Neuropace RNS System User Manual page 96

Specifications and Characteristics
• Televisions, AM/FM radios, stereos, personal music players.
• Vacuum cleaners and electric brooms.
For additional information about devices that generate electromagnetic interference contact
NeuroPace. If a patient suspects EMI is disrupting the operation of their neurostimulator advise
the patient to move away from the source of the EMI.
Guidance and Manufacturer's Declaration
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to EMC information provided. This declaration applies for the
following devices:
®
Neurostimulator, model RNS-300M.
• RNS
• Programmer, model PGM-300.
• Wand, model W-02.
• Remote Monitor, models DTR-300 and DTR-300-E.
The devices comply with IEC 60601-1-2, ISO 14708-3, and FCC 47 CFR Parts 2 and 15.
• Portable and mobile RF communications equipment can affect the devices.
• This equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. The devices may be interfered with by other equipment, even if that
other equipment complies with CISPR emission requirements. It may be necessary to
take mitigation measures, such as re-orienting or relocating the devices or shielding their
location.
Emissions and Immunity Information
The programmer with wand are designed for use in a medical environment by a trained
healthcare professional. The remote monitor with wand are designed for use in the home by a
patient. The devices are intended for use in the electromagnetic environment specified below.
The customer or user of the system should assure they are used in such an environment.
Note: Unless otherwise indicated in the table footnotes, emissions testing information in the
tables below apply to all of the devices addressed in this section as listed above.
electromagnetic emissions – for all equipment and systems
Emissions test
Conducted
emissions
(CISPR 11)
RF emissions
(CISPR 11)
Harmonic emissions
(IEC 61000-3-2)
Voltage fluctuations /
flicker emissions
(IEC 61000-3-3)
a
The Wand (model W-02) was tested for harmonic emissions and flicker. Other products
were excluded from harmonic emissions and flicker testing.
®
RNS System User Manual
Table 2. Guidance and manufacturer's declaration –
Compliance
Class B, Group 1
150 kHz to 30 MHz
Class B, Group 1
30 MHz to 1 GHz
a
Class A Device
Limits per Clause 5 of
a
the Standard
Electromagnetic environment – guidance
®
The RNS System uses RF energy only for
its internal function. Nearby electronic
equipment may be affected.
®
The RNS System is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
94