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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. 

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. 

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 domestic 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.