Braun Aesculap Adtec mini User manual

Instructions for use
Adtec mini instrument system
Gebrauchsanweisung
AdTec mini-Instrumentensystem
Mode d’emploi
Système de mini instruments Adtec
Instrucciones de manejo
Sistema de mini instrumentos Adtec
Istruzioni per l’uso
Sistema di mini strumenti Adtec
Instruções de utilização
Sistema de mini instrumentos Adtec
Gebruiksaanwijzing
Adtec mini-instrumentensysteem
Brugsanvisning
AdTec mini-instrumentsystem
Bruksanvisning
AdTec mini-instrumentsystem
Bruksanvisning
Adtec mini instrumentsystem
Kättöohjeet
AdTec-mini-instrumenttijärjestelmä
Oδηγίες χρήoης
Adtec µίνι σύστηµαεργαλείων
Návod k použití
Systém nástrojù AdTec mini
Instrukcja u¿ytkowania
System mini instrumentów Adtec
Kullanım Kılavuzu
Adtec mini aletler sistemi
CE marking according to directive 93/42/EEC
CE-Kennzeichnung gemäß Richtlinie 93/42/EWG
Marquage CE conforme à la directive 93/42/CEE
Identificación CE en conformidad con la directriz 93/42/CEE
Marchio CE conforme alla direttiva 93/42/CEE
Simbolo CE, em conformeidade com a Directiva 93/42/CEE
CE-certificering conform richtlijn 93/42/EEG
CE-markering iht. retningslinie 93/42/EEC
CE-merking ifølge retninglinje 93/42/EWG
CE-märkning i enlighet med direktiv 93/42/EEG
93/42/EEC-standardin mukainen CE-hyväksyntä
Eνδείξη CE σύµφωνα µετην Oδηγία 93/42/EEC
CE-oznaèení podle smìrnice 93/42/ES
Oznakowanie CE zgodnie z wymaganiami dyrektywy 93/42/WE
93/42/EEG direktifi uyarınca CE işareti
Technical alterations reserved
Technische Änderungen vorbehalten
Sous réserve de modifications techniques
Sujeto a modificaciones técnicas
Con riserva di modifiche tecniche
Salvo alterações técnicas
Technische wijzigingen voorbehouden
Retten til tekniske ændringer forbeholdes
Vi tar forbehold om eventuelle tekniske endringer
Med reservation för eventuella tekniska ändringar
Oikeusteknisistä syistä johtuviin muutoksiin pidätetään
Eπιφυλασσόµεθα για τεχνικές αλλαγές
Technické zmìny vyhrazeny
Zmiany techniczne zastrze¿one
Teknik değişiklikler yapma hakkı saklıdır
Aesculap AG
Am Aesculap-Platz
78532 Tuttlingen
Germany
Phone [phone]
Fax [phone]
www.aesculap.de
TA-Nr. 013248 12/10 V4 Änd.-Nr.
Aesculap Endoscopic Technology
A1
A2
B1
B2
A
B
III
789 2
1
3
5
6
2
4

Adtec mini instrument system
Legend
1Handle (complete)
2Moving handle part
3HF pin
4Star wheel
5Actuating lever
6Switch (lubrication point)
7Jaw insert (lubrication point)
8Pressure bar
9Outer tube
Symbols on product and packages
Intended use
All professional disciplines that apply endoscopy:
• Cutting, preparation, and grasping of tissues
• Biopsies
• Sutures
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on order of a physician!
¾Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge or experience.
¾Read, follow and keep the instructions for use.
¾Use the product only in accordance with its intended use, see Intended use.
¾Remove the transport packaging and thoroughly clean the new product, either by hand or by a mechanical
process, prior to its initial sterilization.
¾Store any new or unused products in a dry, clean and safe place.
¾Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components.
¾Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
¾Replace any damaged components immediately with original spare parts.
¾To avoid damage to the working end: Exercise caution when passing products through the working channel (e.g.
trocar).
¾Adjust the HF power output for the intended operation. Take into account clinical experience or reference
values.
¾Select the lowest possible HF power output.
¾Keep the product’s contact surfaces clean during the operation. Wipe off encrusted tissue residues or body
fluids, using a moistened swab.
The plug end of the product is fitted with the following connector: Pin, 4 mm, sprung.
Refer to our brochures to find the compatible cable.
The accessory voltage rating of the product is 2 kVp.
The accessory voltage rating must exceed or match the maximum peak output voltage with which the product is
operated in combination with an appropriate HF device at an appropriate operating mode/setting (see IEC/DIN
EN 60601-2-2).
To avoid HF burns:
¾Keep the product’s working tip in the user’s field of vision whenever HF power is activated.
¾Prior to activating the HF device, make certain that the working end of the product is not touching any
electrically conductive accessories.
¾Prior to each use, visually check the product for: damage to, or surface changes on, the insulation.
¾Never put down the product on or next to the patient.
¾When using accessories for endoscopy or laparoscopy applications, deactivate the automatic switch-on mode
of the HF device.
¾Follow the instructions for use of the HF device.
Safe operation
¾Open and close the distal end of the jaws:
Open and close the moving handle part 2.
Handle with lock
¾Press actuating lever 5to release the ratchet mechanism.
¾To activate the ratchet mechanism, release actuating lever 5.
Switch 6can be used for permanently deactivating the ratchet mechanism.
¾Deactivate the ratchet mechanism on handle 1:
Position switch 6as shown in I.
The switch 6engages in the front position.
¾Activate the ratchet mechanism on handle 1:
Position switch 6as shown in II.
The switch 6engages in the rear position.
Disassembling
Note
For disassembling the product, also see additional series of illustrations A .
¾Deactivate the ratchet mechanism on handle 1with lock:
Position switch 6as shown in I.
¾Detach the sheath from handle 1:
Push star wheel 4back, hold it there and remove the sheath.
Extract jaw insert 7with outer tube 9from handle 1.
¾Disassemble the sheath:
Remove outer tube 9from jaw insert 7.
Rotate pressure bar 8counterclockwise by 90° and extract it from jaw insert 7.
Assembling
Note
For assembling the product, also see the additional series of illustrations B .
¾Deactivate the ratchet mechanism on handle 1with lock:
Position switch 6as shown in I.
¾Assemble the sheath:
– Slide pressure bar 8into jaw insert 7and rotate it clockwise by 90°.
– Slide outer tube 9onto jaw insert 7down to the positive stop.
¾Hold the sheath assembly at jaw insert 7with one hand.
¾With the other hand, hold handle 1at star wheel 4. The moving handle part 2must remain freely moveable.
¾Push the sheath into handle 1, making certain that the notch on pressure bar 8is aligned with the mark on star
wheel 4.
The moving handle part 2moves upward.
The sheath engages automatically at the positive stop.
¾Test the instrument for proper functioning by opening and closing the jaw elements.
Validated processing procedure
Note
Adhere to national statutory regulations, international standards and guidelines, and local, clinical hygiene
instructions for sterile processing.
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 if processing is performed through a validated
processing procedure. The user/processor is responsible for the validation.
Note
Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net
General notes
To avoid unnecessary, excessive contamination of the complete instrument tray during operations, take care that
contaminated instruments are collected separately and not put back into the instrument tray.
Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause
corrosion of stainless steels. Therefore the time interval between application and cleaning should not exceed 6 h,
and neither potentially fixating pre-cleaning temperatures >45 °C nor any fixating disinfectants (active ingredient:
aldehyde, alcohol) be used.
Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration
of laser inscriptions on stainless steel surfaces, regarding visual reading and machine-readability of the inscriptions.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfecting and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the 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 that have been tested and approved (e.g. VAH/DGHM or FDA approval or CE mark) and
which are compatible with the product’s materials according to the chemical manufacturers’ recommendations. All
process parameters specified by the chemical’s manufacturer, such as temperatures, concentrations and exposure
times, must be strictly observed. Failure to do so can result in the following problems:
• Material damage, e.g. corrosion, cracks, fracturing, premature ageing or swelling.
¾Do not use process chemicals that would cause stress cracking or brittleness of plastics.
¾Clean the product immediately after use.
• Immersion treatment in a 3 % H2O2solution for approx. 5 minutes is a particularly effective and gentle method
to dissolve encrustations from HF instruments. Subsequently, the debris can be removed by hand, with a medium-
hard brush and/or in an ultrasonic cleaning bath. After this pre-treatment, continue through the normal steps of
the processing procedure.
For further detailed advice on hygienically safe and material-/value-preserving reprocessing, see www.a-k-i.org
¾Use suitable cleaning/disinfecting agents if the product is put away in wet condition. To prevent foam formation
and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfecting, rinse the
product thoroughly with running water.
Preparations at the place of use
¾Disassemble the product immediately after use, as described in the respective instructions for use.
¾Open jointed products.
¾Rinse surfaces that cannot be visually inspected, e.g. on products with hidden crevices or lumens or products
with complex geometries, preferably with distilled water, using e.g. a disposable syringe.
¾Remove visible surgical residues as completely as possible, using a lint-free wet wipe.
¾Put the dry product into a closed disposal container and have it transferred to cleaning and disinfecting within
6 h.
Preparation prior to cleaning
¾Disassemble the product prior to cleaning, see Disassembling.
Symbol Explanation
Caution, general warning symbol
Caution, see documentation supplied with the product
WARNING
Danger of injury from burns and/or explosion from flammable gases!
Application of the HF device according to its intended use can involve spark
formation.
¾Observe the safety notices in the instructions for use of the HF device.
WARNING
Thermal injuries to patients/users due to insufficient insulation of leads to active
accessories!
¾Adjust the HF device to a setting appropriate to ensure that the maximum peak
output voltage does not exceed the accessory voltage rating specified for the
product.
¾Use the instrument only with an insulated outer tube.
WARNING
Risk of injury and/or malfunction!
¾Always carry out a function check before using the product.
WARNING
Risk of injury when applying the product outside the field of view!
¾Apply the product only under visual control.

Cleaning/Disinfecting
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting,
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/
disinfecting,
– as an integrated mechanical support measure for mechanical cleaning/disinfecting,
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
Manual cleaning/disinfecting
¾Keep working ends open during cleaning.
¾Clean products with movable links with the links opened or mobilized.
¾Inspect visible surfaces for residual contamination after manual cleaning/disinfecting.
¾Repeat the cleaning process if necessary.
1. Handle
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Fully immerse the product in the cleaning/disinfecting solution. Make certain that all accessible surfaces are
moistened.
¾Clean the product under running tap water, using a suitable cleaning brush if necessary, until all visible residues
have been removed from the surfaces.
¾Brush through surfaces not accessible to visual inspection, e.g. in products with hidden crevices, lumens or
complex geometries, for at least 1 min or until no more residues can be removed, using an appropriate cleaning
brush (brush head length: 50 mm/∅: 3.7 mm, e.g. GK469200).
¾Mobilize non-rigid components, e.g. set screws, links, etc. during cleaning.
¾After cleaning, thoroughly (at least five times) rinse through these components with the cleaning/disinfecting
solution, using a disposable syringe (20 ml).
¾Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
Stage II
¾Rinse the product completely (all accessible surfaces) under running water.
¾Allow water to drip off for a sufficient length of time.
Stage III
¾Fully immerse the product in the disinfecting solution.
¾Rinse lumens at least 5 times at the beginning of the exposure time, using a disposable syringe (20 ml) and an
appropriate rinsing adapter. Make certain that all accessible surfaces are moistened.
Stage IV
¾Carry out a full rinse of the product (all accessible surfaces) under running water.
¾Rinse lumens at least 5 times at the beginning of the exposure time, using a disposable syringe (20 ml) and an
appropriate rinsing adapter. Make certain that all accessible surfaces are moistened.
¾Allow water to drip off for a sufficient length of time.
Stage V
¾Dry the product with lint-free tissue or medical-quality filtered compressed air.
Mechanical cleaning/disinfecting
Note
The disinfector must be of proven effectiveness (e.g. DGHM or FDA approval or CE mark).
Note
Use appropriate (neutral, enzymatic and mild-alkaline) detergents for this product with aluminum components.
Note
For thermal disinfection, always use fully desalinated (demineralized) water. Ensure that Ao is >3 000 for the process.
Note
The disinfector used for processing must be serviced and checked at regular intervals.
¾Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
¾Connect components with lumens and channels directly to the rinsing port of the injector carriage.
¾Keep working ends open during cleaning.
¾Ensure that product links and joints are opened when placing the product on the tray.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber washer/disinfector without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
2. Sheaths
Manual ultrasonic cleaning and immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Clean the product in an ultrasound cleaning bath (frequency 35 kHz). Make sure that all accessible surfaces are
moistened and acoustic shadows are avoided.
¾Clean the product with a suitable cleaning brush until all visible residues have been removed from the surface.
¾Brush through surfaces not accessible to visual inspection, e.g. in products with hidden crevices, lumens or
complex geometries, for at least 1 min or until no more residues can be removed, using an appropriate cleaning
brush (brush head length: 50 mm/∅: 3.7 mm, e.g. GK469200).
¾Mobilize non-rigid components, e.g. set screws, links, etc. during cleaning.
¾After cleaning, use a 20-ml single-use syringe to rinse thoroughly, for at least 5 times, these difficult to access
parts of the product.
¾Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
Stage II
¾Rinse the product completely (all accessible surfaces) under running water.
¾Allow water to drip off for a sufficient length of time.
Stage III
¾Fully immerse the product in the disinfecting solution.
¾Rinse lumens at least 5 times at the beginning of the exposure time, using a disposable syringe (20 ml) and an
appropriate rinsing adapter. Make certain that all accessible surfaces are moistened.
Stage IV
¾Rinse the product completely (all accessible surfaces) under running water.
¾Rinse lumens at least 5 times, using a disposable syringe (20 ml) and an appropriate rinsing adapter.
¾Allow water to drip off for a sufficient length of time.
Stage V
¾Thoroughly dry the product with lint-free tissue or medical-quality filtered compressed air.
Mechanical cleaning/disinfecting with manual pre-cleaning
Note
The disinfector must be of tested and approved effectiveness (e.g. DGHM or FDA approval or CE mark according to DIN
EN ISO 15883).
Note
For thermal disinfection, always use fully desalinated (demineralized) water. Ensure that Ao is >3 000 for the process.
Note
The disinfector used for processing must be serviced and checked at regular intervals.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
¾Use cleaning and disinfecting agents approved for e.g. aluminum, plastics and
high-grade steel, according to the manufacturer’s instructions.
¾Observe specifications regarding concentration, temperature and exposure time.
¾Do not exceed the maximum allowable cleaning temperature of 93 °C.
Stage Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
ICleaning RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QAV-free
II Intermediate
rinse RT (cold)
1-D–W-
III Disinfecting RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QAV-free
IV Final rinse RT
(cold)
1 - FD–W -
VDrying RT - - - -
Stage Step T
[°C/°F] t [min] Water quality Chemical/Note
IPrerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W BBRAUN HELIMATIC CLEANER with
tensides, application solution 0.5 %
III Intermediate rinse >10/50 1 FD–W -
IV Thermal
disinfecting 90/194 5 FD–W -
VDrying - - - According to disinfector program
Stage Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
IUltrasonic cleaning RT
(cold)
5 2 D–W BBraun Stabimed; aldehyde
phenol and QAV-free
II Intermediate rinse RT
(cold)
1-D–W-
III Disinfecting RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde
phenol and QAV-free
IV Final rinse RT
(cold)
1 - FD–W -
VDrying --- --

Manual pre-cleaning with brush
D–W: Drinking water
RT: Room Temperature
Stage I
¾Fully immerse the product in the cleaning/disinfecting solution. Make certain that all accessible surfaces are
moistened.
¾Clean the product with a suitable cleaning brush until all visible residues have been removed from the surface.
¾Brush through surfaces not accessible to visual inspection, e.g. in products with hidden crevices, lumens or
complex geometries, for at least 1 min or until no more residues can be removed, using an appropriate cleaning
brush (brush head length: 50 mm/∅: 3.7 mm, e.g. GK469200).
¾Mobilize non-rigid components, e.g. set screws, links, etc. during cleaning.
¾After cleaning, thoroughly rinse through these components (at least five times) with the cleaning solution, using
a disposable syringe (20 ml).
¾Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
Stage II
¾Rinse the product completely (all accessible surfaces) under running water.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber washer/disinfector without ultrasound
¾Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
¾Connect components with lumens and channels directly to the rinsing port of the injector carriage.
¾Keep working ends open during cleaning.
¾Ensure that product links and joints are opened when placing the product on the tray.
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Inspection, maintenance and checks
¾Allow the product to cool down to room temperature.
¾After each complete cleaning, disinfecting and drying cycle, check that the product is: dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn or fractured
components).
¾Dry the product if it is wet or moist.
¾Repeat cleaning and disinfecting of products that still show impurities or contamination.
¾Check the product for proper functioning.
¾Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see
Technical Service.
¾Assemble the separable product, see Assembling.
¾Check for compatibility with associated products.
Packaging
¾Appropriately protect products with fine working tips.
¾Store products with ratchet locks fully opened or locked no further than in the first notch.
¾Sort the product into its appropriate storage device or put it on a
suitable tray. Make certain that all cutting edges are protected.
¾Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
¾Ensure that the packaging provides sufficient protection against recontamination of the product during storage
(DIN EN ISO 11607).
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or in assembled condition.
Note
To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further
than on the first ratchet tooth.
¾Make certain that all external and internal surfaces will be exposed to the sterilizing agent (e.g. by opening all
valves and faucets).
¾Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285, validated according to DIN EN ISO 17665
– Sterilization through fractionated vacuum process at 134 °C/holding time 5 min
¾When sterilizing several products at the same time in one steam sterilizer: Make certain that the maximum
allowable load capacity of the steam sterilizer, as specified by the manufacturer, is not exceeded.
Sterilization for the US market
• Aesculap does not recommend the device sterilized by flash or chemical sterilization.
• Sterilization may be accomplished by steam autoclave in a standard prevacuum cycle.
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 accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these instruments. Other sterilization
cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to val-
idate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain ste-
rility after processing, such as a wrap, pouch, etc.
Storage
¾Store sterile products in germ-proof packaging under dust protection in a dry, dark and temperature-controlled
room.
Technical Service
¾For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment 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]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood, MO 63042
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
Accessories/Spare parts
For accessories and spare parts, see brochure C 28011 or visit http://www.endoscopy-catalog.com
Disposal
¾Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
TA-Nr.: 013248 12/10
Stage Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
IDisinfecting
cleaning RT (cold)
15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QAV-free
II Irrigation RT
(cold)
1-D–W-
Stage Step T
[°C/°F] t [min] Water quality Chemical/Note
IPrerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD–W BBRAUN HELIMATIC CLEANER alcaline
with tensides; application solution
0.5 %
III Intermediate rinse >10/50 1 FD–W -
IV Thermal
disinfecting 90/194 5 FD–W -
VDrying - - - According to disinfector program
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
¾Prior 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 sterilization: Aesculap STERILIT® I oil spray JG600 or
STERILIT® I drip lubricator JG598).
Aesculap Orga Tray/sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp. Time Minimum drying time
Pre-vacuum 270 °F—275 °F 4 min 20 min
WARNING
Risk of injury and/or malfunction!
¾Do not modify the product.

AdTec mini-Instrumentensystem
Legende
1Griff (komplett)
2Bewegliches Griffteil
3HF-Pin
4Drehstern
5Betätigungshebel
6Schalter (Ölstelle)
7Mauleinsatz (Ölstelle)
8Druckstange
9Außenrohr
Symbole an Produkt und Verpackung
Verwendungszweck
Sämtliche Fachdisziplinen der Endoskopie:
• Schneiden, Präparieren, Fassen von Gewebe
• Biopsie
•Nähten
Sichere Handhabung und Bereitstellung
¾Produkt und Zubehör nur von Personen betreiben und anwenden lassen, die die erforderliche Ausbildung, Kennt-
nis oder Erfahrung haben.
¾Gebrauchsanweisung lesen, einhalten und aufbewahren.
¾Produkt nur bestimmungsgemäß verwenden, siehe Verwendungszweck.
¾Fabrikneues Produkt nach Entfernung der Transportverpackung und vor der ersten Sterilisation gründlich reini-
gen (manuell oder maschinell).
¾Fabrikneues oder unbenutztes Produkt an einem trockenen, sauberen und geschützten Platz aufbewahren.
¾Produkt vor jeder Verwendung visuell prüfen auf: lose, verbogene, zerbrochene, rissige, abgenutzte und abge-
brochene Teile.
¾Kein beschädigtes oder defektes Produkt verwenden. Beschädigtes Produkt sofort aussortieren.
¾Beschädigte Einzelteile sofort durch Originalersatzteile ersetzen.
¾Um Schäden am Arbeitsende zu vermeiden: Produkt vorsichtig durch den Arbeitskanal (z. B. Trokar) einführen.
¾HF-Ausgangsleistung auf den Eingriff abstimmen. Klinische Erfahrungen oder Referenzen berücksichtigen.
¾HF-Ausgangsleistung so gering wie möglich wählen.
¾Kontaktflächen des Produkts während der Operation sauber halten. Angetrocknete Gewebereste oder Körper-
flüssigkeiten mit einem feuchten Tupfer abwischen.
Das Produkt ist steckerseitig mit folgendem Anschluss ausgestattet: Pin 4 mm federnd.
Das zugehörige Kabel kann unseren Prospekten entnommen werden.
Die Bemessungs-Zubehörspannung des Produkts beträgt 2 kVp.
Die Bemessungs-Zubehörspannung muss größer als oder gleich der maximalen Ausgangsspitzenspannung sein, mit
der das Produkt in Kombination mit einem entsprechenden HF-Gerät, einer entsprechenden Betriebsart/Einstellung
betrieben wird (siehe IEC/DIN EN 60601-2-2).
Um HF-Verbrennungen zu vermeiden:
¾Während der HF-Aktivierung das Arbeitsende des Produkts immer im Sichtbereich des Anwenders halten.
¾Vor dem Aktivieren des HF-Geräts sicherstellen, dass das Arbeitsende des Produkts kein elektrisch leitfähiges
Zubehör berührt.
¾Produkte vor jeder Verwendung visuell prüfen auf: Beschädigungen und Oberflächenveränderungen an der Iso-
lierung.
¾Produkt nie auf oder direkt neben dem Patienten ablegen.
¾Bei endoskopisch oder laparoskopisch genutztem Zubehör den automatischen Einschaltmodus des HF-Geräts
ausschalten.
¾Gebrauchsanweisung des HF-Geräts einhalten.
Bedienung
¾Distales Maulteil öffnen und schließen:
Bewegliches Griffteil 2öffnen und schließen.
Griff mit Sperre
¾Zum Lösen der Rastmechanik Betätigungshebel 5drücken.
¾Zum Aktivieren der Rastmechanik Betätigungshebel 5loslassen.
Der Schalter 6dient zum dauerhaften Ausschalten der Rastmechanik.
¾Rastmechanik am Griff 1ausschalten:
Position Schalter 6, siehe I.
Der Schalter 6rastet in der vorderen Position ein.
¾Rastmechanik am Griff 1einschalten:
Position Schalter 6, siehe II.
Der Schalter 6rastet in der hinteren Position ein.
Demontage
Hinweis
Zur Demontage siehe auch zusätzliche Bildserie A .
¾Rastmechanik am Griff 1mit Sperre ausschalten:
Position Schalter 6, siehe I.
¾Schaft und Griff 1trennen:
Drehstern 4nach hinten schieben und halten, bis Schaft entnommen ist.
Mauleinsatz 7zusammen mit Außenrohr 9aus dem Griff 1ziehen.
¾Schaft demontieren:
Außenrohr 9vom Mauleinsatz 7abziehen.
Druckstange 8um 90° gegen den Uhrzeigersinn drehen und aus Mauleinsatz 7ziehen.
Montage
Hinweis
Zur Montage siehe auch zusätzliche Bildserie B .
¾Rastmechanik am Griff 1mit Sperre ausschalten:
Position Schalter 6, siehe I.
¾Schaft montieren:
–Druckstange8in Mauleinsatz 7schieben und um 90° im Uhrzeigensinn drehen.
– Außenrohr 9bis zum Anschlag auf Mauleinsatz 7 schieben.
¾Mit einer Hand den montierten Schaft am Mauleinsatz 7festhalten.
¾Mit der anderen Hand Griff 1am Drehstern 4halten. Das bewegliche Griffteil 2muss frei beweglich bleiben.
¾Schaft in den Griff 1schieben. Dabei sicherstellen, dass die Einkerbung der Druckstange 8in einer Linie zur Mar-
kierung auf dem Drehstern 4steht.
Das bewegliche Griffteil 2bewegt sich nach oben.
Sobald der Anschlag erreicht ist, rastet der Schaft automatisch ein.
¾Funktion des Instruments durch Öffnen und Schließen der Maulteile testen.
Validiertes Aufbereitungsverfahren
Hinweis
Nationale gesetzliche Vorschriften und nationale und internationale Normen und Richtlinien und die eigenen Hygie-
nevorschriften zur Aufbereitung einhalten.
Hinweis
Der maschinellen Aufbereitung ist aufgrund eines besseren und sichereren Reinigungsergebnisses gegenüber der
manuellen Reinigung der Vorzug zu geben.
Hinweis
Es ist zu beachten, dass die erfolgreiche Aufbereitung dieses Medizinproduktes nur nach vorheriger Validierung des
Aufbereitungsprozesses sichergestellt werden kann. Die Verantwortung hierfür trägt der Betreiber/Aufbereiter.
Hinweis
Aktuelle Informationen zur Aufbereitung siehe auch Aesculap Extranet unter www.aesculap-extra.net
Allgemeine Hinweise
Zur Vermeidung einer verstärkten Kontamination des bestückten Instrumententrays bei der Anwendung bereits dar-
auf achten, dass verschmutzte Instrumente getrennt gesammelt und nicht wieder in das Instrumententray gelegt
werden.
Angetrocknete bzw. fixierte OP-Rückstände können die Reinigung erschweren bzw. unwirksam machen und bei nicht
rostendem Stahl zu Korrosion führen. Demzufolge sollte ein Zeitraum zwischen Anwendung und Reinigung von 6 h
nicht überschritten, sollten keine fixierenden Vorreinigungstemperaturen >45 °C angewendet und keine fixierenden
Desinfektionsmittel (Wirkstoffbasis: Aldehyd, Alkohol) verwendet werden.
Überdosierte Neutralisationsmittel oder Grundreiniger können zu einem chemischen Angriff und/oder zur Verblas-
sung und visuellen oder maschinellen Unlesbarkeit der Laserbeschriftung bei nicht rostendem Stahl führen.
Bei nicht rostendem Stahl führen Chlor- bzw. chloridhaltige Rückstände, z. B. in OP-Rückständen, Arzneimitteln,
Kochsalzlösungen, im Wasser zur Reinigung, Desinfektion und Sterilisation zu Korrosionsschäden (Lochkorrosion,
Spannungskorrosion) und somit zur Zerstörung der Produkte. Zur Entfernung muss eine ausreichende Spülung mit
vollentsalztem Wasser mit anschließender Trocknung erfolgen.
Es dürfen nur Prozess-Chemikalien eingesetzt werden, die geprüft und freigegeben sind (z. B. VAH/DGHM- oder FDA-
Zulassung bzw. CE-Kennzeichnung) und vom Chemikalienhersteller hinsichtlich Materialverträglichkeit empfohlen
wurden. Sämtliche Anwendungsvorgaben des Chemikalienherstellers über Temperatur, Konzentration und Einwirk-
zeit sind strikt einzuhalten. Im anderen Fall kann dies zu nachfolgenden Problemen führen:
• Materialschäden, wie z. B. Korrosion, Risse, Brüche, vorzeitige Alterung oder Quellung.
¾Keine Prozess-Chemikalien verwenden, die bei Kunststoffen zu Spannungsrissen oder Versprödung führen.
¾Produkt unmittelbar nach der Anwendung reinigen.
• Das Anlösen von Inkrustierungen auf HF-Instrumenten ist besonders effektiv und schonend durch eine ca. 5-
minütige Tauchbehandlung in einer 3 %igen H2O2-Lösung zu erreichen. Die Entfernung kann manuell, mit mit-
telharter Bürste und/oder im Ultraschallbad erfolgen. Im Anschluss folgen die weiteren, üblichen Schritte zur
Aufbereitung.
Weitere detaillierte Hinweise zu einer hygienisch sicheren und materialschonenden/werterhaltenden Wiederaufbe-
reitung, siehe www.a-k-i.org
¾Bei Nassentsorgung geeignete Reinigungs-/Desinfektionsmittel verwenden. Um Schaumbildung und Ver-
schlechterung der Wirksamkeit der Prozesschemie zu vermeiden: Vor maschineller Reinigung und Desinfektion
Produkt gründlich mit fließendem Wasser spülen.
Vorbereitung am Gebrauchsort
¾Produkt unmittelbar nach dem Gebrauch nach Anleitung demontieren.
¾Produkt mit Gelenk öffnen.
¾Nicht einsehbare Oberflächen, wie z. B. bei Produkten mit verdeckten Spalten, Lumen oder komplexen Geome-
trien, vorzugsweise mit destilliertem Wasser, z. B. mit Einmalspritze, durchspülen.
¾Sichtbare OP-Rückstände möglichst vollständig mit einem feuchten, flusenfreien Tuch entfernen.
¾Produkt trocken in geschlossenem Entsorgungscontainer binnen 6 h zur Reinigung und Desinfektion transpor-
tieren.
Vorbereitung vor der Reinigung
¾Produkt vor der Reinigung zerlegen, siehe Demontage.
Symbol Erklärung
Achtung, allgemeines Warnzeichen
Achtung, Begleitdokumente beachten
WARNUNG
Verletzungsgefahr durch Zündung oder Explosion von brennbaren Gasen!
Beim bestimmungsgemäßen Gebrauch des HF-Geräts können Funken entstehen.
¾Sicherheitshinweise in der Gebrauchsanweisung des HF-Geräts einhalten.
WARNUNG
Thermische Schädigungen des Patienten/Anwenders durch unzureichend isolierte Lei-
tungen von aktivem Zubehör!
¾HF-Gerät so einstellen, dass die maximale Ausgangsspitzenspannung gleich oder
kleiner ist als die Bemessungs-Zubehörspannung, die für das Produkt angegeben
ist.
¾Instrument nur mit isoliertem Außenrohr einsetzen.
WARNUNG
Verletzungsgefahr und/oder Fehlfunktion!
¾Vor jedem Gebrauch Funktionsprüfung durchführen.
WARNUNG
Verletzungsgefahr durch Verwendung des Produkts außerhalb des Sichtbereichs!
¾Produkt nur unter visueller Kontrolle anwenden.