Braun Acculan 3Ti Manual

Aesculap®Acculan 3Ti
Aesculap Power Systems
en Instructions for use/Technical description
Acculan 3Ti small drill GA671
USA Note for U.S. users
This Instructions for Use is NOT intended for United
States users. Please discard. The Instructions for Use
for United States users can be obtained by visiting our
website at www.aesculapusa.com and clicking the
"Products" menu. If you wish to obtain a paper copy
of the Instructions for Use, you may request one by
contacting your local Aesculap representative or Aes-
culap's customer service at 1-800-282-9000. A paper
copy will be provided to you upon request at no addi-
tional cost.
de Gebrauchsanweisung/Technische Beschreibung
Acculan 3Ti Kleine Bohrmaschine GA671
fr Mode d’emploi/Description technique
Petite perceuse Acculan 3Ti GA671
es Instrucciones de manejo/Descripción técnica
Acculan 3Ti taladro pequeño GA671
it Istruzioni per l’uso/Descrizione tecnica
Perforatrice piccola Acculan 3Ti GA671
pt Instruções de utilização/Descrição técnica
Máquina de furar pequena Acculan 3Ti GA671
nl Gebruiksaanwijzing/Technische beschrijving
Acculan 3Ti kleine boormachine GA671
sv Bruksanvisning/Teknisk beskrivning
Acculan 3Ti liten borrmaskin GA671
ru Инструкция по примению/Техническое опи-
сание
Малая дрель Acculan 3Ti GA671
cs Návod k použití/Technický popis
Acculan 3Ti malá vrtačka GA671
pl Instrukcja użytkowania/Opis techniczny
Acculan 3Ti mała wiertarka GA671
sk Návod na použitie/Technický opis
Malá vŕtačka Acculan 3Ti GA671
tr Kullanım Kılavuzu/Teknik açiklama
Acculan 3Ti küçük matkap GA671
ko 사용 설명서 /기술 설명
의료용핸드피스 (ACCULAN 3Ti DRILL, GA671/ 형명
개별기재 )

16
9
4
20 2119

2
en
Aesculap®Acculan 3Ti
Acculan 3Ti small drill GA671
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
Observe important safety infor-
mation such as warnings and pre-
cautions in the instructions for
use.
YYYY-MM
Maintenance label
Indication of the next mainte-
nance appointment (Date: Year-
Month)
Machine-readable, two-dimen-
sional code
The code contains a unique serial
number which can be used for
electronic tracking of the individ-
ual instrument. The serial number
is based on the global standard
sGTIN (GS1).
Date of manufacture
Follow the instructions for use
Labeling of electrical and elec-
tronic devices pursuant to direc-
tive 2002/96/EG (WEEE)
Classification Type BF

3
en
Contents
1. General information . . . . . . . . . . . . . . . . . . . . 4
1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Main functions and design characteristics . . 4
1.3 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Absolute contraindications. . . . . . . . . . . . . . . 4
1.5 Relative contraindications . . . . . . . . . . . . . . . 4
2. Safe handling. . . . . . . . . . . . . . . . . . . . . . . . . . 5
3. Product description. . . . . . . . . . . . . . . . . . . . . 5
3.1 Scope of supply . . . . . . . . . . . . . . . . . . . . . . . . 5
3.2 Components required for operation . . . . . . . 5
3.3 Operating principle . . . . . . . . . . . . . . . . . . . . . 6
4. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5. Working with the Acculan 3Ti small drill . . . 6
5.1 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.2 Function checks. . . . . . . . . . . . . . . . . . . . . . . . 12
5.3 Safe operation. . . . . . . . . . . . . . . . . . . . . . . . . 12
6. Validated reprocessing procedure . . . . . . . . . 14
6.1 General safety information . . . . . . . . . . . . . . 14
6.2 General notes . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.3 Preparation at the place of use . . . . . . . . . . . 15
6.4 Preparation before cleaning. . . . . . . . . . . . . . 15
6.5 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . 16
6.6 Manual cleaning with wipe disinfection. . . . 17
6.7 Automatic cleaning/disinfection with manual
pre-cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.8 Inspection, maintenance and checks. . . . . . . 19
6.9 Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
6.10 Steam sterilization . . . . . . . . . . . . . . . . . . . . . 20
6.11 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8. Troubleshooting list . . . . . . . . . . . . . . . . . . . . 21
9. Technical Service. . . . . . . . . . . . . . . . . . . . . . . 21
10. Accessories/Spare parts . . . . . . . . . . . . . . . . . 21
11. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . 22
11.1 Operating mode. . . . . . . . . . . . . . . . . . . . . . . . 23
11.2 Ambient conditions. . . . . . . . . . . . . . . . . . . . . 23
12. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Reverse button clockwise/coun-
terclockwise rotation + oscillation
mode switch
Motor speed control
Manufacturer’s batch designation
Manufacturer’s serial number
Manufacturer’s article number
Non-sterile medical product
Temperature limits during trans-
port and storage
Air humidity limits during trans-
port and storage
Atmospheric pressure limits dur-
ing transport and storage
Operating mode
R
L
LOT
SN
REF
S9

4
en
1. General information
1.1 Intended use
Task/Function
The small drill GA671, combined with the relevant
attachment and tool, is used for processing hard tissue,
cartilage and the like, as well as bone replacement
material, to screw bone pins in and out and to set
transfixion wires.
Application Environment
The product fulfills the requirements for type BF pursu-
ant to IEC/DIN EN 60601-1 and is used in operating
rooms in sterile environments of explosion risk areas
(such as areas with pure oxygen or anesthesia gases).
1.2 Main functions and design charac-
teristics
Electrical systems generally heat up during continual
operation. It is advised to give the system a break after
use to cool down, as listed in the table on operating
mode.
Heating depends on the tool used and the load. After a
certain number of repetitions, the system should cool
down. This procedure prevents the system overheating
as well as possible injury to the patient or user.
The user is responsible for the use and adherence to the
pause sequence described.
1.3 Indications
The type and area of application depend on the tool
selected.
1.4 Absolute contraindications
The product is not licensed for use on the central ner-
vous system or central circulatory system.
1.5 Relative contraindications
The safe and effective use of the product greatly
depends on influences which can only be controlled by
the user. Therefore the specifications provided repre-
sent framework conditions only.
Clinically successful use of the product is dependent on
the knowledge and experience of the surgeon. The sur-
geon must decide which structures it is sensible to
treat and take into account the safety and warning
information contained in these instructions for use.
Speed min. 0 min-1 to max. 26 000 min-1
Rotational
direction
Right and left rotation, oscillation
Operating
mode
Operation with non-periodic load
and speed changes (type S9 pursu-
ant to IEC EN 60034-1)
Drilling (clockwise/counterclock-
wise rotation):
■60 second application,
60 second pause
■20 repetitions
■30 min cooling time
Drilling (oscillation):
■60 second application,
60 second pause
■4 repetitions
■30 min cooling time
Saw mode with GB660R:
■30 second application,
60 second pause
■3 repetitions
■30 min cooling time

5
en
2. Safe handling
►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 work-
ing order.
►See “Information on electromagnetic compatibility
(EMC) for Acculan components" TA022450, see
Aesculap Extranet at https://extranet.bbraun.com
►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.
3. Product description
3.1 Scope of supply
3.2 Components required for opera-
tion
WARNING
Risk of injury and material
damage if this product is not
used as intended!
►Use the product only for its
intended purpose.
WARNING
Risk of injury and damage to
property due to improper han-
dling of the product!
►Follow the instructions for
use of all products used.
Designation Art. no.
Small drill GA671
Kirschner wire protec-
tion sleeve
GA672207
Rinsing adapter GA672211
Cover GA675
NiMH battery GA666
Sterile funnel GA678
STERILIT Power Systems
adapter
GB600840
Instructions for use for
GA666
TA011867
Instructions for use for
Acculan 3Ti attach-
ments
TA011936
Instructions for use for
GA671
TA012033
Cleaning brush TA011944
Designation Art. no.
Small drill GA671
Battery (rechargeable,
charged)
GA666 (NiMH) or GA346
(Li Ion)
Charger GA677
Drill and reamer attach-
ments
see TA011936
(Acculan 3Ti) and/or
TA014540 (Acculan 4)
Cover GA675
Sterile funnel GA678

6
en
3.3 Operating principle
The small drill 6contains an electric motor, a recharge-
able battery for power supply of the motor, and elec-
tronic 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.
4. Preparation
Non-compliance with the following instructions will
preclude all responsibility and liability in this respect
on the part of Aesculap.
►Do not use products from open or damaged sterile
packaging.
►Prior to use, inspect the product and its accessories
for any visible damage.
►Use the products and their accessories only if they
are in perfect technical condition.
5. Working with the
Acculan 3Ti small drill
WARNING
Risk of infection and contam-
ination!
Product is delivered unsteril-
ized!
►Sterilize the product
before use pursuant to the
operating instructions.
WARNING
Risk of injury and material
damage due to accidental
activation of the product!
►Products which are not
being actively used must be
secured against accidental
activation (position OFF).
WARNING
Risk of injury and material
damage due to inappropriate
use of tools!
►Always follow the safety
advice and information
given in the instructions
for use.
►When coupling/uncou-
pling, handle tools with
cutting edges with care.
WARNING
Damage to the product if
dropped!
►Use the products only if
they are in perfect techni-
cal condition, see Function
check.
WARNING
Risk of burns to skin and tissue
through blunt tools or if prod-
uct has not been maintained
properly!
►Use tools only if they are in
perfect condition.
►Replace blunt tools.
►Maintain the product
properly, see maintenance
guide.

7
en
5.1 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.
Inserting the battery
►Hold small drill 6with the battery compartment
upwards and attach funnel 14 (sterile), see Fig.1.
Fig.1
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.
CAUTION
Damage to, or destruction of
the batteries due to process-
ing!
►Do not sterilize batteries.
14
6

8
en
►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.
►Once the battery has been inserted, have a helper
remove sterile funnel 14 (unsterile), see Fig.3.
Fig.3
14
13
16
14

9
en
►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.
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
WARNING
Risk of injury from hot bat-
tery!
Battery may be hot after use in
the machine.
►Let the battery cool in the
machine and then remove.
–or –
►Remove the battery with
the battery removal device
and let it cool.
CAUTION
Damage to the battery caused
by knocking it against hard
objects!
►Only remove battery by
tapping the product on the
palm of the hand.
11
12
CAUTION
Damage to, or destruction of
the batteries due to process-
ing!
►Do not sterilize batteries.

10
en
►Remove battery 13 from the battery compartment
by knocking the unit against the palm of the hand,
see Fig.6.
Fig.6
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.
WARNING
Risk of injury from hot bat-
tery!
Battery may be hot after use in
the machine.
►Remove the battery with
the battery removal device
and let it cool.
6
8
18

11
en
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 (Acculan 3Ti) and/or TA014540
(Acculan 4).
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.
►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.
1517
6
6
5

12
en
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.
►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 (Acculan 3Ti) and/or TA014540 (Acculan 4).
5.2 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 correct
in each case.
5.3 Safe operation
7
8
9
6
WARNING
Coagulation of patient tissue
or risk of burns for patients
and user through hot product!
►Do not use products for
acetabulum milling.
►Cool the tool during opera-
tion.
►Keep product/tool out of
the reach of patients.
►Let the product/tool cool
down.
►Use a cloth to protect
against burns when chang-
ing the tool.
WARNING
Risk of infection from aerosol
formation!
Risk of injuries caused by par-
ticles coming loose from the
tool!
►Use suitable protection
(such as waterproof pro-
tective clothing, face
mask, safety gases, suc-
tion).

13
en
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 button
8,seeFig.12.
Small drill 6 is controlled continuously to run at a
speed appropriate for the present attachment.
Oscillating or tapping mode
►Activate oscillating or tapping mode: press and
hold button for counterclockwise rotation 7for
3 seconds, see Fig.12.
The drill issues a short acoustic signal.
►Activate counterclockwise rotation: press the rota-
tional speed control button 8in addition to the
button for counterclockwise rotation 7,seeFig.12.
Small drill 6 runs counterclockwise.
►To activate the tapping mode: press rotational
speed control button 8within the first half of its
entire 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.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
WARNING
Risk of injury when attach-
ing/removing attach-
ments/tools in the ON position
through inadvertent activa-
tion of the product!
►Only attach/remove
attachments/tools in the
OFF position.
WARNING
Risk of injury due to applica-
tion of the product outside the
field of view!
►Only use the product under
vision.
WARNING
Risk of injury and damage to
the tool/system!
The rotating tool may get
caught in drapes (such as tex-
tiles).
►Do not let the tool come
into contact with drapes
(such as textiles) during
operation.

14
en
►To activate the oscillating mode: press rotational
speed control button 8within the second half of its
entire travel range, see Fig.12.
Small drill 6 alternately runs counterclockwise and
clockwise.
►Deactivate oscillating or tapping mode: press and
hold button for counterclockwise rotation 7for
3 seconds, see Fig.12.
The drill issues an acoustic signal.
Fig.12
6. Validated reprocessing pro-
cedure
6.1 General safety information
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for reprocessing.
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
It should be noted that successful reprocessing of this
medical device can only be guaranteed following prior
validation of the reprocessing method. The opera-
tor/reprocessor is responsible for this.
The recommended chemical was used for validation.
Note
If there is no final sterilization, then a virucidal disinfec-
tant must be used.
Note
For the latest information on reprocessing and material
compatibility see also the Aesculap extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
7
8
9
6

15
en
6.2 General notes
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore, no more than 6 hours should be left between
use and preparation, pre-clean temperatures >45 °C
liable to fusing should not be employed and disinfec-
tants liable to fusing (aldehyde or alcohol-based)
should not be used.
Excessive neutralizing agents or basic cleaners may
result in a chemical attack and/or fading and the laser
marking becoming unreadable either visually or by
machine in case of non stainless steel.
On stainless steel, residues containing chlorine or chlo-
ride (such as surgical residues, drugs, saline solutions in
water for cleaning, disinfection and sterilization) may
lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. These must
be removed by rinsing thoroughly with demineralized
water and then drying.
Perform additional drying, if necessary.
Only process chemicals that have been tested and
approved (e.g. VAH or FDA approval or CE mark) and
which are compatible with the product’s materials
according to the chemical manufacturers’ recommen-
dations may be used for reprocessing the product. All
the chemical manufacturer's application specifications
must be strictly observed. Failure to do so can result in
the following problems:
■Visual material changes (such as fading or color
changes in titanium or aluminum). For aluminum,
the application/process solution only needs to be
pH >8 to cause visible surface changes.
■Material damage (such as corrosion, cracks, breaks,
premature aging or swelling).
►Do not use metal cleaning brushes or other abra-
sives that would damage the product surface and
could cause corrosion.
►Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, section Publications, Red
Brochure – Proper maintenance of instruments.
6.3 Preparation at the place of use
►Remove all attached components from the product
(tool an accessories).
►Remove any visible surgical residues as much as
possible with a damp, lint-free cloth.
►Place the dry product in a sealed waste container
and forward it on for cleaning and disinfection
within 6 hours.
6.4 Preparation before cleaning
►Prior to the first mechanical cleaning/disinfection
process, mount the ECCOS fixations in a suitable
tray (e.g. GB243800).
►Insert the product in its proper position in the
ECCOS fixations.

16
en
6.5 Cleaning/disinfection
Product-specific safety instructions for the
reprocessing procedure
Note
The indicated drying time is a guide time only. It must be
checked taking into account the specific conditions (e.g.
load) and if applicable adjusted.
CAUTION
Damage to the product due to
inappropriate 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).
►Do not use cleaning agents
that contain acetone.
►Observe specifications
regarding concentration,
temperature and exposure
time.
►Do not exceed the maxi-
mum temperature of 60 °C
during chemical cleaning
and/or disinfection.
►Do not exceed the maxi-
mum temperature of 96 °C
during thermal disinfection
with FD water.
►Dry the product for at least
10 minutes at a maximum
of 120 °C.
CAUTION
Damage or destruction of the
batteries due to processing!
►Protect battery from mois-
ture.

17
en
6.6 Manual cleaning with wipe disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality)
RT: Room temperature
* validated with enzyme cleaner “Cidezyme Johnson & Johnson”
►Do not clean the product in a ultrasonic bath and
do not immerse the product in any fluids. Let any
fluid incursions drain out immediately, otherwise
there is a danger of corrosion and loss of function.
Phase I
►Mobilize non-rigid components during cleaning.
►Clean the product under running water, using a
suitable plastic cleaning brush until all visible resi-
dues have been removed from the surfaces.
►Brush cannulation with cleaning brush TA011944
and difficult to access surfaces with a suitable
plastic cleaning brush for at least 1 min.
Note
For details on difficult to access surfaces, see Acculan
pre-cleaning and care information TA016000 (available
in Aesculap Extranet at https://extranet.bbraun.com).
Phase II
►Follow the operating instructions of the enzyme
cleaner with regard to correct concentration, dilu-
tion, temperature and water quality.
►Spray products with a pH neutral enzyme solution,
let soak in for at least 2 minutes and then wipe off.
Phase III
►Mobilize non-rigid components during cleaning.
►Rinse product under running tap water for at least
5 minutes.
►Follow the operating instructions of the enzyme
cleaner with regard to correct concentration, dilu-
tion, temperature and water quality.
►Contamination should be removed with a lint-free
cloth or soft brush moistened with enzyme cleaner.
►Flexible components (such as sleeves) and cannula-
tions should be rinsed for 20 seconds with the
water pistol (cold water, at least 2.5 bar).
►After manual cleaning, check visible surfaces and
areas of flexible components for residues.
►If necessary, repeat the cleaning process (phase 1
to 3).
Phase IV
►Dry the product in the drying phase with suitable
equipment (such as lint-free cloths, pressurized
air).
Phase V
►Wipe all surfaces of the product with a single-use
disinfecting wipe.
Phase Step D
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemistry
I Pre-cleaning RT (cold) ≥2 - D–W until visually clean
II Cleaning with enzyme
solution
RT (cold) ≥20.8D–W pH-neutral*
III Intermediate rinse RT ≥5- D–W –
IV Drying RT - - - -
V Wipe disinfection - >1 - - Meliseptol HBV wipes
50 % Propan-1-ol
VI Final rinse RT (cold) 0.5 - FD–W -
VII Drying RT - - - -

18
en
Stage VI
►Rinse disinfected surfaces after the prescribed
reaction time for at least 1 minute under running
demineralized water.
►Drain any remaining water fully.
Stage VII
►Dry the product in the drying phase with suitable
equipment (such as lint-free cloths, pressurized
air).
6.7 Automatic cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must fundamen-
tally have a tested efficacy (such as FDA approval or CE
label pursuant to DIN EN ISO 15883).
Note
The washer-disinfector machine used for processing
must be serviced and checked at regular intervals.
Manual pre-cleaning with brush
D–W: Drinking water
RT: Room temperature
►Do not clean the product in a ultrasonic bath and
do not immerse the product in any fluids. Let any
fluid incursions drain out immediately, otherwise
there is a danger of corrosion and loss of function.
Phase I
►Mobilize non-rigid components during cleaning.
►Thoroughly clean the product under running water.
Phase II
►Mobilize non-rigid components during cleaning.
►Brush cannulation with cleaning brush TA011944
and difficult to access surfaces with a suitable
plastic cleaning brush for at least 1 min.
►After manual preparation, check visible surfaces for
residue and repeat the pre-cleaning process as
needed.
Note
For details on difficult to access surfaces, see Acculan
pre-cleaning and care information TA016000 (available
in Aesculap Extranet at https://extranet.bbraun.com).
Phase Step D
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemistry/Note
I Rinsing RT (cold) - - D–W until visually clean
II Brushes RT (cold) - - D–W until visually clean