30 January, 2020 c
Preface
Labels and symbols
The following labels and symbols may be affixed to the Nicolet EDX system:
When applied on device: Attention: Consult Accompanying Doc-
umentation (ISO 7000-0434A)
When used in documentation: Caution, Warning or Precaution
follows.
Consult Operating Instructions. Failure to follow operating instruc-
tions could place the patient or operator at risk (ISO 7010 M002).
Image on blue background.
Consult Operating Instructions. (ISO 7000-1641)
European Authorized Representative
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
608-829-8500
1 800-356-0007
Fax: 608-829-8589
www.natus.com
Disposal at end of operating life instructions.
Medical Device Regulation (MDR) product certified to comply to
EC Regulation 2017/745.
CE Mark and Notified Body
Type BF equipment.
Class II device.
RX Only
CAUTION: USA Federal law restricts this device to sale or on the
order of a licensed Neurology practitioner.