Aesculap®

Aesculap Power Systems

Instructions for use/Technical description Gebrauchsanweisung/Technische Beschreibung

ELAN 4 electro Control unit GA800 ELAN 4 electro Steuereinheit GA800

TA-Nr. 014401 06/15 V2

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9
8

7 6 5

16 17 18

11

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13

14

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26 25 24 23 22

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28

30

29
 GD412804 GA395U

GA822

GA849

GA861–GA864 GA806 GA800

GA836 4

GA837
GA808

GA824
Aesculap®
ELAN 4 electro Control unit GA800

GA800®

Legend
ELAN 4 electro Control unit
Aesculap

“OFF” (power supply)

1 ELAN 4 electro Control unit GA800
2 Display with touch control panel
“ON” (power supply)
3 Close coolant pump
4 Flap
5 Indicator light Type BF applied part
6 Connection socket for foot control
7 Connection sockets for motor cable
8 Power OFF switch Foot control
9 Power ON indicator
10 Power ON switch Terminal for equipotential connector according to
11 Ventilation grate IEC/DIN EN 60601-1
12 Power socket
Fuse
13 Fuse holder
14 Terminal for equipotential bonding conductor Alternating current
15 Bottle holder mount
16 Bottle holder Manufacturer combined with date of manufacture
17 USB interface: Only intended for use by the manufacturer or by Ser- (year)
vice technicians authorized by Aesculap.
18 Interface RS232: Only intended for use by the manufacturer. Labeling of electrical and electronic devices according
Motor cable/applied part to directive 2012/19/EU (WEEE), see Disposal
19 Connection for applied part
20 Visual field "Off"
21 Visual field "On"
22 Release button Date of manufacture
23 Lug
24 Connection for motor cable on applied part
25 Slider for tool release Manufacturer’s batch designation
26 Pull back unlocking sleeve LOT
27 Connection for control unit Manufacturer’s serial number
Foot control SN
28 Function button
Manufacturer’s article number
29 Pedal REF
30 Rotational direction button for motor
Delivery quantity
QTY
Temperature limits during transport and storage
Symbols on product and packaging
Caution
Air humidity limits during transport and storage
Observe important safety information such as warnings
and precautions in the instructions for use.
Follow the instructions for use
Atmospheric pressure limits during transport and stor-
age

2
Applied part types Display/control elements in the pump control
panel
Symbol Text Art. no. Designation

Perforator GA822 ELAN 4 electroPerforator Symbol Designation

driver
Identification of the control panel for the coolant
Intra GA824 ELAN 4 electro Low speed pump
motor with intra coupling Display in active applied part control panel

Saw GA836 ELAN 4 electro Micro sag- To switch on the pump

ittal saw
GA837 ELAN 4 electro Micro To switch off the pump
reciprocating saw
Highspeed GA849 ELAN 4 electro Cranio-
tome and multifunctional To activate the “Flush” function (continuous flush-
handpiece (2-ring) ing)

GA861 ELAN 4 electro Standard To reduce the delivery rate

handpiece (1-ring) L4
GA862 ELAN 4 electro Standard
handpiece (1-ring) L7 To increase the delivery rate

GA863 ELAN 4 electro Standard

handpiece (1-ring) L10
GA864 ELAN 4 electro Standard
handpiece (1-ring) L13
Display/control elements in the system set-
tings menu
Display/control elements in the applied part Symbol Designation
control panel To call up the system settings menu

Symbol Designation
To leave the system settings menu
Activation mode of motor via foot control GA808

Applied part settings

Motor direction indicator for right rotation prese-
lected
The display depends on whether the motor is acti- Control unit settings
vated or disabled.
Motor direction indicator for left rotation prese-
lected Control unit information
The display depends on whether the motor is acti-
vated or disabled.
Maximum speed/stroke rate
To reduce the maximum speed setting

Acceleration rate
To increase the maximum speed setting

3
Aesculap®
ELAN 4 electro Control unit GA800

4.3 Operating principle 6

Symbol Designation
5. Preparation and setup 7
Braking rate 5.1 Set-up environment/set-up location 8
5.2 Stacking of units 8
6. Working with the ELAN 4 electro system 8
Flow rate
6.1 System set-up 8
6.2 Function checks 11
To increase the value 6.3 Safe operation 11
6.4 System settings menu 13
7. Validated reprocessing procedure 15
To reduce the value 7.1 General safety notes 15
7.2 Preparation before cleaning 15
System volume 7.3 Cleaning/disinfection 15
7.4 Wipe disinfection for electrical devices without sterilization 15
7.5 Inspection, maintenance and checks 15
Display brightness 8. Maintenance 16
9. Troubleshooting list 16
9.1 Display error messages 16
System language
9.2 Fuse replacement 19
10. Technical Service 19
To reset device to factory settings 11. Accessories/Spare parts 20
11.1 ELAN 4 electro Motor cables, applied parts and foot controls 20
11.2 Close coolant pump 20
To go back to menu structure
11.3 Power cord 20
11.4 Equipotential bonding leads 20
To call up the submenu 11.5 Spare parts 20
12. Technical data 20
12.1 Classification acc. to Directive 93/42/EEC 20
To move down list 12.2 Performance data, information about standards 21
12.3 Ambient conditions 21
13. Disposal 21
To move back up list
14. Distributor in the US/Contact in Canada for product
information and complaints 21

Contents 1. About this document

1. About this document 4 This document describes all necessary instructions and steps for the pro-
2. Intended use 5 vision, setting and safe operation of the ELAN 4 electro system and its
2.1 Task/function within system 5 accessory components.
2.2 Application Environment 5 Additional instructions and steps regarding the accessory components, in
particular on their connection and reprocessing, can be found in the
2.3 Indications 5
respective instructions for use or supplement for the components.
2.4 Contraindications 5
3. Safe handling 5
4. Product description 6
4.1 Scope of supply 6
4.2 Components required for operation 6

4
2. Intended use 2.4 Contraindications
The ELAN 4 electro motor system is not authorized for use in the central
nervous system or central circulatory system.
2.1 Task/function within system
Note
The ELAN 4 electro control unit GA800 together with the accessory forms
an electrically operated motor system. 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
The ELAN 4 electro control unit GA800 supplies the power and monitors specifications provided represent framework conditions only.
the motors in the ELAN 4 electro applied parts. The speed commands are
sent to the control unit via the hand or foot control. The rotational direc- Note
tion and activation of the pump are controlled via buttons on the foot The clinical success of the use of the ELAN 4 electro motor system is depen-
control. dent on the knowledge and experience of the surgeon. The surgeon must
The purpose of the integrated coolant pump is to deliver coolant or irriga- decide which structures it is sensible to treat and take into account the
tion fluid to the operating field for cooling the tool and tissue or irrigating safety and warning information contained in these instructions for use.
the operating field.

Maximum delivery rate of the pump 65 ml/min

3. Safe handling
2.2 Application Environment CAUTION
The motor system fulfills the requirements of Type BF in accordance with Federal law restricts this device to purchase by, or on instruction by a
IEC/DIN EN 60601-1. physician!
For use in operating rooms, outside of the explosive hazard zone (e.g. areas
with highly pure oxygen or anesthetic gases). Risk of fatal injury from electric shock!
► Do not open the product.
Control unit DANGER ► Connect the product only to a grounded power
supply
Application Environment In the unsterile area
Set-up location Table, ceiling supply unit, equipment cart, Risk of injury and material damage due to inappro-
or similar priate use of the product!
WARNING ► Use the product only in accordance with the
intended purpose.
2.3 Indications
Risk of injury and damage to property due to
improper handling of the product!
!ESCULAP½S
%,!.

IS
INTENDED
FOR
HIGH
SPEED
CUTTINGÍ
SAWINGÍ
DRILLING

AND
MANIPULATION
OF
SOFT
TISSUE
AND
BONE
IN
THE
FIELDS
OF
3PINEÍ
%.4Í
WARNING The ELAN 4 electro control unit GA800 together
.EUROÍ
AND
-AXILLOFACIAL
3URGERY with the accessory forms an electronically operated
motor system.
► Follow the instructions for use of
ELAN 4 electro accessories.
► Follow the instructions for use of all products
used.

■ General risk factors associated with surgical procedures are not

described in this documentation.
■ It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■ The operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
■ The ELAN 4 electro control unit GA800 fulfills the requirements of
CISPR11, Class A.

5
Aesculap®
ELAN 4 electro Control unit GA800

► Inspect the new product after removing its transport packaging and 4.3 Operating principle
prior to first use to ensure it is in good working order.
► Observe “Notes on Electromagnetic Compatibility (EMC)“, see Control unit
TA022130.
The ELAN 4 electro control unit 1 is designed for main voltage ranges of
► To prevent damage caused by improper setup or operation, and in order 100 V~ to 120 V~ and 220 V~ to 240 V~ from 50 Hz to 60 Hz. The mains
not to compromise warranty and manufacturer liability: voltage is converted into safety extra low voltage for supplying the micro
– Use the product only according to these instructions for use. motors in the applied parts.
– Follow the safety and maintenance instructions. The control unit features two connection sockets for applied parts for con-
– Only combine Aesculap products with each other. necting two different applied parts, and has one connection socket for a
► Ensure that the product and its accessories are operated and used only foot control. Only one applied part can be operated at a time.
by persons with the requisite training, knowledge, or experience.
Note
► Keep the instructions for use accessible for the user.
The essential performance features are defined by the "speed" and "rota-
► Always adhere to applicable standards. tional direction" specifications. The exception is a conditionally defined
► Do not pull any of the cables by the actual cable but only by the con- motor stop to a safe state caused by a detected error condition
nector.
Display/control concept
The display 2 indicates the current device status (operating and error sta-
tus) at all times. The display is divided into the applied part control panel
4. Product description and the pump control panel.
The display shows the group of the applied part currently connected.
The display shows information about the speed, rotational direction, acti-
4.1 Scope of supply vation and delivery rate of the irrigation pump. By activating the relevant
panel, the control elements appear. Settings can then be changed. If the
Art. no. Designation control elements are not activated, they will disappear again after a short
time.
GA800 ELAN 4 electro Control unit
GD412804 Bottle holder Explanation with an example
TA014401 Instructions for use of ELAN 4 electro control unit Note
If two applied parts are connected to the control unit, the display is divided
TA014482 Supplement for ELAN 4 electro motor system
into 2/3 for the active applied part and 1/3 for the inactive applied part.
TA022130 Notes on Electromagnetic Compatibility d e f g h

4.2 Components required for operation

c
■ ELAN 4 electro Control unit GA800
■ Power cord, see Accessories/Spare parts
■ ELAN 4 electro Motor cable for foot control GA806
■ ELAN 4 electro Foot control GA808
■ ELAN 4 electro Applied part b
Note
The term "applied part" covers all handpieces and motors of the
ELAN 4 electro motor system, see Accessories/Spare parts.
When using the coolant pump:
a
■ Bottle holder GD412804
■ Single-use tube set GA395SU
■ Coolant or irrigation fluid: Physiological saline solutions up to 1,000 ml i
Fig. 1 Example of control concept
Note
The coolant/irrigation fluid is not an Aesculap accessory.

6
Legend Close coolant pump
a Pump control panel The control unit is equipped with a coolant pump 3.
Selected delivery rate % (here 30 %) The coolant pump can be activated either in the corresponding pump con-
b Applied part control panel trol panel or via the corresponding button on the foot control. It can be
c Applied part type (here ELAN 4 electro high speed motor) started by activating the motor or via the "Flush" function (continuous
d Activation mode: (for foot control) flushing). The delivery rate can only be adjusted via the pump control
panel.
e Qualitative bar display:
Display of the maximum set speed (white bar).
The actual current speed in the range from 0 to the maximum set
speed (green bar)
Difference between the maximum set speed and the upper limit of the
5. Preparation and setup
maximum speed (gray bar) Non-compliance with the following instructions will preclude all respon-
f Maximum set speed: (here 75,000 rpm) sibility and liability in this respect on the part of Aesculap.
g Maximum speed (upper limit) with this group: max. 80,000 rpm ► When setting up and operating the product, adhere to
h To call up the system settings menu – national regulations for installation and operation,
i Rotational direction (here right rotation) – national regulations on fire and explosion protection.

Note
Applied part types
For the safety of patients and users it is essential that the mains power cord
The control unit recognizes the different types of applied parts (motors and, especially, the protective earth connection are intact. In many cases
and handpieces). These are shown in the display as a combination of sym- defective or missing protective earth connections are not registered imme-
bol and text. The size and display depend on which socket the applied part diately.
is connected to and whether the applied part is active or locked.
► Connect the device via the potential equalization terminal at the rear
Identification of control elements on system components panel of the device to the potential equalization system of the room
used for medical purposes.
Control elements on the system components of the ELAN 4 electro motor
system are labeled with a gold marking. Note
The potential equalization lead can be ordered from the manufacturer as
Recognition of connected motor cable and applied part art. no. GK535 (4 m length) or TA008205 (0.8 m length).
The settings last selected for the applied part type on this socket (maxi-
mum speed, rotational direction, pump status and delivery rate) are called
up when the same applied part type is plugged in.

Overload protection
To protect the micro motors in the applied parts against damage from
overheating, the motor temperature is monitored. If the temperature is
too high a warning signal sounds and a thermometer symbol appears in
the display 2.
If the temperature continues to be too high, the applied part is switched
off. The following message appears in the display 2: "The motor currently
being used is overheating. Please let the motor cool down or use another
suitable motor".
After a cooling phase the applied part can be reactivated.
It is recommended to have a second applied part ready at hand.

7
Aesculap®
ELAN 4 electro Control unit GA800

5.1 Set-up environment/set-up location All configurations must comply with basic standard IEC/DIN EN 60601-1.
Any individual connecting devices with one another is responsible for such
Fire and explosion hazard! configuration and must ensure compliance with basic standard IEC/DIN
EN60601-1 or applicable national standards.
► Use the product outside of explosion hazard
DANGER zones (e.g. areas with highly pure oxygen or ► Follow the instructions for use of individual accessories.
anesthetic gases). ► Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
The ELAN 4 electro control unit is authorized for operation in the operat- Technical Service.
ing room.
Connecting the power supply
Note
After being installed and put into operation, the control unit must not be Risk of fatal injury from electric shock!
transported or moved to a different set-up location.
► Connect the product only to a grounded power
Note DANGER supply.
The control unit must not be placed on an Aesculap mobile stand (GA415,
GA416 and GD416M). Note
The mains voltage must correspond to the voltage indicated on the type
► Make certain that the ventilation slots in the bottom of the housing plate at the back of the unit.
and in the rear panel of the control unit are not covered, e.g. by an OR
cloth. ► Plug in the power cord at power cord socket 12.
► Make certain that the control elements, mains power switch and ► Connect power supply by inserting into a wall socket.
power socket 12 are freely accessible for the user.
► Make certain the system is set up on a sufficiently stable support (e.g. Switching on the control unit
a table, ceiling support, equipment cart, etc.). ► Activate the power ON switch 10.
► Follow the instructions for use of the support. The power ON indicator 9 and indicator light 5 light up.
The control unit 1 always performs a power-on self-test when the unit
is switched on.
5.2 Stacking of units
If a malfunction is detected, an error message will appear in the
► Do not exceed a stack height of 415 mm. display 2, see system errors.
► Place the units in a stable position.
► Aesculap devices must be stacked on top of each other facing identi- Switching off the control unit
cally. ► Activate the power OFF switch 8.
► Never stack in an offset arrangement. The power ON indicator 9, the indicator light 5 and the display with
touch control panel 2 will fade out.

Putting out of operation

6. Working with the ELAN 4 electro sys- Note
tem The safe and all-pole disconnection of the product from the main power
supply is only guaranteed when the power cord is unplugged.

► Switching off the product: Activate the power OFF switch 9.

6.1 System set-up
► Unplug the power cord from the power socket 12.

Connecting the accessories The operation of the device is safely terminated.

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.
Also note that any equipment connected at the interfaces must demon-
strably meet the respective IEC standards (e.g. IEC 60950 for data process-
ing equipment, IEC/DIN EN 60601-1 for electromedical devices).

8
ELAN 4 electro To connect the foot control GA808 to the control unit ELAN 4 electro Connecting the motor cable GA806 to the control
Note unit
The plug connection of the foot control has a yellow coded ring and a filled- Note
in dot. The motor cable is sterile. Sterile separation occurs at the motor cable.

► Position connector of foot control c so that marking b on the connector Note

is aligned with marking a on the connection socket for foot control 6, The plug connection of the motor cable has a blue coded ring and a hollow
see Fig. 2. dot.
► Plug the connector for foot control c firmly into the connection socket
for foot control 6. ► Position connector for control unit c on the motor cable so that mark-
ing b on the connector is aligned with marking a on the connection
socket for applied parts 7, see Fig. 3.
► Plug connector for control unit c on the motor cable firmly into one of
the two connection sockets for applied parts 7.

a
b

a
b

c
Fig. 2 Connecting the foot control
Legend
a Marking for connection socket
b Marking for connector Fig. 3 Connecting the motor cable
c Connector for foot control Legend
a Marking for connection socket
b Marking for connector
c Connector for control unit

Note
The motor cable must be connected to the control unit without an applied
part or with the applied part locked ("Off" position).
Otherwise the applied part will not be recognized by the control unit and a
message will appear in the display.

► If the applied part is not recognized;

– Lock the applied part, see Locking the applied part ("Off" position).
– Release the applied part again, see Releasing the applied part for
operation ("On" position).

9
Aesculap®
ELAN 4 electro Control unit GA800

ELAN 4 electro Connecting the single-use tube set GA395SU Legend

Note a Flap of coolant pump
The tube set is sterile. Sterile separation occurs at the tube set. b Roller wheel
c Single-use tube set
► Open flap a of the coolant pump 3, see Fig. 4.
d Pull slide
► Insert single-use tube set c:
e Nib of the single-use tube set
– Place pump tube with loop over the roller wheel b.
– Push nib e of the single-use tube set under the pull slide d until the Connecting the applied part to the motor cable
nib engages.
► Connect connection for motor cable 24 to connection for applied part
► Close flap of the coolant pump a. When doing this, make certain the 19 on the motor cable. When doing so, ensure that the nib 23 on the
pump tube does not get clamped in. motor cable is aligned with the groove on the applied part coupling.
► Insert the bottle holder 16 for the sterile fluid bottle in bottle holder The applied part engages. When the visual field is “Off” 20 on the
mount 15. motor cable, a gold-colored marking is visible.
► Insert the punching spike into the sterile fluid bottle. The control unit 1 recognizes the applied part type and displays this
► When using sterile fluid bottles made from glass: Open the ventilation type in the corresponding applied part control panel in the display 2.
flap on the punching spike. The most recent settings for this applied part type at the same motor
► Hang the sterile fluid bottle from the bottle holder 16. connection socket are shown on the display 2.
► Fasten the tube to the motor cable using fixation clamps.
Note
► Shorten the length of the tubes to correspond with the applied part
being used and connect to the spray nozzle. The applied part connected to this motor cable is only ready for operation
if a gold-colored marking is visible in the visual field "On" 21 on the motor
a cable.

Releasing the applied part for operation ("On" position)

► Activate the release button 22 on the motor cable and push the
applied part further onto the motor cable.
The applied part engages. When the visual field is “On” 21 on the
motor cable, a gold-colored marking is visible.
b
Note
For applied parts with slider for tool release 25, in the "On" position 21 the
c nib 23 on the motor cable blocks the slider. Uncoupling of the tools is
therefore only possible in "Off" position 20.
d For applied parts with unlocking sleeve 26, in the "On" position 21 the con-
nection for applied part 19 on the motor cable blocks the unlocking sleeve.
Uncoupling of the attachments is therefore only possible in "Off" position
e 20.
For applied parts without slider for tool release, it is possible to cou-
ple/uncouple tools in the "On" position, but this must not be done due to
the risk of injury from unintentional activation of the applied part.

Locking the applied part ("Off" position)

► Activate the release button 22 on the motor cable and detach the
motor cable from the applied part.
The applied part engages. When the visual field is “Off” 20 on the
Fig. 4 Connecting the single-use tube set motor cable, a gold-colored marking is visible.

Disconnecting the applied part from the motor cable

► Activate the release button 22 on the motor cable and pull at the con-
nection for applied part 19 to disconnect the motor cable from the
applied part.

10
ELAN 4 electro Disconnecting the foot control GA808 from the con- It is only possible to operate the applied part and change the setting
trol unit parameters on the control unit if:
► Unplug connector for foot control c from the connection socket for ■ the applied part is connected to the control unit,
foot control 6, see Fig. 2. ■ a foot control is connected to the connection socket for foot control 9,
■ there is no second applied part released at the same time and
ELAN 4 electro Disconnecting the motor cable GA806 from the con- ■ the applied part type is shown on the display of the control unit.
trol unit
The following motor settings of the applied part cannot be changed when
► Unplug the motor cable on the connector for control unit c from the the applied part is running::
connection socket for applied parts 7, see Fig. 3. ■ Rotational direction
■ Maximum speed
6.2 Function checks
Activating the motor/pump control panel
► Prior to each use and after every change of applied part, check that all
Note
products to be used are in good working order.
The motor settings of the applied part cannot be changed when the applied
► Check the secure connection of all products to be used.
part is running.
► Ensure that the parameters are set and the unit is operated according
to the instructions for use and the safety information for the applied ► Changing the setting parameters of the applied part: Activate the
parts or tools. applied part control panel a in the display 2, see Fig. 5.
► Check that the cutting edges of the tools are not showing any mechan- ► Changing the setting parameters of the irrigation pump: Activate the
ical damage. pump control panel b in the display 2, .
► Check that the correct applied part type for the applied parts con- The activated control panel switches to the Settings mode. Now the
nected is showing in the corresponding applied part control panel in setting parameters listed below can be changed.
the display.
► Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
► Release the applied part for operation.
► Push the pedal on the foot control down as far as it will go.
The applied part starts running in the preselected rotational direction
and reaches the maximum speed as indicated in the applied part con-
trol panel in the display.
The applied part runs quietly at a constant speed. b
The qualitative bar display for the actual current applied part speed in
the applied part control panel is fully illuminated.
► If necessary, release the coolant pump in the corresponding applied
part control panel or by pressing the function button on the foot con-
trol. a
The coolant pumps starts as soon as the applied part is operated.

Fig. 5 Activating the control panel

6.3 Safe operation
Legend
Risk of injury and/or malfunction! a Pump control panel
► Always carry out a function check prior to using b Applied part control panel
WARNING the product.

Risk of injury and material damage due to inadver-

tent activation when repositioning/moving the foot
WARNING control!
► To reposition the foot control: Use a transport
brace.
► Prior to repositioning: Secure the applied part
against inadvertent activation ("Off" position).

11
Aesculap®
ELAN 4 electro Control unit GA800

Changing the maximum speed setting/rotational direction of the Note

applied part The activation of the "Flush" function does not depend on whether an
► Activate the applied part control panel, see Activating the motor/pump applied part is connected or activated.
control panel.
► To change the rotational direction: Activate the inactive, gray rota-
tional direction button for right rotation/left rotation a/b, see Fig. 6.
The rotational direction is changed from right rotation to left rotation
and vice versa.
a b c d
► Changing the maximum speed setting: Activate the buttons for reduc-
ing/increasing the maximum speed setting c/d. Fig. 7 Activating the irrigation pump/“Flush” function
The maximum speed setting is reduced/increased by increments. Legend
a Button for switching the irrigation pump on/off
Note
b "Flush" button
The increments for changing the maximum speed setting depend on the
c Button for reducing the delivery rate
applied part connected.
d Button for increasing the delivery rate

Deactivating the irrigation pump and changing the delivery rate

Note
The delivery rate of the irrigation pump can only be changed when the irri-
gation pump is activated.

► Activate the pump control panel, see Activating the motor/pump con-
a b c d trol panel.
Fig. 6 Changing the maximum speed setting/rotational direction ► To deactivate the irrigation pump: Activate the button for switching
off the irrigation pump a, see Fig. 7.
Legend
The irrigation pump is inactive and no longer delivers coolant.
a Rotational direction button for left rotation
► To change the delivery rate: Activate the buttons for reducing/increas-
b Rotational direction button for right rotation
ing the delivery rate c/d.
c Button for reducing the maximum speed setting
The delivery rate of the irrigation pump is reduced/increased by incre-
d Button for increasing the maximum speed setting ments.
The delivery rate can be adjusted in the following increments.:
Activating the irrigation pump/“Flush” function (continuous flushing)
■ 1 % to 5 %: 1 % increments
► Activate the pump control panel, see Activating the motor/pump con-
■ 5 % to 100 %: 5-% increments
trol panel.
► To activate the irrigation pump: Activate the button for switching on Activating the applied part via foot control
the irrigation pump a, see Fig. 7.
To activate right rotation:
The irrigation pump is active and delivers coolant at the currently set
delivery rate. ► Set the rotational direction button for motor 30 to right rotation.

► To activate the "Flush" function: Activate and hold down the "Flush" The motor direction indicator for right rotation is illuminated in the
button b. applied part control panel.
The "Flush" function is now active. The irrigation pump delivers coolant ► Activate the pedal 29.
at the maximum delivery rate until the "Flush" button b is released. The applied part runs clockwise.
To activate left rotation:
► Set the rotational direction button for motor 30 to left rotation.
The motor direction indicator for left rotation is illuminated in the
applied part control panel.
► Activate the pedal 29, the applied part runs counterclockwise.
The control unit emits an acoustic signal.

12
Activating the coolant pump via foot control Motor settings
► To switch the coolant pump on/off: Briefly activate function button The motor settings menu displays the applied part types, see Fig. 9.
28.
► To activate the “Flush” function (continuous flushing): Activate the b
function button 28 for a longer period and keep pressed down.

6.4 System settings menu

Note
The system settings menu can only be called up when no applied part is a
being operated.
While the system settings menu is active, the operation of the applied part
is blocked.

► To call up the system settings menu: Activate the button for the system
settings menu h, see Example of control concept.
The system settings menu opens, see Fig. 8.

d Fig. 9 Motor settings – Overview of applied part types

Legend
c a Buttons for applied part types
b Leave the menu
b ► To leave the menu: Activate the "Leave menu" b button.

Fig. 8 System settings menu

Legend
a "Device information" button
b "Device settings" button
c "Motor settings" button
d "Leave system settings" button

Menu Description

Motor settings To display and change the settings for the individ-
ual applied part types
Device settings To display and change the basic settings for the
control unit
Device informa- To display information about the control unit
tion

► To call up menu: Activate the menu button.

► To leave the system settings menu: Activate the "Leave system set-
tings" d button.

13
Aesculap®
ELAN 4 electro Control unit GA800

► To display/change the motor settings of an applied part type: Activate Device settings
the button for the applied part type a.
f g
The submenu for the applied part type selected opens, see Fig. 10.
f g e

e
d

d
c

c
b

b
a

Fig. 11 Device settings

Legend
Fig. 10 Motor settings – Selected applied part type
a To reset device to factory settings
Legend b Language
a Delivery rate c Brightness
b Braking rate d Volume
c Acceleration rate e Leave the menu
d Maximum speed f Reduce the value
e Leave the menu g Increase the value
f To reduce the value
g To increase the value Setting Description

Setting Description Volume To adjust system volume

Brightness To adjust brightness of display
Maximum speed Maximum speed/stroke rate
Language To set system language
Acceleration rate Acceleration rate of the applied part
Reset device to To reset device to factory settings (includes motor
Braking rate Braking rate the applied part
factory settings settings)
Delivery rate Delivery rate of the coolant pump
► To leave the menu: Activate the "Leave menu" e button.
► To leave the menu: Activate the "Leave menu" e button. ► To change the system volume/display brightness: Activate the
► To change the motor setting: Activate the "Increase value" button g or "Increase value" button g or "Decrease value" button f.
"Decrease value" button f. The change is implemented immediately. The set value is displayed.
The change is implemented immediately. The set value is displayed. ► To change the system language:
– Select the “Language” button c.
– Select the required language.
► To restore the default settings:
– Select "Reset device to factory settings" d.
– Confirm the message.

14
Device information 7.2 Preparation before cleaning
The "Device information" menu displays general information about the ► Separate the products from each other immediately after use.
device and the device software. ► Put the control unit 1 out of operation immediately after use, see Put-
► To leave the menu: Activate the "Leave menu" a button. ting out of operation.
► Remove any visible surgical residues as much as possible with a damp,
lint-free cloth.

7. Validated reprocessing procedure

7.3 Cleaning/disinfection

7.1 General safety notes Product-specific safety instructions for the reprocessing procedure

Note
Risk of electric shock and fire hazard!
Adhere to national statutory regulations, national and international stan-
► Unplug the device before cleaning.
dards and directives, and local, clinical hygiene instructions for reprocess-
DANGER ► Do not use flammable or explosive cleaning or
ing.
disinfecting solutions.
Note ► Ensure that no fluids will penetrate the product.
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble variants of CJD, observe the relevant national regulations concerning Damage to, or destruction of the product caused by
the reprocessing of products. mechanical cleaning/disinfection!
CAUTION ► Clean the product with wipe disinfection only.
Note
► Do not sterilize the product under any circum-
It should be noted that successful reprocessing of this medical device can
stances.
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
Damage to the product due to inappropriate clean-
The recommended chemical was used for validation. ing/disinfecting agents!
CAUTION ► Only use cleaning/disinfecting agents approved
for surface cleaning. Follow the manufacturer’s
instructions for the respective cleaning/disin-
fecting agent.

► Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids.

7.4 Wipe disinfection for electrical devices without sterilization

Phase Step T t Conc. Water quality Chemicals

[°C/°F] [min] [%]

I Wipe disinfection RT ≥1 - - Meliseptol HBV wipes 50 % Propan-1-ol

RT: Room temperature

Phase I 7.5 Inspection, maintenance and checks

► Remove any visible residues with a disposable disinfectant wipe. ► Inspect the product after each cleaning and disinfecting cycle to be
► Wipe all surfaces of the optically clean product with a fresh, disposable sure it is: clean, functional, and undamaged.
disinfectant wipe. ► Set aside the product if it is damaged.
► Observe the specified application time (1 min minimum).

15
Aesculap®
ELAN 4 electro Control unit GA800

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.

9.1 Display error messages

Faults that are recognized by the control unit are shown as error messages
in the display.
There are three types of error messages:
■ System error (text in red field): It is not possible to work with the con-
trol unit or system.
■ Accessory error (text in yellow field): It is possible to work with a dif-
ferent component.
■ Operating error (text in blue field): It is possible to work with the sys-
tem after rectifying the cause of the error.

Note
Many faults cannot be clearly categorized. They can be caused by an oper-
ating error or an accessory error. In such cases, an operating error is
assumed first, to avoid any unnecessary changing or sending in of new
products.

System error

Message displayed Cause Remedy

System error The internal monitoring of the control unit Switch the control unit off and on again.
Switch the control unit off and on. recognizes an error or fault. If the message appears again: Replace the control
If the error re-occurs, replace the control unit. unit.

Accessory error

Message displayed Cause Remedy

Motor or motor cable damaged Motor cable or applied part defective Replace motor cable or applied part.
Please replace product
Foot control defective Foot control defective Replace foot control.
Please replace product

16
Operating error

Message displayed Cause Remedy

Motor overheated Motor of the applied part has overheated Allow the applied part to cool down.
The motor currently being used is overheating. If the applied part overheats excessively: Replace
Please let the motor cool down or use another the applied part.
suitable motor.
Motor blocked Applied part blocked Stop applied part actuation and release blockage.
Stop motor actuation and release blockage If the error occurs when the applied part is running
If the error re-occurs, replace the product. idle: Replace the applied part.
Motor not recognized Applied part connected to control unit in "On" Lock the applied part ("Off" position).
Switch the motor to "Off" position and then position The control unit recognizes the applied part type.
back to "On" position In order to work: Release the applied part ("On"
position).
Two motors in "On" position Foot control is activated while two applied Only release the applied part intended to be oper-
Please switch one to "Off" position parts are released on the motor cable ("On" ated ("On" position).
position) Lock the applied part which isn't to be operated
Note: Only one applied part can be operated at ("Off" position).
a time.
Activation of motor in "Off" position. Foot control is activated while the applied part Release the applied part ("On" position).
Switch motor to "On" position before activa- is locked on the motor cable ("Off" position)
tion.
Activation without motor connected. Foot control is activated while the applied part Connect the motor cable to the control unit.
Connect a motor to the control unit is not connected to the control unit Connect the applied part to the motor cable.
The pedal or a button on the foot control is Pedal or button on the foot control is activated Release the activation.
activated on start-up. during automatic self-test. If the pedal or button is not activated, the foot
Please release the pedal or button. control is defective.
If necessary, replace foot control.

Other faults in control unit

Malfunction Cause Detection Remedy

Control unit cannot be switched No power to control unit Control unit not connected to Connect control unit to the main
on. mains power or not switched on power.
(power ON indicator dark, black Switch on the control unit.
display)
Fuses blown Power ON indicator dark, black Replace the fuses.
display
No coolant flow. Coolant container empty Coolant container empty. Replace coolant container.
Tubing inserted incorrectly Tubing inserted incorrectly Insert tubing correctly.
Tubing leaking Coolant is leaking out Replace tubing.
Spray nozzle blocked Coolant pump running. Replace spray nozzle.
Coolant is not being delivered.
Coolant pump motor defective Coolant pump not running. Replace the control unit.

17
Aesculap®
ELAN 4 electro Control unit GA800

Faults when working with the applied part

Malfunction Cause Detection Remedy

Disconnecting/connecting the Release button on the motor cable Coupling processes cannot be per- Release the release button on the
applied part from/with the motor is not released between connect- formed motor cable between connecting/dis-
cable not possible ing/disconnecting and releas- connecting and releasing/locking the
(change from "On" to "Off" posi- ing/locking the applied part applied part and activate again.
tion and vice versa)
Motor coupling defective Change the applied part or motor
cable.
Tool cannot be coupled ELAN 4 electro High speed: Auto- High speed tool doesn't engage Activate slider for tool release and
matic tool lock blocked hold, then couple tool.
ELAN 4 electro High speed: Slider Applied part released for operation Lock the applied part ("Off" position).
for tool release locked ("On" position)
Incompatible tool Wrong tool Select an appropriate tool according
to the instructions for use of the
applied part.
Tool connection or coupling Tool is difficult to couple or cannot Use a new tool.
deformed, defective be coupled
Change applied part.
Attachment for GA849 (cranio- Automatic attachment lock Attachment doesn't engage Pull back unlocking sleeve and hold,
tome) cannot be coupled or blocked then couple the attachment.
uncoupled
Unlocking sleeve blocked Applied part released for operation Lock the applied part ("Off" position).
("On" position)
Attachment coupling defective Attachment is difficult to couple Use a new attachment.
or cannot be coupled
Change applied part.
Attachment coupling is dirty Clean the attachment or use a new
attachment.
Clean the applied part.
Pivotable dura protection GB947R Pivotable dura protection is diffi- Bearing dirty or worn Follow the instructions for use
is difficult to turn cult to move (TA014438/TA014439) (reprocessing,
maintenance).
Change turnable dura guard.
Loud noise coming from applied Gearings/ball bearings defective Loud, irregular noise Change applied part.
part Preventive measure: Ensure that the
applied part is lubricated at regular
intervals.
High speed applied part vibrates Excessive running noises, vibra- Shaft of applied part bent Change applied part.
excessively tions
Applied part defective
Reprocessing carried out incor- Follow instructions for use of the
rectly applied part (reprocessing, mainte-
nance)

18
 Malfunction Cause Detection Remedy

Applied part is getting too hot Blunt tool Tool overheats Change tool.
Applied part defective Cutting edges of the tool are Change applied part.
sharp, but the applied part is heat- Preventive measure: Ensure that the
ing up applied part is lubricated at regular
intervals.
Excessive use Applied part heating up Follow instructions for use of the
Loud running noise applied part (interval operation).
Vibration
Reprocessing/maintenance carried Follow instructions for use of the
out incorrectly applied part (reprocessing, mainte-
nance)
Shaft of applied part bent Change applied part.
Applied part defective
Applied part not running Applied part defective Tool not moving Change applied part.
Foot control defective Pedal not moving Change foot control.
Insufficient power Blunt tool Cutting edge worn Change tool.
Cutting edges coated with sub-
stances, e.g. from too little rinsing
Applied part operated in left rota- Serrated tool run in counterclock- Operate serrated tool in right rotation.
tion wise mode
No central alignment of the crani- Dura protector bracket bent Follow instructions for use
otomy reamer to the dura protec- Poor progress during craniotomy (TA014438/TA014439).
tor bracket Change dura guard
Applied part defective Insufficient power of applied part Follow instructions for use of the
applied part (reprocessing, mainte-
Large amount of heat generated
nance)
after a short time
Change applied part.

9.2 Fuse replacement 10. Technical Service

Risk of fatal injury from electric shock! Danger to life of patients and users if the product
► Unplug the device before changing the fuses! malfunctions and/or protective measures fail or are
DANGER DANGER not used!
► Do not perform any servicing or maintenance
Specified fuses: 2 x IEC 127 - T 6.3 A breaking capacity H (1 500 A at
work under any circumstances while the product
250V/50 Hz)
is being used on a patient.
► Use a small screwdriver to release the clip on the fuse holder 13.
► Do not modify the product.
► Pull out the fuse holder 13.
► Replace both fuses. Modifications carried out on medical technical equipment may result in
► Reinsert the fuse holder 13 in such a way that it audibly snaps into loss of guarantee/warranty rights and forfeiture of applicable licenses.
place. ► For service and repairs, please contact your national
B. Braun/Aesculapagency.
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.

19
Aesculap®
ELAN 4 electro Control unit GA800

Service addresses 11.2 Close coolant pump

Aesculap Technischer Service
Am Aesculap-Platz Art. no. Designation
78532 Tuttlingen / Germany GA395U ELAN 4 electro Single-use tube set
Phone: +49 (7461) 95 -1601
GD412804 Bottle holder
Fax: +49 (7461) 14 -939
E-Mail: [email protected] – Physiological saline solutions up to 1 000 ml
Or in the US: Note: No Aesculap accessories
Aesculap Inc.
Attn. Aesculap Technical Services
11.3 Power cord
615 Lambert Pointe Drive
Hazelwood
Art. no. Approvals Color Length
MO, 63042 USA
Aesculap Repelectro Hotline TE780 Europe black 1.5 m
Phone: +1 (800) 214 -3392 TE730 Europe black 5m
Fax: +1 (314) 895 -4420
TE734 Great Britain black 5m
Other service addresses can be obtained from the address indicated above.
TE735 USA, Canada, Japan gray 3.5 m

11. Accessories/Spare parts 11.4 Equipotential bonding leads

Art. no. Designation

11.1 ELAN 4 electro Motor cables, applied parts and
GK535 Equipotential bonding lead (4 m)
foot controls
TA008205 Equipotential bonding lead (0.8 m)
Art. no. Designation

GA806 ELAN 4 electromotor cable for foot control

11.5 Spare parts
GA808 ELAN 4 electro Foot control
Art. no. Designation
GA822 ELAN 4 electroPerforator driver
GA824 ELAN 4 electro Low speed motor with intra cou- TA021473 Fuse: Fusible cartridge T 6.3 AH
pling
GA836 ELAN 4 electro Micro sagittal saw
GA837 ELAN 4 electro Micro reciprocating saw 12. Technical data
GA849 ELAN 4 electro Craniotome and multifunctional
handpiece (2-ring)
12.1 Classification acc. to Directive 93/42/EEC
GA861 ELAN 4 electro Standard handpiece (1-ring) L4
GA862 ELAN 4 electro Standard handpiece (1-ring) L7 Art. no. Designation Class
GA863 ELAN 4 electro Standard handpiece (1-ring) L10 GA800 ELAN 4 electro Control unit IIa
GA864 ELAN 4 electro Standard handpiece (1-ring) L13 GA806 ELAN 4 electromotor cable for foot control I
GA808 ELAN 4 electro Foot control I
GA822 ELAN 4 electroPerforator driver IIa

20
Art. no. Designation Class
12.3 Ambient conditions

GA824 ELAN 4 electro Low speed motor with intra cou- IIa Operation Storage and transport
pling
Temperature 10 ? to 40 ? -10 ? to 50 ?
GA836 ELAN 4 electro Micro sagittal saw IIa
Relative 30 % to 75 % 10 % to 90 %
GA837 ELAN 4 electro Micro reciprocating saw IIa humidity
GA849 ELAN 4 electro Craniotome and multifunctional IIa Atmospheric 700 hPa to 1060 hPa 500 hPa to 1060 hPa
handpiece (2-ring) pressure
GA861 ELAN 4 electro Standard handpiece (1-ring) L4 IIa
GA862 ELAN 4 electro Standard handpiece (1-ring) L7 IIa
GA863 ELAN 4 electro Standard handpiece (1-ring) L10 IIa 13. Disposal
GA864 ELAN 4 electro Standard handpiece (1-ring) L13 IIa Note
GA395U ELAN 4 electro Single-use tube set IIa The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.

Adhere to national regulations when disposing of or recy-

12.2 Performance data, information about standards cling the product, its components and its packaging!
The recycling pass can be downloaded from the Extranet
Protection class (acc. to IEC / I
as a PDF document under the respective article number.
DIN EN 60601-1)
(The recycling pass includes disassembling instructions for
Housing protection rating IP20 the product, as well as information for proper disposal of
according to IEC/DIN EN components harmful to the environment.)
60529 Products carrying this symbol are subject to separate col-
lection of electrical and electronic devices. Within the
Applied part Type BF European Union, disposal is taken care of by the manufac-
Mains voltage ranges 100 V~–120 V~ ±10 % turer as a free-of-charge service.
220 V~-240 V~ ±10 %
► Detailed information concerning the disposal of the product is avail-
Current consumption (ready 0.2A (at 100 V~ to 120 V~) able through your national B. Braun/Aesculap agency, see Technical
for operation) 0.3A (at 220 V~ to 240 V~) Service.
Current consumption (maxi- 5.4 A–4.4 A (at 100 V~ to 120 V~)
mum load) 2.3 A-2.2 A (at 220 V~ to 240 V~)
Frequency 2 pieces
14. Distributor in the US/Contact in Can-
Operating mode Continuous operation
ada for product information and com-
Device fuse (acc. to IEC T 6.3 AH, 250V
60127-1) Form factor: 5 x 20 mm
plaints
Aesculap Inc.
Maximum delivery rate of 65 ml/min ± 15 %
the coolant pump 3773 Corporate Parkway
Center Valley, PA, 18034,
Weight 9.5 kg ± 10 %
USA
Dimensions (L x W x H) 380 mm x 330 mm x 201 mm ± 5 %
SOP-AIC-5001568 Rev. 1 0517
Dimensions (L x W x H) with 380 mm x 379 mm x 427 mm ± 5 %
bottle holder
Conforming to standard IEC/DIN EN 60601-1
EMC IEC/DIN EN 60601-1-2
CISPR11 Class A

21