ELAN 4 air motor hose for foot control GA705R

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Aesculap® ELAN 4 air motor hose for foot control GA705R Legend 1 2 3 4 5 6 7 8

Medical device

Connection for foot control Visual field “On“ on the motor coupling Visual field “Off“ on the motor coupling Release button Connection for applied part Nib Slider for tool release Unlocking sleeve

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 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

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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 6. 6.1 6.2 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 8. 9. 10. 11. 12. 12.1 12.2 12.3 13.

About this document... Scope... Warnings... General information... Intended use... Application Environment... Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Operating principle... Preparation... Compressed air supply/compressed air hoses... Working with the product... System set-up... Function checks... Validated reprocessing procedure... General safety notes... General information... Reusable products... Preparations at the place of use... Preparation before cleaning... Cleaning/disinfection... Manual cleaning and wipe disinfection... Mechanical cleaning/disinfection with manual pre-cleaning . . Inspection, maintenance and checks... Packaging... Steam sterilization... Storage... Maintenance and repair... Troubleshooting list... Technical Service... Accessories/Spare parts... Technical data... Classification in accordance with Regulation (EC) 2017/745 . . Basic data... Ambient conditions... Disposal...

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en 1.

About this document

1.1

Scope

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

Name

GA705R

ELAN 4 air motor hose

► 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 motor hose for foot control GA705R is an accessory of the ELAN 4 air motor system. The motor hose is used to connect the ELAN 4 air applied parts to the foot control.

2.2

Application Environment

Application in the sterile and unsterile area Sterile separation takes place at the motor hose.

2.3

Indications

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

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

4.

Product description

4.1

Scope of supply

Art. no.

Name

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

GA705R

ELAN 4 air motor hose

GB600850

ELAN 4 air oil spray adapter

2.5

TA014452

Instructions for use for ELAN 4 air motor hose GA705R (leaflet)

2.4

Absolute contraindications

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

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. 3

en 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 ■ ELAN 4 air applied part ■ Tool 4.3

Note For applied parts with slider for tool release 7, in the "On" position 2 the connection for applied part 5 on the motor hose blocks the slider. Uncoupling of the tools is therefore only possible in "Off" position 3, see Fig. C. In the case of application parts having an unlocking sleeve 8, in the ON position 2 the connection for the application 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 without slider for tool release, 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.

Preparation

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► Before using the product and its accessories, check to be sure that neither are damaged. ► Use the products and their accessories only if they are in perfect technical condition.

5.1

Working with the product

WARNING Risk of infection and contamination! Application parts and the motor hose will be delivered non-sterile! ► Carry out sterile processing of the application parts and motor hose prior to use, in accordance with the instructions for use.

Operating principle

The ELAN 4 air motor hose GA705R is connected to the motor hose connection of the foot control using the foot control 1 connector. Two steps are required to connect or disconnect the motor hose to or from the application part. The current position is indicated by a gold marking in one of the two fields of view on the motor hose

5.

6.

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 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! ► Perform functional tests before every use.

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.

6.2

Function checks

► Check the ELAN 4 air motor system by performing a trial run prior to

every usage. ► Make sure the ELAN 4 air application part and the ELAN 4 air motor

hose function properly. ► Check that the ELAN 4 air motor hose is connected correctly and that

it is not leaking. ► To check the motor hose is correctly fitted: Pull the motor hose away

WARNING Operating pressures in excess of 10bar will damage the motor system! ► Set an operating pressure of between 6 bar and 10 bar. CAUTION Reduced performance of the pneumatic motor/damaged compressedair hoses may burst! ► Route compressed air hoses without restraints. ► Do not constrict open hose ends or diffusers. ► Do not wind compressed air hoses too tightly (minimum diameter 20 cm). ► Do not kink, pinch or squeeze the compressed air hoses. ► Ensure that compressed air hoses are not damaged (e.g. by scalpel) or squeezed with sharp-edged objects (e.g. cloth clamps).

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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 sure that the applied part runs at maximum speed when the foot control pedal is stepped on all the way down. ► Do not use a damaged or defective product. Immediately reject any damaged products!

en 7.

Validated reprocessing procedure

7.1

General safety notes

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B. Braun eIFUs at eifu.bbraun.com for up-to-date information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7.2

General information

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

7.3

Reusable products

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

7.4

Preparations at the place of use

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

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

cleaning and disinfection within 6 hours.

7.5

Preparation before cleaning

► Prior to the first mechanical cleaning/disinfection process: Mount 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. A and Fig. B and arrange the hose around the ECCOS holders GB072R.

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.

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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

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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 faucet water, using a suitable clean-

ing 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 ► 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.

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.

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en 7.8

Mechanical cleaning/disinfection with manual pre-cleaning

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

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

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

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

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

during cleaning.

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

Step

T [°C/°F]

t [min]

Water quality

Chemicals

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

max. 120/248

min. 10

-

–

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

► Place the product in the correct position in the ECCOS holder GB053R,

see Fig. A and Fig. B and arrange the hose around the ECCOS holders GB072R. ► After machine cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection process as required.

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en 7.9

Inspection, maintenance and checks

10. Technical Service

► 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.

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.

► 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.

7.10 Packaging ► Follow the instructions for use of the packages and holders used (e.g.

instructions for use TA009721 for Aesculap ECCOS holder systems). ► Place the product in the correct position in the ECCOS holder GB053R,

see Fig. A 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.

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

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.

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.

7.12 Storage

11. Accessories/Spare parts Art. no.

Designation

GB053R

ELAN 4 air ECCOS holder for motor hose GA705R

GB072R

ECCOS winding aid for cables and hoses

GB600

STERILIT Power Systems oil spray

TA014451

Instructions for use for ELAN 4 air motor hose GA705R (A4 for ring-binder)

TA014452

Instructions for use for ELAN 4 air motor hose GA705R (leaflet)

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

a dry, dark, temperature-controlled area.

8.

Maintenance and repair

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

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

9.

Troubleshooting list

Note For further information, see the instructions for use of ELAN 4 air foot control GA708, ELAN 4 air wall hoses, ELAN 4 air wall adapters (TA014450).

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

Name

Class

GA705R

Elan 4 air motor hose

I

12.2 Basic data Weight

538 g ± 10 %

Dimensions (l)

3m±5%

Pressure range

8 bar ± 2 bar

en 12.3 Ambient conditions 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.

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