Aesculap, Inc.

- AIC-AAG Instructions for Use Quality-AIC

Effective
Aesculap® Acculan 4 / ELAN 4 electro -
ELAN 4 Attachments for small Document ID: SOP-AIC-5002245
drill GA344 and drill GA844 Version: 1.0
This document contains information that is the confidential and proprietary property of B. Braun. Any dissemination, distribution or copying of this document is strictly prohibited without the prior written consent of B. Braun. Anyone receiving this document in error should immediately notify B. Braun’s Legal Department and return this document to

TA014552 Effective Date: 2022-04-12 (CET)

Aesculap Power Systems

USA Instructions for use/Technical description

Attachments for small drill GA344 and drill GA844
Aesculap, Inc.. Viewed by:badistus

Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
-
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
drill GA344 and drill GA844 Version: 1.0
TA014552 Effective Date: 2022-04-12 (CET)

18 18 18
19 19

22 19

21
21 20 C
B 20 21
A
24

25
6 23
27

26

D
E F

GB870R GB886R GB896R

GB871R GB887R

GB872R GB891R

GB878R GB892R GB897R

GB881R GB894R

GB882R

GB884R

Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
-
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
drill GA344 and drill GA844 Version: 1.0
TA014552 Effective Date: 2022-04-12 (CET)

7 6 4 5 1

11

2 3

10 19 18

20
24
25

16

17

12

15 14 28
7
13
8

29

Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
USA -
ELAN 4 Attachments for small Document ID: SOP-AIC-5002245
Effective
drill GA344 and drill GA844
Aesculap® Acculan 4 / ELAN 4 electro TA014552
Version: 1.0
Effective Date: 2022-04-12 (CET)

Attachments for small drill GA344 and drill GA844

Legend Manufacturer’s article number
REF
1 Drill
2 Knob (for speed control) Temperature limits during transport and storage
3 Safety catch
4 Rotating sleeve
5 Arrow
Air humidity limits during transport and storage
6 Attachment with collet chuck
7 Unlocking sleeve
8 Tool coupling
9 Attachment with three jaw chuck Atmospheric pressure limits during transport and stor-
10 Tightening key age
11 Tool coupling
12 Kirschner wire attachment
13 Clamping lever Contents
14 Adjustment sleeve
1. Applicable to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
15 Kirschner wire chuck
2. General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
16 Drill attachment for radiolucent angle transmission
2.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
17 Adapter
2.2 Main functions and design characteristics . . . . . . . . . . . . . . . . 3
18 Sagittal saw attachment
2.2.1 Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
19 Tool attachment with L sagittal tool coupling
2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
20 Button for adjusting the tool holder
2.4 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
21 L sagittal saw blade
3. Safe handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
22 Piece on saw blade for tool release
4. Product description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
23 Oil spray adapter
4.1 Scope of supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
24 Reciprocating Saw attachment
4.2 Components required for operation . . . . . . . . . . . . . . . . . . . . . 4
25 Tool attachment with Reciprocating Saw tool coupling
4.3 Operating principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
26 Reciprocating Saw blade (e.g. GP550R to GP576R)
5. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
27 Leaf spring on Reciprocating Saw blade for tool release
6. Working with the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
28 Screw attachment
6.1 System set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
29 Lever
6.1.1 Connecting the accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.1.2 Protection against inadvertent activation . . . . . . . . . . . . . . . . 5
Symbols on product and packages 6.1.3 Attaching/removing attachment for drill . . . . . . . . . . . . . . . . . 5
6.1.4 Attaching and detaching the tool from the attachment. . . . . 5
Caution
Observe important safety information such as warnings 6.2 Function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
and precautions in the instructions for use. 6.3 Safe operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
6.3.1 Operating the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Machine-readable, two-dimensional code
The code contains a unique serial number which can be 6.3.2 Operating the screw attachment. . . . . . . . . . . . . . . . . . . . . . . . 7
used for electronic tracking of the individual instru- 7. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 7
ment. The serial number is based on the global standard 7.1 General safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
sGTIN (GS1). 7.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Manufacturer 7.3 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . 8
7.4 Preparation before cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.5 Cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Date of manufacture 7.5.1 Product-specific safety instructions for the reprocessing
procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.6 Manual cleaning with wipe disinfection. . . . . . . . . . . . . . . . . . 9
Manufacturer’s batch designation 7.7 Mechanical cleaning/disinfection with manual pre-cleaning. 10
LOT 7.7.1 Manual pre-cleaning with a brush . . . . . . . . . . . . . . . . . . . . . . 10
Manufacturer’s serial number 7.7.2 Mechanical alkaline cleaning and thermal disinfection . . . . . 10
SN 7.8 Inspection, maintenance and checks. . . . . . . . . . . . . . . . . . . . . 10
7.9 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2
Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
-
ELAN 4 Attachments for small Document ID: SOP-AIC-5002245
Effective
USA
7.10 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . drill
. . . . . GA344
. . . . . 11and drill
2.2.1GA844
Operating mode
Version: 1.0
7.11 Sterilization for the US market. . . . . . . . . . . . . . . . . . . . . . . . . . TA01455211 Operation with non-periodic load and speed changes (type S9 pursuant to
IEC EN 60034-1)
Effective Date: 2022-04-12 (CET)
7.12 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Drilling (clockwise/counterclockwise rotation)
9. Troubleshooting list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ■ 60 second application, 60 second pause
10. Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ■ 6 repetitions
11. Accessories/Spare parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ■ 30 min cooling time
12. Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ■ Max. Temperature 48 °C
12.1 Classification acc. to Directive 93/42/EEC. . . . . . . . . . . . . . . . . 13 Medullary reaming (clockwise/counterclockwise rotation)
12.2 Performance data, information about standards . . . . . . . . . . . 14 ■ 30 second application, 30 second pause
12.3 Operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ■ 8 repetitions
12.4 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ■ 30 min cooling time
13. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ■ Max. Temperature 48 °C
14. Distributor in the US/Contact in Canada for product
information and complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Drilling (oscillation)
■ 15 second application, 15 second pause
■ 3 repetitions
1. Applicable to ■ 30 min cooling time
► For item-specific instructions for use and information on material ■ Max. Temperature 48 °C
compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com Saw mode with GB891R
■ 30 second application, 60 second pause
■ 4 repetitions
2. General information ■ 30 min cooling time
2.1 Intended use ■ Max. Temperature 48 °C
Task/Function Saw mode with GB892R
The hand-held small drill GA344 and the drill GA844, combined with the ■ 30 second application, 60 second pause
appropriate attachment, is used for driving drilling, milling (medullary ■ 5 repetitions
reaming), sawing and screwing tools. ■ 30 min cooling time
Application Environment ■ Max. Temperature 48 °C
The product is used in operating rooms in sterile zones outside of the
Screwing with GB896R/GB897R
explosion risk zone (such as areas with pure oxygen or anesthesia gases).
■ 10 second mechanical application, 10 second manual application,
30 second pause
2.2 Main functions and design characteristics
■ 30 repetitions
Speed GB870R 0 min-1 to max. 320 min-1 ■ 30 min cooling time
GB871R
■ Max. Temperature 48 °C
GB872R
GB878R 0 min-1 to max. 1 250 min-1 Electrical systems generally heat up during continual operation. It is
GB881R advised to give the system a break after use to cool down, as listed in the
GB882R table on operating mode.
GB884R
Heating depends on the tool used and the load. After a certain number of
GB886R
repetitions, the system should cool down. This procedure prevents the sys-
GB887R
tem overheating as well as possible injury to the patient or user.
GB894R
The user is responsible for the use and adherence to the pause sequence
GB891R 0 min-1 to max. 15 750 min-1 described.
GB892R
GB896R
2.3 Indications for Use
0 min-1 to max. 165 min-1
GB897R 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-
Rotational Right and left rotation, oscillation cial Surgery.
direction

3
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 Aesculap, Inc.
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USA -
ELAN 4 Attachments for small Document ID: SOP-AIC-5002245
Effective
2.4 Contraindications drill GA344 and drill GA844
Attachments
Version: 1.0
TA014552
The product is not licensed for use on the central nervous system or central One of the following attachments (with corresponding chuck key as appli-
Effective Date: 2022-04-12 (CET)
cable) is additionally included with the delivery:
circulatory system.
Note Art. no. Designation
The safe and effective use of electrically driven products greatly depends on
influences which can only be controlled by the user. Therefore the specifi- GB870R Medullary reaming attachment, large Jacobs chuck
cations provided represent framework conditions only. – and –
GA031R Key for large three-jaw chuck
Clinically successful use of the product is dependent on the knowledge and
experience of the surgeon. The surgeon must decide which structures it is GB871R Medullary reaming attachment AO large
sensible to treat and take into account the safety and warning information
contained in these instructions for use. GB872R Medullary reaming attachment Hudson/Zimmer
GB878R Drill attachment for Synthes 511.300
3. Safe handling GB881R Drill attachment large Jacobs chuck
CAUTION – and –
Federal law restricts this device to sale by, or on order of a physician!
GA031R Key for large Jacobs chuck
WARNING GB882R Drill attachment small Jacobs chuck
Risk of injury and material damage if this product is not used as
intended! – and –
► Use the product only for its intended purpose. GA062R Chuck key for small Jacobs chuck
GB884R Drill attachment AO small
WARNING
Risk of injury and damage to property due to improper handling of the GB886R Drill attachment Aesculap hexagon
product!
GB887R Drill attachment dental shaft
► Follow the instructions for use of all products used.
GB891R Sagittal saw attachment
■ General risk factors associated with surgical procedures are not
described in this documentation. GB892R Reciprocating Saw attachment
■ It is the operating surgeon's responsibility to ensure that the surgical GB894R Kirschner wire attachment
procedure is performed correctly.
GB896R Screw attachment AO small
■ The operating surgeon must have a thorough understanding of both the
hands-on and conceptual aspects of the established operating tech- GB897R Screw attachment Aesculap hex
niques.
► Remove the transport packaging and clean the new product, either 4.2 Components required for operation
manually or mechanically, prior to its initial sterilization. ■ Small drill GA344 (ready to use) or drill GA844 (ready to use)
► Prior to use, check that the product is in good working order. ■ Tool (depending on indication)
► To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability: 4.3 Operating principle
– Use the product only according to these instructions for use. The attachment can be attached to the drill in three different positions,
– Follow the safety and maintenance instructions. each 120° difference.
– Only combine Aesculap products with each other. The attachment locks automatically when attached to the drill. The
► Ensure that the product and its accessories are operated and used only attachment can be removed by operating a rotating sleeve.
by persons with the requisite training, knowledge, or experience. A gear in the attachment changes the motor speed.
► Keep the instructions for use accessible for the user. The attachments have various integrated couplings on the working end, to
► Always adhere to applicable standards. enable attachment of various tools, with adapter if necessary.
► Ensure that the electrical installation of the room is consistent with the
requirements of IEC/DIN EN.
5. Preparation
► Do not operate the product in explosion-hazard areas.
Aesculap assumes no liability if the following rules are not followed:
► Sterilize product before use.
► Do not use products from open or damaged sterile packaging.
► When using the ECCOS holder system, adhere to the appropriate
► Prior to use, inspect the product and its accessories for any visible dam-
instructions for use for TA009721, see Aesculap Extranet at
age.
https://extranet.bbraun.com
► Use the products and their accessories only if they are in perfect tech-
nical condition.
4. Product description
4.1 Scope of supply
Art. no. Designation

TA014553 Instructions for use, attachments for small drill GA344

and drill GA844

4
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-
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
USA
6. Working with the device drill GA344 and drill GA844
Unlocking the knob for speed control 2:
Version: 1.0
TA014552
► Twist the safety catch 3 to position ON.
Effective Date: 2022-04-12 (CET)
WARNING The speed control knob 2 is unlocked and the product 1 can be oper-
Risk of infection and contamination! ated.
Product is delivered unsterilized! Note
► Sterilize the product before use pursuant to the operating instruc- For more information on the small drill GA344, see TA014550 and
tions. TA014551 (flyer).
For more information on the drill GA844, see TA014436 and TA014437
WARNING (flyer).
Risk of injury and material damage due to accidental activation of the
product! 6.1.3 Attaching/removing attachment for drill
► Products which are not being actively used must be secured against
accidental activation (position OFF). WARNING
Risk of injury when attaching/removing attachments/tools in the ON
WARNING position through inadvertent activation of the product!
Risk of injury and material damage due to inappropriate use of tools! ► Only attach/remove attachments/tools in the OFF position.
► Always follow the safety advice and information given in the ► Secure drill 1 from inadvertent activation with the safety catch 3, see
instructions for use. Protection against inadvertent activation.
► When coupling/uncoupling, handle tools with cutting edges with
Coupling
care.
Note
WARNING Aesculap recommends coupling the Reciprocating Saw attachment 24
with the label "TOP" upward, aligned to the drill.
Damage to the product if dropped!
► Use the products only if they are in perfect technical condition, see ► Push attachment 6/9/12/16/18/24/28 onto the drill 1 until it clicks
Function check into place.
► Pull on attachment 6/9/12/16/18/24/28 to check secure connection.
WARNING
Uncoupling
Risk of burns to skin and tissue through blunt tools or if product has
not been maintained properly! ► Turn sleeve 4 in the direction of the arrow 5 and simultaneously
remove the attachment 6/9/12/16/18/24/28 from the drill 1.
► Use tools only if they are in perfect condition.
► Replace blunt tools. 6.1.4 Attaching and detaching the tool from the attachment
► Maintain the product properly, see maintenance guide.
WARNING
6.1 System set-up Risk of injury when attaching/removing attachments/tools in the ON
position through inadvertent activation of the product!
6.1.1 Connecting the accessories
► Only attach/remove attachments/tools in the OFF position.
DANGER
► Ensure that the tool connector and attachment type are compatible.
Risk of injury due to unapproved configuration using additional com-
ponents! Attachments with quick-mount chuck
► Ensure that the classification of all components used is consistent GB871R/GB872R/GB884R/GB886R/GB887R/GB896R/GB897R
with the classification of the product (such as type BF or type CF). Coupling:
► Pull back on the unlocking sleeve 7.
Combinations of accessories that are not mentioned in the present
► Insert the tool shaft in the correct position up to the stop in the tool
instructions for use may only be employed if they are specifically intended
holder 8 of the attachment 6.
for the respective application, and if they do not compromise the perfor-
mance and safety characteristics of the products. ► Release the unlocking sleeve 7.
All configurations must fulfill the fundamental standard Tool is attached.
IEC/EN/DIN 60601-1. The person connecting the devices with each other ► Pull at tool to check that it is securely coupled.
is responsible for the configuration and must ensure that the fundamental
Note
standard IEC/EN/DIN 60601-1 or relevant national standards.
Information on operating the screw attachment 28, see Operating the
► Follow the instructions for use of individual accessories.
screw attachment.
► Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
Technical Service. Uncoupling:
► Pull back the unlocking sleeve 7.
6.1.2 Protection against inadvertent activation
► Remove tool.
To prevent the drill being inadvertently activated when changing a tool or
accessory, the knob for speed control can be locked.
Locking the knob for speed control 2:
► Twist the safety catch 3 to position OFF.
The speed control knob 2 is blocked and the product 1 cannot be oper-
ated.

5
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USA -
ELAN 4 Attachments for small Document ID: SOP-AIC-5002245
Effective
drill GA344 and drill
Attachments with three-jaw chuck GB870R/GB881R/GB882R AttachGA844
radiolucent angle transmission on drill attachment GB878R:
Version: 1.0
Coupling: TA014552
► Push the radiolucent angle transmission up to the stop on
Effective Date: 2022-04-12 (CET)
► Open the three jaw chuck with the wrench 10. attachment 17 of the drill attachment.
► Insert the tool shaft in the correct position up to the stop in the tool ► If necessary, slightly move the radiolucent unit.
holder 11 of the attachment 9.
► Close the three jaw chuck 10 and pull tight.
Detach radiolucent angle transmission on drill attachment GB878R:
► Pull at tool to check that it is securely coupled.
► Forcefully pull out the radiolucent angle transmission from the drill
attachment.
Uncoupling:
► Open the three jaw chuck with the wrench 10.
► Remove tool. Attach/detach tool in radiolucent angle transmission:
► Follow the instructions for the radiolucent angle transmission 511.300
Kirschner wire attachment GB894R
in the operating instructions of the Synthes company.
WARNING Sagittal saw attachment GB891R
Risk of injury when using long guide wires! Coupling:
► Use Kirschner wire protection sleeve when using long guide wires. ► Insert saw blade 21 with marking "L" up into the slot of the tool
Note holder 19, see Fig. A. Ensure that the side stops of the saw blade con-
tact the tool holder.
The special Kirschner wire chuck is recommended for the placement of
guide wires. This quick-action chuck adapter allows quick and easy ten- The tool engages.
sioning of drilling wires. ► Pull on the attachment 21 to ensure a secure fit.
When using long guide wires, a Kirschner wire protection sleeve must be
used with the drill to prevent injury. Uncoupling:
For further information on GA344, see TA014550 and TA014551 (leaflet). Note
For further information on GA844, see TA014436 and TA014437 (leaflet). For easier detachment of the tool, set the tool holder to 45° (see Fig. B) or
The following diameters can be set on the Kirschner wire attachment: 90° (see Fig. C), see tool holder adjustment.
■ 0.6 mm to 1.2 mm ► Move the gold bar 22 on the saw blade 21 slightly downward and hold
■ 1.2 mm to 2.2 mm it to unlock the tool.
■ 2.2 mm to 3.2 mm ► Remove the saw blade 21 from the tool holder 19.

Using a Kirschner wire:

Adjusting the tool holder:
► Ensure that the clamping lever 13 is in the starting position (deacti-
► Press the button for tool holder adjustment 20 and keep it depressed.
vated status).
► Turn the tool holder 19 to the desired position (-90°/-45°/0°/45°/90°),
► Set the adjusting sleeve 14 of the Kirschner wire attachment 12 to the
see Fig. B and Fig. C.
desired diameter range:
► Release the adjustment button of the tool holder 20 and secure the
– Push back the adjusting sleeve 14 and turn until the desired diam-
tool holder 19 by clicking it into place. If necessary, slightly move the
eter range has been reached.
tool holder back and forth.
– Release the adjusting sleeve 14. Ensure that the adjustment
sleeve 14 clicks into place. Reciprocating Saw attachment GB892R
► Insert the Kirschner wire into the Kirschner wire chuck 15 until the Coupling:
desired exposed length is achieved. ► Insert connection side of Reciprocating Saw blade 26 into the slot in
The Kirschner wire is held in the intended position in the attachment the tool holder 25, see Fig. D.
by an automatic clamping mechanism. The Reciprocating Saw blade clicks into place.
► Pull on the Reciprocating Saw blade 26 to verify a secure fit.
Tension the Kirschner wire:
Uncoupling:
► Pull on the clamping lever 13 and hold in the desired position.
► Gently press the gold piece for tool release on the Reciprocating Saw
The further the clamping lever is pulled back, the higher the tension of blade 27 downwards and keep pressed down.
the Kirschner wire.
► Remove the Reciprocating Saw blade 26 from the tool holder 25.
Note
The Kirschner wire will only remain tensioned with the clamping lever 6.2 Function checks
pulled back. If the clamping lever is released, it will move back into the The function test must be performed before each use and after each intra-
starting position and the Kirschner wire is freely mobile. operative change of attachment and tool.
► Check that the attachment is coupled properly. To test this, pull on the
Drill attachment for radiolucent angle transmission GB878R
attachment.
The drill attachment allows connecting a radiolucent angle transmission
► Check that the tool is coupled properly. To do this, pull on the tool.
for applying drill holes in the bone under radiographic control.
► For GB891R: check that the tool attachment has locked into place. To
The drill attachment is only suitable for use of the radiolucent angle trans-
do this, turn the tool attachment.
mission 511.300 from the Synthes company.
► Ensure that the tool blades are not mechanically damaged.
► Follow the instructions for the radiolucent angle transmission 511.300
in the operating instructions of the Synthes company. ► Release drill for use (ON position).

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-
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
USA
► Run the drill shortly at maximum speed in right and leftdrill GA344 and drill
rotation. GA844
► Use the following attachments for drilling:
Version: 1.0
► Make certain that the rotational direction is correct in each case. TA014552 – GB881R
Effective Date: 2022-04-12 (CET)
► For GB896R/GB897R: ensure that there is both mechanical and manual – GB882R
functionality. – GB884R
► Check the product for damage, abnormal operation noises, heavy vibra- – GB886R
tion and excessive heat. – GB887R
► Do not use the product if it is damaged or defective.
► Use the following attachments for milling (medullary reaming):
► Set aside the product if it is damaged.
– GB870R
– GB871R
6.3 Safe operation
– GB872R
WARNING ► Use the following attachment for the placement of Kirschner wires:
Coagulation of patient tissue or risk of burns for patients and user – GB894R
through hot product! ► Use only the following attachment for using the radiolucent angle
► Do not use drill attachments to operate milling tools. transmission 511.300 from the Synthes company:
► Do not use the medullary milling attachments for acetabulum mill- – GB878R
ing. ► Use the following attachments for sawing:
► Cool the tool during operation. – GB891R
► Keep product/tool out of the reach of patients. – GB892R
► Let the product/tool cool down. ► Use the following attachments for driving screw tools:
► Use a cloth to protect against burns when changing the tool. – GB896R
– GB897R
WARNING
Risk of infection from aerosol formation! 6.3.2 Operating the screw attachment
Risk of injuries caused by particles coming loose from the tool!
WARNING
► Use suitable protection (such as waterproof protective clothing,
face mask, safety gases, suction). Risk of injury!
► Do not completely screw bone screws in mechanically.
WARNING ► Perform the final rotations and locking of the bone screws manu-
Risk of injury and/or malfunction! ally.
► Always carry out a function check prior to using the product.
WARNING
WARNING Risk of injury and damage to property due to improper handling of the
product!
Risk of injury when using the product beyond the field of view!
► Follow the instructions for use of the implant system that is used.
► Apply the product only under visual control.
Mechanical operation
WARNING ► Activate the knob for speed control 2. Do not activate lever 29 when
Risk of injury and damage to the tool/system! doing so.
The rotating tool may get caught in drapes (such as textiles). Manual operation with ratcheting function
► Do not let the tool come into contact with drapes (such as textiles) ► Pull lever 29 to the stop and hold.
during operation. ► Move product clockwise.
The rotational movement is transferred to the coupled screw tool.
WARNING
► Move product counterclockwise.
Risk of injury through inadvertent release of the saw blade!
The ratcheting function is active. The product can be moved into the
► Do not press the sagittal saw blade tool release during operation.
starting position without also moving the screw tool.
► Do not press the Reciprocating Saw blade tool release leaf spring
during operation.
► Check for secure fixation of the tool after any tool change. 7. Validated reprocessing procedure
6.3.1 Operating the product 7.1 General safety notes
Note Note
For more information on operation of the small drill GA344, see TA014550 Adhere to national statutory regulations, national and international stan-
and TA014551 (flyer). dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
For more information on operation of the drill GA844, see TA014436 and
TA014437 (flyer). Note
► Start the drill at a moderate speed. For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble variants of CJD, observe the relevant national regulations concerning
► Apply moderate pressure to prevent slipping.
the reprocessing of products.
► Do not bend the tool, otherwise there is a danger of breakage.
► When screwing bone screws and bone pins in and out: ensure correct
rotation direction setting.

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 Aesculap, Inc.
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Effective
Note drill GA344 and drill
7.4 GA844
Preparation before cleaning 1.0
Version:
TA014552
Mechanical reprocessing should be favored over manual cleaning as it gives ► Before the first automatic cleaning/disinfection: attach ECCOS holders
Effective Date: 2022-04-12 (CET)
better and more reliable results. in a suitable tray.
► Insert the products in the correct position into the ECCOS fixations, see
Note
Fig. E.
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method. Kirschner wire attachment GB894R
The operator/reprocessing technician is responsible for this. ► Set adjustment sleeve to the largest Kirschner wire diameter.
The recommended chemistry was used for validation.
7.5 Cleaning/disinfection
Note
7.5.1 Product-specific safety instructions for the reprocessing pro-
If there is no final sterilization, then a virucidal disinfectant must be used. cedure
Note CAUTION
For up-to-date information about reprocessing and material compatibility, Damage to the product due to inappropriate cleaning/disinfecting
see also the Aesculap Extranet at https://extranet.bbraun.com agents and/or excessive temperatures!
The validated steam sterilization procedure was carried out in the Aesculap ► Use cleaning and disinfecting agents according to the manufac-
sterile container system. turer’s instructions which
– are approved for plastic material and high-grade steel,
7.2 General information
– do not attack softeners (e.g. in silicone).
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica- ► Do not use cleaning agents that contain acetone.
tion and processing should not exceed 6 h; also, neither fixating pre- ► Observe specifications regarding concentration, temperature and
cleaning temperatures >45 °C nor fixating disinfecting agents (active exposure time.
ingredient: aldehydes/alcohols) should be used. ► Do not exceed the maximum temperature of 60 °C during chemical
Excessive neutralizing agents or basic cleaners may result in a chemical cleaning and/or disinfection.
attack and/or fading and the laser marking becoming unreadable either ► Do not exceed the maximum temperature of 96 °C during thermal
visually or by machine. disinfection with FD water.
On stainless steel, residues containing chlorine or chloride (such as surgi- ► Dry the product for at least 10 minutes at a maximum of 120 °C.
cal residues, drugs, saline solutions in water for cleaning, disinfection and
sterilization) may lead to corrosion (pitting corrosion, tensile corrosion) Note
and thus to the destruction of the product. These must be removed by rins- The indicated drying time is a guide time only. It must be checked taking
ing thoroughly with demineralized water and then drying. into account the specific conditions (e.g. load) and if applicable adjusted.
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 Preparations at the place of use

► Remove all attached components from the product (tool and accesso-
ries).
► Detach the attachment from the drill.
► 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.

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-
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Document ID: SOP-AIC-5002245
7.6 drill GA344 and drill GA844
Manual cleaning with wipe disinfection Version: 1.0
TA014552
Phase Step T t Conc. Water Effective Date:
Chemicals 2022-04-12 (CET)
[°C/°F] [min] [%] quality

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 - - - –

D–W: Drinking water

FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
RT: Room temperature
* Validated with enzyme cleaner “Cidezyme Johnson & Johnson”

► Do not clean the product in a ultrasonic bath and do not immerse the Phase VI
product in any fluids. Let any fluid incursions drain out immediately, ► Rinse disinfected surfaces after the prescribed reaction time for at least
otherwise there is a danger of corrosion and loss of function. 1 minute under running demineralized water.
Phase I ► Drain any remaining water fully.
► Flexible components (such as sleeves) will move during cleaning. Phase VII
► Clean the product under running water, using a suitable plastic clean- ► Dry the product in the drying phase with suitable equipment (such as
ing brush until all visible residues have been removed from the sur- lint-free cloths, pressurized air).
faces.
► 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, 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
► Flexible components (such as sleeves) will move 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.
► Contamination should be removed with a lint-free cloth or soft brush
moistened with enzyme cleaner.
► Flexible components (such as sleeves) and cannulations 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 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.

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USA -
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Document ID: SOP-AIC-5002245
7.7 Mechanical cleaning/disinfection withdrill GA344
manual and drill GA844
pre-cleaning Version: 1.0
TA014552
Note Note Effective Date: 2022-04-12 (CET)
The cleaning and disinfection device must fundamentally have a tested The cleaning and disinfection machine used for processing must be serviced
efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883). and checked at regular intervals.

7.7.1 Manual pre-cleaning with a brush

Phase Step T t Conc. Water Chemistry/Note

[°C/°F] [min] [%] quality

I Rinsing RT (cold) - - D–W Until visually clean

II Brushes RT (cold) - - D–W Until visually clean

D–W: Drinking water

RT: Room temperature

► Do not clean the product in a ultrasonic bath and do not immerse the Phase II
product in any fluids. Let any fluid incursions drain out immediately, ► Flexible components (such as sleeves) will move during cleaning.
otherwise there is a danger of corrosion and loss of function. ► Brush cannulation with cleaning brush TA011944 and difficult to
► For Kirschner wire attachment GB894R: Set the adjustment sleeve to access surfaces with a suitable plastic cleaning brush for at least 1 min.
the greatest Kirschner wire diameter. ► After manual preparation, check visible surfaces for residue and repeat
Phase I the pre-cleaning process as needed.
► Flexible components (such as sleeves) will move during cleaning. Note
► Thoroughly clean the product under running water. For details on difficult to access surfaces, see Acculan pre-cleaning and
care information TA016000 (available in Aesculap Extranet at
https://extranet.bbraun.com).

7.7.2 Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfection device without ultrasound

Phase Step T t Water Chemistry/Note

[°C/°F] [min] quality

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 - - - mind. 10 min at max. 120 °C

D-W: Drinking water

FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
*Recommended: BBraun Helimatic Cleaner alkaline

► For Kirschner wire attachment GB894R: Set the adjustment sleeve to 7.8 Inspection, maintenance and checks
the greatest Kirschner wire diameter. ► Allow the product to cool down to room temperature.
► Insert the product in the correct position into the ECCOS fixation, see ► Spray product after every cleaning and disinfection with oil spray
Fig. E. adapter 23 GB600880 (green) approx. 2 sec with Aesculap STERILIT
► Then connect the interior rinse device to the ECCOS holder and connect Power Systems oil spray GB600, see Fig. F.
to the rinse connector of the cleaning/disinfection device/rinse cart.
Note
► After automatic cleaning/disinfection, check visible surfaces for resi-
dues and repeat the cleaning/disinfection process as needed. Aesculap additionally recommends occasional spraying of moving parts
(such as knobs, couplings, cover lids) 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.

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USA
7.9 Packaging drill GA344 and drill
7.11GA844
Sterilization Version:
for the US market 1.0
► Always follow the instructions for use of the respective packaging TA014552
and ■ Aesculap advises against
Effective Date:
sterilizing 2022-04-12
the device (CET) or
by flash sterilization
storage devices (e.g. instructions for use TA009721 for Aesculap- chemical sterilization.
ECCOS holder system). ■ Sterilization may be accomplished by a standard prevacuum cycle in a
► Insert the products in the correct position into the ECCOS fixations, steam autoclave.
see Fig. E. To achieve a sterility assurance level of 10-6, Aesculap recommends the
► Pack trays appropriately for the sterilization process (e.g. in Aesculap following parameters:
sterile containers).
► Ensure that the packaging will prevent a recontamination of the pro- Aesculap Orga Tray/Sterile container (perforated bottom)
duct. Minimum cycle parameters*

7.10 Steam sterilization Sterilization Temp. Time Minimum drying time

method
Note
Remove all attached components from the product (tools, accessories) Prevacuum 270 °F/275 °F 4 min 20 min
before sterilization.

► Check to ensure that the sterilizing agent will come into contact with
*Aesculap has validated the above sterilization cycle and has the data on
all external and internal surfaces (e.g. by opening any valves and fau-
file. The validation was accomplished in an Aesculap sterile container
cets).
cleared by FDA for the sterilization and storage of these products. Other
► Use a validated sterilization method: sterilization cycles may also be suitable, however individuals or hospitals
– Steam sterilization using fractional vacuum process not using the recommended method are advised to validate any alterna-
– Steam sterilizer DIN EN 285 and validated pursuant to tive method using appropriate laboratory techniques. Use an FDA cleared
DIN EN ISO 17665 accessory to maintain sterility after processing, such as a wrap, pouch, etc.
– Sterilization using the fractionated vacuum process at 134 °C,
holding time 5 min 7.12 Storage
When sterilizing multiple products in one steam sterilizer: ► Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
► Ensure that the maximum permitted load specified by the manufac-
turer for the steam sterilizer is not exceeded.
8. Maintenance
To ensure reliable operation, the product must be maintained at least once
a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.

9. Troubleshooting list
► Have defective products repaired by Aesculap Technical Service, see
Technical Service.
Issue Cause Detection Remedy

Product becomes Excessive use Attachment very hot Follow operating instructions (operating mode).
too hot
Defective attachment Attachment very hot Follow operating instructions (preparation, care).
drive/ball bearings Preventative: lubricate attachment before every steriliza-
tion.
Have the manufacturer repair the attachment.
Fall damage, product Attachment very hot Have the attachment repaired by the manufacturer.
defective
Blunt tool Heating of tool and product Change tool.
Insufficient Product is operating in Serrated tool run in counterclockwise Use serrated tools only in clockwise mode.
power left rotation mode mode
Attachment defective Attachment very hot Follow operating instructions (preparation, care).
Preventative: lubricate attachment before every steriliza-
tion.
Follow operating instructions (operating mode).
Have the attachment repaired by the manufacturer.
Blunt tool Tool blades worn out Change tool.

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 Aesculap, Inc.
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Document ID: SOP-AIC-5002245
drill GA344 and drill GA844Remedy
Issue Cause Detection Version: 1.0
TA014552 Effective Date: 2022-04-12 (CET)
Loud running Defective attachment Loud, perceptible noise during operation Follow operating instructions (preparation, care).
noise drive/ball bearings Preventative: lubricate attachment before every steriliza-
tion.
Have the manufacturer repair the attachment.
Attachment does Attachment not compati- Attachment doesn't engage Use the compatible attachment for drill.
not attach or ble
detach.
Connection on attach- Attachment is difficult to couple or can- Have the manufacturer repair the attachment.
ment deformed/defective not be coupled
Coupling on drill Attachment is difficult to couple or can- Have the manufacturer repair the drill.
deformed/defective not be coupled
Sleeve on drill hard to Attachment doesn't engage Turn and hold the drill sleeve, then attach the attachment.
move Turn the sleeve back if necessary.
Preventative: lubricate the sleeve on the drill before each
sterilization.
Tool does not Incompatible tool Tool does not click into place Use the tool compatible with the attachment.
attach or detach.
Tool connector Tool is difficult to couple or cannot be Use a new tool.
deformed/defective coupled
Coupling on attachment Tool is difficult to couple or cannot be Have the manufacturer repair the attachment.
deformed/defective coupled
Tool coupling dirty Tool is difficult to couple or cannot be Clean tool or use a new tool.
coupled Clean the attachment.
For GB894R: Kirschner wire chuck not Diameter of the Kirschner wire is not Set the adjustment sleeve to the right Kirschner wire diam-
Kirschner wire set correctly consistent with the scale setting eter.
does not insert
into the Kirschner
wire chuck
For GB894R: Kirschner wire chuck not Diameter of the Kirschner wire is not Set the adjustment sleeve to the right Kirschner wire diam-
Kirschner wire set correctly consistent with the scale setting eter.
not turning
Open the clamping lever Open the clamping lever Close the clamping lever.
Clamping lever not pulled Kirschner wire not turning Pull back the clamping lever forcefully and hold it.
back with sufficient force
Tool not moving Attachment not fully Attachment can be pulled out of the drill Correctly attach the attachment and perform a function
attached to the drill test.
Tool not fully attached to Tool can be pulled out of the tool cou- Correctly attach the tool and perform a function test.
the attachment pling
Attachment defective Drill turning, but attachment is not turn- Have the manufacturer repair the attachment.
ing.
Drill defective Drill not turning Have the manufacturer repair the drill.
The safety catch of the Safety catch is in OFF position Turn the safety catch into the ON position.
drill is in the OFF position
For GB896R/GB897R: For GB896R/GB897R: lever pulled For GB896R/GB897R: do not pull lever for mechanical oper-
lever pulled ation.
For Lever mechanism defec- Lever is difficult to move or cannot move. Clean and oil attachment.
GB896R/GB897R: tive Lever is bent. Have the manufacturer repair the attachment.
changing Lever does not move itself back to the Alternatively, use a screwdriver handle.
between starting position.
mechanical and
Ratcheting mechanism Lever is difficult to move or cannot move. Clean and oil attachment.
manual opera-
defective No ratcheting function in manual opera- Have the manufacturer repair the attachment.
tion is not possi-
tion. Alternatively, use a screwdriver handle.
ble.
Oil spray adapter Oil spray adapter not Oil spray adapter not attachable Use the compatible oil spray adapter for GA344.
not attachable compatible

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 Aesculap, Inc.
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Effective
USA
10. Technical Service drill GA344 and drill
12.GA844
Technical Version:
data 1.0
TA014552 Effective Date: 2022-04-12 (CET)
12.1 Classification acc. to Directive 93/42/EEC
WARNING
Danger to life of patients and users if the product malfunctions and/or Art. no. Designation Class
protective measures fail or are not used!
► Do not perform any servicing or maintenance work under any cir- GB870R Medullary reaming attachment, large Jacobs IIa
cumstances while the product is being used on a patient. chuck
► Do not modify the product. GB871R Medullary reaming attachment AO large
Modifications carried out on medical technical equipment may result in GB872R Medullary reaming attachment
loss of guarantee/warranty rights and forfeiture of applicable licenses. Hudson/Zimmer
► For service and repairs, please contact your national B. Braun/Aesculap
agency. GB878R Drill attachment for Synthes 511.300

Service addresses GB881R Drill attachment large Jacobs chuck

Aesculap Technischer Service GB882R Drill attachment small Jacobs chuck
Am Aesculap-Platz
GB884R Drill attachment AO small
78532 Tuttlingen / Germany
Phone: +49 (7461) 95 -1601 GB886R Drill attachment Aesculap hexagon
Fax: +49 (7461) 14 -939 GB887R Drill attachment dental shaft
E-Mail: [email protected] GB891R Sagittal saw attachment
Or in the US:
GB892R Reciprocating Saw attachment
Aesculap Inc.
Attn. Aesculap Technical Services GB894R Kirschner wire attachment
615 Lambert Pointe Drive GB896R Screw attachment AO small
Hazelwood
GB897R Screw attachment Aesculap hex
MO, 63042 USA
Aesculap Repair Hotline
Phone: +1 (800) 214 -3392
Fax: +1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.

11. Accessories/Spare parts

Art. no. Designation

GB257R ECCOS sieve basket with fixation for GA344

GB262R ECCOS sieve basket with fixation for GA844
GB600 STERILIT Power Systems oil spray
GB600880 Oil spray adapter for GA344/GA844
TA011944 Cleaning brush
GB715R ECCOS holder single
GB716R ECCOS holder triple
GA031R Key for large Jacobs chuck
GA062R Chuck key for small three-jaw chuck
TA014552 Instructions for use, attachments for small drill GA344
and drill GA844 (for ring binder)
TA014553 Instructions for use, attachments for small drill GA344
and drill GA844 (flyer)

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 Aesculap, Inc.
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Document ID: SOP-AIC-5002245
12.2 Performance data, information about drill GA344 and drill GA844
standards Version: 1.0
TA014552
Rotational direction Right and left rotation, oscillation Effective Date: 2022-04-12 (CET)
Conforming to stan- IEC/DIN EN 60601-1
dard

The product was subject to 500 preparation cycles as a test by the manu-
facturer and has passed.
The performance data for the individual attachments can be found in the
table below.
Drill attachments

Attach- Connector Dimensions Length x Weight [g] Max. speed Max. torque Cannulation [mm]
ment ∅ [mm] ±5 % ±10 % [min-1], approx. [Nm], approx.

GB878R for Synthes 511.300 111 x 27 181 1 250 1.5 3.2

GB881R Large Jacobs chuck 89 x 29 163 1 250 1.5 3.2
∅ 0.5 mm to 7.4 mm
GB882R Small Jacobs chuck 76 x 22 100 1 250 1.5 3.2
∅ 0.5 mm to 4 mm
GB884R AO small 60 x 22 66 1 250 1.5 2.8
GB886R Aesculap hex 57 x 24 67 1 250 1.5 3.2
GB887R Dental 56 x 22 50 1 250 1.5 1.8

Medullary milling attachments

Attach- Connector Dimensions Length x Weight [g] Max. speed Max. torque Cannulation [mm]
ment ∅ [mm] ± 5 % ±10 % [min-1], approx. [Nm], approx.

GB870R Large Jacobs chuck 105 x 29 230 320 5 3.2

∅ 0.5 mm to 7.4 mm
GB871R AO large 88 x 29 170 320 5 3.2
GB872R Hudson/Zimmer 86 x 25 150 320 5 3.2

Saw attachments

Attach- Connector Dimensions Length x ∅ Weight [g] ± Max. oscillation fre- Cannulation [mm]
ment [mm] ±5 % 10 % quency [min-1],
approx.

GB891R L sagittal saw blade 74 x 33.5 179 15 750 –

GB892R Reciprocating Saw blade 135 x 24.5 166 15 750 –

Kirschner wire attachment

Attach- Connector Dimensions L x W x H Weight [g] Max. speed Cannulation [mm]

ment [mm] ±5 % ±10 % [min-1], approx.

GB894R Kirschner wire ∅ 0.6 mm 92 x 27 x 124 179 1 250 3.2

to 3.2 mm

Screw attachments

Attach- Connector Dimensions L x ∅ x H Weight [g] Max. speed Cannulation [mm]

ment [mm] ± 5 % ±10 % [min-1], approx.

GB896R AO small 95 x 28 x 129.5 235 165 1.7

GB897R Aesculap hex 92 x 28 x 129.5 231 165 1.7

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 Aesculap, Inc.
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12.3 Operating mode drill GA344 and drill
13.GA844
Disposal Version: 1.0
TA014552
Operation with non-periodic load and speed changes (type S9 pursuant to
Note Effective Date: 2022-04-12 (CET)
IEC EN 60034-1)
The user institution is obliged to process the product before its disposal, see
Drilling (clockwise/counterclockwise rotation) Validated reprocessing procedure.
■ 60 second application, 60 second pause
■ 6 repetitions Adhere to national regulations when disposing of or recy-
■ 30 min cooling time cling the product, its components and its packaging!
■ Max. Temperature 48 °C The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
Medullary reaming (clockwise/counterclockwise rotation) (The recycling pass includes disassembling instructions
■ 30 second application, 30 second pause for the product, as well as information for proper disposal
■ 8 repetitions of components harmful to the environment.)
■ 30 min cooling time Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
■ Max. Temperature 48 °C
European Union, disposal is taken care of by the manufac-
Drilling (oscillation) turer as a free-of-charge service.
■ 15 second application, 15 second pause
► Detailed information concerning the disposal of the product is avail-
■ 3 repetitions
able through your national B. Braun/Aesculap agency, see Technical
■ 30 min cooling time Service.
■ Max. Temperature 48 °C
Saw mode with GB891R 14. Distributor in the US/Contact in Canada
■ 30 second application, 60 second pause
■ 4 repetitions for product information and complaints
■ 30 min cooling time Aesculap Inc.
■ Max. Temperature 48 °C 3773 Corporate Parkway
Center Valley, PA, 18034,
Saw mode with GB892R
USA
■ 30 second application, 60 second pause
■ 5 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
Screwing with GB896R/GB897R
■ 10 second mechanical application, 10 second manual application,
30 second pause
■ 30 repetitions
■ 30 min cooling time
■ Max. Temperature 48 °C
12.4 Environmental conditions
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 500 hPa to 1 060 hPa
1 060 hPa

15
Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
-
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
drill GA344 and drill GA844 Version: 1.0
TA014552 Effective Date: 2022-04-12 (CET)

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany

Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com

Aesculap® – a B. Braun brand SOP-AIC-5002245 (TA014552)

2019-12 Rev. 1
Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
Document - Control
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
& Signature Page
B|BRAUN drill GA344 and drill GA844
TA014552
Version: 1.0
Effective Date: 2022-04-12 (CET)

This document is signed electronically in compliance with the B. Braun electronic signature policies and
procedures by following persons:

UserName: Tubner, Valerie_Aesculap (tubnvlus)

Title: Sr Quality Assurance Analyst
Date: Tuesday, 07 December 2021, 21:04 W. Europe Daylight Time
Meaning: Document signed as Author
================================================

UserName: Carman, Tara (carmtaus)

Title:
Date: Tuesday, 07 December 2021, 21:09 W. Europe Daylight Time
Meaning: Precheck of Document
================================================

UserName: Bevan, Melissa (bevameus)

Title: Manager II, Design Assurance – Medical Device
Date: Tuesday, 07 December 2021, 22:08 W. Europe Daylight Time
Meaning: Approve Document
================================================

UserName: Albright_Aesculap, Justine (albrjsus)

Title:
Date: Tuesday, 07 December 2021, 22:15 W. Europe Daylight Time
Meaning: Approve Document
================================================

UserName: Racosky, Kathy (racokaus)

Title: Senior Regulatory Affairs Specialists
Date: Wednesday, 08 December 2021, 16:24 W. Europe Daylight Time
Meaning: Approve Document
================================================

Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)
 Aesculap, Inc.
- AIC-AAG Instructions for Use Quality-AIC
Document - Control
ELAN 4 Attachments for small Effective
Document ID: SOP-AIC-5002245
& Signature Page
B|BRAUN drill GA344 and drill GA844
TA014552
Version: 1.0
Effective Date: 2022-04-12 (CET)

Title: ELAN 4 Attachments for small drill GA344 and drill GA844 TA014552 Initiator: Valerie N Tubner

This document is signed electronically in compliance with the B. Braun electronic signature policies and
procedures by following persons:

UserName: Carman, Tara (carmtaus)

Title:
Date: Tuesday, 12 April 2022, 22:57 W. Europe Daylight Time
Meaning: Final Release of the Document
================================================

Document No.: TA014552 - Version: 1.0 - Document ID: SOP-AIC-5002245 Date/Time Printed/Viewed: 2022-07-20 22:06 (CET)