DRAFT v12 User Manual Gen 2 qualcommlife.
DRAFT v12 Copyright © 2017 Qualcomm Life, Inc. All rights reserved. 2net is a product of Qualcomm Life, Inc. Qualcomm and 2net are trademarks of Qualcomm Incorporated, registered in the United States and other countries. Other product and brand names may be trademarks or registered trademarks of their respective owners. Nothing in these materials is an offer to sell any of the components or devices referenced herein.
Table of Contents Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Save These Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Implantable Medical Devices. . . . . . . . . . . . . . . . . . . . . . 3 Getting to Know Your 2net Hub. . . . . . . . . . . . . . . . . . . . 4 What does each part do?. . . . . . . . . . . . . . . . . . . . . . . . . 5 What do the lights mean?. . . . . . . . . . . . . . . . . . . . . . . . . 6 What do the sounds mean?. . . . .
Innovation, Science and Economic Development Canada (ISED). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Transmitter Information. . . . . . . . . . . . . . . . . . . . . . . . . . . 31 List of Transmitters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Medical Equipment Standards. . . . . . . . . . . . . . . . . . 32 Disposal of the Hub. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Safety Information Save These Instructions Read all instructions in this document before using the 2net Hub. To assure the correct and safe use of the product, retain and follow all product safety measures and operating instructions listed in this user manual. Observe all warnings in the operating instructions on the product.
label upright. Do not plug in the Hub in other orientations (e.g., upside-down, sideways, etc.). • Do not expose the Hub to extreme temperatures. • Plug the Hub only into a power source in accordance with the input voltage ratings marked on the back of the Hub. • Unplug the product from the wall outlet before cleaning. Do not use liquid cleaners or aerosol cleaners. Use a damp cloth for cleaning, but NEVER use water to clean the Hub.
▫▫ Near life-support equipment that might be susceptible to radio interference • The Hub is provided with double insulation and therefore does not require a Protective Earth (PE) ground pin for safe use. In a double insulated appliance, two levels of insulation are provided instead of grounding as a means of protecting the user from risk of electric shock.
Getting to Know Your 2net Hub Qualcomm Life’s 2net Hub securely captures medical device data in near-real time and wirelessly transmits it to cloudbased remote care applications that are offered by a range of health care providers or medical device manufacturers. The 2net Hub is easy-to-use and 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.
What does each part do? Sending indicator light Indicates when the Hub is sending data from your Hub to your provider Reading indicator light Indicates when the Hub is reading data from your medical device m Sounds When enabled, the Hub will play sounds after readings are read and sent USB port For connecting 2net-approved USB medical devices. Not for charging. Standard electric power wall plug (available for U.S./Canada, European, and UK markets) Hub for U.S. market Hub for European market Hub for U.
What do the lights mean? There are two lights on the front of your Hub that light up in different colors to give you information. Each light has an accompanying symbol. l 6 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.
Table 1. Sending status Sending light color (left light) Flashing GREEN Sending status • Your Hub is starting up and searching for a connection to the network. It can take up to 10 minutes to ii complete the initial connection. Do not unplug the Hub while the light is flashing GREEN. • Your Hub is sending data. Solid GREEN Your Hub is connected to the network and is ready to send data. Solid BLUE Your Hub successfully sent your medical device data to the service provider that supplied your Hub.
Sending light color (left light) Solid ORANGE Sending status Your Hub failed to send your medical device data. No user intervention is needed. ii The Hub will attempt to resend the data at a later time. Off (no color) s 8 No power is being supplied to the Hub, or the Hub is not plugged in. 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.
Table 2. Reading status Reading light color (right light) Reading status Solid GREEN Your Hub is ready to read data from your medical device(s). Flashing GREEN Your Hub is reading data from your medical device(s). Solid BLUE Your Hub successfully read data from your medical device(s). Will stay solid BLUE until your Hub has successfully sent your data to the service provider that supplied your Hub. Solid ORANGE (up to 90 seconds) Your Hub failed to read data from your medical device(s).
What do the sounds mean? When sounds are enabled, the Hub plays short sounds/ melodies to indicate specific events or conditions have occurred. Table 3 explains what it means when the Hub plays sounds. Table 3. Sounds on the Hub Title Melody Events/Conditions Hub ready Six tone melody After start up, your Hub is ready to wirelessly connect to your medical device(s). Information received Two short tones Your Hub successfully received data from your medical device.
How Wireless Works Your Hub’s wireless service is different from 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.
Using Your 2net Hub Starting Up the Hub To start using your Hub, first, plug it into a standard electrical wall outlet in the same room as the medical device(s) with which you want to use it. There is no power switch. To ensure the best performance, ii 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.
can take up to 10 minutes to complete the initial iiItconnection. Do not unplug the Hub while the light is flashing GREEN. If you do unplug the Hub, just plug it back in and start up will 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.
If the sending light l is flashing ORANGE, ww it means coverage is bad. Refer to the Troubleshooting Tips, for help. audio is enabled, the Alert sound will play when mmIfyour Hub fails to connect. Collecting Medical Data from Wireless Devices First, confirm 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).
2. The reading light s turns solid BLUE for five seconds when your data has been successfully received. audio is enabled, the Information sound will play mmIfwhen 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.
5. Both the sending light and reading light turn solid BLUE for five seconds when the Hub successfully sends your medical data to the service provider that supplied your Hub. audio is enabled, the Success sound will play mmIfwhen 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.
If the reading light s turns solid ORANGE, it ww means the Hub received incomplete or invalid data. To resolve, wait 90 seconds 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. audio is enabled, the Alert sound will play when mmIfdata collection is incomplete or the Hub detects invalid data.
Alternate Configuration for Wired Devices Most devices will connect wirelessly. The following directions apply only if your device is not wireless and was provided with a USB cable. There is a USB port (type A) on the bottom side of the 2net Hub to connect 2net-approved USB-capable medical devices to the Hub. The USB port is not for charging USB devices. ww To collect data from a USB-capable medical device: 1. Confirm that both the sending light and reading light on your Hub are solid GREEN. 2.
4. After receiving the medical device data, the Hub will automatically send the data to the service provider that supplied your Hub. ▫▫ The Hub’s sending light 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.
Troubleshooting Tips Long Startup Time It can take up to 10 minutes to complete the initial start up and configuration. Do not unplug the Hub while the sending light l is flashing GREEN. If you do unplug the Hub, just plug it back in and start up will resume. Insufficient Coverage If the 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.
Reading Error If the reading light s turns solid ORANGE, it means 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.
Hub Not Receiving Readings Confirm that your medical device is powered on. If the medical device will not power on, or no display appears on the unit, you may need to replace the batteries or connect the device to power. Once your medical device is powered on, verify the 2net Hub is plugged in, has power and both the sending light and reading light are solid GREEN. If the reading light s is OFF, your Hub is not ready to receive data from medical devices. (See troubleshooting for Hub Not Ready below).
medical device might have its own “pairing” button or function. You may need to press that button or activate that function for the device to work with the Hub. Refer to your medical device user manual for “pairing” instructions. Follow the instructions provided by the manufacturer of your medical device to “pair” your medical device to the Hub. If, after following the pairing instructions, your Hub is still not receiving readings, contact the service provider that supplied your Hub.
Hub Off / No Power When both the reading and sending lights are OFF, this means no power is being supplied to the Hub. Confirm that the 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.
2net Regulatory Information Intended Use Statement The 2net Hub is used in the Qualcomm Life Platform to capture and transmit medical device data. The 2net Hub is intended to receive, convert (from one format to another), store and transfer data from a connected medical device and to act as a medical device data system (MDDS). The 2net Hub transfers the data wirelessly, via either WiFi or cellular network, to the Qualcomm Life Platform.
FDA issued a statement on health issues related to usage of cell phones: “The scientific community at large believes that the weight of the scientific evidence does not show an association between exposure to RF from cell phones and adverse health outcomes.” Still, the scientific community does recommend conducting additional research to address gaps in knowledge. That research is being conducted around the world and the FDA continues to monitor developments in this field.
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: Info@hc-sc.gc.
Safety Evaluations The Hub has been tested by Underwriters Laboratories (UL Classified) for safety in accordance with the following safety standards: USA • ANSI/AAMI ES60601-1 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance EU and CB Scheme • IEC 60601-1 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance • IEC 60601-1-6 General requirements for basic safety and essential performance – Collateral Standa
The Hub has been tested to the limits for a Class B digital device, according to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. The Hub generates and radiates radio frequency energy and if not installed and used according to instructions, may cause harmful interference to radio communications or be interfered with. There is no guarantee that interference will not occur in a particular installation.
Innovation, Science and Economic Development Canada (ISED) The Hub should be installed and operated with a minimum distance of 8 inches (20 cm) between the radiator (Hub) and your body. Le Hub doit être installé et utilisé avec une distance minimale de 8 po (20 cm) entre le radiateur (Hub) et votre corps. This Class B digital apparatus complies with Canadian ICES-003. The term IC before the equipment certification number only signifies that the ISED technical specifications were met.
Transmitter Information List of Transmitters Table 4. List of transmitters Technology Band Transmit Frequency Range (MHz) LTE Band 2 1850-1910 1930-1990 23 (25.7 max.) Band 4 1710-1755 2110-2155 23 (25.7 max.) Frequency WCDMA Receive Frequency Range (MHz) Typical Radiated Transmit Power (dBm) Band 5 824-849 869-894 23 (25.7 max.) Band 12 699-716 729-746 23 (25.7 max.) Band 2 1850-1910 1930-1990 23 (25.7 max.) Band 5 824-849 869-894 23 (25.7 max.) 802.
Medical Equipment Standards Table 5. IEC 60601-1-2 Performance Criteria – Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Hub is intended for use in the electromagnetic environment specified below. The customer or the user of the Hub should ensure that it is used in such an environment.
Table 6. IEC 60601-1-2 Electromagnetic Immunity Performance Criteria Guidance and manufacturer’s declaration – electromagnetic immunity The Hub is intended for use in the electromagnetic environment specified below. The customer or the user of the Hub should ensure that it is used in such an environment.
Table 7. IEC 60601-1-2 Electromagnetic Immunity Performance Criteria – Part 2 Guidance and manufacturer’s declaration – electromagnetic immunity The Hub is intended for use in the electromagnetic environment specified below. The customer or the user of the Hub should ensure that it is used in such an environment.
Table 8. IEC 60601-1-2 Recommended Separation Distance Between RF Communication Equipment and the Hub Recommended separation distances between portable and mobile RF communications equipment and the Hub The Hub is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
DRAFT v12 Qualcomm Life, Inc. 5775 Morehouse Drive San Diego, CA 92121 Manufactured and distributed by Venture Corporation. Design by Qualcomm Life, Inc. 80-KA624-1 Rev. A 80-KA624-1Rev.A © 2017 Qualcomm Life, Inc. All rights reserved. 2net is a product of Qualcomm Life, Inc. Qualcomm and 2net are trademarks of Qualcomm Incorporated, registered in the United States and other countries. Other product and brand names may be trademarks or registered trademarks of their respective owners.
