31
Table 5: Entre System – Classification Information
US FDA Medical Device
Class II per 21 CFR 870 .5800 & 21 CFR 890 .5650
Canada Medical Device
Class II per Canadian Medical Device
Regulation SOR/98-282
European Union Medical Device
Class IIa per Medical Devices Directive
93/42/EEC
Protection Against Electric Shock Hazard Class I per UL/EN/IEC 60601-1
Protection Against Fluid Ingress
IP21
Applied Part
BF
Table 6: Entre System – Conformance Information
Quality Assurance
FDA 21 CFR 820 QSR
ISO 13485
Safety
IEC 60601-1
CAN/CSA C22 .2 No . 601 .1
Electromagnetic Compatibility (EMC)
IEC 60601-1-2
Waste Electrical & Electronic Equipment
(WEEE)
Directive 2002/96/EC
Restriction of Hazardous Substances
Directive 2002/95/EC
Table 7: Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
The Entre system is intended for use in the electromagnetic environment specified
below . The customer or the user of the Entre system should assure that it is used in such
an environment .
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions
CISPR 11
Group 1
The Entre system uses RF energy only for its
internal function . Therefore, its RF emissions are
very low and are not likely to cause interference
to nearby electronic equipment .
RF emissions
CISPR 11
Class B
The Entre system is suitable for use in
all establishments, including domestic
establishments and those connected to the
public low-voltage power adapter network that
supplies buildings used for domestic purposes .
Harmonic emissions
IEC 61000-3-2
Not Applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
