User Manual

Appendix: Electrical Safety
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External equipment intended for connection to signal input, signal output or other
connectors shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical equipment). In addition, all such
combinations – systems – shall comply with the standard IEC 60601-1-1, Safety
requirements for medical electrical systems. Equipment not complying with IEC
60601-1 shall be kept outside the patient environment, as defined in the standard.4Any
person who connects external equipment to signal input, signal output or other
connectors has formed a system and is therefore responsible for the system to comply
with the requirements of IEC 60601-1-1. If in doubt, contact a qualified biomedical
engineer or Given Imaging.
The following tables outline the SmartPill GI Monitoring System’s compliance with
INTERNATIONAL STANDARD, International Electrotechnical Commission (IEC)
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for
safety – Collateral standard: Electromagnetic compatibility – Requirements and tests.
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The SmartPill GI Monitoring System is intended for use in the electromagnetic environment specified
below. The customer or the user of the SmartPill GI Monitoring System assures that it is used in such
an environment.
Emissions test
Compliance
Elec
tromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The SmartPill GI Monitoring System uses RF energy exclusively
for its internal function. Thus the RF emission is very low and it
is unlikely that nearby electronic devices would be disturbed.
RF emissions
CISPR 11
Class B
The SmartPill GI Monitoring 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 d
omestic purposes.
Harmonic
emissions
IEC 61000-3-2
IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
4
The normal distance is at least 1.5 m from the patient or the patient support.