LATITUDE NXT Patient Management system Clinician Manual Nov 2011

Table of Contents LATITUDE NXT PATIENT MANAGEMENT INTRODUCTION... 5 Intended Use... 5 Contraindications... 5 Precautions... 5 Adverse Effects... 6 System Limitations... 6 LATITUDE NXT Secure Server... 8 LATITUDE Communicator... 8 LATITUDE Customer Support... 10 Optional Home Health Monitoring Equipment... 11 BASIC CONCEPTS... 12 Access to Patient Data... 12 Registered Users... 12 Patient, Clinician, and Clinic Relationships... 12 Patient Groups... 13 Clinic User Privileges... 14 Alerts... 15 Implanted Device Interrogation... 18 Patient Initiated Interrogation... 19 GETTING STARTED... 20 Requirements... 20 Logging In and Out... 20 Navigating the Site... 24 CLINIC AND PATIENT CONFIGURATION... 24 Configuration Details... 26 THE VIEW PATIENT LIST PAGE... 28 Generating and Printing Patient Reports... 33 SEARCH PATIENTS TOOL... 34 PATIENT ENROLLMENT... 35 Online Patient Enrollment... 36 Enrolling Existing Patients... 37 Communicator Distribution... 37

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PATIENT INITIALIZATION... 42 MANAGING PATIENTS... 42 Changing Patient Demographic and Equipment Information... 42 Changing Patient Groups... 43 Transferring Patients... 43 Unenrolling Patients... 44 MANAGING PATIENT GROUPS... 44 Adding Patient Groups... 44 Deleting Patient Groups... 44 Other Patient Group Management Functions... 45 MANAGING USER ACCOUNTS... 45 Adding User Accounts... 45 Deleting User Accounts... 46 Other User Account Management Functions... 46 User Account Self-Management... 46 PASSWORDS... 47 Temporary Passwords... 47 Security Questions... 47 Changing Your Password... 48 Resetting Your Forgotten Password... 49 EMR SYSTEM INTEGRATION... 50 Configuring the EMR Feature... 51 View EMR Log... 54 LATITUDE COMMUNICATOR... 56 Communicator Buttons, Connectors and Indicators... 57 Indicator Descriptions... 61 Connecting the USB Adapter... 64 LATITUDE GSM DATA PLAN... 65 Activating the LATITUDE GSM Data Plan... 65 Troubleshooting and Support... 65 Discontinuing the LATITUDE GSM Data Plan... 66

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APPENDIX A: TROUBLESHOOTING GUIDE... 67 Monitoring Status Troubleshooting... 67 Communicator Indicator Troubleshooting... 72 Weight Scale and Blood Pressure Troubleshooting... 78 EXPLANATION OF PRODUCT AND LABELING SYMBOLS... 81

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LATITUDE, PaceSafe, and QUICK NOTES are trademarks of Boston Scientific Corporation or its affiliates. Adobe and Acrobat are trademarks of Adobe Systems Incorporated. Mozilla and Firefox are trademarks of the Mozilla Foundation.

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LATITUDE NXT PATIENT MANAGEMENT INTRODUCTION The LATITUDE™ NXT Patient Management system enables authorized members of a clinic to periodically monitor patient and device status remotely (See “Alerts” on page 15 for device conditions that are monitored). Data collected from the implanted device at times scheduled by the clinic are combined with data from an optional weight scale or blood pressure monitor. By combining these internal and external measurements with historical information, clinicians can use the LATITUDE NXT system to develop an informed understanding of the patient's implanted device and cardiac health status. Clinic users can periodically monitor devices and bring patients into the office according to implanted device labeling and also when clinically appropriate.

Intended Use The LATITUDE NXT Patient Management system is intended to remotely communicate with a compatible Boston Scientific implanted device and transfer data to a central database. The LATITUDE NXT system provides patient data that can be used as part of the clinical evaluation of the patient.

Contraindications The LATITUDE NXT Patient Management system 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 NXT system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.

Precautions Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website. Implanted device data and alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is Clinician Manual - 5

unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to two weeks may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: •

System limitations (see page 6).

•

The Communicator is unplugged.

•

The Communicator is not able to connect to the LATITUDE NXT server through the configured phone system.

•

The implanted device and the Communicator cannot establish and complete a telemetry session.

•

The Communicator is damaged or malfunctions.

•

The patient is not compliant with prescribed use or is not using the LATITUDE NXT system as described in the patient manual.

•

If subscribed to the LATITUDE GSM Data Plan, missing two or more payments discontinues the subscription.

The clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List (page 28).

Adverse Effects None known.

System Limitations The LATITUDE NXT system is not intended to assist with medical emergencies. Patients who are not feeling well should call their physician or emergency services number. The LATITUDE NXT system does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT system provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of

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implanted device, sensor, and patient information as intended by the clinician. These factors include: •

Implanted device clock. Proper reporting of implanted device data and alert notifications by the LATITUDE NXT system depends on the implanted device clock being programmed accurately with a Programmer/Recorder/Monitor (PRM). Proper reporting may continue to be impacted for some period of time after the implanted device clock is programmed correctly, depending on the amount of data received with inaccurate time information and the time difference of the implanted device clock error.

•

Patient environment. To transmit data, the Communicator must be plugged into an electrical outlet. It must also be connected to a telephone line if the patient is not subscribed to the LATITUDE GSM Data Plan. Other equipment attached to the telephone line can adversely impact the ability of the Communicator to transmit information to the LATITUDE NXT server. Patients may not be within RF range of the Communicator at the appropriate times. RF interference from wireless electronic products may interfere with communication between the PG and Communicator.

•

Cellular data service. Subscription to the LATITUDE GSM Data Plan does not guarantee coverage. Actual coverage may be affected by such things as terrain, weather, foliage, buildings and other construction, signal strength, timely payment, and other factors.

•

Telephone system. Variations in infrastructure compatibility among telephone service providers as well as variations in the quality of the telephone line from inside the patient's home to telephone company equipment and switching stations can affect LATITUDE NXT data delivery.

•

Communicator memory capacity. Communicator memory used to store implanted device data may reach its capacity if the Communicator cannot connect to the LATITUDE NXT system for an extended period. If this occurs, the Communicator will delete the oldest collected implanted device data that does not contain any red alerts from its memory in order to store newly collected implanted device data. If all implanted device data contains red alerts, the oldest data is deleted.

•

Clinic environment. Delays in contacting clinicians may occur for a variety of reasons including computer equipment that may be down or offline, cell phones that may not be able to receive alert text messages, and the unavailability of clinical staff.

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•

Schedule/configuration changes. Under normal conditions, the patient’s Communicator should be plugged in continuously and operating properly as described in the patient manual. Under these normal conditions, changes in schedule and alert configuration settings can take up to 7 days to be sent to the patient’s Communicator and become effective.

•

Data processing. Data acquisition and delivery can be delayed or prevented due to: •

temporary, scheduled, and unscheduled downtime of computer servers,

•

variations in server loads and processing times,

•

and other data processing issues.

LATITUDE NXT Secure Server The LATITUDE NXT secure server is a centralized computer database that stores patient data, implanted device data, and sensor data sent from LATITUDE NXT Communicators. The LATITUDE NXT secure server also stores clinic and clinic user configuration information. The LATITUDE NXT secure server provides the data presented on the LATITUDE NXT website, which is available over the Internet to authorized users. The data provided to the LATITUDE NXT website includes the most recently received implanted device and sensor data as well as historical data related to previous remote follow-ups for the clinic associated with the currently implanted device.

LATITUDE Communicator A key component of the system is the LATITUDE Communicator, an in-home monitoring device for patients. The Communicator (Figure 1) automatically reads implanted device information for daily device checks and scheduled follow-ups. The Communicator sends data to the LATITUDE NXT server through a standard analog telephone line or over a cellular data network using the LATITUDE GSM Data Plan. The Communicator supports the tone analog dialing mode.

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Heart Button

Status Button Figure 1. LATITUDE Communicator NOTES:

•

The LATITUDE Communicator does not reprogram or change any implanted device functions.

•

The patient receives a LATITUDE Communicator from the clinic after the patient is enrolled in the LATITUDE NXT system. After the patient activates the Communicator according to the instructions in the patient manual, the Communicator is able to interrogate the patient's implanted device (see “Implanted Device Interrogation” on page 18). When the patient is enrolled, the Communicator is configured to communicate with a single implanted device.

•

The LATITUDE Communicator is designed for use by a single patient. Once a Communicator has been used by a patient, it can not be reconfigured or distributed to a different patient.

•

The Communicator has been designed to work in Austria, Belgium, Denmark, Finland, France, Germany, Ireland (Republic), Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Use of the Communicator in other EEA countries is allowed with the LATITUDE GSM Data Clinician Manual - 9

Plan. Use of the Communicator outside of the EEA is restricted due to radio frequency (RF) laws. Please contact LATITUDE Customer Support for specific information. •

Boston Scientific personnel may contact the clinic if a patient returns their assigned Communicator to Boston Scientific. They may also contact the clinic if a patient’s Communicator is reported lost or stolen, or the security credentials are compromised.

LATITUDE Customer Support LATITUDE Customer Support provides LATITUDE technical and general maintenance support to customers using the LATITUDE NXT system. LATITUDE Customer Support telephone numbers are listed in Table 1. Table 1. LATITUDE Customer Support Telephone Numbers Country

Number

Belgique / België

0800 80697

Danmark

70 10 01 82

Deutschland

069 51709 481

España

901 010840

France

0805 5404 22

Ireland (Republic)

1890 812005

Italia

848 781164

Nederland

0800 0292077

Norge

81 00 00 47

Österreich

0800 202289

Portugal

800844729

Schweiz / Suisse / Svizzera

0844 000110

Suomi

010 80 48 19

Sverige

020 160 57 07

United Kingdom

0845 602 9283

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Optional Home Health Monitoring Equipment The LATITUDE Weight Scale and LATITUDE Blood Pressure Monitor are optional components of the LATITUDE Patient Management system. These components are referred to as sensors. They transmit measurements over a wireless connection to the patient’s Communicator. A provided USB adapter must be plugged into the Communicator to communicate with the patient’s sensors. The Communicator automatically sends these measurements to the LATITUDE NXT server where they are made available for clinician review. Weight alerts are sent to the LATITUDE NXT server when detected. Unless an alert is detected, readings are transmitted with the next scheduled connection to the LATITUDE system (up to 7 days). The weight scale and blood pressure monitor are designed for use by a single patient. A patient’s weight scale and blood pressure monitor can not be reconfigured or distributed to another patient. Although the patient may use the scale and blood pressure monitor at any time, only one daily measurement is reported on the LATITUDE NXT website. The measurement displayed is the last measurement within a 20 minute interval that starts with the first measurement of the day. The purpose of the interval is to allow patients to retake their measurement if necessary. Weight measurements that differ by more than 9.1 kg from the previous day are considered invalid. If a measurement is not available for the previous day, then measurements that differ by more than 13.6 kg from the most recent measurement (up to seven days) are considered invalid. Invalidating widely varying values is not done with blood pressure measurements. NOTE: If a patient receives a replacement sensor, their Communicator must connect to the LATITUDE NXT server before measurements from the new sensor will be accepted. CAUTION: The maximum weighing capacity of the scale is 200 kg. Do not place anything on the scale that is beyond the weighing capacity.

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BASIC CONCEPTS The following sections explain the basic concepts of the LATITUDE NXT Patient Management system.

Access to Patient Data The LATITUDE NXT system collects patient data that are protected health information. Access to patient data is provided only to clinic users authorized by the clinic that enrolled the patient. Clinic users must be assigned to a Patient Group of which the patient is a member. Designated Boston Scientific Corporation (BSC) personnel also have access to patient data. All user access of LATITUDE patient data is logged.

Registered Users Any LATITUDE NXT user, including but not limited to a clinic’s third party vendors, must be associated with a clinic that has direct responsibility and authority for the health care treatment of a patient. All LATITUDE NXT users must be registered within that clinic’s LATITUDE account. Boston Scientific reserves the right to deactivate any user or account that uses or accesses the LATITUDE NXT system contrary to the LATITUDE Licensing Agreement (including, in the U.S., the LATITUDE Business Associate Agreement), any policies related to LATITUDE, or any relevant privacy and data protection laws or regulations.

Patient, Clinician, and Clinic Relationships Patient monitoring on the LATITUDE NXT system is based on the relationship of patients to clinics. Each LATITUDE NXT clinic user has a user account that is associated with a specific clinic. Each LATITUDE NXT patient can be associated with up to two different clinics or two different patient groups in one clinic: •

Primary clinic (or patient group) [typically includes an electrophysiologist] This clinic is typically responsible for monitoring a patient’s device, including regularly scheduled device follow-ups. This clinic is also responsible for managing any red alerts detected any time the patient’s implanted device is interrogated. The primary clinic is also responsible for managing yellow alerts if

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notification has been configured. All LATITUDE NXT patients must have an assigned primary clinic in order to be monitored. •

Secondary clinic (or patient group) [typically includes a cardiologist or heart failure specialist] A patient may also be assigned a secondary clinic. This clinic is not notified of red alerts, but can monitor for yellow alert conditions as guided by the type of care they are providing for that patient. Specifically, for a patient with heart failure, this clinic may include the specialist who monitors the patient’s condition through the use of weight, blood pressure, and relevant device measured trends.

Patient Groups A clinic is organized into one or more Patient Groups. Clinic users can be assigned to any number of Patient Groups. Clinic users assigned to a Patient Group have access to all patients enrolled in that Patient Group. Clinic Account Managers have access to all patients in all Patient Groups. Patient Groups provide default alert and schedule configuration settings for their associated patients. A patient can have customized settings that differ from the Patient Group default settings. CAUTION: Ensure that each patient's alert settings are appropriate when the patient is enrolled and after the implanted device is replaced. Clinics that organize patients into Patient Groups have the option of associating a patient with two Patient Groups. One Patient Group is primary and manages the patient’s device; the other Patient Group is secondary and also monitors the patient’s condition.

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Clinic User Privileges Three types of privileges for clinic users control access to patient data as described below. The functions that each can perform are shown in Table 2: •

Read-only access – Intended for users who need to work with patient data but are not responsible for managing the patients within the system. Access is limited to patients in assigned Patient Groups.

•

Limited access – Intended for users who are responsible for managing patients. These users have full capability to manage patients, but access is limited to patients in assigned Patient Groups.

•

Complete access (Clinic Account Managers) – Intended for the user who is responsible for managing the clinic and the clinic’s users and patients. Access is open to all patients in all Patient Groups.

User accounts can be created by the Clinic Account Manager. Table 2. Functions Permitted for Clinic Users by Privilege

Function

Add/Manage clinic users Add/Manage Patient Groups Manage schedule and alert configurations Enroll/Manage patients Dismiss patients on the Patient List View patients on the Patient List View patient data and reports

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Complete Access (Clinic Account Manager)

Limited Access

Read-only Access

All Patient Groups

Assigned Patient Groups

Assigned Patient Groups

Alerts The LATITUDE NXT system generates alert notifications for a number of conditions, which vary depending on the implanted device model. There are two levels of alert conditions: red alerts and yellow alerts. The alerts are designed to notify clinic users of potential health conditions or device clinical events. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. Alerts can be verified by viewing information on the LATITUDE NXT website and by using a PRM to review additional supporting diagnostic information stored in the implanted device. Alert conditions can be detected during daily alert interrogations, scheduled followup interrogations, and patient-initiated interrogations. The LATITUDE NXT system notifies the patient's clinicians of any detected alert conditions. Alert notification is provided through the View Patient List page on the LATITUDE NXT website (page 28). The LATITUDE NXT system sends one notification for an alert condition detected by the system. It does not issue alert notifications for the same condition unless the condition is no longer detected and then reappears during a following data collection activity. Designated Boston Scientific Corporation (BSC) personnel may provide notification of alert conditions in place of the notifications provided by the LATITUDE NXT website. If the LATITUDE NXT system is unable to provide implanted device data, the LATITUDE NXT website or Boston Scientific Corporation (BSC) personnel may provide alert notification. The clinic may be contacted regarding data that is currently not available on the LATITUDE NXT website. For example, if there is an alert condition that cannot be retrieved and displayed automatically by the LATITUDE NXT website, BSC personnel may contact you to inform you of that alert. NOTE: If Daily Measurements and other programmable features are not activated

(programmed on) in the implanted device, the LATITUDE NXT system cannot generate an alert for an event even if the LATITUDE alert is configured on. The implanted device must measure, record, and detect data as out of range in order for the LATITUDE NXT system to detect and generate an alert notification for these types of events.

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Red Alerts Implanted device conditions that could potentially leave the patient without available device therapy result in the declaration of a red alert. The LATITUDE NXT website is designed to notify clinic users assigned to the Primary Patient Group if the Communicator reports a red alert to the LATITUDE NXT server. Red alert notification cannot be disabled. If the Communicator is not able to connect and transfer the red alert data within 24 hours, an indicator on the Communicator is illuminated indicating the patient should call his or her clinic. Red alert notifications occur for the following conditions, depending on device model. •

Remote monitoring disabled due to limited battery capacity

•

Right ventricular or single chamber pacing lead impedance out of range

•

Device in Electrocautery Protection Mode

•

Device in Safety Mode

•

Possible device malfunction

Yellow Alerts Notification of yellow alerts is configurable and may be selected by either of a patient’s LATITUDE NXT Patient Groups. A Patient Group may be configured to receive some, all, or none of the yellow alerts. Yellow alert notifications can be configured for the following conditions, depending on device model. •

Explant indicator reached

•

Voltage was too low for projected remaining capacity

•

Right ventricular or single chamber intrinsic amplitude out of range

•

Right ventricular automatic threshold detected as greater than programmed amplitude or suspended1

•

Left ventricular intrinsic amplitude out of range 1. While the device has an automatic capture feature through PaceSafe, LATITUDE NXT does not assess capture or loss of capture and will only alert if certain criteria are met in the device and the alert is detected from the device.

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•

Left ventricular pacing lead impedance out of range

•

Atrial intrinsic amplitude out of range

•

Atrial pacing lead impedance out of range

•

Atrial automatic threshold detected as greater than programmed amplitude or suspended1

•

VT Episodes (V>A)

•

Atrial Arrhythmia Burden within a 24-hour period (exceeding a user selectable threshold)

•

Patient triggered event stored

•

Cardiac Resynchronization Therapy pacing percentage (less than a user selectable percentage).

NOTE: This condition will not generate an alert if the PG’s Pacing Chamber parameter is programmed to right ventricular (RV) only.

•

Right ventricular pacing percentage (exceeds a user selectable percentage)

•

Device Brady Mode Off

•

Therapy history corruption detected

•

An average daily weight change of 0.91 kg or more over a two or more day period or a change of 2.27 kg or more within a week

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Implanted Device Interrogation The Communicator can perform several types of implanted device interrogations. Each interrogation type varies in the amount and type of data that are collected, as shown in Table 3. Table 3. Data Collection and Schedule Intervals for Each Interrogation Type Interrogation Type

Full Interrogation (with Presenting EGM)

Red Alert Check

Yellow Alert Check

Available Schedule Intervals

Remote Scheduled Follow-up

• Off/Manual • 1 week • 2 weeks • Monthly intervals from 1 to12 months

Alert Check1

• Daily • Not configurable

Alert Interrogation1

• If red or yellow alert is detected, or a recent PRM interrogation has occurred As directed by clinician

Patient Initiated (See page 19)

1. If a red or yellow alert is detected or a recent PRM interrogation has occurred, the alert interrogation will attempt to collect a full interrogation with presenting EGM.

NOTE: Boston Scientific personnel may contact the clinic if an implanted device uses too much RF telemetry to perform remote interrogations.

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Patient Initiated Interrogation The Communicator supports non-scheduled, patient initiated interrogations (PIIs), which provide the same data as a scheduled follow-up interrogation including a presenting EGM. The Communicator limits the number of patient initiated interrogations to one of the following limits as specified by the LATITUDE NXT website: •

5 per week (if enabled)

•

0 (when feature is disabled)

Clinic users who are assigned to the patient’s group(s) and have complete or limited access can enable or disable PIIs. PIIs are configured for all patients in a Patient Group or for an individual patient through their Schedule and Alert Configuration page. If PIIs are disabled or the weekly limit is reached, a clinic user can allow one PII by selecting the Allow one Patient Initiated Interrogation button within the patient’s Schedule and Alert Configuration page. Patients initiate an interrogation by pressing the Heart button on the Communicator (see Figure 1 on page 9). The Communicator will not perform an interrogation if this feature is not enabled or the limit has been reached. If the PII setting is changed, the LATITUDE NXT server will send a notification to the patient’s Communicator the next time the Communicator calls the LATITUDE NXT server. It could take up to seven days for the Communicator to call the LATITUDE NXT server. If PIIs are disabled in the Communicator and the patient attempts to interrogate, the Communicator will call the LATITUDE NXT server to check for updated information. Before recommending a PII, clinicians may want to verify that the patient is stable, not symptomatic, and able to perform the PII. Refer to “Precautions” on page 5 and “System Limitations” on page 6.

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