Tools for Aesculap motor systems – single-use products reusableproducts

Safe handling and preparation

en ®

Aesculap Tools for Aesculap motor systems – single-use products/reusable products

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

Symbols on product and packages

WARNING Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.

Manufacturer’s article number

Manufacturer’s batch designation

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

Not for reuse in intended applications as defined by the manufacturer

Sterilization using irradiation Manufacturer

WARNING Risk of injury and infection if surgical gloves are damaged by sharp cutting edges! ► Avoid contact with cutting tools. ► When coupling/uncoupling, handle tools with cutting edges with care.

■ 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. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-

ufacturer 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. ► Read, follow, and keep the instructions for use. ► Do not modify, re-sharpen or repair the tools. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Store any new or unused products in a dry, clean, and safe place. ► During operations keep a spare product at hand to replace a damaged product if necessary. 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.

Date of manufacture

Unsterile products

Use by

► Sterilize the product prior to use.

Sterile products The product is gamma-sterilized and supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. Non-sterile medical device

Single-use products

CE mark according to Regulation (EU) 2017/745

DANGER Risk of infection for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reuse the product. ► Do not reprocess the product.

Scope

Preparation

These instructions for use apply to tools for Aesculap motor systems - disposable/reusable products (saw blades, reamers, drills, abrasive products, bone rasps, blades and cutting disks).

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition. ► Use suitable drive systems only.

Warnings Warnings indicate hazards to patients, users and/or products that may emerge during the use of the product. Warnings are marked as follows:

Working with the device DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result.

Note For further information, see the instructions for use of the Aesculap motor system used.

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

WARNING Risk of injury from bent or snapped craniotome reamers! ► Only use a dura protector and craniotome reamer with identical length markings. ► Do not use craniotome reamers on which the length markings can no longer be seen.

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

Intended use Tools for use with Aesculap motor systems Saw blades, reamers, drills, abrader tools, bone files, chisels, blades

Working of hard tissue, cartilage, similar tissue and bone replacement materials

Cutting disks, hard metal cylinder reamers

Working on metal (implants, bone screws).

Dermatome blades

Obtaining split thickness skin grafts

Indications The type and area of application depend on the tool selected.

WARNING Risk of injury and material damage due to inadvertent activation of the motor system when changing tools during application! ► Secure motor systems/handpieces that are not in active operation against inadvertent activation by foot or hand controls. WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check WARNING Risk of burns to skin and tissue caused by blunt tools! ► Use tools only if they are in perfect condition. ► Replace blunt tools.

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

Relative contraindications The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the surgery The clinically successful use of the product depends on the knowledge and experience of the surgeon, whose responsibility it is to decide, in consideration of the safety and warning notices in the usage instructions, whether the product can be used successfully.

Intended use environment The product is used in operating rooms in sterile zones outside of the explosion risk zone (such as areas with pure oxygen or anesthesia gases).

WARNING Risk of injury due to application of the product outside the field of view! ► Only use the product under vision. WARNING Risk of injury to patients and users caused by tools bent or broken during operation! ► Avoid overstraining (e.g. bending) of tools during operation. ► Do not use the tool for bracing. WARNING Risk of burns or other injury due to a bent or incorrectly coupled craniotome reamer grinding against the dura protector or the depth stop and holding sleeve! ► Only use perfectly straight and sharp tools. ► Make certain the tool is coupled correctly. ► Do not use tools on which the length markings are not visible anymore.

The following warning applies to all tools with which metal working is not explicitly permitted, see Intended use:

Validated reprocessing procedure

WARNING Danger of injury or infection through abrasion! Risk of damage to the tool due to processing of other materials than those intended (e.g. drilling/sawing into instruments or implants). ► Use the product only as intended.

General safety notes

Function check ► Prior to each use, check that all products to be used are in good working 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 mechanical damage. ► Briefly run the tool at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

Operation WARNING Coagulation of patient tissue or risk of burns for patients and users from hot tool! ► Only use sharp tools. ► Cool the tool during operation. ► Rinse and suction during use. ► Put down the tool beyond reach of the patient. ► Allow the tool to cool down. ► Use a cloth to protect against burns when changing the tool. WARNING Risk of injury and/or malfunction! ► Always carry out a function test prior to each use of the product. WARNING Risk of infection and contamination due to aerosol formation! ► Take appropriate protective measures, e.g. protective clothing, face mask, protective goggles, suction extraction. WARNING Risk of injury if the tool comes loose accidentally! ► Do not activate the tool release during operation. ► Check for secure fixation of the tool after any tool change. WARNING Risk of injury due to small parts in the operation site! ► Do not couple/uncouple tools over the operation site. WARNING Risk of injury from foreign object reactions (e. g. inflammation, encapsulation) if particles remain in the body! When using diamond tools, it is always possible for diamond grains/nickel particles to break away/off. ► Carefully rinse and suction while and after working with diamond tools. WARNING Danger of injury from foreign body reactions (e.g. inflammation, encapsulation) if particles remain in the body! ► Carefully rinse and suction while and after working with tools.

Working with rotating tools WARNING Risk of injury and damage to the tool/system! The rotating tool may catch cover drapes (textile or other). ► Never allow the tool to touch cover drapes (textile or other) during operation. WARNING Risk of injury from bent or snapped tools! ► Only use perfectly straight tools. ► Only apply mild pressure when using a tool.

Working with cutting discs and carbide cylinder cutters CAUTION Risk of injury to the surgeon from metal abrasion/tool breakage! ► Wear protective goggles when working metal. ► Do not tilt the tool in the cutting slot. This can break the tool. ► Avoid metalworking in situs. ► If working the metal at the operating site cannot be avoided, observe the following:

WARNING Risk of tissue trauma/necrosis when working metals (e.g., implants)! ► Cover the operating site with wet cloths to collect the dust from the metal abrasion. ► Carry out extensive flushing during the working in order to cool the worked metal and tool. ► After working the metal, carefully flush the operating site to remove any dust from the metal abrasion. Note Depending on the metal being worked, the tool can quickly wear. ► Have replacement tools on hand when working metals.

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 eIFU at eifu.bbraun.com for current information on processing and material compatibility The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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 pre-cleaning 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 material-friendly/careful processing, please refer to www.a-k-i.org Header "AKI Brochures", "Red Brochure".

Reusable products There is no maximum number of applications and processing cycles for the product. The service life of the product is limited by damage, normal wear, kind and duration of the usage, 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.

Preparations at the place of use ► Separate the products from each other immediately after use and disassemble products. ► 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.

Preparation before cleaning ► Thoroughly rinse (through) the product with running, cold water. ► Place the product in a tray that is suitable for cleaning or place the product in its proper position in the assigned

ECCOS holder.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure WARNING Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents approved for stainless steel according to the manufacturer’s instructions. ► 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 95°C during thermal disinfection using demineralized 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.

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 ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemicals

I

Immersion

RT (cold)

>30

50

D–W

Enzymatic detergent*

II

Rinsing

RT (cold)

-

-

D–W

-

III

Ultrasonic cleaning

55/131

>15

2

D–W

Concentrate-free, aldehydefree, phenol-free, QUAT-free, pH ~ 9*

IV

Cleaning with brush

RT (cold)

-

-

D–W

-

Working with saw blades and cutting blocks (e.g. for knee implant systems) WARNING Risk of injury and damage to the tool/cutting block if the saw blade is inserted into the cutting block with the saw switched on! ► Insert the saw blade into the cutting block before switching the saw on.

D–W: Drinking water RT: Room temperature *Recommended: BBraun Helizyme **Recommended: BBraun Stabimed fresh

Phase I ► Fully immerse the product in enzymatic cleaning solution for at least 30 minutes. Ensure that all accessible surfaces are moistened. Phase II ► Rinse the entire product (all accessible surfaces) under running water. Phase III ► Use a suitable holder to protect the cutting edges of the products, see Accessories. ► If possible, position the holder vertically. ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Phase IV ► Clean the product using a suitable cleaning brush, visually check visible surfaces for residue and repeat the cleaning and disinfection process as required.

Mechanical alkaline cleaning and thermal disinfection Machine type: Phase

Single-chamber cleaning/disinfection device without ultrasound

Step

T [°C/°F]

t [min]

Water quality

Chemicals

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* Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

max. 120/24 8

min. 10

-

–

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► After machine cleaning/disinfection, check visible surfaces for residue and repeat the cleaning/disinfection pro-

cess as required.

Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Inspect the product for broken, damaged or blunt cutting edges. ► Set aside the product if it is damaged.

Packaging ► Sort the product in associated ECCOS holder or place on suitable screen basket. Ensure that any cutting edges

are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization Note The product may only be sterilized in disassembled condition. ► Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent. ► Validated sterilization process

– Steam sterilization using fractionated 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.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

Maintenance No maintenance required for tools. ► Do not modify, re-sharpen or repair the tools. ► Set aside any damaged or blunt tools.

Troubleshooting Note For further information, see the instructions for use of the Aesculap motor system used.

Technical Service DANGER Malfunctions can result in risk of death for the patient and the user! ► Do not modify the product. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► For service, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

Art. no.

Designation

GB481R

ECCOS holder for large saw blades

GB613R

ECCOS holder for 13 Hi-Line XS tools

GB718R

ELAN 4 ECCOS holder for 12 reamers

GB720R

ECCOS holder for saw blades

Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing or recycling the product, its components and their packaging. WARNING Risk of injury from sharp and/or pointed products! ► When disposing of or recycling the product, make sure the packaging prevents injuries from the product.

I

III

Accessories

Note The operator has to process reusable products before disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is available from your national B. Braun/Aesculap

representative, see Technical Service. TA012787

2020-09

V6

Change No. AE0060338