ELAN 4 air motor hose 3 m with manual control GA706R or ELAN 4 airmotor hose 5 m with manual control GA707R, ELAN 4 air Wall adapterGA710R to GA715R

GA706R (3 m) GA707R (5 m)

1

7

32

6

5

4 9

8

9

GA710R

GA712R 8

12

9

GA713R

8

10 11

A

9 GA715R 8

6

4

en

Aesculap® ELAN 4 air motor hose 3 m with manual control GA706R or ELAN 4 air motor hose 5 m with manual control GA707R, ELAN 4 air Wall adapter GA710R to GA715R Legend 1 Connection for wall adapter 2 Field of vision “On“ 3 Field of vision “Off“ 4 Release button 5 Connection for applied part 6 Nib on motor hose 7 Hand lever 8 Connection for compressed-air source 9 Connection for motor hose (with hand control) 10 Groove on connection for motor hose 11 Connection for motor hose of applied part 12 Slider for tool release

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 Two-dimensional machine readable code The code contains a unique serial number that can be used for electronically tracking individual instruments. The serial number is based on the worldwide sGTIN (GS1) standard. Manufacturer

Date of manufacture

Non-sterile medical device

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

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage 2

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

Medical device

Contents 1. 1.1 1.2 2. 2.1 2.2 2.3 2.4 2.5 3. 4. 4.1 4.2 4.3 5. 5.1 5.2 5.3 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.

About this document... 3 Scope... 3 Warnings... 3 General information... 3 Intended use... 3 Application Environment... 3 Indications... 3 Absolute contraindications... 3 Relative contraindications... 3 Safe handling... 3 Product description... 4 Scope of supply... 4 Components required for operation... 4 Operating principle... 4 Preparation... 5 Compressed air supply/compressed air hoses... 5 Operation with central gas supply according to DIN EN ISO 5359... 5 Operation with compressed-gas cylinders according to DIN EN ISO 11117... 5 Working with the product... 5 System set-up... 5 Function checks... 6 Safe operation... 6 Validated reprocessing procedure... 6 General safety notes... 6 General information... 7 Reusable products... 7 Preparations at the place of use... 7 Preparation before cleaning... 7 Cleaning/disinfection... 7 Manual cleaning and wipe disinfection... 8 Mechanical cleaning/disinfection with manual pre-cleaning . . 8 Wipe disinfection... 9 Inspection, maintenance and checks... 9 Packaging... 9 Steam sterilization... 10 Storage... 10 Maintenance... 10

en 8.1 8.2 9. 10. 11. 12. 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 13.

ELAN 4 air wall adapter... ELAN 4 air motor hose with hand control... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745. . ELAN 4 air motor hose 3 m with hand control GA706R... ELAN 4 air motor hose 5 m with hand control GA707R... ELAN 4 air wall adapter Aesculap-Dräger GA710R... ELAN 4 air wall adapter Schrader with diffuser GA712R... ELAN 4 air wall adapter DIN with diffuser GA713R... ELAN 4 air wall adapter Synthes GA715R... Ambient conditions... Disposal...

1.

About this document

1.1

Scope

10 10 10 12 13 13 13 13 13 13 13 13 13 13 13

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

Designation

GA706R

ELAN 4 air motor hose 3 m with manual control

GA707R

ELAN 4 air motor hose 5 m with manual control

GA710R

ELAN 4 air wall adapter Aesculap-Dräger

GA712R

ELAN 4 air wall adapter Schrader with diffuser

GA713R

ELAN 4 air Wall adapter DIN with diffuser

GA715R

ELAN 4 air wall adapter Synthes

► 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.

2.2

Application Environment

ELAN 4 air motor hose with hand control Use in sterile and non-sterile areas. Sterile separation is carried out at the motor hose ELAN 4 air wall adapter Application in the unsterile area.

2.3

Indications

The type and area of application depend on the applied parts and tools selected.

2.4

Absolute contraindications

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

2.5

Relative contraindications

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

3.

Safe handling

DANGER Danger of fire and explosion when operating devices that run on oxygen! ► Never operate the pneumatic motor with oxygen! ► Only use compressed air or nitrogen to power pneumatic motors. 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 instructions for use of all products used.

WARNING Indicates a potential danger. If not prevented, minor or moderate injuries may result.

■ General risk factors associated with surgical procedures are not

CAUTION Indicates a potential damage to property. If not prevented, the product may be damaged.

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

2.

General information

2.1

Intended use

The ELAN 4 air motor hose with hand control GA706R or GA707R and the ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R are accessories of the ELAN 4 air Motor system. The motor hose with hand control is used to connect the ELAN 4 air applied parts to the compressed air supply. The ELAN 4 air wall adapters connect the ELAN 4 air motor hose with hand control to the compressed air supply unit.

described in this documentation.

■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. hands-on and conceptual aspects of the established operating techniques. ► Wall adapter: Manually clean the new product after removal of the transport packaging. ► Motor hose with manual control: Clean brand-new product after removal of the transport packaging and before the first sterilization (manually or mechanically). ► 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. 3

en ► Ensure that the product and its accessories are operated and used only

4.2

Components required for operation

by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards. ► Use the product within the specified pressure range only. ► Sterilize applied parts and motor hose before use. ► When using the Aesculap holder systems observe the relevant instructions for use TA009721, see B. Braun eIFU at eifu.bbraun.com

■ ELAN 4 air wall adapter GA710R, GA712R, GA713R or GA715R ■ ELAN 4 air motor hose 3 m with hand control

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

4.3

4.

Product description

4.1

Scope of supply

ELAN 4 air motor hose with hand control Art. no.

Designation

GA706R GA707R

ELAN 4 air motor hose 3m with manual control – or – ELAN 4 air motor hose 5 m with hand control

GB600850

ELAN 4 air oil spray adapter

TA014481

Instructions for use of ELAN 4 air motor hose with manual control 3 m GA706R or 5 m GA707R

TA014782

Supplement ELAN 4 air motor system

ELAN 4 air wall adapters Art. no.

Name

GA710R GA712R GA713R GA715R

One of the wall adapters below: ELAN 4 air wall adapter Aesculap-Dräger ELAN 4 air wall adapter Schrader with diffuser ELAN 4 air wall adapter DIN with diffuser ELAN 4 air wall adapter Synthes

– or – ELAN 4 air motor hose 5 m with manual control ■ ELAN 4 air applied part ■ Tool

Operating principle

ELAN 4 air motor hose with hand control The ELAN 4 air motor hose with manual control GA706R or GA707R, using the connection for wall adapter 1, is connected to an ELAN 4 air wall adapter. The motor hose with hand control is connected and disconnected to/from the applied part in two steps. The current position is indicated by a gold marking in one of the two visual fields on the motor hose with hand control. By operating the handle 7 of the motor hose having manual control, the user controls the speed of the motor of the connected ELAN 4 air applied part. The hand lever activates a valve of the ELAN 4 air motor hose with manual control. When the hand lever is in its initial position, the valve is closed and the motor of the applied part does not run. When the hand lever is in its end position, the valve is fully open and the motor of the applied part runs at maximum speed. Note For applied parts with slider for tool release 12, in the "On" position 2 the connection for applied part 5 on the motor hose blocks the slide. Uncoupling of the tools is therefore only possible in "Off" position 3, see Fig. A. In the case of applied parts having an unlocking sleeve, in the ‘on’ position 2 the connection for the applied part 5 on the motor hose locks the unlocking sleeve. As a result, the attachments or shafts can only be uncoupled in the ‘off’ position 3. For applied parts, it is possible to couple/uncouple tools in the "On" position, but this must not be done due to the risk of injury from unintentional activation of the applied part. ELAN 4 air wall adapter The ELAN 4 air wall adapters convey compressed air from the compressed air source to the ELAN 4 air motor hose with hand control. The wall adapters have an instant-cutout coupling. This coupling prevents the escape of compressed air during detachment of the parts. The motor hoses with hand control have an exit-air recycling system. The supply hose is embedded in an additional exit air hose, which takes the exit air away from the operating field. The are two exit air recycling systems: ■ Aesculap-Dräger and Synthes wall adapters with complete exit-air recycling: The exit air is channeled back from the O.R. into the central gas supply system. In this way, air turbulences and adverse effects on the climate and hygiene in the O.R. are avoided. ■ Schrader and DIN wall adapters without complete exit-air recycling: The exit air enters the O.R. through a diffuser on the wall adapter.

4

en 5.

Preparation

5.3

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► When setting up and operating the product, comply with: – National installation and operator regulations – National regulations on compressed air supply – National regulations on fire and explosion protection ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in proper technical condition.

5.1

The following conditions must be met: ■ Compressed air or nitrogen is used ■ An adequate stock of full gas cylinders is in place ■ Cylinder pressure reduced to operating pressure of 6 bar to 10 bar through a pressure reducer (e.g., GA099) ■ Operating pressure has been read from the scale on the device and set with the T-screw Note If the system is operated with compressed gas cylinders, the exit air is not removed from the O.R. It emerges from the ELAN 4 wall adapter, away from the operating field.

Compressed air supply/compressed air hoses

WARNING Damage to persons and/or property due to the placing of the hose! The user may injure the patient with an unintentional movement due to shock. ► Be careful not to damage the compressed-air hose. ► Ensure annual repair. WARNING Operating pressures in excess of 10 bar will da-mage the motor system! ► Set an operating pressure of between 6 bar and 10 bar. CAUTION Impaired performance of the pneumatic motor/bursting of damaged compressed-air hoses! ► Lay compressed-air hoses only through unobstructed areas. ► Do not squeeze or block open hose ends or diffusers. ► Do not coil up compressed-air hoses to tightly (minimum coil diameter 20 cm). ► Do not kink, squeeze or clamp compressed-air hoses. ► Verify that the compressed-air hoses are not damaged (e.g., by scalpels) or squeezed with sharp objects (e.g., cloth clips).

5.2

Operation with compressed-gas cylinders according to DIN EN ISO 11117

Operation with central gas supply according to DIN EN ISO 5359

The gas supply must provide clean, dry air and must be set as follows: Nominal operating pressure

8 ± 2 bar

Maximum permissible operating pressure

10 bar

For exhaust air recirculation, the maximum per- 0.5 bar to 0.7 bar missible velocity pressure in the exhaust line during motor operation Minimum gas-supply delivery

300 l/min

6.

Working with the product

WARNING Risk of infection and contamination! Applied parts and the motor hose will be delivered non-sterile! ► Sterilize applied parts and motor cable prior to use, in accordance with the instructions for use. 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 Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check. WARNING Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

6.1

System set-up

Note Operating elements on the system components of the ELAN 4 air 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. Connecting wall adapter to compressed-air source ► Couple connection for compressed-air source 8 of the wall adapter with the compressed-air source. Connecting the motor hose with hand control to the wall adapter ► Attach the connection for wall adapter 1 of the motor hose with hand control to the connection for motor hose 9 of the wall adapter and couple the bayonet lock.

5

en Connecting the applied part to the hand control ► Attach the connection for motor hose of the applied part 11 to the connection for applied part 5 of the motor hose, see Fig. A. When doing so, ensure that the nib 6 on the motor hose is aligned with the groove on the connection for motor hose 10. The applied part engages. When the visual field is “Off” 3 on the motor coupling, a gold-colored marking is visible. Note The applied part attached to this motor hose with hand control is only ready for operation when the release button is in "On" position. Releasing the applied part for operation ("On" position) ► Move the hand lever 7 180°. ► Activate the release button 4 on the motor hose and push the connec-

tion for applied part 5 onto the applied part, see Fig. A. The applied part engages. When the visual field is “On” 2 on the motor coupling, a gold-colored marking is visible. ► Return the hand lever 7 to its initial position. Locking the applied part ("Off" position) ► Move the hand lever 7 180°. ► Activate the release button 4 on the motor hose and detach the motor

hose from the applied part. The applied part engages. When the visual field is “Off” 3 on the motor coupling, a gold-colored marking is visible. Disconnecting the applied part from the motor hose with hand control ► Activate the release button 4 on the motor hose and pull at the con-

nection for applied part 5 to disconnect the motor hose from the applied part. Disconnecting the motor hose with hand control from the wall adapter ► Turn the connection for wall adapter 1 of the motor hose into the mid-

dle position of the bayonet lock to ensure pressure equalization and prevent any loud bangs. ► Disconnect the motor hose fully from the wall adapter. Disconnecting the wall adapter from the compressed-air source ► Uncouple the connection for compressed-air source 8 of the wall

adapter from the compressed-air source.

6.2

Function checks

► Check the ELAN 4 air motor system with a trial run prior to each appli-

cation. ► Make certain that the ELAN 4 air applied part and ELAN 4 air motor

hose with hand control are in good working order. ► Make certain that the ELAN 4 air motor hose with hand control and the

wall adapter are correctly connected and leak-tight. ► To check the motor hose is correctly fitted: Pull the motor hose away

from the applied part at the connection for applied part 5. Do not activate the release button 4. The motor hose must be securely fitted to the applied part and must not come loose. ► Check the secure connection of all products used. ► Make certain that the applied part runs at maximum speed when the hand lever of the ELAN 4 air motor hose with hand control is fully activated. ► Do not use a damaged or broken product. Immediately reject damaged products!

6

6.3

Safe operation

Operation of the applied part is only possible if: ■ ELAN 4 air applied part is released ("On" position) ■ ELAN 4 air motor hose with hand control is connected Activating the applied part with the motor hose with hand control ► Press the hand lever 7 on the motor hose with hand control. The motor of the applied part runs. ► Adjusting speed: Activate the hand lever 7 to a greater or lesser extent. ► To select maximum speed: Activate the hand lever 7 fully.

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.

en 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".

7.3

Reusable products

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

7.4

Preparations at the place of use

► Separate the products from each other immediately after use.

7.6

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure ELAN 4 air motor hose with hand control 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. ELAN 4 air wall adapter CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances. CAUTION Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

► Remove any visible surgical residues as much as possible with a damp,

lint-free cloth. ► ELAN 4 air motor hose with manual control: Place the dry product in a

sealed waste container and take it to be cleaned and disinfected within 6 hours. ► ELAN 4 air wall adapter: Preclean immediately after use, using non-fixating/NaCl-free method.

7.5

Validated cleaning and disinfection procedure Product

Validated procedure

Reference

Motor hose with manual control

Manual cleaning and wipe disinfection

see Manual cleaning and wipe disinfection

Manual pre-cleaning using brushes and subsequent alkaline machine cleaning and thermal disinfection

see Mechanical cleaning/disinfection with manual pre-cleaning

Wipe disinfection without sterilization

see Wipe disinfection

Preparation before cleaning

ELAN 4 air motor hose with hand control ► Prior to first mechanical cleaning/disinfection process: Install the ECCOS holder GB053R and ECCOS holder GB072R in a suitable screen basket (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB053R, see Fig. B and Fig. C and arrange the hose around the ECCOS holders GB072R.

Wall adapter

7

en 7.7

Manual cleaning and wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD–W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

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

product in any fluids. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Phase I ► Clean the product under running tap water, using a suitable cleaning

brush until all visible residues have been removed from the surfaces. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning. Phase II

Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

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

compressed air). Phase III ► Wipe all surfaces of the product with a single-use disinfecting wipe.

7.8

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfecting machine must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

Note The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Brushes

RT (cold)

–

–

D–W

–

II

Rinsing

RT (cold)

1

–

D–W

-

D–W: RT:

Drinking water Room temperature

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

product in any fluids. To avoid the risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately. Phase I ► If necessary, clean the product with a suitable cleaning brush until all

discernible residues have been removed. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning.

8

Phase II ► Rinse the entire product (all accessible surfaces) under running water. ► Move non-rigid components (such as unlocking buttons, levers, sliders) during cleaning.

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 ECCOS holder GB053R,

► After machine cleaning/disinfection, check visible surfaces for residue

see Fig. B and Fig. C and arrange the hose around the ECCOS holders GB072R.

and repeat the cleaning/disinfection process as required.

7.9

Wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Wipe disinfection

RT

≥1

-

-

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

RT: Room temperature * Meliseptol® wipes sensitive (BBraun) are recommended

Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the specified application time (1 min minimum). ► After manual cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

7.10 Inspection, maintenance and checks ► Allow the product to cool down to room temperature.

Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) with the Aesculap STERILIT Power Systems oil spray.

7.11 Packaging ELAN 4 air motor hose with manual control ► Follow the instructions for use of the packagings and holders used (e.g. instructions for use TA009721 for Aesculap ECCOS holder system). ► Insert the product in the correct position in the ECCOS holder GB053R, see Fig. B and Fig. C and arrange the hose around the ECCOS holders GB072R. ► 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.

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

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

9

en 7.12 Steam sterilization

8.

Maintenance

ELAN 4 air motor hose with manual control ► Make sure that all external and internal surfaces of the product are 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.

8.1

ELAN 4 air wall adapter

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

To ensure reliable operation, the product must be maintained at least once every two to three years. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.2

ELAN 4 air motor hose with hand control

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

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

a dry, dark, temperature-controlled area.

9.

Troubleshooting list

Fault

Cause

Detection

Remedy

Applied part malfunctions

No compressed air

Motor coupling in ‘off’ position

Activate applied part for operation (‘on’ position).

Motor hoses with hand control and wall adapters not correctly coupled

Check the coupling points.

No compressed air at the wall outlet

Check building services.

Gas cylinder empty (Pressure Gage set to "0")

Change cylinder.

Valve on cylinder closed

Open valve.

Applied part defective

Tool does not move

Replace applied part.

Motor hose with manual control defective

Hand lever not moving

Replace motor hose with manual control.

Disconnecting/connecting the applied part from/with the motor hose with hand control not possible (Change from ‘on’ to ‘off’ position and vice versa)

Release button on the motor hose is not disengaged between connection/separation and activation/locking of the applied part

Coupling process cannot be performed Move the hand lever 180°. Release the release button on the motor hose between connecting/disconnecting and releasing/locking the applied part and activate again.

Applied part runs without actuation of the motor hose with manual control

Motor hose with manual control defective

10

Motor coupling defective

Replace applied part or engine hose. Applied part runs without activating the motor hose with hand control

Replace motor hose with manual control.

en Fault

Cause

Detection

Remedy

Inadequate performance

Blunt tool

Cutting edge worn

Use a new tool.

Cutting edge is clogged up, e.g. due to insufficient rinsing

Use a new tool.

The craniotome burr is not centrally aligned with the dura guard hook

Dura guard hook bent Poor progress during craniotomy

Use new dura guard, observe instructions for use (TA014473/TA014474).

Applied part broken

Insufficient performance of applied part

Follow instructions for use of the applied part (reprocessing, maintenance). Replace applied part.

Steep rise in temperature after a short period of time

Observe instructions for use of the applied part (processing, maintenance). Replace applied part.

Air resistance in motor hose with manual control and wall adapter too high

Use of extension hoses

Use only the motor hose with hand control.

Hose bent or squashed

Lay hose only through unobstructed areas.

No free exhaust air outlet at the diffuser

Clear openings at the diffuser.

Operating pressure too low

Adjust the operating pressure to min. 6 bar.

Pressure reducer at cylinder defective

Check pressure regulator.

Leak in hose/hose coupling

Replace hose.

Accessory broken

Large amount of heat generated after a short time

Observe the instructions for use of the accessory. Replace accessory.

Excessive use

The applied part becomes hot Loud running noise/vibration

Observe instructions for use of the applied part (intermittent operation).

Air supply too low

Applied part becomes hot

High speed applied part vibrates excessively

Improper processing

Observe instructions for use of the applied part (processing, maintenance).

Shaft of applied part bent

Replace applied part.

Applied part defective

Replace applied part.

Accessory broken

Observe the instructions for use of the accessory. Replace accessory.

Shaft of applied part bent

Excessive running noises, vibrations

Replace applied part.

Applied part defective

Replace the applied part.

Reprocessing carried out incorrectly

Follow instructions for use of the applied part (reprocessing, maintenance).

11

en Fault

Cause

Detection

Remedy

Tool cannot be coupled or uncoupled

ELAN 4 air Highspeed: Automatic tool lock blocked

Highspeed tool doesn't engage

Activate slide for tool lock and hold, then couple tool.

ELAN 4 air Highspeed: Slide for tool release blocked

Applied part activated for operation (‘on’ position)

Lock the applied part ("Off" position).

Tool incompatible

Incorrect tool

Select an appropriate tool according to the instructions for use of the applied part.

Tool connection or coupling deformed, defective

Tool is hard or impossible to attach/detach

Use a new tool.

Automatic attachment lock blocked

Attachment does not click into place

Pull back unlocking sleeve and hold, then couple the attachment.

Unlocking sleeve blocked

Applied part released for operation ("On" position)

Lock the applied part ("Off" position).

Attachment coupling defective

Attachment is hard or impossible to attach/detach

Use a new attachment.

Attachment is difficult to couple or cannot be coupled

Clean attachment or use a new attachment.

Attachment for GA749 (craniotome) cannot be coupled or uncoupled

Attachment coupling is dirty

Replace applied part.

Replace applied part.

Clean the applied part. Pivotable dura protection GB947R is difficult to turn

Bearing dirty or worn

Rotary dura guard hard to move

Instructions for use (TA014473/TA014474) (processing, maintenance). Replace rotary dura guard.

Motor hose with hand control/wall Motor hose with manual conadapter cannot be coupled/uncou- trol/wall adapter not compatible pled

Motor hose with manual control/wall adapter is difficult to couple/uncouple or cannot be coupled/uncoupled

Hose coupling deformed, defective Rinsing adapter cannot be adapted Rinsing adapter not compatible

Oil spray adapter cannot be attached

Select the appropriate motor hose with manual control/wall adapter in accordance with the instructions for use. Replace motor hose with manual control/wall adapter.

Rinsing adapter cannot be adapted

Use matching rinsing adapter

Port on applied part deformed

Replace applied part.

Screw thread on rinsing adapter deformed/defective

Replace rinsing adapter.

Oil spray adapter not compatible

Oil spray adapter cannot be attached

Use the matching oil spray adapter.

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.

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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.

en 11. Accessories/Spare parts

12.6 ELAN 4 air wall adapter DIN with diffuser GA713R

Art. no.

Name

GA099

Pressure reducer with quick-locking coupling

GA710R

ELAN 4 air wall adapter Aesculap Dräger

GA712R

ELAN 4 air wall adapter Schrader with diffuser

12.7 ELAN 4 air wall adapter Synthes GA715R

GA713R

ELAN 4 air wall adapter DIN with diffuser

Weight

150 g ±10 %

GA715R

ELAN 4 air wall adapter Synthes

Dimensions (∅ x l)

26 mm x 110 mm ±5 %

GB053R

ELAN 4 air ECCOS holder for motor hose

12.8 Ambient conditions

GB072R

ECCOS winding aid for cables and hoses

GB600

STERILIT Power Systems oil spray

TA014481

Instructions for use für ELAN 4 air motor hose 3 m with hand control GA706R or ELAN 4 air motor hose 5 m with hand control GA707R

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

Name

Class

GA706R

ELAN 4 air motor hose 3 m with hand control

I

GA707R

ELAN 4 air motor hose 5 m with manual control

I

GA710R

ELAN 4 air wall adapter Aesculap Dräger

I

GA712R

ELAN 4 air wall adapter Schrader with diffuser

I

GA713R

ELAN 4 air wall adapter DIN with diffuser

I

GA715R

ELAN 4 air wall adapter Synthes

I

Weight

156 g ±10 %

Dimensions (∅ x L)

26 mm x 121 mm ±5 %

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. 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.

12.2 ELAN 4 air motor hose 3 m with hand control GA706R Weight

580 g ±10 %

Dimensions (L)

3 m ±5 %

12.3 ELAN 4 air motor hose 5 m with hand control GA707R Weight

840 g ± 10 %

Dimensions (l)

5 m ±5 %

12.4 ELAN 4 air wall adapter Aesculap-Dräger GA710R Weight

290 g ± 10 %

Dimensions (∅ x L)

37 mm x 121 mm ±5 %

12.5 ELAN 4 air wall adapter Schrader with diffuser GA712R Weight

154 g ± 10 %

Dimensions (∅ x l)

26 mm x 126 mm ±5 %

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