Viking EDX And Synergy EDX V21 User English 01 30 2020 CE2797
Nicolet EDX System
Nicolet™ Viking EDX and Synergy EDX User Guide
Issued January 30, 2020
Version 21 or Newer
269-658300 Rev 04
Indications for use statement
The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including:
- Nerve Conduction (NCS)
- Electromyography (EMG)
- Intra-Operative Monitoring including Electroencephalography (EEG)
- Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP)
- Electroretinography (ERG)
- Electrooculography (EOG)
- P300
- Contingent Negative Variation (CNV)
- Motor Evoked Potentials (MEP)
The Nicolet EDX may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability.
The Synergy EDX / Viking EDX software is used to detect changes in the functional state of the nervous system, for the location of neural structures during surgery and to support the diagnosis of neuromuscular disease or condition.
The listed modalities include overlap in functionality. In general,
- Nerve Conduction Studies measure the electrical responses of the nerve.
- Electromyography measures the electrical activity of the muscle.
- Evoked Potentials measure electrical activity from the Central Nervous System.
The Nicolet Synergy EDX / Viking EDX software is intended to be used by a qualified healthcare provider.
Contact information
Natus Neurology Incorporated
3150 Pleasant View Road Middleton, WI USA 53562-3530 608-829-8500 1 800-356-0007 Fax: 608-829-8589
www.Natus.com
Natus EU Authorized Representative
Natus Manufacturing Limited IDA Business Park Gort, Co.Galway, Ireland
Technical Support
Domestic
Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI USA 53562 1-800-356-0007 madison.helpdesk@natus.com www.Natus.com
International
Natus Neurology Incorporated
Phone: 0049 (0) 180 501 5544
Fax: 0049 (0) 89 83942777
Email: service.europe@natus.com
www.Natus.com
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. |
Table Caption: This table outlines various symbols and information relevant to medical devices, including safety warnings, manufacturer details, regulatory compliance marks, and disposal instructions. It differentiates between the application of symbols on the device versus their use in accompanying documentation.
Nicolet EDX
Read the safety reference guide
Please read the Additional Information and Safety Notes for Assorted Nicolet Brand Products Reference Guide on CD furnished with your Nicolet EDX system thoroughly, paying special attention to the Safety information before applying power to and using your Nicolet system.
Electromagnetic Compatibility (EMC)
Please refer to the Electromagnetic Compatibility Reference Guide on CD furnished with your Nicolet EDX system for information concerning your Nicolet EDX system.
In this manual, two labels identify potentially dangerous or destructive conditions and procedures:
The WARNING label identifies conditions or practices that may present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in damage to the equipment.
NOTE: Notes help you identify areas of possible confusion and avoid potential problems during system operation.
Do NOT use outside of the published specification ranges. Use of device outside of the specified ranges may result in inaccurate results.
Safety summary
Inspecting the system
Nicolet EDX Copyright
Routinely check the instrument for exterior damage.
Follow your medical facilities safety guidelines.
Disposal at the end of operating life
Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and Electronic Equipment) Regulations 2014. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at www.natus.com
Electrical and electronic equipment (EEE) contains materials, components and substances that may be hazardous and present a risk to human health and the environment when WEEE is not handled correctly. Therefore, end users also have a role to play in ensuring that WEEE is reused and recycled safely. Users of electrical and electronic equipment must not discard WEEE together with other wastes. Users must use the municipal collection schemes or the producer/ importers take-back obligation or licensed waste carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and electronic equipment and to increase opportunities for reuse,
