LATITUDETM NXT 3.0 Model 6498/6280/6290 Communicator Firmware Upgrade Overview October 2014

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

LATITUDETM NXT 3.0 System Firmware Upgrade

LATITUDE NXT 3.0 firmware release scheduled to begin December 1: 1. Actively Connected 6498, 6280 and 6290 Communicators – Communicator has already received 2.0 firmware – See Model 6498/6280/6290 Active Communicator 2.0 3.0

2. 6280 and 6290 new patient setup – These Communicators include the 2.0 firmware and will download 3.0 at initial setup – See 6280 and 6290 New Setup 2.0 3.0

3. 6498 new patient setup – Communicator does not have 2.0 firmware. Receives 2.0 and 3.0 at initial setup – See 6498 New Setup 1.03.0

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Firmware Upgrade FAQ 1. Why is Boston Scientific updating Communicators in December 2014? Communicator updates ensure that fielded Communicators are compatible with new features. The 3.0 firmware upgrade enables the use of the LATITUDE Ethernet Adapter. 2. Will patients see a flashing white heart button with the 3.0 upgrade? Actively connected 6498 Communicators as well as 6280 and 6290 Communicators will not have a flashing white heart button as part of the upgrade. 6498 patients who set up for the first time after the 3.0 release, will see the flashing white heart button three times as part of the Communicator set-up process. 3. Why do so many Communicators update in the middle of the night? Firmware upgrades occur when the Communicator talks to the LATITUDE server. This can happen any time within a 7-day period as the Communicator calls in routinely to get schedule and alert information. Firmware upgrades are also delivered when the patient is setting up the Communicator for the first time. Additionally firmware upgrades can happen when the Communicator calls the LATITUDE server to deliver alert, programmer check, or scheduled interrogation data. Device checks and scheduled interrogations are typically done between midnight and 5 a.m. local time.

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Firmware Upgrade FAQ (continued) 4. Which of the scenarios will occur most frequently? The scenario of active 6498, 6280 and 6290 Communicators (which already have the 2.0 upgrade) receiving the 3.0 upgrade is the most common scenario. 5. Are there active 6498 Communicators that have not yet downloaded the 2.0 firmware upgrade? Yes. Approximately 10% of active 6498 Communicators have not yet downloaded the 2.0 upgrade. These Communicators have been unplugged since initial set up or are experiencing phone connectivity issues. After December 1, if these Communicators reconnect to the LATITUDE server they will download both the 2.0 and 3.0 upgrades similar to the scenario described in 6498 new Communicator set up. Patients will need to press the white heart button when it blinks and will post to the View Patients page. 6. Can I direct patients to call Boston Scientific for assistance with the Communicator upgrade? Yes. Patients can call 1.866.484.3268 for assistance with any questions about the Communicator or the upgrade. 4

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Model 6498/6280/6290 Active Communicator 2.0 3.0

As part of the LATITUDE NXT 3.0 launch, Model 6498, 6280 and 6290 Communicators require a firmware upgrade Existing patients will receive a firmware upgrade the next time the Communicator calls into the server: •

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Patient may see a flashing yellow LATITUDE indicator light during upgrade At the end of the upgrade, all the lights on the face of the Communicator will illuminate for one second LATITUDE indicator light will return to green “power on” status

• Patients do not need to press any buttons • Patient will not post to the View Patients List 5

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

6498/6280/6290 2.0 3.0 Firmware Download Visible to Patient nothing

Sequence of Events Comm does a background server call. Comm delivers any payloads, then downloads 3.0 firmware Once firmware downloaded, Communicator reboots. LATITUDE Indicator flashes for ~10 minutes as Comm installs the firmware.* When installation complete, Communicator reboots again. All lights on the face of the Communicator will illuminate for one second.* The Communicator will return to its normal display. The LATITUDE indicator will be lit green.

*The lights may come on in the middle of the night 6

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Model 6280 and 6290 New Patient Setup As part of the LATITUDE NXT 3.0 launch, new Model 6280 and 6290 Communicators will require a 3.0 firmware upgrade at set up • • • • • • • • • •

After initial set up (plug in to power and phone or cellular connection), patient will see the flashing white heart button Patient will press the flashing heart button and see green collecting waves Patient will then see a flashing yellow indicator light during installation of the upgrade All lights on the face of the Communicator will illuminate for one second at completion of upgrade Patient will then see a flashing white heart button Patient should press the flashing heart button Collecting and Sending waves will be visible Patient will post to LATITUDE NXT website

Firmware upgrade could take 20 minutes or longer depending on patient’s phone connection. After starting the setup process by pressing the white heart button (see second bullet above), the patient does not need to stay near the Communicator until they press the flashing white heart button at the conclusion of the upgrade 7

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Model 6280 and 6290 New Setup Visible to Patient

Sequence of Events White Heart button flashes at initial set-up. (after power and phone/cellular connections made) Patient presses the Heart Button and sees green Collecting Waves for 2-5 minutes as the Communicator downloads 3.0 firmware Once firmware is downloaded, Communicator reboots. LATITUDE Indicator flashes for ~10 minutes as Comm installs the firmware. When installation complete, Communicator reboots again. All lights illuminate of the face on the Communicator for one second. After reboot, the Heart Button flashes white.

Patient presses the Heart Button and sees green Collecting/Sending Waves as a PII is performed/uploaded. 8

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

Model 6498 Communicator--New Patient Setup 1.0 3.0 Model 6498 Communicators that have not been previously set up, will download 2.0 and 3.0 upgrades when first connected • • • • •

• • • • • • • •

After initial set up (plug in to power and phone or cellular connection), patient will see the flashing white heart button Patient will press the flashing heart button and see green collecting waves. Patient will then see a flashing yellow indicator light during installation of the 2.0 firmware All lights on the face of the Communicator will illuminate for one second Flashing heart button will appear—patient can press and will see green collecting and sending waves. Whether they press or not, firmware upgrade will continue after approximately 5 minutes Patient will then see a flashing yellow indicator light during installation of the 3.0 firmware All lights on the face of the Communicator will illuminate for one second Patient will then see a flashing white heart button Patient should press the flashing heart button Collecting and Sending waves will be visible Patient will post to LATITUDE NXT website

Firmware upgrade could take 50 minutes or longer depending on patient’s phone connection. After starting the setup process by pressing the white heart button (see second bullet above), the patient does not need to stay near the Communicator until they press the flashing white heart button at the conclusion of the upgrade 9

© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

6498 1.0  3.0 Firmware Download New Patient at Setup (page 1 of 2) Visible to Patient

Sequence of Events White Heart button flashes at initial set-up. (after power and phone/cellular connections made) Patient presses the Heart Button and sees green Collecting Waves for 10-20 minutes as the Communicator downloads 2.0 firmware Once firmware is downloaded, Communicator reboots. LATITUDE Indicator flashes for ~15 minutes as Communicator installs the firmware. When installation complete, Communicator reboots again. All lights illuminate on the face of the Communicator for one second. After reboot, the Heart Button flashes white. Communicator does a background server call and downloads 3.0 firmware. Heart button will turn off after a few minutes.

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

6498 1.0  3.0 Firmware Download New Patient at Setup (page 2 of 2) Visible to Patient

Sequence of Events If patient presses the Heart button, collecting waves will light for a few minutes and then will turn off. Once firmware is downloaded, Communicator reboots. LATITUDE Indicator flashes for ~10 minutes as Comm installs the firmware. When installation complete, Communicator reboots again. All lights illuminate on the face of the Communicator for one second. After reboot, the Heart Button flashes white.

Patient presses the Heart Button and sees green Collecting/Sending Waves as a Patient Initiated Interrogation is performed/uploaded.

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014

LATITUDE NXT 3.0 Communicator firmware upgrade

Boston Scientific Patient Services: 1.866.484.3268 Our friendly representatives are happy to assist with: • Communicator set up and operation • Questions about lights on the Communicator • Firmware update information • Traveling with the Communicator • Cellular adapter or Ethernet adapter Connection options • Landline troubleshooting, including VoIP and digital lines

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© 2014 Boston Scientific Corp. CRM-271508-AA SEP2014