ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849and ELAN 4 craniotome attachments GB941R to GB947R

4 5 3 6

2

7

1

GB941R-GB943R

9

9

GB947R

8

2 GB945R

10 2

9

B b

11 12 13 a

A

C

17

15 18

17

14 18

D

E 20

19

16 5

F

en

Aesculap® ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849 and ELAN 4 craniotome attachments GB941R to GB947R Legend

Non-sterile medical device

1 2 3 4 5 6 7

ELAN 4 tool coupling (2-ring) Ring marking ELAN 4 attachment coupling Unlocking sleeve Connector for motor cable Slider for tool release Symbol of the applied part type in display of ELAN 4 electro control unit 8 ELAN 4 craniotome attachments 9 Dot marking 10 ELAN 4 tool (2-ring, 2-dot, craniotome cutter) 11 Dura Guard bridge 12 Front face of the craniotome cutter 13 Dura guard foot a Base b Stop face 14 ELAN 4 single-use spray nozzle for craniotome attachments 15 Tube connector on spray nozzle 16 Oil spray adapter GB600860 ELAN 4 ECCOS holder for 12 reamers GB718R 17 Side handles 18 Holding nibs 19 Tool coupling 20 Tab

Not for reuse in intended applications as defined by the manufacturer Use by

Do not use if packaging is damaged

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

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

Sterilization using irradiation Single sterile barrier system with inner protective packaging

2

EAC symbol of the Eurasian Economic Union Medical device

en Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 2.6 3. 3.1 3.2 4. 4.1 4.2 4.3 5. 6. 6.1 6.2 6.3 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 8. 9. 10. 11. 11.1 12. 12.1 12.2 12.3 12.4 12.5 13.

About this document... Scope... Warnings... General information... Intended use... Performance characteristics... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... Sterile ELAN 4 single-use spray nozzles... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Working with the product... System set-up... 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... Manual cleaning with immersion disinfection - applied part/attachments... Mechanical cleaning/disinfecting with manual pre-cleaning applied part/attachments... Mechanical cleaning/disinfecting with manual pre-cleaning tools... Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance... Troubleshooting... Technical Service... Accessories/Spare parts... attachments... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance data, information about standards... Tool speed/Setting... Short interval operation... Ambient conditions... Disposal...

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

1.

About this document

1.1

Scope

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

Designation

GA849

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

GB941R

ELAN 4 fixed duraguard, pediatric

GB942R

ELAN 4 fixed duraguard, standard

GB943R

ELAN 4 fixed duraguard, long

GB945R

ELAN 4 holding sleeve for craniotome and multifunction handpiece

GB947R

ELAN 4 rotatable duraguard, standard

► 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.

10 11 12 13 13 13 13 14 14 14 14 14 15 15 15 15 15 15 15

2.

General information

2.1

Intended use

The ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849 is an accessory of the ELAN 4 electro motor system. The craniotome and multifunctional handpiece is connected by an ELAN 4 electro motor cable to the control unit. The craniotome and multifunctional handpiece is used for: ■ driving Aesculap ELAN 4 2-ring reamers in combination with an ELAN 4 holding sleeve (e.g. GB945R) and ■ driving ELAN 4 2-ring craniotome cutters in combination with an ELAN 4 dura guard (e.g. GB941R to GB943R, GB947R).

2.2

Performance characteristics

Speed min. 0 rpm to max. 80 000 rpm Direction of rotation Right and left rotation

3

en Short-time intermittent operation Reamers with attachment: ■ 30 second application, 30 second pause ■ ∞ repetitions at 60 000 rpm ■ Max. temperature 48 °C Craniotomy: ■ 30 second application, 30 second pause ■ 6 cycles at 80 000 rpm ■ 30 min cooling time ■ Max. temperature 48 °C Electrical systems generally heat up during continual operation. It is advisable to give the system a break after use to cool down, as indicated below. Heating depends on the tool used and the load. After a certain number of repetitions, the system should be allowed to cool down. This procedure prevents the system from overheating and protects the patient or users against possible injury. The user shall be responsible for the implementation and adherence to the interval sequence described.

2.3

Application Environment

Application in the sterile area

2.4

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 attachments and tools selected.

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.

4

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 caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Ensure that the electrical installations at the premises where the device is to be used meet all requirements acc. to IEC/DIN EN. ► Do not use the control unit and applied part in potentially explosive areas. ► Sterilize application parts, attachments and motor cables before use. ► Observe the relevant instructions for use Aesculap when handling the TA009721 holder systems, see B. Braun eIFU under eifu.bbraun.com ► Only combine tools and attachments with a matching dot marking 9. 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 3.1

Sterile ELAN 4 tools

The product is gamma-sterilized and supplied in sterile packaging. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, observe and store the instructions for use TA012787 for tools. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. Note For further information, see instructions for use for tools TA012787. Single-use products DANGER Reuse can cause infections in patients and/or users, and impairment of product functionality. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product.

3.2

Sterile ELAN 4 single-use spray nozzles

The spray nozzle is used to supply fluid for rinsing and cooling the tool or the place of application. DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not process the product. The product is gamma-sterilized and supplied in sterile packaging. ► Do not reuse the product. ► Ensure that the product and its accessories are operated and used only

by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA849

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

TA014439

Instructions for use for ELAN 4 electro craniotome and multifunctional handpiece (2-ring) (leaflet)

4.2

Components required for operation

4.3

Operating principle

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 craniotome attachment ■ ELAN 4 tool (2-ring) The ELAN 4 electro craniotome and the multifunctional handpiece are equipped with an ELAN 4 tool coupling (2-ring) 1. The craniotome and the multifunctional handpiece are used with ELAN 4 electro foot control or manual control. For the craniotome and multifunction handpiece, the clamped tool rotates at the set motor speed. The motor speed of the craniotome and multifunction handpiece is continuously variable by means of the foot/manual control. The craniotome and multifunctional handpiece can be operated in right or left (clockwise or counterclockwise) rotation mode. The ELAN 4 craniotome attachments can be attached to the craniotome and multifunctional handpiece in 20 positions. For the rotatable duraguard, the guard can be freely rotated in relation to the craniotome and to the multifunctional handpiece. Note The ring marking 2 shows the shaft diameter of the tool to be used. ELAN 4 tools can be only coupled to the applied part if the ring markings (1-ring/2ring) of the applied part and tool match. Note The dot marking 9 on the dura guard indicates the length of the dura guard bracket. The length of the craniotome cutter is matched with the length of the dura guard bridge. The dot markings on the dura guard and craniotome cutter must match.

5.

Preparation

If the rules listed below are not followed, Aesculap will not accept any responsibility. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

5

en 6.

Working with the product

WARNING Risk of infection and contamination! Application parts, attachments and motor cables are delivered nonsterile! ► Sterilize application parts, attachments 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 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. 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 WARNING Risk of injury due to incorrect handling of craniotome cutter! ► During craniotomy, only use the craniotome cutter in combination with dura guard. ► Make certain that the dura guard is not bent.

6.1

System set-up

WARNING Risk of injury when coupling/uncoupling attachments/tools in the "On" position due to accidental activation of the applied part! ► Only couple/uncouple attachments/tools in the "Off" position. WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools and attachments above the surgical field. Note Operating elements on the system components of the ELAN 4 electro motor system are labeled with a gold marking. Connecting the accessories Do not use accessories in combinations that are not mentioned in these instructions for use. ► Follow the instructions for use of individual accessories. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service. Remove the ELAN 4 ECCOS holder for 12 reamers GB718R from the tray The top part of the ELAN 4 ECCOS holder for 12 reamers GB718R can be removed from the tray in conjunction with the tools. ► Pull at the tab 20 and remove the top part of the holder, see Fig. D. Coupling the tool and attachment to the applied part Note When using craniotome cutters, the tool is coupled first, followed by the dura guard. When using other tools, the holding sleeve is coupled first, followed by the tool. ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). To couple a tool: ► Push tool shaft 10 as far as it will go into ELAN 4 tool coupling (2ring) 1. The tool engages. ► Pull at tool 10 to check that it is securely coupled. Coupling the attachment: ► Insert ELAN 4 craniotome attachment 8 as far as it will go into the

ELAN 4 attachment coupling 3. The attachment engages. ► Pull at attachment 8 to check that it is securely coupled.

6

en Uncoupling the tool and attachment from the applied part Note When using craniotome cutters, the dura guard is uncoupled first, followed by the tool. When using other tools, the tool is uncoupled first, followed by the holding sleeve. ► Lock applied part ("Off" position), see instructions for use of

ELAN 4 electro control unit GA800 (TA014401). Uncoupling the attachment:

6.3

Safe operation

WARNING Coagulation of patient tissue or risk of burns for patients and users from hot application part/tool! ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Allow the applied part/tool to cool down. ► When changing the tool, use a cloth as a protection against burns.

► Pull back unlocking sleeve 4 on applied part and remove attachment 8

from ELAN 4 attachment coupling 3. To uncouple a tool: ► Pull back slider for tool release 6 on the applied part and remove tool 10 from ELAN 4 tool coupling (2-ring) 1. Mounting the spray nozzle and tube set ► Connect tube set GA395SU to pump of ELAN 4 electro control unit GA800, see TA014401. ► Push the application-side tube end onto tube connection of the ELAN 4 single-use spray nozzle for craniotome attachments 15. ► Push ELAN 4 single-use spray nozzle for craniotome attachments 14 onto the front area of the dura protector/holding sleeve and turn until it is in the desired position, see Fig. E. Note The spray tube of the ELAN 4 single-use spray nozzle for craniotome attachments is bendable by hand and can be adapted to the requirements of application (e.g. to adjust the direction of spray).

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 that the tool is coupled properly. To do this, pull on the tool.

WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles coming loose from the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, suction extraction. WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING Risk of injury from bent or snapped craniotome reamers! ► Use only undamaged craniotome cutter in perfect condition. WARNING Risk of injury and damage to the tool/system! The rotating tool may catch cover drapes (textile or other). ► Never allow the tool to touch cover drapes (textile or other) during operation.

► Check that the cutting edges of the tools are not showing any mechan-

ical damage. ► Check that the attachment is coupled properly. To test this, pull on the attachment. ► Release applied part for operation ("On" position) and pull unlocking sleeve 4. When doing so, ensure that the attachment does not become uncoupled. ► Briefly run the applied parts at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. When using craniotome cutter and dura guard: ► Make certain that the dura guard bridge 11 is not bent, see Fig. A. ► Make certain that the front face of the craniotome cutter 12 does not

touch the base a of the dura guard foot 13. ► Make certain that the front face of the craniotome cutter12 is positioned between the base a and stop face b of the dura guard foot 13. The front face of the craniotome cutter must not be positioned above the stop face.

WARNING Risk of injury (necroses) and damage to the craniotome cutter due to contact with the dura guard bridge (metal abrasion)! ► Work with mild forward pressure only. ► Replace craniotome cutter after any collision. WARNING Danger of injury from foreign body reactions (e.g. inflammation, encapsulation) if particles remain in the body! When using diamond tools, it is always possible for diamond grains/nickel particles to break away/off. ► Carefully rinse and vacuum while and after working with diamond tools. 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 7 is shown in the display of the control unit. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

7

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.

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".

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

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.

► Separate the products from each other immediately after use.

7.2

7.5

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.

► 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.

Preparation before cleaning

Applied part/attachments ► Prior to first mechanical cleaning/disinfection: ECCOS Install the holders GB085R and GB719R in a suitable tray (e.g. JF222R). ► Insert the application part in the correct position in the ECCOS holder GB085R, see Fig. B. ► Insert the attachments in the correct position in the ECCOS holder GB719R, see Fig. C. Tools ► Thoroughly rinse the product with running, cold water. ► Prior to first mechanical cleaning/disinfection: Mount the bottom part

of the ECCOS holder GB718R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the tool holder 19 of the

ECCOS holder GB718R, see Fig. D. ► Engage the holder in the bottom part. In doing so, make sure that the

holding lugs 18 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 19 using the two side handles 17.

8

en 7.6

Cleaning/disinfection

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. Validated cleaning and disinfection procedure Product

Validated procedure

Reference

Applied part/attachments

Manual cleaning with immersion disinfection

see Manual cleaning with immersion disinfection - applied part/attachments

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfecting

see Mechanical cleaning/disinfecting with manual pre-cleaning applied part/attachments

Manual pre-cleaning with ultra-sound and brush and subsequent alkaline machine cleaning and thermal disinfection

see Mechanical cleaning/disinfecting with manual pre-cleaning tools

Tools

9

en 7.7

Manual cleaning with immersion disinfection - applied part/attachments

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 applied part/attachments under running water, using a suit-

able cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least 3 times for 5 seconds with a water gun. Phase II ► Using a disposable syringe, fill the inside of the applied part with clean-

ing solution through the rinsing adapter GB698R. ► Place the applied part, with rinsing adapter connected, fully in enzymatic cleaning solution for 5 minutes. ► Fully immerse the attachments in disinfectant solution for at least 5 minutes. Phase III ► Rinse the entire applied part/attachments (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 pro-

duct 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. ► Fully immerse the attachments in disinfecting solution for at least 5 min.

10

Phase V ► Rinse the entire applied part/attachments (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as release button, unlocking sleeve, etc. during cleaning. ► Rinse the applied part through the rinsing adapter GB698R at least 3 times for 5 seconds with a water gun. Phase VI ► Dry the applied part/attachments 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.

en 7.8

Mechanical cleaning/disinfecting with manual pre-cleaning - applied part/attachments

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. 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 applied part/attachments with a suitable cleaning brush until

all discernible residues have been removed.

Phase II ► Connect the connector for motor cable 5 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

► Mobilize non-rigid components, such as release button, unlocking

sleeve, etc. during cleaning.

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 5 with ELAN 4 electro rinsing

device GB692R. ► Place the rinsing device on a wire basket suitable for cleaning. ► Connect the rinsing device to the rinsing connection of the rinsing cart. ► Insert the attachments in the correct position in the ECCOS holder GB719R, see Fig. C.

► After machine cleaning/disinfection process:

– Use a compressed air gun to remove any remaining rinsing water from the application parts, 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. 11

en 7.9

Mechanical cleaning/disinfecting with manual pre-cleaning - tools

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. Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Immersion

RT (cold)

>30

50

D–W

Enzymatic detergent*

II

Rinsing

RT (cold)

-

-

D–W

-

III

Ultrasonic cleaning

55/131

>15

2

D–W

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

IV

Cleaning with brush

RT (cold)

-

-

D–W

-

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

► Generally perform ultrasound cleaning solely in the ECCOS holder

GB718R to prevent any damage to the blades. Phase I ► Fully immerse the product in enzymatic cleaning solution for at least

30 minutes. Ensure that all accessible surfaces are moistened. Phase II ► Rinse the entire product (all accessible surfaces) under running water.

Phase III ► Fold up the tool holder 19 of ECCOS the holder GB718R on the side

handles 17, see Fig D. ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Phase IV ► Clean the product with a suitable cleaning brush until all discernible

residues have been removed.

12

en 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

► Place the product in the correct position in the tool holder 19 of the

7.12 Steam sterilization

ECCOS holder GB718R, see Fig. D. ► After machine cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

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

7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Connect the ELAN 4 electro oil spray adapter GB600860 16 (gray) to

the connector for the motor cable 5 and use the STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. F. ► If necessary, use STERILIT Power Systems oil spray GB600 to lubricate the bearing of the rotatable duraguard. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray.

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.

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

a dry, dark, temperature-controlled area.

► 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.

7.11 Packaging ► Observe the instructions for use of the packaging and holders used (e.g.

instructions for use TA009721 for Aesculap ECCOS holder system). ► Place the application part in the correct position in the ECCOS holder

GB085R, see Fig. B. ► Insert the attachments in the correct position on the ELAN 4 ECCOS

holder for three ELAN 4 craniotome attachments GB719R, see Fig. C. ► Insert the tools in the correct position in the ECCOS holder GB718R, see

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

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

duct.

13

en 8.

Maintenance

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

11. Accessories/Spare parts Art. no.

Designation

GA259SU

ELAN 4 single-use spray nozzle for craniotome attachments

GA395SU

ELAN 4 electro single-use tube set

GB085R

ELAN 4 electro ECCOS holder for Craniotome and multifunction handpiece (2-ring) GA849

GB600

STERILIT Power Systems oil spray

GB600860

ELAN 4 electro oil spray adapter

GB692R

ELAN 4 electro rinsing device

GB698R

ELAN 4 electro rinsing adapter

GB718R

ELAN 4 ECCOS holder for 12 reamers

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

GB719R

ELAN 4 ECCOS holder for three ELAN 4 craniotome attachments

TA012787

Instructions for use for tools for Aesculap motor systems - single-use products/reusable products

10. Technical Service

TA014438

Instructions for use for ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849 (A4 for folder)

TA014439

Instructions for use for ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849 (leaflet)

e.g. 2016-07 For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service. Attachments/tools No maintenance necessary for attachments and tools. ► Do not modify or repair attachments. ► Do not modify, re-sharpen or repair tools.

9.

Troubleshooting

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.

14

11.1 attachments Art. no.

Designation

Marking

GB941R

ELAN 4 fixed duraguard, pediatric

●

GB942R

ELAN 4 fixed duraguard, standard

●●

GB943R

ELAN 4 fixed duraguard, long

●●●

GB945R

ELAN 4 holding sleeve for craniotome and multifunctional handpiece

Two rings

GB947R

ELAN 4 rotatable duraguard, standard

●●

en 12. Technical data

12.4 Short interval operation

12.1 Classification in accordance with Regulation (EC) 2017/745

Reamers with attachment: ■ 30 second application, 30 second pause ■ ∞ repetitions at 60 000 rpm ■ Max. temperature 48 °C Craniotomy: ■ 30 second application, 30 second pause ■ 6 cycles at 80 000 rpm ■ 30 min cooling time ■ Max. temperature 48 °C

Art. no.

Designation

Class

GA849

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

IIa

GB941R

ELAN 4 fixed duraguard, pediatric

IIa

GB942R

ELAN 4 fixed duraguard, standard

IIa

GB943R

ELAN 4 fixed duraguard, long

IIa

12.5 Ambient conditions

GB945R

ELAN 4 holding sleeve for craniotome and multifunctional handpiece

IIa

Application part

GB947R

ELAN 4 rotatable duraguard, standard

IIa

12.2 Performance data, information about standards ELAN 4 electro craniotome and multifunctional handpiece (2-ring) GA849 Max. power

approx. 140 W

Max. torque

approx. 2.2 Ncm

Max. motor speed

80 000 rpm

Weight

121g ±10 %

Dimensions (∅ x L)

17 mm x 156 mm ±5 %

Tool connector

ELAN 4 2-ring

Application part

Type BF

EMC

IEC/DIN EN 60601-1-2

Compliance with standards

IEC/DIN EN 60601-1

After 350 processing cycles, the manufacturer tested the product and it passed. Attachments Art. no.

Weight

Dimensions (∅ x L)

GB941R

10.0 g ±10 %

14 mm x 59.5 mm ±5 %

GB942R

10.3 g ±10 %

14 mm x 65.0 mm ±5 %

GB943R

10.5 g ±10 %

14 mm x 70.0 mm ±5 %

GB945R

10.0 g ±10 %

14 mm x 47.5 mm ±5 %

GB947R

17.1 g ±10 %

14 mm x 65.0 mm ±5 %

12.3 Tool speed/Setting

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

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product. Note The operator must process the product before 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. ► In case of questions regarding the disposal of the product, contact your

Adjustable motor direction

Clockwise/counterclockwise rotation

Adjustable maximum speed setting

10 000 rpm to 80 000 rpm

Increment of the upper speed range limit

5 000 rpm

Default factory setting of upper speed range limit

75 000 rpm, clockwise

local B. Braun/Aesculap representative, see Technical Service.

15