REGULATORY COMPLIANCE
SYLVER is a monitoring ultrasound imaging system manufactured in France by RESOLVE STROKE
SYLVER is a Class IIa medical device according to European Regulation 2017/745.
SYLVER is not CE-marked
INTENDED USE, INDICATIONS, MODES , INTENDED USERS
The SYLVER system is intended to provide ultrasound imaging data of cerebral hemodynamics, in order to supplement neuromonitoring, bringing additional quantitative information to the usual standard of care. The SYLVER system is not intended to replace other means of vital physiological nor paraclinical evaluation.
The use of the SYLVER system is indicated when the clinician suspects a risk of cerebral hypoperfusion, i.e. inadequate blood flow to the brain.The intended users are qualified physicians
SAFETY GUIDELINES
SYLVER is contraindicated whenever the use of an ultrasound contrast agent is contraindicated.
The SYLVER system must not be used on:
- Patients with craniectomy in the vicinity of the temple region (the probe is designed to be used in front of the skull bone).
- Patients with open wounds or fresh scars in the vicinity of the temple region (the probe should only come in contact with healthy skin).
The SYLVER system must be applied only on intact skin area of the patient’s temple. The SYLVER system is not intended for use on injured skin, nor in sterile conditions such as those found in an operating room.
Carefully read the instructions for use available in the labeling of the device.
Report any serious incident occurring with the device to the manufacturer and the appropriate competent authority.
In the event of breakdown or damage to the device, only a RESOLVE STROKE employee may work on the device. Under no circumstances should the user attempt to open the product.