For healthcare professionals
Clinical guidance for healthcare professionals using the Nurochek-Pro System.
Intended purpose
The Nurochek-Pro System is intended for prescription use in healthcare facilities for patients aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment. Rx only
The Nurochek-Pro System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyse captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in patients aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
Clinical use context
To be used by, or under the supervision of, qualified healthcare professionals.
As an aid to diagnosis, in conjunction with a standard neurological assessment.
To provide objective, quantitative brain-function data to support clinical judgment, within the intended purpose.
Important safety information
This device should only be used by trained operators familiar with its intended use. Observe the following before operating the Nurochek-Pro System.
Use under direct medical supervision or by a medical professional. Wear medical examination gloves when cleaning, fitting and handling the headset.
The headset produces bright flashing lights that may trigger a seizure. Use clinical judgement before exposing a patient to the visual stimulus.
Power only via the supplied USB-A connection with a medical-grade or IEC 60601-compliant computer, an approved USB isolator, or a laptop not connected to mains power.
Do not repair, disassemble, service or modify the headset or its accessories. Report any faults to the manufacturer for assessment.
The headset and accessories are not defibrillator-proof. Remove the headset and all accessories from the patient before defibrillation.
Follow the reprocessing instructions before use and between every patient to mitigate potential biohazards.
Do not use the device where any of the following apply.
Discontinue use on the patient and seek medical advice if these occur.
Regulatory status by jurisdiction
Regulatory status is stated as fact. Status in one jurisdiction does not imply approval, endorsement or availability in another.
The Nurochek™-Pro System has received FDA 510(k) clearance as a Class II medical device for the aid in diagnosis of mild traumatic brain injury (mTBI).
Notified on the WAND (Web Assisted Notification of Devices) database and available in New Zealand.
WAND is a notification system; it is not a pre-market approval and does not constitute a Medsafe assessment or endorsement of the device.
Not yet included in the ARTG; not available for supply in Australia.
ARTG inclusion in progress.