Medical & Aesthetic systems

No. TBH does not place its Health filtration and extraction systems on the market as medical devices under Regulation (EU) 2017/745 (MDR). They are designed for the local extraction of laser smoke and aerosols during medical and aesthetic applications and are intended to operate without contact with the patient.

Regulatory classification depends on the manufacturer’s intended purpose. Whether additional requirements apply to equipment used in a particular application must be assessed individually. Using a TBH Health system does not automatically mean that the system is classified as a Class IIa medical device.

Both systems have a compact design and feature a patented InLine pre-filter and a combined H13 particulate and activated carbon filter. The main difference is the motor technology: the Health Basic uses a brushed motor and is intended for occasional applications with short daily operating times. The Health Pro features a brushless motor and is suitable for more frequent applications and longer daily operating times.

Both systems use brushless motor technology and are designed for regular use. The Health Pro is more compact and features a combined H13 particulate and activated carbon filter. The Health Pro Silence is designed for noise-sensitive treatment environments, offering quieter operation and a higher effective airflow. It uses an H14 particulate filter and a separately replaceable activated carbon filter, but requires more installation space.

The required replacement intervals depend on usage, filter loading and the hygiene requirements of the facility. Electronic filter monitoring helps assess the condition of the monitored main filters. Filter replacement may also be necessary even if no saturation warning is displayed.

Activated carbon filters and InLine pre-filters cannot be assessed solely through differential pressure monitoring. TBH recommends replacing the InLine filter daily and no later than after one week. For the main filters and activated carbon filter, the current operating and hygiene instructions for the respective system apply.

Regular maintenance includes filter replacement and cleaning of the designated surfaces and extraction components. The extraction hood and extraction arm must be cleaned in accordance with the facility’s applicable hygiene requirements and TBH instructions.

Regularly check the positioning and secure attachment of the extraction arm. The type and extent of further maintenance work depend on the operating instructions for the respective model.

The patented InLine filter is a replaceable pre-filter positioned at the extraction point. It captures particles and aerosols at an early stage, reducing deposits inside the extraction arm and the particle load on the downstream main filters.

The optional suction nozzle is an extraction attachment with a smaller diameter and may obstruct the view of the treatment area less. It does not provide additional pre-filtration itself. The possible combinations of extraction attachments and InLine filters depend on the respective accessory configuration.

The main filters can be replaced without tools, following the operating instructions. Switch off the system before replacing the filters. Remove the used filters and insert the replacement filters specified for the respective model. In the Health Basic and Health Pro, the combined H13 particulate and activated carbon filter unit is replaced. In the Health Pro Silence, the H14 particulate filter and activated carbon filter can be replaced separately.

The InLine filter is replaced directly at the extraction point. Used filters must then be disposed of in accordance with the applicable disposal and hygiene requirements. A video tutorial is available on this page.

Setup depends on the respective Health system and the extraction attachment used. Follow the supplied operating and maintenance instructions, particularly the requirements for safe positioning of the system and secure attachment of the extraction arm. A video tutorial is available on this page.

The extraction arm can be positioned using the designated joints and adjustment screws. Do not move the arm beyond its permissible adjustment range or compromise the stability of the system. For detailed adjustment instructions, refer to the operating manual or the video tutorial on this page.

The TBH hygiene concept includes measures for cleaning and maintaining Health filtration and extraction systems. These include pre-filtration by the InLine filter, its regular replacement, cleaning of the designated components and replacement of the main filters as required.

The used InLine filter is removed and disposed of properly. The removable protective grille can be cleaned in accordance with the specified reprocessing instructions. The TBH hygiene concept complements the hygiene requirements of the respective facility but does not replace them.

Additional tip: Position the extraction element as close as practicable to the source of laser smoke and aerosols to support effective local capture. Regular replacement of the InLine filter, cleaning of the extraction arm and disinfection of designated surfaces should be carried out in accordance with the facility’s hygiene procedures. Local extraction is a supplementary measure and does not replace the required ventilation, cleaning and infection prevention measures.

The requirements depend on the type of treatment, the applicable regulations and your facility’s hygiene concept. This should specify how often extraction attachments, the extraction arm and system surfaces must be cleaned, when filters must be replaced and how used filters must be disposed of.

The current TBH operating and hygiene instructions, together with the requirements applicable at your location, govern the specific cleaning, maintenance and inspection procedures. Health systems are designed for the local extraction of emissions and do not replace other necessary protective and hygiene measures.