Amalgam separator: obligations, choice and maintenance

01What the European regulation says

Regulation (EU) 2017/852 on mercury governs dental amalgam in its Article 10. For practice equipment, it essentially provides (Regulation (EU) 2017/852, Art. 10, EUR-Lex consolidated text):

• operators of dental facilities where amalgam is used, or where amalgam fillings or teeth containing it are removed, equip their facilities with amalgam separators that retain and collect particles, including in waste water;
• these separators provide a retention level of at least 95 % of amalgam particles;
• they are maintained according to the manufacturer's instructions to ensure the highest possible retention level;
• separators complying with European standards, or with standards guaranteeing an equivalent level, are presumed to comply;
• practitioners hand over their amalgam waste (residues, particles, fillings, contaminated teeth) to an authorised waste management establishment or undertaking, and never release it into the environment.

Regulation (EU) 2024/1849 amended Regulation 2017/852 with regard to dental amalgam. However, removing old fillings continues to generate amalgam waste: the separator remains necessary. Check the consolidated version in force on EUR-Lex and the regional rules where you practise.

Cattani itself links amalgam retention to European Regulation 2017/852 and the ISO 11143 standard, and points out that semi-wet systems incorporate amalgam retention according to ISO 11143 (95 %) (Cattani technical documentation, 2022, p. 19 and 22).

02How a Cattani Hydrocyclone works

The Hydrocyclone is mounted beneath the suction unit's centrifugal separator. The principle as described by Cattani (Hydrocyclone ISO 18 manual, French section, p. 23-24):

1. The centrifugal separator separates the air from the aspirated liquid.
2. The liquid reaches diffusion holes that distribute it into the cone and give it a downward rotating motion.
3. At the bottom of the cone, the direction of rotation and the flow reverse: at this moment of zero speed, the amalgam particles fall into the collection container, while the liquid leaves through the centre of the cone.
4. Recirculation valves open or close the drain: as long as the set flow rate has not been reached, the liquid is returned to the Hydrocyclone; with a suitable flow rate, separation takes place and the treated liquid goes to the drain.

A filter with a maximum mesh of 1.2 mm on the centrifugal separator protects the Hydrocyclone from particles that could damage it (p. 26). A photodiode sensor measures the amalgam level in the container: alarm at 95 %, then at 100 %; at 100 %, the Hydrocyclone runs until the machine stops and only restarts once the container has been replaced (p. 25). On Smart suction units, these alarms appear as codes I14 (level above 95 %) and I15 (level above 100 %) (Cattani poster “Manutenzione ordinaria”, 09/2023).

03Which Hydrocyclone for which suction unit?

Sources: Hydrocyclone ISO 6 manual, p. 23; Hydrocyclone ISO 18 manual, p. 24; Cattani Maxi Smart data sheet 035215; Cattani data sheets for containers 043132, 043135, 043138. The Hydrocyclones are tested by TÜV according to ISO 11143 (Cattani data sheets 043378, 043391, 035215).

Smart suction units can be ordered with their separator, for example the Turbo-Smart A with Hydrocyclone ISO 18, the Turbo-Smart 2V with Hydrocyclone ISO 18 or the Micro-Smart Cube with Hydrocyclone ISO 6 ; the separator is always supplied with its instructions for use and maintenance instructions (Cattani Smart manual, p. 18). To equip an existing Turbo-Smart suction unit, Cattani offers Hydrocyclone ISO 18 kits according to the machine version (Cattani data sheet 043391).

With dry suction, the air-liquid separator is at the chair and amalgam retention requires additional separators, which increases maintenance and costs according to Cattani (training 2022, p. 19).

04Replacing the amalgam container, step by step

Cattani procedure for the Hydrocyclone ISO 18 (Hydrocyclone ISO 18 manual, p. 26):

1. Put on disposable gloves, a mask and splash-protection glasses.
2. Switch off the power to the machine on which the separator is installed.
3. Open the screw tap and the ball valve, then wait for the liquids in the Hydrocyclone and some of those in the container to return to the centrifugal separator.
4. Hold the container with one hand, slowly lift the handle and remove the container.
5. Fill the used container with a suitable disinfectant (ask your dealer for advice).
6. Open the lid valve, lightly grease the seal with Lubri-Jet, fit the lid and close the valve.
7. Insert a new container and lower the handle until it grips the container.
8. Close the screw tap and the ball valve to put the unit back into operation.

The container is unbreakable and leak-proof, but its contents are toxic, harmful and contaminating: handle it with care. For the list of companies authorised to collect this waste, Cattani refers to professional associations and the competent local authorities (same source).

Always keep a spare container at the practice: the 95 % alarm leaves time to order, the 100 % alarm requires replacement before the next restart.

05Daily, annual and five-yearly maintenance

By practice staff

• After surgery or a particularly long treatment, rinse by aspirating clean water.
• Every evening, clean and disinfect with a non-aggressive, non-foaming product for suction systems and amalgam separators, for example Puli-Jet Plus, diluted according to the manufacturer.
• Every morning, check that an anti-foam tablet is in place in the unit's secretion filter.
• Check for leaks; in the event of an anomaly or alarm, call the technician.

Source: Hydrocyclone ISO 18 manual, p. 28.

By the authorised technician, every year

1. Flush the pipework by aspirating at least 2 litres of detergent-disinfectant solution.
2. Remove the container and test the level sensor by sliding a metal object between the photodiodes.
3. Dismantle and clean the tip of the cone.
4. Dismantle the upper part, clean the five diffusion holes, check the seals and lubricate them with Lubri-Jet.
5. Check the joints and that there are no leaks; the joints are replaced every two years.

Source: Hydrocyclone ISO 18 manual, p. 29. The Cattani extraordinary maintenance poster (09/2023) includes this annual check of the inside of the Hydrocyclone, its five holes and the small cone.

The original connecting hoses are replaced every two years at most, without changing diameter (ISO 18 manual, p. 24; ISO 6 manual, p. 24). The manual also describes maintenance every five years: dismantling and cleaning of the valves and the recirculation system, inspection of parts and seals (ISO 18 manual, p. 29-30).

06Installing the separator correctly

• Hydrocyclone beneath the separator, in a vertical position, accessible from all sides (ISO 18 manual, p. 26-27).
• Free space beneath the container: at least 3 cm for the ISO 18 (p. 26), at least 10 cm for the ISO 6 (ISO 6 manual, p. 26).
• Liquids drain by gravity: provide a slope towards the sewer (ISO 18 manual, p. 27).
• After installation, the installer shows staff how to replace the container and clean the filter on a new machine that is not yet contaminated (p. 27).
• If the separator is in a separate plant room, fit the units with the spittoon draining unit (Cattani data sheet 021960).

Installation and any work on the separator are reserved for dental technicians authorised by the manufacturer (ISO 18 manual, p. 27). For a replacement or to bring your installation into compliance, contact AxeMed or a partner dealer.

→Products mentioned

Disposable amalgam container (for Hydrocyclone ISO 18)Ref. 04313542,90 € excl. VATVersion for Turbo-Smart 2V 2017 WI-FIRef. 043391909,00 € excl. VATTurbo-Smart “A” version without box, fitted with hydrocyclone ISO 18Ref. 0351155 184,00 € excl. VATTURBO-SMART 2V Without box, fitted with hydrocyclone ISO 18Ref. 0351356 164,00 € excl. VATMicro-Smart CUBE fitted with Hydrocyclone ISO 6Ref. 0350304 469,00 € excl. VATSpittoon draining filter unitRef. 021960454,00 € excl. VAT

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