1. LATITUDE Consult™ System
LATITUDE Consult System Training
4/16/2018
These slides with script are intended to be used for customer training of the LATITUDE Consult System.
LATITUDE Consult™ System
Slides and Script for Customer Training

2. LATITUDE Consult™ Communicator
LATITUDE Consult Training
4/16/2018
LATITUDE Consult™ Communicator
LATITUDE Consult system provides access to expert technical review of a BSC implanted device system in locations such as the ER, Radiology, pre- or post-op, or at satellite locations without immediate access to a Boston Scientific programmer or representative.
The LATITUDE Consult system provides clinicians a convenient and secure way to review data from a Boston Scientific implanted device. Virtual technical support is available 24/7 when you call CARDIAC. You will be able to discuss the reviewed implanted device data live with a trained US-based LATITUDE Consult Technical Services Consultant. Optional reports are available via fax or ed link and include a transmission report and reports similar to the standard programmer or LATITUDE reports.
The system is designed to be easy to use by any clinician who is at the patient’s bedside in a health care facility. Easy touch-screen graphics provide step-by-step instructions.
The system allows clinicians to receive technical review and documentation of the implanted device data for use in the patient’s clinical evaluation without the need to wait for a company representative or company programmer. In this way, the LATITUDE Consult System is designed to improve turn- around time and increase patient satisfaction.
Emergency Room
Pre / Post Op
Virtual Technical Support at the Point-of-Care
LATITUDE Consult Technical Services
LATITUDE Consult Communicator
Hospital
Expert Technical Review
Simple to Use
Focused Device Report
Improved Customer Efficiency and Patient Satisfaction
Radiology
Satellite
Facility

3. LATITUDE Consult™ Communicator How the System Works
LATITUDE Consult Training
4/16/2018
LATITUDE Consult™ Communicator How the System Works
SYSTEM LIMITATIONS
This system is intended for use by health care providers in a health care facility. As appropriate, clinical care needs to be provided to the patient separate from the use of the Communicator.
The LATITUDE Consult system can only read data from an implanted device and cannot reprogram, command lead tests, or change any functions of the implanted device.
The LATITUDE Consult Communicator interrogations are not intended to be used in place of in-office follow ups that involve programming of the implanted device (e.g., changing device settings) or commanding lead test (e.g., pacing threshold test). The implanted device can only be programmed with a Programmer/Recorder/Monitor (PRM).
The system is used to:
The system is not
The LATITUDE Consult Communicator is used to read data from a patient’s implanted device via a telemetry wand placed over the patient’s device
Once the data is read, the clinician uses the Communicator to send the data to the secure LATITUDE Consult server
The clinician then contacts Boston Scientific to request a review of the data and to optionally obtain reports
If the patient is enrolled in the LATITUDE Remote Monitoring System, device data will be updated and all LATITUDE Consult reports will be available on the LATITUDE NXT System
This is not a LATITUDETM Remote Monitoring System
No remote monitoring
The Communicator is not MRI safe
Similar to the programmer this equipment will be labeled as unsafe in the MRI suite
This is not a programmer
No commanded test e.g., no thresholds
No reprogramming possible

4. LATITUDE Consult Training
4/16/2018
LATITUDE Consult™ Workflow
Increase patient throughput and decrease waiting costs with LATITUDE Consult™ System.
91% of patient follow-up cases were resolved via the LATITUDE Consult System rather than requiring a wait for BSC personnel with a BSC programmer.1
Clinicians had access to full technical consultation in an average of 15 minutes or less.2
If requested, average call back time is 14 minutes.2
The workflow for the LATITUDE Consult system starts when a patient arrives who needs to have device data retrieved and viewed.
The LATITUDE Consult communicator is used to read the patient’s implanted device via a telemetry wand placed over the patient’s device.
Once the device’s data has been read, the clinician uses the Communicator to send the data to the secure LATITUDE Consult server.
The clinician then contacts Boston Scientific LATITUDE Consult Technical Services to request a review of the data and obtain reports. The clinician will need to be prepared to provide: his/her name, patient name, model/serial number of implanted device, location calling from and phone number for return call. A LATITUDE Consult Technical Service Consultant will call back to discuss the data with the clinician.
This system can only read data from a supported Boston Scientific implanted device and cannot reprogram, command leads, or change any functions of the implanted device.
If the patient is enrolled in the LATITUDE NXT Remote Patient Management System, device data will be updated and all reports, including the LATITUDE Consult Transmission report, will be available on to the LATITUDE NXT System website.
Consult Technical Services can complete a real-time review with no need for a call back.
1 LATITUDE ConsultTM System Limited Launch Dashboard, October-December, 2014.
2 LATITUDE ConsultTM System Limited Launch Dashboard, May-December, 2014.

5. LATITUDE Consult Training
4/16/2018
Training Topics
In today’s training we’ll review the EASY process as well as cover some troubleshooting and maintenance topics.
The EASY process covers:
The EQUIPMENT the account will be using
The actions the accounts needs to ACQUIRE the data from the implanted device
The way the account will SEND the data to the central server
And
The Boston Scientific number the account must CALL to request a review of the data and optional reports.
Equipment
Acquire
Send
You call
resources
Parts what’s in the bag
Wand placement
Press Continue if remained On
(1-800-CARDIAC)
Troubleshooting or
Setup
usage and storage
Touch Screen
prompts
Press Send if unplugged and reconnected
Request
review
Software Updates 
Connect power and phone
Obtain
optional reports
Maintenance
Data sent to LATITUDE NXT
if patient is enrolled

6. LATITUDE Consult Training
4/16/2018
What’s in the Bag
First let’s review what equipment is included in the convenient storage bag.
Within the bag you’ll find the “Easy setup reference card” which describes the steps to using the communicator as well as a diagram identifying each of the system components.
The LATITUDE Consult Communicator itself is a small, portable device that when plugged into an AC power outlet allows you to acquire a patient’s implanted device data. Along with the Communicator, you will find a power cord, an analog phone cord, and an attached telemetry wand. On the back of the communicator you will find ports for the power cord and the analog phone cord.
It is important to keep the communicator in a safe and secure yet accessible location. When it is being stored, the communicator does not need to remain plugged in to power or a phone line.
Carrying /
Storage Bag
2-sided Easy Setup Card 1 2
LATITUDE
ConsultTM Communicator
ports on the back of the Communicator
Place the LATITUDE Consult System in a secure and accessible location 3
Power Cord
Phone Cord

7. Communicator Components
LATITUDE Consult Training
4/16/2018
Communicator Components
Let’s now review the specific components of the Communicator.
The most important components for you to be familiar with are the touch screen, power light, telemetry wand, phone and power ports. The other buttons, indicators and ports are less commonly used.
The first thing you’ll notice when you plug in the device is that the small power light (marked D in the diagram) will illuminate green to indicate that the Communicator is connected to a power source.
Once the Communicator is powered up, the touch screen (marked B in the diagram) will illuminate with on-screen instructions. By gently touching the screen surface with your gloved or ungloved fingertip you will be able to follow the instructions and command its operation. After a period of inactivity, the Communicator enters a power- saving mode and the LCD screen dims. Simply touch any part of the screen or the Start Button (marked A in the diagram) to illuminate it again.
The Telemetry Wand (Marked F) is used to read device data by placing it over the patient’s implanted device. Return the wand to the cradle when not in use.
Note: the Communicator does not need to be plugged into a phone line or within range of the LATITUDE Wireless Internet Adapter in order to gather device data. However, when the data is ready to be sent, the Communicator should be connected to an analog phone or if using an internet connection, ensure that the Communicator is within 100 feet (30 meters) of the LATITUDE Wireless Internet Adapter and the Adapter is set up and paired to the Communicator.
The ports for the power cord and the analog phone line are found on the back of the Communicator and marked as G and I on this diagram.
Front View C
A lighted or flashing Indicator light notifies the clinician that action is required
Indicator Light
Start Action Button A D B
Power Light
Touch Screen
Back View
Telemetry Wand F
After a period of non-use, the Communicator enters a power-saving mode— tap the touch screen or press the start action button to illuminate the touch screen
Wand Cradle E
Communicator must be plugged into a power source to operate and an analog phone line to send data
Power Port G H
Phone Port I
Auxiliary Port for Fax or Telephone Line

8. Communicator Components
LATITUDE Consult Training
4/16/2018
Communicator Components
On the bottom of the communicator you will find an information sticker. Among other things this provides the phone number for LATITUDE Consult Technical Services, and the model and serial number of the unit.
Technical Support is available 24/7 at CARDIAC.
Bottom View
Technical Support phone number
Model number
Serial number

9. LATITUDE Wireless Internet Adapter
LATITUDE Consult Training
4/16/2018
LATITUDE Wireless Internet Adapter
Configuring the Communicator using an Internet connection
The LATITUDE Wireless Internet Adapter is required to set up an Internet connection. 3 2 4 5 6 7
1. Position the Communicator within 100 Feet (30 meters) of the wireless internet adapter. Avoid physical obstructions between the Communicator and wireless internet adapter whenever possible.
2. Insert the micro end of the USB power cable (included with the wireless internet adapter) into the port on the back labeled “USB.”
3. Insert the standard (narrow) end of the USB power cable into the USB power adapter (included with the wireless internet adapter).
4. Plug the USB power adapter into an electrical outlet.
• The power light on the front of the wireless internet adapter will light solid green.
Important: For the following steps, make sure you use the Ethernet cable provided with the wireless internet adapter and not the telephone cord provided with the Communicator.
5. Insert the Ethernet cable (included with the wireless internet adapter) into the port on the back of the wireless internet adapter labeled “ETHERNET.”
6. Plug the other end of the Ethernet cable into the Ethernet port of a modem, a router, or a Ethernet wall jack.
7. To begin pairing, press the button on the back of the wireless internet adapter. The indicator on front will flash green indicating pairing mode is active.
• Pairing mode will end automatically after 60 minutes.
NOTE: You can manually end pairing mode by pressing the button on the back of the wireless internet adapter for 5 seconds.
8. From the Home screen of the Communicator, press the gear icon to display the Settings screen.
9. Press the upgrade icon on the Communicator to pair with the wireless internet adapter.
10. Press OK to confirm and continue.
11. Press the Home icon to return to the Home screen. The settings are saved in the Communicator.
Position the Communicator within 100 feet of the wireless internet adapter 1 8

10. Acquiring the Patient’s Data
LATITUDE Consult Training
4/16/2018
Acquiring the Patient’s Data
Place LATITUDE ConsultTM System
Wand over patient’s implanted device and press the Patient icon
To use the LATITUDE Consult communicator, first plug it into a power source. When the Communicator is powered On the green light in the lower-right corner will illuminate. If this power light is not green, check that both ends of the power supply are firmly plugged in.
The clinician should place the wand flat-side down over the patient’s implanted device and then press the patient icon on the screen to begin reading data. The screen will indicate that an interrogation is in progress. Placing the telemetry wand on a patient who has an unsupported implanted device or who does not have an implanted device causes no harm to the patient. The LATITUDE Consult system can only read data from a supported implanted device and cannot reprogram, command lead tests, or change any functions of the implanted device.
Hold the wand in place until the Communicator has finished reading the data reading. Once this is complete, the screen will indicate that the interrogation was successful and a Continue button will appear. The clinician may then return the wand back in the cradle. The patient’s implanted device data has been collected and is now ready to be sent.
At this point if the Communicator is not plugged into the analog wall jack, unplug the system from the power source and move it to the telephone line or if using an internet connection, ensure that the Communicator is within 100 feet (30 meters) of the LATITUDE Wireless Internet Adapter.
It is important to note that the patient’s implanted device data will NOT be lost when the power source is disconnected. The data remains on the Communicator until it is sent or erased—it must be sent or erased before another patient’s implanted device data can be read.
If the reading of a supported implanted device is unsuccessful and a retry is unsuccessful, the clinician should contact LATITUDE Consult Technical Services at CARDIAC for assistance. 3 1 2
After several minutes the Communicator will be finished reading the patient’s implanted device—you may return the Wand to its cradle when the Continue button is displayed

11. Sending the Patient’s Implanted Device Data
LATITUDE Consult Training
4/16/2018
Sending the Patient’s Implanted Device Data
Press Continue if Communicator has remained On after reading device or
power light is green
If using an analog telephone line, plug one end of the phone cord into the far-left phone port on the back of the Communicator and the other end into a standard analog wall jack such as those used by many fax machines. If using an internet connection, ensure that the Communicator is within feet (30 meters) of the LATITUDE Wireless Internet Adapter and the Adapter is set up and paired to the Communicator. Ensure that the Communicator is powered On.
If the Communicator has remained powered On since reading the patient’s implanted device, press the CONTINUE button. If Communicator has been unplugged and then reconnected since reading the patient’s device, press the SEND icon. Device can be unplugged, moved and plugged in without losing data.
Once the Communicator indicates that the implanted device data has been successfully sent, press the “Done” icon and call LATITUDE Consult Technical Services at CARDIAC to request a technical review of the data.. As soon as the patient’s implanted device data has been successfully sent, that data is erased from the Communicator.
If the sending of implanted device data is unsuccessful and a retry is unsuccessful, the clinician should also contact LATITUDE Consult Technical Services for assistance.
ports on the back of the Communicator
Successfully sent data
is erased from the Communicator
phone*
power
Press Send if Communicator was unplugged and reconnected after reading device
Device can be unplugged, moved and plugged in without losing data
*If using an internet connection, ensure that the Communicator is within 100 feet of the LATITUDE Wireless Internet Adapter

12. Review Icons and Process
LATITUDE Consult Training
4/16/2018
Review Icons and Process
Read Data Icons
The patient’s implanted device data remains on the Communicator until it is sent—it must be sent or erased before another patient’s implanted device data can be read
System Ready
Begin
Interrogation
or Cancel
Let’s take a closer look at the screen icons you’ll see and quickly review the data acquisition and sending process once more..
When you first turn on the system you’ll see the System Ready screen, which features a Patient icon and a Gear icon.
After you’ve put the wand over your patient’s device, you can push the patient icon to start the interrogation and the Begin Interrogation screen appears.
You will next see an icon indicating that the data interrogation is in progress, and then text telling you that the interrogation has been successful.
If you are already connected to an analog phone line or Internet connection you can push the Continue button to begin sending the data to the secure LATITUDE Consult server.
If you’ve had to disconnect the Communicator and move it, then once you’ve reconnected it to a power source you will see a screen with a Send Data icon, an Erase Data icon (in case you didn’t want to send the data and instead wanted to do a new interrogation), and a Gear icon. Push the Send Data icon to start the data transfer.
The screen will display a message when the data has been successfully sent and direct you to call CARDIAC to speak with LATITUDE Consult Technical Services and a request a review of the device data.
Send
Icons
Send
Successful
Call Cardiac
Interrogation
in Progress
Interrogation
Successful
connect to continue
Send Data
v5.1

13. Request Review and Obtain Reports
LATITUDE Consult Training
4/16/2018
Request Review and Obtain Reports
In order to ensure a review by Boston Scientific, call LATITUDE Consult Technical Services at CARDIAC upon successful transmission of the implanted device data and request a LATITUDE Consult technical review. You may also request any of a number of available reports. Please provide caller name and facility, patient name and model/serial number and the caller’s phone number.
Once the data has been reviewed a LATITUDE Consult Technical Services consultant can call back to discuss the technical review.
HCP calls LATITUDE Consult™ Technical Services to request review of the patient’s implanted device data and to obtain reports1. Must specify “Consult” 85
1-800-CARDIAC ( )
Request LATITUDE Consult
Please provide:
Caller name & facility
Patient name & model/serial number
Caller phone number
1 When using the Auto-send device report plan, no call to LATITUDE Consult Technical Services is required and the Technical Service Consult is optional. The HCP is responsible for the technical review of the patient data.

14. Available LATITUDE ConsultTM Reports
LATITUDE Consult Training
4/16/2018
Available LATITUDE ConsultTM Reports
The available reports include PDF reports similar to those received from the BSC programmer or the BSC LATITUDE system (such as Quick Notes, Arrhythmia logbook, Device Settings, etc) and a transmission report which contains summary notes of the technical review performed by the LATITUDE Consult Technical Services.
The data contained in these reports is current as of the time the device was read, which can include up to 12 months of device and lead trend data plus the most recent 72 hours of stored episodes.
If you request a LATITUDE Consult report, it is available via fax or ed link. This link takes you to a secure website where PDF reports can be viewed, saved, and printed.
Transmission Report
LATITUDE Consult Reports
LATITUDE Consult Reports are similar to programmer and LATITUDE reports
Transmission
Report
Includes review summary and notes completed by LATITUDE Consult Technical Services1
Quick Notes
Status Messages
Events since last reset
Battery Status
Leads Summary
Settings Summary
Arrhythmia
Logbook
Complete logbook available in device at time of upload
Combined Follow-up
Quick Notes data +
Histograms
Leads Trends
Health Trends¹
HRV Data
Presenting EGM¹
Device Settings
Complete listing of device settings
Presenting EGM
10- or 30-seconds of presenting intercardiac electrogram tracings
Event Detail / Episodes
Last 72-hours of stored episode details / episodes 
NOTE:
Implanted device data in each report is current as of the time the device was read, which can include up to 12-months of device/lead trend data and most recent 72-hours of stored episode details
¹ Presenting EGM and some health trends not available for ALTRUA/INSIGNIA on Combined Follow-up Report.
When using Auto-send report plan, no call to LATITUDE Consult Technical Services is required and the Technical Service Consult is optional. The customer will receive a transmission report without Technical Services review/notes. Other reports are the same.

15. LATITUDE NXT Integration
LATITUDE Consult Training
4/16/2018
LATITUDE NXT Integration
LATITUDE Consult adds another tool to assist clinicians in managing their patients. If the patient is interrogated anywhere by a LATITUDE Consult Communicator and is enrolled in LATITUDE NXT, this transmission will be available on the LATITUDE NXT website. The patient will appear on the View Patients List with a review reason of LATITUDE Consult System. Device data will be updated and all reports will be available, including the LATITUDE Consult Transmission report. The Transmission report will provide information on where the patient was interrogated as well as review from the Consult Technical Services team if that was requested.
For those clinics using LATITUDE NXT EMR integration, the LATITUDE Consult system transmission will flow to EMR when it appears on the View Patients List as do other LATITUDE NXT transmissions. As with all interrogations that show up on the View Patients List, the LATITUDE Consult transmission will be available in the patient’s follow up history on the website.
View Patient List
Patient Summary Page

16. LATITUDE Consult Training
4/16/2018
Training Topics
This next section describes some Resources you have for using the system, i.e. troubleshooting.
Equipment
Acquire
Send
You call
resources
Parts what’s in the bag
Wand placement
Press Continue if remained On
(1-800-CARDIAC)
Troubleshooting or
Setup
usage and storage
Touch Screen
prompts
Press Send if unplugged and reconnected
Request
review
Software Updates +
Connect power and phone/ internet
Obtain
optional reports
Maintenance
Data sent to LATITUDE NXT
if patient is enrolled

17. Troubleshooting Initial Configuration
LATITUDE Consult Training
4/16/2018
Troubleshooting Initial Configuration
Before you use the Communicator for the first time it will need to go through a simple initial configuration. This only needs to be completed once and could be done by clinical staff or a BSC Representative. Follow the instructions on the screen.
First the user selects the gear icon and then the phone icon.
Next you will select the Tone icon or Pulse icon depending on the dialing service of your phone line. For most institutions, this will be the Tone option. Touch OK. If using an internet connection, choose either option.
If it is necessary to dial a number to reach an outside line at your institution, the backward/forward icons on the screen can be used to display the desired PBX prefix number.
Then the user touches OK. If using an internet connection, this step can be skipped.
Press the “home” icon to return to the Home screen. The settings are now stored in the Communicator for future transmissions.
NOTE:
Communicator needs to be configured only once—the settings are saved when you return to the home screen
PBX prefix is the number you dial to get an outside line
Tone is the most common type of phone
Questions: Call LATITUDE Consult Technical Services CARDIAC ( ) request Consult
If I need to dial a number to get an outside line, how do I initially configure the Communicator?
From the Communicator home screen, touch the Gear icon 1 2
Touch the Phone icon 3
Choose either the Tone icon or the Pulse icon (rotary dial) and then touch OK or
Choose the desired PBX prefix by pressing either the Back or Forward icon or 4 5
Press the Home Icon to return to the Communicator home screen.

18. Troubleshooting Test the Connection
LATITUDE Consult Training
4/16/2018
Troubleshooting Test the Connection
If you would like to verify that the Communicator has a good connection you can touch the “Gear” icon, then the “Upgrade” icon.
If the connection is good, the touch screen will show that “Updates are being installed” or the “Software is up-to-date”.
If there is not a good connection, then the touch screen will show either “Check connection and retry” or “Upgrade failed”.
How can I check if the Communicator is connected to a phone line or internet?
NOTE:
Manually checking for a software upgrade will test the phone line or internet connection.
Questions: Call LATITUDE Consult Technical Services CARDIAC ( ) request Consult 1
From the Communicator home screen, touch the Gear icon 2
Touch the Upgrade icon
If the phone line connection is good, the touch screen will show Updates are being installed or Software is up-to-date or
If the phone line connection is not good, the touch screen will show Check connection and retry or Upgrade failed.

19. Troubleshooting Unable to Read or Send
LATITUDE Consult Training
4/16/2018
Troubleshooting Unable to Read or Send
What do I do if the LATITUDE ConsultTM Communicator can’t read the device or send data?
“Fail” messages
appear on the Communicator touch screen 
Are both ends of the power cord securely plugged in?
Power light on the Communication is green when the system is On
There are several quick avenues to check if you are having Communicator issues.
If the Communicator is unable to read the device, first of all ensure that the system is properly powered and that both ends of the power cord are securely plugged in.
If you haven’t already, confirm that the patient does indeed have a supported Boston Scientific Device.
You should also check that the wand is correctly positioned over the device with the flat side toward the patient.
If problems persist call LATITUDE Consult Technical Services at CARDIAC.
If instead the communicator is unable to send the patient data, you would want to again ensure that it is properly plugged in to both power source and an analog phone line.
You can also test the phone or internet connection as described in the last slide. If you’ve recently obtained the Communicator at your institution, check to see that the initial configuration has been performed.
If problems persist call LATITUDE Consult Technical Services at CARDIAC
You can also refer to the reference card insert in the bag or the Clinician’s Manual. 
Is device a BSC supported device?
Check the Patient Medical Device ID for information regarding their device 
Is wand positioned correctly over the device?
Touch screen will prompt you to reposition the wand 
Has initial configuration been performed?
Refer to Easy Set-Up Card or Clinician Manual instructions 
Call CARDIAC and request LATITUDE Consult if problem persists

20. LATITUDE Consult Training
4/16/2018
Software Updates
As newly supported BSC devices and connectivity options are added to the LATITUDE Consult system a software update will be needed.
You will not need to do anything to initiate this action. If there is a software update waiting it will automatically begin installing after a successful data transmission.
If you want to manually check for software updates between data transmissions, simply press the “Gear” icon on the Home screen and then press the “Upgrade” icon. You will either see a screen showing “updates are being installed” or “software is up-to-date”.
If a software update is available, it will be automatically installed on the Communicator after a successful data transmission. To manually check for software updates: touch the Gear icon on the home screen and then touch the Upgrade icon and continue following the screen prompts. or or

21. LATITUDE Consult Training
4/16/2018
Maintenance
Finally, a few last things to remember about the LATITUDE Consult System:
When the system is not in use it doesn’t need to be connected to either the power source or the fax line if it is inconvenient to do so. However, there is no harm in leaving it connected if you can.
To clean the Communicator, use water, isopropyl alcohol or mild detergent to wipe down. Do not submerge or spray. Do not sterilize it.
If you determine that the Communicator is lost or broken, or you are having any issues operating it, please contact Boston Scientific Technical Services at CARDIAC for assistance.
When not in use, the system does not need to be connected. Clean the Communicator with water, isopropyl alcohol, or mild detergent—do not submerge or spray. Do not sterilize. If lost or broken, contact LATITUDE Consult Technical Services at CARDIAC for assistance.

22. LATITUDE Consult™ System Prescriptive Information
LATITUDE Consult System Training
4/16/2018
LATITUDE Consult™ System Prescriptive Information
Intended Use
The LATITUDE Consult™ system is intended to read data from a compatible Boston Scientific implanted device and transfer it to a central server. The LATITUDE Consult system can provide implanted device data that may be used as part of the clinical evaluation of the patient.
Contraindications
The LATITUDE Consult Communicator is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE Consult system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being read.
Warnings
The Communicator is MR (Magnetic Resonance) Unsafe. The Communicator is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices1. Under no circumstances should the Communicator be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.
Precautions
In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call LATITUDE Consult Technical Services at CARDIAC ( ) after sending the data.
Adverse Effects
None known.
System Limitations
This system is intended for use by health care providers in a health care facility. As appropriate, clinical care needs to be provided to the patient separate from the use of the Communicator. The LATITUDE Consult system can only read data from an implanted device and cannot reprogram, command lead tests, or change any functions of the implanted device. Therefore, LATITUDE Consult Communicator interrogations are not intended to be used in place of in-office follow ups that involve programming of the implanted device (e.g., changing device settings) or commanding lead tests (e.g., pacing threshold test). The implanted device can only be programmed with a Programmer/Recorder/Monitor (PRM). There are many internal and external factors that can hinder, delay, or prevent reading and sending implanted device information. These factors include: telephone system, health care environment, equipment, & data processing. The system does not provide continuous real-time monitoring. The LATITUDE Consult Communicator is non-sterile equipment. DO NOT STERILIZE. The wand must be contained in a sterile barrier to be used in the sterile field.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. A)