Medical Alert Service t f a r d Instructions for use GoSafe Lite 2 Mobile Personal Emergency Response System and Service Instructions for 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.
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.
Contents Philips Lifeline Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Welcome to Philips Lifeline Setting up your Lifeline Service Responders and People to Notify Calling for help Signal Range Battery information Equipment service Contact Philips Lifeline or your representative GoSafe 2 Mobile System Help Buttons – General Information . . . . . . . . . . . . . . .
About This Manual Training Reading and understanding these Instructions for Use and the Quick Setup Guide serves as adequate training for the safe installation, use and disposal of the equipment. Users of this product must review and understand the instructions for use document to ensure safe and effective use. If you require further information about training in the use of this product, please contact Philips Lifeline or your Philips Lifeline representative.
Charger Pins: The gold pins on the charger itself that engage with the charging interface contacts. Charging Interface Contacts: The gold circles on the back side of the pendant. Coverage Area: The area from which your pendant is capable of sending & connecting a help call. As a cellular communication device, the coverage area for GoSafe Lite is defined by the cellular network availability and signal in your location, at the time of activating the pendant.
GoSafe Lite Mobile Pendant, or Pendant: This is the pendant that you physically wear around your neck. Also, known as the 7150 MHB. Help Alarm Signal: This is the type of signal that the Philips Lifeline call center receives from the Pendant when the Help Button is pressed. Indicator Light: A small light just above the Help Button, inside the grey area on the front of the Pendant. It will illuminate in either green, orange or red, and either blink or shine consistently depending on what it is indicating.
Philips Lifeline: the name of the company that provides GoSafe Lite and the Lifeline emergency response service. Recommended Usage: How you should use and interact with the Pendant can Call Center for normal use. Responder(s): If you should need emergency assistance and activate your Lifeline system, a responder is someone you want Philips Lifeline to contact to physically go to you and help you. You can have more than one responder.
Your Philips Lifeline Service Welcome to Philips Lifeline Thank you for choosing the Lifeline Medical Alert Service from Philips. Please refer to the Quick Setup Guide provided for instructions on setting up your equipment. These Instructions for Use will provide you with information about your equipment and the Philips Lifeline Medical Alert Service. Please read this manual and the Quick Setup Guide carefully, and note the Warnings and Cautions.
These Instructions for Use and the Quick Setup Guide describe the most extensive configuration of the product. This manual covers the following: GoSafe Lite Mobile Pendant (7150MHB) Works inside and outside of your home* Can only be worn around neck as a pendant Can detect falls** in your home Can detect falls** outside* your home 2-way voice communication with Philips Lifeline Waterproof to 1 meter (3.3’) for up to 30 minutes * When access to the AT&T wireless network is available.
Responders and People to Notify What is a “Responder”? As a Philips Lifeline subscriber, you should have designated people who have agreed to be “Responders.” These are people whom Lifeline should call in an emergency, when appropriate. Examples include: neighbors, friends, relatives, your current nursing aide, etc.
It’s very important that you keep your Responders and their contact information up to date. Remember to contact Philips Lifeline if one of your Responders is no longer able to assist you or if they get a new telephone number. Please contact Philips Lifeline for any questions about selecting or being a Responder. Most importantly, if you list someone as a Responder, make sure you tell that person that you have done so, and that they agree to act as a Responder.
Note: The Response Center is available 24 hours a day, 365 days a year. Your Lifeline subscription provides for unlimited calls to the response center without penalty. A trained Personal Response Associate is always available to assist you. 1 Help call in progress. Please wait. 2 Hello, Mrs. Smith. Do you need help? 2. Your Pendant calls the Lifeline Response Center. When it dials the Response Center, your pendant will repeatedly say: “Your Help Call is in progress; please wait.
Note: If you cannot speak or be heard, the Response Associate will try calling you back. If you cannot answer or if the Response Associate cannot hear you, Lifeline will contact your Responder(s) or emergency services.* *In the case of a fall detected, if the response associate cannot hear you and/or is unable to contact you through your GoSafe Lite pendant or your alternate contact numbers such as your home or cell phone, EMS will be contacted to respond.
Signal Range Please see the Quick Setup Guide located in the box for instructions on how to set up your GoSafe Lite system. and test the range of your Help Button. The coverage area of the your Help Button must be tested prior to use. The GoSafe Lite pendant is a radio frequency (RF) device that transmits a signal to the Lifeline call center over the Cellular network. It depends upon cellular network availability to send your help signal to the Lifeline call center.
Signal Range Test Battery information Your GoSafe Lite mobile pendant contains a battery that can only be replaced at the Philips factory. Your pendant will automatically send a signal to Philips Lifeline when the battery needs to be replaced. We will contact you directly to make arrangements for a replacement.
can have the service, but each individual user requires their own pendant. Safety information CAUTION: The GoSafe Pendant uses the AT&T wireless network to communicate with the Lifeline Response Center. 1. The strength of the wireless (cellular) signal may be stronger in some areas of your home than others.
GoSafe Lite Mobile Personal Emergency Response System General Information The information in this section applies to your GoSafe Lite Pendant. Cleaning and Care Your GoSafe Lite pendant is water resistant to the IPX7 standard. This means that you can submerge it in up to 1 meter (about 40”) of water for up to 30 minutes without damaging the pendant. As such, you can submerge it in warm water for easy cleaning and can also bathe/shower without removing it. 1.
Note: If you accidentally push your Help Button during cleaning, don’t panic. Allow the call to connect. A Personal Response Associate will answer the call when it connects. Simply tell them that “No help is needed”, and confirm to them that you are OK. Warnings • Any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries.
• Do not use any neck cord other than the one provided by Philips Lifeline or your representative. Other neck cords may not provide the feature to break apart therefore increasing the risk of strangulation. • Do not tie a knot in your neck cord since this may prevent the break away feature from working properly. • There are no user-serviceable parts inside the pendant. Do not attempt to open or modify the device. • The pendant contains a lithium battery that must be disposed of properly.
GoSafe Lite Mobile Pendant (7150MHB) The GoSafe Lite Mobile Pendant allows you to connect to the Lifeline Response Center 24 hours a day, 7 days a week. It can be used at home, or from any other location in the United States where the AT&T wireless network is available. The GoSafe Lite Mobile Pendant includes Philips AutoAlert fall detection technology, which provides an added layer of protection for the user by automatically calling for help when a fall is detected.
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.
GoSafe 2 Pendant (7150MHB) Front view Indicator light – This light will indicate the status of the GoSafe Lite Pendant. (see: Alarm Descriptions / Summary Tables section.) Microphone – The GoSafe Lite Mobile Pendant has a microphone that is used to talk to the Response Associate Button activation area Help Button – The Help Button is the portion of your Pendant that can be pressed to send a Help Call to Lifeline. Charger The GoSafe Lite Mobile Pendant has a rechargeable battery.
Back view Speaker – The GoSafe Lite Mobile Pendant has a builtin speaker that allows you to hear the Personal Response Associate, voice prompts and alert sounds. Charging Contacts – The gold circles on the back of the Pendant are the charging interface contacts. When you place your Pendant in the Charger, the charger Pins engage with these contact points. Important: This area is part of the fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products).
Determining your location In Alarm State, the GoSafe Lite Mobile Pendant is designed to help identify your general location, at or away from home. However, you should always tell the Personal Response Associate your exact location if you are able to do so. Even if you are unable to speak or describe your exact location, Lifeline will contact help to find and assist you where you are. Lifeline cannot guarantee that your location can be determined at all times.
What to expect when the AutoAlert fall detection technology in your GoSafe Lite Mobile Pendant detects a fall • A Help Call is automatically generated after approximately 30 seconds of a fall being detected While the fall may be detected in only a few seconds, the 30 second period is provided for users to “self-recover” from a fall if able. • If the Button detects that you have self-recovered from the fall, within approximately 30 seconds of a fall being detected, a Help Call will not be generated.
• Lowering oneself slowly to the ground (to brace the impact of a fall) • A fall from a height of less than 20 inches (0.5 meters) Caution Certain conditions can affect the ability of the AutoAlert Help Button to detect a fall: • If you live at an altitude above 6,600 feet (2000 meters) • If you are less than 4 feet 6 inches in height (1.4 meters) • If you weigh less than 88 pounds (40 kilograms) However, the ability to send a help call by pressing the button is not affected by such conditions.
Button if you are able to. Note that if your Pendant did detect the fall and is already in-process of calling Lifeline, pressing the button WILL NOT cancel or interrupt the call already in-progress, and will not interfere with system operation in any way. The vent area located on the back of the Pendant is part of the AutoAlert fall detection sensor system and needs to remain clear of obstructions (e.g., lint or food products). A continuous flow of water (e.g.
Sleep Mode. Be sure to place your Pendant in sleep mode when on an airplane. Please see instructions for putting your GoSafe Mobile Button in Sleep Mode on page 31. The GoSafe Mobile Button can only place a Help Call when in Stand-by mode, and when the AT&T wireless network is available.
the Indicator Light will flash orange whenever it initially needs to be charged. Typically, it will take less than 45 minutes to charge your GoSafe Mobile Button if you put it in the charger at this initial charge indication point. It will take longer than this if you wait additional time after this indication point to put the Pendant in the charger. Your Pendant is fully charged when it chimes and the Indicator Light turns to a steady green.
3. Charge until the light turns to a steady green. To provide the user with the longest possible battery life between charges, there is no constantly illuminated power indicator. Instead, the Pendant includes a “shake to indicate” feature. 4. Remove from the charger. The green light will turn off, and the Button is ready to use. 5. To provide the user with the longest possible battery life between charges, there is no constantly illuminated power indicator.
indicates charging is needed. In general, you will have to charge your GoSafe Lite Pendant once every 2 days. Sleep mode The GoSafe Lite Mobile Pendant utilizes cellular communication technology. As such, you must turn it off in the following circumstances: • During Air Travel (when flying on an airplane) regardless of whether you are “carrying-on” the pendant into the passenger cabin, or if you pack the Pendant in your checked luggage. Either way, it must be placed in Sleep mode.
Caution You will not be able to send a Help Call when the Pendant is in sleep mode. Be sure to remember to exit sleep mode as soon as wireless/electronic device use is allowed, e.g., after the airplane has landed. Note: If you are returning a GoSafe Lite Mobile Pendant to Philips Lifeline for service, replacement or recycling, you must contact Lifeline at the number at the bottom of the page before returning it.
• During an alarm, you can talk to Lifeline using GoSafe’s microphone and speaker. For best results, hold the pendant up and away from your chest when you are speaking to Lifeline. Maintain a minimum separation distance of 10 mm/ 0.394 inches when operating the device in this manner. • Your GoSafe Lite pendant should be worn while showering or bathing. The GoSafe Pendant carries an IPX7 waterproof rating. This means that it can be submerged to a depth of 1 meter in water for up to 30 minutes.
GoSafe Lite Pendant – Alarms Introduction There are two types of alarms processed by the GoSafe Lite Pendant. • High Priority – Require immediate response (by the Call Center) • Medium Priority – Require prompt response (by the operator/user) Additionally, the Pendant also plays verbal informational messages and confirmation alerts that notify you of conditions that need attention but do not qualify as alarm conditions (e.g. installation prompts).
alarm has already been reported to the Call Center, they will likely attempt to contact the Subscriber. If an alarm is accidentally initiated by the User, they should not put the Pendant to sleep. Instead, they should wait for the Call Center to establish voice communication and simply state that no help is needed. The Pendant self-cancels certain Medium Priority alarms if the cause of the alarm is corrected, stopping the orange flashing Indicator Light.
Help Needed – No Cell Signal Available Alarm Event Description Help Alarm initiated by the User pressing the button on the Pendant or by the Pendant detecting a fall; and the AT&T wireless network is unavailble. Then a verbal Warning Message is delivered by the pendant. Priority High Device Action The Help Alarm Signal will be buffered in the device. The device will continue to try to connect to the network and deliver the alarm.
Device Error (Medium Priority) Alarms The GoSafe Lite Pendant alarms described below are automatically generated alarms designed to periodically let the Call Center know that the Pendant is working properly They are part of normal operation and are the result of no intensional action by the user.
Depleted Battery – 7150 MHB Alarm Event Description When the charge level of the rechargeable battery is critically low, a Warning Message is announced. Priority Medium Device Action Device shuts down after the message is announced. Alarm Event Reported/ Displayed Locally? Yes. Indicator Light flashes orange, Voice Prompt plays: “Your help button is now out of power and will shut down. Please charge your device as soon as possible”.
Software Failure-End Device 7150 MHB Alarm Event Description In the event that a device senses it has a Software Error, a Warning Message is displayed Priority Medium Device Action May have limited operation, depending on the failure Alarm Event Reported/Displayed Locally? No Alarm Event Reported to Lifeline? Yes. A silent Maintenance Signal is sent to the Response Center.
Supervision Failure – 7150 MHB Alarm Event Description End Devices periodically check-in to the Communicator. If the Communicator has not received a check-in from the End Devices for a week, then a silent alarm is sent to the Response Center [What happens here?] Priority N/A Device Action Operates normally Alarm Event Reported/Displayed No visual or audible alarm is generated by the devices. Locally? Alarm Event Reported to Lifeline? Yes.
Logging Alarms All alarm events reported to the Response Center are logged by the Response 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.
Safety and Regulatory Compliance IEC Regulations The GoSafe Lite Pendant complies with the relevant National and International standards listed in the Technical Section. It is classified as medical electrical (ME) equipment in the USA according to the FDA product classification. According to Health Canada GoSafe Lite Pendant is not classified as a medical device. It falls under the Canada Consumer Product Safety Act. Medical electrical equipment can either generate or receive electromagnetic interference.
FCC Notice to Users This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: • 1) Device may not cause harmful interference • 2) Device must accept any interference received, including interference that may cause undesired operation. Pursuant to Part 15.21 of the FCC Rules, any changes or modifications not expressly approved by Philips Healthcare, Home Monitoring, Lifeline Systems Inc. could void the user’s authority to operate the equipment.
Industry Canada Notice to Users This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: • 1) Device may not cause interference • 2) Device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence.
Essential performance The GoSafe Lite Help Button provides essential performance (EP) under normal operating conditions (includes EMC exposure) by sending Help Calls to the Lifeline Response Center . If the GoSafe Lite is incapable of sending Help Calls, it will periodically send a status alarm to the Lifeline Response Center. need to either remove or edit for accuracy.
Risks and Benefits The GoSafe Lite Pendant depends on connecting to the AT&T wireless network in order to communicate with the Philips Lifeline Call Center. As with all wireless devices, the availability of the network cannot always be guaranteed. The GoSafe System Pendant depends on the user being capable of pressing the Help Button when they are in need of help.
Explosion safety a Warnings • Do not use this product in the presence of explosive gases or vapors, such as certain anesthetic gases. • Do not use flammable or potentially explosive disinfecting sprays in the presence of this product. • Use of this product in an environment for which it was not designed can lead to fire or explosion. Caution Portable and Mobile Phones: Portable and mobile RF communications can affect the GoSafe Lite device.
[Bill to Clarify - where does this come from, and does this mean that a person cannot carry a cell phone with them if they are using GoSafe? Also, with GoSafe being a medical device, shouldn’t the other devices accept interference from it?] Maintenance Expected Service Life The Expected Service Life of the GoSafe Pendant is as follows: • GoSafe Lite Mobile Help Button (7150MHB) – 2-3 years* *The Service Life indicated above is primarily based on the expected life of the device’s internal battery.
Technical Specifications Standards Compliance This device is designed to conform to the following Standards and Regulations: • IEC/ANSI/ AAMI60601-1:2005/R(12)2012, SE FEJUJPO 1BSU General requirements for basic safety and essential performance.’ • CSA C22.2 # 60601-1:2014 Ed.
Environmental Ratings Operating Storage Bathing* Temperature 41° F to 95° F (5° C to 35° C) -4° F to 140° F (-20° C to 60° C) Up to 122° F (50° C)* Relative 10 to 90% (non-condensing) 10 to 90% (non-condensing) Atmospheric Pressure 101 kPa to 77 kPa (approximately 0-7500 ft/02286 m) N/A Altitude 6,600 feet (2 km) Maximum N/A Humidity * Up to 30 minutes exposure. Electrical Specifciations GoSafe Lite Mobile Pendant (7150MHB) AC Voltage Source[1] (VAC) N/A - EUT battery operated.
Product Disposal Environmental Requirements Introduction Philips Lifeline is concerned to help protect the natural environment, and to help ensure continued safe and effective use of this product, through proper support, maintenance and training. Therefore Philips products are designed and manufactured to comply with relevant guidelines for environmental protection. As long as the product is properly operated and maintained, it presents no environmental risks.
Electromagnetic Comparability - EMC Medical electrical equipment can either generate or receive electromagnetic interference. The GoSafe Lite (7150MHB) has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 6060-1 collateral standard IEC 60601-1-2:2007, the international standard for EMC for medical electrical equipment.
EMC Informational Tables Table 1 - Guidance and Manufacturer’s Declaration – Emissions The EUT "GoSafe Lite" model 7150MHB is intended for use in the electromagnetic environment specified below. The EUT is provided with battery power adapter charger. The customer or user of the GoSafe Lite should ensure that it is used in such an environment.
Immunity Test EN/IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance Surge EN/IEC 61000-4-5 ±1 kV line(s) to line(s)±2 kV line(s) to earth ±1 kV line(s) to line(s)±2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. 3A/m Power frequency magnetic fields should be that of a typical commercial or hospital environment.
Table 4 - Guidance and Manufacturer’s declaration – Immunity The GoSafe Lite 7150MHB is intended for use in the electromagnetic environment specified below. The customer or user of the GoSafe Lite should ensure that it is used in such an environment. Immunity Test EN/IEC 60601 Compliance Electromagnetic Environment – Guidance Level Test Level Conducted RF 3 Vrms EN/IEC 150 kHz 61000-4-6 to 80 MHz 3 Vrms* D=1.17√P D=0.35√P 80 to 800 MHz D=0.70√P 800 MHz to 2.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Table 6 - Recommended Separations Distances between Portable and Mobile RF Communications equipment and GoSafe Lite The GoSafe Lite 7150MHB is intended for use in the electromagnetic environment in which radiated disturbances are controlled.
Symbols Symbol Description Symbol for DC (Direct Current) Power. Polarity symbol. Indicates that the center (tip) of the output plug is Positive (+) and the barrel of the output plug is Negative (-). The power supply efficiency performance is Level 5, indicating a high standard in use efficiencies and no-load power consumption. The CE Mark is a conformity symbol for European countries. The symbol stands for Conformité Européenne. A Class II or double insulated electrical device.
Consult accompanying instructions for use. Symbol for non-ionizing radiation. Indicates that the device(s) include(s) RF transmitters. Indicates the device manufacturer. Indicates the date when the device was manufactured. Use by Date. Indicates the 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.
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.
Philips Lifeline 111 Lawrence Street Framingham, MA 01702-8156 Tel: 1-800-451-0525 www.lifelinesystems.com Confidential Draft for Agency Submission Only. Not for Posting on Suite any105Public-Facing Website© 2017. All rights reserved. 95 Barber Greene Road, Toronto, Ontario, Canada M3C 3E9 range may vary due to environmental factors. Not for dissemination to the public without theSignal express written consent of Philips. Tel: 1-800-387-8120 P/N XXXXXXX, Rev.
