BipoJet – Bipolar scissors

► Select the lowest possible HF power output. ► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with

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AESCULAP BipoJet® Bipolar scissors Legend 1 Bipolar scissors with ceramic protector in closed condition (for sterilization and transport) 2 Bipolar scissors with ceramic protector in open condition (for transport in a wire basket after an operation, and for mechanical cleaning)

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 BipoJet bipolar scissors. ► 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.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The BipoJet bipolar scissors are used for cutting, dissecting, and coagulating tissues in 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

Absolute contraindications

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

2.1.4

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. ■ Use on or in the direct vicinity of the peripheral nervous system (PNS). In the presence of relative contraindications, the user decides individually regarding the use of the product.

a moistened swab. The plug end of the product is fitted with the following connector: 1.6 mm pin. Refer to our brochures to find a compatible cable. The insulation of the product is rated for a maximum recurrent peak voltage of 600 Vp ≈ 1 200 Vss in coagulation mode. The insulation of the accessories (e. g., HF cable, instruments) must be adequate for the maximum peak output voltage, see the IEC/DIN EN 60601-2-2 standard. 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 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. 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.

2.2.3

Sterility

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

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 due to unintentional hemorrhage caused by a hasty cut or the HF current being too high or too low! ► Cut slowly. ► Adjust the HF current to a level appropriate for the application. ► Connect the HF cable to the instrument. ► Connect the plug of the HF cable to the bipolar output of the HF device. ► Press the tips of the slightly opened instrument onto a cloth soaked in a saline solution. ► Activate the HF device, making sure that the instrument is only touched where it is insulated.

The formation of steam means that the instrument is ready for operation. ► If no steam becomes visible, check the connections between the HF cable and the HF device. ► Slowly increase the current supplied.

3.

Validated reprocessing procedure General safety instructions

2.2

Safety information

3.1

2.2.1

Clinical user

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

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

Product

Product-specific safety information ► Only use the product under vision. Risk of burns due to tissue outside the coagulation site touching non-insulated areas of the bipolar scissors! ► Be careful that only insulated areas of the bipolar instruments come into contact with tissue. Thermal injuries to patients/users due to insufficient insulation of leads in active accessories! ► Adjust the HF device to an appropriate setting to ensure that the peak output voltage does match or not exceed the accessory voltage rating specified for the product. Risk of injury to the patient/medical personnel due to incorrect handling! ► Operate the instrument with authentic Aesculap HF cables only. ► Do not connect the instrument to the monopolar output. ► Do not use instruments with damaged ceramic parts. Damage to the working tips and ceramic parts due to incorrect handling! ► Apply caution when using the instrument. ► Do not apply excessive force. ► Do not try to cut or remove any clamps or clips. ► Protect the instrument against knocks and impacts. ► Transport and reprocess the instrument only in the ceramics protector. ► Prior to each application, inspect the ceramic insulation of the instrument for missing parts and/or cracks. ► Prior to and after each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Adjust the HF power output to the intended surgical intervention. Take into account clinical experience or ref-

erence values.

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. BC685R to BC690R: The manufacturer has tested the product and verified that its insulation can withstand 100 reprocessing cycles. BC691R to BC699R: The manufacturer has tested the product and verified that its insulation can withstand 30 reprocessing cycles. 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

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

► Open up product with hinges.

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

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 aluminum, Peek, PTFE and surgical steel. ► 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 reprocessing steps. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water ► Mount jaws protection on the product. ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement). ► 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.

3.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Soft cleaning brushes ■ Keep working ends open for

Chapter Manual cleaning/disinfection and subsection:

cleaning.

■ Chapter Manual cleaning with immersion disinfection

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

product in the open state; see Fig. 2.

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

3.7

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.

3.9

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.

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: BBraun Stabimed fresh infection procedure.

cloth or medical compressed air

■ Soft cleaning brushes ■ Place ceramic protector on

3.8

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

■ Drying phase: Use a lint-free 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.

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection

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

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

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]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

3.7.1

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

Intermediate rinse

>10/50

1

FD-W

-

III

Disinfection

RT (cold)

5

2

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

IV

Thermal disinfecting

90/194

5

FD–W

-

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

V

Drying

RT

-

-

-

-

D–W: FD–W:

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh ► 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. ► 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.

– pH = 13 – <5 % anionic surfactant

■ working solution 0.5% – pH = 11*

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun 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 Tech-

nical service.

3.10.2 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). ► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,

and free of damage (e. g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► 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. ► 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 ► Apply ceramic protector to product in closed state, see Fig. 1. ► 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.

3.12 Steam sterilization Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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). ► 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 ► Place the ceramic protector on the product. ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

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.

4.1

Accessories / spare parts

Art. no.

Designation

JG884R

Ceramic protector for fine BipoJet scissors BC691R to BC699R

JG885R

Ceramic protector for BipoJet scissors BC685R to BC690R

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 reprocess the product before its disposal, see Validated reprocessing procedure. TA011127

2021-06

Change No. AE0060500