ELAN 4 air perforator driver GA722

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Aesculap® ELAN 4 air perforator driver GA722 Legend

CE mark according to Regulation (EU) 2017/745

1 HUDSON tool coupling 2 Unlocking sleeve 3 Connection for motor hose 4 HUDSON tool shaft 5 Connection for applied part 6 Field of vision “On“ on the motor coupling 7 Field of vision “Off“ on the motor coupling 8 Release button 9 Nib on motor hose 10 Groove on connection for motor hose 11 Oil spray adapter GB600850

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 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

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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. 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 8. 9. 10. 11. 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... 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... 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 . . Performance Data... Short interval operation... 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.

Designation

GA722

ELAN 4 air perforator driver

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.

► 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.

3.

Safe handling

WARNING Risk of injury and material damage if this product is not used as intended! ► Use the product only as intended. WARNING Risk of injury and damage to property due to improper handling of the product! This product is 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

2.

General information

2.1

Intended use

The ELAN 4 air perforator driver GA722 is an accessory of the ELAN 4 air motor system. The perforator driver 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 perforator driver is used to drive cranial perforators with HUDSON connection.

2.2

Application Environment

Application in the sterile area

2.3

Indications

Modes of application Cranial trepanation Surgical discipline/areas of application Neurosurgery Note The operator shall be responsible for the compatibility and proper, safe use of the tools used with this application part.

2.4

Absolute contraindications

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

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 to not compromise the manufacturer warranty and liability: – Use product only in accordance with these instructions for use. – Observe safety information and maintenance instructions. ► 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 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. 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.

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en 4.

Product description

4.1

Scope of supply

Art. no.

Designation

GA722

ELAN 4 air pneumatic perforator driver

TA014460

Instructions for use for ELAN 4 air perforator driver GA722 (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 ■ Cranial perforator with HUDSONconnector

4.3

Operating principle

The ELAN 4 air perforator driver can be used to drive perforation tools. No wrenches are required for coupling/uncoupling the tools (HUDSON coupling). The perforator driver is used with the ELAN 4 air foot control or manual controls. The rotating speed is continuously variable by means of the foot/manual control.

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.

6.

Working with the product

WARNING Malfunction can cause injuries! ► Keep alternative treatment method or replacement system available. WARNING Risk of infection and contamination! Application parts and the motor hose will be delivered non-sterile! ► Sterilize the application parts and the motor cable prior to use, in accordance with the instructions for use.

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

6.1

System set-up

WARNING Risk of injury when coupling/uncoupling tools in the "On" position due to accidental activation of the applied part! ► Only couple/uncouple tools in the "Off" position. WARNING Risk of injury due to small parts that could enter the surgical field! ► Do not couple/uncouple tools above the surgical field. 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. The combination of accessories used must not adversely affect performance and safety requirements. ► Observe the instructions for use of individual accessories. ► In case of questions please contact your B. Braun/Aesculap Partner or the Aesculap Technical Service, Address see Technical Service. Connecting the applied part to the motor hose ► Attach the connection for motor hose of the applied part 3 to the connection for applied part 5 of the motor hose, see Fig. C. When doing so, ensure that the nib 9 on the motor hose is aligned with the groove on the connection for motor hose 10. The applied part engages. When the field of vision is “Off” 7 on the motor hose, a gold-colored marking is visible. Note The applied part attached to this motor hose is only ready for operation when the release button is in "On" 6 position. Coupling the tool to the applied part ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). 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. 4

► Pull back unlocking sleeve 2 on the applied part and push tool shaft in

the correct position as far as it will go into the tool coupling 1. ► Release unlocking sleeve 2. ► Pull at tool shaft to check that it is securely coupled.

Releasing the applied part for operation ("On" position) ► Activate the release button 8 on the motor hose and push the connection for applied part 5 onto the applied part, see Fig. C. The applied part engages. When the field of vision is “On” 6 on the motor hose, a gold-colored marking is visible.

en Locking the applied part ("Off" position) ► Activate the release button 8 on the motor hose and detach the motor hose from the applied part, see Fig. C. The applied part engages. When the field of vision is “Off” 7 on the motor hose, a gold-colored marking is visible. Uncoupling the tool from the applied part

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.

► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► Pull back the unlocking sleeve 2 at the application part and pull the tool by the tool shaft 4 out of the tool coupling 1. Disconnecting the applied part from the motor hose ► Lock the applied part ("Off" position), see Locking the applied part

("Off" position). ► Activate the release button 8 on the motor hose and pull at the connection for applied part 5 to disconnect the motor hose from the applied part, see Fig. C.

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. ► Briefly run the applied parts at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the prod-

uct if it is damaged.

6.3

Safe operation

DANGER Improper use can result in injury to the dura mater and brain tissues! ► Apply special care when using perforator drivers. ► Make certain that the user is familiar with the skull perforator and its mode of operation. ► Only use sharp tools. WARNING Coagulation of patient tissue or risk of burns for patients and users from hot applied part/tool! ► Cool the tool during use. ► Put down the applied part/tool beyond reach of the patient. ► Let the application part/tool cool down. ► Use a cloth to protect against burns when changing the tool. WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles peeling off the tool! ► Take appropriate protective measures, e.g. watertight protective clothing, face mask and protective goggles, extraction system. WARNING Risk of injury and/or malfunction! ► Perform functional tests before every use.

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".

Operation of the applied part is only possible if:

■ the applied part is released ("On" position) ■ a foot control or manual control is connected.

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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

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 first mechanical cleaning/disinfection: Install ECCOS holder

GB056R in a suitable tray (e.g. JF222R). ► Place the product in the correct position in the ECCOS holder GB056R,

see Fig. A.

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.

7.7

Manual cleaning with immersion disinfection

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

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en ► 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 product under running water, using a suitable 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.

Phase IV ► Prior to manual disinfection, allow rinsing water to drain off the product for a sufficient length of time and use compressed air to blow all liquid out of the product through the rinsing adapter GB697R in order to prevent dilution of the disinfecting solution. ► Using a disposable syringe, fill the inside of the applied part with disinfectant solution through the rinsing adapter GB697R. ► Immerse the application part including the connected rinsing adapter at least 5 min in disinfecting solution. Phase V ► Rinse the entire product (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 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.

Phase III ► Rinse the entire product (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.

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

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 II ► Connect the connection for motor hose 3 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

Phase I ► Clean the product 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. 7

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 3 with ELAN 4 air rinsing

7.11 Steam sterilization

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. ► 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.

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

7.9

Inspection, maintenance and checks

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.

► Allow the product to cool down to room temperature.

7.12 Storage

► Connect ELAN 4 air oil spray adapter GB600850 11 (purple) to connec-

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

tion for motor hose 3 and spray through the application part for approx. 2 s using STERILIT Power Systems oil spray GB600, see Fig. B. Note Aesculap additionally recommends the occasional spraying of moving parts (such as knobs, couplings) using the Aesculap STERILIT Power Systems oil spray. ► 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.

7.10 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

GB056R, see Fig. A. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap

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

uct.

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a dry, dark, temperature-controlled area.

en 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.

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

Designation

Class

GA722

ELAN 4 air perforator driver

IIa

12.2 Performance Data

9.

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

Max. power

approx. 100 W at 8 bar

Max. torque

approx. 4 Ncm at 8 bar

Max. motor speed

approx. 1 200 rpm at 8bar

Weight

427 g ±10 %

Dimensions (∅ x L)

35 mm x 155 mm ±5 %

Tool connection

HUDSON

Direction of rotation

Right-hand rotation

Pressure range

8 bar ±2 bar

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.

12.3 Short interval operation

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.

12.4 Ambient conditions

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.

11. Accessories/Spare parts Art. no.

Designation

GB056R

ELAN 4 air ECCOS holder for perforator driver GA722

GB600

STERILIT Power Systems oil spray

GB600850

ELAN 4 air oil spray adapter

GB697R

ELAN 4 air rinsing adapter

GB691R

ELAN 4 air rinsing device

TA014459

Instructions for use for ELAN 4 air perforator driver GA722 (A4 for folder)

TA014460

Instructions for use for ELAN 4 air perforator driver GA722 (leaflet)

■ 1 min application, 3 min rest ■ 3 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Application part 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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