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, s p i t Getting to know your 2net Hub The 2netTM Hub securely captures medical device data in near-real time and wirelessly transmits it to cloud-based remote care applications that are offered by a range of health care providers or medical device manufacturers. STEP 2 Use a medical device provided with your Hub to take a reading. Take Reading Receiving Reading Reading Received Sending indicator light Indicates when the Hub is sending data from your Hub to your provider m Sounds When enabled, the Hub will play sounds after readings are received and sent Reading indicator light Indicates when the Hub is reading data from your medical device Glucometer Your reading USB port For connecting 2net-approved USB medical devices. Not for charging.

(Use a medical device provided with your Hub) Right light flashing GREEN

(5-30 seconds) Right light solid BLUE STEP 1 Plug in your Hub to begin the startup process. Startup is automatic, but may take up to 5 minutes to complete. STEP 3 i To ensure the best reception, plug in the Hub in an upright position. Your Hub will automatically upload your reading to the provider who supplied your Hub. Plug In Starting Up Hub is Ready Reading Sent Hub is Ready Sending Reading Left light flashing GREEN

(up to 5 minutes) Both lights solid GREEN Left light flashing GREEN Right light solid BLUE

(30-60 seconds) Both lights solid BLUE Both lights solid GREEN

User Manual // Gen 2 2net.com Copyright 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. 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 law is strictly prohibited. 80-KA624-2 Rev. A MAY CONTAIN U.S. AND INTERNATIONAL EXPORT CONTROLLED INFORMATION 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? . 10 How 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) Information . 28 Contents i 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 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. The 2net Hub is not intended to be:

A diagnostic tool Used in hospitals or emergency rooms Used for active patient monitoring nor in any situation in which a patients physiological processes or parameters are monitored 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 Hub is intended for use in households and office areas only. Do not install the device in locations that may expose the product to ignitable or flammable gases or liquids. Plug the Hub in to an electrical wall outlet with the front 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. Safety Information 1 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. Do not operate the Hub with a damaged plug, after the product malfunctions, or is dropped or damaged in any manner. In the event of the need for service or a replacement Hub, please contact the service provider that supplied your Hub. CAUTION: Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information in the 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 environments such as refueling points, fuel depots or chemical plants 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. A double-insulated appliance is marked with the words DOUBLE INSULATION or DOUBLE INSULATED, or with the symbol:

2 Safety Information The Hub has no parts that are serviceable by users. Servicing of this device requires extreme care and knowledge of the system and should only be done by qualified service personnel or by the manufacturer. This equipment has no applied parts. Operating and Storage Ratings:

Operating temperature: 0-35C Storage temperature: -20C - 70C Operating and storage humidity: 95%

Operating 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 follow the directions from the manufacturer of your implantable medical device. If you have any questions about using your Hub with your implantable medical device, consult your healthcare provider. Safety Information 3 Getting to Know Your 2net Hub The 2net Hub securely captures medical device data in near-real time and wirelessly transmits it to cloud-based 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. 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 cellular network or WiFi, to the 2net service platform for delivery to the service provider that supplied your Hub. 4 Getting to Know Your Hub What does each part do?

Sending indicator light Indicates when the Hub is sending data from your Hub to your provider m Sounds When enabled, the Hub will play sounds after readings are read and sent Reading indicator light Indicates when the Hub is reading data from your medical device 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.K. market Philips North America 3000 Minuteman Road Andover, MA 01810 Philips North America 3000 Minuteman Road Andover, MA 01810 Product label Serial number Philips North America 3000 Minuteman Road Andover, MA 01810 Getting to Know Your Hub 5 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 The sending light (left light) The radio tower symbol shows you the status of the Hubs sending function. Table 1 explains what it means when the light for this symbol changes color. 6 Getting to Know Your Hub Table 1. Sending status Sending light color (left light) Sending status Flashing GREEN Solid GREEN Solid BLUE Flashing ORANGE Your Hub is starting up and searching for a connection to the network. ii It can take up to 5 minutes to complete the initial connection. Do not unplug the Hub while the light is flashing GREEN. Your Hub is sending data. Your Hub is connected to the network and is ready to send data. 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. Your Hub is unable to connect to the network and is not ready to send data. ii Wait for up to 5 minutes to see if a signal is found and the light turns solid GREEN. If not, unplug the Hub and move it to a new location with better cellular (or WiFi) coverage. Move all the medical device(s) you want to use with the Hub to the new location.

(table continued on next page) Getting to Know Your Hub 7 Sending light color (left light) Sending status Solid ORANGE Your Hub failed to send your medical device data. ii 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 Hubs reading function. Table 2 explains what it means when the light for this symbol changes color. 8 Getting to Know Your Hub Table 2. Reading status Reading light color (right light) Reading status Solid GREEN Flashing GREEN Solid BLUE Solid ORANGE

(up to 90 seconds) Off

(no color) Your Hub is ready to read data from your medical device(s). Your Hub is communicating with your medical device(s). 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. Your Hub failed to read data from your medical device(s). ii 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. Your Hub is not ready to read data from medical devices. ii If this condition persists for more than 5 minutes, your Hub will automatically restart. No user intervention is needed. If your Hub does not return to the ready state within 30 minutes, contact the service provider that supplied your Hub. Getting to Know Your Hub 9 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 Information received Two short tones Success Four short tones Alert Long tone repeated one or more times After start up, your Hub is ready to wirelessly connect to your medical device(s). Your Hub successfully received data from your medical device. Your Hub successfully transmitted your data to the service provider that supplied your Hub. Your Hub failed to receive valid data from your medical device. Your Hub is unable to connect to the long-

range network. ii Sounds are turned off by default. If you would like your Hub to play sounds, notify the service provider that supplied your Hub. 10 Getting to Know Your Hub How Wireless Works Your Hubs 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. Getting to Know Your Hub 11 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. ii 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. 12 Using Your Hub ii It can take up to 5 minutes to complete the initial connection. 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. When both the reading light and the sending light are solid GREEN, your Hub is ready to receive data from your medical devices. im If audio is enabled, the Hub Ready sound will play when the Hub is ready. Using Your Hub 13 iw If the sending light l is flashing ORANGE, it means coverage is bad. Refer to the Troubleshooting Tips, for help. im If audio is enabled, the Alert sound will play when your 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). The reading light s flashes GREEN while medical data is being received. ii Your medical device might have a transmit button or function that you may need to activate to transmit data. Follow the instructions provided in the user manual for your medical device. 14 Using Your Hub 2. The reading light s turns solid BLUE for five seconds when your data has been successfully received. im 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. Using Your Hub 15 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. im 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. 16 Using Your Hub iw If the reading light s turns solid ORANGE, it 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. im If audio is enabled, the Alert sound will play when data collection is incomplete or the Hub detects invalid data. iw 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 resend the data at a later time. Using Your Hub 17 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. iw The USB port is not for charging USB devices. 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. 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 the instructions provided in the user manual for your medical device. The Hubs reading light s flashes GREEN while medical data is being received. The Hubs reading light s turns solid BLUE when your data has been successfully received. 18 Using Your Hub 4. After receiving the medical device data, the Hub will automatically send the data to the service provider that supplied your Hub. The Hubs 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. 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. Using Your Hub 19 Troubleshooting Tips Long Startup Time It can take up to 5 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. 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 into an electrical wall outlet there. Remember to also move your medical device(s) to the same room as the Hub. 20 Troubleshooting Tips 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. Troubleshooting Tips 21 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). If the reading light s is solid GREEN, your Hub is ready to receive data from medical devices. Then, do the following:

1. Ensure your medical device, and your Hub are in the same room. 2. Take a new reading. The Hubs 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 it back on. Make sure your device has fresh batteries and, if it has a battery indicator, confirm it shows a full battery charge. 3. Wait for your Hub and medical device to be ready. 4. Take another reading with your medical device. If, after completing the steps above, your Hub still does not receive the reading, your medical device might need to pair with the Hub. (Pair/pairing means to establish connectivity between medical devices and the Hub). Your 22 Troubleshooting Tips 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 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 an update, just plug it back in and the update will resume at a later time. If your Hub does not return to the ready state (the reading light is solid GREEN) within 30 minutes, contact the service provider that supplied your Hub. Troubleshooting Tips 23 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. 24 Troubleshooting Tips 2net Regulatory Information Intended Use Statement The 2net Hub is used in the 2net 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 2net Platform. The 2net Hub performs these functions without controlling or altering the function or parameters of any connected medical devices. The transfer of data from the 2net Hub is subject to time delays and potential data loss due to conditions in which the 2net Hub and the 2net Platform are operating, including: network or power disruptions, connectivity interruptions, medical and mobile device limitations 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 radio transmitters and uses non-ionizing radio frequencies (RF). The Hub operates within the exposure limits for an uncontrolled environment as set by the U.S. Federal Communications Commission (FCC) and Innovation and Science and Economic Development Canada (ISED). The 2net Hub should be installed and operated with a minimum distance of 8 inches (20 cm) between the radiator (Hub) and any person. Scientific research on wireless devices and RF energy has been conducted worldwide for many years, and continues. In the United States, the Food and Drug Administration (FDA) and the FCC set standards and regulations pertaining to wireless devices. The Regulatory Information 25 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. You can access the FDA website at http://www.fda.gov (Under C in the subject index, select Cell Phones > Health Issues). You can also contact the FDA toll free at

(888) 463-6332 or (888) INFO-FDA. The FCC has 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

(888) CALL-FCC. Can I minimize my RF exposure?

If you are concerned about RF, there are several simple steps you can take to minimize your RF exposure. You can: minimize usage of the device near the body by placing more distance between your body and the source of the RF. Exposure levels drop off dramatically with distance. Wireless devices marketed in the United States are required to meet safety requirements regardless of whether they are used in close contact with the head or against the body. 26 Regulatory Information 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.ca Telephone: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-267-1245 Regulatory Information 27 Safety Evaluations The Hub has been tested by Underwriters Laboratories

(UL Classified) for safety in accordance with the following safety standards:

USA EU and CB Scheme ANSI/AAMI ES60601-1 Medical Electrical Equipment Part 1:

General requirements for basic safety and essential performance 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 Standard: Usability IEC 60601-1-8 General requirements for basic safety and essential performance 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) Information Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. The Hub 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. 28 Regulatory Information 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. The Hub should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, then the Hub should be observed to verify normal operation in the configuration in which it will 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 TV or radio is connected. Consult the dealer where you bought your radio/TV or an experienced radio/TV technician. If the Hub is being interfered with, try to correct the interference by taking one or more of the following actions:

Make sure that the Hub is no closer than 10 ft (3 m) from a Wi-Fi access point, microwave oven or 2.4 GHz cordless phone. Increase the distance between the Hub and all other electronic equipment by moving the Hub to a different electrical wall outlet. Contact your service provider that provided you with your Hub. Regulatory Information 29 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 tre install et utilis 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. Cet appareil numerique de la classe B est conforme a la norme NMB-003 du Canada. Le terme IC avant le numero dhomologation ne signifie seulement queles normes dInnovation, Sciences et Dveloppement conomique Canada ont ete 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 prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

1. lappareil ne doit pas produire de brouillage, et 2. lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le onctionnement. Caution:

(i) Devices operating in the 5150-5250 MHz band are only for indoor use in order to reduce the risk of harmful interference to mobile satellite systems operating on the same channels. 30 Regulatory Information

(ii) Users should also be advised that high-power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to Wireless LAN devices. Avertissement:

(i) les dispositifs fonctionnant dans la bande 5 150-5 250 MHz sont rservs uniquement pour une utilisation lintrieur afin de rduire les risques de brouillage prjudiciable aux systmes de satellites mobiles utilisant les mmes canaux;

(ii) De plus, les utilisateurs devraient aussi tre aviss que les utilisateurs de radars de haute puissance sont dsigns utilisateurs principaux (c.--d., quils ont la priorit) pour les bandes 5 250-5 350 MHz et 5 650-5 850 MHz et que ces radars pourraient causer du brouillage et/ou des dommages aux dispositifs LAN-EL. Regulatory Information 31 Transmitter Information List of Transmitters Table 4. List of transmitters Technology LTE WCDMA 802.11a 802.11b 802.11g BLE Bluetooth 2.1+EDR Frequency Band Band 2 Band 4 Band 5 Band 12 Band 2 Band 5 5 GHz 2.4 GHz 2.4 GHz 2.4 GHz 2.4 GHz 1 EDR power as measured in the GFSK header. Transmit Frequency Range

(MHz) Receive Frequency Range

(MHz) 1850-1910 1930-1990 1710-1755 2110-2155 824-849 699-716 869-894 729-746 1850-1910 1930-1990 824-849 869-894 5180-5825 2400-2484 2400-2484 2402-2480 Typical Radiated Transmit Power (dBm) 23 (25.7 max.) 23 (25.7 max.) 23 (25.7 max.) 23 (25.7 max.) 23 (25.7 max.) 23 (25.7 max.) 17.6 (1 dBm) 20.8 (1 dBm) 18.8 (1 dBm) 11 (1 dBm)1 4 (avg. pwr., 0.5 dBm) 32 Regulatory Information Medical Equipment Standards Table 5. IEC 60601-1-2 Performance Criteria Electromagnetic Emissions Guidance and manufacturers 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. Emissions test Compliance Electromagnetic environment 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. The Hub is suitable for use in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions, CISPR 11 Harmonic emissions, IEC 61000-3-2 Voltage fluctuations/

flicker emissions/

IEC 61000-3-3 Class B Class A Complies Regulatory Information 33 Table 6. IEC 60601-1-2 Electromagnetic Immunity Performance Criteria Guidance and manufacturers 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. Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Main power quality should be that of a typical domestic or commercial environment. Main power quality should be that of a typical domestic or commercial environment. Main power quality should be that of a typical domestic or commercial environment. Immunity Test IEC 60601 Test Level Compliance Level Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient/burst, IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines 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

<5 % UT

(>95 % dip in UT) for 0,5 cycle 40 % UT

(60 % dip in UT) for 5 cycles 70 % UT

(30 % dip in UT for 25 cycles

<5 % UT

(>95 % dip in UT) for 5 s

<5 % UT

(>95 % dip in UT) for 0,5 cycle 40 % UT

(60 % dip in UT) for 5 cycles 70 % UT

(30 % dip in UT for 25 cycles

<5 % UT

(>95 % dip in UT) for 5 s Power frequency

(50/60 Hz) magnetic field, IEC 61000-4-8 3 A/m 3 A/m The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low. NOTE: UT is the a.c. main voltage prior to application of the test level. 34 Regulatory Information Table 7. IEC 60601-1-2 Electromagnetic Immunity Performance Criteria Part 2 Guidance and manufacturers 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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 V Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the Hub, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 6.0 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (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 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 radios, amateur radio, AM and FM radio broadcast and TV 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 Hub is used exceeds the applicable RF compliance level above, the Hub should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the Hub. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. Regulatory Information 35 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. The customer or the user of the Hub can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Hub as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 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 0.1 1 10 100 0.12 0.37 1.17 3.69 11.67 0.12 0.37 1.17 3.69 11.67 0.23 0.74 2.33 7.38 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 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. Disposal of the Hub Dispose of the Hub according to applicable local regulations. For information about correct disposal, please contact your local authority, government agency or electronics recycling center. 36 36 Regulatory Information This page intentionally left blank 37 This page intentionally left blank 38 This page intentionally left blank 39 Philips North America 3000 Minuteman Road Andover, MA 01810 Manufactured by Venture Corporation Limited for Philips North America Designed by 2net 80-KA624-1Rev.D 80-KA624-2 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.

CONFIDENTIAL AND PROPRIETARY - PHILIPS NORTH AMERICA COPYRIGHT (C) 2020 PHILIPS NORTH AMERICA ALL RIGHTS RESERVED. NOT TO BE USED, COPIED, REPRODUCED, OR MODIFIED IN WHOLE OR IN PART, NOR ITS CONTENTS REVEALED IN ANY MANNER TO OTHERS WITHOUT THE EXPRESS WRITTEN PERMISSION OF PHILIPS NORTH AMERICA. 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 LAW IS STRICTLY PROHIBITED. 2NET IS A REGISTERED TRADEMARK OF PHILIPS NORTH AMERICA REGISTERED IN THE UNITED STATES AND OTHER COUNTRIES. OTHER PRODUCT AND BRAND NAMES MAY BE TRADEMARKS OR REGISTERED TRADEMARKS OF THEIR RESPECTIVE OWNERS. m m 0 0

. 2 3 MODEL: QCL-HUB-2.0-US 65-KAXXX-PXX barcode XXXXXXXXXXXXXXXX YYYYMMDD barcode barcode Manufactured by Philips North America Andover, MA USA Made in Malaysia 75.00mm 100%

SCALE DWG NO. AW15-KA663-P2 SH 1 REV A REVISIONS REV DESCRIPTION A INITIAL RELEASE DATE

APPROVED

Kit MCN (Material Control Number). Variable field defined by kit MCN ordered HubID. 8 digit CUST ID+8 digit unique serial number. Reference 80-KA092-1 for CUST ID Date of manufacture in YYYYMMDD format 3mm High Code 128 Barcode, 3PL DO NOT PRINT OUTLINE or barcode Manufactured by Philips North America Andover, MA USA Made in Malaysia MODEL: QCL-HUB-2.0-US 65-KAXXX-PXX barcode XXXXXXXXXXXXXXXX YYYYMMDD barcode barcode 200%

SCALE 6. COLOR: TEXT, BLACK. 5. COLOR: BACKGROUND, WHITE LABEL STOCK. 4. WORKMANSHIP SHALL BE IN ACCORDANCE BEST COMMERCIAL PRACTICES. 3. INTERPRET DIMENSIONS AND TOLERANCES PER ASME Y14.5-2009. 2. ALL DIMENSIONS SHOWN ON THIS DRAWING ARE IN MILLIMETERS. 1. INTERPRET DRAWING PER ASME Y14.100. NOTES UNLESS OTHERWISE SPECIFIED.

-P2 PHILIPS NORTH AMERICA 3000 MINUTEMAN ROAD, ANDOVER, MA 01810, U.S.A. TITLE ARTWORK, MEDIA, LABEL, PACKAGING, US, 2NET2 CAGE CODE DRAWING NO SIZE B 1DN14 AW15-KA663-P2 SCALE 1:1 Adobe Illustrator CC REV A SHEET 1 OF 1

2net2 LTE Hub Label Document QCL-AGILE-DOC-0965 (80-KA915-105) Rev. B May 5, 2020 Confidential and Proprietary Philips North America Not to be distributed to anyone who is not an employee of either Philips North America. or its affiliated companies without the express approval of Philips North America or its affiliated companies. Not to be used, copied, reproduced, or modified in whole or in part, nor its contents revealed in any manner to others without the express written permission of Philips North America. Revision history Revision Date Description August 2017 Initial release May 2020 Updated for new FCC ID Submission A B QCL-AGILE-DOC-0965 (80-KA915-105) Rev. B Confidential and Proprietary Philips North America Page 2 of 5 Contents 1 2net2 LTE Hub Labels ................................................................................................ 4 2 2net2 LTE FCC/IC Label Placement .......................................................................... 5 Figures Figure 1: 2net2 LTE Hub label shown at 100% ..........................................................................4 Figure 2: 2net2 LTE Hub label shown at 200% ..........................................................................4 Figure 3: 2net2 LTE Hub FCC/IC label placement .....................................................................5 QCL-AGILE-DOC-0965 (80-KA915-105) Rev. B Confidential and Proprietary Philips North America Page 3 of 5 2net2 LTE Hub Label Document 2net2 LTE Hub Labels 1 2net2 LTE Hub Labels

(56.00)mm m m

) 5 2

. 9 3

MODEL: QCL-HUB-2.0-US WLAN MAC 1: XXXXXXXXXXX XXXXXXXXXXX BT MAC:

XXXXXXXXXXXXXXX IMEI:

FCC ID: 2ATC9 - PHC2NET IC: 25528 - PHC2NET INPUT:100-240V~, 50/60Hz, 0.5A MEDICAL EQUIPMENT ANSI/AAMI ES60601-1 E473134 Philips North America 3000 Minuteman Road Andover, M A 01810 YYYYMMDD COO: XX S/N QUALC001T XXXXXXXXX Figure 1: 2net2 LTE Hub label shown at 100%

MODEL: QCL-HUB-2.0-US WLAN MAC 1: XXXXXXXXXXX BT MAC:

XXXXXXXXXXX IMEI:

XXXXXXXXXXXXXXX FCC ID: 2ATC9 - PHC2NET IC: 25528 - PHC2NET INPUT:10 0-240V~, 50/60Hz, 0.5A MEDICAL EQUIPMENT ANSI/AAMI ES60601-1 E473134 Philips North America 3000 Minuteman Road Andover, MA 01810 YYYYM M DD COO: XX S/N QUALC001T XXXXXXXXX Figure 2: 2net2 LTE Hub label shown at 200%

QCL-AGILE-DOC-0965 (80-KA915-105) Rev. B Confidential and Proprietary Philips North America Page 4 of 5 2net2 LTE Hub Label Document 2net2 LTE FCC/IC Label Placement 2 2net2 LTE FCC/IC Label Placement Figure 3: 2net2 LTE Hub FCC/IC label placement QCL-AGILE-DOC-0965 (80-KA915-105) Rev. B Confidential and Proprietary Philips North America Page 5 of 5

PHILIPS Date: 5/7/2020 UL Verification Services Inc. 47173 Benicia Street Fremont, CA 94538, USA To whom it may concem:

I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own.

|, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:

a) b) c) qd) 8) h) fulfill the requirements for the scope of certification requested, including implementing any appropriate changes requested by UL Verification Services Telecommunications Certification Body (TCB) and / or the FCC;

supply any and all information needed for the evaluation of the products for which certification is sought;

make claims regarding certification only in respect of the scope for which certification has been granted;

not use our product certification in such a manner as to bring the TCB or FCC into disrepute and to not make any statement regarding product certification which the TCB or FCC may consider misleading or unauthorized;

discontinue use of all advertising matter that contains any reference thereto and complies with any and all actions required by the FCC upon suspension or cancellation of certification;

use certification only to indicate that products are certified in conformity with specified standards;

endeavor to ensure that no certificate or report or any part thereof is used in a misleading manner, and any copies of the grants/certificates shall be reproduced in their entirety;

comply with the requirements of the TCB and FCC, including the use of marks and label information prescribed for the scope of certification, when making reference to product certification in communication media such as documents, brochure or advertisements;

Philips North America LLC Philips Healthcare, 3000 Minuteman Road, Andover, MA 01810, United States Phone: (888)744-5477 Fax: +1 978 659 7561 PHILIPS pate: 7/7 bole Page: 2 i) comply with the requirements for certification, supply any information needed for evaluation of products to be certified and, where applicable, make provision for the participation of observers;

j) ensure that products marketed under the scope of the requested certification continue to comply with the certification requirements;

k) provide a sample of a production unit for testing within 30 days of the request should this product be selected as part of either the TCBs or the FCCs market surveillance requirements;

1) keep a record of all complaints relating to products compliance with requirements of relevant standard; make records available to UL or FCC when requested; take appropriate action with respect to such complaints and any deficiencies found in the product that affect compliance with requirements for certification; document the actions taken with respect to complaints and/or deficiencies;

m) inform the TCB immediately of any changes that may affect its ability to comply with the certification requirements. This authorization is valid until 7 May 2021 Sincerely Yours, Mark Nolin Philips North America LLC 3000 Minuteman Rd Andover MA 01810

PHILIPS May 6, 2020 Subject : Request to change in Identification. Dear Regulatory Authority, This Change of Identification request applies for a new FCC ID: as established in 47CFR 2.933(b) for a currently approved device. This application by Philips North America LLC will establish a new FCC ID:

2ATC9-PHC2NET under Philips North America LLC grantee code for purpose of marketing. The original grant to Qualcomm Technologies Inc. will remain in effect. Per 2.933(b) 1. The original identification is FCC ID: J9C2NET2LTE 2. The original grant date was 9/26/2017 and we want to include the C2PC to add LTE channel bandwidths greater than 5 MHz that was granted on 3/21/2019 3. The equipment is electrically identical. Only the model name, trade name, and FCC ID number are different. 4. The original test results are applicable and representative of this changed device. 5. Exterior photographs are included in this application. The following files are electronically submitted as attachments:

Cover Letter External Photos FCC ID iabei format and location Sincerely, Mark Nolin Philips North America LLC 3000 Minuteman Rd Andover MA 01810 Philips North America LLC Philips Healthcare, 3000 Minuteman Road, Andover, MA 01810, United States Phone: (888)744-5477 Fax: +1 978 659 7561

Qualcomm Technologies, Inc. 5775 Morehouse Drive, San Diego, CA 92121 www.qualcomm.com May 8, 2020 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Change of Identification Authorization, FCC ID: J9C2NET2LTE To Whom It May Concern:

This letter grants authorization for representatives of Philips North America LLC to apply to the FCC for a change in identification as specified under 47CFR2.933 of the FCC rules. This authorization applies to the Qualcomm Technologies Inc, Model QCL-HUB-2.0-US, FCC ID: J9C2NET2LTE, original grant issued on 9/26/2017 and a C2PC to add LTE channel bandwidths greater than 5 MHz granted on 3/21/2019. We are aware that Philips Health Systems intends to market the above referenced product under their own FCC ID: 2ATC9 - PHC2NET. Sincerely, Paul Guckian Qualcomm Technologies, Inc. 5775 Morehouse Drive, San Diego, CA 92121