Aesculap
AVM microclip applying forceps
AVM microclip applying forceps Instructions for Use/Technical Description
3 Pages
Preview
Page 1
Disassembling Aesculap® AVM microclip applying forceps CAUTION
Legend 1 Jaw piece with pulling rod 2 Sheath outer tube 3 Sheath 4 Rotary element 5 Lock pushbutton 6 Locking button 7 Branches left/right 8 Lock 9 Handle part 10 AVM microclip applying forceps
Symbols on product and packages Caution, see documentation supplied with the product
Ź Turn locking button 6 until it is in the position shown in Fig. 4. Ź Extract jaw piece with pulling rod 1 from sheath outer tube 2. Ź Extract sheath outer tube 2 from handle part 9, see Fig. 5.
Note Jaw piece with pulling rod 1 and sheath outer tube 2 cannot be removed from handle part 9 at the same time!
Assembling
CAUTION
CAUTION
at https://extranet.bbraun.com
Reduced functionality of the AVM microclip applying forceps caused by bending of, or damage to a component! Ź Proceed cautiously when disassembling the AVM microclip applying forceps. Ź Observe the sequential order of disassembly.
Ź Turn locking button 6 back to its initial position, see Fig. 6.
Applicable to Ź For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
Reduced functionality of the AVM microclip applying forceps caused by bending of, or damage to a component! Ź Proceed cautiously when disassembling the AVM microclip applying forceps. Ź Observe the sequential order of disassembly.
Excessive load on the AVM clips, caused by using a wrong combination of jaw piece with pulling rod, sheath outer tube and handle part! Ź Make certain the jaw piece with pulling rod, the sheath outer tube and the handle part carry the same code number. Ź Fully insert the sheath outer tube into the handle part.
Ź Insert jaw piece with pulling rod 1 into the sheath outer tube 2 as far as it will go, see Fig. 7. Ź Ensure that the correct position of the jaw piece with pulling rod 1 is maintained, see Fig. 8. Ź Check AVM microclip applying forceps 10 for proper functioning, see Safe operation.
Intended use The AVM microclip applying forceps is used for opening and closing the Aesculap AVM microclips. AVM microclips are used for temporary or permanent occlusion of small blood vessels in cases of arteriovenous malformation (AVM) in the brain.
Validated reprocessing procedure General safety notes
Indications, see Intended use.
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing.
Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.
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.
Contraindications
Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessing technician is responsible for this. The specified chemistry was used for validation.
Indications
None known.
Risks and side effects As part of the legal duty to inform, the following typical risks and side effects associated with the use of surgical instruments are referred to. These are predominantly procedure-specific, non product-specific and not limited to unwanted damage to surrounding tissue resulting in e.g. bleeding, infection, material incompatibilities or instrument parts remaining unnoticed in the patient, etc.
Available sizes The AVM microclip applying forceps are available in various working lengths, see brochure AVM microclips.
Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician! Ź Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. Ź Read, follow, and keep the instructions for use. Ź Use the product only in accordance with its intended use, see Intended use. Ź Clean the new product mechanically after removing its transport packaging and prior to its initial sterilization. Ź Store any new or unused products in a dry, clean, and safe place. Ź Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. Ź Do not use the product if it is damaged or defective. Set aside the product if it is damaged. Ź Replace any damaged components immediately with original spare parts.
Safe operation Risk of injury and/or malfunction! Ź Always carry out a function check prior to using the product. WARNING
Note For up-to-date information about 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 neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine. 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 damage to metallic products. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform 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: Ŷ Optical changes in 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. Ŷ Material damage such as corrosion, cracks, fracturing, premature aging, or swelling. Ź Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion Ź For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure Ź Disassemble the product immediately after use, as described in the respective instructions for use.
Preparations at the place of use Ź If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),
Engaging the lock and handing over the AVM microclip (Fig. 1) Ź Push the lock pushbutton 5 while simultaneously compressing the branches left/right 7.
Lock 8 is engaged now. With lock 8 engaged, jaw piece 1 is set in such a way that the AVM microclip is slightly clamped between jaws 1.
Releasing the lock and applying the AVM microclip (Fig. 2) Ź Swivel rotary element 4 until the AVM microclip is in the required position. Ź Compress branches left/right 7.
Jaw piece 1 of AVM microclip applying forceps 10 closes and the clamped AVM microclip opens. Lock 8 with lock pushbutton 5 automatically snaps back into the unlocked position, so that the AVM microclip can be applied. Ź Apply the AVM microclip on the blood vessel.
using a disposable syringe, for example. Ź Remove any visible surgical residues as much as possible with a damp, lint-free cloth. Ź Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
Cleaning/disinfection Product-specific safety notes on the reprocessing procedure Danger to the patient! Ź Reprocess the product only with manual pre-cleaning followed by mechanical cleaning. DANGER Risk to patient due to cross contamination! Ź Do not clean contaminated products together with uncontaminated products in a tray.
Detaching the AVM microclip applying forceps from the AVM microclip (Fig. 3) Ź Release the pressure on branches left/right 7.
Jaw piece 1 opens and the AVM microclip closes. Ź Detach AVM microclip applying forceps 10 from the AVM microclip.
DANGER
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! Ź Use cleaning and disinfecting agents according to the manufacturer’s instructions which are approved for (e.g. aluminum, plastics, high-grade steel). Ź Observe specifications regarding concentration, temperature and exposure time. Ź Do not exceed the maximum permitted cleaning temperature of 55 °C.
Ź 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. Ź 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. Ź Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.
Ź Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service. Ź Assemble dismountable products, see Assembling. Ź Check for compatibility with associated products.
Packaging Ź Appropriately protect products with fine working tips. Ź Store products with ratchet locks fully opened or locked no further than in the first notch. Ź Close the locks so that the jaw tips just touch each other. Ź Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. Ź Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). Ź Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Ź 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). Ź Validated sterilization process
Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfecting machine 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 machine used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with ultrasound Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Ultrasonic cleaning
RT (cold)
>15
1
D–W
Dr. Weigert neodisher® SeptoClean*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) Phase I Ź Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 15 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Ź Clean the product with a suitable cleaning brush (e.g. FM732800) in the solution until all visible residues have been removed from the surface. Ź If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush (e.g. FM732800). Ź Mobilize non-rigid components, such as set screws and hinges, during cleaning. Ź Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable syringe (20 ml). Phase II Ź Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. Ź Mobilize non-rigid components, such as set screws and hinges, during rinsing.
– 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 18 minutes for prion inactivation Ź When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.
Sterilization for the US market Ŷ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. Ŷ 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 Ź 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! Ź Do not modify the product.
Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound WARNING Phase
Step
T [°C/°F]
t [min]
Water quality
Chemicals
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD–W
Dr. Weigert neodisher® SeptoClean 1 %* working solution
III
Intermediate rinse
>10/50
1
FD–W
-
IV
Thermal disinfection
90/194
5
FD–W
-
V
Drying
-
-
-
In accordance with the program for the cleaning and disinfecting machine
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean) Ź Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots) Ź Connect components with lumens and canals directly to the special rinsing port of the injector cart. Ź Keep working ends open for cleaning. Ź Place instruments in the tray with their hinges open. Ź Check visible surfaces for residues after mechanical cleaning/disinfecting.
Ź 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 Ź Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Inspection, maintenance and checks
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! Ź 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).
Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA
Ź Allow the product to cool down to room temperature. Ź After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
TA-Nr. 011117
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). Ź Dry the product if it is wet or damp. Ź Repeat cleaning and disinfection of products that still show impurities or contamination. Ź Check that the product functions correctly.
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Änd.-Nr. 51256
SOP-AIC-5000549 Rev. 2 0318