BBraun

19 Modulift VBR Sz. S Footplate Trial 10°

Modulift VBR General Instruments

45 Pages

File Type: PDF

File Size: 1.58 MB

File Name: BBraun - MODULIFT - TA015036 - Modulift VBR General Instruments - 2018-01.pdf

Preview

Page 1

Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. ► Do not use MF810R if the epoxy paint is scratched or damaged.

Aesculap® Modulift VBR General Instruments WARNING

Legend 1 Modulift VBR Sz. S Expansion Driver (MF801R) 2 Modulift VBR Sz. S Set Screw Driver (MF802R) 3 Modulift VBR Sz. S Set Screw Removal Driver (MF827R) 4 Modulift VBR Sz. S/M Bone Tamp (MF708R) 5 Modulift VBR Sz. S/M Graft Funnel (MF709R) 6 Modulift VBR Sz. S Implant Tamp (MF806R) 7 Modulift VBR Sz. S/M Caliper (MF807R) 8 Modulift VBR Sz. S Bench Block (MF809P) 9 Modulift VBR Sz. S Footplate Sizer (MF810R) 10 Modulift VBR Sz. S Trial Implant 19-23mm (MF811T) 11 Modulift VBR Sz. S Trial Implant 21-27mm (MF812T) 12 Modulift VBR Sz. S Trial Implant 25-35mm (MF813T) 13 Modulift VBR Sz. S Trial Implant 30-45mm (MF814T) 14 Modulift VBR Sz. S Trial Implant 38-57mm (MF815T) 15 Modulift VBR Sz. S Trial Implant 48-74mm (MF816T) 16 Modulift VBR Sz. S Trial Implant 34-49mm (MF808T) 17 Modulift VBR Sz. S Footplate Trial 0° (MF795T) 18 Modulift VBR Sz. S Footplate Trial 5° (MF796T) 19 Modulift VBR Sz. S Footplate Trial 10° (MF797T) 20 Modulift VBR Sz. S Handle for Trial Implants (MF817R)

Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product

Date of manufacture

Intended use The application of this instrument as a medical measure relates to the specific clinical disease which is intended for the application of Modulift VBR System. Autonomous indications/contra-indications cannot be declared for this instrument itself, as they comply with the indications/contraindications of the implants of the Modulift VBR System. The implant indications/contraindications can be found in the implant IFU TA015038. ■ The Modulift VBR Sz. S Expansion Driver (MF801R) is used in conjunction with the implant inserter under fluoroscopic conditions to extend the Modulift VBR implants to the appropriate height and optimal curvature correction after insertion. They also provide a tactile feel during use to ensure the desired expansion is achieved. ■ The Modulift VBR Sz. S Set Screw Driver (MF802R) and the Modulift VBR Sz. S Set Screw Removal Driver (MF827R) are used to tighten or loosen the grub screws that lock the implant at the desired expansion height. ■ The Modulift VBR Sz. S/M Bone Tamp (MF708R) is used to thrust bone substitute through the graft funnel into the designated cavities of the Modulift VBR implants. ■ The Modulift VBR Sz. S/M Graft Funnel (MF709R) is used to facilitate the addition of bone substitute into the desired Modulift VBR implant cavities prior to expansion. ■ The Modulift VBR Sz. S Implant Tamp (MF806R) is used to adjust the position of the VBR implant after insertion. ■ The Modulift VBR Sz. S/M Caliper (MF807R) is used to approximately measure the displacement between prepared vertebral bodies so that the appropriate VBR height selection can be made. ■ The Modulift VBR Sz. S Bench Block (MF809P) is used to stabilize the Modulift VBR implants so that the graft funnel and bone tamp can be used to pack bone or bone substitute into the implant. ■ The Modulift VBR Sz. S Footplate Sizer (MF810R) is used to establish the proper implant footplate size cranially and caudally to provide sufficient coverage of the VBR endplate. ■ The Modulift VBR Sz. S Trial Implants (MF811T, MF812T, MF813T, MF814T, MF815T, MF816T, MF808T) and the Modulift VBR Sz. S Footplate Trials (MF795T, MF796T, MF797T) help to establish the expansion height and curvature correction angle of the VBR. ■ The Modulift VBR Sz. S Handle for Trial Implants (MF817R) is used to hold and control the VBR and footplate trials during insertion.

Validated reprocessing procedure 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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at https://extranet.bbraun.com 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 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 Publications, Red Brochure – Proper maintenance of instruments.

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.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► 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. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g., MF801R in MF800R).

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 (e.g., aluminum, plastics, high-grade steel), – do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable washing temperature.

Validated cleaning and disinfection procedure All instruments should be cleaned and washed outside of the provided Aesculap tray unless otherwise instructed by an Aesculap representative. For MF801R, MF802R, MF827R, MF708R, MF806R*, MF810R, MF795T*, MF796T*, MF797T*, and MF817R 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 sub-chapter:

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

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

■ Chapter Manual cleaning with immersion disinfection Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

* If bone, tissue, or other gore is present on the instrument, remove it with a brush before initiating mechanical cleaning.

For MF709R, MF809P, MF811T, MF812T, MF813T, MF814T, MF815T, MF816T, and MF808T Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Keep working ends open for

Chapter Manual cleaning/disinfection and sub-chapter:

■ Chapter Manual cleaning with immersion disinfection

cleaning. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

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

■ Connect components with

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning

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.

Manual cleaning with ultrasound and immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Ultrasonic cleaning

RT (cold)

>15

D–W

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

Intermediate rinse

RT (cold)

D–W

III

Disinfection

RT (cold)

D–W

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

Final rinse

RT (cold)

FD-W

Drying

with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

lumens and channels directly to the rinsing port of the injector carriage

■ Keep working ends open for cleaning

■ Place products in the ray with their hinges open. For MF807R* 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 sub-chapter:

D–W: FD–W:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

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

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

* If bone, tissue, or other gore is present on the instrument, remove it with a brush before initiating mechanical cleaning.

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.

Manual cleaning with immersion disinfection

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► 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

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfecting cleaning

RT (cold)

>15

D–W

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

Intermediate rinse

RT (cold)

D–W

III

Disinfection

RT (cold)

D–W

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

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

Final rinse

RT (cold)

FD-W

Mechanical cleaning/disinfecting

Drying

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

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.

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

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

► 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

Step

T [°C/°F]

Prerinse

<25/77

Cleaning

55/131

t [min]

Water quality

Chemical/Note

D–W

FD-W

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

■ 0.5 % working solution – pH = 11*

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.

III

Intermediate rinse

>10/50

FD-W

Thermal disinfecting

90/194

FD-W

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.

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 alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Mechanical cleaning/disinfection with manual pre-cleaning

Inspection, maintenance and checks

Damage (metal seizure/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: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

CAUTION

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

Disinfectant cleaning

RT (cold)

>15

D–W

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

► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-

Rinsing

RT (cold)

D–W

free of damage (e.g., broken insulation or loose, bent, broken, cracked, worn, or fractured components).

nical Service. ► Check for compatibility with associated products.

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

Packaging

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

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Ultrasonic cleaning

RT (cold)

>15

D–W

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

Rinsing

RT (cold)

D–W

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

Prerinse

<25/77

D–W

Cleaning

55/131

FD-W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

FD-W

Thermal disinfecting

90/194

FD-W

Drying

According to the program for cleaning and disinfection device

D–W: FD–W:

Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces. ► All instruments should be sterilized inside of the provided Aesculap tray unless otherwise instructed by an Aes-

culap representative. ► Validated sterilization process

– Steam sterilization through 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.

Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.

Manual pre-cleaning with ultrasound and brush

► Place the product in its holder or on a suitable tray. Ensure that all 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.

To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. 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] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 015036

2018-02

Änd.-Nr. 58241

Previous Page Next Page