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Table of Contents
1. TECHNICAL INFORMATION . ............................................................................................................... 2
1.1 - Classification . ................................................................................................................................... 2
1.2 - Environmental Conditions .......................................................................................................... 2
1.3 - Minimizing Skin Irritation . ........................................................................................................... 2
1.4 - Protection against Ingress of Solids and Liquids . ................................................................ 2
1.5 - Avoiding Unsafe Use Conditions .............................................................................................. 2
1.6 - Information on Electromagnetic and Other Interferences . .............................................. 3
1.7 - Information on the Radio Subsystem ...................................................................................... 3
1.9 - CISPR Interference Statement . ................................................................................................... 7
1.10 - FCC Interference Statement ..................................................................................................... 8
1.11 - FCC Wireless Notice . .................................................................................................................... 8
1.12 - FCC Identifier ................................................................................................................................. 8
2 - DISPOSAL OF WASTE PRODUCTS .................................................................................................. 8
3 - MANUFACTURER CONTACT INFORMATION ............................................................................. 9
LBL-0176, Rev 1| User Supplemental Information,
Proteus® Patch
THE PROTEUS PATCH
SPC-0800
USER SUPPLEMENTAL INFORMATION
Page 1 of 1
Effective: 19DEC2013
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Table of Contents
Summary of Contents for Proteus SPC-0800
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Page 1: Table Of Contents
THE PROTEUS PATCH SPC‐0800 USER SUPPLEMENTAL INFORMATION Table of Contents 1. TECHNICAL INFORMATION ........................ 2 1.1 – Classification ............................ 2 1.2 – Environmental Conditions ...................... 2 1.3 – Minimizing Skin Irritation ...................... 2 1.4 – Protection against Ingress of Solids and Liquids .............. 2 1.5 – Avoiding Unsafe Use Conditions .................... 2 1.6 – Information on Electromagnetic and Other Interferences .......... 3 1.7 – Information on the Radio Subsystem .................. 3 1.8 – European R&TTE Declaration of Conformity ................. 7 1.9 – CISPR Interference Statement .................... 7 1.10 – FCC Interference Statement ..................... 8... -
Page 2: Technical Information
DO NOT wear the same Patch for more than one week. DO NOT drop or bump with excessive force. 1.4 – Protection against Ingress of Solids and Liquids The Proteus Patch has an Ingress Protection rating of IP27. This means that the enclosure has no penetrations and it has been rated for immersion in liquid up to 1m depth. For continued safety, should the enclosure become penetrated or torn, remove the Patch immediately and replace it with a new one. ... -
Page 3: Information On Electromagnetic And Other Interferences
EMC and needs to be installed and put into service according to the EMC information provided in this User Manual. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Proteus Patch should not be used adjacent to or stacked with other electromagnetic equipment. If adjacent or stacked use with other electromagnetic ... - Page 4 RF emissions Class B The Patch is suitable for use in all establishments, CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply Harmonic Not applicable network that supplies buildings used for domestic emissions purposes. IEC 61000‐3‐2 Voltage Not applicable fluctuations/ flicker emissions IEC 61000‐3‐3 LBL‐0176, Rev 1| User Supplemental Information, Page 4 of 4 Effective: 19DEC2013 Proteus® Patch ...
- Page 5 Guidance and manufacturer’s declaration – electromagnetic immunity The Proteus Patch is intended for use in the electromagnetic environment specified below. The customer or the user of the Patch should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment – level guidance Electrostatic +/‐ 6kV contact +/‐ 6kV Floors should be wood, concrete discharge (ESD) IEC +/‐ 8kV air contact or ceramic tile. If floors are 61000‐4‐2 +/‐ 8kV air covered with synthetic material, the relative humidity should be at least 30%. Electrical fast +/‐ 2 kV for power Not applicable ...
- Page 6 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Proteus Patch is used exceeds the applicable RF compliance level above, the Proteus Patch should be observed to verify normal operation. If abnormal ...
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Page 7: European R&Tte Declaration Of Conformity
Recommended separation distances between portable and mobile RF communications equipment and the Proteus Patch The Proteus Patch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Patch can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Proteus Patch as recommended below, ... -
Page 8: 0 - Fcc Interference Statement
EQUIPMENT. The Proteus Patch may be interfered with by other equipment, even if that equipment complies with CISPR emission requirements. 1.10 – FCC Interference Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Proteus Digital Health could void your authority to operate the equipment. 1.11 – FCC Wireless Notice This product emits radio frequency energy, but the radiated output power of this device is far below the FCC radio frequency exposure limits. ... -
Page 9: 3 - Manufacturer Contact Information
3 – MANUFACTURER CONTACT INFORMATION To request technical information or to report unexpected events, please contact the manufacturer at one of these locations. United States United Kingdom Proteus Digital Health UK Ltd Proteus Digital Health, Inc 2600 Bridge Parkway, Suite 101 Floor, 41‐44 Great Queen St. Redwood City, CA 94065 London WC2B 5AD Phone Number: 650‐632‐4031 Fax Number: 650‐632‐4071 ...