Aesculap
®
Trocars
Legend
1
Sealing cap
2
Trocar body
3
Silicone flap valve
4
Ring (with or without Luer Lock insufflation connector)
5
Sealing cap for Luer Lock connector
6
Code ring
7
Trocar shaft
8
Fixation screw
9
Obturator
10
Trocar
11
Suture fixation
Symbols on product and packages
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The trocars are used in laparoscopic operations for introducing instruments and endoscopes into the operating field.
They may only be used in conjunction with the silicone flap valve.
Available sizes
See Endoscopy online catalog (www.endoscopy-catalog.com) or Aesculap brochure C357.01/02 (MIT System)
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
►
Read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended use.
►
Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
►
Replace any damaged components immediately with original spare parts.
►
Use suture fixation
11
only with smooth trocar shaft
7
.
Safe operation
The trocar
10
is introduced into the operating field with an obturator
9
, which is passed through the trocar
10
.
►
For trocar shafts
7
with suture fixation
11
: Secure trocar shaft
7
with prepared fixation suture in the incision.
►
Connect the insufflation tube, either directly or via a metal tap or a single-use plastic tap, at the insufflation
connector.
►
Introduce instrument into the trocar
10
.
The silicone flap valve
3
flaps sideways to allow friction free instrumentation.
Sealing cap
1
prevents loss of CO
2
.
►
Remove instrument.
Silicone flap valve
3
seals trocar
10
against loss of CO
2
.
►
To avoid damage to silicone flap valve
3
slightly turn cutting instruments or hook-shaped instruments while pull-
ing them out of trocar
10
.
Disassembling
►
Remove sealing cap
1
from trocar body
2
.
►
Unscrew trocar body
2
from trocar shaft
7
.
►
Remove silicone flap valve
3
from trocar body
2
.
►
Remove ring
4
from trocar shaft
7
if the ring was installed.
►
Remove code ring
6
from trocar shaft
7
if the code ring was installed.
►
Remove the sealing cap for Luer Lock connector
5
if applicable.
►
Slide suture fixation
11
from trocar shaft
7
and completely unscrew fixation screw
8
.
Assembling
►
Put code ring
6
on trocar shaft
7
if applicable.
►
Put ring
4
on trocar shaft
7
if applicable.
►
Install the sealing cap for Luer Lock connector
5
if applicable.
►
Insert silicone flap valve
3
in trocar body
2
. Make certain that silicone flap valve
3
is pushed down to its position
below the thread.
►
Screw trocar body
2
onto trocar shaft
7
.
►
Place sealing cap
1
on the trocar body
2
.
►
Slide suture fixation
11
onto trocar shaft
7
and screw in fixation screw
8
.
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:
■
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.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
►
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
►
Disassemble the product immediately after use, as described in the respective instructions for use.
►
Remove the sealing cap from the Luer lock connector.
►
Open all valves/faucets.
Preparations at the place of use
►
If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
►
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
►
Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►
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.
Caution, general warning symbol
Caution, see documentation supplied with the product
Latex-free
WARNING
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
►
Apply the product only under visual control.
CAUTION
Leaks caused by damaged or defective sealing elements (sealing cap, silicone flap
valve, sealing cap for Luer Lock connector, code ring)!
►
Replace damaged/defective sealing elements.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
–
are approved for (e.g. aluminum, plastics, high-grade steel),
–
do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 94 °C.
