Medical Alert Service GoSafe 2 Mobile Medical Alert Service Instructions for use MHB3_7250_IFU 2020c.
Important Notice to User The GoSafe 2 Mobile Pendant is a radio frequency (RF) device that transmits all of its signals to the Lifeline Response Center over a cellular network. As such, it relies upon adequate cellular network availability and signal strength, at the time and location of alarm generation, to send your help signal to the Lifeline Response Center.
Contents About This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Training Definitions and Terminology Philips Lifeline Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Welcome to Philips Lifeline Setting up your Philips 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 Medical Alert System General Information. . . . . . . . . . . . .
About This Manual Training Reading and understanding these Instructions for Use and the Quick Setup Guide serves as adequate training for the installation, use and disposal of the equipment. Users of this product must review and understand the Instructions for Use document to help provide 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.
Cellular Network: The AT&T cellular/wireless network. Charger: The component of your GoSafe 2 Mobile System that is used to re-charge your Mobile Pendant. See page 22. 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 and connecting a help call.
within that time period, the fall will not be reported. Users should always press the Help Button when they need help if they are able to do so. Help Button: The Help Button is the depressed square area inside the grey field on the front of the Pendant itself. When pressed, a prompt call to the Philips Lifeline Response Center is placed. To initiate a call to Philips Lifeline, press the Help Button.
Initial Recharge Indication: The Pendant chimes and the orange Indicator Light starts to blink. This is the point at which you should re-charge your Pendant. Intended Use: The purpose for which the system was specifically designed. GoSafe 2 was designed for people to wear and help maintain their independence, knowing that if they need assistance at home or away,* they can access help. Lifeline: The emergency response service associated with your GoSafe 2 Mobile Pendant.
Responder(s): If you should need emergency assistance and activate your Pendant, a responder is someone you want Philips Lifeline to contact to physically go to you and help you. You can have more than one Responder. In an emergency, Philips Lifeline will contact them in prioritized order until we are able to connect with someone that can get to you and help you. See page 11. Response Center: The Philips Lifeline call center where calls from your Pendant are answered.
Your Philips Lifeline Service Welcome to Philips Lifeline Thank you for choosing the Philips Lifeline Medical Alert Service. Please refer to the Quick Setup Guide provided for instructions on setting up your equipment. These Instructions for Use will provide you with information about your equipment and the 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.
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.
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.
calls to the Response Center without penalty. A trained Personal Response Associate will be available to assist you. 1 Your help call is in progress. Please wait. 2 Hello, Mrs. Smith. Do you need help? 2. Your Pendant calls the Lifeline Response Center. When it dials the Response Center, your Pendant will repeatedly say: “Your Help Call is in progress; please wait.” Once it connects with the Response Center, it will say: “Your call has been connected; Lifeline will be right with you.
*Note: If you cannot speak or be heard through the Pendant, the Response Associate may try calling you back on the alternate phone number you have provided - typically your home phone. If you cannot answer or if the Response Associate cannot hear you, Lifeline will contact your Responder(s) or emergency services.
Signal Coverage Please see the Quick Setup Guide located in the box for instructions on how to set up your GoSafe 2 system. Your Pendant must be tested prior to use by initiating a call to the Response Center. The GoSafe 2 Mobile Pendant is a radio frequency (RF) device that transmits a signal to the Lifeline Response Center over a wireless network. It relies upon adequate network signal strength and availability to send your help signal to the Lifeline Response Center.
of building construction, large masses covering the Pendant (i.e. a person laying on top of it) and submersion in liquid. * Due to technology limitations, Lifeline may not always be able to determine your location. During an alarm, always tell the Response Associate where you are if you are able to do so. Battery information Your GoSafe 2 Mobile Pendant contains a rechargeable battery that can only be replaced at the Philips factory.
address to which you want it transferred. For the change to take effect, you must call Philips to confirm that you are residing at the new address. • 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, but each individual User requires their own Pendant.
GoSafe 2 Mobile Medical Alert System General Information The information in this section applies to the proper use and care of your GoSafe 2 Mobile Pendant. Cleaning and Care Your GoSafe 2 Mobile Pendant is water proof 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 it. 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 press the 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 8235 to them 8235 that you are OK.
• The Pendant contains a lithium battery that must be disposed of properly. Do not discard the Pendant in the trash or expose it to flames or intense heat. • The Pendant is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. See page 51. • Do not put your Pendant through the dishwasher, clothes washer or dryer. Please be sure to remove your Pendant from articles of clothing that are being dry-cleaned. • Excessive heat may damage your Pendant.
GoSafe 2 Mobile Pendant (7250MHB) The GoSafe 2 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 2 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.
GoSafe 2 Mobile Pendant (7250MHB) Front view Indicator light – This light will indicate the status of the GoSafe 2 Mobile Pendant. (see: Alarm Descriptions / Summary Tables section.) Microphone – The GoSafe 2 Mobile Pendant has a microphone that is used to talk to the Response Associate. Help Button Help Button – The Help Button is the portion of your Pendant that can be pressed to send a Help Call to Philips Lifeline. Charger Charger The GoSafe 2 Mobile Pendant has a rechargeable battery.
Back view Speaker – The GoSafe 2 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. Note: The Pendant should be worn with this back surface against your body and the front surface with the Help Button facing away from you.
Back view with labeling description Philips Lifeline Logo Ingress Protection (IP) Rating GTIN Number FCC,IC code Refer to IFU Icon 0088483807XXXX FCC ID: BDZ7250MHB IC: 655C-7250MHB Product Barcode Applied Part Icon REF 300000012345 SN 1030148235 MDL 7150MHB 7250MHB YYYY-MM-DD Engineering Part Number Last 4 Digits of Serial Number Emmission Icon Serial Number Model Number Date of Manufacture 24 Item 1 2 3 4 5 6 7 8 9 10 11 12 13 Description Philips Lifeline Logo GTIN Number Refer to IFU Icon Ser
Determining your location When in Alarm State, the GoSafe 2 Mobile Pendant is designed to help identify your 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. 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 2 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 Pendant detects that you have self-recovered from the fall, within less than approximately 30 seconds of a fall being detected, a Help Call will not be generated.
• A gradual slide such as from a seated position - such as from a wheelchair, • Lowering oneself slowly to the ground, • Bracing the impact of a fall or interrupting the fall in-process, such as by holding-on to a piece of furniture during the fall, • A fall from a height of less than 20 inches (0.
Allow the call to connect. A Philips 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. There are no additional charges for false alarms. Note: Occasional false alarms do not indicate that the Pendant is malfunctioning. Vent Area 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).
Air Travel Because it is a cellular communication device, the GoSafe 2 Mobile Pendant may interfere with aircraft communications while in normal Stand-by mode. For this reason, the Pendant has a Sleep Mode. Be sure to place your Pendant in Sleep Mode during air travel. Please see instructions for putting your Pendant in Sleep Mode on page 32.
charge your Pendant if it reaches this point, but this will not hurt the device. Warning: Once the Critical Charge Warning is played and the Pendant shuts down, it cannot be used to make a help call of any type until it is re-charged. Flashing orange Indicator Light = charging needed Flashing green Indicator Light = charging in progress When connected to the charger, a steady green Indicator Light = fully charged When charging: 1.
2. Attach your Pendant to the Charger. You will hear a chime and a voice prompt that says “I am now charging. My light will turn solid green when I am ready to use.” to acknowledge that you are charging. The Indicator Light will begin flashing Green. 3. Charge until the Indicator Light shines a steady green. 4. Remove from the charger. The green Indicator Light will turn off, and the Pendant is ready to use. 5.
• Do not wear and charge your Pendant while sleeping or bathing. • Battery life varies based on activity level, cellular signal strength in your area, battery age, and actual emergency use. Your GoSafe 2 Mobile Pendant provides audible and visual reminders of when to charge. You should charge it when it indicates charging is needed. Depending on environmental conditions and your level of mobility, you will have to charge your GoSafe 2 Pendant once approximately every 2-3 days.
re-orient to its new location. To exit Sleep Mode, press the Help Button once and release it. Your Pendant will say: “Your Help Button is now ready to use. If you need help, please press your Help Button again”. This initial button press that wakes the Pendant out of Sleep Mode will not initiate a Help Call. If you need help in this instance, be sure to press the Help Button a second time. Caution You will not be able to send a Help Call when the Pendant is in Sleep Mode.
• During an alarm, you can talk to Philips Lifeline using the microphone and speaker on your Pendant. For best results, hold the Pendant up and away from your chest when you are speaking to Lifeline. Maintain a minimum separation distance of 10mm/0.394 inches when operating the device in this manner. 10mm is less than the thickness of your finger. • Your GoSafe 2 Mobile Pendant should be worn while showering or bathing. The Pendant has an IPX7 waterproof rating.
GoSafe 2 Mobile Pendant – Alarms Introduction There are two types of alarms processed by the GoSafe 2 Mobile Pendant. • High Priority – Require immediate response (by the Response 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).
Silencing Alarms Once a High Priority alarm is detected, it cannot be silenced. During Medium Priority alarms, the Pendant will play a sound and possibly a voice prompt once upon detection of the alarm, but the orange Indicator Light flashes until the alarm condition is corrected. Resetting an Alarm – what does reset mean? High Priority alarms are normally reset (cancelled once addressed) by the Response Center.
response. If an alarm is accidentally initiated by the User, they should not put the Pendant in Sleep Mode to try to cancel the alarm. Instead, the User should wait for the Response Center to establish voice communication and simply state that no help is needed. The GoSafe 2 Mobile Pendant self-cancels certain Medium Priority alarms if the cause of the alarm is corrected, stopping the orange flashing Indicator Light from illuminating.
Help Needed – No Cell Signal Available Alarm Event Description Help Alarm initiated by the User pressing the Help Button on the End Device or by the End Device detecting a fall; and the AT&T wireless network is unavailable: a verbal warning message is delivered by the End Device. Priority High Device Action The Help Alarm Signal will be buffered in the End Device. The End Device will continue to try to connect to the network and deliver the alarm.
Help Needed – Fall Detected by Pendant Alarm Event Description Help Alarm initiated by the End Device detecting a fall. Priority High Device Action Operates normally Alarm Event Reported/ Displayed Locally? Yes. When the End Device has detected a fall, it plays a Voice Message and the Indicator Light flashes red. Voice Message: “Your help call is in progress. Please wait. For proper use, hold your Help Button up in front of you.” Alarm Event Reported to Philips Lifeline? Yes.
Device Error (Medium Priority) Alarms The GoSafe 2 Mobile Pendant alarms described below are automatically generated alarms designed to periodically let the Response Center know that the Pendant is working properly. They are part of normal operation and are not the result of intentional action by the User.
Battery Requires Charging – 7250 MHB Alarm Event Description When the rechargeable battery in the End Device needs to be charged, a visual and audible warning Message is activated on the End Device. Priority Medium Device Action Operates normally until the battery is critically low. Alarm Event Reported/ Displayed Locally? Yes. The Indicator Light flashes orange and a single chime is played. This alarm will self cancel once the battery charge reaches an acceptable level.
Device Hardware Failure – 7250 MHB Alarm Event Description In the event that internal diagnostics indicate that the End Device has a Hardware Error, a Warning Message is displayed, if possible, based on the nature of the failure. Priority Medium Device Action May have limited operation, depending on the nature of the failure Alarm Event Reported/ Displayed Locally? No. Alarm Event Reported to Philips Lifeline? Yes.
Software Failure-End Device 7250 MHB Alarm Event Description In the event that an End Device senses it has a software error, a warning message may be sent to the Response Center depending on the nature of the error. Priority Medium Device Action May have limited operation, depending on the failure Alarm Event Reported/ Displayed Locally? No Alarm Event Reported to Lifeline? Yes.
Check-in Alarms (Informational Messages) The alarms described below are automatically generated alarms designed to periodically let the Lifeline Response Center know that the End Device is working properly. These alarms are silent and require no immediate action from the User/Subscriber. Alarm Event Type Auto Test Call 7250 MHB Alarm Event Description Auto Test calls are automatically generated silent alarms sent by the End Device at regular intervals to the Response Center.
Delay in Determining Alarms Reporting high priority help alarms from the GoSafe 2 Mobile Pendant to the Lifeline Response Center is done promptly when generated by a button press, depending on the status of the wireless network and signal strength available. The GoSafe 2 Mobile Pendant provides an added layer of protection. It is designed to detect falls under certain conditions.
Safety and Regulatory Compliance IEC regulations The GoSafe 2 Mobile Pendant (7250MHB) 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 the GoSafe 2 Mobile Pendant (7250MHB) is not classified as a medical device. It falls under the Canada Consumer Product Safety Act.
2) The 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. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment.
1) The Device may not cause interference 2) The 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.
Contraindications Caution This device may be contraindicated for any person who is connected to, or has implanted in their body, an implanted electronic medical device or instrument such as a pacemaker or defibrillator. This device may cause the electronic medical device to malfunction.
Safety Warnings Maintenance & faults: If any part of the product is known (or suspected) to be defective or wrongly adjusted, DO NOT USE the product until a repair has been made. Operation of the product with defective or wrongly adjusted components could expose the User or the patient to safety hazards. Safety awareness: Do not use this product for any application until you read and understand the safety information, safety procedures and emergency procedures contained in this SAFETY section.
Caution Portable and Mobile Phones: Portable and mobile RF communications may affect the GoSafe 2 Mobile Pendant (7250MHB). Use caution when using such communication devices within the specified range of the GoSafe 2 Mobile Pendant (7250MHB). Maintenance Expected Service Life The Expected Service Life of the GoSafe 2 Mobile Pendant is as follows: • GoSafe 2 Mobile Pendant (7250MHB) – 2-3 years* * The Service Life indicated above is primarily based on the expected life of the device’s internal battery.
• IEC/ANSI/ AAMI60601-1:2005/R(12)2012, 3rd edition, Part 1- General requirements for basic safety and essential performance.’ • CSA C22.2 # 60601-1:2014 Ed.
• UL 1637:2017 Standard for Home Health Care Signaling Equipment. Open source software The GoSafe 2 Mobile Pendant (7250MHB) utilizes the Wiced™ SDK and associated third party, open-source code and object files which are used under license from their respective providers within the SDK. Wiced is a trademark of Cypress Semiconductor Corporation.
[1] The means of isolating the device from the supply mains is by disconnecting the device from the wall outlet. [2] The capacity restored by the cell varies according to current drain, temperature and cut-off. [3] Recharging of the GoSafe 2 Mobile Pendant (7250MHB) battery is done by the User as needed, when connected to the charger.
The GoSafe 2 Mobile Pendant (7250MHB) complies with relevant laws and standards on electro-magnetic compatibility (EMC) for this type of product when used as intended. Such laws and standards define both the permissible electromagnetic emission levels from this product and its required immunity to electromagnetic interference from external sources. The GoSafe 2 Mobile Pendant (7250MHB) must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
Table 1 – Emissions The GoSafe 2 Mobile Pendant (7250MHB) complies with the emissions standards and levels specified in the table below. The GoSafe 2 Mobile Pendant (7250MHB) is provided with a battery power. Emissions Test Compliance Guidance RF Emissions CISPR 11 Group 2 RF Emissions CISPR 11 Class B The 7250MHB must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Harmonics IEC 61000-3-2 N/A for GoSafe 2.
Table 2 – Immunity The GoSafe 2 Mobile Pendant (7250MHB) complies with the immunity standards and levels specified in the table below.
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.
Symbol Description 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.
SECURITY and PRIVACY-related controls that are supported by this product: • The GoSafe 2 Mobile Pendant (7250MHB), the “Device”, is sealed. The User has no access to any of the internal components of the Device without violating/destroying the device enclosure. • Specialized, precision manufacturing equipment is required to access the physical components that store data within the Device.
Questions? Call 1-800-635-6156 MHB3_7250_IFU 2020c.
Questions? Call 1-800-635-6156 MHB3_7250_IFU 2020c.
Questions? Call 1-800-635-6156 MHB3_7250_IFU 2020c.
Philips Lifeline 111 Lawrence Street Framingham, MA 01702-8156 Tel: 1-800-451-0525 www.lifelinesystems.com 95 Barber Greene Road, Suite 105 Toronto, Ontario, Canada M3C 3E9 Tel: 1-800-387-8120 MHB3_7250_IFU 2020c.indd 1 © 2020. All rights reserved. Signal range may vary due to environmental factors. P/N 300004627021 Rev.
