HAMILTON MEDICAL has received US FDA 510(k) clearance for its new MR-conditional ventilator, the HAMILTON-MR1, according to a company announcement.
The HAMILTON-MR1 allows ventilation of critically ill or injured patients during MRI, where strong magnetic fields can pose a danger for both the patient and the operator. The device can be used at the 500 gauss line, in the presence of either 1.5T or 3T magnets.
Positioning a medical device too close to the MRI can have fatal consequences and cause serious injury to the patient or clinician. In addition, significant financial losses can occur if an MRI shutdown is required. In response, HAMILTON-MR1’s integrated gaussmeter continuously monitors the magnetic field and gives the clinician both an audible and a visual signal if the MR1 is getting too close to the MRI magnet, according to the company.
The HAMILTON-MR1 can be used in:
- ICU special care areas
- cardiac surgery recovery rooms
- step-down or sub-acute care units, and
- transporting patients to the MRI-department.
The device covers a full range of clinical requirements such as: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive Ventilation (NIV).
The MR1 can also be used as an MRI-proprietary ventilator, waiting in the MRI department for the patient. The device includes a trolley made out of non-ferrous materials, which will not be attracted to electromagnetic forces from the MRI.