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®
Aesculap
Neuropilot IV + EA
Legend
1 Adjustment knob (direction X)
2 Adjustment knob (direction Z)
3 Adjustment knob (direction Y)
4 Reduction sleeve
5 Locking nut
6 Holding arm connector
7 Fixation knob (fixation)
8 Holding arm locking/release sleeve
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
The Neuropilot IV + EA is used as a holder in neurosurgery to fix and fine tune the position of endoscopes or trocars.
It is designed specially for endoscope-assisted surgery, but can also be used for fully endoscopic intraventricular pro-
cedures.
The Neuropilot IV + EA may only be used together with the holding arm (RT040R and FF168). Adjustment knobs
allow the position of the trocar or endoscope to be fine tuned in three different directions in Neuropilot IV + EA.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
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Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
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Read, follow, and keep the instructions for use.
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Use the product only in accordance with its intended use, see Intended use.
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Clean the new product mechanically after removing its transport packaging and prior to its initial sterilization.
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Store any new or unused products in a dry, clean, and safe place.
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Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Replace any damaged components immediately with original spare parts.
Safe operation
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Ensure that the reduction sleeve fits the endoscope or trocar to be inserted.
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Follow the instructions for the endoscope or trocar.
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Rotate the fixation knob 7 in a counterclockwise direction as far as it will go, see Fig. 1.
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Slide the endoscope/trocar into the reduction sleeve 4 in Neuropilot IV + EA from above.
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Insert the endoscope into the reduction sleeve 4 as far as it will go to avoid adverse leverage effects and breakage
of the glass lenses in the endoscope.
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Rotate the fixation knob 7 in a clockwise direction until the endoscope/trocar is seated securely.
The endoscope/trocar is now fixed.
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Prior to the operation, rotate the adjustment knobs 1, 2 and 3 so that the trocar spindle of Neuropilot IV + EA
is center-positioned in all directions, see Fig. 2.
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During the operation, use the adjustment knobs 1, 2 and 3 to fine position the endoscope/trocar in
Neuropilot IV + EA:
– Use the adjustment knob 1 in direction X.
– Use the adjustment knob 2 in direction Z.
– Use the adjustment knob 3 in direction Y.
Disassembling
Removing the Neuropilot IV + EA from the holding arm
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Follow the instructions for use of the holding arm.
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Unscrew locking nut 5, see Fig. 3.
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Turn the sleeve 8 of the holding arm to release the quick-action coupling.
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Slide the sleeve 8 forward and remove the adapter 6 from the quick-action coupling on the support arm.
Removing the reduction sleeve
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Rotate the fixation knob 7 in a counterclockwise direction, see Fig. 4.
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Push the reduction sleeve 4 out of the opening from underneath and pull it out from above.
Assembling
Mounting the Neuropilot IV + EA on the holding arm
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Follow the instructions for use of the holding arm.
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Rotate the adjustment knobs 1, 2 and 3 so that the endoscope or trocar spindle of Neuropilot IV + EA is center-
positioned in all directions.
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Unscrew the locking nut 5 in the opposite direction of the arrow.
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Slide the holding arm connector 6 into the quick-action coupling of the holding arm until the sleeve 8 snaps
back, see Fig. 5.
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To secure the quick-release coupling against inadvertent opening, turn sleeve 8 of the support arm to the locking
position.
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Screw on the locking nut 5 until Neuropilot IV + EA is seated securely.
Inserting the reduction sleeve
Accidental pushing of the reduction sleeve into the operating field!
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Always insert the reduction sleeve in a proximal to distal direction.
WARNING
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Select a reduction sleeve 4 that is compatible with the endoscope or trocar being used.
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Rotate the fixation knob 7 in a counterclockwise direction as far as it will go, see Fig. 6.
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Always insert the reduction sleeve 4 in a proximal to distal direction.
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Slide the reduction sleeve 4 into the opening from above, until it audibly snaps into place.
Validated reprocessing procedure
General safety instructions
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.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/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 temper-
atures >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. Fail-
ure to do so can result in the following problems:
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Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/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.
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Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
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Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
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Disassemble the product immediately after use, as described in the respective instructions for use.
Preparations at the place of use
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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
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Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
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Dismantle the product prior to cleaning, see Disassembling.
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Turn the adjustment knobs to their maximum open position.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Risk to patients!
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The product must only be cleaned mechanically!
DANGER
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
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Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which
CAUTION
– are approved for use, for example, on aluminum, plastic materials, and
high-grade steel,
– do not attack softeners (e.g. in silicone).
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Observe specifications regarding concentration, temperature and exposure
time.
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Do not exceed the maximum allowable temperature of 60 °C.
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Do not use oxidizing chemicals (e.g. H
O
), which could cause bleaching/layer loss of the product.
2
2
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Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
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