Bipolar Adapter Instructions for Use/Technical Description

Aesculap Neurosurgery

Bipolar Adapter Symbols on product and packages Symbol

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

Intended use Bipolar adapters are used to connect Aesculap HF cables to the equipment of other manufacturers.

Product no.

Illustration

GN228

For connecting to equipment of the company: Aesculap GN300 Aesculap GN060 (Serial no. <2000)

Pin distance on the device: 25 mm Note Further information about the HF adapters can be found in Aesculap brochure C-304-81.

Product variants Plug ¾ Check the plug for compatibility with the socket of the HF device. The bipolar adapters come in the following designs: Product no.

Illustration

For connecting to equipment of the company: Conmed

GN219

Pin distance on the device: 31.7 mm GN224

Codman

Pin distance on the device: 38.1 mm GN226

EMC DOLLEY

Pin distance on the device: 22 mm 2

Safe handling and preparation CAUTION Federal law restricts this device to sale by or on order of a physician! ¾ Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ¾ Read, follow, and keep the instructions for use. ¾ Use the product only for its intended purpose, see Intended use. ¾ Clean the new product thoroughly (manually or mechanically) after removal of the transport packaging. ¾ Store any new or unused products in a dry, clean, and safe place. ¾ Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. ¾ Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ¾ Disconnect plug connections only by pulling at the plug.

WARNING

WARNING

Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ¾ Observe the safety guidelines in the instructions for use of the HF device. Thermal injuries to patients/users due to insufficient insulation! ¾ Set the HF device for a maximum peak output voltage smaller than or equal to the peak voltage rating specified for the product.

Safe operation Risk of injury and/or malfunction! ¾ Always carry out a function check before using the product. WARNING

WARNING

CAUTION The accessory voltage rating of the bipolar adapters is 1 000 Vp. The accessory voltage rating must exceed or be equal to the maximum peak output voltage at which the product is operated in combination with an appropriate HF device and an appropriate operating mode/setting (see IEC 60601-2-2). To avoid HF burns: ¾ Prior to each use, visually inspect the product for: damage or surface changes to the insulation. ¾ Follow the instructions for use of the HF device.

Risk of injury when applying the product outside the field of view! ¾ Apply the product only under visual control. Malfunctions or error messages when deploying an automatic on/ off function with the device when combined with certain bipolar adapters and HF cables! ¾ Follow the instructions for use of the product. ¾ As necessary, deactivate the automatic function.

Validated processing procedure Note National laws, national and international standards and directives, and product-specific hygiene regulations for processing must be observed. Note It should be noted that successful processing of this medical device can only be guaranteed following prior validation of the processing procedure. The operator/ technician is responsible for this. Note Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net

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Aesculap Neurosurgery

Bipolar Adapter General information

Preparations at the place of use

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion of stainless steel. You should therefore leave no more than 6 hours between use and cleaning, not use preclean fixing temperatures >45 °C, and ensure that non-fixing disinfectants ( aldehyde, alcohol) are used. Only use process chemicals which have been tested and approved (e.g. VAH/DGHM or FDA-certified or CE marking), and recommended by the chemical manufacturer as being compatible with the given materials. All the chemical manufacturer's application specifications regarding temperature, concentration and contact time should be strictly observed. Failure to do so may result in the following problems: • Visible changes to materials e.g. fading or changes in the color of titanium or aluminum. • Material damage such as corrosion, cracks, fractures, premature deterioration or swelling. ¾ Do not use process chemicals which cause stress cracks or brittleness in plastics. ¾ Clean the product immediately after use. Please see www.a-k-i.org for more detailed information on hygienically safe reprocessing methods which serve to protect the materials as well as retain their value. ¾ 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 disinfecting, rinse the product thoroughly with running water.

¾ Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.

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Cleaning/disinfection

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ¾ Use cleaning and disinfecting agents approved for use with plastics, as recommended by the manufacturer. ¾ Observe specifications regarding concentration, temperature and exposure time. ¾ Do not exceed the maximum allowable cleaning temperature of 95 °C.

Manual cleaning/disinfection Wipe disinfection without sterilization Phase

Step

I

Wipe disinfection

RT:

T [°C/°F]

t [min]

RT

≥1

Conc. [%] -

Water quality -

Chemical

Meliseptol HBV wipes 50 % propan-1-ol

Room temperature

Phase I ¾ Remove any visible residues with a disposable disinfectant wipe. ¾ Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe. ¾ Observe the specified contact time (1 minute minimum).

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Aesculap Neurosurgery

Bipolar Adapter Inspection, maintenance and checks

Service addresses

¾ Allow the product to cool down to room temperature. ¾ 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). ¾ Dry the product if it is wet or damp. ¾ Repeat cleaning and disinfection of products that still show impurities or contamination. ¾ Check that the product functions correctly. ¾ Set aside the product if it is damaged or dysfunctional.

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1602 Fax: +49 7461 16-5621 E-Mail: [email protected]

Maintenance Note Defective products must not be repaired under any circumstances! ¾ Set aside the product if it is damaged.

Technical Service Risk of injury and/or malfunction! ¾ Do not modify the product. WARNING ¾ 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.

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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.

Accessories/Spare parts Note Further information about the HF adapters can be found in Aesculap brochure C-304-81.

Technical data Bipolar Adapter

Class I*

Accessory voltage rating

1 000 Vp

*Classification according to Directive 93/42/EEC

Conforming to standard IEC/DIN EN 60601-2-2

Ambient conditions Storage and transport conditions Relative humidity

0 % to 75 %, no condensation

Ambient temperature

-20 °C to +50 °C

Atmospheric pressure

500 hPa to 1 600 hPa

Direct sunlight

Protect against direct sunlight

Disposal ¾ 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

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