Coated, bipolar BIPOJET scissors

Function checks

Aesculap® Coated, bipolar BIPOJET scissors Legend

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product. WARNING

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)

► 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.

Symbols on product and packages

► If no steam or sparks become visible, check the connections between the HF cable and the HF device. ► Slowly increase the current supplied.

The onset of steam or sparks means that the instrument is ready for operation.

Caution, general warning symbol Caution, see documentation supplied with the product

Applicable to

Safe operation

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.

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

Validated reprocessing procedure Intended use The coated, bipolar scissors are used for cutting, preparing and coagulating tissue in surgical operations.

General safety instructions

Safe handling and preparation

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

CAUTION Federal law restricts this device to sale by, or on order of a physician! ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ► Observe the safety guidelines in the instructions for use of the HF device. WARNING

WARNING

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.

WARNING

Risk of burns due to tissue outside the coagulation site touching non-insulated areas of the bipolar instruments! ► Be careful that only insulated areas of the bipolar instruments come into contact with tissue outside of the coagulation area.

WARNING

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.

CAUTION

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.

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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

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 Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Open up instruments with hinges.

Preparations at the place of use The manufacturer has tested the product and verified that its insulation can withstand 30 reprocessing cycles. In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions. ► Prior to each use, inspect the products for: damage or surface changes to the insulation. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Adjust the HF power output to the intended surgical intervention. Take into account clinical experience or reference values. ► 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. 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. To avoid HF burns: ► Set the HF device for a maximum peak output voltage lower than or equal to the peak voltage rating specified for the product. ► 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. ► Never place the product on or next to the patient. ► Follow the instructions for use of the HF device.

► 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.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for the product (e.g., aluminum, PEEK, PTFE, high-grade steel). ► Observe specifications regarding concentration, temperature and exposure time.

Immersion treatment in a 3 % H2O2 solution for approx. 5 minutes is a particularly effective and gentle method to dissolve encrustations from HF instruments. The debris can be removed manually with a soft brush. This is followed by the conventional reprocessing steps. ► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Mount jaws protection on the product.

Validated cleaning and disinfection procedure

Manual pre-cleaning with a brush

Validated procedure

Specific requirements

Reference

Phase

Step

t [min]

Conc. [%]

Water quality

Chemical

■ Soft cleaning brushes ■ 20 ml disposable syringe ■ When cleaning instruments with movable

T [°C/°F]

Manual cleaning with immersion disinfection

Chapter Manual cleaning/ disinfection and sub-chapter:

I

Disinfectant cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Chapter Manual cleaning with immersion disinfection

■ Drying phase: Use a lint-free cloth or medical

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

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

■ Soft cleaning brushes ■ 20 ml disposable syringe ■ Mount jaws protection on the product. Jaws

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

protection closes audibly (see Fig. 1 and Fig. 2).

■ Chapter Manual pre-

■ Place the instrument in a tray that is suitable

■ Chapter Mechanical

for cleaning (avoiding rinsing blind spots).

cleaning with a brush alkaline cleaning and thermal disinfecting

■ Keep working ends open for cleaning. ■ Place instruments in the tray with their hinges open.

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.

► 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.

Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound

Manual cleaning with immersion disinfection 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:

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)

15

2

D–W

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

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

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► 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. 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.

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/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: Aesculap 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. ► Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see Technical Service. ► Check for compatibility with associated products.

Packaging ► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further than in the first notch. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization 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.

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 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 instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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 Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.

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

Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► 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 forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Inc. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 013774

06/13

V6

Änd.-Nr. 47287