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1 2 | Manual 1 | Users Manual | 3.98 MiB | / December 12 2017 |
Philips Lifeline Medical Alert Service Includes: GoSafe Mobile System and HomeSafe System Instructions for use Contents Philips Lifeline Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Welcome to Philips Lifeline Setting up your Lifeline Service Responders and People to Notify Calling for help inside your home Signal Range Battery information Equipment service Contact Philips Lifeline or your representative HomeSafe System and GoSafe Mobile System Communicators General Information . . . . . . . . . . . . . . . .13 Safety information regarding the Home Communicator Cleaning Backup battery Landline Communicator (7000L) . . . . . . . . . . . . . . . . . . . . .16 Description Safety information Wireless Communicator (7000C) . . . . . . . . . . . . . . . . . . . . .19 Description Safety information HomeSafe System and GoSafe Mobile System Help Buttons General Information . . . . . . . . . . . . . . . . . .22 Compatible Home Communicators Setting up a replacement Help Button Cleaning 2 HomeSafe Personal Help Buttons
(7000PHB or 7000PHW) . . . . . . . . . . . . . . . . . . . . . . . . . . . Using the wristband Adjusting the neck cord Battery Recommended usage
.26 HomeSafe AutoAlert Button (7000AHB) Battery Recommended usage
. . . . . . . . . . . . . .29
.33 GoSafe Mobile Button
(7000MHB/7100MHB) . . . . . . . . . . . . . . . . . . . Charging the battery Sleep mode Recommended usage Safety and Regulatory Compliance . . . . . . . . . . . . . . . . . . . .41 IEC regulations System classification Radio specifications FCC Notice to Users Compliance Intended Use Compatibility Risks and Benefits Training Safety Maintenance Communicator Alarms GoSafe Mobile Help Button Alarms Alarm Descriptions / Summary Tables Technical Specifications 3 Philips Lifeline Service Welcome to Philips Lifeline Thank you for choosing the Philips Lifeline Medical Alert Service. Please refer to the Quick Setup Guide provided for instructions on setting up your equipment. These Instructions for Use will provide you with information about your equipment and the Lifeline Medical Alert Service. Please read the manual and Quick Setup Guide carefully, and note the Warnings and Cautions. If you have questions, call Lifeline at any time. Please save this manual in case you need to refer to it later. Please pay special attention to all the instructions provided in the Warning and Caution sections. A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury, and/or cause environmental pollution. These Instructions for Use and the Quick Setup Guide describe the most extensive configuration of the product, with the maximum number of options and accessories. Not every function described may be available on your product. 4 This manual covers the following:
Landline Communicator (7000L) A Communicator that connects to Lifeline using your homes existing landline telephone service. Landline telephone service is required. Wireless Communicator (7000C) A Communicator that connects to Lifeline using the AT&T wireless network; no phone line is required. Wireless service is provided as part of your Lifeline Service; no additional wireless equipment is needed. 5 HomeSafe Personal Help Button
(7000PHB and 7000PHW) HomeSafe AutoAlert Button
(7000AHB) GoSafe Mobile Button
(7000MHB/
7100MHB) Hello, Mrs. Smith. Do you need help?
Help call in progress. Please wait. Works within the range of your Help call in progress. Communicator Please wait. Works outside* your home Can be worn around neck as a pendant Can be worn on a wristband Can detect falls** in your home Can detect falls**
outside* your home Has a built-in speaker and microphone
* When access to the AT&T wireless network is available.
** The HomeSafe AutoAlert Button and GoSafe Mobile Button provide an extra layer of protection Hello, Mrs. Smith. Welcome to Philips Lifeline. Hello, Mrs. Smith. Welcome to Philips Lifeline. Help call in progress. Please wait. by placing a Help Call if a fall is detected and you cant push the Button. Not all falls can be detected. If you need help, press your Help Button. 6 Setting up your Lifeline Service Before you can use your system, your Communicator must be properly set up, and the coverage range of your Help Button must be determined. Please see the Quick Setup Guide for instructions on how to set up your system and test the coverage range of your Help Button. If you have any questions, please contact Philips Lifeline or your representative. Responders and People to Notify What is a Responder?
As a Lifeline subscriber, you should have designated people who have agreed to be Responders. These are people whom Lifeline should call in an emergency, when appropriate. Examples include: neighbors, friends, relatives, your current nursing aide, etc. Choosing a Responder It is best to choose a Responder who:
Has a key to your home or knows where one is located (perhaps in a key lockbox) Could come to help you at different times of the day or night Lives or works within 10 minutes of where you live Has a phone, preferably a cell phone Ideally has a drivers license and access to a vehicle If you are using the GoSafe System, choose a Responder who can also:
Drive to your location, whether you are at home or away from home, and provide help if needed 7 Information Lifeline needs about Responders Please ensure that Lifeline has the following information about each person acting as a Responder:
Name Phone numbers home, work and cell phone Whether or not the Responder has a key to your home Its very important that you keep your Responders and their contact information up to date. Remember to contact Lifeline if one of your Responders is no longer able to assist you or if they get a new telephone number. Please contact Lifeline for any questions about selecting or being a Responder. Who are People to Notify?
If you call for help, Lifeline will contact the People to Notify to let them know that you received assistance. People to Notify will not be contacted to help you, unless they are also on your list of Responders. Calling for help inside your home 1. Press the Help Button that you wear or the gray Help button on the top of your Home Communicator. You can press either button, but you do not need to press both. The Home Communicator will beep and dial the Lifeline Response Center. Note: The Response Center is available 24 hours a day, 365 days a year. A trained Personal Response Associate is always available to assist you. 8 Help call in progress. Please wait. Hello, Mrs. Smith. Do you need help?
2. The Home Communicator calls the Response Center. When it dials the Response Center, the Home Communicator will repeatedly say:
Your Help Call is in progress; please wait. Once it connects with the Response Center, it will say: Your call has been connected; Lifeline will be right with you. 3. The Response Center will answer the call. A Response Associate will speak to you through the Home Communicators built-in speaker and hear you through the Home Communicators highly sensitive microphone. He/she will ask if you need help. If you do not need help, just tell the Response Associate that help is not needed. Note: If you cannot speak or be heard, the Response Associate will try calling you back. If you cannot answer or if the Response Associate cannot hear you, Lifeline will contact your Responders or emergency services. 4. The Response Center will assess the situation. If help is needed, the Response Associate will contact your list of Responders (i.e., a caregiver, neighbor, loved one) or emergency services in accordance with your request. 9 5. Once your Responder or the emergency service arrives, they should press your Help Button to let Lifeline know that help has arrived. The Response Associate will contact the household to confirm that you received the help that you needed. 6. Once Lifeline confirms that you have been assisted, a Response Associate will contact the People to Notify youve designated, letting them know you needed and received help. Note: If you accidentally press your Help Button, a Response Associate will respond to your call and ask if you need help. Just tell them that it was pressed accidentally and that you do not need assistance. Dont be concerned that you are bothering Lifeline; we just want to be sure that you are alright. Signal Range Caution Please see the Quick Setup Guide located in the box for instructions on how to set up your system and test the range of your Help Button. The Communicator must be properly set up, and the coverage area of the Help Button must be tested prior to use. The Help Button is a radio frequency (RF) device that transmits a signal to a compatible Lifeline Communicator. Your Help Button and Home Communicator provide coverage inside your home and may provide coverage in the area immediately outside (in the yard, etc.). If you live in an apartment building or condominium, you may have coverage in areas immediately outside your apartment (e.g., the hallway, stairway, or another floor of the building). A Signal Range Test is required to determine which areas are covered. Be sure to thoroughly test the coverage range of the system in all areas of your home. 10 The signal range may be affected by environmental factors, including building materials, large masses covering the Help Button (i.e. a person falling on top of it) and submersion in liquid. A Signal Range Test will determine your coverage range, which is the distance you can move away from your Home Communicator and still call for help. If you press your Help Button outside of your apartment, but still within the range of the Home Communicator, help will be sent to the location of the Home Communicator (i.e., your apartment). Note: If you have the GoSafe Mobile Button you can call for help outside the range of your Home Communicator when the AT&T Wireless network is available. Help will be sent to your location. Please refer to page 35 for further information. Signal Range Test You should conduct a Signal Range Test during installation, and if you move your Home Communicator to a different location in your home. 1. Make sure that your Home Communicator is ON and that you have your Help Button in hand. 2. PRESS and HOLD DOWN the Message button. The Home Communicator will beep and announce: Continue to hold the Message button for AutoLearn. When you are ready for Range Test, please release the Message button. 3. Release the Message button. The Home Communicator will announce:
Please press the flashing orange Message button after you have completed the range test. Begin Signal Range Test. 4. Press your Help Button. The Home Communicator will beep and play a voice message and the light on your Help Button will flash green to indicate that the Home Communicator has received the signal. 11 5. Move to other parts of your home and press your Help Button again. Listen for the beep and check to see if the green light is flashing. 6. Once you have tested different locations in your home and immediately outside your home, return to the Home Communicator and press the flashing orange Message button. Battery information All Philips Lifeline equipment contains batteries that can only be replaced by Philips Lifeline in the factory. The equipment will automatically send a signal to Lifeline when the battery needs to be replaced. Philips Lifeline will contact you directly to make arrangements for a replacement. Equipment service Every Home Communicator and Help Button is manufactured to high quality standards. Philips Lifeline equipment can only be factory-serviced by Philips Lifeline. The HomeSafe/GoSafe devices perform periodic diagnostic self-tests to verify their functionality. If you ever experience issues with your equipment, or if it becomes damaged, please contact Philips Lifeline or your representative. Contact Philips Lifeline or your representative If you would like to transfer your service to a new or second home. If your Responder or People to Notify list needs to be updated. It is important that your list is up to date with the correct people and telephone numbers. If someone else in your home needs to use the Lifeline Service. More than one person living in the same household can have the service. 12 HomeSafe System and GoSafe Mobile System Communicators General Information Safety information regarding the Home Communicator 1. The Home Communicator must be placed in an indoor living area. Please keep in mind that sunlight may make it difficult to see the status lights. 2. Make sure that you do not plug your Home Communicator into a power outlet that is controlled by a wall switch because someone could accidentally turn off the wall switch and shut off the power to your Home Communicator. 3. Do not place anything on top of the Home Communicator. The Help button and the Message button must always be visible and accessible. 4. The Home Communicator contains a speaker and microphone. Take care not to block these, since doing so will make it difficult for you to communicate with Lifeline. 5. Make sure your Home Communicator is away from any clutter or any object that might block its ability to receive a signal from the Help Button. The Home Communicator should not be placed on or near your refrigerator or any type of metal cabinet or bookcase, since this may limit the overall range of the system. 6. To reduce the risk of electrical shock or fire, do not place the Home Communicator in or near water or other liquids. 13 7. Never carry the Home Communicator by the cord or yank on the cord to disconnect the plug from a power outlet. Instead, grasp the plug and pull to disconnect. Periodically inspect electrical cords and cables for damage or signs of wear. Cleaning Keep the Home Communicator free of dust by wiping it with a soft cotton cloth. If additional cleaning is required, follow the steps below:
1. Move the power switch on the back of the Home Communicator to the OFF position and unplug the power cord from the power outlet. If you have the Landline Communicator, unplug the telephone cord from the wall jack. Warning Always unplug the Communicator from the power outlet before cleaning to prevent electric shocks. Note: You cannot call for help while the Home Communicator is off. Accordingly, you may wish to have a family member or caregiver present while you are cleaning your Home Communicator. 2. Slightly dampen a soft cloth with a mild soap and water and gently wipe the surfaces clean. Do not use detergent or abrasive cleaners on your Home Communicator. 3. Reconnect the power cord to the power outlet. If you have the Landline Communicator, reconnect the telephone cord to the wall jack, and then move the power switch on the back of the Home Communicator to the ON position. 4. Test your system by pressing your Help Button. Tell the Response Associate that you are just testing your equipment after cleaning it and no help is needed. 14 Caution Never allow water or other liquids to enter the product, since these may cause electrical short-circuits or metal corrosion. Do not spray water or cleaners directly on your Home Communicator. Excessive moisture could get inside the Home Communicator and cause damage. Backup battery Your Home Communicator uses a factory-installed battery for back up. If you lose power, the backup battery begins to work automatically. The Communicator will send an alarm to the Lifeline Response Center to indicate that the Communicator is using its backup battery. The backup battery can last for up to 30 hours, depending on the battery age and environmental conditions. If your Communicator battery needs to be replaced, a silent signal will be sent to Lifeline, and Lifeline or your representative will contact you to arrange for a replacement. 15 Landline Communicator
(7000L) Description Microphone Used to talk to Lifeline Green status light Steady green when the Communicator is ON. Flashes green when the Communicator is running on backup battery
(AC power loss). 16 Help button Press to send a Help Call to the Response Center Flashes red while a Help Call is connecting and after Lifeline has contacted your Repsonders or emergency services Steady red when a Help Call is connected Message button Used during the setup process When the button is flashing orange, press to hear a status message Volume control Controls the volume of the speaker on the Communicator Green phone jack Used to connect the Communicator to your household phone jack Blue phone jack Allows you to connect a telephone to the Communicator (optional) Power switch Used to turn the Communicator ON or OFF. The Communicator must be ON for your Lifeline service to work. 17 Safety information 1. If you have multiple phones in your home, and any of them are left off the hook, the Home Communicator will not be able to place a Help Call. This problem can be addressed by plugging the Home Communicator phone cord into an RJ31X/CA38A type jack, sometimes referred to as a line seizure jack, on your main phone line. Contact your phone company for further assistance with this option. If (and only if) there is only one phone jack in your home, there is an RJ31X jack in the Home Communicator that is designed to seize the line if installed properly. Please refer to the Customer Premises Equipment and Wiring diagram on page 44 in the Safety and Regulatory Compliance section. 2. This product cannot be used on party lines/shared service lines. 3. If you have DSL Internet service, you will need to install a DSL filter between your phone jack and the Home Communicator. Contact your phone company to obtain a DSL filter or purchase one from a local electronics store. Warning Using telephone services provided via the internet, broadband, VoIP, or any other nontraditional telephone service presents additional risks for non-transmission of signals from the Equipment, and the Equipment may not operate as intended. Contact Lifeline if you have questions in this regard. If your landline phone service is deemed not compatible with the 7000L, a 7000C Wireless Communicator may possibly be used to provide Lifeline service. 18 Wireless Communicator
(7000C) Description Microphone Used to talk to Lifeline Green status light Steady green when the Communicator is ON. Flashes green when the Communicator is running on backup battery
(AC power loss). Help button Press to send a Help Call to the Response Center Flashes red while a Help Call is connecting and after Lifeline has contacted your Repsonders or emergency services Steady red when a Help Call is connected Message button Used during the setup process When the button is flashing orange, press to hear a status message 19 Volume control Controls the volume of the speaker on the Communicator Signal strength Indicates the strength of the wireless signal*
Power switch Used to turn the Communicator ON or OFF. The power switch must be ON at all times for your Lifeline service to work.
* Signal strength may vary 20 Safety information The Wireless Communicator (7000C) uses the AT&T wireless network to communicate with the Lifeline Response Center. 1. The strength of the wireless signal may be stronger in some areas of your home than others. When you set up your Home Communicator, look at the signal strength indicator on the back of the Home Communicator. The number of green bars that are glowing indicate the signal strength; the more bars you see, the stronger the signal. Place your Home Communicator in a location where you spend the majority of your time, and the signal strength indicator shows two or more bars. 2. If the AT&T wireless network experiences an outage or the Home Communicator loses its signal, the Message button on top of the Home Communicator will flash and it will not be able to send a Help Call to Lifeline. If you press your Button and the AT&T wireless network is not available, you will hear a message saying: Your call cannot be connected. There is no signal strength. Move your Home Communicator to a different location. Try moving the Home Communicator to a different location in your home. Once the signal is restored, you will hear a message saying: Connection has been restored. Your Help Call will then be dialed. 21 HomeSafe System and GoSafe Mobile System Help Buttons General Information The information in this section applies to all types of wearable Help Buttons. Compatible Home Communicators The HomeSafe Personal Help Button, the HomeSafe AutoAlert Button, and the GoSafe Mobile Button are compatible only with the following Philips Lifeline Home Communicators:
Landline Communicator (7000L) Wireless Communicator (7000C) Setting up a replacement Help Button If you receive a replacement Help Button, you will need to set it up to work with your Home Communicator. Youll need to be within arms reach of the Home Communicator to set up your replacement Help Button. If more than one Help Button is used in your home, gather them all for this process. You will need to reprogram all of them, even if you are only replacing one of them. 1. Make sure that your Home Communicator is ON and that you have your replacement Help Button in hand. 22 2. PRESS and HOLD DOWN the Message button on the Home Communicator. The Home Communicator will beep and announce: Continue to hold the Message button for AutoLearn. When you are ready for Range Test, please release the Message button. Do not release the Message button until you get to Step 4 . 3. Continue to hold down the Message button on your Home Communicator. With your other hand, press the wearable Help Button. You will hear a long beep and a voice message saying: Your Lifeline Help Button is now auto-learned and ready to use. The Communicator will also announce the four large digits that appear on the back of your Help Button. This will indicate that the Help Button is working with the Home Communicator. If the AutoLearn process fails, please contact Philips Lifeline or your representative. 4. Repeat step 3 to reprogram all the other Help Buttons in your home. Then, release the Message button on the Home Communicator. The Home Communicator will announce: Please press the flashing Message button after you have completed the range test. Begin Signal Range Test. 5. Press your Help Button. The Home Communicator will beep and the light on your Help Button will flash green to indicate that the Home Communicator has received the signal. 6. Move to other parts of your home and press your Help Button again. Listen for the beep and check to see if the green light on the Button is flashing. 23 7. Once you have tested different locations in your home and immediately outside your home, return to the Home Communicator and press the flashing orange Message button. Cleaning Your Help Button is waterproof (IPX7, 1 meter for 30 minutes), so you can submerge it in warm water for easy cleaning. 1. Wash your wrist strap or adjustable neck cord with a mild liquid dishwashing detergent. 2. Wash the Help Button under warm running water. You may also gently wipe it with an isopropyl (rubbing) alcohol wipe or a cotton pad moistened with alcohol. However, do not soak it in alcohol. 3. Blot excess moisture with a towel and allow the Help Button to finish air-drying while youre wearing it. Note: If you accidentally push your Help Button during cleaning, please simply tell the Personal Response Associate that you accidentally pressed the Button. 8235 8235 Model: 7000AHB 2000148235-YYYYMMDD Model: 7000AHB FCC: BDZ7000AHB IC: 655C-7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB Warnings Any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries. This may be of more concern to wearers in wheelchairs, using walkers, using beds with guard rails, or who might encounter other protruding objects upon which the cord can become tangled. Philips Lifeline neck cords contain a special fuse (see image on right) designed to break away under certain conditions to reduce the remote risk of strangulation. If this fuse breaks apart, contact Philips Lifeline or your representative for a replacement, as the fuse cannot be repaired or re-used. FCC: BDZ7000PHB IC: 655C-7000PHB 8235 2000148235-YYYYMMDD Model: 7000PHB 24 Do not use any neck cord other than the one provided by Philips Lifeline or your representative. Other neck cords may not provide the feature to break apart therefore increasing the risk of strangulation. Do not tie a knot in your neck cord since this may prevent the break away feature from working properly. There are no user-serviceable parts inside the Help Button. Do not attempt to open or modify the device. The Help Button contains a lithium battery that must be disposed of properly. Do not discard the Help Button in the trash or expose it to flames or intense heat. The Help Button is not suitable for use in the presence of flammable mixtures. Do not put your Help Button through the dishwasher, clothes washer or dryer. Please be sure to remove your Help Button from articles of clothing that are being dry-cleaned. Excessive heat may damage your Help Button. Do not leave your Help Button on the dashboard of your car or on a windowsill that receives direct sunlight. Likewise, do not wear your Help Button into a hot tub or sauna. Normal bathing and showering temperatures WILL NOT damage your Help Button. Caution Your Help Button may interfere with certain medical equipment, such as magnetic resonance imaging (MRI), X-ray machines, as well as metal detectors. 25 HomeSafe Personal Help Buttons (7000PHB, 7000PHW) 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB The HomeSafe Personal Help Button can be configured to be worn on the neck or wrist and allows you to connect to the Lifeline Response Center 24 hours a day, 7 days a week. When you press your Help Button, it transmits a signal to your Home Communicator. The Home Communicator then calls the Lifeline Response Center for you. You must be within the range of the Home Communicator for your Help Call to be placed. Front view Indicator light Flashes green during range testing. Flashes red when the Communicator has received a Help Call signal. 8235 Model: 7000PHB 2000148235-YYYYMMDD FCC: BDZ7000PHB IC: 655C-7000PHB Button area Press here to send a Help Call to the Lifeline Response Center. 26 Explanation of symbols Product code: Report this code if you ever have to replace the unit Attention: Read the Instructions for Use for important information Type BF applied part Serial number and date of manufacture Federal Communications Commission ID Industry Canada ID Model Number Interference to electronic equipment may occur in the vicinity of devices marked with this symbol Barcode 8235 Model: 7000PHB 2000148235-YYYYMMDD FCC: BDZ7000PHB IC: 655C-7000PHB Using the wristband To wear the HomeSafe Personal Help Button on your wrist, place it on your wrist and adjust the strap so that it is snug and comfortable. Adjusting the neck cord To shorten: With a tab between your first finger and thumb of each hand, slide both tabs apart in line with your shoulders. To lengthen: Pull one strand of the neck cord while sliding the tab to the back. Repeat on the other side. 27 Battery The HomeSafe Personal Help Button has a non-rechargeable battery that can only be replaced at the factory. The HomeSafe Personal Help Button will send a low battery signal to Lifeline when there are approximately 30 days of battery life remaining. Lifeline or your representative will contact you to arrange for a replacement. Recommended usage Wear your Help Button in your home at all times, especially while sleeping and bathing. The bathroom is a place where people often fall and need help. Your Help Button is waterproof (IPX7, 1 meter for 30 minutes) and should be worn in the shower or bath. Your Help Button does not contain a microphone, so you dont talk into it. Instead, press the Help Button and speak in the direction of your Home Communicator. You may continue to wear your Help Button when you leave your home. However, the Help Button will not provide coverage outside of the range determined by the Signal Range Test. If you are traveling on an airplane and need to bring your HomeSafe System with you, do not take it into the cabin of the airplane. Instead, pack the Help Button in your checked luggage along, with your Home Communicator. Please remember to contact Lifeline before moving the HomeSafe System to a new address. 28 HomeSafe AutoAlert Button
(7000AHB) The HomeSafe AutoAlert Button allows you to connect to the Lifeline Response Center 24 hours a day, 7 days a week. When you press your Help Button, it transmits a signal to your Home Communicator. The Home Communicator then calls the Lifeline Response Center for you. You must be within the range of the Home Communicator for your Help Call to be placed. The HomeSafe AutoAlert Button provides an added layer of protection by automatically calling for help when a fall is detected. The HomeSafe AutoAlert Button does not detect 100% of falls. If you are able, you should always press your Button when you need help. Help call in progress. Please wait. Hello, Mrs. Smith. Welcome to Philips Lifeline. 29 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB Front view Button area Press here to send a Help Call to the Lifeline Response Center. 8235 Model: 7000AHB Indicator light Flashes green during range testing. Flashes red when the Communicator has received a Help Call signal. FCC: BDZ7000AHB IC: 655C-7000AHB 2000148235-YYYYMMDD Model: 7000AHB 8235 Back view Important: The vent area located on the back of the HomeSafe AutoAlert Button is part of the fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products). FCC: BDZ7000AHB IC: 655C-7000AHB 2000148235-YYYYMMDD 8235 What to expect when the AutoAlert Button detects a fall A Help Call is automatically generated after approximately 30 seconds FCC: BDZ7000PHB IC: 655C-7000PHB 2000148235-YYYYMMDD Model: 7000PHB of a fall being detected. If the Button detects you have gotten up within approximately 30 seconds of a fall being detected, a Help Call will not be generated. Do not attempt to stand if you feel unable to. If you think you need assistance, push your Help Button to initiate 8235 Model: 7000PHB 2000148235-YYYYMMDD the Help Call. Pushing the Help Button generates the Help Call immediately. FCC: BDZ7000PHB IC: 655C-7000PHB 30 Explanation of symbols Product code: Report this code if you ever have to replace the unit Attention: Read the Instructions for Use for important information Model number Type BF applied part Serial number and date of manufacture Federal Communications Commission ID Industry Canada ID Interference to electronic equipment may occur in the vicinity of devices marked with this symbol Barcode 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB False fall detected alarms may occasionally occur While the AutoAlert Help Button is designed to have very few false alarms, it might occasionally trigger a fall detected alarm when there was not a fall (i.e., a false alarm). If this occurs, please simply tell the Response Associate that it was a false alarm. Note: Occasional false alarms do not indicate that the AutoAlert Help Button is malfunctioning. Caution In certain situations, the HomeSafe AutoAlert Button may not detect a fall. A gradual slide from a seated position such as from a wheelchair may not register as a fall and would not be detected. If you fall and need help, always press the Help Button if you are able to. The vent area located on the back of the HomeSafe AutoAlert Button is part of the fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products). A continuous flow of water (e.g., a shower) hitting the vent directly may also temporarily obstruct the vent. However, your HomeSafe AutoAlert Button is waterproof and should be worn at all times even when bathing or showering. To conserve battery power for Help Calls, the sensors that are used to detect falls will be disabled when there are approximately 7 days of battery life remaining. During this time, the HomeSafe AutoAlert Button will not detect falls. But, it will continue to function as a Help Button, which you can press if you need help. See the Battery section below for further information. 31 Battery The HomeSafe AutoAlert Button has a non-rechargeable battery that can only be replaced at the factory. The HomeSafe AutoAlert Button will send a low battery signal to Lifeline when there are approximately 30 days of battery life remaining. Lifeline or your representative will contact you to arrange for a replacement. Recommended usage Wear your AutoAlert Help Button in your home at all times, especially while sleeping and bathing. The bathroom is a place where people often fall and need help. Your AutoAlert Help Button is waterproof (IPX7, 1 meter for 30 minutes) and should be worn in the shower or bath. Press your AutoAlert Help Button any time you need help. Your AutoAlert Help Button does not contain a microphone, so you dont talk into it. Instead, press the Help Button and speak in the direction of your Home Communicator. Do not throw or toss the AutoAlert Help Button onto a bed, table, or other surface because it may accidentally send a Help Call. You may continue to wear your AutoAlert Help Button when leaving your home. However, it will not provide coverage outside of the range determined by the Signal Range Test. If you are traveling on an airplane and need to bring your HomeSafe System with you, do not take it into the cabin of the airplane. Instead, pack the Help Button in your checked luggage along with your Home Communicator. Please remember to contact Lifeline before moving the HomeSafe System to a new address. 32 GoSafe Mobile Button
(7000MHB and 7100MHB) The GoSafe Mobile Button allows you to connect to the Lifeline Response Center 24 hours a day, 7 days a week. The GoSafe Mobile Button can be used at home, in conjunction with the 7000C or 7000L Home Communicator, or from any other location in the United States and Canada where the AT&T wireless network is available. The GoSafe Mobile Button provides an added layer of protection by automatically calling for help when a fall is detected. The GoSafe Mobile Button does not detect 100% of falls. If you are able, you should always press your Button when you need help. Help call in progress. Please wait. Hello, Mrs. Smith. Welcome to Philips Lifeline. 33 Front view Indicator light This light will indicate the status of the GoSafe Mobile Button. Microphone The GoSafe Mobile Button has a microphone that you can use to talk to the Response Associate when you are outside the range of the Home Communicator. Back view Speaker The GoSafe Mobile Button has a built-in speaker. Important: This area is part of the fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products). Charger The GoSafe Mobile Button has a rechargeable battery. Use the charger provided with your GoSafe system to recharge the Button when the light indicates that the Button needs to be charged. See the Charging the battery section on page 37. 34 7100MHB Back view Determining your location The GoSafe Mobile Button is designed to help identify your general location, at or away from home. You should always tell the Personal Response Associate your exact location if you are able to do so. If you are unable to speak or explain your exact location, Lifeline will still contact help to find and assist you where you are. Lifeline cannot guarantee that your location can be determined at all times. If your Responder or emergency services is having trouble locating you, Lifeline will activate the audio beacon feature. This is a very loud, siren-like noise that will come from the GoSafe Mobile Button and will allow responders to find you more easily. Each time the audio beacon is activated, it will sound for 5 minutes. Pressing the Button will silence the audio beacon and will not initiate another Help Call. What to expect when the GoSafe Mobile Button detects a fall A Help Call is automatically generated after approximately 30 seconds of a fall being detected. If the Button detects you have gotten up within approximately 30 seconds of a fall being detected, a Help Call will not be generated. Do not attempt to stand if you feel unable to. If you think you need assistance, push your Help Button immediately to initiate the Help Call. Pushing the Help Button generates the Help Call immediately. False fall detected alarms may occasionally occur While the GoSafe Mobile Button is designed to have very few false alarms, it might occasionally trigger a fall detected alarm when there was not a fall (i.e., a false alarm). If this occurs, please simply tell the Response Associate that it was a false alarm. 35 Note: Occasional false alarms do not indicate that the GoSafe Mobile Button is malfunctioning. Warning Do not use the GoSafe Mobile Button if you have an implantable cardiac device, such as a defibrillator or pacemaker. Cautions In certain situations, the GoSafe Mobile Button may not detect a fall. A gradual slide from a seated position such as from a wheelchair may not register as a fall and would not be detected. If you fall and need help, always press the Help Button if you are able to. The vent area located on the back of the GoSafe Mobile Button is part of the fall detection sensor system and needs to remain clear of obstructions
(e.g., lint or food products). A continuous flow of water (e.g., a shower) hitting the vent directly may also temporarily obstruct the vent. However, your GoSafe Mobile Button is waterproof and should be worn at all times even when bathing or showering. The GoSafe Mobile Button may interfere with certain medical equipment, such as magnetic resonance imaging (MRI), X-ray machines, Automatic External Defibrillators, cardiac monitors, insulin pumps, hearing aides, as well as metal detectors. It may also interfere with aircraft communications. Be sure to place your GoSafe Mobile Button in sleep mode when on an airplane. Please see instructions for putting your GoSafe Mobile Button in sleep mode on page 38. The GoSafe Mobile Button can only place a Help Call when it is within the range of the Home Communicator to which it has been programmed and/
or when the AT&T wireless network is available. 36 Charging the battery Flashing orange light
= charging needed Flashing green light
= charging in progress When connected to the charger, a steady green light
= fully charged Your GoSafe Mobile Button will chime once and the light will flash orange whenever it needs to be charged. Typically, it will take less than 45 minutes to charge your GoSafe Mobile Button. It is fully charged when it chimes and the light turns to a steady green. 1. Make sure the charger is plugged into a power outlet. 2. Attach your GoSafe Mobile Button to the charger. You will hear a chime and a voice message to acknowledge that you are charging. 3. Charge until the light turns to a steady green. 4. Remove from the charger. The green light will turn off, and the Button is ready to use. 37 To determine if your GoSafe Mobile Button is on, shake it briefly:
A flashing green light means that the Button has battery power No light means that the battery is dead and needs to be charged or, it is in sleep mode Important reminders You should continue wearing your GoSafe Mobile Button while it is being charged. Please be cautious not to trip on the cord. When you are charging your GoSafe Mobile Button while wearing it, be sure to remove it from the charger prior to standing up. Failure to do so may compromise the fall detection capability of your GoSafe system. Do not charge your GoSafe Mobile Button while sleeping or bathing. Battery life varies based on activity level, time spent away from your Home Communicator, and actual emergency use. In general, you should charge your GoSafe Mobile Button at least once a week. It may be helpful to pick a specific day and time to complete the charging, e.g., Sundays at 4pm. Sleep mode The GoSafe Mobile Button is a mobile device much like a cell phone. As such, you must turn it off in the following circumstances:
When you are traveling by airplane If you are returning the GoSafe Mobile Button to Lifeline The GoSafe Button has a sleep mode for these situations. To put the GoSafe Mobile Button into sleep mode, press and hold the Button for 10 seconds. It will say: If you would like to turn off your Help Button, please press it again. Press again. The GoSafe Mobile Button will confirm it is entering sleep mode by saying: Your Help Button is now turning off. 38 To exit sleep mode, press the Help Button. Your Button will say: Your Help Button is now ready to use. If you need help, please press your Help Button again. The button press that takes the Button out of sleep mode will not initiate a Help Call. If you need help in this instance, be sure to press the Button a second time. Caution You will not be able to send a Help Call when the GoSafe Mobile Button is in sleep mode. Be sure to remember to exit sleep mode as soon as wireless/electronic device use is allowed, e.g., after the airplane has landed. Note: If you are returning a GoSafe Mobile Button to Philips Lifeline for service, replacement or recycling, you must contact Lifeline before returning the Button. Lifeline will provide you with special packaging and instructions for return. Recommended usage Press your GoSafe Mobile Button any time you need help, or in situations/locations outside the home where you want to determine if the AT&T wireless network is available. Wear your GoSafe Mobile Button at ALL times, even when you are away from home. The GoSafe Mobile Button will send a Help Call from any location where the AT&T wireless network is available. 39 If you are outside of the signal or voice range of your Home Communicator, you can talk to Lifeline using the GoSafe Mobile Buttons microphone and speaker. For best results, hold the Button up and away from your chest when you are speaking to Lifeline. Maintain a minimum separation distance of 10 mm/ 0.394 inches when operating the device in the held to face configuration. Your Help Button is waterproof (IPX7, 1 meter for 30 minutes) and should be worn in the shower or bath. Do not throw or toss the GoSafe Mobile Button onto a bed, table, or other surface because it may accidentally send a Help Call. When entering and exiting your vehicle, take care to prevent the GoSafe Mobile Button from hitting the steering wheel because it may accidentally send a Help Call. 40 Communicator Alarms Introduction There are two types of alarms processed by the HomeSafe/GoSafe Communicator:
High Priority Require immediate response (by the Call Center) Medium Priority Require prompt response (by the operator/user) Additionally, the Communicator also displays informational messages and confirmation alerts that notify you of conditions that need attention but do not qualify as alarm conditions (e.g. installation prompts). Note: If multiple alarms occur at the same time, all alarms are processed and displayed, but the alarms are ordered first by priority and then by occurrence, with the newest, highest priority alarms at the top of the list. The alarm precedence is in the following order: high priority, medium priority, and informational messages. Note: Not all alarms are available in every mode (e.g. during installation); some alarms are mode-
dependent. Audible and Visual Alarm Indicators When the device detects a High priority alarm: The Help button on the Communicator flashes red, the device audible alarm sounds and a recorded voice message is played. When the device detects a Medium priority alarm: The Message button on the Communicator flashes yellow/orange. The operator must press the Message button to hear a recorded voice message describing the alarm condition and/or what to do about the alarm condition. Silencing Alarms Once a High Priority alarm is detected, it cannot be silenced. Lowering the volume slider on the Communicator will lower the volume of the voice prompts played, but the alarm messages will still play. Medium Priority alarms are silent until the User presses the Message button to hear what the alarm condition is and how to act upon it. The recorded voice messages will continue to play each time the Message button is pressed, until the alarm condition is corrected. Resetting an Alarm High priority alarms are normally reset by the Call Center after the alarm has been responded to. Additionally, the Communicator may periodically poll the Call Center to see if the alarm should be reset and does so accordingly. Note: Powering down the Communicator during the reporting of a high priority alarm will reset the device, but since the alarm has already been reported to the Call Center, the Call Center will likely attempt to contact the Subscriber. If an alarm is accidentally initiated by the User, they should not turn off the Communicator. Instead, they should wait for the Call Center to establish voice communication and simply state that the alarm was sent accidentally. The Communicator self-cancels certain Medium Priority alarms if the cause of the alarm is corrected, shutting off the flashing message LED. 49 GoSafe Mobile Help Button Alarms Introduction There are two types of alarms processed by the GoSafe Mobile Help Button:
High Priority Require immediate response (by the Call Center) Medium Priority Require prompt response (by the operator/user) Additionally, the Mobile Button also plays informational messages and confirmation alerts that notify you of conditions that need attention but do not qualify as alarm conditions (e.g. installation prompts). Note: If multiple alarms occur at the same time, all alarms are processed and displayed, but the alarms are ordered first by priority and then by occurrence, with the newest, highest priority alarms at the top of the list. The alarm precedence is in the following order: high priority, medium priority, and informational messages. Note: Not all alarms are available in every mode (e.g. during installation); some alarms are mode-
dependent. Audible and Visual Alarm Indicators When the device detects a High priority alarm: The light on the Mobile Help Button flashes red, the device audible alarm sounds and a recorded voice message is played. When the device detects a Medium priority alarm: The light on the Mobile Help Button flashes orange, the device may play a sound and/or a recorded voice message. Silencing Alarms Once a High Priority alarm is detected, it cannot be silenced. Medium Priority alarms play a sound and possibly a recorded voice message once upon detection of the alarm, but the light flashes until the alarm condition is corrected. Resetting an Alarm High Priority alarms are normally reset by the Call Center after the alarm has been responded to. Additionally, the Mobile Help Button may periodically poll the Call Center to see if the alarm should be reset and does so accordingly. If the alarm is not reset by the Call Center, the Mobile Help Button will automatically reset the alarm after 30 minutes. Note: Putting the Mobile Button to sleep during an active high priority alarm will reset the device, but a Voice Message is played requiring the user to confirm this action. Since the alarm has already been reported to the Call Center, they will likely attempt to contact the Subscriber. If an alarm is accidentally initiated by the User, they should not put the Mobile Button to sleep. Instead, they should wait for the Call Center to establish voice communication and simply state that the alarm was sent accidentally. The Mobile Button self-cancels certain Medium Priority alarms if the cause of the alarm is corrected, stopping the orange flashing LED. 50 Alarm Descriptions / Summary Tables The following tables summarize all of the Communicator high and medium priority alarms and informational messages (Supervision/Check-in alarms). Help Needed (High Priority) Alarms The HomeSafe/GoSafe Communicator and Help Button alarms described below are User-initiated high priority alarms designed to let the Call Center know that the User needs assistance. Alarm Event Type HELP NEEDED Communicator (7000C / 7000L) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Help Alarm initiated by User pressing the Help button on the Home Communicator High Operates normally Yes. Home Communicator plays Voice Message upon pressing the Help button. Help button flashes red and turns solid red once a voice connection is established with the Call Center. Yes. A Help Alarm Signal is sent to the Call Center by the Home Communicator. Upon receiving the Help Signal, the Call Center calls the Home Communicator to establish contact with the Subscriber and to see what kind of help they need. Alarm Event Reported to Lifeline?
Help Alarm initiated by User pressing the Button on the End Device HELP NEEDED End Device (7000PHB / 7000AHB / 7000MHB/7100MHB) in range of Communicator Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
High Operates normally Yes. Upon pressing the button on the End Device a Help Signal is sent to the Home Communicator. When the Home Communicator receives and acknowledges the signal, the indicator on the End Device / Help Button flashes red. The Home Communicator plays Voice Message and its Help Button flashes red. The Home Communicator Help button turns solid red once a voice connection is established with the Lifeline Call Center. Yes. A Help Alarm Signal is sent to the Call Center by the Home Communicator. Upon receiving the Help Signal, the Call Center calls the Home Communicator to establish contact with the Subscriber and to see what kind of help they need. Alarm Event Reported to Lifeline?
51 HELP NEEDED End Device (7000MHB) out of range of Communicator Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
Help Alarm initiated by the User pressing the button on the End Device High Operates normally Yes. Upon pressing the button on the End Device, a Voice Message plays and the LED flashes red. Yes. A Help Alarm Signal is sent to the Call Center by the End Device from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the Help Signal, the Call Center calls the End Device to establish contact with the Subscriber and to see what kind of help they need. HELP NEEDED End Device (7000MHB/7100MHB) out of range of Communicator / no Signal Strength Alarm Event Description Help Alarm initiated by the User pressing the button on the End Device or by the End Device detecting a fall; and the AT&T wireless network is unavailble. Then a Warning Message is displayed. High The Help Alarm Signal will be sent to the Call Center once the connection to the AT&T wireless network is re-established. Yes. Upon pressing the button on the End Device or when the End Device has detected a fall, a Voice Message plays and the LED flashes red. This is an alarm that will self-cancel once connection to the AT&T wireless network is re-established. No. If the AT&T wireless network is unavailable a Help Alarm Signal cannot be sent to the Call Center. Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
52 Help Alarm initiated by End Device detecting a fall. HELP NEEDED Fall Detected End Device (7000AHB / 7000MHB/7100MHB) in range of Communicator Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
High Operates normally Yes. When the AutoAlert or Mobile Help Button has detected a fall has occurred, a fall detected Help Signal is sent to the Home Communicator. When the Home Communicator receives and acknowledges the signal, the indicator on the End Device flashes red. The Home Communicator plays a Voice Message and its Help button flashes red. The Home Communicator Help button turns solid red once a voice connection is established with the Call Center. Yes. A fall detected Help Alarm Signal is sent to the Call Center by the Home Communicator. Upon receiving the fall detected Help Signal, the Call Center calls the Home Communicator to establish contact with the Subscriber and to see what kind of help they need. Alarm Event Reported to Lifeline?
Help Alarm initiated by the End Device detecting a fall. HELP NEEDED Fall Detected End Device (7000MHB/7100MHB) out of range of Communicator Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
High Operates normally Yes. When the Mobile Help Button has detected a fall, it plays a Voice Message and its LED flashes red. Yes. The Mobile Help Button sends a "fall detected" Help Alarm Signal to the Call Center from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the "fall detected" Help Signal, the Call Center calls the Mobile Button to establish contact with the Subscriber and to see what kind of help they need. 53 Device Error (Medium Priority) Alarms The HomeSafe/GoSafe Communicator and Help Button alarms described below are automatically generated alarms designed to periodically let the Call Center know that the Communicator and Help Buttons are working properly. Alarm Event Type AC Power Lost Communicator (7000C / 7000L) Alarm Event Description Priority Device Action In the event that the Home Communicator loses its connection to AC Power, a Warning Message is displayed Medium Switches to backup battery and operates normally Alarm Event Reported/
Displayed Locally?
Yes. The Message Button on the Home Communicator flashes yellow-
orange. A Voice Message plays upon pressing the Message Button. This is an alarm that will self-cancel once connection to the AC power is re-established. No. Alarm Event Reported to Lifeline?
LOW BATTERY + AC Power Lost Communicator (7000C / 7000L) Alarm Event Description When the charge level of the Communicator backup battery is low
(less than 4.88V) AND the Communicator has lost AC Power, a Warning Message is displayed Medium Operates normally under battery power until battery is depleted Yes. The Message Button on the Home Communicator flashes yellow-
orange. A Voice Message plays upon pressing the Message Button. Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
54 LOW BATTERY Communicator (7000C / 7000L) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
When the capacity / life of the Communicator backup battery has diminished, a Warning Message is displayed Medium Operates normally on AC Power Yes. Message Button Flashes. Voice Message plays upon pressing the Message Button. Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. LOW BATTERY End Device (7000PHB / 7000AHB / 7000MHB/7100MHB) Alarm Event Description Priority When the capacity / life of the Help Button battery has diminished, a Warning Message is displayed Medium Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
Operates normally until battery is depleted Yes. Message Button Flashes. Voice Message plays upon pressing the Message Button. Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. BATTERY REQUIRES CHARGING End Device (7000MHB/7100MHB) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
When the Mobile Help Button rechargeable battery needs to be charged (below 350 mAh), a warning Message is displayed. Medium Operates normally until the battery is critically low. Yes. Mobile Help Button LED flashes orange and plays single sound/
tone. Message Button on the Home Communicator flashes, when the End Device is within range. Voice Message plays upon pressing the Message Button. This alarm will self cancel once the battery charge reaches an acceptable level. No. Alarm Event Reported to Lifeline?
55 DEPLETED BATTERY End Device (7000MHB/7100MHB) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
When the charge level of the Mobile Help Button rechargeable battery is critically low (below 3.7V), a Warning Message is displayed. Medium Operates normally until the battery is fully depleted. Yes. Mobile Help Button LED flashes orange, plays single sound/tone, and a Voice Message. Message Button on the Home Communicator flashes, when the End Device is within range. Voice Message plays upon pressing the Message Button. This alarm will self cancel once the battery charge reaches an acceptable level. Yes. A silent Maintenance Signal is sent to the Call Center by the End Device from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the Maintenance Signal, the Call Center stores the status information but no direct action is taken. Alarm Event Reported to Lifeline?
Device Hardware Failure (7000PHB / 7000AHB / 7000MHB /7100MHB/ 7000C / 7000L) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
In the event that a device senses it has a Hardware Error, a Warning Message is displayed. Medium May have limited operation, depending on the failure Yes. Message Button Flashes. Voice Message plays upon pressing the Message Button. Alarm Event Reported to Lifeline?
Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Software Failure End Device (7000PHB / 7000AHB / 7000MHB/7100MHB) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
In the event that a device senses it has a Software Error, a Warning Message is displayed Medium May have limited operation, depending on the failure Yes. Message Button Flashes. Voice Message plays upon pressing the Message Button. Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. 56 NO PHONE LINE Communicator (7000L) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
In the event that the Home Communicator loses its connection to the phone line, a Warning Message is displayed. Medium Any alarms generated will be sent to the Call Center once connection to the phone line is established. Yes. Message Button flashes. Voice Message plays upon pressing the Message Button. This is an alarm that will self-cancel once connection to the phone line is re-established. No. If connection to the phone line is lost, a Maintenance Signal cannot be sent by the Home Communicator to the Call Center. Alarm Event Reported to Lifeline?
NO SIGNAL STRENGTH Communicator (7000C) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
In the event that the Home Communicator loses its connection to the AT&T wireless network for a period of more than 2 minutes continuously, a Warning Message is displayed. Medium Any alarms generated will be sent to the Call Center once connection to the AT&T wireless network is established Yes. Message Button Flashes. Voice Message plays upon pressing the Message Button. This is an alarm that will self-cancel once connection to the AT&T wireless network is re-established. No. If connection to the AT&T wireless network is lost, a Maintenance Signal cannot be sent by the Home Communicator to the Call Center. 57 Supervision and Check-in Alarms (Informational Messages) The alarms described below are automatically generated alarms designed to periodically let the Call Center know that the Communicator and Help Buttons are working properly. These alarms are silent and require no immediate action from the User/Subscriber. Alarm Event Type AUTO TEST CALL (aka Check-in) (7000C / 7000L / 7000MHB/7100MHB) Alarm Event Description Auto Test calls are automatically generated silent alarms designed to periodically let the Call Center know that the Communicator or End Device is working properly. N/A Operates normally No visual or audible alarm is generated by the devices. Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator or End Device. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. SUPERVISION FAILURE (7000PHB / 7000AHB / 7000MHB/7100MHB) Alarm Event Description End Devices periodically check-in to the Communicator. If the Communicator has not received a check-in from the End Devices for a week, then a silent alarm is sent to the Call Center N/A Operates normally No visual or audible alarm is generated by the devices. Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
Yes. A silent Maintenance Signal is sent to the Call Center by the Home Communicator. Upon receiving the Maintenance Signal, the Call Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
58 AC Power Restored Communicator (7000C / 7000L) Alarm Event Description Priority Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Lifeline?
If AC power is restored within 24 hours of the Communicators Low Battery + NO AC Power alarm event occurring, then the Communicator will report a silent alarm to the Call Center N/A Operates normally No visual or audible alarm is generated when AC Power is restored. Instead, the flashing message light / alarm generated by the AC Power Lost is reset and the Message button stops flashing. Yes. If AC power is restored within 24 hours of a reported low battery
+ no AC condition, a Maintenance Signal is sent to the Call Center, letting the Call Center know the Home Communicator is receiving power. Priority of Device Error Alarms The Communicator plays messages in the priority order shown in the table below separated when multiple fault conditions are active simultaneously and the Message button is pressed. Audio Message Unfortunately, the signal strength in this location is not strong enough. Move your Home Communicator to a different location. Please check the phone line and connections A phone is off-hook. Please check other phones in your home. Please charge your Help Button as soon as possible. The battery is very low. No power is detected. Please check the power cord. The backup battery is low. There is a fault with your Home Communicator. Please contact Philips Lifeline. There is a fault with your Help Button. Please contact Philips Lifeline. Fault Condition Wireless connection lost / No Wireless Signal No Phone line External Phone off Hook Low Battery GoSafe Mobile Button AC Power Loss Communicator Low Battery Communicator has a Hardware or Software Failure End Device has a:
Hardware Failure OR Software Failure OR Battery Low 59 Delay in Determining Alarms Reporting high priority help alarms from the End Devices to the Home Communicator is done in less than a second when generated by a button press. The HomeSafe AutoAlert and GoSafe Mobile Help Buttons provide an added layer of protection by being able to detect falls under certain conditions. This takes approximately 30 seconds to determine that an activity that resembles a fall has occurred. An alarm signal is then sent to the Home Communicator. If a fall is detected by the 7000MHB when outside of range of the Home Communicator, the signal is sent directly to the Call Center via the AT&T wireless nework, if available. Logging Alarms All alarm events reported to the Call Center are logged by the Call Center. There are no user accessible logs. 60 Safety and Regulatory Compliance IEC regulations The HomeSafe/GoSafe Help Buttons and Home Communicator comply with the relevant National and International standards listed in the Technical Section. They are classified as medical electrical
(ME) equipment in the US according to the FDA product classification. According to Health Canada they are not classified as medical devices. They fall under the Canada Consumer Product Safety Act. Medical electrical equipment can either generat e or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment. The HomeSafe/GoSafe Help Buttons and Home Communicator must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. The use of accessories, transducers and/or cables other than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. System classification The HomeSafe/GoSafe Help Buttons and Home Communicator are FDA Class II devices. They are internally powered devices for continuous operation. Radio specifications The HomeSafe/GoSafe Help Buttons and Home Communicator have radios with the following characteristics: 3 channel frequency agility (917 MHz, 919 MHz, 921 MHz); maximum EIRP -1.23 dBm;
FSK digital modulation. It fully complies with FCC Part 15, Section 15.249. Additionally, the 7100MHB complies with the FCC Part 15, 22 and 24 Subparts B, C and E. Its radio frequency transmitters have the following characteristics:
Cellular 3G (824-849MHz and 1850-1910MHz transmission bands). WiFi (a, b, g) 2.4 MHz and 5MHz ISM band; maximum EIRP 15 dBm; OFDM modulation Bluetooth ISM band 2.4MHz; maximum EIRP 2 dBm; GFSK modulation 41 FCC Notice to Users 7000L FCC Regulations The 7000L Home Communicator (landline) has been registered with the U.S. Federal Communications Commission (FCC) in accordance with Part 15 and Part 68. Notice The FCC requires that the Communicator be connected to the nationwide telephone network through a modular telephone jack (USOC RJ11C, RJ11W, RJ14 or RJ31X). This equipment may not be used with coin telephone lines or party lines. Contact the state public utility commission, public service commission or corporation commission for more information. Notification for the Telephone Company Upon request of your local telephone company, you are required to provide them with the following information:
1. The Line to which the Communicator is connected (that is, your phone number); and 2. The Communicators FCC Registration Number and Ringer Equivalence Number (REN). Those numbers are on the bottom of the Communicator. The REN is used to determine how many devices may be connected to a telephone line. Excessive RENs on a telephone line may result in the devices not ringing in response to an incoming call. In most, but not all, areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact your local telephone company. The REN for the Communicator is part of the product identifier that has the format US:AAAEQ##TXXXX. The digits represented by ## are the REN without a decimal point (e.g., 03 is a REN of 0.3). Rights of the Telephone Company If the Communicator causes harm to the telephone network, the telephone company will notify you in advance that temporary discontinuance of service may be required. But if advance notice isnt practical, the telephone company will notify the customer as soon as possible. Also, you will be advised of your right to file a complaint with the FCC if you believe it is necessary. The telephone company may make changes in its facilities, equipment, operations or procedures that could affect the operation of the equipment. If this happens, the telephone company will provide advance notice in order for you to make necessary modifications to maintain uninterrupted service. Interference Information: FCC Rules Part 15 The Communicator 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. 42 Note: The Communicator 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. The Communicator 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 installation. 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:
Move the Communicator away from your radio or television. Plug the Communicator into a different power outlet than your radio or television. ACTA (Administration Council for Terminal Attachments) Information The Communicator complies with Part 68 of the FCC rules and the requirements adopted by the ACTA. On the bottom of the Communicator is a label that contains, among other information, a product identifier in the format US:AAAEQ##TXXXX. If requested, this number must be provided to the telephone company. A plug and jack used to connect this equipment to the premises wiring and telephone network must comply with the applicable FCC Part 68 rules and requirements adopted by the ACTA. A compliant telephone cord and modular plug is provided with this product. It is designed to be connected to a compatible modular jack that is also compliant. See installation instructions for details. If your home has specially wired alarm equipment connected to the telephone line, ensure that the installation of the Communicator does not disable your alarm equipment. If you have questions about what will disable alarm equipment, consult your telephone company or a qualified installer. Caution In order for alarm dialing equipment to be able to seize the phone line to report an alarm or other event when other equipment (telephone, answering system, computer modem, etc.) is connected to the same line is in use, alarm dialing equipment must be connected to a properly installed RJ31X jack. The RJ31X jack must be connected in series with, and ahead of, all other equipment attached to the same phone line. Series installation of an RJ31X jack is depicted in the figure shown below. If you have any questions concerning these instructions, you should consult your telephone company or a qualified installer about installing the necessary jack and alarm dialing equipment for you. 43 Caution If the above diagram is not used, the Communicator cannot report an alarm when other equipment
(telephone, answering system, computer modem, etc.) connected to the same phone line is in use. 44 HomeSafe/GoSafe FCC Regulations The HomeSafe/GoSafe devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) Device may not cause harmful interference 2) Device must accept any interference received, including interference that may cause undesired operation. Pursuant to Part 15.21 of the FCC Rules, any changes or modifications not expressly approved by Philips Healthcare, Home Monitoring, Lifeline Systems Inc. could void the users authority to operate the equipment. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. 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 installation. 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. Radio interference The GoSafe equipment comply with FCC RF radiation exposure limits set forth for an uncontrolled environment. For /body-worn operation, this equipment has been tested and meets the FCC RF exposure guidelines. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Use of other accessories may not ensure compliance with FCC RF guidelines. Do not attempt to repair or modify this equipment. Any repairs or alterations made by the user to the equipment may void the warranty and compliance of the equipment. Changes or modifications made to this equipment not expressly approved by Philips may void the FCC authorization to operate this equipment. For assistance visit our website www.philips.com/support or call toll-free 1-800- Industry Canada Notice to Users The HomeSafe/GoSafe devices comply with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:
1) Device may not cause interference 2) Device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:
lappareil ne doit pas produire de brouillage lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Class B digital device notice This Class B digital apparatus complies with Canadian ICES-003, RSS-Gen and RSS-210. Cet appareil numrique de la classe B est conforme la norme NMB-003, CNR-Gen et CNR-210 du Canada. Essential performance The HomeSafe/GoSafe Help Buttons provide essential performance (EP) under normal operating conditions (includes EMC exposure) only as a complete system, consisting of the HomeSafe /GoSafe Help Buttons and the 7000C or 7000L Communicators. The system achieves its essential performance by sending Help Calls to the Lifeline Response Center. If the system is incapable of sending Help Calls, it will periodically send a status alarm to the Lifeline Response Center. Contraindications The GoSafe devices may contraindicated for any person who is connected to a implanted electronic medical device or instrument such as a pacemaker or defibrillator. This device may cause the electronic medical device to malfunction. Compliance The Philips Lifeline HomeSafe/GoSafe Wireless System complies with relevant international and national standards and laws. Information on compliance will be supplied on request by Philips Lifeline or your Philips Lifeline representative. Intended Use This Philips product is intended to be installed, used and operated only in accordance with the safety procedures and operating instructions given in, the Quick Setup Guide and the Instructions for Use for the purpose for which it was designed. The purpose for which the product is intended is given below. The Philips Lifeline Medical Alert Service and HomeSafe/GoSafe System uses a wireless (7000C) or landline (7000L) Communicator with portable Help Buttons that connect to an emergency help service. The HomeSafe Personal Help Button (7000PHB) can be worn as a pendant or a wristband and must be activated manually. The HomeSafe AutoAlert Button (7000AHB) and GoSafe Mobile Button (7000MHB/7100MHB) are worn as pendants and are capable of detecting certain types of falls or being activated manually. When outside the range of the Home Communicator, the GoSafe Mobile Button (7000MHB/7100MHB) can also be used to directly connect to an emergency help service via the AT&T wireless network. Help Calls can also be generated by pressing the Help button of the Communicator. Uses of the HomeSafe/GoSafe System for purposes other than those intended and expressly stated by Philips Lifeline, as well as incorrect use or operation, may relieve Philips Lifeline (or its agent) from all or some responsibility for resultant non-compliance, damage or injury. Questions? Call 1-800-635-6156 Compatibility The products and systems described in this manual are compatible only with the components described herein and should not be used in combination with any other products or components unless such other products or components are expressly recognized as compatible by Philips Lifeline. Changes and/or additions to the product should only be carried out by Philips Lifeline or by third parties expressly authorized by Philips Lifeline to do so. Such changes and/or additions must comply with all applicable laws and regulations that have the force of law within the jurisdiction(s) concerned, and with best engineering practice. Warning Changes and/or additions to the product that are carried out by persons without the appropriate training and/or using unapproved spare parts may void the warranty. As with all complex technical products, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the product and of personal injury. Risks and Benefits The 7000L HomeSafe System depends on connecting to a landline in order to communicate with the Philips Lifeline Call Center. The 7000C HomeSafe System depends on connecting to the AT&T wireless network in order to communicate with the Philips Lifeline Call Center. When outside the range of the Communicator the GoSafe Mobile Button (7000MHB/7100MHB) also depends on connecting to the AT&T wireless network to function properly. As with all wireless devices, the availability of the network cannot always be guaranteed. The HomeSafe/GoSafe System depends on the user being capable of pressing a Help Button when they are in need of help and also capable of pressing the Message button on the Communicator for important recorded messages regarding the status of the device(s). Any impairment the user may have in this regard should be considered when using this product. Training Reading and understanding these Instructions for Use and the Quick Setup Guide serve as adequate training for the safe installation, use and disposal of the equipment. Users of this product must review and understand the instructions for use document to ensure safe and effective use. If you require further information about training in the use of this product, please contact Philips Lifeline or your Philips Lifeline representative. Questions? Call 1-800-635-6156 45 Safety Warnings Maintenance & faults: If any part of the product is known (or suspected) to be defective or wrongly adjusted, DO NOT USE the product until a repair has been made. Operation of the product with defective or wrongly adjusted components could expose the user or the patient to safety hazards. Safety awareness: Do not use this product for any application until you read and understand the safety information, safety procedures and emergency procedures contained in this SAFETY section. Operation of the product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. Safety devices: Never attempt to remove, modify, or otherwise defeat any safety device on the product. Interfering with safety devices could lead to fatal or other serious personal injury. Intended use and compatibility: Do not use this product for any purpose other than those for which it is intended. Do not use the product with any product other than that which Philips Lifeline recognizes as compatible. Operation of the product for unintended purposes, or with incompatible product, could lead to fatal or other serious injury. Electrical safety Warnings Do not remove covers or cables from this product. Dangerous electrical voltages are present within this product. Removing covers or cables could lead to serious or fatal personal injury. Covers or cables should only be removed by qualified and authorized service personnel. Unplug the Communicator from the main electrical supply (power outlet) before cleaning it. Explosion safety Warnings Do not use this product in the presence of explosive gases or vapors, such as certain anesthetic gases. Do not use flammable or potentially explosive disinfecting sprays in the presence of this product. Use of this product in an environment for which it was not designed can lead to fire or explosion. Electromagnetic Compatibility (EMC) This product complies with relevant laws and standards on electro-magnetic compatibility (EMC) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from this product and its required immunity to electromagnetic interference from external sources. 46 Other electronic products exceeding the limits defined in such EMC standards could, under unusual circumstances, affect the operation of the product. Medical electrical products need special precautions regarding EMC, and need to be installed and put into service according to EMC information provided in the accompanying documents. The use of accessories and cables other than those specified may result in increased emission or decreased immunity levels. The product should not be used adjacent to or stacked with other products and that if adjacent or stacked use is necessary, it should be observed to verify normal operation. Other equipment could interfere with the medical device or device system, even if the other equipment complies with CISPR emission requirements. Caution Portable and Mobile Phones: Portable and mobile RF communications can affect the HomeSafe /
GoSafe devices. Use caution when using such communication devices within the specified range of the devices. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect this equipment and should be kept at least a distance 3.3 meters or 11 feet from the HomeSafe/GoSafe devices
(based on a typical cell phone with a maximum output power of 2 W). 47 Maintenance Expected Service Life The Expected Service Life of the HomeSafe/GoSafe Devices are as follows:
Wireless Communicator (7000C) 4 years Landline Communicator (7000L) 4 years HomeSafe Personal Help Button (7000PHB) 5 years HomeSafe AutoAlert Help Button (7000AHB) 1.5-2 years*
GoSafe Mobile Help Button (7000MHB/7100MHB) 2-3 years*
*Usage Dependent The Service Life indicated above is based on the expected life of the devices internal batteries. Actual performance may vary depending upon conditions concerning charging, discharging, temperature, and other factors. Power Supplies, Extension Cords and Power strips Route the power supply cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by chairs or other furniture. Do not use extension cords or power strips with this device. Latex This product does not contain natural latex rubber or dry natural rubber in user or operator accessible areas. Passing the product on to another user (excludes GoSafe Mobile Button) This product cannot be passed to another user by an existing user. In the event an existing user wishes to end their service, they must return the devices to Philips Lifeline or their representative 48 Technical Specifications Standards Compliance This device is designed to conform to the following standards:
IEC/ANSI/ AAMI60601-1:2005/R(12)2012, 3rd edition, Part 1- General requirements for basic safety and essential performance. CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. IEC/UL/CSA 60601-1, 2nd Edition (2003), Medical Electrical Equipment, Part 1: General Requirements for Safety (except for 7100MHB). IEC 62133, Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. IEC 60601-1-2, 3rd Edition (2007-03), General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests IEC 60601-1-4, 2nd Edition (2000), Collateral standard: Programmable Electrical Medical Systems (except for 7100MHB) IEC 62366, 1st Edition (2015), Medical devices Application of usability engineering to medical devices IEC 60601-1-6, 2nd Edition (2004), Collateral standard: Usability (except for 7100MHB) IEC 60601-1-6, 3rd Edition (2013), Collateral standard: Usability IEC 60601-1-8, 2nd Edition (2006), Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-11, 2nd Edition (2015) Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
(Biocompatibility) ISO 14971, 2nd Edition (2007), Medical devices Application of risk management to medical devices CSA C22.2 No. 205-12 (2012), Signal Equipment(Canada). CFR47 FCC Part 15 Subpart B, Sections15.207 & 15.209;
CFR47 FCC Part 15 Subpart C, Section 15.247. CFR47 FCC Part 15 Subpart E. RSS-210 Licence - Exempt Radio Apparatus: Category I Equipment RSS-247; Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-
Exempt Local Area Network (LE-LAN) Devices. RSS-GEN General Requirements for Compliance of Radio Apparatus (Canada) ICES 003 Information Technology Equipment (Including Digital Apparatus) Limits and Methods of Measurement (Canda) CFR47 FCC Part 15 Subpart C, Section 15.249:2012 (7000AHB & 7000PHB) CFR47 FCC Part 15 Subpart C, Section 15.249, October 1, 2011 (7000C, 7000MHB, 7100MHB) CFR47 FCC Part 68 (7000L) UL1635, UL1637 and CSA 22 .2 No. 205 Compliance The maximum separation (range) of the equipment, under open field test conditions and for comparative purposes only, is 600 feet. This range may be significantly reduced when the equipment is installed in a typical home. The 700MHB and 7100MHB comply to UL1635 and UL 1637 when GoSafe are within the range of communicators. For compliance to UL 1637 for U.S. installations only:
A clear, plastic power supply retaining strip is provided in the packaging with this system. Its purpose is to prevent the home communicator power supply from accidentally pulling out of the AC wall outlet under force. To use:
1. Plug the home communicator power supply into the outlet you select to power your system, following the instructions and precautions herein. 2. Clean the wall area roughly 3 on either side of the wall outlet cover with a paper towel or cloth and a general purpose household cleaner such as glass cleaner. Do not use furniture polish or oil-based cleaners for this step as this cleaning is to ensure that the adhesion area is devoid of any dirt, oil or grease that would otherwise prevent the adhesive from sticking properly. 3. Spray the cleaner on the cloth and gently wipe the target area on either side of the outlet cover as described in step 2. Do not spray the cleaner on the wall. 4. Ensure the area you have cleaned is dry prior to proceeding to the step 5. 5. Peel the release liner from the adhesive panels on the strip and affix it across the back of the power supply, adhering the 2 adhesive panels to the wall on each side of the power supply. Environmental Temperature Relative Humidity Atmospheric Pressure Altitude*
*applies to AHB and MHB only Operating 41 F to 95 F
(5 C to 35 C) 10 to 90% (non-condensing) Storage
-4 F to 140 F
(-20 C to 60 C) 10 to 90% (non-condensing) 101 kPa to 77 kPa (approximately 0-7500 ft/0-2286 m) 6,600 feet (2 km) Maximum N/A N/A 61 Electrical 4.8 Vdc, 2000mAH[2], Nickel Metal Hydride Battery (Rechargeable[3]
Internal Battery) 12 Vdc, 1.25 A (Power Supply Output) Class II (To be used with external Class II power supply only) Drip Proof, IP21 Type BF Applied Part Wireless Communicator (7000C), Landline Communicator (7000L) AC Voltage Source[1]
100-240 Vac, 50/60 Hz, 0.5 A (Power Supply Input)
(VAC) DC Power Source
(VDC) Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Water Mode of Operation Sound Pressure Level HomeSafe Personal Help Button (7000PHB) AC Voltage Source[1]
(VAC) DC Power Source
(VDC) Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Water Mode of Operation Water Resistant (1 meter, for 30 Minutes), IPX7 Continuous 92-106 dB at 1 kHz (measured 10 cm from the speaker) N/A - Internal battery Type BF Applied Part Continuous Class II 3.2V, 225mAh[2], Manganese Dioxide Lithium Coin Primary Battery 62 3.6 Vdc, 1200mAh[2], Lithium-thionyl chloride (Li-SOCl2) Primary Battery HomeSafe AutoAlert Button (7000AHB) Water Resistant (1 meter, for 30 Minutes), IPX7 N/A Class II Continuous Type BF Applied Part AC Voltage Source[1]
(VAC) DC Power Source
(VDC) Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Water Mode of Operation GoSafe Mobile Help Button (7000MHB/7100MHB) AC Voltage Source[1]
N/A for 7000MHB & 7100MHB. Battery charger rated: 100-240Vac, 50/60Hz, 0.5A
(VAC) DC Power Source
(VDC) Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Water Mode of Operation Sound Pressure Level Type BF Applied Part Class II Water Resistant (1 meter, for 30 Minutes), IPX7 Continuous 116-123 dB at 1 kHz (measured 1 cm from the speaker) 3.7 Vdc, 920mAh[2], Lithium Ion Rechargeable [4] Battery
[1] The means of isolating the device from the supply mains is by disconnecting the device from the wall outlet.
[2] The capacity restored by the cell varies according to current drain, temperature and cut-off.
[3] Recharging of the backup battery is done automatically, as needed, when the device is plugged into an AC power outlet.
[4] Recharging of the GoSafe Mobile Button battery is done by the user as needed, when connected to the charger. 63 Product Disposal Environmental Requirements Introduction Philips Lifeline is concerned to help protect the natural environment, and to help ensure continued safe and effective use of this product, through proper support, maintenance and training. Therefore Philips products are designed and manufactured to comply with relevant guidelines for environmental protection. As long as the product is properly operated and maintained, it presents no environmental risks. However, the product may contain materials, which could be harmful to the environment if disposed of incorrectly. Use of such materials is essential to performing the functions of the product, and to meeting statutory and other requirements. Final disposal of the product Final disposal is when the user disposes of the product in such a way that it can no longer be used for its intended purpose. In the event a user wishes to end their service or no longer needs the HomeSafe/GoSafe devices, it must return the device to Philips Lifeline or their representative for proper disposal. Philips supports users in:
Recovering reusable parts. Recycling of useful materials by competent disposal companies. Safe and effective disposal of product Electromagnetic Comparability - EMC Medical electrical equipment can either generate or receive electromagnetic interference. The HomeSafe/GoSafe devices have been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 6060-1 collateral standard IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment. The HomeSafe/GoSafe devices comply with relevant laws and standards on electro-
magnetic compatibility (EMC) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from this product and its required immunity to electromagnetic interference from external sources. The HomeSafe/GoSafe devices must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. Other electronic products exceeding the limits defined in such EMC standards could, under unusual circumstances, affect the operation of the product. 1. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents. 2. Other equipment such as Portable and Mobile RF Communications Equipment may interfere with the medical device even of the other equipment complies with CISPR emission requirements . 3. The use of accessories and cables other than those specified, with the exception of those sold by the manufacturer may result in increased emissions or decreased immunity of the equipment or system. 4. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. xx EMC Informational Tables Table 1 - Guidance and Manufacturers Declaration Emissions The EUT
"HomeSafe/GoSafe devices are intended for use in the electromagnetic environment specified below. The 7000MHB and 7100MHB devices are provided with battery power adapter charger. The customer or user of the HomeSafe/GoSafe should ensure that it is used in such an environment. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonics IEC 61000-3-2 Flicker IEC 61000-3-3 Compliance Group 2 Class B Electromagnetic Environment Guidance The HomeSafe/GoSafe devices must emit Electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. N/A for EUT Class A for charger Complies The EUTsBattery Powered. The GoSafe 7000AHB and 7100MHB power chargers are suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Table 2 - Guidance and Manufacturers declaration Immunity The HomeSafe/GoSafe devices are intended for use in the electromagnetic environment specified below. The customer or user of the HomeSafe/GoSafe should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Test Level 6kV Contact 8kV Air Compliance Level 6kV Contact 8kV Air Electrostatic Discharge (ESD) EN/IEC 61000-4-2 Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are synthetic the relative humidity should be at least 30%
Electrical power quality should be that of a typical commercial or hospital environment. Electrical fast transient/burst EN/IEC 61000-4-4
(only for devices with battery charger power supply-7000MHB &
7100MHB) 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines Immunity Test EN/IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Surge EN/IEC 61000-4-5
(only for devices with battery charger power supply
-7000MHB & 7100MHB) Power Frequency 50/60Hz Magnetic Field EN/IEC 61000-4-8 Voltage dips, short interruptions and voltage variations on power supply input lines EN/
IEC 61000-4-11
(only for devices with battery charger power supply -7000MHB &
7100MHB) 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 Mains power quality should be that of a typical commercial or hospital environment. 3A/m 3A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment.
<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 sec.
<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 sec. Electrical power quality should be that of a typical commercial or hospital environment. During charging, if the the user of the GoSafe (7000MHB/7100MHB) requires continued operation during power mains interruptions, it is recommended that the GoSafe device power adapter is powered from an uninterrupted power supply or a battery. NOTE : UT is the a.c. mains voltage prior to application of the test level. Table 4 - Guidance and Manufacturers declaration Immunity The HomeSafe/GoSafe are intended for use in the electromagnetic environment specified below. The customer or user of the HomeSafe/
GoSafe should ensure that it is used in such an environment. Immunity Test Conducted RF EN/IEC 61000-4-6 EN/IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz Compliance Electromagnetic Level 3 Vrms*
Environment Guidance D=1.17P D=0.35P 80 to 800 MHz Radiated RF EN/IEC 61000-4-3 10 V/m 80 MHz to 2.5 GHz 10V/m D=0.70P 800 MHz to 2.5 GHz Portable and mobile communications equipment should be separated from the HomeSafe/GoSafe by no less than the distances calculated/ listed below*:
D=(3.5/V1)(P) D=(3.5/E1)(P) 80 to 800 MHz D=(7/Eq)(P) 800 MHz to 2.5 GHz where P is the maximum power in watts (W) and D is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,(a) 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: Conducted RF Immunity does not apply to an internal battery operated devices (7000PHB, 7000AHB, 7000MHB and 7100MHB). Limit above is set for the battery charger For assistance, call 1-800-635-6156 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 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 HomeSafe/GoSafe is used exceeds the applicable RF compliance level above, the HomeSafe/
GoSafe should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the HomeSafe/GoSafe.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 6 - Recommended Separations Distances between Portable and Mobile RF Communications equipment and HomeSafe/GoSafe devices The HomeSafe/GoSafe are intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the HomeSafe/GoSafe can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communication Equipment and HomeSafe/GoSafe as recommended below, according to the maximum output power of the communications equipment. Max Output Power (Watts) 0.01 0.1 1 10 100 Separation (m) 150kHz to 80MHz d = 1.17P*
0.117 0.37 1.17 3.7 11.7 Separation (m) 80 to 800MHz d = 0.35P
.035
.11068
.35 1.1068 3.5 Separation (m) 800MHz to 2.5GHz d = 0.70P
.07
.22136
.7 2.2136 7 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. Symbols Symbol 64 Description Symbol for DC (Direct Current) Power. Polarity symbol. Indicates that the center (tip) of the output plug is Positive (+) and the barrel of the output plug is Negative (-). The power supply efficiency performance is Level 5, indicating a high standard in use efficiencies and no-load power consumption. Symbol to indicate for indoor use only. The CE Mark is a conformity symbol for European countries. The symbol stands for Conformit Europenne. A Class II or double insulated electrical device. This is one which has been designed in such a way that it does not require a safety connection to electrical earth (ground). The TV logo is a certification mark of TV Rheinland, a Nationally Recognized Testing Laboratory (NRTL). The C on the left of the mark denotes compliance in Canada and the US on the right indicating compliance for the US. The symbol for WEEE Waste Electrical and Electronic Equipment. This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. Note: Please return the HomeSafe/GoSafe devices to Philips Lifeline or your Philips Lifeline representative for proper disposal. The ETL Listed Mark demonstrates compliance to the requirements of widely accepted product safety standards, as determined through independent testing and periodic follow-up inspections by a Nationally Recognized Testing Laboratory (NRTL). The C on the left of the mark denotes compliance in Canada and the US on the right indicating compliance for the US. The IP Code, or Ingress Protection Rating, classifies and rates the degree of protection provided against the intrusion of solid objects
(including body parts such as hands and fingers), dust, accidental contact, and water in mechanical casings and with electrical enclosures. A rating of IP21 provides a protection against access to hazardous parts with a finger and ensures dripping water (vertically falling drops) has no harmful effect on the device. Device is protected against the effects of continuous immersion in water (up to 1 m of submersion for 30 minutes). Type BF Applied Part Consult accompanying instructions for use. Symbol for non-ionizing radiation. Indicates that the device(s) include(s) RF transmitters. Indicates the device manufacturer. Indicates the date when the device was manufactured. Use by Date. Indicates the manufacturers batch code so that the batch or lot can be identified. Indicates the manufacturers catalog number so that the device can be identified. Indicates the manufacturers serial number so that a specific device can be identified. To identify the temperature limits, for example on transport packaging to indicate limits within which the package has to be kept and handled. The temperature values may be shown adjacent to the symbol. To indicate the acceptable upper and lower limits of relative humidity for transport and storage. Refer to instruction manual/booklet 65 Notes 66 67 Philips Lifeline 111 Lawrence Street Framingham, MA 01702-8156 Tel: 1-800-451-0525 www .lifelinesystems .com Philips Lifeline Canada 95 Barber Greene Road, Suite 105 Toronto, Ontario, Canada M3C 3E9 Tel: 1-800-387-8120 www .lifeline .ca 2015. All rights reserved. Signal range may vary due to environmental factors. P/N 0940837, Rev. 0X
1 2 | Manual 2 | Users Manual | 2.72 MiB | / December 12 2017 |
Medical Alert Service Instructions for use GoSafe Lite 2 Mobile Personal Emergency Response System and Service Instructions for use draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. 2 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Contents Philips Lifeline Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Welcome to Philips Lifeline Setting up your Lifeline Service Responders and People to Notify Calling for help Signal Range Battery information Equipment service Contact Philips Lifeline or your representative GoSafe 2 Mobile System Help Buttons General Information . Setting up a replacement Help Button Cleaning
. . . . . . . . . . . . . . . 17 GoSafe Mobile 2 Mobile Pendant (7150 MHB) . . . . Charging the battery Sleep mode Recommended usage 20 Safety and Regulatory Compliance . . . . . . . . . . . . . . . . XX IEC regulations System classification Radio specifications FCC Notice to Users Compliance Intended Use Compatibility Risks and Benefits Training Safety Maintenance GoSafe 2 Mobile Pendant Alarms Alarm Descriptions /
Summary Tables Technical Specifications 3 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. About This Manual Training Reading and understanding these Instructions for Use and the Quick Setup Guide serves as adequate training for the safe installation, use and disposal of the equipment. Users of this product must review and understand the instructions for use document to ensure safe and effective use. If you require further information about training in the use of this product, please contact Philips Lifeline or your Philips Lifeline representative. Definitions & Clarifying Terminology 7150 MHB: The technical /Model name for the GoSafe Lite Pendant for FDA registration purposes. This name is used in the Alarms and "Safety and Regulatory Compliance sections . Alarm State: When you press the Help Button or when an un-
recovered fall is detected, the Pendant will initiate a help call to Philips Lifeline. During this time, until the Pendant is reset, the Pendant is in alarm state. Certain behaviors described herein only take place during Alarm State. Audio Beacon: A very loud, siren-like noise generated by the Pendant. It is designed to help responders find you more easily while searching for you. AutoAlert: The Philips fall detection technology that is used by the GoSafe Lite Mobile Pendant. Call Center: The Philips Lifeline call center. 4 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Charger Pins: The gold pins on the charger itself that engage with the charging interface contacts. Charging Interface Contacts: The gold circles on the back side of the pendant. Coverage Area: The area from which your pendant is capable of sending & connecting a help call. As a cellular communication device, the coverage area for GoSafe Lite is defined by the cellular network availability and signal in your location, at the time of activating the pendant. Refer to the Terms and Conditions of Use document you received with your system for details on the limitations of cellular service. Critical Charge Indication: The point at which the Pendant no longer has sufficient battery power left to operate normally. It will play a voice prompt and turn off at this point. End Device: The device that initiated the alarm. In this case, the GoSafe Lite Pendant. GoSafe Help Button or Help Button: The button is the depressed square area inside the grey field on the front of the pendant itself. When pressed, an immediate call to the Philips Lifeline Call Center is placed. To initiate a call to Philips Lifeline, press the Help Button. A voice prompt and Red light will confirm that you have activated the pendant and that your call is in progress. GoSafe Lite: GoSafe Lite is a product-enabled service. The mobile pendant that you wear works in conjunction with the mobile network to connect to the Philips Lifeline response service. Together, the pendant, network and response center comprise the service elements. 5 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. GoSafe Lite Mobile Pendant, or Pendant: This is the pendant that you physically wear around your neck. Also, known as the 7150 MHB. Help Alarm Signal: This is the type of signal that the Philips Lifeline call center receives from the Pendant when the Help Button is pressed. Indicator Light: A small light just above the Help Button, inside the grey area on the front of the Pendant. It will illuminate in either green, orange or red, and either blink or shine consistently depending on what it is indicating. A complete guide to the different colors and whether they are blinking or not is included at the back of this Instruction. Initial Charge Indication: The Pendant chimes and the orange Indicator Light starts to blink. This is the point at which you should re-charge your Pendant. Intended Use: The purpose for which the system was specifically designed. GoSafe Lite was designed for people to wear to help maintain their independence, knowing that if they need assistance at home or away, they can call for help. Lifeline: The emergency response service provided by Philips Lifeline Notify: An individual who will be advised, after the fact, of any alarm whereby assistance was required. A person or persons who you want to be told if you experienced an emergency whereby Philips Lifeline was engaged to facilitate response. Notifies will not be advised of false alarms or test calls. 6 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Philips Lifeline: the name of the company that provides GoSafe Lite and the Lifeline emergency response service. Recommended Usage: How you should use and interact with the Pendant can Call Center for normal use. Responder(s): If you should need emergency assistance and activate your Lifeline system, a responder is someone you want Philips Lifeline to contact to physically go to you and help you. You can have more than one responder. In an emergency, Philips Lifeline will contact them in prioritized order until we are able to connect with someone that can get to you and help you. Response Associate: A Lifeline operator. Response Associates are trained to take emergency calls and facilitate assistance for Lifeline subscribers. Sleep Mode: The Pendant is essentially turned off. When in Sleep Mode, the Pendant will not detect falls, will not automatically update its location information, and will not make a help call with a single button press. Stand-by mode: This is the mode that the Pendant is most often in while you are wearing it. The pendant is powered-on, with all systems functioning, but is not in Alarm State. Subscriber: A user of the Lifeline Personal Emergency Response Service. Also, User. 7 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Your Philips Lifeline Service Welcome to Philips Lifeline Thank you for choosing the Lifeline Medical Alert Service from Philips. Please refer to the Quick Setup Guide provided for instructions on setting up your equipment. These Instructions for Use will provide you with information about your equipment and the Philips Lifeline Medical Alert Service. Please read this manual and the Quick Setup Guide carefully, and note the Warnings and Cautions. If you have questions, call Lifeline at any time using the number listed at the bottom of the page. Please save this manual. It includes important information you may need to refer to later. Warnings and Cautions Please pay special attention to all the instructions provided in the Warning and Caution sections. A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury, and/or cause environmental pollution. 8 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. These Instructions for Use and the Quick Setup Guide describe the most extensive configuration of the product. This manual covers the following:
GoSafe Lite Mobile Pendant (7150MHB) Works inside and outside of your home*
Can only be worn around neck as a pendant Can detect falls** in your home Can detect falls** outside*
your home 2-way voice communication with Philips Lifeline Waterproof to 1 meter (3.3) for up to 30 minutes
* When access to the AT&T wireless network is available.
** The GoSafe Lite Mobile Button provides an extra layer of protection by placing a Help Call if a fall is detected and you cant push the Button. Not all falls can be detected. If you need help, always press your Help Button if you are able to do so. Setting up your Lifeline Service Before you can use your GoSafe Lite system, the coverage range of your Help Button must be determined. Please see the Quick Setup Guide for instructions on how to set up your system and test the coverage range of your Help Button. If you have any questions, please contact Philips Lifeline or your representative. 9 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Responders and People to Notify What is a Responder?
As a Philips Lifeline subscriber, you should have designated people who have agreed to be Responders. These are people whom Lifeline should call in an emergency, when appropriate. Examples include: neighbors, friends, relatives, your current nursing aide, etc. Choosing a Responder It is best to choose a Responder who:
Has a key to your home or knows where one is located
(perhaps in a key lockbox) Could come to help you at different times of the day or night Lives or works within 10 minutes of where you live Has a phone, preferably a cell phone Ideally has a drivers license and access to a vehicle Since the GoSafe Lite System allows you to call for help both at and away from home, it is best to choose a Responder who can also:
Drive to your location, whether you are at home or away from home, and provide help if needed. Information Philips Lifeline needs about Responders Please ensure that Philips Lifeline has the following information about each person acting as a Responder:
Name Phone numbers home, work and cell phone Whether or not the Responder has a key to your home 10 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Its very important that you keep your Responders and their contact information up to date. Remember to contact Philips Lifeline if one of your Responders is no longer able to assist you or if they get a new telephone number. Please contact Philips Lifeline for any questions about selecting or being a Responder. Most importantly, if you list someone as a Responder, make sure you tell that person that you have done so, and that they agree to act as a Responder. Who are People to Notify?
If you use your Lifeline system to call for help, after response has been facilitated, Philips Lifeline will contact the People to Notify identified in your subscription profile to let them know that you received assistance. People to Notify will not be contacted to help you, unless they are also on your list of Responders. Neither responders nor notifies will be contacted in the event of a test signal or when you activate your system but do not need help such as during an accidental button press. Calling for help inside your home 1. Press the button area on the GoSafe Lite pendant Help Button that you wear. The pendant will tell you that your call is in progress, and to please wait. Once the call has registered with the Lifeline response center, your button will tell you that your call has been connected. This means that our system has compiled all of your information and is being delivered to a Lifeline response associate who will call you momentarily. 11 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Note: The Response Center is available 24 hours a day, 365 days a year. Your Lifeline subscription provides for unlimited calls to the response center without penalty. A trained Personal Response Associate is always available to assist you. 1 Help call in progress. Please wait. 2 Hello, Mrs. Smith. Do you need help?
2. Your Pendant calls the Lifeline Response Center. When it dials the Response Center, your pendant will repeatedly say:
Your Help Call is in progress; please wait. Once it connects with the Response Center, it will say: Your call has been connected; Lifeline will be right with you. It is normal to experience a slight delay prior to speaking with a response associate. 3. The Response Center will answer the call. A Lifeline Response Associate will speak to you through the pendants built-in speaker and hear you through the highly sensitive microphone. He/she will ask if you need help. If you do not need help, just tell the Response Associate that no help is needed. 12 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Note: If you cannot speak or be heard, the Response Associate will try calling you back. If you cannot answer or if the Response Associate cannot hear you, Lifeline will contact your Responder(s) or emergency services.*
*In the case of a fall detected, if the response associate cannot hear you and/or is unable to contact you through your GoSafe Lite pendant or your alternate contact numbers such as your home or cell phone, EMS will be contacted to respond. Please contact Philips Lifeline to opt out of this escalation protocol. 4. The Response Center will assess the situation. If help is needed, the Response Associate will begin contacting your list of Responders (or emergency services) in accordance with your request, until they are able to reach someone who accepts the action of going to help you. 5. Once your Responder or the emergency service arrives, they should press your Help Button to let Lifeline know that help has arrived. The Response Associate will contact the household to confirm that you received the help that you needed. [Need to check this behavior]
6. Once Lifeline confirms that you have been assisted, a Response Associate will contact the People to Notify youve designated, letting them know you needed and received help. Note: If you accidentally press your Help Button dont panic. Allow the call to connect. A Response Associate will answer your call and ask if you need help. Simply tell them that No help is needed, and confirm to them that you are OK. Dont be concerned that you are bothering Lifeline; we just want to be sure that you are alright. This is part of the serivce that you are paying for and there is no extra charge for accidental calls. 13 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Signal Range Please see the Quick Setup Guide located in the box for instructions on how to set up your GoSafe Lite system. and test the range of your Help Button. The coverage area of the your Help Button must be tested prior to use. The GoSafe Lite pendant is a radio frequency (RF) device that transmits a signal to the Lifeline call center over the Cellular network. It depends upon cellular network availability to send your help signal to the Lifeline call center. Signal availability inside of your home is defined during the system setup process, but can vary from time to time depending on multiple factors. It is recommended that, once your welcome/setup call is complete, you go to areas of your home where you commonly spend time, as well as areas where you are most likely to have an accident such as the bathroom and kitchen to help ensure that your GoSafe Lite pendant has sufficient signal to operate reliably. Caution
[add note about cellular limitations indoors here], for example: The strength of the wireless (cellular) signal, etc.... same as in page 16. Note: Your GoSafe Lite pendant is designed to work inside and outside of your home from anywhere sufficient connectivity to the AT&T cellular network is available. When you activate your pendant away from home, Help will be sent to your location. Please refer to page 24 for further information. It is important to note that the ability of your GoSafe Lite Pendant to make a help call may be affected by environmental factors, including building materials, large masses covering the Help Button (i.e. a person laying on top of it) and submersion in liquid. 14 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Signal Range Test Battery information Your GoSafe Lite mobile pendant contains a battery that can only be replaced at the Philips factory. Your pendant will automatically send a signal to Philips Lifeline when the battery needs to be replaced. We will contact you directly to make arrangements for a replacement. Equipment service Every GoSafe Lite mobile pendant is manufactured to high quality standards, and can only be factory-serviced by Philips Lifeline, with the exception of the neck cord, which can be replaced by the user. You can only replace the neck cord with a Philips replacement neck cord designed specifically for your pendant. Your GoSafe Lite pendant performs periodic diagnostic self-tests to verify proper functionality. If you ever experience issues with your equipment, or if it becomes damaged, please contact Philips Lifeline or your representative to arrange service or a replacement.. Contacting Philips Lifeline or your representative If you would like to transfer your service to a new or second home. If your Responder or People to Notify list needs to be updated. It is important that your list is up to date with the correct people and contact information. If someone else in your home needs to use the Lifeline Service. More than one person living in the same household 15 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. can have the service, but each individual user requires their own pendant. Safety information CAUTION:
The GoSafe Pendant uses the AT&T wireless network to communicate with the Lifeline Response Center. 1. The strength of the wireless (cellular) signal may be stronger in some areas of your home than others. Be sure to test your GoSafe pendant from the locations in your home where you spend the majority of your time to help to ensure that the pendant is capable of connecting to the cellular network from these areas. 2. If the AT&T wireless network experiences an outage or your pendant loses its signal, it will not be able to send a Help Call to Lifeline. 16 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. GoSafe Lite Mobile Personal Emergency Response System General Information The information in this section applies to your GoSafe Lite Pendant. Cleaning and Care Your GoSafe Lite pendant is water resistant to the IPX7 standard. This means that you can submerge it in up to 1 meter
(about 40) of water for up to 30 minutes without damaging the pendant. As such, you can submerge it in warm water for easy cleaning and can also bathe/shower without removing it. 1. Wash the neck cord with a mild liquid dishwashing detergent. Replacement neck cords are available from Philips Lifeline for a nominal fee and include a convenient tool that simplifies replacement. 2. Wash the Help Button under warm running water. You may also gently wipe it with an isopropyl (rubbing) alcohol wipe or a cotton pad moistened with alcohol. However, do not soak it in alcohol or pour alcohol into the microphone or speaker area of the pendant. 3. Blot excess moisture with a towel and allow the Help Button to finish air-drying while youre wearing it. 17 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Note: If you accidentally push your Help Button during cleaning, dont panic. Allow the call to connect. A Personal Response Associate will answer the call when it connects. Simply tell them that No help is needed, and confirm to them that you are OK. Warnings Any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries. This may be of more concern to wearers in wheelchairs, using walkers, using beds with guard rails, or who might 8235 Model: 7000AHB 2000148235-YYYYMMDD FCC: BDZ7000AHB IC: 655C-7000AHB encounter other protruding objects upon which the cord can become tangled. The neck cord on your GoSafe Lite pendant employs a special fuse (see image below). This fuse is designed to break away under certain conditions to reduce the remote risk of strangulation. If this fuse breaks apart, contact Philips Lifeline or your authorized representative for a replacement, as the fuse cannot be repaired or re-used. 18 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Do not use any neck cord other than the one provided by Philips Lifeline or your representative. Other neck cords may not provide the feature to break apart therefore increasing the risk of strangulation. Do not tie a knot in your neck cord since this may prevent the break away feature from working properly. There are no user-serviceable parts inside the pendant. Do not attempt to open or modify the device. The pendant contains a lithium battery that must be disposed of properly. Do not discard the pendant in the trash or expose it to flames or intense heat. The pendant is not suitable for use in the presence of flammable mixtures. Do not put your pendant through the dishwasher, clothes washer or dryer. Please be sure to remove your pendant from articles of clothing that are being dry-cleaned. Excessive heat may damage your pendant. Do not leave your Help Button on the dashboard of your car, a window sill or on any other area that receives intense, direct sunlight. Likewise, do not wear your Help Button into a hot tub or sauna. Normal bathing and showering temperatures WILL NOT damage your Help Button. Caution Your Help Button may interfere with certain medical equipment, such as magnetic resonance imaging (MRI), X-Ray machines, as well as metal detectors. 19 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. GoSafe Lite Mobile Pendant
(7150MHB) The GoSafe Lite Mobile Pendant allows you to connect to the Lifeline Response Center 24 hours a day, 7 days a week. It can be used at home, or from any other location in the United States where the AT&T wireless network is available. The GoSafe Lite Mobile Pendant includes Philips AutoAlert fall detection technology, which provides an added layer of protection for the user by automatically calling for help when a fall is detected. AutoAlert technology is highly accurate, but does not detect 100% of falls. If you are able, you should always press your Button when you need help. 20 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. 21 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. GoSafe 2 Pendant (7150MHB) Front view Indicator light This light will indicate the status of the GoSafe Lite Pendant.
(see: Alarm Descriptions /
Summary Tables section.) Microphone The GoSafe Lite Mobile Pendant has a microphone that is used to talk to the Response Associate Help Button The Help Button is the portion of your Pendant that can be pressed to send a Help Call to Lifeline. Charger The GoSafe Lite Mobile Pendant has a rechargeable battery. Use only the charger provided with your GoSafe system to recharge the Pendant when the light &
voice prompts indicate indicates that the Pendant needs to be charged. See the Charging the battery section on page 28. 22 Button activation area Charger Excess cord storage Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-FacingWebsite Not for dissemination to the public without the express written consent of Philips. Back view Speaker The GoSafe Lite Mobile Pendant has a built-
in speaker that allows you to hear the Personal Response Associate, voice prompts and alert sounds. Charging Contacts The gold circles on the back of the Pendant are the charging interface contacts. When you place your Pendant in the Charger, the charger Pins engage with these contact points. Important: This area is part of the fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products). 23 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Determining your location In Alarm State, the GoSafe Lite Mobile Pendant is designed to help identify your general location, at or away from home. However, you should always tell the Personal Response Associate your exact location if you are able to do so. Even if you are unable to speak or describe your exact location, Lifeline will contact help to find and assist you where you are. Lifeline cannot guarantee that your location can be determined at all times. If your Responder or emergency services is having trouble locating you, Lifeline may activate the audio beacon feature on the pendant. This is a very loud, siren-like noise that will come from the Pendant speaker and will help responders to find you more easily. Each time the audio beacon is activated, it will sound for 5 minutes. Pressing the Help Button will silence the audio beacon and will not initiate another Help Call. 24 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. What to expect when the AutoAlert fall detection technology in your GoSafe Lite Mobile Pendant detects a fall A Help Call is automatically generated after approximately 30 seconds of a fall being detected While the fall may be detected in only a few seconds, the 30 second period is provided for users to self-recover from a fall if able. If the Button detects that you have self-recovered from the fall, within approximately 30 seconds of a fall being detected, a Help Call will not be generated. Do not attempt to stand if you feel unable to. Regardless of whether you have fallen or not, if you think you need assistance, always push the Help Button immediately to initiate the Help Call if you are able to do so. Pushing the Help Button generates the Help Call immediately. If your Pendant has detected a fall but 30 seconds have not yet passed, pressing the Help Button WILL NOT cancel the help call. It will send the help call immediately. Limitations on Fall Detection The AutoAlert fall detection technology may not detect every fall. In certain situations, the AutoAlert Help Button may not detect a fall. Some movements may not register as a fall and would not be detected. Examples include, but are not limited to:
A gradual slide such as from a seated position 25 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Lowering oneself slowly to the ground (to brace the impact of a fall) A fall from a height of less than 20 inches (0.5 meters) Caution Certain conditions can affect the ability of the AutoAlert Help Button to detect a fall:
If you live at an altitude above 6,600 feet (2000 meters) If you are less than 4 feet 6 inches in height (1.4 meters) If you weigh less than 88 pounds (40 kilograms) However, the ability to send a help call by pressing the button is not affected by such conditions. False fall detected alarms may occasionally occur While the GoSafe Lite Mobile Pendant is designed to have very few false alarms, a fall detected alarm it might occasionally occur when there was not a fall (i.e., a false alarm). This is considered normal operation. If this occurs, please simply dont panic. Allow the call to connect. A Philips Response Associate answer the call when it connects. Simply tell them that No help is needed, and confirm to them that you are OK. There are no additional charges for false alarms. Note: Occasional false alarms do not indicate that the GoSafe Lite Pendant is malfunctioning. Warning About fall detection In certain situations, the Pendant may not detect a fall. A gradual slide from a seated position such as from a wheelchair may not register as a fall and would not be detected. If you fall and need help, always press the Help 26 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Button if you are able to. Note that if your Pendant did detect the fall and is already in-process of calling Lifeline, pressing the button WILL NOT cancel or interrupt the call already in-progress, and will not interfere with system operation in any way. The vent area located on the back of the Pendant is part of the AutoAlert fall detection sensor system and needs to remain clear of obstructions
(e.g., lint or food products). A continuous flow of water (e.g., a shower) hitting the vent directly may also temporarily obstruct the vent. However, your Pendant should be worn at all times as it is waterproof for showering and bathing. Back view CAUTION Potential Interference Do not use the GoSafe Lite Mobile Pendant if you have an implantable cardiac device, such as a defibrillator or pacemaker. The GoSafe Lite Mobile Pendant may interfere with certain medical equipment, such as magnetic resonance imaging (MRI), X-ray machines, Automatic External Defibrillators, cardiac monitors, pacemakers, insulin pumps, hearing aids, as well as metal detectors. Air Travel Because it is a cellular communication device, the GoSafe Lite Pendant may interfere with aircraft communications while in normal Stand-by mode. For this reason, the Pendant has a 27 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Sleep Mode. Be sure to place your Pendant in sleep mode when on an airplane. Please see instructions for putting your GoSafe Mobile Button in Sleep Mode on page 31. The GoSafe Mobile Button can only place a Help Call when in Stand-by mode, and when the AT&T wireless network is available. Charging the battery Flashing orange light
= charging needed Flashing green light = charging in progress When connected to the charger, a steady green light
= fully charged Your GoSafe Lite Mobile Pendant is powered by a rechargeable battery. This means that it must be re-charged regularly, as indicated, for proper function. The Pendant will chime once and 28 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. the Indicator Light will flash orange whenever it initially needs to be charged. Typically, it will take less than 45 minutes to charge your GoSafe Mobile Button if you put it in the charger at this initial charge indication point. It will take longer than this if you wait additional time after this indication point to put the Pendant in the charger. Your Pendant is fully charged when it chimes and the Indicator Light turns to a steady green. If you do not charge the Pendant at the time of Initial Charge Indication, the battery charge will continue to deplete and the orange light will continue to blink. Once it reaches a critical power state, the Pendant will reach the Critical Charge Indication. When this happens, the Pendant will play a voice prompt: Your Help Button is not out of power and will shut down. Please charge your device as soon as possible. It may take more than one hour to charge your Pendant if it reaches this point, but will not hurt the device. Warning: once the Critical Charge Warning is played and the Pendant shuts down, it cannot be used to make a help call of any type until it is re-charged. When charging:
1. Make sure the charger is plugged into a power outlet (wall plug) that is receiving power. For this reason, we do not recommend plugging the charger into outlets controlled by a wall switch, or power strips unless you can confirm that they are powered on. 2. Attach your GoSafe Mobile Button to the charger. You will hear a chime and a voice prompt that says I am now charging. My light will turn solid green when I am ready to use. to acknowledge that you are charging. The Indicator Light will begin flashing Green. 29 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. 3. Charge until the light turns to a steady green. To provide the user with the longest possible battery life between charges, there is no constantly illuminated power indicator. Instead, the Pendant includes a shake to indicate feature. 4. Remove from the charger. The green light will turn off, and the Button is ready to use. 5. To provide the user with the longest possible battery life between charges, there is no constantly illuminated power indicator. Instead, the Pendant includes a shake to indicate feature. To determine if your GoSafe Mobile Button is powered on, hold it in your hand and shake it briefly, watching the Indicator Light while shaking. A flashing green light means that the Button has battery power. No flashing green light means that the battery is dead and needs to be charged or, it is in sleep mode. Important reminders You should continue wearing your Pendant while it is being charged. Please be cautious not to trip on the cord. When you are charging your Pendant while wearing it, be sure to remove it from the charger prior to standing up. Failure to do so may compromise the fall detection capability of your GoSafe system. Do not charge your Pendant while sleeping or bathing. Battery life varies based on activity level, Cellular signal strength in your area, battery age, and actual emergency use. Your GoSafe Lite Pendant provides audible and visual reminders of when to charge. You should charge it when it 30 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. indicates charging is needed. In general, you will have to charge your GoSafe Lite Pendant once every 2 days. Sleep mode The GoSafe Lite Mobile Pendant utilizes cellular communication technology. As such, you must turn it off in the following circumstances:
During Air Travel (when flying on an airplane) regardless of whether you are carrying-on the pendant into the passenger cabin, or if you pack the Pendant in your checked luggage. Either way, it must be placed in Sleep mode. If you are returning the Pendant to Lifeline The Pendant has a sleep mode for these situations. To put the Pendant into sleep mode, press and hold down the Help Button for 10 seconds. Your Pendant will say: If you would like to turn off your Help Button, please press it again. Release the Help Button and then press and release it again without holding it down. The Pendant will confirm it is entering sleep mode by saying: Your Help Button is now turning off. You should take the Pendant out of Sleep Mode as soon as conveniently possible upon exiting the plane to allow it to re-
orient to its new Geolocation. To exit sleep mode, press the Help Button. Your Button will say: Your Help Button is now ready to use. If you need help, please press your Help Button again. This button press that wakes the Pendant out of sleep mode will not initiate a Help Call. If you need help in this instance, be sure to press the Button a second time. 31 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Caution You will not be able to send a Help Call when the Pendant is in sleep mode. Be sure to remember to exit sleep mode as soon as wireless/electronic device use is allowed, e.g., after the airplane has landed. Note: If you are returning a GoSafe Lite Mobile Pendant to Philips Lifeline for service, replacement or recycling, you must contact Lifeline at the number at the bottom of the page before returning it. Philips Lifeline will provide you with special packaging and instructions for return to help ensure that the button does not send signals to Lifeline while in-transit. Do not ship the Pendant without notifying Philips Lifeline that you are doing so. Recommended usage Press the Help Button on your Pendant any time you need help, or in situations/locations outside the home where you want to determine if the AT&T wireless network is available. Wear your GoSafe Mobile Button at ALL times, even when you are away from home. The GoSafe Mobile Button can send a Help Call from any location where the AT&T wireless network is available. 32 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. During an alarm, you can talk to Lifeline using GoSafes microphone and speaker. For best results, hold the pendant up and away from your chest when you are speaking to Lifeline. Maintain a minimum separation distance of 10 mm/ 0.394 inches when operating the device in this manner. Your GoSafe Lite pendant should be worn while showering or bathing. The GoSafe Pendant carries an IPX7 waterproof rating. This means that it can be submerged to a depth of 1 meter in water for up to 30 minutes. It is not designed for submersion deeper than 1 meter for any period of time, and should not be left submerged under water at any depth up to and including one meter for longer than 30 minutes. Do not throw or toss the GoSafe Mobile Button onto a bed, table, or other surface because it may interpret this as a fall and accidentally send a Help Call. Your Pendant may be worn outside of or underneath your clothing depending on your preference. Regardless, it must always be worn as a pendant to help ensure proper function. GoSafe is safe to use while driving. However, when entering and exiting your vehicle, take care to prevent the GoSafe Mobile Button from hitting the steering wheel because it may accidentally send a Help Call. 33 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. GoSafe Lite Pendant Alarms Introduction There are two types of alarms processed by the GoSafe Lite Pendant. High Priority Require immediate response (by the Call Center) Medium Priority Require prompt response (by the operator/user) Additionally, the Pendant also plays verbal informational messages and confirmation alerts that notify you of conditions that need attention but do not qualify as alarm conditions (e.g. installation prompts). Note: If multiple alarms occur at the same time, all alarms are processed and displayed, but the alarms are ordered first by priority and then by occurrence, with the newest, highest priority alarms at the top of the list. The alarm precedence is in the following order: high priority, medium priority, and informational messages. Note: Not all alarms are available in every mode (e.g. during installation); some alarms are mode-dependent. Audible and Visual Alarm Indicators When the device detects a High priority alarm: The light on the Mobile Help Button flashes red, the device audible alarm sounds and a recorded voice message is played. When the device detects a Medium priority alarm: The light on the Mobile Help Button flashes orange, the device may play a chime and/or a voice prompt. Silencing Alarms Once a High Priority alarm is detected, it cannot be silenced. Medium Priority alarms play a sound and possibly a voice prompt once upon detection of the alarm, but the red Indicator Light flashes until the alarm condition is corrected. Resetting an Alarm what does reset mean?
High Priority alarms are normally reset (cancelled once addressed) by the Call Center after the alarm has been responded to. Additionally, the Mobile Help Button may periodically poll the Call Center to see if the alarm should be reset and does so accordingly. If the alarm is not reset by the Call Center, the Mobile Help Button will automatically reset the alarm after 30 minutes. Note: Putting the Mobile Button to sleep during an active high priority alarm will reset the device, but a Voice Message is played requiring the user to confirm this action. Since the Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. alarm has already been reported to the Call Center, they will likely attempt to contact the Subscriber. If an alarm is accidentally initiated by the User, they should not put the Pendant to sleep. Instead, they should wait for the Call Center to establish voice communication and simply state that no help is needed. The Pendant self-cancels certain Medium Priority alarms if the cause of the alarm is corrected, stopping the orange flashing Indicator Light. Alarm Descriptions / Summary Tables Help Needed 7150 MHB Alarm Event Description Priority Help Alarm initiated by the User pressing the Help Button High Device Action Operates normally Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Philips Lifeline?
Yes. Upon pressing the Help Button on the End Device, a Voice Message plays and the Indicator Light LED flashes red. Yes. A Help Alarm Signal is sent to the Call Center by the End Device from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the Help Signal, the Call Center calls the End Device to establish contact with the Subscriber and to see what kind of help they need. Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Help Needed No Cell Signal Available Alarm Event Description Help Alarm initiated by the User pressing the button on the Pendant or by the Pendant detecting a fall; and the AT&T wireless network is unavailble. Then a verbal Warning Message is delivered by the pendant. Priority High Device Action Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Philips Lifeline?
The Help Alarm Signal will be buffered in the device. The device will continue to try to connect to the network and deliver the alarm. It will re-announce the voice prompt every 5 minutes until: the condition is corrected and the alarm signal is delivered, or, 30 minutes has elapsed, or, the battery is exhausted. button re-tries constantly, annunciates every 5 minutes, resets after 30 minutes. Yes. Upon pressing the Help Button on the Pendant or when the Pendant has detected a fall, a Voice Message plays:
Your call cannot be connected. There is no signal strength. Please move to another area. The Indicator Light flashes red. This is an alarm that will self-cancel once connection to the AT&T wireless network is re-established. No. If the AT&T wireless network is unavailable a Help Alarm Signal cannot be sent to the Call Center. Help Needed Fall Detected by Pendant Alarm Event Description Priority Help Alarm initiated by the Pendant detecting a fall. High Device Action Operates normally Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Philips Lifeline?
Yes. When the Pendant has detected a fall, it plays a Voice Message and the Indicator Light flashes red. Voice Message:
Your help call is in progress. Please wait. For proper use, hold your help button up in front of you. Yes. The Pendant sends a "fall detected" Help Alarm Signal to the Response Center from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the
"fall detected" Help Signal, the Response Center calls the Mobile Button to establish contact with the Subscriber and to see what kind of help they need. xx Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Device Error (Medium Priority) Alarms The GoSafe Lite Pendant alarms described below are automatically generated alarms designed to periodically let the Call Center know that the Pendant is working properly They are part of normal operation and are the result of no intensional action by the user. Alarm Event Type Low Battery Capacity 7150 MHB Alarm Event Description When the capacity / life of the battery in the Pendant has diminished materially and should be replaced, a Warning Message is displayed Priority Medium Device Action Charge cycle frequency increases, otherwise. Operates normally until battery is depleted. Alarm Event Reported/Displayed Locally?
No. Alarm Event Reported to Philips Lifeline?
Yes. A silent Maintenance Signal is sent to the Response Center by the device. Upon receiving the Maintenance Signal, the Response Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Battery Requires Charging 7150MHB Alarm Event Description When the rechargeable battery in the Pendant needs to be charged, a visual and audible warning Message is activated on the device. Priority Medium Device Action Operates normally until the battery is critically low. Alarm Event Reported/
Displayed Locally?
Alarm Event Reported to Philips Lifeline?
Yes. The Indicator Light flashes orange and plays a single chime. This alarm will self cancel once the battery charge reaches an acceptable level. No. Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Depleted Battery 7150 MHB Alarm Event Description Priority When the charge level of the rechargeable battery is critically low, a Warning Message is announced. Medium Device Action Device shuts down after the message is announced. Alarm Event Reported/
Displayed Locally?
Yes. Indicator Light flashes orange, Voice Prompt plays: Your help button is now out of power and will shut down. Please charge your device as soon as possible. This alarm will self cancel once the battery charge reaches an acceptable level. Alarm Event Reported to Lifeline?
Yes. A silent Maintenance Signal is sent to the Response Center by the End Device from anywhere wireless signal is available on the AT&T wireless network. Upon receiving the Maintenance Signal, the Response Center stores the status information but no direct action is taken. Device Hardware Failure 7150 MHB Alarm Event Description In the event that internal diagnostics indicate that the Pendant it has a Hardware Error, a Warning Message is displayed if possible based on the nature of the failure. Priority Medium Device Action May have limited operation, depending on the failure Alarm Event Reported/Displayed Locally?
No. Alarm Event Reported to Philips Lifeline?
Yes. A silent Maintenance Signal is sent to the Response Center. Upon receiving the Maintenance Signal, the Response Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Software Failure-End Device 7150 MHB Alarm Event Description Priority In the event that a device senses it has a Software Error, a Warning Message is displayed Medium Device Action May have limited operation, depending on the failure Alarm Event Reported/Displayed Locally?
No Alarm Event Reported to Lifeline?
Yes. A silent Maintenance Signal is sent to the Response Center. Upon receiving the Maintenance Signal, the Response Center prioritizes the response and contacts the Subscriber to verify the status of their equipment.
[No communicator . What happens here?]
Supervision and Check-in Alarms (Informational Messages) The alarms described below are automatically generated alarms designed to periodically let the Lifeline Call Center know that the Pendant is working properly. These alarms are silent and require no immediate action from the User/Subscriber. Alarm Event Type Auto Test Call 7150 MHB Alarm Event Description Auto Test calls are automatically generated silent alarms designed to periodically let the Response Center know that the Pendant is working properly. Priority N/A Device Action Operates normally Alarm Event Reported/Displayed Locally?
Alarm Event Reported to Philips Lifeline?
No visual or audible alarm is generated by the devices. Yes. A silent Maintenance Signal is sent to the Response Center by the Pendant. Upon receiving the Maintenance Signal, the Response Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Supervision Failure 7150 MHB Alarm Event Description End Devices periodically check-in to the Communicator. If the Communicator has not received a check-in from the End Devices for a week, then a silent alarm is sent to the Response Center [What happens here?]
Priority N/A Device Action Operates normally Alarm Event Reported/Displayed Locally?
Alarm Event Reported to Lifeline?
No visual or audible alarm is generated by the devices. Yes. A silent Maintenance Signal is sent to the Response Center by the Home Communicator. Upon receiving the Maintenance Signal, the Response Center prioritizes the response and contacts the Subscriber to verify the status of their equipment. [What happens here?]
Priority of Device Error Alarms Fault Condition Audio Message Delay in Determining Alarms Reporting high priority help alarms from the GoSafe Lite Pendant to the Lifeline Response Center is typically done in less than a minute when generated by a button press, depending on the status of the cellular network and signal strength available clarify time to voice on line. The GoSafe Lite Mobile Pendant provides an added layer of protection by being able to detect falls under certain conditions. This takes approximately 30 seconds to determine that an activity that resembles a fall has occurred, and that the user has not recovered from the fall on their own. If a fall is detected by the 7150MHB, the signal is sent directly to the Response Center via the AT&T wireless nework, if available. xx Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Logging Alarms All alarm events reported to the Response Center are logged by the Response Center. There are no user accessible logs. Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Safety and Regulatory Compliance IEC Regulations The GoSafe Lite Pendant complies with the relevant National and International standards listed in the Technical Section. It is classified as medical electrical (ME) equipment in the USA according to the FDA product classification. According to Health Canada GoSafe Lite Pendant is not classified as a medical device. It falls under the Canada Consumer Product Safety Act. Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment. Refer to EMC section on page xx for details. The GoSafe Pendant must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. The use of accessories, transducers and/or cables other than those specified, with the exception of those sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Device classification The GoSafe Lite pendant is a FDA Class II device. It is an internally powered device for continuous operation. Radio specifications The GoSafe Lite 7150MHB pendant complies with the FCC Parts 15, 22 and 24 Subparts B, C and E. Its radio transmitter have the following characteristics:
Cellular 3G (824-849MHz and 1850-1910MHz transmission bands). Bluetooth ISM band 2.4MHz; maximum EIRP 2 dBm, GFSK modulation WiFi (a, b, g) ISM bands 2.4 MHz and 5MHz; maximum EIRP 15 dBm; OFDM modulation 34 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. FCC Notice to Users This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) Device may not cause harmful interference 2) Device must accept any interference received, including interference that may cause undesired operation. Pursuant to Part 15.21 of the FCC Rules, any changes or modifications not expressly approved by Philips Healthcare, Home Monitoring, Lifeline Systems Inc. could void the users authority to operate the equipment. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. 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 installation. 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. Radio interference This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. For /body-worn operation, this equipment has been tested and meets the FCC RF exposure guidelines. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. Use of other accessories may not ensure compliance with FCC RF guidelines. Do not attempt to repair or modify this equipment. Any repairs or alterations made by the user to the equipment may void the warranty and compliance of the equipment. Changes or modifications made to this equipment not expressly approved by Philips may void the FCC authorization to operate this equipment. For assistance visit our website www.philips.com/support or call toll-free 1-800- Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Industry Canada Notice to Users This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:
1) Device may not cause interference 2) Device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:
lappareil ne doit pas produire de brouillage lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Class B digital device notice This Class B digital apparatus complies with Canadian ICES-003, RSS-Gen and RSS-210. Cet appareil numrique de la classe B est conforme la norme NMB-003, CNR-Gen et CNR-210 du Canada. Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Essential performance The GoSafe Lite Help Button provides essential performance (EP) under normal operating conditions (includes EMC exposure) by sending Help Calls to the Lifeline Response Center . If the GoSafe Lite is incapable of sending Help Calls, it will periodically send a status alarm to the Lifeline Response Center. need to either remove or edit for accuracy. Intended Use This Philips product is intended to be installed, used and operated only in accordance with the safety procedures and operating instructions provided in, the Quick Setup Guide and the Instructions for Use for the purpose for which it was designed. The purpose for which the product is intended is given below. The GoSafe Mobile Pendant (7150MHB) is intended to be worn as a pendant and is capable of detecting certain types of falls or being activated manually. The GoSafe Mobile Pendant (7150MHB) is designed to directly connect to an emergency help service via the AT&T wireless network. Uses of the GoSafe System for purposes other than those intended and expressly stated by Philips Lifeline, as well as its agent) may relieve Philips Lifeline for resultant non-compliance, damage or injury. incorrect use or operation, from all or some responsibility
(or Contraindications This device may contraindicated for any person who is connected to a implanted electronic medical device or instrument such as a pacemaker or defibrillator. This device may cause the electronic medical device to malfunction. Compatibility The products described in this manual are compatible only with the components described herein and should not be used in combination with any other products or components unless such other products or components are expressly recognized as compatible by Philips Lifeline. Changes and/or additions to the product should only be carried out by Philips Lifeline or by third parties expressly authorized by Philips Lifeline to do so. Such changes and/
or additions must comply with all applicable laws and regulations that have the force of law within the jurisdiction(s) concerned, and with best engineering practice. Warning Changes and/or additions to the product that are carried out by persons without the appropriate training and/or using unapproved spare parts may void the warranty. As with all complex technical products, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the product and of personal injury. 35 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Risks and Benefits The GoSafe Lite Pendant depends on connecting to the AT&T wireless network in order to communicate with the Philips Lifeline Call Center. As with all wireless devices, the availability of the network cannot always be guaranteed. The GoSafe System Pendant depends on the user being capable of pressing the Help Button when they are in need of help. Safety Warnings Maintenance & faults: If any part of the product is known (or suspected) to be defective or wrongly adjusted, DO NOT USE the product until a repair has been made. Operation of the product with defective or wrongly adjusted components could expose the user or the patient to safety hazards. Safety awareness: Do not use this product for any application until you read and understand the safety information, safety procedures and emergency procedures contained in this SAFETY section. Operation of the product without a proper awareness of how to use it safely could lead to fatal or other serious personal injury. Safety devices: Never attempt to remove, modify, or otherwise defeat any safety device on the product. Interfering with safety devices could lead to fatal or other serious personal injury. Intended use and compatibility: Do not use this product for any purpose other than those for which it is intended. Do not use the product with any product other than that which Philips Lifeline recognizes as compatible. Operation of the product for unintended purposes, or with incompatible product, could lead to fatal or other serious injury. Electrical safety Warnings Do not remove covers or cables from the provided power supply adapter. Dangerous electrical voltages are present within this product. Removing covers or cables could lead to serious or fatal personal injury. Covers or cables should only be removed by qualified and authorized service personnel. 36 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Explosion safety a Warnings Do not use this product in the presence of explosive gases or vapors, such as certain anesthetic gases. Do not use flammable or potentially explosive disinfecting sprays in the presence of this product. Use of this product in an environment for which it was not designed can lead to fire or explosion. Caution Portable and Mobile Phones: Portable and mobile RF communications can affect the GoSafe Lite device. Use caution when using such communication devices within the specified range of the GoSafe Lite Pendant. Refer to Table 6 in the EMC section for the for separation distances between portable and mobile RF communications equipment and GoSafe Lite device. ss communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies can affect this equipment and should be kept at least a distance 3.3 meters or 11 feet from the GoSafe devices (based on a typical cell phone with a maximum output power of 2 W). 37 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips.[Bill to Clarify - where does this come from, and does this mean that a person cannot carry a cell phone with them if they are using GoSafe? Also, with GoSafe being a medical device, shouldnt the other devices accept interference from it?]
Maintenance Expected Service Life The Expected Service Life of the GoSafe Pendant is as follows:
GoSafe Lite Mobile Help Button (7150MHB) 2-3 years*
*The Service Life indicated above is primarily based on the expected life of the devices internal battery. Actual performance may vary depending upon conditions such as battery charge cycling, temperature, cell signal strength in your area and other factors. Power Supplies, Extension Cords and Power strips Do not use extension cords or power strips with this device. Biocompatible materials, Latex-Free This product does not contain natural latex rubber or dry natural rubber in user or operator accessible areas. All materials of construction of this product that come into contact with the skin of the user during normal use are certified biocompatible. Passing the product on to another user This product cannot be passed to another user by an existing user or re-sold to another user. Please see the Terms and Conditions of Use for more information. In the event the original user wishes to end their service, they must call Philips Lifeline to cancel their service.
*Usage Dependent 38 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Technical Specifications Standards Compliance This device is designed to conform to the following Standards and Regulations:
IEC/ANSI/ AAMI60601-1:2005/R(12)2012, General requirements for basic safety and essentialperformance. CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance IEC 60601-1-2, 3rd Edition (2007-03), General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 62366, 1st Edition (2015), Medical devices Application of usability engineering to medical devices IEC 60601-1-6, 3rd Edition (2013), Collateral standard: Usability IEC 60601-1-8, 2nd Edition (2006), Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-11, 2nd Edition (2015) Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
(Biocompatibility) ISO 14971, 2nd Edition (2007), Medical devices Application of risk management to medical devices.
46 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Environmental Ratings Temperature Relative Humidity Atmospheric Pressure Operating 41 F to 95 F
(5 C to 35 C) 10 to 90% (non-condensing) 101 kPa to 77 kPa
(approximately 0-7500 ft/0-
2286 m) Bathing*
Up to 122 F
(50 C)*
Storage
-4 F to 140 F
(-20 C to 60 C) 10 to 90%
(non-condensing) N/A Altitude 6,600 feet (2 km) Maximum N/A
* Up to 30 minutes exposure. Electrical Specifciations GoSafe Lite Mobile Pendant (7150MHB) AC Voltage Source[1] (VAC) N/A - EUT battery operated. AC battery charger adapter 100-240Vac 50/60Hz, 0.5A DC Power Source (VDC) Type of Protection Against Electric Shock Degree of Protection Against Electric Shock Degree of Protection Against Ingress of Water 3.7 V, 920mAh[2], Lithium Ion Rechargeable [3] Battery Class II (Power Supply Adapter) / GoSafe Lite is Battery operated Type BF Applied Part Water Resistant (1 meter, for 30 Minutes), IPX7 Mode of Operation Continuous Operation Sound Pressure Level 116-123 dB at 1 kHz (measured 1 cm from the speaker)
[1] The means of isolating the device from the supply mains is by disconnecting the device from the wall outlet.
[2] The capacity restored by the cell varies according to current drain, temperature and cut-off.
[3] Recharging of the GoSafe Mobile Button battery is done by the user as needed, when connected to the charger. 47 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Product Disposal Environmental Requirements Introduction Philips Lifeline is concerned to help protect the natural environment, and to help ensure continued safe and effective use of this product, through proper support, maintenance and training. Therefore Philips products are designed and manufactured to comply with relevant guidelines for environmental protection. As long as the product is properly operated and maintained, it presents no environmental risks. However, the product may contain materials, which could be harmful to the environment if disposed of incorrectly. Use of such materials is essential to performing the functions of the product, and to meeting statutory and other requirements. Final disposal of the product Final disposal is when the user disposes of the product in such a way that it can no longer be used for its intended purpose. In the event a user wishes to end their service or no longer needs the GoSafe Lite device, it must return the device to Philips Lifeline or their representative for proper disposal. Philips supports users in:
Recovering reusable parts. Recycling of useful materials by competent disposal companies. Safe and effective disposal of product Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Electromagnetic Comparability - EMC Medical electrical equipment can either generate or receive electromagnetic interference. The GoSafe Lite (7150MHB) has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 6060-1 collateral standard IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment. The GoSafe Lite pendant complies with relevant laws and standards on electro-magnetic compatibility (EMC) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from this product and its required immunity to electromagnetic interference from external sources. The GoSafe Pendant must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents. Other electronic products exceeding the limits defined in such EMC standards could, under unusual circumstances, affect the operation of the product. 1. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents. 2. Other equipment such as Portable and Mobile RF Communications Equipment may interfere with the medical device even of the other equipment complies with CISPR emission requirements . 3. The use of accessories and cables other than those specified, with the exception of those sold by the manufacturer may result in increased emissions or decreased immunity of the equipment or system. 4. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. xx Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. EMC Informational Tables Table 1 - Guidance and Manufacturers Declaration Emissions The EUT "GoSafe Lite" model 7150MHB is intended for use in the electromagnetic environment specified below. The EUT is provided with battery power adapter charger. The customer or user of the GoSafe Lite should ensure that it is used in such an environment. Emissions Test RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonics IEC 61000-3-2 Flicker IEC 61000-3-3 Electromagnetic Environment Guidance The GoSafe Lite 7150MHB must emit Electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The EUT is Battery Powered. The GoSafe Lite 7150MHB power charger is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. N/A for EUT Class A for charger Compliance Group 2 Complies Class B Table 2 - Guidance and Manufacturers declaration Immunity The GoSafe Lite 7150MHB is intended for use in the electromagnetic environment specified below. The customer or user of the GoSafe Lite should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Test Level 6kV Contact 8kV Air Compliance Level 6kV Contact 8kV Air Electrostatic Discharge (ESD) EN/IEC 61000-4-2 Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are synthetic the relative humidity should be at least 30%
Electrical power quality should be that of a typical commercial or hospital environment. Electrical fast transient/burst EN/IEC 61000-4-4
(only for battery charger power supply) 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Immunity Test Surge EN/IEC 61000-4-5
(only for battery charger power supply) EN/IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 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 Mains power quality should be that of a typical commercial or hospital environment. Power Frequency 50/60Hz Magnetic Field EN/IEC 61000-4-8 Voltage dips, short interruptions and voltage variations on power supply input lines EN/IEC 61000-4-11
(only for battery charger power supply) 3A/m 3A/m
<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 sec.
<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 sec. Power frequency magnetic fields should be that of a typical commercial or hospital environment. Electrical power quality should be that of a typical commercial or hospital environment. During charging, if the the user of the GoSafe Lite 7150MHB requires continued operation during power mains interruptions, it is recommended that the GoSafe Lite device power adapter is powered from an uninterrupted power supply or a battery. NOTE : UT is the a.c. mains voltage prior to application of the test level. Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Table 4 - Guidance and Manufacturers declaration Immunity The GoSafe Lite 7150MHB is intended for use in the electromagnetic environment specified below. The customer or user of the GoSafe Lite should ensure that it is used in such an environment. Immunity Test Conducted RF EN/IEC 61000-4-6 EN/IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz Compliance Electromagnetic Level 3 Vrms*
Environment Guidance D=1.17P D=0.35P 80 to 800 MHz Radiated RF EN/IEC 61000-4-3 10 V/m 80 MHz to 2.5 GHz 10V/m D=0.70P 800 MHz to 2.5 GHz Portable and mobile communications equipment should be separated from the GoSafe Lite 7150MHB by no less than the distances calculated/ listed below*:
D=(3.5/V1)(P) D=(3.5/E1)(P) 80 to 800 MHz D=(7/Eq)(P) 800 MHz to 2.5 GHz where P is the maximum power in watts (W) and D is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,(a) 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: Conducted RF Immunity does not apply to an internal battery operated devices. Limit above is set for battery charger For assistance, call 1-800-635-6156Confidential Draft for Agency Submission Only.Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. 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 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 GoSafe Lite is used exceeds the applicable RF compliance level above, the GoSafe Lite should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the GoSafe Lite.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Table 6 - Recommended Separations Distances between Portable and Mobile RF Communications equipment and GoSafe Lite The GoSafe Lite 7150MHB is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the GoSafe Lite 7150MHB can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communication Equipment and GoSafe Lite 7150MHB as recommended below, according to the maximum output power of the communications equipment. Max Output Power (Watts) 0.01 0.1 1 10 100 Separation (m) 150kHz to 80MHz d = 1.17P*
0.117 0.37 1.17 3.7 11.7 Separation (m) 80 to 800MHz d = 0.35P
.035
.11068
.35 1.1068 3.5 Separation (m) 800MHz to 2.5GHz d = 0.70P
.07
.22136
.7 2.2136 7 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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. Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Symbols Symbol Description Symbol for DC (Direct Current) Power. Polarity symbol. Indicates that the center (tip) of the output plug is Positive (+) and the barrel of the output plug is Negative (-). The power supply efficiency performance is Level 5, indicating a high standard in use efficiencies and no-load power consumption. The CE Mark is a conformity symbol for European countries. The symbol stands for Conformit Europenne. A Class II or double insulated electrical device. This is one which has been designed in such a way that it does not require a safety connection to electrical earth (ground). The TV logo is a certification mark of TV Rheinland, a Nationally Recognized Testing Laboratory (NRTL). The C on the left of the mark denotes compliance in Canada and the US on the right indicating compliance for the US. The symbol for WEEE Waste Electrical and Electronic Equipment. This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. Note: Please return the HomeSafe/GoSafe devices to Philips Lifeline or your Philips Lifeline representative for proper disposal. The ETL Listed Mark demonstrates compliance to the requirements of widely accepted product safety standards, as determined through independent testing and periodic follow-up inspections by a Nationally Recognized Testing Laboratory (NRTL). The C on the left of the mark denotes compliance in Canada and the US on the right indicating compliance for the US. Per EN 60529. The IP27 rating indicates (2)protection against fingers or other object not greater than 12mm in diameter and (7) Ingress of water in harmful quantity shall not be possible when the enclosure is immersed in water up to 1 meter of submersion for up to 30 minutes. Type BF Applied Part 48 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Consult accompanying instructions for use. Symbol for non-ionizing radiation. Indicates that the device(s) include(s) RF transmitters. Indicates the device manufacturer. Indicates the date when the device was manufactured. Use by Date. Indicates the manufacturers batch code so that the batch or lot can be identified. Indicates the manufacturers catalog number so that the device can be identified. Indicates the manufactu To identify the temperature limits, for example on transport packaging to indicate limits within which the package has to be kept and handled. The temperature values may be shown adjacent to the symbol. To indicate the acceptable upper and lower limits of relative humidity for transport and storage. Refer to instruction manual/booklet 49 Questions? Call 1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. 50 Questions? Call1-800-635-6156draftConfidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips. Philips Lifeline 111 Lawrence Street Framingham, MA 01702-8156 Tel: 1-800-451-0525 www .lifelinesystems .com 95 Barber Greene Road, Suite 105 Toronto, Ontario, Canada M3C 3E9 Tel: 1-800-387-8120 2017. All rights reserved. Signal range may vary due to environmental factors. P/N XXXXXXX, Rev. 01 Confidential Draft for Agency Submission Only. Not for Posting on any Public-Facing Website Not for dissemination to the public without the express written consent of Philips.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-06-16 | 917 ~ 921 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
2 | 2402 ~ 2480 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2017-06-16
|
||||
1 2 | Applicant's complete, legal business name |
Lifeline Systems Inc
|
||||
1 2 | FCC Registration Number (FRN) |
0014134019
|
||||
1 2 | Physical Address |
111 Lawrence Street
|
||||
1 2 |
Framingham, Massachusetts 01702
|
|||||
1 2 |
Framingham, MA
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
T******@intertek.com
|
||||
1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
1 2 |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
BDZ
|
||||
1 2 | Equipment Product Code |
7100MHB
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
C****** D******
|
||||
1 2 | Title |
Manager, Engineering Services
|
||||
1 2 | Telephone Number |
508 9********
|
||||
1 2 | Fax Number |
508 9********
|
||||
1 2 |
c******@lifelinesys.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Lifeline Systems Inc
|
||||
1 2 | Name |
C**** L****
|
||||
1 2 | Physical Address |
111 Lowrence Street
|
||||
1 2 |
111 Lawrence Street
|
|||||
1 2 |
Framingham, 52402
|
|||||
1 2 |
Framingham, 01702
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
01702********
|
||||
1 2 |
508-9********
|
|||||
1 2 |
C******@philips.com
|
|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
Lifeline Systems Inc
|
||||
1 2 | Name |
C**** D********
|
||||
1 2 | Physical Address |
111 Lawrence Street
|
||||
1 2 |
Framingham, 01702
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
508 9********
|
||||
1 2 |
C******@philips.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 12/12/2017 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | GoSafe and GoSafe 2 Mobile Help Button | ||||
1 2 | GoSafe and GoSafe 2-Mobile Help Button for a Personal Emergency System (PERS) | |||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | The device contains Bluetooth and Wi-Fi 2.4 GHz, GSM 850/1900 and UMTS bands II/V transmitters. | ||||
1 2 | The output power listed is EIRP for BTLE and average conducted for Wi-Fi. The device must not be co-located or operation with any other antenna or transmitter except as described in this filing or in accordance with multi-transmitter product procedure. Only those antennas were tested or similar antennas having the same or less gain may be used with these transmitters. SAR tested as described in this filing. The highest reported SAR for face, body-worn and extremity exposure conditions are 1.09 W/kg, 1.55 W/kg, and 1.91 W/kg, respectively. The device contains GSM 850/1900 and UMTS bands II/V transmitters. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Intertek Testing Services NA Inc.
|
||||
1 2 | Name |
Y****** L****
|
||||
1 2 | Telephone Number |
978 6********
|
||||
1 2 |
y******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 917.00000000 | 921.00000000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2402 | 2480 | 0.0013 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15C | 2412 | 2462 | 0.05 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC