SycoTec 2003 1990 Instructions For Use Manual Download Page 12

 

5 Reprocessing 

 

 

12 

EN 

 

When placing the parts in the WD, make sure that all the areas will be reachable during cleaning. 

 

Place the cannulas in suitable holders in the WD, e.g. injector nozzle for Miele WD 

 

 

 

E.g. Miele injector nozzle A 816 for cleaning cannulas 

 

Inspecting and checking the components following cleaning and disinfection 

 

Once the cleaning and disinfection cycle is complete, inspect the components for residual dirt and residual moisture. 

 

Repeat the cycle if necessary. 

 

Replace damaged components if necessary. 

 

Pack away the components as soon as possible following drying and inspection. 

 

5.5 

Sterilization in accordance with ISO 17665 

 

Risk to health due to improper sterilization 

Improper procedures may hamper the effectiveness of sterilization. 
Using instruments that have not been sufficiently sterilized may put the patient’s health at risk. 

 

Only steam sterilization is permissible. 

 

Observe all process parameters. 

 

When operating the steam sterilizer, always follo

w the manufacturer’s instructions. 

 

Do not apply any other methods. 

 

 

Risk of property damage due to improper sterilization 

Improper handling during sterilization may damage the product. 

 

When operating the steam sterilizer, always follow the manufacture

r’s instructions. 

 

Observe all process parameters. 

 

The suction cannulas and cannula adapters can be sterilized in a steam sterilizer (B and N cycle). The permissible 
process varies from country to country. 
The suction cannulas and cannula adapters have a temperature resistance of up to 138°C (280°F). 

 

Wrapping 

Before being sterilized, the suction cannulas and cannula adapters must be shrink-wrapped using suitable wrapping. 
Please note the following: 

 

The wrapping used must meet the applicable national standards and be suitable for use with steam sterilization. 

 

The wrapping must be large enough to accommodate single suction cannulas and cannula adapters without the bag 
being over-stretched. 

 

The suction cannulas and cannula adapters must be shrink-wrapped individually in separate pieces of wrapping. 

 

Sterilization 

Please note the following during sterilization: 

 

Sterilization must only be performed in a steam sterilizer that meets the applicable standards (e.g. EN 13060) and 
has a validated B or N cycle. 

 

Only use programs that are suitable for the products being sterilized (e.g. when sterilizing hollow parts, use the 
fractionated vacuum method with three vacuum stages). 

 

Observe the applicable national and regional guidelines. 

 

Follow the operating instructions provided by the sterilizer manufacturer. 

 

 

 

Summary of Contents for 2003 1990

Page 1: ...SycoTec Aerosol suction system Instructions for Use EN www sycotec eu Aerosol suction system aer x REF 2 003 1990 Copyright 2021 SycoTec All rights reserved Doc no 2 003 1812 Rev 2021 08 02...

Page 2: ...oduct may be modified or improved as a result of technical developments This does not give entitlement to have already existing products upgraded Manufacturer Distributed by SycoTec GmbH Co KG SycoTec...

Page 3: ...processing________________________________________________________________________________ 9 5 1 Steps in the place of use__________________________________________________________________ 10 5 2 Manu...

Page 4: ...date Atmospheric pressure limitation USA Professional use only Handle with care Humidity limitation Wear protective gloves Keep dry Temperature limitation Wear eye protection Stacking limitation Steam...

Page 5: ...l The suction cannulas and cannula holder must be thermally disinfected and or sterilized in autoclaves at a temperature of up to 135 C each time a patient is treated Clean and disinfect the suction h...

Page 6: ...upply Fully assembled headphones Cannula holder right Cannula holder left Suction cannulas 5 pieces Reducing adapter to 11 mm Fixing strap Disposable protective covers 100 pieces Headphone holder USB...

Page 7: ...ot be used on patients with pacemakers or implants that are sensitive to magnets due to the magnet on the headphones and adapter Patients with hearing aids Patients with skull deformities Treatments f...

Page 8: ...power suction power should be 300 l min 3 5 Operating conditions Only suitable for use in enclosed spaces Only suitable for professional use May only be used by trained staff Cannot be used as a subs...

Page 9: ...using it for the first time and reprocess it after treating each patient The aerosol suction should be reprocessed as soon as possible following treatment Also follow the processing steps in the user...

Page 10: ...of brush heads 2 Bristle material nylon Brush head length 25 and 35 mm Bristle length 5 and 10 mm Handle length min 170 mm Water of drinking water quality 30 C 5 C 86 F 41 F Take the following steps...

Page 11: ...aning and drying procedures Make sure that the medical device is dry following reprocessing In some countries national guidelines require mechanical reprocessing to be conducted using a validated wash...

Page 12: ...en operating the steam sterilizer always follow the manufacturer s instructions Observe all process parameters The suction cannulas and cannula adapters can be sterilized in a steam sterilizer B and N...

Page 13: ...torage Store the reprocessed aerosol suction in a dry dark and cool room that is free from germs and dust Please observe the sterilized product s use by date 6 Operation and control The aerosol suctio...

Page 14: ...to the cannula adapter and suction hose To do this use the magnetic fasteners on the headphones left and right side and cannula adapter 6 5 Positioning the suction cannula on the patient s mouth 1 Po...

Page 15: ...ervice partners Unauthorized repairs or modifications to the product invalidate the product s license and warranty Please contact your dealer for information about authorized service partners 8 Dispos...

Page 16: ...oloration e g of plastic parts Warranty claims are only valid if all the instructions in the product s user manual are followed SycoTec does not assume any liability in the event of gross negligence o...

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