ELAN 4 Model GA800 Instructions for Use -Technical Description V6 Dec 2019

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25

24

19

20 21

23

22

27

31

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28 30 29

29 30 GA808

GA810

GA822

GA849 GD412804

GA861–GA864

GA865–GA869

GA804

GA860

GA805

GA836

GA395SU

GA806 GA808

GA831

GA837

GA832

GA833

GA824

GA810

GA844

en

Aesculap® ELAN 4 electro control unit GA800 Legend

Type BF applied part

1 ELAN 4 electro control unit GA800 2 Display with touch control panel 3 Coolant and irrigation pump 4 Flap 5 Indicator light 6 Connection socket for foot control 7 Connection sockets for motor cable 8 Power OFF switch 9 Power ON indicator 10 Power ON switch 11 Ventilation grate 12 Fuse holder 13 Power socket 14 Terminal for equipotential bonding conductor 15 Bottle holder mount 16 Bottle holder 17 USB interface: Only intended for use by the manufacturer or by Service technicians authorized by Aesculap. 18 Interface RS232: Only intended for use by the manufacturer. Motor cable/applied part 19 Connection for applied part 20 Visual field "Off" 21 Visual field "On" 22 Release button 23 Lug 24 Connection for motor cable on applied part 25 Slider for tool release 26 Pull back unlocking sleeve 27 Connection for control unit Foot control 28 Function button 29 Pedal 30 Rotational direction button for motor 31 Speed range limit button (only for wireless foot control GA810)

Symbols on product and packaging

Terminal for equipotential connector according to IEC/DIN EN 60601-1 Fuse Alternating current Manufacturer Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Chapter 13.

Date of manufacture

Manufacturer’s batch designation Manufacturer’s serial number Manufacturer’s article number Delivery quantity Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage Non sterile medical device

Caution Observe important safety information such as warnings and precautions in the instructions for use.

CE marking according to Directive 93/42/EEC

Follow the instructions for use

Federal law restricts this device to sale by or on order of a physician

“OFF” (power supply)

“ON” (power supply)

2

Foot control

en Applied part types Symbol

Display/control elements in the applied part control panel

Text

Art. no.

Designation

Perforator

GA822

ELAN 4 electro perforator driver

Intra

GA824

ELAN 4 electro Lowspeed motor with intra coupling

Saw

GA831

ELAN 4 electro sagittal saw

GA832

ELAN 4 electro reciprocating saw

Activation of motor via hand control GA804/GA805/GA844

GA833

ELAN 4 electro transverse saw

GA836

ELAN 4 electro micro sagittal saw

Motor direction indicator for clockwise rotation preselected The display depends on whether the motor is activated or disabled.

GA837

ELAN 4 electro micro reciprocating saw

GA849

ELAN 4 electro craniotome and multifunctional handpiece (2-ring)

Symbol

Designation Activation mode of motor via foot control GA808

Activation of motor via wireless foot control GA810

Highspeed

Drill

GA860

ELAN 4 electro hand piece

GA861

ELAN 4 electro Standard handpiece (1-ring) L4

GA862

ELAN 4 electro Standard handpiece (1-ring) L7

GA863

ELAN 4 electro Standard handpiece (1-ring) L10

GA864

ELAN 4 electro Standard handpiece (1-ring) L13

Motor direction indicator for counterclockwise rotation preselected The display depends on whether the motor is activated or disabled. Reduce the maximum speed setting

MIS Increase the maximum speed setting

Display/control elements in the pump control panel Symbol

Designation Identification of the control panel for the coolant and irrigation pump Display in active applied part control panel

GA865

ELAN 4 electro Standard handpiece (2-ring) L7

GA866

ELAN 4 electro Standard handpiece (2-ring) L10

GA867

ELAN 4 electro Standard handpiece (2-ring) L13

Switch off the pump

GA868

ELAN 4 electro Standard handpiece (2-ring) L17

Activate the “Flush” function (continuous flushing)

GA869

ELAN 4 electro Standard handpiece (2-ring) L22

Reduce the delivery rate

GA844

Switch on the pump

ELAN 4 electro power drill Increase the delivery rate

3

en Display/control elements in the system settings menu Symbol

Symbol

Designation Reset device to factory settings

Designation Call up the system settings menu

Go back to menu structure

Leave the system settings menu

Call up the submenu

User profiles

Move down list

Applied part settings

Move back up list

Control unit settings

Add new user profile

Wireless foot control settings

Delete existing user profile

Control unit information

Edit existing user profile

Maximum speed/stroke rate

Save user profile

Speed up

Contents Slow down

Oscillation mode

Oscillation angle

Flow rate

Increase the value

Reduce the value

System volume

Display brightness

System language

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1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 3. 4. 4.1 4.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 5. 5.1 5.2 6. 6.1 6.1.1 6.1.2

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Control unit... Display/control concept... Explanation with an example... Applied part types... Identification of control elements on system components . . . Recognition of connected motor cable and applied part... Overload protection... Coolant and irrigation pump... Preparation and setup... Set-up environment/set-up location... Stacking of units... Working with the ELAN 4 electro system... System set-up... Connecting the accessories... Connecting the power supply...

5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 8 9 9 9 9

en 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8

6.1.9 6.1.10 6.1.11 6.1.12 6.1.13 6.1.14 6.1.15

6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 7. 7.1 7.2 7.3 7.4 7.4.1 7.5 7.6 8. 9. 9.1 9.1.1 9.1.2 9.1.3 9.1.4 9.1.5 9.2 10. 11.

Switching on the control unit... 9 Switching off the control unit... 9 Putting out of operation... 9 Connecting the ELAN 4 electro to wireless foot control GA810 9 Connecting the ELAN 4 electro foot control GA808 to the control unit... 9 Connecting the ELAN 4 electro motor cable GA804/GA805/GA806 or ELAN 4 electro drill tool GA844 to control unit... 9 Connecting the ELAN 4 electro single-use tube set GA395SU 10 Connecting the applied part to the motor cable... 10 Releasing the applied part for operation ("On" position)... 11 Locking the applied part ("Off" position)... 11 Disconnecting the applied part from the motor cable... 11 Disconnecting the ELAN 4 electro foot control GA808 from the control unit... 11 Disconnecting the ELAN 4 electro motor cable GA804/GA805/GA806 or ELAN 4 electro drill tool GA844 from control unit... 11 Function checks... 11 Safe operation... 11 Activating the motor/pump control panel... 12 Changing the maximum speed setting/rotational direction of the applied part... 12 Activating the coolant and irrigation pump/“Flush” function (continuous flushing)... 12 Deactivating the coolant and irrigation pump and changing the delivery rate... 12 Enable application part using foot control GA808 or wireless foot control GA810... 13 Activating the applied part via hand control GA804/GA805 . . 13 Activating the coolant pump via foot control... 13 System settings menu... 13 User profiles... 14 Motor settings... 14 Device settings... 15 Wireless foot control... 15 Device information... 15 Reprocessing procedure... 16 General safety notes... 16 Reusable products... 16 Preparation before cleaning... 16 Cleaning/disinfection... 16 Product-specific safety instructions for the reprocessing procedure... 16 Wipe disinfection for electrical equipment... 16 Inspection, maintenance and checks... 16 Maintenance... 16 Troubleshooting list... 17 Display error messages... 17 System error... 17 Accessory error... 17 Operating error... 18 Other faults in control unit... 19 Faults when working with the applied part... 19 Fuse replacement... 21 Technical Service... 21 Accessories/Spare parts... 21

11.1 11.2 11.3 11.4 11.5 12. 12.1 12.2 12.3 13.

ELAN 4 electro motor cables, applied parts and foot controls Coolant and irrigation pump... Power cord... Equipotential bonding leads... Spare parts... Technical data... Classification according to Directive 93/42/EEC... Performance data, information about standards... Ambient conditions... Disposal...

1.

About this document

21 22 22 22 22 22 22 22 23 23

Note General risk factors associated with surgical procedures are not described in these instructions for use. ► For article-specific instructions for use and material compatibility

information, see B. Braun eIFUs at eifu.bbraun.com

1.1

Scope

This document describes all necessary instructions and steps for the provision, setting and safe operation of the ELAN 4 electro system and its accessory components. Additional instructions and steps regarding the accessory components, in particular on their connection and reprocessing, can be found in the respective instructions for use or supplement for the components.

1.2

Warnings

Warnings indicate hazards to patients, users and/or products that may occur during the use of the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. If not prevented, minor or moderate injuries may result. CAUTION Indicates a potential damage to property. If not prevented, the product may be damaged.

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en 2.

General information

3.

2.1

Intended use

DANGER Risk of death by electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply

The ELAN 4 electro control unit GA800 together with the accessory forms an electrically operated motor system. The ELAN 4 electro control unit GA800 supplies the energy and monitors the motors in the ELAN 4 electro applied parts. The control unit receives the speed request via the hand or foot control. The direction of rotation is preselected by means of the foot control buttons, by means of the display when using a hand control and by means of the pushers for the drill tool. The purpose of the integrated coolant and irrigation pump is to deliver coolant or irrigation fluid to the operating field for cooling the tool and tissue or irrigating the operating field. It is activated via the buttons on the foot control or via the display. Maximum delivery rate of the pump

2.2

65 ml/min

Application Environment

The motor system fulfills the requirements of Type BF in accordance with IEC/DIN EN 60601-1. For use in operating rooms, outside of the explosive hazard zone (e.g. areas with highly pure oxygen or anesthetic gases).

Safe handling

WARNING Risk of injury and material damage due to inappropriate use of the product! ► Use the product only in accordance with the intended use. WARNING Risk of injury and damage to property due to improper handling of the product! The ELAN 4 electro control unit GA800 together 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

Control unit

procedure is performed correctly. Application Environment

In the unsterile area

■ The operating surgeon must have a thorough understanding of both the

Set-up location

Table, ceiling supply unit, equipment cart, or similar

hands-on and conceptual aspects of the established operating techniques. ■ The ELAN 4 electro control unit GA800 fulfills the requirements of CISPR11, Class A. ► Inspect the new product after removing its transport packaging and prior to first use to ensure it is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC) for ELAN 4 electro control unit GA800“ TA022452 , see B. Braun eIFU at eifu.bbraun.com ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Do not pull any of the cables by the actual cable but only by the connector.

2.3

Indications

Modes of application

Separation, removal and modeling of hard tissue, cartilage, related matter and bone substitutes

Surgical discipline/areas of application

Neurosurgery, ENT surgery, OMF surgery, orthopedics and trauma surgery

Note Mode and area of application depend on the applied parts and tools selected.

2.4

Absolute contraindications

The product is not approved for use in the central nervous system or central circulatory system.

2.5

Relative contraindications

The safe and effective use of the product strongly depends on influences only the user can assess. For that reason, the above information only outlines general conditions. The clinically successful use of the product depends on the knowledge and experience of the surgeon. The surgeon has to decide which structures can be properly treated taking into account the safety and warning notices listed in these instructions for use.

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Note The user agrees to report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

en 4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA800

ELAN 4 electro control unit

GD412804

Bottle holder

TA014401

Instructions for use of ELAN 4 electro control unit

TA014482

Supplement for ELAN 4 electro motor system

4.2

Components required for operation

■ ELAN 4 electro control unit GA800 ■ Power cord, see Chapter 11. ■ ELAN 4 electro motor cable for foot control GA806 and ELAN 4 electro foot control GA808 – or – ■ ELAN 4 electro motor cable with hand lever GA804 (from software version 2.00) – or – ■ ELAN 4 electro motor cable with hand control GA805 (from software version 2.00) – or – ■ ELAN 4 electro wireless foot control GA810 (software version 3.00 and higher) ■ ELAN 4 electro applied part Note The installed software version is displayed in the system settings menu in the device information sub-item. Contact the national B. Braun/Aesculap representative to upgrade the control unit to the current software version,see Chapter 10. Note The term “Applied part” comprises all handpieces and motors of the ELAN 4 electro motor system, see Chapter 11. When using the coolant and irrigation pump:

■ Bottle holder GD412804 ■ Single-use tube set GA395SU ■ Coolant or irrigation fluid: Physiological saline solutions up to 1 000 ml Note The coolant/irrigation fluid is not an Aesculap accessory.

4.3

Operating principle

4.3.1 Control unit The ELAN 4 electro control unit 1 is designed for main voltage ranges of 100 V~ to 120 V~ and 220 V~ to 240 V~ from 50 Hz to 60 Hz. The mains voltage is converted into safety extra low voltage for supplying the micro motors in the applied parts. The control unit features two connection sockets for applied parts for connecting two different applied parts, and has one connection socket for a foot control. Only one applied part can be operated at a time.

4.3.2 Display/control concept The display 2 indicates the current device status (operating and error status) at all times. The display is divided into the applied part control panel 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, activation and delivery rate of the coolant and irrigation pump. By activating the relevant panel, the control elements appear. Settings can then be changed. If the control elements are not activated, they will disappear again after a short time. 4.3.3 Explanation with an example Note If two applied parts are connected to the control unit, the display is divided into 2/3 for the active applied part and 1/3 for the inactive applied part.

d

e

f

g

h

c

b

a i Fig. 1

Example of control concept

Legend a Pump control panel Selected delivery rate % (here 30 %) b Applied part control panel c Applied part type (here ELAN 4 electro high speed motor) d Activation mode: (for foot control) 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 maximum speed (gray bar) f Maximum set speed: (here 75 000 rpm) g Maximum speed (uppermost limit) with this group: max. 80 000 rpm h Call up the system settings menu i Rotational direction (here clockwise rotation)

Note The essential performance features are defined by the "speed" and "rotational direction" specifications. The exception is a conditionally defined motor stop to a safe state caused by a detected error condition

7

en 4.3.4 Applied part types The control unit recognizes the different types of applied parts (motors and handpieces). These are shown in the display as a combination of symbol and text. The size and display depend on which socket the applied part is connected to and whether the applied part is active or locked. 4.3.5 Identification of control elements on system components Control elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. 4.3.6 Recognition of connected motor cable and applied part The settings (upper speed limit, pump status and delivery volume) last selected with this application part type on this bushing are retrieved upon inserting the same application part type. When several different hand/foot controls are connected to the control unit, they are prioritized in the following order (higher items have priority over lower): ■ Hand controls GA804/GA805 or drill tool GA844 ■ Foot control GA808 ■ GA810 wireless foot control 4.3.7 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. 4.3.8 Coolant and irrigation pump The control unit is equipped with a coolant and irrigation pump 3. The pump can be activated either in the corresponding pump control panel or via the corresponding button on the foot control. It can be started by activating the motor or via the “Flush” function (continuous flushing). The delivery rate can only be adjusted via the pump control panel.

5.

Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► When setting up and operating the product, adhere to – national regulations for installation and operation, – national regulations on fire and explosion protection. Note For the safety of patients and users it is essential that the mains power cord and, especially, the protective earth connection are intact. In many cases defective or missing protective earth connections are not registered immediately. ► Connect the device via the potential equalization terminal at the rear

panel of the device to the potential equalization system of the room used for medical purposes. Note The potential equalization lead can be ordered from the manufacturer as art. no. GK535 (4 m length) or TA008205 (0.8 m length).

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5.1

Set-up environment/set-up location

DANGER Fire and explosion hazard! ► Use the product outside of explosion hazard zones (e.g. areas with highly pure oxygen or anesthetic gases). The ELAN 4 electro control unit is authorized for operation in the operating room. Note After being installed and put into operation, the control unit must not be transported or moved to a different set-up location. Note The control unit must not be placed on an Aesculap mobile stand (GA415, GA416 and GD416M). ► Make certain that the ventilation slots in the bottom of the housing

and in the rear panel of the control unit are not covered, e.g. by an OR cloth. ► Make certain that the control elements, mains power switch and power socket 13 are freely accessible for the user. ► Make certain the system is set up on a sufficiently stable support (e.g. a table, ceiling support, equipment cart, etc.). ► Follow the instructions for use of the support.

5.2

Stacking of units

► Do not exceed a stack height of 415 mm. ► Place the units in a stable position. ► Aesculap devices must be stacked on top of each other facing identi-

cally. ► Never move stack devices.

en 6.

Working with the ELAN 4 electro system

6.1

System set-up

WARNING Risk of injury and material damage due to inadvertent activation of the applied part! ► Secure applied parts that are not actually used against inadvertent activation ("Off" position), see section on locking applied part ("Off" position). 6.1.1 Connecting the accessories Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices). All configurations must fulfill the basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► Follow the instructions for use of individual accessories. ► In case of questions, contact your B. Braun/Aesculap partner or Aesculap Technical Service, Address see Chapter 10. 6.1.2

6.1.5 Putting out of operation Note 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 8. ► Unplug the power cord from the power socket 13.

The operation of the device is safely terminated. 6.1.6

Connecting the ELAN 4 electro to wireless foot control GA810 The system configuration menu is used to connect the wireless foot control to the control unit, see Chapter 6.4.4 6.1.7

Connecting the ELAN 4 electro foot control GA808 to the control unit

Note The plug connection of the foot control has a yellow coded ring and a filledin dot. ► Position connector of foot control c so that marking b on the connector

is aligned with marking a on the connection socket for foot control 6, see Fig. 2. ► Plug the connector for foot control c firmly into the connection socket for foot control 6.

Connecting the power supply

DANGER Risk of death by electric shock! ► Connect the product only to a grounded power supply.

a b

Note The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. ► Plug in the power cord at power cord socket 13. ► Connect power supply by inserting into a wall socket.

6.1.3 Switching on the control unit ► Activate the power ON switch 10. 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. If a malfunction is detected, an error message will appear in the display 2, see system errors. 6.1.4

Switching off the control unit

► Activate the power OFF switch 8.

The power ON indicator 9, the indicator light 5 and the display with touch control panel 2 will fade out.

c

Fig. 2

Connecting the foot control

Legend a Marking for connection socket b Marking for connector c Connector for foot control 6.1.8

Connecting the ELAN 4 electro motor cable GA804/GA805/GA806 or ELAN 4 electro drill tool GA844 to control unit

Note The motor cable is sterile. Sterile separation occurs at the motor cable. Note The plug connection of the motor cable has a blue coded ring and a hollow dot.

9

en ► Position connector for control unit c on the motor cable so that mark-

a

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.

b

c

a b

d e

c

Fig. 3

Connecting the motor cable

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 control unit will not recognize the applied part, and a message will appear on the display (except for drill tool GA844). ► If the applied part is not recognized;

– Lock the applied part, see Chapter 6.1.12. – Release the applied part again, see Chapter 6.1.11. 6.1.9 Connecting the ELAN 4 electro single-use tube set GA395SU Note The tube set is sterile. Sterile separation occurs at the tube set. ► Open flap a of the coolant and irrigation pump 3, see Fig. 4. ► Insert single-use tube set c:

– 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 nib engages. ► Close flap of the coolant and irrigation pump a. When doing this, make certain the pump tube does not get clamped in. ► Insert the bottle holder 16 for the sterile fluid bottle in bottle holder mount 15. ► Insert the punching spike into the sterile fluid bottle. ► When using sterile fluid bottles made from glass: Open the ventilation flap on the punching spike. ► Hang the sterile fluid bottle from the bottle holder 16. ► Fasten the tube to the motor cable using fixation clamps. ► Shorten the length of the tubes to correspond with the applied part being used and connect to the spray nozzle.

10

Fig. 4

Connecting the single-use tube set

Legend a Flap of the coolant and irrigation pump b Roller wheel c Single-use tube set d Pull slide e Nib of the single-use tube set 6.1.10 Connecting the applied part to the motor cable Note All ELAN 4 electro motor cables (GA804/GA805/GA806) can be used in combination with all applied parts that do not have a fixed connection with a cable. ► Connect connector for motor cable 24 to connector for application

part 19 of the motor cable. Ensure that the nose 23 on the motor cable is aligned with the groove on the coupling of the application part. The applied part engages. When the visual field is “Off” 20 on the motor cable, a gold-colored marking is visible. The control unit 1 recognizes the applied part type and displays this type in the corresponding applied part control panel in the display 2. The most recent settings for this applied part type at the same motor connection socket are shown on the display 2. Note 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 cable.

en 6.1.11 Releasing the applied part for operation ("On" position) Note The operation of the drill tool GA844 is different. Refer to drill tool instruction manual GA844 (TA014436). ► 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. Note For applied parts with slider for tool release 25, in the "On" position 21 the nib 23 on the motor cable blocks the slider. Uncoupling of the tools is therefore only possible in "Off" position 20. For applied parts with unlocking sleeve 26, in the "On" position 21 the connection for applied part 19 on the motor cable blocks the unlocking sleeve. Uncoupling of the attachments is therefore only possible in "Off" position 20. For applied parts without slider for tool release, it is possible to couple/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.

6.1.12 Locking the applied part ("Off" position) Note The operation of the drill tool GA844 is different. Refer to drill tool instruction manual GA844 (TA014436). ► 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 motor cable, a gold-colored marking is visible. 6.1.13 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. 6.1.14 Disconnecting the ELAN 4 electro foot control GA808 from the control unit ► Unplug connector for foot control c from the connection socket for foot control 6, see Fig. 2. 6.1.15 Disconnecting the ELAN 4 electro motor cable GA804/GA805/GA806 or ELAN 4 electro drill tool GA844 from control unit ► Unplug the motor cable on the connector for control unit c from the connection socket for applied parts 7, see Fig. 3.

6.2

Function checks

► Prior to each use and after every change of applied part, check that all

products to be used are in good working order. ► Check the secure connection of all products to be used. ► Ensure that the parameters are set and the unit is operated according

to the instructions for use and the safety information for the applied parts or tools. ► Check that the cutting edges of the tools are not showing any mechanical damage. ► Check that the correct applied part type for the applied parts connected is showing in the corresponding applied part control panel in the display. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Release the applied part for operation. ► Activate the foot or hand control down to the limit stop. The applied part starts running in the preselected rotational direction and reaches the maximum speed as indicated in the applied part control panel in the display. The applied part runs quietly at a constant speed. 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 and irrigation pump in the corresponding applied part control panel or by pressing the function button on the foot control. The coolant and irrigation pump starts as soon as the applied part is operated.

6.3

Safe operation

WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury and material damage due to inadvertent activation when repositioning/moving the foot control! ► To reposition the foot control: Use a transport brace. ► Prior to repositioning: Secure the applied part against inadvertent activation ("Off" position). It is only possible to operate the applied part and change the setting parameters on the control unit if: ■ the applied part is connected to the control unit by a motor cable, ■ a foot control is connected to the connection socket for foot control 6 (when using the ELAN 4 electro motor cable GA806), ■ there is no second applied part released at the same time and ■ the applied part type is shown on the display of the control unit. The following motor settings of the applied part cannot be changed when the applied part is running: ■ Rotational direction (except for GA844, via pusher for rotational direction) ■ Maximum speed

11

en 6.3.1 Activating the motor/pump control panel Note Motor settings of applied parts that are not connected to a cable cannot be changed while the applied part is running. ► Changing the setting parameters of the applied part: Activate the

applied part control panel b in the display 2, see Fig. 5. ► Changing the setting parameters of the coolant and irrigation pump: Activate the pump control panel a in the display 2. The activated control panel switches to the Settings mode. Now the setting parameters listed below can be changed.

b

Legend a Rotational direction button for counterclockwise rotation b Rotational direction button for clockwise rotation c Button for reducing the maximum speed setting d Button for increasing the maximum speed setting 6.3.3

Activating the coolant and irrigation pump/“Flush” function (continuous flushing) ► Activate the pump control panel, see Chapter 6.3.1. ► Activate the coolant and irrigation pump: Activate the button for switching on the irrigation pump a, see Fig. 7. The coolant and irrigation pump is active and delivers coolant or irrigation fluid at the currently set delivery rate. ► Activate the "Flush" function: Activate and hold down the "Flush" button b. The "Flush" function is now active. The coolant and irrigation pump delivers coolant or irrigation fluid at the maximum delivery rate until the "Flush" button b is released. Note The activation of the "Flush" function does not depend on whether an applied part is connected or activated.

a

Fig. 5

Activating the control panel

Legend a Pump control panel b Applied part control panel 6.3.2

Changing the maximum speed setting/rotational direction of the applied part ► Activate the applied part control panel, see Chapter 6.3.1. ► Change direction of rotation (except for drill tool GA844): Actuate the inactive, grey clockwise/counterclockwise rotation button a/b, see Fig. 6. The rotational direction is changed from clockwise rotation to counterclockwise rotation and vice versa. ► Change speed range limit: Press the buttons to reduce/increase the speed range limit c/d or the speed range limit switch 31 on the wireless foot switch. The maximum speed setting is reduced/increased by increments. Note The increments for changing the maximum speed setting depend on the applied part connected.

a Fig. 6

12

b c d Changing the maximum speed setting/rotational direction

a Fig. 7

b c d Activating the coolant and irrigation pump/“Flush” function

Legend a Button for switching the coolant and irrigation pump on/off b "Flush" button c Button for reducing the delivery rate d Button for increasing the delivery rate 6.3.4

Deactivating the coolant and irrigation pump and changing the delivery rate

Note The delivery rate of the coolant and irrigation pump can only be changed when the irrigation pump is activated. ► Activate the pump control panel, see Chapter 6.3.1. ► Deactivate the coolant and irrigation pump: Activate the button for

switching off the irrigation pump a, see Fig. 7. The coolant and irrigation pump is inactive and no longer delivers coolant. ► Change the delivery rate: Activate the buttons for reducing/increasing the delivery rate c/d. The delivery rate of the coolant and irrigation pump is reduced/increased by increments. The delivery rate can be adjusted in the following increments: ■ 1 % to 5 %: 1 % increments ■ 5 % to 100 %: 5 % increments

en 6.3.5

Enable application part using foot control GA808 or wireless foot control GA810

Note Applied parts connected to a hand control cable cannot be operated via the foot control. Note When an applied part is plugged in, clockwise rotation is always pre-set. To activate clockwise rotation: ► Set the rotational direction button for motor 30 to clockwise rotation. The motor direction indicator for clockwise rotation is illuminated in the applied part control panel. ► Activate the pedal 29. The applied part runs clockwise. To activate counterclockwise: ► Set the rotational direction button for motor 30 to counterclockwise rotation. The motor direction indicator for counterclockwise 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. Set rotary speed range limit (for wireless foot control GA810): ► Actuate the switch for speed range limit 31.

6.4

► Call up the system settings menu: Activate the button for the system

settings menu h, see Chapter Fig. 1. The system settings menu opens, see Fig. 8.

a b c d e f Fig. 8

6.3.6 Activating the applied part via hand control GA804/GA805 Note When an applied part is plugged in, clockwise rotation is always pre-set. To activate clockwise rotation: ► Set the motor direction to clockwise rotation on the control unit.

The motor direction indicator for clockwise rotation is illuminated in the applied part control panel. ► Activate the control element of the hand control. The applied part rotates clockwise. To activate counterclockwise rotation: ► Set the motor direction to counterclockwise rotation on the control unit. The motor direction indicator for counterclockwise rotation is illuminated in the applied part control panel. ► Activate the control element of the hand control. The applied part rotates counterclockwise. The control unit emits an acoustic signal. 6.3.7

Activating the coolant pump via foot control

System settings menu

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

System settings menu

Legend a “Exit system settings” button b “user profiles” button c “motor settings” button d “device settings” button e “radio footcontrol” button f “device information” button Menu

Description

user profiles

Manage user profiles

motor settings

Display and change the settings for the individual applied part types

device settings

Display and change the basic settings for the control unit

radio footcontrol

Connect/disconnect the GA810 wireless foot control

device information

Display information about the control unit

► Switch the coolant and irrigation pump on/off: Briefly activate func-

tion button 28. ► Activate the “Flush” function (continuous flushing): Activate the function button 28 for a longer period and keep pressed down.

► Call up menu: Activate the menu button. ► Exit system configuration menu: Press “Exit configuration menu” a

button.

13

en 6.4.1 User profiles User profiles can be created and edited in the user profiles menu.

6.4.2 Motor settings The motor settings menu displays the applied part types, see Fig. 10.

Note When the control unit is restarted, the default profile is loaded automatically.

a

d

e

f

a

b

b

c Fig. 10 Motor settings – Overview of applied part types Legend a Exit menu b Buttons for the types of applied parts Fig. 9

► Exit menu: Press “Exit menu” a button.

User profiles

Legend a Exit menu b User profile button c Import/export user profiles from/to USB stick d Delete user profile e Modify user profile f Create user profile ► Exit menu: Press “Exit menu” a button.

► View/change the motor settings of a type of applied part: Press the type

of applied part b button. The submenu for the applied part type selected opens, see Fig. 11.

g f e

► Select user profile: Press the user profile b button.

The active user profile is highlighted in black. ► Create user profile: – Press button “Create user profile” f. – Enter the name of the user profile. The settings below can be made for every user profile: – Motor settings – Device settings – Oscillation settings (only for drill tool GA844) ► Modify user profile: Press button “Modify user profile” e. ► Delete user profile: Press button “Delete user profile” d. ► Import/export user profiles from/to USB stick: – Inset USB stick into USB port of the control unit. – Press button “import/export of profiles” c. – Press button “import” or “export”. – Follow the instructions on the display. Note Profiles must be saved after creation or modification. ► Save Profile: Press button

14

.

d c b a Fig. 11 Motor settings – Selected applied part type Legend a Factory reset b Flow rate of the coolant and irrigation pump c Slow down rate of the applied part d Speed up rate of the applied part e Maximum speed (maximum speed/stroke rate) f Leave menu g Reduce value h Increase value

h

en ► Leave menu: Press button “Leave menu” f. ► Change motor settings: Press button “Reduce value” h or “Increase

value” g. The change is implemented immediately. The set value is displayed. ► Reset motor settings to default settings – Press button “Factory reset” a. – Confirm message.

6.4.4 Wireless foot control The wireless foot control GA810 can be connected to the control unit or disconnected from the control unit via the menu “radio footcontrol”.

a

Drill tool GA844 The settings below are additionally available for the drill tool GA844: Setting

Description

Oscillation mode

Determines whether the oscillation function on the drill can be activated.

Oscillation angle

Total oscillation angle

Thread cutting operation angle left

Thread cutting operation angle counterclockwise

Thread cutting operation angle right

Thread cutting operation angle clockwise

6.4.3

Device settings f

g

Fig. 13 Wireless foot control settings Legend a Connect wireless foot control (or disconnect if a wireless foot control is connected) ► Connect the GA810 wireless foot control:

a b c d

– Select Connect to GA810 button and – follow the instructions on the display. Compare the serial number in the control unit display to the – serial number of the wireless foot control and select "Yes" to confirm the message. ► Disconnect the GA810 wireless foot control – by pressing the “Disconnecting from GA810” button – or – – switch off the control unit for approx. 10 min.

e

Fig. 12 Device settings

6.4.5 Device information The “device information” menu displays general information about the device and the device software. ► Leave the menu: Activate the “Leave menu” e button.

Legend a Exit menu b Set system volume c Setting display brightness d Reset system volume and brightness to default settings e Set system language f Reduce value g Increase value ► Exit menu: Press Exit menu a button. ► Change system volume/brightness: Press button “Increase value” g or

“Reduce value” f. The change is implemented immediately. The set value is displayed. ► Set system language: – Press button “language” e. – Select desired language. ► Reset system volume and brightness to default settings – Press button “factory reset” a. – Confirm message.

15

en 7.

Reprocessing procedure

7.4

Cleaning/disinfection

7.1

General safety notes

7.4.1

Product-specific safety instructions for the reprocessing procedure

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this.

7.2

Reusable products

DANGER Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product. CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Clean the product with wipe disinfection only. ► Do not sterilize the product under any circumstances.

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

7.3

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

Preparation before cleaning

► Separate the products from each other immediately after use.

product in any fluids.

► Shut down control unit 1 immediately after use, see Chapter 6.1.5. ► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth.

7.5

Wipe disinfection for electrical equipment

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT

1

-

-

17 % Propan-1-ol, 0.23 % Didecyldimethylammonium chloride*

II

Wipe disinfection

RT

≥1

-

-

17 % Propan-1-ol, 0.23 % Didecyldimethylammonium chloride*

RT: *

Room temperature Recommended: Meliseptol® wipes sensitive (B. Braun)

Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe contact time requirements (at least 1 min).

7.6

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.

16

8.

Maintenance

To ensure reliable operation, the product must be maintained at least once a year. Contact your national B. Braun/Aesculap representative if you need these services, see Chapter 10.

en 9.

Troubleshooting list

► Have defective products repaired by Aesculap Technical Service, see

Chapter 10.

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 control unit or system. ■ Accessory error (text in yellow field): It is possible to work with a different component. ■ Operating error (text in blue field): It is possible to work with the system after rectifying the cause of the error. 9.1.1

Note Many faults cannot be clearly categorized. They can be caused by an operating 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 Switch the control unit off and on. If the error re-occurs, replace the control unit.

The internal monitoring of the control unit recognizes an error or fault.

Switch the control unit off and on again. If the message appears again: Replace the control unit.

Message displayed

Cause

Remedy

Motor or motor cable could be damaged

Motor cable or applied part defective

Replace motor cable or applied part.

9.1.2

Accessory error

Malfunction of foot control Foot control defective If this message is displayed frequently, please perform a technical inspection on the foot control

Replace foot control.

Critical Foot Control Error Unexpected error occurred in the area of the foot control. If this message does not disappear automatically, please restart the device.

Foot control defective

Replace foot control.

Critical error in manual control module Unexpected error occurred in the area of the hand control. If this occurs repeatedly, please replace the hand control.

Unexpected error in the area of the hand con- Restart device trol Hand control defective

Replace hand control.

Prohibited combination of accessories A prohibited combination of application part A prohibited combination of motor and cable cod- and motor cable is connected to the control ing was found on socket 1/socket 2. unit.

Check inserted products and replace with a permissible combination of application part and motor cable as applicable.

Motor not recognized It was impossible to recognize the motor type. Please replace the motor. If this does not work, replace the motor cable as well.

Wrong applied part Applied part defective

Change applied part.

Motor cable defective

Replace motor cable.

Unknown motor type Please verify that the software version of the device is suitable for this motor type.

Software version of the control unit is incom- Verify software version of the control unit. patible with the application part used. Have control unit software updated by Technical Service.

Motor overheated Motor of the applied part has overheated The motor currently being used is overheating. Please let the motor cool down or use another suitable motor.

Allow the applied part to cool down. If the applied part overheats excessively: Replace the applied part.

Motor blocked Stop motor actuation and release blockage If the error re-occurs, replace the product.

Stop applied part actuation and release blockage. If the error occurs when the applied part is running idle: Replace the applied part.

Applied part blocked

17

en 9.1.3

Operating error

Message displayed

Cause

Remedy

Motor turned off in operation. The motor was turned to the off-position n The motor was turned to the off-position n opera- operation. tion. Stop the engine before turning off the engine

Stop the engine before turning off the engine

Motor not recognized Switch the motor to "Off" position and then back to "On" position

Applied part connected to control unit in "On" position

Lock the applied part ("Off" position). The control unit recognizes the applied part type. In order to work: Release the applied part ("On" position).

Two motors simultaneously in on position Foot control is activated while two applied Please move one of the motors to the Off position. parts are released on the motor cable ("On" position) Note: Only one applied part can be operated at a time.

Only release the applied part intended to be operated ("On" position). Lock the applied part which isn't to be operated ("Off" position).

Activation in off-position Foot control is activated while the applied part Activation of the motor in Off position is locked on the motor cable ("Off" position) Switch the motor into the On position before activation.

Release the applied part ("On" position).

Activation of foot control without motor Connect a motor to the control unit.

Connect the motor cable to the control unit. Connect the applied part to the motor cable.

Foot control is activated while the applied part is not connected to the control unit

Activation of foot control during initialization Pedal or button on the foot control is activated The pedal or a foot control button was activated during automatic self-test. during initialization. Please release pedal and buttons. If this message still does not disappear, please subject the foot control to a technical check.

Release the activation. If the pedal or button is not activated, the foot control is defective. If necessary, replace foot control.

Multiple control elements of the foot control acti- Multiple control elements were activated vated simultaneously. Multiple control elements were activated simultaneously. Please release all control elements. If this message does not disappear, please have the foot control inspected.

Release all foot control operating elements. If this message continues to appear: foot control must undergo a technical inspection.

Extended button activation on foot control A foot control button was activated for longer than 20 seconds without interruption. Please release all buttons. If this message does not disappear, please have the foot control inspected.

A foot control operating element was activated for longer than 20 seconds without interruption.

Release all foot control operating elements. If this message continues to appear: foot control must undergo a technical inspection.

Activation of manual control without motor Connect a motor to the control unit.

Manual control was activated without an application part being connected to the control unit.

Connect application part to control unit.

Manual control activated upon connecting Please move the manual control lever/slider to an unactivated position one time.

Manual control lever/slider was activated dur- Move manual control level/slider to an unactivated ing connection. position one time.

Touchscreen timeout The touchscreen was activated for longer than 20 seconds without interruption. Please release the touchscreen. If this message continues to display, the device may be damaged.

The touchscreen was activated for longer than 20 seconds without interruption.

18

Release touchscreen. If this message continues to display, the control unit may be damaged. Replace the control unit.