User's Manual

14
User's Guide
Electromagnetic Compatibility
The NESS H200 Wireless System is medical electrical equipment and was
tested for electromagnetic compatibility (EMC) in accordance with International
Electrotechnical Committee (IEC) 60601-1-2. The tables in the Appendix
provide information regarding the EMC testing and guidance for safe use
of the system. The NESS H200 Wireless System should be configured and
used in accordance with the instructions provided in this guide.
The NESS H200 Wireless System was tested and certified to use the
following:
• DC power supply as provided by Bioness Inc, manufactured by FRIWO,
Part No. FW7555M/05.
•
Y cable (2-way splitter) as provided by Bioness Inc, Model No. L3G-5C00.
Manufactured by Tamuz Electronics Ltd.
The plug-in AC/DC adapters for the H200 Wireless Control Unit and Orthosis
are the only means for disconnecting the devices from the AC power.
Warnings and Cautions
• Use caution when treating patients with implanted intrathecal/intravascular
drug delivery systems. During initial trials with the NESS H200 Wireless
System, clinicians should monitor carefully patients on intraspinal/
intravascular therapy for any new neurological or other medical signs
or symptoms. Those clinicians should be advised to inform patients of
the signs and symptoms of drug underdose or overdose. Clinicians and
patients also should be advised to follow programming guidelines and
precautions provided in the relevant drug delivery system product manuals.