Braun Aesculap ELAN 4 Manual

Aesculap®
Aesculap Power Systems
USA Instructions for use/Technical description
ELAN 4 electro drill GA844
Document No.: TA014436 - Version: 1.0 - Document ID: SOP-AIC-5002244 Date/Time Printed/Viewed: 2022-04-13 16:01 (CET)
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Aesculap®
ELAN 4 electro drill GA844
Legend
1Product (ELAN 4 electro drill)
2Rotational speed control button
3Safety catch
4Screw handle
5Cable
6Connector for control unit
7Knob for left-rotation
8Coupling
9Arrow
10 Rotating sleeve
11 Adapter (for Kirschner wire protection sleeve and rinsing adapter)
12 Kirschner wire protection sleeve
13 Attachment
14 Rinsing adapter
15 Oil spray adapter
16 Symbol of the application part type in the display of the
ELAN 4 electro control unit
Symbols on product and packages
Contents
1. About this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Main functions and design characteristics. . . . . . . . . . . . . . . . 3
2.3 Application environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.5 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4. Product description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.1 Scope of supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
4.2 Components required for operation . . . . . . . . . . . . . . . . . . . . . 4
4.3 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6. Working with the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Caution
Observe important safety information such as warn-
ings and precautions in the instructions for use.
YYYY-MM
Maintenance label
Indication of the next maintenance appointment
(Date: Year-Month)
Machine-readable, two-dimensional code
The code contains a unique serial number which can be
used for electronic tracking of the individual instru-
ment. The serial number is based on the global stan-
dard sGTIN (GS1).
Manufacturer
Date of manufacture
Follow the instructions for use
Labeling of electrical and electronic devices pursuant
to directive 2002/96/EG (WEEE)
Classification Type BF
Reverse button clockwise/counterclockwise rotation +
oscillation mode switch
Motor speed control
Manufacturer’s batch designation
Manufacturer’s serial number
Manufacturer’s article number
Delivery quantity
Non-sterile medical device
According to US federal law, this product may only be
sold by a physician or by the order of a physician
Temperature limits during transport and storage
Air humidity limits during transport and storage
Atmospheric pressure limits during transport and stor-
age
R
L
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6.1.1 Connecting the accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.2 Protection against inadvertent activation. . . . . . . . . . . . . . . . . 5
6.1.3 Attaching and removing product attachments . . . . . . . . . . . . . 5
6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.3 Safe operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.1 Normal Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.3.2 Oscillating operation or thread cutting operation . . . . . . . . . . 6
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 6
7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.3 Reusable products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.4 Preparations at the place of use. . . . . . . . . . . . . . . . . . . . . . . . . 7
7.5 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.6 Cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.6.1 Product-specific safety instructions for the reprocessing
procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.7 Manual cleaning with wipe disinfection . . . . . . . . . . . . . . . . . . 8
7.8 Automatic cleaning/disinfection with manual pre-cleaning . . 8
7.8.1 Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . . 8
7.8.2 Mechanical alkaline cleaning and thermal disinfection. . . . . . 9
7.9 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 9
7.10 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.11 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.12 Sterilization for the US market. . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.13 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
12.1 Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 10
12.2 Performance data, information about standards . . . . . . . . . . . 10
12.3 Short-time interval operation. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
12.4 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
14. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1. About this document
Note
General risks of surgical intervention are not described in these instructions
for use.
1.1 Scope
These instructions for use apply to the ELAN 4 electro drill tool GA844.
►For article specific instructions for use and material compatibility and
lifetime information, see B. Braun eIFU at eifu.bbraun.com
1.2 Warnings
Warnings indicate risks to patients, users, and/or products which may
develop during the use of the product. Warnings are marked as follows:
DANGER
Indicates a potential danger. If it is not prevented, death or severe
injuries may result.
WARNING
Indicates a potential danger. If it is not prevented, minor or moderate
injuries may result.
CAUTION
Indicates a potential damage to property. If it is not prevented, the
product may be damaged.
2. General information
2.1 Intended use
Task/Function
The ELAN 4 electro drill GA844 is an accessory of the ELAN 4 electro motor
system.
The drill is connected to the control unit.
The ELAN 4 electro drill GA844, combined with the corresponding attach-
ment 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, to drive
screw tools and to set transfixion wires.
2.2 Main functions and design characteristics
Speed
min. 0 min-1 to max. 1 250 min-1
Rotational direction
Right and left rotation, oscillation
Short-time interval operation
Drilling (clockwise/counterclockwise rotation):
■60 second application, 60 second pause
■6 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Medullary reaming (clockwise/anti-clockwise rotation):
■30 second application, 30 second pause
■8 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Drilling (oscillation):
■15 s application, 15 s pause
■3 repetitions
■30 min cooling time
■Max. temperature 48 °C
Saw operation with GB891R:
■30 second application, 60 second pause
■4 repetitions
■30 min cooling time
■Max. temperature 48 °C
Saw operation with GB892R:
■30 second application, 60 second pause
■5 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Screws with GB896R and GB897R:
■10 s machine application, 10 s manual application, 30 s pause
■30 repetitions
■30 min cooling time
■Max. Temperature 48 °C
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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 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.
2.3 Application environment
Use in sterile and non-sterile areas
Sterile separation at the control unit.
2.4 Indications for Use
The ELAN 4 Electro Motor System is intended for high speed cutting, saw-
ing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofa-
cial Surgery.
2.5 Contraindications
The product is not licensed for use on the central nervous system or central
circulatory system.
Note
The safe and effective use of the product greatly depends on influences
which can only be controlled by the user. Therefore the specifications pro-
vided represent framework conditions only.
Clinically successful use of the product is dependent on the knowledge and
experience of the surgeon. The surgeon must decide which structures it is
sensible to treat and take into account the safety and warning information
contained in these instructions for use.
3. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
WARNING
Risk of injury and material damage if this product is not used as
intended!
►Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
►Follow the instructions for use of all products used.
■General risk factors associated with surgical procedures are not
described in this documentation.
■It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■The operating surgeon must have a thorough understanding of both the
hands-on and conceptual aspects of the established operating tech-
niques.
►Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►Prior to use, check that the product is in good working order.
►To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►Keep the instructions for use accessible for the user.
►Always adhere to applicable standards.
►Ensure that the electrical installation of the room is consistent with the
requirements of IEC/DIN EN.
►Do not operate the product in explosion-hazard areas.
►Sterilize product before use.
►When using the ECCOS holder system, observe the pertinent instruc-
tions for use for TA009721, see Aesculap Extranet at
https://extranet.bbraun.com
Note
The user is obligated to report all serious incidents occurring in connection
with the product to the manufacturer and to the competent authority of
the country in which the user is registered.
4. Product description
4.1 Scope of supply
4.2 Components required for operation
■Operationally ready ELAN 4 electro control unit GA800, see TA014401
(from software: V3.00)
■Attachment (depending on the indication, see also instructions for use
TA014552 or TA014553)
■Tool (depending on indication)
4.3 Operating principle
The product 1has an electric motor which is connected to the ELAN 4
control unit and supplied with voltage by means of a permanently con-
nected cable 5.
The output speed is controlled electronically and can be continuously reg-
ulated with the knob for speed control 2.
The direction of rotation can be changed from right to left again using the
knob for left rotation 7. The product can also be operated in an oscillation
mode.
On the output side, the product 1has a coupling 8, which enables the
coupling of various drilling, medullary reamers, sawing, and screw attach-
ments. These attachments lock themselves when plugging into the pro-
duct.
By actuating a rotating sleeve 10 the attachment 13 can be loosened.
Gearing in the various attachments changes the tool speed and enable
operation of the motor at an ideal operating point.
The attachments have various integrated couplings on the working end, to
receive corresponding tools, with adapters as applicable.
The product is equipped with a cannulation to receive guide spears or the
like.
Art. no. Designation
GA844 ELAN 4 electro drill
GA344244 Kirschner wire protection sleeve
GA344211 Rinsing adapter
GB600880 Oil spray adapter for GA344/GA844
TA011944 Cleaning brush
TA014437 Instructions for use for GA844 (flyer)
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5. Preparation
Aesculap assumes no liability if the following rules are not followed:
►Do not use products from open or damaged sterile packaging.
►Prior to use, inspect the product and its accessories for any visible dam-
age.
►Use the products and their accessories only if they are in perfect tech-
nical condition.
6. Working with the device
WARNING
Risk of infection and contamination!
Product is delivered unsterilized!
►Sterilize the product before use according to the operating instruc-
tions.
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/uncoupling, handle tools with cutting edges with
care.
WARNING
Damage to the product if dropped!
►Use the products only if they are in perfect technical condition, see
Function check.
WARNING
Risk of burns to skin and tissue through blunt tools or if product has
not been maintained properly!
►Use tools only if they are in perfect condition.
►Replace blunt tools.
►Maintain the product properly, see Maintenance.
WARNING
Damage to the product due to incorrect handling!
►Do not kink, jam, crush, and pull on the motor cable, also do not
damage it using sharp objects.
6.1 System set-up
WARNING
Risk of injury due to small parts that could enter the surgical field!
►Do not couple/uncouple tools and attachments over the surgical
field.
6.1.1 Connecting the accessories
Do not use accessories in combinations that are not mentioned in these
instructions for use.
►Follow the instructions for use of individual accessories.
►Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
Technical Service.
6.1.2 Protection against inadvertent activation
Note
The safety catch at the ELAN 4 electro drill tool GA844 is only used for
mechanical protection against an unintentional actuation of the speed
control pusher 2. When the safety catch is activated there is no communi-
cation with the control unit and it is not shown in the display.
To prevent the product being inadvertently activated when changing a tool
or accessory, the knob for speed control can be locked.
To lock rotational speed control button 2:
►Twist the safety catch 3to position OFF.
The speed control knob 2is blocked and the product 1cannot be oper-
ated.
Unlocking the knob for speed control 2:
►Twist the safety catch 3to position ON.
The speed control knob 2is unlocked and the product 1can be oper-
ated.
6.1.3 Attaching and removing product attachments
Note
For additional information on the attachments, see TA014552 and
TA014553 (flyer).
WARNING
Risk of injury when attaching/removing attachments/tools in the ON
position through inadvertent activation of the product!
►Only attach/remove attachments/tools in the OFF position.
►Secure product 1from inadvertent activation with the safety catch 3,
see Protection against inadvertent activation.
Coupling
►Push attachment 13 into coupling 8until it clicks into place.
►Pull on the attachment 13 to ensure a secure fit.
Uncoupling
►Turn the sleeve 10 in the direction of the arrow 9and simultaneously
remove the attachment 13 from the product 8.
Attach the Kirschner wire protection sleeve
Note
The special Kirschner wire chuck is recommended for the placement of
guide wires.
WARNING
Risk of injury when using long guide wires!
►Use Kirschner wire protection sleeve when using long guide wires.
►Screw on the Kirschner wire protection sleeve 12 into attachment 11.
Attach the tool to the attachment
Note
Attachment of the tools is described in operating instructions TA014552
and TA014553 (leaflet).
6.2 Function checks
A function check must be carried out prior to each use and attachment
change.
►Check the secure connection of all products to be used.
►Check that the attachment is coupled properly. To test this, pull on the
attachment.
►Check that the tool is coupled properly. To do this, pull on the tool.
►For GB891R: check that the tool attachment has locked into place. To
do this, turn the tool attachment.
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►Ensure that the tool blades are not mechanically damaged.
►Release product for use (ON position).
►Run the product shortly at maximum speed in right and left rotation.
►Make certain that the rotational direction is correct in each case.
►Check the product for damage, abnormal operation noises, heavy vibra-
tion and excessive heat.
►Do not use the product if it is damaged or defective.
►Set aside the product if it is damaged.
6.3 Safe operation
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 operation.
►Keep product/tool out of the reach of patients.
►Let the product/tool cool down.
►Use a cloth to protect against burns when changing the tool.
WARNING
Risk of infection from aerosol formation!
Risk of injuries caused by particles coming loose from the tool!
►Use suitable protection (such as waterproof protective clothing,
face mask, safety gases, suction).
WARNING
Risk of injury and/or malfunction!
►Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
►Apply the product only under visual control.
WARNING
Risk of injury and damage to the tool/system!
The rotating tool may get caught in drapes (such as textiles).
►Do not let the tool come into contact with drapes (such as textiles)
during operation.
The application part can only be used and the setting parameters at the
control unit can only be altered if:
■the application part is connected to the control unit,
■there is no second application part activated (position "On”) at the
same time and
■the application part type 16 is shown in the display for the control unit.
Note
When two ELAN 4 electro drill tools GA844 are connected to the
ELAN 4 electro control unit GA800, the drill tool whose speed control safety
catch is actuated first is active.
Note
For additional information, see the operating instructions for the
ELAN 4 electro control unit GA800 (TA014401).
Note
The product drive motor is operated using a magnetic sensor system. In
order to prevent inadvertent activation of the motor, the product may not
be exposed to any magnetic fields (such as magnetic instrument pads).
6.3.1 Normal Operation
Product operating in right rotation mode:
►Activate the knob for speed control 2.
The speed of the product 1is continuously regulated pursuant to the
attachment utilized.
Product operating in left rotation mode:
►Press the knob for left rotation 7completely in and keep it depressed.
►Activate the knob for speed control 2.
The speed of the product 1is continuously regulated pursuant to the
attachment utilized.
6.3.2 Oscillating operation or thread cutting operation
Note
Check that the oscillation mode is set to "ON" at the control panel on the
ELAN 4 control unit (GA800).
Enable oscillating operation or thread cutting operation:
►Keep the knob for left rotation 7pressed for 3 seconds.
There will be multiple signal tones.
Oscillating operation:
►Press the knob for speed control 2in all the way.
Product 1will rotate clockwise and counterclockwise in alternation.
Tapping operation:
►Depress the speed control knob 2up to a maximum of half-way.
Product 1will gradually turn counterclockwise and clockwise, whereby
the rotational angle in the clockwise direction is greater than that of
the counterclockwise direction.
To activate left rotation:
►Press the speed control knob 2in addition to the knob for left
rotation 7.
The product 1will rotate counterclockwise.
Disable oscillating operation or thread cutting operation:
►Keep the knob for left rotation 7pressed for 3 seconds.
There will be multiple signal tones.
7. Validated reprocessing procedure
7.1 General safety notes
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives
better and more reliable results.
Note
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
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Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility,
see also the Aesculap Extranet at https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
7.2 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica-
tion and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting agents (active
ingredient: aldehydes/alcohols) should be used.
Excessive neutralizing agents or basic cleaners may result in a chemical
attack and/or fading and the laser marking becoming unreadable either
visually or by machine.
On stainless steel, residues containing chlorine or chloride (such as surgi-
cal residues, drugs, saline solutions in water for cleaning, disinfection and
sterilization) may lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. These must be removed by rins-
ing thoroughly with demineralized water and then drying.
Perform additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or
FDA approval or CE mark) and which are compatible with the product’s
materials according to the chemical manufacturers’ recommendations
may be used for processing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
■Visual material changes (such as fading or color changes in titanium or
aluminum). For aluminum, the application/process solution only needs
to be pH >8 to cause visible surface changes.
■Material damage (such as corrosion, cracks, breaks, premature aging or
swelling).
►Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion
►For further detailed information on hygienically safe and material-pre-
serving/value-preserving reprocessing, see www.a-k-i.org, link to Pub-
lications, Red Brochure – Proper maintenance of instruments.
7.3 Reusable products
The service life of the product is limited by damage, normal wear, type and
duration of the application, handling, storage and transportation of the
product.
Careful visual and functional testing prior to next use is the best way to
identify a malfunctioning product.
7.4 Preparations at the place of use
►Remove all attached components from the product (tool an accesso-
ries).
►Remove any visible surgical residues as much as possible with a damp,
lint-free cloth.
►Place the dry product in a sealed waste container and forward it on for
cleaning and disinfection within 6 hours.
7.5 Preparation before cleaning
►Prior to first mechanical cleaning/disinfection process: Install the
Aesculap ECCOS holder system in a suitable tray.
►Insert products in the correct position into the Aesculap ECCOS holder
system, see Fig. B.
7.6 Cleaning/disinfection
7.6.1 Product-specific safety instructions for the reprocessing pro-
cedure
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting
agents and/or excessive temperatures!
►Use cleaning and disinfecting agents according to the manufac-
turer’s instructions which
–are approved for plastic material and high-grade steel,
–do not attack softeners (e.g. in silicone).
►Do not use cleaning agents that contain acetone.
►Observe specifications regarding concentration, temperature and
exposure time.
►Do not exceed the maximum temperature of 60 °C during chemical
cleaning and/or disinfection.
►Do not exceed maximum temperature when using 95°C DI water
for thermal disinfection.
►Dry the product for at least 10 minutes at a maximum of 120 °C.
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.
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7.7 Manual cleaning with wipe disinfection
DW: Drinking water
FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality)
RT: Room temperature
* Suitable enzyme solution: Helizyme, Cidezyme (the latter being used for validation purposes)
►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
►Move flexible components (such as sleeves) during cleaning.
►Clean the product under running water, using a suitable plastic clean-
ing brush until all visible residues have been removed from the sur-
faces.
►Brush cannulation with cleaning brush TA011944 and difficult to
access surfaces with a suitable plastic cleaning brush for at least 1 min.
Phase II
►Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►Spray products with a pH neutral enzyme solution, let soak in for at
least 2 minutes and then wipe off.
Phase III
►Move flexible components (such as sleeves) during cleaning.
►Rinse product under running tap water for at least 5 minutes.
►Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►Remove contamination with a lint-free cloth or soft brush moistened
with enzyme cleaner.
►Rinse flexible components (such as sleeves) and cannulations for
20 seconds with the water pistol (cold water, at least 2.5 bar).
►After manual cleaning, check visible surfaces and areas of flexible com-
ponents for residues.
►If necessary, repeat the cleaning process (phase 1 to 3).
Phase IV
►Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
Phase V
►Wipe all surfaces of the product with a single-use disinfecting wipe.
Phase VI
►Rinse disinfected surfaces after the prescribed reaction time for at least
1 minute under running demineralized water.
►Drain any remaining water fully.
Stage VII
►Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
7.8 Automatic cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must fundamentally have a tested
efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883).
Note
The cleaning and disinfection machine used for processing must be serviced
and checked at regular intervals.
7.8.1 Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
►Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids. Let any fluid incursions drain out immediately,
otherwise there is a danger of corrosion and loss of function.
Phase I
►Move flexible components (such as sleeves) during cleaning.
►Thoroughly clean the product under running water.
Phase II
►Move flexible components (such as sleeves) 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 pre-cleaning, check visible surfaces for residue and
repeat the pre-cleaning process as required.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water quality Chemicals
I Pre-cleaning RT (cold) ≥2 - D-W Until visually clean
II Cleaning with enzyme
solution
RT (cold) ≥2 0.8 D–W pH-neutral*
III Intermediate rinse RT ≥5- D-W –
IV Drying RT - - - -
V Wipe disinfection - >1 - - Meliseptol HBV wipes 50 % Propan-1-ol
VI Final rinse RT (cold) 0.5 - FD–W -
VII Drying RT - - - -
Phase Step T
[°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
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7.8.2 Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
D-W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►Insert product 1in the correct position in the Aesculap ECCOS holder
systems, see Fig. B.
►Attach the rinsing adapter 14 (GA344211) to the product 1in the
mount 11.
►Then connect the interior rinse device and connect to the rinse connec-
tor of the cleaning/disinfection device/rinse cart.
►Attach the Kirschner wire protection sleeve 12 to a rinse hose.
►After automatic cleaning/disinfection, check visible surfaces for resi-
dues and repeat the cleaning/disinfection process as needed.
7.9 Inspection, maintenance and checks
►Allow the product to cool down to room temperature.
►Spray product after every cleaning and disinfection with Aesculap
STERILIT Power Systems oil spray GB600 using the oil spray adapter 15
GB600880 (green) for approx. 2 s, see Fig. A.
Note
Aesculap additionally recommends the occasional spraying of moving parts
(such as knobs, couplings) with the Aesculap STERILIT Power Systems oil
spray.
►Check the product after each cleaning and disinfection for the follow-
ing: cleanliness, damage, function, abnormal operation noise, excessive
heat or heavy vibration.
►Set aside the product if it is damaged.
7.10 Packaging
►Follow the instructions for use of the respective packaging and holders
(e.g. instructions for use TA009721 for Aesculap ECCOS holder sys-
tems).
►Insert products in the correct position into the Aesculap ECCOS holder
system, see Fig. B.
►Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►Ensure that the packaging will prevent a recontamination of the pro-
duct.
7.11 Steam sterilization
Note
Remove all attached components from the product (tools, accessories)
before sterilization.
►Make certain that all external and internal surfaces of the product will
be exposed to the sterilizing agent.
►Use a validated sterilization method:
– Steam sterilization using fractional vacuum process
– Steam sterilizer DIN EN 285 and validated pursuant to
DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
When sterilizing multiple products in one steam sterilizer:
►Ensure that the maximum permitted load specified by the manufac-
turer for the steam sterilizer is not exceeded.
7.12 Sterilization for the US market
■Aesculap advises against sterilizing the device by flash sterilization or
chemical sterilization.
■Sterilization may be accomplished by a standard prevacuum cycle in a
steam autoclave.
To achieve a sterility assurance level of 10-6, Aesculap recommends the
following parameters:
*Aesculap has validated the above sterilization cycle and has the data on
file. The validation was accomplished in an Aesculap sterile container
cleared by FDA for the sterilization and storage of these products. Other
sterilization cycles may also be suitable, however individuals or hospitals
not using the recommended method are advised to validate any alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemistry/Note
I Pre-rinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W ■Concentrate, alkaline:
–pH~13
– <5 % anionic surfactant
■0.5 % working solution
– pH ~ 11*
III Intermediate rinse >10/50 1 FD–W -
IV Thermal disinfection 90/194 5 FD–W -
V Drying - - - at least 10min at max. 120°C
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization
method
Temp. Time Minimum drying time
Prevacuum 270 °F/275 °F 4 min 20 min
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7.13 Storage
►Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
8. Maintenance
To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance labeling or at least once a year.
YYYY-MM
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
9. Troubleshooting list
Note
For additional information, see the operating instructions for the
ELAN 4 electro control unit GA800 (TA014401).
10. Technical Service
DANGER
Risk of death to patients and users in case of malfunction and/or fail-
ure of protective measures!
►Do not perform any servicing or maintenance work under any cir-
cumstances while the product is being used on a patient.
►Do not modify the product.
CAUTION
Modifications of medical devices may result in a loss of potential
guarantee/warranty claims and forfeiture of applicable licenses.
►Do not modify product.
►Contact national B. Braun/Aesculaprepresentative for service and
repair.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
►For service and repairs, please contact your national B. Braun/Aesculap
agency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
11. Accessories/Spare parts
12. Technical data
12.1 Classification acc. to Directive 93/42/EEC
12.2 Performance data, information about standards
After 350 preparatory cycles, the product was tested by the manufacturer
and passed.
Art. no. Designation
GA344244 Kirschner wire protection sleeve
GA344211 Rinsing adapter
GB072R ECCOS winding aid for cables and hoses
GB073R ELAN 4 electro ECCOS motor cable
GB262R ECCOS tray with fixations for GA844
GB600 STERILIT Power Systems oil spray
GB600880 Oil spray adapter for GA344/GA844
TA011944 Cleaning brush
GB482R ECCOS fixation for GA344/GA844
TA014401 Instructions for use for ELAN 4 electro control unit
GA800 (A4 for ring-binder)
TA014436 Instructions for use for ELAN 4 electro drill tool
GA844 (A4 for ring-binder)
TA014437 Instructions for use of ELAN 4 electro drill GA844
(flyer)
TA014452 Instructions for use for attachments for the small
drill tool GA344 and the drill tool GA844 (A4 for
ring-binder)
TA014453 Instructions for use for attachments for the small
drill tool GA344 and the drill tool GA844 (flyer)
Art. no. Designation Class
GA844 ELAN 4 electro drill IIa
Max. power approx. 200 W
Speed 0 rpm to max. 1,250 rpm ± 5 %
Rotational direction Right and left rotation, oscillation
Cannulation 3.3 mm
Weight 0.8 kg ± 10 %
Cable length 4 m ± 10 %
Dimensions (L × W × H) 122 × 130 × 27 mm ± 5 %
Applied part Type BF
EMC IEC/DIN EN 60601-1-2
Conforming to standard IEC/DIN EN 60601-1
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12.3 Short-time interval operation
Drilling (clockwise/counterclockwise rotation):
■60 second application, 60 second pause
■6 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Medullary reaming (clockwise/anti-clockwise rotation):
■30 second application, 30 second pause
■8 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Drilling (oscillation):
■15 s application, 15 s pause
■3 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Saw operation with GB891R:
■30 second application, 60 second pause
■4 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Saw operation with GB892R:
■30 second application, 60 second pause
■5 repetitions
■30 min cooling time
■Max. Temperature 48 °C
Screws with GB896R and GB897R:
■10 s machine application, 10 s manual application, 30 s pause
■30 repetitions
■30 min cooling time
■Max. temperature 48 °C
12.4 Environmental conditions
13. Disposal
WARNING
Risk of infection from contaminated products!
►Observe national regulations when disposing of or recycling the
product, its components, and their packaging.
Note
The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.
►Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Technical
Service.
14. Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Operation Storage and transport
Temperature 10 °C to 27 °C -10 °C to 50 °C
Relative
humidity
30 % to 75 % 10 % to 90 %
Atmospheric
pressure
700 hPa to 1 060 hPa 500 hPa to 1 060 hPa
The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
(The recycling pass includes disassembling instructions for
the product, as well as information for proper disposal of
components harmful to the environment.)
Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufac-
turer as a free-of-charge service.
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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone [phone] | Fax [phone] | www.aesculap.com
Aesculap®– a B. Braun brand SOP-AIC-5002244 (TA014436)
2019-09 Rev. 1
Document No.: TA014436 - Version: 1.0 - Document ID: SOP-AIC-5002244 Date/Time Printed/Viewed: 2022-04-13 16:01 (CET)
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