Legend Fig. 1-111 Rod2 White button3 Lever to fold UNITRAC support arm for storage4 Coupling piece5 UNITRAC quick-release coupling RT020R6 Sterile cover JG9017 Symbol8 UNITRAC compressed-air connector9 Sleeve compressed-air hose10 UNITRAC compressed-air hose11 Pressure reducer GA09912 Compressed gas cylinder13 Slide sleeve cartridge adapter14 Instrument15 SleeveFig. 12-2316 UNITRAC support arm17 Mount - quick-release coupling18 Lock nut19 UNITRAC quick-release coupling RT020R20 Coupling piece21 Adapter22 Sterile cover23 Carton blank24 Adhesive strips for fixating the sterile cover25 Sleeve26 Four adhesive strips for fixating hoses and cables
Symbols on product and packages
1. Safe handlingCAUTIONFederal law restricts this device to sale by, or on order of a physician!► Manually clean the new product thoroughly after removal of all packaging, see Chapter 5.► Prior to use, conduct a function check, see Chapter 4.► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-
ufacturers liability: – Use the product only in accordance with these instructions for use.– Follow the safety and maintenance instructions.– Only combine Aesculap products with the UNITRAC coupling piece or UNITRAC quick-release coupling
RT020R, see Fig. 7 (4)/Fig. 13 (17).► 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.
2. Product description
2.1 Intended useThe UNITRAC support arm is used in order to hold optics, cameras, instruments, trocars, retractors and spatulas dur-ing surgical operations.
2.2 Operating principleIn the event of a loss of compressed air supply to the UNITRAC support arm: The arm is designed to be failure safein the locked position. Therefore no risk of collapse of the UNITRAC support arm is posed by the system in this excep-tional case.
NoteAlthough the UNITRAC support arm is designed to remain stable in the event of compressed air failure, if such failureoccurs discontinue use of the UNITRAC support arm.
3. Preparation and setup
3.1 PreparationNon-compliance with the following instructions will preclude all responsibility and liability in this respect on thepart of Aesculap.
3.1.1 Attaching the UNITRAC to the operating table
► Attach UNITRAC support arm 16 with clamping element RT090R to the operating table rail so that the symbol 7is pointing away from the operating table, see Fig. 1.
► Ensure that enough space remains below the clamping element for connecting the compressed-air hose or forthe cartridge adapter.
► Please contact your B. Braun/Aesculap representative or Aesculap Technical Service (address see Chapter 6.) withany inquiries in this respect.
4. Working with the UNITRAC support arm RT040R
4.1 System set-up
4.1.1 Connecting the compressed-air supplyNoteThe UNITRAC support arm can be connected to the central compressed-air supply system, a compressed-gas cylinderwith pressure reducer GA099 or to the CO2 cartridge adapter RT043R, see Fig. 3, Fig. 4 and Fig. 5.Ensure a minimum pressure of 5,5 bar. The recommended operating pressure is 8 bar. The maximum pressure is 12 bar.
► Pull back sleeve 9 on UNITRAC compressed-air hose 10.► Push compressed-air hose onto the UNITRAC compressed-air connector 8, see Fig. 3.
4.1.2 Functional checks► Conduct this function test after set up and before every use to ensure the UNITRAC support arm is in good work-
ing order.► Attach UNITRAC support arm 16 to the operating table, see Chapter 3.1.1.► Anchor UNITRAC support arm 16 to the OP table track at maximum extension length (vertical), see Fig. 12.► Press and hold white button 2 on UNITRAC support arm 16.► Move UNITRAC support arm 16 within its range of freedom (350° per joint). Ensure that every joint moves easily
and can be rotated freely in the operating range.► Release the white button 2.
UNITRAC support arm 16 is stable. All joints must remain in position.► If the joints do not move freely or if the set position drifts during the function test:
– Do not use UNITRAC support arm.– Contact your B. Braun/Aesculap representative or Aesculap Technical Service (address see Chapter 6.)
4.1.3 Attaching sterile cover with quick-release coupling (optional)Use of the sterile cover JG901 and the coupling piece RT020R eliminates the need for multiple cleaning and steril-ization cycles for the UNITRAC support arm and may increase the life of the UNITRAC support arm.The sterile cover allows a higher frequency of use of UNITRAC support arm as the time for cleaning, disinfection andsterilization can be omitted.► Anchor UNITRAC support arm 16 to the OP table track at maximum extension length (vertical), see Fig. 12.► Turn lock nut 18 on the UNITRAC quick-release coupling 19 as far as it will go in the direction of mount 17, see
Fig. 13.► Insert UNITRAC quick-release coupling 19 with the male coupling piece 20 into the adapter 21 of the UNITRAC
support arm 16 until this audibly and visibly engages, see Fig. 14.► Turn lock nut 18 on UNITRAC quick-release coupling 19 in the opposite direction until just before the stop,
see Fig. 15.► Pull the sterile cover 22 from above over the UNITRAC quick-release coupling 19 and the UNITRAC support
arm 16,see Fig. 16.► Tear off the carton blank 23, which hangs when pulling over lock nut 18, and dispose of it, see Fig. 17.► Pull the sterile cover 22 down over the UNITRAC support arm 16 and secure using adhesive strip 24 between
the lock nut 18 and mount 17, see Fig. 18.► Turn sleeve 25 clockwise to avoid unintentional opening of UNITRAC quick-release coupling 19, see Fig. 19.► Turn lock nut 18 with the adapter 21 tightly as far as it will go to ensure a clearance- and wobble-free connec-
tion between the UNITRAC quick-release coupling 19 and the UNITRAC support arm 16, see Fig. 20.► Pull the sterile cover 22 over the entire UNITRAC support arm 16, see Fig. 21 and Fig. 22.► If necessary, use the four adhesive strips 26 to secure the hoses and/or cable on the UNITRAC support arm 16
so that they do not interfere with the surgical procedure, see Fig. 23.
4.2 Safe operation
4.2.1 Positioning of the UNITRAC support armNoteThe turning range of the UNITRAC support arm is limited to 350°.
► Hold the proximal mechanical joint, see Fig. 6 and Fig. 11.► Press and hold white button 2 on UNITRAC support arm 16.
The UNITRAC support arm is disengaged, see Fig. 10.► Move UNITRAC support arm 16 within its range of freedom (350° per joint).► Release the white button 2.
UNITRAC support arm 16 is stable.
4.2.2 Attaching the instrumentsNoteThe design of the UNITRAC quick-release coupling allows the instrument to be positioned at angles of 60°, see Fig. 9.
► Rotate the sleeve 15 in a clockwise direction, see Fig. 8.The coupling piece 4 is secured against inadvertently opening.
► Rotate the sleeve 15 in a counterclockwise direction, see Fig. 8.The coupling piece 4 is unlocked.
► Push sleeve 15 forward.The instrument is unlocked and is automatically released from the UNITRAC quick-release coupling, see Fig. 8.
4.2.3 Removing the UNITRAC support arm from the operating field in case of failure of compressed-air supply
NoteAlthough the UNITRAC support arm is designed to remain stable in the event of compressed air failure, if such failureoccurs discontinue use of the UNITRAC support arm.
► Press and hold white button 2 on UNITRAC support arm 16, see Fig. 10.UNITRAC support arm 16 is disengaged.
► Remove UNITRAC support arm 16 from the operating field and release white button 2.
Caution, general warning symbolCaution, see documentation supplied with the product
Follow the instructions for use
CAUTION
Risk of injury due to incorrect attachment of UNITRAC support arm!► Check the securement by pulling on the UNITRAC support arm horizontally and
vertically.
DANGER
Fire and explosion hazard!► Do not use oxygen as a compressed-air supply.
WARNING
Risk of injury and/or malfunction!► Always carry out a function check prior to using the product.
4.2.4 Folding the UNITRAC support arm for storage► Press and hold white button 2.► Position UNITRAC support arm 16, see Fig. 6.► Press lever 3 and fold UNITRAC support arm 16 fully, see Fig. 11.► Remove compressed-air hose from UNITRAC support arm 16.► Press white button 2.
The joints are easily adjusted for cleaning and disinfection.
5. Validated reprocessing procedure
5.1 General safety instructionsNoteAdhere to national statutory regulations, national and international standards and directives, and local, clinicalhygiene instructions for sterile processing.
NoteFor patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevantnational regulations concerning the reprocessing of products.
NoteSuccessful processing of this medical device can only be ensured if the processing method is first validated. The oper-ator/sterile processing technician is responsible for this.The recommended chemistry was used for validation.
NoteIf the sterile drape is used, sterilization is not required. Follow wipe disinfection procedure, see Chapter 5.6.
NoteFor the latest information on reprocessing and material compatibility see also the Aesculap extranet atwww.extranet.bbraun.comThe validated steam sterilization procedure was carried out in the Aesculap sterile container system.
5.2 General informationDried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore thetime interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-atures >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 thelaser 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 waterused for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result inthe destruction of stainless steel products. These should be removed thoroughly with demineralized water and thendrying.Additional drying, if necessary.Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which arecompatible with the product’s materials according to the chemical manufacturers’ recommendations may be usedfor processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-ure 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 applica-
tion/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.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
5.3 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.
5.4 Preparation before cleaning► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
5.5 Cleaning/disinfection
5.5.1 Product-specific safety instructions for the reprocessing procedure
5.5.2 Validated cleaning and disinfection procedure
5.6 Wipe disinfection
RT: Room temperature
Phase I► Remove any visible residues with a disposable disinfectant wipe.► Wipe all surfaces of the visually clean product with a fresh, virucidal and bactericidal disposable disinfectant
wipe.► Observe the specified application time (1 minute minimum).
5.7 Inspection, maintenance and checks► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged.
5.8 SterilizationNoteIf the optional sterile cover is not used the sterilization has to be performed by the following parameters.
► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. byopening any valves and faucets).
► Validated sterilization process– 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 capacityof the steam sterilizer specified by the manufacturer is not exceeded.
5.9 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 has validated the above sterilization cycle and has the data on file. The validation was accomplished in anAesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cyclesmay also be suitable, however individuals or hospitals not using the recommended method are advised to validateany alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterilityafter processing, such as a wrap, pouch, etc.
6. Technical Service
► 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 for-feiture of applicable licenses.
Service addressesAesculap Technischer ServiceAm Aesculap-Platz 78532 Tuttlingen / GermanyPhone: +49 (7461) 95 -1601Fax: +49 (7461) 14 -939E-Mail: [email protected] in the US: Aesculap Inc.Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 USA Aesculap Repair Hotline Phone: +1 (800) 214 -3392 Fax: +1 (314) 895 -4420Other service addresses can be obtained from the address indicated above.
CAUTION
Damage to, or destruction of the product caused by mechanical cleaning/disinfec-tion!► Only clean and disinfect the product manually.
CAUTION
Damage to, or destruction of the product can be caused if cleaning/disinfecting agents penetrate into the joints!► Ensure that no fluids penetrate into the joints.► Ensure that joints are completely dried and free of any residues.
CAUTION
Damage to or destruction of the product can be caused by oiling of the ball joints!► Do not oil ball joints, as this will reduce the holding force.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents!► Only use cleaning/disinfecting agents approved for surface cleaning. Follow
the manufacturer’s instructions for the respective cleaning/disinfecting agent.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures!► Use cleaning and disinfecting agents approved for surgical instruments made
from stainless steel and anodized aluminum according to the manufacturer’s instructions.
► Observe specifications regarding concentration, temperature and exposure time.
CAUTION
Risk of corrosion/malfunction of the product due to cleaning in a ultrasonic bath!► Do not clean the product in a ultrasonic bath.
Validated pro-cedure
Special features Reference
Manual disin-fection
■ When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.
