BBraun
Acetabular reamer NG538R ... NG568R Reamer shafts NG621R ... NG639RFS940R, FS941R (navigable
40 Pages
Preview
Page 1
4.3
Aesculap® Acetabular reamer NG538R ... NG568R NG639R FS940R, FS941R (navigable)
Assembling the reamer shafts
Note The direction of the arrow for assembly is indicated on the instrument with the marking "Apply".
Reamer shafts NG621R ...
► Place the spring bolt in its receptacle. When doing so, ensure that the trigger remains in the slotted hole. ► Push driver plate 1 onto the reamer shaft in the direction of the arrow.
5.
Validated reprocessing procedure
5.1
General safety instructions
Legend 1 Driver plate 2 Shaft 3 Bolt
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
1.
Applicable to
► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
2.
Safe handling
CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
3.
Product description
3.1
Intended use
The acetabular reamers are used for preparing the implant bed for spherical hip cups. They are powered preferably by motor handpieces with a maximum rotational speed of 3001/min.
3.2
Operating principle
The appropriate reamer shaft is selected according to the reamer size. Up to and including reamer size 48 mm, reamer shafts are available with a small adapter (NG621R ... NG629R, FS940R), for reamer sizes larger than 50 mm, reamer shafts are available with a large adapter (NG631R ... NG639R, FS941R). Shaft adapters with Harris, AO/Protek, Hudson or triangular connectors are available for the individual motor handpieces.
4.
Working with the acetabular reamers
WARNING
Risk of injury and material damage due to inappropriate use of handpieces or motors! ► Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ► Do not exceed the specified maximum motor speed. Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.
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 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.
5.2
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.
5.3
Dismantling prior to carrying out the reprocessing procedure
Note The reamer shafts can be disassembled for cleaning without tools. Note The direction of the arrow for disassembly is indicated on the instrument with the marking "Clean". ► Push driver plate 1 in the direction of the arrow beyond the locking resistance of the shaft 2 . ► Remove bolt 3 together with the spring.
5.4
Preparations at the place of use
► 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.
5.5
Preparation before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
WARNING
5.6
WARNING
Risk of injury from cutting instruments! The acetabulum can become too big. The pelvic floor can be breached. ► Work carefully with caution ► Avoid applying excessive pressure
Note Use of the appropriate tissue protection sleeve is recommended to protect soft parts and for a better guide of the instrument.
4.1
Assembling/disassembling the reamers and shafts
Note The reamer shaft can be guided using the protective sleeve. ► Lock the reamer attachment (reamer head) to the reamer shaft via the bayonet adapter. ► Pull back the bolt, turn the shaft back in a counterclockwise direction as far as it will go and detach.
4.2
Working with the reamers
Note Empty the reamer basket when full. When the reamer basket is full, the reamer no longer cuts properly and the shaft coupling becomes difficult to open. It may be necessary to empty the reamer basket before the end of the procedure. Note Normally, the end face of the reamer corresponds to the correct insertion depth of the hip cup. Observe the manufacturer's instructions for the cup components used. ► Prepare the acetabulum step by step, starting with a small reamer. The reamer profile is hemispherical.
Cleaning/disinfection
Product-specific safety instructions for 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 – be approved for plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.
► 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/disinfecting.
5.8
Validated cleaning and disinfection procedure Validated procedure
Special features
Reference
Manual cleaning with ultrasound and immersion disinfection
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free
Chapter Manual cleaning/disinfecting and subsection:
■ Chapter Manual cleaning with ultrasound and immersion disinfection
cloth or compressed air for medical purposes Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfecting
■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the instrument in a tray
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
that is suitable for cleaning (avoiding rinsing blind spots).
with ultrasound and brush
■ Chapter Manual pre-cleaning ■ Chapter Mechanical alkaline cleaning and thermal disinfecting
5.7
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 device used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with ultrasound and brush Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic 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
Manual cleaning/disinfecting
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infecting solution.
infection procedure.
► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.
Manual cleaning with ultrasound and immersion disinfection Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic 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
-
-
-
-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed
Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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]
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*
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
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
Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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.
D–W: FD–W:
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.
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline
5.9
Inspection, maintenance and checks
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 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 sort out damaged or inoperative products and have them sent to AesculapTechnical Service, see Technical Service. ► Assemble separable products, see Assembling the reamer shafts. ► Check for compatibility with associated products.
5.10 Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.
5.11 Steam sterilization Note The product may only be sterilized when dismantled. ► 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
– Disassemble the instrument – Steam sterilization through 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.
5.12 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.
5.13 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
6.
Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING
► For service and repairs, please contact your national B. Braun/Aesculapp 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 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420 Other service addresses can be obtained from the address indicated above.
7.
Disposal
Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
agency, see Technical Service.
8.
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. 010035
11/12
V6
Änd.-Nr. 46258