ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 and ELAN 4 craniotome attachments GB941R to GB947R

4 3 5 2

6

1

GB941R-GB943R

8

8

GB947R

7

2 GB945R

9 2

8

B b

10 11 12 a

A

14

C 13 5 15

14 15

E

D 17

16 5 18

23

F

22

21

20 19

en

Aesculap® ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 and ELAN 4 craniotome attachments GB941R to GB947R Legend 1 ELAN 4 tool coupling (2-ring) 2 Ring marking 3 ELAN 4 attachment coupling 4 Unlocking sleeve 5 Connection for motor hose 6 Slider for tool release 7 ELAN 4 craniotome attachments 8 Dot marking 9 ELAN 4 tool (2-ring, 2-dot, craniotome cutter) 10 Dura guard bridge 11 Front face of the craniotome cutter 12 Dura guard foot a Base b Stop face 13 Oil spray adapter GB600850 ELAN 4 ECCOS holder for 12 reamers GB718R 14 Side handles 15 Holding lugs 16 Tool coupling 17 Tab 18 Connection for applied part 19 Field of vision “On“ 20 Field of vision “Off“ 21 Release button 22 Nib on motor hose 23 Groove on connection for motor hose

Single sterile barrier system with inner protective packaging Non-sterile medical device

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

2

Medical device

en Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 3. 3.1 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 13.

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Sterile ELAN 4 tools... 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 list... Technical Service... Accessories/Spare parts... Attachments... Technical data... Classification in accordance with Regulation (EC) 2017/745. . Performance Data... 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 7 7 7 7 8 8 8 8 9 10 12 13 13 13 13 14 14 14 14 14 15 15 15 15 15 15

1.

About this document

1.1

Scope

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

Designation

GA749

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

GB941R

Fixed ELAN 4 duraguard, pediatric

GB942R

Fixed ELAN 4 duraguard, standard

GB943R

Fixed ELAN 4 duraguard, long

GB945R

Holding sleeve for ELAN 4 craniotome and multifunction handpiece

GB947R

Rotatable ELAN 4 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.

2.

General information

2.1

Intended use

The ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 are ELAN 4 air accessories of the motor system. The craniotome and multifunctional handpiece is connected by an ELAN 4 air motor hose GA705R to the ELAN 4 air foot control GA708 or to an ELAN 4 air motor hose with hand control GA706R or GA707R. The craniotome and multifunctional handpiece are used for: ■ to drive ELAN 4 2-ring reamers in conjunction with a ELAN 4 holding sleeve (e.g. GB945R) and ■ to drive ELAN 4 2-ring craniotome reamers in conjunction with a ELAN 4 duraguard (e.g. GB941R to GB943R, GB947R).

2.2

Application Environment

Application in the sterile area

3

en 2.3

Indications

Application types Separation, removal and modeling of hard tissue, cartilage, etc. and bone replacement material

► Sterilize application parts and motor hose before use. ► Observe the relevant instructions for use TA009721 when handling the

Aesculap holder systems, see B. Braun eIFU under eifu.bbraun.com ► Use the applied parts and tools within the specified pressure range

only.

Surgical category/applications Neurosurgery, ENT surgery, OMF surgery, orthopedics and trauma surgery

► Only combine tools and attachments with a matching dot marking 8.

Note The type and area of application depend on the attachments and tools selected.

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.

2.4

3.1

Absolute contraindications

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

Sterile ELAN 4 tools

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.

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 for tools TA012787. ► 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.

3.

Note For further information, see instructions for use for tools TA012787.

2.5

Relative contraindications

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. WARNING Risk of injury and damage to property due to improper handling of the product! This product is part of the ELAN 4 air motor system. ► Follow the general safety advice given in the instructions for use of ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapters (TA014450) and/or instructions for use of ELAN 4 air motor hose with hand control (TA014481). ► 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.

4

Single-use products DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Contamination and/or impaired function of the products may result in injury, illness and death! ► Do not reprocess the product.

en 4.

Product description

6.

4.1

Scope of supply

WARNING Risk of infection and contamination! Application parts, attachments and the motor hose are delivered nonsterile! ► Sterilize application parts, attachments and motor cable prior to use in accordance with the instructions for use.

Art. no.

Designation

GA749

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

TA014474

Instructions for use for ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 (leaflet)

4.2

Components required for operation

■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air wall hose GA702R or GA703R, ELAN 4 air foot control GA708 and ELAN 4 air motor hose GA705R – or – ELAN 4 air motor hose with manual control GA706R or GA707R ■ ELAN 4 craniotome attachment ■ ELAN 4 tool (2-ring)

4.3

Operating principle

The ELAN 4 air craniotome and multifunctional handpiece are fitted with an ELAN 4 tool coupling (2-ring) 1. The craniotome and the multifunctional handpiece are used with ELAN 4 air foot control or manual controls. The motor speed can be adjusted continuously using the foot/manual control. The craniotome and multifunctional handpiece are operated in clockwise rotation. 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 (1ring/2-ring) of the applied part and tool match. Note The point marking 8 indicates the length of the duraguard. The length of the craniotome reamers is adapted to the length of the duraguard. The point markings of the duraguard and craniotome reamer have to be aligned.

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.

Working with the product

WARNING Risk of injury and material damage due to inadvertent activation of the applied part! ► Secure application parts that are not actively used against inadvertent activation (off position). 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 Coupling/uncoupling attachments/tools in the "On" position can cause injuries if the application part is accidentally activated! ► Only couple/uncouple tools/attachments 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 air motor system are labeled with a gold marking.

5

en 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. Connecting the applied part to the motor hose ► Connect the connector of the motor hose for the application part 5 to

the connector for the application part 18 of the motor hose, see Fig. F. When doing so, ensure that the tip 22 on the motor hose is aligned with the groove at the connector for the motor hose 23. The application part clicks into place. A gold-colored mark becomes visible in the “Off” window 20 on the motor hose. Note The application part attached to this motor hose is only ready for operation when the release button is in the "On” position 19. 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 17 and remove the top part of the holder, see Fig. D. Coupling the tool and attachment to the applied part Note When using craniotome cutter, 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 the applied part ("Off" position), see Locking the applied part

("Off" position). To couple a tool: ► Push tool shaft 9 as far as it will go into ELAN 4 tool coupling

(2-ring) 1. The tool engages. ► Pull at tool 9 to check that it is securely coupled. Coupling the attachment: ► Insert ELAN 4 craniotome attachment 7 as far as it will go into the

ELAN 4 attachment coupling 3. The attachment engages. ► Pull at attachment 7 to check that it is securely coupled. Releasing the applied part for operation ("On" position) ► Activate the release button 21 on the motor hose and push the connector for the application part 18 onto the application part, see Fig. F. The application part clicks into place. A gold-colored mark becomes visible in the “On” window 19 at the motor hose. Locking the applied part ("Off" position) ► Press the release button21 on the motor hose and pull the motor hose from the application part, see Fig. F. The application part clicks into place. A gold-colored mark becomes visible in the “Off” window 20 on the motor hose.

6

Uncoupling the tool and attachment from the applied part Note When using craniotome cutter, the dura guard is coupled first, followed by the tool. When using other tools, the tool is coupled first, followed by the holding sleeve. ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). Uncoupling the attachment: ► Pull back unlocking sleeve 4 on applied part and remove attachment 7

from ELAN 4 attachment coupling 3. To uncouple a tool: ► Pull back slider for tool release 6 on the applied part and remove tool 9 from ELAN 4 tool coupling (2-ring) 1. Disconnecting the applied part from the motor hose ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► Press the release button 21 on the motor hose and disconnect the

motor hose from the application part by pulling at the connector for the application part 18, see Fig. F.

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. ► 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 10 is not bent, see Fig. A. ► Make certain that the front face of the craniotome cutter 11 does not touch the base a of the dura guard foot 12. ► Make certain that the front face of the craniotome cutter 11 is positioned between the base a and stop face b of the dura guard foot 12. The front face of the craniotome cutter must not be positioned above the stop face.

en 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. 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 cutter! ► 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. 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. CAUTION 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. Operation of the applied part is only possible if:

■ the applied part is released, ■ a foot control or hand control is connected.

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".

7

en 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

Validated cleaning and disinfection procedure Product

Validated procedure

Applied part/attachments

Manual cleaning with immer- see Manual cleaning sion disinfection with immersion disinfection - applied part/attachments

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

Applied part/attachments ► Prior to first mechanical cleaning/disinfection: Install the ECCOS holders GB065R and GB719R in a suitable tray (e.g. JF222R). ► Insert the application part in the correct position in the ECCOS holder GB065R, 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 16 of the

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

holding lugs 15 on the insert are inserted in the recesses in the bottom part. ► Lift and fold down the tool holder 16 using the two side handles 14.

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.

8

Tools

Reference

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 mechanical cleaning and thermal disinfection

see Mechanical cleaning/disinfecting with manual pre-cleaning - tools

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. ► Never place the applied part in liquid without an ELAN 4 air rinsing adapter GB697R connected. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. ► Leave the rinsing adapter GB697R on the applied part for the entire cleaning process. 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 GB697R 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 cleaning solution through the rinsing adapter GB697R. ► Place the applied part, with rinsing adapter connected, fully in enzymatic cleaning solution for 5 minutes. ► Fully immerse the attachments in enzymatic cleaning solution for at least 5 minutes.

Phase IV ► Prior to manual disinfection, let rinsing water drain off the application part sufficiently and use compressed air to blow all liquid out of the application part through the rinsing adapter GB697R to prevent the disinfecting solution from becoming diluted. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB697R. ► Immerse the application part including the connected rinsing adapter for at least 5 min in disinfecting solution. ► Fully immerse the attachments in disinfecting solution for at least 5 min. 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 GB697R 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.

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 GB697R at least

3 times for 5 seconds with a water gun.

9

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. ► Never place the applied part in liquid without an ELAN 4 air rinsing adapter GB697R connected. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Phase I ► Clean the applied part/attachments 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 connection for motor hose 5 with ELAN 4 air rinsing

device GB691R. ► Rinse the applied part:

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

10

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

► Connect the connection for motor hose 5 with ELAN 4 air rinsing

device GB691R. ► 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 and shafts, 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, QUATfree, 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 16 of ECCOS the holder GB718R on the side

handles 14, 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 16 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 air oil spray adapter GB600850 13 (purple) to the

connector for the motor hose 5 and use STERILIT Power Systems oil spray GB600 to spray through the application part for approx. 2 s, see Fig. E. ► 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 packagings and holders used

(e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Insert the application part in the correct position in the ECCOS holder

GB065R, 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

GB065R

ELAN 4 air ECCOS holder for craniotome and multifunction handpiece (2-ring) GA749

GB691R

ELAN 4 air rinsing device

GB600

STERILIT Power Systems oil spray

GB600850

ELAN 4 air oil spray adapter

Attachments/tools No maintenance necessary for attachments and tools. ► Do not modify or repair attachments. ► Do not modify, re-sharpen or repair tools.

GB697R

ELAN 4 air rinsing adapter

GB718R

ELAN 4 ECCOS holder for 12 reamers

GB719R

ELAN 4 ECCOS holder for three ELAN 4 craniotome attachments

9.

TA012787

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

TA014473

Instructions for use for ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 (A4 for folder)

TA014474

Instructions for use for ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 (leaflet)

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

Troubleshooting list

Note For further information, see instructions for use for ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapter (TA014450) or instructions for use for ELAN 4 air motor hose with manual control (TA014481).

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.

14

11.1 Attachments Art. no.

Designation

Marking

GB941R

Fixed ELAN 4 duraguard, pediatric

●

GB942R

Fixed ELAN 4 duraguard, standard

●●

GB943R

Fixed ELAN 4 duraguard, long

●●●

GB945R

ELAN 4 holding sleeve for craniotome and multifunctional handpiece

Two rings

GB947R

Rotatable ELAN 4 duraguard, standard

●●

en 12. Technical data

12.4 Ambient conditions

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

Application part

Art. no.

Designation

Class

GA749

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

GB941R

Operation

Transport and storage

Temperature

10 °C to 27 °C

-10 °C to 50 °C

IIa

Relative humidity

30 % to 75 %

10 % to 90 %

Fixed ELAN 4 duraguard, pediatric

IIa

700 hPa to 1 060 hPa

500 hPa to 1 060 hPa

GB942R

Fixed ELAN 4 duraguard, standard

IIa

Atmospheric pressure

GB943R

Fixed ELAN 4 duraguard, long

IIa

GB945R

ELAN 4 holding sleeve for craniotome and multifunctional handpiece

IIa

Rotatable ELAN 4 duraguard, standard

IIa

GB947R

12.2 Performance Data ELAN 4 air craniotome and multifunctional handpiece (2-ring) GA749 Max. Power

approx. 80 W at 8 bar

Max. Torque

approx. 3.5 Ncm at 8 bar

Max. motor speed

approx. 80 000 rpm at 8 bar

Weight

108 g ±10 %

Dimensions (∅ x l)

18 mm x 128 mm x ±5 %

Tool connector

ELAN 4 2-ring

Direction of rotation

Clockwise rotation

Pressure range

8 bar ±2 bar

13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packaging. Note The operator must process the product before disposal, see Validated reprocessing procedure. ► In case of questions regarding the disposal of the product, contact your

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

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 Short interval operation Reamers with attachment: ■ 30 s application, 30 s pause ■ ∞ repetitions ■ Max. temperature 48 °C Craniotomy: ■ 30 s application, 30 s pause ■ 6 cycles ■ 30 min cooling time ■ Max. temperature 48 °C

15