Initial Clinic Setup Reference Guide. Merlin.net Patient Care Network (PCN)

Initial Clinic Setup Reference Guide Merlin.net Patient Care Network (PCN) 1

Initial Clinic Setup Merlin.net Patient Care Network (PCN) offers flexibility to best fit the clinic s specific needs and desired workflows, saving time when enrolling patients and helping create a more efficient workflow to improve clinic efficiency. Getting started Please complete the Merlin.net PCN clinic enrollment form and return via email or fax to contact information, listed on the form. Once the enrollment form is received and processed, a clinic account is created. The Main Clinic Administrator (the primary person responsible for device follow-up) for the Merlin.net PCN is the person specified on the enrollment form. Once the profile for this user has been set up, his/her user ID and password will be sent via email. 2

Initial Clinic Setup General tips to streamline the Merlin.net PCN setup process. When selecting your Clinic Preferences: Consider the majority of your patients, as the initial settings you choose will be applied to all patients. Most settings can be changed at the patient level if needed. Consider options that would best benefit your clinic s workflow. Before you begin the process, gather the names, phone numbers and email addresses of all possible system users. 3

Initial Clinic Setup Entering Users Main Clinic Administrator will have: Access to and ability to edit Clinic Preferences Ability to reset passwords for clinic users Ability to add, edit and delete clinic users and locations All other user privileges It is recommended to assign another user administrative privileges in case the main administrator is unavailable. This person needs to be assigned administrative rights within his/ her User Profile. This person must be a clinic staff member. 4

Initial Clinic Setup Entering Users Assign User Type for each person who may access the system. This is required as it sets permissions for each person within the system. User Type Permissions/ Access to System Considerations Physician Allied Professional Assistant Can view and archive all transmissions Can enroll patients, edit patient profiles Can view and archive all transmissions Can enroll patients, edit patient profiles Can enroll patients, edit patient profiles Can view and print transmissions This user s default screen for Recent Transmissions and Patient List is My Patients; patients shown are specific to this physician, who is listed on the Medical Team in patient profiles. User can also view all patients via the Filter drop-down menu. User s default screen for Recent Transmissions is All Transmissions. User s default screen for Patient List is A Specific Patient. Cannot be assigned administrative privileges. This user has read-only access to Recent Transmissions; cannot archive recent transmissions or add a clinical comment (move transmissions off Recent Transmissions screen). NOTE: All patient transmissions can be found in Past Transmissions. 5

Initial Clinic Setup Entering Users Complete User Profile for each person include email, security stamp and phone number. This is required for every user (no matter what type). The information is necessary for notification of important issues and technical support. te: Upon creating a new user account in Merlin.net PCN, the clinic administrator should provide the new user the User ID and temporary password that was created for them. The system does not automatically generate an email to the new user; therefore, it is up to the administrator to provide it to the user. 6

Initial Clinic Setup Entering Users Merlin.net Patient Care Network PCN DirectAlerts tification Q: Should this user be notified of alerts received after hours? Under After-Hours Contact, enter information (phone, fax, email) for receipt of alerts that occur outside of clinic hours. This user must be added to the Medical Team in the Patient Profiles. Select ne. Under DirectAlerts Settings, select Medical Team under After Hours tifications. te: Another way to manage your after-hours alert notification is to utilize the On-Call Physician selection on the Clinic Profile page. Here you can enter the contact information for one On-Call Physician. If this selection is made, the system will have alerts directed to the contact information entered in this spot when the On-Call Physician is encountered during the alert distribution processing. te: The On-Call Physician is ALWAYS a member of all patient's medical teams. It can be anywhere in the list of the medical team (top, middle, end). When the alert notification processing traverses the medical team list, it will send to the on-call physician if early members of the medical team do not have contact information or if early members with contact information cannot be contacted. 7

Initial Clinic Setup Clinic Profile Clinic Profile Data Main Phone Number should be one that patients can call. NOTE: If DirectCall messages are used, this number will be displayed on caller ID at the patient s phone. Phone, text, fax and email information entered here will be used for DirectAlerts notifications during and after office hours based on preferred selections within the DirectAlerts feature. Clinic Time Zone Important: This setting affects all screens throughout your clinic s system and can impact scheduling and the receipt time of transmissions. This setting also affects the delivery time of DirectCall messages and Call the Clinic notifications from the Merlin@home transmitter. 8

Initial Clinic Setup Clinic Profile Review On-Call Physician Q: Do you want to be notified of alerts after hours? The on-call physician can be linked to a specific user or a general clinic contact. NOTE: This setting does not necessarily refer to a specific user; it is a way of assigning the appropriate Medical Team member(s) as on-call responders for Merlin.net PCN alerts. Enter information (phone, fax, email, SMS) for preferred contact method for alerts that occur outside of clinic hours under the On-Call Physician section of the Clinic Profile. NOTE: The On-Call Physician is the default Medical Team member (found at the top of the Medical Team list of all patients); unless this is changed in the Patient Profile, this contact will be notified of after-hours alerts. Select ne for On-Call Physician. 9

Initial Clinic Setup Clinic Locations Clinic Secondary Location Q: Do you want to sort by those satellite clinic locations? Enter satellite clinic information. In Clinic Administration add the names for any locations where patients may be seen. Once all locations have been added, upon enrolling patients, add the location for which they are seen to the patient profile. Skip this step. te: These clinics will share the main clinic s demographic data/settings. 10

Initial Clinic Setup Report Settings Select information that should always be included in printed reports. A patient privacy cover sheet is the system default. 11

Initial Clinic Setup Export Options EHRDirect Export Q: Does your clinic use an electronic health record (EHR) to manage patient data? Merlin.net Patient Care Network (PCN) is designed to seamlessly transfer complete reports to these systems*: GEMMS ONE EHR NextGen Ambulatory EHR Healthcare ScottCare OneView GE Centricity EMR EpicCare Ambulatory EHR Allscripts Professional EHR Allscripts Enterprise EHR Siemens Soarian EHR Contact your St. Jude Medical representative or the St. Jude Medical Connectivity Team at www.merlinehr@sjm.com for information. Skip this step. NOTE: St. Jude Medical continually adds new vendors to this list. 12 *Availability of EHRs may vary from region to region.

Initial Clinic Setup Export Options Paceart Software Q: Does your clinic use Paceart software? Create a Merlin folder on the computer where Merlin.net PCN transmissions will be viewed. This computer must also contain a Paceart software module. To create a new folder on the C drive: Go to My Computer. Double click on C:drive. Create new folder and give it a name (Merlin). Save the folder. Type link to Merlin folder into PC-based database; enter this pathway into the Export option screen on Merlin.net PCN (e.g., c:\merlin). Skip this step. To learn more about other device management alternatives to Paceart software, such as EHRDirect export, contact your St. Jude Medical representative or the St. Jude Medical Connectivity Team at MerlinEHR@sjm.com. Paceart is a trademark of Medtronic USA, Inc. 13

Initial Clinic Setup Scheduling & Messaging Select Scheduling Method for routine transmissions. Scheduling Method Considerations SmartSchedule Calendar Manual Entry Calendar ne This 18-month, rotating perpetual calendar creates an automatic schedule; you can specify whether you want to schedule a patient by date or day of the week. US Programmable SmartSchedule calendar allows you to schedule specific intervals. Among the available options are 91 or 182 days, allowing you to coordinate follow-up appointments with your reimbursement calendar. ID Programmable SmartSchedule calendar allows you to schedule in intervals that fits your clinic workflow. This method allows you to set schedules manually at the patient level. You select specific dates for transmissions: Up to six specific dates can be entered. These dates can be entered up to 12 months in advance. If your clinic does not want automated transmissions, you may turn them off by selecting ne as the scheduling method. If you select this option, patients can trigger transmissions manually on the day of their routine follow-up. This is the system default. 14

Initial Clinic Setup Scheduling & Messaging RF (Wireless) Daily DirectAlerts tification Checks Q: Do you want to be able to perform daily DirectAlerts notification checks on patients with RF (wireless) transmitters? DirectAlerts notification checks monitor patient status daily, identifying important changes in a patient s device or disease status. The clinic or physician may be notified of alerts via phone, fax or e- mail, or via Merlin.net TM PCN; alert-initiated transmissions will appear on the Recent Transmissions page. This feature is used for patients with RF (wireless) implanted devices paired with Merlin@home TM transmitters. This is the system default. If you choose this option rather than the system default, the Merlin@home TM transmitter will not check the patient s device each day for alerts, but is still capable of performing scheduled remote follow-ups. You will still be able to authorize patientinitiated transmissions and alert checks. 15

Initial Clinic Setup Scheduling & Messaging Lockout Unscheduled Patient Transmissions Q: Do you want to prevent patients from being able to send patient-initiated transmissions? Patients will be unable to initiate transmissions. Allowing patients to initiate transmissions provides clinicians NOTE: This feature can be turned on or off on a per-patient basis through the Patient Profile as needed. Lockout Unscheduled Patient DirectAlerts tification Checks Q: Do you want to prevent patients from being able to send patient-initiated DirectAlerts notification checks? with a valuable triage tool when patients call with concerns. This is the system default. Patients will be unable to initiate alert checks. Allowing patients to initiate alert checks enables clinicians to have advanced notice of important changes in a patient s device or disease state between follow-ups. This is the system default. 16

Initial Clinic Setup Scheduling & Messaging DirectTrend Viewer Diagnostics Q: Do you want the system to collect trended diagnostic data? Trended data, such as percent pacing, will be displayed in an interactive screen one that includes transmissions, device alerts, clinical comments and episodes for at-a-glance triage and monitoring. This provides dynamic, quick and complete views of patient device and clinical activity. Select. If at a later time you would like to gather this information on a specific patient, this option can be turned on in the Patient Profile. This is the system default. 17

Initial Clinic Setup Scheduling & Messaging Automatically Clear Q: Do you want to clear Diagnostics, Episodes, and stored EGMs from a device after you view them? Diagnostics, episodes and EGMs are erased from a patient device once interrogation for a scheduled or patient-initiated transmission is complete. Data is not cleared if a transmission is initiated by an alert condition. Alerts and diagnostics may be cleared without clearing EGMs (EGMs will still be in the device in case a patient visits the Emergency Room after a patientinitiated transmission). This is the system default. NOTE: If this feature is changed after initial system setup, changes will automatically affect new and existing patients; changes for specific patients must be made manually at the patient level. General Rule: Alerts associated with an episode such as High Ventricular rate get cleared alongside EGMs, other alerts are cleared when clearing diagnostics. If data is not cleared from a device, past data will continue to appear on future transmissions until cleared in the clinic. EGMs will still be stored on the device, but may not display on the transmission. 18

Initial Clinic Setup Scheduling & Messaging DirectCall Messages Q: Do you want the system to send patients automated follow-up reminders and overdue transmission notices? The system will send automated phone calls or text messages to patients for follow-up reminders and overdue/missed transmission notices. Clinicians may also send patients reminders to call the clinic or messages to let them know about normal results. If no time selections are made, communications are sent between 9 a.m. and 4 p.m., the default time frame. This service is available in more than 20 languages to accommodate all patients. Languages are selectable in individual patient profiles. NOTE: If this feature is turned on at the clinic level, automatic DirectCall messages will merely be an option at the patient level; they will not automatically be turned on for each patient. ALSO: If this feature is changed after initial system setup, changes will automatically affect only new patients; changes for existing patients must be made manually at the patient level. If this feature is turned Off at the clinic level: It will not be offered as an option in patient profiles. The feature will be grayed out and unavailable for all patients. 19

Initial Clinic Setup Clinic Profile Important: Make sure these regional settings are correct since they affect all screens throughout your clinic s system. Determine the format for your Merlin.net Patient Care Network (PCN) screen information. Language Date/Time/Number format Weight units 20

Initial Clinic Setup Clinical Comment Comments within Reports Q: Would you like to be able to include pre-set comments or free-form text in patient reports? Pre-set comments can be edited and prioritized to meet your needs. As an Administrator, you create clinic-specific Clinical Comments. You can also allow free-form text in the comment fields. NOTE: At the time a comment is added to a patient record, comments (free-form and pre-set) cannot be edited for typographical errors once the comment has been saved. Make sure there are no check marks in the boxes for Allow Preset Comments or Allow Free-Form Text. 21

Initial Clinic Setup Hours/Holidays Important: This feature is NOT associated with the scheduler; it applies to the alerts distribution feature of Merlin.net PCN. Q: Will a clinician be on call after office hours for notification of alerts? Enter regular office hours and holidays. Be sure to update the holiday calendar once expired as the system will not automatically update. Skip this step. 22

Initial Clinic Setup DirectAlerts tification Basic Information Successful alert management with Merlin.net PCN begins on the Clinic Administration Screen. On the Recent Transmissions screen, go to the Clinic Administration from the main page. Clinic-level preferences based on device type can be made here. Think of your selections as standing orders that are applicable to the majority of your patients. ICD/CRT-D (tachycardia) Merlin.net PCN alerts can be found under the ICD/CRT-D menu (unless turned On at the Clinic Administrator level). All pacemaker (bradycardia) Merlin.net PCN alerts can be found under the Pacemaker/CRT-P menu. 23

24 Initial Clinic Setup DirectAlerts tification Basic Information Changes to clinic-level (Clinic Profile) alert selections will update all patientlevel (within the patient profiles) alert selections, except those in Override. Override indicates a selection within a patient s profile that differs from the clinic preferences. All VT/VF related alerts provide a range of VT/VF monitoring available to them, from any VT/VF episodes occurring to All Therapies Exhausted. The VT/VF related DirectAlerts messages in order of criticality are: - All therapies exhausted - Therapy Accelerated Rhythm - Three or more VT/VF episodes in 24 hours - At least one shock unsuccessful - HV Therapy Delivered - ATP was successful in an episode - Episodes with Alert Conditions (Epic/Atlas) - VT/VF Episode Occurred - n-sustained VT Episode Occurred - n-sustained VF Episode Occurred

Initial Clinic Setup DirectAlerts tification Basic Information, cont. Any selected Merlin.net PCN alert can trigger an alert-initiated transmission. Any selected Merlin.net PCN alert can trigger a transmission during the daily DirectAlerts notification check. Priority levels, red or yellow, affect when and how clinics or clinicians are notified. Default alert settings are On and Red (Urgent). If your clinic has decided against sending alert notifications to the clinic or clinicians, select the Off box, prioritization of alerts may not be necessary. If an alert has occurred, a scheduled transmission or a patient-initiated transmission will display the alert on the Alert Summary. All transmissions with or without alerts will appear on the Recent Transmissions screen. If the clinic or clinicians want to be notified of alerts, then prioritization may be used. If not customized for the clinic and patient, one VT/VF episode will result in multiple DirectAlerts messages being delivered. te: VT/VF occurred includes any episode in the monitor zone. If you are only interested in events outside of the monitor zone, use ATP Successful and HV Therapy Delivered alerts. 25

Initial Clinic Setup DirectAlerts tification Alert Classification Q: Would you like to classify alerts as red (urgent) or yellow (standard)? Don t Choose alert classification for ICD/CRT-D patients and Pacemaker/ CRT-P patients. If a red or yellow classification is selected for an alert, detection of that alert will trigger a transmission regardless of DirectAlerts notification settings. You may also choose whether or not to inform patients of alerts via their Merlin@home TM transmitter (see next section for explanation). System Default is Urgent. Skip this step. te: If this step is skipped, all alerts will default to Red. Don t Select turns off an alert so a condition will not trigger a transmission. Q: Do you want the Merlin@home TM transmitter to beep as a method to notify the patient when alerts are received from their device? Place a check mark in the Inform Patient column. Each time an alert is detected: The stars icon and five progress lights on a patient s Merlin@home transmitter will light up. The transmitter will beep until the white Start button is pressed (within select messaging hours). NOTE: Default time frame for patient alert notification is 9 a.m. to 4 p.m.; this setting can be modified at the patient level. IMPORTANT: These alerts are different than the vibratory or auditory alerts available on the 26 devices themselves. Make sure there are no check marks in the Inform Patient column. This is the system default.

Initial Clinic Setup DirectAlerts tification DirectAlerts Distribution Q: Should the clinic be notified of alerts? 27 Select notification method: phone, fax or email. Numbers and addresses used for notification are those listed in the Clinic Profile. Q: Would you like to notify a Medical Team member of alerts after hours? Place a check in the Send to Medical Team column. Medical Team can be a specific physician or the on-call physician. If one specific clinician will be used as the on-call contact: That Medical Team member must be the first person listed in the Medical Team in the Patient Profile. After-Hours Contact information must be completed in that User s Profile. If the on-call physician is an after-hours rotating medical team member: Complete the On-Call Physician information in the Clinic Profile. IMPORTANT: This is only an after-hours option and is not valid during regular clinic hours. NOTE: When an alert comes in, the clinician listed first on the Medical Team in a Patient s Profile will be notified immediately; this may be as early as 2 a.m. Select the Don t Send Alerts option; alert notifications will not be sent to the clinic; however, all transmissions will still appear on and be available on the Recent Transmissions screen in Merlin.net PCN website. Make sure there is no check mark in the Send to Medical Team column.

Initial Clinic Setup DirectAlerts tification Mobile DirectAlerts tifications Q: Do you want physicians to receive alert notifications on their smartphones or mobile devices? Select After Hours contact method as email. Email address must be one that is set up for smartphone access. Smartphones/mobile devices supported*: iphone 3G and higher Android Windows Phone Version 7.0 and higher ipad tablet Make sure there is no check mark in the Send to Medical Team column. *Devices must have an Internet connection and an advanced browser. 28

Technical Support Device Monitoring For: Transmitter setup questions Fax/email delivery questions or modifications Transmission or connectivity difficulties Phone: US: 1-877- My Merlin ID: please contact the local rep or call (+46) 8 474-4756 Email: US: mymerlin@sjm.com ID: Remote.monitoring@sjm.com merlinehr@sjm.com 29

Rx Only Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. GEMMS ONE is a trademark of GEMMS, Inc. NextGen is a trademark of NextGen Healthcare Information Systems, LLC. OneView is a trademark of The ScotCare Corporation. Centricity is a trademark of General Electric Company. EpicCare is a trademark of Epic Systems Corporation. Professional EHR and Enterprise EHR are registered trademarks of Allscripts. Soarian is a trademark of Siemens Corporation. iphone and ipad are registered trademarks of Apple Inc. Android is a registered trademark of Google Inc. Windows is a registered trademark of Microsoft Corporation. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. 2014 St. Jude Medical, Inc. All Rights Reserved. GL-2001653 A EN (08/14) This document is approved for U.S. use only. 30