BBraun
Noir Suprême micro instruments
33 Pages
Preview
Page 1
Aesculap® Noir Suprême micro instruments Legend 1 2 3 4
Spring connection Spring with eye Branches Spring with hook
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
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
► 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 ► For needle holders and scissors: Open the spring connection prior to cleaning, see Disassembling.
Cleaning/disinfection
Intended use
Product-specific safety notes on the reprocessing procedure
The Noir Suprême micro instruments include scissors, needle holders and forceps. The micro needle holders are used for grasping, holding and guiding surgical suture needles and surgical suture material in microsurgical procedures. The micro scissors are used for cutting cut tissue and vessels in microsurgical procedures. The micro forceps and grasping forceps are used for grasping/removing tumors or tissue and for inserting/removing synthetic or natural materials in microsurgical procedures.
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. ► Always carry out a function test prior to each use of the product.
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfectant agents in line with the manufacturer's instructions that are approved for stainless steel. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permissible cleaning temperature of 90 °C.
► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product.
Validated cleaning and disinfection procedure Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Keep working ends open for
Chapter Manual cleaning/disinfection and sub-chapter:
movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ Drying phase: Use a lint-free
► To undo the spring connection 1:
Assembling
immersion disinfection
■ When cleaning products with
Disassembling – Carefully pull apart branches 3 until the springs 2 and 4 are at an angle of approx. 90° from each other, see Fig. A. – Press the spring with eye 2 at the point marked with the arrow and separate branches 3.
■ Chapter Manual cleaning with
cleaning.
cloth or medical compressed air Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
► Join branches 3 together, see Fig. B. ► Press spring with eye 2 and engage the opposite spring with hook 4 in eye.
■ Keep working ends open for
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
cleaning.
■ Place products in the tray with
Validated reprocessing procedure
their hinges open.
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.
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*
Note If there is no final sterilization, then a virucidal disinfectant must be used.
II
Intermediate rinse
RT (cold)
1
-
D–W
-
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.
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
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.
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.
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.
Inspection, maintenance and checks
CAUTION
► 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. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.
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.
Packaging
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
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.
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).
► 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.
► 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
– 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 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.
Storage Manual pre-cleaning with a brush
► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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*
Rinsing
RT (cold)
1
II
-
Validated reprocessing procedure for the US market
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 ► 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.
Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
I
Prerinse
<25/77
II
Cleaning
55/131
t [min]
Water quality
Chemical
3
D–W
-
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
Manual cleaning and disinfection Phase I ► Prepare washing solution following instructions on solution label using unheated utility water. ► Open or disassemble instrument/s so solution can reach all instrument surfaces and submerge instrument/s in solution. ► Brush all surfaces until visibly clean with a soft or medium bristle brush brushing hard to clean areas such as lumens, special rotating areas and hidden surfaces 4 times (back and forth = 1 time). ► Move moving parts during washing to reach all surfaces and flush lumens 4 times with at least 20cc washing solution using a syringe. Phase II ► Rinse by placing instruments under critical water and expose all surfaces of the device under the water flow for 3 times. ► Move parts during the rinsing to rinse all surfaces and flush lumens 4 times with at least 20cc washing solution using a syringe. Phase III ► Use heat or low-linting cloth to dry instruments following final rinse (not required if followed by mechanical cleaning process). Phase IV ► Visually inspect instruments for remaining soil or washing solution. ► Repeat manual washing and/or rinsing steps until instrument is free from soil or washing solution.
Mechanical Cleaning Phase I ► Use unheated utility water rinse for at least 1 minute (may be part of automated washer program). Phase II ► Using unheated utility water, follow washing instructions for recommended dilution in washer. ► Open or disassemble instrument/s so washing solution can reach all instrument surfaces and wash tube structure (lumens) using flush attachments in washer if available or use manual method. ► Use wash cycle for at least 6 minutes. Phase III ► Use minimum 180 °F critical water rinse for at least 2 minutes. Phase IV ► Dry at 194 °F for 10 minutes – or – ► Use the manual dry method. Phase V ► Visually inspect instruments for remaining soil or washing solution. ► Repeat cleaning steps until instrument is free from soil or washing solution.
Steam sterilization Steam sterilization parameters Sterilization
Validation testing exposure time
Validation testing dry time
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
Sterilization method
Temperature
Packaged
Length
Terminal sterilization Dynamic air removal (Pre-Vac)
270 °F (132 °C)
4 minutes
15 minutes
Terminal Sterilization Dynamic air removal (Pre-Vac) without dry time
0 minutes
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 Inc. 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 Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 014287
2017-10
V6
Änd.-Nr. 57571