S4 bending template for rods (single-use instrument)

► 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.

®

Aesculap S4 bending template for rods (single-use instrument)

Cleaning/disinfection

Symbols on product and packages

Product-specific safety notes on the reprocessing procedure

Product supplied in unsterile condition Not for reuse in intended applications as defined by the manufacturer

WARNING

Date of manufacture CAUTION

Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess the product if it has been directly or indirectly contaminated with blood.

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 plastic material and 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 temperature of 55 °C.

LOT

Manufacturer’s batch designation

REF

Manufacturer’s article number

► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

Delivery quantity

► Carry out ultrasound cleaning:

QTY

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. – 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.

CE-approved in accordance with Directive 93/42/EEC

Validated cleaning and disinfection procedure

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

at https://extranet.bbraun.com

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

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

Chapter Manual cleaning/disinfection and sub-chapter:

Intended use The S4 bending template for rods is used to determine the final shape of the S4 spinal rods to be implanted.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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. ► Do not reprocess the product if it has been directly or indirectly contaminated with blood. ► Store any new or unused products in a dry, clean, and safe place. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not shorten the product. ► Do not implant the product.

■ Chapter Manual cleaning with immersion disinfection

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

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

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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 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

-

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.

III

Disinfection

RT (cold)

15

2

D–W

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

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

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 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 up-to-date information about 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.

D–W: FD–W:

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 ► 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.