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Chapter 3 - Environmental Conditions that Affect Use
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.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g., cardiac
monitors, ECG alarms), which may not operate properly when the electrical stimulation
device is in use.
• Advise patients to remove the NESS H200 Wireless System before undergoing any
diagnostic or therapeutic medical procedure such as x-ray examination, ultrasound,
Magnetic Resonance Imaging (MRI), etc.
• The use of accessories, transducers, and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the NESS H200 Wireless
System as replacement parts for internal components, may result in increased emissions
or decreased immunity of the NESS H200 Wireless System.
• The use of the accessory, transducer, or cable with equipment and systems other than
those specified may result in increased emissions or decreased immunity of the NESS
H200 Wireless System.
• The NESS H200 Wireless System may be interfered with by other equipment, even if
that other equipment complies with CISPR (International Special Committee on Radio
Interference, International Electrotechnical Commission) emission requirements.
• Do not use the NESS H200 Wireless System within three feet of short wave or microwave
therapy equipment. Such equipment may produce instability in the stimulation output by
the Orthosis.
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