S4 Cervical flexible insertion instrument for locking screws

Safe operation

WARNING

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

Use a locking screw

DANGER

Damage to the S4 C screw due to incorrectly applied S4 C screwdriver when screwing in the locking screw! ► Always use a FW104R counter-torque for assistance when screwing in the S4 C locking screw into the plate socket. ► Never use the S4 C flexible insertion instrument for FW109R locking screws for tightening the locking screw. ► Always bend S4 C flexible insertion instrument for FW109R locking screws straight before removing the instruments. ► There is further information on this in TA011984 and TA012266

Removing S4 Cervical implants

DANGER

Damage to the S4 C flexible insertion instrument for FW109R locking screws! ► Never use the S4 C flexible insertion instrument for FW109R locking screws for turning out the locking screws. ► To turn out the locking screw, use the S4 C instrument for turning out screws (FW099R from the occipital instrument set or FW064R from the standard instrument set) and counter-torque.

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Aesculap® S4® Cervical flexible insertion instrument for locking screws S4 C flexible insertion instrument for locking screws FW109R

DANGER

Malpositioning of the instruments or implants may cause external/serious complications for the patient! ► Perform all surgical steps with x-ray control. ► When removing the S4 C flexible insertion instruments for FW109R locking screws and in subsequent surgical steps, always ensure that the connecting end is positioned securely in the FW104R countertorque. ► Ensure that the S4 C flexible insertion instrument for FW109R locking screws is no longer under bending tension when it is removed.

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.

► Insert the SW002T or SW003T locking screw

securely into the self-holding hexagon screw retainerof the bendable instrument, see Use a locking screw. ► Insert the locking screw into the plate socket and tighten in using the counter-torque, see Use a locking screw ► Let the locking screw grip in the socket and detach the S4 C flexible insertion instrument for FW109R locking screws. ► With the torque handle, tighten the FW103R locking screw to the final torque as per TA012367.

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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.

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.a-k-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.

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Aesculap® S4® Cervical flexible insertion instrument for locking screws Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

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 surgical steels, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 55 °C. ► Do not use any cleaning and disinfecting agents that contain hydrogen peroxide.

► Use suitable cleaning/disinfecting agents if the

product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

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► 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 Validated procedure

Specific requirements

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with

Chapter Manual cleaning/disinfection and sub-chapter: ■ Chapter Manual cleaning and wipe disinfecting

movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth ■ Ensure that the product is positioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.)

■ Hold the product in such a way that water cannot enter e.g. through couplings or adapters. Mechanical alkaline cleaning and thermal disinfection

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

■ Connect components with lumens

Chapter Mechanical cleaning/disinfecting and sub-chapter: ■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

■ Place products in the tray with their hinges open.

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off

for a sufficient length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.

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Aesculap® S4® Cervical flexible insertion instrument for locking screws Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

Phase I

Phase IV

► Clean the product under running faucet water,

► After the specified exposure time (at least 1 min),

using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning.

rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.

Phase II ► Dry the product in the drying phase with suitable

equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use

disinfectant wipe.

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Phase V ► Dry the product in the drying phase with suitable

equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

Mechanical cleaning/disinfecting 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 Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Prerinse

<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* 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 alkaline ► Check visible surfaces for residues after mechani-

cal cleaning/disinfecting.

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Aesculap® S4® Cervical flexible insertion instrument for locking screws Inspection, maintenance and checks ► Allow the product to cool down to room tempera-

ture. ► 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 Technical Service. ► Check for compatibility with associated products.

Packaging

► 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

► Appropriately protect products with fine working

tips. ► 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 ► 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

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*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.

Storage

Disposal

► Store sterile products in germ-proof packaging,

► Adhere to national regulations when disposing of

protected from dust, in a dry, dark, temperaturecontrolled area.

or recycling the product, its components and its packaging!

Technical Service

WARNING

Risk of injury and/or malfunction! ► Do not modify the product.

► 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.

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

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.

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