Lifeline Systems 7000PHB Halifax Personal Help Button with ISM User Manual

Lifeline Systems Inc Halifax Personal Help Button with ISM

User Manual

Philips Lifeline Medical Alert ServiceHomeSafe Wireless SystemInstructions for use
2ContentsPhilips Lifeline Service ...............................4Welcome to Philips LifelineSetting up your Lifeline ServiceResponders and People to NotifyCalling for helpSignal rangeBattery informationEquipment serviceContact Lifeline or their representative HomeSafe Wireless Communicator (7000C) ...........12DescriptionSafety information CleaningBackup batteryHomeSafe Help Buttons – General Information ..............................17Warnings and CautionsCompatible Home CommunicatorSetting up a replacement Help ButtonCleaningRecommended usageHomeSafe Personal Help Button (7000PHB) ...........22FeaturesUsing the wristbandAdjusting the neck cord
3HomeSafe AutoAlert Button (7000AHB) ..............25CautionsFeaturesWhat to expect if you fallBatterySafety and Regulatory Compliance ....................30Safety standardsRecommended environmental conditionsIEC regulationsSystem classicationRadio specicationsFCC Notice to UsersIndustry Canada Notice to UsersClass B digital device noticeUL1635 and UL1637 Compliance
4HomeSafe Wireless Communicator (7000C)The communicator connects to Lifeline using a wireless network, no phone line is required. Wireless service is provided as part of your Lifeline Service, no additional wireless equipment is needed.Help call in progress. Please wait.Hello, Mrs. Smith.Do you need help?Philips Lifeline ServiceWelcome to Philips LifelineThank you for choosing the Philips Lifeline Medical Alert Service.Please refer to the Quick Setup Guide provided with this equipment for instructions on setting up the HomeSafe Wireless System. These Instructions for Use will provide you with information about your equipment and the Lifeline Medical Alert Service. Please read the manual carefully, and if you have questions, call Lifeline at any time. Please save this manual to refer to later.This document covers the following:
5Help call in progress. Please wait.Hello, Mrs. Smith.Do you need help?Help call in progress. Please wait.Hello, Mrs. Smith.Do you need help?HomeSafe Personal Help ButtonHomeSafe AutoAlert ButtonWorks inside your home  Can be worn as a pendant  Can be worn on a wristband Detects falls* in your home * The AutoAlert Help Button provides an added 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 fall and need help, press your Help Button.Setting 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 for your Lifeline Service. 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. HomeSafe Help Buttons
6Responders 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 in a key lockbox)• Could come to help you at different times of the day or night• Lives or works within 10 minutes of where you live• Has a phone, preferably a cell phone• Ideally has a driver’s license and access to a vehicleInformation 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 home.It’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.
7Who are “People to Notify”?If you call for help, Lifeline will contact the “People to Notify” to let them know that you received assistance once we receive conrmation. “People to Notify” will not be contacted to help you, unless they are also on your list of “Responders.”Calling for help1. Press the Help Button that you wear or the gray Help Button on the top of your Home Communicator. You can press either button, but you do not need to press both. The Home Communicator will beep and dial the Lifeline Response Center. Note: The Response Center is available 24 hours a day, 365 days a year. A trained Personal Response Associate is always available to assist you.Help call in progress. Please wait.Hello, Mrs. Smith.Do you need help?
82. The Home Communicator calls the Response Center. When it dials the Response Center, the Home Communicator will repeatedly say: “Your Help Call is in progress; please wait.” Once it connects with the Response Center, it will say: “Your call has been connected; Lifeline will be right with you.”3. The Response Center will answer the call. A Response Associate will speak to you through the Home Communicator’s built-in speaker and hear you through the Home Communicator’s highly sensitive microphone. He/she will ask if you need help. If you do not need help, just tell the Response Associate that help is not needed.Note: If you cannot speak or be heard, the Response Associate will try calling you back. If you cannot answer or if the Response Associate cannot hear you, Lifeline will contact your Responder or emergency services. 4. The Response Center will assess the situation. If help is needed, our response associate will contact your list of Responders (i.e., a caregiver, neighbor, loved one) or emergency services in accordance with your request.5. Once your Responder or the emergency service arrives, they should press your Help Button to let Lifeline know that help has arrived. The Response Associate will contact the household to conrm that you received the help that you needed. 6. Once Lifeline conrms that you have been assisted, a Response Associate will contact the “People to Notify” you’ve designated, letting them know you needed and received help.
9Accidental help calls: 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 all right. Signal rangeCAUTIONPlease see the Quick Setup Guide included in the box for instructions on how to set up your system and test the range of your Help Button. The Home Communicator must be properly set up, and the coverage range 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 Home 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 oor 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.The signal range may be affected by environmental factors, including building materials, large masses covering the AutoAlert Help Button (e.g. a person falling on top of it) and submersion in liquid.
10A 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 in range of the Home Communicator, help will be sent to the location of the Home Communicator (i.e., your apartment).Signal Range TestYou should conduct a Signal Range Test during initial installation and, if you move your Home Communicator to a different location in your home.1. Make sure that your Home Communicator is ON and that you have your Help Button in hand.2. PRESS and HOLD DOWN the Message button. The Home Communicator will beep and announce: “Continue to hold the Message button for AutoLearn. When you are ready for Range Test, please release the Message button.”3. Release the Message button. The Home Communicator will announce: “Please press the ashing orange Message button after you have completed the range test. Begin Signal Range Test.”4. Press your Help Button. The Home Communicator will beep and the light on your Help Button will ash green to indicate that the Home Communicator has received the signal.5. Move to other parts of your home and press your Help Button again. Listen for the beep and check to see if the green light is ashing.6. Once you have tested different locations in your home and immediately outside your home, return to the Home Communicator and press the ashing orange Message button.
11Battery 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 or your representative 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. If you need service or a repair, please contact Philips Lifeline or your representative. Contact Lifeline or their representative • If you would like to transfer your service to a new or second home.• If your Responder or People to Notify list needs to be updated. It is important that your list is up to date with the correct people and telephone numbers.• If someone else in your home needs to use the Lifeline Service. More than one person living in the same household can have the service.
12HomeSafe Wireless Communicator (7000C)Help button• Press to send a Help Call to the Response Center• Flashes red while a Help Call is connecting• Steady red when a Help Call is connectedMessage button • Used during the setup process• When the button is ashing orange, press to hear a status messageGreen status light• Steady green when the Communicator is ON• Flashes green when the communicator is running on battery (AC power loss)Microphone• Used to talk to LifelineDescription
13Volume control• Controls the volume of the speaker on the Communicator Signal strength • Indicates the strength of the wireless signal*Power switch • Used to turn the Communicator ON or OFF. The power switch must be ON at all times for your Lifeline service to work.* Signal strength may vary.
14Safety informationThe Wireless Communicator (7000C) uses a wireless network* to communicate with the Lifeline Response Center. 1. The strength of the wireless signal may be stronger in some areas of your home than others. When you set up our Home Communicator, look at the signal strength indicator on the back of the Home Communicator. The number of green bars that are glowing indicate signal strength, the more bars you see, the stronger the signal. Place your Home Communicator in a location where you spend the majority of your time, and the signal strength indicator shows two or more bars. 2. If the wireless network experiences an outage or the Home Communicator loses its signal, the Message button on top of the Home Communicator will ash and it will not be able to send a Help Call to Lifeline. If you press your Button and the wireless network is not available, you will hear a message saying: “Your call cannot be connected. There is no signal strength. Move your Home Communicator to a different location.” Try moving the Home Communicator to a different location in your home. Once the signal is restored, you will hear a message saying: “Connection has been restored.” Your Help Call will then be dialed. 3. The Home Communicator must be placed in an indoor living area. Please keep in mind that direct sunlight may make it difcult to see the status lights.Help call in progress. Please wait.Hello, Mrs. Smith.Do you need help?* The HomeSafe Wireless Communicator uses the AT&T wireless network.
154. Make sure that you do not plug your Home Communicator into a power outlet that is controlled by a switch because someone could accidentally turn off the switch and shut off the power to your Home Communicator. 5. Do not place anything on top of the Home Communicator. The Help Button and the Message button must always be visible and accessible.6. The Home Communicator contains a speaker and microphone. Take care not to block these, since doing so will make it difcult for you to communicate with Lifeline. 7. 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.8. To reduce the risk of electrical shock or re, do not place the Home Communicator in or near water or other liquids.9. Do not abuse the cords. Never carry the Home Communicator by the cord or yank the cord to disconnect it from a power outlet. Instead, grasp the plug and pull to disconnect.
16CleaningKeep the Home Communicator free of dust by wiping it with a soft cotton cloth. If additional cleaning is required, follow the steps below: 1. Move the power switch on the back of the Home Communicator to the OFF position and unplug the power cord from the power outlet. Note: You cannot call for help while the Home Communicator is off. Accordingly, you may wish to have a family member or caregiver present while you are cleaning your Home Communicator. 2. Slightly dampen a soft cloth with a mild soap and water and gently wipe the surfaces clean. Do not use detergent or abrasive cleaners on your Home Communicator. 3. Reconnect the power cord to the power outlet. Move the power switch on the back of the Home Communicator to the ON position. 4. Test your system by pressing your Help Button. Tell the Response Associate that you are just testing your equipment after cleaning it.Caution: 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 back-up battery begins to work automatically.
17HomeSafe Help Buttons – General Information Warnings and CautionsWarnings are:Potentially hazardous situations which could result in injury, death, or other serious adverse reactions if these instructions are not followed. WARNING• Any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries. This may be of more concern to wearers in wheelchairs, using walkers, using beds with guard rails, or who might encounter other protruding objects upon which the cord can become tangled.• Philips Lifeline neck cords contain a special fuse designed to breakaway under certain conditions to reduce the remote risk of strangulation. If the neck cord breaks apart, contact Philips Lifeline or your representative for a replacement.• Do not use any neck cord other than the one provided by Philips Lifeline or your representative. Other neck cords may not provide the feature to break apart therefore increasing the risk of strangulation.• Do not tie a knot in your neck cord since this may prevent the break away feature from working properly.8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ700 0PHBIC: 655C -7000P HB82352000148235-YYYYMMDDFCC: BDZ700 0AHBIC: 655C -7000A HBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB
18CAUTION indicates the potential of device malfunctions, device failures, damage to the device, or damage to other property. And if these instructions are not followed may result in minor or moderate injury. CAUTIONThere are no user-serviceable parts inside the Help Button. Do not attempt to open or modify the device.The Help Button contains a lithium battery that must be disposed of properly. Do not discard the Help Button in the trash or expose it to ames or intense heat. The Help Button is not suitable for use in the presence of ammable mixtures.Do not put your Help Button through the dishwasher, clothes washer or dryer. Please be sure to remove your Help Button from articles of clothing that are being dry-cleaned.Do not leave your Help Button on the dashboard of your car or on a windowsill that receives direct sunlight since the excessive heat may damage it. Likewise, do not wear your Help Button into a whirlpool bath, hot tub or sauna. Compatible Home CommunicatorThe HomeSafe Personal Help Button and the HomeSafe AutoAlert Button are only compatible with the following Philips Lifeline Home Communicator:• HomeSafe Wireless Communicator (7000C)
19Setting 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 them all, even if you are only replacing one of them.1. Make sure that your Home Communicator is ON and that you have your replacement Help Button in hand.2. PRESS and HOLD DOWN the Message button on the Home Communicator. The Home Communicator will beep and announce: “Continue to hold the Message button for AutoLearn. When you are ready for Range Test, please release the Message button.” Do not release the Message button until you get to Step 5.3. Continue to hold down the Message button on your Home Communicator. With your other hand, press the Help Button until you hear a long beep and a voice announcement saying: “Your Lifeline Help Button is now auto-learned and ready to use.” This will indicate that the Help Button is working with the Home Communicator.4. After you’ve heard the announcement, release the Help Button.5. Repeat steps 3 and 4 to reprogram all the other Help Buttons in your home. Then, release the Message button on the Home Communicator. The Home Communicator will announce: “Please press the ashing
20orange Message button after you have completed the range test. Begin Signal Range Test.”6. Press your Help Button. The Home Communicator will beep and the light on your Help Button will ash green to indicate that the Home Communicator has received the signal.7. 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 ashing.8. Once you have tested different locations in your home and immediately outside your home, return to the Home Communicator and press the ashing orange Message button.CleaningYour Help Button is waterproof (IPX7 or up to 1 meter or 3 feet), so you can submerge it in warm water for easy cleaning.1. Wash your neck cord with a mild liquid dishwashing detergent. 2. Wash the Help Button under warm running water, being careful not to accidentally press the Help Button. You may also gently wipe your AutoAlert Help Button with an isopropyl (rubbing) alcohol wipe or a cotton pad moistened with alcohol. However, do not soak it in the alcohol. 3. Blot excess moisture with a towel and allow the Help Button to nish air-drying while you’re wearing it.4. If you accidentally push your Help Button during cleaning and a Help Call is placed, please simply tell the Personal Response Associate that you accidentally pressed the button.
21Recommended usage• Wear your Help Button in your home at all times, especially while sleeping and bathing. The bathroom is often a place where people fall and need help.• Your Help Button is waterproof and should be worn in the shower or bath.• Press your Help Button any time you need help. • Your Help Button does not contain a microphone, so you don’t need to talk into it. Press the Help Button and speak in the direction of your Home Communicator when talking to Lifeline.• Do not throw or toss the Help Button onto a bed, table, or other surface because it may accidentally send a Help Call.• You may continue to wear your Help Button when leaving your home. However, the Help Button will not provide coverage outside of the range determined by the Signal Range Test.• Please remember to contact Lifeline before moving the HomeSafe Wireless System to a new address.• If you are traveling on an airplane and need to bring your HomeSafe Wireless System with you, do not take it into the cabin of the airplane. Instead, pack your Help Button and Home Communicator in your checked luggage. Make sure that the Home Communicator’s power switch is turned off.
22HomeSafe Personal Help Button (7000PHB)Features• The HomeSafe Personal Help Button is waterproof• The HomeSafe Personal Help Button can be worn on the neck or wristThe Help Button allows you to summon assistance anytime. 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 in 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 viewConrmation light – Flashes green during range testing. Flashes red when an alarm is received by the Communicator.Button – Press here to send a Help Call to the Lifeline Response Center.
23BarcodeExplanation 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 NumberType BF applied part8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ7000PHBIC: 655C-7000PHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB
24Using 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 cord To shor ten: With a tab between your rst nger 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.
25HomeSafe AutoAlert Button (7000AHB)CautionsCAUTION indicates the potential of device malfunctions, device failures, damage to the device, or damage to other property. And if these instructions are not followed, may result in minor or moderate injury.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 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 ow 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.The HomeSafe AutoAlert Button may interfere with certain medical equipment, such as magnetic resonance imaging (MRI), X-ray machine as well as metal detectors. It may also interfere with aircraft communications, so do not take the HomeSafe AutoAlert Button aboard an airplane.
26To 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 battery information section for more on battery life and replacements.The HomeSafe AutoAlert Button may not detect every fallIn certain situations, the HomeSafe AutoAlert Button may not detect a fall. Some movements may not register as a fall and would not be detected. Examples include, but are not limited to:• A gradual slide such as from a seated position• Lowering oneself slowing to the ground (to brace the impact of a fall)• A fall from a height of less than 20 inches (0.5 meters)Certain conditions can affect the ability of the HomeSafe AutoAlert Button to detect a fall:• If you live at an altitude above 6,600 feet (2000 meters)• If you are less than 4 feet 6 inches in height (1.4 meters)• If you weigh less than 88 pounds (40 kilograms)However, the ability to send a Help Call by pressing the button is not affected by such conditions.
27Features• The HomeSafe AutoAlert Button allows you to summon assistance anytime, day or night. 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 in 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 if it detects you have fallen. The HomeSafe AutoAlert Button does not detect 100% of falls. If you are able, you should always press your Button when you need help.8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ70 00PHBIC: 655C-700 0PHB82352000148235-YYYYMMDDFCC: BDZ70 00AHBIC: 655C-7000AH BModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ70 00PHBIC: 655C-700 0PHB82352000148235-YYYYMMDDFCC: BDZ70 00AHBIC: 655C-7000AH BModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBFront viewButton – Press here to send a Help Call to the Lifeline Response Center. Conrmation light – Flashes green during range testing. Flashes red when an alarm is received by the Communicator. Back viewImportant: The vent hole 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).
28Product code: Report this code if you ever have to replace the unitAttention: Read the Instructions for Use for important informationModel numberSerial 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 part8235Model: 7000PHB2000148235-YYYYMMDDFCC: BDZ7000PHBIC: 655C-7000PHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHB82352000148235-YYYYMMDDFCC: BDZ7000AHBIC: 655C-7000AHBModel: 7000AHBExplanation of symbols
29What 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 Help Button detects that you have gotten up within approximately 30 seconds of a fall being detected, a Help Call will not be generated.• Do not attempt to stand if you feel unable to.• If you think you need assistance, push your Help Button immediately to initiate the Help Call. Pushing the Help Button generates the Help Call immediately.False “fall detected” alarms may occasionally occur• While the 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.• Occasional false alarms do not indicate that the AutoAlert Help Button is malfunctioning.BatteryThe 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. Philips Lifeline or your representative will contact you to arrange for a replacement.
30Safety and Regulatory ComplianceSafety standardsThe HomeSafe Help Buttons and Home Communicator comply with the following safety standards for medical devices and home healthcare equipment:Safety StandardsUL1637 Home Healthcare Signaling EquipmentCSA C22.2 NO 205-M1983 Signal EquipmentIEC60601-1:2005 (3rd Edition)Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance (CA/EN/US National Differences)IEC60601-1-2 Electromagnetic CompatibilityIEC62133 Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applicationsRSS-GEN General Requirements and Information for the Certication of Radio ApparatusRSS-210 Licence-exempt Radio Apparatus (All Frequency Bands): Category I EquipmentISO10993-1 Biological evaluation of medical devices
31Recommended environmental conditionsAltitude 6,600 feet (2 km) maximum*Operating Temperature 41°F (5°C) to 113°F (45°C) Storage Temperature -4°F (-20°C) to 140°F (60°C)Humidity 10% to 90% * AutoAlert button onlyIEC regulationsThe HomeSafe Help Buttons and Home Communicator are medical electrical (ME) equipment.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 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 specied, 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 conguration in which it will be used.
32System classicationThe HomeSafe Help Buttons and Home Communicator are FDA Class II devices. They are an internally powered devices for continuous operation.Radio specicationsThe HomeSafe 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.FCC Notice to UsersThis device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: • Device may not cause harmful interference• Device must accept any interference received, including interference that may cause undesired operation. Changes or modications 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 modications 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:
33• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.Industry Canada Notice to UsersThis device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: • Device may not cause interference• Device must accept any interference, including interference that may cause undesired operation of the device. 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 le brouillage est susceptible d’en compromettre le fonctionnement.Class B digital device noticeCAN ICES-3 (B) / NMB-3 (B).
34RF Exposure GuidanceDuring the operation of the Home Communicator (7000C), a separation distance of 20 cm is required to be maintained from users during transmission to ensure compliance with RF Exposure requirements.Pour assurer la conformité aux exigences de la FCC/IC en matière d’exposition aux radiofréquences lors du fonctionnement du Home Communicator (7000C), une distance de 20 cm (8 pouces) doit être maintenue entre l’utilisateur et l’appareil durant la transmission. UL1635 and UL1637 ComplianceThe maximum separation (range) of the equipment, under test conditions and for comparative purposes only, is 650 feet. This range may be signicantly reduced when the equipment is installed in a typical home. A clear, plastic power supply retaining strip is provided in the packaging with this system. To prevent the power supply from accidentally pulling out of the AC wall outlet under force, plug the power supply into the outlet you select to power your system, peel the release liner from the adhesive panels on the strip and afx it across the back of the power supply, adhering the 2 adhesive panels to the wall on each side of the power supply. Be sure that the adhesion area is devoid of any dirt, oil or grease that would prevent the adhesive from sticking properly.
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© 2013. All rights reserved.Signal range may vary due to environmental factors.P/N 0940864, Rev. 02 - DRAFT

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