BBraun
Instruments for minimally invasive thoracic surgery
43 Pages
Preview
Page 1
Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.
Aesculap® Instruments for minimally invasive thoracic surgery WARNING
Legend 1 2 3 4 5 6 7 8 9
Handle (complete) Actuating button for assembly/disassembly HF pin Movable handle part Actuating lever for lock Shaft (complete) Outer tube Instrument shaft Pushing rod
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
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 Modular tubular shaft instruments for use in minimally invasive thoracic surgery. Depending on the particular jaw configuration, the instruments are used for the following, among others: ■ Cutting ■ Dissecting ■ Grasping ■ Taking biopsies ■ Coagulating tissue ■ Suturing tissue
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 tip: Exercise care when passing the product through the working channel. Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ► Observe the safety guidelines in the instructions for use of the HF device. WARNING
WARNING
Thermal injuries to patients/users due to insufficient insulation of leads in active accessories! ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage does match or not exceed the accessory voltage rating specified for the product. ► Use the instrument only with an insulated outer tube.
The manufacturer has tested the product and verified that its insulation can withstand 300 reprocessing cycles. In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions. ► Adjust the HF power output (and argon flow rate) to the intervention to be carried out. Take into account clinical experience or reference values. ► Select the lowest possible HF power output. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab. The product is furnished with the following connection on the plug side: pin, 4 mm, sprung. Refer to our brochures to find a compatible cable. The accessory voltage rating of the product is 2 500 Vp. The accessory voltage rating must exceed or be equal to the maximum peak output voltage at which the product is operated in combination with an appropriate HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2). To avoid HF burns: ► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated. ► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories. ► Before each use, inspect products visually for damage and surface changes on the insulation. ► Never place the product on or next to the patient. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device. ► Follow the instructions for use of the HF device. Note Push rods from bent instruments must not be used in straight instrument shafts.
Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING
DANGER
Risk of injury from unintentional opening of the lock or pressing the actuating button! ► During use, ensure that the lock is not released and the actuating button is not pressed.
► To open and close the distal end of the jaws: Open and close the movable part of the handle 4.
Handle with lock The actuating lever 5 is used for deactivating the locking mechanism both permanently and temporarily. ► For releasing the locking mechanism permanently: Push the actuating lever 5 forward, see Fig. A. The actuating lever 5 engages in the top position. ► For releasing the locking mechanism temporarily: Push the actuating lever 5 backward, see Fig. B.
Disassembling ► Release the locking mechanism permanently: Push the actuating lever 5 forward, see Fig. A. ► Detach the shaft 6 from the handle1:
– Press the actuating button 2, see Fig. C. – Hold the instrument shaft 8 by the tip and remove it from the handle 1 together with the outer tube 7. Do not hold the movable part of the handle at this stage. The movable part of the handle 4 will move up. ► Disassemble the shaft 6: – Remove the outer tube 7 from the instrument shaft 8, see Fig. D. – Turn the push rod 9 90° counterclockwise (from Position 2 to Position 1) and remove it from the instrument shaft 8, see Fig. E.
Assembling ► Release the locking mechanism permanently: Push the actuating lever 5 forward, see Fig. A. ► Assemble the shaft 6:
– Insert the push rod 9 into the instrument shaft 8 (Position 1) and turn it 90° clockwise (from Position 1 to Position 2), see Fig. E. – Slide the outer tube 7 onto the instrument shaft 8 as far as it will go. ► Push the shaft 6 into the handle 1: – With one hand, hold the shaft 6 by the tip. – With the other hand, hold the handle 1 near to the insertion opening. When doing so, make certain that the movable handle part is freely movable. – Push the shaft 6 into the handle 1, observing the markings, see Fig. C. The movable part of the handle 4 will move down. The actuating button 2 engages automatically when it reaches the stop. ► Carry out a function test: Open and close the jaw parts.
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 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. 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
Manual cleaning/disinfection
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.
Risk to patients! ► The product must only be cleaned mechanically! DANGER ► 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
-
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
-
-
-
-
Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use. ► Open up products with hinges.
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.
Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection
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.
Product-specific safety notes on the reprocessing procedure
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Only use permitted cleaning and disinfecting agents and follow the manufacturers’ instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection 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.
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:
cleaning.
■ Chapter Manual cleaning with immersion disinfection
■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning. cloth or medical compressed air
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.
■ Keep working ends open for cleaning.
■ Place products in the tray with 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. ► 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. 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. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
■ Drying phase: Use a lint-free Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
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.
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
Mechanical cleaning/disinfection with manual pre-cleaning
Steam sterilization
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 product can be sterilized either in disassembled or in assembled condition.
Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Note To avoid breakage due to stress crack corrosion, sterilize the product 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
Manual pre-cleaning with a brush
opening any valves and faucets).
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*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed
► Validated sterilization process
– Steam sterilization using fractional 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.
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:
► 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.
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.
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.
Storage
Mechanical alkaline cleaning and thermal disinfecting
Technical Service
Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
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:
Risk of injury and/or malfunction! ► Do not modify the product. WARNING
– 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
CAUTION
► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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. ► Assemble dismountable products, see Assembling. ► 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 Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
► 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.
Accessories/Spare parts For accessories and spare parts, see brochure C85601.
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. 014894
11/16
V6
Änd.-Nr. 55864