Boston Scientific LATITUDE 6288 Patient Manual Download Page 95

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LATITUDE

™

Communicator

Patient Manual

Additional Inf

orma

tion

European Union Importer

EU Importer: Boston Scientific International B.V., Vestastraat 6, 6468 EX Kerkrade,

The Netherlands.

Essential Performance

In accordance with clause 4.3 of IEC/EN 60601-1, the Communicator has no

performance that qualifies as essential performance.

Software Statement

The software included in this product contains copyrighted software that is

licensed under the GNU General Public License (GPL). Under the terms of the

GPL as published by the Free Software Foundation, you may obtain the complete

corresponding source code from us for a period of three years after our shipment of

this product.

Summary of Contents for LATITUDE 6288

Page 1: ...LATITUDE Communicator PATIENT MANUAL ...

Page 2: ......

Page 3: ... shown as any other color including white means that it is lit Follow the instructions in this manual when using the Communicator Keep all of your Communicator information in a convenient location for easy access in the future LATITUDE is a trademark of Boston Scientific Corporation or its affiliates GlobTek is a trademark of GlobTek Inc Excelsus is a trademark of Pulse Electronics MultiConnect is...

Page 4: ...LATITUDE Communicator Patient Manual ii ...

Page 5: ...TOR 7 Important Notes 7 Where to Place Your Communicator 8 Heart Button and Indicators 9 Heart Button and Indicator Descriptions 11 Normal Operation of the Communicator 16 Using the Heart Button 16 Status Button 19 Confirming Successful Operation 19 Confirming Connection to the Clinician Website 20 Canceling an Interrogation 20 Loss of Power 21 Traveling With Your Communicator 21 Care and Maintena...

Page 6: ... Method 34 Cellular Connection 35 Using Previous Cellular Connection Accessories 38 Replacement 39 Internet Connection 40 Replacement 42 Standard Telephone Connection 43 Communicator Use of the Telephone 45 Using the Telephone While the Communicator is Making a Call 46 DSL Internet Service 47 Replacement 47 Hotspot Connection Mobile Device 47 USB Accessory Adapter Connection 48 Software Download a...

Page 7: ...5 LATITUDE Support 75 Frequently Asked Questions 77 Specifications 80 Safety and Standards Compliance 85 European Union Importer 87 Essential Performance 87 Software Statement 87 Electromagnetic Emissions and Immunity 88 Explanation of Product and Label Symbols 90 ...

Page 8: ...s Button 19 Figure 3 Location of Switches 26 Figure 4 Dial out Number Switch Settings 1 3 33 Figure 5 Back of Communicator 34 Figure 6 Connecting a USB Cellular Adapter 35 Figure 7 Connecting a USB Ethernet Adapter 40 Figure 8 Connecting a Telephone Cable 43 Figure 9 Connecting a USB Accessory Adapter 48 ...

Page 9: ...are provider The LATITUDE System is designed to help your health care provider manage your ongoing care in a manner that is convenient for both of you The LATITUDE System uses advanced security methods to protect your personal medical information Only authorized health care providers have access to your information through the password protected Clinician Website CAUTION CAUTION The LATITUDE Syste...

Page 10: ...d data will be sent to the Clinician Website only as needed Scheduled Follow ups Scheduled Follow ups At times set by your health care provider typically every few months your Communicator collects and then sends your implanted device data to the Clinician Website Manual Manual If this feature is enabled by your health care provider you may initiate the Communicator to read your implanted device b...

Page 11: ...in the provided documentation Call your health care provider if you need assistance setting up or using your Communicator The Communicator does not provide continuous monitoring The Communicator does not reprogram or change any functions of your implanted device Only your health care provider can do this during an office visit The Communicator is designed to work only with your implanted device It...

Page 12: ...ferenced in this manual 6250 Power supply replacement Connection Accessories 6359 3G USB cellular adapter current model 6205 6213 4G USB cellular adapter current models 6293 USB Ethernet adapter 6250 Telephone cable may be included 6250 Telephone jack adapter 6421 DSL filter 6454 USB accessory adapter 6296 3G USB cellular adapter previous model 6456 MT200A2W Multi Tech Model Number Analog to wirel...

Page 13: ...rovides a wireless connection between these products and your Communicator Refer to USB Accessory Adapter Connection on page 48 for more information The Clinician Website Between office visits the Clinician Website gives your health care provider access to the implanted device data that was collected and sent by your Communicator The Clinician Website features advanced analysis and trending tools ...

Page 14: ... Reduces the number of in person clinical evaluations at the clinic Improves the consistency of follow up by your health care provider Provides more information on certain heart conditions to your health care provider For a more detailed description of clinical benefits please consult https ec europa eu tools eudamed and discuss with your health care provider which provisions may apply to you ...

Page 15: ...Notes Check your Communicator every day to see if any of the indicators are lit solid or flashing Refer to Heart Button and Indicators on page 9 and the Troubleshooting section starting on page 51 for more information on the meaning of indicator lights Call your health care provider if the Call Doctor Icon lights red flashing or solid It is very important that the Communicator is always always plu...

Page 16: ...t Connection on page 40 Standard Telephone Connection on page 43 Some household appliances and other sources of electromagnetic energy could interfere with wireless communication between the Communicator and your implanted device When you are using the Communicator it should be at least 30 cm 12 in away from televisions digital video disc DVD players personal computers modems routers microwaves an...

Page 17: ...c will give advice on better Communicator placement to correct this issue Heart Button and Indicators The following figure shows the Heart button and all the indicators on the front of your Communicator Use this figure for reference as you follow this manual s instructions for using your Communicator Figure 1 1 2 3 4 5 6 7 8 1 Patient icon 2 Collecting Waves 3 Heart button 4 Sending Waves 5 Doctor...

Page 18: ...ence of each indicator shown in Figure 1 are explained in the following section Note Note When the words interrogate or interrogation are used in this manual it means that the Communicator is collecting data from your implanted device If indicators light other than as explained in this section refer to the applicable error in the Troubleshooting section starting on page 51 to find out if you need ...

Page 19: ...e a scheduled follow up interrogation Press the Heart button to complete A solid white light for 2 minutes means the interrogation is complete Note that the solid white light may appear dim An unlit Heart button may also be used to manually initiate an interrogation of your implanted device Only press an unlit Heart button when instructed to do so by your health care provider Refer to Using the He...

Page 20: ... pressed and an interrogation has started Lights solid blue for 2 minutes after a successful interrogation Collecting Waves Shows the Communicator is interrogating your implanted device Each wave flashes green in sequence and repeats showing the Communicator is interrogating your implanted device All three waves light green for 2 minutes to indicate the interrogation was a success ...

Page 21: ...cian Website is in progress All three waves light green for 2 minutes to indicate the connection to the Clinician Website was a success and any collected device data was sent Doctor Icon Lights blue for 2 minutes to indicate the Communicator has successfully connected to the Clinician Website The Communicator sends any data it has collected from your implanted device or prescribed weight scale or ...

Page 22: ... Communicator successfully received a weight or blood pressure measurement LATITUDE Indicator Shows the Communicator is connected to electrical power and ready to use It also shows if the Communicator startup process is being performed Lights green to indicate the Communicator is connected to electrical power and is ready to use Flashes yellow briefly after the Communicator is plugged into electri...

Page 23: ...r in the Troubleshooting section starting on page 51 for more information Flashes yellow briefly after the Communicator is plugged into electrical power does not require contacting your health care provider It then turns off after the Communicator completes the startup process Lights solid yellow if the startup process does not complete If the Call Doctor icon lights red flashing or solid call you...

Page 24: ...utton has been pressed Note Note In this manual a gray heart shown inside the blue circle means that it is not lit a white heart means that it is lit Using the Heart Button Always press the Heart button when it is flashing or when told to do so by your health care provider Stay next to the Communicator until lights are lit as shown here Do not press the Heart button if it is unlit unless instructe...

Page 25: ...our implanted device after the Heart button is pressed 2 The Patient icon lights blue The Collecting Waves flash green in sequence and repeat while the Communicator interrogates your device 3 All three Collecting Waves light green The Heart button lights solid white showing the interrogation was a success ...

Page 26: ...data to the Clinician Website The indicators stay lit for 2 minutes to show the entire process was a success No further action is required CAUTION CAUTION Normal use of the LATITUDE System has been accounted for in the projected battery life of your implanted device Pressing the Heart button more often than when the Heart button flashes or when instructed to do so by your health care provider may ...

Page 27: ...g indicators will stay lit for 2 minutes If you see the following image all six Collecting and Sending Waves lit green your Communicator is working correctly No further action is needed If the indicators are different than the above image refer to the applicable error in the Troubleshooting section starting on page 51 to learn what actions you should take Note Note If you pressed the Heart button ...

Page 28: ... for the sequence to end Then press the Status button again for more more than 3 seconds than 3 seconds Wait a few minutes for the connection to complete If all three Sending Waves light a solid green as shown in the following image for 2 minutes the connection was a success If the Sending Waves are other than all lit solid green refer to the applicable error in the Troubleshooting section startin...

Page 29: ...m home for an extended period of time multiple days or weeks consult with your health care provider to determine whether you should take your Communicator with you If you take it with you your health care provider may need to temporarily change your interrogation schedule If you are traveling outside the country your health care provider may need to give you information about connecting to the Cli...

Page 30: ...g To ensure optimum performance of your Communicator and accessories and protect them from damage follow these directions CAUTIONS Do not drop or mishandle the Communicator or its accessories in a manner that would cause damage Avoid getting liquid on the unit other than cleaning it as recommended Do not use abrasive cloth or solvents to clean the unit Do not submerge the Communicator or its acces...

Page 31: ...g fluid near the electrical plugs on the back of the Communicator Note that the finish on some types of furniture could be affected as a result of continuous contact with rubber material such as the type used on the base of the Communicator Returning Replacing or Disposing of the Communicator or Accessories If you need to replace your Communicator or any accessories because of damage or malfunctio...

Page 32: ...LATITUDE Communicator Patient Manual 24 ...

Page 33: ... 35 Internet Connection on page 40 Standard Telephone Connection on page 43 Hotspot Connection Mobile Device on page 47 Not every connection method is available in all locations Contact your health care provider to learn which connection method is available and right for you Only one connection method can be used with your Communicator cellular internet standard telephone or hotspot Using more tha...

Page 34: ...y or may not already be correctly set when you receive your Communicator Figure 3 Location of Switches The correct switch settings for your Communicator depend on your country as well as supported method of connection to the Clinician Website Refer to Table 1 Switch Settings and compare the switch settings shown for your country and method of connection to the switch settings on the bottom of your...

Page 35: ...try Switch Settings Switch Settings Per Supported Connection Method Per Supported Connection Method Cellular or Internet Cellular or Internet Standard Telephone Standard Telephone Australia Australia Austria Austria Belgium Belgium Czech Czech Republic Republic Denmark Denmark Finland Finland France France ...

Page 36: ... Settings Per Supported Connection Method Per Supported Connection Method Cellular or Internet Cellular or Internet Standard Telephone Standard Telephone Germany Germany Greece Greece Hong Kong Hong Kong Hungary Hungary Iceland Iceland Not available Not available Ireland Ireland Republic Republic Italy Italy ...

Page 37: ...nnection Method Per Supported Connection Method Cellular or Internet Cellular or Internet Standard Telephone Standard Telephone Kuwait Kuwait Not available Not available Lebanon Lebanon Not available Not available Malaysia Malaysia Not available Not available Netherlands Netherlands New Zealand New Zealand Norway Norway Poland Poland ...

Page 38: ...od Cellular or Internet Cellular or Internet Standard Telephone Standard Telephone Portugal Portugal Qatar Qatar Not available Not available Saudi Arabia Saudi Arabia Not available Not available Singapore Singapore Not available Not available Slovak Slovak Republic Republic South Africa South Africa Not available Not available South Korea South Korea Not available Not available ...

Page 39: ...r Internet Cellular or Internet Standard Telephone Standard Telephone Spain Spain Sweden Sweden Switzerland Switzerland Thailand Thailand Not available Not available United Arab United Arab Emirates Emirates Not available Not available United United Kingdom Kingdom Switch settings for the standard telephone connection method if available also work for cellular or internet connection methods ...

Page 40: ... Website and if you need to use a dial out or prefix number to place an outside telephone call switches 1 3 need to be changed from the off position shown in Figure 4 Dial out Number Switch Settings 1 3 on page 33 A dial out number to one of the settings shown in Figure 4 Dial out Number Switch Settings 1 3 on page 33 may be required in a managed care facility or hotel For example if you need to d...

Page 41: ...33 Setting Up Your Communicator LATITUDE Communicator Patient Manual Figure 4 Dial out Number Dial out Number None 0 1 7 8 9 99 Dial out Number Switch Settings 1 3 ...

Page 42: ...e 43 Hotspot Connection Mobile Device on page 47 Even though all connection method options are described in this section local limitations may impact availability The following figure shows the Status button and all the connectors on the back of your Communicator Use this figure for reference as you follow this manual s instructions for setting up your Communicator with a connection method Figure ...

Page 43: ...ice signals It is completely separate and cannot be used with your cell phone Your cellular connection may be affected by such things as terrain weather foliage buildings and other construction signal strength customer equipment and other factors Complete the following steps to set up your Communicator with a cellular connection to send your data to the Clinician Website The numbers in Figure 6 re...

Page 44: ...r Adapter on page 35 for depiction of steps 1 4 1 Insert the power supply included into the jack labeled 2 Plug the power supply into an electrical outlet that is easily accessible The LATITUDE indicator will flash yellow for up to 1 minute All the Communicator indicators will light for approximately 1 second If the LATITUDE indicator is not lit check that both ends of the power supply are plugged...

Page 45: ...press it Your Communicator s wave lights will flash green in sequence and repeat for several minutes as shown in Using the Heart Button on page 16 If this process takes longer than several minutes software download and installation may be occurring If the Heart button flashes again press it again Refer to Software Download and Installation on page 49 If you have previously completed initial setup ...

Page 46: ... the Sending Waves sections of Troubleshooting starting on page 67 If your Communicator is still unable to connect contact your health care provider for assistance When using the cellular connection method keep your Communicator plugged in to the electrical outlet and connected to the USB cellular adapter Using Previous Cellular Connection Accessories If you have a Model 6296 USB cellular adapter ...

Page 47: ... cellular adapter or a different connection accessory standard telephone internet or hotspot contact your health care provider For information on returning replacing or disposing of your USB cellular adapter see page 23 If you wish to discontinue using your USB cellular adapter contact your health care provider ...

Page 48: ... to send your data to the Clinician Website The numbers in Figure 7 refer to the corresponding steps Figure 7 6 Adapter light Connecting a USB Ethernet Adapter When using the internet connection method place your Communicator near but no closer than 1 m 3 ft to an internet modem or router Refer to Figure 7 Connecting a USB Ethernet Adapter for depiction of steps 1 6 1 Insert the power supply inclu...

Page 49: ...le included with the USB Ethernet adapter into one of the USB ports on the Communicator labeled 4 Insert the square end of the USB cable into the end of the USB Ethernet adapter nearest the adapter light 5 Insert the Ethernet cable included with the USB Ethernet adapter into the opposite end of the adapter 6 Plug the Ethernet cable into an Ethernet port for your internet service such as a modem ro...

Page 50: ...or has successfully connected to the Clinician Website if the lights are lit as shown as follows Setup is complete and no further action is needed at this time Leave your Communicator plugged in If the wave lights are not lit a solid green refer to the applicable error in the Troubleshooting section starting on page 51 When using the internet connection method keep your Communicator plugged in to ...

Page 51: ...ers in Figure 8 refer to the corresponding steps Connecting a telephone to your Communicator is optional To do so plug your telephone into the jack labeled or into a telephone jack adapter Your Communicator and a telephone can share the same telephone wall jack However they cannot be used at the same time Figure 8 Connecting a Telephone Cable When using the standard telephone connection place your...

Page 52: ...pter If you do plug the other end of the telephone cable into the telephone jack adapter Then plug the other end of the cable into the telephone jack on the wall Note Note If you have DSL internet service you may need to use a DSL filter between the telephone wall jack and the Communicator Refer to DSL Internet Service on page 47 5 When the Heart button flashes on your Communicator press it Your C...

Page 53: ...a solid green refer to the applicable error in the Troubleshooting section starting on page 51 When using the standard telephone connection keep your Communicator plugged in to the electrical outlet and connected to the telephone wall jack Communicator Use of the Telephone When using a standard telephone connection the Communicator uses your phone line to make telephone calls to send your data to ...

Page 54: ...ave heavy phone line usage that delays or prevents the Communicator from placing or completing phone calls it may be appropriate to install an additional telephone line Your Communicator and a telephone can share the same telephone wall jack however they cannot be used at the same time The Communicator will relinquish control of the telephone line shortly after you pick up the phone provided that ...

Page 55: ...ne For assistance contact your DSL service provider Replacement If you need a replacement telephone cable or a different connection accessory cellular internet or hotspot contact your health care provider For information on returning replacing or disposing of your telephone cable see page 23 Hotspot Connection Mobile Device The hotspot feature on your mobile device may be used for a wireless conne...

Page 56: ...on Mobile Device on page 47 Figure 9 Connecting a USB Accessory Adapter Plug the USB accessory adapter into either of the USB ports labeled on the back of the Communicator Leave the USB accessory adapter plugged into the Communicator so it can receive data when you use your prescribed weight scale or blood pressure monitor The USB accessory adapter also must stay plugged into your Communicator if ...

Page 57: ...If a software update is waiting pressing the Heart button will trigger the download and installation process which could take an additional several minutes Wait for the Heart button to flash again then press it Follow the remaining setup steps for the connection method you are using During normal use with Communicator already set up During normal use with Communicator already set up Software downl...

Page 58: ...LATITUDE Communicator Patient Manual 50 ...

Page 59: ... take and verification steps as applicable are shown for each type of error For clarity only the pertinent error colors are shown in the images in this Troubleshooting section A white Heart in the Heart button means it is lit a gray Heart means it is not lit If none of the steps in this Troubleshooting section work to resolve the error try resetting your Communicator by unplugging it from the elec...

Page 60: ...ion Press the Heart button to complete setup or the interrogation Refer to Using the Heart Button on page 16 for the light sequence when the Heart button is pressed Verify After pressing the Heart button if the indicators are lit as shown below the interrogation or device check was successful If the indicators are not lit as shown above refer to the applicable error in the Yellow Wave Errors secti...

Page 61: ...nutes but may take longer Action Check that both ends of the power supply are plugged in firmly Check if the light on the power supply is lit Make sure the electric outlet is active or try a different outlet Unplug the power supply from both the wall outlet and the Communicator for 1 minute 1 minute After 1 minute reconnect the power supply to both Lights will flash during the transition If the ab...

Page 62: ...tor Patient Manual Verify If indicator lights flash and then you get a solid green LATITUDE indicator as shown below the issue is resolved If all indicators are still unlit including the LATITUDE indicator contact your health care provider ...

Page 63: ...er or may be downloading and installing software This process typically lasts 5 minutes but may take longer Action Wait 5 minutes 5 minutes for a possible software update to complete Verify If indicator lights flash and then you get a solid green LATITUDE indicator as shown below the issue is resolved If the LATITUDE indicator is still flashing yellow contact your health care provider ...

Page 64: ...tial problem with your implanted device was detected but the Communicator cannot send any information collected from your implanted device to the Clinician Website The Call Doctor icon and LATITUDE indicator will remain lit solid as shown until the problem is resolved Action Your immediate response is required Call your health care provider ...

Page 65: ... read your implanted device or send its data to the Clinician Website Monitoring of your implanted device was suspended The Call Doctor icon and LATITUDE indicator will remain lit solid yellow as shown until the problem is resolved Action Unplug the power supply from both the wall outlet and the Communicator for 1 1 minute minute After 1 minute reconnect the power supply to both Lights will flash ...

Page 66: ...ooting LATITUDE Communicator Patient Manual Verify If successful the LATITUDE indicator will light green as shown below If the Call Doctor icon and LATITUDE indicator remain yellow contact your health care provider ...

Page 67: ...cting Action Unplug the power supply from both the wall outlet and the Communicator for 1 minute 1 minute After 1 minute reconnect the power supply to both Lights will flash during the transition Verify If successful the LATITUDE indicator will light green as shown below If the Call Doctor icon remains yellow you may need a replacement Communicator Contact your health care provider ...

Page 68: ... same time After 60 minutes all wave lights are turned off and the LATITUDE indicator is lit green even if the problem was not resolved If you suspect the Yellow Wave light errors are still an issue after the wave lights are turned off press the Status button for 1 second 1 second as explained in Status Button on page 19 to verify the error Then refer to the applicable Yellow Wave error in this se...

Page 69: ...mally placed as described in Where to Place Your Communicator on page 8 Face the Communicator Sit directly in front of the Communicator Make sure you are within 1 m 3 ft of the Communicator Move any wireless electronic products such as cordless or cellular phones baby monitors or modems routers at least 1 m 3 ft away from the Communicator Press the Heart button to start another interrogation Refer...

Page 70: ...tient Manual Verify If the indicators are lit as shown below the interrogation was a success If one Yellow Collecting Wave remains contact your health care provider If other Yellow Wave errors remain refer to the applicable error in this section ...

Page 71: ...irectly in front of the Communicator Make sure you are within 1 m 3 ft of the Communicator Remain still until the interrogation is complete as shown in the Verify section on page 64 Do not move away from the Communicator Move any wireless electronic products such as cordless or cellular phones baby monitors or modems routers at least 1 m 3 ft away from the Communicator Press the Heart button to st...

Page 72: ...tient Manual Verify If the indicators are lit as shown below the interrogation was a success If two Yellow Collecting Waves remain contact your health care provider If other Yellow Wave errors remain refer to the applicable error in this section ...

Page 73: ... use the Heart button You may be sitting too close to your modem router Action If you suspect you may have exceeded your weekly interrogation limit or are not allowed to use the Heart button contact your health care provider Move at least 1 m 3 ft away from your modem router Press the Heart button to start another interrogation Refer to Using the Heart Button on page 16 for the light sequence when...

Page 74: ...ient Manual Verify If the indicators are lit as shown below the interrogation was a success If three Yellow Collecting Waves remain contact your health care provider If other Yellow Wave errors remain refer to the applicable error in this section ...

Page 75: ...cellular connection Make sure the USB cellular adapter is plugged into the Communicator Unplug the Communicator from the electrical outlet wait 1 minute 1 minute then plug it back in Move the Communicator to another location that may have better cellular reception Press the Status button for 3 seconds 3 seconds as explained in Confirming Connection to the Clinician Website on page 20 Then proceed ...

Page 76: ...ke sure the Ethernet cable provided with the USB Ethernet adapter is firmly connected at one end to the USB Ethernet adapter and at the other end to the Ethernet port for your internet service If the green light on the front of the USB Ethernet adapter is not on make sure the internet modem or router is powered on Press the Status button for 3 seconds 3 seconds as explained in Confirming Connectio...

Page 77: ...et service ensure you are using a DSL filter between the Communicator and the telephone wall jack Check that the analog telephone service supports the tone dialing mode Press the Status button for 3 seconds 3 seconds as explained in Confirming Connection to the Clinician Website on page 20 Then proceed to the Verify section on page 69 Verify all connection types If the connection was a success the...

Page 78: ...r cellular signal Press the Status button for 3 seconds 3 seconds as explained in Confirming Connection to the Clinician Website on page 20 Then proceed to the Verify section on page 72 Action if using an internet connection Make sure the Ethernet cable provided with the USB Ethernet adapter is connected to the Ethernet port for your internet service Press the Status button for 3 seconds 3 seconds...

Page 79: ...ween the Communicator and the telephone wall jack If you have DSL internet service ensure you are using a DSL filter between the Communicator and the telephone wall jack Check that the switches on the bottom of the Communicator are set correctly for your country and whether you need to dial a number to get an outside line Refer to Confirming Setting Switch Settings on page 26 Press the Status butt...

Page 80: ...al Verify all connection types If the connection was a success the indicators will be lit as shown below If two Yellow Sending Waves remain contact your health care provider If other Yellow Wave errors remain refer to the applicable error in this section ...

Page 81: ...and whether you need to dial a number to get an outside line Refer to Confirming Setting Switch Settings on page 26 Action if using an internet connection Make sure that other computers or devices connected to your internet modem or router are able to access the internet Verify all connection types If the connection was a success the indicators will be lit as shown below If three Yellow Sending Wa...

Page 82: ...LATITUDE Communicator Patient Manual 74 ...

Page 83: ...When instructed to contact Boston Scientific call the applicable telephone number from the following list Australia 1800 528 488 Austria 0800 202289 Belgium 0800 80697 Czech Republic 239 016 657 Denmark 70 10 01 82 Finland 010 80 48 19 France 0805 5404 22 Germany 069 51709 481 Greece 442 035 647 788 Hong Kong 852 8105 5433 Hungary 06 80 981 579 Iceland 8004174 Ireland Republic 1890 812005 Italy 84...

Page 84: ...40 Sweden 020 160 57 07 Switzerland 0844 000110 Thailand 1800012420 United Arab Emirates 800035770015 United Kingdom 0800 678 16 44 Report any serious incident that occurs in relation to your device to Boston Scientific and to the relevant local regulatory authority for medical devices in your country For customers in Australia report any serious incident that occurs in relation to your device to ...

Page 85: ... emergency No The LATITUDE System is not meant to assist with health emergencies If you are not feeling well or need urgent health care call your health care provider or your local emergency service Refer to About the LATITUDE Patient Management System on page 1 Where should I place my Communicator Refer to Where to Place Your Communicator on page 8 How do I set up my Communicator using a USB cell...

Page 86: ...te This does not indicate a problem with your implanted device Press the Heart button Stay next to the Communicator until all lights are as shown in the next row Data from your implanted device has been sent to the Clinician Website No further action required There is a potential problem that needs to be addressed by your health care provider Call your health care provider OR Any Yellow Wave or Ye...

Page 87: ...Using the Heart Button on page 16 What do I need to do with my Communicator if I travel Refer to Traveling With Your Communicator on page 21 How do I dispose of my Communicator and Accessories Refer to Returning Replacing or Disposing of the Communicator or Accessories on page 23 Where can I go for more help Contact your health care provider ...

Page 88: ... GTM41061 1512 7 0 or SL Power Electronics AUS NZL MENB1020A0540H02 Europe except GBR IRL MENB1020A0540M02 GBR HKG IRL SAU MENB1020A0540G02 Power Supply Input 100 240 VAC 0 6 A 50 60 Hz Maximum Output 15 W Supply Mains Isolation AC adapter power supply plug Protection against electric shock Class II Minimum Operational Loop Current 20 mA Expected Service Life Up to 15 years Safety Classification o...

Page 89: ...specifications apply with or without Communicator protective packaging Communicator Implanted Device Radio Model 6288 ISM Radio Band for Australia New Zealand Receive Bandwidth 190 160 kHz Frequency Band 916 5 MHz Modulation Transmit Type ASK Amplitude Shift Keying Effective Radiated Power 1 25 dBm 0 75 mW Antenna Type Monopole Antenna Gain 0 3 dBi at 916 5 MHz Communicator Implanted Device Radio ...

Page 90: ...ht scale and blood pressure monitor may also be available separately Operational Frequency 2400 0 to 2480 0 MHz Modulation Type Adaptive Frequency Hopping Effective Radiated Power 19 4 dBm 87 1 mW Operating Temperature 0 C to 70 C 32 F to 158 F Storage and Transport Temperature 20 C to 85 C 4 F to 185 F Operating Humidity 10 to 85 noncondensing Storage and Transport Humidity 10 to 85 noncondensing...

Page 91: ...Hz W CDMA 900 TX 880 915 MHz RX 925 960 MHz Effective Radiated Power 18 0 dBm Antenna Type Monopole Antenna Gain 1 7 dBi at 897 4 MHz W CDMA 2100 TX 1920 1980 MHz RX 2110 2170 MHz Effective Radiated Power 18 4 dBm Antenna Type Monopole Antenna Gain 1 8 dBi at 1949 9 MHz Network and Connectivity Specifications Required Characteristics of IT Network Ethernet IEEE 802 3 10 Mbps IEEE 802 3u 100 Mbps W...

Page 92: ...l Information Required Configuration of IT Network Ethernet Static IP addressing Wi Fi None Ethernet MAC address On dongle label Internet protocol IPv4 Dynamic Host Configuration Protocol DHCP mode Automatic DHCP mode supported Wi Fi MAC address None ...

Page 93: ... adjacent to or stacked with other equipment please contact your health care provider to verify normal operation Do not use the Communicator in the presence of flammable gas mixtures including anesthetics oxygen or nitrous oxide The user is cautioned to maintain a 20 cm 8 in spacing from the product to ensure compliance with European Norm EN or Federal Communications Commission Industry Canada FCC...

Page 94: ... complies with minimum conditions for connection to its network It indicates no endorsement of the product by Telecom nor does it provide any sort of warranty Above all it provides no assurance that any item will work correctly in all respects with another item of Telepermitted equipment of a different make or model nor does it imply that any 101 PTC 200 May 2006 product is compatible with all of ...

Page 95: ...of IEC EN 60601 1 the Communicator has no performance that qualifies as essential performance Software Statement The software included in this product contains copyrighted software that is licensed under the GNU General Public License GPL Under the terms of the GPL as published by the Free Software Foundation you may obtain the complete corresponding source code from us for a period of three years...

Page 96: ...are not likely to cause any interference in nearby electronic equipment Protection of the public mains network CISPR 11 Class B IEC 61000 3 2 IEC 61000 3 3 The LATITUDE Communicator is suitable for use in a professional health care facility or home environment Electrostatic discharge 8 kV contact 2 kV 4 kV 8 kV and 15 kV air Radiated RF EM field 3 V m from 80 MHz to 2 7 GHz Proximity fields from R...

Page 97: ...3 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz 40 66 MHz to 40 70 MHz The amateur radio bands between 0 15 MHz and 80 MHz are 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 0 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 0 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz 50 0 MHz to 54 0 MHz Voltage dipsa 0 UT for 0 5 cycle at 0 45 90 135 ...

Page 98: ...ction Direct Current Reference Number Solid foreign objects and water protection Follow instructions for use Class II equipment IEC 60601 Non Ionizing electromagnetic radiation Discard with electronic waste ACMA compliance mark New Zealand Radio Spectrum Management RSM radio compliance mark Representative sample of label that indicates that this device may lawfully be connected to the network in N...

Page 99: ...elecommunications standards Complies with IMDA Standards Dealer s Licence No Representative sample of label that indicates this product complies with applicable Singaporean telecommunications standards Indicates this product complies with applicable Malaysian telecommunications standards Part Number Serial Number Date of Manufacture Open Here Medical Device under EU Legislation Manufacturer Temper...

Page 100: ...nformation Symbol Meaning Australian sponsor address Corrugated recycles Consult instructions for use applies to USB accessory adapter Indicates this product complies with applicable Japanese telecommunications standards applies to USB accessory adapter ...

Page 101: ......

Page 102: ...egem Belgium 1 800 CARDIAC 227 3422 Worldwide 1 651 582 4000 www bostonscientific com www bostonscientific com patientlabeling Boston Scientific Australia Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 92435999 001 92435999 001 en OUS 2020 07 2020 Boston Scientific Corporation or its affiliates All rights reserved ...

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