Lifeline Systems 7100MHB GoSafe and GoSafe 2 Mobile Help Button User Manual Manual 1

Lifeline Systems Inc GoSafe and GoSafe 2 Mobile Help Button Manual 1

Contents

Manual 1

Philips Lifeline Medical Alert ServiceIncludes: GoSafe Mobile System and HomeSafe SystemInstructions for useConfidential 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.
2ContentsPhilips Lifeline Service ...............................4Welcome to Philips LifelineSetting up your Lifeline ServiceResponders and People to NotifyCalling for help inside your homeSignal RangeBattery informationEquipment serviceContact Philips Lifeline or your representativeHomeSafe System and GoSafe Mobile System Communicators – General Information ................13Safety information regarding the Home CommunicatorCleaningBackup batteryLandline Communicator (7000L) .....................16DescriptionSafety informationWireless Communicator (7000C) .....................19DescriptionSafety informationHomeSafe System and GoSafe Mobile System Help Buttons – General Information ..................22Compatible Home CommunicatorsSetting up a replacement Help ButtonCleaningConfidential 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.
3.26..............29.33HomeSafe Personal Help Buttons (7000PHB or 7000PHW) ...........................Using the wristbandAdjusting the neck cordBatteryRecommended usageHomeSafe AutoAlert Button (7000AHB) BatteryRecommended usageGoSafe Mobile Button (7000MHB/7100MHB) ................... ........... Charging the batterySleep modeRecommended usageSafety and Regulatory Compliance ....................41IEC regulationsSystem classificationRadio specificationsFCC Notice to UsersComplianceIntended UseCompatibilityRisks and BenefitsTrainingSafetyMaintenanceCommunicator AlarmsGoSafe Mobile Help Button AlarmsAlarm Descriptions / Summary TablesTechnical SpecificationsConfidential 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.
4Philips Lifeline ServiceWelcome to Philips LifelineThank 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.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.
5This manual covers the following: Landline Communicator (7000L)A Communicator that connects to Lifeline using your home’s 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.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.
6Help call in progress.Please wait.Hello, Mrs. Smith.Do you need help?HomeSafe Personal Help Button (7000PHB and 7000PHW)HomeSafe AutoAlert Button (7000AHB)GoSafe Mobile Button (7000MHB/7100MHB)Works within the range of your Communicator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 by placing a Help Call if a fall is detected and you can’t push the Button. Not all falls can be detected. If you need help, press your Help Button.Help call in progress.Please wait.Hello, Mrs. Smith.Welcome toPhilips Lifeline.Help call in progress.Please wait.Hello, Mrs. Smith.Welcome toPhilips Lifeline.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.
7Setting up your Lifeline ServiceBefore 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 NotifyWhat 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 ResponderIt is best to choose a Responder who:•Has a key to your home or knows where one is located (perhaps ina 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 driver’s license and access to a vehicleIf 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 neededConfidential 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.
8Information Lifeline needs about RespondersPlease 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 homeIt’s 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 home1. Press the Help Button that you wear or the gray Help button on thetop of your Home Communicator. You can press either button, butyou do not need to press both. The Home Communicator will beepand 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.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.
9Help 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 Associatewill speak to you through the Home Communicator’s built-in speakerand hear you through the Home Communicator’s highly sensitivemicrophone. 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., acaregiver, neighbor, loved one) or emergency services in accordancewith your request.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.
105. Once your Responder or the emergency service arrives, they shouldpress your Help Button to let Lifeline know that help has arrived. TheResponse Associate will contact the household to confirm that youreceived the help that you needed.6. Once Lifeline confirms that you have been assisted, a ResponseAssociate will contact the “People to Notify” you’ve 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. Don’t be concerned that you are bothering Lifeline; we just want to be sure that you are alright. Signal RangeCautionPlease 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.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.
11The 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 TestYou 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 haveyour Help Button in hand.2. PRESS and HOLD DOWN the Message button. The HomeCommunicator will beep and announce: “Continue to hold theMessage 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 havecompleted the range test. Begin Signal Range Test.”4. Press your Help Button. The Home Communicator will beep and playa voice message and the light on your Help Button will flash green toindicate that the Home Communicator has received the signal.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.
125. 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 andimmediately outside your home, return to the Home Communicatorand press the flashing orange Message button.Battery informationAll 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 serviceEvery 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. Itis important that your list is up to date with the correct people andtelephone numbers.•If someone else in your home needs to use the Lifeline Service. Morethan one person living in the same household can have the service.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.
13HomeSafe System and GoSafe Mobile System Communicators – General InformationSafety information regarding the Home Communicator1. The Home Communicator must beplaced in an indoor living area. Pleasekeep in mind that sunlight may make itdifficult 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 HomeCommunicator in or near water or other liquids.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.
147. Never carry the Home Communicator by the cord or yank on thecord to disconnect the plug from a power outlet. Instead, grasp theplug and pull to disconnect. Periodically inspect electrical cords andcables for damage or signs of wear.CleaningKeep 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 tothe OFF position and unplug the power cord from the power outlet.If you have the Landline Communicator, unplug the telephone cordfrom 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 gentlywipe the surfaces clean. Do not use detergent or abrasive cleanerson your Home Communicator.3. Reconnect the power cord to the power outlet. If you have theLandline Communicator, reconnect the telephone cord to the walljack, and then move the power switch on the back of the HomeCommunicator to the ON position.4. Test your system by pressing your Help Button. Tell the ResponseAssociate that you are just testing your equipment after cleaning itand no help is needed.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.
15Caution 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 batteryYour 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.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.
16Landline Communicator (7000L)DescriptionHelp button•Press to send a HelpCall to the ResponseCenter•Flashes red while aHelp Call isconnecting and afterLifeline has contacted your Repsonders or emergency services•Steady red whena Help Call isconnectedMessage button •Used during thesetup process•When the buttonis flashing orange,press to hear a statusmessageMicrophone•Used to talkto LifelineGreen status light•Steady green when the Communicator is ON. Flashes green when the Communicator is running on backup battery (AC power loss).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.
17Volume controlControls the volume of the speaker on the Communicator Green phone jackUsed to connect the Communicator to your household phone jack Blue phone jackAllows you to connect a telephone to the Communicator (optional) Power switchUsed to turn the Communicator ON or OFF. The Communicator must be ON for your Lifeline service to work.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.
18Safety information1. If you have multiple phones in your home, and any of them areleft off the hook, the Home Communicator will not be able toplace a Help Call. This problem can be addressed by plugging theHome 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 isan RJ31X jack in the Home Communicator that is designed to seizethe line if installed properly. Please refer to the Customer PremisesEquipment and Wiring diagram on page 44 in the Safety and RegulatoryCompliance 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 filterbetween your phone jack and the Home Communicator. Contact yourphone company to obtain a DSL filter or purchase one from a localelectronics 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.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.
19Wireless Communicator (7000C)DescriptionHelp button•Press to send a HelpCall to the ResponseCenter•Flashes red while aHelp Call isconnecting and afterLifeline has contacted your Repsonders or emergency services•Steady red whena Help Call isconnectedMessage button •Used during thesetup process•When the buttonis flashing orange,press to hear a statusmessageMicrophone•Used to talkto LifelineGreen status light•Steady green when the Communicator is ON. Flashes green when the Communicator is running on backup battery (AC power loss).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.
20Volume controlControls 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 varyConfidential 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.
21Safety informationThe 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 ofyour home than others. When you set up your Home Communicator,look at the signal strength indicator on the back of the HomeCommunicator. The number of green bars that are glowing indicate thesignal strength; the more bars you see, the stronger the signal. Placeyour Home Communicator in a location where you spend the majorityof your time, and the signal strength indicator shows two or more bars.2. If the AT&T wireless network experiences an outage or the HomeCommunicator loses its signal, the Message button on top of theHome Communicator will flash and it will not be able to send aHelp Call to Lifeline. If you press your Button and the AT&T wirelessnetwork is not available, you will hear a message saying: “Your callcannot be connected. There is no signal strength. Move your HomeCommunicator to a different location.” Try moving the HomeCommunicator to a different location in your home. Once the signalis restored, you will hear a message saying: “Connection has beenrestored.” Your Help Call will then be dialed.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.
22HomeSafe System and GoSafe Mobile System Help Buttons – General InformationThe information in this section applies to all types of wearable Help Buttons. Compatible Home CommunicatorsThe 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 ButtonIf you receive a replacement Help Button, you will need to set it up to work with your Home Communicator. You’ll need to be within arm’s 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 haveyour replacement Help Button in hand.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.
232. PRESS and HOLD DOWN theMessage button on the HomeCommunicator. The HomeCommunicator will beep andannounce: “Continue to hold theMessage button for AutoLearn. Whenyou are ready for Range Test, pleaserelease 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. TheHome Communicator will announce: “Please press the flashing Messagebutton after you have completed the range test. Begin Signal RangeTest.”5. Press your Help Button. The Home Communicator will beep and thelight on your Help Button will flash green to indicate that the HomeCommunicator 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 Buttonis flashing.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.
247. Once you have tested different locations in your home andimmediately outside your home, return to the Home Communicatorand press the flashing orange Message button.CleaningYour 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 liquiddishwashing detergent.2. Wash the Help Button under warm running water. You may alsogently wipe it with an isopropyl (rubbing) alcohol wipe or a cotton padmoistened with alcohol. However, do not soak it in alcohol.3. Blot excess moisture with a towel and allow the Help Button to finishair-drying while you’re 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.Warnings•Any cord worn around the neck can pose a strangulation risk, includingthe possibility of death and serious injuries. This may be of moreconcern to wearers in wheelchairs, using walkers, using beds with guardrails, or who might encounter other protruding objects upon which thecord can become tangled.•Philips Lifeline neck cords contain a special fuse (seeimage on right) designed to break away under certainconditions 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.8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ700 0PHBIC: 655C -7000PH B82352000148235-YYYYMMDDFCC: BDZ700 0AHBIC: 655C -7000AH BModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBConfidential 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.
25•Do not use any neck cord other than the one provided by PhilipsLifeline or your representative. Other neck cords may not provide thefeature to break apart therefore increasing the risk of strangulation.•Do not tie a knot in your neck cord since this may prevent the breakaway feature from working properly.•There are no user-serviceable parts inside the Help Button. Do notattempt to open or modify the device.•The Help Button contains a lithium battery that must be disposed ofproperly. Do not discard the Help Button in the trash or expose it toflames or intense heat.•The Help Button is not suitable for use in the presence of flammablemixtures.•Do not put your Help Button through the dishwasher, clothes washeror dryer. Please be sure to remove your Help Button from articles ofclothing that are being dry-cleaned.•Excessive heat may damage your Help Button. Do not leave your HelpButton on the dashboard of your car or on a windowsill that receivesdirect sunlight. Likewise, do not wear your Help Button into a hot tubor sauna. Normal bathing and showering temperatures WILL NOTdamage your Help Button.Caution•Your Help Button may interfere with certain medical equipment, suchas magnetic resonance imaging (MRI), X-ray machines, as well as metaldetectors.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.
26HomeSafe Personal Help Buttons (7000PHB, 7000PHW)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. 8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ70 00PHBIC: 655C-7000PHB82352000148235-YYYYMMDDFCC: BDZ70 00AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBFront viewIndicator light – Flashes green during range testing. Flashes red when the Communicator has received a Help Call signal.Button area – Press here to send a Help Call to the Lifeline Response Center.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.
8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ7000PHBIC: 655C-7000PHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBExplanation of symbolsProduct code: Report this code if you ever have to replace the unitSerial number and date of manufactureFederal Communications Commission IDIndustry Canada IDAttention: Read the Instructions for Use for important informationInterference to electronic equipment may occur in the vicinity of devices marked with this symbolModel NumberBarcodeType BF applied partConfidential 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.
27Using the wristbandTo 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 cordTo 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.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.
28BatteryThe 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 whilesleeping and bathing. The bathroom is a place where people often falland need help.•Your Help Button is waterproof (IPX7, 1 meter for 30 minutes) andshould be worn in the shower or bath.•Your Help Button does not contain a microphone, so you don’t talkinto it. Instead, press the Help Button and speak in the direction of yourHome 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 rangedetermined by the Signal Range Test.•If you are traveling on an airplane and need to bring your HomeSafeSystem with you, do not take it into the cabin of the airplane. Instead,pack the Help Button in your checked luggage along, with your HomeCommunicator. Please remember to contact Lifeline before moving theHomeSafe System to a new address.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.
29HomeSafe 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 toPhilips Lifeline.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.
308235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ70 00PHBIC: 655C-7000 PHB82352000148235-YYYYMMDDFCC: BDZ70 00AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ70 00PHBIC: 655C-7000 PHB82352000148235-YYYYMMDDFCC: BDZ70 00AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBFront viewButton area – Press here to send a Help Call to the Lifeline Response Center. Indicator light – Flashes green during range testing. Flashes red when the Communicator has received a Help Call signal.Back viewImportant: 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).What to expect when the AutoAlert 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 30seconds 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 initiatethe Help Call. Pushing the Help Button generates the Help Call immediately.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.
8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ7000PHBIC: 655C-7000PHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBProduct code: Report this code if you ever have to replace the unitAttention: Read the Instructions for Use for important informationModel numberExplanation of symbolsSerial number and date of manufactureFederal Communications Commission IDIndustry Canada IDInterference to electronic equipment may occur in the vicinity of devices marked with this symbolBarcodeType BF applied partConfidential 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.
31False “fall detected” alarms may occasionally occurWhile 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.CautionIn 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.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.
32BatteryThe 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, especiallywhile sleeping and bathing. The bathroom is a place where people oftenfall and need help.•Your AutoAlert Help Button is waterproof (IPX7, 1 meter for 30minutes) 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 youdon’t talk into it. Instead, press the Help Button and speak in thedirection of your Home Communicator.•Do not throw or toss the AutoAlert Help Button onto a bed, table, orother surface because it may accidentally send a Help Call.•You may continue to wear your AutoAlert Help Button when leavingyour home. However, it will not provide coverage outside of the rangedetermined by the Signal Range Test.•If you are traveling on an airplane and need to bring your HomeSafeSystem with you, do not take it into the cabin of the airplane. Instead,pack the Help Button in your checked luggage along with your HomeCommunicator. Please remember to contact Lifeline before moving theHomeSafe System to a new address.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.
33GoSafe Mobile Button (7000MHB and 7100MHB) Help call in progress.Please wait.Hello, Mrs. Smith.Welcome toPhilips Lifeline.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. 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.
34Front viewIndicator 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 viewSpeaker – 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).ChargerThe 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.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.
7100MHB Back viewConfidential 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.
35Determining your locationThe 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 secondsof a fall being detected.•If the Button detects you have gotten up within approximately 30seconds 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 immediatelyto initiate the Help Call. Pushing the Help Button generates the HelpCall immediately.False “fall detected” alarms may occasionally occurWhile 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.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.
36Note: Occasional false alarms do not indicate that the GoSafe Mobile Button is malfunctioning. WarningDo not use the GoSafe Mobile Button if you have an implantable cardiac device, such as a defibrillator or pacemaker.CautionsIn 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.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.
37Charging the batteryFlashing orange light = charging neededFlashing green light = charging in progressWhen connected to the charger, a steady green light = fully chargedYour 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 achime 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 Buttonis ready to use.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.
38To 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 modeImportant reminders•You should continue wearing your GoSafe Mobile Button while it isbeing 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 todo so may compromise the fall detection capability of your GoSafesystem.•Do not charge your GoSafe Mobile Button while sleeping or bathing.•Battery life varies based on activity level, time spent away from yourHome Communicator, and actual emergency use. In general, youshould charge your GoSafe Mobile Button at least once a week. It maybe helpful to pick a specific day and time to complete the charging, e.g.,Sundays at 4pm.Sleep modeThe 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 LifelineThe 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.”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.
39To 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 insituations/locations outside the home where you want to determineif the AT&T wireless network is available.•Wear your GoSafe Mobile Button at ALL times, even when you areaway from home. The GoSafe Mobile Button will send a Help Callfrom any location where the AT&T wireless network is available.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.
40•If you are outside of the signal or voice rangeof your Home Communicator, you can talkto Lifeline using the GoSafe Mobile Button’smicrophone and speaker. For best results,hold the Button up and away from your chestwhen you are speaking to Lifeline. Maintain aminimum separation distance of 10 mm/ 0.394inches when operating the device in the held to face configuration.•Your Help Button is waterproof (IPX7, 1 meter for 30 minutes) andshould be worn in the shower or bath.•Do not throw or toss the GoSafe Mobile Button onto a bed, table, orother surface because it may accidentally send a Help Call.•When entering and exiting your vehicle, take care to prevent theGoSafe Mobile Button from hitting the steering wheel because it mayaccidentally send a Help Call.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.
49Note: 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 IndicatorsWhen 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 AlarmsOnce 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 AlarmHigh 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.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).•High Priority – Require immediate response (by the Call Center)•Medium Priority – Require prompt response (by the operator/user)Communicator AlarmsIntroductionThere are two types of alarms processed by the HomeSafe/GoSafe Communicator: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.
50GoSafe Mobile Help Button AlarmsIntroductionThere 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 IndicatorsWhen 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 AlarmsOnce 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 AlarmHigh 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.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.
51Alarm Descriptions / Summary TablesThe following tables summarize all of the Communicator high and medium priority alarms and informational messages (Supervision/Check-in alarms). Help Needed (High Priority) AlarmsThe 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 TypeHELP NEEDED Communicator (7000C / 7000L)Alarm Event DescriptionHelp Alarm initiated by User pressing the Help button on the Home CommunicatorPriority HighDevice Action Operates normallyAlarm Event Reported/Displayed Locally?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.Alarm Event Reported to Lifeline?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.HELP NEEDED End Device (7000PHB / 7000AHB / 7000MHB/7100MHB) in range of CommunicatorAlarm Event DescriptionHelp Alarm initiated by User pressing the Button on the End Device Priority HighDevice Action Operates normallyAlarm Event Reported/Displayed Locally?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.Alarm Event Reported to Lifeline?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.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.
52HELP NEEDED End Device (7000MHB) out of range of CommunicatorAlarm Event DescriptionHelp Alarm initiated by the User pressing the button on the End DevicePriority HighDevice Action Operates normallyAlarm Event Reported/ Displayed Locally?Yes. Upon pressing the button on the End Device, a Voice Message plays and the LED flashes red.Alarm Event Reported to Lifeline?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 StrengthAlarm Event DescriptionHelp 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.Priority HighDevice Action The Help Alarm Signal will be sent to the Call Center once the connection to the AT&T wireless network is re-established.Alarm Event Reported/ Displayed Locally?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.Alarm Event Reported to Lifeline?No. If the AT&T wireless network is unavailable a Help Alarm Signal cannot be sent to the Call Center.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.
53HELP NEEDED Fall Detected End Device (7000AHB / 7000MHB/7100MHB) in range of CommunicatorAlarm Event DescriptionHelp Alarm initiated by End Device detecting a fall.Priority HighDevice Action Operates normallyAlarm Event Reported/Displayed Locally?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.Alarm Event Reported to Lifeline?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.HELP NEEDED Fall Detected End Device (7000MHB/7100MHB) out of range of CommunicatorAlarm Event DescriptionHelp Alarm initiated by the End Device detecting a fall.Priority HighDevice Action Operates normallyAlarm Event Reported/ Displayed Locally?Yes. When the Mobile Help Button has detected a fall, it plays a Voice Message and its LED flashes red.Alarm Event Reported to Lifeline?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.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.
54Device Error (Medium Priority) AlarmsThe 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 TypeAC Power Lost Communicator (7000C / 7000L)Alarm Event DescriptionIn the event that the Home Communicator loses its connection to AC Power, a Warning Message is displayed Priority MediumDevice Action Switches to backup battery and operates normallyAlarm 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.Alarm Event Reported to Lifeline?No.LOW BATTERY + AC Power Lost Communicator (7000C / 7000L)Alarm Event DescriptionWhen 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 displayedPriority MediumDevice Action Operates normally under battery power until battery is depletedAlarm Event Reported/Displayed Locally?Yes. The Message Button on the Home Communicator flashes yellow-orange. A 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.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.
55LOW BATTERY Communicator (7000C / 7000L)Alarm Event DescriptionWhen the capacity / life of the Communicator backup battery has diminished, a Warning Message is displayedPriority MediumDevice Action Operates normally on AC PowerAlarm Event Reported/Displayed Locally?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.LOW BATTERY End Device (7000PHB / 7000AHB / 7000MHB/7100MHB)Alarm Event DescriptionWhen the capacity / life of the Help Button battery has diminished, a Warning Message is displayedPriority MediumDevice Action Operates normally until battery is depletedAlarm Event Reported/Displayed Locally?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.BATTERY REQUIRES CHARGING End Device (7000MHB/7100MHB)Alarm Event DescriptionWhen the Mobile Help Button rechargeable battery needs to be charged (below 350 mAh), a warning Message is displayed.Priority MediumDevice Action Operates normally until the battery is critically low.Alarm Event Reported/ Displayed Locally?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.Alarm Event Reported to Lifeline?No.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.
56DEPLETED BATTERY End Device (7000MHB/7100MHB)Alarm Event DescriptionWhen the charge level of the Mobile Help Button rechargeable battery is critically low (below 3.7V), a Warning Message is displayed.Priority MediumDevice Action Operates normally until the battery is fully depleted.Alarm Event Reported/ Displayed Locally?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.Alarm Event Reported to Lifeline?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.Device Hardware Failure (7000PHB / 7000AHB / 7000MHB /7100MHB/ 7000C / 7000L)Alarm Event DescriptionIn the event that a device senses it has a Hardware Error, a Warning Message is displayed.Priority MediumDevice Action May have limited operation, depending on the failureAlarm Event Reported/Displayed Locally?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 DescriptionIn the event that a device senses it has a Software Error, a Warning Message is displayedPriority MediumDevice Action May have limited operation, depending on the failureAlarm Event Reported/Displayed Locally?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.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.
57NO PHONE LINE Communicator (7000L)Alarm Event DescriptionIn the event that the Home Communicator loses its connection to the phone line, a Warning Message is displayed.Priority MediumDevice Action Any alarms generated will be sent to the Call Center once connection to the phone line is established.Alarm Event Reported/ Displayed Locally?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.Alarm Event Reported to Lifeline?No. If connection to the phone line is lost, a Maintenance Signal cannot be sent by the Home Communicator to the Call Center.NO SIGNAL STRENGTH Communicator (7000C)Alarm Event DescriptionIn 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.Priority MediumDevice Action Any alarms generated will be sent to the Call Center once connection to the AT&T wireless network is establishedAlarm Event Reported/Displayed Locally?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. Alarm Event Reported to Lifeline?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. 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.
58Supervision 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 TypeAUTO TEST CALL (aka Check-in) (7000C / 7000L / 7000MHB/7100MHB)Alarm Event DescriptionAuto Test calls are automatically generated silent alarms designed to periodically let the Call Center know that the Communicator or End Device is working properly. Priority N/ADevice Action Operates normallyAlarm Event Reported/Displayed Locally?No visual or audible alarm is generated by the devices.Alarm Event Reported to Lifeline?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 DescriptionEnd 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 Priority N/ADevice Action Operates normallyAlarm Event Reported/Displayed Locally?No visual or audible alarm is generated by the devices.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.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.
59AC Power Restored Communicator (7000C / 7000L)Alarm Event DescriptionIf AC power is restored within 24 hours of the Communicator’s “Low Battery + NO AC Power” alarm event occurring, then the Communicator will report a silent alarm to the Call Center Priority N/ADevice Action Operates normallyAlarm Event Reported/Displayed Locally?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.Alarm Event Reported to Lifeline?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 receivingpower.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.Fault Condition Audio MessageWireless connection lost / No Wireless Signal “Unfortunately, the signal strength in this location is not strong enough. Move your Home Communicator to a different location.”No Phone line “Please check the phone line and connections”External Phone off Hook“A phone is off-hook. Please check other phones in your home.”Low Battery GoSafe Mobile Button“Please charge your Help Button as soon as possible. The battery is very low.”AC Power Loss “No power is detected. Please check the power cord.”Communicator Low Battery“The backup battery is low.”Communicator has a Hardware or Software Failure“There is a fault with your Home Communicator. Please contact Philips Lifeline.”End Device has a: ‘Hardware Failure’ OR ‘Software Failure’ OR ‘Battery Low’ “There is a fault with your Help Button. Please contact Philips Lifeline.”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.
60Delay in Determining AlarmsReporting 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 AlarmsAll alarm events reported to the Call Center are logged by the Call Center. There are no user accessible logs.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.
41Safety and Regulatory ComplianceIEC regulationsThe 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 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.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 classificationThe HomeSafe/GoSafe Help Buttons and Home Communicator are FDA Class II devices. They are internally powered devices for continuous operation.Radio specificationsThe 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 modulationConfidential 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.
42FCC Notice to Users7000L FCC RegulationsThe 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 CompanyUpon 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); and2. The Communicator’s FCC Registration Number and Ringer Equivalence Number (REN). Thosenumbers are on the bottom of the Communicator. The REN is used to determine how manydevices 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 CompanyIf 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 isn’t 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 15The 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.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.
43Note: 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) InformationThe 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.CautionIn 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.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.
44CautionIf 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.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.
HomeSafe/GoSafe FCC RegulationsThe 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 maycause 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 user’s 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 thereceiver is connected.•Consult the dealer or an experienced radio/TV technician for help.Radio interferenceThe GoSafe equipment comply with FCC RF radiation exposure limits set forth for an uncontrolled environment. For IBOEIFME/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.
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes:•l’appareil ne doit pas produire de brouillage•l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si lebrouillage est susceptible d’en compromettre le fonctionnement.Class B digital device noticeThis Class B digital apparatus complies with Canadian ICES-003, RSS-Gen and RSS-210.Cet appareil numérique de la classe B est conforme à la norme NMB-003, CNR-Gen et CNR-210 du Canada.•1) Device may not cause interference•2) Device must accept any interference, including interference that may causeundesired operation of the device.Industry Canada Notice to UsersThe HomeSafe/GoSafe devices comply with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: 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 performanceThe 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. ContraindicationsThe 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 1-800-635-6156Confidential 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.
45Compatibility 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. WarningChanges 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 BenefitsThe 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 1-800-635-6156Confidential 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.
46SafetyWarningsMaintenance & 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 presentwithin 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 anestheticgases.•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. 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.
47Other 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 andput 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 ordecreased immunity levels.•The product should not be used adjacent to or stacked with other products and that if adjacentor 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 otherequipment complies with CISPR emission requirements.CautionPortable 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 andshould 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).Questions? 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.
48Maintenance 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 DependentThe Service Life indicated above is based on the expected life of the device’s internal batteries. Actual performance may vary depending upon conditions concerning charging, discharging, temperature, and other factors.Power Supplies, Extension Cords and Power stripsRoute 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.LatexThis 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 representativeConfidential 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.
•IEC/ANSI/ AAMI60601-1:2005/R(12)2012, 3rd edition, Part 1- General requirements for basicsafety and essential performance.’•CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance.•IEC/UL/CSA 60601-1, 2nd Edition (2003), ‘Medical Electrical Equipment, Part 1: GeneralRequirements 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 MedicalSystems’ (except for 7100MHB)•IEC 62366, 1st Edition (2015), ‘Medical devices – Application of usability engineering to medicaldevices’•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 foralarm systems in medical electrical equipment and medical electrical systems’•IEC 60601-1-11, 2nd Edition (2015) ‘Collateral standard: Requirements for medical electricalequipment 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 medicaldevices’•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 Methodsof Measurement (Canda)Technical SpecificationsStandards ComplianceThis device is designed to conform to the following standards: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.
61•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 ComplianceThe 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 clothand a general purpose household cleaner such as glass cleaner. Do not use furniture polish oroil-based cleaners for this step as this cleaning is to ensure that the adhesion area is devoid of anydirt, 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 asdescribed 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 thepower supply, adhering the 2 adhesive panels to the wall on each side of the power supply.Environmental Operating StorageTemper ature 41° F to 95° F (5° C to 35° C)-4° F to 140° F(-20° C to 60° C)Relative Humidity10 to 90% (non-condensing) 10 to 90% (non-condensing)Atmospheric Pressure 101 kPa to 77 kPa (approximately 0-7500 ft/0-2286 m)N/AAltitude*6,600 feet (2 km) Maximum N/A*applies to AHB and MHB onlyConfidential 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.
62Electrical Wireless Communicator (7000C), Landline Communicator (7000L)AC Voltage Source[1] (VAC)DC Power Source (VDC)Type of Protection Against Electric ShockDegree of Protection Against Electric ShockDegree of Protection Against Ingress of WaterMode of OperationSound Pressure Level100-240 Vac, 50/60 Hz, 0.5 A (Power Supply Input)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)Type BF Applied PartDrip Proof, IP21Continuous92-106 dB at 1 kHz (measured 10 cm from the speaker)HomeSafe Personal Help Button (7000PHB)AC Voltage Source[1] (VAC)N/A - Internal battery DC Power Source (VDC)3.2V, 225mAh[2], Manganese Dioxide Lithium Coin Primary BatteryType of Protection Against Electric ShockClass IIDegree of Protection Against Electric ShockType BF Applied PartDegree of Protection Against Ingress of WaterWater Resistant (1 meter, for 30 Minutes), IPX7Mode of Operation ContinuousConfidential 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.
63HomeSafe AutoAlert Button (7000AHB)AC Voltage Source[1](VAC)N/ADC Power Source (VDC)3.6 Vdc, 1200mAh[2], Lithium-thionyl chloride (Li-SOCl2) Primary BatteryType of Protection Against Electric ShockClass IIDegree of Protection Against Electric ShockType BF Applied PartDegree of Protection Against Ingress of WaterWater Resistant (1 meter, for 30 Minutes), IPX7Mode of Operation ContinuousGoSafe Mobile Help Button (7000MHB/7100MHB)AC Voltage Source[1] (VAC)N/A for 7000MHB & 7100MHB. Battery charger rated: 100-240Vac, 50/60Hz, 0.5ADC Power Source (VDC)3.7 Vdc, 920mAh[2], Lithium Ion Rechargeable [4] Battery Type of Protection Against Electric ShockClass IIDegree of Protection Against Electric ShockType BF Applied PartDegree of Protection Against Ingress of WaterWater Resistant (1 meter, for 30 Minutes), IPX7Mode of Operation ContinuousSound 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 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.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.
Product DisposalEnvironmental RequirementsIntroductionPhilips 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 productConfidential 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.
xxElectromagnetic Comparability - EMCMedical 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 EMCand needs to be installed and put into service according to the EMCinformation provided in the Accompanying Documents.2. Other equipment such as Portable and Mobile RF CommunicationsEquipment may interfere with the medical device even of the otherequipment complies with CISPR emission requirements .3. The use of accessories and cables other than those specified, with theexception of those sold by the manufacturer may result in increasedemissions or decreased immunity of the equipment or system.4. The equipment or system should not be used adjacent to or stackedwith other equipment and that if adjacent or stacked use is necessary,the equipment or system should be observed to verify normaloperation in the configuration in which it will be used.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.
Emissions Test ComplianceRF Emissions CISPR 11Group 2RF Emissions CISPR 11Class BHarmonics IEC 61000-3-2N/A for EUTClass A for chargerElectromagnetic Environment – GuidanceThe HomeSafe/GoSafe devices must emit Electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.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.Flicker IEC 61000-3-3Table 2 - Guidance and Manufacturer’s declaration – ImmunityThe 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.CompliesEN/IEC 60601 Test LevelComplianceLevelImmunity TestElectrostatic Discharge (ESD) EN/IEC 61000-4-2±2 kV for power supply lines±2 kV for power supply lines ±1 kV for input/output lines6kV Contact 8kV Air6kV Contact 8kV AirElectromagnetic Environment – GuidanceFloors should be wood, concrete or ceramic tile. If floors are synthetic the relative humidity should be at least 30%Electrical fast transient/burst EN/IEC 61000-4-4 (only for devices with battery charger power supply-7000MHB & 7100MHB)EMC Informational TablesTable 1 - Guidance and Manufacturer’s 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.Electrical power quality should be that of a typical commercial or hospital environment.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.
EN/IEC 60601 Test Level ±1 kV line(s) to line(s)±2 kV line(s) to earth<5% UT(>95% dip in UT) for 0.5 cycle. 40% UT (60% dip in UT ) for 5 cycles.70% UT (30% dip in UT ) for 25 cycles5% UT (>95% dip in UT ) for 5 sec.Compliance Level ±1 kV line(s) to line(s)±2 kV line(s) to earthImmunity TestSurge EN/IEC 61000-4-5(only for devices with battery charger power supply -7000MHB & 7100MHB)3A/m 3A/mPower 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)<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 cycles5% UT (>95% dip in UT ) for 5 sec.Electromagnetic Environment – GuidanceNOTE : UT is the a.c. mains voltage prior to application of the test level.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.Mains power quality should be that of a typical commercial or hospital environment.Power frequency magnetic fields should be that of a typical commercial or hospital environment.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.
For assistance, call 1-800-635-6156LevelImmunity TestConducted RF EN/IEC 61000-4-6Radiated RF EN/IEC 61000-4-3EN/IEC 60601 Test Level3 Vrms 150 kHz to 80 MHz10 V/m 80 MHz to 2.5 GHz10V/mCompliance Electromagnetic 3 Vrms*Table 4 - Guidance and Manufacturer’s declaration – ImmunityThe 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.Environment – GuidanceD=1.17√PD=0.35√P 80 to 800 MHzD=0.70√P 800 MHz to 2.5 GHzPortable 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 MHzD=(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 vicinityof equipment marked with the following symbol:*NOTE: Conducted RF Immunity does not apply to an internal battery operateddevices (7000PHB, 7000AHB, 7000MHB and 7100MHB). Limit above is set for thebattery chargerConfidential 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, AMand FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromagnetic environment due to fixed RFtransmitters, an electromagnetic site survey should be considered. If themeasured field strength in the location in which the HomeSafe/GoSafe isused exceeds the applicable RF compliance level above, the HomeSafe/GoSafe should be observed to verify normal operation. If abnormalperformance 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 beless 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 HomeSafe/GoSafe devicesThe 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)Separation (m) 80 to 800MHz d = 0.35√PSeparation (m) 800MHz to 2.5GHz d = 0.70√P0.01 .035 .070.1 .11068 .221361.35 .710 1.1068 2.2136100Separation (m) 150kHz to 80MHz d = 1.17√P* 0.1170.371.173.711.7 3.5 7For 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.
64SymbolsSymbol DescriptionSymbol 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 Conformité Européenne.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 TÜV logo is a certification mark of TÜV 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.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.
65Device is protected against the effects of continuous immersion in water (up to 1 m of submersion for 30 minutes).Type BF Applied PartConsult 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 manufacturer’s batch code so that the batch or lot can be identified.Indicates the manufacturer’s catalog number so that the device can be identified.Indicates the manufacturer’s 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/bookletConfidential 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.
66NotesConfidential 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.
67Confidential 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 Lifeline111 Lawrence Street Framingham, MA 01702-8156Tel: 1-800-451-0525www.lifelinesystems.comPhilips Lifeline Canada95 Barber Greene Road, Suite 105Toronto, Ontario, Canada M3C 3E9Tel: 1-800-387-8120www.lifeline.ca© 2015. All rights reserved.Signal range may vary due to environmental factors. P/N 0940837, Rev. 0XConfidential 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.

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