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.

3 Product description
6 EN
2.6 Technical condition
Technical condition
If the aerosol suction is not in a perfect technical condition, e.g. if it has uneven surfaces or if there is damage to the hose
adapter, this may cause harm to patients and third parties.
Before each treatment, check that the aerosol suction is in a perfect technical condition and inspect it for any signs of
damage or wear and tear.
Observe the care and maintenance requirements and the service plan.
Make sure that the headphones are positioned correctly on the patient’s head to avoid pinching their skin or trapping
their hair.
3 Product description
3.1 Scope of supply
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-C charging cable
Instructions for use
Recommended classification when the product is used as intended:
- Class I medical device
- Non-critical medical device (a medical device that only comes into contact with intact skin.)
The suction cannulas and cannula holders form a sterilizable aerosol suction that can be thermally disinfected. The
headphones cannot be thermally disinfected or sterilized.
The aerosol suction is connected to an existing spray mist hose on a treatment unit and activated. This reduces aerosol
transmission in the treatment room and decreases the risk of aerosol mist being transferred to or infecting the practice
staff.

3 Product description
7 EN
3.2 Intended purpose
Intended use
Patients receive preventative dental care involving the regular removal of plaque and tartar. Aerosols are produced by the
spray cooling used by turbines, handpieces, contra-angle pieces and prophylaxis instruments. These cooling media
generate aerosol clouds inside and outside of the patient’s mouth. These aerosol clouds cannot be fully removed by the
saliva ejector tube or the spray mist suction cannula.
This product provides extraoral aerosol suction that removes the contaminated aerosol mist (germs and bacteria)
generated during the preventative work from directly in front of the patient’s mouth.
The product is intended to be used in the area in front of the patient’s oral cavity during the following types of work:
•Dental prophylaxis
•Restoration work
•Endodontics
•Orthodontics
When using the product for restoration work and endodontics, an additional spray mist suction unit can be operated in
parallel using an additional device-specific kit.
In the practice, the system can be used on the patient for 60 minutes per treatment with breaks. This corresponds to the
typical way of performing dentistry work.
This aerosol suction does not replace the usual protective equipment of the practice staff.
Contraindications/side effects
•Cannot 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 for children (who cannot follow the instructions given by the practice staff)
•Treatments for people with disabilities (who cannot follow the instructions given by the practice staff)
Not intended to be used for the following
•Unsuitable for implantology and surgery!
•Unsuitable for use in technical dentistry (e.g. work on plaster models, metal casting and model casting)
User group
For use by trained personnel who speak the respective local language
•Dentists
•Specialist dental staff (dental assistants, medical device reprocessing specialists)
Patient group
All people of all ages regardless of their state of health who can follow the instructions given by the dentist or dental staff.
Requirements:
•Intact skin
•External parts of the ears (auricles) are present
•No skull deformities
•Ensure that the patient’s head is of the required size (e.g. when treating children)
Hearing aids may affect the patient’s ability to wear headphones.
Keep the headphones switched off and only use them to hold the cannula adapter.
Functionality
The aerosol suction is intended to be used for the following:
•Removal of aerosol mist from in front of the oral cavity
•Protection of practice staff from being infected by diseases transmitted by aerosol mist
•Operation on a treatment unit connected to an existing spray mist suction unit

3 Product description
8 EN
3.3 Technical specifications –headphones
Style
Over ear
Design
Closed
Transducer principle
Dynamic
Audio transmission range (earpiece)
10 –30,000 Hz
Impedance
21.75 ohms
Sound pressure level (SPL)
99.6 dB
Pressure averaged from large and small head
584.5 g
Weight with cable
293 g
Weight without cable
284 g
Cable length
120 cm
Battery life
Up to 45 h
Battery life with ANC*
Up to 24.5 h
*ANC = active noise cancellation
3.4 Technical specifications –suction system
Suction power* during prophylaxis
Minimum 300 l/min
Suction power* during preparation
Minimum 400 l/min
*The specific suction power must be calculated each time (for this, please contact the competent service partner at your
dental retailer).
The extraction 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 substitute for practice staff’s usual protective equipment
Place of operation
Permitted in indoor spaces
Suction volume of the suction system:
> 300 l/min
Ambient temperature:
10 –35°C (50 –95°F)
Relative humidity:
30 –75%
Max. altitude
2,000 m
3.6 Storage and transport conditions
Protect the product from impact and moisture and observe stacking limitations
Ambient temperature - Storage
0 –40°C (32 –104°F)
Ambient temperature - Transport
-30 –70°C (-22 –158°F)
Relative humidity:
15 –93%, noncondensing
Air pressure:
700 –1,060 hPa
Headphones stored in cold conditions
Using the headphones immediately after removing them from cold storage conditions may result in malfunctioning.
Before operation, allow the headphones to warm up to a temperature of 20 –25°C (68 –77°F)

4 Commissioning
9 EN
4 Commissioning
Check the aerosol suction as follows before using it/putting it into operation for the first time:
•Has the suction power of the single place/central suction system been set correctly (min. > 300 l/min)?
•Check how the headphones work with the treatment unit’s electric scale removal device by looking out for any
possible generation of heat.
•Has the suction cannula been correctly fitted to the cannula adapter?
•Has the cannula adapter been correctly connected to the suction hose on the spray mist suction unit?
•Has the aerosol suction been correctly fastened to the headphones?
•Are the headphones with aerosol suction correctly seated on the patient's head?
•Are the protective covers on the headphone cups?
•What is the level of wear on the suction cannulas? Do not use badly worn suction cannulas.
•Device-specific kit; see the separate installation instructions for information on the additional aerosol suction.
5 Reprocessing
Reprocessing methods –in accordance with ISO 17664:2018
Always perform all the reprocessing steps provided in these instructions for use as described and in the order
given.
Process the aerosol suction prior to 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 manuals provided by the relevant treatment device manufacturers of the suction system.
The manufacturer guarantees effective reprocessing up to 250 cycles in accordance with these instructions for use.
The suction hoses of the various kits for treatment units are to be carried out according to the specifications of the
treatment steps from the operating instructions of the corresponding treatment unit manufacturers.
Reprocessing may only be conducted by qualified personnel.
No special servicing, maintenance, inspection or testing needs to be performed following the reprocessing.
Reprocessing restrictions
The following restrictions apply to the reprocessing of the headphones. Failure to observe the following may damage the
headphones or cause malfunctioning:
•Do not clean inside the headphones
•Do not use disinfectants inside the headphones
•Do not perform automatic cleaning
•Do not use thermal disinfection
•Do not perform automatic disinfection
•Do not perform ultrasonic cleaning
•Do not submerge the headphones in liquid (e.g. cleaning agents/disinfectants)
Only clean the headphones using wipe-down disinfection as described in Chapter 5.3 Manual disinfection.

5 Reprocessing
10 EN
5.1 Steps in the place of use
Preparation at the place of use:
Wear protective gloves
Wear a mask
Wear eye protection
Wear protective clothing
Take the following steps immediately after treating each patient:
•Remove the protective covers from the headphones.
•Remove any heavy soiling such as residual cement, composite or blood from the components of the aerosol suction
immediately in the place of use.
•You can use the accessories described in chapters 5.2 and 5.3 for this purpose.
•Only the aerosol suction needs to be reprocessed.
•The headphones only need to be cleaned using wipe-down disinfection.
These steps must be taken before the aerosol suction is reprocessed.
These steps must be performed in addition to normal practice hygiene.
5.2 Manual cleaning
Clean the surfaces of the suction cannulas and cannula adapters. Use the following materials:
•Brush, e.g. cleaning brush with nylon bristles (double-sided)
–Number 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:
1. Clean the suction cannula and cannula adapter under running
water with continuous and oscillating brushing motions.
2. Perform a visual inspection of the surfaces. Repeat step 1 if any
dirt remains on the suction cannula.
3. Then perform manual disinfection.
5.3 Manual disinfection
Disinfect the surfaces of the suction cannulas and cannula adapters.
Use the following materials:
•Disinfectant solution and cotton cloth (e.g. SciCan OPTIM Blue / Metrex CaviCide / DÜRR DENTAL FD 322)
or
•Disinfectant wipes (e.g. SciCan OPTIM Blue Wipes / Metrex CaviWipes / Dr. Schumacher CLEANISEPT WIPES
FORTE)
or
•Place the suction cannulas and cannula adapters in a disinfection bath (non-fixing and aldehyde free, all parts must
be covered).
Observe the exposure times of the cleaning agents and disinfectants
Do not put the headphones into a disinfection bath.
The manufacturer has tested the disinfectants to ensure that they are compatible with the aerosol suction.