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Regulatory Information

Regulatory Information

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Where can I obtain further information?

For further information, see the following additional resources.

U.S. Food and Drug Administration

FDA Consumer Magazine

November-December, 2000

1-888-INFO-FDA

http://www.fda.gov

Under “C” in the subject index, select Cell Phones > Research

American National Standards Institute

1819 L Street, N.W. Suite 600

Washington D.C., 20036

1-202-293-8020

In Canada:

Health Canada

Address Locator 0900C2

Ottawa, Ontario K1A 0K9

Email:

[email protected]

Telephone: 613-957-2991

Toll free: 1-866-225-0709

Fax: 613-941-5366

TTY: 1-800-267-1245

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Содержание 2net Gen 2

Страница 1: ...2net com User Manual Gen 2 ...

Страница 2: ...arks of their respective owners Nothing in these materials is an offer to sell any of the components or devices referenced herein The 2net Hub is manufactured by Venture Corporation Limited for Philips North America and designed to work with 2net services This technical data may be subject to U S and international export re export or transfer export laws Diversion contrary to U S and international...

Страница 3: ...w Wireless Works 11 Using Your 2net Hub 12 Starting Up the Hub 12 Collecting Medical Data from Wireless Devices 14 Alternate Configuration for Wired Devices 18 Troubleshooting Tips 20 2net Regulatory Information 25 Intended Use Statement 25 Wireless Devices 25 Can I minimize my RF exposure 26 Where can I obtain further information 27 Safety Evaluations 28 Federal Communications Commission FCC Info...

Страница 4: ...Innovation Science and Economic Development Canada ISED 30 Transmitter Information 32 List of Transmitters 32 Medical Equipment Standards 33 Disposal of the Hub 36 ii Contents ...

Страница 5: ... for variations that indicate harm or danger to the patient Used for accessing the Internet To reduce the risk of bodily injury electric shock fire and damage to the equipment observe the following precautions Operate the Hub only as intended Do not use the Hub for any other purpose The Hub is for indoor use only and should be kept away from water or chemical contact Do not let the Hub get wet The...

Страница 6: ... Regulatory Information and Transmitter Information sections of this document Portable and mobile RF communications equipment can affect medical electrical equipment CAUTION The Hub should not be used in airplanes or locations where cellular telephones and other electronic devices are prohibited Do not operate the Hub in the following environments In active blasting areas In potentially explosive ...

Страница 7: ...ing and storage atmospheric pressure 70 0 kPa 106 0 kPa Implantable Medical Devices Persons with implantable medical devices should observe the following precautions Always keep the Hub more than 6 inches 15 cm from the implantable medical device when the Hub is plugged into electrical power Unplug the Hub immediately if you have any reason to suspect that interference is taking place Read and fol...

Страница 8: ...nd is designed for use in the home You simply plug the Hub into a standard electrical wall outlet in your home or office The 2net Hub does not contain any medical sensors The Hub collects data from commercially available medical devices including but not limited to Blood pressure monitors Glucose meters Weight scales Pulse oximeters Thermometers The Hub transfers the data wirelessly via either cel...

Страница 9: ...ing data from your Hub to your provider m Sounds When enabled the Hub will play sounds after readings are read and sent Standard electric power wall plug available for U S Canada European and UK markets Product label Serial number Hub for U S market Philips North America 3000 Minuteman Road Andover MA 01810 Hub for European market Hub for U K market Philips North America 3000 Minuteman Road Andove...

Страница 10: ...f your Hub that light up in different colors to give you information Each light has an accompanying symbol l The sending light left light The radio tower symbol shows you the status of the Hub s sending function Table 1 explains what it means when the light for this symbol changes color ...

Страница 11: ...s ready to send data Solid BLUE Your Hub successfully sent your medical device data to the service provider that supplied your Hub Both the sending light and reading light will turn solid BLUE for 5 seconds Flashing ORANGE Your Hub is unable to connect to the network and is not ready to send data i i Wait for up to 5 minutes to see if a signal is found and the light turns solid GREEN If not unplug...

Страница 12: ...No user intervention is needed The Hub will attempt to resend the data at a later time Off no color No power is being supplied to the Hub or the Hub is not plugged in s The reading light right light The home symbol shows you the status of the Hub s reading function Table 2 explains what it means when the light for this symbol changes color ...

Страница 13: ...ovider that supplied your Hub Solid ORANGE up to 90 seconds Your Hub failed to read data from your medical device s i i To resolve take the reading on the medical device s again If the reading light turns solid ORANGE a second time contact the service provider that supplied your Hub Off no color Your Hub is not ready to read data from medical devices i i If this condition persists for more than 5 ...

Страница 14: ...relessly connect to your medical device s Information received Two short tones Your Hub successfully received data from your medical device Success Four short tones Your Hub successfully transmitted your data to the service provider that supplied your Hub Alert Long tone repeated one or more times Your Hub failed to receive valid data from your medical device Your Hub is unable to connect to the l...

Страница 15: ...your wired home phone service Unlike wired services wireless communications travel over the air and can be affected by the environment Rain snow fog falling leaves water mountains canyons and even buildings may affect service All wireless services are subject to dead zones or no coverage areas ...

Страница 16: ...e medical device s with which you want to use it There is no power switch i i To ensure the best performance plug in the Hub in an upright position and leave it plugged in 1 When you plug the Hub into an electrical wall outlet the sending light l flashes GREEN This means your Hub is starting up and searching for a connection to the cellular or WiFi network ...

Страница 17: ...ill resume 2 The sending light l stops flashing and remains solid GREEN when the Hub has successfully connected to the network and coverage is good 3 After startup the reading light s turns solid GREEN When both the reading light and the sending light are solid GREEN your Hub is ready to receive data from your medical devices m m If audio is enabled the Hub Ready sound will play when the Hub is re...

Страница 18: ...rm that both the sending light and reading light on your Hub are solid GREEN Then use the medical device s provided with your Hub to take a reading 1 Your Hub automatically receives data from your medical device s The reading light s flashes GREEN while medical data is being received i i Your medical device might have a transmit button or function that you may need to activate to transmit data Fol...

Страница 19: ...If audio is enabled the Information sound will play when your data has been successfully received 3 After receiving the medical device data the Hub will automatically send the data to the service provider that supplied your Hub 4 The sending light l flashes GREEN when the Hub is sending data over the cellular or WiFi network ...

Страница 20: ...ds your medical data to the service provider that supplied your Hub m m If audio is enabled the Success sound will play when your data has been successfully sent 6 When the Hub has finished sending data both the sending light and reading light turn solid GREEN which means the Hub is again ready to read and send medical data ...

Страница 21: ... then take the reading again If the reading light turns solid ORANGE a second time contact the service provider that supplied your Hub m m If audio is enabled the Alert sound will play when data collection is incomplete or the Hub detects invalid data w w If the sending light l turns solid ORANGE it means the Hub failed to send your data No user intervention is needed The Hub will attempt to resen...

Страница 22: ... that both the sending light and reading light on your Hub are solid GREEN 2 Take a reading on your medical device 3 Connect your medical device to the Hub using the USB cable supplied with your medical device Your Hub should automatically receive data from your medical device If not your medical device might have a transmit button or function that you may need to activate to transmit data Follow ...

Страница 23: ... l flashes GREEN when the Hub is sending data over the cellular or WiFi network Both the sending light and reading light turn solid BLUE for five seconds when the Hub successfully sends your medical data 5 When the Hub has finished sending data both the sending light and reading light turn solid GREEN which means the Hub is again ready to read and send your medical data ...

Страница 24: ...he sending light l is flashing ORANGE it means the cellular or WiFi coverage is inadequate Wait for up to 5 minutes to see if the sending light turns solid GREEN which means the cellular or WiFi signal has been found If the sending light continues flashing ORANGE unplug the Hub and take it to another location in your home or office where the cellular or WiFi signal may be stronger Replug the Hub i...

Страница 25: ...ns the Hub received incomplete or invalid data To resolve wait 5 minutes for the Hub to return to its ready state with the reading light s lit solid GREEN then take the reading again If the reading light turns solid ORANGE a second time contact the service provider that supplied your Hub ...

Страница 26: ... your medical device and your Hub are in the same room 2 Take a new reading The Hub s reading light s will flash GREEN when receiving medical data If your Hub does not respond to the new reading do the following 1 Restart your Hub Unplug the Hub wait 5 seconds then plug it back in 2 Restart your medical device Power it off turn it off unplug it or remove the batteries for 5 seconds and then power ...

Страница 27: ...ll not receiving readings contact the service provider that supplied your Hub Hub Not Ready If the reading light s is OFF your Hub is not ready to receive data from medical devices Do not unplug the Hub at this time Your Hub may be processing an update If this condition persists for more than 5 minutes your Hub will automatically restart No user intervention is needed If you unplug the Hub during ...

Страница 28: ...he Hub is plugged in to an electrical wall outlet and verify that the wall outlet you are using is working correctly If the wall outlet is controlled by a wall switch verify the switch is in the ON position Consider moving the Hub to a different wall outlet No Sounds If the Hub is not playing sounds m contact your service provider to enable this feature ...

Страница 29: ...tions and user error time zone offsets and other conditions outside the control of the 2net Hub or the 2net Platform The 2net Hub is not to be relied upon for transmitting data necessary to inform immediate medical decisions for transmitting continuously 24 7 or similar for the time sensitive monitoring of a patient or for connecting to emergency response systems Wireless Devices The Hub contains ...

Страница 30: ...s also issued the following statement According to the FDA and the World Health Organization WHO among other organizations to date the weight of scientific evidence has not effectively linked exposure to radio frequency energy from mobile devices with any known health problems available at https www fcc gov consumers guides wireless devices and health concerns or through the FCC at 888 225 5322 or...

Страница 31: ...ember December 2000 1 888 INFO FDA http www fda gov Under C in the subject index select Cell Phones Research American National Standards Institute 1819 L Street N W Suite 600 Washington D C 20036 1 202 293 8020 In Canada Health Canada Address Locator 0900C2 Ottawa Ontario K1A 0K9 Email Info hc sc gc ca Telephone 613 957 2991 Toll free 1 866 225 0709 Fax 613 941 5366 TTY 1 800 267 1245 ...

Страница 32: ...Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 11 General requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment Federal Communications Commission FCC Inform...

Страница 33: ...ll be used If you suspect the Hub is causing harmful interference to radio or television reception unplug the Hub from electrical power If the interference stops please take one or more of the following steps before attempting to use the Hub again Increase the distance between the Hub and radio or television receiver Connect the 2net Hub into an outlet on a circuit different from that to which the...

Страница 34: ... respectees This device complies with Part 15 of the FCC Rules and with ISED license exempt RSS standard s 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 Le présent appareil est conforme aux CNR d Innovation Sciences et Développeme...

Страница 35: ...bande 5 150 5 250 MHz sont réservés uniquement pour une utilisation à l intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes de satellites mobiles utilisant les mêmes canaux ii De plus les utilisateurs devraient aussi être avisés que les utilisateurs de radars de haute puissance sont désignés utilisateurs principaux c à d qu ils ont la priorité pour les bandes 5 250 5 350...

Страница 36: ... 1930 1990 23 25 7 max Band 4 1710 1755 2110 2155 23 25 7 max Band 5 824 849 869 894 23 25 7 max Band 12 699 716 729 746 23 25 7 max WCDMA Band 2 1850 1910 1930 1990 23 25 7 max Band 5 824 849 869 894 23 25 7 max 802 11a 5 GHz 5180 5825 17 6 1 dBm 802 11b 2 4 GHz 2400 2484 20 8 1 dBm 802 11g 2 4 GHz 2400 2484 18 8 1 dBm Bluetooth 2 1 EDR 2 4 GHz 2402 2480 11 1 dBm 1 BLE 2 4 GHz 4 avg pwr 0 5 dBm 1...

Страница 37: ...ironment guidance RF emissions CISPR 11 Group 1 The Hub must emit electromagnetic energy in order to perform its intended function as a communication device Nearby electronic equipment may be affected The Hub is not a Group 2 device as RF energy is not used as a form of patient treatment RF emissions CISPR 11 Class B The Hub is suitable for use in domestic establishments and those directly connect...

Страница 38: ...input output lines Main power quality should be that of a typical domestic or commercial environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Main power quality should be that of a typical domestic or commercial environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip ...

Страница 39: ...s m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 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 ...

Страница 40: ... 80 MHz d 3 5 P V 1 80 MHz to 800 MHz 3 5 E1 sqrt P 800 MHz to 6 0 GHz d 7 P E 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 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 out...

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Страница 44: ...24 2 Rev A 2020 Philips North America All rights reserved 2net is a product of Philips North America 2net is a trademark or a registered trademark of Philips North America in the United States Canada the European Union and other countries Other product and brand names may be trademarks or registered trademarks of their respective owners 80 KA624 1Rev D ...

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