Bipolar Cup – Trial head

en

2.4

AESCULAP Bipolar Cup Trial head Legend

2.4.1

A Trial head (assembled) B Trial head and instruments 1 2 3 4

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.

®

Sizing

The size of the acetabulum can be determined with the Bipolar Cup trial heads. ► Screw trial head 1 onto insertion instrument 3 NF770R (straight) or NF771R (curved). ► Perform size determination in situ.

Trial head Locking ring Insertion instrument Holding forceps

2.4.2

Trial repositioning

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

Trial reduction with a corresponding femoral trial head and an AESCULAP hip endoprosthesis stem can be performed with the Bipolar Cup trial heads. ► Place locking ring 2 on the neck of the femoral stem before the assembly of the femoral trial head. Ensure that the bores of the locking ring face towards the femoral stem. ► Assemble the locking ring 2 with the Bipolar Cup trial head 1 by using the holding forceps 4. Ensure that the locking ring 2 is engaged with the Bipolar Cup trial head 1. ► Disassemble locking ring 2 in situ after trial reposition by using the holding forceps 4.

1.1

3.

Validated reprocessing procedure

3.1

General safety instructions

1.

About this document

Scope

These instructions for use apply to Bipolar Cup trial heads with locking ring, as well as to the individually obtainable locking rings. Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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

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 processing of products. Note Mechanical processing 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 Sterilization should always be favored over disinfection under all circumstances. Only if final sterilization is not possible should disinfection with a virucidal agent be preferred.

The Bipolar Cup trial heads are instruments used in orthopedic surgery with Bipolar Cup implants to determine the size of the acetabulum and for trial repositioning.

Note Up-to-date information about processing and material compatibility can be found on the B. Braun eIFU site at eifu.bbraun.com The validated steam sterilization procedure was carried out in the AESCULAP sterile container system.

2.1.2

3.2

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

Absolute contraindications

The absolute contraindications correspond to those of the Bipolar Cup implants.

2.1.4

Relative contraindications

The relative contraindications correspond to those of the Bipolar Cup implants. In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.2

Product description

2.2.1

Components required for use

Art. no.

Designation

NF770R

Bipolar Cup insertion instrument straight

NF771R

Bipolar Cup insertion instrument curved

ND930R

Holding forceps

2.2.2

3.3

Available sizes

Art. no. trial head

∅

Corresponding additional locking ring

NF719 to NF735

22.2 mm

NF773

NG091 to NG105

26 mm

–

NF743 to NF759, NF762

28 mm

NF774

Note Locking rings are delivered with the trial heads. The locking rings NF773 (∅ 22.2 mm) and NF774 (∅ 28 mm) can also be ordered separately.

2.3

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.

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".

Reusable products

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.

3.4

Preparations at the place of use

► 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.

3.5

Preparing for cleaning

► Disassemble locking ring 2 from trial head 1 using the holding forceps 4 prior to cleaning.

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

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

3.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

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

Chapter Manual cleaning/disinfection and subsection:

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.

2.3.2

Sterility

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

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

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical mild alkaline cleaning and thermal disinfecting

3.7

Manual cleaning/disinfection

3.8.2

► 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.

Phase

3.7.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting 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

-

RT

-

V

Drying

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate: – pH = 9.5 – < 5 % anionic surfactant

■ 0.5 % solution 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: -

-

-

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

infection procedure.

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality)

► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

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

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► 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 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► 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. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.8

Mechanical mild alkaline cleaning and thermal disinfecting

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

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.8.1

Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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 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 Technical service.

3.9.2

head 1. ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check rotating products (e.g. reusable drills and cutters) for bends and deformities. To do this, roll the product

on an even surface. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.10 Packaging ► Disassemble locking ring prior to packaging, see Preparing for cleaning. ► Place the product in its holder or on a suitable tray. ► 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 Note The product may only be sterilized in disassembled condition. ► 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

– Disassemble the product – 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. D–W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► 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.

Functional test

► Insert locking ring 2 into trial head 1 using holding forceps 4. Ensure that locking ring 2 is engaged with the trial

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.

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. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA016201

2021-10