Aesculap
245 mm Titanium Double Bayonet Clip Applier with Latch, Color-Coded Red, Accommodates Mini Clips
YASARGIL Aneurysm Clip Applier Forceps Instructions for Use/Technical Description
4 Pages
Preview
Page 1
Detach the clip applier forceps from the aneurysm clip ► Fully release branches left/right 2, see Fig. D).
Jaw piece 1 of clip applier forceps 7 opens and the aneurysm clip closes.
®
Aesculap YASARGIL aneurysm clip applier forceps
► Detach clip applier forceps 7 from the aneurysm clip.
Validated reprocessing procedure Legend 1 2 3 4 5 6 7
General safety instructions
Jaw part Branches left/right Color-coding button Lock pushbutton Lock Spring Clip applier forceps
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note Sincepatients no reprocessing methods have been validated for removal of transmissible spongiform encephalopathy agents medical For with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD,(TSE) observe thefrom relevant devices, this device should not be usedthe forreprocessing patients with known or suspected TSE agent disease, including CJD and vCJD. national regulations concerning of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
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.
Intended use
Intended useaneurysm clip applier forceps are used for opening and applying Aesculap The YASARGIL
The YASARGILaneurysm aneurysm clip applier forceps are used for opening, closing and applying Aesculap YASARGIL aneurysm YASARGIL clips. clips.
The clip appliers are MR Unsafe.
Note Aesculap In the following text, Aesculap YASARGIL aneurysm clips are referred to as aneurysm clips.
Available sizes All clip applier forceps are marked according to size (Mini or Standard) and clip material (Phynox or titanium) so that their correct application with aneurysm clips of the respective size and material is ensured. For detailed information on the available sizes, see the YASARGIL Aneurysm clip brochurefor clip applier forceps.
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.
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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
Safe operation
► Open up products with hinges.
Damage to, imprecise functioning and incorrect closing force of the aneurysm clips caused by using the wrong applier forceps! ► Use aneurysm clips only with the matching applier forceps; note the respective color of the color-coding button.
CAUTION
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.
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.
► Observe color of color-coding button 3.
Size
Titanium aneurysm clips
Phynox aneurysm clips
Standard
Blue
Black
Mini
Red
Gray
Use clips and clip applier forceps only in the following combinations: ■ Phynox aneurysm clips with the clip applier forceps for Phynox aneurysm clips ■ Titanium aneurysm clips with the clip applier forceps for titanium aneurysm clips ■ Mini and Standard aneurysm clips must be applied with the clip applying forceps of the appropriate size (Mini or Standard, respectively).
Cleaning/disinfection Product-specific safety notes on the reprocessing procedure
CAUTION
Locking function Note The clip applier forceps can be used with or without locking function.
Use without locking function ► Insert the aneurysm clip into jaw piece 1. ► Compress branches left/right 2.
The inserted aneurysm clip opens.
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 55 °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. ► 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
► Fully release branches left/right 2.
The aneurysm clip closes. ► Detach clip applier forceps 7 from the aneurysm clip.
Use with locking function Inserting the aneurysm clip and engaging the lock ► Insert the aneurysm clip into jaws 1. ► Press lock push button 4 while compressing branches left/right 2, see Fig. A).
Lock 5 is engaged, see Fig. B). With lock 5 engaged, jaws 1are tensioned so that the aneurysm clip is lightly clamped in between jaws 1.
Releasing the lock ► Compress branches left/right 2 to the positive stop.
Jaws 1 of clip applier forceps 7 closes and the aneurysm clip opens. Spring 6 switches automatically to the unlocked position, see Fig. C).
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Cleaning brush ■ 20 ml disposable syringe ■ When cleaning products with mov-
Chapter Manual cleaning/disinfection and sub-chapter:
able hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ Drying phase: Use a lint-free cloth or medical compressed air
■ Chapter Manual cleaning with immersion disinfection
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 is
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:
suitable for cleaning (avoiding rinsing blind spots).
■ Place products in the tray with
► 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.
■ Chapter Manual pre-cleaning with a brush
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
their hinges open.
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
Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
Phase
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
-
III
Disinfection
RT (cold)
15
2
D–W
IV
Final rinse
RT (cold)
1
-
V
Drying
RT
-
-
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: – 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
-
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
V
Drying
-
-
-
According to the program for cleaning and disinfection device
FD-W
-
D–W: FD–W:
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed
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
► 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.
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. ► Check for compatibility with associated products.
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. 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 ► 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
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 fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractional 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.
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).
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.
Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters*
Manual pre-cleaning with a brush Phase
I
II
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
Disinfectant cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed
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.
► 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.
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. 012544 09/14
11/12
V6
Änd.-Nr. 45567