Supplemental information
Contents
1. Supplemental Information Page 7 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT The Proteus FitWell Wearable Sensor 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 Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular instal2. 3 yP 23 7 4 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 8 European R amp TTE Declaration of Conformity Hereby Proteus Digital Health Inc declares that the Proteus FitWell Wearable Sensor is in compliance with the essential requirements and other relevant provisions of R amp TTE Radio and Telecommunications Terminal Equipment Directive 1999 5 EC The product is compliant with the following standards and or other normative documents Safety art 3 1a EN 60601 1 3 Ed IEC 60601 1 11 EMC art 3 1b EN 301 489 17 v2 2 1 Spectrum art 3 2 EN 300 328 v1 8 1 Other EN 60601 1 2 2007 The Proteus FitWell Wearable Sensor can be used in countries in the European Union 1 9 CISPR Interference Statement MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this section of the manual User
3. Sensor for more than one week DO NOT drop or bump with excessive force 1 4 Protection against Ingress of Solids and Liquids The Proteus FitWell Wearable Sensor 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 User Supplemental Information Page 2 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor continued safety should the enclosure become penetrated or torn remove the FitWell Wearable Sensor immediately and replace it with a new one 1 5 Avoiding Unsafe Use Conditions The FitWell Wearable Sensor is a Fitness and Wellness device The Proteus FitWell Wearable Sensor has not been tested or approved as safe for operation during air travel DO NOT use the FitWell Wearable Sensor during air travel it may interfere with the aircraft navigational instruments The Proteus FitWell Wearable Sensor has not been tested or approved for use in the presence of strong magnetic or electric fields DO NOT wear the FitWell Wearable Sensor during magnetic resonance imaging MRI cautery and external defibrillation procedures Damage to the FitWell Wearable Sensor your skin or an unexpected magnetic attraction may result Please inform your healthcare professional that the FitWell Wearable Sensor must be removed prior to engaging in one of these procedures WARNING No modification of this equipment is allowed Modifying the Proteus FitWel
4. THE FITWELL WEARABLE SENSOR SPC 0532 SPC 0801 SPC 1006 USER SUPPLEMENTAL INFORMATION Table of Contents te GECHNICALANEO RIVIATHON sits ssestiaite sche sande tearecataraacraebadusaiseataate O 2 EI cane gt Bement oe Eee a a ee 2 E2 Environmental COMINGS eais a e abel asin dediosteecaaates 2 CS MIPIMIZING SKIN ealo a a tains yAiaanheenbmeiuaasacd 2 1 4 Protection against Ingress of Solids and LIQUICS cccccceceeceeeeeeeeeeeeeeeeeeeeeaeeeeeeeenaaees 2 RO Avoiding Unsate USe COnciiONS c2s wet encores wi ieee ea e a els 3 1 6 Information on Electromagnetic and Other Interferences ccccceeececceeeeeeeeeeseeeeeeeeeeees 3 t Mormatlonronihe Radio SUDSYSIEM anaenda E a E 3 1 8 European R amp TTE Declaration of Conformity ccceeeccceceeeeeeeeeeeeeeeeeeeeeeseeeeeeesaeeeeeeeesaaees 7 1 0 CISPR Intenerence Statement aria TE E E EE EE TE E 7 11 0 r CE Interner ence Stemme iE E E N E a T 8 t ECO Wireless INOUCE racord a a E E 8 ede OG GAGS MSY sao R A 8 2 DISPOSAL OF WASTE PRODUC TS sri A di vanneoteianaunnadeumantadavaad Mantes 9 3 MANUFACTURER CONTACT INFORMATION User Supplemental Information Page 1 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor 1 TECHNICAL INFORMATION 1 1 General The Proteus FitWell Wearable Sensor Also known as FitWell Patch is a not for medical use device intended for Fitness and Wellness applications The FitWell Wearable Sensor WS c
5. dios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Proteus FitWell Wearable Sensor is used exceeds the applicable RF compliance level above the Proteus FitWell Wearable Sensor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Proteus FitWell Wearable Sensor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m User Supplemental Information Page 6 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor Recommended separation distances between portable and mobile The Proteus FitWell Wearable Sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the FitWell Wearable Sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Proteus FitWell Wearable Sensor as recommended below according to the maximum output power of the communications equipment Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter Ww d 1 2 yP d 1 2 yP d 2
6. l Wearable Sensor may cause a safety hazard for the user 1 6 Information on Electromagnetic and Other Interferences The Proteus FitWell Wearable Sensor has been evaluated and deemed compliant with the requirements in EN60601 1 2 Class B for Electromagnetic Compatibility EMC Medical Electrical Equipment needs special precautions regarding 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 FitWell Wearable Sensor should not be used adjacent to or stacked with other electromagnetic equipment If adjacent or stacked use with other electromagnetic equipment is necessary verify that the Proteus FitWell Wearable Sensor operation is normal in the configuration s in which it will be used 1 7 Information on the Radio Subsystem The Proteus FitWell Wearable Sensor incorporates a Bluetooth radio subsystem which is compliant with the Bluetooth standard The following information is provided to satisfy the requirements of EN IEC 60601 1 2 The Bluetooth radio transmits and receives on 79 frequency bands which are equally spaced at 1MHz intervals between 2402MHz and 2480MHz The effective receive bandwidth is 1 25MHz The transmit modulation is frequency hopping using GFSK Gaussian Frequency Shift Keying with a bandwidth bit period product BT 0 5 The Modulation index is between 0 28 a
7. lation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help 1 12 FCC Identifier FCC ID X7901750 For SPC 0532 FCC ID X7906120 For SPC 0801 FCC ID X7906550 For SPC 1006 User Supplemental Information Page 8 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor 2 DISPOSAL OF WASTE PRODUCTS Production of this equipment required the extraction and use of natural resources The equipment may contain substances that could be harmful to the environment or human health if improperly handled at the product s end of life In order to avoid release of such substances into the environment and to reduce the use of natural resources all devices both used and unused should not be disposed with household waste Return to a recycling point for electric and electronic devices Z User Supplemental Information Page 9 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor 3 MANUFACTURER CONTACT INFORMATION To request technical information or to report u
8. ll Wearable Sensor should ensure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Proteus FitWell Wearable Sensor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms Not Applicable Not Applicable IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17VP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile ra
9. nd 0 35 The effective radiated power is 15dBm P 0 032mW User Supplemental Information Page 3 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor Guidance and manufacturer s declaration electromagnetic emissions The Proteus FitWell Wearable Sensor is intended for use in the electromagnetic environment specified below The customer or the user of Proteus FitWell Wearable Sensor should ensure that it is used in such an environment Emissions test_ Compliance Electromagnetic environment guidance RF emissions The FitWell WS uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The FitWell WS is suitable for use in all establishments a including domestic establishments and those directly Harmonic Not applicable connected to the public low voltage power supply network emissions that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage Not applicable fluctuations flicker emissions IEC 61000 3 3 User Supplemental Information Page 4 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor Guidance and manufacturer s declaration electromagnetic immunity The Proteus FitWell Wearable Sensor is intended for use in the electromagnetic environment specified below The customer or the user of the FitWell Wearable Sensor should ensure that it is used in
10. nexpected events please contact the manufacturer at one of these locations United States United Kingdom tt Proteus Digital Health Inc Proteus Digital Health UK Ltd 2600 Bridge Parkway Suite 101 6th Floor 41 44 Great Queen St Redwood City CA 94065 USA London WC2B 5AD UK Phone Number 650 632 4031 Fax Number 650 632 4071 proteus User Supplemental Information Page 10 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor
11. ollects a variety of health and behavioral information Note Proteus Digital Health Inc is the manufacturer of both medical and non medical devices Although the FitWell Wearable Sensor device is not intended to be used for any medical purposes or therapy the FitWell Wearable Sensor is built under more stringent quality standards used for Proteus Patch the medical product Hereby this equipment has been tested and found to comply with the limits for a Class B Medical Electrical Equipment 1 2 Environmental Conditions The Proteus FitWell Wearable Sensor is intended for storage and operation in a room temperature environment Od ee Operating 20C 28C 15 93 700 hPa 1060 hPa 15C 30C 15 93 700 hPa 1060 hPa 2C 38C 15 85 700 hPa 1060 hPa 1 3 Minimizing Skin Irritation The Proteus FitWell Wearable Sensor has been designed to minimize the possibility of skin irritation Observing these cautions will reduce the likelihood of skin irritation or bruising under the FitWell Wearable Sensor DO NOT continue use until further instruction by a physician if your skin is irritated or inflamed around the FitWell Wearable Sensor DO NOT place in locations where your skin is scraped cracked inflamed or irritated DO NOT place in a location that overlaps the area of the most recently removed FitWell Wearable Sensor DO NOT use if you are allergic to adhesive tape DO NOT wear the same FitWell Wearable
12. such an environment Immunity test IEC 60601 test level Compliance Electromagnetic level environment guidance Electrostatic 6kV contact 6KV Floors should be wood discharge ESD 8kV air contact concrete or ceramic tile If IEC 61000 4 2 8kV air floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power Not applicable transient burst IEC supply lines 61000 4 4 1 kV for input output lines Surge IEC 61000 4 1 kV line s to Not applicable 5 line s 2 kV line s to earth Voltage dips short lt 5 UT gt 95 dip in UT Not applicable interruptions and for 0 5 cycle voltage variations 40 UT 60 dip in UT on power supply for 5 cycles input lines 70 UT 30 dip in UT IEC 61000 4 1 1 for 25 cycles lt 5 UT gt 95 dip in UT for5s Power frequency Power frequency magnetic 50 60 Hz magnetic fields should be at levels field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level User Supplemental Information Page 5 of 10 LBL 0098 Rev 2 16JUL2014 Fitwell Wearable Sensor Guidance and manufacturer s declaration electromagnetic immunity The Proteus FitWell Wearable Sensor is intended for use in the electromagnetic environment specified below The customer or the user of the Proteus FitWe
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