manufacturer’s instructions.
Cleaning and disinfecting agents
must
- be approved for plastics and
high-grade steel,
- not attack softeners (e.g.
silicone).
¾ Observe specifications regarding
concentration, temperature and
exposure time.
¾ Do not exceed the maximum
allowable cleaning temperature
of 55 °C.
¾ Do not clean the motors/handpieces in an
ultrasound bath and do not immerse them in any
fluid.
Let any fluid that penetrates into the product drain
out immediately to avoid the risk of corrosion/
malfunctioning of the product.
16
9.5 Manual cleaning/disinfecting
Manual cleaning and wipe disinfection
Stage Step T
[°C/°F]t[min]
I Cleaning RT
(cold)
II Drying RT - - - -
III Wipe disinfection - ≥1 - - Meliseptol HBV wipes
IV Final rinse RT
(cold)
V Drying RT - - - -
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾ Clean the product under running tap water, using
a suitable cleaning brush if necessary, until all
visible residues have been removed from the
surfaces.
¾ Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
¾ Make certain the product is positioned in such a
way that water will not enter the product e.g.
through coupling interfaces. (Immediately remove
any fluid that entered inadvertently.)
¾ Use the special cleaning brush (TA011944) for
cleaning the cannulation of drill and reamer
attachments/Kirschner wire attachment GB643R.
¾ To avoid the risk of corrosion, do not use a metal
brush or other abrasives that would damage the
surfaces for cleaning the product.
¾ Clean difficult-to-access areas with soft round
plastic brushes of fitting diameter.
Conc.
[%]
--D–W-
0.5 - FD–W -
Stage II
¾ Dry the product with lint-free tissue or medical-
Stage III
¾ Wipe all surfaces of the product with a single-use
Stage IV
¾ After the specified exposure time (of at least
¾ Hold the product in such a way that water cannot
¾ Allow water to drip off for a sufficient length of
Water
quality
50 % Propan-1-ol
quality filtered compressed air.
disinfecting wipe.
1 minute), rinse the disinfected surfaces under
running FD water.
enter it e.g. through couplings or adapters.
time.
Chemical
17
Aesculap Power Systems
Acculan® 3Ti attachments
Stage V
¾ Dry the product with lint-free tissue or medical-
quality filtered compressed air.
9.6 Mechanical cleaning/disinfecting
Note
The disinfector must be of proven effectiveness (e.g.
DGHM or FDA approval or CE mark).
Note
For thermal disinfection, always use fully desalinated
(demineralized) water. Ensure that Ao is >3 000 for the
process.
Note
The disinfector used for processing must be serviced
and checked at regular intervals.
¾ If the washer/disinfector is not fitted with internal
rinsing, carry out manual precleaning of the
cannulation, see Manual cleaning/disinfecting,
Stage I.
¾ For Kirschner wire attachment GB643R: Set
adjustment sleeve 4.2 to the largest Kirschner wire
diameter.
¾ For sagittal saw attachment GB660R: Do not rinse
through the interior of the sagittal saw
attachment. Do not connect the Eccos® holder of
the sagittal saw attachment to the rinsing
connector of the washer/disinfector.
¾ Use the Eccos® tray fitted with Acculan® 3Ti
holders, or mount appropriate holders in a suitable
tray (instructions for use TA009721 for Aesculap
Eccos® holder system).
¾ Insert the product in its proper position in the
Eccos® holder.
¾ Connect the internal rinsing equipment at the
Eccos® holder and at the special connector of the
rinsing cart.
18
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber washer/disinfector without ultrasound
Stage Step T
[°C/°F]
I Prerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W BBRAUN HELIMATIC CLEANER
III Intermediate rinse >10/50 1 FD–W -
IV Thermal disinfecting 90/194 5 FD–W -
V Drying - - - according to disinfecting
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
t
[min]
Water
quality
Chemical/Note
alkaline with tensides,
application solution 0.5 %
program
19
Aesculap Power Systems
Acculan® 3Ti attachments
9.7 Inspection, maintenance and checks
Note
Aesculap recommends occasional spraying of moving
parts, e.g. triggers, couplings, cover lids, etc. with
Aesculap STERILIT® Power Systems Oil Spray GB600!
Fig. 10
¾ Allow the product to cool down to room
temperature.
¾ Inspect the product after each cleaning and
disinfecting cycle to be sure it is clean, functional
and undamaged.
¾ Mount the STERILIT® Power Systems adapter
supplied with the product on Aesculap STERILIT®
Power Systems Oil Spray and spray into the
cannulation of the small power drill, see Fig. 10,
and through the drill, reamer and Kirschner wire
attachments, see Fig. 11, in each case from the rear
end and for about 1 sec.
¾ After cleaning/disinfecting, inspect all surfaces and
difficult to access spots on the product for visible
dirt or debris.
¾ Check the product for any damage, atypical
running noise, overheating or excessive vibration.
¾ Inspect tools for broken, damaged or blunt edges.
¾ Set aside the product if it is damaged.
9.8 Packaging
¾ Follow the instructions for use of the respective
packaging and storage holders (e.g. instructions for
use TA009721 for the Aesculap Eccos® holder
system).
¾ Insert the product in its proper position in the
Eccos® holder, or p ut it on a tray in such a way that
the product is protected against damage. Make
certain that all cutting edges are protected.
¾ Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
¾ Pack the product in such a way that the packaging
will prevent recontamination of the product
(DIN EN ISO 11607).
Fig. 11
20
9.9 Sterilization method and
parameters
Note
The product may only be sterilized with all tools etc.
unmounted.
¾ Make certain that all external and internal surfaces
of the product will be exposed to the sterilizing
agent.
¾ Validated sterilization process
– Disassemble the product
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization through fractionated vacuum process
at 134 °C/2 bar; holding time 5 min.
¾ When sterilizing several products at the same time
in one steam sterilizer: Make certain that the
maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not
exceeded.
9.10 Sterilization for the US market
• Aesculap does not recommend the device sterilized
by flash or chemical sterilization.
• Sterilization may be accomplished by steam autoclave in a standard prevacuum cycle.
To achieve a sterility assurance level of 10
recommends the following parameters:
Aesculap Orga Tray/Sterilcontainer (perforated
bottom)
Minimum cycle parameters*
Sterilization
method
Pre-vacuum 270 °F—
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accomplished in an Aesculap Sterilcontainer cleared by FDA
for the sterilization and storage of these instruments.
Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended 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.
Temp. Time Minimum
4 min 20 min
275 °F
-6
, Aesculap
drying time
9.11 Storage
¾ Store sterile products in germ-proof packaging
under dust protection in a dry, dark and
temperature-controlled room.
21
Aesculap Power Systems
Acculan® 3Ti attachments
10. Troubleshooting list
10.1 General malfunctions
Malfunction Cause Finding Remedy
Loud noise Defective gearing Loud noise Have product repaired by the
manufacturer
Tool not moving Attachment not coupled
properly
Defective gearing Motor drive not turning;
- - see TA011869
Deficient cutting
performance
Tool cannot be
coupled
Blunt tool Tool overheats Use a new tool
Wrong tool Incompatible tool Insert appropriate tool
Debris Debris on tool or in
Deformation Deformed tools/coupling
Attachment can not be
extracted from the motor
unit
blocked
Motor running, but not
driving the saw
coupling
components
Couple the attachment
correctly, see Coupling and
uncoupling of attachments on
the drill and reamer motor
unit
Have product repaired by the
manufacturer
Have product repaired by the
manufacturer
Clean the tool/coupling
Have product repaired by the
manufacturer
22
10.2 Malfunctions of the Kirschner wire attachment
Malfunction Cause Finding Remedy
Kirschner wire cannot
be inserted into
Kirschner wire
attachment
Kirschner wire not
turning
Incorrect adjustment of
Kirschner wire
attachment
Incorrect adjustment of
Kirschner wire
attachment
Clamping lever open Clamping lever open Close the clamping lever
Kirschner wire diameter
not matching the
setting of the adjustment
sleeve
Kirschner wire diameter
not matching the
setting on the
adjustment scale
Set the adjustment sleeve to
the correct Kirschner wire
diameter
Set the adjustment sleeve to
the correct Kirschner wire
diameter
10.3 Malfunctions of the sagittal saw attachment
Malfunction Cause Finding Remedy
Saw blade cannot be
uncoupled
Release button not
pressed through
properly
Locking pin not fully
releasing the saw blade
Fully press down the release
button, see Coupling the saw
blade
23
Aesculap Power Systems
Acculan® 3Ti attachments
11. Maintenance
To ensure reliable operation, maintenance has to be
carried out as indicated on the service label, see Fig. 12,
e.g. February 2012.
Such maintenance must also include a safety
inspection according to §6 MPBetreibV (or equivalent).
The extent of the safety inspection is specified in the
Service Manual, which is available as a separate
document.
For services to this end, please contact your national B.
Braun/Aesculap agency, see Technical Service.
Fig. 12
12. Technical Service
For service and repairs, please contact your national
B. Braun/Aesculap agency.
Modifications carried out on medical technical
equipment may result in loss of guarantee/warranty
rights and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-1601
Fax: +49 7461 14-939
E-Mail: ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood, MO 63042
Aesculap Repair Hotline
Phone: +1 800 214-3392
Fax: +1 314 895-4420
Other service addresses can be obtained from the
address indicated above.
24
13. Accessories/Spare parts
Designation Application Art. no.
Cleaning brush All drill and reamer attachments/Kirschner wire
Key for Jacobs chuck attachments Only for drill attachment GB638R GA031201
Eccos® holder, triple All attachments GB496R
Eccos® holder, single All attachments GB497R
Aesculap STERILIT® Power
Systems oil spray
STERILIT® Power Systems adapter All drill, reamer and Kirschner wire attachments GB600840
Eccos® tray with holders for
Acculan® 3Ti
Note
For further information about the Aesculap Eccos® holder system, see TA009721.
attachment GB643R
Only for Kirschner wire attachment GB644R TA011327
All attachments GB600
All attachments GB243R
TA011944
GB244R
25
Aesculap Power Systems
Acculan® 3Ti attachments
14. Technical specifications
Classification acc. to Directive 93/42/EEC
Art. no. Designation Class
GB628R Adapter IIa
GB630R Drill attachment Hudson/Zimmer IIa
GB634R Jacobs chuck, keyless IIa
GB635R Drill attachment AO small IIa
GB636R Drill attachment Aesculap
hexagon
GB637R Drill attachment Trinkle IIa
GB638R Drill attachment Jacobs chuck
with key
GB643R Kirschner wire attachment IIa
GB645R Drill attachment for radiolucent
angle transmission
GB654R Reamer attachment Harris IIa
GB655R Reamer attachment A0 large IIa
GB656R Reamer attachment Hudson/
Zimmer
GB660R Sagittal saw attachment IIa
IIa
IIa
IIa
IIa
14.1 Ambient conditions
Operation Transport and
storage
Temperature
Relative
humidity
Atmospheric
pressure
26
15. Disposal
Note
The user institution is obliged to process the product
before its disposal, see Validated processing procedure.
Adhere to national regulations
when disposing of or recycling 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 collection of
electric and electronic devices.
Within the European Union, disposal
is taken care of by the manufacturer
as a free-of-charge service.
¾ Please contact your national B. Braun/Aesculap
agency with any inquiries regarding the disposal of
the product, see Technical Service
16. Distributor in the US/Contact
in Canada for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
27
Aesculap Power Systems
Acculan® 3Ti Aufsätze
Legende
1 Bohraufsatz (schwarze Entriegelungshülse)
2 Fräsaufsatz (blaue Entriegelungshülse)
2.1 Entriegelungshülse
3 Bohraufsatz mit Dreibackenfutter
4 Spickdrahtfutter
4.1 Skala
4.2 Einstellhülse
4.3 Spannhebel
5 Bohraufsatz (für röntgenstrahldurchlässiges
Winkelgetriebe)
5.1 Aufnahme für röntgenstrahldurchlässiges
Winkelgetriebe
6 Adapter (AO groß auf DHS/DCS)
6.1 Entriegelungshülse
7 Sagittalsägeaufsatz
7.1 Sägeblattkupplung
7.2 Druckknopf zur Sägeblattentriegelung/-fixierung
Symbole an Produkt und Verpackung
Gebrauchsanweisung einhalten
Hinweis auf den nächsten
Instandhaltungstermin (Datum)
bei der internationalen B. Braun/
Aesculap-Vertretung, siehe
Instandhaltung
Herstelldatum
Inhaltsverzeichnis
1. Sichere Handhabung ............................................29
2. Gerätebeschreibung .............................................29
2.1 Lieferumfang ..........................................................29
2.2 Zum Betrieb erforderliche Komponenten ......29
3. Bohr- und Fräsaufsätze .......................................30
3.1 Verwendungszweck ..............................................30
3.2 Funktionsweise ......................................................30
3.3 Bedienung ...............................................................30
Werkzeug kuppeln................................................ 30
Werkzeug entkuppeln.......................................... 30
3.4 Technische Daten ..................................................31
4. Spickdrahtfutter GB643R ...................................32
4.1 Verwendungszweck ..............................................32
4.2 Funktionsweise ......................................................32
4.3 Bedienung ...............................................................32
Spickdraht einführen ........................................... 33
Spickdraht spannen.............................................. 33
4.4 Technische Daten ..................................................33
5. Bohraufsatz GB645R (für röntgenstrahldurch-
lässiges Winkelgetriebe) .....................................34
5.1 Verwendungszweck ..............................................34
5.2 Funktionsweise ......................................................34
5.3 Bedienung ...............................................................34
Röntgenstrahldurchlässiges Winkelgetriebe
kuppeln .................................................................... 34
Röntgenstrahldurchlässiges Winkelgetriebe
entkuppeln.............................................................. 34
Werkzeug kuppeln................................................ 35
Werkzeug entkuppeln.......................................... 35
5.4 Technische Daten ..................................................35
6. Adapter GB628R (AO groß auf DHS/DCS) .....36
6.1 Verwendungszweck ..............................................36
6.2 Funktionsweise ......................................................36
6.3 Bedienung ...............................................................36
Adapter kuppeln.................................................... 36
Adapter entkuppeln.............................................. 36
Werkzeug kuppeln................................................ 36
Werkzeug entkuppeln.......................................... 36
6.4 Zubehör ....................................................................36
6.5 Technische Daten ..................................................36
7. Sagittalsägeaufsatz GB660R .............................37
7.1 Verwendungszweck ..............................................37
7.2 Funktionsweise ......................................................37
7.3 Bedienung ...............................................................37
Sägeblatt kuppeln................................................. 37
Sägeblatt entkuppeln........................................... 37
7.4 Technische Daten ..................................................37
8. Arbeiten mit den Aufsätzen ...............................38
28
Loading...