Bipolar Adapter

en

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.

®

Aesculap Bipolar Adapter 1.

About this document

2.4.2

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 bipolar adapter. ► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Product

Product specific safety information Sparks, which can result in the ignition or explosion of flammable gases, can occur during normal use of the RF instrument. ► Observe the safety guidelines in the instructions for use of the RF device. RF instruments can cause thermal damage of the patient/user. ► Adjust the RF device to an appropriate setting to ensure that the maximum peak output voltage is equal to or lower than the rated accessory voltage specified for the product.

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:

To prevent RF burns: ► Prior to every use, visually inspect the product for: damage to and surface changes of the insulation. ► Observe the instructions for use of the RF device.

DANGER Indicates a potential danger. If it is not avoided, death or serious injury can result.

Environmental conditions The environmental conditions listed below apply to the storage, transport and use of the product:

WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.

Temperature

-20 °C to +50 °C

Relative humidity

0 % to 75 %, non-condensing

Atmospheric pressure

500 hPa to 1 600 hPa

Sunlight

Keep away from direct sunlight

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

2.

Clinical use

2.1

Product description

2.4.3

The rated accessory voltage of the product is 1 000 Vp. The accessory voltage rating must be greater than or equal to the maximum peak output voltage at which the product is operated in combination with a suitable RF device at an appropriate operating mode/setting (see IEC/EN 60601-2-2).

2.2

Design variants

2.2.1

Connector

► Check the connector for compatibility with the socket of the RF device.

Sterility

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

2.5

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.

Bipolar adapters are available in the following versions: Figure/Name

Art. no.

Suitable e.g. for devices by

GN219

Conmed

WARNING Risk of injury due to application of the product outside the field of view! ► Only use the product under visual control. CAUTION Malfunctions or error messages when using an automatic activation/deactivation function of the device with particular combinations of bipolar adapters and RF cables! ► Observe the directions for use of the device. ► Disable the automatic function if necessary.

Pin spacing on device: 31.7mm GN224

Codman

3.

Processing procedure

3.1

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 option to determine if a product is no longer functional, see Inspection.

Pin spacing on device: 38.1mm GN226

EMC DOLLEY

Pin spacing on device: 22mm GN228

Aesculap GN300 Aesculap GN060 (Serial No. <2000)

3.2

Cleaning/Disinfection

3.2.1

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! ► Use cleaning agents and disinfectants approved for plastics 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. ► 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. Pin spacing on device: 25mm Note Further information on the bipolar adapters is available in the Aesculapbrochure C-304-81.

2.3

Areas of use and limitations of use

2.3.1

Intended use

3.3

Manual cleaning and wipe 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

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

17 % Propan-1-ol, 0.23 % Didecyldimethylammonium chloride*

II

Wipe disinfection

RT

≥1

-

-

17 % Propan-1-ol, 0.23 % Didecyldimethylammonium chloride*

The bipolar adapters are used to connect Aesculap HF cables to devices from other manufacturers.

2.3.2

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.

2.3.3

Contraindications

No known contraindications.

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. 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.

RT: Room temperature * The manufacturer recommends Meliseptol® wipes sensitive (B. Braun) Phase I ► Remove any visible residues using a disposable disinfectant wipe. Phase II ► Completely wipe the visually clean product using an unused disposable disinfectant wipe. ► Observe contact time (at least 1 min).

3.4

Inspection

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

3.4.1

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 Tech-

nical service.

3.4.2

Functional test

► Check that the product functions correctly. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.5

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.

4.

Maintenance and Service

4.1

Maintenance and repair

Note As a matter of principle, defective products may not be repaired! ► Immediately set aside any damaged products!

4.2

Technical service

DANGER Malfunctions and/or failure of safety measures can be life-threatening for patients and users! ► Do not perform any service or maintenance work under any circumstances while the product is being used on a patient. CAUTION Modifications of medical equipment may result in the voiding of any guarantee/warranty claims and any approvals. ► 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/spare parts

Note Further information on the bipolar adapters is available in the Aesculapbrochure 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, make sure the packaging prevents injuries from the product. Note The user institution is obliged to reprocess the product before its disposal, see Processing procedure.

6.

Technical data

6.1

Classification in accordance with Regulation (EC) 2017/745

Designation

Class

Bipolar Adapter

I

6.2

Performance data, information on standards

Rated accessory voltage

1 000 Vp

Compliance with standards

IEC/EN 60601-2-2

TA022309

2020-05

V6

Change No. 62259