PLASMACUP insertion instrument FS944R and FS947R

Assembling Aesculap® Plasmacup Insertion Instrument NF284R and FS947R

► Insert the connecting screw 6 through the upper opening in the handle 3 and press in until it is mounted in place. ► For the bent PLASMACUP insertion instrument FS947R, screw in the screw 7 with screwdriver NF371R (Fig. 4).

Using the T-handle NF283R (optional)

Legend 1 2 3 4 5 6 7 8

Risk of injury and/or material damage if hammer blows are applied to the T-handle! ► Do not apply blows to the T-handle NF283R.

Hammer head Cross-hole Handle Hammer plate Anti-rotation hexagon Fastening screw Fastening screw Instrument

WARNING ► Position T-handle NF283R between handle 3 and hammer head 1. ► Remove connecting screw 6 and apply T-handle NF283R to the square on the upper end of the handle 3. ► Mount connecting screw, see Assembling.

The T-handle NF283R is held in position by the hammer head 1. Its full load-bearing capacity is only ensured when the implant has been tightly screwed in.

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

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.

Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

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.

Intended use The insertion instrument NF284R/FS947R is used with the PLASMACUP implant system. It is used for the rotationfree adaptation, positioning and implantation of the implant, as well as its explantation. The insertion instrument is separated from the implant without stress on the implant. The insertion instrument can also be used with T-handle NF283R.

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,

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 www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

knowledge, or experience. ► Read, follow, and keep the instructions for use. ► The instructions for use of the implant must be followed. ► 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.

Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING

WARNING

Risk of injury and/or damage to the implant/insertion instrument from carrying out a position correction or if the connection is loose! ► Do not correct the position of an implant that has been firmly impacted in place. ► Carry out position corrections only if the implant has not been impacted in place. ► If the connection between the implant and insertion instrument becomes loose, re-tighten this connection immediately.

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.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble straight PLASMACUP insertion instrument NF284R immediately after use, as described in the

respective instructions for use.

Preparations at the place of use Implantation Note For all PLASMACUP insertion instruments there is an optional T-handle. Risk of damage to the implant thread due to overtightening of the connection screw! ► Do not tighten connection screw with an extension in the cross-hole. CAUTION ► Apply the insertion instrument onto the adaption site of the chosen PLASMACUP (Fig. 1 or Fig. 3). When doing

► 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.

Preparation before cleaning ► Disassemble straight PLASMACUP insertion instrument NF284R prior to cleaning, see Disassembling.

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

so, make certain that the anti-rotation hexagon 5 is correctly fitted in place. ► Turn fconnecting screw 6 to the right to connect the implant securely to the insertion instrument. ► PLASMACUP is implanted by applying powerful hammer blows on the hammer head 1 of the connecting screw or directly onto the instrument 8 (Fig. 3). CAUTION

Explantation ► Prior to explantation of the PLASMACUP insertion instrument, apply it to the adaption site and connect it

securely to the implant, see Implantation. ► Apply powerful blows with the slotted hammer NF275R against the hammer plate 4 of the insertion instrument

to explant the implant.

Disassembling ► Pull on the hammer head 1 and remove the fastening screw 6. ► If the connecting screw 6 is too tightly screwed in, insert the extension through the cross-hole 2 in the hammer

head 1 and loosen the connecting screw. ► For the bent PLASMACUP insertion instrument FS947R, remove the screw 7 with screwdriver NF371R (Fig. 4).

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 the material in question (e.g., aluminum, plastics, highgrade steel), – do not attack softeners, e.g. silicone. ► Observe specifications regarding concentration, temperature and exposure time.

► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure

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

Validated procedure

Specific requirements

Reference

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

■ Cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that

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

■ straight PLASMACUP insertion

is suitable for cleaning (avoiding rinsing blind spots).

instrument only FS947R

■ Chapter Manual pre-cleaning with a brush

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

■ Chapter Mechanical alkaline

– pH = 13 – <5 % anionic surfactant

cleaning and thermal disinfecting Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ Cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that

■ bent PLASMACUP insertion

is suitable for cleaning (avoiding rinsing blind spots).

instrument only NF284R

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

■ 0.5 % working solution – pH = 11* 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

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

Manual cleaning/disinfection Risk to patients! ► The product must only be cleaned mechanically!

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

DANGER

Inspection, maintenance and checks Mechanical cleaning/disinfection with manual pre-cleaning 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.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

CAUTION

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).

► 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

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

nical Service.

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

► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

Packaging

► 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.

Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

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

-

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-

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.

► 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.

Steam sterilization Note The straight PLASMACUP insertion instrument FS947R can be sterilized either in disassembled or in assembled 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 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. 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.

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

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: 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 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 010181

02/13

V6

Änd.-Nr. 46127