ELAN 4 electro low-speed motor with intra coupling GA824

1

2

3

4

5 3

A

B

en

Aesculap® ELAN 4 electro low-speed motor with intra coupling GA824 Legend

Contents

1 2 3 4

1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.1.1 6.1.2 6.1.3 6.2 6.3 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.6.1

5

Handpiece coupling intra Handpiece unlock button Connector for motor cable Symbol of the applied part type in display of ELAN 4 electro control unit Oil spray adapter GB600860

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

YYYY-MM

Maintenance indicator Date of the next recommended servicing (year-month) by the international B. Braun/Aesculap agency, see Technical Service Machine-readable, two-dimensional code The code contains a unique serial number that can be used for electronically tracking individual instruments. The serial number is based on the worldwide sGTIN (GS1) standard. Manufacturer

Date of manufacture

Non-sterile medical device

Manufacturer batch ID Manufacturer’s serial number Manufacturer’s article number Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage According to US federal law, this product may only be sold by a physician or on the orders of a physician CE mark according to Regulation (EU) 2017/745 EAC symbol of the Eurasian Economic Union Medical device

2

7.7 7.8 7.8.1 7.8.2 7.9 7.10 7.11 7.12 8. 9. 10. 11.

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... Connecting the accessories... Couple the handpiece to the applied part... Uncouple the handpiece from the applied part... Function checks... Safe operation... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Product-specific safety instructions for the reprocessing procedure... Manual cleaning with immersion disinfection... Mechanical cleaning/disinfection with manual pre-cleaning. Manual pre-cleaning with a brush... Mechanical alkaline cleaning and thermal disinfection... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance and repair... Troubleshooting... Technical Service... Accessories/Spare parts...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 6 6 7 8 8 9 9 9 9 9 10 10 10 10

en 12. 12.1 12.2 12.3 12.4 12.5 13.

Technical data... Classification in accordance with Regulation (EC) 2017/745 . Performance data, information about standards... Tool speed/Setting... Short interval operation... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

10 10 10 11 11 11 11

These operating instructions apply to the products listed below: Art. no.

Designation

GA824

ELAN 4 electro low-speed motor intra

► For article-specific instructions for use and material compatibility

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

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.

Short-time interval operation Drilling/milling at 20 000 rpm: ■ 30 s application, 30 s pause ■ 15 repeats ■ 30 min cooling time ■ Max. temperature 48 °C Drilling/milling at 40 000 rpm: ■ 30 s application, 30 s pause ■ 8 repeats ■ 30 min cooling time ■ Max. temperature 48 °C Sawing at 18 000 rpm: ■ 30 s application, 60 s pause ■ 10 repeats ■ 30 min cooling time ■ Max. temperature 48°C Trepanning at 20 000 rpm: ■ 60 s application, 180 s pause ■ 3 repeats ■ 30 min cooling time ■ Max. temperature 48°C Electrical systems generally heat up during continual operation. It is advised to give the system a break after use to cool down, as indicated here. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.

2.3

Application in the sterile area

2.4

2.

General information

2.1

Intended use

The ELAN 4 electro low-speed motor with Intra coupling GA824 is an accessory of the ELAN 4 electro motor system. The low-speed motor is connected by an ELAN 4 electro motor cable to the control unit. The low-speed motor is used to drive handpieces having an Intra coupling (in accordance with EN ISO 13940 or ISO 3964).

2.2

Main functions and design characteristics

Speed ■ min. 0 min-1 to max. 20 000 min-1 (with control unit GA800 up to software version 2.00) ■ min. 0 min-1 to max. 40 000 min-1 (with control unit GA800 software version 3.00 and higher) Direction of rotation Right and left rotation

Application Environment Indications

Modes of application Separating, resecting and shaping hard tissue, cartilage, similar and bone substitute materials Surgical discipline/areas of application Neurosurgery, ENT surgery, OMF surgery, orthopedics and trauma surgery Note The type and area of application depend on the handpiece and tool selected. Note The operator is responsible for the compatibility and proper and safe use of the handpieces and tools used together with this application part.

2.5

Absolute contraindications

The product is not licensed for use on the central nervous system or central circulatory system.

2.6

Relative contraindications

The safe and effective use of the products greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. The clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide on which bodily structures to use the product and take into account the safety and warning information contained in these instructions for use.

3

en 3.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only as intended. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the ELAN 4 electro control unit GA800. ► Follow the instructions for use of the ELAN 4 electro control unit GA800 (TA014401). ► Follow the instructions for use of all products used.

■ General risk factors associated with surgical procedures are not described in this documentation.

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.

■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage due to improper setup or operation and not to compromise the manufacturer warranty and liability: – Use product only in accordance with these instructions for use. – Observe safety information and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Ensure that the electrical installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas. ► Sterilize application parts and motor cable before use. ► Observe the relevant instructions for use TA009721 when handling the Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com ► Do not use a low-speed motor in combination with motor cables with hand control for thread cutting. 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.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA824

ELAN 4 electro low-speed motor Intra

TA014421

Instructions for use for ELAN 4 electro low-speed motor with intra coupling GA824 (leaflet)

4.2

Components required for operation

4.3

Operating principle

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ Handpiece with intra coupling Handpieces equipped with an Intra coupling can be driven by the ELAN 4 electro low-speed motor. Handpieces with compatible coupling are coupled/uncoupled without keys. The low-speed motor is used with the ELAN 4 electro foot controls or manual controls. The foot control/manual control can be used to continuously adapt the rotating speed.

5.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

6.

Working with the product

WARNING Risk of infection and contamination! Application parts and motor cables are delivered non-sterile! ► Sterilize application parts and motor cables prior to use in accordance with the instructions for use. WARNING Risk of injury and material damage due to inadvertent activation of the application part! ► Secure applied parts that are not actually used against inadvertent activation ("Off" position), see instructions for use for ELAN 4 electro control unit GA800 (TA014401). WARNING Incorrect use of the handpiece can result in injury and property damage! ► Observe the safety and other information of the instructions for use of the handpiece. ► Observe the maximum drive speed of the handpiece.

4

en WARNING Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care.

6.2

Function checks

► Prior to each use, check that all products to be used are in good work-

ing order. ► Check the secure connection of all products to be used. ► Check safe coupling of handpiece: Pull on the handpiece. ► Check that the handpieces are not mechanically damaged. ► Run the handpiece briefly at maximum permitted speed.

WARNING Risk of burns to skin and tissue due to blunt tools/ lack of maintenance of the applied part! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Ensure correct maintenance of the applied part, see Maintenance. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check

6.1

System set-up

► Do not use the product if it is damaged or defective. Set aside the prod-

uct if it is damaged.

6.3

Safe operation

WARNING Coagulation of patient tissue or risk of burns for patients and users from hot applied part/tool! ► Cool the tool during use. ► Put down the applied part/tool beyond reach of the patient. ► Let the application part/tool cool down. ► Use a cloth to protect against burns when changing the tool.

WARNING Inadvertently actuating the applied part when coupling/uncoupling the handpiece in the ON position can cause injuries! ► Only couple/uncouple the handpiece in the OFF position.

WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles peeling off the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, extraction system.

WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple handpiece above the surgical field.

WARNING Risk of injury and/or malfunction! ► Perform functional tests before every use.

Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. 6.1.1 Connecting the accessories Do not use accessories in combinations that are not mentioned in these instructions for use. The combination of accessories used must not adversely affect performance and safety requirements. ► Observe the instructions for use of individual accessories. ► In case of questions please contact your B. Braun/Aesculap Partner or the Aesculap Technical Service, Address see Technical Service. 6.1.2

Couple the handpiece to the applied part

► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401).

WARNING The accidental release of the handpiece can result in injuries! ► Do not press the handpiece unlock button in operation. ► After every change of handpiece, check that the handpiece is fitted securely. It is only possible to operate the applied part and change the setting parameters on the control unit if: ■ the applied part is connected to the control unit, ■ there is no second applied part released ("On" position) at the same time and ■ the applied part type 4 is shown on the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

► Place the handpiece with the connection side on the handpiece cou-

pling intra 1. The handpiece engages audibly. ► Pull on the handpiece to check for secure coupling. 6.1.3

Uncouple the handpiece from the applied part

► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). ► Press the button to unlock the handpiece 2 slightly downwards and

hold. ► Remove the handpiece.

5

en 7.

Validated reprocessing procedure

7.1

General safety notes

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 Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine. Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and result damage to metallic products. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Material damage such as corrosion, cracks, fracturing, premature aging, or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion ► For detailed information on hygienically safe and materialfriendly/careful processing, please refer to www.a-k-i.org Header "AKIBrochures", "Red brochure".

6

7.3

Reusable products

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

7.4

Preparations at the place of use

► Separate the products from each other immediately after use. ► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection: Install ECCOS holder

GB077R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB077R,

see Fig. A.

7.6

Cleaning/disinfection

7.6.1

Product-specific safety instructions for the reprocessing procedure

CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Do not use cleaning agents that contain acetone. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C during chemical cleaning and/or disinfection. ► Do not exceed maximum temperature of 96°C during thermal disinfection using DI water. ► Dry the product for at least 10 minutes at a maximum of 120 °C. Note The indicated drying time is a guide time only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted.

en 7.7

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Pre-cleaning

RT (cold)

-

-

D–W

–

II

Cleaning

RT (cold)

>5

1

D–W

pH-neutral, pH ~ 9*

III

Intermediate rinse

RT (cold)

-

-

D–W

-

IV

Disinfection

RT (cold)

>5

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUATfree, pH ~ 9**

V

Final rinse

RT (cold)

-

-

D–W

-

VI

Drying

RT

-

-

-

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh

► Follow the instructions for use of the ELAN 4 rinsing devices and rins-

ing adapters TA014447 and TA014448. ► Do not clean the applied part in an ultrasound bath. Phase I ► Clean the product under running water, using a suitable cleaning brush

Phase VI ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase II ► Using a disposable syringe, fill the inside of the applied part with clean-

ing solution through the rinsing adapter GB698R. ► Place the applied part, with rinsing adapter connected, fully in enzy-

matic cleaning solution for 5 minutes. Phase III ► Rinse the entire product (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during rinsing. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun. Phase IV ► Prior to manual disinfection, allow rinsing water to drain off the prod-

uct for a sufficient length of time and use compressed air to blow all liquid out of the product through the rinsing adapter GB698R in order to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB698R. ► Immerse the application part including the connected rinsing adapter at least 5 min in disinfecting solution. Phase V ► Rinse the entire product (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least

3 times for 5 seconds with a water gun.

7

en 7.8

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. 7.8.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Brushing

RT (cold)

–

–

D–W

-

II

Rinsing

RT (cold)

5

-

D–W

-

D–W: RT:

Drinking water Room temperature

► Follow the instructions for use of the ELAN 4 rinsing devices and rins-

ing adapters TA014447 and TA014448. ► Do not clean the applied part in an ultrasound bath. Phase I ► Clean the product with a suitable cleaning brush until all discernible

residues have been removed. ► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning. Phase II ► Connect the connector for motor cable 3 with ELAN 4 electro rinsing

device GB692R. ► Rinse the applied part:

– For 5 min with a tap/hose or – 3 times for 5 seconds with a water gun

8

en 7.8.2 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

■ Concentrate, alkaline: – pH ~ 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

max. 120/248

min. 10

-

–

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

► Connect the connector for motor cable 3 with ELAN 4 electro rinsing

7.11 Steam sterilization

device GB692R. ► Place the rinsing device on a wire basket suitable for cleaning. ► Connect the rinsing device to the rinsing connection of the rinsing cart. ► After machine cleaning/disinfection: – Use a compressed air gun to remove any remaining rinsing water from the application part, see the instructions for use ELAN 4 for rinsing system and rinsing adapter TA014447 or TA014448. – Visually check for residue on visible surfaces and repeat the cleaning/disinfection process if necessary.

► Make sure that all external and internal surfaces of the product are

7.9

Inspection, maintenance and checks

exposed to the sterilizing agent. ► Validated sterilization process

– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

► Allow the product to cool down to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 (gray) 5 to the

connector for the motor cable 3 and use the STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. B.

7.12 Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area.

Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray. ► Inspect the product after every cleaning and disinfecting cycle for:

cleanliness, damage, function, abnormal operation noise, excessive heat or strong vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged.

7.10 Packaging ► Observe the instructions for use of the packagings and holders used

(e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Place the product in the correct position in the ECCOS holder GB077R,

see Fig. A. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap

sterile containers). ► Ensure that the packaging will prevent a recontamination of the prod-

uct.

9

en 8.

Maintenance and repair

To ensure reliable operation, the product must be maintained in accordance with the maintenance labeling or at least once a year.

e.g. 2016-07 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

9.

Troubleshooting

Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

10. Technical Service DANGER Danger to life of patients and users in case of malfunctions and/or failure of protective measures! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap representative. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

11. Accessories/Spare parts Art. no.

Designation

GB077R

ELAN 4 electro ECCOS holder for low speed motor with Intra coupling GA824

GB600

STERILIT Power Systems oil spray

GB600860

ELAN 4 electro oil spray adapter

GB692R

ELAN 4 electro rinsing device

GB698R

ELAN 4 electro rinsing adapter

GA395SU

ELAN 4 electro disposable tubing set

TA014420

Instructions for use for ELAN 4 electro low-speed motor with intra coupling GA824 (A4 for ringbinder)

TA014421

Instructions for use for ELAN 4 electro low-speed motor with intra coupling GA824 (leaflet)

12. Technical data 12.1 Classification in accordance with Regulation (EC) 2017/745 Art. no.

Designation

Class

GA824

ELAN 4 electro low-speed motor intra GA824

IIa

12.2 Performance data, information about standards Max. power

approx. 180 W

Max. torque

approx. 10 Ncm

Max. motor speed

■ 20 000 min-1 (with control unit GA800 up to software version 2.00)

■ 40 000 min-1 (with control unit GA800 software version 3.00 and higher) Weight

150 g ±10 %

Dimensions (∅ x L)

23 mm x 123 mm ±5 %

Applied part

Type BF

EMC

IEC/EN 60601-1-2

Conforming to standard

IEC/DIN EN 60601-1

After 350 processing cycles, the manufacturer tested the product and it passed.

10

en 13. Disposal

12.3 Tool speed/Setting Adjustable motor direction

clockwise/counterclockwise rotation

Adjustable maximum speed setting

■ 1 000 rpm to 20 000 rpm (with control unit GA800 up to software version 2.00)

■ 1 000 rpm to 40 000 rpm (with control unit GA800 software version 3.00 and higher) Step width for maximum speed setting

1 000 rpm

Default factory setting of upper speed range limit

16 000 rpm, clockwise rotation

Handpiece coupling

Intra coupling (in accordance with EN ISO 13940 or ISO 3964)

12.4 Short interval operation Drilling/milling at 20 000 rpm: ■ 30 s application, 30 s pause ■ 15 repeats ■ 30 min cooling time ■ Max. temperature 48 °C Drilling/milling at 40 000 rpm: ■ 30 s application, 30 s pause ■ 8 repeats ■ 30 min cooling time ■ Max. temperature 48 °C Sawing at 18 000 rpm: ■ 30 s application, 60 s pause ■ 10 repeats ■ 30 min cooling time ■ Max. temperature 48 °C Trepanning at 20 000 rpm: ■ 60 s application, 180 s pause ■ 3 repeats ■ 30 min cooling time ■ Max. temperature 48 °C

WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. The recycling passport can be downloaded from the extranet as a PDF document for on the individual part number. (The recycling passport contains instructions on how to disassemble the device, including information on the proper disposal of environmentally harmful components.) Any product labeled with this symbol must be disposed of separately together with electrical and electronic equipment. Within the European Union, the manufacturer will perform the disposal free of charge. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

12.5 Ambient conditions Application part Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

Relative humidity

30 % to 75 %

10 % to 90 %

Atmospheric pressure

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

11