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®
Aesculap
PROSPACE® PEEK Inserter SN002R
Legend
1 Connector
2 Clamp
3 Tube
4 Adjustment knob
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
About this document
Note
General risk factors associated with surgical procedures are not described in this documentation.
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use
PROSPACE® PEEK inserter SN002R is an instrument used for inserting PROSPACE® PEEK implants in the interverte-
bral space of the lumbar spine.
Indications
See intended use.
Absolute contraindications
No known absolute contraindications.
Relative contraindications
The following conditions, individual or combined, can lead to delayed healing or compromise the success of the oper-
ation:
■
Medical or surgical conditions (e.g. comorbidities) which could hinder the success of the operation.
In the presence of relative contraindications, the user decides individually regarding the use of the product.
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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Remove the transport packaging and clean the new product, either manually or mechanically, 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
Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
WARNING
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Attach the clamp 2 and open PROSPACE® PEEK inserter SN002R to its widest point, see Assembling.
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Place the chosen implant onto the connector 1 of the clamp 2.
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Turn the adjustment knob 4 clockwise until the implant is held securely, making sure that the pins on the con-
nector 1 of the clamp 2 have engaged with the rear sections of the implant.
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Insert the implant into the prepared intervertebral disk cavity.
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Keep turning the adjustment knob 4 counterclockwise until the two arrow markings meet, see Fig. 4.
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Release PROSPACE® PEEK inserter SN002R from the implant.
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Carefully remove PROSPACE® PEEK inserter SN002R along the longitudinal axis of the implant.
Disassembling
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Keep turning the adjustment knob 4 counterclockwise until the clamp 2 is released.
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Pull clamp 2 out of tube 3 in the direction of the arrow, see Fig. 1.
Assembling
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Insert the clamp 2 into the tube 3 in the direction of the arrow until it engages, see Fig. 2. In doing so, be mindful
of the groove in the clamp 2 to expanding pins in the tube 3, see Fig. 3.
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Once it has engaged, continue pushing the clamp 2 in the direction of the arrow and keep turning the adjustment
knob 4 clockwise until the two arrow markings meet, see Fig. 4.
The PROSPACE® PEEK inserter SN002R has been opened to its widest point.
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 up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://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:
■
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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Disassemble the product prior to cleaning, see Disassembling.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
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 (e.g. aluminum, plastics, 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 permitted cleaning 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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Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/dis-
infection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
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