PATIENT PATIENT PATIENT PATIENT MANUAL MANUAL MANUAL MANUAL LATITUDE® Communicator LATITUDE® Communicator LATITUDE® Communicator LATITUDE® Communicator Caution: Federal (USA) law restricts this device to distribution and use by or on the lawful order of a physician.
LATITUDE is a registered trademark of Boston Scientific Corporation or its affiliates. Delta Mobile Systems is a trademark of Delta Mobile Systems GlobTek is a registered trademark of GlobTek, Inc.
Table of Contents LATITUDE Patient Management The LATITUDE Communicator Items You Should Receive Optional Health Monitoring Equipment Clinician Website 3 3 4 5 5 When to Use Your Communicator 6 When Not to Use Your Communicator 6 Where to Place Your Communicator 7 Important Notes 7 Identifying Buttons, Connectors and Indicators 9 How to Connect Your Communicator Connections When Using a Telephone Connections for the LATITUDE Cellular Data Plan 10 11 Normal Operation of the Communicator 16 In
What to Do if the Electrical Power is Interrupted 44 Checking that the Communicator Can Connect to LATITUDE 45 Traveling with Your Communicator 46 Communicator Use of the Telephone System What to Do If You Need to Use the Telephone While the Communicator is Making a Call DSL Internet Service 46 Care and Maintenance Cleaning the Communicator Returning or Replacing the Communicator Communicator Disposal Setting Switches for Your Country Setting Switches for PBX or Dial-out Numbers 49 49 50 50 51 52
LATITUDE Patient Management LATITUDE Patient Management is a remote monitoring system that gives your health care provider access to your implanted device data between scheduled office 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 Communicator does not reprogram or change any functions of your implanted device. Only your health care provider can do this during an office visit. Your Communicator is designed to be used only in the United States, Canada, and Puerto Rico. The telephone (land line) 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.
Optional Health Monitoring Equipment If 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 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.
When to Use Your Communicator The Communicator performs many functions automatically on a regular schedule that is set by your health care provider. Other functions require you to respond when the indicators on the front of the Communicator light or flash. Check the Communicator daily to see if any of the indicators are lit or flashing. Use the Communicator only as instructed by your health care provider.
Where to Place Your Communicator Place 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.
• 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. • Boston Scientific personnel may contact the clinic or patient if an implanted device uses too much RF telemetry to perform remote interrogations.
Identifying Buttons, Connectors and Indicators Figure 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. Heart Button LATITUDE Indicator Status Button USB ports (wireless connection to sensors) Power input To telephone (optional) To telephone wall jack Figure 1.
Patient Icon Collecting Waves Sensor Reading Icon Heart Button Sending Waves LATITUDE Indicator Doctor Icon Call Doctor Icon Figure 2. Indicators How to Connect Your Communicator Complete the following steps to connect and install the Communicator.
Connections When Using a Telephone Complete the following steps to setup the Communicator. 1. Set switches 4 through 8 on the bottom of the Communicator to match your country as shown in Figure 3. If you are in a location that requires you to enter a dial-out number or prefix to place an external telephone call, set switches 1, 2, and 3. Refer to “Setting Switches for PBX or Dial-out Numbers” on page 52. United States, Puerto Rico Canada Figure 3.
Connecting a telephone is optional Figure 4. Connecting to a telephone wall jack Your Communicator and a telephone can share the same telephone wall jack. However, they can not be used at the same time. 2. Plug one end of the Communicator telephone cord (included) into the jack labeled . 3. 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 filter between the telephone wall jack and the Communicator.
4. If you also want to use a telephone with this wall jack, you may plug your telephone into the jack labeled . 5. Insert the AC adapter into the jack labeled . 6. Plug the AC adapter into an electrical outlet that is easily accessible. 7. Make sure the LATITUDE Indicator on the front of the Communicator is lit. The LATITUDE Indicator flashes for up to one minute while the Communicator starts up. If the LATITUDE Indicator is not lit, check that both ends of the AC adapter are plugged in firmly.
“Indicator Sequence When Using the Heart Button” on page 17 section for more information. Connections for the LATITUDE Cellular Data Plan If you have signed up for the LATITUDE Cellular Data Plan, no telephone cords need to be attached. Refer to “LATITUDE Cellular Data Plan” on page 41 for more information. 1. Set switches 4 through 8 on the bottom of the Communicator to match your country as shown in Figure 3 on page 11. Figure 5.
2. Insert the AC adapter into the jack labeled . 3. Plug the AC adapter into an electrical outlet that is easily accessible. 4. Make sure the LATITUDE Indicator on the front of the Communicator is lit. The LATITUDE Indicator flashes for up to one minute while the Communicator starts up. If the LATITUDE Indicator is not lit, check that both ends of the AC adapter are plugged in firmly. Check if the light on the AC adapter is on. Important: Your Communicator should remain connected to the electrical outlet.
Normal Operation of the Communicator During normal operation, only the LATITUDE indicator will be lit (green). The Communicator automatically interrogates your implanted device on a regular schedule that is set by your health care provider. Daily device checks are also performed automatically. None of the Communicator indicators will light during a scheduled interrogation or daily device check.
Indicator Sequence When Using the Heart Button This 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 detailed information describing the colors and purpose of all the indicators is provided later in the manual. The Communicator begins interrogating your implanted device after the Heart button is pressed. The Patient icon lights blue.
All three Collecting Waves will light green. The Heart button lights white indicating the interrogation was successful. 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 indicating the Communicator successfully sent your data to the LATITUDE system. All the indicators shown stay lit for two minutes to indicate the entire process was successful.
Indicator Descriptions The indicators will light to indicate the Communicator’s progress when: • Manually interrogating your implanted device • Connecting and sending your device information to the LATITUDE system • Collecting a measurement from a prescribed weight scale or blood pressure monitor One or more indicators may light or flash a different color to indicate some type of action may need to be taken. Refer to “Troubleshooting Errors” on page 27.
• These waves light green in sequence and repeat, indicating the Communicator is interrogating your implanted device. • All three waves light green for 2 minutes to indicate the interrogation was successful. Heart Button The Heart button flashes with a white light if you need to complete a previously scheduled interrogation. The Heart button lights a solid white to indicate the interrogation is complete. The Heart button can also be used to manually initiate an interrogation of your implanted device.
• All three waves light green for 2 minutes to indicate the connection to the LATITUDE system was successful and any collected device data was sent. Doctor Icon Lights blue to indicate the Communicator has successfully connected to the LATITUDE system. The Communicator sends any data from your implanted device, scale, or blood pressure monitor that is stored in the Communicator’s memory.
Sensor Reading Icon Indicates the Communicator has successfully communicated with a prescribed weight scale or blood pressure monitor. • Flashes green five times and remains lit for 5 minutes to indicate the Communicator successfully received a weight or blood pressure measurement. LATITUDE Indicator Indicates the Communicator is connected to electrical power. It also indicates if the Communicator startup process is being performed or if the Communicator is ready to use.
• If an error exists, the LATITUDE Indicator stays yellow for 60 minutes or until the error is resolved. Call Doctor Icon The Call Doctor icon lights yellow or red to indicate a problem was detected that should be communicated to your health care provider. Refer to the error description in “Troubleshooting Errors” on page 27. A red light has higher priority than a yellow light. If an error for each color occurs at the same time, only the red error indicator is displayed.
Status Button The Status Button is located on the back of the Communicator as shown in Figure 6. Figure 6. Status Button 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.
Note: If you pressed the Heart button, the Status button will not function until the resulting interrogation is completed or is cancelled. Confirming Normal Operation You can use the Status button to check if the Communicator is operating normally. The above image shows that all the Collecting and Sending Waves are lit green, indicating that the last interrogation and the last connection to LATITUDE system were successful. When the waves are lit like this, you don’t need to take any action.
26 LATITUDE® Communicator Patient Manual
Troubleshooting Errors One or more of the indicators on the front of the Communicator may light or flash to indicate some type of Communicator, phone 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 on the following pages along with suggested actions to resolve each error.
No Indicators are Lit Description: 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 firmly. • 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.
Call Doctor Icon is Red and LATITUDE Icon is Yellow Description: The Call Doctor icon is red and the LATITUDE icon is yellow. The Call Doctor icon will stay lit until the problem is resolved. If the Call Doctor icon is flashing, it will light solid after the error is acknowledged (by pressing the Status button). A potential problem with your implanted device was detected.
Call Doctor Icon is Yellow and LATITUDE Icon is Yellow Description: The Call Doctor icon is yellow and the LATITUDE icon is yellow. The Call Doctor icon will stay lit until the problem is resolved. If the Call Doctor icon is flashing, it will light solid after the error is acknowledged (by pressing the Status button). Indicates one of the following errors: • Your Communicator is currently unable to monitor your implanted device.
Call Doctor Icon Lit Description: Only the Call Doctor icon is lit yellow (the LATITUDE Indicator is not lit). This indicates your Communicator may not be working properly. Action: Press the Status button and check that the Call Doctor icon lights a solid yellow and does not flash. Also check that the LATITUDE icon still does not light. If only the Call Doctor icon lights a solid yellow, you may need to get a replacement Communicator. Call your health care provider.
Wave Indicator Colors The Wave indicators will light yellow to indicate an error. Wave errors stay lit for 60 minutes, or until the cause of the error is resolved. Please respond to error indicators as soon as possible. • Green. All three Collecting Waves will light green for 2 minutes to indicate a successful interrogation of your implanted device. All three Sending Waves will light green for 2 minutes to indicate the Communicator successfully sent your information to the LATITUDE system. • Yellow.
One Yellow Collecting Wave Description: The Communicator was unable to start an interrogation of your implanted device or your implanted device is now out of range. Action: • Ensure the Communicator is optimally placed as described in “Where to Place Your Communicator” on page 7. • Face the Communicator. Sit directly in front of the Communicator. Make sure you are within 10 ft (3 m) of the Communicator.
Two Yellow Collecting Waves Description: The Communicator was unable to establish wireless communication with your implanted device due to interference from other wireless electronic devices . 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 7. • Face the Communicator. Sit directly in front of the Communicator.
Three Yellow Collecting Waves Description: Any of the following reasons could cause this error: • You may have exceeded your weekly interrogation limit, so you are not able 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.
One Yellow Sending Wave Description: 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 the Communicator will use a telephone line, check that the telephone cord provided with the Communicator is plugged in tightly to a telephone wall jack and the Communicator.
• After trying the above actions, initiate a connection to LATITUDE by pressing and holding the Status button until the Sending Waves light green in sequence and repeat. All three Sending Waves should light a constant green to indicate a successful connection was made to the LATITUDE system. • Check if the Communicator can connect to the LATITUDE system. Refer to “Checking that the Communicator Can Connect to LATITUDE” on page 45.
Two Yellow Sending Waves Description: An attempt to connect to the LATITUDE system failed. Action: The Communicator established a connection using the LATITUDE Cellular Data Plan, but the connection was dropped or the signal was lost . Check if the Communicator can connect to the LATITUDE system. Refer to “Checking that the Communicator Can Connect to LATITUDE” on page 45. If using a telephone line: • If you use a telephone, make sure your telephone is not being used at this time.
• Check that the switches on the bottom of the Communicator are set correctly for your country and if you need to dial a number to get an outside line. Refer to “Setting Switches for Your Country” on page 51 and “Setting Switches for PBX or Dial-out Numbers” on page 52. If using the LATITUDE Cellular Data Plan: • Move the Communicator to another location that may provide a stronger cellular signal.
Three Yellow Sending Waves Description: The Communicator was able to establish a connection, but no information reached the LATITUDE system. Action: 40 A telephone, answering machine, computer or other device may be using or attempted to use the telephone line . • Check if the Communicator can connect to the LATITUDE system. Refer to “Checking that the Communicator Can Connect to LATITUDE” on page 45. • If you see three yellow waves after trying the above action, contact your health care provider.
LATITUDE Cellular Data Plan The LATITUDE Cellular Data Plan uses a cellular data network rather than a standard telephone line 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. You need either a standard analog telephone line or the LATITUDE Cellular Data Plan to use the LATITUDE Patient Management system. The LATITUDE Cellular Data Plan uses a data only network.
Connect to LATITUDE” on page 45. If you travel to another location with your Communicator, check the connection from that location. Troubleshooting and Support Subscription 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.
Interrogating Your Implanted Device The Communicator automatically interrogates your implanted device on a regular schedule that is 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, without being set by a health care provider. None of the Communicator indicators will light during a scheduled interrogation or daily device check.
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.
Checking that the Communicator Can Connect to LATITUDE Complete 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 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.
5. 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 32 for actions to take. Traveling with Your Communicator You can use your Communicator away from home if you will be gone for an extended period.
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 telephone lines like those found in most homes and supports tone dialing over an analog line. The Communicator may work on other telephone systems, such as Digital Subscriber Line (DSL) and Voice over IP (VoIP), if those systems provide an analog interface for connecting the Communicator.
What to Do If You Need to Use the Telephone While the Communicator is Making a Call If 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.
Care and Maintenance To ensure optimum performance of your Communicator and protect it from damage, follow these directions: CAUTIONS: • Do not drop or mishandle the Communicator 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 in liquid. • Do not attempt to open the Communicator. • Use this unit as described in this instruction manual.
CAUTIONS: • Do not use other cleaning fluids. They may damage the front lens of the Communicator. Never spray any cleaning fluid directly on the Communicator front lens. Do not allow moisture to accumulate on or around the lens or Heart button. • Avoid using any cleaning fluid near the electrical plugs on the back of the Communicator. Returning or Replacing the Communicator If your Communicator becomes damaged or it malfunctions, contact your health care provider for return and replacement instructions.
Setting Switches for Your Country Switches 4 through 8 on the bottom of the Communicator must be set for the country where you are using the Communicator (Figure 8). Your Communicator is designed to be used only in the United States, Canada, and Puerto Rico. United States, Puerto Rico Canada Figure 8.
Setting Switches for PBX or Dial-out Numbers You can use your Communicator in a managed care facility, hotel, or other location that requires you to enter a dial-out number or prefix to place an external call. The first three switches (1, 2, and 3) on the bottom of the Communicator must be set to match your dial-out number. Switch settings for different dial-out numbers are shown in Figure 9. Switches 4 through 8 should be set to match the country you are in as shown in Figure 8.
Connecting the USB Adapter The USB adapter is included with a LATITUDE weight scale and blood pressure monitor. The USB adapter provides a wireless connection between these products and the Communicator. Plug the USB adapter into either of the USB ports labeled on the back of the Communicator. Refer to Figure 10. Leave the USB adapter plugged into the Communicator so the Communicator can receive measurements whenever you use your scale or blood pressure monitor. Figure 10.
5.0 VDC, 3.0 A, continuous service Class II AC adapter, GlobTek® model GTM410601505, part 358462-001 (included) Power Source: Power Supply Input: 100-240 VAC, 0.6 A, 50-60 Hz Maximum Output: 15 W Supply Mains Isolation: AC adapter plug Minimum Operational Loop Current: 20 mA Expected Service Life: Meets the useful life of the implanted device, from 5.6 to 12.
Communicator Pulse Generator Radio: Receive Bandwidth: +190/-160 kHz Receive Frequency: 916.5 MHz Transmit Frequency: 916.5 MHz Modulation Transmit Type: ASK (Amplitude-Shift keying) Effective Radiated Power: <-1.25 dBm (0.75 mW) USB Adaptor: 2.4 GHz wireless USB dongle Delta Mobile Systems model DM210 Boston Scientific model 6454 (included with LATITUDE scale and blood pressure monitor) Operational Frequency: 2400.0 to 2480.
Safety and Standards Compliance • Changes or modifications not expressly approved by Boston Scientific could void the user’s authority to operate this equipment. • The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the LATITUDE Communicator. Using accessories and cables supplied with the Communicator in other medical equipment and systems may result in increased emissions or decreased immunity of the other medical equipment or systems.
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.
respective IEC standards. Anyone who connects additional equipment to the signal input parts or signal output parts may configure 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. Software The software included in this product contains copyrighted software that is licensed under the GNU General Public License (GPL).
Explanation of Product and Label Symbols Symbol Meaning Input from telephone jack Output to telephone (optional) AC/DC adapter power input Direct current (DC) Universal Serial Bus (USB) connector P/N: Part number Serial number Reference number Non-ionizing electromagnetic radiation IEC 60601 Class II medical equipment, protection against electrical shock Manufacturer Date of manufacture Consult instructions for use IP21 Protection against ingress of water. Light rain proof.
Symbol Meaning Waste, Electrical, and Electronic Equipment (WEEE) symbol. Indicates separate collection for electrical and electronic equipment (i.e.
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