Reusable bipolar connecting cables Instructions for Use

Instrument-side plugs

en ®

Aesculap Reusable bipolar connecting cables 1.

Suitable for instruments by e.g.

Illustration/Designation

Aesculap

About this document

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

1.1

Scope

Flat connector Aesculap

These instructions for use apply for reusable bipolar connecting cables. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Round-pin plug

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:

Erbe Martin

DANGER Shows a possible threat of danger. If not avoided, death or severe injuries may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

Euro plug, flat AesculapBipoJet instruments

CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

Socket plug with hexagon AesculapLandolt coagulation forceps

2.

Clinical use

2.1

Product description

Socket plug with hexagon

The product is furnished with the following connection on the plug side: see Product variants. The accessory voltage rating of the product is 1 000 Vp. 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 60601-2-2).

2.2

Product variants

2.2.1

Pull out plug

The bipolar connecting cables are available in the following variants: Device-side plugs

Intended use

The reusable bipolar connecting cables are used as conductors for HF current from the HF device to the operating site.

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.

Illustration/Designation

2.3.3

Contraindications

No known contraindications.

Aesculap ACMI Berchtold Martin Wolf

2.4

Safety information

2.4.1

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.

Erbe Storz EMC Dolley

Pin spacing 22 mm Aesculap Bowa EMC Lamidey Söring Valleylab Erbe

Areas of use and limitations of use

2.3.1

2.3.2

► Check the plug for compatibility with the socket of the HF device.

Suitable for HF devices by e.g.

2.3

Pin spacing 29 mm

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.

2.4.2 Codman

Product

Product-specific safety information 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.

Pin spacing 38 mm

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. ► Adjust the HF power output appropriately 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. ► 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. Ambient conditions The following environmental conditions apply to use, transport and storage of the product: Temperature

-20 °C to +50 °C

Relative humidity

0 % to 75 %, no condensation

Atmospheric pressure

500 hPa to 1 600 hPa

Direct sunlight

Protect against direct sunlight

2.4.3

Sterility

3.6.2

Validated cleaning and disinfection procedure

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

Validated procedure

Specific requirements

Reference

2.5

Mechanical alkaline cleaning and thermal disinfection

■ Place the product on a tray that

Chapter Mechanical cleaning/disinfection and subsection:

Application

is suitable for cleaning (avoid rinsing blind spots).

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 if the product is used outside the field of view! ► Only use the product with visual control.

3.

Validated reprocessing procedure

3.1

General safety information

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.

cleaning and thermal disinfection

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.

3.7.1

Mechanical alkaline cleaning and thermal disinfection

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

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

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

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. Evidence of biocompatibility and processibility for the product was produced by the manufacturer after 200 preparation cycles. The product can be used up to 200 times with the proper care and if it is undamaged and clean. Any additional reuse falls under the responsibility of the user. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection.

3.4

■ 0.5 % working solution – 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

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

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.

■ Chapter Mechanical alkaline

D–W: FD–W:

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.

3.8

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 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 Tech-

nical service.

3.8.2

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.

3.9

Packaging

► Immediately after use, disconnect the product first at the HF device, then at the instrument.

► 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.

3.6

Cleaning/Disinfection

3.10 Steam sterilization

3.6.1

Product-specific safety information on the reprocessing method

3.5

Preparing for cleaning

Danger to the patient! The product must not be manually prepared. ► Only mechanically reprocess the product. 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, plastics, stainless 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. ► 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.

► 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.

3.11 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

Note Defective products must not be repaired under any circumstances! ► Set aside the product if it is damaged.

4.2

Technical service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. 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.

4.3

Accessories/Replacement Parts

Note Information about accessories and spare/replacement parts can be found in brochure Aesculap C-304-81!

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 from sharp and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents the product from causing injury. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a freeof-charge service.

► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap

agency, see Technical service.

6.

Technical Data

6.1

Classification acc. to Directive (EU) 2017/745

Designation

Class

Reusable bipolar connecting cables

I

6.2

Performance data, information about standards

Accessory voltage rating

1 000 Vp.

Conforming to standard

IEC/DIN EN 60601-2-2

TA022290

2021-01

V6

Change No. 64152