UNITRAC support arm RT040R

4

11

11

1

12

Fig. 10

Fig. 1

13

15

14

Fig. 11

Fig. 2 14 15 16

13

11 5 6

Fig. 12

Fig. 13

7

17

14

13

18

Fig. 3 11 5

Fig. 14

Fig. 15

8 12

19 14

13 17 11

20

Fig. 4

10

9

Fig. 17

Fig. 16

3

17

Fig. 5 60°

10

Fig. 6

13 16

60° 1

11 Fig. 18

Fig. 7

Fig. 19

Fig. 8

11 21

2

17

Fig. 20 Fig. 9

11

Fig. 21

2.2.2

en ®

Aesculap UNITRAC support arm RT040R Legend Fig. 1-9 1 White button 2 Lever to fold UNITRAC support arm for storage 3 Coupling piece 4 Symbol 5 UNITRAC compressed-air connector 6 Sleeve compressed-air hose 7 UNITRAC compressed-air hose 8 Slide sleeve cartridge adapter 9 Instrument 10 Sleeve Fig. 10-21 11 UNITRAC support arm 12 Mount - quick-release coupling 13 Lock nut 14 UNITRAC quick-release coupling RT020R 15 Coupling piece 16 Adapter 17 Sterile cover JG901 18 Carton blank 19 Adhesive strips for fixating the sterile cover 20 Sleeve 21 Four adhesive strips for fixating hoses and cables

Product

Product-specific safety information ► Manually clean the new product thoroughly after removal of all packaging, see Reprocessing procedure. ► Prior to use, conduct a function check, see Preparation. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturers 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. 5 (3) / Fig. 11 (14).

2.2.3

Operating principle

In the event of a loss of compressed air supply to the UNITRAC support arm: The arm is designed to be failure safe in the locked position. Therefore no risk of collapse of the UNITRAC support arm is posed by the system in this exceptional case. Note Although the UNITRAC support arm is designed to remain stable in the event of compressed air failure, if such failure occurs discontinue use of the UNITRAC support arm.

2.2.4

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging.

2.3

Preparation

Non-compliance with these rules will result in complete exclusion of liability on the part of Aesculap.

2.3.1

Attaching the UNITRAC to the operating table

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. ► Attach UNITRAC support arm 11 with clamping element RT090R to the operating table rail so that the symbol 4

is pointing away from the operating table, see Fig. 1 and Fig. 2.

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for the following products: Art. no.

Designation

RT040R

UNITRAC support arm

► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun

eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The UNITRAC support arm is used in order to hold optics, cameras, instruments, trocars, retractors and spatulas during surgical operations.

2.1.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

2.1.3

Contraindications

No known contraindications.

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

► Ensure that enough space remains below the clamping element for connecting the compressed-air hose or for

the cartridge adapter. ► Please contact your B. Braun/Aesculap representative or Aesculap Technical Service (address see Technical ser-

vice) with any inquiries in this respect.

2.3.2

Connecting the compressed-air supply

Note The UNITRAC support arm can be connected to the central compressed-air supply system or to the CO2 cartridge adapter RT043R, see Fig. 3 and Fig. 4. Ensure a minimum pressure of 6 bar. The recommended operating pressure is 8 bar. The maximum pressure is 12 bar. DANGER Fire and explosion hazard! ► Do not use oxygen as a compressed-air supply. ► Pull back sleeve 6 on UNITRAC compressed-air hose 7. ► Push compressed-air hose onto the UNITRAC compressed-air connector 5, see Fig. 3.

2.3.3

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 11 to the operating table, see Attaching the UNITRAC to the operating table. ► Press and hold white button 1 on UNITRAC support arm 11. ► Move UNITRAC support arm 11 within its range of freedom (350° per joint). Ensure that every joint moves easily and can be rotated freely in the operating range. ► Anchor UNITRAC support arm 11 to the OP table track at maximum extension length (vertical), see Fig. 10. ► Release the white button 1. UNITRAC support arm 11 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 Technical service)

2.3.4

Attaching sterile cover with quick-release coupling

► Anchor UNITRAC support arm 11 to the OP table track at maximum extension length (vertical), see Fig. 10. ► Turn lock nut 13 on the UNITRAC quick-release coupling 14 as far as it will go in the direction of mount 12, see

Fig. 11. ► Insert UNITRAC quick-release coupling 14 with the male coupling piece 15 into the adapter 16 of the UNITRAC

support arm 11 until this audibly and visibly engages, see Fig. 12. ► Turn lock nut 13 on UNITRAC quick-release coupling 14 in the opposite direction until just before the stop,

see Fig. 13. ► Pull the sterile cover 17 from above over the UNITRAC quick-release coupling 14 and the UNITRAC support

arm 11,see Fig. 14. ► Tear off the carton blank 18, which hangs when pulling over lock nut 13, and dispose of it, see Fig. 15. ► Pull the sterile cover 17 down over the UNITRAC support arm 11 and secure using adhesive strip 19 between

the lock nut 13 and mount 12, see Fig. 16. ► Turn sleeve 20 clockwise to avoid unintentional opening of UNITRAC quick-release coupling 14, see Fig. 17. ► Turn lock nut 13 with the adapter 16 tightly as far as it will go to ensure a clearance- and wobble-free connec-

tion between the UNITRAC quick-release coupling 14 and the UNITRAC support arm 11, see Fig. 18. ► Pull the sterile cover 17 over the entire UNITRAC support arm 11, see Fig. 19 and Fig. 20. ► If necessary, use the four adhesive strips 21 to secure the hoses and/or cable on the UNITRAC support arm 11

so that they do not interfere with the surgical procedure, see Fig. 21.

2.4

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.

2.4.1

Positioning of the UNITRAC support arm

Note The turning range of the UNITRAC support arm is limited to 350°. ► Hold the proximal mechanical joint. ► Press and hold white button 1 on UNITRAC support arm 11.

The UNITRAC support arm is disengaged, see Fig. 8. ► Move UNITRAC support arm 11 within its range of freedom (350° per joint). ► Release the white button 1.

UNITRAC support arm 11 is stable.

2.4.2

3.6

Attaching/detaching the instruments

Inspection

Note The design of the UNITRAC quick-release coupling allows the instrument to be positioned at angles of 60°, see Fig. 7.

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

► Insert instrument 9 in UNITRAC quick-release coupling 14, see Fig. 5.

3.6.1

The sleeve 10 snaps back. UNITRAC quick-release coupling locks automatically. ► Rotate the sleeve 10 in a clockwise direction, see Fig. 6.

The coupling piece 3 is secured against inadvertently opening. ► Rotate the sleeve 10 in a counterclockwise direction, see Fig. 6.

The coupling piece 3 is unlocked. ► Push sleeve 10 forward.

The instrument is unlocked and is automatically released from the UNITRAC quick-release coupling, see Fig. 6.

2.4.3

Removing the UNITRAC support arm from the operating field (also in case of failure of compressed-air supply)

Note Although the UNITRAC support arm is designed to remain stable in the event of compressed air failure, if such failure occurs discontinue use of the UNITRAC support arm. ► Press and hold white button 1 on UNITRAC support arm 11, see Fig. 8.

UNITRAC support arm 11 is disengaged. ► Remove UNITRAC support arm 11 from the operating field and release white button 1.

2.4.4

Folding the UNITRAC support arm for storage

► Press and hold white button 1. ► Position UNITRAC support arm 11, see Fig. 1. ► Press lever 2 and fold UNITRAC support arm 11 fully, see Fig. 9. ► Remove compressed-air supply from UNITRAC support arm 11. ► Press white button 1.

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed

areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service.

3.6.2

Functional test

► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.7

Steam sterilization

► Do not sterilize the product. ► Always use the sterile cover.

The joints are easily adjusted for cleaning and disinfection.

3.8

3.

Reprocessing procedure

3.1

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 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.

3.2

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.3

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.

3.4

Cleaning/Disinfection

3.4.1

Product-specific safety information on the reprocessing method

CAUTION Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► 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.

3.5

Wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

Alcohol(s), quaternary compound(s) *

II

Wipe disinfection

RT

≥1

-

-

Alcohol(s), quaternary compound(s) *

RT: *

Storage

► Store products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

Room temperature Recommended: Meliseptol® wipes sensitive (B. Braun)

Phase I ► Remove any visible residues with a disposable disinfectant wipe. Phase II ► Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ► Observe the application time (1 min minimum).

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Accessories / spare parts

Art. no.

Designation

RT090R

Clamping element

RT044SU

CO2 cartridge

RT043R

CO2 cartridge adapter

GA464R (3 m) GA466R (5 m)

Compressed air hose with recycling

RT020R

UNITRAC quick-release coupling

JG901

Sterile cover

6.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Reprocessing procedure.

7.

Technical data

7.1

Classification acc. to Directive 93/42/EEC

RT040R

UNITRAC support arm

Maximum holding force

4 kg

Operating pressure

6 bar to 12 bar

Dimensions (folded)

500 mm

Dimensions (extended length up to the proximal joint)

750 mm

Weight

3 kg

TA009480

2020-10

V6

Change No. 63474