SurgiCube has renewed the ISO 13485 certificate for its quality management system. We are happy that we continue to meet the highest standards within our organisation. This certificate is provided by the Notified Body Dekra Certification BV.
The coronavirus correlates to particles sizes from 0.05µm-0.15µm and these particles – as well as many different sizes of potentially harmful particles – are captured by the SurgiCube® filter(s) efficiently. For comparison a diagram of particle sizes that shows the efficiency of ‘absolute filters’ and ‘fine filters’ – both used in the SurgiCube®:
It is the conclusion that the SurgiCube® is an efficient airflow device to be used for minimizing the spread of airborne contamination, including the latest coronavirus SARS-CoV-2.
At SurgiCube International BV we take GDPR seriously and we have implemented routines for the safe an correct handling of personal data.
Read our policy in full here: Privacy Statement SurgiCube
Please have a look at our latest movie that shows the easy installation and setup for any SurgiCube®.
Installing the SurgiCube® can be done in a matter of hours. Once the SurgiCube® is available on-site, the trained technicians can set it up quite easily.
The SurgiCube® comes in prefab parts and can be assembled in your clinic in a suitable room. Once installed, it should be cleaned and switched on. After running correctly and setting the correct air velocity, a validation needs to be done.
For all information please contact your local contact person or SurgiCube® International directly.
We are happy to announce that SurgiCube International BV is fullfilling the Quality Management Systems standard ISO 13485:2016 for its organisation. This certificate is provided by the Notified Body Dekra Certification BV. Inspection and audit are carried out on a yearly basis.
Since September 2017 the SurgiCube has been cleared by the FDA according to 510(K).
This means that the SurgiCube can now be marketed in the US for ophthalmic surgery.
We have asked a lot of experts about their opinion on bringing the SurgiCube to the clinic.
First we are proud to show you the interview we had with Dr. Petr Masek from The University Hospital Ostrava.
Download the information here:
As of April we can support our trusted distributors via the SurgiCube Kit on our website.
The SurgiCube Kit maintains all relevant information about the SurgiCube. This information is spread through various folders, brochures and online pages, some of which we use infrequently.
This way it is more easy to convince stakeholders in the hospitals and show them the unique selling points of the SurgiCube.
From now on, it only takes a minute to locate, login, and access all the SurgiCube information.
We are proud of this extra tool and believe it can be helpful for our distributors to promote the SurgiCube.
During this congress in September we promoted the SurgiCube as well as the Operio Mobile and other tools.
Toul Meditech AB is proud to announce that Operio has been cleared by the FDA according to 510(k) and the device can now be marketed in the US. Operio is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery.
