Braun Aesculap MINOP InVent trocar 30 Manual

Aesculap®
Aesculap Neurosurgery
Instructions for use/Technical description
MINOP InVent trocar 30°
Gebrauchsanweisung/Technische Beschreibung
MINOP InVent-Trokar 30°
Mode d’emploi/Description technique
Trocart MINOP InVent 30°
Instrucciones de manejo/Descripción técnica
Trocar MINOP InVent 30°
Istruzioni per l’uso/Descrizione tecnica
Trocar MINOP InVent 30°
Instruções de utilização/Descrição técnica
Trocarte MINOP InVent 30°
Gebruiksaanwijzing/Technische beschrijving
MINOP inVent-trocart 30°
Bruksanvisning/Teknisk beskrivning
MINOP InVent-Trokar 30°
Инструкция по примению/Техническое опи-
сание
Троакар MINOP inVent 30°
Návod k použití/Technický popis
30° trokar MINOP InVent
Instrukcja użytkowania/Opis techniczny
Trokar MINOP inVent 30°
Návod na použivanie/Technický opis
MINOP InVent-Trokár 30°
Kullanım Kılavuzu/Teknik açiklama
MINOP InVent trokar 30°

11 10
1
4 3
2
9 8
7
5
6

2
Aesculap®
MINOP InVent trocar 30°
Aesculap® MINOP InVent trocar 30°
Legend
1MINOP InVent trocar
2Groove
3Release button
4Irrigation connector
5Endoscope
6Locking pin endoscope
7Obturator for the oval working channel
8Obturator for optical channel
9Locking pin obturator
10 Wing nut
11 Holding arm adapter
Symbols on product and packages
Applicable to
►For item-specific instructions for use and informa-
tion on material compatibility, see also the
Aesculap Extranet at https://extranet.bbraun.com
Intended use
The MINOP InVent trocar system is used for endoscopic
and endoscope-assisted surgery on the central nervous
system, particularly for the treatment of intraventric-
ular and paraventricular pathological structures. The
MINOP InVent trocar system can be used either free-
hand or via the holding arm adapter RT068R on the
appropriate holding arm, and can be used with the
instruments for the MINOP InVent system.
Indications
Indications, see Intended use.
Note
The manufacturer is not responsible for any use of the
product against the specified indications and/or the
described applications.
Contraindications
None known.
Risks and side effects
As part of the legal duty to inform, the following typi-
cal risks and side effects associated with the use of
surgical instruments are referred to. These are predom-
inantly procedure-specific, non product-specific and
not limited to unwanted damage to surrounding tissue
resulting in e.g. bleeding, infection, material incom-
patibilities or instrument parts remaining unnoticed in
the patient, etc.
Caution, general warning symbol
Caution, see documentation sup-
plied with the product

3
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
Note
A specially designed Aesculap endoscope is offered for
the MINOP InVent trocar system. For reasons of com-
patibility, the MINOP InVent trocars may only be used
with this special Aesculap endoscope.
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site 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 compo-
nents.
►Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
►Replace any damaged components immediately
with original spare parts.
►Perform a function check of the irrigation channel
before each use.
►Perform a function check of the endoscope's stop
mechanism before each use.
►To avoid burns when using the MINOP InVent tro-
car in combination with HF electrodes, ensure that
HF current is activated only under visual control.
►When inserting the trocar into the brain/the ven-
tricle, close the working channel with the obtura-
tor provided.
Safe operation
WARNING
Risk of injury caused by incor-
rect operation of the product!
►Attend appropriate prod-
uct training before using
the product.
►For information about
product training, please
contact your national
B. Braun/Aesculap agency. WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion 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.
WARNING
Risk of injury caused by pro-
truding 30° endoscope in
locked position!
►Insert the endoscope only
when the trocar is in its
final position.
WARNING
Risk of burns due to high tem-
perature of the instrument-
side end of the optical cable of
a light source!
►Apply proper care when
operating the light source.

4
Aesculap®
MINOP InVent trocar 30°
Note
There is an approx. 2 mm marking on the shafts of the
MINOP InVent sliding shaft and round shaft instru-
ments. As soon as this marking passes the proximal end
of the oval working channel, the instrument emerges
from the trocar.
The MINOP InVent trocar 1is used with a 30° endo-
scope 5(MINOP 30° angled endoscope).
►In order to close the working end of the trocar
atraumatically,
– insert obturator for optical channel 8into the
optical channel 14 and
– insert obturator for the oval working channel 7
into the working channel 12, see Fig.1.
There is constant irrigation via the irrigation channel.
The irrigation fluid drains out via the large working
channel 12 and the small working channel 13, see
Fig.1.
Fig.1
►For hands free operation, attach the MINOP InVent
trocar 1to the holding arm using the holding arm
adapter 11 and the wing nut 10.
Note
The endoscopes offered for application with the MINOP
InVent system must be used with a light source
equipped with a spare bulb.
Camera assembly
Note
Connect the camera only with the endoscope locked in
the working trocar!
►Lock the endoscope 5in the MINOP InVent
trocar 1, see Fig.2,
►Making sure that the locking pin 6of the endo-
scope 5is on the same side as the release button 3
of the MINOP InVent trocar 1.
CAUTION
Damage to the endoscope due
to incorrect handling or oper-
ation!
►Insert the endoscope into
the trocar only if the tro-
car is not deformed, bent
or kinked.
CAUTION
Malfunction and/or OP delay!
►Insert balloon catheters or
other instruments which
change in volume through
the oval working channel
only.
13 12
14

5
Fig.2
►Connect light cable and camera, see Fig.3–5.
Fig.3
5
6
3
1
5
1

6
Aesculap®
MINOP InVent trocar 30°
Fig.4
Fig.5
Camera disassembly
Note
Extract the endoscope from the working trocar only
after the camera has been demounted from the endo-
scope.
►Disconnect camera and light cable from the
endoscope 5, see Fig.6 and see Fig.7.
Fig.6
5
1
5
1
5
1

7
Fig.7
►Press the release button 3and remove the endo-
scope 5from the MINOP InVent trocar 1, see Fig.8.
Fig.8
5
1
5
3
1

8
Aesculap®
MINOP InVent trocar 30°
Trocar disassembly
Removing the obturator for work-
ing/drainage channels
Note
This step is only necessary if the obturator for the work-
ing or drainage channel is being used.
►Remove the obturator for the oval working
channel 7carefully from the MINOP InVent
trocar 1, see Fig.9.
Fig.9
Removing the obturator for optical chan-
nel or endoscope
►Press the release button 3and carefully remove
the obturator for the optical channel 8from the
MINOP InVent trocar 1, see Fig.10.
Fig.10
7
8
1
8
3
1

9
►Press the release button 3and remove the endo-
scope 5from the MINOP InVent trocar 1, see
Fig.11.
Fig.11
Removing irrigation tube
►Remove tube from irrigation connector 4, see
Fig.12.
Fig.12
7
1
3
1
4

10
Aesculap®
MINOP InVent trocar 30°
Removing the holding arm adapter
►Unscrew the wing nut 10.
►Remove holding arm adapter 11, see Fig.13.
Fig.13
Trocar assembly
Inserting the endoscope/obturators
►Carefully insert the endoscope 5/obturator for the
optical channel 8into the MINOP InVent trocar 1
axially,
►making sure that the locking pin 6of the
endoscope 5or locking pin 9of the obturator for
the optical channel 8is on the same side as the
release button 3of the MINOP InVent trocar 1, see
Fig.14 and see Fig.15.
Fig.14
1
11
10
1
6
3
5

11
Fig.15
►Insert the endoscope 5/obturator for optical
channel 8as far as the stop or until the locking
pin 6or 9clicks into place, so that the
endoscope 5/obturator for optical channel 8can
only be removed by activating the release
button 3.
Inserting the obturator for the oval
working channel
►Hold the obturator for the oval working channel 7
at the distal end and carefully insert it into the
working channel 12 as far as the stop, see Fig.16.
Due to friction in the channel, the obturator is
secured from falling out.
Fig.16
1
9
3
8
7

12
Aesculap®
MINOP InVent trocar 30°
Assembling the holding arm adapter
►Unscrew the wing nut 10 of the holding arm
adapter 11, see Fig.17.
Fig.17
►Insert the holding arm adapter 11 laterally into the
hole (either right or left), until the flange engages
in the appropriate groove 2that secures the hold-
ing arm in place, see Fig.18.
Fig.18
11
10
11
2

13
►Screw on the wing nut 10 until the holding arm
adapter 11 is fixed in place, see Fig.19.
MINOP InVent-Trocar 1is now ready to be fitted to
the holding arm.
Fig.19
Connecting the irrigation tube
►Connect the irrigation tube with the irrigation
connector 4, see Fig.20.
►Check the irrigation function.
Fig.20
11
1
10
4

14
Aesculap®
MINOP InVent trocar 30°
Validated reprocessing procedure
General safety notes
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for reprocessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD, or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
It should be noted that successful reprocessing of this
medical device can only be guaranteed following prior
validation of the reprocessing method. The opera-
tor/reprocessing technician is responsible for this.
The specified chemistry was used for validation.
Note
For up-to-date information about 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 temperatures >45 °C nor fixating disin-
fecting agents (active ingredient: aldehydes/alcohols)
should be used.
Excessive neutralizing agents or basic cleaners may
result in a chemical attack and/or fading and the laser
marking becoming unreadable either visually or by
machine.
Residues containing chlorine or chlorides, e.g., in sur-
gical residues, medicines, saline solutions, and in the
service water used for cleaning, disinfection, and ster-
ilization, will cause corrosion damage (pitting, stress
corrosion) and result damage to metallic products.
These must be removed by rinsing thoroughly with
demineralized water and then drying.
Perform 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’ recommen-
dations may be used for processing the product. All the
chemical manufacturer's application specifications
must be strictly observed. Failure to do so can result in
the following problems:
■Optical changes in materials, e.g., fading or discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fractur-
ing, premature aging, or swelling.
►Do not use metal cleaning brushes or other abra-
sives that would damage the product surface and
could cause corrosion
►For further detailed information on hygienically
safe and material-preserving/value-preserving
reprocessing, see www.a-k-i.org, link to Publica-
tions, Red Brochure – Proper maintenance of
instruments.

15
Disassembling the product before carry-
ing out the reprocessing procedure
►Disassemble the product immediately after use, as
described in the respective instructions for use.
Preparations at the place of use
►If applicable, rinse surfaces that are not accessible
to visible inspection (preferably with demineralized
water), using a disposable syringe, for example.
►Remove any visible surgical residues as much as
possible with a damp, lint-free cloth.
►Place the dry product in a sealed waste container
and forward it on for cleaning and disinfection
within 6 hours.
Preparation before cleaning
►Disassemble the product prior to cleaning, see Tro-
car disassembly.
Cleaning/disinfection
Product-specific safety notes on the repro-
cessing procedure
►Do not use oxidizing chemicals (e.g. H2O2), which
could cause bleaching/layer loss of the product.
►Use suitable cleaning/disinfecting agents if the
product is put away in a wet condition. To prevent
foam formation and reduced effectiveness of the
process chemicals: Prior to mechanical cleaning
and disinfection, rinse the product thoroughly with
running water.
►Carry out ultrasound cleaning:
– as an effective mechanical supplement to man-
ual cleaning/disinfection.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechan-
ical cleaning/disinfection.
– as an integrated mechanical support measure
for mechanical cleaning/disinfection.
– for additional cleaning of products with resi-
dues left after mechanical cleaning/disinfec-
tion.
DANGER
Risk to patients!
►Reprocess the product only
with manual pre-cleaning
followed by mechanical
cleaning.
DANGER
Risk to patient due to cross
contamination!
►Do not clean contaminated
products together with
uncontaminated products
in a tray.
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents and/or exces-
sive temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instruc-
tions which
–are approved for the
material in question
(e.g., aluminum, plas-
tics, high-grade steel),
–do not attack softeners
(e.g. in silicone).
►Observe specifications
regarding concentration,
temperature and exposure
time.
►Do not exceed the maxi-
mum permitted cleaning
temperature of 55 °C.

16
Aesculap®
MINOP InVent trocar 30°
►Clean and disinfect microsurgical products
mechanically if they can be placed securely in the
machine or on the positioning aids.
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfecting machine must be of
tested and approved effectiveness (e.g. FDA approval or
CE mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection machine used for pro-
cessing must be serviced and checked at regular inter-
vals.
Manual pre-cleaning with ultrasound and brush
D–W: Drinking water
RT: Room temperature
*Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)
Phase I
►Clean the product in an ultrasound cleaning bath
(frequency of 35 kHz) for at least 15 minutes.
Ensure that all accessible surfaces are immersed
and acoustic shadows are avoided.
►Clean the product with a suitable cleaning brush
(for a small working channel, e.g. TA013543) in the
solution until all visible residues have been
removed from the surface.
►If applicable, brush non-visible surfaces for at least
1 minute with a suitable cleaning brush (for a small
working channel, e.g. TA013543).
►Mobilize non-rigid components, such as set screws
and hinges, during cleaning.
►Then flush these areas thoroughly at least five
times with the cleaning disinfectant solution using
a disposable syringe (20 ml).
Phase II
►Rinse/flush the instrument thoroughly (all accessi-
ble surfaces) under running water.
►Mobilize non-rigid components, such as set screws
and hinges, during rinsing.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemicals
I Ultrasonic cleaning RT (cold) >15 1 D–W Dr. Weigert neodisher®
SeptoClean*
II Rinsing RT (cold) 1 - D–W -

17
Mechanical alkaline cleaning and thermal disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
►Place the product in a tray that is suitable for
cleaning (avoiding rinsing blind spots)
►Connect components with lumens and channels
directly to the rinsing port of the injector carriage.
►Keep working ends open for cleaning.
►Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
Inspection, maintenance and checks
►Allow the product to cool down to room tempera-
ture.
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemicals
I Pre-rinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W Dr. Weigert neodisher® SeptoClean
1 %* working solution
III Intermediate rinse >10/50 1 FD–W -
IV Thermal disinfection 90/194 5 FD–W -
VDrying - - - In accordance with the program
for the cleaning and disinfecting
machine
CAUTION
Damage (metal seizure/fric-
tion corrosion) to the product
caused by insufficient lubrica-
tion!
►Prior to function checks,
lubricate moving parts (e.g.
joints, pusher components
and threaded rods) with
maintenance oil suitable
for the respective steriliza-
tion process (e.g. for steam
sterilization: Aesculap
STERILIT® I oil spray JG600
or STERILIT® I drip lubrica-
tor JG598).

18
Aesculap®
MINOP InVent trocar 30°
►After each complete cleaning, disinfecting and dry-
ing cycle, check that the instrument is dry, clean,
operational, and free of damage (e.g. broken insu-
lation or corroded, loose, bent, broken, cracked,
worn, or fractured components).
►Dry the product if it is wet or damp.
►Repeat cleaning and disinfection of products that
still show impurities or contamination.
►Check that the product functions correctly.
►Immediately put aside damaged or inoperative
products and send them to Aesculap Technical Ser-
vice, see Technical Service.
►Assemble separable products, see Trocar assembly.
►Check for compatibility with associated products.
Packaging
►Place the product in its holder or on a suitable tray.
Ensure that all cutting edges are protected.
►Pack trays appropriately for the intended steriliza-
tion process (e.g. in sterile Aesculap containers).
►Ensure that the packaging provides sufficient pro-
tection against recontamination of the product
during storage.
Steam sterilization
Note
The product may only be sterilized when dismantled.
►Check to ensure that the sterilizing agent will come
into contact with all external and internal surfaces
(e.g. by opening any valves and faucets).
►Validated sterilization process
– Disassemble the product
– Steam sterilization using fractionated vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization using fractional vacuum process at
134 °C, holding time 18 minutes for prion inac-
tivation
►When sterilizing several instruments at the same
time in a steam sterilizer, ensure that the maxi-
mum load capacity of the steam sterilizer specified
by the manufacturer is not exceeded.
Sterilization for the US market
■Aesculap advises against sterilizing the device by
flash sterilization or chemical sterilization.
■Sterilization may be accomplished by a standard
prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10-6, Aesculap
recommends the following parameters:
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or sus-
pected of having Creutzfeldt-Jakob Disease (CJD),
the device cannot be reused and must be destroyed
due to the inability to reprocess or sterilize to elim-
inate the risk of crosscontamination.
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Steriliza-
tion method
Temp. Time Minimum
drying
time
Prevacuum 270 °F/27
5°F
4 min 20 min