BBraun
MINOP TREND (TRansnasal ENDoscopy system)
93 Pages
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Aesculap® 3
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Instructions for use/Technical description MINOP TREND (TRansnasal ENDoscopy system) 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. Gebrauchsanweisung/Technische Beschreibung MINOP TREND (TRansnasales ENDoskopiesystem) Mode d’emploi/Description technique MINOP TREND (système TRansnasal ENDoscopique) Instrucciones de manejo/Descripción técnica MINOP TREND (sistema TRansnasal de ENDoscopia) Istruzioni per l’uso/Descrizione tecnica MINOP TREND (sistema per ENDoscopia TRansnasale) Instruções de utilização/Descrição técnica MINOP TREND (sistema TRansnasal para ENDoscopia) Gebruiksaanwijzing/Technische beschrijving MINOP TREND (TRansnasaal ENDoscopiesysteem) Brugsanvisning/Teknisk beskrivelse MINOP TREND (TRansnasalt ENDoskopisystem) Bruksanvisning/Teknisk beskrivning MINOP TREND (TRansnasalt ENDoskopisystem) Käyttöohje/Tekninen kuvaus MINOP TREND (TRansnasaaliseen ENDoskopiajärjestelmään) Lietošanas instrukcijas/tehniskais apraksts MINOP TREND (TRansnasales ENDoskopijas sistēma) Naudojimo instrukcija/techninis aprašas MINOP TREND (TRansnazalinės ENDoskopijos sistema) Инструкция по примению/Техническое описание MINOP TREND (система для трансназальной эндоскопии) Návod k použití/Technický popis MINOP TREND (TRansnasální ENDoskopický systém) Instrukcja użytkowania/Opis techniczny MINOP TREND (przeznosowy system endoskopii) Návod na použitie/Technický opis MINOP TREND (TRansnazálny ENDoskopický systém) Használati útmutató/Műszaki leírás MINOP TREND (TRansznazális ENDoszkóprendszer) Navodila za uporabo/Tehnični opis MINOP TREND (TRansnazalni ENDoskopski sistem) Upute za uporabu/Tehnički opis MINOP TREND (TRansnazalni ENDoskopski sustav) Manual de utilizare/Descriere tehnică MINOP TREND (sistem TRansnazal de ENDoscopie) Упътване за употреба/Техническо описание MINOP TREND (TРансназална система за EНДоскопия) Kullanım Kılavuzu/Teknik açiklama MINOP TREND (TRansnazal ENDoskopi sistemi) Οδηγίες χρήσης/Τεχνική περιγραφή MINOP TREND (Σύστημα διαρρινικής ενδοσκόπησης)
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Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com
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Aesculap® – a B. Braun brand TA012407
2020-11
V6
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Change No. 63662
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en
2.4
Application
Aesculap MINOP TREND (TRansnasal ENDoscopy system)
WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product.
Legend
The MINOP TREND handle can be combined with the following suction/irrigation sheaths: ■ MINOP TREND-suction/irrigation sheath 0° and MINOP TREND-endoscope 0°, PE487A ■ MINOP TREND-suction/irrigation sheath 30° and MINOP TREND-endoscope 30°, PE507A When the irrigation button 4 is pressed, the field of view of the adapted MINOP TREND endoscope 5 is rinsed and thus cleansed of any blood and secretion. ► To rinse MINOP TREND endoscope 5: press irrigation button 4 down to the stop. Suction is interrupted while irrigation is active. ► To stop rinsing MINOP TREND endoscope 5: release irrigation button 4. The valve automatically switches to continuous suction and interrupts the irrigation.
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MINOP TREND (TRansnasal ENDoscopy system) MINOP TREND suction/irrigation sheath, rotatable MINOP TREND-handle Irrigation button MINOP TREND-Endoscope Adapter for holding arm Conical sheath connection
1.
About this document
Note General risk factors associated with surgical procedures are not described in these instructions for use.
1.1
Scope
Note Suction is permanently active, except for the short periods when irrigation is activated. Note There is a danger of deformation and/or breakage due to excessive mechanical load.
These instructions for use apply for the following products:
3.
Validated reprocessing procedure
Art. no.
Designation
3.1
General safety information
FH615
MINOP TREND-handle (with irrigation button)
FH610R
MINOP TREND-suction/irrigation sheath 0°
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
FH611R
MINOP TREND-suction/irrigation sheath 30°
FH605SU
MINOP TREND suction/irrigation sheath for FH615
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.
RT099R
Adapter for holding arm
Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
► For article specific instructions for use and material compatibility and lifetime information, see B. Braun eIFU at
eifu.bbraun.com
1.2
Safety messages
Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows:
Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used.
WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result.
Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.
3.2
2.
Clinical use
2.1
Product description
2.1.1
Components required for use
Art. no.
Designation
PE487A
MINOP TREND-endoscope 0°, ∅ 4 mm
PE507A
MINOP TREND-endoscop 30°, ∅ 4 mm
2.2
Areas of use and limitations of use
2.2.1
Intended use
The MINOP TREND (Transnasal ENDoscopy system) is provided for operation areas and interventions which can be reached via the transnasal access.
2.2.2
Indications
Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.
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 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. Failure 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 application/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 "AKI-Brochures", "Red brochure".
3.3
Single-use products
For indications, see Intended use.
2.2.3
Contraindications
No known contraindications.
2.3
Safety information
2.3.1
Clinical user
General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located.
Art. no.
Designation
FH605SU
MINOP TREND irrigation/suction tube
► Do not reuse the product.
The preparation of the product affects its functionality. Risk of injury, illness or death due to contamination and/or impaired functionality of the product. ► Do not reprocess the product.
3.4
Reusable products
Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection.
3.5
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.
3.6
Preparing for cleaning
Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.
► Disassemble the product prior to cleaning, see Disassembly.
2.3.2
3.7.2
Product
Product-specific safety information ► Only combine Aesculap products with each other.
3.7
Disassembly
3.7.1
Loosen MINOP TREND suction/irrigation sheath from MINOP TREND handle
► Turn the MINOP TREND suction/irrigation sheath 2 with the MINOP TREND endoscope 5 used and, at the same
time, pull backwards out of the MINOP TREND handle 3.
Disconnecting the tubes and the irrigation button
► Remove the tubes from the tube connectors. ► Unscrew irrigation button 4, see Fig. 1.
3.7.3
Disconnecting adapter for holding arm RT099R
► Undo the cap nut. ► Remove adapter for holding arm RT099R.
3.7.4
3.9.1
Manual cleaning with immersion disinfection
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Disinfecting cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
5
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
Remove MINOP TREND endoscope out of the MINOP TREND suction/irrigation sheath
► Unscrew the light cable from the MINOP TREND Endoscope 5. ► Take the camera from the eyepiece of the MINOP TREND Endoscope 5. ► Unlatch the locking lever of the MINOP TREND suction/irrigation sheath 2 and remove the MINOP TREND
Endoscope 5.
3.8
Cleaning/Disinfection
3.8.1
Product-specific safety information on the reprocessing method
Danger to the patient! The product must not be manually processed. ► Process the product only with mechanical or manual pre-cleaning followed by mechanical cleaning. WARNING Inadequate cleaning result if the irrigation button remains screwed in! ► Remove the irrigation button prior to cleaning. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastic material and high-grade steel. – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and
degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.
3.8.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Cleaning brush PM995200 ■ 20 ml disposable syringe ■ When cleaning instruments
Chapter Manual cleaning/disinfection and subsection:
■ MINOP TREND-handle ■ MINOP TREND suction/irrigation shafts
■ Chapter Manual cleaning with immersion disinfection
with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.
■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection
■ Adapter for holding arm ■ Irrigation button
■ Cleaning brush PM995200 ■ 20 ml disposable syringe ■ When cleaning instruments
Chapter Manual cleaning/disinfection and subsection:
■ Chapter Manual cleaning with ultrasound and immersion disinfection
with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.
■ Drying phase: Use a lint-free
■ MINOP TREND-handle ■ MINOP TREND suction/irrigation shafts
■ Cleaning brush PM995200 ■ 20 ml disposable syringe ■ Place the product on a tray that
Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection
Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.
Chapter Mechanical cleaning/disinfection and subsection:
3.9.2
Manual cleaning with ultrasound and immersion disinfection
■ Chapter Mechanical alkaline
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
5
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
cleaning and thermal disinfection
is suitable for cleaning (avoid rinsing blind spots).
■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.
■ Keep working ends open for cleaning.
■ Place the product on the tray with all product links and joints open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection
■ Adapter for holding arm ■ Irrigation button
■ Cleaning brush PM995200 ■ 20 ml disposable syringe ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■ Connect components with
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:
■ Chapter Manual pre-cleaning with ultrasound and brush
■ Chapter Mechanical alkaline
lumens and channels directly to the rinsing port of the injector carriage.
cleaning and thermal disinfecting
■ Keep working ends open for cleaning.
■ Place the product on the tray with all product links and joints open.
3.9
Manual cleaning/disinfection
► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.
Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
3.12.1 Visual inspection
3.12 Inspection ► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.
► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed
areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely
3.10 Mechanical cleaning/disinfection Note The cleaning and disinfection device 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 device used for processing must be serviced and checked at regular intervals.
3.10.1 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound
scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical service.
Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical/Note
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11*
3.12.2 Functional test CAUTION Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication! ► 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 sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
3.13.1 Insert MINOP TREND endoscope into the MINOP TREND suction/irrigation sheath
V
Drying
-
-
-
According to the program for cleaning and disinfection device
CAUTION Damage to components caused by excessive force! ► Handle the components with appropriate care.
3.13 Assembly
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
► Insert MINOP TREND Endoscope 5 axially into the MINOP TREND suction/irrigation sheath 2, see Fig. 2. Whilst
completing this step, ensure that the lever of the MINOP TREND suction/irrigation sheath 2 is open and the peg fits into the groove on the bayonet of the MINOP TREND Endoscope 5. ► Turn the locking lever of the MINOP TREND suction/irrigation sheath 2 as far as it will go. The MINOP TREND Endoscope 5 has been securely locked.
3.13.2 Connecting the tubes and the irrigation button
3.11 Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device 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 device used for processing must be serviced and checked at regular intervals.
3.11.1 Manual pre-cleaning with ultrasound and brush Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
CAUTION Restricted functionality of the MINOP TREND (TRansnasal ENDoscopy System) if the irrigation button is not screwed in completely! ► Make certain that the irrigation button in the MINOP TREND handle is screwed into handle down to the stop. CAUTION Restricted functionality of the MINOP TREND (TRansnasal ENDoscopy System) due to incorrect connecting direction of the tubes! ► Note the arrow direction on the MINOP TREND handle. ► Carry out function checks before using the product. ► Verify that the irrigation button 4 does not show any damage (valve seals, surfaces, etc.). ► Screw the irrigation button 4 all the way into the MINOP TREND handle 3, see Fig. 3. ► Connect the suction tube to the suction connector, making certain that the arrow points away from the
MINOP TREND handle 3. ► Connect the irrigation tube to the irrigation connector, making certain that the arrow points towards the
MINOP TREND handle 3. D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh
Note In order to facilitate connection, a MINOP TREND suction/irrigation tube is available, the irrigation tube of which is identified along its entire length with a blue line running through it. The suction tube is not marked.
► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
3.13.3 Connect the MINOP TREND suction/irrigation sheath with the MINOP TREND handle ► Insert the MINOP TREND suction/irrigation sheath 2 with the MINOP TREND endoscope 5 from the rear into the
infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
3.11.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
MINOP TREND handle, until the MINOP TREND suction/irrigation shaft 2 engages, see Fig. 4. The MINOP TREND suction/irrigation sheath 2 is rotatable. ► Check the irrigation and suction tubes and the conical seating for any leaks. ► Press irrigation button 4 to check that it functions properly.
3.13.4 Mounting adapter for holding arm RT099R ► Unscrew the cap nut of the adapter for holding arm 6. ► Insert adapter for holding arm 6 from either side (left/right) into the borehole until the flange engages in the
provided groove, see Fig. 5. ► Screw on the cap nut and tighten it until adapter for holding arm 6 is fixed, see Fig. 6.
The MINOP TREND ( TRansnasal ENDoscopy System) is ready for connection to the holding arm.
3.14 Packaging ► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.15 Steam sterilization ► 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).
– pH ~ 13 – <5 % anionic surfactant
■ working solution 0.5% – pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
In accordance with the program for the cleaning and disinfecting machine
► Validated sterilization process
– Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.
3.16 Storage ► Store sterile single-use products in germ-proof packaging in a dust-protected, dry, dark and temperature-con-
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline
trolled room.
4.
Technical service
CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.
4.1
Accessories/Replacement Parts
Art. no.
Designation
FF357R
MINOP TREND tray for trocars and optics
FH605SU
MINOP TREND irrigation/suction tube
FH615801
Irrigation button
PM995200
Cleaning brush
5.
Disposal
WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA012407
2020-11
V6
Change No. 63662