Boston Scientific 6498 Patient Manual Download Page 7

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LATITUDE

Communicator Patient Manual

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.

An accessory for the Communicator is a USB adapter

that is included with the scale and blood pressure

monitor.

Clinician Website

The 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.

Summary of Contents for 6498

Page 1: ...L PATIENT MANUAL PATIENT MANUAL Caution Federal USA law restricts this device to distribution and use by or on the lawful order of a physician LATITUDE Communicator LATITUDE Communicator LATITUDE Communicator LATITUDE Communicator ...

Page 2: ...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 ...

Page 3: ... and Indicators 9 How to Connect Your Communicator 10 Connections When Using a Telephone 11 Connections for the LATITUDE Cellular Data Plan 14 Normal Operation of the Communicator 16 Indicator Sequence When Using the Heart Button 17 Indicator Descriptions 19 Status Button 24 Confirming Normal Operation 25 Troubleshooting Errors 27 Wave Indicator Colors 32 LATITUDE Cellular Data Plan 41 Activating ...

Page 4: ...System 46 What to Do If You Need to Use the Telephone While the Communicator is Making a Call 48 DSL Internet Service 48 Care and Maintenance 49 Cleaning the Communicator 49 Returning or Replacing the Communicator 50 Communicator Disposal 50 Setting Switches for Your Country 51 Setting Switches for PBX or Dial out Numbers 52 Connecting the USB Adapter 53 Specifications 53 Safety and Standards Comp...

Page 5: ...ed to assist with medical emergencies If you are not feeling well call your health care provider or dial 911 The LATITUDE Communicator The 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 schedu...

Page 6: ... 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 Read the instructions in this manual thoroughly before using the Communicator Keep all of your LATITUDE information in a convenient location for easy access in the future Items ...

Page 7: ... the Communicator is a USB adapter that is included with the scale and blood pressure monitor Clinician Website The 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 lon...

Page 8: ...n of your implanted device If the Heart button is flashing press it and then watch the indicators on the Communicator Call your health care provider if the Call Doctor icon Figure 2 on page 10 is lit When Not to Use Your Communicator The 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 ...

Page 9: ...mmunicator remain 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 Some hous...

Page 10: ...tector 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 ...

Page 11: ...s 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 connectors To telephone wall jack To telephone optional Power input Status Button USB ports wireless connection to sensors Heart Button LATITUDE Indicator ...

Page 12: ...nections When Using a Telephone page 11 Connections for the LATITUDE Cellular Data Plan page 14 These instructions also appear in the Communicator installation guide NOTE If you have DSL Internet service you may need to use a DSL filter between the wall phone jack and the Communicator Refer to DSL Internet Service on page 48 Figure 2 Indicators Heart Button Sending Waves Collecting Waves Patient I...

Page 13: ...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 Figure 3 Switch settings United States Puerto Rico Canada ...

Page 14: ... 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 Refer to DSL Internet Service on page 48 Figure 4 Connecting to a telephone wall jack Connecting a telephone is optional ...

Page 15: ...t 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 and telephone wall jack 8 When electrical power is supplied the Communicator begins a startup process The Communicator lights all the indicators for approximately one second to indicate all indicators are working 9 During the in...

Page 16: ...lular 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 Connections when using the LATITUDE Cellular Data Plan ...

Page 17: ...C adapter is on Important Your Communicator should remain connected to the electrical outlet 5 When electrical power is supplied the Communicator begins a startup process The Communicator lights all the indicators for approximately one second to indicate all indicators are working 6 During the initial startup process the Heart button will flash with a white light Press the flashing Heart button th...

Page 18: ...lly 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 They will light when you use the Heart button as described in Indicator Sequence When Using the Heart Button on page 17 ...

Page 19: ...r 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 The Collecting Waves light green in sequence and repeat while the Communicator interrogates your...

Page 20: ...cessful 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 ...

Page 21: ...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 Patient Icon Indicates the Communicator is interrogating collecting data from your implanted device Lights blue when the Heart button is pressed and an interrogation has started The Patient icon stays lit for 2 minutes after a successful interrogat...

Page 22: ...ht 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 Refer to Interrogating Your Implanted Device on page 43 before using this button Sending Waves Indicates the Communicator is connecting to the LATITUDE system ...

Page 23: ... 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 ...

Page 24: ...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 Lights green to indicate the Communicator is connected to electrical power and is ready to use Flashes yellow during the startup process The LATITUDE indicator could flash yellow for an extended pe...

Page 25: ...h 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 The Call Doctor icon flashes yellow briefly after the Communicator is plugged into electrical power The light turns off after the Communicator successfully completes the s...

Page 26: ...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 ...

Page 27: ...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 ...

Page 28: ...26 LATITUDE Communicator Patient Manual ...

Page 29: ... 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 Yellow Collecting Waves Indicate errors collecting information from your implanted device Yellow Sending Waves Indicate errors sending information to the LATITUDE system Call Doctor Icon Call your doctor when lit LATITUDE Indicator Green light indicates po...

Page 30: ... 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 ...

Page 31: ... 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 The Communicator is monitoring your device but it cannot send any information collected from your implanted device to the LATITUDE system Action Your immediate response is required Call your health car...

Page 32: ...on 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 Monitoring of your implanted device was suspended through the LATITUDE system Action Call your health care provider ...

Page 33: ...is 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 ...

Page 34: ...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 or more of the Wave indicators will light yellow to indicate some type of error as described below The Waves flash for 60 minutes unless the error is resolved sooner After 6...

Page 35: ...vice 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 Move any wireless electronic products such as cordless phones or baby monitors that are within 11 ft 3 3 m of the Communicator ...

Page 36: ...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 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 suc...

Page 37: ...e 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 interrogatio...

Page 38: ...ellular 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 If a telephone is connected to the Communicator pick the telephone up and check for dial tone If the Communicator will use a telephone line check that the analog telephone service supports the tone di...

Page 39: ...e 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 ...

Page 40: ...al was lost Action 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 Remove any splitters between the Communicator and the telephone wall jack Ensure you are using a DSL filter between the Communicator and the...

Page 41: ...n page 52 If using the LATITUDE Cellular Data Plan Move the Communicator to another location that may provide a stronger cellular signal If other locations do not work after trying another connection see below try plugging the Communicator into an active telephone wall jack To verify troubleshooting was successful Press and hold the Status button until the Sending Waves light green in sequence and...

Page 42: ...e LATITUDE system A telephone answering machine computer or other device may be using or attempted to use the telephone line Action 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 ...

Page 43: ...used with your cellular phone service NOTE Your Communicator is designed to use a telephone line if it is connected to an active telephone jack If connected your Communicator will send your device data over the telephone line even if you are subscribed to the LATITUDE Cellular Data Plan Activating the LATITUDE Cellular Data Plan Contact Patient Services at 1 866 484 3268 to subscribe to the LATITU...

Page 44: ...ata Plan If this happens move the Communicator to another location and check the connection If this does not work contact Patient Services at 1 866 484 3268 for assistance If your Communicator is not able to connect to LATITUDE using the LATITUDE Cellular Data Plan try plugging the Communicator into an active telephone jack Discontinuing Your LATITUDE Cellular Data Plan Contact Patient Services to...

Page 45: ... repeated attempts the Heart button will flash to allow you to complete the interrogation manually The Heart button also flashes the first 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...

Page 46: ...tem has been accounted for in the projected battery life of your implanted device Using the Heart button more often than when the Heart button flashes 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 poorly or are in need of immediate medical care call your health care provider or dial 911 What to Do if the E...

Page 47: ...tton 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 attem...

Page 48: ...ded period whether or not you take your Communicator Your interrogation schedule may need to be temporarily changed to use your Communicator away from home NOTE Your Communicator is designed to be used only in the United States Canada and Puerto Rico Use of the Communicator in other countries is restricted due to radio frequency RF laws Please contact Patient Services at 1 866 484 3268 for specifi...

Page 49: ... 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 de...

Page 50: ...r telephone to make or answer calls while you are interrogating your device DSL Internet Service If you have Digital Subscriber Line DSL Internet service provided through your telephone line you may need to install a DSL filter between the wall phone jack and the LATITUDE Communicator Most DSL filters are small rectangular devices with standard telephone jack connectors at each end These filters a...

Page 51: ...tor in liquid Do not attempt to open the Communicator 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 becomes damaged or it malfunctions contact your health care provider Cleaning the Communicator When necessary clean the Communicator with a soft clean lint free cloth moi...

Page 52: ...lfunctions contact your health care provider for return and replacement instructions Your Communicator may contain encrypted personal health information Communicator Disposal United States If your Communicator is not damaged dispose of it properly at a local recycling site that accepts electrical and electronic equipment Do not throw the Communicator in the trash Many areas of the country have set...

Page 53: ...ches 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 Canada United States Puerto Rico Figure 8 Country switch settings ...

Page 54: ...t 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 Dial out Number Dial out Number None 0 1 7 8 9 99 Figure 9 Dial out number switch setti...

Page 55: ...ommunicator 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 Specifications Model 6498 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 ...

Page 56: ...n 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 6 years Analog dialing mode Tone Operating Temperature 41 F to 104 F 5 C to 40 C Storage Temperature 13 F to 158 F 25 C to 70 C Operating Humidity 15 to 93 noncondensing Storage Humidity 15 to 93 noncondensing Storage Operating Pressure 50 to 106 kPa Protectio...

Page 57: ...model DM210 Boston Scientific model 6454 included with LATITUDE scale and blood pressure monitor Operational Frequency 2400 0 to 2480 0 MHz Modulation Type Adaptive Frequency Hopping Effective 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 Cellular Radio GSM 850 TX 824 849 MHz RX 869...

Page 58: ...n and pets Small parts may cause choking or serious injury if swallowed Consult a health care professional immediately if this occurs Do not insert anything other than a telephone connector into the telephone jacks on the back of the Communicator There can be voltage on the electrical contacts in the connector and there is potential to receive a shock The user is cautioned to maintain an 8 in 20 c...

Page 59: ...lt your telephone company or a qualified 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 modifications to maintain uninterrupted service If the equipment is causing harm to the telephone network t...

Page 60: ...irements 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 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 p...

Page 61: ... 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 ...

Page 62: ...n 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 certified by a Nationally Recognized Testing Laboratory Temperature range limits Humidity range limits Atmospheric pressure range limits ...

Page 63: ......

Page 64: ...Paul MN 55112 5798 USA Telephone 651 582 4000 Medical Professionals 1 800 CARDIAC 227 3422 Patients and Families 1 866 484 3268 www bostonscientific com 2011 Boston Scientific or its affiliates All rights reserved 358736 002 ENSP US 11 11 358736 002 ...

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