ELAN 4 shortening sleeve (1-ring or 2-ring) GB861P to GB863P andlateral burr guard (1-ring) GB866R

en

Aesculap® ELAN 4 shortening sleeve (1-ring or 2-ring) GB861P to GB863P and lateral burr guard (1-ring) GB866R Legend 1 2 3 4 5

10. 11. 12.

GB861P ELAN 4 shortening sleeve (1-ring) GB862P ELAN 4 MIS sleeve (1-ring) GB863P ELAN 4 shortening ring (2-ring) GB866R ELAN 4 lateral burr guard (1-ring) GB727R ELAN 4 ECCOS holder

1.

Contents

2

Applicable to compatibility, see also https://extranet.bbraun.com

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

Applicable to... Intended use... Task/function within system... Application Environment... Indications... Contraindications... Safe handling... Non-sterile ELAN 4 shortening sleeves, MIS sleeves and lateral burr guard... 4. Product description... 4.1 Package includes... 4.2 Components required for operation... 4.3 Operating principle... 5. Preparation... 6. Working with the applied part... 6.1 System set-up... 6.2 Function check... 6.3 Operation... 7. Validated reprocessing procedure... 7.1 General safety notes... 7.2 General information... 7.3 Preparations at the place of use... 7.4 Preparation before cleaning... 7.5 Cleaning/disinfection... 7.6 Manual cleaning with immersion disinfection – ELAN 4 shortening sleeves and lateral burr guard... 7.7 Mechanical cleaning/disinfection with manual pre-cleaning – ELAN 4 shortening sleeves and lateral burr guard... 7.8 Inspection, maintenance and checks... 7.9 Packaging... 7.10 Steam sterilization... 7.11 Storage... 8. Troubleshooting... 9. Technical Service...

9 9 9

► For item-specific instructions for use and information on material

Symbols on product and packages

1. 2. 2.1 2.2 2.3 2.4 3. 3.1

Accessories/Spare parts... Technical Data... Disposal...

2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 5 6 7 8 8 8 8 8 9

the

2.

Intended use

2.1

Task/function within system

Aesculap

Extranet

at

The ELAN 4 standard shortening sleeve for handpieces (1-ring), the ELAN 4 MIS standard sleeve for handpieces (1-ring) and the ELAN 4 HD shortening sleeve for handpieces (2-ring) are accessories of the ELAN 4 motor system. The ELAN 4 standard shortening sleeve for handpieces (1-ring), the ELAN 4 MIS standard sleeve for handpieces (1-ring) and the ELAN 4 HD shortening sleeve for handpieces (2-ring) are only for use in combination with the ELAN 4 air/electro handpieces standard (1-ring) or HD (2-ring). The ELAN 4 lateral burr guard 1-ring is an accessory of the ELAN 4 motor system. The ELAN 4 lateral burr guard 1-ring can only be used in combination with the ELAN 4 air/electro handpieces (1-ring). When using the ELAN 4 lateral burr guard 1-ring in combination with the ELAN 4 air/electro handpieces (1-ring), only 1-ring tools with a burr head diameter of max. 4.5 mm must be used. Note Use accessories only in combination with the specified handpieces!

2.2

Application Environment

Application in the sterile area

2.3

Indications

Modes of application

Separating, removing and shaping hard tissue, cartilage and similar, as well as for drilling holes in bone 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 tools selected.

en 2.4

Contraindications

The ELAN 4 electro motor system is not authorized for use in the central nervous system or central circulatory system. Note The safe and effective use of electrically driven applied parts depends heavily on influences that only the user can control him or herself. Therefore the specifications provided represent framework conditions only. Note The clinical success of the use of the ELAN 4 electro motor system is dependent on the knowledge and experience of the surgeon. The surgeon must decide which structures it is sensible to treat and take into account the safety and warning information contained in these instructions for use.

3.

Safe handling

WARNING Risk of injury and material damage due to inappropriate use of the product! ► Use the product only in accordance with the intended purpose. WARNING Risk of injury and damage to property due to improper handling of the product! This product is an accessory of the following products: ■ ELAN 4 electro handpieces Standard (1-ring) GA861 - GA864 ■ ELAN 4 air handpieces Standard (1-ring) GA761 - GA764 ■ ELAN 4 electro handpieces HD (2-ring) GA865 - GA869 ■ ELAN 4 air handpieces HD (2-ring) GA765 - GA769 ► Follow the instructions for use for ELAN 4 handpieces air/electro. ► Follow the instructions for use of all products used.

3.1

Non-sterile ELAN 4 shortening sleeves, MIS sleeves and lateral burr guard

Note Sterilize the products before each use! The products are packaged unsterile and must be reprocessed before each use. Steam sterilization is used, see Steam sterilization. The products may be reused. ► Only have the products operated and used by suitably qualified, trained and experienced personnel. ► Read, follow, and keep the instructions for use. ► Use the products only in accordance with their intended use, see Intended use. ► Prior to each use, visually inspect the products for: loose, bent, broken, cracked, worn, or fractured components. ► Never use damaged or faulty products. Immediately set any damaged products aside.

4.

Product description

4.1

Package includes

Art. no.

Designation

GB861P

ELAN 4 shortening sleeve (1-ring) - or -

GB862P

ELAN 4 MIS sleeve (1-ring) - or -

GB863P

ELAN 4 shortening sleeve (2-ring) - or -

GB866R

ELAN 4 lateral burr guard (1-ring) - or -

TA015081

Instructions for use for ELAN 4 shortening sleeves (1-ring or 2-ring) GB861P to GB863P and lateral burr guard (1-ring) GB866R

■ 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. ► Carry out sterile processing in any reusable applied parts, motor cables and tools prior to use. ► When handling, observe instructions for use that are relevant to Aesculap holder systems TA009721, see Aesculap Extranet at https://extranet.bbraun.com

4.2

Components required for operation

■ Operation-ready ELAN 4 electro control unit GA800, see TA014401 ■ ELAN 4 electro handpieces Standard (1-ring) or HD (2-ring) – or – ■ ELAN 4 air handpieces Standard (1-ring) or HD (2-ring) ■ ELAN 4 tool (1 ring or 2 ring)

4.3

Operating principle

The ELAN 4 shortening sleeves and MIS sleeves are accessories for the ELAN 4 handpieces. They extend the holding area in the direction of the tool and enable a further holding position The ELAN 4 lateral burr guard is an accessory for the ELAN 4 handpieces, for the lateral covering of the rotating tool head. This prevents unwanted contact between tissue and the tool head.

3

en 5.

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ► 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.

Assembling the ELAN 4 lateral burr guard Note When using the ELAN 4 lateral burr guard 1-ring in combination with the ELAN 4 air/electro handpieces (1-ring), only 1-ring tools with a maximum burr head diameter of ø 4.5 mm must be used. ► Select the position of the burr guard 4 on the handpiece shaft. ► Lock the burr guard on the handpiece shaft. ► If necessary, disassemble the burr guard, select a new position and re-

6.

Working with the applied part

WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check.

6.1

assemble. The burr guard should be disassembled without a tool in the shaft. ► Pull on the lateral burr guard to check that it is securely coupled.

System set-up

Note Control elements on the system components of the ELAN 4 air/electro motor system are labeled with a gold marking. Connecting the accessories Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. All configurations must comply with basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards. ► Follow the instructions for use of individual accessories. ► Please contact your B. Braun/Aesculap Partner or Aesculap Technical Service, address see Technical Service with any inquiries in this respect.

Fig. 1

Assembling the lateral burr guard.

Fig. 2

Disassembling the lateral burr guard.

6.2

Function check

ELAN 4 Assembling the MIS sleeve and shortening sleeves WARNING Risk of injury due to small parts in the operation site! ► Do not couple/uncouple MIS sleeve and reduction sleeves over the operation site. Note First connect the holding sleeve and then the tool to the handpiece.

► 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.

► Slide the holding sleeve onto the shaft from the front as far as the

► Briefly run the applied parts at maximum speed.

holding area of the handpiece. Turn slightly until it locks in place. Then the holding sleeve automatically locks with the holding area of the handpiece. ► Pull gently on the holding sleeve to check that it is securely coupled. ► To disassemble, remove the holding sleeve from the handpiece.

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

uct if it is damaged.

6.3

Operation

WARNING Risk of injury and/or malfunction! ► Always carry out a function test prior to each use of the product. WARNING Risk of injury due to application of the product outside the field of view! ► Only use the product under vision. Note For further information, see instructions for use of ELAN 4 electro control unit GA800 (TA014401).

4

en 7. 7.1

Validated reprocessing procedure 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. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com 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: ■ Do not exceed a period of 6 hours between use and reprocessing. ■ Do not use fixating pre-cleaning temperatures >45 °C. ■ Do not use fixating disinfecting agents (active ingredient: aldehyde, alcohol). 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, e.g. 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 further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

7.3

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.

7.4

Preparation before cleaning

ELAN 4 shortening sleeves and lateral burr guard ► Prior to first mechanical cleaning/disinfection process: Mount the bottom part of the ECCOS holder GB727R in a suitable tray. ► Place shortening sleeves with the larger open side facing upward in the tool holder of the ECCOS holder GB727R 5, see foldout page. ► Place the burr guard in a suitable tray.

7.5

Cleaning/disinfection

Product-specific safety guidelines on the reprocessing procedure CAUTION Damage to the product due to inappropriate cleaning and disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents 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 the maximum temperature of 96 °C during thermal disinfection with FD 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

Shortening Manual cleaning with immer- see Manual cleaning sleeves and lat- sion disinfection with immersion diseral burr guard infection – ELAN 4 shortening sleeves and lateral burr guard Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

Shortening Steam sterilization sleeves and lateral burr guard

see Mechanical cleaning/disinfection with manual pre-cleaning – ELAN 4 shortening sleeves and lateral burr guard see Steam sterilization

5

en 7.6

Manual cleaning with immersion disinfection – ELAN 4 shortening sleeves and lateral burr guard

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)

>15

2

D–W

Concentrate-free, aldehyde-free, phenol-free, QUAT-free, 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

Phase I Note Only clean the outside of the shortening sleeves with a suitable cleaning brush. Do not clean the inside of the shortening sleeves with a brush. ► Clean the ELAN 4 shortening sleeves and ELAN 4 lateral burr guard

under running water until all visible residues have been removed from the surfaces. ► If necessary, use a suitable cleaning brush for outer surfaces. Phase II ► Fully immerse the applied part in enzymatic cleaning solution for at

least 5 minutes. Phase III ► Rinse the entire product (all accessible surfaces) under running water.

Phase IV ► Prior to manual disinfection, allow rinsing water to drip off the product. ► Fully immerse the applied part in disinfectant solution for at least

15 minutes. Phase V ► Rinse the entire product (all accessible surfaces) under running water.

Phase VI ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air). ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

6

en 7.7

Mechanical cleaning/disinfection with manual pre-cleaning – ELAN 4 shortening sleeves and lateral burr guard

Note The cleaning and disinfection device 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 device 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

Pre-cleaning

RT (cold)

–

–

D–W

-

D–W: RT:

Drinking water Room temperature

Note Only clean the outside of the shortening sleeves with a suitable cleaning brush. Do not clean the inside of the shortening sleeves with a brush. ► Clean the ELAN 4 shortening sleeves and ELAN 4 lateral burr guard

under running water until all visible residues have been removed from the surfaces. ► If necessary, use a suitable cleaning brush for outer surfaces.

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

-

-

-

In accordance with the program for the cleaning and disinfecting machine

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

► Place ELAN 4 shortening sleeves with the larger open side facing

upward on the ECCOS holder GB727R 5, see fold-out page. ► Connect the ECCOS holder GB727R 5 to the rinsing connection of the rinsing cart.

7

en 7.8

Inspection, maintenance and checks

► Allow the ELAN 4 shortening sleeves and ELAN 4 lateral burr guard to

cool to room temperature. ► Check the ELAN 4 shortening sleeves and ELAN 4 lateral burr protec-

tion after every cleaning and disinfection process to ensure they are: clean, functional, and undamaged. ► Set aside the product if it is damaged.

7.9

Packaging

► Always follow the instructions for use of the respective packaging and

storage devices (e.g. instructions for use TA009721 for the Aesculap ECCOS holding system). ► Place ELAN 4 shortening sleeves with the larger open side facing upward on the ECCOS holder GB727R 5, see figure on front page. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

7.10 Steam sterilization ► Make certain that all external and internal surfaces of the product will

be 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 instruments 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.

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

a dry, dark, temperature-controlled area.

8.

Troubleshooting

Malfunction

Detection

Cause

Remedy

Shortening sleeve cannot be slid onto the shaft or handpiece from the front.

Shortening sleeve cannot be assembled with manual force.

Shortening sleeve defective

Use a new shortening sleeve.

Shortening sleeve cannot be securely coupled with the shaft or handpiece.

No clicking in place in the end position

Shortening sleeve defective

Use a new shortening sleeve.

Shortening sleeve cannot be securely coupled with the shaft or handpiece.

Shortening sleeve cannot be gently slid up and down the shaft.

Shortening sleeve defective

Use a new shortening sleeve.

Lateral burr guard cannot be attached to the shaft of the handpiece.

Lateral burr guard cannot be assembled with manual force.

Lateral burr guard defective/bent

Use a new lateral burr guard.

Lateral burr guard cannot be locked on the shaft.

Lateral burr guard cannot be gently slid up and down the shaft.

Lateral burr guard defective/bent

Use a new lateral burr guard.

8

en 9.

Technical Service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. ► Do not modify the product. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► For service and repairs, please contact your national B. Braun/Aesculap agency. 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.

10. Accessories/Spare parts Art. no.

Designation

TA015080

Instructions for use for ELAN 4 shortening sleeves (1ring or 2-ring) GB861P to GB863P and ELAN 4 lateral burr guard GB866R (Extranet version)

TA015081

Instructions for use for ELAN 4 shortening sleeves (1ring or 2-ring) GB861P to GB863P and ELAN 4 lateral burr guard GB866R (Leaflet)

11. Technical Data Classification acc. to Directive 93/42/EEC Art. no.

Designation

Class

GB861P

ELAN 4 shortening ring (1-ring)

I

GB862P

ELAN 4 MIS sleeve (1-ring)

I

GB863P

ELAN 4 shortening ring (2-ring)

I

GB866R

ELAN 4 lateral burr guard (1-ring)

IIa

12. Disposal ► Adhere to national regulations when disposing of or recycling the prod-

uct, its components and its packaging.

9