BBraun
S4 MIS Spyder compressor distractor instrumentation set
50 Pages
Preview
Page 1
Aesculap® S4® MIS Spyder compressor/distractor instrumentation set
Damage to the torque wrench due to improper use loosening screws! ► Always use the removal screwdriver for set screws (FW193R or ME299R) to loosen tightened set screws. CAUTION ► Ensure that the compressor lever 3 or distractor lever 4 are attached to the down tube 2 following the procedure.
Incorrectly assembled components will lead to complications such as the inability to hold the desired compression/distraction using the rack.
Legend 1 2 3 4 5 6 7 a b 8 9
S4/S4 Element MIS torque limiting driver (ME395R) S4/S4 Element MIS down tube (ME396R) S4 MIS compressor lever (ME307R) S4 MIS distractor lever (ME308R) S4 MIS counter torque wrench (ME309R) S4 MIS set screw starter (ME314R) Disassembling S4/S4 Element MIS down tube (ME396R) Down tube not ready for cleaning Down tube disassembled and ready for cleaning Assembling S4 MIS compressor lever (ME307R) Assembling S4 MIS distractor lever (ME308R)
Symbols on product and packages Caution, general warning symbol Caution, see documentation supplied with the product
Maintenance label Recommended date of next service (format: month/year)
► Ensure that the down tube 2 as well as the compressor lever 3 or distractor lever 4 are placed as low down as
possible – with the drive tube down onto the level of the rod and the nubs on the distal tip of the compressor lever or distractor lever contacting the screw below the level of the rod. Risk of over-distraction/compression! The instruments apply forces with a significant mechanical advantage. ► Do not over-compress or distract. WARNING ► When using the counter torque wrench and applying torque to tighten the set screw always follow the instruc-
tions in the general S4 instructions for use.
CAUTION
Risk of damage to down tube or screw! Over-tightening or incorrect tightening can lead to head splaying that will result in difficulty removing the down tube or even potentially subsequent screw loosening problems. ► Do not over-tighten the set screw.
► Always use the counter torque wrench 5 fitted in the groove of the down tube 2 to apply counter torque.
Risk of damage to rack mounting or pins on the instrument handles! ► Do not apply counter torque using the rack or branch of the compressor/distractor handle. CAUTION
MM-YY Date of manufacture
Disassembling S4/S4 Element MIS down tube (ME396R) (Fig. 7)
Serial Number
► Thread the nut away from the shaft until it completely disengages from the threaded part of the lever and is
within the “CLEAN” zone printed at the end of the lever.
Assembling Compressor lever (ME307R) onto down tube (ME396R) (Fig. 8)
Applicable to S4, S4 Element and Spyder retractor system ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use The instrumentation is intended for use during posterior fusion of the lumbar spine with the S4 and S4 Element systems to apply compression and/or distraction forces between the S4 pedicle screws. The instrumentation is designed for use during the minimal invasive approach to the spine.
Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order 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.
Safe operation
Risk of injury/correction loss due to improper mounting of the clamping screw! ► Set the clamping screw in place correctly. ► Make certain that rods are correctly positioned on the floor of the groove. ► Tighten the clamping screw with the torque limiting driver (ME395R) in one hand and always apply counter-pressure using the counter torque wrench (ME309R) in the other hand. ► Break off the tabs on the S4 screws only when the clamping screw has been fully tightened. Damage to the down tube (ME396R) due to improper usage! ► Always slide the down tube over the screw head onto the rod as far as it will go. In doing so, make sure that the rod entirely engages into the slot at the working tip. ► Make sure that the rod protrudes on both sides of the down tube.
► Tighten the clamping screws turning the torque limiting driver 1 evenly in a clockwise direction. In doing so,
ensure that the torque limiting driver is turned without jerk.
WARNING
with the ‘1b’ arrow on the down tube slot. The proximal (longer) arm of the compressor lever should be underneath the hinged ratchet. The nubs on the end of the distal end of the compressor lever should be facing inward towards the down tube. ► Lower the hinged ratchet until it engages the proximal arm of the compressor lever. ► Thread the thumb nut so that it secures the proximal arm on the outside. The compressor lever is ready for use.
Distractor lever (ME308R) onto down tube (ME396R) (Fig. 9) Note The distractor lever 4 must be assembled onto the down tube prior to attaching the counter torque wrench 5 onto the down tube. ► Lift the hinged ratchet on the down tube 2 until it is fully upright. ► Lower the distractor lever 4 onto the down tube so that the ‘2’ arrow on the distractor lever pin is aligned with
the ‘2’ arrow on the down tube slot. The proximal (longer) arm of the distractor lever should be underneath the hinged ratchet. The nubs on the end of the distal arm of the distractor lever should be facing outwards away from the down tube. ► Lower the hinged ratchet until it engages the proximal arm of the distractor lever. ► Thread the thumb nut so that it secures the proximal arm on the outside. The distractor lever is ready for use.
General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
WARNING
CAUTION
► Lift the hinged ratchet on the down tube 2 until it is fully upright. ► Lower the compressor lever 3 onto the down tube so that the ‘1’ arrow on the compressor lever pin is aligned
Validated reprocessing procedure Risk of injury and/or malfunction! ► Always carry out a functional check prior to using the product.
WARNING
Note The compressor lever 3 must be assembled onto the down tube 2 prior to inserting the torque limiting driver 1 and the counter torque wrench 5 onto the down tube.
Risk of injury/correction loss by using an unchecked torque wrench! ► Prior to each use, check whether the next service date has been reached. ► Do not continue to use torque wrenches with an expired service date. ► Send torque wrenches with an expired service date to technical service for checking, see Technical Service.
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 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.
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
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.
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
-
-
-
-
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.
Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection Product-specific safety notes on 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 – are approved for high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time.
► 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.
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.
► Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting. ► Use caution during cleaning and sterilization. A non-fibrous sponge should be used to wipe off all blood and debris. ► Wear appropriate protective gloves, eyewear and clothing when handling biologically contaminated instruments.
Validated cleaning and disinfection procedure Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Cleaning brush: TA011944,
Chapter Manual cleaning/disinfection and sub-chapter:
TE654202 or GK469200
■ Chapter Manual cleaning with
■ Cleaning brush: TA011944,
■ ME396R
TE654202 or GK469200
Chapter Manual cleaning/disinfection and sub-chapter:
■ Disposable syringe 20 ml ■ When cleaning products with
ultrasound and immersion disinfection
movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
■ ME307R ■ ME308R ■ ME309R ■ ME314R ■ ME395R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection
■ ME396R
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
-
-
-
-
immersion disinfection
Manual cleaning with ultrasound and immersion disinfection
Mechanical alkaline cleaning and thermal disinfection
Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
Manual cleaning with ultrasound and immersion disinfection
Validated procedure
■ ME307R ■ ME308R ■ ME309R ■ ME314R ■ ME395R
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.
■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Chapter Manual cleaning with
D–W: FD–W: Chapter Mechanical cleaning/disinfecting and sub-chapter:
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
■ Cleaning brush: TA011944, TE654202 or GK469200
■ Disposable syringe 20 ml ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed
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
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. 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. ► 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.
Mechanical alkaline cleaning and thermal disinfecting Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
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.
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
Machine type: single-chamber cleaning/disinfection device without ultrasound
– pH = 13 – <5 % anionic surfactant
Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
■ 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
Mechanical cleaning/disinfecting 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. D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline
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/Note
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
Inspection, maintenance and checks – 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
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). -
-
-
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
► 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
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
► 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.
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.
Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► 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).
Manual pre-cleaning with a brush
► Validated sterilization process
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 ► 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.
– 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 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: 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 ► 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: Aesculap Implant Systems LLC 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 Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 013901
2017-12
V6
Änd.-Nr. 57993