Responsibility when using lasers in the clinic

Using a professional laser in a clinic entails an independent responsibility. Responsibility is not only about the equipment itself, but also about correct documentation, safety procedures and use in accordance with applicable regulations.

For clinics, it is important to understand the division of roles between manufacturer, supplier and user.

Who is responsible?

Responsibilities can be divided between:

• Manufacturer
• Importer
• Distributor
• Clinic

The clinic is responsible for the correct use, storage of documentation and implementation of safety procedures.

Read about the clinic's responsibilities here:
https://velurex.dk/pages/klinikkens-ansvar

Class 4 and safety responsibility

Many professional lasers are classified as Class 4.

This means requirements for:

• Safety glasses
• Access control
• Signage
• Documented risk assessment
• Training of personnel

Read about laser class 4 here:
https://velurex.dk/pages/laser-klasse-4

Read about safety here:
https://velurex.dk/pages/class-4-laser-safety

Documentation responsibility

The clinic should be able to demonstrate:

• CE documentation
• EU Declaration of Conformity
• Instructions for use
• Service history
• Risk assessment

Read about documentation when purchasing here:
https://velurex.dk/pages/dokumentation-ved-koeb-af-klinikudstyr

Read about the EU Declaration of Conformity here:
https://velurex.dk/pages/eu-declaration-of-conformity

Import and extended liability

With direct imports from third countries, the clinic may have an expanded regulatory role.

Read about imports here:
https://velurex.dk/pages/import-af-medicinal-udstyr

Technology and proper use

Responsibility also involves understanding technology:

• Wavelength
• Effect
• Pulse duration
• Cooling system

Read about wavelengths here:
https://velurex.dk/pages/755-vs-808-vs-1064-nm

Read about 1200W vs 1600W here:
https://velurex.dk/pages/1200w-vs-1600w-diode-laser

The role of the supplier

A professional supplier should be able to explain documentation, classification and safety conditions.

Read about the supplier here:
https://velurex.dk/pages/leverandoer-af-klinikudstyr-danmark

Contact

If you would like to discuss liability and regulatory issues when using lasers in clinics, you can contact us here:
https://velurex.dk/kontakt