Aesculap Neurosurgery

Instructions for use/Technical description

Bipolar Adapter
Gebrauchsanweisung/Technische Beschreibung
Bipolar-Adapter
Mode d’emploi/Description technique
Adaptateur bipolaire
Instrucciones de manejo/Descripción técnica
Adaptador bipolar
Istruzioni per l’uso/Descrizione tecnica
Adattatore bipolare
 Aesculap Neurosurgery

Bipolar Adapter
Symbols on product and packages
Product Illustration For connecting
Symbol Explanation no. to equipment of
the company:
Caution, general warning symbol
GN228 Aesculap GN300
Caution, see documentation
supplied with the product Aesculap GN060
(Serial no. <2000)

Intended use Pin distance on the

Bipolar adapters are used to connect Aesculap HF device: 25 mm
cables to the equipment of other manufacturers.
Note
Product variants Further information about the HF adapters can be
found in Aesculap brochure C-304-81.
Plug
¾ Check the plug for compatibility with the socket of Safe handling and preparation
the HF device. CAUTION
The bipolar adapters come in the following designs: Federal law restricts this device to sale by or on
order of a physician!
Product Illustration For connecting
¾ Ensure that the product and its accessories are
no. to equipment of
operated and used only by persons with the requi-
the company:
site training, knowledge, or experience.
GN219 Conmed 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
Pin distance on the mechanically) after removal of the transport
device: 31.7 mm packaging.
¾ Store any new or unused products in a dry, clean,
GN224 Codman
and safe place.
¾ Prior to each use, inspect the product for: loose,
bent, broken, cracked, worn, or fractured
components.
Pin distance on the
¾ Do not use the product if it is damaged or
device: 38.1 mm
defective. Set aside the product if it is damaged.
GN226 EMC DOLLEY ¾ Disconnect plug connections only by pulling at the
plug.

Pin distance on the

device: 22 mm

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 Risk of injury from ignition or Safe operation
explosion of flammable gases!
Sparks may occur when using the Risk of injury and/or malfunction!
WARNING HF device as directed. ¾ Always carry out a function
¾ Observe the safety guidelines in check before using the product.
the instructions for use of the WARNING
HF device.
Risk of injury when applying the
Thermal injuries to patients/users product outside the field of view!
due to insufficient insulation! ¾ Apply the product only under
¾ Set the HF device for a WARNING visual control.
WARNING maximum peak output voltage
smaller than or equal to the Malfunctions or error messages
peak voltage rating specified for when deploying an automatic on/
the product. off function with the device when
CAUTION combined with certain bipolar
The accessory voltage rating of the bipolar adapters is adapters and HF cables!
1 000 Vp. ¾ Follow the instructions for use
The accessory voltage rating must exceed or be equal of the product.
to the maximum peak output voltage at which the ¾ As necessary, deactivate the
product is operated in combination with an automatic function.
appropriate HF device and an appropriate operating
mode/setting (see IEC 60601-2-2).
To avoid HF burns: Validated processing procedure
¾ Prior to each use, visually inspect the product for:
damage or surface changes to the insulation. Note
¾ Follow the instructions for use of the HF device. 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 ¾ Remove any visible surgical residues to the extent
more difficult or ineffective and lead to corrosion of possible with a damp, lint-free cloth.
stainless steel. You should therefore leave no more
than 6 hours between use and cleaning, not use pre- Cleaning/disinfection
clean fixing temperatures >45 °C, and ensure that
non-fixing disinfectants ( aldehyde, alcohol) are used. Damage to the product due to
Only use process chemicals which have been tested inappropriate cleaning/disinfecting
and approved (e.g. VAH/DGHM or FDA-certified or CE agents and/or excessive tempera-
marking), and recommended by the chemical CAUTION tures!
manufacturer as being compatible with the given ¾ Use cleaning and disinfecting
materials. All the chemical manufacturer's application agents approved for use with
specifications regarding temperature, concentration plastics, as recommended by the
and contact time should be strictly observed. Failure to manufacturer.
do so may result in the following problems: ¾ Observe specifications regarding
• Visible changes to materials e.g. fading or changes concentration, temperature and
in the color of titanium or aluminum. exposure time.
• Material damage such as corrosion, cracks, ¾ Do not exceed the maximum
fractures, premature deterioration or swelling. allowable cleaning temperature
¾ Do not use process chemicals which cause stress of 95 °C.
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.

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Manual cleaning/disinfection
Wipe disinfection without sterilization

Phase Step T t Conc. Water Chemical

[°C/°F] [min] [%] quality

I Wipe disinfection RT ≥1 - - Meliseptol HBV wipes

50 % propan-1-ol

RT: 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 Aesculap Technischer Service
temperature. Am Aesculap-Platz
¾ After each complete cleaning, disinfecting and 78532 Tuttlingen / Germany
drying cycle, check that the instrument is: dry, Phone: +49 7461 95-1602
clean, operational, and free of damage (e.g. broken Fax: +49 7461 16-5621
insulation or corroded, loose, bent, broken, cracked, E-Mail: [email protected]
worn or fractured components).
¾ Dry the product if it is wet or damp. Or in the US:
¾ Repeat cleaning and disinfection of products that Aesculap Inc.
still show impurities or contamination. Attn. Aesculap Technical Services
¾ Check that the product functions correctly. 615 Lambert Pointe Drive
¾ Set aside the product if it is damaged or Hazelwood, MO 63042
dysfunctional. Aesculap Repair Hotline
Phone: +1 800 214-3392
Fax: +1 314 895-4420
Maintenance
Other service addresses can be obtained from the
Note address indicated above.
Defective products must not be repaired under any
circumstances! Accessories/Spare parts
¾ Set aside the product if it is damaged. Note
Further information about the HF adapters can be
Technical Service found in Aesculap brochure C-304-81.

Risk of injury and/or malfunction!

Technical data
¾ Do not modify the product. Bipolar Adapter Class I*

WARNING Accessory voltage rating 1 000 Vp

*Classification according to Directive 93/42/EEC

¾ For service and repairs, please contact your
national B. Braun/Aesculap agency. Conforming to standard
Modifications carried out on medical technical IEC/DIN EN 60601-2-2
equipment may result in loss of guarantee/warranty
rights and forfeiture of applicable licenses.

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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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CE marking according to directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE en conformidad con la directriz 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE

Technical alterations reserved

Technische Änderungen vorbehalten
Sous réserve de modifications techniques
Sujeto a modificaciones técnicas
Con riserva di modifiche tecniche

Aesculap AG
Am Aesculap-Platz
78532 Tuttlingen
Germany
Phone +49 7461 95-0
Fax +49 7461 95-2600
TA-Nr. 022309 10/10 V4 Änd.-Nr. www.aesculap.de