User Manual

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Proteus Two-part Patch Technical description Effective: xxXXX2016
This product complies with all applicable provisions of the EU Restriction of Hazardous
Substances directive (RoHS)
This product complies with all applicable provisions of the EU Medical Device Directive (MDD)
The pod and strip do not contain natural latex rubber
Strip and Pod packaging materials meet the meet transit requirements per ASTM D4169,
distribution cycle 13, Assurance Level II.
7.5. Patch Specifications
Battery (in strip) CR2016 Lithium Manganese DiOxide coin cell (3V)
Battery capacity Sufficient for at least 7 days of use
Patch memory capacity Sufficient for at least 14 days of continuous recording w/o uploads
7.6. Blutooth® Wireless Technology Specifications
Compliance Version 4.0 single mode low energy
Operating Frequency 2.4 to 2.4835 GHz
Output Power TX: -15dBm (P=0.03125mW)
Effective Bandwidth 1.25 MHz
Modulation Frequency hopping using GFSK (Gaussian Frequency Shift
Keying)
7.7. EMC Information
RF Emissions CISPR 11 Group 1
RF Environment CISPR 11 Class B
RF Interference Immunity IEC 61000-4-3 Level 3
ESD Discharge Immunity IEC 61000-4-2 Level 4
The two-part Patch uses RF energy for its internal function. Its RF emissions are
however very low and are not likely to cause any interference in nearby
electronic equipment. This device is suitable for use in all establishments,
including domestic.
The device should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use
is necessary, the device should be observed to verify normal operation in the configuration in which it
will be used.
The use of accessories, sensors, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of
this equipment and result in improper operation.
The patch needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this document.
WARNING: Portable and mobile RF communications equipment can affect the Patch. Portable and
mobile F communications equipment (including peripherals such as antenna cables and external