B. Braun Aesculap Manual

Aesculap®
Aesculap Power Systems
Instructions for use/Technical description
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 /
ELAN 4 electro HD handpiece (2 ring) GA865 to GA869
Gebrauchsanweisung/Technische Beschreibung
ELAN 4 electro Handstück Standard (1-Ring) GA861 bis GA864 /
ELAN 4 electro Handstück HD (2-Ring) GA865 bis GA869
Mode d’emploi/Description technique
Pièce à main ELAN 4 electro Standard (1 anneau) GA861 à GA864 / pièce à
main ELAN 4 electro HD (2 anneaux) GA865 à GA869
Instrucciones de manejo/Descripción técnica
Pieza de mano ELAN 4 electro Standard GA861 (1 anillo) a GA864 / pieza de
mano ELAN 4 electro HD (2 anillos) GA865 a GA869
Istruzioni per l’uso/Descrizione tecnica
Manipolo ELAN 4 electro Standard (a un anello) da GA861 a GA864 / mani-
polo ELAN 4 electro HD (a due anelli) da GA865 a GA869
Instruções de utilização/Descrição técnica
ELAN 4 electro peça de mão Standard (1 anel) GA861 a GA864 /
ELAN 4 electro peça de mão HD (2 anéis) GA865 a GA869
Gebruiksaanwijzing/Technische beschrijving
ELAN 4 electro handstuk Standard (1-ring) GA861 tot GA864 /
ELAN 4 electro handstuk HD (2-ring) GA865 tot GA869
Brugsanvisning/Teknisk beskrivelse
ELAN 4 electro håndstykke Standard (1 ring) GA861 til GA864 /
ELAN 4 electro håndstykke HD (2 ringe) GA865 til GA869
Bruksanvisning/Teknisk beskrivning
ELAN 4 electro handstycke Standard (1 ring) GA861 till GA864 /
ELAN 4 electro handstycke HD (2 ringar) GA865 till GA869
Käyttöohje/Tekninen kuvaus
ELAN 4 electro-käsikappale vakio (1-renkainen) GA861–GA864 /
ELAN 4 electro-käsikappale HD (2-renkainen) GA865–GA869
Kasutusjuhend/Tehniline kirjeldus
ELAN 4 electro käsiseade Standard (1 rõngaga) GA861 kuni GA864 /
ELAN 4 electro käsiseade HD (2 rõngaga) GA865 kuni GA869
Инструкция по примению/Техническое описание
ELAN 4 electro наконечник Standard (1-кольцо) GA861 – GA864 /
ELAN 4 electro наконечник HD (2-кольца) GA865 – GA869
Návod k použití/Technický popis
ELAN 4 electro násadec Standard (1 kroužek) GA861 až GA864 /
ELAN 4 electro násadec HD (2 kroužky) GA865 až GA869
Instrukcja użytkowania/Opis techniczny
Uchwyt ELAN 4 electro Standard (1-pierścieniowy) GA861 do GA864 /
uchwyt ELAN 4 electro HD (2-pierścieniowy) GA865 do GA869
Návod na použitie/Technický opis
ELAN 4 electro rukoväť Standard (1-prstencová) GA861 až GA864 /
ELAN 4 electro rukoväť HD (2-prstencová) GA865 až GA869
Kullanım Kılavuzu/Teknik açiklama
ELAN 4 electro El cihazı Standard (1 halka) GA861 ila GA864 /
ELAN 4 electro el cihazı HD (2 halka) GA865 ila GA869

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Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
Aesculap® ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro HD handpiece (2 ring) GA 865 to GA869
Legend
1ELAN 4 tool coupling (1 ring or 2 ring)
2Ring marking
3Connector for motor cable
4Slider for tool release
5Symbol of the applied part type in display of ELAN 4 electro control
unit
6ELAN 4 tool (1 ring or 2 ring)
7ELAN 4 single-use spray nozzle for 1 ring or 2 ring handpieces
ELAN 4 ECCOS holder for 12 drills GB718R
8Side handles
9Holding nibs
10 Tool coupling
11 Tab
Symbols on product and packages
Contents
1. Applicable to. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Task/function within system . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Application Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.3 Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.1 Sterile ELAN 4 tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.2 Sterile ELAN 4 single-use spray nozzles . . . . . . . . . . . . . . . . . . . 4
4. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.1 Available sizes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.2 Package includes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.3 Components required for operation . . . . . . . . . . . . . . . . . . . . . . 5
4.4 Operating principle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6. Working with the applied part . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.1 System set-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.2 Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 General safety notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.3 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.4 Preparation before cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.6 Manual cleaning with immersion disinfection - applied part . 10
7.7 Mechanical cleaning/disinfecting with manual pre-cleaning -
applied part. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.8 Mechanical cleaning/disinfecting with manual pre-cleaning -
tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
7.9 Inspection, maintenance and checks . . . . . . . . . . . . . . . . . . . . . 14
Caution
Observe important safety information such as warn-
ings and precautions in the instructions for use.
YYYY-MM
Maintenance label
Recommended date of next service (format: YYYY-
MM) by international B. Braun-/Aesculap agents, see
Technical Service
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).
Date of manufacture
Sterilization using irradiation
Not for reuse in intended applications as defined by the
manufacturer
Use by
Manufacturer’s batch designation
Manufacturer’s serial number
LOT
SN
Manufacturer’s article number
Temperature limits during transport and storage
Air humidity limits during transport and storage
Atmospheric pressure limits during transport and stor-
age
REF

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7.10 Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.11 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.12 Sterilization for the US market . . . . . . . . . . . . . . . . . . . . . . . . . . 15
7.13 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10. Technical Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
11. Accessories/Spare parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
12. Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
12.1 Classification acc. to Directive 93/42/EEC . . . . . . . . . . . . . . . . . 16
12.2 Performance data, information about standards . . . . . . . . . . . . 16
12.3 Tool speed/Setting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12.4 Short interval operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
12.5 Ambient conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
14. Distributor in the US/Contact in Canada for product
information and complaints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1. Applicable to
►For item-specific instructions for use and information on material
compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
2. Intended use
2.1 Task/function within system
The handheld Highspeed ELAN 4 electro Standard handpiece (1 ring)
GA861 to GA864 or ELAN 4 electro HD handpiece (2 ring) GA865 to
GA869 is an accessory of the ELAN 4 electro motor system.
The handpiece is connected by an ELAN 4 electro motor cable to the con-
trol unit.
The handpiece is used to drive Aesculap ELAN 4 tools (1 ring or 2 ring).
2.2 Application Environment
Application in the sterile area
2.3 Indications
Note
The type and area of application depend on the tools selected.
2.4 Contraindications
The ELAN 4 electro motor system is not authorized for use in the central
nervous system or central circulatory system.
Note
The safe and effective use of electrically driven applied parts depends heav-
ily on influences that only the user can control him or herself. Therefore the
specifications provided represent framework conditions only.
Note
The clinical success of the use of the ELAN 4 electro motor system is depen-
dent 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.
Speed min. 0 rpm to max. 80 000 rpm
Rotational direction Right and left rotation
Short interval operation 30 second application, 30 second pause
at 60 000 RPM
Modes of application Separating, removing and shaping hard tis-
sue, cartilage and similar, as well as for drill-
ing holes in bone and bone replacement
materials.
Surgical discipline/areas
of application
Neurosurgery, ENT surgery, OMF surgery,
orthopedics and trauma surgery

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Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
3. Safe handling
CAUTION
Federal law restricts this device to sale by or on order of a physician!
■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
techniques.
►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.
►Observe “Notes on Electromagnetic Compatibility (EMC)“, see
TA022130.
►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 installations at the premises where the
device is to be used meet all requirements acc. to IEC/DIN EN.
►Do not use the control unit and applied part in potentially explosive
areas.
►Carry out sterile processing in any reusable applied parts, motor cables
and tools prior to use.
►When handling, observe instructions for use that are relevant to
Aesculap holder systems TA009721, see Aesculap Extranet at
https://extranet.bbraun.com
3.1 Sterile ELAN 4 tools
The product is gamma-sterilized and supplied in sterile packaging.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►Read, follow, and keep the instructions for use.
►Use the product only in accordance with its intended use, see Intended
use.
►Do not use products from open or damaged sterile packaging.
►Prior to each use, inspect the product for: loose, bent, broken, cracked,
worn, or fractured components.
►Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►Do not use the product after its use-by date.
3.2 Sterile ELAN 4 single-use spray nozzles
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►read, follow, and keep the instructions for use.
►Use the product only in accordance with its intended use, see Intended
use.
►Do not use products from open or damaged sterile packaging.
►Prior to each use, inspect the product for: loose, bent, broken, cracked,
worn, or fractured components.
►Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►Do not use the product after its use-by date.
WARNING
Risk of injury and material damage due to inappro-
priate use of the product!
►Use the product only in accordance with the
intended purpose.
WARNING
Risk of injury and damage to property due to
improper handling of the product!
This product is an accessory of the ELAN 4 electro
control unit GA800.
►Follow the instructions for use of the
ELAN 4 electro control unit GA800
(TA014401).
►Follow the instructions for use of all products
used.
DANGER
Risk of infection for patients and/or users and
impairment of product functionality due to reuse.
Risk of injury, illness or death due to contamination
and/or impaired functionality of the product!
►Do not reprocess the product.

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4. Product description
4.1 Available sizes
Note
The shaft length can be seen on the shaft of the drill handpiece.
ELAN 4 electro Standard handpiece (1 ring)
ELAN 4 electro HD handpiece (2 ring)
4.2 Package includes
ELAN 4 electro Standard handpiece (1 ring)
ELAN 4 electro HD handpiece (2 ring)
4.3 Components required for operation
■Operation-ready ELAN 4 electro control unit GA800, see TA014401
■ELAN 4 tool (1 ring or 2 ring)
4.4 Operating principle
Note
The ring marking 2shows the shaft diameter of the tool to be used. ELAN 4
tools can be only coupled to the applied part if the ring markings
(1 ring/2 ring) of the applied part and tool match.
The drill handpiece is fitted with an ELAN 4 tool coupling (1 ring or 2 ring).
It is used with ELAN 4 electro foot controls/manual controls.
With the drill handpiece, the coupled tool rotates at the set motor speed.
The motor speed of the drill handpiece can be adjusted continuously by
the manual/foot control.
The drill handpiece can be operated in right or left (clockwise or counter-
clockwise) rotation mode.
5. Preparation
Non-compliance with these rules will result in complete exclusion of lia-
bility 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 tech-
nical condition.
Art. no. Length of shaft
GA861 L4 (approx. 4 cm)
GA862 L7 (approx. 7 cm)
GA863 L10 (approx. 10 cm)
GA864 L13 (approx. 13 cm)
Art. no. Length of shaft
GA865 L7 (approx. 7 cm)
GA866 L10 (approx. 10 cm)
GA867 L13 (approx. 13 cm)
GA868 L17 (approx. 17 cm)
GA869 L22 (approx. 22 cm)
Art. no. Designation
GA861–GA864 ELAN 4 electro Standard handpiece (1 ring)
TA014443 Instructions for use of ELAN 4 electro Standard
handpiece (1 ring) GA861 to GA864 /
ELAN 4 electro HD handpiece (2 ring) GA865 to
GA869 (leaflet)
Art. no. Designation
GA865–GA869 ELAN 4 electro handpiece HD (2-Ring)
TA014443 Instructions for use of ELAN 4 electro Standard
handpiece (1 ring) GA861 to GA864 /
ELAN 4 electro HD handpiece (2 ring) GA865 to
GA869 (leaflet)

6
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
6. Working with the applied part
6.1 System set-up
Note
Operating elements on the system components of the ELAN 4 electro motor
system are labeled with a gold marking.
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.
All configurations must comply with basic standard IEC/DIN EN 60601-1.
Any individual connecting devices with one another is responsible for such
configuration and must ensure compliance with basic standard IEC/DIN
EN 60601-1 or applicable national standards.
►Follow the instructions for use of individual accessories.
►Please contact your B. Braun/Aesculap Partner or Aesculap Technical
Service (address: see Technical Service with any inquiries in this
respect.
Removing ELAN 4 ECCOS holder for 12 burrs GB718R from the tray
The insert of the ELAN 4 ECCOS holder for 12 burrs GB718R can be
removed from the tray together with the tools.
►Pull the tab 11 and remove the insert of the holder, see Fig. C.
Coupling the tool to the applied part
►Lock applied part ("Off" position), see instructions for use of
ELAN 4 electro control unit GA800 (TA014401).
►Push tool shaft 6as far as it will go into ELAN 4 tool coupling (1 ring
or 2 ring) 1, see Fig. A.
The tool engages. The tool is correctly coupled when the ring marking 2
on the tool is no longer visible.
►Pull at tool 6to check that it is securely coupled.
Uncoupling the tool from the applied part
►Lock applied part ("Off" position), see instructions for use of
ELAN 4 electro control unit GA800 (TA014401).
►Pull back slider for tool release 4on the applied part and remove tool 6
from ELAN 4 tool coupling (1 ring or 2 ring) 1, see Fig. A.
WARNING
Risk of infection and contamination!
Applied parts and motor cable are delivered unster-
ile!
►Carry out sterile processing of the applied parts
and motor cable prior to use, in accordance with
the instructions for use.
WARNING
Risk of injury and material damage due to inadver-
tent activation of the applied part!
►Secure applied parts that are not actually used
against inadvertent activation ("Off" position),
see instructions for use for ELAN 4 electro con-
trol unit GA800 (TA014401).
WARNING
Risk of injury and material damage due to inappro-
priate 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 due to blunt tools/
lack of maintenance of the applied part!
►Use tools only if they are in perfect condition.
►Replace blunt tools.
►Ensure correct maintenance of the applied part,
see Maintenance.
WARNING
Risk of injury when coupling/uncoupling tools in
the "On" position due to accidental activation of
the applied part!
►Only couple/uncouple tools in the "Off" posi-
tion.
WARNING
Risk of injury due to small parts in the operation
site!
►Do not couple/uncouple tools over the operation
site.
WARNING
Risk of injury when coupling/uncoupling tools in
the "On" position due to accidental activation of
the applied part!
►Only couple/uncouple tools in the "Off" posi-
tion.
WARNING
Risk of injury due to small parts in the operation
site!
►Do not couple/uncouple tools over the operation
site.

7
Mounting the spray nozzle and tube set
►Connect tube set GA395SU to pump of ELAN 4 electro control unit
GA800, see TA014401.
►Push application-side tube end onto tube connection of the ELAN 4
single-use spray nozzle for 1 ring or 2 ring handpieces 7.
►Push single-use spray nozzle for ELAN 4 1 ring or 2 ring
handpieces 7onto the shaft of the applied part and push/turn into the
desired position, see Fig. A.
Note
The spray tube of the ELAN 4 single-use spray nozzle for 1 ring or 2 ring
handpiece is bendable by hand and can be adapted to the requirements of
application (e.g. aligned to tool head).
6.2 Function check
►Prior to each use, check that all products to be used are in good work-
ing order.
►Check the secure connection of all products to be used.
►Check that the tool is coupled properly. To do this, pull on the tool.
►Check that the cutting edges of the tools are not showing any mechan-
ical damage.
►Briefly run the applied parts at maximum speed.
►Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
6.3 Operation
It is only possible to operate the applied part and change the setting
parameters on the control unit if:
■the applied part is connected to the control unit,
■there is no second applied part released ("On" position) at the same
time and
■the applied part type 5is shown in the display of the control unit.
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
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.
The recommended chemical was used for validation.
WARNING
Coagulation of patient tissue or risk of burns for
patients and users from hot applied part/tool!
►Cool the tool during operation.
►Put down the applied part/tool beyond reach of
the patient.
►Allow the applied part/tool to 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!
►Take appropriate protective measures, e.g.
watertight protective clothing, face mask and
protective goggles, suction extraction.
WARNING
Risk of injury and/or malfunction!
►Always carry out a function test prior to each
use of the product.
WARNING
Risk of injury due to application 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 catch cover drapes (textile or
other).
►Never allow the tool to touch cover drapes (tex-
tile or other) during operation.
WARNING
Danger of injury from foreign body reactions (e.g.
inflammation, encapsulation) if particles remain in
the body!
When using diamond tools, it is always possible for
diamond grains/nickel particles to break away/off.
►Carefully rinse and vacuum while and after
working with diamond tools.

8
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
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 appli-
cation 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.
Residues containing chlorine or chlorides, e.g., in surgical residues, medi-
cines, saline solutions, and in the service water used for cleaning, disin-
fection, and sterilization, will cause corrosion damage (pitting, stress cor-
rosion) and result damage to metallic products. 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’ 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:
■Material damage such as corrosion, cracks, fracturing, 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 Preparations at the place of use
►Separate the products from each other immediately after use.
►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.
7.4 Preparation before cleaning
Applied part
►Prior to first mechanical cleaning/disinfection process: Mount ECCOS
holder GB082R/GB083R in a suitable tray (e.g. JF222R).
►Place the product in the correct position in the ECCOS holder
GB082R/GB083R, see Fig. B.
Tools
►Thoroughly rinse the product with running, cold water.
►Prior to first mechanical cleaning/disinfection process: Mount the bot-
tom part of the ECCOS holder GB718R in a suitable tray (e.g. JF222R).
►Place the tools in the correct position in the tool holder 10 of the
ECCOS holder GB718R, see Fig. C.
►Engage the insert of the holder in the bottom part. When doing so,
ensure that the holding nibs 9on the top part are inserted in the
recesses in the bottom part.
7.5 Cleaning/disinfection
Product-specific safety guidelines on 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 clean-
ing/disinfecting agents and/or excessive tempera-
tures!
►Following the manufacturer's instructions, use
cleaning and disinfecting agents 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 ace-
tone.
►Observe specifications regarding concentration,
temperature and exposure time.
►Do not exceed the maximum temperature of
60 °C during chemical cleaning and/or disinfec-
tion.
►Do not exceed the maximum temperature of
90 °C during thermal disinfection with DI water.
►Dry the product for at least 10 minutes at a
maximum of 120 °C.

9
Validated cleaning and disinfection procedure
Product Validated procedure Reference
Applied part Manual cleaning with immer-
sion disinfection
see Manual clean-
ing with immer-
sion disinfection -
applied part
Manual pre-cleaning with
brush and subsequent mechan-
ical alkaline cleaning and ther-
mal disinfection
see Mechanical
cleaning/disin-
fecting with man-
ual pre-cleaning -
applied part
Tools Manual pre-cleaning with
ultrasound and brush, and sub-
sequent mechanical alkaline
cleaning and thermal disinfec-
tion
see Mechanical
cleaning/disin-
fecting with man-
ual pre-cleaning -
tools

10
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
7.6 Manual cleaning with immersion disinfection - applied part
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Helizyme
**Recommended: BBraun Stabimed
►Follow the instructions for use of the ELAN 4 rinsing devices and rins-
ing adapters TA014447 and TA014448.
►Do not clean the applied part in an ultrasound bath.
Phase I
►Clean the product under running water, using a suitable cleaning brush
until all visible residues have been removed from the surfaces.
►Mobilize non-rigid components, such as release button, unlocking
sleeve, etc. during cleaning.
►Rinse the applied part through the rinsing adapter GB698R at least
3 times for 5 seconds with a water gun.
Phase II
►Using a disposable syringe, fill the inside of the applied part with
cleaning solution through the rinsing adapter GB698R.
►Place the applied part, with rinsing adapter connected, fully in enzy-
matic cleaning solution for 5 minutes.
Phase III
►Rinse the entire product (all accessible surfaces) under running water.
►Mobilize non-rigid components, such as release button, unlocking
sleeve, etc. during rinsing.
►Rinse the applied part through the rinsing adapter GB698R at least
3 times for 5 seconds with a water gun.
Phase IV
►Prior to manual disinfection, allow rinsing water to drain off the prod-
uct for a sufficient length of time and use compressed air to blow all
liquid out of the product through the rinsing adapter GB698R in order
to prevent dilution of the disinfecting solution.
►Using a disposable syringe, fill the inside of the applied part with dis-
infectant solution through the rinsing adapter GB698R.
►Place the applied part, with rinsing adapter connected, fully in disin-
fectant solution for 15 minutes.
Phase V
►Rinse the entire product (all accessible surfaces) under running water.
►Mobilize non-rigid components, such as release button, unlocking
sleeve, etc. during cleaning.
►Rinse the applied part through the rinsing adapter GB698R at least
3 times for 5 seconds with a water gun.
Phase VI
►Dry the product in the drying phase with suitable equipment (e.g. cloth,
compressed air).
►After manual cleaning/disinfection, check visible surfaces visually for
residues.
►Repeat the cleaning/disinfection process if necessary.
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemicals
I Pre-cleaning RT (cold) - - D–W –
II Cleaning RT (cold) >5 1 D–W pH-neutral, pH ~ 9*
III Intermediate rinse RT (cold) - - D–W -
IV Disinfection RT (cold) >15 2 D–W Concentrate-free, aldehyde-free, phenol-free, QUAT-free, pH ~ 9**
VFinalrinse RT (cold) - - D–W -
VI Drying RT - - - -

11
7.7 Mechanical cleaning/disinfecting with manual pre-cleaning - applied part
Note
The cleaning and disinfection device must be of tested and approved effec-
tiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced
and checked at regular intervals.
Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
►Follow the instructions for use of the ELAN 4 rinsing devices and rins-
ing adapters TA014447 and TA014448.
►Do not clean the applied part in an ultrasound bath.
Phase I
►Clean the product with a suitable cleaning brush until all discernible
residues have been removed.
►Mobilize non-rigid components, such as release button, unlocking
sleeve, etc. during cleaning.
Phase II
►Connect the connector for motor cable 3with ELAN 4 electro rinsing
device GB692R.
►Rinse the applied part:
– For 5 min with a tap/hose or
– 3 times for 5 seconds with a water gun
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemicals
IBrushes RT (cold) – – D–W -
II Rinsing RT (cold) 5 - D–W -

12
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
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
►Connect the connector for motor cable 3with ELAN 4 electro rinsing
device GB692R.
►Place the rinsing device on a wire basket suitable for cleaning.
►Connect the rinsing device to the rinsing connection of the rinsing cart.
►After the mechanical cleaning/disinfection process:
– Remove any residual rinsing water from the applied part using a
compressed-air gun, see instructions for use ELAN 4 rinsing device
and rinsing adapter TA014447 and TA014448.
– Check visible surfaces for residues.
Phase Step T
[°C/°F] t [min] Water quality Chemicals
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 -
VDrying - - - In accordance with the program for the cleaning and disinfecting machine

13
7.8 Mechanical cleaning/disinfecting with manual pre-cleaning - tools
Note
The cleaning and disinfection device must be of tested and approved effec-
tiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced
and checked at regular intervals.
Manual pre-cleaning with ultrasound and brush
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Helizyme
**Recommended: BBraun Stabimed
►Only perform ultrasound cleaning in the ECCOS holder GB718R to pre-
vent any damage to the cutting edges.
Phase I
►Fully immerse the product in enzymatic cleaning solution for at least
30 minutes. Ensure that all accessible surfaces are moistened.
Phase II
►Rinse the entire product (all accessible surfaces) under running water.
Phase III
►Tilt up the tool holder 10 of the ECCOS holder GB718R by the side
handles 8, see Fig. C.
►Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for
at least 15 minutes. Ensure that all accessible surfaces are immersed
and acoustic shadows are avoided.
Phase IV
►Clean the product with a suitable cleaning brush until all discernible
residues have been removed.
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemicals
I Immersion RT (cold) >30 50 D–W Enzymatic detergent*
II Rinsing RT (cold) - - D–W -
III Ultrasonic cleaning 55/131 >15 2 D–W Concentrate-free, aldehyde-free, phenol-free, QUAT-free, pH ~ 9**
IV Cleaning with brush RT (cold) - - D–W -

14
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
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
►Place the tools in the correct position in the tool holder 10 of the
ECCOS holder GB718R, see Fig. C.
►Check visible surfaces for residues after mechanical cleaning/disinfect-
ing.
7.9 Inspection, maintenance and checks
►Allow the product to cool down to room temperature.
►Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
►ELAN 4 electro Connect oil spray adapter GB600860 (gray) to connec-
tor for motor cable 3and spray through the applied part for approx.
2 seconds with Aesculap-STERILIT oil spray GB600, see Fig. D.
►Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►Inspect tools for broken, damaged or blunt edges.
►Set aside the product if it is damaged.
7.10 Packaging
►Always follow the instructions for use of the respective packaging and
storage devices (e.g. instructions for use TA009721 for Aesculap-
ECCOS holder system).
►Place the applied part in the correct position in the ECCOS holder
GB082R/GB083R, see Fig. B.
►Place the tools in the correct position in the ECCOS holder GB718R, see
Fig. C.
►Pack trays appropriately for the intended sterilization process (e.g. in
Aesculap sterile containers).
►Ensure that the packaging will prevent a recontamination of the prod-
uct.
Phase Step T
[°C/°F] t [min] Water quality Chemicals
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 -
VDrying - - - In accordance with the program for the cleaning and disinfecting machine

15
7.11 Steam sterilization
Note
For further information, see Technical Data.
►Make certain that all external and internal surfaces of the product will
be exposed to the sterilizing agent.
►Validated sterilization process
– Steam sterilization using fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according
to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
►When sterilizing several instruments at the same time in a steam ster-
ilizer: ensure that the maximum load capacity of the steam sterilizer
specified by the manufacturer 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.
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.
e.g. 2016-07
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
9. Troubleshooting
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
10. Technical Service
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
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
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
DANGER
Danger to life of patients and users if the product
malfunctions and/or protective measures fail or are
not used!
►Do not perform any servicing or maintenance
work under any circumstances while the product
is being used on a patient.
►Do not modify the product.

16
Aesculap®
ELAN 4 electro Standard handpiece (1 ring) GA861 to GA864 / ELAN 4 electro
HD handpiece (2 ring) GA865 to GA869
11. Accessories/Spare parts 12. Technical Data
12.1 Classification acc. to Directive 93/42/EEC
12.2 Performance data, information about standards
The product can be reprocessed 350 times. This was proved after
350 reprocessing cycles by a high voltage test at 1,6 kV.
Art. no. Designation
GA261SU ELAN 4 single-use spray nozzle for 1 ring handpiece L4
GA262SU ELAN 4 single-use spray nozzle for 1 ring handpiece L7
GA263SU ELAN 4 single-use spray nozzle for 1 ring handpiece L10
GA264SU ELAN 4 single-use spray nozzle for 1 ring handpiece L13
GA265SU ELAN 4 single-use spray nozzle for 2 ring handpiece L7
GA266SU ELAN 4 single-use spray nozzle for 2 ring handpiece L10
GA267SU ELAN 4 single-use spray nozzle for 2 ring handpiece L13
GA268SU ELAN 4 single-use spray nozzle for 2 ring handpiece L17
GA269SU ELAN 4 single-use spray nozzle for 2 ring handpiece L22
GA395SU ELAN 4 electro single-use tube set
GB082R ELAN 4 electro ECCOS holder for reamer handpiece
GA861 to GA869, 1 handpiece
GB083R ELAN 4 electro ECCOS holder for reamer handpiece
GA861 to GA869, 3 handpieces
GB600 STERILIT Power Systems oil spray
GB600860 ELAN 4 electro oil spray adapter
GB692R ELAN 4 electro rinsing device
GB698R ELAN 4 electro rinsing adapter
GB718R ELAN 4 ECCOS holder for 12 burrs
GP111R–
GP243R
ELAN 4 tools (1 ring), reusable
GP301R–
GP397R
ELAN 4 tools (2 ring), reusable
GP398SU
GP399TC-SU
ELAN 4 tools (2 ring), single use
TA014442 Gebrauchsanweisung für ELAN 4 electro Handstück
Standard (1-Ring) GA861 bis GA864 / ELAN 4 electro
Handstück HD (2-Ring) GA865 bis GA869 (A4 für
Ringordner)
TA014443 Instructions for use of ELAN 4 electro Standard hand-
piece (1 ring) GA861 to GA864 / ELAN 4 electro HD
handpiece (2 ring) GA865 to GA869 (leaflet)
Art. no. Designation Class
GA861–
GA864
ELAN 4 electro Standard handpiece (1 ring) IIa
GA865–
GA869
ELAN 4 electro HD handpiece (2 ring) IIa
GP111R–
GP243R
ELAN 4 tools (1 ring), reusable IIa
GP301R–
GP397R
ELAN 4 tools (2 ring), reusable IIa
GP398-SU
GP399TC-SU
ELAN 4 tools (2 ring), single use IIa
Max. power approx. 140 W
Max. torque approx. 2,2 Ncm
Max. motor speed 80 000 rpm
Tool connection ELAN 4 1 ring (GA861 to GA864)
ELAN 4 2 ring (GA865 to GA869)
Applied part Type BF
EMC IEC/DIN EN 60601-1-2
Conforming to stan-
dard
IEC/DIN EN 60601-1
Art. no. Weight Dimensions (∅x L)
GA861 80 g ± 10 % 16 mm x 152 mm ± 5 %
GA862 83 g ± 10 % 16 mm x 177 mm ± 5 %
GA863 87 g ± 10 % 16 mm x 206 mm ± 5 %
GA864 91 g ± 10 % 16 mm x 237 mm ± 5 %
GA865 89 g ± 10 % 16 mm x 176 mm ± 5 %
GA866 95 g ± 10 % 16 mm x 206 mm ± 5 %
GA867 100 g ± 10 % 16 mm x 236 mm ± 5 %
GA868 108 g ± 10 % 16 mm x 276 mm ± 5 %
GA869 118 g ± 10 % 16 mm x 326 mm ± 5 %

17
12.3 Tool speed/Setting
12.4 Short interval operation
12.5 Ambient conditions
13. Disposal
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 Can-
ada for product information and com-
plaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
Adjustable motor direction Clockwise/counterclockwise rota-
tion
Adjustable maximum speed set-
ting
10 000 rpm to 80 000 rpm
Step width for maximum speed
setting
5000rpm
Factory pre-setting for maximum
speed setting
75 000 rpm, right rotation
Ambient temperature 10 °C to 27 °C
Application cycle 30 second application
30 second pause
Max. application cycles ∞at 60 000 rpm
Max. temperature 48 °C
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
Adhere to national regulations when disposing of or recy-
cling 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 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.

18
Aesculap®
ELAN 4 electro Handstück Standard (1-Ring) GA861 bis GA864 /
ELAN 4 electro Handstück HD (2-Ring) GA865 bis GA869
Aesculap® ELAN 4 electro Handstück Standard (1-Ring) GA861 bis GA864 / ELAN 4 electro Handstück HD (2-Ring) GA8 65 bis GA869
Legende
1ELAN 4 Werkzeugkupplung (1-Ring bzw. 2-Ring)
2Ringmarkierung
3Stecker für Motorkabel
4Schieber für Werkzeugentriegelung
5Symbol des Anwendungsteil-Typs im Display der ELAN 4 electro Steu-
ereinheit
6ELAN 4 Werkzeug (1-Ring bzw. 2-Ring)
7ELAN 4 Einmal-Sprühdüse für 1-Ring- bzw. 2-Ring-Handstück
ELAN 4 ECCOS-Halterung für 12 Fräser GB718R
8Seitliche Griffe
9Haltenasen
10 Werkzeugaufnahme
11 Lasche
Symbole an Produkt und Verpackung
Vorsicht
Wichtige sicherheitsbezogene Angaben wie Warnhin-
weise und Vorsichtsmaßnahmen in Gebrauchsanwei-
sung beachten.
YYYY-MM
Instandhaltungskennzeichen
Hinweis auf den nächsten empfohlenen Instandhal-
tungstermin (Datum: Jahr-Monat) bei der internatio-
nalen B. Braun-/Aesculap-Vertretung, siehe Techni-
scher Service
Maschinenlesbarer zweidimensionaler Code
Der Code enthält eine eindeutige Seriennummer, die
zum elektronischen Einzelinstrumententracking ver-
wendet werden kann. Die Seriennummer basiert auf
dem weltweiten Standard sGTIN (GS1).
Herstelldatum
Sterilisation durch Bestrahlung
Nicht zur Wiederverwendung im Sinne des vom Her-
steller festgelegten bestimmungsgemäßen Gebrauchs
Verwendbar bis
Chargenbezeichnung des Herstellers
Seriennummer des Herstellers
Bestellnummer des Herstellers
Temperaturgrenzwerte bei Transport und Lagerung
Luftfeuchtigkeits-Grenzwerte bei Transport und Lage-
rung
Atmosphärendruck-Grenzwerte bei Transport und
Lagerung
LOT
SN
REF