SycoTec aer x User manual

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

Contents
2 EN
All the trademarks mentioned in these instructions for use are the property of their respective owners.
All the technical data, information and properties of the product described in these instructions for use were correct at
the time of printing.
The product 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 GmbH & Co. KG
Wangener Strasse 78
Wangener Strasse 78
88299 Leutkirch
88299 Leutkirch
GERMANY
GERMANY
Phone:
[phone]
Phone:
[phone]
Fax:
[phone]
Fax:
[phone]
Email:
[email protected]
Email:
[email protected]
Website:
www.sycotec.eu
Website:
www.sycotec.eu

Contents
3 EN
Contents
1User information _____________________________________________________________________________ 4
1.1 Target group of the document_______________________________________________________________ 4
1.2 Applied symbols _________________________________________________________________________ 4
2Safety _____________________________________________________________________________________ 4
2.1 Reporting obligation ______________________________________________________________________ 5
2.2 Warning signs ___________________________________________________________________________ 5
2.3 Risk of infection__________________________________________________________________________ 5
2.4 Magnetic fields __________________________________________________________________________ 5
2.5 Risk of burns____________________________________________________________________________ 5
2.6 Technical condition _______________________________________________________________________ 6
3Product description ___________________________________________________________________________ 6
3.1 Scope of supply__________________________________________________________________________ 6
3.2 Intended purpose ________________________________________________________________________ 7
3.3 Technical specifications –headphones________________________________________________________ 8
3.4 Technical specifications –suction system______________________________________________________ 8
3.5 Operating conditions______________________________________________________________________ 8
3.6 Storage and transport conditions ____________________________________________________________ 8
4Commissioning ______________________________________________________________________________ 9
5Reprocessing________________________________________________________________________________ 9
5.1 Steps in the place of use__________________________________________________________________ 10
5.2 Manual cleaning ________________________________________________________________________ 10
5.3 Manual disinfection ______________________________________________________________________ 10
5.4 Thermal disinfection _____________________________________________________________________ 11
5.5 Sterilization in accordance with ISO 17665____________________________________________________ 12
5.6 Storage _______________________________________________________________________________ 13
6Operation and control ________________________________________________________________________ 13
6.1 Positioning the headphones _______________________________________________________________ 13
6.2 Connecting the suction cannula to the cannula adapter __________________________________________ 14
6.3 Connecting the cannula adapter to the existing suction hose of the assistant element___________________ 14
6.4 Connecting the aerosol suction to the headphones _____________________________________________ 14
6.5 Positioning the suction cannula on the patient’s mouth___________________________________________ 14
6.6 Disassembly ___________________________________________________________________________ 14
7Care, maintenance and service_________________________________________________________________ 15
7.1 Troubleshooting ________________________________________________________________________ 15
7.2 Servicing ______________________________________________________________________________ 15
8Disposal___________________________________________________________________________________ 15
9Accessories and spare parts ___________________________________________________________________ 16
10 Manufacturer's warranty ______________________________________________________________________ 16

1 User information
4 EN
1 User information
Before using this product for the first time, please read the user manuals for the aerosol suction and headphones
carefully and keep them in a safe place for future reference.
Dear user,
We hope that you will enjoy using this high-quality product. Please observe the following instructions to ensure that you
can work safely and without encountering any problems.
The aerosol suction has the following features:
•Flexible and compact, making it easy to use
•Hygienic, sterilizable components that can be thermally disinfected
•Biocompatible suction cannulas
•The information on the headphones is provided separately alongside this user manual.
1.1 Target group of the document
This document is intended for:
•Dentists
•Specialist practice staff (dental assistants, medical device reprocessing specialists)
Chapter 4 Commissioning is primarily intended for:
•Dental professionals
1.2 Applied symbols
In the instructions for use / on the product / on the packaging
Important information
Health industry bar code
Serial number
CE label
Unique device identification
Reference number
Manufacturer and
manufacturing 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 sterilizable up to 135°C
(275°F)
Wear a mask
Disposal information
Thermally disinfectable up to
95°C (203°F)
Wear protective clothing
Packaging unit
Refer to the
instructions for use
2 Safety
It is the duty of the user to:
•Only use the product as intended
•Not misuse the product in any way
•Only use products that are free from defects and that are in full working order
•Protect themselves, their patients and third parties from danger
•Take suitable protective measures, especially to avoid cross-contamination
The following provisions and instructions must always be followed when using the aerosol suction:
•The applicable occupational health and safety regulations
•The applicable accident prevention measures
•These instructions for use
•Only qualified users are permitted to use the system
The manufacturer does not accept any liability for damage or harm caused to the product, users, patients or third parties
as a result of:
•Failure to observe the operating, repair, installation and/or assembly instructions
•The use of incorrect information
•Misuse or improper use
•Repairs by unauthorized persons
•Changes or manipulations to the product

2 Safety
5 EN
2.1 Reporting obligation
Users and/or patients must report any serious incidents that arise in relation to the product to the manufacturer and
the competent authorities in the country in which the user and/or patient is resident.
2.2 Warning signs
Structure of warning sign
HAZARD SYMBOL
Nature or source of hazard
Description of the nature or source of hazard and its possible consequences.
Measures to avoid the hazard
Risk levels
Warning
Indicates a hazardous situation that could lead to serious or fatal injuries.
Caution
Indicates a hazardous situation that could lead to minor or moderate injuries.
Attention
Indicates a hazardous situation that could lead to property damage.
2.3 Risk of infection
Risk of infection
If the aerosol mist in or in front of the patient’s oral cavity is not properly removed, this may lead to bacterial transmission
and cross-contamination in the treatment room. There is a risk that patients, users or third parties may be infected.
Take appropriate personal protection measures.
Observe the reprocessing requirements in these instructions for use.
Reprocessing may only be conducted by trained or qualified personnel.
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 hoses and aerosol suction in accordance with the hygiene and reprocessing measures
specified by the treatment device/suction system manufacturer.
This aerosol suction does not replace the usual protective equipment of the practice staff.
2.4 Magnetic fields
Magnetic fields
Magnetic fields are created when operating the headphones with the magnetic fasteners. This may impact the functioning
of implants like pacemakers.
Before starting treatment, ask patients if they have any implants and inform them of the potential risks.
Do not place or put down the headphones or cannula adapter on the patient.
2.5 Risk of burns
Overheating
The headphone earpieces may heat up when using electrically operated scale removal devices. There is a risk of
overheating and a potential risk of burns. Also pay attention to the headphone batteries during charging. These may also
heat up.
Stop the electric scale removal device if you notice unexpected overheating.
Before each treatment, check that the headphones are in a perfect technical condition and inspect them for any signs
of damage.
Only use properly functioning electrically operated scale removal devices with the headphones.