Boston Scientific CRM628013 6280 User Manual 359081 001 US EN indb

Boston Scientific Corporation 6280 359081 001 US EN indb

User Manual

LATITUDE® CommunicatorComunicador LATITUDE®PATIENT MANUALMANUAL DEL PACIENTE
English .................................................... 1Español................................................... 75
EnglishLATITUDE® CommunicatorENGLISH
EnglishLATITUDE is a trademark ofBoston Scientifi c Corporation or its affi liates.Delta Mobile Systems is a trademark of Delta Mobile Systems.GlobTek is a trademark of GlobTek, Inc.MultiConnect is a trademark of Multi-Tech Systems, Inc. This manual contains instructions for the use of Models 6280 and 6290 LATITUDE Communicators. These instructions are identical for both models. Technical differences, however, do exist between the models and are identifi ed where appropriate. The model number for your Communicator is located on its bottom label.
LATITUDE® Communicator Patient Manual EnglishiTable of ContentsLATITUDE Patient Management System 1The LATITUDE Communicator 1Items You Should Receive 2Optional Health Monitoring Equipment 3Clinician Website 3When to Use Your Communicator 4When Not to Use Your Communicator 4Where to Place Your Communicator 5Important Notes 5Buttons, Connectors, and Indicators 7Installing Your Communicator 9Confi rming Switch Settings 9Connecting Your Communicator 10Software Download and Installation 10Connecting to a Landline Telephone Jack 11Connecting to the LATITUDE NXT USB Cellular Adapter 13Where to Place Your USB Cellular Adapter 13Normal Operation of the Communicator 16Indicator Sequence When Using the Heart Button 17Indicator Descriptions 19Status Button 24Confi rming Successful Operation 25Troubleshooting Errors 26Wave Indicator Colors 31
LATITUDE® Communicator Patient Manual EnglishiiLATITUDE Cellular Data Plan 40Cellular Converter 40Activating the LATITUDE Cellular Data Plan 41Troubleshooting and Support 41Discontinuing Your LATITUDE Cellular Data Plan 42Interrogating Your Implanted Device 43Interrupted Electrical Power 44Checking that the Communicator Can Connect to the LATITUDE System 45Traveling with Your Communicator 46Communicator Use of the Telephone System 47Using the Telephone While the Communicator is Making a Call 48DSL Internet Service 48Care and Maintenance 49Cleaning the Communicator and Accessories 50Returning, Replacing, or Disposing of the Communicator or USB Cellular Adapter 51Setting Switches for PBX or Dial-out Numbers 52Connecting the USB Sensor Adapter 53Specifi cations 54Safety and Standards Compliance 58Essential Performance 63Electromagnetic Emissions and Immunity 65Software 72
1LATITUDE® Communicator Patient Manual EnglishLATITUDE Patient Management SystemThe LATITUDE Patient Management System (referred to as “LATITUDE system” throughout this manual) is a remote monitoring system that gives your health care provider access to your implanted device data between scheduled offi ce visits. The LATITUDE system is designed to improve patient care while providing convenience to 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 secure clinician website. The LATITUDE system is not meant to assist with health emergencies. If you are not feeling well, call your health care provider or dial 911. The LATITUDE CommunicatorThe LATITUDE Communicator is an in-home monitoring system that uses a wireless communication system to communicate with your implanted device. The Communicator does not provide continuous monitoring. It automatically reads implanted device information at times scheduled by your health care provider. At scheduled intervals, the Communicator sends your implanted device data to the LATITUDE system through a standard telephone line or over a cellular data network using the LATITUDE Cellular Data Plan (see page 40). The Communicator receives periodic schedule updates made by your health care provider when it connects to the LATITUDE system.
2LATITUDE® Communicator Patient Manual EnglishThe Communicator does not reprogram or change any functions of your implanted device. Only your health care provider can do this during an offi ce visit.Model 6280 only: Your Communicator is designed to be used only in the United States, Canada, Puerto Rico, and Mexico. For more information, see “Traveling with Your Communicator” on page 46.The telephone (landline) feature of the Communicator is designed to operate on standard telephone lines like those found in most homes. The Communicator supports tone dialing over an analog line. The Communicator may work on other telephone systems, such as digital subscriber line (DSL) and voice over Internet Protocol (VoIP), if those systems provide an analog interface for connecting the Communicator.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.Items You Should ReceiveThe following items are included with the Communicator:• Communicator unit• Alternating current (AC) adapter(GlobTek® Model GTM41061-1512-7.0)• Communicator installation guide• Communicator patient manual (this book)• Communicator telephone cord
3LATITUDE® Communicator Patient Manual EnglishOptional Health Monitoring EquipmentIf prescribed by your health care provider, your Communicator can also collect information from an optional LATITUDE heart failure management system. This system includes a LATITUDE weight scale and LATITUDE blood pressure monitor.These specially designed products provide additional information to monitor your health. Refer to the handbook that is included with the weight scale and blood pressure monitor products.A universal serial bus (USB) sensor adapter is included with the weight scale and blood pressure monitor. The USB sensor adapter provides a wireless connection between these products and the Communicator. See “Connecting the USB Sensor Adapter” on page 53.Clinician WebsiteThe clinician website provides authorized health care providers a convenient and secure way to obtain and analyze information from a patient’s implanted device.The LATITUDE system normally displays your device information on the clinician website within 15 minutes. However, it may take longer for your information to appear due to many external factors. The website provides advanced analysis and trending tools designed at improving patient care. Only your physician and medical personnel authorized by your physician can access your medical data on the password-protected clinician website.
4LATITUDE® Communicator Patient Manual EnglishWhen to Use Your CommunicatorThe Communicator performs many functions automatically on a schedule set by your health care provider. Other functions need you to respond when the indicators on the front of the Communicator light or fl ash. Check the Communicator daily to see if any of the indicators are lit or fl ashing.Use the Communicator only as instructed by your health care provider. The Communicator’s Heart button (Figure 1 on page 7) will fl ash if it needs you to manually complete an interrogation of your implanted device as scheduled by your health care provider. If the Heart button is fl ashing, press it and then watch the indicators on the Communicator. Call your health care provider if the Call Doctor icon (Figure 2 on page 8) is lit. When Not to Use Your CommunicatorThe Communicator is designed to work only with your implanted device. It will not work with another patient’s implanted device. The Communicator should be used only as authorized by the prescribing physician. The Communicator is not for use with any implanted device other than a Boston Scientifi c device.Ask your health care provider if you have questions about any risks with using the Communicator or your implanted device. There is also valuable information about risks and reliability in the patient handbook for your implanted device.
5LATITUDE® Communicator Patient Manual English Where to Place Your CommunicatorPlace your Communicator:• Near a telephone wall jack (not required if you are subscribed to the LATITUDE Cellular Data Plan).• Near an electrical outlet that is easily accessible.• Where you can sit comfortably and see the front of the Communicator. • Close to where you sleep or near your bedside. If this is not possible, place your Communicator where you spend a considerable amount of time each day.• Where the Communicator and all its cables and accessories will be kept dry and not exposed to humidity or potential water contact.Important Notes• It is very important that the Communicator remains plugged into the electrical outlet.• Your Communicator should remain connected to a telephone line unless you are subscribed to the LATITUDE Cellular Data Plan.• This equipment needs to be installed and put into service in accordance with the information in the provided documentation. Call your health care provider if you need assistance setting up or using your Communicator.
6LATITUDE® Communicator Patient Manual English• 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, you should be at least 3 ft (1 m) away from televisions, videocassette recorders (VCRs), digital video disc (DVD) players, personal computers, and other electronic equipment.• Electrical safety: It is recommended that the customer install a surge protector between the electrical wall outlet and the Communicator. This is to avoid damage to the Communicator caused by local lightning strikes and other electrical surges. Electrical cable wall plugs and other accessories must be in good condition before use.• Boston Scientifi c personnel may contact the clinic or patient to advise on the best Communicator placement if an implanted device uses too much radio-frequency (RF) telemetry.
7LATITUDE® Communicator Patient Manual EnglishButtons, Connectors, and IndicatorsFigure 1 and Figure 2 show the buttons, indicators, and connectors on the front and back of the Communicator. Refer to “Indicator Descriptions” on page 19 for a description of each indicator.Figure 1. Buttons and connectorsTo telephone wall jackTo telephone(optional)Power inputStatus buttonUSB ports** to connect the USB sensor adapter and/or theLATITUDE NXT USB Cellular Adapter Heart buttonLATITUDE indicator
8LATITUDE® Communicator Patient Manual English1. Patient Icon: Stay close to the Communicator when lit.2. Collecting Waves:Green = successfully collecting data.Yellow = error collecting data.3. Heart Button: Press when fl ashing or press to send data.4. Sending Waves:Green = successfully sending data.Yellow = error sending data.5. Doctor Icon: Data successfully sent when lit.6. Sensor Reading Icon: Sensor reading received when lit.7. LATITUDE Indicator: Green = Communicator is active and ready to use.Yellow = Flashes yellow during start-up process or toindicate an error.8. Call Doctor Icon: Call your doctor when lit.Figure 2. IndicatorsFor more information about indicators, see “Indicator Descriptions” on page 19. Heart Button Sending Waves Collecting Waves PatientIcon DoctorIcon LATITUDE Indicator Sensor Reading Icon Call Doctor Icon
9LATITUDE® Communicator Patient Manual EnglishInstalling Your Communicator Confi rming Switch Settings• Confi rm that the white switches numbered 4-8 on the bottom of the Communicator match the country switch settings as shown in Figure 3. • If the white switches on the bottom of your Communicator do not match the switch settings shown below, slide them up or down to set them as shown.• Landline telephone connection only: Switches numbered 1-3 may differ from those shown if a dial-out number or prefi x is needed to place an outside telephone call. Refer to “Setting Switches for PBX or Dial-out Numbers” on page 52 for those switch settings. Figure 3. *6290*TMUnited Statesand Puerto RicoCanadaDial-out CountryMexicoSwitch settings
10 LATITUDE® Communicator Patient Manual EnglishConnecting Your Communicator• If using a landline telephone jack, follow the steps in “Connecting to a Landline Telephone Jack” on page 11 to connect your Communicator to the LATITUDE system.• If using the LATITUDE NXT USB Cellular Adapter, follow the steps in “Connecting to the LATITUDE NXT USB Cellular Adapter” on page 13. These instructions also appear in the Communicator installation guide.Note: Stay close to the Communicator during the entire installation process to ensure the best connection between your implanted device and the Communicator. Software Download and InstallationUpdated software may occasionally be pushed to your Communicator for download and installation.If a software download is ready when installing the Communicator for the fi rst time, pressing the Heart button will trigger the download and installation process. Wait for this process to complete, which could take anywhere from a few minutes to more than an hour. When the Heart button fl ashes again, press it and wait 5 minutes to determine if the installation succeeded (all indicators are lit a steady color) or failed. Refer to “Indicator Sequence When Using the Heart Button” on page 17 for more information.If your Communicator is already set up, software download and installation may happen without your knowledge.
11LATITUDE® Communicator Patient Manual English Connecting to a Landline Telephone JackComplete the steps below to set up the Communicator for a landline telephone connection.Figure 4. Connecting to a landline telephone jack3. Connecting a telephone is optional.1. Plug one end of the Communicator telephone cord (included) into the jack labeled .2. Plug the other end of the cord into the telephone jack on the wall. Note: If you have DSL Internet service, you may need to use a DSL fi lter between the telephone wall jack and the Communicator. Refer to “DSL Internet Service” on page 48. 3. Optional: To use a telephone with this wall jack, you may plug your telephone into the jack labeled .Note: Your Communicator and a telephone can share the same telephone wall jack. However, they cannot be used at the same time.
12 LATITUDE® Communicator Patient Manual English4. Insert the AC adapter (included) into the jack labeled .5. Plug the AC adapter into an electrical outlet that is easily accessible.6. When electrical power is supplied, the Communicator begins a startup process. The LATITUDE indicator fl ashes for up to one minute while the Communicator starts up. The Communicator then lights all the indicators for approximately one second to indicate all indicators are working.If the LATITUDE indicator is not lit, check that both ends of the AC adapter are plugged in fi rmly. Check if the light on the AC adapter is on.Important: Your Communicator should remain connected to the electrical outlet and telephone wall jack. 7. When installing the Communicator for the fi rst time, wait for the Heart button to fl ash with a white light. Press the fl ashing Heart button to check if the Communicator can interrogate your implanted device and send your data to the LATITUDE system. Continue with step 8 unless installation takes longer than 5 minutes or the Heart button fl ashes again. In that case, continue with “Software Download and Installation” on page 10. 8. Determine whether the installation succeeded ( all indicators are lit a steady color) or failed by referring to “Indicator Sequence When Using the Heart Button” on page 17.
13LATITUDE® Communicator Patient Manual English Connecting to the LATITUDE NXT USB Cellular AdapterIf you have signed up for the LATITUDE Cellular Data Plan, no telephone cords need to be attached. Instead, a cellular adapter provided upon subscription to the Data Plan must be connected to the Communicator. Refer to “LATITUDE Cellular Data Plan” on page 40 for more information.Where to Place Your USB Cellular AdapterPlace your USB cellular adapter:• Away from other electronic products or metal surfaces.• Alongside the Communicator and not under or on top of it.Figure 5. Connecting to the LATITUDE NXT USB Cellular Adapter
14 LATITUDE® Communicator Patient Manual English1. Insert the AC adapter (included) into the jack labeled .2. Plug the AC adapter into an electrical outlet that is easily accessible.3. Insert the USB connector into one of the USB ports labeled . Refer to “Figure 5. Connecting to the LATITUDE NXT USB Cellular Adapter” on page 13.Important: Maintain a distance of at least 6 inches (15 cm) between the USB cellular adapter and your implanted device. 4. When electrical power is supplied, the Communicator begins a startup process.• The power indicator on the top of the USB cellular adapter lights and remains lit except during a LATITUDE system reboot.Note: The wireless indicator will fl ash at various times and at various sequences. This indicator is of no concern during normal operation.• The LATITUDE indicator fl ashes for up to one minute while the Communicator starts up. The Communicator then lights all the indicators for approximately one second to indicate all indicators are working.If the LATITUDE indicator is not lit, check that both ends of the AC adapter are plugged in fi rmly. Check if the light on the AC adapter is on.
15LATITUDE® Communicator Patient Manual EnglishImportant: Your Communicator should remain connected to the electrical outlet and the USB cellular adapter.5. When installing the Communicator for the fi rst time, wait for the Heart button to fl ash with a white light. Press the fl ashing Heart button to check if the Communicator can interrogate your implanted device and send your data to the LATITUDE system. Continue with step 6 unless installation takes longer than 5 minutes or the Heart button fl ashes again. In that case, continue with “Software Download and Installation” on page 10. 6. Determine whether the installation succeeded ( all indicators are lit a steady color) or failed by referring to “Indicator Sequence When Using the Heart Button” on page 17.
16 LATITUDE® Communicator Patient Manual EnglishNormal Operation of the CommunicatorYour Communicator performs device checks every day, and when operating normally, only the LATITUDE indicator will be lit (green). Also, the Communicator automatically interrogates your implanted device on a regular schedule set by your health care provider. None of the Communicator indicators will light during a scheduled interrogation or daily device check. They will light when you use the Heart button as described in “Interrogating Your Implanted Device” on page 43 or when using the Status button as described in “Checking that the Communicator Can Connect to the LATITUDE System” on page 45.Note: When color is used in this manual to explain operation of the Communicator, an indicator shown as gray means that it is not lit. An indicator shown as any other color, including white, means that it is lit.(A gray heart shown inside the blue circle means that it is not lit. A white heart shown inside the blue circle means that it is lit.)
17LATITUDE® Communicator Patient Manual English Indicator Sequence When Using the Heart ButtonThis section describes how the indicators will light after you press the Heart button. The Communicator interrogates your implanted device and then sends your data to the LATITUDE system. More details about the colors and purpose of the indicators appear later in this manual.The Communicator begins interrogating your implanted device after the Heart button is pressed.The Patient icon lights blue. The Collecting Waves light green in sequence and repeat while the Communicator interrogates your device.
18 LATITUDE® Communicator Patient Manual EnglishAll three Collecting Waves will light green. The Heart button lights white showing the interrogation was a success. The Sending Waves light green in sequence and repeat while the Communicator places a call and starts sending your data to the LATITUDE system.The Doctor icon lights blue showing the Communicator successfully sent your data to the LATITUDE system. All the indicators shown stay lit for 2 minutes to show the entire process was a success.
19LATITUDE® Communicator Patient Manual English Indicator DescriptionsThe indicators will light to indicate the Communicator’s progress when:• Manually interrogating your implanted device• Manually connecting and sending your implanted device information to the LATITUDE system• Collecting a measurement from a prescribed weight scale or blood pressure monitorOne or more indicators may light or fl ash a different color to indicate some type of action may need to be taken. Refer to “Troubleshooting Errors” on page 26. Patient IconShows the Communicator is interrogating (collecting data from) your implanted device. • Lights blue when the Heart button is pressed and an interrogation has started.• Stays lit for 2 minutes after a successful interrogation.
20 LATITUDE® Communicator Patient Manual English Collecting WavesShow the Communicator is collecting data from your implanted device.• Light green in sequence and repeat, showing the Communicator is interrogating your implanted device.• Light green for 2 minutes to indicate the interrogation was a success. Heart Button• Flashes with a white light if you need to complete a previously scheduled interrogation. • Lights a solid white for 2 minutes to indicate the interrogation is complete.• May also be used to manually initiate an interrogation of your implanted device. Refer to “Interrogating Your Implanted Device” on page 43 before using this button.
21LATITUDE® Communicator Patient Manual EnglishSending WavesShow the Communicator is connecting to the LATITUDE system. • Light green in sequence and repeat, showing a connection to the LATITUDE system is in progress.• Light green for 2 minutes to indicate the connection to the LATITUDE system was a success and any collected device data was sent.Doctor IconLights blue for 2 minutes to indicate the Communicator has successfully connected to the LATITUDE system. The Communicator sends any data it has collected from your implanted device, weight scale, or blood pressure monitor.
22 LATITUDE® Communicator Patient Manual EnglishSensor Reading IconShows the Communicator has successfully communicated with a prescribed weight scale or blood pressure monitor. • Flashes green fi ve times and remains lit for 5 minutes to indicate the Communicator successfully received a weight or blood pressure measurement. LATITUDE IndicatorShows the Communicator is connected to electrical power. It also shows if the Communicator startup process is being performed or if the Communicator is ready to use.• Lights green to indicate the Communicator is connected to electrical power and is ready to use. • Flashes yellow during the startup process.• May fl ash yellow for a long time. This means that new software is being installed on the Communicator.
23LATITUDE® Communicator Patient Manual EnglishCall Doctor IconLights yellow or red to signal a problem that you should report to your health care provider. Refer to the error in “Troubleshooting Errors” on page 26.A red light ranks higher than a yellow light. If an error for each color occurs at the same time, only the red light is displayed.• Flashes yellow briefl y after the Communicator is plugged into AC power.• The light turns off after the Communicator completes the startup process. • If the startup process does not complete, it remains lit solid yellow.
24 LATITUDE® Communicator Patient Manual EnglishStatus ButtonThe Status button is located on the back of the Communicator as shown in Figure 6. The Status button performs one the following actions depending on how long the button is pressed:• Press for less than 3 seconds: The Communicator indicators will light to display:• The status of the last interrogation.• The status of the last connection to the LATITUDE system.The indicators will light for 2 minutes. If the Call Doctor icon was blinking, it will stop blinking and stay lit.• Press and hold for more than 3 seconds: The Sending Waves light green in sequence and repeat while the Communicator connects to the LATITUDE system.Note: If you pressed the Heart button, the Status button will not function until the resulting interrogation is completed or is cancelled.Figure 6. Status button
25LATITUDE® Communicator Patient Manual English Confi rming Successful OperationYou can use the Status button to check if the Communicator has been operating normally. The above image shows that all the Collecting and Sending Waves are lit green, confi rming that the last interrogation and the last connection to the LATITUDE system were a success. When all the waves are green, no action is needed.
26 LATITUDE® Communicator Patient Manual English Troubleshooting ErrorsOne or more of the indicators on the front of the Communicator may light or fl ash to indicate some type of Communicator, communication, or LATITUDE system error. A general description of the types of errors are shown in Figure 7. A description of each error is provided in this section, along with suggested actions to resolve each error.Yellow Collecting WavesIndicate errors collecting information from your implanted deviceYellow Sending WavesIndicate errors sending information to the LATITUDE systemCall Doctor IconCall your doctor when lit LATITUDE IndicatorYellow light indicates an error Figure 7. Types of errors
27LATITUDE® Communicator Patient Manual EnglishNo Indicators are LitDescription: The Communicator is not connected to electric power or it is not functioning.Action: • If the LATITUDE indicator is not lit, check that both ends of the AC adapter are plugged in fi rmly. • Check if the light on the AC adapter is on.• If the Communicator is plugged into electric power and the light on the AC adapter is on, contact your health care provider.
28 LATITUDE® Communicator Patient Manual EnglishCall Doctor Icon is Red LATITUDE Indicator is Yellow Description: The Call Doctor icon is red, and the LATITUDE indicator is yellow.A potential problem with your implanted device was detected, but the Communicator cannot send any information collected from your implanted device to the LATITUDE system.The Call Doctor icon and LATITUDE indicator will stay lit until the problem is resolved. Action: Your immediate response is required. Call your health care provider.
29LATITUDE® Communicator Patient Manual EnglishCall Doctor Icon is YellowLATITUDE Indicator is YellowDescription: The Call Doctor icon is yellow, and the LATITUDE indicator is yellow.Indicates one of the following errors: • Your Communicator is currently unable to monitor your implanted device.• Monitoring of your implanted device was suspended through the LATITUDE system.The Call Doctor icon and LATITUDE indicator will stay lit until the problem is resolved. Action: Call your health care provider.
30 LATITUDE® Communicator Patient Manual EnglishCall Doctor Icon LitLATITUDE Indicator Not LitDescription: The Call Doctor icon is lit yellow, and the LATITUDE indicator is not lit. This indicates your Communicator may not be working properly.Action: You may need a replacement Communicator. Contact your health care provider.
31LATITUDE® Communicator Patient Manual English Wave Indicator ColorsOne or more of the Wave indicators will light yellow to indicate some type of error as described in the following Wave sections. Wave indicators light for 60 minutes unless the error is resolved sooner. After 60 minutes, all Wave lights are turned off and the LATITUDE indicator is lit green, even if the problem was not resolved.Note: In addition to the Wave indicators lighting yellow to indicate an error, the LATITUDE indicator lights yellow at the same time.
32 LATITUDE® Communicator Patient Manual EnglishOne Yellow Collecting WaveDescription: The Communicator was unable to start an interrogation of your implanted device, or your implanted device was out of range at the time of the attempted interrogation.Action: • Ensure the Communicator is optimally placed as described in “Where to Place Your Communicator” on page 5.• Face the Communicator. Sit directly in front of the Communicator. Make sure you are within 10 ft (3 m) of the Communicator.• Move any wireless electronic products (such as cordless or cellular phones or baby monitors) that are within 3 ft (1 m) of the Communicator.To verify that troubleshooting was a success:• Press the Heart button to start another interrogation. If the interrogation was a success, all three Collecting Waves will light green for 2 minutes.
33LATITUDE® Communicator Patient Manual EnglishTwo Yellow Collecting WavesDescription: The Communicator started but was not able to complete the interrogation within the time allowed.Action: • Ensure the Communicator is optimally placed as described in “Where to Place Your Communicator” on page 5.• Face the Communicator. Sit directly in front of the Communicator. Make sure you are within 10 ft (3 m) of the Communicator.• Remain still until the interrogation is complete. Do not move away from the Communicator.• Move any wireless electronic products (such as cordless or cellular phones or baby monitors) that are within 3 ft (1 m) of the Communicator.To verify that troubleshooting was a success:• Press the Heart button to start another interrogation. If the interrogation was a success, all three Collecting Waves will light green for 2 minutes.
34 LATITUDE® Communicator Patient Manual EnglishThree Yellow Collecting WavesDescription: Any of the following reasons could cause this error:• You may have exceeded your weekly interrogation limit, or you may not be allowed to use the Heart button.• The Communicator was unable to establish wireless communication with your implanted device due to interference from another person’s implanted device.Action: • If you are planning to interrogate your device, wait 10 minutes. Then try pressing the Heart button again to initiate the interrogation.• Do not press the Heart button while the interrogation is in progress unless you intend to stop the interrogation.• If you see three yellow waves after pressing the Heart button, contact your health care provider.
35LATITUDE® Communicator Patient Manual English One Yellow Sending WaveDescription: The Communicator was not able to make a connection to the LATITUDE system for one of the following reasons:• No dial tone was detected when attempting to use the telephone line.• No cellular providers were detected when attempting to connect using the LATITUDE Cellular Data Plan.Action: If using a landline telephone connection:• Check that the telephone cord provided with the Communicator is plugged in tightly to a telephone wall jack and the Communicator.• Pick up the telephone and check for dial tone. If no dial tone, try a different telephone wall jack.• If you have DSL Internet service, ensure you are using a DSL fi lter between the Communicator and the telephone wall jack.• Check that the analog telephone service supports the tone dialing mode.
36 LATITUDE® Communicator Patient Manual EnglishIf using the LATITUDE Cellular Data Plan:• If you have not activated the LATITUDE Cellular Data Plan, see page 40.• Make sure the USB cellular adapter is plugged into the Communicator.• Move the Communicator to another location that may have better cellular reception. • If other locations do not work after trying another connection, try plugging the Communicator into an active telephone wall jack.To verify that troubleshooting was a success:• Press and hold the Status button until the Sending Waves light green in sequence and repeat. If the connection is successful, all three Sending Waves will light green for 2 minutes.
37LATITUDE® Communicator Patient Manual EnglishTwo Yellow Sending Waves Description: An attempt to connect to the LATITUDE system failed due to connection issues relating to the landline telephone or cellular network.If using a landline telephone connection, another device (telephone, answering machine, or computer) may be using or attempting to use the telephone line.Action: If using a landline telephone connection:• Make sure your telephone is not being used at this time.• Pick up the telephone and check for dial tone. If no dial tone, try a different telephone wall jack.• Remove any splitters between the Communicator and the telephone wall jack.• If you have DSL Internet service, ensure you are using a DSL fi lter between the Communicator and the telephone wall jack.
38 LATITUDE® Communicator Patient Manual English• 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 “Confi rming Switch Settings” on page 9.If using the LATITUDE Cellular Data Plan:• If you have not activated the LATITUDE Cellular Data Plan, see page 40.• Move the Communicator to another location that may provide a stronger cellular signal.• If other locations do not work after trying another connection, try plugging the Communicator into an active telephone wall jack.To verify that troubleshooting was a success:• Press and hold the Status button until the Sending Waves light green in sequence and repeat. If the connection is successful, all three Sending Waves will light green for 2 minutes.
39LATITUDE® Communicator Patient Manual English Three Yellow Sending WavesDescription: The Communicator was able to establish a connection, but no information reached the LATITUDE system.Action: • 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 “Confi rming Switch Settings” on page 9.• Press and hold the Status button until the Sending Waves light green and show progress.• If you see three yellow waves after trying the above action, your Communicator may not be set up correctly in the LATITUDE system. Contact your health care provider.
40 LATITUDE® Communicator Patient Manual English LATITUDE Cellular Data PlanThe LATITUDE Cellular Data Plan uses a cellular data network rather than a standard landline telephone connection to send your implanted device data to the LATITUDE system. The LATITUDE Cellular Data Plan is an optional subscription service that must be activated before your Communicator can use this service. Upon subscription, you will receive a cellular adapter that enables cellular communication between your Communicator and the LATITUDE system.You need either a standard analog landline telephone connection or the LATITUDE Cellular Data Plan to use the LATITUDE system. The LATITUDE Cellular Data Plan uses a data-only network. It does not send voice signals and it cannot be used with your cellular phone service.Note: Your Communicator is designed to use a landline telephone connection if it is plugged into an active telephone jack. If connected, your Communicator will send your device data over the landline telephone connection even if you are subscribed to the LATITUDE Cellular Data Plan. Cellular ConverterYou may already have a Multi-Tech Systems MultiConnect™ MT200A2W analog-to-wireless cellular converter from a previous Communicator. Your LATITUDE Communicator may use the Multi-Tech Systems MultiConnect™ MT200A2W analog-to-wireless cellular converter to access a cellular network. The MultiConnect Converter has been tested and found to be compatible with the LATITUDE Communicator. Use of the converter is optional.
41LATITUDE® Communicator Patient Manual EnglishActivating the LATITUDE Cellular Data PlanContact LATITUDE Patient Services at 1-866-484-3268 to subscribe to the LATITUDE Cellular Data Plan. There is a cost for this service unless your clinic has made other arrangements. An activated plan works only with your LATITUDE NXT USB Cellular Adapter. If a replacement adapter is ever needed, or if you need to update your subscription, contact LATITUDE Patient Services.Once the LATITUDE Cellular Data Plan is activated, you can verify the connection by following the instructions in “Checking that the Communicator Can Connect to the LATITUDE System” on page 45. If you travel to another location with your Communicator, check the connection from that location. Troubleshooting and SupportSubscription to the LATITUDE Cellular Data Plan does not guarantee coverage. Actual coverage may be affected by such things as terrain, weather, foliage, buildings and other construction, signal strength, customer equipment, and other factors.The Sending Waves may light yellow if your Communicator cannot connect through an activated LATITUDE Cellular Data Plan. If this happens, refer to the Sending Waves sections of this manual, page 35 through page 39. If the Communicator is still unable to connect, contact LATITUDE Patient Services for assistance.If your Communicator is not able to connect to the LATITUDE system using the LATITUDE Cellular Data Plan, try plugging the Communicator into an active telephone jack.
42 LATITUDE® Communicator Patient Manual EnglishDiscontinuing Your LATITUDE Cellular Data PlanContact LATITUDE Patient Services to discontinue use of the LATITUDE Cellular Data Plan. Your subscription will automatically be discontinued if you miss two or more payments. You will need to discontinue your subscription if you stop using the LATITUDE system or if you want to return to using a landline telephone connection. Make sure your health care provider is aware of any changes in service.For information on returning, replacing, or disposing of your USB cellular adapter, see page 51.
43LATITUDE® Communicator Patient Manual English Interrogating Your Implanted DeviceThe Communicator automatically interrogates your implanted device on a regular schedule set by your health care provider. This may happen without your awareness and should not require any action on your part. Daily device checks are also performed automatically. None of the Communicator indicators will light during a scheduled interrogation or daily device check. A scheduled interrogation will not be completed if you are out of range (10 ft/3 m) from the Communicator when it attempts to communicate with your implanted device. If the Communicator is unable to automatically interrogate your device after repeated attempts, the Heart button will fl ash to allow you to complete the interrogation manually. The Heart button also fl ashes the fi rst time you use the Communicator.The Heart button is designed to enable you to manually interrogate your implanted device. Manual interrogation is a feature that must be enabled by your health care provider. When you press the Heart button, the Communicator checks to make sure that the interrogation is permitted. You should only use the Heart button if it is fl ashing or when instructed to do so by your health care provider.If you press the Heart button by mistake (not intending to perform an interrogation), press and hold the Heart button again for at least 5 seconds to cancel the interrogation. The Collecting Waves may light yellow and show progress while the interrogation is being cancelled.
44 LATITUDE® Communicator Patient Manual EnglishWhen using the Heart button, you should stay close to the Communicator during the entire interrogation process to ensure optimum communication between your implanted device and the Communicator.If a manual interrogation is not permitted, either because the limit has been reached or because the feature is disabled, the Communicator automatically calls the LATITUDE system. This is done to check for a change in the number of manual interrogations allowed or to check if this feature has been re-enabled.CAUTIONS:• Normal use of the LATITUDE system has been accounted for in the projected battery life of your implanted device. Using the Heart button more often than when the Heart button fl ashes or more often than instructed by your health care provider may lead to a decrease in the battery life of your implanted device.• If you feel unwell or are in need of urgent health care, call your health care provider or dial 911.Interrupted Electrical PowerThe Communicator has internal memory that stores your interrogation and other information in case the electrical power is interrupted or the AC adapter is unplugged. The LATITUDE indicator will transition back to green once power is restored to the Communicator.
45LATITUDE® Communicator Patient Manual English Checking that the Communicator Can Connect to the LATITUDE SystemComplete the following steps to check that the Communicator can connect to the LATITUDE system. You should do this if you have moved the Communicator or if there has been a change in your telephone service or LATITUDE Cellular Data Plan subscription.1. Check that the Communicator is plugged in and the LATITUDE indicator is green.2. Press and hold the Status button on the back of the Communicator for more than 3 seconds. The Sending Waves light green in sequence and repeat while the Communicator attempts to connect to the LATITUDE system.If both Collecting and Sending Waves light, you did not press the Status button long enough. Pressing the Status button for less than 3 seconds displays the status of the last interrogation and the status of the last attempt to connect to the LATITUDE system.3. Watch the front of the Communicator. The Sending Waves should light in sequence and repeat, showing a connection to the LATITUDE system is in progress.4. Wait approximately 5 minutes for the connection to complete.
46 LATITUDE® Communicator Patient Manual English5. If the connection was successful, all three of the Sending Waves will light green for 2 minutes.If the connection was unsuccessful, one or more of the Sending Waves will light yellow. Refer to the appropriate condition in the “Wave Indicator Colors” section beginning on page 31 for actions to take. Traveling with Your CommunicatorYou can use your Communicator away from home if you will be gone for an extended period. Consult your health care provider before planning to travel for an extended period, whether or not you take your Communicator. Your health care provider may need to temporarily change your interrogation schedule or, if you are traveling outside the country, give you information about connecting to the LATITUDE system.Note (Model 6280 only): Your Communicator is designed to be used only in the United States, Canada, Puerto Rico, and Mexico. Use of the Communicator in other countries is restricted due to radio-frequency (RF) laws. Please contact LATITUDE Patient Services at 1-866-484-3268 for specifi c information.If you take your Communicator with you, check that the Communicator can connect to the LATITUDE system. Refer to “Checking that the Communicator Can Connect to the LATITUDE System” on page 45.
47LATITUDE® Communicator Patient Manual EnglishCommunicator Use of the Telephone SystemThe Communicator makes telephone calls when there is a need to send data to the LATITUDE system. These calls usually last for approximately 5 minutes.The Communicator can only make outgoing calls. It cannot receive calls. The Communicator is designed to operate on standard landline telephone connections like those found in most homes and supports tone dialing over an analog line. The Communicator may work on other telephone systems, such as DSL and VoIP, if those systems provide an analog interface for connecting the Communicator. The Communicator should not be connected to a digital phone interface, such as those commonly used in some businesses, hotels, and managed care facilities (nursing homes, skilled care facilities, rehabilitation centers) where telephones are typically provided by the facility. If you have other telephone equipment (including fax machine, answering system or computer modem) connected to the same phone line and the line is in use, the Communicator will wait and attempt to place a call later. If you have 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 the telephone line meets the specifi cations stated on page 54.
48 LATITUDE® Communicator Patient Manual EnglishUsing the Telephone While the Communicator is Making a CallIf you pick up the phone while the Communicator is using the telephone line, hang up the receiver, wait 3 or more seconds, and then pick up the telephone receiver again. The Communicator will disconnect and dial tone will be restored. If the Communicator does not disconnect and restore dial tone, hang up the receiver. Then unplug the Communicator from electrical power. You can then use your phone. Plug the Communicator back in after you have fi nished using the phone.The Communicator will attempt to reconnect later. DSL Internet ServiceIf you have digital subscriber line (DSL) Internet service provided through your telephone line, you may need to install a DSL fi lter between the wall phone jack and the LATITUDE Communicator.Most DSL fi lters are small rectangular devices with standard telephone jack connectors at each end. These fi lters are typically provided by DSL service providers to connect telephones, an answering machine, or a fax machine to your telephone line.If you use DSL fi lters for such devices, you will need to install a DSL fi lter to use the Communicator. If you use a dual-port DSL fi lter, connect the Communicator to the port labeled PHONE or where you would typically connect a telephone. For assistance, contact your DSL service provider or LATITUDE Patient Services at 1-866-484-3268.
49LATITUDE® Communicator Patient Manual EnglishCare and MaintenanceYour Communicator does not require any regular service or maintenance.Your Communicator does not require electrical safety testing after installation or during periodic maintenance.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 accessories in liquid.• Do not attempt to open the Communicator or any of its accessories.• Use this unit as described in this instruction manual. Use only authorized parts and accessories. Do not attempt to modify or alter this unit or accessories.If your Communicator or accessories become damaged or malfunction, contact your health care provider.
50 LATITUDE® Communicator Patient Manual EnglishCleaning the Communicator and AccessoriesWhen necessary, clean the Communicator and its accessories with a soft, clean, lint-free cloth moistened in water or mild detergent. Note that the fi nish 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.CAUTIONS:• Do not use other cleaning fl uids. They may damage the front lens of the Communicator. Never spray any cleaning fl uid directly on the Communicator front lens. Do not allow moisture to accumulate on or around the lens or Heart button.• Avoid using any cleaning fl uid near the electrical plugs on the back of the Communicator.
51LATITUDE® Communicator Patient Manual English Returning, Replacing, or Disposing of the Communicator or USB Cellular AdapterIf you need to replace either your Communicator or USB cellular adapter because it is damaged or no longer works, or if you need a different model, contact your health care provider to learn how to return and replace it.If you no longer need to use either your Communicator or USB cellular adapter:• United States: Do not throw the Communicator or adapter in the trash. Dispose of it at a local recycling site that accepts electronics. Contact your local authorities to learn how to dispose of it.• Puerto Rico, Canada, or Mexico: Do not dispose of the Communicator or adapter. Contact your health care provider to learn how to return it. Your Communicator may contain encrypted health data. Dispose of it only as described above.
52 LATITUDE® Communicator Patient Manual English Setting Switches for PBX or Dial-out Numbers(This section applies only to landline telephone connections.) You can use your Communicator with a private branch exchange (PBX) in a managed care facility, hotel, or other location that requires you to enter a dial-out number or prefi x to place an outside call. The fi rst three white switches (1, 2, and 3) on the bottom of the Communicator must be set to match your dial-out number. If using the USB cellular adapter, switches 1-3 do not matter.Switch settings for different dial-out numbers are shown in Figure 8. Refer to “Confi rming Switch Settings” on page 9 for information on switches 4-8.Figure 8. Dial-out Number Dial-out NumberNone01789*99Dial-out number switch settings
53LATITUDE® Communicator Patient Manual English Connecting the USB Sensor AdapterThe USB sensor adapter is included with a LATITUDE weight scale and blood pressure monitor. The USB sensor adapter provides a wireless connection between these products and the Communicator. Refer to Figure 9. 1. Remove the cap from the USB sensor adapter.2. Plug the USB sensor adapter into either of the USB ports labeled on the back of the Communicator. Leave the USB sensor adapter plugged into the Communicator so the Communicator can receive measurements whenever you use your weight scale or blood pressure monitor.Figure 9. USB sensor adapter connection
54 LATITUDE® Communicator Patient Manual EnglishSpecifi cationsModel: 6280 and 6290(Unless specifi ed, values apply to both models.)Dimensions: Length: 8.00 in (20.3 cm)Width: 4.50 in (11.4 cm)Height: 2.71 in (6.9 cm)Weight: 0.83 lbs ( 0.38 kg)Power Source: 5.0 VDC, 3.0 A, continuous service Class II AC adapter, GlobTek® Model GTM41061-1512-7.0, part 350118-001 (included)Power Supply:Input: 100-240 VAC, 0.6 A, 50-60 HzMaximum Output: 15 WSupply Mains Isolation: AC adapter plugMinimum Operational Loop Current: 20 mAProtection Against Electric Shock: Class IIExpected Service Life:Meets the useful life of the implanted device, from 4.2 to 12.6 yearsAnalog Dialing Mode: ToneOperating Temperature: 41° F to 104° F (5° C to 40° C)Storage and Transport Temperature:-13° F to 158° F(-25° C to 70° C)Operating Humidity: 15% to 93% noncondensing
55LATITUDE® Communicator Patient Manual EnglishStorage and Transport Humidity: 15% to 93% noncondensingOperating Pressure: 70 to 106 kPaStorage and Transport/Pressure: 50 to 106 kPaProtection Against Ingress of Water: IP21 (light rain proof)Communicator Implanted Device Radio (Model 6280):Receive Bandwidth: +190/-160 kHzFrequency Band: 916.5 MHzModulation Transmit Type: ASK (Amplitude-Shift keying)Effective Radiated Power: <-1.25 dBm (0.75 mW) Communicator Implanted Device Radio (Model 6290):Receive Bandwidth: <300 kHzMICS/MedRadio: 402-405 MHzModulation Transmit Type: FSK (Frequency-Shift keying)Effective Radiated Power: <-16 dBm (25 μW)
56 LATITUDE® Communicator Patient Manual EnglishUSB Sensor Adapter:2.4 GHz wireless USB dongle Delta Mobile Systems® Model DM210Boston Scientifi c Model 6454 (included with LATITUDE weight scale and blood pressure monitor)Operational Frequency: 2400.0 to 2480.0 MHzModulation Type: Adaptive Frequency HoppingEffective Radiated Power: 14 dBm (25 mW)Operating Temperature: 32° F to 158° F (0° C to 70° C)Storage Temperature: -4° F to 185° F (-20° C to 85° C)Relative Humidity: 10% to 85% noncondensing
57LATITUDE® Communicator Patient Manual EnglishLATITUDE NXT USB Cellular Adapter (Model 6295):GSM-850: TX 824-849 MHzRX 869-894 MHzEffective Radiated Power: 22.93 dBmPCS-1900: TX 1850-1910 MHzRX 1930-1990 MHzEffective Radiated Power: 26.42 dBmW-CDMA 850: TX 824-849 MHzRX 869-894 MHzEffective Radiated Power: 15.83 dBmW-CDMA 1900: TX 1850-1910 MHzRX 1930-1990 MHzEffective Radiated Power: 18.76 dBm
58 LATITUDE® Communicator Patient Manual EnglishSafety and Standards Compliance• Changes or modifi cations not expressly approved by Boston Scientifi c could void the user’s authority to operate this equipment.• Before each use, visually inspect your Communicator to make sure the housing has no cracks and the AC adapter and any other connecting items are intact.• The use of accessories and cables other than those specifi ed may result in increased emissions or decreased immunity of the LATITUDE Communicator. • Keep your Communicator and all accessories out of the reach of small children and pets. Small parts may cause choking or serious injury if swallowed and attached cords may pose a strangulation hazard. Consult a health care professional immediately if this occurs.• Do not insert any object other than a phone connector into the phone jacks on the back of the Communicator. There can be voltage on the electrical contacts in the jacks. There is potential to receive a shock.• Do not use the Communicator adjacent to or stacked with other equipment. If it is necessary to use the Communicator adjacent to or stacked with other equipment, please contact LATITUDE Patient Services at 1-866-484-3268 to verify normal operation.
59LATITUDE® Communicator Patient Manual English• The user is cautioned to maintain an 8 in. (20 cm) spacing from the product to ensure compliance with Federal Communications Commission/Industry Canada (FCC/IC) requirements.• To help prevent electromagnetic interference, it may be necessary to keep other wireless communications equipment such as cellular telephones and their base stations, mobile phones, and wireless home network devices at least 1.6 ft (0.5 m) away from the Communicator.• Other wireless communication equipment could interfere with the Communicator even if the other equipment complies with CISPR (Special International Committee on Radio Interference) emission requirements. • This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.• This equipment complies with Part 68 of the FCC rules and the requirements adopted by the Administrative Council for Terminal Attachments (ACTA). On the bottom of this equipment is a label that contains, among other information, a product identifi er in the format US: AAAEQ##TXXX. If requested, this number must be provided to the telephone company. The Ringer Equivalence Number (REN) for this product is part of the product identifi er. The digits represented by ## are the REN.
60 LATITUDE® Communicator Patient Manual English• The REN is used to determine the number of devices that may legally connect to a telephone line. In most, but not all areas, the sum of RENs should not exceed fi ve (5.0). You should contact your telephone company to determine the maximum REN for your calling area.• This equipment uses the following Universal Service Order Codes (USOC) jacks: RJ11C.• An FCC compliant telephone cord and modular plug are provided with this equipment, which is designed to connect to the telephone network or premises wiring using a Part 68 compliant compatible jack. See installation instructions for details.• Model 6290 only: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference.
61LATITUDE® Communicator Patient Manual English• If your home has specially wired alarm equipment connected to the telephone line, ensure the installation of the Communicator does not disable your alarm equipment. If you have questions about what will disable alarm equipment, consult your telephone company or a qualifi ed installer.• The telephone company may make changes in its facilities, equipment, operations, or procedures that could affect the operation of the equipment. If this happens, the telephone company will provide advance notice in order for you to make necessary modifi cations to maintain uninterrupted service.• If the Communicator causes harm to the telephone network, the telephone company will notify you in advance that temporary discontinuance of service may be required. But if advance notice isn’t practical, the telephone company will notify the customer as soon as possible. Also, you will be advised of your right to fi le a complaint with the FCC if you believe it is necessary.• Connection to party line service is subject to state tariffs. Contact the state public utility commission, public service commission or corporation commission for information.• This equipment has been tested and found to comply with applicable safety portions of the AAMI ES 60601-1:2005, CAN/CSA-C22.2 NO. 60601-1:08 and IEC 60601-1:2005 standards.
62 LATITUDE® Communicator Patient Manual English• This equipment has been tested and found to comply with the following electromagnetic compatibility (EMC) standard: IEC 60601-1-2:2007.• Accessory equipment connected to the analog and digital interfaces (signal inputs and signal outputs) must be certifi ed according to the respective IEC standards. Anyone who connects additional equipment to the signal input parts or signal output parts may confi gure a medical system, and is therefore responsible that the system complies with the requirements of clause 16 of IEC 60601-1:2005. If in doubt, consult the technical service department or your local representative.
63LATITUDE® Communicator Patient Manual EnglishEssential PerformanceThe performance of the Communicator that is determined to be essential by Boston Scientifi c for electromagnetic compatibility (EMC) testing, as per IEC 60601-1-2, is the ability to:• Communicate with your implanted device.• Identify alert conditions in your implanted device.• Receive measurements from optional health monitoring equipment.• Communicate implanted device data and alert conditions to the LATITUDE system.• Communicate measurements and alert conditions from optional health monitoring equipment to the LATITUDE system.• Receive confi guration updates from the LATITUDE system.
64 LATITUDE® Communicator Patient Manual English
65LATITUDE® Communicator Patient Manual EnglishElectromagnetic Emissions and ImmunityTable 1. Guidance and manufacturer’s declaration—electromagnetic emissions—for all equipment and systemsa bEmissions test Compliance Electromagnetic environment—guidanceRF emissions (CISPR 11)Group 1 The LATITUDE Communicator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF emissions (CISPR 11)Class B The LATITUDE Communicator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions (IEC 61000-3-2)Class AVoltage fl uctuations/fl icker emissions (IEC 61000-3-3)Compliesa. The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment.b. The LATITUDE Communicator is also compliant with IEC 60601-1-2:2007.
66 LATITUDE® Communicator Patient Manual EnglishTable 2. Guidance and manufacturer’s declaration—electromagnetic immunity—for all equipment and systemsa bImmunity test IEC 60601 test level Compliance level Electromagnetic environment—guidanceElectrostatic discharge (ESD) (IEC 61000-4-2)±6 kV contact±8 kV air±8 kV contact±15 kV airThe relative humidity should be at least 15 percent.Electrical fast transient/burst (IEC61000-4-4)±2 kV for power supply lines±1 kV for input/output lines±2 kV for power supply lines±1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.Surge (IEC 61000-4-5)±1 kV differential mode±2 kV common mode±1 kV differential mode±2 kV common modeMains power quality should be that of a typical commercial or hospital environment.
67LATITUDE® Communicator Patient Manual EnglishImmunity test IEC 60601 test level Compliance level Electromagnetic environment—guidanceVoltage dips, short interruptions, and voltage variations on power supply input lines (IEC 61000-4-11)<5% UTb (>95% dip in UT) for 0.5 cycle<5% UT (>95% dip in UT) for 0.5 cycleMains power quality should be that of a typical commercial or hospital environment. If the user of the LATITUDE Communicator requires continued operation during power mains interruptions, it is recommended that the LATITUDE Communicator be powered from an uninterruptible power supply or a battery.40% UT (60% dip in UT) for 5 cycles40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles70% UT (30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 sec<5% UT(>95% dip in UT) for 5 secPower frequency (50/60 Hz) magnetic fi eld (IEC 61000-4-8)3 A/m 30 A/m Power frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.a. The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment.b. UT is the AC main’s voltage prior to application of the test level.
68 LATITUDE® Communicator Patient Manual EnglishTable 3. Guidance and manufacturer’s declaration—electromagnetic immunity—for equipment and systems that are not life supportinga b c dImmunity test IEC 60601 test levelCompliance levelElectromagnetic environment—guidancePortable and mobile RF communications equipment should be used no closer to any part of the LATITUDE Communicator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distances:Conducted RF (IEC 61000-4-6)3 Vrms150 kHz to 80 MHz3 Vrms10 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHzed = 1.7 √P (150 kHz to 80 MHz)where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey,f should be less than the compliance level in each frequency range.g
69LATITUDE® Communicator Patient Manual EnglishImmunity test IEC 60601 test levelCompliance levelElectromagnetic environment—guidanceRadiated RF (IEC 61000-4-3)3 V/m80 MHz to 2.5 GHz10 V/m 80 MHz to 1000 MHzh3 V/m 1 GHz to 2.7 GHzi8 V/m 5.1 GHz to 5.8 GHzd = 0.5 √P (80 MHz to 1000 MHz)d = 0.29 √P (380 MHz to 390 MHz)d = 0.36 √P (430 MHz to 470 MHz)d = 0.21 √P (800 MHz to 960 MHz)d = 1.7 √P (1 GHz to 2.7 GHz)d = 0.21 √P (1.7 GHz to 1.99 GHz)d = 0.21 √P (2.4 GHz to 2.57 GHz)d = 0.63 √P (5.1 GHz to 5.8 GHz)where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).Field strengths from fi xed RF transmitters, as determined by an electromagnetic site survey,e should be less than the compliance level in each frequency range.fInterference may occur in the vicinity of equipment marked with the following symbol:Non-iodizing electromagnetic radiationa. The LATITUDE Communicator is intended for use in the electromagnetic environment specifi ed above. The customer or the user of the LATITUDE Communicator should assure that it is used in such an environment.b. At 80 MHz and 1 GHz, the higher frequency range applies.c. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects, and people.d. The separation distances are calculated using the following equation adopted from the 4th edition draft of IEC 60601-1-2: d = (5/E) √P where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer, d is the separation distance in meters (m), and E is the compliance level.e. The ISM (industrial, scientifi c and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 150 kHz 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 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz,
70 LATITUDE® Communicator Patient Manual English18.07 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 and 50.0 MHz to 54.0 MHz.f. Field strengths from fi xed 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. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the LATITUDE Communicator is used exceeds the applicable RF compliance level above, the LATITUDE Communicator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the LATITUDE Communicator.g. Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3 V/m.h. The compliance level used in the following sub-bands is higher than in the table: 380 – 390 MHz at 17 V/m, 430 – 470 MHz at 14 V/m, and 800 – 960 MHz at 24 V/m.i. The compliance level used in the following sub-bands is higher than in the table: 1700 – 1990 MHz at 24 V/m, and 2400 – 2570 MHz at 24 V/m.
71LATITUDE® Communicator Patient Manual EnglishTable 4. Recommended separation distances between portable and mobile RF communications equipment and the LATITUDE Communicatora b c dRated maximum output power of transmitter(Watts)Separation distance according to frequency of transmitter (meters)150 kHz to 80 MHzd = 1.7 √P80 MHz to 1000 MHzd = 0.5 √P380 MHz to 390 MHzd = 0.29 √P430 MHz to470 MHzd = 0.36 √P800-960 MHz1.7-1.99 GHz2.4-2.57 GHzd = 0.21 √P1 GHz to2.7 GHzd = 1.7 √P5.1 GHz to5.8 GHzd = 0.63 √P0.01 0.17 0.050 0.029 0.036 0.021 0.17 0.0630.1 0.54 0.16 0.092 0.11 0.066 0.54 0.201 1.7 0.50 0.29 0.36 0.21 1.7 0.6310 5.4 1.6 0.92 1.1 0.66 5.4 2.0100 17 5.0 2.9 3.6 2.1 17 6.3a. The LATITUDE Communicator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LATITUDE Communicator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LATITUDE Communicator as recommended in Table 4, according to the maximum output power of the communications equipment.b. For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer.c. At 80 MHz, 800 MHz, and 1 GHz, the separation distance for the highest frequency range applies.d. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects, and people.
72 LATITUDE® Communicator Patient Manual EnglishSoftwareThe 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.
73LATITUDE® Communicator Patient Manual EnglishExplanation of Product and Label SymbolsSymbol MeaningInput from telephone jackOutput to telephone (optional)AC/DC adapter power inputDirect current (DC)Universal serial bus (USB) connectorPart numberSerial numberReference numberNon-ionizing electromagnetic radiationIEC 60601 Class II medical equipment, protection against electrical shockManufacturerDate of manufactureFollow instructions for useProtection against ingress of water. Light rain proof.
74 LATITUDE® Communicator Patient Manual EnglishSymbol MeaningCE mark of conformity (applies to USB sensor adapter)Indicates the product complies with applicable Australia radiocommunications standards(applies to USB sensor adapter)Authorized representative in the European Community (applies to distribution box)Australian sponsor address(applies to distribution box)Power indicator (applies to USB cellular adapter)Wireless indicator (applies to USB cellular adapter)Waste, Electrical, and Electronic Equipment (WEEE) symbol. Indicates separate collection for electrical and electronic equipment (i.e., do not throw this device in the trash)Indicates this product has passed a comprehensive testing procedure and the production plant is regularly monitored as certifi ed by a Nationally Recognized Testing LaboratoryTemperature range limitsHumidity range limitsAtmospheric pressure range limits
Boston Scientific4100 Hamline Avenue NorthSt. Paul, MN 55112-5798 USATelephone: 651.582.4000Medical Professionals: 1.800.CARDIAC (227.3422) Patients and Families: 1.866.484.3268www.bostonscientific.com© 2013 Boston Scientific Corporation or its affiliates.All rights reserved.359081-001 ENES US 2013-07*359081-001*

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