Bipolar, reusable instruments

en AESCULAP® Bipolar, reusable instruments Legend 1 Moveable ring 2 Fixed ring 3 Rotating sleeve 4 Working insert 5 Insulating outer tube 6 Inner tube 7 Pin protection 8 HF connection 9 Rotation knob 10 Flexible tongue 11 Groove a Handle b Shaft

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 to the following products: ■ Bipolar, reusable instruments Note Instructions for use and further information about B. Braun / AESCULAP products can be found on the B. Braun eIFU website 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.

2.

Clinical use

2.1

Product description

The plug end of the product is fitted with the following connector: Aesculap flat connector. Refer to our brochures to find a compatible cable. The accessory voltage rating of the product is 1 kVp. The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-22).

2.2

Areas of use and limitations of use

2.2.1

Intended use

Depending on the design of the working end, the instruments are used for cutting, dissecting, grasping and suturing tissues, as well as for thermal tissue treatment during minimal-invasive procedures.

2.2.2

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.

2.2.3

Absolute contraindications

Do not use: ■ on the central circulatory system ■ on the central nervous system ■ on bone or bone-like tissue ■ on metallic materials

2.2.4

Relative contraindications

The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the operation. ■ Working on or in the close environment of the peripheral nervous system (PNS) In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.3

Safety information

2.3.1

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.

2.3.2

Product-specific safety information

Damage to the working insert due to incorrect handling or operation! To avoid damage to the working tip, especially to the ceramic insulation: ► Apply caution when operating the product. ► To prevent damage at the working end: carefully insert the product through the working channel (e.g. trocar). ► Do not apply excessive force. ► Protect the working tip against knocks and impacts. ► Use the protecting cap when the product is not in use. Sparks may be created during proper use of the HF instrument, which may lead to ignition or explosion of flammable gases. ► Observe the safety guidelines in the instructions for use of the HF device. HF instruments may lead to thermal damage to the patient/user. ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage is equal to or less than the accessory voltage rating specified for the product. ► Use HF output power (and – if applicable – argon flow rate) settings appropriate for the intended procedure. ► Select the lowest possible HF power output. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab. ► Use the instrument only with an insulated outer tube. ► Avoid tissue contact with non-insulated areas of the working tip. ► Push the plug of the HF cable onto the HF pin as far as it will go. ► Check that the plug is held securely before HF activation. To avoid HF burns: ► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated. ► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories. ► Before each use, inspect products visually for: damage and surface changes on the insulation. ► Never place the product on or next to the patient. ► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF device. ► Follow the instructions for use of the HF device.

2.3.3

Sterility

The product is supplied non-sterile and intended to be used in sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

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. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

2.4.1

Bipolar coagulation

From the health-and-safety perspective, bipolar coagulation is the safer alternative to monopolar coagulation, because the current does not flow through the whole body, but only through a narrowly defined tissue region between the jaw pieces/scissors blades of the instrument.

2.4.2

Bipolar grasping

Note If both jaw pieces of the grasping forceps come into direct contact, coagulation cannot occur as the power source is short-circuited. ► Make certain the grasping surfaces are clean and of metal appearance. ► Grasp and compress the tissue in such a way that it is in contact with both metal jaw pieces. ► Switch on the HF current.

2.4.3

Bipolar cutting

► Compress the tissue between the two scissor blades. ► Switch on the HF current. ► Cut through the tissue mechanically. The slower the cut, the larger the coagulation zone at the edge of the

cut. Note To ensure effective coagulation, make certain that the tissue cut by the metal-ceramic scissor blade is in contact with the metal part of the blade (see arrow), see Fig. B.

2.4.4

Grasping variants

The bipolar handle a can be operated either in the traditional ring grip hold or in the more ergonomic handembrace hold, see Fig. G.

3.

Validated processing 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 processing of products. Note Mechanical processing 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 Sterilization should always be favored over disinfection under all circumstances. Only if final sterilization is not possible should disinfection with a virucidal agent be preferred. Note Up-to-date information about processing and material compatibility can be found on the B. Braun eIFU site at eifu.bbraun.com The validated steam sterilization procedure was carried out in the AESCULAP sterile container system.

3.2

General information

3.8

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 precleaning 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.a-k-i.org, link to "AKI-Brochures", "Red brochure".

3.3

Service life

The biocompatibility, insulation and processability was verified by the manufacturer after a specific number of processing cycles: Product component

Number of processing cycles

Working insert 4

50 cycles

Insulating outer tube 5

450 cycles

Handle a

20 cycles

Manual cleaning/disinfecting

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of

the disinfectant. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfecting process if necessary.

3.8.1

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)

5

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: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfection procedure.

The product can be used up to the number of processing cycles with the proper care and if it is undamaged and clean. Any additional reuse falls under the responsibility of the user. Careful visual and functional inspection before each 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

Disassembly

Removing the pin protector ► Compress pin protector 7 and slide it carefully off the shaft, see Fig. C. Releasing the handle a/shaft b connection ► Pull back rotating sleeve 3 in the direction of the arrow (towards the handle a) as far as it will go, see Fig. D. ► Hold the sleeve to the stop while simultaneously pulling out the shaft b with moveable ring 1 left loose, see Fig. D. ► Remove rotation knob 9 from rotating sleeve 3, see Fig. A. Disassembling the shaft b ► Slide off insulating outer tube 5. ► Detach inner tube 6 from working insert 4, see Fig. A.

Cleaning/Disinfection

3.7.1

Product-specific safety information on the processing method

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. Immersion treatment in a 3% H2O2 solution for approx. 5 minutes is a particularly effective and gentle method for dissolving encrustations on HF instruments. Subsequently, the debris can be removed by hand, with a medium-hard brush and or in an ultrasonic bath. This is followed by the next standard processing steps. ► If the microsurgical products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

Validated cleaning and disinfection procedure

Note Processing may only take place in accordance with the following listed procedures in version V6. These are documented in the brochure “Validated Reprocessing Procedures” (AVA-V6) C63402. You will also find this brochure on the B. Braun eIFU site at eifu.bbraun.com Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Keep working ends open for cleaning. ► When cleaning instruments with movable hinges,

Chapter Manual cleaning/disinfecting and subsection:

ensure that these are in an open position and, if applicable, move the hinge while cleaning. ► Drying phase: Use a lint-free cloth or medical compressed air.

cleaning with immersion disinfection

► Use a suitable cleaning brush. ► Use a disposable syringe 20 ml. ► Place the product on a tray that is suitable for

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

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. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

3.9

3.7

3.7.2

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.

► Disassemble the product prior to cleaning, see Disassembly. ► Open up product with hinges.

3.6

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.

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. compliance with EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

3.9.1

Manual pre-cleaning with a brush

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

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: B. Braun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and

disinfection procedure.

cleaning (avoid rinsing blind spots). ► Connect components with lumens and channels

directly to the rinsing port of the injector carriage. ► Keep working ends open for cleaning. ► Place the product on the tray with all product links and joints open.

■ Chapter Manual

■ Chapter Manual precleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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.

3.9.2

Mechanical alkaline cleaning and thermal disinfecting

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

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical

3

D–W

-

10

FD-W

■ Concentrate, alkaline: – pH = 13 – < 5 % anionic surfactant

■ working solution 0.5% – 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

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: B. Braun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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

3.10.1 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 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.

3.10.2 Assembly Assembling the shaft b ► Slide inner tube 6 onto working insert 4 until flexible tongues 10 snap into position, see Fig. E. ► Slide insulating outer tube 5 over inner tube 6 with working insert 4 as far as it will go, see Fig. E. Establishing the handle a/shaft b connection CAUTION Damage to handle/shaft or working insert due to incorrect handling! ► When establishing the connection, do not hold the product at the insulating outer tube when pushing the shaft into the handle as, otherwise, the outer tube will be displaced. ► Do not hold or pull the moveable handle part, since the proximal end of the working insert could get bent. ► Slide rotation knob 9 onto rotating sleeve 3, see Fig. A. ► Pull back rotating sleeve 3 in the direction of the handle a as far as it will go and hold it there, see Fig. F. ► Swivel moveable ring 1 towards distal. Grasp the shaft b at working insert 4 and slightly rotate and push

it into handle a until the rotating sleeve 3 snaps towards distal, see Fig. F. Attaching the pin protector ► Compress pin protector 7 and guide it carefully over the jaw parts. Engage the pin protector in groove 11 of working insert 4, see Fig. H.

3.10.3 Functional test CAUTION Damage (metal cold welding/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: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► 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.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical

service.

3.11 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 stor-

age.

3.12 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). ► Use validated sterilization process: – 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.

3.13 Storage ► Store sterile products in germ-proof packaging (sterile barrier system). Observe the information provided

by the manufacturer of the sterile barrier system in regards to storage.

4.

Maintenance and service

4.1

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.

4.2

Accessories / spare parts

For accessories and spare parts, see brochure C758 or visit http://www.endoscopy-catalog.com

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. 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 process the product before its disposal, see Validated processing procedure. TA010096

2022-10

Change No. AE0062044