B. Braun Aesculap MINOP InVent trocar Manual

Aesculap®
Aesculap Neurosurgery
en Instructions for use/Technical description
MINOP InVent trocar 30°
USA Note for U.S. users
This Instructions for Use is NOT intended for United States users.
Please discard. The Instructions for Use for United States users can
be obtained by visiting our website at www.aesculapusa.com. If you
wish to obtain a paper copy of the Instructions for Use, you may
request one by contacting your local Aesculap representative or
Aesculap's customer service at 1-800-282-9000. A paper copy will
be provided to you upon request at no additional cost.
de Gebrauchsanweisung/Technische Beschreibung
MINOP InVent-Trokar 30°
fr Mode d’emploi/Description technique
Trocart MINOP InVent 30°
es Instrucciones de manejo/Descripción técnica
Trocar MINOP InVent 30°
it Istruzioni per l’uso/Descrizione tecnica
Trocar MINOP InVent 30°
pt Instruções de utilização/Descrição técnica
Trocarte MINOP InVent 30°
nl Gebruiksaanwijzing/Technische beschrijving
MINOP inVent-trocart 30°
da Brugsanvisning/Teknisk beskrivelse
MINOP InVent-trokar 30°
sv Bruksanvisning/Teknisk beskrivning
MINOP inVent-troakar 30°
fi Käyttöohje/Tekninen kuvaus
MINOP InVent -troakaari 30°
lv Lietošanas instrukcijas/tehniskais apraksts
MINOP InVent 30° troakārs
lt Naudojimo instrukcija/techninis aprašas
MINOP InVent troakaras 30°
ru Инструкция по примению/Техническое описание
Троакар MINOP inVent 30°
cs Návod k použití/Technický popis
30° trokar MINOP InVent
pl Instrukcja użytkowania/Opis techniczny
Trokar MINOP inVent 30°
sk Návod na použitie/Technický opis
MINOP InVent-Trokár 30°
hu Használati útmutató/Műszaki leírás
MINOP InVent trokár 30°
sl Navodila za uporabo/Tehnični opis
MINOP InVent-Trokar 30°
hr Upute za uporabu/Tehnički opis
MINOP InVent trokar 30°
ro Manual de utilizare/Descriere tehnică
Trocar MINOP InVent 30°
bg Упътване за употреба/Техническо описание
Троакар MINOP InVent 30°
tr Kullanım Kılavuzu/Teknik açiklama
MINOP InVent trokar 30°
el Οδηγίες χρήσης/Τεχνική περιγραφή
Τροκάρ MINOP 30°

11 10
1
4 3
2
9 8
7
5
6

2
en
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
1. 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 intraventricu-
lar 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.
2. 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.
3. Contraindications
3.1 Absolute contraindications
None known.
3.2 Relative contraindications
Based on our current knowledge, there are no product-
specific relative contraindications. However, there are
medical or surgical conditions that may interfere with
endoscopic technique, such as strong bleeding or high
protein levels within the ventricular system limiting
the view in the surgical field.
In the case of relative contraindications, the user
decides individually on the use of the product.
4. Risks and side effects
As part of the legal obligation to provide information,
the possible risks and side effects in connection with
the use of surgical instruments known to the manufac-
turer are highlighted below. These are predominantly
process-specific, not product-specific, and include
unwanted damage to surrounding tissue, such as
bleeding, infection, incompatibility of materials, or
parts of instruments left in the patient unperceived.
5. Safe handling and prepara-
tion
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.
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
WARNING
Risk of injury caused by incor-
rect operation of the product!
►Attend appropriate product
training before using the
product.
►For information about
product training, please
contact your national
B. Braun/Aesculap agency.

3
en
►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 defective.
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 trocar
in combination with HF electrodes, ensure that HF
current is activated only under visual control.
►When inserting the trocar into the brain/the ventri-
cle, close the working channel with the obturator
provided.
6. Safe operation
WARNING
Risk of injury and/or malfunc-
tion!
►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.
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.
CAUTION
Damage to the endoscope due
to incorrect handling or opera-
tion!
►Insert the endoscope into
the trocar only if the trocar
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.

4
en
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.
6.1 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.
Fig.2
13 12
14
5
6
3
1

5
en
►Connect light cable and camera, see Fig.3–5.
Fig.3
Fig.4
Fig.5
6.2 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
5
1

6
en
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

7
en
7. Trocar disassembly
7.1 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
7.2 Removing the obturator for opti-
cal channel 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

8
en
►Press the release button 3and remove the endo-
scope 5from the MINOP InVent trocar 1, see
Fig.11.
Fig.11
7.3 Removing irrigation tube
►Remove tube from irrigation connector 4, see
Fig.12.
Fig.12
7
1
3
1
4

9
en
7.4 Removing the holding arm adapter
►Unscrew the wing nut 10.
►Remove holding arm adapter 11, see Fig.13.
Fig.13
8. Trocar assembly
8.1 Inserting the endoscope/obtura-
tors
►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

10
en
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.
8.2 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

11
en
8.3 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

12
en
►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
8.4 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

13
en
9. Validated reprocessing procedure
9.1 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.
9.2 General information
Dried and hardened or clotted surgical residues can
complicate cleaning or render it ineffective and cause
corrosion. Therefore, do not exceed a period of 1h
between use and processing, make sure pre-cleaning
temperatures are <45°C to prevent clotting, and do not
use disinfectants that can cause clotting (active ingre-
dient: aldehyde, alcohol).
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 surgi-
cal residues, medicines, saline solutions, and in the ser-
vice water used for cleaning, disinfection, and steriliza-
tion, 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:
■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 detailed information on hygienically safe and
material-friendly/careful processing, please refer to
www.a-k-i.org Header "AKI-Brochures", "Red
brochure".
9.3 Reusable products
There are no known effects of processing that result in
damage to the product.
The product can be re-used up to 75 times with proper
care and if it is undamaged and clean. The user shall be
responsible for any further reuse.
Careful visual and functional testing prior to next use
is the best way to identify a malfunctioning product.
9.4 Disassembling the product before
carrying out the reprocessing pro-
cedure
►Disassemble the product immediately after use, as
described in the respective instructions for use.
9.5 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 wet product in a sealed waste container
and take it to be cleaned and disinfected within 1h.
9.6 Preparation before cleaning
►Disassemble the product prior to cleaning, see Tro-
car disassembly.

14
en
9.7 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.
►Clean and disinfect microsurgical products
mechanically if they can be placed securely in the
machine or on the positioning aids.
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 excessive
temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instructions
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.

15
en
9.8 Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must in principle
have a tested effectiveness (e.g. compliance with
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 using brush
D–W: Drinking water
RT: Room temperature
Phase I
►Clean the product using a suitable cleaning brush
in the solution until there is no residue visible on
the surface.
►If applicable, use a suitable cleaning brush to brush
any surfaces that are not visible for at least 1 min.
►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 Cleaning RT
(cold)
>15 1 D–W B. Braun Stabimed® fresh
II Rinsing RT
(cold)
1- D–W-

16
en
Mechanical alkaline cleaning and thermal disinfection
Type of device: Single-chamber cleaning/disinfection device without ultrasound1)
D–W: Drinking water
DI–W: Deionized water
1) The cleaning and disinfection devices listed below were used to verify cleanability: Miele 7836 CD
2) Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean)
►Place the product in a tray that is suitable for
cleaning (avoiding rinsing blind spots)
►Open the links and joints before placing the product
on the sterilization tray.
►Connect components with lumens and channels
directly to the rinsing port of the injector carriage.
►Check visible surfaces for residues after mechanical
cleaning/disinfecting.
9.9 Inspection, maintenance and
checks
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemicals
IPre-rinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W Dr. Weigert neodisher® SeptoClean 1%
Working solution2)
III Neutralization >10/50 2 DI–W B. Braun Helimatic® Neutralizer C
Working solution 0.15%
IV Intermediate rinse I >10/50 1 FD–W -
V Intermediate rinse II >10/50 1 DI–W -
VI Thermal disinfection 90/194 5 FD–W -
VII Drying - - - In accordance with the program for the
cleaning and disinfecting machine
CAUTION
Damage (metal seizure/friction
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 sterilization
process (e.g. for steam ster-
ilization: Aesculap
STERILIT® I oil spray JG600
or STERILIT® I drip lubrica-
tor JG598).

17
en
►Allow the product to cool down to room tempera-
ture.
►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.
9.10 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.
9.11 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 maximum
load capacity of the steam sterilizer specified by
the manufacturer is not exceeded.
9.12 Storage
►Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
10. Technical Service
►For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical equip-
ment may result in loss of guarantee/warranty rights
and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Other service addresses can be obtained from the
address indicated above.
11. Accessories/Spare parts
12. Disposal
►Adhere to national regulations when disposing of
or recycling the product, its components and its
packaging!
WARNING
Risk of injury and/or malfunc-
tion!
►Do not modify the product.
Art. no. Designation
FH620R MINOP InVent Trocar 30°
PE204A MINOP Endoscope 30°
RT068R MINOP InVent holding arm
adapter

18
de
Aesculap®
MINOP InVent-Trokar 30°
Legende
1MINOP InVent-Trokar
2Nut
3Entriegelungsknopf
4Spülanschluss
5Endoskop
6Verriegelungsbolzen Endoskop
7Obturator für ovalen Arbeitskanal
8Obturator für Optikkanal
9Verriegelungsbolzen Obturator
10 Flügelmutter
11 Haltearmadapter
Symbole an Produkt und
Verpackung
1. Verwendungszweck
Das MINOP InVent-Trokarsystem wird für endoskopi-
sche und endoskopassistierte Eingriffe am zentralen
Nervensystem verwendet, besonders zur Behandlung
intra- und paraventrikulärer pathologischer Struktu-
ren. Das MINOP InVent-Trokarsystem kann wahlweise
freihand oder über den Haltearmadapter RT068R am
entsprechenden Haltearm betrieben werden und mit
dem Instrumentarium für das MINOP InVent System
eingesetzt werden.
2. Indikationen
Indikationen, siehe Verwendungszweck.
Hinweis
Eine Verwendung des Produkts entgegen der genannten
Indikationen und/oder der beschriebenen Anwendun-
gen erfolgt außerhalb der Verantwortung des Herstel-
lers.
3. Kontraindikationen
3.1 Absolute Kontraindikationen
Keine bekannt.
3.2 Relative Kontraindikationen
Nach unserem derzeitigen Kenntnisstand gibt es keine
produktspezifischen relativen Kontraindikationen.
Dennoch gibt es medizinische oder chirurgische
Zustände, welche die endoskopische Technik behindern
können, wie starke Blutungen oder eine hohe Protein-
konzentration innerhalb des ventrikulären Systems,
welche die Sicht im Operationsfeld einschränken.
Bei relativen Kontraindikationen entscheidet der
Anwender individuell über die Verwendung des Pro-
duktes.
4. Risiken und Nebenwirkungen
Im Rahmen der gesetzlichen Informationspflicht wer-
den die folgenden, dem Hersteller bekannten, mögli-
chen Risiken und Nebenwirkungen im Zusammenhang
mit der Verwendung chirurgischer Instrumente hervor-
gehoben. Diese sind überwiegend verfahrensspezifisch,
nicht produktspezifisch und umfassen unerwünschte
Schädigungen des umgebenden Gewebes, welche z. B.
zu Blutungen, Infektionen, Materialinkompatibilitäten
oder unbemerkt im Patienten verbleibenden Instru-
mententeilen führen können.
5. Sichere Handhabung und
Bereitstellung
Achtung, allgemeines Warnzei-
chen
Achtung, Begleitdokumente
beachten
WARNUNG
Verletzungsgefahr durch Fehl-
bedienung des Produkts!
►Vor der Verwendung des
Produkts an der Produkt-
Schulung teilnehmen.
►Wenden Sie sich an die
nationale B. Braun/
Aesculap-Vertretung, um
Informationen bezüglich
der Schulung zu erhalten.