Hudson brace hand drill

en

2.3.2

Aesculap Hudson brace hand drill

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

Legend 1 2 3 4 5 6 7

Perforator handle FF056R Fastening screw for perforator handle Tool connection for perforator handle Extension piece FF057R Fastening screw for extension piece Tool connection for extension piece Tool

1.

About this document

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.

2.3.3

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for the Hudson brace hand drill Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The Hudson hand drill device, consisting of trepan bracket FF056R and extender FF057R as applicable, is used in combination with the corresponding tools for trepanation (drilling) of the skull.

2.1.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

2.1.3

Components required for use

The following burrs and perforatore can be used with the brace hand drill: Art. no.

Designation

∅

FF037R

Perforator Hudson

0.43 in

FF038R

Perforator Hudson

0.51 in

FF039R

Perforator Hudson

0.63 in

FF061R

Perforator Hudson, cylindrical

0.35 in

FF062R

Burr Hudson, conical

0.55 in

FF063R

Burr Hudson, spherical

0.63 in

FF064R

Burr Hudson, spherical

0.87 in

FF065R

Burr Adson, spherical

0.59 in

FF066R

Spiral burr McKenzie, cylindrical

0.51 in

FF067R

Perforator Cushing

0.55 in

FF068R

Spiral burr

0.08 in

2.4

Safety information

2.3.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap. ► Sterilize the product prior to use. ► Pull on the tool to check that it is securely coupled.

2.5

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. 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. 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 patient or user if tool is bent or breaks during use! ► Avoid overstraining (e.g. bending) of tools during operation. 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 in accordance with the intended purpose.

Assembly

If using the instrument without an extension piece: ► Insert the tool 7 into the tool coupling for perforator handle 3. When doing so, ensure that the notches of the tool connection engage in the recesses on the tool. ► Fix the tool in place by turning fastening screw for perforator handle 2 clockwise to tighten. If using the instrument with an extension piece: ► Insert the extension piece 4 into the tool connection for perforator handle 3. When doing so, ensure that the notches of the tool connection engage in the recesses on the extension piece. ► Fix the extension piece in place by turning fastening screw for perforator handle 2 clockwise to tighten. ► Insert the tool 7 into the tool connection for extension piece 6. When doing so, ensure that the notches of the tool connection engage in the recesses on the tool. ► Fix the tool in place by turning fastening screw for extension piece 5 clockwise to tighten.

2.5.2

Functional test

► 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. ► Pull on the tool to check that it is securely coupled. ► Check that the cutting edges of the tools are not showing any mechanical damage. ► Briefly run tool at maximum speed. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

2.5.3

2.3

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.5.1

Contraindications

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

2.2

Product

Product-specific safety information Risk of injury and material damage due to inappropriate use of the product! ► Use the product only in accordance with the intended purpose.

®

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 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 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.

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.

3.7

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

WARNING Risk of injury from bent or snapped tools! ► Only use perfectly straight tools. ► Only apply mild pressure when using a tool.

3.7.1

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

2.5.4

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

Disassembly

To disassemble the product, follow the steps for assembly in reverse order, see Assembly.

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. 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 Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

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 pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. 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 in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ 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 surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Reusable products

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.4

3.8

Preparations at the place of use

Mechanical cleaning/disinfection with manual pre-cleaning

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

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

3.5

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

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly. ► Remove the fastening screws 2/5 from the perforator handle and extension piece.

3.8.1

Manual pre-cleaning with ultrasound and brush

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents that are approved for stainless steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

3.6.2

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

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Drying phase: Use a lint-free

Chapter Manual cleaning/disinfection and subsection:

cloth or medical compressed air Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Mount jaws protection on the product.

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Chapter Manual cleaning with ultrasound and immersion disinfection Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

3.8.2

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical

3

D–W

-

10

FD-W

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

■ working solution 0.5%

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.

– pH = 11* TA014267 III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.9

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.9.1

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

nical service.

3.9.2

Functional test

CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Screw the fastening screws 2/5 into the perforator handle and the extension piece. ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.10 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.11 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by

opening any valves and faucets). ► 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 ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

2020-06

V6

Change No. 62504