B.Braun 011883 Mode D'emploi page 2

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
Intended use
The trocars are used in endoscopic 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!
Read, follow and keep the instructions for use.
Use the product only in accordance with its intended use, see Intended use.
Clean the new product either manually or mechanically prior to the 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: Fixate trocar shaft 7 with prepared fixation suture in the incision.
Connect the insufflation tube, either directly or via a metal stop-cock or a single-use plastic stop-cock, 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
To avoid damage to silicone flap valve 3 slightly turn cutting instruments or hook-shaped instruments while
pulling 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
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
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 the sealing cap 1 on the trocar body 2.
Slide suture fixation 11 onto trocar shaft 7 and screw in fixation screw 8.
Validated processing procedure
Note
Observe all relevant national regulations and standards with regard to 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 the products.
Note
Mechanical processing should be preferred over manual cleaning because of the better and more reliable cleaning
results of mechanical processing.
Note
Successful processing of this medical product can only be ensured through a validated processing procedure. The user/
processor is responsible for the validation.
Due to process tolerances, manufacturer's specifications can only serve as guide values for the processing procedures
applied by the individual user.
Note
Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net
.
2
General notes
Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause
corrosion of "stainless" steels. Consequently the time interval between application and processing should not exceed
6 h, and neither fixating pre-cleaning temperatures > 45 °C nor any fixating disinfecting agents (active ingredient:
aldehyde, alcohol) should be used.
Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading of the laser engrav-
ing on stainless steel.
Residues containing chlorine or chlorides, as contained e.g. in surgical residues, tinctures, medicines, saline solutions,
servicewater used for cleaning, and in cleaning/disinfecting agents, will cause corrosion damage (pitting, stress cor-
rosion) and, consequently, destruction of stainless steel products. To remove such residues, the products must be
rinsed sufficiently with fully desalinated water and dried thoroughly.
Only use process chemicals recommended by the chemicals' manufacturers as effective cleaning/disinfecting agents
compatible with the materials used in the respective product. Strictly observe all application instructions, e.g.
regarding temperatures, concentrations, exposure times, etc. Failure to do so can result in the following problems
• Optical changes to the material, e.g. fading or discoloration of titanium or aluminum. For aluminum, the appli-
cation/process solution only needs to be of pH > 8 to cause visible surface changes or
• Material damage, e.g. corrosion, cracks, fracturing, premature aging or swelling.
• Do not use process chemicals that cause stress cracking of plastics such as PPSU, or attack and cause brittleness
e.g. of silicone softeners.
Clean the product immediately after use.
Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at
www.a-k-i.org, Publications, Red Brochure – Proper maintenance of instruments.
Use suitable cleaning/disinfecting agents if the product is put away in wet condition. Prior to mechanical clean-
ing and disinfecting, rinse the product thoroughly with running water.
Preparations at the place of use
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/stop-cocks.
Remove visible residues as completely as possible, using a lint-free, single-use cleaning tissue.
Preparations prior to cleaning
Have the product dry in a disposal container and ready for immediate cleaning and disinfecting within 30 min
after use.
Cleaning/Disinfecting
Damage to the product due to inappropriate cleaning/disinfecting agents and/or exces-
sive temperatures!
Use cleaning and disinfecting agents according to manufacturer's instructions. The
cleaning and disinfecting agent must
- be approved for high-grade steel,
CAUTION
- not attack softeners (e.g. silicone).
Observe specifications regarding concentration, temperature and exposure time.
Do not exceed the maximum allowable cleaning temperature of 94 °C.
Manual cleaning/disinfecting
Clean hinged or jointed products in open and closed positions.
Check visible surface for residues after manual cleaning/disinfecting.
Repeat the cleaning process if necessary.
Manual cleaning with immersion disinfection and cleaning with brush
Stage Step T
[°C/°F]
I Disinfecting RT
cleaning (cold)
II Intermediate rinse RT
(cold)
III Final rinse RT
(cold)
IV Drying RT
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
Fully immerse the product in the disinfecting solution. Make certain that all accessible surfaces are moistened.
Clean under running tap water, if necessary using a fitting cleaning brush (see Endoscopy online catalog
www.endoscopy-catalog.com or Aesculap brochure C357.01/02 (MIT System)) until no visible residues are left
on the surface.
Brush through all surfaces that are not accessible to visual inspection, e.g. in products with hidden crevices,
lumens or complex geometries, for at least 5 min or until no more residues can be removed. Mobilize non-rigid
components, e.g. set screws, joints, etc. during cleaning.
After that, thoroughly rinse (at least 5 times) with the cleaning solution these difficult to access areas of the
product, using a single-use syringe (20 ml).
To avoid the risk of corrosion, do not use a metal brush or other abrasives, which would damage the surfaces,
for cleaning the product.
Stage II
Rinse the product completely (all accessible surfaces) under running water.
Stage III
Carry out a full rinse of the product (all accessible surfaces) under running water.
Allow water to drip off for a sufficient length of time.
Stage IV
Dry the product completely with compressed air.
t Conc. Water Chemical
[min] [%] quality
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
1 - D–W -
0.5 - FD–W -
- - - -