BBraun
Radiolucent valves for CASPAR CERVICAL RETRACTOR
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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.
Aesculap® Radiolucent valves for CASPAR CERVICAL RETRACTOR
Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Legend
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.
1 CCR valve, radiolucent, blunt, 19 x 70 mm SL, front view, BW269P 2 CCR valve, radiolucent, blunt, 19 x 70 mm SL, rear view, BW269P 3 CCR valve, radiolucent, serrated, 19 x 70 mm SL, rear view, BW259P
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
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 Date of manufacture
Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use The radiolucent valves for the CASPAR CERVICAL RETRACTOR are used for creating and keeping open the surgical approach in the anterior cervical region of the spine (e.g., for dynamic cervical plate osteosynthesis). The radiolucent valves made of plastic and the retractors with radiolucent blade adapters complement the existing range of valves and retractors made of steel and titanium. They serve for X-ray monitoring of the position of the implant and instruments during the implantation of a cervical disk replacement, for example (activ C). The radiolucent plastic used as the valve material precludes the shadow formation that hinders the lateral view when steel or titanium valves are used. The blade adapters made of radiolucent plastic material ensure visibility in the anteriorposterior direction.
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
Available sizes Art. no.
Designation
BW251P
CCR valve, radiolucent, serrated, 19 x 30 mm SL
BW252P
CCR valve, radiolucent, serrated, 19 x 35 mm SL
BW253P
CCR valve, radiolucent, serrated, 19 x 40 mm SL
BW254P
CCR valve, radiolucent, serrated, 19 x 45 mm SL
BW255P
CCR valve, radiolucent, serrated, 19 x 50 mm SL
BW256P
CCR valve, radiolucent, serrated, 19 x 55 mm SL
BW257P
CCR valve, radiolucent, serrated, 19 x 60 mm SL
BW258P
CCR valve, radiolucent, serrated, 19 x 65 mm SL
BW259P
CCR valve, radiolucent, serrated, 19 x 70 mm SL
BW261P
CCR valve, radiolucent, blunt, 19 x 30 mm SL
BW262P
CCR valve, radiolucent, blunt, 19 x 35 mm SL
BW263P
CCR valve, radiolucent, blunt, 19 x 40 mm SL
BW264P
CCR valve, radiolucent, blunt, 19 x 45 mm SL
BW265P
CCR valve, radiolucent, blunt, 19 x 50 mm SL
BW266P
CCR valve, radiolucent, blunt, 19 x 55 mm SL
BW267P
CCR valve, radiolucent, blunt, 19 x 60 mm SL
BW268P
CCR valve, radiolucent, blunt, 19 x 65 mm SL
► 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
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 materials, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 93 °C.
► 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/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfection. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.
Validated cleaning and disinfection procedure
BW269P
CCR valve, radiolucent, blunt, 19 x 70 mm SL
Validated procedure
Specific requirements
Reference
Manual cleaning and wipe disinfection
■ When cleaning instruments
Chapter Manual cleaning/disinfection and sub-chapter:
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. trocar).
Validated reprocessing procedure
with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ Chapter Manual cleaning and wipe disinfecting
■ Drying phase: Use a lint-free cloth Mechanical alkaline cleaning and thermal disinfection
■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).
Chapter Mechanical cleaning/disinfecting and sub-chapter:
■ Chapter Mechanical alkaline
■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.
■ Place instruments 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 dis-
infecting solution.
General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
cleaning and thermal disinfecting
► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.
Steam sterilization
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
-
-
-
-
Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature
RT:
Phase I ► Clean the product under running faucet water, 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. 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. Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► 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.
– Steam sterilization using 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 instruments 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. 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 ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Technical Service
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.
Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.
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 mechanical cleaning/disinfecting.
Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument 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. ► Check for compatibility with associated products.
Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► 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 sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
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. 012590
2017-11
V6
Änd.-Nr. 57867