B. Braun Aesculap Gebrauchsanweisung Seite 2

®
Aesculap
Reusable trocar system 5 mm
Legend
1 Trocar sleeve (with optional thread)
2 Insufflation valve (optional, open position)
2a Stopcock
3 Spring cap
4 Notch
5 Trocar obturator
6 Positioning lug
7 Single-use valve unit
8 Valve unit (reusable)
9 Sealing cap
10 Cross slot valve
11 Tab
12 Suture fixation (only for smooth trocar sleeves)
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
Latex-free
Applicable to
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For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The reusable trocar system is used in laparoscopic general surgery, gynecology and urology. It serves to create and
maintain an approach to the operating field for instruments and endoscopes in laparoscopic operations. Endoscopic
instruments of up to 5 mm diameter can be inserted through the trocars.
Note
Do not use if laproscopic operating techniques are contraindicated.
Available sizes
The reusable trocar system of the EK series is available in the following variants:
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Working lengths:
– 60 mm
– 110 mm
– 150 mm
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Diameter: 5 mm (red)
For a complete overview of trocar systems, see the Endoscopy Online Catalog at www.endoscopy-catalog.com
Note
The reusable trocar sleeves can be combined with either reusable or single-use trocar obturators and sealing elements.
Safe handling and preparation
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If laser, ultrasonic or electrosurgical techniques are applied in combination with the trocar system, ensure that
the user is sufficiently trained and experienced for these applications. Follow the instructions for use of the
respective implants and instruments.
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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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Follow the instructions for use of the insufflation device/tube used with the trocar system.
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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.
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To avoid damage to the valve unit: Carefully insert the product through the working channel (e.g. trocar).
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Only combine Aesculap trocar components of the EK series with each other.
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Only combine trocar sleeves and trocar obturators with the same color code (diameter) and the same working
length.
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Use suture fixation 12 only with smooth trocar sleeve 1.
Note
All trocar components of the EK series are latex-free.
Safe operation
Risk to patients due to inappropriate application!
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Make certain the user is sufficiently trained and experienced in endoscopic
surgical techniques, and familiar with the relevant anatomic features (blood
vessels, structures).
WARNING
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Prior to inserting the trocar into the patient, prepare an abdominal pneumo-
peritoneum e.g. with a Verress cannula.
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Apply skin incisions in order to avoid excessive application of force.
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Position any further trocars under intra-abdominal visual control.
Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
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Replace sealing element if necessary.
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WARNING To prevent damage to the sealing element, apply appropriate care when insert-
ing any instruments.
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If possible, insert instruments in their closed position, straight and central
through the sealing element.
Malfunction due to incompatible instruments!
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Check for mutual compatibility of the trocar system and instruments. To do
this, carefully insert the instrument into the trocar and check for patency.
CAUTION
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Insert valve unit 7/8 into trocar sleeve 1, see Assembling.
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When using a trocar sleeve with insufflation valve 2: Close stopcock 2a by turning it clockwise by 90°.
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Insert trocar obturator 5 into trocar sleeve 1. Position positioning lug 6 in recess 4.
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Insert the trocar into the patient by alternating left/right rotating movements, applying even and controlled pres-
sure.
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For trocar sleeve 1 with thread: Turn in a clockwise direct until the trocar is in the desired position.
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Retract trocar obturator 5.
Trocar sleeve 1 remains positioned in the patient.
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When using suture fixation 12: Wind the suture around suture fixation 12 at least twice, into the slots.
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To use an insufflation device connected at insufflation valve 2: Connect the insufflation device, start the device
and open stopcock 2a.
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Carry out intra-abdominal visual control.
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Post application, unwind the suture thread from suture fixation 12.
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Post application of trocar sleeve 1 with thread: Turn the sleeve counterclockwise until the thread is fully released.
Note
Apply rotary movement to remove hook-shaped instruments.
Note
The valve unit can be removed from the trocar sleeve for retrieving larger portions of resected tissue. The depressur-
ization caused by this action has to be compensated when re-installing the valve unit.
Disassembling
Trocars
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With insufflation valve 2: Unscrew spring cap 3.
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Remove stopcock 2a.
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If necessary, open the screw of suture fixation 12 and slide off the suture fixation from trocar sleeve 1.
Reusable valve unit
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Grasp tab 11 of valve unit 8 and extract the valve unit from trocar sleeve 1.
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For cleaning, extract cross slot valve 10 from sealing cap 9.
Single-use valve unit
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Grasp tab 11 of single-use valve unit 7, extract the valve unit from trocar sleeve 1 and dispose of the valve unit.
Assembling
Trocars
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With insufflation valve 2: Install stopcock 2a in insufflation valve 2.
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Screw on spring cap 3.
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If applicable, slide suture fixation 12 onto trocar sleeve 1 and tighten the screw of suture fixation 12.
Valve unit
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With reusable valve unit 8: Engage cross slot valve 10 in sealing cap 9.
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Completely press the valve unit 7/8 in the trocar sleeve 1 with the tab 11 in the notch 4.
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.
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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.