M-TRAC – Support arm

en

2.4 ®

Aesculap M-TRAC Support arm

®

Legend 1 2 3 4 5 6 7 8 9

Support arm Proximal part of the support arm Fastening element Silicone washer Clamping handle Distal part of the support arm Quick-release coupling Sleeve Instrument shaft

1.

About this document

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. WARNING Injuries caused by unstable fixation of optics, cameras, instruments or trocars! ► Apply appropriate care when supporting and fixing optical systems, cameras, instruments or trocars. ► Tighten the clamping handle and check the fixation of the support arm. ► Do not overload the support arm. CAUTION Damage to the joints of the support arm! ► Loosen the clamping handle before changing the position of the support arm. Note The holding arm 1 is fitted with insulation in the distal part 6 to isolate the connected instrument shaft 9 from earth.

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

► Ensure that the insulation during HF application is not bypassed. ► Lift the distal part of the support arm 6 and loosen the clamping handle 5 by turning it counterclockwise b, see

1.1

► Position support arm 1 in the operating field. ► Tighten clamping handle 5 by turning it clockwise a.

Scope

These instructions for use apply to the M-TRAC® support arm FF168R. ► 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: 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.

Fig. A.

The joints of support arm 1 are fixated simultaneously. ► Check the fixation of support arm 1.

2.5

Disassembly

► Remove any optical systems, cameras, instruments or trocars coupled to the support arm from quick-release cou-

pling 7. ► Turn sleeve 8 of quick-release coupling 7 counterclockwise. Sleeve 8 of quick-release coupling 7 is unlocked. ► Pull sleeve 8 of quick-release coupling 7 towards instrument shaft 9, see Fig. B. Instrument shaft 9 is pushed out from quick-release coupling 7. ► Remove fastening element 3 and silicone washer 4 from the support arm.

Clinical use

3.

Validated reprocessing procedure

2.1

Areas of use and limitations of use

3.1

General safety instructions

2.1.1

Intended use

2.

The M-TRAC® support arm is used in minimally invasive surgery to support e.g. optical systems, cameras, instruments and trocars. Additionally, a fastening element is used at the proximal end of the support arm and an adapter (e.g. NeuroPilot®) at the distal end. The maximum support capacity of the support arm is 40 N.

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.

2.2.2

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.3

Assembly

WARNING Injuries caused by unstable fixation of optics, cameras, instruments, trocars, support arms and fastening elements! ► Apply appropriate care when supporting and fixing optical systems, cameras, instruments or trocars. ► Tighten the clamping handle and check the fixation of the support arm. ► Do not overload the support arm. ► Ensure that the instrument shaft engages properly. ► With the instrument shaft engaged, turn the sleeve clockwise. ► Firmly tighten the fastening element at the operating table rail and the support arm. ► To separate the sterile region from the unsterile region, slide silicone washer 4 over the rod, starting from the

bottom end. ► Fasten holding arm 1 using fastening element 3 FF151R*, FF280R* or RT090R* to the operating table rail, see

Fig. C. *Optional accessory, not part of delivery scope ► Check for correct fixation of support arm 1: Slide the support arm 1 vertically and horizontally. ► Insert instrument shaft 9 into the sleeve 8, see Fig. D. Quick-release coupling 7 is locked automatically. ► Position instrument shaft 9 at angles of 60°, see Fig. E. ► To secure quick-release coupling 7 against inadvertent opening, rotate sleeve 8 clockwise, see Fig. D.

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. 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 B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

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 "AKI-Brochures", "Red brochure".

3.3

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.

3.4

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.

3.5

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly. ► Tighten the clamping handle by turning it clockwise.

3.6

Cleaning/Disinfection

3.8.2

3.6.1

Product-specific safety information on the reprocessing method

CAUTION Support arm malfunction due to improper maintenance! ► Do not lubricate with oil the joints of the support arm.

Danger to the patient! The product must not be manually reprocessed. ► Reprocess the product only in a mechanical washer/disinfector. Damage to the clamping mechanism of the support arm during processing! ► Do not immerse the support arm in any fluid. ► Tighten the clamping handle by turning it clockwise. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastic material and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. For products with plasma layers (e.g. Noir instruments), the layer is attacked or removed when special cleaning procedures with the addition of oxidizing chemicals (e.g. hydrogen peroxide H2O2) are used. ► Do not use oxidizing chemicals for cleaning.

3.6.2

Validated cleaning and disinfection procedure Specific requirements

Reference

Mechanical neutral or mild-alkaline cleaning and thermal disinfection

■ Mount jaws protection on the

Chapter Mechanical cleaning/disinfection and subsection:

product.

■ Chapter Mechanical neutral or

■ Place the product on a tray that

mild alkaline cleaning and thermal disinfecting

is suitable for cleaning (avoid rinsing blind spots).

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

3.9

Packaging

► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage. ► Open the clamping handle of the support arm by turning it counterclockwise as far as it will go.

3.10 Steam sterilization ► 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). – 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 ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Maintenance and service

4.1

Maintenance

This product is maintenance-free. In cases of damage, stiffness or insufficient clamping force, please contact your national B. Braun/Aesculap agency, see Technical service.

■ To flush the product: Use a flushing nozzle or flushing sleeve.

4.2

■ Keep working ends open for cleaning.

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.

■ Place the product on the tray with all product links and joints open.

Mechanical cleaning/disinfection

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.

3.7.1

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

► Validated sterilization process

Validated procedure

3.7

Functional test

Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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.

Machine type: single-chamber cleaning/disinfection device without ultrasound

4.3

Accessories / spare parts

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical Art. no.

Designation

I

Prerinse

<25/77

3

D–W

-

FF280R

Flexible fastening element with ball joint

II

Cleaning

55/131

10

FD-W

Neutral:

RT090R

Flexible fastening element with tooth rim

FF151R

Rigid fastening element

RT046P

Adapter for endoscope holder

Mildly alkaline:

RT060R

NeuroPilot®

■ Concentrate:

RT079R

Adapter for fixation on endoscope body/eyepiece

RT099R

MINOP® TREND adapter for holding arm

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution

– pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution 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 neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

3.8

Inspection

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

3.8.1

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 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.

RT081R

Adapter for attaching RT055P

RT068R

MINOP® InVent adapter for holding arm

5.

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. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA011949

2020-05

V6

Change No. 62752